A stent for mitral valve repair

By improving the stent skeleton structure and using upturned fasteners and arc-shaped support segments, the problems of contact damage and instability between the existing stent and the leaflet are solved, the risk of thrombosis is reduced, and the effect of mitral valve repair is improved.

CN114831778BActive Publication Date: 2025-10-10SUZHOU INNOMED MEDICAL DEVICE CO LTD
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Patent Information

Application Number
CN202210604695.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-05-31
Publication Date
2025-10-10
Estimated Expiration
2042-05-31

AI Technical Summary

Technical Problem

Existing transcatheter mitral valve repair stents have problems during use, such as contact between the stent and the native valve leaflet, causing damage, instability, high risk of thrombosis, and difficulty in positioning.

Method used

It adopts a skeleton structure design, including atrial limiters and membrane fixing parts, and uses an upward-turned fastening part to replace the limit curve segment. Combined with an arc-shaped support segment and a multi-core sleeve, the stability and sealing of the stent are enhanced. The diaphragm is designed to be closed at the top and bottom and gradually thickens to reduce contact with the valve leaflet and the risk of thrombosis.

Benefits of technology

It improves the stability and sealing of the stent, reduces the risk of leaflet damage and thrombosis, simplifies the positioning process, and enhances the repair effect.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application relates to a stent for repairing a mitral valve, which comprises a framework and a membrane assembly. The framework comprises an atrium limiting piece and a membrane fixing piece. The membrane fixing piece comprises a V-shaped supporting section and a first sleeve and a second sleeve which are symmetrically connected to the left and right ends of the V-shaped supporting section. The membrane assembly is fixed in the membrane fixing piece. The atrium limiting piece comprises a first limiting curve section on the front side and a second limiting curve section on the back side. The first and second limiting curve sections are connected to the upper ends of the first and second sleeves after being crossed twice on the left and right sides and forming annular parts. The framework further comprises an upward pressing piece on the front side and / or the back side of the membrane fixing piece. The lower end of the upward pressing piece is connected to the lower tip of the V-shaped supporting section, and the upper end of the upward pressing piece is pressed against the lower surface of the mitral valve ring. The application can effectively overcome the defects of the existing stents, such as unstable anchoring, failure to recover to the initial state, limited indications and increased thrombosis risk during use.
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Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and relates to a repair device for mitral valve insufficiency, in particular to a stent for repairing mitral valve. BACKGROUND

[0002] Surgical treatment of mitral valve insufficiency is divided into valve repair and valve replacement. Surgical valve repair or replacement is considered the standard treatment for the disease. However, surgical procedures have the disadvantages of large trauma, high risk, and slow recovery. With the development of interventional therapy technology, transcatheter mitral valve replacement or repair has been rapidly developed and applied in clinical practice. Interventional catheters are sent through the femoral vein, jugular vein, or apex of the heart, and artificial heart valves or repair devices are delivered to the valve area to open, which can maximize the preservation of the original structure of the mitral valve to restore valve function.

[0003] As a minimally invasive interventional treatment, transcatheter valve intervention has the advantages of low surgical risk and strong tolerance for high-risk patients, and has become the development trend of future heart valve treatment methods. Existing transcatheter repair procedures include edge-to-edge repair, annuloplasty, and artificial chord implantation, which have the same principle as surgical procedures. The MitraClip technology in edge-to-edge repair has been applied in clinical practice and has the characteristics of high surgical success rate and relatively good safety, but also has the following shortcomings: complex operation, easy damage to the valve, sacrifice of the effective opening area of the valve, and lack of long-term effectiveness.

[0004] To solve the above problems, the applicant discloses a mitral valve repair stent in CN113476181A, which makes structural innovations, reduces the upper inflation beam extending into the atrium, increases the front and rear V-shaped connecting segments, and improves the membrane assembly. The stent basically eliminates the effect of the stent on the pulmonary vein ridge and improves the compliance of the membrane assembly. Based on the above stent, further research has found that it also has the following problems: (1) The limiting curved segments (such as the third limiting curved segment 12 and the fourth limiting curved segment 13 in CN113476181A) at the bottom of the stent, which have the function of positioning the stent, will have more contact with the native leaflet of the mitral valve during use. On the one hand, it will cause the stent to jump up and down with a large amplitude, the instrument will be unstable, the position of the membrane assembly in the stent will not be fixed, and the native leaflet will be damaged due to the frequent and continuous contact with the membrane assembly. (2) When the stent is subjected to extrusion, especially the force in the left and right directions, the front and rear membrane pieces of the membrane assembly are prone to deformation and are not flat, which causes the membrane assembly to not fit tightly with the native leaflet. In addition, the narrow passage between the front and rear membrane pieces for blood flow increases the risk of thrombosis, and since the front and rear membrane pieces are separable, the positioning requirements for implanting the stent are high to ensure the repair effect. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a stent for mitral valve repair, aiming to overcome the above-mentioned deficiencies in the prior art.

[0006] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A stent for mitral valve repair includes a skeleton and a membrane assembly, the skeleton includes an atrial limiting member and a membrane fixing member, the membrane fixing member includes a V-shaped support segment and a first sleeve and a second sleeve symmetrically connected to the left and right ends of the V-shaped support segment, the membrane assembly is fixed in the membrane fixing member, the atrial limiting member includes a first limiting curve segment located above the front side and a second limiting curve segment located above the rear side, the first limiting curve segment and the second limiting curve segment respectively cross twice on the left and right sides and form an annular portion and are connected to the upper ends of the first sleeve and the second sleeve, the skeleton also includes an upward-folding fastening member located on the front side and / or the rear side of the membrane fixing member, the lower end of the upward-folding fastening member is connected to the lower tip of the V-shaped support segment, the upper end of the upward-folding fastening member is folded and bent toward the front side or the rear side and extends to press against the lower surface of the mitral valve annulus.

[0007] On the basis of the above technical solution, the present invention can also be improved as follows.

[0008] Furthermore, the upward-folding and tightening member is formed by bending a memory alloy wire, and the shape of the upward-folding and tightening member is fishtail-shaped with a wide upper end and a narrow lower end.

[0009] The advantage of adopting the above-mentioned further structural improvement is that the wider fishtail end can contact a larger area of ​​the bottom surface of the valve ring when facing upward, which is equivalent to a large contact area. At the same pressure, the pressure at the contact point is small, which can not only ensure the limitation of the stent, but also minimize the compression damage to the valve ring.

[0010] Furthermore, both sides of the middle portion and the lower end of the upward-folding fastening member are bent to form locking line limiting rings.

[0011] The benefit of adopting the above-mentioned further structural improvement is that the middle and lower locking wire rings can limit the locking wire when the valve stent is loaded into the delivery system (catheter). The advantage is that when the instrument is recovered and released during surgery, the locking wire will not slide along the V-shaped support segment or the memory alloy wire corresponding to the upward fastening part, and it can return to the initial loading state more easily and better.

[0012] Furthermore, the lower end of the upward-folding abutting member is connected to the lower tip of the V-shaped supporting section through a third sleeve.

[0013] The advantage of adopting the above-mentioned further structural improvement is that the third sleeve can clamp and fix the memory alloy wire that passes around the tip of the V-shaped support section, which is beneficial to enhancing the stability of the support structure.

[0014] Furthermore, the number of the upward-folding fastening member is one and the member is located at the front side or the rear side of the membrane fixing member.

[0015] Furthermore, the number of the upward-folding abutting members is two and they are symmetrically distributed on the front and rear sides of the membrane fixing member.

[0016] The advantage of adopting the above-mentioned further structural improvement is that, depending on the specific situation of the patient, the number of the upward-turned abutment parts can be selected to be one and located on the front or back side of the stent, which is suitable for situations where reflux occurs due to lax closure due to unilateral valve damage; the number of the upward-turned abutment parts can also be selected to be two and arranged symmetrically on the front and back sides, which is suitable for central reflux.

[0017] Furthermore, the membrane fixing member further includes an arc-shaped support segment, the arc-shaped support segment opens downward, and the left and right ends of the opening correspond to and are fixedly connected to the upper ends of the first sleeve and the second sleeve.

[0018] The advantage of adopting the above-mentioned further structural improvement is that when the heart contracts, the stent is squeezed in the long axis direction of the atrial limiter, and the arc-shaped support section can provide a certain support force for the membrane assembly, so that the membrane assembly remains flat, thereby fitting more closely with the native valve leaflet and better sealing incomplete closure.

[0019] Furthermore, the membrane assembly includes a diaphragm with closed upper and lower ends, and the left side, right side and bottom of the diaphragm are connected to the first sleeve, the second sleeve and the V-shaped support section in sequence.

[0020] The benefits of adopting the above further structural improvements are:

[0021] Furthermore, the diaphragm is formed by sewing a front diaphragm and a rear diaphragm that are symmetrical in front and back along the periphery, and the thickness of the diaphragm in the front-to-back direction gradually increases from top to bottom.

[0022] The benefit of adopting the above-mentioned further structural improvement is that both the top and the bottom are sealed by sutures. The advantage is that no blood flows through the narrow membrane component channel, reducing the possibility of thrombosis. At the same time, the effective clamping area of ​​the native leaflet to the membrane component is increased, and the difficulty of positioning the valve stent implantation is reduced.

[0023] Furthermore, the first sleeve and the second sleeve are both multi-core tubes, and the multi-core tubes have multiple fixed channels extending and passing through in the axial direction. The V-shaped support section, the first limiting curve section, the second limiting curve section and the upward-turned fastening member are formed by bending and winding the same memory metal wire and then heat-setting. During the winding process, the memory metal wire passes through the multiple fixed channels of the first sleeve and the second sleeve respectively.

[0024] The advantage of adopting the above-mentioned further structural improvement is that the memory alloy wire can be fixed separately in each fixed channel of each multi-core tube. Compared with the structure of fixing multiple alloy wires in one channel in the prior art, the fixing effect is better, and it can better prevent the alloy wire from undergoing lateral or longitudinal displacement in the sleeve, which is beneficial to improving the structural stability of the bracket itself.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] (1) The bottom of the stent is provided with an upward-folding abutting piece that is folded and bent toward the upper front side or the upper rear side to replace the limiting curve section originally extending forward and backward at the bottom of the existing stent. This not only effectively overcomes the problem that the limiting curve section extending outward and forward at the bottom of the existing stent has more contact with the native leaflets of the mitral valve and is easy to cause leaflet damage (the upward-folding abutting piece basically does not contact the native leaflets when working), but also can clamp the valve ring together with the first and second limiting curve sections of the atrial limiting piece, anchor it firmly, play the role of limiting the stent, and overcome the deficiency of the existing stent that the large beating occurs due to the contraction and relaxation of the heart.

[0027] (2) The membrane fixing part has an arc-shaped support section with an upper opening facing downward and extending in the left and right directions. When the heart contracts and compresses the stent, the arc-shaped support section can effectively resist deformation caused by pressure in the left and right directions, thereby ensuring that the diaphragm of the membrane assembly remains flat, thereby fitting more closely with the native leaflet and achieving a better effect in repairing mitral valve insufficiency.

[0028] (3) The membrane assembly has a diaphragm that is sealed at the top and bottom, which overcomes the deficiency of the existing diaphragm that is composed of two diaphragms in the front and back with a narrow channel running through the middle, which is prone to thrombosis. It effectively reduces the possibility of thrombosis. At the same time, after the upper and lower ends are sutured and closed, the integrity of the diaphragm is better and the area is larger. The native leaflets are easier to clamp the diaphragm, and the difficulty of positioning the valve stent for implantation is reduced. The diaphragm is preferably a wedge-shaped diaphragm that gradually becomes thicker from top to bottom, and the leak-proof effect is better when cooperating with the native leaflets. It is suitable for severe insufficiency, and the resultant force on the diaphragm of this structure when clamped by the native leaflets is downward, which is conducive to a more stable stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is an axonometric view of the skeleton of a stent for mitral valve repair provided by the present invention;

[0030] Figure 2 for Figure 1 a top view of the skeleton shown;

[0031] Figure 3 for Figure 1 a front view of the skeleton shown;

[0032] Figure 4 for Figure 1 The skeleton shown in the figure forms a stent shaft view after the film assembly is installed (the third sleeve is not shown);

[0033] Figure 5 For Figure 4 The front view of the stent shown in the figure;

[0034] Figure 6 For Figure 4 The top view of the stent shown in the figure;

[0035] Figure 7 For Figure 5 The schematic diagram of the stent shown in the figure when the diaphragm is thick at the top and thin at the bottom;

[0036] Figure 8 For Figure 5 The schematic diagram of the stent shown in the figure when the upper turning abutting member is provided on both sides;

[0037] Figure 9 For Figure 8 The top view of the stent shown in the figure;

[0038] Figure 10 For Figure 1 The axonometric view of the first sleeve in the stent shown in the figure;

[0039] Figure 11 For Figure 4 And 5 The axonometric view of the diaphragm that is thick at the top and thin at the bottom in the stent shown in the figure;

[0040] Figure 12 For Figure 4 The schematic diagram of the stent shown in the figure after being implanted in a designated position of the heart.

[0041] In the drawings, the components represented by each reference number are listed as follows:

[0042] 1, V-shaped support section; 2, first sleeve; 3, second sleeve; 4, first limiting curved section; 5, second limiting curved section; 6, upper turning abutting member; 7, wire locking limiting ring; 8, third sleeve; 9, arc-shaped support section; 10, diaphragm; 11, fixed channel. DETAILED DESCRIPTION

[0043] The principles and characteristics of the present application are described below in combination with the drawings and specific embodiments, and the examples given are only used to explain the present application and are not used to limit the scope of the present application.

[0044] In the description of the present invention, if terms indicating directions such as "up", "down", "left", "right", "top", "bottom", "inside" and "outside" are used, the directions or positional relationships indicated are based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operate in a specific direction. Therefore, they should not be understood as limiting the present invention.

[0045] like Figures 1 to 12 As shown, the present invention provides a stent for mitral valve repair, comprising a skeleton and a membrane assembly, the skeleton comprising an atrial limiting member and a membrane fixing member, the membrane fixing member comprising a V-shaped support segment 1 and a first sleeve 2 and a second sleeve 3 symmetrically connected to the left and right ends of the V-shaped support segment 1, the membrane assembly being fixed in the membrane fixing member, the atrial limiting member comprising a first limiting curve segment 4 located above the front side and a second limiting curve segment 5 located above the rear side, the first limiting curve segment 4 and the second limiting curve segment 5 being respectively crossed twice on the left and right sides and forming an annular portion and then connected to the upper ends of the first sleeve 2 and the second sleeve 3, the skeleton further comprising an upward-folding fastening member 6 located on the front and / or rear side of the membrane fixing member, the lower end of the upward-folding fastening member 6 being connected to the lower tip of the V-shaped support segment 1, the upper end of the upward-folding fastening member 6 being folded and bent toward the upper front side or the upper rear side and then pressed against the lower surface of the mitral valve ring.

[0046] It should be noted that the annular portion formed by the first and second limiting curve segments, which intersect twice on the left and right sides, is a saddle-shaped annular arc. The annular portion is located in the left atrium and fits the upper surface of the valve annulus. After the stent is installed in place, the annular portion and the upward-turned abutment clamp clamp the valve annulus together to position the stent at the mitral valve. The annular atrial limiting member formed by the first and second limiting curve segments has an upward curvature that adapts to the saddle shape of the mitral valve annulus. The upward-turned abutment does not contact the native valve leaflets during operation and will not cause damage to the native valve leaflets. The valve stent has a smaller amplitude of movement with blood flow and the beating of the native valve leaflets, and the anchoring is more stable.

[0047] In addition, the first limiting curve segment and the second limiting curve segment cross twice on the left and right sides respectively, one intersection point is located at the upper part, close to the junction of the anterior and posterior leaves of the mitral valve annulus after implantation, and the other intersection point is located between the arc-shaped support section of the membrane assembly and the top of the first sleeve or the second sleeve. The scissor-type intersection plane is at an angle of 10 to 30 degrees to the annular plane of the atrial limiter. No fixing treatment is performed at the intersection point, so that when the heart contracts, the first and second curve segments are subjected to anterior-posterior pressure, and a small displacement of misalignment can occur at the intersection point as a preload force released when the heart relaxes, ensuring that the first and second limiting curve segments are in close contact with the annular wall, providing stable dynamic support to prevent the stent from falling into the ventricle and the membrane assembly from deflecting.

[0048] In one embodiment of the present invention, the upwardly turned fastening member 6 is formed by bending a memory alloy wire. Figure 1 As shown, the shape of the upward-turned abutting member 6 is preferably fishtail-shaped with a wider upper end and a narrower lower end.

[0049] It is understandable that the shape of the upward-turned pressing member is not limited to a fishtail shape, and any other optional shape is acceptable as long as the upper end can effectively press against the lower surface of the valve annulus without causing significant damage to the valve annulus.

[0050] It should be noted that the design of the upward-turned fastener allows the valve stent body to pulsate slightly with the heart's blood flow and the native leaflets, making it less likely for tissue to creep over, and better adapting to the structure of the native leaflet's incomplete closure. Since the curved section of the upward-turned fastener has a small range of motion, in order to prevent tissue from creeping over, the corresponding memory alloy wire surface can be covered with a PTFE film. When working, the upward-turned fastener is located behind the free edge of the native leaflet, and its top is fishtail-shaped, which can form a stable support at the root of the leaflet. The width of the upward-turned fastener gradually decreases from the top to the root. This design allows it to avoid the chordae tendineae at the tip of the native leaflet and does not damage the chordae tendineae. The upward-turned fastener extends upward in an arc shape from the bottom of the membrane assembly. Compared with the original lower limiter, its advantage is that it does not contact the leaflet during the opening and closing process of the native leaflet and will not damage the native leaflet.

[0051] In one embodiment of the present invention, both sides of the middle portion and the lower end of the upwardly turned fastening member 6 are bent to form a locking wire limiting ring 7 .

[0052] It should be noted that the locking wire passes through the locking wire limiting ring, so the position of the locking wire is effectively limited, ensuring that the locking wire will not slide along the V-shaped supporting section or the flip-up clamping member when pulled by the locking wire, so that the force point of the locking wire on the bracket is relatively fixed. The locking wire limiting ring at the lower end can be an extension from the lower end of the flip-up fastener, or it can be an extension from the lower end of the V-shaped supporting section. A locking wire limiting ring is provided in the middle of the flip-up fastener, and when the flip-up fastener is compressed and loaded into the conveying system, the locking wire and the middle curved section of the flip-up fastener will not produce relative displacement, thereby maintaining the consistency of the state of the flip-up fastener after loading. The arc design at the bottom of the flip-up fastener facilitates its downward flipping, thereby compressing and loading into the sheath of the conveying system.

[0053] In one embodiment of the present invention, the lower end of the upward-turned abutting member 6 is connected to the lower tip of the V-shaped supporting section 1 through a third sleeve 8 .

[0054] It should be noted that the third sleeve can be a multi-core tube or a single-core tube, preferably a multi-core tube.

[0055] In one embodiment of the present invention, the number of the upward-turned abutting member 6 is one and the upward-turned abutting member 6 is located at the front side or the rear side of the membrane fixing member.

[0056] In one embodiment of the present invention, the number of the upward-turned abutting members 6 is two and they are symmetrically distributed on the front and rear sides of the membrane fixing member.

[0057] In one embodiment of the present invention, the membrane fixing member further comprises an arcuate support segment 9 , which opens downward and has left and right ends corresponding to and fixedly connected to the upper ends of the first sleeve 2 and the second sleeve 3 .

[0058] In one embodiment of the present invention, the membrane assembly includes a membrane 10 with closed upper and lower ends. The left side, right side and bottom of the membrane 10 are connected to the first sleeve 2, the second sleeve 3 and the V-shaped support section 1 in sequence.

[0059] It is understandable that the present invention eliminates the connection between the diaphragm made of implantable material and the atrial limiter, and the top and bottom of the diaphragm are sealed by sutures, without channels, and the diaphragm is in the form of an integral sheet, which acts as a plug. The single front diaphragm is the same shape as the rear diaphragm. The front and rear diaphragms are first sutured into a sleeve shape by sutures, and then sutured and fixed to the membrane assembly support section. The closed diaphragm forms a wedge shape, which is adapted to the shape of the native leaflet when closed, and can fill the gap of incomplete closure. The diaphragm material can be made of elastic biocompatible material (such as biological pericardial tissue, PTFE, polyurethane, silicone rubber, etc.), which will not cause damage to the native valve when in contact with the native valve.

[0060] In one embodiment of the present invention, the diaphragm 10 is formed by sewing a front diaphragm 10 and a rear diaphragm 10 symmetrically along the periphery. Figure 5 and Figure 11 As shown in a preferred embodiment, the thickness of the diaphragm 10 in the front-to-back direction gradually increases from top to bottom, and the diaphragm 10 is wedge-shaped as a whole.

[0061] In one embodiment of the present invention, Figure 10 As shown, the first sleeve 2 and the second sleeve 3 are both multi-core tubes, and the multi-core tubes have multiple fixed channels 11 extending and passing through in the axial direction. The V-shaped support section 1, the first limiting curve section 4, the second limiting curve section 5 and the upward-turned fastening member 6 are formed by bending and winding the same memory metal wire and then heat-setting. During the winding process, the memory metal wire passes through the multiple fixed channels 11 of the first sleeve 2 and the second sleeve 3 respectively.

[0062] It should be noted that the first and second sleeves are both five-core tubes with five fixed channels extending and passing through in the axial direction, and the five fixed channels are distributed in a trapezoidal shape. The first limiting curve section, the second limiting curve section, the arc-shaped support section, the V-shaped support section and the upward-turned fastening member can be formed by weaving and heat-setting the same memory alloy wire (nickel-titanium wire). During the weaving process, the memory alloy wire passes through the five fixed channels of the first sleeve and the second sleeve in turn, and then applies pressure on the outer surface of the five-core tube through the pre-tightening device to cause it to deform slightly to achieve the purpose of reducing the aperture and clamping the alloy wire. Compared with multiple alloy wires passing through one channel at the same time, each fixed channel passing through one alloy wire can greatly enhance the effective friction between the outer surface of each alloy wire and the inner surface of the connecting tube channel, which can effectively prevent the alloy wire from falling out of the connecting tube, which is beneficial to the structural stability of the bracket.

[0063] In the present invention, by adopting different diameters of memory alloy wires and heat setting treatment processes, the strength of the atrial limiter can be made higher than that of the upward-turned fastener. Since the upward-turned fastener is not subject to the force of the ventricular wall, in this case, the position of the membrane component between the native leaflets after the valve stent is implanted is mainly determined by the atrial limiter, which is suitable for central regurgitation. Since the valve repair stent is non-directional, according to the patient's condition, it is also possible to choose to place the upward-turned fastener on the anterior leaflet or posterior leaflet of the mitral valve, while reducing the strength of the atrial limiter. In this case, the membrane component of the valve stent will be attached to the anterior leaflet or posterior leaflet of the mitral valve, and as the anterior leaflet or posterior leaflet of the native valve moves, it will form a compensatory effect on the damaged side. Therefore, the mitral valve repair stent provided by the present invention has a wider range of indications.

[0064] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A stent for mitral valve repair, comprising a skeleton and a membrane assembly, wherein the skeleton comprises an atrial limiting member and a membrane fixing member, wherein the membrane fixing member comprises a V-shaped support segment (1) and a first sleeve (2) and a second sleeve (3) symmetrically connected to the left and right ends of the V-shaped support segment (1), wherein the membrane assembly is fixed in the membrane fixing member, wherein the atrial limiting member comprises a first limiting curve segment (4) located above the front side and a second limiting curve segment (5) located above the rear side, wherein the first limiting curve segment (4) and the second limiting curve segment (5) are respectively connected to the upper ends of the first sleeve (2) and the second sleeve (3) after being crossed twice on the left and right sides and forming an annular portion, wherein the first limiting curve segment (4) and the second limiting curve segment (5) are connected to the upper ends of the first sleeve (2) and the second sleeve (3), wherein the stent is characterized in that: The skeleton further comprises an upwardly turned abutting member (6) located at the front side and / or the rear side of the membrane fixing member, the lower end of the upwardly turned abutting member (6) being connected to the lower tip of the V-shaped support segment (1), and the upper end of the upwardly turned abutting member (6) being bent and extended toward the upper front side or the upper rear side and then abutting against the lower surface of the mitral valve ring; The membrane assembly comprises a membrane sheet (10) with closed upper and lower ends, and the left side, right side and bottom of the membrane sheet (10) are sequentially connected to the first sleeve (2), the second sleeve (3) and the V-shaped support section (1).

2. A stent for mitral valve repair according to claim 1, characterized in that: The upward-turned abutting piece (6) is formed by bending a memory alloy wire. The upward-turned abutting piece (6) is in the shape of a fishtail and is wide at the upper end and narrow at the lower end.

3. The stent for mitral valve repair according to claim 2, characterized in that: Both sides of the middle part and the lower end of the upward-folding fastening member (6) are bent to form a locking line limiting ring (7).

4. The stent for mitral valve repair according to claim 2, characterized in that: The lower end of the upward-turned abutting member (6) is connected to the lower tip of the V-shaped supporting section (1) through a third sleeve (8).

5. The stent for mitral valve repair according to claim 2, characterized in that: The number of the upward-turned abutting member (6) is one and the member is located at the front side or the rear side of the membrane fixing member.

6. The stent for mitral valve repair according to claim 2, characterized in that: The number of the upward-turned abutting parts (6) is two and they are symmetrically distributed on the front side and the rear side of the membrane fixing part.

7. The stent for mitral valve repair according to claim 1, characterized in that: The membrane fixing member further comprises an arc-shaped support section (9), the arc-shaped support section (9) opens downward, and the left and right ends of the opening correspond to and are fixedly connected to the upper ends of the first sleeve (2) and the second sleeve (3).

8. The stent for mitral valve repair according to claim 1, characterized in that: The diaphragm (10) is formed by sewing a front diaphragm and a rear diaphragm that are symmetrical in front and back along the periphery. The thickness of the diaphragm (10) in the front-to-back direction gradually increases from top to bottom.

9. The stent for mitral valve repair according to any one of claims 1 to 8, characterized in that: The first sleeve (2) and the second sleeve (3) are both multi-core tubes, and the multi-core tubes have a plurality of fixed channels (11) extending in the axial direction and passing through. The V-shaped support section (1), the first limiting curve section (4), the second limiting curve section (5) and the upward-turning fastening member (6) are formed by bending and winding the same memory metal wire and then heat-setting. During the winding process, the memory metal wire passes through the plurality of fixed channels (11) of the first sleeve (2) and the second sleeve (3).

Citation Information

Patent Citations

  • Mitral valve repair stent

    CN113476181A

  • Two stage anchor and mitral valve assembly

    US20150359629A1