CN117752471A

CN117752471A - Transcatheter atrioventricular valve pinching device and repair system

Info

Publication number: CN117752471A
Application number: CN202410126246.7A
Authority: CN
Inventors: 王建安; 刘先宝; 张伟伟; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2024-01-30
Filing date: 2024-01-30
Publication date: 2024-03-26

Abstract

The application discloses transcatheter atrioventricular valve clamping device and repair system, the transcatheter atrioventricular valve clamping device includes a base, a first clamping member and a second clamping member, and an adjusting member. The first clamping piece and the second clamping piece are hinged on the base and can be opened or closed relatively. The base is provided with a supporting rod, the first clamping piece and the second clamping piece are connected to the supporting rod, and the first clamping piece and the second clamping piece are respectively provided with a grabbing element for grabbing the valve leaflet of the atrioventricular valve. The adjusting piece is connected with the first clamping piece and the second clamping piece, and the adjusting piece can be driven to enable the first clamping piece and the second clamping piece to move under the acting force of the elastic piece, so that the grabbing element grabs the moving position of the valve leaflet of the atrioventricular valve relative to the first clamping piece and the second clamping piece.

Description

Transcatheter atrioventricular valve pinching device and repair system

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a transcatheter atrioventricular valve clamping device and a repairing system.

Background

The atrioventricular valves, such as mitral valve, tricuspid valve, etc., are check valves within the heart that allow normal healthy atrioventricular valves to control blood flow from the atrium to the ventricle while avoiding regurgitation of blood from the ventricle to the atrium, as shown in fig. 1, mitral valve MV manages blood flow from left atrium LA to left ventricle LV, and tricuspid valve TV manages blood flow from right atrium RA to right ventricle RV.

Taking the tricuspid valve as an example, the tricuspid valve is 3 triangular valve leaflets including anterior, posterior and septal leaflets attached to a fibrous stent ring of connective tissue on the right atrioventricular orifice. As a one-way valve between the right ventricle and the right atrium, the normal tricuspid valve can be opened and closed along with the cycle of the heart beat, so that when the valve is opened, blood is ensured to flow from the right atrium to the right ventricle in a directional manner, and when the valve is closed, the valve is prevented from flowing back from the right ventricle to the right atrium. When the leaflet structure on the tricuspid valve is changed organically or functionally, the "check valve" formed by the 3 leaflets is closed poorly, thereby causing a part of blood to flow back from the right ventricle to the right atrium, and the tricuspid valve as shown in fig. 2 is reversed, and the right atrium expands or other pathophysiological manifestations are caused. Serious tricuspid regurgitation can burden the right atrium, cause enlargement of the right atrium, cause congestion of the systemic circulation, and appear right heart failure manifestations such as edema of lower limbs. The difficulty of tricuspid valve treatment comes from its own structural complexity, greater annulus and orifice area, weaker leaflet tissue, etc., compared to mitral valve treatment. Current surgical treatments for tricuspid regurgitation mainly include valve replacement and tricuspid annuloplasty. However, the operation needs to be performed on chest opening and the like, and the defects of high wound degree, complex operation process, high complication risk, long recovery time and the like of the operation bring certain requirements to the physical conditions of patients, and are not suitable for the patients with poor recovery capability such as the elderly. In addition, there are also minimally invasive prosthetic procedures performed via a catheter, wherein the main solution is to draw together the two flaps She Gage via a clip, thereby reducing the regurgitation gap.

However, since the cause of regurgitation of the mitral valve or tricuspid valve is various, and the leaflets of the mitral valve or tricuspid valve are always in a state of wide-ranging, strong opening and closing movement, the leaflets themselves are difficult to grasp during the operation, and even if they are grasped, the positions where they may be grasped are not suitable, for example, the leaflets may be grasped only partially, not in full contact with the holding members. This may result in less than ideal closure or final flap She Hui slippage, allowing for repeated surgical procedures.

Disclosure of Invention

To solve or at least partially solve the above-described technical problems, the present invention provides a transcatheter atrioventricular valve clamping device and a repair system.

In a first aspect of the invention, there is provided a transcatheter atrioventricular valve occlusion device comprising:

the base is provided with a supporting rod;

the first clamping piece and the second clamping piece are hinged on the base and can be relatively unfolded or closed;

the first clamping piece and the second clamping piece are connected to the supporting rod, and each of the first clamping piece and the second clamping piece is provided with a grabbing element for grabbing the valve leaflet of the atrioventricular valve; and

And an adjusting member coupled to the first and second clamping members, the adjusting member being actuatable to move the first and second clamping members such that the gripping elements grip the petals She Xiangdui in the first and second clamping member movement positions.

In a preferred embodiment, the gripping element is an anchor towards the first and second jaws, the anchor anchoring into the leaflet, the anchor moving the leaflet as the first and second jaws move.

In a preferred embodiment, the first clamping member and the second clamping member are connected to the support rod through a connecting seat, the connecting seat and the adjusting member are hollow respectively and are sleeved on the support rod respectively, the adjusting member and the support rod are provided with mutually matched threads, and the adjusting member is connected with the connecting seat, so that the adjusting member can rotate relative to the connecting seat when rotating, and can drive the connecting seat to move along the support rod.

In a preferred embodiment, the device further comprises an elastic piece, the first clamping piece and the second clamping piece are connected to the supporting rod through a connecting seat, the elastic piece is sleeved on the supporting rod, the adjusting piece is abutted to the upper surface of the connecting seat, one end of the elastic piece is abutted to the lower surface of the connecting seat, and the other end of the elastic piece is abutted to the surface of the base.

In a preferred embodiment, the adjusting member is a sleeve or a sleeve, and at least one of the adjusting member or the support rod is provided with a thread or a roughened surface.

In a preferred embodiment, the side wall of the adjusting member is provided with a bayonet for cooperation with the catheter for adjusting the position.

In a preferred embodiment, a detachable clutch connection structure is arranged at one end of the support rod, which is far away from the base, the adjusting piece is lower than the clutch connection structure, and the first clamping piece, the second clamping piece and the connecting seat are integrally formed.

In a preferred embodiment, the support bar includes a central support bar and two side support bars, the two side support bars are lower than the central support bar, one end of the central support bar away from the base is provided with a clutch connection structure for being detachable with the catheter, the first clamping member and the second clamping member are respectively provided with a connecting seat and are connected to the corresponding side support bars through the corresponding connecting seats, and the adjusting member includes two parts to be connected with the two connecting seats respectively.

In a preferred embodiment, the first and second clamping members, and/or the support bar are provided with an ultrasound-enhancing development material.

In a second aspect of the invention, a transcatheter atrioventricular valve repair system is provided comprising a atrioventricular valve clamping device and a delivery device for delivering the atrioventricular valve clamping device to a atrioventricular valve, the delivery device comprising a multi-layered catheter, wherein,

the atrioventricular valve clamping device comprises:

the base is provided with a clutch connection structure;

the first clamping piece and the second clamping piece are connected to the base through connecting seats, and are used for clamping the valve leaflet of the atrioventricular valve in a matched mode with the first clamping piece and the second clamping piece; and

the adjusting piece and the elastic piece are respectively arranged on two opposite sides of the connecting seat and respectively abut against the connecting seat;

the multi-layer catheter is provided with a connector and an adjusting structure, the connector is detachably connected to a clutch connecting structure of the atrioventricular valve clamping device, the adjusting structure is used for adjusting the adjusting piece, so that the connecting seat overcomes the acting force of the elastic piece to move, the first clamping piece and the second clamping piece move, and the valve leaf is driven to move relatively to the first clamping piece and the second clamping piece.

In a preferred embodiment, the multilayered catheter comprises an adjustment catheter, a connection catheter and an introducer sheath, the connector being formed at a distal end of the connection catheter, the adjustment structure being formed at a distal end of the adjustment catheter, the atrioventricular valve clamping device and the connection catheter being movable in and extendable out of the introducer sheath.

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

The transcatheter atrioventricular valve clamping device and the repairing system provided by the invention have at least the following beneficial effects:

the transcatheter atrioventricular valve clamping device is provided with the driven adjusting piece, and because the adjusting piece is connected with the first clamping piece and the second clamping piece, when the first clamping piece and the second clamping piece clamp the valve leaflet of the atrioventricular valve in the operation process, the movement of the first clamping piece and the second clamping piece can drive the valve leaflet of the atrioventricular valve to move, and for the condition that the valve leaflet is redundant or the clamping is insufficient, the movement of the first clamping piece and the second clamping piece can straighten and flatten the redundant valve leaflet or drive the valve leaflet to the proper position of the first clamping piece or the second clamping piece.

Drawings

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

In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, and it will be obvious to a person skilled in the art that other drawings can be obtained from these drawings without inventive effort.

Fig. 1 is a schematic view of the mitral valve and tricuspid valve in a normal state.

Fig. 2 is a schematic view of the tricuspid valve of fig. 1 in the event of a disease.

Fig. 3 is a schematic front view of a transcatheter atrioventricular valve pinching device according to a first embodiment of the present invention.

Fig. 4 is a schematic illustration of the engagement of the base of fig. 3 with the tissue gripping member, the adjustment member, and the resilient member.

Fig. 5 is a schematic perspective view of the tissue gripper of fig. 4.

Fig. 6 is a perspective view of one embodiment of the base of fig. 4.

Fig. 7 is a perspective view of the adjustment member of fig. 4.

Fig. 8 is a perspective view of the elastic member of fig. 4.

Fig. 9 is a schematic view of the transcatheter atrioventricular valve clamping device of fig. 3 adjusting a leaflet of the atrioventricular valve.

Fig. 10 is a schematic view of the engagement of the base and locking mechanism of fig. 3.

Fig. 11 is a schematic view of a conditioning catheter of a delivery device provided by an embodiment of the present invention.

Fig. 12 is a schematic view of a multilayer catheter of a delivery device provided by an embodiment of the present invention.

Fig. 13 is a schematic view of the connection catheter of fig. 12 connected to an atrioventricular valve clamping device.

Fig. 14 is a schematic view of the adjustment catheter of fig. 11 in cooperation with an adjustment member to adjust the atrioventricular valve clamping device.

Fig. 15 is a schematic view of tricuspid insufficiency in FTR patients.

Fig. 16 is a schematic view of a transcatheter atrioventricular valve pinching device having a occluding mesh provided by an embodiment of the present invention.

Fig. 17 is a schematic perspective view of a base provided in a variant embodiment.

Fig. 18 is a schematic perspective view of an adjustment member provided in a modified embodiment.

Fig. 19 is a schematic view of a support bar of a base provided with a developing mark according to an embodiment of the present invention.

Fig. 20 is a schematic perspective view of a transcatheter atrioventricular valve pinching device according to a second embodiment of the present invention.

Fig. 21 is a schematic view of the adjustment member and support rod mating relationship of the transcatheter atrioventricular valve clamping device of fig. 20.

Fig. 22 is a schematic perspective view of a transcatheter atrioventricular valve pinching device according to a third embodiment of the present invention.

Fig. 23 is a schematic view of the engagement of the base, tissue gripper and adjustment assembly of fig. 22.

Fig. 24 is a perspective view of a split clamp of the tissue clamp of fig. 22.

Fig. 25 is a schematic representation of one leaflet prolapse and the other leaflet shortness of the tricuspid valve of a DTR patient.

Fig. 26 is a schematic illustration of the initial gripping position of the tricuspid valve leaflet of the transcatheter atrioventricular valve gripping device of fig. 22 on a DTR patient.

Fig. 27 is a schematic view of the transcatheter atrioventricular valve clamping device of fig. 26 after adjustment of the clamping position of the leaflet.

Fig. 28 is a schematic front view of a transcatheter atrioventricular valve pinching device according to a fourth embodiment of the present invention.

Fig. 29 is a schematic illustration of a transcatheter atrioventricular valve repair system for performing repair of adjacent leaflets of a tricuspid valve according to an embodiment of the invention.

Fig. 30 is a schematic view of the transcatheter atrioventricular valve clamping device of fig. 29 in a closed clamping position.

Fig. 31 is a schematic view of the transcatheter atrioventricular valve occlusion device of fig. 30 separated from a delivery device.

Fig. 32 is a schematic illustration of a transcatheter atrioventricular valve clamping device according to an embodiment of the present invention after repair of adjacent leaflets of a tricuspid valve.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.

In describing the present invention, it should be noted that:

the terms "upper," "lower," "inner," "outer," and the like are used for convenience in describing and simplifying the description only, and do not denote or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance;

when an element is referred to as being "fixed" or "disposed on" another element, it can be directly connected to the other element or be 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 can be directly connected to the other element or be connected to the other element by one or more connecting elements.

In the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the direction of the rotation central axis of the column body, the tube body and other objects is defined as an axial direction; the circumferential direction is the direction (perpendicular to the axis and the radius of the section) around the axis of the cylinder, the pipe body and the like; radial refers to a direction along the wire diameter or radius. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs. The above definitions are for convenience of description only and are not to be construed as limiting the invention.

The transcatheter atrioventricular valve clamping device is used for repairing heart valves, particularly mitral valves and tricuspid valves, and achieves the purposes of reducing valve leaflet gaps and relieving mitral valve or tricuspid valve regurgitation.

Referring to fig. 3 to 5, a transcatheter atrioventricular valve clamping device 100 according to a first embodiment of the present invention mainly includes a base 110, a clamping assembly 130, and a tissue clamping member 140. The tissue gripper 140 is used to grip the leaflets of the valve in cooperation with the clamping assembly 130.

The clamping assembly 130 is hinged to the base 110, and the tissue gripper 140 may also be connected to the base 110. In this embodiment, the base 110 includes a main body 112, and a supporting rod 114 disposed on the main body 112, the supporting rod 114 is fixedly connected to or integrally formed with the main body 112, the clamping assembly 130 is hinged to the main body 112, and the tissue clamping member 140 is connected to the supporting rod 114.

The clamping assembly 130 includes a first clamping member 130a and a second clamping member 130b, where the first clamping member 130a and the second clamping member 130b are disposed on two opposite sides of the main body 112 in a paddle shape, and in this embodiment, the first clamping member 130a and the second clamping member 130b are hinged on the main body 112 and extend to two sides. The articulation herein and in this application includes a swivel, hinge, or the like, that allows one element to rotate relative to the other element, i.e., the first and second clamp members 130a, 130b can rotate relative to the body portion 112. In this embodiment, the first clamping member 130a and the second clamping member 130b are hinged to the main body 112 at a common hinge point 112a, and in other embodiments, may be hinged to the main body 112 at different hinge points.

The tissue clamping member 140 includes a first clamping member 142 and a second clamping member 144, and in this embodiment, the first clamping member 142 and the second clamping member 144 share a connecting seat, i.e., are integrally connected by 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 supporting rod 114.

The first clamping member 142 and the second clamping member 144 may be preformed to have a natural state biased toward the first clamping member 130a and the second clamping member 130b, for example, bending at the connection portion of the first clamping member 142 and the second clamping member 144 with the connection seat 146, so that the ends of the first clamping member 142 and the second clamping member 144 have a natural state biased against the first clamping member 130a and the second clamping member 130b, which is 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 leaflet of the atrioventricular valve. The bending amplitude of the connection portion between the first clamping member 142 and the second clamping member 144 and the connection seat 146 can be designed according to the requirements of the clamping angle.

The first and second clamps 142, 144 may be provided with threading holes 142b, 144b through ends for pulling the first and second clamps 142, 144 through the control lines 142c, 144 c.

The first and second clamping members 142 and 144 are made of an elastic material or a material having a shape memory function, are deformed when an external force is applied, and tend to be restored to the original shape and position due to elasticity or shape memory ability after the external force is removed, so that the first and second clamping members 142 and 144 can be pulled toward the center of the connection seat 146 during the delivery process, and can be restored to a natural state of not being applied with an external force due to their own material characteristics after being released, in which the first and second clamping members 142 and 144 can be coupled to the leaflet, thereby being capable of clamping the leaflet in cooperation with the first or second clamping members 130a and 130 b. In this embodiment, the materials of the first clamping member 142 and the second clamping member 144 are nickel-titanium alloy with shape memory function.

In a preferred embodiment, the first and second clamps 142, 144 are provided with gripping elements 142a,144a, respectively, which gripping elements 142a,144a are used to grip the leaflets of the atrioventricular valve. In this embodiment, the gripping members 142a,144a are anchors directed toward the first and second clamping members 130a, 130b, the anchors being in a plurality of rows and having a degree of inclination, the anchors being capable of anchoring into the leaflets of the atrioventricular valve. In other embodiments, the gripping elements 142a,144a may also be other structures that face the first and second clamping members 130a, 130b, such as bumps, which may grip the leaflets of the atrioventricular valve due to their softness.

Referring to fig. 6 to 8, in 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 base 146.

In this embodiment, the elastic member 20 is disposed between the connection seat 146 and the surface of the main body 112 of the base 110, and the adjusting member 10 is disposed above the connection seat 146. In this embodiment, the elastic member 20 is an annular spring, the adjusting member 10 is a sleeve, and the adjusting member 10 and the elastic member 20 are respectively sleeved on the supporting rod 114 and respectively abut against the connecting seat 146. The elastic member 20 plays a role of supporting and balancing the connection base 146, and has a pushing force on the connection base 146 when the adjusting member 10 is adjusted. In this embodiment, the adjusting element 10 is not necessarily fixedly connected to the connecting socket 146, but the adjusting element 10 is only adjustably fastened to the support rod 114 under the effect of an adjusting force.

The adjustment member 10 is provided with a plurality of bayonets 10a for cooperating with adjustment formations 530a (see fig. 11) on an adjustment conduit of the delivery device to apply a force to the adjustment member 10 to adjust the adjustment member 10. In this embodiment, the bayonets 10a are two opposite, and open directly downward from the end face of the adjusting member 10. In other embodiments, the bayonet 10a may also be formed on the side of the adjustment member 10, which cooperates with an adjustment structure 530a on the adjustment conduit of the delivery device.

The support rod 114 is provided with a damping portion 114b, for example, the damping portion 114b may be a section of screw thread, the damping portion 114b may be disposed 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 polished rod section, where the polished rod section is a sleeved section of the elastic member 20. The inner surface of the adjusting member 10 may also be provided with threads 10b, and the adjusting member 10 may be moved along the supporting rod 114 by rotating the adjusting member 10, so as to push the connecting seat 146 against the elastic pushing force of the elastic member 20, so as to move along the supporting rod 114, thereby moving the first clamping member 142 and the second clamping member 144 relative to the first clamping member 130a and the second clamping member 130 b.

The elastic member 20 may be selected to have a suitable length according to the need, for example, a longer length of the elastic member 20 may enable the tissue clamping member 140 to be moved in an adjustable manner, and a shorter length of the elastic member 20 may enable the tissue clamping member 140 to be moved closer to the clamping assembly 130, thereby facilitating the clamping of the valve leaflet. The different lengths of the elastic member 20 adapt to different valve leaflet conditions, such as a condition that the valve leaflet is short, the adjustable distance is limited, and the valve leaflet condition of a patient can be observed through medical images before operation to select the elastic member 20 with proper length for assembly. In this embodiment, the length of the elastic member 20 in the natural state is between 1.5 and 4mm, preferably between 2 and 3mm.

When the transcatheter atrioventricular valve clamping device 100 of the present invention is in an atrioventricular valve, such as a tricuspid valve operation position, the first clamping member 130a and the second clamping member 130b are positioned below the leaflet to be clamped of the tricuspid valve, the first clamping member 142 and the second clamping member 144 are positioned above the leaflet to be clamped of the tricuspid valve, 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 leaflet and the right leaflet. The gripping members 142a,144a may be anchored into the leaflet.

Referring to fig. 9, after the leaflet is clamped, when the first clamping member 142 and the second clamping member 144 move, the flexible leaflet 80a, 80b is combed and the leaflet 80a, 80b is driven to move, for example, when the leaflet is lengthy or the clamping is insufficient, the movement of the first clamping member 142 and the second clamping member 144 can smooth the lengthy leaflet, or the leaflet not clamped in place can be readjusted to the position of the first clamping member 130a or the second clamping member 130 b. The physician can view the direction in which the leaflet is to be adjusted under the ultrasound image, thereby allowing the leaflet to move properly to the proper gripping position by adjusting the adjusting member 10 upward or adjusting the adjusting member 10 downward. In fig. 9, the adjustment member 10 is adjusted downward to move the leaflet a distance H to increase the depth of the gripping.

The adjusting member 10 of the present invention is used to control movement of the first clamping member 142 and the second clamping member 144 to move the leaflet to the proper position when the leaflet is not clamped in the proper 162 position 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, when the length of the clamped leaflet is too short.

Referring to fig. 3, 6 and 10, the main body 112 of the base 110 is hollow, 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 passage of the main body 112.

As shown in fig. 3, the transcatheter atrioventricular valve clamping device 100 comprises a driving mechanism 150, the driving mechanism 150 comprising a driving shaft 154, the driving shaft 154 being adapted to drive the first clamping member 130a and the second clamping member 130b to relatively open or close, the driving shaft 154 passing through the hollow passage of the base 110 and extending into the support rod 114 for connection with a driving spindle 510 (see fig. 12) of the delivery device.

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 ends of the two connecting rods 153 are respectively hinged to two ends of the base 152, and the other ends of the two connecting rods are respectively and 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 may move up and down along with the driving shaft 154, thereby causing the link 153 to rotate relative to the base 152, and the link 153 may rotate to pull or drive the first and second clamping members 130a and 130b to open or close.

As shown in fig. 10, a locking mechanism 113 may be disposed in the hollow interior of the main body 112, the locking mechanism 113 may engage the steel sheet 113b with the driving shaft 154 to lock the driving shaft 154 by engaging the steel sheet 113a with the steel sheet 113b, or disengage the engagement to move the driving shaft 154 up and down, and the locking mechanism 113 may be controlled by unlocking the elastic wire 115a and the control wire 115b extending to the doctor control end of the delivery device. The locking mechanism 113 also functions to re-unlock and re-clip when the leaflet is clipped in an improper position.

Referring to fig. 3 and 11-14, the distal end of the support rod 114 of the transcatheter atrioventricular valve clamping device 100 is provided with a clutch connection structure 114a, and the delivery device 500 of the transcatheter atrioventricular valve clamping device 100 comprises a multi-layer catheter and a driving mandrel 510, wherein the multi-layer catheter comprises an adjusting catheter 530, a connecting catheter 520 and an guiding sheath 540. The drive spindle 510 is axially movable or independently rotatable within the connecting conduit 520. The adjustment catheter 530 has an inner diameter greater than the drive mandrel 510, and the adjustment catheter 530 is also axially movable or independently rotatable within the connecting catheter 520 and is located outside the drive mandrel 510.

The end of the connecting duct 520 is provided with a connector 520a, and the connector 520a is provided with a structure matched with the clutch connection structure 114a so as to be detachably connected with the clutch connection structure 114 a. The drive mandrel 510 is removably coupled, such as threadably coupled, to the drive shaft 154 of the transcatheter atrioventricular valve clamping device 100. The clutch connection 114a of the support rod 114 of the transcatheter atrioventricular valve clamping device 100 is connected to the connector 520a of the connecting catheter 520 in advance before delivery.

The distal end of the adjustment catheter 530 has an adjustment structure 530a, the adjustment structure 530a being in the form of a resilient clip which is slightly deformable to snap into the bayonet 10a of the adjustment member 10 and which is releasable from the bayonet 10a when the tension force with the adjustment member 10 is greater than a certain value. In this embodiment, the adjusting structure 530a may be driven to rotate the adjusting member 10 by rotation, and move the adjusting member 10 on the supporting rod 114 to drive the first clamping member 142 and the second clamping member 144 to move.

In actual use, the connecting catheter 520 may be a single length, the length of connecting catheter 520 may be secured to the distal end of a multi-lumen tube, and the multiple channels of the multi-lumen tube may be used to house the control wires of the tissue gripper 140, as well as the control wires of the locking mechanism 113.

The adjustment catheter 530, transcatheter atrioventricular valve clamping device 100 and connecting catheter 520 described above, together with the multi-lumen tube, can be moved in the introducer sheath 540 and extend out of the introducer sheath 540.

After the adjustment of the adjustment member 10 by the adjustment catheter 530, the adjustment catheter 530 can be retracted, i.e., moved proximally, so as not to interfere with the disconnection of the connecting catheter 520 from the clutch connection 114 a.

Clinically, there is a type of tricuspid regurgitation (Functional Tricuspid Regurgitation, FTR) with valve functionality, referring to fig. 15, the tricuspid valve of the FTR patient cannot be closed naturally, for example, the coaptation margin of the front leaflet 80a and the septum 80b is insufficient, which easily results in insufficient gripping length of the front leaflet 80a and the septum 80b by the catheter atrioventricular valve gripping device 100, at this time, referring again to fig. 9, the first gripping member 142 and the second gripping member 144 are driven to move, so that the gripping members 142a and 144a grip the front leaflet 80a and the septum 80b to pull toward the center of the connecting seat 146, and the gripped lengths of the front leaflet 80a and the septum 80b are adjusted to a sufficient position, i.e. to conform to the proper gripping position of the FTR patient. So that the anterior leaflet 80a and the septal leaflet 80b of the FTR patient can be held in place by the transcatheter atrioventricular valve clamping device 100.

Referring to fig. 16, in a preferred embodiment, the transcatheter atrioventricular valve device 100 is provided with a occluding mesh 120 on the support shaft 114. The plugging net 120 is a three-dimensional net structure, preferably a three-dimensional net structure formed by weaving wires or cutting tubes with a shape memory function, for example, super-elastic materials such as nitinol wires, and the plugging net 120 can adapt to gaps between different valve leaflets to generate self-adaptive deformation, so that the pulling degree of the valve prosthetic device 100 on the valve leaflets is adjusted, and the plugging effect of the plugging net is better for treating regurgitation.

The plugging net 120 may have one end fixed to the support rod 114 via a shaft sleeve, 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 connection conduit 520 of the conveying device extends into the opening 120a to be connected with the clutch connection structure 114 a.

Referring to fig. 17 and 18, in a modified embodiment, a base 160 is provided, and the base 160 is different from the base 110 in that: the damping section 164b of the support bar 164 of the base 160 is unthreaded and has only a roughened surface. The adjustment member 60 may take the form of the internal threads of the adjustment member 10 described above, or may take the form of an internal roughened surface 60a as shown in fig. 18. The threads and roughened surface are both dampening, allowing the adjustment member to be secured to the support bar and moved only by external forces such as adjustment conduit 530 (see fig. 11). When the adjusting member 60 is the inner rough surface 60a, the adjusting conduit 530 can directly push the adjusting member 60 downward; when the adjustment member 60 is internally threaded, the adjustment conduit 530 can rotate the adjustment member 60 in a forward direction or rotate the adjustment member 60 in a reverse direction to move the adjustment member 60 downward or upward. The elastic member 20 may be fixed at one end to the base 160.

When only one of the support rod and the adjustment member has an internal thread, or both have a rough surface, the adjustment member 60 may not rotate but only move. The adjustment member 60, and thus the first and second clamping members 142, 144, can be moved by the adjustment conduit 530.

Referring to fig. 19, in the embodiment of the present invention, an ultrasonic-enhanced developing material 170a may be disposed on the support bar 174 of the base 170, so that a doctor can observe the movement of the first and second clamps under the ultrasonic sound and know the adjustment distance when the first and second clamps are moved. The ultrasonically enhanced developing material 170a may be on the damping section 174 b.

In other embodiments, the ultrasonically enhanced developing material 170a may also be disposed on the first and second clamps described above, which may be observed under ultrasound as the first and second clamps move.

Referring to fig. 20-21, a second embodiment of the present invention provides a transcatheter atrioventricular valve device 200 in which the adjustment member 70 is in the form of a sleeve that is longer than the length of the adjustment member in the form of the sleeve, thereby facilitating coupling of the adjustment catheter 530 (see fig. 11). The adjusting member 70 and the elastic member 75 still respectively abut against the connecting seats 246 of the first clamping member 242 and the second clamping member 244. The elongated adjustment member 70 may still facilitate access to the previously described occluding and retaining mesh (see figure 16). The inner side of the elongated adjustment member 70 has internal threads that may still be threadably coupled to the support rod 274.

The bayonet 70a of the adjuster 70 may be lower than the clutch connection 274a of the support bar 274. When it is desired to adjust the adjustment member 70, the adjustment conduit 530 is coupled to the bayonet 70a of the adjustment member 70 to rotate or move the adjustment member 70, and when the adjustment is completed, the adjustment conduit 530 can be retracted so as not to interfere with the disengagement of the clutch connection 274a of the support rod 274 from the connection conduit 520 (see FIG. 12).

Referring to fig. 22-24 together, a third embodiment of the present invention provides a transcatheter atrioventricular valve clamping device 300, in which the base 380 includes a central support rod 381 and two side support rods 382 disposed on the side of the central support rod 381, the two side support rods 382 are lower than the central support rod 381, and a clutch connection structure 381a is disposed at an end of the central support rod 381 away from the base 380.

In this example, the first clamping member 342 and the second clamping member 344 are separate, each have the connection base 342a, 344a, and are connected to the two side support rods 382 through the corresponding connection base 342a, 344a, and the two sets of adjusting members 81, 82 and the elastic members 83, 84 are respectively disposed on two opposite sides of the two connection bases 342a, 344 a.

Since the first and second clamping members 342 and 344 are separated, the two sets of adjusting members 81 and 82 and the elastic members 83 and 84 can respectively adjust the first and second clamping members 342 and 344, thereby respectively adjusting the leaflet clamped between the first and second clamping members 342 and 330a or the leaflet clamped between the second clamping member 344 and 330 b.

Clinically, patients with heart tricuspid regurgitation have a type of degenerative tricuspid regurgitation (Degenerative Tricuspid Regurgitation, DTR). Referring to fig. 25-27, the tricuspid valve of the dtr patient has one leaflet 610a prolapsed and the other leaflet 620a is shorter, and in the initial gripping position of fig. 26, the leaflet 610a is held in redundancy and the leaflet 620a is not sufficiently long to be gripped. By applying the adjustment member 81 of the transcatheter atrioventricular valve clamping device 300 of the present invention to slightly adjust the leaflet 610a to straighten, the operation of the adjustment member to which the leaflet 620a is not sufficiently clamped with reference to the aforementioned FTR patient pulls the moving leaflet 620a so that the clamped length of the leaflet 620a is adjusted to a sufficient position to conform to the proper clamping position of the treated DTR patient, as shown in fig. 27.

The repair procedure of the transcatheter atrioventricular valve clamping device of the present invention is performed under medical imaging, such as ultrasound, or in conjunction with guidance and monitoring by CT, magnetic Resonance (MRI), digital Subtraction Angiography (DSA), where the clamping of the leaflets by the tissue clamping member of the transcatheter atrioventricular valve clamping device is observed, e.g. the initial clamping position is already in place, and the adjustment member may not be moved.

In some cases, it is also possible that the single leaflet has too long a clamping depth, and the adjusting member can be reversely rotated to reversely move, so that the leaflet moves along with the first clamping member 342 or the second clamping member 344 to a proper 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.

Referring to fig. 28, a fourth embodiment of the present invention provides a transcatheter atrioventricular valve clamping device 400, wherein the transcatheter atrioventricular valve clamping device 400 is different from the transcatheter atrioventricular valve clamping device 100 described above in that: the transcatheter atrioventricular valve clamping device 400 is not provided with an elastic member, and the adjusting member 10 is connected with the connecting seat 146 of the first clamping member 142 and the second clamping member 144, so that the adjusting member 10 can rotate relative to the connecting seat 146 when rotating, and can drive the connecting seat 146 to axially move along the supporting rod 114.

The adjusting member 10 and the connecting seat 146 are both sleeved on the supporting rod 114, and internal threads are disposed in the adjusting member 10, and a section of external threads may be disposed on the supporting rod 114. 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 required, so that the purpose of the invention can be achieved without providing an elastic member on the lower surface of the connecting seat 146.

In this embodiment, the connection manner between the adjusting member 10 and the connecting seat 146 may be, for example, a T-shaped slot (not shown) formed in a wall of the connecting seat 146, the adjusting member 10 is accommodated in the T-shaped slot, the adjusting member 10 can rotate independently in the T-shaped slot, the connecting seat 146 is not caused to rotate, and the adjusting member 10 can push the connecting seat 146 to move axially together when moving axially.

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, and in this case, the bending width of the connection portion between the first clamping member 142 and the second clamping member 144 and the connection seat 146 may be slightly smaller, so that the grasping elements 142a,144a on the first clamping member 142 and the second clamping member 144 can still grasp the valve leaflet.

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 leaflet, and the tissue clamping member is provided with an adjustment member that is controllably movable so that when the leaflet is not clamped in place, e.g., too short a clamping length, the transcatheter atrioventricular valve clamping device does not have to reopen the tissue clamping member to re-clamp, and only the adjustment member is used to move the leaflet into place.

The surfaces of the above-mentioned clamping assemblies, the surfaces of the tissue clamping members may be covered with a respective coating (not shown), which may be made of a biocompatible, oxidation-resistant, dissolution-resistant polymer material, such as PET, ePTFE, polyester, PTFE, silicone, urethane, metal fiber, or other biocompatible polymer, preferably PET material. It is understood that a coating made of biocompatible material can promote endothelial cell climbing and can effectively reduce rejection reactions caused by direct contact of metal with biological tissue.

The transcatheter atrioventricular valve clamping device of the present invention may be applied to regurgitation treatment of heart valves, including mitral or tricuspid valves, as exemplified by the anterior leaflet and septal leaflet repair procedure of the tricuspid valve, and exemplified by transcatheter atrioventricular valve clamping device 100 with a blocking mesh 120, as exemplified by transcatheter atrioventricular valve clamping device 100 being delivered to the tricuspid valve via delivery device 500, delivery device 500 consisting essentially of a connecting catheter 520, a drive mandrel 510 and an adjustment catheter 530 delivered within connecting catheter 520, and an introducer sheath 540, as shown in fig. 3, 16, 29-32.

The drive shaft 154 of the transcatheter atrioventricular valve clamping device 100 is detachably connected to the drive spindle 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 adjustment catheter 530 pass through the introducer sheath 540. The introducer sheath 540 has a deflection function that may assist in accessing the patient's heart.

The surgical method of operation of the transcatheter atrioventricular valve clamping device 100 described above generally includes the steps of:

the distal end of the delivery device 500 and the transcatheter atrioventricular valve clamping device 100 are delivered via the inferior vena cava to the right atrium RA 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 which time the first and second clamps 142, 144 of the tissue clamp 140 are pulled with a control wire.

Unlocking the locking mechanism in the base 110, pushing the drive mandrel 510 and the drive shaft 154 distally, driving the first and second clamping members 130a, 130b to open relative to the blocking net 120, adjusting the direction of the first and second clamping members 130a, 130b, at which time the relative positions of the first and second clamping members 130a, 130b and the anterior leaflet and the septal leaflet of the tricuspid valve TV can be observed by a medical developing or imaging device, such that the first and second clamping members 130a, 130b are substantially perpendicular to the free edges of the anterior leaflet and septal leaflet; pushing the transcatheter atrioventricular valve clamping device 100 to the right ventricle RV by the conveying device 500, placing the transcatheter atrioventricular valve clamping device 100 under the anterior leaflet and the septal leaflet, and continuing to open the first clamping member 130a and the second clamping member 130b to the capturing position; meanwhile, the first clamping member 142 and the second clamping member 144 are controlled to be attached to the outer surface of the plugging web 120, and 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, respectively.

Simultaneously or sequentially releasing the first clamping piece 142 and the second clamping piece 144 on two sides, wherein the first clamping piece 142 and the second clamping piece 144 are matched with the first clamping piece 130a or the second clamping piece 130b to capture the front leaf and the partition leaf; the drive mandrel 510 and drive shaft 154 are then pulled proximally, thereby driving the first or second clamp 130a, 130b closed such that the anterior leaflet and septal leaflet are clamped between the first and second clamps 142, 144 and the corresponding first or second clamp 130a, 130 b.

The adjustment member 10 may not be moved when the clamping of the leaflet by the tissue clamping member 140 of the transcatheter atrioventricular valve clamping device 100 is observed under medical imaging, e.g. the initial clamping position is already in place. If the initial clamping position is not in place, the adjustment member 10 is driven to move so that the first and second clamping members 142, 144 move and drive the leaflet to move to the proper position of the first or second clamping member 130a, 130 b.

The connection between the drive mandrel 510 and the drive shaft 154 is released and the drive mandrel 510 is withdrawn, the connection between the catheter atrioventricular valve clamping device 100 and the delivery device 500 is released, after which the delivery device 500 is withdrawn from the body to obtain the implanted state shown in fig. 32, and the anterior leaflet 80a and the septal leaflet 80b of the tricuspid valve TV are pulled toward each other via the catheter atrioventricular valve clamping device 100, completing the edge-to-edge repair of the anterior leaflet 80a and the septal leaflet 80 b.

The transcatheter atrioventricular valve device 100 is suitable for use in tricuspid valve surgery, although it may be used in mitral valve surgery, with the exception of the path of intervention, which may be femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-left ventricle, or via the transapical approach.

It is to be understood that the present invention encompasses transcatheter atrioventricular valve repair systems, including any of the transcatheter atrioventricular valve clamping devices described above, as well as catheter delivery systems 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 leaflets.

The foregoing is only a specific embodiment of the invention to enable those skilled in the art to understand or practice the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A transcatheter atrioventricular valve occlusion device, comprising:

the base is provided with a supporting rod;

2. The transcatheter atrioventricular valve clamping device of claim 1, wherein the gripping element is an anchor towards the first and second clamping members, the anchor anchoring into the leaflet, the anchor moving the leaflet upon movement of the first and second clamping members.

3. The transcatheter atrioventricular valve clamping device according to claim 1, wherein the first clamping member and the second clamping member are connected to the support rod through connecting seats, the connecting seats and the adjusting members are hollow respectively and sleeved on the support rod respectively, the adjusting members and the support rod are provided with mutually matched threads, and the adjusting members are connected with the connecting seats, so that the adjusting members can rotate relative to the connecting seats when rotating, and can drive the connecting seats to move along the support rod when axially moving.

4. The transcatheter atrioventricular valve clamping device according to claim 1, further comprising an elastic member, wherein the first clamping member and the second clamping member are connected to the support rod through a connecting seat, the elastic member is sleeved on the support rod, the adjusting member is abutted to the upper surface of the connecting seat, one end of the elastic member is abutted to the lower surface of the connecting seat, and the other end of the elastic member is abutted to the surface of the base.

5. The transcatheter atrioventricular valve clamping device of claim 4, wherein the adjustment member is a sleeve or sleeve and at least one of the adjustment member or the support rod is provided with a thread or roughened surface.

6. A transcatheter atrioventricular valve clip device according to claim 3 or claim 5, wherein the side wall of the adjustment member is provided with a bayonet for cooperation with a catheter for position adjustment.

7. The transcatheter atrioventricular valve clamping device according to claim 3 or 4, wherein the end of the support rod remote from the base is provided with a clutch connection structure for detachable connection with a catheter, the adjusting member is lower than the clutch connection structure, and the first clamping member, the second clamping member and the connection base are integrally formed.

8. The transcatheter atrioventricular valve clamping device according to claim 1, wherein the support bar comprises a central support bar and two side support bars, the two side support bars being lower than the central support bar, one end of the central support bar remote from the base being provided with a clutch connection structure for detachable connection with a catheter, the first clamping member and the second clamping member each having a connection seat and being connected to the corresponding side support bar by the corresponding connection seat, the adjusting member comprising two members for connection with the two connection seats, respectively.

9. A transcatheter atrioventricular valve clamping device according to claim 3 or 4, wherein the first and second clamping members and/or the support bar are provided with an ultrasound-enhancing visualization material.

10. A transcatheter atrioventricular valve repair system comprising an atrioventricular valve clamping device and a delivery device for delivering the atrioventricular valve clamping device to an atrioventricular valve, the delivery device comprising a multi-layered catheter, wherein,

the atrioventricular valve clamping device comprises:

the base is provided with a clutch connection structure;

11. The transcatheter atrioventricular valve repair system of claim 10, wherein the multi-layered catheter comprises an adjustment catheter, a connection catheter, and an introducer sheath, the connector being formed at a distal end of the connection catheter, the adjustment structure being formed at a distal end of the adjustment catheter, the atrioventricular valve clamping device, and the connection catheter being movable within and extendable from the introducer sheath.

12. The transcatheter atrioventricular valve repair system of claim 11, wherein the side wall of the adjustment member is provided with a bayonet, and wherein the adjustment structure is a resilient clip formed at a distal end of the adjustment catheter.