CN218220396U - Mitral annulus contracting device - Google Patents

Abstract

The utility model discloses a mitral annular constriction device, which comprises a far-end anchor for anchoring in the great cardiac vein near the intersection position of the circumflex artery and a near-end anchor for anchoring in the coronary sinus; the proximal anchor and the distal anchor are connected by a connecting piece; an arch for spanning over the coronary artery is provided in the distal outer portion of the distal anchor, the proximal outer portion of the distal anchor, or the distal anchor, and the arch is arched in a direction toward the apex of the distal anchor. The utility model discloses be suitable for different patients, do not oppress the arteria gyri, guarantee that the mitral valve ring contracts the device and can surround the peripheral long as possible distance of mitral valve ring, when taut mitral valve ring contracts the device, can increase the degree that the mitral valve ring dwindles, improve the palirrhea curative effect of mitral valve, adapt to wider clinical application scope.

Description

Mitral annulus contracting device

Technical Field

The utility model belongs to the technical field of intervene medical instrument, a mitral valve ring contracts device is related to.

Background

The mitral valve is the most critical valve in the heart, which is located in the left ventricular opening between the left atrium and the left ventricle, and is intended to prevent backflow of blood from the left ventricle to the left atrium when the left ventricle contracts. In a healthy mitral valve, the geometry of the mitral valve ensures that the leaflets overlap each other to prevent backflow of blood during left ventricular contraction. Dilated cardiomyopathy, caused by disease or certain natural defects, may impair the proper functioning of the mitral valve in preventing regurgitation. For example, certain diseases may dilate the mitral annulus, distorting the mitral valve geometry, causing mitral insufficiency during left ventricular contraction, resulting in blood leakage and regurgitation.

Surgery is an effective method for treating mitral insufficiency, but the surgery causes great trauma to human bodies, and has more complications and higher mortality rate for elderly patients and patients with more complications.

At present, minimally invasive interventional surgery is the more preferable choice for most heart valve diseases, and the main interventional therapy modes include artificial chordae tendineae implantation, mitral valve annuloplasty, mitral valve edge-to-edge repair and the like. Wherein the annuloplasty includes a direct annuloplasty and an indirect annuloplasty. Indirect annuloplasty is mainly to tighten the vascular tissue around the mitral valve annulus to achieve the purpose of contracting the mitral valve annulus and closing and compacting the mitral valve leaflets. The coronary sinus-great cardiac vein is mainly a blood vessel around the periphery of the mitral annulus, which also makes it the best implant for indirect annuloplasty.

One currently available solution is to implant a device through the jugular vein into the body, in the coronary sinus and the great cardiac vein, with two anchoring elements, a distal anchor anchored in the great cardiac vein and a proximal anchor anchored in the coronary sinus, connected by a connecting element. By tightening the device, inward pressure is applied to the mitral annulus, which contracts and substantially restores normal geometry, thereby causing the mitral leaflets to close tightly and improve mitral regurgitation. But a part of the population has the coronary arteries located beneath the coronary sinus-great cardiac vein and crossed. In order to achieve the best treatment, the distal anchor is anchored as close as possible to the intersection of the circumflex artery and the coronary sinus-great cardiac vein. However, after the device is tensioned, the great cardiac vein at the upper part of the coronary artery can be pulled straight, tensed and pressed down by the rearward pulling force of the distal anchor, and the great cardiac vein is pressed to the coronary artery, so that the blood flow of the artery is insufficient, and the myocardial infarction and the like are caused. In order to avoid compressing the coronary artery as much as possible, the device can only be placed between the proximal end of the intersection of the rotary artery and the great cardiac vein and the coronary sinus ostium, and because the distance between the proximal end of the intersection of the rotary artery and the great cardiac vein and the coronary sinus ostium is smaller and the position of the valve ring corresponding to the posterior mitral valve is a region P2-P3, the distance for tensioning and contracting of the device is smaller, the degree of contracting of the mitral valve ring is smaller, and the effect of treating the mitral valve is poor. The range of indications is small.

Another technical scheme is that a ring ligature is used, enters the coronary sinus after entering the right atrium through the jugular vein, passes through the great cardiac vein, enters the right ventricle through the septum vein of the proximal ventricle, and returns to the right atrium again after passing through the tricuspid valve. A closed loop around the mitral annulus is formed by the above paths. And then applying tension to tighten the ring tying rope to achieve the effect of tightening the mitral valve ring, so that the mitral valve leaflets close and compact, and the mitral valve regurgitation is improved. The cerclage rope is provided with a coronary artery protector which is connected with the cerclage rope by using PTFE biocompatible materials. For preventing the cerclage rope from pressing against the coronary artery when the cerclage rope is tightened. However, the coronary artery protector and the cerclage rope are coated and connected together by using biocompatible high polymer materials such as PTFE, the coating belongs to flexible connection, the connecting force is not large enough, and the coronary artery protector and the cerclage rope can be displaced when the heart beats. In addition, although the cerclage rope is in a tightened state, the cerclage rope is not effectively fixed in the coronary sinus-great cardiac vein, and the cerclage rope can be displaced when the heart beats, so that the coronary artery protector is also displaced, and the cerclage rope cannot play a role in protecting the coronary artery against compression.

SUMMERY OF THE UTILITY MODEL

The to-be-solved technical problem of the utility model lies in, to prior art's defect, provide a mitral valve ring device that contracts, the device is suitable for different patients, does not oppress the artery that circles round, guarantees that mitral valve ring contracts the device and can surround the peripheral as long as possible distance of mitral valve ring, and during taut mitral valve ring contracts the device, can increase the degree that mitral valve ring dwindles, improves the palirrhea curative effect of mitral valve, adapts to wider clinical application scope.

The utility model provides a technical scheme that its technical problem adopted is:

a mitral annuloplasty device comprising a distal anchor for anchoring in the great cardiac vein near the intersection with a circumflex artery, a proximal anchor for anchoring in the coronary sinus; the proximal anchor and the distal anchor are connected by a connecting piece;

an arch for spanning over the coronary artery is provided in the distal outer portion of the distal anchor, the proximal outer portion of the distal anchor, or the distal anchor, and the arch is arched in a direction toward the apex of the distal anchor.

Further, in the mitral valve annular compressing device, it is preferable that the arch includes a bottom portion extending axially outward from or disposed inside the bottom portion of the distal anchor and arched toward the top portion of the distal anchor.

Further, in the mitral valve annular constriction device, it is preferable that at least the top of the arch is a non-sharp smooth structure.

Further, in the mitral valve annular ring compressing device, preferably, the arch of the arch located beyond the distal end of the distal anchor has a guide portion extending outward.

Furthermore, in the mitral valve annular contraction device, the guide part is preferably provided with a hollow structure or an inner concave structure for improving the flexibility of the guide part; or the guide part is a bendable structure made of flexible materials.

Further, in the mitral valve annular constriction device, preferably, the arch-shaped member is a single tubular or thick wire, or the arch-shaped member is a twisted structure of two or more strands.

Further, in the mitral annular constriction device, preferably, at least a part of the surface of the tubular arch is provided with a hollow structure extending at least in the circumferential direction; or at least part of the surface of the thick-wire-shaped arch part is provided with concave structures extending at least in the circumferential direction.

Further, in the mitral valve annular constriction device, it is preferable that a puncture preventing member for preventing puncture of a blood vessel is provided outside the distal end of the arch member provided at the distal end of the distal anchor.

Further, in the mitral annular constriction device, preferably, the stab-resistant member has a solid or hollow structure with a smooth outer surface and a diameter or width larger than that of the arch member.

Further, in the mitral valve annular constriction device, preferably, the guide portion is provided with a hollow structure or an inner concave structure for improving the flexibility of the guide portion.

Further, in the mitral annular compression device, it is preferable that the distal end of the arch is provided with a positioning member for preventing the arch and the annular compression device from falling over.

Further, in the mitral valve annular constriction device, the positioning member is preferably a closed-loop structure or an open-loop structure.

Further, in the mitral valve annular constriction device, the closed-loop structure preferably includes one of a single-loop structure, a multi-loop structure, a radial loop structure, and an axial three-dimensional ring structure.

Further, in the mitral annulus constriction device, the positioning element is preferably of a same diameter structure, a radial diameter-changing structure or an axial diameter-changing structure.

Further, in the mitral valve annular constriction device, the proximal anchor, the distal anchor, the connecting member and the arch-shaped member are preferably of a woven integral structure; or at least two of the proximal anchor, the distal anchor, the connecting piece and the arch-shaped piece are fixedly connected together in a split manner.

Further, in the mitral valve annular constriction device, preferably, the bottom of the near-end anchor and the bottom of the far-end anchor are respectively sleeved with a fixing sleeve, the bottom of the near-end anchor and the bottom of the far-end anchor are provided with locking knots outside the fixing sleeves, and the near-end anchor and the far-end anchor are locked and extend to form a three-dimensional structure.

Further, in the mitral annular constriction device, preferably, the tip of at least one of the proximal and distal anchors is an interwoven twist structure.

The utility model discloses the arch-shaped piece that is equipped with outside the distal end of distal end anchor, outside the near-end of distal end anchor or in the distal end anchor, arch-shaped piece arches to distal end anchor top direction, and on arch-shaped piece can span the coronary artery of circling round, when distal end anchor is taut backward, the great cardiac vein on coronary artery of circling round upper portion is stretched straight tight and is pressed down equally, nevertheless arch-shaped piece this moment can be with the great cardiac vein up-pushing, protects the coronary artery of circling round not oppressed. In addition, the distal anchor is stuck and anchored on the wall of the great cardiac vein after being released, and the fixation is reliable. Therefore, the arch-shaped piece is accurate and stable in position, cannot be displaced along with the heartbeat, and is high in safety. In addition, the arch-shaped part has three positions which can be arranged, so that the arch-shaped part is suitable for different patients, and has stronger adaptability and wider application range.

Drawings

The invention will be further explained with reference to the drawings and examples, wherein:

FIG. 1 is a schematic structural diagram of a first embodiment of example 1 of the present invention;

FIG. 2 is a schematic structural diagram of a second embodiment of example 1 of the present invention;

FIG. 3 is a schematic structural view of a third embodiment of example 1 of the present invention;

FIG. 4 is a schematic structural view of a fourth embodiment of example 1 of the present invention;

fig. 5-6 are schematic structural views of the mitral valve annular contraction device according to embodiment 1 of the present invention in the heart;

fig. 7 is a schematic structural view of a first embodiment of example 2 of the present invention;

fig. 8 is a schematic structural view of a second embodiment of example 2 of the present invention;

fig. 9 is a structural schematic view of the mitral valve annular contraction device according to embodiment 2 of the present invention in position in the heart;

fig. 10 is a schematic view of the mitral valve annular contraction device of example 2 of the present invention closing the mitral valve leaflets;

fig. 11 is a schematic structural view of embodiment 3 of the present invention;

fig. 12 is a schematic structural view of a first embodiment of example 4 of the present invention;

fig. 13 is a schematic structural view of a second embodiment of example 4 of the present invention;

fig. 14 is a schematic structural view of a third embodiment of example 4 of the present invention;

fig. 15 is a schematic structural view of a fourth embodiment of example 4 of the present invention.

Detailed Description

In order to clearly understand the technical features, objects, and effects of the present invention, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

An element is said to be "secured to" or "disposed on" another element, either directly or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element.

The terms "upper," "lower," "left," "right," "front," "back," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like refer to an orientation or position based on the orientation or position shown in the drawings.

The terms "axial" and "radial" refer to the length of the entire device or component as "axial" and the direction perpendicular to the axial direction as "radial".

The term "circumferential" refers to along the circumferential direction.

The terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "plurality" is two or more unless specifically limited otherwise.

"far" and "near" are directions relative to the operator, near and far from the operator.

The above terms are for convenience of description only and are not to be construed as limiting the present technical solution.

1-15, a mitral valve annular compression device for placement in the coronary sinus-great cardiac vein, wherein a distal anchor 100 is fixed in the great cardiac vein 1, a proximal anchor 200 is fixed in the coronary sinus 3, and an arch 300 is placed in the great cardiac vein 1 over a circumflex artery 2, ensuring that the circumflex artery 2 is not compressed.

The mitral annuloplasty device comprises a distal anchor 100 for anchoring in the great cardiac vein 1 near the intersection with the circumflex artery 2, a proximal anchor 200 for anchoring in the coronary sinus 3; the proximal anchor 200 and the distal anchor 100 are connected by a connecting element 500; an arch 300 is provided in the distal outer portion of the distal anchor 100, the proximal outer portion of the distal anchor 100 or the distal anchor 100 for spanning over the coronary artery 2, the arch 300 being arched in the direction of the top of the distal anchor 100.

The proximal 200 and distal 100 anchors are body structures. The distal anchor 100 is formed by weaving and shaping nickel-titanium wires into a cage shape, and comprises two support rings 110 with annular structures, the two support rings 110 with annular structures are connected into a cage shape through weaving wires 120 at the top and weaving wires 130 at the bottom, preferably, a fixing sleeve 150 is sleeved outside the bottom of the distal anchor 100, namely the weaving wires 130, and the fixing sleeve 150 is used for keeping the bottom structure of the distal anchor 100 unchanged and plays a supporting role. Similarly, the proximal anchor 200 is formed by braiding ni-ti wires into a cage shape, and includes two ring structures 210, wherein the two ring structures 210 are connected into a cage shape by a top braid wire 220 and a bottom braid wire 230, and preferably the proximal anchor 200 is externally sleeved with a fixation sleeve 270 by the bottom braid wire 230. The weaving yarn 130 and the weaving yarn 230 may be a single yarn or a plurality of yarns twisted. At least one of the top braided wires 120 and 220 of the proximal anchor 200 and the distal anchor 100 is of an interwoven twist structure, preferably, both the top braided wires 120 and the braided wires 220 are of twist structures, so that the twist structure has stronger supporting force, and is more favorable for maintaining the three-dimensional cage-shaped structures of the distal anchor and the proximal anchor compared with the existing monofilament or monofilament crossed top structure.

The locking ring 160 is arranged outside the proximal end of the fixing sleeve 150 at the bottom of the distal anchor 100, the locking ring 160 is formed by winding nickel-titanium wires on the braided wires 130 at the bottom of the distal anchor 100, the locking ring 160 can slide at the bottom of the distal anchor 100, similarly, the locking ring 260 is arranged outside the proximal end of the fixing sleeve 250 at the bottom of the proximal anchor 200, and the locking ring 260 is also formed by winding nickel-titanium wires on the braided wires 230 at the bottom of the proximal anchor 200. The two locking rings 160, 260 are larger in diameter than the respective proximally disposed fixation sleeves 150, 250, respectively, for maintaining the cage-like spatial configuration of the distal anchor 100.

The proximal 200 and distal 100 anchors are provided with locking knots 170, 270, respectively, at the bottom outside the hubs 150, 250, specifically, at the proximal ends of the locking loops 160, 260, the locking knots 170, 270 being extensions of the braided wires 130, 230, respectively. The fixation sleeve 150 and locking knot 170 cooperate, and the fixation sleeve 250 and locking knot 270 cooperate to positionally constrain the locking rings 160, 260 provided with the distal anchor 100, proximal anchor 200, respectively, to maintain the proximal anchor 200 and distal anchor 100 in the expanded shape.

The distal anchor 100 and the proximal anchor 200 are both in a collapsed state during delivery within the sheath, with the locking ring 160 on the proximal side of the locking knot 170, such that the distal anchor 100 is easily advanced. After deployment of distal anchor 100 within the vessel, locking ring 160 is pushed to the distal side of locking knot 170, causing distal anchor 100 to expand and hold, strengthening the support. The locking ring 260 of the proximal anchor 200 is on the proximal side of the locking knot 270. The locking knot 270 is connected to the push rod of the delivery device, and the locking ring 260 is sleeved over the push rod, and when the proximal anchor 200 is released, the locking ring 260 is pushed distally along the push rod, locks across the locking knot 270, expands and holds the proximal anchor 200, and enhances the support force.

Connecting element 500 is disposed between distal anchor 100 and proximal anchor 200 and may be braided from braided filaments, may be a single filament, or may be two or more braided filaments juxtaposed or twisted together. The twisting means twists a plurality of filaments into one strand; winding refers to a structure in which one or more filaments are centered and the remaining filaments are wound thereon. The utility model discloses in other many transposition and winding methods with this, no longer give unnecessary details.

In particular, since the intersection of the circumflex artery and great cardiac vein may be located at different distances from the ostium of the coronary sinus in different patients, there are three embodiments of the placement of the arch-shaped member 300 to accommodate different patients. The first embodiment is provided distally outside of the distal anchor 100. The second embodiment is provided outside the proximal end of the distal anchor 100, either integrally formed with or fixedly attached to the connector 500. A third embodiment is provided in distal anchor 100 by arching the bottom wire 130 of distal anchor 100 toward the top of distal anchor 100 to form arch 300, where arch 300 is integrally formed with bottom wire 130 of distal anchor 100, or alternatively, the wire may be fixedly attached to arch 300.

The structural bodies of the arch 300 are in particular: the arch 300 includes an arch 310, and the arch 310 has three positions: extending axially outward from the bottom of the distal anchor 100 (including distally outward, proximally outward) or disposed at the bottom of the distal anchor 100 and arching toward the top of the distal anchor 100. The arch 300 is made of elastic memory metal wire. The present invention extends in either the distal or proximal direction of the pointing device, or in general (the primary direction of extension) in both directions.

The portion 310 of arching of arch piece 300 at least top is for sharp-pointed smooth structure, for example arc, sharp-pointed angular shape of non-, plane etc. promptly the utility model discloses require arching portion 310 top and vascular wall contact, preferably the arc, prevent to pierce through the blood vessel, it is big with vascular wall area of contact, be favorable to the location. Except that the top surface is arc-shaped, the shapes of other positions can be not limited, and only no sharp structure is needed. The specific shape of the arch part 310 may be an arc structure with the same curvature, an arc structure formed by connecting and smoothly transiting a plurality of sections of arcs with different curvatures, an angular shape after chamfering or a rectangular structure.

The arch 300 may be a single tube or thick wire, the arch 300 may be a twisted structure of two or more strands, and the arch 300 may be a twisted structure of two or more strands. The main structure of the arch 300 and the arch 310 adopt the structure described above. The single arch 300 may be of a relatively large diameter tubular or thick wire construction, with the double or multi-strand construction being a thin wire construction, twisted and wound as described above.

The arch 310 may be provided separately, i.e., with the arch 310 of the arch 300 being provided outside the distal end of the distal anchor 100, or with the arch 310 being provided outside the proximal end of the distal anchor 100, or with the arch 310 being provided in the distal anchor 100. The provision of the separate dome 310 requires passivation of the free end of the dome 310, i.e. the provision of a corner-free structure.

For better shaping or bending, the raised portion 310 may be at least partially surface-textured, i.e. the surface of the tubular raised portion 310 is provided with a hollow structure extending at least in the circumferential direction; or at least part of the surface of the thick thread-shaped arch part 310 is provided with a concave structure extending at least in the circumferential direction. For example: the hollow structure and the concave structure may be disposed inside the top surface of the arch portion 310, at the position where both ends of the bottom of the arch portion 310 are bent, or inside both sides of the arch portion 310. To facilitate the bowing 310 and maintain the bowed state. The hollowed-out structure and the recessed structure may be slits, grooves, etc. arranged along the circumferential surface, wherein the hollowed-out structure runs through to the inner cavity.

To avoid puncturing the vessel by the arch 300 being unsettled at its distal end and too stiff, the distal end of the arch 300 disposed beyond the distal end of the distal anchor 100 is provided with a puncture preventing member 600 for preventing puncturing of the vessel. The stab-resistant member 600 may be a solid or hollow structure with a smooth exterior and a diameter or width greater than the diameter or width of the arch member 300, for example, the stab-resistant member 600 may be a smooth sphere, hemisphere or other non-angular structure.

In another configuration, the arch 310 of the arch 300 has a distally extending pilot 320. The guide portion 320 may be formed by extending the arch 300 directly outward, and the guide portion 320 may be provided with a hollowed-out structure or a concave structure for improving the flexibility of the guide portion 320, for example, by cutting a spiral spring shape or a snake bone shape by laser cutting, so as to increase the elasticity and flexibility of the stab-resistant member 600.

The distal end of the arch 300 is provided with a retainer 700 for preventing the arch and the ring-like retraction device from tipping over. The positioning member 700 is used to position and fix the arch 300, and the arch 300 disposed at the distal end of the distal anchor 100 may not be accurately positioned in the great cardiac vein 1 above the circumflex artery 2 due to its free movement such as swinging and bending, and if the arch is not positioned in the great cardiac vein 1, the arch 300 may not be able to play its role, therefore, the distal end of the arch 300 is preferably provided with the positioning member 700. Positioning requires that the diameter or width of the spacer 700 be comparable to, or substantially the same as, the diameter or width of the distal anchor 100, i.e., that the differences between them do not affect the function of the spacer 700, and can serve an anchoring function while preventing the arch 300 from toppling over. In addition, it is preferred that the center or central axis of the spacer 700 coincide or substantially coincide with the central axis of the distal anchor or the entire device, to ensure that the center of gravity of the spacer 700 does not shift, and to better increase the stability of the device.

The positioning member 700 has a closed-loop structure or an open-loop structure. The closed-loop structure refers to a structure having no opening in the circumferential direction, and the open-loop structure refers to a structure having an opening in the circumferential direction. The shape or the cross section of the closed loop structure and the open loop structure can be a circular ring shape, an annular shape formed by connecting the arc surfaces with different curvatures end to end, and an annular shape formed by a plurality of straight lines and curves end to end.

Wherein the closed loop structure comprises one of a single loop structure, a multiple loop structure, a radial loop structure and an axial stereo ring structure. The single-ring structure means that the braided wire is looped around one circle to form a ring. The multi-ring structure means that the braided filaments are looped around a plurality of circles. The radial loop structure means that the weaving filaments reciprocate around a central point to form a ring surface structure. The circumferential three-dimensional annular structure is a cylindrical structure formed by reciprocating braided wires around a central axis.

In the above structure, the diameter or width may be: the same diameter structure, the radial diameter-changing structure or the axial diameter-changing structure. The same diameter structure means that the diameter or width of the positioning member 700 formed by a plurality of rings is the same, and a straight cylinder structure is formed, such as a spiral circular ring with the same diameter, a spiral square ring with the same diameter, an irregular spiral ring with the same diameter, and the like, and the radial diameter-changing structure is an annular plane structure, and a plurality of rings are sleeved together. The axial reducing structure is a cylindrical structure, and the diameters or the widths of the axial reducing structure at different positions are different. For example: trumpet shape, ellipsoid shape, spherical shape, etc.

In the utility model, each part can be made of elastic memory metal wire, such as nickel, titanium or alloy material of the two, for example, nickel-titanium wire, and the near-end anchor 200, the far-end anchor 100, the connecting piece 500 and the arch-shaped piece 300 are of an integrated structure formed by weaving; or at least two of the proximal anchor 200, distal anchor 100, connecting element 500 and arch 300 may be fixedly connected together in separate pieces. The fixed connection mode can adopt a connecting sleeve, and can also adopt press riveting, welding, or connection modes such as screw connection, clamping connection and the like.

The following is illustrated by specific examples:

example 1, as shown in fig. 1-6, the mitral annulus reduction device is comprised of a distal anchor 100, a proximal anchor 200, a connecting member 500, and an arch 300. The distal anchor 100 and the proximal anchor 200 are formed by weaving and shaping nickel-titanium wires into a cage shape, respectively, the distal anchor 100 comprises two support rings 110 which are oppositely arranged in an annular structure, the top parts of the support rings are connected by weaving wires 120 in a twist structure, and the bottom parts of the support rings are connected by weaving wires 130 which are arranged in parallel. The proximal anchor 200 also includes two oppositely disposed loops 210 of loop configuration, connected at the top by braided filaments 220 of twist configuration and at the bottom by braided filaments 230 arranged side-by-side. The connector 500 is provided with a locking ring 160 and a locking knot 170 at the distal end and the proximal end of the distal anchor 100, respectively, and is provided with a locking ring 260 and a locking knot 270 at the proximal end and the proximal end of the proximal anchor 200. Locking collar 160 is retained by retaining sleeve 150 and locking knot 170 disposed on bottom braid 130 to maintain distal anchor 100 in the expanded shape. The locking collar 260 is retained by the retaining sleeve 250 and locking knot 270 disposed on the bottom braid 230 to maintain the proximal anchor 200 in the expanded shape. Preferably, the locking knot 170 is a structure formed by arching the distal end of the connector 500 toward both sides.

The arch 300 of this embodiment is formed of nitinol and is disposed distally beyond the distal end of the distal anchor 100. The arch 300 is semi-circular in shape. The length is about 10mm-15mm, and the height is 4-10mm. The arch 300 is placed on the circumflex artery 2, and the semicircle of the arch 300 can let the circumflex artery 2 pass through, so as to avoid compressing the circumflex artery 2. In order to avoid the distal end (free end) of the arch-shaped member 300 being suspended and too hard to puncture the blood vessel, the distal end of the arch-shaped member 300 is cut into a spiral spring shape as shown in fig. 1 or into a snake bone shape as shown in fig. 7 by laser cutting, so as to increase the elasticity and flexibility of the distal end. The arch 300, the distal end of the connector 500 and the wire head of the ni-ti wire of the distal anchor 100 are secured together by a retaining sleeve 150, which may be press-fit, welded or snap-fit. In this embodiment, the arch 300 is provided with only the arch 310.

The proximal end of the proximal anchor 200 is provided with a locking knot 270 and fixation sleeve 250 that positionally retains the locking collar 260 of the proximal anchor 200 to maintain the proximal anchor 200 in the expanded shape. The connecting member 500, the nitinol head of the proximal anchor 200 and the locking knot 270 are connected and fixed by the fixation sheath 250, which may also be fixed by riveting, welding or structural clamping.

The arch 300 is placed over the circumflex artery 2 and when the distal anchor 100 is tightened after anchoring, the arch 300 will push the great cardiac vein 1 up so that it cannot be depressed, avoiding compression of the circumflex artery 2.

This arrangement of the arch 300 distal to the distal anchor 100 is suitable for patients with a large distance from the ostium 3 of the coronary sinus where the circumflex artery 2 intersects the great cardiac vein 1.

As shown in fig. 2, the distal end of the arch-shaped member 300 is provided with a stab-resistant member 600, and the stab-resistant member 600 can be directly welded by laser welding or argon arc welding, so that the end of the arch-shaped member 300 is welded to the stab-resistant member 600 with a smooth and non-pricking surface, such as the stab-resistant member 600 with a spherical or hemispherical structure. When the stab guard 600 is not used as shown in fig. 1, mechanical grinding is required to smooth the distal end of the arch 300.

As shown in fig. 3, the arch 300 may be formed by twisting a nitinol wire or a plurality of nitinol wires together, braided into a twist-like shape, and then shaped into an arch, with the wire ends of the nitinol wires both being disposed in the retaining sleeve 150 of the distal anchor 100. The dome 300 includes a dome 310 and a guide 320, the guide 320 being disposed at a distal end of the dome 310. In this embodiment, the distal end of the guide portion 320 is formed by knitting a knitting yarn, and has no sharp portion, and can be used as it is.

As shown in fig. 4, the dome 300 includes a dome 310 and a guide 320, the guide 320 being disposed at a distal end of the dome 310. The free end of the guide part 320 is provided with a stab-resistant member 600.

As shown in fig. 5-6, which are the effect views of the mitral valve annular compression device of the present embodiment implanted in the heart, the distal anchor 100 is fixed in the great cardiac vein 1, the proximal anchor 200 is fixed in the coronary sinus 3, and the arch 300 is placed in the great cardiac vein 1 above the circumflex artery 2 to ensure that the circumflex artery 2 is not compressed.

Example 2 this example is an improvement over example 1, as shown in fig. 7-10, and the mitral valve annular reduction device is composed of a distal anchor 100, a proximal anchor 200, and a connecting member 500. The structure of the distal anchor 100 and the proximal anchor 200 is the same as in embodiment 1. And will not be described in detail herein.

As shown in fig. 7-8, the difference from embodiment 1 is that arch 300 is disposed out of the proximal end of distal anchor 100, i.e., arch 300 is coupled to coupling element 500. Arch 300 is positioned in two locations, one of which is between distal anchor 100 and connecting element 500 as shown in fig. 7; second, the connector 500 shown in fig. 8 is divided into two parts, and the arch 300 is disposed between the two parts of the connector 500.

As shown in fig. 7, arch 300 is disposed between distal anchor 100 and connecting element 500, arch 300 is disposed directly on the proximal end of distal anchor 100, connecting element 500 is formed by shaping nitinol wires, and arch 300 may be integrated with connecting element 500 or fixedly connected together. The distal most locking nub 160 of connector 500 becomes part of arch 300, beginning with locking nub 160, and deforms upward with arch 300.

As shown in fig. 8, arch 300 may also be disposed in connector 500, i.e., connector 500 may be connected at a portion of each of the distal and proximal ends of arch 300, and distal anchor 100 may be connected proximally to locking collar 160 and locking knot 170.

As shown in fig. 9-10, the distal anchor 100 is secured in the great cardiac vein 1, the proximal anchor 200 is secured in the coronary sinus 3, and the arch 300 is placed in the great cardiac vein 1 over the circumflex artery 2 to ensure that the circumflex artery 2 is not compressed. In this embodiment, the distal anchor 100 is designed with the arch 300 out of the proximal end, and the distal anchor 100 may be anchored further distally in the great cardiac vein 1 across the circumflex artery 2. The anchoring position of the whole mitral valve annular constriction device in the great cardiac vein 1 corresponds to the P1-P3 area of the mitral valve, the mitral valve annular constriction device surrounds the periphery of the mitral valve for a longer distance, the degree of mitral valve annular constriction can be increased after the device is tensioned, the valve leaves of the mitral valve can be completely closed, and the treatment effect of mitral valve regurgitation is better.

Example 3, as shown in fig. 11, this example is an improvement on the basis of example 1. The mitral annular reduction device is comprised of a distal anchor 100, a proximal anchor 200, and a connecting element 500. The proximal anchor 200 and the connecting member 500 are the same as those of embodiment 1 and will not be described in detail.

The differences from example 1 are: an arch 300 is arranged in the distal anchor 100, the arch 300 is connected in the braided wire 130 at the bottom of the distal anchor 100, namely, the braided wire 130 at the bottom of the distal anchor 100 is arched upwards to form the arch 300, or the arch 300 can be made separately and fixedly connected at the middle position of the braided wire 130, and the arch 300 is formed by nickel-titanium wires or nickel-titanium tubes in a shaping mode.

The arch 300 in the distal anchor 100 is placed on the superior side of the circumflex artery 2 to avoid compression of the circumflex artery 2.

Example 4, as shown in fig. 12 to 13, this example is an improvement on the basis of example 1, and differs from example 1 in that: a retainer 700 is attached to the distal end of the arch 300.

The positioning member 700 extends outwards from the far end of the arch-shaped member 300 and can be formed by shaping a nickel-titanium wire, the positioning member 700 is in a radial diameter-changing multi-ring structure, specifically, the positioning member 700 is a single ring and a multi-ring, as shown in fig. 12, the number of the rings in the embodiment is one and a half, and the rings can also be wound by multiple rings, the back ring is on the inner side of the front ring, and the nickel-titanium wire head is finally positioned on the innermost ring, so that the blood vessel can be prevented from being punctured by the wire head. The outermost diameter of the loop at the distal end of arch 300, which corresponds to the diameter of distal anchor 100, serves as an anchor while preventing arch 300 from tipping over.

In addition to the above structure, the positioning member 700 may be: the arch 300 is a plurality of cyclically decreasing sizes, such as a circle with decreasing diameter, a sector with decreasing sides, and the like. The method can also comprise the following steps: spiral circular rings with the same diameter as shown in fig. 13, spiral square rings with the same diameter as shown in fig. 14, irregular spiral rings with the same diameter, and the like.

As shown in fig. 15, the arch 300 is of a wave-ring structure, namely: the braided filaments reciprocate about the central axis to form a tubular structure. The three-dimensional cylindrical structure can be supported on the vessel wall, and can play a better role in anchoring and preventing the arch-shaped element 300 from toppling over.

Claims (16)

1. A mitral annuloplasty device comprising a distal anchor for anchoring in the great cardiac vein near the intersection with a circumflex artery, a proximal anchor for anchoring in the coronary sinus; the proximal anchor and the distal anchor are connected by a connecting piece; wherein an arch for spanning over the coronary artery is provided in the distal outer portion of the distal anchor, the proximal outer portion of the distal anchor or the distal anchor, the arch being arched in a direction toward a tip of the distal anchor.

2. The mitral valve annulus constricting device of claim 1, wherein the arch comprises a base extending axially outward from or disposed within a base of the distal anchor and arching in a direction toward a top of the distal anchor.

3. The mitral valve annulus constriction device of claim 2, wherein at least the top of the arch is a non-sharp smooth structure.

4. The mitral valve annulus constriction device of claim 2, wherein the arch of the arch beyond the distal end of the distal anchor has a guide portion that extends outward.

5. The mitral valve annuloplasty device of claim 4, wherein the guide portion is provided with a hollowed or concave structure that improves the compliance of the guide portion; or the guide part is a bendable structure made of flexible materials.

6. The mitral valve annuloplasty device of claim 1, wherein the arch is a single tubular or thick wire, or a twisted double or stranded structure.

7. The mitral valve annuloplasty device of claim 6, wherein at least a portion of the tubular arcuate surface is provided with at least circumferentially extending cutouts; or at least part of the surface of the thick-wire-shaped arch part is provided with concave structures extending at least in the circumferential direction.

8. The mitral valve annuloplasty device of claim 1, wherein a distal end of the arch disposed beyond a distal end of the distal anchor is provided with a puncture prevention member to prevent puncture of a blood vessel.

9. The mitral valve annuloplasty device of claim 8, wherein the stab-resistant member is a solid or hollow structure with a smooth outer surface and a diameter or width greater than the diameter or width of the arch.

10. The mitral valve annulus constriction device of claim 1, wherein the distal end of the arch is provided with a retainer for preventing the arch and the constriction device from tipping over.

11. The mitral valve annuloplasty device of claim 10, wherein the positioning member is in a closed-loop configuration or an open-loop configuration.

12. The mitral valve annuloplasty device of claim 11, wherein the closed loop structure comprises one of a single loop structure, a multiple loop structure, a radial loop structure, and an axial solid loop structure.

13. The mitral valve annuloplasty device of claim 10, wherein the positioning element is of a constant diameter configuration, a radially tapered configuration, or an axially tapered configuration.

14. The mitral valve annulus reduction device of claim 1, wherein the proximal anchor, distal anchor, connector, and arch are woven as a unitary structure; or at least two of the proximal anchor, the distal anchor, the connecting piece and the arch-shaped piece are fixedly connected together in a split manner.

15. The mitral valve annuloplasty device of claim 14, wherein the proximal and distal anchors are sleeved with fixation sleeves at their bottoms, and locking knots are provided at the bottoms of the proximal and distal anchors outside the fixation sleeves to lock the proximal and distal anchors in a three-dimensional configuration.

16. The mitral valve annulus constriction device of claim 1, wherein the top of at least one of the proximal and distal anchors is an interwoven twist structure.

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