CN214857834U - Mitral annulus ring-contracting device - Google Patents

Abstract

The utility model discloses a mitral valve annulus ring-contracting device, which comprises at least two fixing mechanisms, a puncture mechanism and a locking mechanism; the fixing mechanism comprises a fixing knot and a traction line, the traction line is arranged on the fixing knot, and two ends of the traction line are positioned outside the near end of the fixing knot; the puncture mechanism is used for puncturing the fixing knot and the traction line of the fixing mechanism on the valve ring, and enabling the fixing knot to be located on one side of the valve ring, and two ends of the traction line to be located on the other side of the valve ring; the pulling wires of two adjacent fixing mechanisms are driven to mutually approach under the driving of traction force so as to shorten the distance between two adjacent fixing knots, so that the valve ring part between the two adjacent fixing knots is bent or folded, the circumference of the valve ring is reduced, and the size of an inner hole of the valve ring is locked; when the distance between the two fixing knots is adjusted to be in place, the end parts of the pulling wires in the two adjacent fixing mechanisms are locked on the valve ring by adopting the locking mechanisms, so that the valve ring is kept in a state that the inner hole is reduced, the valve ring is easier to close, and the repairing effect is achieved.

Description

Mitral annulus ring-contracting device

Technical Field

The utility model belongs to the technical field of medical instrument, concretely relates to ring of mitral valve ring contracts device.

Background

The human heart has four chambers and four valves, which are the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral valve is located between the left atrium and the left ventricle, and acts as a one-way valve to ensure that blood circulation flows from the left atrium to the left ventricle and passes through a certain flow. The mitral valve is composed of valve leaflets, an annulus, papillary muscles, chordae tendinae, and five boundary parts. When the normal mitral valve is closed, the two valve leaflets are in the same plane and closely appose, so that the backflow of the left ventricular blood flow can be completely blocked. The functional integrity of the mitral valve requires that the mitral valve annulus is proper in size, the valve leaflets are complete in structure, the contraction of papillary muscles pulls the chordae tendineae to play the role of the valve leaflets, the contraction of left ventricular muscle produces proper closing force, and the ventricle is normal in shape and function. If any of these factors become abnormal, mitral regurgitation can result, with blood flowing back from the left ventricle into the left atrium.

With the development of society and the aging population, the incidence of mitral regurgitation is obviously increasing, and is now a common heart valve disease, mainly caused by mitral insufficiency, so that an annuloplasty device for repairing mitral insufficiency is needed.

SUMMERY OF THE UTILITY MODEL

Therefore, the technical problem to be solved by the present invention is to provide a device for compressing mitral insufficiency.

Therefore, the utility model provides a mitral valve annulus ring-contracting device, which comprises

At least two securing mechanisms; any one fixing mechanism comprises a fixing knot and a traction line, wherein the traction line is arranged on the fixing knot, and two ends of the traction line are positioned outside the near end of the fixing knot;

the puncture mechanism is used for puncturing the fixing knot and the traction line of any one fixing mechanism on the valve ring, the fixing knot is positioned on one side of the valve ring, and two ends of the traction line are positioned on the other side of the valve ring; the pulling wires of two adjacent fixing mechanisms are driven to mutually approach under the driving of traction force so as to shorten the distance between two adjacent fixing knots;

and the locking mechanism is used for locking the end parts of the traction wires in the two adjacent fixing mechanisms on the valve ring when the traction wires of the two adjacent fixing mechanisms are drawn into place.

Optionally, the above mitral annulus annuloplasty device, wherein the locking mechanism comprises

A locking body having a first channel extending along a length thereof;

and the locking plug is inserted into the first channel to clamp the traction line between the locking plug and the locking main body.

Optionally, in the mitral valve annulus annuloplasty device, a side wall of the locking body is provided with a locking hole through which an end of the pulling wire passes.

Optionally, in the mitral valve annulus annuloplasty device, the side wall of the locking body is further provided with a first mounting hole;

the elastic body is provided with a first mounting hole and a second mounting hole, wherein the first mounting hole is provided with a first end and a second end, the second end is provided with a second mounting hole, and the first mounting hole is provided with a first mounting hole;

when the locking plug is plugged towards the first channel, the elastic body swings towards the first mounting hole under the extrusion force of the outer wall of the locking plug; after the locking plug passes over the distal end of the elastic body, the elastic body is reset and the distal end of the elastic body is blocked on the locking plug.

Optionally, in the mitral valve annulus annuloplasty device, the locking plug includes a base and a first annular boss formed on an outer circumference of a distal end of the base, and the first annular boss applies the compressive force to the elastic body;

when the elastic body is reset, the far end of the elastic body is blocked on the near end side of the first annular boss.

Optionally, in the mitral valve annulus annuloplasty device, an inner wall of the distal end of the locking body is provided with a second annular boss protruding inward;

the distal end of the first annular boss is blocked by the second annular boss and retained between the second annular boss and the elastomeric body; and/or

The elastic body is a spring sheet.

Optionally, the mitral valve annulus annuloplasty device described above, wherein the locking mechanism further comprises a delivery mechanism; the conveying mechanism comprises an outer tube, a hanging head sheath tube which is slidably arranged in the outer tube and a pushing inner tube which is slidably arranged in the hanging head sheath tube;

the far end of the hanging head sheath tube is detachably connected with the near end of the locking main body, and the far end of the pushing inner tube is inserted into or matched with the near end of the locking plug in a sleeved mode; the locking body and the locking plug are both located within the outer tube before the locking body is not released.

Optionally, the above mitral valve annulus ring-contracting device, the puncturing mechanism comprises

An outer sheath tube;

the puncture needle is slidably arranged in the outer sheath tube, and the outer wall of the far end of the puncture needle is provided with a notch channel extending along the length direction of the puncture needle;

the pushing sheath is slidably arranged in the outer sheath tube and sleeved outside the puncture needle;

the fixation knot has a collapsed state collapsed within the outer sheath and a released state punctured on the annulus;

in a furled state, the fixing knot is sleeved on the outer wall of the opening channel of the puncture needle, and the near end of the puncture needle and the far end of the push sheath are distributed oppositely; the first end of the pulling wire is positioned in the notch channel, and the second end of the pulling wire passes through the notch channel, then is wound on the outer wall of the fixing knot from the far end of the fixing knot and extends into the puncture needle through the near end of the notch channel, so that the first end and the second end are overlapped and distributed;

in a release state, the traction line is sleeved on the side wall of the fixing knot and punctures on the valve ring, and the fixing knot is pulled by the traction line to be bent into a ring shape.

Optionally, in the above mitral valve annulus annuloplasty device, an inwardly concave notch is formed on a sidewall of the notch channel of the puncture needle; in a furled state, the far end of the fixing knot is sleeved at the notch, and the second end of the traction line passes through the notch and then is wound on the outer wall of the fixing knot.

Optionally, in the mitral valve annulus annuloplasty device, the fixation knot is in a shape of a spiral or a circular tube; and/or

The utility model discloses a sheath pipe, including outer sheath pipe, be equipped with fixed head end on the distal end terminal surface of outer sheath pipe, fixed head end is the loudspeaker form by its near-end orientation distal end.

The utility model discloses technical scheme has following advantage:

1. the utility model provides a mitral valve annulus ring-shrinking device, which comprises at least two fixing mechanisms, a puncture mechanism and a locking mechanism; the fixing mechanism comprises a fixing knot and a traction line, the traction line is arranged on the fixing knot, and two ends of the traction line are positioned outside the near end of the fixing knot; the puncture mechanism is used for puncturing the fixing knot and the traction line of any fixing mechanism on the valve ring, the fixing knot is positioned on one side of the valve ring, and two ends of the traction line are positioned on the other side of the valve ring; the pulling wires of two adjacent fixing mechanisms are driven to mutually approach under the driving of traction force to shorten the distance between two adjacent fixing knots, so that the valve ring part between the two adjacent fixing knots is bent or folded, the circumference of the valve ring is reduced, and the size of an inner hole of the valve ring is further locked; after the distance between the two fixing knots is adjusted in place, the end parts of the pulling wires in the two adjacent fixing mechanisms are locked on the valve ring by adopting the locking mechanisms so that the valve ring is kept in a state that the inner hole is reduced.

2. The utility model provides a mitral valve annulus ring-contracting device, a locking mechanism comprises a locking main body and a locking plug, wherein the locking main body is provided with a first channel extending in the length direction; the locking plug is inserted into the first channel, and the pulling line is clamped between the locking plug and the locking main body, so that the pulling lines of two adjacent fixing mechanisms are locked, and the distance between two fixing knots is kept.

3. The utility model provides a ring of mitral valve annulus contracts device is equipped with the confession on the lateral wall of locking main part the locking hole that the tip that leads the acting as go-between passed ensures that the locking plug when sliding in first passageway, leads the acting as go-between and remains throughout to wear to establish in the locking hole, can not follow outside the first passageway of length direction roll-off of first passageway, further ensures the locking effect to leading the acting as go-between.

4. The utility model provides a mitral valve ring contracting device, the side wall of the locking main body is also provided with a first mounting hole; the elastic body is provided with a first mounting hole and a second mounting hole, wherein the first mounting hole is provided with a first end and a second end, the second end is provided with a second mounting hole, and the first mounting hole is provided with a first mounting hole; when the locking plug is inserted towards the first channel, the elastic body swings towards the first mounting hole under the extrusion force of the outer wall of the locking plug; after the locking plug passes over the distal end of the elastic body, the elastic body is reset, and the distal end of the elastic body is blocked on the locking plug, so that the locking plug is further ensured not to be separated from the proximal end of the locking main body when being inserted into the position even along with the movement of the mitral valve annulus.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the technical solutions in the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a sectional view of a puncture mechanism of a mitral valve annulus annuloplasty device according to embodiment 1 of the present invention;

fig. 2 is a sectional view of another embodiment of the puncture mechanism according to example 1 of the present invention;

FIG. 3 is a schematic view of the structure of the needle of the lancing mechanism of FIG. 1;

FIG. 4a is a schematic view of the fixation tip of the puncture mechanism of FIG. 1 secured to the valve annulus;

FIG. 4b is a schematic view of the puncture needle, the push sheath and the fixation knot of the puncture mechanism of FIG. 1 after puncturing the valve annulus;

FIG. 4c is a schematic view of the puncture mechanism of FIG. 1 with the push sheath not retracted after the puncture needle has been retracted;

FIG. 4d is a schematic view of the puncture mechanism of FIG. 1 with the anchor knot bent;

FIG. 4e is a schematic view of the entire lancing mechanism of FIG. 1 after retraction;

fig. 5 is a sectional view of a lock mechanism in embodiment 1 of the present invention;

FIG. 6 is a schematic structural view of the locking body of FIG. 5;

FIG. 7 is a schematic structural view of the locking body of FIG. 5;

FIG. 8a is a schematic cross-sectional view of the locking body of FIG. 5;

FIG. 8b is a cross-sectional view of the locking body of FIG. 8a shown in engagement with a puller wire;

FIG. 9 is a schematic view of the locking plug of FIG. 5;

FIG. 10 is a schematic representation of a transapical implantation of a mitral annulus annuloplasty device;

fig. 11a is a schematic view of the mitral valve annulus with the annuloplasty device punctured on the annulus and unlocked;

FIG. 11b is a schematic view of the mitral valve annulus with the device for annuloplasty puncturing the annulus and locking the annulus

FIG. 12 is a schematic representation of the mitral annulus annuloplasty device in an atrial aspect annulus position;

fig. 13 is a schematic view of the mitral annulus annuloplasty device locked in a compressed state;

description of reference numerals:

1-a puncture mechanism; 11-a fixed head end; 12-puncture needle; 121-a gap channel; 122-a notch; 13-outer sheath; 14-a fixed knot; 15-a pull line; 16-pushing the sheath;

2-a locking mechanism; 21-a locking body; 211-a second annular boss; 212-a notch groove; 213-first mounting hole; 22-a locking plug; 221-a first annular boss; 222-a base;

23-hanging a head sheath tube; 24-an outer tube; 25-pushing the inner tube; 26-an elastomer; 27-a locking hole; 3-mitral annulus.

Detailed Description

The technical solution of the present invention will be described clearly and completely with reference to the accompanying drawings, and obviously, the described embodiments are some, but not all embodiments of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Furthermore, the technical features mentioned in the different embodiments of the invention described below can be combined with each other as long as they do not conflict with each other.

Example 1

The present embodiment provides a mitral valve annulus annuloplasty device, as shown in fig. 1 to 13, which includes at least two fastening mechanisms, a puncturing mechanism 1 and a locking mechanism 2.

Any fixing mechanism comprises a fixing knot 14 and a traction line 15, the traction line 15 is arranged on the fixing knot 14, and two ends of the traction line 15 are positioned outside the near end of the fixing knot 14; the puncture mechanism 1 is used for puncturing the fixing knot 14 and the pulling wire 15 of any fixing mechanism on the valve annulus, and the fixing knot 14 is positioned on one side of the valve annulus (for example, on the left atrium side), and two ends of the pulling wire 15 are positioned on the other side of the valve annulus (for example, on the left ventricle side), as shown in fig. 11 a; the pulling wires 15 of two adjacent fixing mechanisms are driven to approach each other under the driving of traction force to shorten the distance between two adjacent fixing knots 14, so that the valve ring part between two adjacent fixing knots 14 is bent or folded, the circumference of the valve ring is reduced, as shown in fig. 11b, and the size of the inner hole of the valve ring is reduced; after the distance between the two fixing knots 14 is adjusted to the right position, the locking mechanism 2 is adopted to lock the end part of the pulling line 15 in the two adjacent fixing mechanisms on the valve ring, so that the valve ring is kept in a state that the inner hole is reduced, the valve ring is easier to close due to the reduction of the size of the inner hole of the valve ring, the problem of incomplete closing of the valve ring is solved, and the repairing effect is achieved.

As for the lock mechanism 2, preferably, as shown in fig. 5, the lock mechanism 2 includes a lock body 21 and a lock plug 22. Wherein the locking body 21 has a first channel extending along its length; the locking plug 22 is inserted into the first channel to clamp the pulling wire 15 between the locking plug 22 and the locking body 21, and at this time, both ends of the pulling wire 15 need to extend out of the proximal end of the locking body 21 to lock the pulling wire 15 on the locking body 21, so that the adjusted distance between the two fixing knots 14 can be maintained. During the locking process, the locking plug 22 is simply inserted into the locking body 21 from the proximal end to the distal end of the locking plug 22.

Further preferably, as shown in fig. 7, the side wall of the locking body 21 is provided with a locking hole 27 through which the end of the pulling wire 15 passes. Before the locking plug 22 is inserted into the locking main body 21, two ends of the pulling line 15 pass through the first channel and then pass through the locking hole 27, and then traction force is applied to the pulling line 15 to adjust the distance between the two fixing knots 14, after the pulling line is adjusted to the right position, the locking plug 22 is inserted into the locking main body 21, the locking hole 27 is arranged, two ends of the pulling line 15 do not need to extend out of the near end of the first channel, only the locking plug 27 needs to extend out, and traction force is applied to the pulling line 15 conveniently.

Further preferably, as shown in fig. 8a and 6, the side wall of the locking body 21 is further provided with a first mounting hole 213; the locking mechanism 2 further comprises at least one elastic body 26, wherein the proximal end of the elastic body 26 is formed in the first mounting hole 213, and the distal end of the elastic body 26 tends to extend into the first channel under the action of self deformation; when the locking plug 22 is inserted into the first passage, the elastic body 26 is pressed by the outer wall of the locking plug 22 to swing toward the first mounting hole 213; after the lock plug 22 passes over the distal end of the elastic body 26, the elastic body 26 is reset and the distal end thereof is blocked on the lock plug 22, so that the proximal end of the lock plug 22 is restrained on the lock body 21 and prevented from sliding out of the proximal end of the lock body 21.

Specifically, as shown in fig. 9, the locking plug 22 includes a seat 222 and a first annular projection 221 formed on the outer periphery of the distal end of the seat 222, the first annular projection 221 applying a pressing force to the elastic body 26; when the elastic body 26 is restored, the distal end of the elastic body 26 is stopped on the proximal end side of the first annular projection 221 to achieve the stopping force for the lock plug 22. As a modification, only the distal end of the seat 222 and the first annular projection 221 may be provided, and the end surface of the first annular projection 221 may be the proximal end surface of the lock plug 22.

The locking body 21 and the elastic body 26 are integrally formed, and preferably, a nickel titanium alloy material, or other medical deformable alloy materials, or a memory alloy material is used. For the elastic body 26, preferably, the elastic body 26 is a spring sheet or a spring.

As for the material of the locking plug 22, it is preferable to use a rubber material to form a rubber plug, or other medical polymer material.

Further preferably, as shown in fig. 8a and 8b, the inner wall of the distal end of the locking body 21 is provided with a second annular boss 211 protruding inward; the distal end of the first annular land 221 is blocked by the second annular land 211 and is retained between the second annular land 211 and the elastomeric body 26. That is, after the locking plug 22 slides to a certain position on the locking body 21, the locking plug 22 is restrained on the locking body 21 by the cooperation of the second annular boss 211 and the elastic body 26, and the locking plug 22 cannot move relative to the locking body 21, thereby further ensuring the locking action on the pulling wire 15.

For the shape of the first channel and the first mounting hole 213, a circular hole is preferred, but other shapes of holes are also possible, such as a rectangular hole or an elliptical hole, or other shapes of holes are also possible.

Preferably, as shown in fig. 5, the above-mentioned locking mechanism 2 further includes a conveying mechanism for conveying the locking body 21 and the locking plug 22; the conveying mechanism comprises an outer tube 24, a hanging head sheath tube 23 which is slidably arranged in the outer tube 24, and a pushing inner tube 25 which is slidably arranged in the hanging head sheath tube 23; wherein, the far end of the hanging head sheath tube 23 is detachably connected with the near end of the locking main body 21, and the far end of the pushing inner tube 25 is inserted into the near end inner hole of the locking plug 22 or sleeved outside the near end of the locking plug 22; before the locking body 21 is not released, both the locking body 21 and the locking plug 22 are located within the outer tube 24.

The whole conveying mechanism is conveyed to the vicinity of the mitral valve annulus through the apex of the heart by the movement of the outer tube 24, the outer tube 24 stops moving, the head hanging sheath 23 pushes the locking body 21 to enable the locking body 21 to extend out of the far end of the outer tube 24, and the head hanging sheath 23 is separated from the locking body 21; the end of the pulling line 15 penetrates through the locking hole 27, the distance between the two fixing knots 14 is adjusted by applying a pulling force to the end of the pulling line 15, after the distance between the two fixing knots 14 is adjusted to the right position, the pushing inner tube 25 pushes the locking plug to be inserted into the locking main body 21, the pushing inner tube 25 is withdrawn and locked to be separated due to the limiting effect of the elastic body 26, and finally the whole conveying mechanism is withdrawn out of the human body through the withdrawal of the outer tube 24.

Preferably, as shown in fig. 6, two slit grooves 212 are symmetrically distributed on the proximal end of the locking main body 21, and correspondingly, a tab (not shown in the figure) adapted to be clamped in each tab slit is arranged on the distal end of the hanging head sheath tube 23; before the release, the hanging lug is kept clamped in the notch groove 212 by the radial constraint force of the outer tube 24; when the hanging head sheath 23 extends out of the outer tube 24, the hanging lug resets under the action of the deformation of the hanging head sheath 23, tends to swing outwards and retreats from the notch groove 212, so that the hanging head sheath 23 is separated from the locking main body 21.

As shown in fig. 1, 2, and 3, the puncture mechanism 1 includes a sheath tube 13, a puncture needle 12, and a push sheath 16. The puncture needle 12 is slidably arranged in the sheath tube 13, and the outer wall of the far end of the puncture needle 12 is provided with a notch channel 121 extending along the length direction of the puncture needle 12; the pushing sheath 16 is slidably arranged in the outer sheath tube 13 and is sleeved outside the puncture needle.

The fixing knot 14 has a furled state furled in the sheath tube 13 and a released state punctured on the valve ring; in a folded state, as shown in fig. 1 and fig. 2, the fixing knot 14 is sleeved on the outer wall of the notch channel 121 of the puncture needle, and the proximal end of the puncture needle is distributed opposite to the distal end of the push sheath 16; the first end of the pulling wire 15 is positioned in the notch channel 121, the second end of the pulling wire passes through the notch channel 121 and then is wound on the outer wall of the fixed knot 14 from the distal end of the fixed knot 14, and extends into the puncture needle through the proximal end of the notch channel 121, so that the first end and the second end are distributed in an overlapping manner, and the end parts of the pulling wire 15 in the overlapping manner can extend out of the proximal end of the puncture needle, thereby facilitating an operator to exert pulling force on the pulling wire 15; or distributed in the puncture needle and connected with the operating mechanism to apply traction force to the traction line 15.

When the fixing knot 14 needs to be released, as shown in fig. 4a, the distal end face of the outer sheath 13 is firstly abutted on the valve annulus, then the puncture needle and the push sheath 16 are synchronously slid towards the distal end, and the push sheath 16 is used for pushing the fixing knot 14, so that when the puncture needle and the push sheath 16 integrally puncture on the mitral valve annulus, the fixing knot 14 is positioned on the side of the mitral valve close to the atrium, as shown in fig. 4 b; due to the existence of the gap channel 121, the puncture needle is separated from the fixing knot 14, and the puncture needle is firstly withdrawn, as shown in fig. 4 c; then, a pulling force is applied to the pulling wire 15, so that the fixing knot 14 is bent into a ring shape, as shown in fig. 4 d; the outer sheath is then withdrawn entirely out of the body, the fixation knot 14 and puller wire 15 remaining on the mitral annulus, as shown in fig. 4e, to complete the release process of the fixation knot 14; in the released state, the pulling wire 15 is sleeved on the side wall of the fixing knot 14, the pulling wire 15 punctures on the valve ring, and the fixing knot 14 is bent into a ring shape under the traction of the pulling wire 15.

Preferably, as shown in fig. 3, the side wall of the channel 121 of the puncture needle 12 is provided with an inwardly concave notch 122; in the furled state, the distal end of the knot 14 is fitted over the notch 122, and the second end of the pulling wire 15 is wound around the outer wall of the knot 14 after passing through the notch 122, thereby facilitating the positioning of the knot 14 and the pulling wire 15.

Further preferably, as shown in fig. 1, a fixing head 11 is disposed on a distal end surface of the outer sheath 13, and the fixing head 11 is flared from a proximal end to a distal end thereof, so as to increase an abutting area of the fixing head 11 on the mitral valve annulus, and to support the mitral valve annulus in a direction towards the atrium, thereby facilitating a subsequent puncture by the puncture needle 12. Preferably, the fixing head 11 is made of medical polymer material, and has a certain flexibility, so as to protect the valve annulus from being punctured by the valve annulus. For example, nitinol, or other memory alloy materials, may be used.

For the fixed knot 14, as shown in fig. 2, the fixed knot 14 may be a spiral tube, i.e., a spring-like tube; alternatively, as shown in FIG. 1, the fixed knot 14 may also be directly in the form of a circular tube. For the fixing knot 14, preferably, the fixing knot 14 is made of polytetrafluoroethylene (ePTFE), or nitinol, or other medical polymers or degradable medical materials, and has a certain deformation amount, so that after the subsequent puncture is completed, a ring shape is formed, the arc surface is in contact with the organ of the human body, the organ in contact with the arc surface is not damaged,

in addition, the annular puncture needle 12 is preferably made of high-strength metal, and the tip is ground at an angle. The push sheath 16 is made of metal or polymer material, and preferably, the pull wire 15 is made of polytetrafluoroethylene (ePTFE) or other polymer material.

The mitral annulus ring-contracting device of the best embodiment of this embodiment can realize small incision insertion and repair of the dilated annulus without beating the heart, and the working process of the mitral annulus ring-contracting device is described by taking the repair of the annulus between the left ventricle and the left atrium as an example:

in an initial state, as shown in fig. 1 or fig. 2, the fixing knot 14 and the pulling wire 15 are both positioned in the sheath 13;

first, as shown in fig. 10, the heart apex is punctured to enter the left ventricle, the outer sheath tube 13 is delivered below the mitral valve annulus 3, the fixation head 11 is abutted against the valve annulus, the valve annulus is pushed toward the left atrium, and the distal end face of the valve annulus fixation head 11 is used to fix the puncture point on the valve annulus in the adjusted direction, as shown in fig. 4 a;

then, the outer sheath 13 is kept still, and the puncture needle 12, the fixing knot 14, the pulling wire 15 and the pushing sheath 16 are pushed forward (towards the left atrium) to push the puncture valve annulus together, the puncture needle 12, the pulling wire 15 and the pushing sheath 16 are all punctured on the valve annulus, and the fixing knot 14 is positioned on the left atrium side, as shown in fig. 4 b; thereafter, the needle 12 is first withdrawn and the pusher tube remains pushed out of the proximal end of the fixation knot 14, as shown in FIG. 4 c; subsequently, a pulling force is applied to the pulling wire 15 to loop the fixing knot 14 and to knot the part of the fixing knot 14 located in the left ventricle to fix the position of the annulus puncture site, as shown in fig. 4d, and then the sheath 13 is withdrawn to the outside of the apex of the heart to complete the puncture of the first fixing knot 14, as shown in fig. 4 e; in the same way, another fixation knot 14, a second fixation knot 14, is implanted at the annulus at a distance L1 from the first fixation knot 14, as shown in fig. 11 a.

Then, the locking mechanism 2 is conveyed to the valve annulus by adopting a conveying mechanism, the outer tube 24 is punctured through the apex of the heart and conveys the mitral valve annulus 3, the outer tube 24 stops moving, the head hanging sheath tube 23 moves to push the locking main body 21 to the bottom of the mitral valve annulus 3, and the end parts of the pulling wires 15 of the two adjacent fixing knots 14 pass through the locking holes 27 through the first channel of the locking main body 21 and then extend towards the near end; then, under three-dimensional ultrasound and contrast navigation, a pulling force is applied to the two pulling lines 15, and the distance between the two valve annulus fixing knots 14 is adjusted in real time until the regurgitation disappears, for example, the distance between the two fixing knots 14 is finally adjusted to be L2, the circumference of the mitral valve annulus 3 is shortened, and further the reduction of the valve annulus is realized; at this time, the locking plug 22 is pushed to the farthest end of the locking body 21 through the pushing inner tube 25, the spring plate blocks the locking plug 22, the pulling wire 15 is fixed on the locking body 21, the single annular contraction of the mitral valve annulus 3 is completed, and as shown in fig. 11b, the outer tube 24, the hitching sheath tube 23 and the pushing inner tube 25 are finally withdrawn from the human body as a whole.

As shown in fig. 12 and 13, pairs of fixation knots 14 may be implanted in the mitral annulus 3 in the same manner as described above to further reduce the size of the annulus.

The number of the fixing mechanisms is even, the ring-shrinking function of the valve ring can be realized by one pair of fixing mechanisms, and the specific number is not limited and can be selected according to actual requirements.

In addition, the knotted positions of the two ends of the pulling line 15 of each fixing knot 14 are close to the valve annulus, and the pulling line 15 can be knotted and fixed at the heart apex according to the focus of a patient, so as to complete the implantation and fixation of the ring-shaped device.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications can be made without departing from the scope of the invention.

Claims (10)

1. A mitral annulus annuloplasty device, comprising

At least two securing mechanisms; any one fixing mechanism comprises a fixing knot (14) and a traction line (15), wherein the traction line (15) is arranged on the fixing knot (14), and two ends of the traction line (15) are positioned outside the near end of the fixing knot (14);

the puncture mechanism (1) is used for puncturing the fixing knot (14) and the traction line (15) of any fixing mechanism on the valve annulus, the fixing knot (14) is positioned on one side of the valve annulus, and two ends of the traction line (15) are positioned on the other side of the valve annulus; the pulling wires (15) of two adjacent fixing mechanisms are driven to mutually approach under the driving of traction force so as to shorten the distance between two adjacent fixing knots (14);

and the locking mechanism (2) is used for locking the end parts of the traction wires (15) in the two adjacent fixing mechanisms on the valve ring when the traction wires (15) of the two adjacent fixing mechanisms are drawn into position.

2. The mitral valve annulus annuloplasty device according to claim 1, wherein the locking mechanism (2) comprises

A locking body (21) having a first channel extending along its length;

a locking plug (22) which clamps the pulling wire (15) between the locking plug (22) and the locking body (21) by being inserted into the first channel.

3. The mitral valve annulus annuloplasty device according to claim 2, wherein the side wall of the locking body (21) is provided with a locking hole (27) through which the end of the pulling wire (15) passes.

4. The mitral valve annulus annuloplasty device according to claim 2 or 3, wherein the side wall of the locking body (21) is further provided with a first mounting hole (213);

the device also comprises at least one elastic body (26), the proximal end of which is formed in the first mounting hole (213), and the distal end of which tends to extend into the first channel under the action of self deformation;

when the locking plug (22) is plugged towards the first channel, the elastic body (26) swings towards the inside of the first mounting hole (213) under the extrusion force of the outer wall of the locking plug (22); after the locking plug (22) passes over the distal end of the elastic body (26), the elastic body (26) is reset and the distal end thereof is blocked on the locking plug (22).

5. The mitral valve annulus annuloplasty device according to claim 4, wherein the locking plug (22) comprises a base (222) and a first annular boss (221) formed on the outer circumference of the distal end of the base (222), the first annular boss (221) applying the compressive force to the elastic body (26);

when the elastic body (26) is reset, the far end of the elastic body (26) is blocked at the near end side of the first annular boss (221).

6. The mitral valve annulus annuloplasty device according to claim 5, wherein the inner wall of the distal end of the locking body (21) is provided with a second annular boss (211) protruding inward;

the distal end of the first annular boss (221) is blocked by the second annular boss (211) to be held between the second annular boss (211) and the elastic body (26); and/or

The elastic body (26) is a spring sheet.

7. The mitral valve annulus annuloplasty device according to any of claims 2-6, wherein the locking mechanism (2) further comprises a delivery mechanism; the conveying mechanism comprises an outer pipe (24), a hanging head sheath pipe (23) which is slidably arranged in the outer pipe (24) and a pushing inner pipe (25) which is slidably arranged in the hanging head sheath pipe (23);

the far end of the hanging head sheath tube (23) is detachably connected with the near end of the locking main body (21), and the far end of the pushing inner tube (25) is inserted into or matched with the near end of the locking plug (22) in a sleeved mode; the locking body and the locking plug are both located within the outer tube (24) before the locking body is unreleased.

8. The mitral valve annulus annuloplasty device according to any of claims 1-7, wherein the puncturing mechanism (1) comprises

An outer sheath tube (13);

the puncture needle (12) is slidably arranged in the sheath tube (13), and the outer wall of the far end of the puncture needle (12) is provided with a notch channel (121) extending along the length direction of the puncture needle (12);

the pushing sheath (16) is slidably arranged in the outer sheath tube (13) and sleeved outside the puncture needle;

the fixing knot (14) has a furled state furled in the sheath tube (13) and a released state punctured on the valve ring;

in a furled state, the fixing knot (14) is sleeved on the outer wall of the opening channel (121) of the puncture needle, and the near end of the puncture needle is distributed opposite to the far end of the pushing sheath (16); the first end of the pulling wire (15) is positioned in the notch channel (121), and the second end of the pulling wire passes through the notch channel (121), then winds around the outer wall of the fixing knot (14) from the far end of the fixing knot (14), and extends into the puncture needle through the near end of the notch channel (121), so that the first end and the second end are distributed in an overlapping way;

in a release state, the traction line (15) is sleeved on the side wall of the fixing knot (14), the traction line (15) punctures on the valve ring, and the fixing knot (14) is pulled by the traction line (15) to bend into a ring shape.

9. The mitral valve annulus annuloplasty device according to claim 8, wherein the side wall of the slit channel (121) of the puncture needle (12) is provided with an inwardly recessed notch (122); in a furled state, the far end of the fixed knot (14) is sleeved at the notch (122), and the second end of the pulling wire (15) passes through the notch (122) and then is wound on the outer wall of the fixed knot (14).

10. The mitral valve annulus annuloplasty device according to claim 8, wherein the fixation knot (14) is in the shape of a spiral or a circular tube; and/or

Be equipped with fixed head end (11) on the distal end terminal surface of outer sheath pipe (13), fixed head end (11) are the loudspeaker form by its near-end towards the distal end.

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