A valve repair clamping device

Abstract

The present invention discloses a valve repair clamping device, comprising: an elastic member, which is located on the inner side of an opening and closing component; the elastic member is of a bent design, and the other side is connected to a traction wire, and the two wings of the elastic member are respectively provided with barbs; when the elastic member is pulled by the traction wire, the two wings are retracted, so that the barbs are reversely recovered along the extension direction of the barbs from the state of protruding from the two wings, so that the barbs are recovered inside the two wings; when the device is in a pulled-up state, the barbs can be hidden in the two wings, and when the leaflets enter the supporting structure, the barbs will not contact the leaflets; when the leaflets need to be captured, the barbs are exposed from a hidden state to capture and position the leaflets.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a valve repair clamping device. Background Art

[0002] The leaflet clamping assembly of the existing edge-to-edge valve repair system usually consists of a support arm and an elastic fixing member. The support arm is used to position and lift the diseased part of the leaflet from under the valve; the elastic member can be controlled by a traction wire. One side of the elastic member in contact with the support arm has a barbed structure. When the external force acting on the traction wire is removed, the elastic member is a shape memory alloy and will rebound to its original position, pressing the leaflet in the support arm, and the barbs will penetrate into the leaflet to play a role in fixing the leaflet; when the diseased part is not located during the operation, the traction wire can be pulled up, and the barbed structure will separate from the leaflet. At this time, the captured leaflet is released, the support arm opens, and the captured leaflet can be released, enabling the operator to reposition and capture the diseased tissue, ensuring the positioning and release process of the implant during the valve repair interventional treatment operation.

[0003] However, in the existing clamping assembly, when the elastic member is pulled up, if the leaflet is not adjusted in place, the barbs are likely to hook the leaflet, and surgical adjustment cannot be performed, which is likely to damage the leaflet. Especially when the diseased area needs to be located multiple times, the assembly opens and closes multiple times, and the barbs damage the leaflet, which may even cause perforation in severe cases.

[0004] The patent with the publication number CN114176839A provides a valve clip and a valve repair system. The valve clip includes a locking mechanism, a plurality of clamping arms, and at least one sliding member. The sliding member is connected to the clamping arms through a pivoting mechanism, so that the clamping arms can be rotated and unfolded or rotated and closed according to the axial sliding of the sliding member; the locking mechanism includes a pulling member, a locking buckle, and a locking bar. The first end of the locking bar is connected to the sliding member or the pivoting mechanism, and the second end of the locking bar is connected to the pulling member. The pulling member is used to drive the locking bar to extend into the locking buckle to cooperate with the locking buckle. The locking bar can prevent the clamping arms from rotating and unfolding under the condition of cooperating with the locking buckle.

[0005] However, this technical solution mainly optimizes the locking mechanism below, which can achieve a better clamping effect, but the structure for hooking the valve part still has the above problems. Summary of the Invention

[0006] The purpose of the present invention is to solve the deficiencies in the prior art and propose a valve repair clamping device.

[0007] To achieve the above purpose, the present invention adopts the following technical solution: A valve repair clamping device includes:

[0008] An elastic member, located inside the opening and closing assembly;

[0009] The elastic member is of a bent design, with the other side connected to a traction wire, and the two wings of the elastic member are respectively provided with barbs;

[0010] The two wings of the elastic member are folded under the traction of the traction wire, so that the barb part is reversely recovered along the extending direction of the barb part from the state of protruding from the two wings, so that the barb part is recovered inside the two wings.

[0011] As a further description of the above technical solution: when the elastic member is in a non-stressed state, the two wings are unfolded and the barbs located on the two wings protrude outward.

[0012] As a further description of the above technical solution: the elastic member also includes an extension portion and a bending portion, and the barb portion is connected to the extension portion through the bending portion to form the two wings of the elastic member; a plurality of through holes are opened in the middle or on both sides of the extension portion, and a plurality of barbs are provided on the inner side of the barb portion, and the barbs pass through the extension portion from the through holes and protrude outward, and the barbs are retracted into the inner side of the extension portion by pulling the traction wire.

[0013] As a further description of the above technical solution: under the continuous application of a force by the opening and closing assembly, the outer sides of the two wings of the elastic member change their states from open to contact and then to clamped, so that the barbs continue to protrude toward the outside of the extension portion.

[0014] As a further description of the above technical solution: the distribution interval a of the barbs is 4-12 mm, the barbs and the barb portion form an inclination angle r, the angle range is 30°-70°, and the height h of the barbs is 0.5-1.5 mm.

[0015] As a further description of the above technical solution: in a non-stressed state, the height h of the barb is greater than or equal to the distance between the extension portion and the barb portion; in a stressed state, the height h of the barb is less than or equal to the distance between the extension portion and the barb portion.

[0016] As a further description of the above technical solution: the bending portion is deformed under the force driven by the traction wire, and the bending angle d is 0°-40° in the non-stress state. The bending portion can be an arc or curved spring state, and the size s is 0.3-5.0mm.

[0017] As a further description of the above technical solution: the surface of the barb portion provided with the barbs is coated.

[0018] As a further description of the above technical solution: the material of the elastic member is nickel-titanium alloy.

[0019] As a further description of the above technical solution: The opening and closing assembly includes support structures on both sides, and a linkage assembly located below the support structures for driving the movement of the support structures. A central shaft is provided at the center of the linkage assembly. The central shaft penetrates through the interior of the central tube and moves axially along the central tube. The side surface of the central tube is connected to the support structure. By controlling the axial movement of the central shaft, the linkage assembly drives the support structure to rotate, and the elastic member clamps the valve leaflet.

[0020] As a further description of the above technical solution: When the elastic member clamps with the support structure, the barbs above the elastic member are attached and clamped under the pressure applied by the support structure.

[0021] The above technical solution has the following advantages or beneficial effects:

[0022] 1. In the pulled-up state, the barbs can be hidden inside the two wings. When the valve leaflet enters the support structure, the barbs will not catch or damage the valve leaflet, reducing the damage caused by the barbs to the valve leaflet. During positioning and capturing, the operating space of the clip becomes larger, reducing the failure of the operation and saving the operation time.

[0023] 2. When it is necessary to perform a capturing action on the valve leaflet, the barbs can be exposed from the hidden state through the internal stress of the nitinol alloy to capture and position the valve leaflet, and clamping and fixing of the valve leaflet can be achieved.

[0024] 3. When the assembly is in the closed state, the bent part of the barb can adaptively capture the depth according to the strength of the valve leaflet, and at the same time can block the middle gap of the assembly, reducing backflow. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a schematic structural diagram of the valve repair clamping device proposed by the present invention;

[0026] Figure 2 is a schematic diagram of the closed state of the valve repair clamping device proposed by the present invention;

[0027] Figure 3 is a schematic structure of the elastic member in the natural state in the present invention Figure 1 ;

[0028] Figure 4 is a schematic structure of the elastic member in the natural state in the present invention Figure 2 ;

[0029] Figure 5 is a schematic structural diagram of the elastic member in the stressed state in the present invention;

[0030] Figure 6 is a cross-sectional view of the extension part of the elastic member in the present invention;

[0031] Figure 7 Cross-sectional view of the extension part of the elastic part in the present invention;

[0032] Figure 8 Schematic structural diagram of the bent part of the elastic part in the present invention;

[0033] Figure 9 Schematic structural diagram of another embodiment of the bent part of the elastic part in the present invention;

[0034] Figure 10 Schematic structural diagram of the barb part of the elastic part in the present invention.

[0035] Legend:

[0036] 1. Elastic part; 11. Extension part; 12. Bent part; 13. Barb part; 14. Through hole; 15. Barb; 2. Opening and closing assembly; 3. Traction wire; 4. Support structure; 5. Linkage assembly; 6. Central axis; 7. Central tube. Specific embodiments

[0037] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0038] Refer to Figures 1 - 5 , an embodiment provided by the present invention: A valve repair clamping device includes: an elastic part 1 located inside the opening and closing assembly 2; the elastic part 1 is bent, and the other side is connected to a traction wire 3. Barb parts 13 are respectively arranged on both wings of the elastic part 1; under the traction of the traction wire 3, the two wings of the elastic part 1 are closed, so that the barb parts 13 are reversely retracted along the extending direction of the barb parts 13 from the state of protruding from both wings, and the barb parts 13 are retracted within both wings.

[0039] In the non-force state of the elastic part 1, the two wings are unfolded and the barb parts 13 located on both wings protrude outward; under the continuous application of a force by the opening and closing assembly 2 on the outer sides of the two wings of the elastic part 1, the state changes from open to contact and then to clamping, so that the barbs 15 continuously protrude outward from the extension part 11.

[0040] In this embodiment, the two wings of the elastic part 1 extend to both sides in the natural state. The ends of the two wings of the elastic part 1 are connected to the traction wire 3. By controlling the traction wire 3, the two wings of the elastic part 1 move upward, deforming, moving to the vertical direction on both sides, and the barb part 13 in the middle drives the barbs 15 to contract along the extending direction away from the barb part 13.

[0041] Continue to refer toFigure 3 , Figures 6 - 7 , the elastic member 1 further includes an extension portion 11 and a bending portion 12. The barbed portion 13 is connected to the extension portion 11 through the bending portion 12 to form two wings of the elastic member 1;

[0042] A plurality of through holes 14 are provided in the middle or on both sides of the extension portion 11. A plurality of barbs 15 are provided on the inner side of the barbed portion 13. The barbs 15 penetrate through the extension portion 11 from the through holes 14 and protrude outwards. By pulling the traction wire 3, the barbs 15 retract inside the extension portion 11.

[0043] In this embodiment, the elastic member 1 is in the shape of an inverted hook. The bottom of the extension portion 11 is connected to the support structure 4. The top of the extension portion 11 is connected to the bending portion 12. The barbed portion 13 is connected below the bending portion 12, so that the extension portion 11 and the bending portion 12 are in the same vertical plane. The through holes 14 are provided in the middle of the extension portion 11 and are sized to fit the barbs 15, or are provided on both sides of the extension portion 11, so that the middle portion of the extension portion 11 is in a slender connection shape, and the barbs 15 can extend from both sides.

[0044] Refer to Figures 3 - 4 , on one side of the barbed portion 13, there are barbs 15. The number of barbs 15 is at least two. The distribution interval a of the barbs 15 is 4 - 12 mm. The barbs 15 and the barbed portion 13 form an inclination angle r, and the angle range is 30° - 70°. The height h of the barbs 15 is 0.5 - 1.5 mm.

[0045] In this embodiment, the distribution interval a of the barbs 15 is 4 - 12 mm, and the preferred interval is 9 mm. The barb inclination angle r is preferably 50°, and the height h is preferably 0.7 mm.

[0046] Specifically, the barbs 15 penetrate through the extension portion 11 through the through holes 14. When in the non - stressed state, the height h of the barbs 15 is greater than or equal to the distance between the extension portion 11 and the barbed portion 13. When in the stressed state, the height h of the barbs 15 is less than or equal to the distance between the extension portion 11 and the barbed portion 13.

[0047] Refer to Figure 4 , Figures 8 - 9 , under the drive of the traction wire 3, the bending portion 12 deforms under force. In the non - stressed state, the bending angle d is 0° - 40°. The bending portion 12 can be in the state of an arc or a curved spring, and the dimension s is 0.3 - 5.0 mm.

[0048] In this embodiment, the height dimension s of the bending portion 12 should cover the gap width between the two sides of the elastic member 1 when the support structure 4 is closed at 0° - 40°. The dimension s ranges from 0.3 - 5.0 mm. Preferably, when at 20°, the dimension s is 2.3 mm.

[0049] Refer to Figure 10, a film coating treatment is performed on the surface of the barbed portion 13 where the barbs 15 are provided.

[0050] Only the surface of the barbed portion 13 needs to be film-coated, and there is no need to film-coat the two wings of the elastic member 1. The film-coated area on the surface of the elastic member 1 is reduced, the process difficulty is lowered, and it is beneficial to the growth of tissues after implantation.

[0051] The material of the elastic member 1 is nitinol, which is a memory metal and can automatically reset after deformation, having an elastic memory effect. When pulled up, it can be separated from the support structure 4; when dropped, the barbs 15 can be exposed and penetrate into the middle between the support structure 4 and the elastic member 1.

[0052] Continue to refer to Figures 1 - 2 , the opening and closing assembly 2 includes support structures 4 on both sides, and a linkage assembly 5 located below the support structures 4 for pushing the support structures 4 to move. A central shaft 6 is provided at the center of the linkage assembly 5. The central shaft 6 penetrates through the inside of the central tube 7 and moves axially along the central tube 7. The side surface of the central tube 7 is connected to the support structure 4. By controlling the axial movement of the central shaft 6, the linkage assembly 5 drives the support structure 4 to rotate and clamp the valve leaf with the elastic member 1.

[0053] In this embodiment, the support structures 4 are located on both sides. A central tube 7 is provided at the bottom of the support structures 4 and the elastic member 1. By controlling the axial movement of the central shaft 6, the linkage assembly 5 drives the support structures 4 to rotate. The support structures 4 on both sides move upward and close until the support structures 4 are in a vertical state, and the heart valve leaf between the elastic member 1 and the support structure 4 is clamped and fixed.

[0054] The central shaft 6 provides the overall power of the opening and closing assembly 2 through forward and backward movement. The linkage assembly 5 converts the forward and backward movement of the central shaft 6 into the opening and closing movement of the support structure 4. The support structure 4 adjusts the angle through opening and closing, and can hold up the valve leaf during the operation.

[0055] When the elastic member 1 and the support structure 4 are clamped, the barbs 15 above the elastic member 1 are attached and clamped under the pressure applied by the support structure 4.

[0056] Specifically, when the traction wire 3 is pulled up, the barbs 15 will be hidden between the extension part 11 and the barb part 13. When the leaflet enters between the extension part 11 and the support structure 4, it will not come into contact with the barbs 15. When it is necessary to grasp the leaflet, the support structure holds up the leaflet, the traction wire 3 is released, the two wings of the elastic member 1 open and press on the leaflet, and the barbs 15 project outward through the through holes 14 and pierce into the leaflet, and together with the support structure 4, the leaflet is clamped and positioned. At this time, the support structure 4 is slowly closed, and the pressure exerted on the two barbs 15 will slowly press the leaflet until the bent parts 12 of the two wings are close, the barb parts 13 of the left and right membranes are close, filling the central position of the valve repair fixture to prevent blood backflow after the leaflets are clamped together.

[0057] Working principle: During the operation, the central axis 6 is adjusted to open the support structure 4, the traction wire 3 is pulled up to make the elastic member 1, so that its barbs 15 are separated from the support structure 4 and hidden between the barb part 13 and the extension part 11. The leaflet moves freely between the support structure 4 and the elastic member 1 and will not come into contact with the barbs 15, avoiding the risk of perforation and tearing of the leaflet caused by the barbs hooking the moving leaflet, which is beneficial to adjusting the device to the lesion area during the operation. After the doctor adjusts the position, the support structure 4 is used to hold up the leaflet, the traction wire 3 is released, the two wings of the elastic member 1 open and press on the leaflet. At this time, the barbs 15 at the top of the two wings are exposed and pierce into the leaflet between the extension part 11 and the support structure 4. The support structure 4 is closed to clamp the leaflet until the two bent parts 12 are close, filling the central position of the valve repair fixture to prevent blood backflow after the leaflets are clamped together.

[0058] Finally, it should be noted that the above are only the preferred embodiments of the present invention and are not used to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, for those skilled in the art, they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A valve repair clamping device, characterized in that, include: An elastic member (1) is located inside the opening and closing assembly (2); The elastic member (1) is of a bent design, and the other side is connected to the traction wire (3), and the two wings of the elastic member (1) are respectively provided with barbs (13); The elastic member (1) is pulled by the traction wire (3) so that the two wings are retracted, so that the barb portion (13) is reversely retracted along the extending direction of the barb portion (13) from the state of protruding from the two wings, so that the barb portion (13) is retracted into the two wings; When the elastic member (1) is in a non-stressed state, the two wings are spread out and the barbed portions (13) located on the two wings protrude outwards; The elastic member (1) further comprises an extension portion (11) and a bending portion (12), wherein the barb portion (13) is connected to the extension portion (11) via the bending portion (12) to form the two wings of the elastic member (1); a plurality of through holes (14) are provided in the middle or on both sides of the extension portion (11), a plurality of barbs (15) are provided on the inner side of the barb portion (13), the barbs (15) pass through the extension portion (11) from the through holes (14) and protrude outward, and the barbs (15) are retracted into the inner side of the extension portion (11) by pulling the traction wire (3); The outer sides of the two wings of the elastic member (1) are continuously subjected to a force applied by the opening and closing assembly (2), and the states change from open to contact and then to clamped, so that the barbs (15) continue to protrude toward the outer side of the extension portion (11); The opening and closing component (2) comprises supporting structures (4) on both sides, and a linkage component (5) located below the supporting structure (4) and used to push the supporting structure (4) to move. A central axis (6) is provided at the center of the linkage component (5). The central axis (6) penetrates the interior of a central tube (7) and moves axially along the central tube (7). The side of the central tube (7) is connected to the supporting structure (4). By controlling the central axis (6) to move axially, the linkage component (5) drives the supporting structure (4) to rotate, and clamps the leaflet together with the elastic member (1). When the elastic member (1) and the supporting structure (4) are clamped, the barbs (15) above the elastic member (1) are attached and clamped under the pressure applied by the supporting structure (4).

2. The valve repair clamping device according to claim 1, characterized in that: The distribution interval a of the barbs (15) is 4-12 mm, the barbs (15) and the barb portion (13) form an inclination angle r in the range of 30°-70°, and the height h of the barbs (15) is 0.5-1.5 mm.

3. The valve repair clamping device according to claim 1, characterized in that: In a non-stressed state, the height h of the barb (15) is greater than or equal to the distance between the extension portion (11) and the barb portion (13); in a stressed state, the height h of the barb (15) is less than or equal to the distance between the extension portion (11) and the barb portion (13).

4. The valve repair clamping device according to claim 1, characterized in that: Driven by the traction wire (3), the bent part (12) deforms under force. In the non-loaded state, the bending angle d is 0° - 40°, and the bent part (12) can be in the state of an arc or a curved spring, with the dimension s being 0.3 - 5.0 mm.

5. The valve repair clamping device according to claim 1, characterized in that: The surface of the barbed part (13) where the barbs (15) are provided is subjected to film covering treatment.

6. The valve repair clamping device according to claim 1, characterized in that: The material of the elastic member (1) is nitinol.

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