A drive locking device for a tissue fixation system

Abstract

This application relates to the field of medical devices, and more particularly to a drive locking device for a tissue fixation system. The tissue fixation system includes a fixation clamp and a delivery device, the delivery device being connected to the fixation clamp. The fixation clamp includes a main body, a clamping arm, and a locking device. The clamping arm is connected to the main body via a hinge structure, and the locking device is connected to the main body. The clamping arm includes a clamping part for clamping tissue and an opening / closing control part. The opening / closing control part includes a first control arm and a second control arm. When the locking device abuts against at least two of the first control arms and moves along a first direction, the locking device drives the clamping arm to open. When the locking device abuts against at least two of the second control arms and moves along a second direction, the locking device drives the clamping arm to gradually close to a locked state. In this invention, the switching between the open and closed states of the fixation clamp can be achieved using only the locking device, without the need for additional components, greatly simplifying the structural design and operation steps of the device.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a drive locking device for a tissue fixation system. Background Technology

[0002] Traditional surgical methods for treating posterior mitral valve prolapse can be divided into leaflet-level surgical methods, commonly using folding techniques (McGoon technique) and resection (triangular resection, quadrangular resection, sliding plasty, or wedge resection). Among these surgical methods, typical open-chest and open-heart surgeries are too invasive, require the establishment of cardiopulmonary bypass, and have a high incidence of complications and infection risks. Many patients cannot tolerate the enormous surgical risks and can only helplessly wait for death.

[0003] The main mature interventional valve repair technique is edge-to-edge leaflet clipping. This technique alters the original physiological structure of the valve, resulting in a significant reduction in the effective opening area of ​​the valve and severely impacting secondary interventional procedures.

[0004] For example, patent application CN202011511245.2 discloses a valve clip with a locking mechanism, including a first clamping arm, a second clamping arm, a connecting member, a push-pull device, and a locking device. The locking device partially cooperates with the connecting member. The locking device includes a locking head and a self-locking rod. The connecting member is hinged to the first clamping arm and the second clamping arm respectively. The clamping arm includes a long arm and a short arm. One end of the long arm is hinged to the push-pull device, and one end of the short arm is provided with a locking part. When the push-pull device is operated to increase the angle between the long arms of the first clamping arm and the second clamping arm and put them in an open state, the locking part on the first clamping arm and the locking part on the second clamping arm are partially misaligned. When the push-pull device is operated to decrease the angle between the long arms of the first clamping arm and the second clamping arm and put them in a closed state, the locking device is moved so that the locking head and the locking part cooperate and lock. This patented solution uses multiple push-pull tubes to open and close the valve clamp. However, stacking multiple tubes increases the diameter of the delivery device, which is not conducive to transvascular access. At the same time, the increased rigidity of the delivery device can lead to problems such as difficulty in bending.

[0005] Patent application CN116327437B discloses an anti-rotation transmission mechanism and a tissue fixation device, comprising: a support mechanism, a clutch mechanism, and an anti-rotation locking assembly. The support mechanism includes a fixed connection assembly and a drive assembly that is threadedly engaged with the fixed connection assembly to achieve relative axial movement. The anti-rotation locking assembly includes a locking biasing member and a locking member. The locking biasing member provides a biasing force to the locking member toward the drive assembly. The drive assembly has an anti-rotation locking opening. The anti-rotation locking assembly is configured such that when the drive assembly is separated from the lever and moves relative to the fixed connection assembly to a preset area, the locking member is pressed into the anti-rotation locking opening by the locking biasing member to restrict the rotation of the drive assembly relative to the fixed connection assembly. This patented solution uses an axially moving slide drive to move within a guide slide and drive the clamping arm to open and close. When the clamping arm opens or closes to the expected position, a positioning pin rotates and slides into the locking opening, thereby preventing the rotation of the drive assembly and achieving locking. The drawback of this solution is that when the sliding drive component slides in the guide slide, there will inevitably be frictional resistance between the sliding drive component and the slide. Furthermore, since the guide slide of the clamp arm is in a cross shape, there will be a large frictional resistance, which means that the operator needs to exert a large force to drive the clamp arm to open and close. Once locked, it cannot be unlocked, and its locking structure is not reversible.

[0006] Patent application CN103826548A discloses a method for fixing tissue, the method comprising: providing an implantable fixation device including a pair of fixation elements, each fixation element having a first end, a free end opposite to the first end, and an engagement surface located between the first end and the free end to engage tissue, the first ends being movably coupled together such that the fixation elements are movable between a closed position and a first open position, in which the engagement surfaces face each other, and in the first open position, the engagement surfaces are positioned away from each other; the locking mechanism of the patent includes one or more wedge-shaped elements, such as rolling elements; the rolling elements include a pair of barbell elements arranged on opposite sides of a stud, the barbell elements being operated by a release device with a hook end, the hook end resisting a spring to raise the barbell elements when an upward force is applied to the device through a locking line, the barbell elements moving along a sidewall or inclined surface towards Pulling upwards releases the barbell from the stud; the upward force on the barbell is released through the hook end, the spring forces the barbell downwards, and weds it between the instrument surface and the stud, restricting the stud's movement and locking the braking mechanism and distal components into place. The technical drawbacks of the MitraClip locking mechanism are: the locking structure design is relatively complex, requiring a rolling element, spring, locking line, and the wedge-shaped instrument surface to cooperate with the stud, demanding high assembly standards; the spring is initially deformed under stress and returns to its original shape after the locking line is released, therefore the locking structure is not reversible. If an operational error occurs during surgery before valve clamping is completed, the locking mechanism cannot unlock, meaning the surgery has failed; postoperatively, with the implanted instrument remaining in the body, the spring will fatigue due to prolonged stress, affecting the valve clamping force, thus posing a safety hazard to the unlocking mechanism.

[0007] In summary, the locking mechanism of the fixed clamp has the defects of irreversible operation and unstable locking. Furthermore, other structures used for opening and closing the fixed clamp may lead to problems such as increased pipe diameter, increased rigidity, or greater control force required for opening and closing operations. Therefore, it is necessary to improve the device and design a drive locking device that can achieve a slimmer conveying system, lower operating resistance, reversible locking, simplified structure, and improved long-term reliability. Summary of the Invention

[0008] This application is made in view of the above and other ideas.

[0009] One of the purposes of this application is to overcome the shortcomings of the prior art and provide a drive locking device for tissue fixation systems, addressing many problems such as unstable locking, complex structure and high operating resistance in existing fixing clamps.

[0010] The technical solution adopted to solve the technical problem of the present invention is to provide a driving locking device for a tissue fixation system. The tissue fixation system includes a fixation clamp and a conveying device. The conveying device is detachably connected to the fixation clamp and is configured to convey the fixation clamp to the target tissue. The fixation clamp includes a main body, at least two clamping arms, and a locking device. The clamping arms are connected to the main body via a hinge structure. The clamping arms include a clamping part for clamping tissue and an opening and closing control part. The opening and closing control part includes a first control arm and a second control arm. When the locking device abuts against at least two of the first control arms and moves along a first direction, the locking device drives the clamping arms to open. When the locking device abuts against at least two of the second control arms and moves along a second direction opposite to the first direction, the locking device drives the clamping arms to gradually close to a locked state. This structural design can realize the switching between the open and closed states of the fixation clamp using only the locking device, without the need for additional components, greatly simplifying the structural design and operation steps of the instrument.

[0011] As a further improvement of the present invention, the locking device includes a drive rod and a drive locking block connected to the drive rod. The drive locking block includes an upper drive surface and a lower drive locking surface. The drive rod can move axially along the main body. When the upper drive surface abuts against at least two of the first control arms and moves along a first direction, the clamping arm is opened. When the lower drive locking surface abuts against at least two of the second control arms and moves along a second direction, the clamping arm gradually closes until the lower drive locking surface and the second control arms form a wedge lock. When the clamping arm is subjected to tissue rebound force and outward expansion force, the expansion force is transmitted to the lower drive locking surface through the second control arm and converted into a radial component force that further presses the drive locking block against the wedge mating surface, thereby achieving a self-locking effect of "the tighter it gets," effectively preventing accidental loosening of the locked state.

[0012] As a further improvement of the present invention, the driving locking block is an irregularly shaped metal block. In a preferred embodiment, the driving locking block is a wedge-shaped metal block.

[0013] As a further improvement of the present invention, when the drive rod moves to the desired position, the drive rod and the main body are relatively fixed.

[0014] As a further improvement of the present invention, the locking device is threadedly engaged with the main body, allowing the locking device to move axially along the main body; and the drive rod is also provided with a limiting structure, which is used to limit the travel of the drive rod along the axial direction of the main body.

[0015] As a further improvement of the present invention, the clamping arm is opened by the locking device to capture the leaflet tissue, and is closed and locked by the locking device to include the leaflet tissue into the clamping area formed by the clamping arm, thereby realizing the folding of the leaflet tissue.

[0016] As a further improvement of the present invention, the first control arm is located near the end of the second control arm, and the drive locking block moves axially between the first control arm and the second control arm. Furthermore, the width of the upper drive surface is greater than the maximum width of the two first control arms when they are open, and the width of the lower drive locking surface is greater than the maximum width of the two second control arms when they are open, so that the drive locking block can form an effective abutment engagement with the corresponding first control arm or second control arm.

[0017] As a further improvement of the present invention, when the fixing clamp is in the open state, the second control arms of the two clamping arms contact and abut against each other to limit the maximum opening angle of the clamping arms.

[0018] As a further improvement of the present invention, the conveying device includes a pre-fixing component and a pushing component; wherein, the pre-fixing component is configured to cooperate with the clamping arm to pre-fix the target leaflet tissue; the pushing component is configured to push the pre-fixed target leaflet tissue toward the clamping area formed by the clamping part after the pre-fixing component has completed the pre-fixation of the leaflet.

[0019] As a further improvement of the present invention, the pre-fixing component includes at least one pressure flap, and the pushing component includes a pushing rod and a set of deformable thrust members disposed at the distal end of the pushing rod, the set of thrust members being configured to diverge and expand in a circumferential direction.

[0020] As a further improvement of the present invention, the valve spring is provided with a guide hole. After the target valve tissue is pre-fixed, the push rod passes through the guide hole along a preset path. At this time, until the push rod completes the push and retracts, the thrust stop provides the push rod with a counter-thrust force toward the proximal end.

[0021] As a further improvement of the present invention, the conveying device includes an inner core tube, an operating sleeve, and a limiting plate; wherein, the inner core tube is threadedly connected to the fixed clamp, and the operating sleeve engages with the drive rod; both the inner core tube and the operating sleeve are configured to be operable by rotation, and the limiting plate is used to restrict the fixed clamp from rotating circumferentially relative to the conveying device, so as to realize the axial movement of the drive rod or the disengagement of the inner core tube from the fixed clamp.

[0022] As a further improvement of the present invention, the operating sleeve is sleeved outside the inner core tube, and before the inner core tube is disconnected from the fixing clamp, the operating sleeve can be retracted along the axial direction of the inner core tube or re-engaged with the drive rod.

[0023] As a further improvement of the present invention, after the fixation clip is folded and clamps the leaflet tissue, the operator can remove the manipulator cannula and limiting plate from the heart and observe the leaflet alignment and blood backflow through imaging equipment. If further adjustments are needed, the operator can re-engage the manipulator cannula with the drive rod along the path of the inner core tube and readjust the state of the fixation clip to capture and fold the leaflet again, which greatly improves the fault tolerance of the device and ensures the repair effect of the device.

[0024] As a further improvement of the present invention, taking mitral valve repair as an example, the specific operating steps of the tissue fixation system of the present invention are as follows: 1. The fixation clip is loaded into the delivery sheath. At this time, the fixation clip is in a retracted configuration and loaded into the delivery sheath. The delivery sheath passes through the fossa ovalis and enters the left atrium; 2. The delivery sheath advances, and the fixation clip enters the left ventricle; 3. The operating sleeve is rotated so that its drive rod moves upward with the drive locking block and presses against the first control arm so that its clamping arm opens to support the leaflet. The pre-fixation component is operated so that it cooperates with the clamping arm to press against the leaflet. The push assembly is operated. 4. The push rod and its thrust stop push the leaflet tissue into the clamping area of ​​the fixation clamp; 5. The drive rod is further manipulated to move the locking block downward and against the second control arm, so that the clamping arm switches from the open state to the closed state, the push rod and its thrust stop are pulled out, and the pre-fixation assembly is pulled up; 6. The manipulation sleeve is removed and the instrument effect is evaluated by imaging to see if further adjustment is needed; 7. If the instrument effect is good, the inner core tube is disconnected from the fixation clamp, the delivery device is removed from the body, and only the fixation clamp is anchored on the leaflet tissue to complete the operation.

[0025] As a further improvement of the present invention, at least two of the clamping arms are respectively controlled to open by the locking device to capture two different leaflet tissues, and are controlled to close and lock by the locking device, so that the two leaflets are close to each other and form two independent blood flow channels.

[0026] As a further improvement of the present invention, the fixing clamp also includes a clamping arm, which is configured to cooperate with the clamping arm to capture and fix the petals.

[0027] As a further improvement of the present invention, the clamping arm is configured to insert into the annular tissue in the open state, and to close and lock by the locking device, so that the annular region where the clamping arm is located undergoes local shrinkage.

[0028] As a further improvement of the present invention, a linkage unit is provided between the two clamping arms, wherein the linkage unit includes two linkage rods, the two ends of which are respectively hinged to the two clamping arms; when the locking device moves along the second direction to close and lock the clamping arms, the linkage unit moves downward with the closing action of the clamping arms, thereby applying downward pressure to the annular tissue, causing the middle region of the annular tissue to be concave downward, and the tissue located between the clamping arms and the linkage rods to bulge upward and produce local wrinkling, so that the tissue located between the two clamping arms presents an M-shaped structural morphology.

[0029] As a further improvement of the present invention, the fixation clip includes a positioning guide unit; the positioning guide unit is connected to the main body, wherein the positioning guide unit is configured to be pre-inserted and anchored in the tissue to guide the fixation clip to the target position along the positioning guide unit.

[0030] As a further improvement of the present invention, at least three clamping arms are provided, which are controlled to open to capture the nipple muscle tissue by the locking device, and are controlled to close and lock by the locking device to achieve the capture and fixation of the nipple muscle tissue.

[0031] Compared with the prior art, the advantages of the technical solution of this application include at least the following: In existing technologies, the opening, closing, and locking of the clamp require multiple layers of push-pull tubing, while locking requires a separate locking device. This results in a large number of stacked tubing components in the delivery device, increasing its diameter and rigidity, which is detrimental to transvascular access. Furthermore, the surgeon must perform two separate operations: "push-pull control for opening and closing" and "moving the locking device for locking," leading to numerous operational steps and poor coordination. According to a concept proposed in this application, the locking device simultaneously performs the dual functions of "drive-opening" and "drive-close-locking." Opening is achieved by moving the same component along a first direction, and locking is achieved by moving it along a second direction. This eliminates the need for separate drive components and transmission tubing for opening, closing, and locking, thus eliminating the need for multiple layers of push-pull tubing stacks in the delivery device. This significantly reduces the radial dimension of the delivery system, lowers the risk of trauma from transvascular access, and allows the surgeon to complete the entire "open → clamp → lock" process simply by moving the locking device, without switching between the opening / closing control and locking devices. This simplifies the operational steps and significantly shortens the surgical time.

[0032] Unlike existing technologies that use a driving component to move within a groove to control the opening and closing of the clamping arm, this invention uses a locking block that moves within the opening and closing control unit and utilizes the upper driving surface and lower driving locking surface to drive the opening and closing of the clamping arm. Because the frictional resistance between the driving surface and the control arm is small, its operating resistance is much smaller than that of existing technologies, making its operation smoother. Furthermore, its structural components are greatly simplified, which not only significantly improves its reliability but also reduces the difficulty of processing.

[0033] Unlike existing technologies that require separate opening / closing control and locking structures, this invention integrates the opening and closing locking of the clamping arm into a single component by setting a drive-locking block comprising an upper drive surface and a lower drive-locking surface. This achieves integrated opening, closing, and locking functions, simplifies the structural components of the delivery device, reduces the diameter of the delivery device, and significantly improves its bending performance. At the same time, the functional division of the upper and lower drive surfaces ensures a clear operating sequence and avoids misoperation. The wedge-shaped locking structure of the lower drive-locking surface and the second control arm forms a self-locking effect under the long-term pulsation of the heart, effectively preventing the lock from loosening. This significantly improves the convenience of surgical operation and the locking reliability of the implant.

[0034] According to a concept of this application, after the fixing clamp completes the folding and anchoring of the leaflet for the first time, the rest of the delivery device, except for the inner core tube, can be removed from the centrifuge. The alignment status of the valve can be observed through imaging. If it is necessary to adjust the folding area of ​​the leaflet, the operating sleeve can be re-engaged with the drive rod along the path of the inner core tube, and the state of its fixing clamp can be readjusted to capture and fold the leaflet again. This greatly improves the fault tolerance of the instrument and ensures the repair effect of the instrument.

[0035] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0036] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figures 1 to 5 This is a schematic diagram of the fixing clip of the present invention.

[0037] Figure 6 , Figure 7 This is a schematic diagram of the delivery device entering the heart in this invention.

[0038] Figures 8 to 12 This is a schematic diagram of the operation process of the fixing clamp of the present invention.

[0039] Figure 13 This is a schematic diagram of the final implantation of the fixation clip in this invention.

[0040] Figure 14 This is a schematic diagram of the structure of Embodiment 2 of the present invention.

[0041] Figure 15 and Figure 16 This is a schematic diagram of the structure of Embodiment 3 of the present invention.

[0042] Figure 17 and Figure 18 This is a schematic diagram of the structure of Embodiment 4 of the present invention.

[0043] The features represented by the numbers in the attached diagram are as follows: 1-Fixing clamp, 11-Main body, 12-Clamping arm, 121-Clamping part, 122-Opening and closing control part, 1221-First control arm, 1222-Second control arm, 13-Locking device, 131-Drive rod, 132-Drive locking block, 14-Clamping arm, 15-Linkage unit, 151-Linkage rod, 16-Positioning guide unit, 2-Conveying device, 21-Pre-fixed assembly, 211-Pressure flap spring, 2111-Guide hole, 212-Thrust member, 22-Pushing assembly, 23-Inner core tube, 24-Operating sleeve, 25-Restriction plate. Detailed Implementation

[0044] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0045] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0046] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0047] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0048] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0049] Example 1: In this example, mitral valve repair is achieved using folded leaflets. Figures 1 to 5 As shown, a drive locking device 13 for a tissue fixation system is disclosed. The tissue fixation system includes a fixation clamp 1 and a conveying device 2. The conveying device 2 is detachably connected to the fixation clamp 1 and configured to convey the fixation clamp 1 to a target tissue. The fixation clamp 1 includes a main body 11, at least two clamping arms 12, and a locking device 13. The clamping arms 12 are connected to the main body 11 via a hinge structure. The clamping arms 12 include a clamping part 121 for clamping tissue and an opening and closing control part 122. The opening and closing control part 122 includes a first control arm 1221 and a second control arm. 1222;l When the locking device 13 abuts against at least two of the first control arms 1221 and moves along the first direction, the locking device 13 drives the clamping arm 12 to open. When the locking device 13 abuts against at least two of the second control arms 1222 and moves along the second direction opposite to the first direction, the locking device 13 drives the clamping arm 12 to gradually close to the closed locking state. This structural design can realize the switching between the open and closed states of the fixed clamp 1 using only the locking device 13, without the need to add other components, which greatly simplifies the structural design and operation steps of the instrument.

[0050] In this embodiment, the locking device 13 includes a drive rod 131 and a drive locking block 132 connected to the drive rod 131. The drive rod 131 can move axially along the main body 11. When the drive rod 131 moves along the second direction to the point where the drive locking block 132 forms a wedge-shaped locking engagement with at least two second control arms 1222, the clamping arm 12 is in a closed and locked state. When the clamping arm 12 is subjected to tissue rebound force and outward expansion force, the expansion force is transmitted to the drive locking block 132 through the second control arm 1222 and converted into a radial component force that further presses the drive locking block 132 against the wedge-shaped engagement surface, thereby achieving a self-locking effect of "the tighter it gets," effectively preventing accidental loosening of the locked state.

[0051] In this embodiment, the drive locking block 132 is a wedge-shaped metal block.

[0052] In this embodiment, the locking device 13 is threadedly engaged with the main body 11, allowing the locking device 13 to move axially along the main body 11; and the drive rod 131 is also provided with a limiting structure, which is used to limit the stroke of the drive rod 131 moving axially along the main body 11.

[0053] In this embodiment, the clamping arm 12 is opened by the locking device 13 to capture the leaflet tissue, and is closed and locked by the locking device 13 to include the leaflet tissue within the clamping area formed by the clamping arm 12, thereby achieving folding of the leaflet tissue.

[0054] In this embodiment, the first control arm 1221 is located near the end of the second control arm 1222, and the drive locking block 132 moves axially between the first control arm 1221 and the second control arm 1222. When the locking device 13 is in a position that engages the drive locking block 132 with the first control arm 1221 or the second control arm 1222, the maximum distance between the first control arm 1221 or the second control arm 1222 of the two clamping arms 12 is less than or equal to the width dimension of the drive locking block 132 in the corresponding direction, so that the drive locking block 132 can form an effective abutment engagement with the corresponding first control arm 1221 or second control arm 1222.

[0055] In this embodiment, when the fixing clamp 1 is in the open state, the second control arms 1222 of the two clamping arms 12 contact and abut against each other to limit the maximum opening angle of the clamping arms 12.

[0056] In this embodiment, the conveying device 2 includes a pre-fixing component 21 and a pushing component 22; wherein, the pre-fixing component 21 is configured to cooperate with the clamping arm 12 to pre-fix the target leaflet tissue; the pushing component 22 is configured to push the pre-fixed target leaflet tissue toward the clamping area formed by the clamping part 121 after the pre-fixing component 21 has completed the pre-fixation of the leaflet.

[0057] In this embodiment, the pre-fixing component 21 includes at least one pressure flap 211, and the pushing component 22 includes a pushing rod and a set of deformable thrust members 212 disposed at the distal end of the pushing rod. The set of thrust members 212 is configured to expand outward in a circumferential direction.

[0058] In this embodiment, the valve spring 211 is provided with a guide hole 2111. After the target valve tissue is pre-fixed, the push rod passes through the guide hole 2111 along a preset path. At this time, until the push rod completes the push and retracts, the thrust stop 212 provides the push rod with a counter-thrust force toward the proximal end.

[0059] In this embodiment, the conveying device 2 includes an inner core tube 23, an operating sleeve 24, and a limiting plate 25; wherein, the inner core tube 23 is threadedly connected to the fixing clamp 1, and the operating sleeve 24 is engaged with the drive rod 131; both the inner core tube 23 and the operating sleeve 24 are configured to be operable by rotation, and the limiting plate 25 is used to restrict the fixing clamp 1 from circumferentially rotating relative to the conveying device 2, so as to realize the axial movement of the drive rod 131 or the connection and release of the inner core tube 23 from the fixing clamp 1.

[0060] In this embodiment, the manipulator sleeve 24 is fitted outside the inner core tube 23. Before the inner core tube 23 is disconnected from the fixing clip 1, the manipulator sleeve 24 can be retracted along the axial direction of the inner core tube 23 or re-engaged with the drive rod 131. After the fixing clip 1 is folded and clamps the leaflet tissue, the surgeon can remove the manipulator sleeve 24 and the limiting plate 25 from the heart and observe the leaflet alignment and blood backflow through imaging equipment. If further adjustment is needed, the surgeon can re-engage the manipulator sleeve 24 with the drive rod 131 along the path of the inner core tube 23 and readjust the state of the fixing clip 1 to capture and fold the leaflet again, which greatly improves the fault tolerance of the device and ensures the repair effect of the device.

[0061] The implantation process of the foldable leaflet fixation clip 11 system of the present invention into the left heart is as follows: 1. The fixing clip 1 is loaded inside the delivery sheath. At this time, the fixing clip 1 is in a retracted configuration, loaded inside the delivery sheath, which passes through the fossa ovalis and enters the left atrium, as shown. Figure 6 As shown; 2. The delivery sheath advances, and the fixing clamp 1 enters the left ventricle, as shown. Figure 7 As shown; 3. Rotate the operating sleeve 24 to move its drive rod 131 upward with the drive locking block 132 and press against the first control arm 1221, causing the clamping arm 12 to open and support the leaflet. Operate the pre-fixing component 21 to cooperate with the clamping arm 12 to press the leaflet. Operate the pushing component 22 to push the pushing rod and its thrust stop 212 to push the leaflet tissue into the clamping area of ​​the fixing clamp 1, as shown. Figure 8 and Figure 9 As shown; 4. Further manipulate the drive lever 131 to move its drive locking block 132 downward and abut against the second control arm 1222, so that the clamping arm 12 switches from the open state to the closed state, as shown. Figure 10 and Figure 11 As shown, remove the push rod and its thrust stop 212, and pull up the pre-fixed assembly 21; 5. Remove the operating sleeve 24 and evaluate the instrument's effect via imaging to determine if further adjustments are needed, such as... Figure 12 As shown; 6. If the instrument works well, disconnect the inner core tube 23 from the fixation clip 1, remove the delivery device 2 from the body, leaving only the fixation clip 1 anchored to the leaflet tissue to complete the surgery. Figure 13 As shown. Example 2

[0062] Example 2 is largely the same as Example 1, except that the clamping arm 12 grabs and fixes two different leaflets respectively, so that the two leaflets are close to each other and form two independent blood flow channels.

[0063] In this embodiment, as Figure 14 and Figure 15 As shown, at least two of the clamping arms 12 are opened by the locking device 13 to capture two different leaflet tissues, and are closed and locked by the locking device 13 to bring the two leaflets close to each other and form two independent blood flow channels.

[0064] In this embodiment, the fixing clamp 1 further includes a clamping arm 14, which is configured to cooperate with the clamping arm 12 to capture and fix the petals.

[0065] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here. Example 3

[0066] Example 3 is largely the same as Example 1, except that the clamping arm 12 is inserted into the annular tissue and the distance between the clamping arms 12 is brought together by the locking device 13, so that the annular tissue located between the clamping arms 12 wrinkles, thereby achieving the purpose of annular shaping.

[0067] In this embodiment, as Figure 15 and Figure 16 As shown, the clamping arm 12 is configured to insert into the valve annulus tissue in the open state, and is closed and locked by the locking device 13, causing local shrinkage in the valve annulus region where the clamping arm 12 is located.

[0068] In this embodiment, a linkage unit 15 is provided between the two clamping arms 12 (further explained in the specification: the linkage unit 15 includes two linkage rods 151, the two ends of which are respectively hinged to the two clamping arms 12); when the locking device 13 moves along the second direction to close and lock the clamping arms 12, the linkage unit 15 moves downward with the closing action of the clamping arms 12, thereby applying downward pressure to the annular tissue, causing the middle region of the annular tissue to be concave downward, and the tissue located between the clamping arms 12 and the linkage rods 151 to bulge upward and produce local wrinkling, so that the tissue located between the two clamping arms 12 presents an M-shaped structural morphology.

[0069] In this embodiment, the fixing clip 1 includes a positioning guide unit 16; the positioning guide unit 16 is connected to the main body 11, wherein the positioning guide unit 16 is configured to be pre-inserted and anchored in the tissue to guide the fixing clip 1 to the target position along the positioning guide unit 16.

[0070] In this regard, the relevant construction and concept of Embodiment 3 are similar to those of Embodiment 1, and therefore will not be described again here. Example 4

[0071] Example 4 is largely the same as Example 1, except that at least three gripping arms 12 are configured, and the gripping arms 12 are used to grasp and fix the papillary muscle tissue.

[0072] In this embodiment, as Figure 17 and Figure 18 As shown, at least three clamping arms 12 are configured. They are opened by the locking device 13 to capture the nipple muscle tissue, and closed and locked by the locking device 13 to achieve the capture and fixation of the nipple muscle tissue.

[0073] In this embodiment, the clamping arms 12 are evenly distributed in the circumferential direction.

[0074] In this embodiment, the distal end of the clamping arm 12 is provided with barbs to increase the friction between it and the nipple muscle tissue.

[0075] In this regard, the relevant construction and concept of Embodiment 4 are similar to those of Embodiment 1, and therefore will not be described again here.

[0076] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A drive locking device for a tissue fixation system, the tissue fixation system comprising a fixation clamp and a conveying device, the conveying device being detachably connected to the fixation clamp and configured to convey the fixation clamp to a target tissue, characterized in that: The clamping device includes a main body, at least two clamping arms, and a locking device. The clamping arms are connected to the main body via a hinge structure. The locking device is connected to the main body and can move axially along the main body. The clamping arms include a clamping part for clamping tissue and an opening and closing control part. The opening and closing control part includes a first control arm and a second control arm. When the locking device abuts against at least two of the first control arms and moves along a first direction, the locking device drives the clamping arms to open. When the locking device abuts against at least two of the second control arms and moves along a second direction opposite to the first direction, the locking device drives the clamping arms to gradually close to a locked state.

2. The drive locking device for a tissue fixation system according to claim 1, characterized in that: The locking device includes a drive rod and a drive locking block connected to the drive rod. The drive locking block includes an upper drive surface and a lower drive locking surface. The drive rod can move axially along the main body. When the upper drive surface abuts against at least two of the first control arms and moves along a first direction, the clamping arm is opened. When the lower drive locking surface abuts against at least two of the second control arms and moves along a second direction, the clamping arm gradually closes until the lower drive locking surface and the second control arms form a wedge lock.

3. The drive locking device for a tissue fixation system according to claim 2, characterized in that: When the drive rod moves to the desired position, the drive rod and the main body are relatively fixed.

4. The drive locking device for a tissue fixation system according to claim 2, characterized in that: The first control arm is located near the end of the second control arm, and the drive locking block moves axially between the first control arm and the second control arm. The width of the upper drive surface is greater than the maximum width of the two first control arms when they are open, and the width of the lower drive locking surface is greater than the maximum width of the two second control arms when they are open.

5. The drive locking device for a tissue fixation system according to claim 1, characterized in that: The clamping arm is opened by the locking device to capture the leaflet tissue, which is then included in the clamping area formed by the clamping arm. The locking device is then used to close and lock the leaflet tissue, thereby achieving folding of the leaflet tissue.

6. The drive locking device for a tissue fixation system according to claim 1, characterized in that: The conveying device includes a pre-fixing component and a pushing component; wherein, the pre-fixing component is configured to cooperate with the clamping arm to pre-fix the target leaflet tissue; the pushing component is configured to push the pre-fixed target leaflet tissue toward the clamping area formed by the clamping part after the pre-fixing component has completed the pre-fixation of the leaflet.

7. A drive locking device for a tissue fixation system according to claim 6, characterized in that: The conveying device includes an inner core tube, an operating sleeve, and a limiting plate; wherein, the inner core tube is threadedly connected to the fixed clamp, and the operating sleeve engages with the drive rod; both the inner core tube and the operating sleeve are configured to be operated by rotation, and the limiting plate is used to restrict the fixed clamp from rotating circumferentially relative to the conveying device, so as to realize the axial movement of the drive rod or the disengagement of the inner core tube from the fixed clamp.

8. A drive locking device for a tissue fixation system according to claim 1, characterized in that: At least two of the clamping arms are opened by the locking device to capture two adjacent leaflet tissues, and are closed and locked by the locking device to bring the two leaflets close to each other and form two independent blood flow channels.

9. A drive locking device for a tissue fixation system according to claim 8, characterized in that: The fixing clamp also includes a clamping arm, which is configured to cooperate with the clamping arm to capture and fix the petals.

10. A drive locking device for a tissue fixation system according to claim 1, characterized in that: The clamping arm is configured to insert into the annular tissue in the open state, and is closed and locked by the locking device, causing local shrinkage in the annular region where the clamping arm is located.

11. A drive locking device for a tissue fixation system according to claim 10, characterized in that: A linkage unit is provided between the two clamping arms; when the locking device moves in the second direction to close and lock the clamping arms, the linkage unit moves downward with the closing action of the clamping arms, thereby applying downward pressure to the annular tissue and causing the middle region of the annular tissue to be concave downward.

12. A drive locking device for a tissue fixation system according to claim 11, characterized in that: The clamp includes a positioning guide unit; the positioning guide unit is connected to the main body, wherein the positioning guide unit is configured to be pre-inserted and anchored in the tissue to guide the clamp to the target position along the positioning guide unit.

13. A drive locking device for a tissue fixation system according to claim 1, characterized in that: The clamping arms are configured with at least three, which are controlled to open to capture the nipple muscle tissue by the locking device, and are also controlled to close and lock by the locking device to achieve the capture and fixation of the nipple muscle tissue.

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