CN114831778A - Support for repairing mitral valve - Google Patents

Support for repairing mitral valve Download PDF

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Publication number
CN114831778A
CN114831778A CN202210604695.9A CN202210604695A CN114831778A CN 114831778 A CN114831778 A CN 114831778A CN 202210604695 A CN202210604695 A CN 202210604695A CN 114831778 A CN114831778 A CN 114831778A
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CN
China
Prior art keywords
membrane
sleeve
mitral valve
section
piece
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202210604695.9A
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Chinese (zh)
Inventor
王青
李云龙
刘浩
李超
龚霄雁
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Suzhou Innomed Medical Device Co ltd
Original Assignee
Suzhou Innomed Medical Device Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Suzhou Innomed Medical Device Co ltd filed Critical Suzhou Innomed Medical Device Co ltd
Priority to CN202210604695.9A priority Critical patent/CN114831778A/en
Publication of CN114831778A publication Critical patent/CN114831778A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to a support for repairing a mitral valve, which comprises a framework and a membrane assembly, wherein the framework comprises an atrium limiting piece and a membrane fixing piece, the membrane fixing piece comprises a V-shaped supporting section, a first sleeve and a second sleeve which are bilaterally and symmetrically connected to the left end and the right end 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 positioned above the front side and a second limiting curve section positioned above the rear side, the first limiting curve section and the second limiting curve section are respectively crossed twice on the left side and the right side to form a ring part and then are connected with the upper ends of the first sleeve and the second sleeve, the framework further comprises an upturning and supporting piece positioned on the front side and/or the rear side of the membrane fixing piece, the lower end of the upturning and supporting piece is connected with the lower part of the V-shaped supporting section, and the upper end of the upturning and supporting piece is abutted against the lower surface of the mitral valve ring. The invention has the advantages that the defects of unstable anchoring, incapability of recovering an initial state, adaptation disease limitation, increased thrombosis risk in use and the like of the conventional stent can be effectively overcome.

Description

Support for repairing mitral valve
Technical Field
The invention belongs to the field of medical equipment, relates to a repair device applied to mitral insufficiency, and particularly relates to a stent for repairing a mitral valve.
Background
Surgical treatment of mitral insufficiency is divided into valve repair and valve replacement. Surgical valve repair or replacement is considered the standard treatment for this disease. However, surgery has the disadvantages of large trauma, high risk, slow recovery, etc. With the development of interventional treatment technology, transcatheter mitral valve replacement or repair is rapidly developed and applied to clinic, an interventional catheter is sent through a femoral vein, a jugular vein or an apex of the heart, a prosthetic heart valve or a repair device is conveyed to a valve area to be opened, and the original structure of the mitral valve can be furthest reserved to restore the function of the valve.
The transcatheter valve interventional therapy is used as a minimally invasive interventional therapy means, has the advantages of low surgical risk and strong tolerance of high-risk patients, and becomes the development trend of future heart valve therapy methods. Existing transcatheter repair procedures include edge-to-edge repair, annuloplasty, artificial chordae implantation, etc., on the same principle as surgery. The MitraClip technology in the edge-to-edge repair is applied to clinic, has the characteristics of high operation success rate and relatively good safety, but has the following defects: the operation is complex, the valve is easily damaged, the effective opening area of the valve is sacrificed, and the long-term effectiveness is deficient.
In view of the above problems, the applicant disclosed in CN113476181A a mitral valve repair stent with structural innovation, reducing the upper expansion beam extending into the atrium, increasing the concave front and rear V-shaped connecting sections, and improving the membrane module, substantially eliminating the effect of the stent on the pulmonary vein ridge and improving the compliance of the membrane module. On the basis of the bracket, the following intensive researches find that the bracket also has the following problems: (1) the bottom of the stent extends outwards to form a limit curve section (such as a third limit curve section 12 and a fourth limit curve section 13 in CN 113476181A) which has a function of positioning the stent, and the limit curve section is in more contact with the native valve leaflets of the mitral valve in the use process, so that on one hand, the up-and-down jumping amplitude of the stent is large, the instrument is unstable, the part of a membrane component in the stent is not fixed, the part of the native valve leaflet clamping the membrane component is downward to influence the valve repair effect, and on the other hand, the frequent and continuous contact function can also cause the damage of the native valve leaflets; (2) when the support receives the effect of extrusion especially left right direction's effort, preceding diaphragm and the back diaphragm of its interior membrane module easily produce deformation and unevenness, lead to the laminating of membrane module and primary valve leaf not inseparable enough, have the narrow passageway that supplies the blood flow to pass through between the diaphragm around in addition, research discovers that the existence of this passageway has increased the risk of thrombus formation, simultaneously because preceding diaphragm is detachable, in order to guarantee the repair effect, the location when implanting the support requires highly.
Disclosure of Invention
The invention aims to solve the technical problem of providing a bracket for repairing a mitral valve, aiming at overcoming the defects in the prior art.
The technical scheme for solving the technical problems is as follows: a bracket for repairing a mitral valve comprises a framework and a membrane assembly, wherein the framework comprises an atrium limit piece and a membrane fixing piece, the membrane fixing piece comprises a V-shaped supporting section, a first sleeve and a second sleeve which are symmetrically connected to the left end and the right end of the V-shaped supporting section, the membrane assembly is fixed in the membrane fixing member, the atrium position limiting member comprises a first position limiting curve section positioned above the front side and a second position limiting curve section positioned above the rear side, the first limit curve section and the second limit curve section are crossed twice on the left side and the right side respectively to form an annular part and then are connected with the upper ends of the first sleeve and the second sleeve, the armature further comprises an upper flap fastener located on the front and/or back side of the film fastener, the lower end of the upper turning and resisting piece is connected with the tip of the lower part of the V-shaped supporting section, and the upper end of the upper turning and resisting piece is bent and extended towards the upper part of the front side or the upper part of the rear side and then is pressed against the lower surface of the mitral valve annulus.
On the basis of the technical scheme, the invention can be improved as follows.
Furthermore, the upper overturning and abutting piece is formed by bending a memory alloy wire, and is fishtail-shaped, wide in upper end and narrow in lower end.
Adopt above-mentioned further institutional advancement's benefit to be, the wider up area contact that can be bigger with the valve ring bottom surface of fishtail form tail end is equivalent to area of contact big, and the pressure of contact department is little during same pressure, can guarantee spacing to the support, can reduce the oppression damage to the valve ring as far as possible again.
Furthermore, the two sides and the lower end of the middle part of the upper turning and abutting piece are respectively bent and wound to form a lock line limiting ring.
The advantage of adopting the above further structural improvement is that the middle and lower lock wire rings can limit the lock wire when the valve stent is loaded in the delivery system (catheter), and the advantage is that when the device is recovered and released again in the operation, the lock wire can not slide along the V-shaped supporting section or slide along the memory alloy wire corresponding to the upper overturn fastener, and can return to the initial loading state more easily and better.
Further, the lower end of the upper overturning and supporting piece is connected with the lower tip of the V-shaped supporting section through a third sleeve.
The advantage of adopting above-mentioned further structural improvement is that the third sleeve can be fixed by clamping to the memory alloy silk that walks around this position at the point of V-arrangement support section, is favorable to strengthening the stability of supporting structure.
Further, the number of the upper overturning supporting pieces is one, and the upper overturning supporting pieces are located on the front side or the rear side of the film fixing piece.
Further, the number of the upper turning and abutting pieces is two, and the upper turning and abutting pieces are symmetrically distributed on the front side and the rear side of the film fixing piece.
The further structural improvement has the advantages that the number of the upturning propping pieces can be selected to be one according to the specific situation of a patient, and the upturning propping pieces are positioned on the front side or the rear side of the bracket, so that the support is suitable for the situation of untight closing and regurgitation caused by unilateral valve injury; the number of the upper overturning and supporting pieces can be two, the upper overturning and supporting pieces are symmetrically arranged in the front and back directions, and the upper overturning and supporting pieces are suitable for central reflux.
Further, the membrane fixing part further comprises an arc-shaped supporting section, wherein the opening of the arc-shaped supporting section is downward, and the left end and the right end of the opening correspond to and are fixedly connected with the upper ends of the first sleeve and the second sleeve.
Adopt above-mentioned further institutional advancement's benefit to be, the support receives the extrusion in the major axis direction of atrium locating part during the systole, and the arc supports the section and can provides certain holding power for the membrane module, makes the membrane module keep leveling to it is inseparabler with the laminating of native leaflet, and the shutoff is closed incomplete effect better.
Further, the membrane assembly comprises a membrane with the upper end and the lower end both closed, and the left side, the right side and the bottom of the membrane are sequentially connected with the first sleeve, the second sleeve and the V-shaped supporting section.
The advantage of using the above further structural improvements is that,
further, the diaphragm is sewed up along the periphery by preceding diaphragm and the back diaphragm of front and back symmetry and forms, the thickness of diaphragm in front and back direction is from last to getting bigger gradually down.
Adopt the benefit of above-mentioned further structural improvement to be sealed through the stylolite formation in top and bottom, the advantage lies in no blood flow through constrictive membrane module passageway, reduces the possibility of thrombosis, has increased the effective clamping area of native valve leaflet to the membrane module simultaneously, reduces to the location degree of difficulty of valve support implantation.
Furthermore, first sleeve pipe and second sleeve pipe are many core pipes, many core pipes have many fixed channels that extend and link up along axial direction, V-arrangement support section, first spacing curve section, the spacing curve section of second and turn over on support the piece by the crooked coiling back heat setting of same memory wire and form, the coiling in-process memory wire passes first sleeve pipe and second sleeve pipe are respective many fixed channels.
Adopt above-mentioned further institutional advancement's benefit to be, the memory alloy silk can be fixed respectively in each fixed passage of every many core pipes, compares in prior art its fixed effect of the structure of many alloy silks of a passageway internal fixation better, can be better prevent that the alloy silk from taking place horizontal or longitudinal displacement in the sleeve pipe, is favorable to improving the structural stability of support self.
Compared with the prior art, the invention has the beneficial effects that:
(1) the upper overturning and supporting piece which is bent and extended towards the upper part of the front side or the upper part of the rear side is arranged at the bottom of the support to replace a limiting curve section which is originally extended forwards and backwards at the bottom of the existing support, so that the problem that the valve leaflets are easily damaged due to more contact between the limiting curve section which is extended outwards forwards and backwards at the bottom of the existing support and the native valve leaflets of the mitral valve is effectively solved (the upper overturning and supporting piece is basically not contacted with the native valve leaflets during working), the valve annulus can be clamped together with the first and second limiting curve sections of the atrium limiting piece, the anchoring is stable, the effect of limiting the support is achieved, and the defect that the existing support is greatly jumped due to systole and diastole is overcome.
(2) The membrane mounting has and is located the downward arc support section that just left right direction of top opening extends, and when the heart shrink compresses tightly the support, the arc support section can effectively resist the deformation that leads to because of left right direction's pressure to guarantee that the diaphragm of membrane module keeps leveling, thereby it is inseparabler to laminate with native leaflet, and it is better to repair the incomplete effect of mitral valve shutoff.
(3) The membrane component is provided with the membranes which are sealed up and down, so that the defect that thrombus is easily formed when the existing membranes are front and back membranes and the middle part of the existing membranes is provided with a narrow passage which is communicated up and down is overcome, the possibility of thrombus formation is effectively reduced, meanwhile, after the upper end and the lower end of the existing membranes are sewn and sealed, the membranes have better integrity and larger area, the original valve leaflets are more easily clamped with the membranes, and the positioning difficulty of implantation of the valve stent is reduced; the membrane is preferably in a wedge shape which becomes thick gradually from top to bottom, the leakage stoppage effect matched with the native valve leaflet is better, the membrane is suitable for severe incomplete closure, and the resultant force applied when the membrane of the structure is clamped by the native valve leaflet is downward, so that the support is more stable.
Drawings
Fig. 1 is an isometric view of a frame of a mitral valve repair stent provided in accordance with the present invention;
FIG. 2 is a top view of the armature shown in FIG. 1;
FIG. 3 is a front view of the armature shown in FIG. 1;
FIG. 4 is an isometric view of the frame of FIG. 1 after installation of the membrane module (third sleeve not shown);
FIG. 5 is a front view of the bracket shown in FIG. 4;
FIG. 6 is a top view of the bracket shown in FIG. 4;
FIG. 7 is a schematic view of the stent of FIG. 5 with the membrane being thick at the top and thin at the bottom;
FIG. 8 is a schematic view of the bracket of FIG. 5 with upper retaining members on both sides;
FIG. 9 is a top view of the bracket shown in FIG. 8;
FIG. 10 is an isometric view of a first sleeve in the stent of FIG. 1;
FIG. 11 is an isometric view of a thin top and thick bottom membrane of the stent of FIGS. 4 and 5;
fig. 12 is a schematic view of the stent of fig. 4 after implantation in a designated location in the heart.
In the drawings, the components represented by the respective reference numerals are listed below:
1. a V-shaped support section; 2. a first sleeve; 3. a second sleeve; 4. a first limit curve segment; 5. a second limit curve segment; 6. turning up the abutting piece; 7. a wire locking limiting ring; 8. a third sleeve; 9. an arc support section; 10. a membrane; 11. and fixing the channel.
Detailed Description
The principles and features of this invention are described in connection with the drawings and the detailed description of the invention, which are set forth below as examples to illustrate the invention and not to limit the scope of the invention.
In the description of the present invention, if terms indicating orientation such as "upper", "lower", "left", "right", "top", "bottom", "inner", "outer", etc., are used, they indicate orientation or positional relationship based on that shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, should not be construed as limiting the present invention.
As shown in fig. 1 to 12, the present invention provides a stent for repairing a mitral valve, comprising a frame and a membrane module, wherein the frame comprises an atrium retaining member and a membrane fixing member, the membrane fixing member comprises a V-shaped supporting section 1 and a first sleeve 2 and a second sleeve 3 symmetrically connected to the left and right ends of the V-shaped supporting section 1, the membrane module is fixed in the membrane fixing member, the atrium retaining member comprises a first retaining curve section 4 positioned above the front side and a second retaining curve section 5 positioned above the rear side, the first retaining curve section 4 and the second retaining curve section 5 are respectively connected with 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 a ring-shaped portion, the frame further comprises an upper flipping member 6 positioned on the front side and/or the rear side of the membrane fixing member, the lower end of the upper flipping member 6 is connected with the tip of the lower portion of the V-shaped supporting section 1, the upper end of the upper turning and supporting piece 6 is bent and extended towards the upper part of the front side or the upper part of the back side and then is supported against the lower surface of the mitral valve annulus.
It should be noted that, the ring-shaped part formed by the first limit curve section and the second limit curve section by twice crossing at the left side and the right side respectively is a saddle-shaped ring-shaped arc, the ring-shaped part is positioned in the left atrium and attached to the upper surface of the valve ring, and after the stent is installed in place, the ring-shaped part and the upper turning and abutting part clamp the valve ring together, so that the stent can be positioned at the mitral valve; the annular atrium limiter formed by the first limiting curve segment and the second limiting curve segment has upward curvature and is adapted to the saddle shape of the mitral valve annulus. The upper turning and supporting piece does not contact the native valve leaflets during working, and the native valve leaflets cannot be damaged; the valve support has smaller jumping amplitude along with blood flow and native valve leaflets, and is more stable in anchoring.
In addition, the first limit curve segment and the second limit curve segment are crossed twice on the left side and the right side respectively, one crossing point is positioned at the upper part and is close to the joint of an anterior valve and a posterior valve of the mitral valve annulus after being implanted, and the other crossing point is positioned between the arc-shaped supporting segment of the membrane component and the top of the first sleeve or the second sleeve. The scissor-like intersection plane is at an angle of 10 to 30 degrees to the loop plane of the atrial stop. The first and second curve segments are not fixed at the intersection point, so that when the heart contracts, the first and second curve segments are stressed in the front-back direction, and the small displacement which can generate dislocation at the intersection point is released as pretightening force during diastole, so that the first and second limit curve segments are ensured to be attached to the valve annulus wall, and stable dynamic support is provided for preventing the support from falling off the ventricle and preventing the membrane assembly from deflecting.
In one embodiment of the present invention, the upper flipping abutment 6 is formed by bending a memory alloy wire, and as shown in fig. 1, the upper flipping abutment 6 is preferably fishtail-shaped and has a wider upper end and a narrower lower end.
It will be appreciated that the shape of the upper retaining member is not limited to a fishtail shape, as long as the upper end can be effectively retained against the lower surface of the annulus without causing significant damage to the annulus.
It should be noted that the design of the upper-turning-over holding piece enables the valve stent main body to beat with the cardiac blood flow and the native valve leaflet in a small amplitude, so that the valve stent main body is not easy to generate tissue creeping and covering, and can better adapt to the structure that the native valve leaflet is not closed completely. Because the motion amplitude of the curved section of the upper turning and abutting piece is small, in order to prevent the tissues from climbing and covering, the surface of the corresponding memory alloy wire can be covered with a PTFE film. The upper turning and supporting piece is located behind the free edge of the native valve leaflet during working, the top of the upper turning and supporting piece is in a fishtail shape, and stable support can be formed at the root of the valve leaflet. The width dimension of the upper turning and supporting piece is gradually reduced from the top to the root, and the design can enable the upper turning and supporting piece to avoid the chordae tendineae at the tips of the native valve leaflets and avoid damage to the chordae tendineae. The upper turning and supporting piece extends upwards in an arc shape from the bottom of the membrane assembly, and compared with the original lower limiting piece, the upper turning and supporting piece has the advantages that the upper turning and supporting piece is not contacted with the valve leaflets in the opening and closing process of the native valve leaflets, and the native valve leaflets cannot be damaged.
In one embodiment of the invention, the upper flip resisting member 6 is formed with a locking wire limiting ring 7 around the middle portion of the upper flip resisting member at both sides and at the lower end.
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, and the locking wire pulled by the locking wire can not slide along the V-shaped supporting section or the upturning clamping piece, so that the acting point of the locking wire on the bracket is relatively fixed. The lower end lock line limiting ring can be extended from the lower end of the upper overturning and supporting piece and also can be extended from the lower end of the V-shaped supporting section. The middle part of the upper turning abutting piece is provided with a locking wire limiting ring, and when the upper turning abutting piece is compressed and loaded to a conveying system, the locking wire and the middle curve section of the upper turning abutting piece cannot generate relative displacement, so that the consistency of the loaded state of the upper turning abutting piece is maintained. The radian design of the bottom of the upper overturning and supporting piece is convenient for the upper overturning and supporting piece to overturn downwards, so that the upper overturning and supporting piece is compressed and loaded into the sheath tube of the conveying system.
In one embodiment of the invention, the lower end of the upper turning abutment 6 is connected to the lower tip of the V-shaped support section 1 by a third bushing 8.
It should be noted that the third sleeve may be a multi-core tube or a single core tube, and is preferably a multi-core tube.
In one embodiment of the invention, the number of the upper flap abutment 6 is one and is located on the front or rear side of the film fastener.
In one embodiment of the invention, the number of upper flap fasteners 6 is two and symmetrically distributed on the front and back sides of the film fastener.
In one embodiment of the present invention, the membrane holder further comprises an arc-shaped supporting section 9, wherein the arc-shaped supporting section 9 is downward opened, and the left end and the right end of the opening correspond to and are fixedly connected with the upper ends of the first sleeve 2 and the second sleeve 3.
In one embodiment of the invention, the membrane module comprises a membrane 10 with closed upper and lower ends, and the left side, the right side and the bottom of the membrane 10 are sequentially connected with the first sleeve 2, the second sleeve 3 and the V-shaped support section 1.
It will be appreciated that the invention eliminates the attachment of a membrane made of implantable material to the atrial stop and that the top and bottom of the membrane are sealed by sutures, with no channels, and the membrane is in the form of a unitary piece that acts as a caulking. The shape of the single front membrane is the same as that of the single rear membrane, the front membrane and the rear membrane are firstly sewed into a sleeve shape by a sewing line and then are sewed and fixed with the membrane component supporting section. The closed membrane forms a wedge shape, conforming to the shape of the native leaflets when closed, filling the gap that is not fully closed. The membrane material can be elastic biocompatible material (such as biological pericardial tissue, PTFE, polyurethane, silicon rubber and the like), and when the membrane material is contacted with the native valve, the native valve can not be damaged.
In an embodiment of the present invention, the membrane 10 is formed by sewing a front membrane 10 and a back membrane 10 which are symmetrical to each other in a front-back direction along the periphery, as shown in fig. 5 and 11, and preferably, the thickness of the membrane 10 in the front-back direction is gradually increased from top to bottom, and the whole membrane is in a wedge shape.
In an embodiment of the present invention, as shown in fig. 10, the first sleeve 2 and the second sleeve 3 are both multi-core tubes, the multi-core tubes have a plurality of fixing channels 11 extending in an axial direction and penetrating through the multi-core tubes, the V-shaped support section 1, the first limit curve section 4, the second limit curve section 5 and the upper turning and fastening member 6 are formed by bending and winding the same memory metal wire and then performing heat setting, and the memory metal wire passes through the plurality of fixing channels 11 of the first sleeve 2 and the second sleeve 3 during the winding process.
It should be noted that the first sleeve and the second sleeve are both five core pipes, and each of the first sleeve and the second sleeve is provided with five fixing channels which extend along the axial direction and are communicated with each other, and the five fixing channels are distributed in a trapezoidal shape. The first limiting curve section, the second limiting curve section, the arc-shaped supporting section, the V-shaped supporting section and the upper turning and supporting piece can be formed by weaving and heat setting the same memory alloy wire (nickel-titanium wire), the memory alloy wire sequentially penetrates through the respective five fixing channels of the first sleeve and the second sleeve in the weaving process, and then pressure is applied to the outer surface of the five-core tube through a pre-tightening device, so that the memory alloy wire is slightly deformed to achieve the purpose of clamping the alloy wire by reducing the aperture. Compared with the situation that a plurality of alloy wires simultaneously pass through one channel, each fixed channel can greatly enhance the effective friction force between the outer surface of each alloy wire and the inner surface of the channel of the connecting pipe through one alloy wire, can effectively prevent the alloy wires from being separated from the connecting pipe, and is favorable for the structural stability of the support.
In the invention, the atrium limit part has higher strength than the upper overturn resisting part by adopting different memory alloy wire diameters and heat setting treatment processes, and the position of the membrane component between the native valve leaflets after the valve stent is implanted is mainly determined by the atrium limit part and is suitable for central regurgitation because the upper overturn resisting part is not acted by the ventricular wall. Because the valve repair support is non-directional, the upward-turning resisting piece can be placed on the anterior leaflet or the posterior leaflet of the mitral valve according to the condition of a patient, and the strength of the atrium limiting piece is reduced.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (10)

1. A support for repairing a mitral valve comprises a framework and a membrane assembly, wherein the framework comprises an atrium limiting part and a membrane fixing part, the membrane fixing part comprises a V-shaped supporting section (1), a first sleeve (2) and a second sleeve (3) which are bilaterally symmetrically connected to the left end and the right end of the V-shaped supporting section (1), the membrane assembly is fixed in the membrane fixing part, the atrium limiting part comprises a first limiting curve section (4) positioned above the front side and a second limiting curve section (5) positioned above the rear side, the first limiting curve section (4) and the second limiting curve section (5) are respectively crossed twice on the left side and the right side to form a ring part and then are connected with the upper ends of the first sleeve (2) and the second sleeve (3), and the support is characterized in that,
the skeleton is still including being located membrane mounting front side and/or the last piece (6) of supporting of turning over of rear side, on turn over support piece (6) lower extreme with the lower part point department of V-arrangement support section (1) is connected, on turn over support piece (6) upper end to the front side top or the bending of turning over above the rear side and support tightly with the lower surface of mitral valve annulus after extending.
2. The mitral valve repair stent according to claim 1, wherein the upper flap member (6) is formed by bending a memory alloy wire, and the upper flap member (6) has a fishtail shape with a wider upper end and a narrower lower end.
3. The mitral valve repair stent according to claim 2, wherein the upper flap retainer (6) is formed with locking wire retainers (7) around both sides and the lower end of the middle portion thereof.
4. A mitral valve repair stent according to claim 2, wherein the lower end of the upper flap retainer (6) is connected to the lower tip of the V-shaped support section (1) by a third sleeve (8).
5. The mitral valve repair stent according to claim 2, wherein the number of the upper flap fasteners (6) is one and is located on the anterior or posterior side of the membrane fastener.
6. The mitral valve repair stent according to claim 2, wherein the number of the upper flap fasteners (6) is two and symmetrically distributed on the anterior and posterior sides of the membrane fastener.
7. The stent for mitral valve repair according to claim 1, wherein the membrane holder further comprises an arc-shaped support section (9), and the arc-shaped support section (9) has a downward opening and has left and right ends corresponding to and fixedly connected with the upper ends of the first sleeve (2) and the second sleeve (3).
8. The stent for mitral valve repair according to claim 1, wherein the membrane assembly comprises a membrane (10) with closed upper and lower ends, and the left side, right side and bottom of the membrane (10) are connected with the first sleeve (2), the second sleeve (3) and the V-shaped support section (1) in sequence.
9. The stent for mitral valve repair according to claim 8, wherein the membrane (10) is formed by sewing an anterior membrane (10) and a posterior membrane (10) which are symmetrical with each other in the front-back direction along the periphery, and the thickness of the membrane (10) in the front-back direction gradually increases from top to bottom.
10. The stent for repairing a mitral valve according to any one of claims 1 to 9, wherein the first sleeve (2) and the second sleeve (3) are multi-core tubes having a plurality of fixing passages (11) extending in an axial direction and penetrating therethrough, and the V-shaped support section (1), the first limit curve section (4), the second limit curve section (5) and the upturned abutment member (6) are formed by bending and winding a same memory wire and then performing heat setting, wherein the memory wire passes through the plurality of fixing passages (11) of the first sleeve (2) and the second sleeve (3) during winding.
CN202210604695.9A 2022-05-31 2022-05-31 Support for repairing mitral valve Pending CN114831778A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116138931A (en) * 2023-02-20 2023-05-23 上海诠昕医疗科技有限公司 Mitral valve artificial intervention valve
WO2024139169A1 (en) * 2022-12-30 2024-07-04 杭州端佑医疗科技有限公司 Valve repair apparatus and system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024139169A1 (en) * 2022-12-30 2024-07-04 杭州端佑医疗科技有限公司 Valve repair apparatus and system
CN116138931A (en) * 2023-02-20 2023-05-23 上海诠昕医疗科技有限公司 Mitral valve artificial intervention valve

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