Heart valve repair clamp device

Abstract

The present invention discloses a clamping device for repairing a heart valve, which includes an elastic member located inside an opening / closing assembly, the elastic member is designed to be folded, and a pull wire is connected to the opposite side, and the two wings of the elastic member are provided with barbs, and the elastic member is pulled by the pull wire, and the two wings are pulled together, so that the barbs are retracted in the opposite direction from the state where the two wings protrude into the two wings along the extension direction of the barbs. When the device is in a raised state, the barbs can be hidden by the two wings, and when the leaflet enters the support structure, the barbs do not contact the leaflet, and when it is necessary to capture the leaflet, the barbs are exposed from the hidden state to capture and position the leaflet.

Description

【Technical Field】 【0001】 The present invention relates to the field of medical devices, and particularly to a clamp device for heart valve repair. 【Background Art】 【0002】 The valve tip clamp assembly of an existing edge-to-edge repair system for heart valves usually consists of a support arm and an elastic fixing member. The support arm is positioned from below the heart valve and used to lift the valve tip, which is the lesion site. The elastic member may be controlled by a pull wire. There is a barb structure on the surface of the elastic member that contacts the support arm. When the external force acting on the pull wire is removed, the elastic member, which is a shape memory alloy, returns to its original position, presses the valve tip within the support arm, and the barb pierces the valve tip, playing a role in fixing the valve tip. If the lesion site is not positioned during the operation and the pull wire is pulled up, the barb structure is separated from the valve tip. At this time, the captured valve tip may be released, the support arm may be opened, and the captured valve tip may be released. Thus, the surgeon can reposition and capture the lesion tissue, thereby ensuring the positioning and release process of the implant during the heart valve repair interventional treatment operation. 【0003】 In the existing clamp assembly, when the elastic member is pulled up and the valve tip is not adjusted to a predetermined position, the barb easily catches the valve tip, making it surgically non-adjustable and prone to damaging the valve tip. Especially when it is necessary to reposition the lesion area multiple times, the assembly is opened and closed multiple times, and the barb damages the valve tip, which may lead to perforation in severe cases. 【0004】 The patent, publication number CN114176839A, provides a heart valve clamp and a heart valve repair system, the heart valve clamp comprising a locking mechanism, a plurality of clamp arms and at least one sliding member, the sliding member being connected to the clamp arms via a pivot mechanism to enable rotational deployment or rotational closure as the clamp arms slide axially on the sliding member, the locking mechanism comprising a tension member, a lock buckle and a lock bar, the lock bar having a first end connected to the sliding member or pivot mechanism and a second end connected to the tension member, the tension member being used to move the lock bar so that it extends into the lock buckle and engages with the lock buckle, the lock bar being able to prevent rotational deployment of the clamp arms when engaged with the lock buckle. 【0005】 However, while this technical solution can achieve a better clamping effect, mainly by optimizing the lower locking mechanism, the structure for hooking the heart valve portion still suffers from the aforementioned problems. [Overview of the Initiative] [Problems that the invention aims to solve] 【0006】 The objective of the present invention is to provide a heart valve repair clamping device in order to solve the shortcomings of the prior art. [Means for solving the problem] 【0007】 To achieve the above objective, the present invention employs the following technical solution, namely a clamping device for heart valve repair. 【0008】 The aforementioned heart valve repair clamp device is It includes an elastic member located inside the opening and closing assembly, The elastic member is designed to bend, a pull wire is connected to the opposite side, and barbs are provided on both wings of the elastic member. The elastic member is pulled by the pull wire, drawing both wings together, which causes the barb portion to retract in the opposite direction into the wings along the direction of extension of the barb portion, from a state where both wings protrude. 【0009】 As a further explanation of the above technical solution, when no force is being applied, the elastic member has both wings extended, and the barb portions located on both wings protrude outward. 【0010】 As a further explanation of the above technical solution, the elastic member further includes an extended portion and a bent portion, the bent portion connecting the barb portion and the extended portion, forming the wings of the elastic member, several through holes are provided in the center or on both sides of the extended portion, several barbs are provided on the inside of the barb portion, the barbs protrude outward through the through holes and through the extended portion, and when the pull wire is pulled, the barbs are retracted inward from the extended portion. 【0011】 As a further explanation of the above technical solution, when a continuous force is applied to the opening and closing assembly, the outer surfaces of both wings of the elastic member move from an open state to a contact state and then to a clamped state, thereby causing the barb to continue to protrude outward toward the extended portion (11). 【0012】 As a further explanation of the above technical solution, the distribution interval a of the barbs is 4 to 12 mm, the barbs and the barb portion form an inclination angle r in the range of 30° to 70°, and the height h of the barbs is 0.5 to 1.5 mm. 【0013】 As a further explanation of the above technical solution, when no force is being applied, the height h of the barb is greater than or equal to the distance between the extended portion and the barb portion, and when a force is being applied, the height h of the barb is less than or equal to the distance between the extended portion and the barb portion. 【0014】 As a further explanation of the above technical solution, the bent portion is pulled by the pull wire and deformed under force, and the bending angle d when no force is applied is 0° to 40°, and the bent portion may be in the form of an arc-shaped spring or a curved spring, with a size s of 0.3 to 5.0 mm. 【0015】 As a further explanation of the above technical solution, the surface of the barb portion on which the barb is provided is covered with a film. 【0016】 As a further explanation of the above technical solution, the material of the elastic member is a nickel-titanium alloy. 【0017】 As a further explanation of the above technical solution, the opening and closing assembly includes support structures on both sides and an interlocking assembly located below the support structures for pushing and moving the support structures, wherein a central axis is provided at the center of the interlocking assembly, the central axis passes through the inside of a central tube and moves axially along the central tube, the side of the central tube is connected to the support structures, and by controlling the axial movement of the central axis, the interlocking assembly moves and rotates the support structures and clamps the valve leaflets together with the elastic member. 【0018】 As a further explanation of the above technical solution, when the elastic member and the support structure are clamped, the barb above the elastic member is bonded and clamped by the pressure applied by the support structure. 【0019】 The above technical solution has the following advantages or beneficial effects. 【0020】 1. When raised, the barb can be concealed by both wings, and when the valve leaflet enters the support structure, the barb will not catch on or damage the valve leaflet, reducing damage to the valve leaflet by the barb, and when positioning and capturing, there is ample working space for the clamp, reducing surgical failure and saving surgical time. 【0021】 2. When it is necessary to capture the valve tip, the barb can be exposed from the hidden state by the internal stress of the nickel-titanium alloy to capture and position the valve tip, thereby realizing clamping fixation to the valve tip. 【0022】 3. When the assembly is in the closed state, the bent portion of the barb can adapt to the depth of capture according to the strength of the valve tip. At the same time, it can also block the intermediate gap of the assembly to reduce backflow. 【Brief Description of the Drawings】 【0023】 [Figure 1] It is a schematic structural diagram of the clamp device for heart valve repair according to the present invention. [Figure 2] It is a schematic diagram of the clamp device for heart valve repair in the closed state according to the present invention. [Figure 3] It is Schematic Structural Diagram 1 of the elastic member in the natural state in the present invention. [Figure 4] It is Schematic Structural Diagram 2 of the elastic member in the natural state in the present invention. [Figure 5] It is a schematic structural diagram of the elastic member in the state of receiving force in the present invention. [Figure 6] It is a cross-sectional view of the extending portion of the elastic member in the present invention. [Figure 7] It is a cross-sectional view of an embodiment of the extending portion of the elastic member in the present invention. [Figure 8] It is a schematic structural diagram of the bent portion of the elastic member in the present invention. [Figure 9] It is a schematic structural diagram of another embodiment of the bent portion of the elastic member in the present invention. [Figure 10] It is a schematic structural diagram of the barb portion of the elastic member in the present invention. 【Modes for Carrying Out the Invention】 【0024】 The technical solutions in embodiments of the present invention will be clearly and completely described below with reference to the drawings of embodiments of the present invention, and obviously the embodiments described are only a part of, and not all, embodiments of the present invention. All other embodiments obtained by those skilled in the art without creative effort based on embodiments of the present invention are within the scope of the protection of the present invention. 【0025】 Referring to Figures 1 to 5, the heart valve repair clamp device of the embodiment according to the present invention comprises an elastic member 1 located inside the opening and closing assembly 2, the elastic member 1 is designed to bend, a pull wire 3 is connected to the opposite side, and barb portions 13 are provided on both wings of the elastic member 1, the elastic member 1 is pulled by the pull wire 3 and both wings are pulled together, thereby retracting the barb portions 13 in the opposite direction along the extending direction of the barb portions 13 from a state in which both wings protrude. 【0026】 When no force is being applied, the elastic member 1 has both wings extended, and the barb portions 13 located on both wings protrude outward. When a continuous force is applied to the opening / closing assembly 2, the outer surfaces of both wings of the elastic member 1 move from an open state to a contact state, and then to a clamped state, causing the barbs 15 to continue protruding outward toward the extended portion 11. 【0027】 In this embodiment, both wings of the elastic member 1 extend to both sides in their natural state, and pull wires 3 are connected to the ends of both wings of the elastic member 1. By controlling the pull wires 3, both wings of the elastic member 1 move upward and deform, move vertically from both sides, and the central barb portion 13 is contracted along the extending direction away from the barb portion 13 by moving the barb 15. 【0028】 Continuing to refer to Figures 3, 6, and 7, the elastic member 1 further includes an extended portion 11 and a bent portion 12, and the bent portion 12 connects the barb portion 13 and the extended portion 12, forming both wings of the elastic member 1. Several through holes 14 are provided in the center or on both sides of the extended portion 11, and several barbs 15 are provided on the inside of the barb portion 13. The barbs 15 protrude outward through the through holes 14 and through the extended portion 11, and when the pull wire 3 is pulled, the barbs 13 are retracted inward into the extended portion 11. 【0029】 In this embodiment, the elastic member 1 is in a return shape, the bottom of the extended portion 11 is connected to the support structure 4, the upper part of the extended portion 11 is connected to the bent portion 12, the lower part of the bent portion 12 is connected to the barb portion 13 so that the extended portion 11 and the bent portion 12 are located in the same vertical plane, the through hole 14 is opened at the central position of the extended portion 11 and has a size to match the barb 15, or is opened on both sides of the extended portion 11 so that the central part of the extended portion 11 has an elongated connection shape, and the barb 15 can extend from both sides. 【0030】 Referring to Figures 3 and 4, a barb 15 is provided on one side of the barb section 13, there are at least two barbs 15, the distribution spacing a of the barbs 15 is 4 to 12 mm, the barbs 15 and the barb section 13 form an inclination angle r in the range of 30° to 70°, and the height h of the barbs 15 is 0.5 to 1.5 mm. 【0031】 In this example, the distribution interval a of the barbs 15 is 4 to 12 mm, preferably 9 mm, the inclination angle r of the barbs is preferably 50°, and the height h is preferably 0.7 mm. 【0032】 Specifically, the barb 15 penetrates the extended portion 11 through the through hole 14, and when no force is being applied, the height h of the barb 15 is greater than or equal to the distance between the extended portion 11 and the barb portion 13. When a force is being applied, the height h of the barb 15 is less than or equal to the distance between the extended portion 11 and the barb portion 13. 【0033】 Referring to Figures 4, 8, and 9, the bent portion 12 is pulled by the pull wire 3 and deforms under force, with a bending angle d of 0° to 40° when no force is applied. The bent portion 12 may also be in the form of an arc-shaped spring or a curved spring, with a size s of 0.3 to 5.0 mm. 【0034】 In this embodiment, the height dimension s of the bent portion 12 needs to cover the gap width on both sides of the elastic member 1 when the support structure 4 is closed at 0° to 40°, and the dimension s is in the range of 0.3 to 5.0 mm, preferably 2.3 mm at 20°. 【0035】 Referring to Figure 10, the surface of the barb portion 13 where the barb 15 is provided is covered with a film. 【0036】 By covering only the surface of the barb portion 13 with film, without covering both wings of the elastic member 1, the surface area covered by the film is reduced, lowering the difficulty of the process and contributing to the growth of transplanted tissue. 【0037】 The material of the elastic member 1 is a nickel-titanium alloy, which is a shape memory metal. It may automatically reset after deformation and has an elastic memory effect. When pulled up, it can separate from the support structure 4, and when dropped, the barb 15 can be exposed and pierce the support structure 4 and the central part of the elastic member 1. 【0038】 Continuing to refer to Figures 1 and 2, the opening and closing assembly 2 includes support structures 4 on both sides and an interlocking assembly 5 located below the support structures 4 for pushing and moving the support structures 4. A central axis 6 is provided at the center of the interlocking assembly 5, and the central axis 6 penetrates the inside of the central tube 7 and moves axially along the central tube 7. The sides of the central tube 7 are connected to the support structures 4, and by controlling the axial movement of the central axis 6, the interlocking assembly 5 moves and rotates the support structures 4, clamping the valve leaflets together with the elastic member 1. 【0039】 In this embodiment, the support structures 4 are located on both sides, and a central tube 7 is provided at the bottom of the support structures 4 and the elastic member 1. By controlling the central axis 6 to move in the axial direction, the interlocking assembly 5 moves and rotates the support structures 4, and the support structures 4 on both sides are pulled upward. When the support structures 4 are in a vertical position, the heart valve leaflets between the elastic member 1 and the support structures 4 are clamped and fixed. 【0040】 The central axis 6 provides the overall power to the opening and closing assembly 2 through its forward and backward movement, and the interlocking assembly 5 converts the forward and backward movement of the central axis 6 into opening and closing movement of the support structure 4, which adjusts its angle through opening and closing, allowing it to lift the valve leaflets during surgery. 【0041】 When the elastic member 1 and the support structure 4 are clamped together, the barb 15 above the elastic member 1 is bonded and clamped by the pressure applied by the support structure 4. 【0042】 Specifically, when the pull wire 3 is pulled up, the barb 15 is hidden between the extended portion 11 and the barb portion 13. When the valve leaflet enters between the extended portion 11 and the support structure 4, it does not come into contact with the barb 15. When it is necessary to capture the valve leaflet, the support structure pulls up the valve leaflet and when the pull wire 3 is released, both wings of the elastic member 1 unfold and press against the valve leaflet, and the barb 15 protrudes outward through the through hole 14, piercing the valve leaflet and clamping and positioning the valve leaflet together with the support structure 4. At this time, the support structure 4 slowly closes, the folded portions 12 of both wings move closer to each other, and the two barb portions 13 on the left and right, covered with film, move closer to each other, and the pressure applied to the two barbs 15 slowly compresses the valve leaflet until it fills the center position of the heart valve repair fixture, preventing blood backflow after the valve leaflet is clamped. 【0043】 The operating principle is as follows: During surgery, the central axis 6 is adjusted to open the support structure 4, and when the pull wire 3 pulls up the elastic member 1, the barb portion 15 of the elastic member 1 separates from the support structure 4 and is hidden between the barb portion 13 and the elastic member 11. The valve leaflet moves freely between the support structure 4 and the elastic member 1 without contacting the barb 15, thus avoiding the risk of perforation or laceration of the valve leaflet due to the barb 15 catching on the moving valve leaflet, which is advantageous for adjusting the device to the lesion area during surgery. After adjusting the position, the physician uses the support structure 4 to lift the valve leaflet and loosens the pull wire 3, causing both wings of the elastic member 1 to unfold and press against the valve leaflet. At this time, the barbs 15 at the top of both wings are exposed and pierce the valve leaflet between the extended portion 11 and the support structure 4. The support structure 4 is then pulled in, and the two bent portions 12 move closer to each other, clamping the valve leaflet until it fills the central position of the heart valve repair fixture, preventing blood backflow after the valve leaflet has been clamped. 【0044】 Finally, it should be noted that the above are merely preferred embodiments of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art can still modify the technical solutions described in each of the above embodiments or make equivalent substitutions for some of the technical features therein, and any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should all be within the scope of protection of the present invention. [Explanation of symbols] 【0045】 1. Elastic member 11 Extension 12 Folding section 13 Barb section 14 Through holes 15 barbs 2 Opening and closing assembly 3 pull wires 4 Support structure 5. Interlocking Assembly 6 center axis 7 Central canal

Claims

[Claim 1] A heart valve repair clamp device comprising an elastic member (1) and an opening / closing assembly (2), The elastic member (1) is A pair of linearly formed extensions (11), A pair of barb sections (13) formed in a straight line, A pair of bent portions (12) are bent relative to each of the extending portions (11) and each of the barb portions (13) so as to connect the upper end of each of the extending portions (11) and the upper end of each of the barb portions (13), Each of the aforementioned extended portions (11) has a through hole (14), Each of the through holes (14) has a barb (15) formed on the side of each barb portion (13) facing the extended portion (11), A pull wire (3) is connected to the side of the lower end of each barb portion (13) that faces away from each of the extended portions (11). The opening and closing assembly (2) has a pair of support structures (4) connected to the lower ends of the pair of extended portions (11), The pair of support structures (4) are hinged together at one end so that they can be opened and closed. When the pull wire (3) is pulled up, the lower end of each barb portion (13) elastically deforms so that it separates from each extension portion (11), so that the tip of each barb (15) detaches from the through hole (14) and is positioned between each barb portion (13) and each extension portion (11). When the elastic member (1) is not subjected to force, the lower end of each barb portion (13) approaches each extension portion (11), so that the barb (15) penetrates the through hole (14). With the pair of support structures (4) closed and the valve leaflet clamped between the extended portion (11) and the support structure (4), the barb (15) has a tip that penetrates the through hole (14) and pierces the valve leaflet. A clamping device for heart valve repair, characterized by the following features. [Claim 2] The heart valve repair clamp device according to claim 1, characterized in that the surface of the barb portion (13) on which the barb (15) is provided is covered with a film. [Claim 3] The opening and closing assembly (2) is A pair of interlocking assemblies (5) whose upper ends are hinged to each of the pair of support structures (4) so ​​as to open and close the pair of support structures (4), The device further comprises a connecting member (6) hinged to the lower ends of each of the pair of interlocking assemblies (5), The central axis is fixed to the connecting member (6), The side of the central tube (7) is connected to the support structure (4), The heart valve repair clamping device according to claim 1, characterized in that the central axis penetrates the inside of the central tube (7) and moves along the axial direction of the central tube (7), so that the pair of interlocking assemblies (5) rotate the pair of support structures (4) to close and clamp the valve leaflets between the extended portion (11) and the support structures (4).

Images