Atrioventricular valve clamping device

Abstract

This application discloses an atrioventricular valve clamping device, comprising a support member, a first clamping member and a second clamping member, a first covering membrane, and a second covering membrane. The first and second clamping members are openable or closed relative to the support member. The first covering membrane is disposed on the support member, and the second covering membrane is disposed on the first and second clamping members and extends between them. The first covering membrane is connected to the second covering membrane. The atrioventricular valve clamping device of this application has advantages such as reduced snagging of chordae tendineae in certain corner areas and reduced thrombus accumulation.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to an atrioventricular valve clamping device. Background Technology

[0002] The mitral and tricuspid valves, among others, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles while preventing blood from flowing from the ventricles to the atria. For example: Figure 1 As shown, the mitral valve (MV) is a one-way valve located between the left atrium (LA) and the left ventricle (LV) of the heart. It controls the flow of blood from the left atrium (LA) to the left ventricle (LV) while preventing blood from flowing from the left ventricle (LV) to the left atrium (LA). The tricuspid valve (TV) is a one-way valve located between the right atrium (RA) and the right ventricle (RV) of the heart. It controls the flow of blood from the right atrium (RA) to the right ventricle (RV) while preventing blood from flowing from the right ventricle (RV) to the right atrium (RA). The leaflets of both the mitral valve (MV) and the tricuspid valve (TV) are connected to the chordae tendineae (T).

[0003] The mitral valve consists of anterior and posterior leaflets, while the tricuspid valve consists of anterior, posterior, and septal leaflets. Under normal circumstances, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve should completely align to prevent blood from flowing from the ventricle to the atrium. If the adjacent leaflets of the mitral or tricuspid valve do not align properly, the mitral or tricuspid valve cannot close completely when the left or right ventricle contracts, causing blood to flow back from the ventricle to the atrium. This leads to a series of pathophysiological changes known as "mitral regurgitation" or "tricuspid regurgitation."

[0004] Interventional valve clipping refers to the implantation of valve clipping devices into atrioventricular valves such as the mitral and tricuspid valves to pull the two misaligned leaflets together, reducing or eliminating the leaflet gap, thereby treating regurgitation. However, current clinical trials have found that some corner areas of the valve clipping device are prone to snagging on the chordae tendineae and accumulating thrombi. Summary of the Invention

[0005] In order to solve the above-mentioned technical problems, or at least partially solve the above-mentioned technical problems, the present invention provides an atrioventricular valve clamping device.

[0006] In a first aspect, the present invention provides an atrioventricular valve clamping device, comprising:

[0007] Support components;

[0008] A first clamping member and a second clamping member, wherein the first clamping member and the second clamping member can be opened or closed relative to the support member;

[0009] A first coating, wherein the first coating is disposed on the support member; and

[0010] A second coating is disposed on the first clamping member and the second clamping member, and extends between the first clamping member and the second clamping member, and the first coating is connected to the second coating.

[0011] The atrioventricular valve clamping device provided by this invention has a first covering on the support member and a second covering on the clamping member. The first and second coverings are connected, resulting in a smooth connection without gaps. This prevents the corner areas of the atrioventricular valve clamping device from snagging on the chordae tendineae and reduces the likelihood of thrombus accumulation. Furthermore, the connection between the first and second coverings integrates the support member, the first clamping member, and the second clamping member into a single unit. The leaflets of the atrioventricular valve can contact both the first and second coverings, avoiding direct contact with metal components. The coverings also facilitate cell adhesion, thus better ensuring postoperative outcomes. Attached Figure Description

[0012] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate some embodiments of the invention and, together with the description, serve to explain the principles of the invention.

[0013] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0014] Figure 1 This is a schematic diagram of the structure of the mitral and tricuspid valves.

[0015] Figure 2 This is a front view schematic diagram of the atrioventricular valve clamping device provided in the first embodiment of the present invention.

[0016] Figure 3 yes Figure 2 A schematic diagram of the atrioventricular valve clamping device after the covering membrane has been removed.

[0017] Figure 4 yes Figure 3 Diagram showing the fit between the connecting elements, the central support rod, and the unlocking control.

[0018] Figure 5 yes Figure 2 A front view schematic diagram of a conjoined membrane for an atrioventricular valve clamping device.

[0019] Figure 6 yes Figure 5 A top view of the conjoined membrane.

[0020] Figure 7 yes Figure 2A front view schematic diagram of another type of conjoined membrane in the atrioventricular valve clamping device.

[0021] Figure 8 yes Figure 2 A schematic diagram of a closed state of the atrioventricular valve clamping device.

[0022] Figure 9 yes Figure 2 A schematic diagram of a closed state in which the atrioventricular valve clamping device clamps the valve leaflets.

[0023] Figure 10 This is a three-dimensional schematic diagram of an open state of the atrioventricular valve clamping device provided in the second embodiment of the present invention.

[0024] Figure 11 yes Figure 10 A schematic diagram of the atrioventricular valve clamping device after the covering membrane has been removed and in a state where improper valve clamping is detected.

[0025] Figure 12 yes Figure 10 A front view schematic diagram of the atrioventricular valve clamping device.

[0026] Figure 13 yes Figure 10 A top view of the clamping components.

[0027] Figure 14 yes Figure 10 A schematic diagram of the covering and threading of the tissue clamping component of the atrioventricular valve clamping device.

[0028] Figure 15 yes Figure 14 A schematic diagram of a modified embodiment of the tissue clamping component.

[0029] Figure 16 This is a schematic diagram of the atrioventricular valve clamping device provided in the third embodiment of the present invention.

[0030] Figure 17 yes Figure 16 A schematic diagram of the conjoined membrane of the atrioventricular valve clamping device.

[0031] Figure 18 yes Figure 16 A schematic diagram of a closed state of the atrioventricular valve clamping device.

[0032] Figure 19 This is a partial schematic diagram of the delivery system of the transcatheter atrioventricular valve repair system according to an embodiment of the present invention.

[0033] Figure 20 This is a schematic diagram showing the connection between the atrioventricular valve clamping device and the delivery system provided in an embodiment of the present invention.

[0034] Figure 21This is a schematic diagram of a transcatheter atrioventricular valve repair system according to an embodiment of the present invention, which is prepared to repair adjacent leaflets of the mitral valve.

[0035] Figure 22 yes Figure 21 A schematic diagram showing the state of the clamping component of the atrioventricular valve clamping device entering the ventricle.

[0036] Figure 23 yes Figure 22 A schematic diagram showing the state of the atrioventricular valve clamping device separated from the delivery device. Detailed Implementation

[0037] The technical solutions in the embodiments of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0038] In the description of this invention, it should be noted that:

[0039] The terms "upper," "lower," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention. In addition, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0040] When an element is referred to as being "fixed to" or "set on" another element, the element may be directly connected to the other element or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or connected to the other element through one or more connecting elements.

[0041] It should also be noted that in the field of interventional medical devices, "proximal" refers to the end closer to the operator, while "distal" refers to the end farther from the operator. The direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction refers to the direction along the diameter or radius. It is worth noting that the "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, end point, or end face, but also includes a portion extending axially and / or radially from the tip, end point, or end face on the element to which the tip, end point, or end face belongs. The above definitions are for convenience only and should not be construed as limiting the invention.

[0042] The atrioventricular valve clamping device provided by this invention is suitable for treating regurgitation of atrioventricular valves, such as the mitral and tricuspid valves.

[0043] Example 1

[0044] Please see Figure 2-4 The atrioventricular valve clamping device 100 provided in the first embodiment of the present invention basically includes a support member 110 and a clamping assembly 130. The clamping assembly 130 includes a first clamping member 130a and a second clamping member 130b disposed opposite to each other. The support member 110 has a first covering film 112, and the first clamping member 130a and the second clamping member 130b have a second covering film 130d.

[0045] In this embodiment, the support member 110 includes a central support rod 110j and a resilient connecting element 110h. The connecting element 110h has a hollow three-dimensional shape. The central support rod 110j extends into the connecting element 110h from one end. The connecting element 110h surrounds the central support rod 110j, and the distal end of the connecting element 110h can be fixed to the central support rod 110j by a threaded sleeve S. The proximal end P of the connecting element 110h can be higher than the central support rod 110j, and the proximal end P has an opening to facilitate the connection between the central support rod 110j and the conveying system (see...). Figure 20 )connect.

[0046] The axial length of the central support rod 110j is between 10mm and 18mm, and its outer diameter can be between 1.5mm and 2mm, thus giving it a slender shape. Its specific shape can be, for example, cylindrical or irregular. The material of the central support rod 110j is generally stainless steel, titanium alloy, or cobalt-chromium alloy. The proximal section of the central support rod 110j has a connection structure 110a for detachable connection with the catheter.

[0047] The connecting element 110h can be a three-dimensional mesh structure woven from filaments with shape memory function or cut from tubing, such as a super-elastic material like nickel-titanium alloy wire. The mesh density in different areas can be designed as needed. The connecting element 110h is subjected to external forces, such as pressure from the leaflets of the atrioventricular valve or the clamping assembly 130 (see...). Figure 9 It can contract when it is not subjected to external force (see...) Figure 8 Under certain conditions, it will naturally expand back to its maximum expanded size.

[0048] The joining element 110h can be non-cylindrical, such as olive-shaped. The outer diameter of the joining element 110h when it naturally expands back to its maximum expanded state can reach a maximum of 5 mm, and the outer diameter can be around 2 mm. When the joining element 110h naturally expands to its compressed state, the degree of elastic deformation towards the pair of clamping members 130 is greater than the degree of deformation in other directions.

[0049] The joining element 110h includes two opposing clamping portions facing the pair of clamping members 130, and two ends perpendicular to the two clamping portions. The two ends of the joining element 110h may extend beyond the edges of the pair of clamping members 130. The first coating 112 is attached to the outer surface of the joining element 110h, and its shape can be adapted to the joining element 110h. The two clamping portions of the joining element 110h correspond to the two side positions D1 of the first coating 112 (see...). Figure 6 The two ends of the aforementioned bonding element 110h correspond to the two end positions D2 of the first coating 112 (see...). Figure 6 ).

[0050] The thickness of the first coating 112 can be between 0.3mm and 1.5mm. The first coating 112 is a biocompatible membrane, and its material can be PTFE, EPTFE, polyester, silicone resin, etc., but is not limited to the materials listed above. The first coating 112 is used to contact the leaflets of the atrioventricular valve, which can prevent the connecting element 110h itself from directly contacting the leaflets.

[0051] In this embodiment, the central support rod 110j and a fixed base 114 are integrally formed. The fixed base 114 is wider and shorter than the central support rod 110j. The central support rod 110j extends from the upper end of the fixed base 114 towards the proximal end. Both the central support rod 110j and the fixed base 114 are hollow, and the hollow portion 114c of the fixed base 114 can accommodate the locking component 113. The central support rod 110j and the fixed base 114 have through holes for a driving component, such as a drive shaft, to pass through from the lower end of the fixed base 114 towards the interior of the central support rod 110j. The front and rear end faces of the fixed base 114 are also provided with pin holes.

[0052] Both the first clamping member 130a and the second clamping member 130b are hinged to the pin holes of the fixed base 114 via pins 114d. In this embodiment, the first clamping member 130a and the second clamping member 130b share the same pin 114d and are hinged to the same pin hole. The materials of the first clamping member 130a and the second clamping member 130b can be stainless steel sheets. Through the hinged connection, both the first clamping member 130a and the second clamping member 130b can rotate relative to the fixed base 114. During the opening and closing of the first clamping member 130a and the second clamping member 130b, the fixed base 114 and the central support rod 110j can remain stationary.

[0053] The rotation of the first clamping member 130a and the second clamping member 130b can be achieved by the driving component 150. In this embodiment, the driving component 150 includes a base 152, a connecting rod 153 and a driving shaft 154. The connecting rod 153 includes a pair, which are respectively pivotally connected to the base 152 and connected to the first clamping member 130a and the second clamping member 130b on the same side. That is, the connecting rod 153 can rotate relative to the base 152 respectively, and the connecting rod 153 can be fixedly connected to the first clamping member 130a and the second clamping member 130b by a pin. The rotation of the connecting rod 153 can pull or push the first clamping member 130a and the second clamping member 130b to rotate relative to the fixed base 110. When the drive shaft 154 is driven axially, the base 152 can move up and down with the drive shaft 154, thereby causing the connecting rod 153 to rotate. When the connecting rod 153 rotates, it pulls or drives the first clamping member 130a and the second clamping member 130b to open or close. One end of the drive shaft 154 is fixedly connected to the base 152, and the other end extends into the fixed base 114 and extends into the interior of the central support rod 110j. A connecting structure 154a is provided at the end of the drive shaft 154 inside the central support rod 110j (see...). Figure 3 The connection structure 154a is used to connect with a drive mechanism, such as a drive spindle 520 extending from a conveyor system (see [link]). Figure 19The drive shaft 154 is detachably connected, and its axial movement along the distal or proximal direction can drive the first clamping member 130a and the second clamping member 130b to open or close relative to each other. In this application, "open" and "close" are relative concepts and do not necessarily mean that they are completely open or completely closed.

[0054] Please see Figure 5-6 The second coating 130d extends between the first clamping member 130a and the second clamping member 130b, that is, the second coating 130d covers the first clamping member 130a, the driving member 150, and the second clamping member 130b therein. Specifically, the second coating 130d has two arms L1 and L2 for covering the first clamping member 130a and the second clamping member 130b, and a connecting portion L3 extending between the first clamping member 130a and the second clamping member 130b and covering the driving member 150.

[0055] In specific wrapping, the second covering 130d can be a biocompatible membrane fabric that first wraps the first clamping member 130a, the driving member 150, and the second clamping member 130b, and then the edges of the fabric are sewn together. Alternatively, the second covering 130d can be a sleeve with a three-dimensional shape and an annular opening L4. The annular opening L4 is directly fitted onto the first clamping member 130a, the driving member 150, and the second clamping member 130b. This is generally done when the atrioventricular valve clamping device 100 is closed to its minimum extent.

[0056] The first covering 112 can be a biocompatible membrane covering the support 110, which is then sutured together. Alternatively, the first covering 112 can be a three-dimensional shape with an annular opening L4. The annular opening L4 of the first covering 112 and the second covering 130d are sutured together to form a conjoined membrane. There is no gap between the first covering 112 and the second covering 130d, and the first covering 112 and the second covering 130d form a basically smooth connection. This helps to reduce the accumulation of thrombi and prevents the atrioventricular valve clamping device 100 from snagging the chordae tendineae of the heart at the hinged ends 130j of the first clamping member 130a and the second clamping member 130b during the implantation of the atrioventricular valve.

[0057] The first covering film 112 has an opening D4 at its proximal end to allow the conduit of the delivery system to extend into the opening at the proximal end of the coupling element 110h and connect to the central support rod 110j. In this embodiment, as... Figure 6 As shown, the inner surfaces of the two arms L1 and L2 of the second coating 130d are continuous.

[0058] Please see Figure 7The first membrane 112 and the second membrane 130d can also be integrally formed into a single membrane or a three-dimensional pocket with an opening, such that their densities can be the same, and the pocket opening can be located, for example, at the bottom. After covering the support member 110, the first clamping member 130a, the drive member 150, and the second clamping member 130b, the edges of the membrane are sewn together, or the opening is sewn together.

[0059] The connection between the first membrane 112 and the second membrane 130d encapsulates the support member 110, the first clamping member 130a, and the second clamping member 130b into a whole, thereby reducing the accumulation of thrombi between the components. The density of the first membrane 112 and the second membrane 130d can be set according to the needs, for example, it can be completely non-permeable, or a small amount of permeability can be achieved without affecting the operation.

[0060] Please refer to it again. Figure 4 The locking member 113, housed within the hollow portion 114c of the fixing base 114, can be used to lock the drive shaft 154 to prevent movement of the drive shaft 154 after accurately clamping the leaflets of the atrioventricular valve. The locking member 113 can be a stainless steel sheet with a through hole, and the drive shaft 154 can be provided with a rough section for engagement. The locking member 113 engages by being tilted. The locking member 113 can be provided with an unlocking control member 113a for unlocking the locking member 113. In this embodiment, the unlocking control member 113a is a double-row wire loop that extends across one side of the locking member 113 within the hollow portion 114c of the fixing base 114, and across the front and rear sides of the fixing base 114. When an unlocking force is applied to the unlocking control member 113a and its end is pulled proximally, the unlocking control member 113a can move the locking member 113, causing it to become substantially perpendicular to the drive shaft 154. This unlocks the drive shaft 154, preventing it from being engaged by the through-hole of the locking member 113. When no unlocking force is applied to the unlocking control member 113a, the locking member 113 returns to its natural tilted state and engages with the drive shaft 154.

[0061] The locking component 113 is used to unlock the valve leaflets when they are clamped in an improper position, after which the atrioventricular valve clamping device 100 can re-clamp the leaflets. After the atrioventricular valve clamping device 100 is implanted into the patient, the unlocking control 113a remains in the body along with the entire atrioventricular valve clamping device 100. The unlocking control 113a is typically made of nickel-titanium wire, stainless steel wire, cobalt-chromium alloy wire, or tungsten wire, with a wire diameter ranging from 0.08 to 0.40 mm, preferably between 0.16 and 0.25 mm, and is relatively thin and flexible. In this embodiment, the unlocking control 113a enters the coupling element 110h from the distal end near the fixing seat 114 (see...). Figure 4 ).

[0062] Please refer to it again. Figure 2-3 The aforementioned atrioventricular valve clamping device 100 further includes a tissue clamping member 140, which is disposed between the central support rod 110j and the clamping assembly 130. The tissue clamping member 140 is integral and includes a connecting seat 146, and a first spring piece 142 and a second spring piece 144 extending outward from opposite sides of the connecting seat 146. The first spring piece 142 and the second spring piece 144 are each approximately strip-shaped, and the width of the strip is less than the width of the first clamping member 130a and the width of the second clamping member 130b. The first spring piece 142 and the second spring piece 144 each include a bent connecting end 145 connected to the connecting seat 146, and a free end extending from the bent connecting end 145. Inverted anchor spikes 145b are formed on both sides of the free end.

[0063] The bent connecting end 145 is bent relative to the edge of the connecting seat 146, so that the free end tends to move towards the first clamping member 130a and the second clamping member 130b in a natural state without external force, and the free end 145a is partially recessed into the first clamping member 130a and the second clamping member 130b, so as to clamp the leaflets of the atrioventricular valve in the first clamping member 130a and the second clamping member 130b. The anchor 145b can abut against or anchor into the leaflet to help position the leaflet.

[0064] The tissue clamp 140 is made of an elastic material or a material with shape memory function. It deforms when subjected to external force and tends to return to its original shape and position after the force is removed due to its elasticity or shape memory capability. Therefore, during transport, the first spring 142 and the second spring 144 can be pulled together relative to the connecting seat 146 by external force, and return to their original shape and position after release. The material commonly used for the tissue clamp 140 is a nickel-titanium alloy.

[0065] The connecting seat 146 is basically U-shaped, and the fixing seat 114 is housed in the connecting seat 146, thereby organizing the clamping member 140 to be assembled with the fixing seat 114. Figure 2 The first spring 142 and the second spring 144 shown are each coated with a film. For ease of description, this film is defined as a third film 145c. This third film 145c is also a biocompatible polymer film, and its density can be slightly higher than that of the aforementioned first film 112. The first spring 142 and the second spring 144 can respectively pass through control line 145d (see...). Figure 14 The free end 145a is pulled up relative to the connecting seat 146 by an external force and retracts. The control line 145d can pass directly through the third membrane 145c and extend to the conveying system (see...). Figure 20 When the control line 145d is pulled out by the conveying system, it can be withdrawn from the third covering 145c and separated from the entire atrioventricular valve clamping device 100. The first spring 142 and the second spring 144 each have multiple holes, through which the control line 145d can pass and extend from the end face of the first spring 144. When the third covering 145c covers the first spring 142 and the second spring 144, it binds the control line 145d.

[0066] Please see Figure 8 In this embodiment, since the joining element 110h can self-expand and fill between the first clamping member 130a and the second clamping member 130b, when the first clamping member 130a and the second clamping member 130b are relatively closed, for example, when the included angle A1 between the first clamping member 130a and the second clamping member 130b is 30 degrees, the first clamping member 130a and the second clamping member 130b can just partially contact and overlap with the first coating 112, but no compressive pressure is applied to the joining element 110h and the first coating 112. Please refer to Figure 9 When the atrioventricular valve clamping device 100 clamps the two opposing leaflets 80a and 80b of the atrioventricular valve, a depth of leaflets 80a and 80b starting from their end edges can be clamped between the tissue clamping member 140 and the first clamping member 130a and the second clamping member 130b. Since the first spring 142 and the second spring 144 of the tissue clamping member 140 are narrower than the first clamping member 130a and the second clamping member 130b, when part of the leaflets 80a and 80b contact the first covering membrane 112, the first covering membrane 112 together with the connecting element 110h is compressed. After clamping the leaflets 80a and 80b, the atrioventricular valve clamping device 100 can be closed relative to each other so that the included angle A2 between the first clamping member 130a and the second clamping member 130b is within 20 degrees.

[0067] The aforementioned connecting element 110h is not fixedly connected to the central support rod 110j at its proximal end, but is in a free-floating state. This allows the connecting element 110h to move slightly along the central support rod 110j, so that the connecting element 110h can be compressed to a relatively small extent when compressed. In addition to supporting the first covering membrane 112, the connecting element 110h also plays a sealing role, thus having a therapeutic effect on the central reflux of the two clamped leaflets 80a and 80b.

[0068] Example 2

[0069] Please see Figure 10-13 The second embodiment of the present invention provides an atrioventricular valve clamping device 200, which differs from the atrioventricular valve clamping device 100 described above in that: the tissue clamping member 140e of the atrioventricular valve clamping device 200 has the function of detecting whether the valve leaflet is clamped in the appropriate position; the first clamping member 130g and the second clamping member 130h have windows 130k; the second covering film 130e is disposed on the first clamping member 130g and the second clamping member 130h and extends between the first clamping member 130g and the second clamping member 130h; and the center of the atrioventricular valve clamping device 200 may only have a central support rod 110j and a first covering film 112e.

[0070] Please refer to the following: Figure 11 and Figure 14 The tissue clamp 140e has a mother spring 140g and a bullet spring 140h on opposite sides. The mother spring 140g is longer and the bullet spring 140h is shorter. When the first clamping member 130g and the second clamping member 130h are closed relative to each other, if the leaflets 80a and 80b are not clamped at the appropriate depth, the bullet spring 140h will be exposed from the window 130k and can be observed by the doctor under medical imaging. If the leaflets 80a and 80b are clamped at the appropriate depth, the bullet spring 140h is also blocked by the leaflets and will not be exposed from the window 130k, thus facilitating the doctor's judgment. Therefore, the tissue clamp 140e has the function of detecting whether the leaflets are clamped in the appropriate position.

[0071] The second film 130e also has a window 130k, and a stitch closing ring 130f is provided on the inner side of the window 130k between the first clamping member 130g and the second clamping member 130h. The stitch closing ring 130f is made of thicker thread, which serves to reinforce the edge of the window 130k. The stitch closing ring 130f on the inner side prevents the bullet fragment 140h from getting caught on the outer side of the first clamping member 130g and the second clamping member 130h when it enters or exits the window 130k.

[0072] The first cover 112e is also connected to the second cover 130e by sutures at its end 112k, or is integrally formed with the second cover 130e. The first cover 112e and the second cover 130e can be smoothly connected, which helps to reduce the accumulation of thrombi and also makes it less likely that some corners of the first clamp 130a and the second clamp 130b will snag on the chordae tendineae of the heart during the implantation of the atrioventricular valve clamping device 400.

[0073] The aforementioned central support rod 110j is elongated in shape, and the first covering film 112e is disposed on the central support rod 110j. The outer diameter of the central support rod 110j together with the first covering film 112e is smaller than the width of the first clamping member 130g or the second clamping member 130h. The unlocking control member 113a is inserted between the first covering film 112e and the central support rod 110j. The first covering film 112e forms a certain radial and / or axial constraint on the unlocking control member 113a, but allows the unlocking control member 113a to move axially when subjected to force.

[0074] Figure 14 This application demonstrates that a tissue clamp 140e can be controlled via a control line 145d, in which the mother fragment 140g and the bullet fragment 140h on the same side are controlled by the same control line 145d. Specifically, the tissue clamp 140e can have holes, through which a flexible wire loop 140k is used for threading. The flexible wire loop 140k can prevent wear of the control line 145d by the holes of the tissue clamp 140e. In this application, it is specifically proposed that the flexible wire loop 140k can be fixed by using a coating on the tissue clamp 140e, which is also the aforementioned third coating 145c. Figure 14 In this design, the mother fragment 140g does not have a flexible loop, and the control line 145d can pass directly through the third cover 145c. That is, the control line 145 does not need to pass through the hole of the tissue clamp 140e to pull up the mother fragment 140g. In this way, because the third cover 145c has a certain binding effect, the third cover 145c on the mother fragment 140g also serves to separate the two ends of the same control line 145d, so that the two ends of the same control line 145d can operate the mother fragment 140g and the bullet fragment 140h on the same side respectively without affecting each other.

[0075] Please see Figure 15In one modified embodiment, the pre-forming angle between the mother bullet 140g and the bullet 140h on the same side can be reduced during molding. That is, the mother bullet 140g and the bullet 140h can be flush in their natural state, or have a slightly smaller angle. The mother bullet 140g has a hollow portion j3, and the length of the bullet 140h is less than the hollow portion j3. The mother bullet 140g and the bullet 140h on the same side can both pass through a flexible wire loop 140j. One end j1 of the flexible wire loop 140j is larger than the size of one hole of the tissue clamp 140e, and the other end j2 extends out of the mother bullet 140g and the bullet 140h. The other end j2 of the flexible wire loop 140j on the bullet 140h is exposed in the hollow portion j3 of the mother bullet 140g. The control line can pass through the hollow portion j3 and be threaded onto the flexible wire loop 140 on the bullet 140h. In this method, the mother bullet pieces 140g on both sides can share a single control line, and the bullet pieces 140h on both sides can also share a single control line. In this embodiment, the mother bullet pieces 140g and the bullet pieces 140 can also be covered with a third coating 145c. The third coating 145c can bind and fix the flexible wire ring 140j, so the flexible wire ring 140j does not need to be glued or welded.

[0076] Example 3

[0077] Please see Figure 16-17 The third embodiment of the present invention provides an atrioventricular valve clamping device 300, which differs from the atrioventricular valve clamping device 100 described above in that: the support member only has a central support rod 110j, and there are no other connecting components between the first covering film 112j and the central support rod 110j, that is, the first covering film 112j is directly set on the central support rod 110j, and there is a gap between the first covering film 112j and the central support rod 110j.

[0078] The central support rod 110j is elongated. One end 112k of the first covering 112j is still connected to the second covering 130d, and the second covering 130d is still fitted between the first clamping member 130a and the second clamping member 130b. Only the unlocking control member 113a exists between the first covering 112j and the central support rod 110j; there are no other supporting components. The first covering 112j provides at least a certain radial constraint to the unlocking control member 113a, preventing the unlocking control member 113a from impacting the fixed seat (see...). Figure 4 The label 114) tilted to the side.

[0079] The thickness of the first membrane 112j can be between 0.3mm and 1.5mm, and its density can be set as needed, for example, to achieve a small amount of blood permeability or no blood permeability at all. The entire first membrane 112j is thin and soft. Compared with cases where there are other supporting components inside, the first membrane 112j can be pressed against the central support rod 110j more easily when subjected to the pressure of the valve leaflets. Therefore, the gap between the first membrane 112j and the central support rod 110j does not affect the fact that the atrioventricular valve clamping device 300 can achieve a smaller closing angle when closed.

[0080] Please see Figure 18 Compared to the aforementioned atrioventricular valve clamping device 100, the first clamping member 130a and the second clamping member 130b in the atrioventricular valve clamping device 300 can close to each other at an angle A3 to a smaller angle, such as 15 degrees. At this time, the first clamping member 130a and the second clamping member 130b can partially contact and overlap with the first covering membrane 112 without applying pressure to it. The atrioventricular valve clamping device 300 can also continue to close. When clamping the two opposing leaflets 80a and 80b of the atrioventricular valve, based on the different thicknesses of the leaflets, the atrioventricular valve clamping device 300 can close to an angle A3 to about 5-10 degrees.

[0081] The first diaphragm 112j and the central support rod 110j have a certain length. When clamping the leaflets 80a and 80b of the atrioventricular valve, the distal end of the first diaphragm 112j and the central support rod 110j can be in the ventricle, and the proximal end can be in the atrium. Since this atrioventricular valve clamping device 300 can achieve a small closure angle, it can reduce central regurgitation. In addition, the first diaphragm 112j plays a certain role in blocking central regurgitation. Therefore, this atrioventricular valve clamping device 300 can achieve a good effect on central regurgitation.

[0082] In summary, the atrioventricular valve clamping device provided by this invention has a first covering on the support member and a second covering on the clamping member, with the first and second coverings connected. This design prevents the corner areas of the atrioventricular valve clamping device from snagging on the chordae tendineae and reduces the likelihood of thrombus accumulation. Furthermore, the connection between the first and second coverings integrates the support member, the first clamping member, and the second clamping member into a single unit. The leaflets of the atrioventricular valve can contact both the first and second coverings, avoiding direct contact with metal components. The coverings also facilitate cell adhesion, thus better ensuring postoperative outcomes.

[0083] Please see Figures 19-20Taking the atrioventricular valve clamping device 300 described above as an example, this application illustrates the process of delivering the device to the atrioventricular valve via a multi-layer catheter through a delivery system 500. The delivery system 500 fundamentally includes a delivery sheath 530, an interventional catheter 510, and a drive spindle 520. The drive shaft 154 of the atrioventricular valve clamping device 300 is detachably connected to the drive spindle 520 of the delivery system 500. When the atrioventricular valve clamping device 300 is closed to its minimum extent, it, along with the interventional catheter 510, can be housed within the delivery sheath 530 during delivery. The delivery sheath 530 has a bending function to deliver the atrioventricular valve clamping device 300 to the atrioventricular valve treatment position within the patient's body. The interventional catheter 510 has a distal matching structure 510a for matching and connecting the connection structure 110a of the aforementioned central support rod 110j.

[0084] The atrioventricular valve clamping device 300 and the delivery system 500 described above constitute the atrioventricular valve clamping system of the present invention. The following will use the repair process of the mitral valve membrane of the atrioventricular valve as an example to illustrate the operation method of the atrioventricular valve clamping system of the present invention, which mainly includes the following steps:

[0085] Please refer to the following: Figures 19-20 as well as Figure 21-23 The procedure involves inserting a sheath 530 via the femoral vein and delivering it to the left atrium through the inferior vena cava. A drive spindle 520 then extends from the sheath 530, controlling the atrioventricular valve clamping device 300 to approach the anterior and posterior leaflets of the mitral valve. The drive spindle 520 is then delivered distally, driving the drive shaft 154 to move, thereby deploying the clamping assembly 130. The orientation of the clamping assembly 130 can be adjusted at this point, and its relationship with the anterior leaflet of the mitral valve can be observed using medical imaging such as ultrasound. The relative positions of the anterior and posterior leaflets make the clamping assembly 130 approximately perpendicular to the free edges of the anterior and posterior leaflets; then, the atrioventricular valve clamping device 300 is pushed to the left ventricle by the drive spindle 520, placing the atrioventricular valve clamping device 300 under the anterior and posterior leaflets, and continuing to open the clamping assembly 130 to the capture position; at the same time, the two first springs 142 and second springs 144 of the tissue clamping member 140 are pulled, at which time the first springs 142 and second springs 144 respectively form a leaflet receiving space between themselves and the clamping assembly 130.

[0086] Simultaneously or sequentially, the first spring 142 and the second spring 144 on both sides are released. The first spring 142 and the second spring 144 cooperate with the clamping assembly 130 to capture the anterior leaflet 80a and the posterior leaflet 80b. Under medical imaging such as ultrasound, it is determined whether the leaflets are clamped in the appropriate position. When it is determined that both the anterior leaflet 80a and the posterior leaflet 80b have been clamped in the appropriate position, the drive spindle 520 is pulled proximally to drive the drive shaft 154, thereby driving the clamping assembly 130 to close, so that the anterior leaflet 80a and the posterior leaflet 80b are clamped between the first spring 142 and the second spring 144 and the clamping assembly 130.

[0087] The threaded connection between the drive spindle 520 and the drive shaft 154 is released, and the drive spindle 520 is withdrawn. The connection between the atrioventricular valve clamping device 300 and the drive spindle 520 is released. Then, the delivery system 500, along with the unlocking wire 113f and the control line 145d, is removed from the body, resulting in the following: Figure 23 As shown in the implantation state, the atrioventricular valve clamping device 300 pulls the anterior and posterior leaflets of the mitral valve together to clamp them, completing the edge-to-edge repair of the mitral valve.

[0088] The aforementioned valve repair system and valve clipping device are suitable for use in mitral or tricuspid valve clipping surgery, and can be applied via the femoral vein-atrial septum-atrium-ventricle approach or the transapical approach. One or more atrioventricular valve clipping devices 300 can be implanted when needed.

[0089] In tricuspid valve treatment, three clamping elements and three spring clips that cooperate with the three clamping elements can be set in the valve clamping device, so that one valve clamping device can clamp the anterior leaflet, posterior leaflet and septal leaflet of the tricuspid valve at one time to treat tricuspid regurgitation.

[0090] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. An atrioventricular valve clamping device, characterized in that, include: Support components; A first clamping member and a second clamping member, wherein the first clamping member and the second clamping member can be opened or closed relative to the support member; A first coating is disposed on the support member; The second coating is disposed on the first clamping member and the second clamping member, and extends between the first clamping member and the second clamping member, and the first coating is connected to the second coating; there is no gap between the first coating and the second coating and the connection is substantially smooth; And a tissue clamping member disposed between the support member and the first clamping member and the second clamping member.

2. The atrioventricular valve clamping device according to claim 1, characterized in that, The support member is a hollow, slender shape. The atrioventricular valve clamping device also includes a driving component. One end of the driving component is connected to the first clamping member and the second clamping member, and the other end of the driving component extends into the support member.

3. The atrioventricular valve clamping device according to claim 1, characterized in that, The support includes a hollow central support rod and an elastic connecting element, the connecting element surrounding the central support rod, the first coating covering the connecting element and adapted to the shape of the connecting element, the atrioventricular valve clamping device further includes a driving component, one end of the driving component being connected to the first clamping component and the second clamping component, and the other end of the driving component extending into the central support rod.

4. The atrioventricular valve clamping device according to claim 2 or 3, characterized in that, The second coating includes two arms for covering the first clamp and the second clamp, and a connecting portion connecting the two arms, the connecting portion extending between the first clamp and the second clamp and covering the drive component, the first coating being connected to the connecting portion.

5. The atrioventricular valve clamping device according to claim 4, characterized in that, Both the first and second coatings are biocompatible membranes. The first coating is connected to the second coating by sutures, or the first and second coatings are integrally formed.

6. The atrioventricular valve clamping device according to claim 5, characterized in that, The first cover is attached to the support member by sewing it with a membrane cloth, or by sleeve it on the support member with an annular opening; the second cover is fixed by sewing it with a membrane cloth covering the first clamping member, the driving member and the second clamping member, or by sleeve it on the first clamping member, the driving member and the second clamping member with an annular opening, and connected to the first cover with the first cover with a suture at the annular opening.

7. The atrioventricular valve clamping device according to claim 2 or 3, characterized in that, The support member and the first coating are selected from either cylindrical or non-cylindrical shapes. The axial length of the support member is between 10mm and 18mm, and the outer diameter of the support member is between 2mm and 5mm. The thickness of the first coating is between 0.3mm and 1.5mm.

8. The atrioventricular valve clamping device according to claim 1, characterized in that, The first clamping member, the second clamping member, and the second covering film are provided with windows. Part of the tissue clamping member can extend out of the window to detect the leaflets of the atrioventricular valve. The second covering film is provided with a suture closing ring in the window.

9. The atrioventricular valve clamping device according to claim 8, characterized in that, It also includes a third covering, wherein the tissue holder is controlled to move by a flexible loop and a control line threaded through the flexible loop, and the flexible loop is bound and fixed to the tissue holder by the third covering.

10. The atrioventricular valve clamping device according to claim 2 or 3, characterized in that, With the atrioventricular valve leaflets not clamped, and the angle between the first clamping member and the second clamping member being 15-30 degrees, the second covering film can contact at least a portion of the first covering film. With the leaflets of the atrioventricular valve clamped, at least a portion of the leaflets of the atrioventricular valve is in contact with the second covering and the first covering, and the angle between the first clamping member and the second clamping member is less than 20 degrees.

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