Transcatheter atrioventricular valve clipping devices and repair systems

Abstract

The present application discloses a transcatheter atrioventricular valve clamping device and a repair system, wherein the transcatheter atrioventricular valve clamping device comprises a base, a first clamp and a second clamp, a first clamp and a second clamp, and an adjusting member. The first clamp and the second clamp are hinged on the base and can be relatively expanded or closed. The base has a support rod, the first clamp and the second clamp are connected to the support rod, and the first clamp and the second clamp respectively have a grasping element for grasping the leaflets of the atrioventricular valve. The adjusting member is connected to the first clamp and the second clamp, and the adjusting member can be driven so that the first clamp and the second clamp move under the action of the elastic member, so that the grasping element grasps the leaflets of the atrioventricular valve relative to the first clamp and the second clamp to move the position.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a transcatheter atrioventricular valve clamping device and a repair system. Background Art

[0002] The atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart. Normal and healthy atrioventricular valves can control the flow of blood from the atria to the ventricles and prevent blood from flowing back from the ventricles to the atria. Figure 1 As shown, the mitral valve MV manages blood flow from the left atrium LA to the left ventricle LV, and the tricuspid valve TV manages blood flow from the right atrium RA to the right ventricle RV.

[0003] Take the tricuspid valve as an example. The tricuspid valve is composed of three triangular leaflets attached to a fibrous support ring made of connective tissue on the right atrioventricular orifice, including the anterior leaflet, posterior leaflet and septal leaflet. As a "one-way valve" between the right ventricle and the right atrium, a normal tricuspid valve can open and close with the heart cycle, ensuring that blood flows from the right atrium to the right ventricle when it is open, and preventing blood from flowing back from the right ventricle to the right atrium when it is closed. When there are organic or functional changes in the leaflet structure of the tricuspid valve, the "one-way valve" formed by the three leaflets will not close properly, causing part of the blood to flow back from the right ventricle to the right atrium, resulting in symptoms such as Figure 2 The tricuspid regurgitation shown in the figure may cause right atrial dilatation or other pathological and physiological manifestations. Severe tricuspid regurgitation will increase the burden on the right atrium, causing right atrial dilatation, congestion in the systemic circulation, and right heart failure manifestations such as lower limb edema. Compared with the treatment of the mitral valve, the difficulty of tricuspid valve treatment comes from the complexity of its own structure, larger valve ring and valve orifice area, and more fragile valve leaflet tissue. At present, the main surgical treatments for tricuspid regurgitation include valve replacement and tricuspid annuloplasty. However, this type of surgery requires thoracotomy and other operations, and its defects such as high degree of trauma, complex surgical process, high risk of complications and long recovery time put forward certain requirements on the patient's physical condition, especially for elderly patients with poor recovery ability. In addition, there is a minimally invasive repair procedure through a catheter, among which the mainstream solution is to clamp and pull the two valve leaflets together with a clip to reduce the regurgitation gap.

[0004] However, since there are many causes of mitral or tricuspid regurgitation, and the leaflets of the mitral or tricuspid valves are always in a state of opening and closing with large amplitude and force, it is difficult to grasp the leaflets themselves during surgery, and even if they are grasped, the grasping position may be inappropriate, for example, the leaflets may be only partially grasped instead of being in full contact with the clamping element. This may lead to less than ideal closure or the leaflets may eventually slip, and the surgical operation can only be repeated. Summary of the invention

[0005] In order to solve the above technical problems or at least partially solve the above technical problems, the present invention provides a transcatheter atrioventricular valve clamping device and a repair system.

[0006] A first aspect of the present invention provides a transcatheter atrioventricular valve clamping device, comprising:

[0007] A base, wherein the base is provided with a support rod;

[0008] A first clamping member and a second clamping member, wherein the first clamping member and the second clamping member are hinged on the base and can be relatively opened or closed;

[0009] A first clamp and a second clamp, wherein the first clamp and the second clamp are connected to the support rod, and the first clamp and the second clamp respectively have a gripping element for gripping the leaflets of the atrioventricular valve; and

[0010] An adjusting member is connected to the first clamping member and the second clamping member, and the adjusting member can be driven to move the first clamping member and the second clamping member, so that the grasping element grasps the leaflet to move the position relative to the first clamping member and the second clamping member.

[0011] In a preferred embodiment, the grasping element is an anchoring barb facing the first clamping member and the second clamping member, the anchoring barb is anchored in the leaflet, and when the first clamping member and the second clamping member move, the anchoring barb drives the leaflet to move.

[0012] In a preferred embodiment, the first clamping member and the second clamping member are connected to the support rod via a connecting seat, the connecting seat and the adjusting member are respectively hollow and are respectively sleeved on the support rod, the adjusting member and the support rod are provided with mutually matching threads, and the adjusting member is connected to the connecting seat, so that when the adjusting member rotates, it can rotate relative to the connecting seat and can drive the connecting seat to move along the support rod.

[0013] In a preferred embodiment, it also includes an elastic member, the first clamping member and the second clamping member are connected to the support rod via a connecting seat, the elastic member is sleeved on the support rod, the adjusting member abuts against the upper surface of the connecting seat, one end of the elastic member abuts against the lower surface of the connecting seat, and the other end abuts against the surface of the base.

[0014] In a preferred embodiment, the adjusting member is a bushing or a sleeve, and at least one of the adjusting member or the supporting rod is provided with a thread or a rough surface.

[0015] In a preferred embodiment, a side wall of the adjusting member is provided with a bayonet for cooperating with the catheter to adjust the position.

[0016] In a preferred embodiment, the support rod is provided with a clutch connection structure detachable from the catheter at one end away from the base, the adjustment member is lower than the clutch connection structure, and the first clamping member, the second clamping member and the connecting seat are formed integrally.

[0017] In a preferred embodiment, the support rod includes a central support rod and two side support rods, the two side support rods are lower than the central support rod, and the end of the central support rod away from the base is provided with a clutch connection structure for detachable connection with the catheter, the first clamping member and the second clamping member respectively have connecting seats, and are connected to the corresponding side support rods through the corresponding connecting seats, and the adjusting member includes two, which are respectively connected to the two connecting seats.

[0018] In a preferred embodiment, the first clamping member and the second clamping member, and / or the support rod are provided with an enhanced ultrasound imaging material.

[0019] A second aspect of the present invention provides a transcatheter atrioventricular valve repair system, which includes an atrioventricular valve clamping device and a delivery device for delivering the atrioventricular valve clamping device to the atrioventricular valve, wherein the delivery device includes a multi-layer catheter, wherein:

[0020] The atrioventricular valve clamping device comprises:

[0021] A base, wherein the base has a clutch connection structure;

[0022] A first clamping member and a second clamping member, wherein the first clamping member and the second clamping member are hinged on the base and can be relatively opened or closed;

[0023] A first clamping member and a second clamping member, wherein the first clamping member and the second clamping member are both connected to the base via a connecting seat, and the first clamping member and the second clamping member are used to cooperate with the first clamping member and the second clamping member to clamp the leaflets of the atrioventricular valve; and

[0024] An adjusting member and an elastic member, wherein the adjusting member and the elastic member are respectively arranged on opposite sides of the connecting seat and respectively abut against the connecting seat;

[0025] The multi-layer catheter has a connector and an adjustment structure. The connector is detachably connected to the clutch connection structure of the atrioventricular valve clamping device. The adjustment structure is used to adjust the adjustment member so that the connecting seat overcomes the force of the elastic member and moves, thereby moving the first clamping member and the second clamping member, and driving the leaflet to move relative to the first clamping member and the second clamping member.

[0026] In a preferred embodiment, the multi-layer catheter includes an adjustment catheter, a connecting catheter and a guide sheath, the connector is formed at the distal end of the connecting catheter, the adjustment structure is formed at the distal end of the adjustment catheter, and the adjustment catheter, the atrioventricular valve clamping device and the connecting catheter can move in and extend out of the guide sheath.

[0027] In a preferred embodiment, a bayonet is provided on a side wall of the adjusting member, and the adjusting structure is an elastic block formed at the distal end of the adjusting catheter.

[0028] The transcatheter atrioventricular valve clamping device and repair system provided by the present invention have at least the following beneficial effects:

[0029] The transcatheter atrioventricular valve clamping device of the present invention is provided with a drivable adjusting member. Since the adjusting member is connected to the first clamping member and the second clamping member, during the operation, when the first clamping member and the second clamping member have clamped the leaflets of the atrioventricular valve with the first clamping member and the second clamping member, the movement of the first clamping member and the second clamping member will drive the leaflets of the atrioventricular valve to move. In the case where the leaflets are too long or not clamped enough, the movement of the first clamping member and the second clamping member will straighten and flatten the long leaflets, or drive the leaflets to the appropriate position of the first clamping member or the second clamping member. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of the present invention and, together with the description, serve to explain the principles of the present invention.

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0032] Figure 1 This is a schematic diagram of the mitral valve and tricuspid valve in their normal state.

[0033] Figure 2 yes Figure 1 Schematic diagram of tricuspid valve disease.

[0034] Figure 3 It is a front schematic view of the transcatheter atrioventricular valve clamping device provided by the first embodiment of the present invention.

[0035] Figure 4 yes Figure 3 Schematic diagram of the cooperation between the base and the tissue clamping member, the adjusting member and the elastic member.

[0036] Figure 5 yes Figure 4 A three-dimensional schematic diagram of a tissue clamp.

[0037] Figure 6 yes Figure 4 A three-dimensional schematic diagram of an implementation scheme of a base.

[0038] Figure 7 yes Figure 4 A three-dimensional schematic diagram of the adjustment part.

[0039] Figure 8 yes Figure 4 A three-dimensional schematic diagram of an elastic member.

[0040] Fig. 9 yes Figure 3 Schematic representation of a transcatheter atrioventricular valve clamping device that regulates the leaflets of the atrioventricular valve.

[0041] Fig.10 yes Figure 3 Schematic diagram of the cooperation between the base and the locking mechanism.

[0042] Fig.11 Schematic diagram of an adjustment catheter of a delivery device provided in an embodiment of the present invention.

[0043] Fig.12 Schematic diagram of a multi-layer catheter of a delivery device provided in an embodiment of the present invention.

[0044] Fig.13 yes Fig.12 Schematic diagram of the connection between the connecting catheter and the atrioventricular valve clamping device.

[0045] Fig.14 yes Fig.11 Schematic diagram of the adjusting catheter and the adjusting piece cooperating to adjust the atrioventricular valve clamping device.

[0046] Fig.15 is a schematic diagram of tricuspid regurgitation in a patient with FTR.

[0047] Fig.16 Schematic diagram of a transcatheter atrioventricular valve clamping device with an occluding mesh provided in an embodiment of the present invention.

[0048] Fig.17 The present invention is a three-dimensional schematic diagram of a base provided by a modified implementation manner.

[0049] Fig.18 The present invention is a three-dimensional schematic diagram of an adjusting member provided by a modified implementation manner.

[0050] Fig.19 It is a schematic diagram of a support rod of a base provided by an embodiment of the present invention having a developing mark.

[0051] Fig. 20It is a three-dimensional schematic diagram of a transcatheter atrioventricular valve clamping device provided by a second embodiment of the present invention.

[0052] Fig.21 yes Fig. 20 Schematic diagram of the coordination relationship between the adjusting member and the support rod of the transcatheter atrioventricular valve clamping device.

[0053] Fig. 22 It is a three-dimensional schematic diagram of a transcatheter atrioventricular valve clamping device provided in a third embodiment of the present invention.

[0054] Fig.23 yes Fig. 22 Schematic diagram of the coordination of the base, tissue clamping member and adjustment assembly.

[0055] Fig.24 yes Fig. 22 A three-dimensional schematic diagram of a split clamping piece of a tissue clamping piece.

[0056] Fig.25 This is a schematic diagram of a DTR patient with one tricuspid valve leaflet prolapsed and the other leaflet shortened.

[0057] Fig.26 yes Fig. 22 Schematic diagram of the initial clamping position of the tricuspid valve leaflets of a DTR patient using the transcatheter atrioventricular valve clamping device.

[0058] Fig. 27 yes Fig.26 Schematic diagram of the state after the transcatheter atrioventricular valve clamping device adjusts the clamping position of the valve leaflet.

[0059] Fig.28 1 is a front schematic view of a transcatheter atrioventricular valve clamping device provided in a fourth embodiment of the present invention.

[0060] Fig.29 It is a schematic diagram of the transcatheter atrioventricular valve repair system according to an embodiment of the present invention repairing adjacent leaflets of the tricuspid valve.

[0061] Fig.30 yes Fig.29 Schematic diagram of the state of the transcatheter atrioventricular valve clamping device when closing and clamping the valve leaflets.

[0062] Fig.31 yes Fig.30 Schematic diagram of the state where the transcatheter atrioventricular valve clamping device is separated from the delivery device.

[0063] Fig.32 It is a schematic diagram of a tricuspid valve adjacent leaflets repaired by a transcatheter atrioventricular valve clamping device according to an embodiment of the present invention. DETAILED DESCRIPTION

[0064] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0065] In the description of the present invention, it should be noted that:

[0066] The directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance;

[0067] When an element is referred to as being "fixed to" or "disposed 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.

[0068] It should also be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction refers to the direction along the wire diameter or radius. It is worth noting that the "end" in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes a portion extending from the end, endpoint, or end face on the element to which the end, endpoint, or end face belongs for an axial distance and / or radial distance. The above definitions are only for the convenience of expression and cannot be understood as limitations on the present invention.

[0069] The transcatheter atrioventricular valve clamping device provided by the present invention is used for repairing heart valves, especially mitral valves and tricuspid valves, so as to reduce the valve leaflet gap and alleviate mitral valve or tricuspid valve regurgitation.

[0070] Please also read Figures 3 to 5The transcatheter atrioventricular valve clamping device 100 provided in the first embodiment of the present invention mainly comprises a base 110, a clamping assembly 130, and a tissue clamping member 140. The tissue clamping member 140 is used to cooperate with the clamping assembly 130 to clamp the leaflets of the valve.

[0071] The clamping assembly 130 is hinged on the base 110, and the tissue clamping piece 140 can also be connected to the base 110. In this embodiment, the base 110 includes a main body 112 and a support rod 114 disposed on the main body 112, the support rod 114 is fixedly connected to the main body 112 or integrally formed, the clamping assembly 130 is hinged on the main body 112, and the tissue clamping piece 140 is connected to the support rod 114.

[0072] The clamping assembly 130 includes a first clamping member 130a and a second clamping member 130b. The first clamping member 130a and the second clamping member 130b are both arranged in a paddle shape on two opposite sides of the main body 112. In this embodiment, the first clamping member 130a and the second clamping member 130b are both hinged on the main body 112 and extend to both sides. The hinges herein and in this application include a rotating shaft type, a hinge type, etc., so that one element can rotate relative to another element. Here, the first clamping member 130a and the second clamping member 130b can rotate relative to the main body 112. In this embodiment, the first clamping member 130a and the second clamping member 130b are hinged on the main body 112 at a common hinge point 112a. In other embodiments, they can also be hinged on the main body 112 at different hinge points.

[0073] The tissue clamp 140 includes a first clamp 142 and a second clamp 144. In this embodiment, the first clamp 142 and the second clamp 144 share a connecting seat, that is, they are connected as a whole through a substantially U-shaped connecting seat 146. A through hole 147 is formed in the center of the connecting seat 146, and the through hole 147 is sleeved on the support rod 114.

[0074] The first clamping member 142 and the second clamping member 144 may be pre-shaped to have a natural state biased toward the first clamping member 130a and the second clamping member 130b, for example, the first clamping member 142 and the second clamping member 144 may be bent at the portion where the first clamping member 142 and the second clamping member 144 are connected to the connecting seat 146, so that the ends of the first clamping member 142 and the second clamping member 144 have a natural state biased toward the first clamping member 130a and the second clamping member 130b, so that the first clamping member 142 and the second clamping member 144 and the corresponding first clamping member 130a and the second clamping member 130b can be more convenient for the first clamping member 142 and the second clamping member 144 to cooperate with the corresponding first clamping member 130a and the second clamping member 130b to clamp the leaflets of the atrioventricular valve. The bending range of the portion where the first clamping member 142 and the second clamping member 144 are connected to the connecting seat 146 can be designed according to the needs of the clamping angle.

[0075] The first clamping member 142 and the second clamping member 144 may be provided with threading holes 142b and 144b at their ends for passing control lines 142c and 144c to pull the first clamping member 142 and the second clamping member 144.

[0076] The first clamping member 142 and the second clamping member 144 are made of elastic material or material with shape memory function, and deform when subjected to external force. After the external force disappears, they tend to restore their original shape and position due to elasticity or shape memory ability. Therefore, during the transportation process, the first clamping member 142 and the second clamping member 144 can be tightened and gathered toward the center of the connecting seat 146. After being released, they can restore to a natural state without external force due to their own material properties. In this natural state, the first clamping member 142 and the second clamping member 144 can be engaged with the leaflet, so that they can cooperate with the first clamping member 130a or the second clamping member 130b to clamp the leaflet. In this embodiment, the materials of the first clamping member 142 and the second clamping member 144 are both nickel-titanium alloy with shape memory function.

[0077] In a preferred embodiment, the first clamp 142 and the second clamp 144 are respectively provided with gripping elements 142a and 144a, and the gripping elements 142a and 144a are used to grip the leaflets of the atrioventricular valve. In this embodiment, the gripping elements 142a and 144a are anchoring spikes facing the first clamp 130a and the second clamp 130b, and the anchoring spikes are in multiple rows and have a certain inclination, and the anchoring spikes can be anchored into the leaflets of the atrioventricular valve. In other embodiments, the gripping elements 142a and 144a can also be other structures facing the first clamp 130a and the second clamp 130b, such as convex points. Since the leaflets of the atrioventricular valve are soft, multiple convex points can grip the leaflets of the atrioventricular valve.

[0078] Please also read Figures 6 to 8In the present invention, the tissue clamping member 140 can be driven, and the first clamping member 142 and the second clamping member 144 can be driven by the driving connection seat 146.

[0079] In this embodiment, an elastic member 20 is arranged between the connection seat 146 and the surface of the main body 112 of the base 110, and an adjusting member 10 is arranged above the connection seat 146. In this embodiment, the elastic member 20 is an annular spring, and the adjusting member 10 is a shaft sleeve. The adjusting member 10 and the elastic member 20 are respectively sleeved on the support rod 114 and respectively abut the connection seat 146. The elastic member 20 plays a role in supporting and balancing the connection seat 146, and has a pushing force on the connection seat 146 when the adjusting member 10 is adjusted. In this embodiment, the adjusting member 10 does not need to be fixedly connected to the connection seat 146, and the adjusting member 10 is only adjustably fastened to the support rod 114 under the action of the adjusting force.

[0080] The adjusting member 10 is provided with a plurality of bayonet holes 10a for engaging with the adjusting structure 530a (see Fig.11 ) to exert force on the adjusting member 10, thereby adjusting the adjusting member 10. In this embodiment, the bayonet 10a is two opposite ones, and is opened directly downward from the end surface of the adjusting member 10. In other embodiments, the bayonet 10a can also be opened on the side of the adjusting member 10, which can be matched with the adjusting structure 530a on the adjusting conduit of the conveying device.

[0081] The support rod 114 is provided with a damping portion 114b, for example, the damping portion 114b may be a section of thread, and the damping portion 114b may be provided only on a section of the support rod 114, and a section between the damping portion 114b and the surface of the main body 112 may be a bare rod section, and the bare rod section is a sleeve section of the elastic member 20. The inner surface of the adjusting member 10 may also be provided with a thread 10b, and the adjusting member 10 may be moved along the support rod 114 by rotating the adjusting member 10, thereby pushing the connecting seat 146 to overcome the elastic thrust of the elastic member 20 and move along the support rod 114, so that the first clamping member 142 and the second clamping member 144 move relative to the first clamping member 130a and the second clamping member 130b.

[0082] The elastic member 20 can be selected to have a suitable length as needed. For example, a longer length of the elastic member 20 can make the tissue clamp 140 adjustable to a longer travel. A shorter length of the elastic member 20 can be adjusted to a shorter distance, so that the tissue clamp 140 can be closer to the clamping assembly 130, which is conducive to clamping the leaflets. The different lengths of the elastic member 20 are adapted to different leaflet conditions. For example, if the leaflets are short, the adjustable distance is limited. Before surgery, the leaflet condition of the patient can be observed through medical imaging to select the elastic member 20 of a suitable length for assembly. In this embodiment, the length of the elastic member 20 in the natural state is between 1.5-4 mm, preferably 2-3 mm.

[0083] When the transcatheter atrioventricular valve clamping device 100 of the present invention enters the atrioventricular valve, such as the tricuspid valve surgical site, the first clamping member 130a and the second clamping member 130b are located below the tricuspid valve leaflets to be clamped, the first clamping member 142 and the second clamping member 144 are located above the tricuspid valve leaflets to be clamped, and the first clamping member 142 and the second clamping member 144 respectively cooperate with the first clamping member 130a and the second clamping member 130b to clamp the left and right leaflets. The gripping elements 142a and 144a can be anchored into the leaflets.

[0084] See also Fig. 9 After clamping the leaflets, when the first clamping member 142 and the second clamping member 144 move, they will comb the soft leaflets 80a, 80b and drive the leaflets 80a, 80b to move. For example, if the leaflets are too long or not clamped enough, the movement of the first clamping member 142 and the second clamping member 144 will straighten the long leaflets, or readjust the leaflets that are not clamped in the proper position to the position of the first clamping member 130a or the second clamping member 130b. The doctor can observe the direction of the leaflets to be adjusted under the ultrasound image, and thus adjust the adjustment member 10 upward or downward to move the leaflets appropriately to the proper clamping position. Fig. 9 In the middle, the adjusting member 10 is adjusted downward so that the leaflet is driven to move a distance H to increase the clamping depth.

[0085] The adjusting member 10 of the present invention is used for when the leaflet is not clamped at the appropriate position 162 by the first clamping member 142 and the second clamping member 144 and the first clamping member 130a and the second clamping member 130b, for example, the length of the clamped leaflet is too short. The adjusting member 10 can be controlled to move and drive the first clamping member 142 and the second clamping member 144 to drive the leaflet to move to the appropriate position.

[0086] Please also read Figure 3 , Figure 6 and Fig.10The main body 112 of the base 110 is hollow inside, and the upper wall and the lower wall are provided with through holes 110a, and the through holes 110a and the main body 112 form a hollow channel. The support rod 114 is hollow inside and communicates with the hollow channel of the main body 112.

[0087] like Figure 3 As shown, the transcatheter atrioventricular valve clamping device 100 includes a driving mechanism 150, and the driving mechanism 150 includes a driving shaft 154. The driving shaft 154 is used to drive the first clamping member 130a and the second clamping member 130b to expand or close relative to each other. The driving shaft 154 passes through the hollow channel of the base 110 and extends into the interior of the support rod 114 to mate with the driving core shaft 510 (see Fig.12 )connect.

[0088] The driving mechanism 150 further includes a base 152 and two connecting rods 153. The driving shaft 154 is fixed to the base 152. One end of the two connecting rods 153 is respectively hinged to the two ends of the base 152, and the other ends are respectively fixedly connected to the first clamping member 130a and the second clamping member 130b. When the driving shaft 154 is driven in the axial direction, the base 152 can move up and down following the driving shaft 154, thereby causing the connecting rod 153 to rotate relative to the base 152. When the connecting rod 153 rotates, it pulls or drives the first clamping member 130a and the second clamping member 130b to expand or close.

[0089] like Fig.10 As shown, the hollow interior of the main body 112 may be provided with a locking mechanism 113, which can lock the steel sheet 113b by the cooperation of the spring sheet 113a and the steel sheet 113b, or release the engagement so that the driving shaft 154 can move up and down, and the locking mechanism 113 can be controlled by the unlocking elastic wire 115a and the control wire 115b extending to the doctor-controlled end of the delivery device. The locking mechanism 113 also functions to unlock and re-clamp the leaflets when they are clamped in an inappropriate position.

[0090] Please also read Figure 3 , Figure 11-14The end of the support rod 114 of the transcatheter atrioventricular valve clamping device 100 is provided with a clutch connection structure 114a. The delivery device 500 of the transcatheter atrioventricular valve clamping device 100 includes a multi-layer catheter and a driving core shaft 510. The multi-layer catheter includes an adjustment catheter 530, a connecting catheter 520 and a guide sheath 540. The driving core shaft 510 can move axially or rotate independently in the connecting catheter 520. The inner diameter of the adjustment catheter 530 is larger than that of the driving core shaft 510. The adjustment catheter 530 can also move axially or rotate independently in the connecting catheter 520 and is located outside the driving core shaft 510.

[0091] The end of the connecting catheter 520 has a connector 520a, and the connector 520a has a structure matching the clutch connection structure 114a, so as to be detachably connected to the clutch connection structure 114a. The driving mandrel 510 is detachably connected to the driving shaft 154 of the transcatheter atrioventricular valve clamping device 100, for example, by threading. Before delivery, the clutch connection structure 114a of the support rod 114 of the transcatheter atrioventricular valve clamping device 100 is first connected to the connector 520a of the connecting catheter 520.

[0092] The distal end of the adjusting conduit 530 has an adjusting structure 530a, which is in the form of an elastic block, which can be slightly deformed and inserted into the bayonet 10a of the adjusting member 10, and can be separated from the bayonet 10a when the tension between the adjusting member 10 and the adjusting member 10 is greater than a certain value. In this embodiment, the adjusting structure 530a can drive the adjusting member 10 to rotate under rotational drive, and make the adjusting member 10 move on the support rod 114, so as to drive the first clamping member 142 and the second clamping member 144 to move their positions.

[0093] In actual use, the connecting catheter 520 may be only one section, which may be fixed at the end of a multi-lumen tube, and the multiple channels of the multi-lumen tube may be used to accommodate the control line of the tissue clamp 140 and the control line of the locking mechanism 113 .

[0094] The above-mentioned adjustment catheter 530, the transcatheter atrioventricular valve clamping device 100 and the connecting catheter 520, together with the multi-lumen tube, can move in the guide sheath 540 and extend out of the guide sheath 540.

[0095] After the adjusting tube 530 has finished adjusting the adjusting member 10 , the adjusting tube 530 can be withdrawn, that is, moved toward the proximal end, so as not to affect the disengagement of the connecting tube 520 and the clutch connecting structure 114 a .

[0096] Clinically, patients with tricuspid regurgitation are classified into one type, called functional tricuspid regurgitation (FTR). Fig.15 The tricuspid valve of the FTR patient cannot close naturally, for example, the coaptation margins of the anterior leaflet 80a and the septal leaflet 80b are not sufficient, which may easily cause the transcatheter atrioventricular valve clamping device 100 to have insufficient clamping length for the anterior leaflet 80a and the septal leaflet 80b. In this case, please refer to Fig. 9 By driving the first clamping member 142 and the second clamping member 144 to move, the grasping elements 142a and 144a grasp the anterior leaflet 80a and the septal leaflet 80b and pull them toward the center of the connecting seat 146, so that the clamped lengths of the anterior leaflet 80a and the septal leaflet 80b are adjusted to a sufficient position, that is, to meet the appropriate clamping position for treating FTR patients. Thus, the anterior leaflet 80a and the septal leaflet 80b of the FTR patient can be clamped at an appropriate position by the transcatheter atrioventricular valve clamping device 100.

[0097] See also Fig.16 In a preferred embodiment, the transcatheter atrioventricular valve clamping device 100 is provided with a blocking net 120 on the support rod 114. The blocking net 120 is a three-dimensional mesh structure, preferably a three-dimensional mesh structure made of woven wire or cut tube with shape memory function, such as superelastic materials such as nickel-titanium alloy wire. The blocking net 120 can adapt to the gap between different leaflets and undergo adaptive deformation, thereby adjusting the pulling degree of the leaflets by the valve repair device 100, and the blocking of the blocking net makes the treatment effect of reflux better.

[0098] The blocking net 120 can be fixed on the support rod 114 through a shaft sleeve at one end, and the other end 120a is freely suspended in the air. The opening 120a is higher than the clutch connection structure 114a of the support rod 114, and the connecting conduit 520 of the conveying device extends into the opening 120a and is connected to the clutch connection structure 114a.

[0099] Please also read Fig.17 and Fig.18 In a modified embodiment, a base 160 is provided. The base 160 is different from the base 110 in that the damping section 164b of the support rod 164 of the base 160 has no threads and only has a rough surface. The adjusting member 60 can adopt the internal thread form of the adjusting member 10, or can adopt the internal thread form of the adjusting member 10. Fig.18 The inner rough surface 60a is in the form of a damping effect, so that the adjustment member is fastened to the support rod and only by external forces, such as the adjustment guide tube 530 (see Fig.11) can move the adjusting member. When the adjusting member 60 has an inner rough surface 60a, the adjusting conduit 530 can directly push the adjusting member 60 downward; when the adjusting member 60 has an inner thread, the adjusting conduit 530 can rotate the adjusting member 60 forward, or rotate the adjusting member 60 reversely to move the adjusting member 60 downward or upward. One end of the elastic member 20 can be fixed on the base 160.

[0100] When only one of the support rod and the adjusting member has internal threads, or both have only rough surfaces, the adjusting member 60 may not rotate but only move. The adjusting guide tube 530 may push the adjusting member 60 to move, thereby pushing the first clamping member 142 and the second clamping member 144 to move.

[0101] See also Fig.19 In an embodiment of the present invention, an ultrasound-enhanced development material 170a may be provided on the support rod 174 of the base 170, so that when the first clamp and the second clamp move, the doctor can observe the movement of the first clamp and the second clamp under ultrasound and know the adjustment distance. The ultrasound-enhanced development material 170a may be on the damping section 174b.

[0102] In other embodiments, the ultrasound enhanced development material 170a may also be disposed on the first clamp and the second clamp, and may be observed under ultrasound when the first clamp and the second clamp move.

[0103] Please also read Figure 20-21 The second embodiment of the present invention provides a transcatheter atrioventricular valve clamping device 200. In the transcatheter atrioventricular valve clamping device 200, the adjusting member 70 is in the form of a sleeve, which is longer than the aforementioned adjusting member in the form of a sleeve, so it is more convenient for the aforementioned adjusting catheter 530 (see Fig.11 ) is coupled thereto. The adjusting member 70 and the elastic member 75 still respectively abut against the connecting seat 246 of the first clamping member 242 and the second clamping member 244. The elongated adjusting member 70 can still be easily inserted into the aforementioned blocking net (see Fig.16 The inner side of the elongated adjusting member 70 has an internal thread, which can still be threadedly connected with the supporting rod 274.

[0104] The bayonet 70a of the adjusting member 70 may be lower than the clutch connection structure 274a of the support rod 274. When the adjusting member 70 needs to be adjusted, the adjusting conduit 530 is coupled with the bayonet 70a of the adjusting member 70, thereby rotating or moving the adjusting member 70. When the adjustment is completed, the adjusting conduit 530 may be withdrawn, so as not to affect the clutch connection structure 274a of the support rod 274 and the connecting conduit 520 (see Fig.12 ) dissociation.

[0105] Please also read Figure 22-24 The third embodiment of the present invention provides a transcatheter atrioventricular valve clamping device 300. In the transcatheter atrioventricular valve clamping device 300, the base 380 includes a central support rod 381 and two side support rods 382 arranged on the sides of the central support rod 381, and the two side support rods 382 are lower than the central support rod 381. The end of the central support rod 381 away from the base 380 is provided with a clutch connection structure 381a.

[0106] In this example, the first clamping member 342 and the second clamping member 344 are separate, each having the connecting seat 342a, 344a, and are connected to the two side support rods 382 through the corresponding connecting seats 342a, 344a, and two groups of adjustment members 81, 82 and elastic members 83, 84 are respectively arranged on the opposite sides of the two connecting seats 342a, 344a.

[0107] Since the first clamping member 342 and the second clamping member 344 are separate, the two groups of adjusting members 81, 82 and elastic members 83, 84 can respectively adjust the first clamping member 342 and the second clamping member 344, thereby respectively adjusting the leaflets clamped between the first clamping member 342 and the first clamping member 330a, or the leaflets clamped between the second clamping member 344 and the second clamping member 330b.

[0108] Clinically, patients with tricuspid regurgitation are classified into a type of degenerative tricuspid regurgitation (DTR). Figure 25-27 In patients with DTR, one leaflet 610a of the tricuspid valve is prolapsed and the other leaflet 620a is short. Fig.26 In the initial clamping position of the present invention, the leaflet 610a is clamped too long, and the clamping length of the leaflet 620a is insufficient. By slightly adjusting the adjusting member 81 of the transcatheter atrioventricular valve clamping device 300 of the present invention to straighten the leaflet 610a, the leaflet 620a is pulled and moved by the adjusting member with reference to the insufficient clamping length of the aforementioned FTR patient, so that the clamped length of the leaflet 620a is adjusted to a sufficient position, so that it meets the appropriate clamping position for treating DTR patients, such as Fig. 27 shown.

[0109] The repair surgery of the transcatheter atrioventricular valve clamping device of the present invention is performed under the guidance and monitoring of medical images, such as ultrasound, or in combination with CT, magnetic resonance imaging (MRI), and digital subtraction angiography (DSA). The clamping of the valve leaflets by the tissue clamping members of the transcatheter atrioventricular valve clamping device is observed under the medical images. For example, when the initial clamping position is already in the appropriate position, the adjustment member does not need to be moved.

[0110] In some cases, the clamping depth of a single leaflet may be too long. The above-mentioned adjustment member can be rotated in the opposite direction to move in the opposite direction, so that the leaflet moves along with the first clamping member 342 or the second clamping member 344 to the appropriate position of the first clamping member 130a or the second clamping member 130b, and then the first clamping member 130a or the second clamping member 130b is relatively closed to clamp the leaflet.

[0111] See also Fig.28 The fourth embodiment of the present invention provides a transcatheter atrioventricular valve clamping device 400. The difference between the transcatheter atrioventricular valve clamping device 400 and the above-mentioned transcatheter atrioventricular valve clamping device 100 is that the transcatheter atrioventricular valve clamping device 400 is not provided with an elastic member, and the adjusting member 10 is connected to the connecting seat 146 of the first clamping member 142 and the second clamping member 144, so that when the adjusting member 10 rotates, it can rotate relative to the connecting seat 146 and can drive the connecting seat 146 to move axially along the support rod 114.

[0112] The adjusting member 10 and the connecting seat 146 are both sleeved on the supporting rod 114, and the adjusting member 10 is provided with an internal thread inside, and the supporting rod 114 can be provided with a section of external thread. Through the threaded connection between the adjusting member 10 and the supporting rod 114, the adjusting member 10 can be fastened to the supporting rod 114, and the position of the adjusting member 10 on the supporting rod 114 can be adjusted as needed, so the purpose of the present invention can still be achieved without the elastic member on the lower surface of the connecting seat 146.

[0113] In this embodiment, the connection method between the adjusting member 10 and the connecting seat 146 can be, for example, a T-shaped groove (not shown) is opened in the wall of the connecting seat 146, and the adjusting member 10 is accommodated in the T-shaped groove. The adjusting member 10 can rotate independently in the T-shaped groove without causing the connecting seat 146 to rotate, and the adjusting member 10 can push the connecting seat 146 to move axially when moving axially.

[0114] In this embodiment, since no elastic member is provided, the first clamping member 142 and the second clamping member 144 are closer to the first clamping member 130a or the second clamping member 130b. In this case, the bending amplitude of the connection part between the first clamping member 142 and the second clamping member 144 and the connecting seat 146 can be slightly smaller, and the grasping elements 142a, 144a on the first clamping member 142 and the second clamping member 144 can still grasp the leaflets.

[0115] In summary, the transcatheter atrioventricular valve clamping device of the present invention has a tissue clamping member that cooperates with the clamping assembly to clamp the valve leaflet. An adjusting member is provided on the tissue clamping member, and the adjusting member can be controlled to move. In this way, when the valve leaflet is not clamped in the appropriate position, for example, when the clamping length is too short, the transcatheter atrioventricular valve clamping device does not need to reopen the tissue clamping member to re-clamp, but only needs to use the adjusting member to move the valve leaflet to the appropriate position.

[0116] The surface of the clamping assembly and the surface of the tissue clamp can be covered with a layer of film (not shown), which can be made of a biocompatible, anti-oxidation, and anti-dissolution polymer material, such as PET, ePTFE, polyester, PTFE, silicone, urethane, metal fiber, or other biocompatible polymers. PET material is preferably used in this application. It is understood that the film made of a biocompatible material can promote the crawling of endothelial cells and can effectively reduce the rejection reaction caused by direct contact of metal with biological tissue.

[0117] The transcatheter atrioventricular valve clamping device of the present invention can be used in the treatment of heart valve regurgitation, including mitral valve or tricuspid valve. Figure 3 , Fig.16 , Figure 29 to Figure 32 The following will take the repair process of the anterior leaflet and septal leaflet of the tricuspid valve as an example, and take the transcatheter atrioventricular valve clamping device 100 with an occluding mesh 120 as an example. The transcatheter atrioventricular valve clamping device 100 is delivered to the tricuspid valve via a delivery device 500. The delivery device 500 mainly includes a connecting catheter 520, a driving core shaft 510 and an adjustment catheter 530 delivered in the connecting catheter 520, and a guide sheath 540.

[0118] The driving shaft 154 of the transcatheter atrioventricular valve clamping device 100 is detachably connected to the driving core shaft 520, and the clutch connection structure 114a of the support rod 114 of the transcatheter atrioventricular valve clamping device 100 is detachably connected to the connecting catheter 520. The transcatheter atrioventricular valve clamping device 100, the connecting catheter 520 and the adjusting catheter 530 pass through the guiding sheath 540. The guiding sheath 540 has a bending function, which can help enter the patient's heart.

[0119] The surgical operation method of the above-mentioned transcatheter atrioventricular valve clamping device 100 mainly includes the following steps:

[0120] By means of femoral vein puncture, the distal end of the delivery device 500 and the transcatheter atrioventricular valve clamping device 100 are delivered to the right atrium RA via the inferior vena cava, and then the transcatheter atrioventricular valve clamping device 100 is controlled to approach the anterior leaflet and septal leaflet of the tricuspid valve TV. At this time, the first clamping member 142 and the second clamping member 144 of the tissue clamping member 140 are pulled by a control line.

[0121] The locking mechanism in the base 110 is unlocked, and the driving mandrel 510 and the driving shaft 154 are pushed to the distal end to drive the first clamp 130a and the second clamp 130b to open relative to the occluding mesh 120, and the directions of the first clamp 130a and the second clamp 130b are adjusted. At this time, the relative positions of the first clamp 130a and the second clamp 130b and the anterior leaflet and the septal leaflet of the tricuspid valve TV can be observed by medical imaging or imaging equipment, so that the first clamp 130a and the second clamp 130b are approximately perpendicular to the free edges of the anterior leaflet and the septal leaflet. ; Then, the transcatheter atrioventricular valve clamping device 100 is pushed to the right ventricle RV through the conveying device 500, and the transcatheter atrioventricular valve clamping device 100 is placed under the anterior leaflet and the septal leaflet, and the first clamping member 130a and the second clamping member 130b continue to be opened to the capture position; at the same time, the first clamping member 142 and the second clamping member 144 are controlled to fit the outer surface of the occluding net 120. At this time, a leaflet accommodating space is formed between the first clamping member 142 and the second clamping member 144 and the corresponding first clamping member 130a or second clamping member 130b.

[0122] The first clamping members 142 and the second clamping members 144 on both sides are released simultaneously or successively, and the first clamping members 142 and the second clamping members 144 cooperate with the first clamping member 130a or the second clamping member 130b to capture the anterior leaflet and the septal leaflet; then the driving core shaft 510 and the driving shaft 154 are pulled proximally to drive the first clamping member 130a or the second clamping member 130b to close, so that the anterior leaflet and the septal leaflet are clamped between the first clamping member 142 and the second clamping member 144 and the corresponding first clamping member 130a or the second clamping member 130b.

[0123] When the tissue clamping member 140 of the transcatheter atrioventricular valve clamping device 100 is observed to clamp the valve leaflet under medical imaging, for example, when the initial clamping position is already in the proper position, the adjusting member 10 does not need to be moved. If the initial clamping position is not in the proper position, the adjusting member 10 is driven to move, so that the first clamping member 142 and the second clamping member 144 move and drive the valve leaflet to move to the proper position of the first clamping member 130a or the second clamping member 130b.

[0124] The connection between the driving core shaft 510 and the driving shaft 154 is released, and the driving core shaft 510 is withdrawn, and the connection between the transcatheter atrioventricular valve clamping device 100 and the delivery device 500 is released, and then the delivery device 500 is withdrawn from the body, and the following is obtained: Fig.32 In the implanted state shown, the transcatheter atrioventricular valve clipping device 100 pulls the anterior leaflet 80a and the septal leaflet 80b of the tricuspid valve TV toward each other, completing the edge-to-edge repair of the anterior leaflet 80a and the septal leaflet 80b.

[0125] The transcatheter atrioventricular valve clamping device 100 is suitable for use in tricuspid valve clamping, and of course can also be used in mitral valve clamping, but the interventional pathways are different. For example, the interventional pathway of mitral valve clamping can be femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-left ventricle, or it can be a transapical approach.

[0126] It will be understood that the present invention covers a transcatheter atrioventricular valve repair system, including any of the above-mentioned transcatheter atrioventricular valve clamping devices and a catheter delivery system capable of delivering the transcatheter atrioventricular valve clamping device from outside the body to the vicinity of the tricuspid valve or mitral valve and clamping the valve leaflets.

[0127] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be 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 present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A transcatheter atrioventricular valve clamping device, characterized in that: include: A base, wherein the base is provided with a support rod; A first clamping member and a second clamping member, wherein the first clamping member and the second clamping member are hinged on the base and can be relatively opened or closed; A first clamping member and a second clamping member, wherein the first clamping member and the second clamping member are connected to the support rod via a connecting seat, and the first clamping member and the second clamping member respectively have a grasping element for grasping the leaflets of the atrioventricular valve; and 4. The repairing kit for automotive dents, according to claim 1, wherein the two trackbacks are connected along the vertical folding path, the trackback having the vertical folding structure and the vertical folding structure being connected along the vertical folding path. The trackback has two members, one of which is an elastic member and a member made up of the plurality of members. The elastic member and the member are both mounted on the support rod, the plurality of trackbacks are connected along the vertical folding path, and the plurality of trackbacks are connected along the vertical folding path.

2. The transcatheter atrioventricular valve clamping device according to claim 1, characterized in that: The grasping element is an anchoring barb facing the first clamping member and the second clamping member, the anchoring barb is anchored in the valve leaflet, and when the first clamping member and the second clamping member move, the anchoring barb drives the valve leaflet to move.

3. The transcatheter atrioventricular valve clamping device according to claim 1, characterized in that: The connecting seat and the adjusting member are respectively hollow and are respectively sleeved on the supporting rod. The adjusting member and the supporting rod are provided with mutually matching threads, so that the adjusting member can rotate relative to the connecting seat when rotating, and can drive the connecting seat to move along the supporting rod when moving axially.

4. The transcatheter atrioventricular valve clamping device according to claim 1, characterized in that: The length of the elastic member in a natural state is between 1.5 and 4 mm.

5. The transcatheter atrioventricular valve clamping device according to claim 1, characterized in that: The first clamping member, the second clamping member and the connecting seat are formed integrally, and the parts where the first clamping member and the second clamping member are connected to the connecting seat are bent, so that the ends of the first clamping member and the second clamping member are respectively in a natural state biased towards the first clamping member and the second clamping member.

6. The transcatheter atrioventricular valve clamping device according to claim 1, characterized in that: The support rod includes a central support rod and two side support rods, the two side support rods are lower than the central support rod, the clutch connection structure is provided at one end of the central support rod away from the base, the first clamping member and the second clamping member respectively have connecting seats, and are connected to the corresponding side support rods through the corresponding connecting seats, and the adjusting member includes two, which are respectively connected to the two connecting seats.

7. The transcatheter atrioventricular valve clamping device according to claim 1, characterized in that: The first clamping member, the second clamping member, and / or the support rod are provided with an enhanced ultrasonic imaging material.

8. A transcatheter atrioventricular valve repair system, characterized in that: It comprises the transcatheter atrioventricular valve clamping device as claimed in claim 1 and a delivery device for delivering the transcatheter atrioventricular valve clamping device to the atrioventricular valve, wherein the delivery device comprises a multi-layer catheter, wherein: The multi-layer catheter has a connector and an adjustment structure movable relative to the connector. The connector is detachably connected to the clutch connection structure. The adjustment structure is an elastic block used to cooperate with the bayonet to adjust the adjustment member so that the connecting seat overcomes the force of the elastic member and moves, thereby moving the first clamping member and the second clamping member, and driving the leaflet to move relative to the first clamping member and the second clamping member.

9. The transcatheter atrioventricular valve repair system according to claim 8, characterized in that: The multi-layer catheter includes an adjusting catheter, a connecting catheter and a guide sheath, the connecting head is formed at the distal end of the connecting catheter, the elastic block is formed at the distal end of the adjusting catheter, the adjusting catheter, the transcatheter atrioventricular valve clamping device and the connecting catheter can move in the guide sheath and can extend out of the guide sheath.

Images