CN117297838A - Outer clip for mitral valve clip - Google Patents

Outer clip for mitral valve clip Download PDF

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Publication number
CN117297838A
CN117297838A CN202210726066.3A CN202210726066A CN117297838A CN 117297838 A CN117297838 A CN 117297838A CN 202210726066 A CN202210726066 A CN 202210726066A CN 117297838 A CN117297838 A CN 117297838A
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CN
China
Prior art keywords
proximal
clip
distal
bendable
mitral valve
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
CN202210726066.3A
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Chinese (zh)
Inventor
吴明明
朱鹏
陈大凯
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.)
Koka Nantong Lifesciences Co Ltd
Original Assignee
Koka Nantong Lifesciences 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.)
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Publication date
Application filed by Koka Nantong Lifesciences Co Ltd filed Critical Koka Nantong Lifesciences Co Ltd
Priority to CN202210726066.3A priority Critical patent/CN117297838A/en
Publication of CN117297838A publication Critical patent/CN117297838A/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic 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 discloses an outer clip for a mitral valve clip, which comprises: an outer holder end located at the proximal end; two non-deforming proximal arms extending integrally from both sides of the outer holder end symmetrically toward the distal end; two deformable distal arms respectively extend from the distal ends of the non-deformable proximal arms symmetrically and integrally towards the distal ends. The outer clamping arms of the outer clamp can be bent into a three-section structure under the action of the clamping shaft and the first substrate and the second substrate, and the outer clamping arms of the three-section structure are bent to be stretched out to form two large included angles, so that an expanding foundation can be provided for capturing the primary valve leaflets.

Description

Outer clip for mitral valve clip
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to an outer clamp for a mitral valve clamp.
Background
In the cardiovascular system, natural heart valves (e.g., aortic, pulmonary, mitral, and tricuspid valves) play a critical role in ensuring a positive flow of adequate supply of blood. However, these heart valves may be damaged by congenital anomalies, inflammatory processes, infectious conditions, or diseases, thereby reducing their efficiency. These disease processes include degenerative processes (e.g., barlow disease or fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease, etc.), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left or right ventricle from a pre-heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy, etc.) can distort the geometry of the native valve, which can cause the native valve to malfunction. Most patients undergoing valve surgery, such as mitral valve surgery, suffer from degenerative diseases that result in leaflet dysfunction of the native valve, such as the mitral valve, causing prolapse and regurgitation.
For example, mitral regurgitation may be caused by a number of different mechanical defects of the mitral valve or left ventricle wall. The leaflets, the chordae clathrae connecting the leaflets to the papillary muscles, or the papillary muscles themselves or the left ventricle wall may be damaged or otherwise dysfunctional. In general, the annulus may be damaged, dilated or weakened, thereby limiting the ability of the mitral valve to close sufficiently against the large pressure of the left ventricle, which can lead to serious cardiovascular damage or death.
For many years, definitive treatment for such damaged valves has been surgical repair or replacement of the valve in open heart surgery, and most clamps are fixed by using elasticity of materials due to relatively small space in the heart and unstable elastic deformation process of the clamps, which may cause secondary injury to patients. In particular, most prior art clampers employ an outer clamping arm having a proximal end hinged to a proximal end of a base plate and a distal end hinged to a distal end of an inner clamp. Under such dual hinge structure, the heart valve leaf is clamped in the process, but because the base plate is opened or the base plate is closed, the outer clamp works by virtue of the elasticity, and the two side arms of the inner clamp deform due to the elasticity, so that the process of opening and closing the base plate is an uncertain unique track process, the opening process and the closing process of the base plate are particularly unstable, instantaneous elastic mutation can sometimes occur, the base plate is rapidly clamped to hurt a human body, the elastic deformation process of the whole clamp is uncontrollable, unstable and easy to cause secondary injury to a patient.
Disclosure of Invention
The invention aims at solving the technical problem that the deformation of a clamp is unstable in the opening and closing processes of the clamp due to the double hinge structure among the proximal ends and the distal ends of a base plate, an outer clamp and an inner clamp in the prior art, and aims to provide a mitral valve clamp with stable and controllable deformation.
The mitral valve clamp of the present invention has:
the inner clamp is provided with a first inner clamp arm and a second inner clamp arm which are symmetrically arranged along the axial lead and are integrally connected with the distal end;
the proximal ends of the first base plate and the second base plate are hinged with the proximal ends of the first inner clamping arm and the second inner clamping arm respectively;
the first clamping piece and the second clamping piece are provided with a fixed piece and a movable piece which are integrally connected with the proximal ends, the fixed pieces of the first clamping piece and the second clamping piece are respectively fixed on the inner side walls of the first substrate and the second substrate, and the distal ends of the movable pieces of the first clamping piece and the second clamping piece can be respectively connected with the distal ends of the first inner clamping arm and the second inner clamping arm in a pulling way;
the outer clamp is provided with two outer clamp arms which are symmetrically arranged along the axial lead and are integrally connected with the near end, and the inner side walls of the two outer clamp arms are respectively attached and fixed on the outer side walls of the first substrate and the second substrate.
It is preferred that the first and second heat sinks,
the mitral valve clamp is provided with an inner rod which is arranged at the far end of the inner clamp in a penetrating way along the axial lead, and the far section of the inner rod is provided with an engagement section;
the proximal ends of the first base plate and the second base plate are respectively engaged ends, and the engaged ends are engaged with the engaged sections of the inner rod.
Preferably, the outer surface of the distal section of the inner rod is integrally formed and sleeved with a coaxial square column, and the meshing section is positioned on the square column.
It is preferred that the first and second heat sinks,
the meshing section of the square column is provided with a first rack and a second rack which are opposite to each other, and teeth and tooth grooves of the first rack and the second rack are perpendicular to the axial direction of the inner rod and are arranged at intervals in parallel along the length direction of the surface of the square column;
the meshing ends of the first base plate and the second base plate are gears respectively, teeth and tooth grooves of the gears are also perpendicular to the axial direction of the inner rod, and the gears of the first base plate and the second base plate are respectively connected with a first rack and a second rack of the square column in a rolling and meshing mode in a back-and-forth mode.
It is preferred that the first and second heat sinks,
the first rack and the second rack are positioned at the far end of the square column, the far ends of the first rack and the second rack are abutted against the far end of the square column, the heights of teeth of the first rack and the second rack are flush with the surface of the near section of the square column, and bottoms of tooth grooves of the first rack and the second rack are flush with the surface of the inner rod.
It is preferred that the first and second heat sinks,
the gear is a half gear having teeth on half side surfaces.
It is preferred that the first and second heat sinks,
the modulus of the first rack and the modulus of the second rack are respectively the same as the modulus of the gears at the meshing ends of the first base plate and the second base plate, and the heights of teeth of the first rack and the second rack are smaller than those of teeth of the gears at the meshing ends. Preferably, the body of the engagement end of the first base plate and the second base plate is cylindrical, the axial direction of the engagement end is perpendicular to the inner rod, the side surface of the engagement end is provided with racks or tooth grooves which are arranged at intervals along the circumferential direction of the engagement end, and the axle center of the engagement end is provided with a through hinge hole.
Preferably, the first substrate and the second substrate are respectively provided with the engagement end, a flat plate section and a connecting section, and two ends of the connecting section are respectively connected with the engagement end and the flat plate section in an integral way.
Preferably, the width of the engagement end is less than the width of the plate segment; the width of the proximal end of the connecting section is consistent with the width of the engagement end, the width of the distal end of the connecting section is consistent with the width of the flat plate section, and the width of the connecting section continuously and smoothly increases from the proximal end to the distal end.
Preferably, the proximal section of the inner rod is provided with a conveying external thread, the proximal end of the outer clamp is provided with a conveying internal thread, the conveying external thread is in matched connection with the conveying internal thread, and the proximal section of the inner rod is arranged at the proximal end of the outer clamp in a penetrating way;
the distal end of the inner clip is provided with a rod hole, and the distal end of the inner rod is arranged in the rod hole of the inner clip in a penetrating way.
Preferably, the mitral valve clamp further has:
the first hinge shaft and the second hinge shaft are respectively and correspondingly arranged in the hinge holes of the axle centers of the meshing ends of the first base plate and the second base plate in a penetrating way;
the two ends of the first hinge shaft are respectively movably penetrated through one ends of the two limiting parts, and the two ends of the second hinge shaft are respectively movably penetrated through the other ends of the two limiting parts.
Preferably, the limiting piece is a limiting plate,
one end of the two limiting plates is provided with a circular hole, and two ends of the first hinge shaft are respectively movably arranged in the circular holes of the two limiting plates in a penetrating way;
the other ends of the two limiting plates are provided with waist-shaped holes, and two ends of the second hinge shaft are respectively movably arranged in the waist-shaped holes of the two limiting plates in a penetrating mode.
Preferably, the limiting piece is a limiting plate,
One end of the two limiting plates is provided with a waist-shaped hole, and two ends of the first hinge shaft are respectively movably arranged in the waist-shaped holes of the two limiting plates in a penetrating way;
the other ends of the two limiting plates are provided with round holes, and two ends of the second hinge shaft are respectively movably arranged in the round holes of the two limiting plates in a penetrating mode.
Preferably, the distal ends of the first substrate and the second substrate are provided with a U-shaped elbow.
Preferably, the distal ends of the first substrate and the second substrate are provided with a convex strip towards the inner side.
Preferably, the outer clip has:
an outer holder end located at the proximal end;
the two outer clamping arms symmetrically extend towards the far end integrally from two sides of the outer clamping seat end.
Preferably, the outer clip arm has:
a non-deforming proximal arm integrally extending from one side of the outer holder end toward the distal end;
a deformable distal arm integrally extends distally from the distal end of the non-deformable proximal arm.
Preferably, the deformable distal arm has, in order from the proximal end to the distal end:
a bendable proximal segment integrally extending from the distal end of the non-deformable proximal arm;
a bendable middle section integrally extending from the distal end of the bendable proximal section;
a bendable distal section integrally extending from a distal end of the bendable middle section;
Wherein, the included angle theta formed by the bendable near section and the bendable far section is 60-200 degrees. Preferably, the angle θ formed by the bendable proximal section and the bendable distal section is between 90 ° and 190 °.
In one example, the widths of the bendable proximal section, the bendable middle section, and the bendable distal section remain consistent with the width of the non-deforming proximal arm.
It is preferred that the first and second heat sinks,
the width of the bendable proximal section is consistent with the width of the non-deformable proximal arm;
the width of the proximal end of the bendable middle section is consistent with the width of the bendable proximal section, and the width of the bendable middle section gradually narrows from the proximal end to the distal end;
the width of the bendable distal section is consistent with the distal width of the bendable distal section.
It is preferred that the first and second heat sinks,
the remote sections of the first substrate and the second substrate are respectively provided with at least one substrate fixing hole;
the fixing pieces of the first clamping piece and the second clamping piece are respectively provided with at least one clamping piece fixing hole corresponding to the fixing pieces;
the distal sections of the two outer clamping arms are respectively provided with at least one clamping arm fixing hole;
the fixing plates of the first clamping piece and the second clamping piece are sequentially penetrated through the corresponding clamping piece fixing holes, the substrate fixing holes and the clamping arm fixing holes through the fixing rods, and the far sections of the first substrate and the second substrate and the far sections of the two outer clamping arms are respectively and correspondingly fixedly connected together.
Preferably, the non-deforming proximal arm has: and a mounting seat extending from the side wall of the non-deformable proximal arm. Preferably, the mounting extends from an inner side wall of the non-deformable proximal arm.
Preferably, the mounting base has at least one mounting hole.
Preferably, the outer clip further has a furling assembly, the furling assembly having:
two pairs of clamping shafts respectively clamped on the inner side wall and the outer side wall of the deformable far arm of the two outer clamping arms;
the two ends of each pair of clamping shafts are respectively arranged in the sliding holes in a sliding manner in a manner of leaning inwards, so that the outer clamps are clamped.
Preferably, the slide hole is L-shaped, and has:
a proximal aperture, the proximal end of the proximal aperture being inboard and the distal end of the proximal aperture being outboard;
the proximal end of the distal hole is connected with the distal end of the proximal hole in a communicating way, the proximal end of the distal hole is positioned on the outer side, and the distal end of the distal hole is positioned on the inner side.
It is preferred that the first and second heat sinks,
the hole distance from the inner side to the outer side of the proximal hole is gradually increased;
the hole distance of the distal hole from the outer side to the inner side is gradually increased, and the maximum hole distance of the inner side of the distal hole is equal to the diameter of the clamping shaft; so that the clamping shaft tends to slide inwardly, thereby clamping the outer clamp together.
It is preferred that the first and second heat sinks,
the included angle beta formed by the two side edges of the near-end hole is 3-10 degrees;
the included angle alpha formed by the two side edges of the far-end hole is 1-5 degrees.
It is preferred that the first and second heat sinks,
an included angle gamma formed by the central line of the proximal hole and the axial line of the mitral valve clamp is 15-25 degrees;
the included angle delta formed by the central line of the distal hole and the central line of the mitral valve clamp is 60-70 degrees.
Preferably, both ends of the clamping shaft are respectively provided with an anti-falling cover.
Preferably, proximal side corners of both sides of the seat cover plate are respectively provided with at least one fixing hole for mounting the seat cover plate on the two outer clamping arms.
Preferably, the seat cover is trapezoidal-like, with the proximal side of the seat cover being smaller than the distal side.
Preferably, the distal side edge of the seat cover plate is concave arc-shaped.
Preferably, the proximal side angles of both sides of the seat cover plate are respectively provided with at least one fixing hole;
The side wall of the non-deformable near arm is provided with a mounting seat, and the mounting seat is provided with at least one mounting hole corresponding to the fixing hole;
the mounting rod penetrates through the fixing hole and the mounting hole to mount the seat cover plate on two sides of the mounting seat.
Preferably, the deformable distal arm has, in order from the proximal end to the distal end: a bendable proximal section, a bendable middle section, and a bendable distal section;
the clamping shafts are respectively abutted against the inner side wall and the outer side wall of the bendable middle section, and the supporting force for bending deformation is provided for the deformable far arm by providing a fulcrum through the clamping shafts, so that an included angle theta formed by bending the deformable far arm is 60-200 degrees, preferably 90-190 degrees.
Preferably, the mitral valve clamp further has:
the two petal outer frames are respectively positioned at the outer sides of the outer clamping arms, the proximal ends of the petal outer frames are two opposite mounting rods, and the mounting rods sequentially penetrate through fixing holes in the seat cover plate and mounting holes of the mounting seats of the non-deformable proximal arms.
Preferably, the mitral valve clamp further has:
and the petal outer frames and the corresponding outer clamping arms are coated together by the two coating films.
Preferably, the inner clamp comprises:
the inner clamping seat end is positioned at the far end;
the first inner clamping arm and the second inner clamping arm integrally extend from two sides of the inner clamping seat end towards the proximal end respectively;
the two first hinge ends and the two second hinge ends are cylindrical, are integrally formed on two sides of the proximal ends of the first inner clamping arm and the second inner clamping arm body, and are respectively hinged with the meshing ends of the first base plate and the second base plate.
It is preferred that the first and second heat sinks,
the axle centers of the two first hinge ends and the two second hinge ends are respectively provided with a hinge hole, and the meshing ends of the first base plate and the second base plate are also provided with hinge holes;
the first hinge shaft is arranged in the hinge holes of the two first hinge ends and the hinge hole of the meshing end of the first base plate in a penetrating manner, and the meshing end of the first base plate is positioned in the middle of the two first hinge ends so as to hinge the proximal end of the first base plate and the proximal end of the first inner clamping arm together;
the second hinge shaft is arranged in the hinge holes of the two second hinge ends and the hinge hole of the meshing end of the second base plate in a penetrating mode, the meshing end of the second base plate is located in the middle of the two second hinge ends, and the proximal end of the second base plate and the proximal end of the second inner clamping arm are hinged together.
Preferably, the inner clamping seat end is U-shaped and is provided with an axial rod hole, and the distal end of the inner rod is arranged in the rod hole of the inner clamping seat end in a penetrating way.
Preferably, the distal end of the inner holder end is continuously integrally connected with a block end, and the rod hole extends all the way through the block end.
Preferably, the first clamping piece and the second clamping piece are respectively a large long sheet body;
the movable sheets of the first clamping sheet and the second clamping sheet are long frame bodies left after a small sheet body is hollowed out from the middle part of the large sheet body;
the fixing pieces of the first clamping piece and the second clamping piece are hollowed-out small pieces;
the hollow part near end of the long frame body is connected with the near end of the small piece body into a whole.
It is preferred that the first and second heat sinks,
the large long sheet body is of a double-layer structure, and the long frame body and the small sheet body also have double-layer structures;
the long frame body faces one layer of the first substrate and the second substrate, and a plurality of barbs with consistent directions are cut on the long frame body.
It is preferred that the first and second heat sinks,
the distal ends of the first base plate and the second base plate are provided with first operation holes for the first stay wires to pass through;
the distal ends of the first inner clamping arm and the second inner clamping arm are provided with a second operation hole for a second stay wire to pass through;
The distal ends of the movable sheets of the first clamping sheet and the second clamping sheet are provided with clamping sheet operation holes for the second stay wires to pass through, and the distal ends of the first inner clamping arm and the second inner clamping arm can be respectively connected with the distal ends of the movable sheets of the first clamping sheet and the second clamping sheet in a traction way through the second stay wires.
The outer clamp arm of the outer clamp can be bent into a three-section structure under the action of the clamping shaft and the first substrate and the second substrate, and the outer clamp arm of the three-section structure is bent to be unfolded to form two large included angles, so that an unfolding foundation can be provided for capturing the primary valve leaflet.
An outer clip for a mitral valve clip, comprising:
an outer holder end located at the proximal end;
two non-deforming proximal arms extending integrally from both sides of the outer holder end symmetrically toward the distal end;
two deformable distal arms respectively extend from the distal ends of the non-deformable proximal arms symmetrically and integrally towards the distal ends.
Preferably, the deformable distal arm has, in order from the proximal end to the distal end:
a bendable proximal segment integrally extending from the distal end of the non-deformable proximal arm;
A bendable middle section integrally extending from the distal end of the bendable proximal section;
a bendable distal section integrally extending from a distal end of the bendable middle section;
wherein the angle θ formed by the bendable proximal section and the bendable distal section is 60 ° to 200 °, preferably 90 ° to 190 °.
Preferably, the width of the bendable proximal section, the bendable middle section and the bendable distal section is consistent with the width of the non-deforming proximal arm.
It is preferred that the first and second heat sinks,
the width of the bendable proximal section is consistent with the width of the non-deformable proximal arm;
the width of the proximal end of the bendable middle section is consistent with the width of the bendable proximal section, and the width of the bendable middle section gradually narrows from the proximal end to the distal end;
the width of the bendable distal section is consistent with the distal width of the bendable distal section.
Preferably, the bendable distal section has a plurality of clamp arm securing holes.
Preferably, the non-deforming proximal arm has:
and a mounting seat extending from the side wall of the non-deformable proximal arm.
Preferably, the non-deforming proximal arm has:
the mounting seat extends from the inner side wall of the non-deforming near arm.
Preferably, the mounting base has at least one mounting hole.
Preferably, the outer clip further has a furling assembly, the furling assembly having:
Two pairs of clamping shafts respectively clamped on the inner side wall and the outer side wall of the deformable far arm;
the two ends of each pair of clamping shafts are respectively arranged in the sliding holes in a sliding manner in the inward direction, so that the outer clamp is clamped and folded.
Preferably, the slide hole is L-shaped, and has:
a proximal aperture, the proximal end of the proximal aperture being inboard and the distal end of the proximal aperture being outboard;
the proximal end of the distal hole is connected with the distal end of the proximal hole in a communicating way, the proximal end of the distal hole is positioned on the outer side, and the distal end of the distal hole is positioned on the inner side.
It is preferred that the first and second heat sinks,
the hole distance from the inner side to the outer side of the proximal hole is gradually increased;
the hole distance from the outer side to the inner side of the distal hole is gradually increased; so that the clamping shaft tends to slide inwardly, thereby clamping the outer clamp together.
It is preferred that the first and second heat sinks,
the included angle beta formed by the two side edges of the near-end hole is 3-10 degrees;
the included angle alpha formed by the two side edges of the far-end hole is 1-5 degrees.
It is preferred that the first and second heat sinks,
an included angle gamma formed by the central line of the proximal hole and the axial line of the mitral valve clamp is 15-25 degrees;
The included angle delta formed by the central line of the distal hole and the central line of the mitral valve clamp is 60-70 degrees.
Preferably, both ends of the clamping shaft are respectively provided with an anti-falling cover.
Preferably, proximal corners of both sides of the seat cover plate are provided with at least one fixation hole, respectively, for mounting the seat cover plate to an outer clip of the mitral valve clamp.
Preferably, the seat cover is trapezoidal-like, with the proximal side of the seat cover being smaller than the distal side.
Preferably, the distal side edge of the seat cover plate is concave arc-shaped.
It is preferred that the first and second heat sinks,
proximal side angles on two sides of the seat cover plate are respectively provided with at least one fixing hole;
the side wall of the non-deformable near arm is provided with a mounting seat, and the mounting seat is provided with at least one mounting hole corresponding to the fixing hole;
the mounting rod penetrates through the fixing hole and the mounting hole to mount the seat cover plate on two sides of the mounting seat.
It is preferred that the first and second heat sinks,
the deformable distal arm has, in order from the proximal end to the distal end: a bendable proximal section, a bendable middle section, and a bendable distal section;
the clamping shafts are respectively abutted against the inner side wall and the outer side wall of the bendable middle section, and the supporting force for bending deformation is provided for the deformable far arm by providing a fulcrum through the clamping shafts, so that an included angle theta formed by bending of the deformable far arm is 60-200 degrees.
Compared with the prior art, the invention has the beneficial effects that:
1) According to the invention, the fixing pieces of the first clamping piece and the second clamping piece and the far sections of the two outer clamping arms are respectively and directly fixed on the inner side wall and the outer side wall of the first substrate and the second substrate, so that the outer clamping arms move along with the movement of the first substrate and the second substrate in a fixed connection rather than a hinged manner, and the outer clamping arms cannot generate larger deformation due to the problem of elastic materials;
2) The proximal ends of the first base plate and the second base plate are respectively hinged with the proximal ends of the inner clamp, the proximal ends of the first base plate and the second base plate, which are hinged at the proximal ends, are also meshed with the meshed section of the far section of the inner rod, and even if the first base plate and the second base plate are hinged, the first base plate and the second base plate need to move along with the direction control of the meshed section of the far section of the inner rod, namely, the opening and the closing of the first base plate and the second base plate are limited by the meshing, and do not move freely up and down, the degree of freedom of the first base plate and the second base plate is limited by the meshing design, so that the stability is improved, the opening and the closing process of the whole clamp is completely independently controllable, and secondary injury to a patient is not easy to cause;
3) The near section of the outer clamping arm is provided with the mounting seat, and the mounting seat is provided with the folding component for folding the outer clamping arm, so that the folding function of the clamping device can be well realized.
Drawings
FIG. 1 is a schematic view of the delivery device of the mitral valve clamp of the present invention;
FIGS. 2A-2D are schematic illustrations of the structure of a mitral valve clamp of the present invention;
FIGS. 3A-3B are schematic side elevational views of the mitral valve clamp of the present invention after deployment;
FIGS. 4A-4B are schematic views of the structure of the inner clip 20 of the present invention;
FIGS. 5A-5B are schematic views of the structure of the inner rod 10 of the present invention;
fig. 6A to 6B are schematic structural views of the first and second substrates 30a and 30B according to the present invention;
FIG. 7 is a schematic view of the structure of the first and second clips 40a, 40b of the present invention;
FIGS. 8A-8B are schematic views of the structure of the outer clip 50 of the present invention;
FIGS. 9A-9B are schematic structural views of a furling assembly of the present invention;
fig. 10 is a schematic view of the structure of the petal outer frame 60 according to the present invention;
fig. 11A-11B are schematic structural views of a mitral valve clamp of the present invention capturing a native leaflet 80.
Detailed Description
Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.
During operation, the left atrium receives oxygenated blood from the lungs, and during diastole or diastole, through expansion of the left ventricle, blood previously collected in the left atrium moves through the mitral valve and into the left ventricle during systole. During the systolic phase or systole, the left ventricle contracts to force blood into the body through the aortic valve and ascending aorta. During systole, the leaflets of the mitral valve close to prevent backflow of blood from the left ventricle and back into the left atrium, and blood collects in the left atrium from the pulmonary veins. In one example embodiment, the mitral valve clamp of the present invention is used to repair the function of a defective mitral valve. That is, the mitral valve clamp is configured to facilitate closing leaflets of the mitral valve to prevent backflow of blood from the left ventricle and back into the left atrium.
In the field of interventional medical devices, when describing the mitral valve clamp of the present invention, the "proximal" and "proximal" sections refer to the side of the delivery device or the side in the direction of the user-manipulated end when the mitral valve clamp of the present invention is in the collapsed state, and correspondingly, the "distal" and "distal" sections refer to the side of the mitral valve clamp of the present invention that is distal from the delivery device or the side in the direction of the user-manipulated end when the mitral valve clamp is in the collapsed state.
In the present invention, the spatial term "outside" refers to the reference direction of the internal central axis of the mitral valve clip of the present invention with the axis in the folded state of the entire clip, the direction away from the central axis being the outside and the direction closer to the central axis being the inside. The meaning of "outer sidewall", "inner sidewall" is also the same.
In the present invention, when one or more elements or components are described as being connected, joined, fixed, journaled, hinged, coupled, attached or otherwise interconnected, such interconnection may be directly between the components or may be indirect, such as through the use of one or more intervening components. Moreover, references to "an assembly," "a component," "a member" or "a portion" as described herein should not be limited to a single structural component, member, or element, but may include an assembly of components, members, or elements. Moreover, as described herein, the terms "substantially" and "about" are defined as at least approaching (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).
In the present invention, the term "hinge structure" refers to a structure that connects two components by means of hinge, and in a specific application, the hinge structure may be a shaft hole structure that mates with a shaft hole, a shaft that mates with a shaft hole, or a pivoting structure; the hinge structure may be formed by folding or crimping a sheet of material.
In the present invention, the terms "integral", "integrally connected", "integrally formed" refer to a structure that is integrally formed as one piece by a machining process such as stamping, cutting, pouring, casting, etc., and is not separable as a single element.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; either directly, or indirectly, through intermediaries, may be in communication with each other, or may be in interaction with each other, unless explicitly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, "axial direction" and "axis line" refer to an axis symmetry line in a folded state of the clip, and of course, also refer to an axis symmetry line of a certain axis symmetry component or element itself, and may be appropriately understood from the description and drawings.
The mitral valve clamp of the present invention is implanted via a delivery catheter/delivery sheath of a delivery device that extends the mitral valve clamp from the delivery catheter/delivery sheath into the left ventricle and controls the mitral valve clamp to open by controlling the pull wire, as shown in fig. 11A-11B, by controlling the first and second jaws to open to capture the native leaflets, and then collapsing the mitral valve clamp together by the outer clamp, the first and second base plates, after capturing the native leaflets, the mitral valve clamp fully closes to achieve clamping thereof against the native mitral valve, pulling the pull wire away from the pulling hole of the jaw assembly, and then disengaging the mitral valve clamp from the mitral valve clamp by operating the drive shaft of the delivery device, i.e., by operating the delivery device to disengage the mitral valve clamp from the distal end of the delivery catheter/delivery sheath, thus holding the mitral valve clamp against the native valve, thereby completing partial clamping of the native valve. It is stated here that the mitral valve clamp is required to capture native leaflets in the left ventricle, can be transnasally delivered to the left ventricle, can be transnasally delivered into the left ventricle, and can be used for tricuspid valve etc. clamping.
Referring to fig. 1, taking a transfemoral delivery device as an example, a schematic structural diagram of a delivery device according to an embodiment of the present invention is shown, and as shown in fig. 1, in this embodiment, the delivery device 9 may sequentially include, from a proximal end to a distal end, a release mechanism 91, a delivery mechanism 92, an adjustable bending mechanism 93, a loader mechanism 94, and an outer sheath mechanism 95, where the delivery mechanism 92 is detachably connected to the mitral valve clamp, and the delivery mechanism 92 is used to deliver the mitral valve clamp to a target site. The delivery mechanism 92 includes a delivery tube 920 and a delivery handle 921. The delivery tube 920 may extend through and out of the adjustable bend 930. The delivery handle 921 includes a delivery housing and a pull wire control assembly 922. The distal end of the delivery housing is connected to the proximal end of the delivery tube 920, and a delivery end cap is removably disposed at the distal end of the delivery housing. The pull wire control assembly 922 can slide on the conveying shell along the axial direction of the conveying pipe, the pull wire control assembly 922 is connected with the first clamping piece, the second clamping piece, the first substrate and the second substrate of the mitral valve clamp, when the pull wire control assembly 922 slides along the axial direction, the opening and the closing of the first clamping piece and the opening of the first substrate and the second substrate are controlled, and the number of the knobs of the pull wire control assembly 922 is at least equal to the sum of the number of the first clamping piece and the second clamping piece and the number of the first substrate and the second substrate, so that one knob can control the opening and the closing of the clamping piece of the first substrate and the opening of the first substrate and the second substrate. In this embodiment, the conveying device 9 is used in cooperation with the mitral valve clamp, when in use, the conveying pull wire of the conveying structure 92 is detachably connected with the movable plates in the first clamping piece and the second clamping piece of the mitral valve clamp, and passes through the second operation holes at the distal ends of the first base plate and the second base plate, the second operation holes provide support for the pull wire, and the conveying pull wire of the remaining conveying structure 92 passes through the operation holes at the distal ends of the first base plate and the second base plate, so that the two outer clamping arms are opened, and the driving shaft 90 (i.e. the inner rod of the invention) of the release structure 91 is detachably connected with the mitral valve clamp. In some embodiments, the mitral valve clamp can also be referred to as a valve repair clip.
As shown in fig. 2A-2D, and 3A-3B, one example of a mitral valve clamp of the present invention is an inner stem 10, an inner clip 20, first and second base plates 30a, 30B, first and second clips 40a, 40B, and an outer clip 50.
In another example of a mitral valve clamp of the present invention, there are an inner stem 10, an inner clip 20, first and second base plates 30a, 30b, first and second jaws 40a, 40b, an outer clip 50, a petal outer frame 60, and a coating (not shown).
As shown in fig. 4A-4B, in this example, the inner clip 20 is an elongated U-clip. The distal end of the inner clip 20 is an inner clip seat end 21, which is the closed bottom of the long U-shaped clip. The inner holder end 21 is also U-shaped, but has a relatively short length, the inner holder end 21 has an axial rod hole 211, and the distal end of the inner rod 10 is disposed through the rod hole 211 of the inner holder end 21. In another example, the distal end of the inner holder end 21 continues to integrally connect with the block end 212, and the rod hole 211 extends all the way through the block end 212, so that the inner rod 10 also passes into the rod hole 211 of the block end 212. The two sides of the inner clamping seat end 21 continue to symmetrically and integrally extend the body of the long sheet-shaped straight first inner clamping arm 22a and the second inner clamping arm 22b towards the proximal end. The first and second inner clip arms 22a, 22b are symmetrically arranged along the axis and the distal ends are integrally connected by the inner clip base 21. The thickness of the body of the first and second inner clip arms 22a, 22b is less than the thickness of the inner clip seat end 21; the width of the body of the first and second inner clip arms 22a, 22b is equal to the width of the body of the inner clip seat end 21. The distal ends of the first and second inner clip arms 22a and 22b are provided at both sides thereof with a second operation hole 221 through which a second wire 923 (a delivery wire) of the delivery structure 92 passes, the second operation hole 221 providing a fulcrum for the second wire 923. In a preferred example, the spacing between the proximal ends of the bodies of the first and second inner clip arms 22a, 22b is less than the spacing between the distal ends in a natural state without external forces. To this end, the body extension of the first and second inner clip arms 22a, 22b is completed. However, the two side corners of the body of the first inner arm 22a continue to integrally extend towards the proximal end and the outer side to form two first hinge ends 23a; the two side corners of the body of the second inner clamping arm 22b continue to integrally extend towards the proximal end and the outer side to form two second hinge ends 23b. The first and second hinged ends 23a, 23b are proximal ends of the first and second inner clip arms 22a, 22b, respectively, and are cylindrical in shape. The first and second hinge ends 23a, 23b are integrally formed with the proximal ends of the bodies of the first and second inner clip arms 22a, 22b with cylindrical side surfaces. The axes of the first and second hinge ends 23a, 23b (the axis here refers to the axis of the cylindrical hinge end) have hinge holes 231a, 231b, respectively. The proximal ends of the first and second base plates 30a, 30b are engagement ends, and the axes of the engagement ends also have hinge holes. The first hinge shaft 24a is inserted into the hinge holes of the two first hinge ends 23a and the hinge hole of the engagement end of the first base plate 30a, and the engagement end of the first base plate 30a is located in the middle of the two first hinge ends 23a, so that the proximal end of the first base plate 30a and the proximal end of the first inner clip arm 22a are hinged together. Similarly, the second hinge shaft 24b is disposed through the hinge holes of the two second hinge ends 23b and the hinge hole of the engagement end of the second base plate 30b, and the engagement end of the first base plate 30b is located in the middle of the two second hinge ends 23b, so as to hinge the proximal end of the second base plate 30b and the proximal end of the second inner clip arm 22b together. The two ends of the first hinge shaft 24a are respectively movably arranged at one ends of the two limiting parts in a penetrating manner, and the two ends of the second hinge shaft 24b are respectively movably arranged at the other ends of the two limiting parts in a penetrating manner. The setting of the limiting piece prevents the first and second inner clamping arms 22a and 22b of the inner clamp from being deformed towards the two sides, thereby limiting the left-right displacement of the proximal ends of the first and second substrates in the opening/closing process of the first and second substrates, and further increasing the stability of the opening/closing process of the first and second substrates 30a and 30 b. In an example, the limiting piece 25 is a limiting plate 25 with a waist-shaped hole, one end of each limiting plate 25 is provided with a circular hole, and two ends of the first hinge shaft 24a are respectively movably arranged in the circular holes of the two limiting plates 25 in a penetrating manner; the other ends of the two limiting plates 25 are provided with waist-shaped holes, and two ends of the second hinge shaft 24b are respectively movably arranged in the waist-shaped holes of the two limiting plates 25 in a penetrating mode. In another example, one end of the two limiting plates 25 is provided with a kidney-shaped hole, and two ends of the first hinge shaft 24a are respectively movably arranged in the kidney-shaped holes of the two limiting plates 25 in a penetrating manner; the other ends of the two limiting plates 25 are provided with circular holes, and two ends of the second hinge shaft 24b are respectively movably arranged in the circular holes of the two limiting plates in a penetrating mode. The ends of the first and second hinge shafts 24a and 24b penetrating through the proximal ends of the inner clip through the arrangement of the kidney-shaped holes can slide along the kidney-shaped holes, so that the proximal ends of the inner clip 20 are allowed to generate small deformation, the occurrence of the condition that the proximal ends of the inner clip 20 lose flexibility to cause the engagement and dislocation of the proximal end gears and racks of the first and second base plates 30a and 30b to be blocked is prevented, and the machining precision of the clip can be effectively reduced. The limiting member may be not only a limiting plate 25 with a waist-shaped hole, but also an elastic connecting rod for connecting the proximal ends of the first inner clamping arm 22a and the second inner clamping arm 22b of the inner clamp, such as a curved rod, a spring, or even an elastic wire.
As shown in fig. 5A-5B, in this example, the inner rod 10 is a circular elongate rod, i.e. a drive shaft 90 of a release structure 91 of the delivery device 9, for delivering the entire clip. The proximal end of the inner rod 10 protrudes from the proximal end of the delivery device 9 for ease of manipulation, and the distal end of the inner rod 10 is threaded into the rod bore 211 of the inner holder end 21 distal of the inner clip 20. The outer surface of the distal section of the inner rod 10 is integrally formed with a coaxial square post 11, the cross-sectional side of the square post 11 being larger than the diameter of the inner rod 10, so that the square post 11 protrudes from the outer surface of the inner rod 10 as seen in cross section. While the far section of the square column 11 is provided with an engagement section. The engagement section is in rolling engagement with gears on the proximal engagement ends of the first and second base plates 30a, 30 b. Specifically, the meshing section of the square column 11 has a first rack 12a and a second rack 12b, and the teeth and the tooth grooves of the first and second racks 12a, 12b are perpendicular to the axial direction of the inner rod 10 and are arranged at parallel intervals along the length direction of the surface of the square column 11, that is, the intervals between two adjacent teeth or tooth grooves are the same. While the first rack 12a faces away from the second rack 12b so as to be perfectly intermeshed with the gears of the engagement ends of the proximal ends of the oppositely disposed first and second base plates 30a, 30 b. In a preferred example, the first and second racks 12a, 12b are located at the distal section of the square column 11 and the distal ends of the first and second racks 12a, 12b abut against the distal end of the square column 11, the heights of the teeth of the first and second racks 12a, 12b are flush with the surface of the proximal section of the square column 11, and the bottoms of the tooth grooves of the first and second racks 12a, 12b are flush with the surface of the inner rod 10. The arrangement is that the tooth design is not needed at the far end of the meshing section, when the first base plate and the second base plate are opened and adjusted again, the meshing end is not needed to be meshed with the meshing section when the first base plate and the second base plate are opened a small amount, and the quick adjustment is convenient. The non-meshing section and surface height of the proximal end of the square post 11 are flush with the tooth heights of the first and second racks 12a, 12b, because when the first and second base plates 30a, 30b are opened, the gears move relatively toward the proximal ends of the first and second racks 12a, 12b, and when the gears rotate to the proximal ends of the first and second racks 12a, 12b without tooth gaps, the gears cannot move further downwards, so that the opening angle of the first and second base plates 30a, 30b is limited, the relative opening angle of the first and second base plates 30a, 30b is generally not more than 160 degrees, and the tooth is not arranged on the surface of the inner rod 10 outside the distal ends of the first and second base plates 12a, 12b, so that after the lobes are clamped, as shown in fig. 10, the first and second base plates 30a, 30b cannot be interfered by the interference of the first and second racks 12a, 12b, and the clamping force cannot be influenced, because the gears rotate relatively toward the distal ends of the first and second base plates 30a, 30b, and the inner rod 12a, 12b can be withdrawn smoothly when the first and second base plates 30a, 30b are closed. In a preferred example, the modulus of the first and second racks 12a, 12b is the same as the modulus of the gears at the meshing ends of the first and second substrates 30a, 30b, respectively, and the heights of the teeth of the first and second racks 12a, 12b are smaller than the heights of the teeth of the gears at the meshing ends, or the meshing sections employ negative displacement racks. The fault tolerance rate in the meshing process of the meshing end and the meshing section is improved, when the distance between the circle center of the meshing end and the graduation line of the meshing section is constant, even if the meshing end is slightly deviated from the meshing section, the meshing end can still be clamped into the first and second racks 12a and 12b of the meshing section, and meanwhile, the second reason is that the inner rod 10 is convenient to withdraw, because the meshing section is arranged on the square column 11, and when the inner rod 10 withdraws, the square column 11 must pass through the threaded hole at the proximal end of the outer clamp 50, the maximum distance between any two points of the profile line of the cross section of the meshing section is smaller than the inner diameter of the threaded hole, and the meshing section can smoothly pass through the threaded hole, and adopts the negative displacement setting, so that the difficulty of the square column passing through the threaded hole is effectively reduced. The proximal section of the inner rod 10 (here proximal section refers to the proximal section that is closer to the distal section corresponding to the engagement section, but still distal section from the perspective of the entire inner rod 10) has a delivery external thread 13. The proximal end of the outer clip 50 has a delivery female thread, through which the delivery male thread 13 is matingly coupled, and the proximal section of the inner rod 10 (and likewise herein) is threaded through the proximal end of the outer clip 50.
As shown in fig. 6A to 6B, in this example, the first substrate 30a and the second substrate 30B serve as bases for fixing the fixing pieces of the first and second clips 40a, 40B and the outer clip arms of the outer clip 50. The first and second substrates 30a, 30b have an engagement end 31, a connection section 32 and a flat plate section 33 in this order from the proximal end to the distal end, and both ends of the connection section 33 are integrally connected to the engagement end 31 and the flat plate section 33, respectively. The width of the engagement end 31 is smaller than the width of the flat plate segment 33; the width of the proximal end of the connecting section 32 corresponds to the width of the engaging end 31, the width of the distal end of the connecting section 32 corresponds to the width of the flat plate section 33, and the width of the connecting section 32 itself continuously and smoothly increases from the proximal end to the distal end. The plate sections 33 of the first and second substrates 30a and 30b have at least one substrate fixing hole 331, for example, 2 substrate fixing holes 331, respectively; the fixing pieces of the first and second clips 40a and 40b are respectively provided with at least one clip fixing hole 421, for example, 2 clip fixing holes; the distal sections of the two outer arms of the outer clip 50 each have at least one arm attachment hole 5224, e.g., 2 arm attachment holes. The fixing pieces of the first and second clamping pieces 40a and 40b, the distal sections of the first and second substrates 30a and 30b, and the distal sections of the two outer clamping arms of the outer clamp 50 are respectively and fixedly connected together by sequentially penetrating the corresponding clamping piece fixing holes 421, the substrate fixing holes 331 and the clamping arm fixing holes 5224 through the fixing rods. The distal end of the flat plate segment 33 of the distal section of the first and second substrates 30a, 30b also has a first operation hole 332 through which a first wire 924 (transport wire) of the transport structure 92 passes. The first and second substrates 30a and 30b can be opened by a pulling operation of the first pull wire 924. The body of the engagement end 31 of the first and second base plates 30a, 30b is cylindrical in shape. The axis of the cylindrical engagement end 31 has a hinge hole therethrough. Accordingly, the first and second hinge shafts 24a, 24b are inserted into the hinge holes of the first and second hinge ends 23a, 23b and the hinge holes of the engagement ends 31 of the first and second base plates 30a, 30b, wherein the engagement ends 31 of the first and second base plates 30a, 30b are positioned in the middle of the hinge holes of the first and second hinge ends 23a, 23b, respectively, and the proximal ends of the first and second base plates 30a, 30b are hinged with the proximal ends of the first and second inner clip arms 22a, 22b, respectively. The axial direction of the cylindrical engaging end 31 is perpendicular to the inner rod 10, the engaging end 31 is a gear, for example, a half gear having teeth and tooth grooves on one half side surface, and the half side surface has a plurality of teeth 311 and tooth grooves arranged at intervals along the circumferential direction of the engaging end 31, that is, the teeth and tooth grooves of the engaging end 31 are also perpendicular to the axial direction of the inner rod 10, the interval between adjacent teeth 311 is equal, and the modulus is equal to that of the first and second racks 12a, 12 b. So arranged, the gears of the first and second base plates 30a, 30b are respectively engaged with the first and second racks 12a, 12b of the inner rod 10 in a rolling and back-and-forth manner. Therefore, when the distal ends of the first and second base plates 30a, 30b are opened by the first wire 924, even if the engaging ends 31 of the first and second base plates 30a, 30b are hinged to the proximal ends of the first and second hinge ends 23a, 23b of the first and second inner clip arms 22a, 22b, the movement of the engaging ends 31 of the first and second base plates 30a, 30b is restricted by the engaging section of the inner rod 10, but is controlled to roll along the first and second racks on the engaging section of the inner rod 10, so that the first and second base plates do not move freely due to many uncontrollable factors (such as the hinge of both ends, the elasticity of the outer clip arms, etc.) like a simple hinge structure. Thus, the movement of the first and second substrates 30a, 30b during operation of the clutch in the present application is very easily controllable. And because the outer clip arms of the outer clip 50 are fixed to the outer side walls of the distal flat plate sections 33 of the first and second substrates 30a, 30 b; the fixing pieces of the first and second clips 40a, 40b are fixed to the inner side walls of the distal flat plate sections 33 of the first and second substrates 30a, 30b. During the controlled and stable opening of the first and second substrates 30a, 30b by the first pull wire 924, the opening of the first and second jaws 40a, 40b and the outer clip arms of the outer clip 50 is also a controlled and stable opening process. The distal ends of the first and second substrates 30a, 30b are provided with a U-shaped elbow 34, the U-shaped elbow 34 wraps the distal ends of the outer clamping arms, the stability of the clamp is improved, the outer clamping arms of the outer clamp 50 are not easy to separate from the first and second substrates, and the distal ends of the outer clamping arms are prevented from freely moving to scratch tissues such as heart valve leaflets. The distal ends of the first and second base plates 30a, 30b have ribs 35 facing inward to provide a tortuous path for the native leaflets after they have been pinched.
As shown in fig. 7, in this example, the first and second clips 40a and 40b are large long sheets, respectively, and the large long sheets have a double-layered structure. The middle part of the large long sheet body is engraved with a small sheet body, and a hollow long frame body is left, wherein the long frame body is a movable sheet 41, and the engraved small sheet body is a fixed sheet 42, so that the long frame body and the small sheet body also have a double-layer structure. The hollow part proximal end of the long frame body is connected with the proximal end of the tablet body into a whole, that is, the proximal ends of the movable piece 41 and the fixed piece 42 are integrally connected. The fixing piece 42 is provided with a clamping piece fixing hole 421, and the clamping piece fixing hole 421, the substrate fixing hole 331 and the clamping arm fixing hole 5224 of the corresponding fixing piece 42 are sequentially penetrated through the fixing rod, so that the fixing pieces 42 of the first clamping piece 40a and the second clamping piece 40b, the far sections of the first substrate 30a and the second substrate 30b and the far sections of the two outer clamping arms of the outer clamp are respectively and correspondingly fixedly connected together. That is, the outer side walls of the fixing pieces 42 of the first and second clips 40a, 40b are respectively bonded and fixed to the inner side walls of the first and second substrates 30a, 30 b. The movable piece 41, i.e. one layer of the long frame facing the first and second substrates 30a, 30b, is cut with barbs 43 in a plurality of directions at the edges. The distal end of the movable plate 41 has a clip operation hole 411 through which a second wire 923 (a feeding wire) of the feeding structure 92 passes. In operation, the distal ends of the first and second inner clip arms 22a, 22b are respectively connected to the distal ends of the movable pieces 41 of the first and second clip pieces 40a, 40b by pulling together the second pull wire 923. When the second pull wire 923 is pulled, the second pull wire 923 can provide supporting force by the second operation holes 221 of the first and second inner clamping arms 22a and 22B, and the movable piece 41 and the fixed piece 42 are pulled to open and close to the native valve leaflet, as shown in fig. 11A-11B, so that the opened first and second clamping pieces 40a and 40B can capture the native valve leaflet.
As shown in fig. 8A-8B, in this example, the outer clip 50 has an outer clip seat end 51, located proximally; the outer holder end 51 has a threaded bore with a delivery internal thread 511, the delivery external thread 13 passing through the proximal section of the inner rod 10 being matingly connected to the delivery internal thread 511, the proximal section of the inner rod 10 (this proximal section being the proximal section relative to the engagement section; here still the distal section from the entire inner rod 10) being threaded through the proximal end of the outer holder 50. Two outer clip arms 52 integrally extend distally from both sides of the outer clip seat end 51 symmetrically. That is, the two outer clamping arms 52 are symmetrically arranged along the axial line and the proximal ends are integrally connected through the outer clamping seat end 51. Specifically the outer clip arm 52 has an undeformed proximal arm 521 and a deformable distal arm 522. The non-deforming proximal arm 521 integrally extends distally from one side of the outer holder end 51; the deformable distal arm 522 continues integrally from the distal end of the non-deformable proximal arm 521 distally. The deformable distal arm 522 has, in order from the proximal end to the distal end, a bendable proximal segment 5221, a bendable middle segment 5222, and a bendable distal segment 5223. The bendable proximal segment 5221 integrally extends from the distal end of the non-deformable proximal arm 521; the bendable middle section 5222 integrally extends from the distal end of the bendable proximal section 5221; a bendable distal section 5223 integrally extends from the distal end of the bendable middle section 5222. The bendable distal section 5223 of the outer clip arms 52 has clip arm attachment holes 5224. The fixing pieces of the first and second clips 40a and 40b, the distal sections of the first and second substrates 30a and 30b, and the distal sections of the two outer clip arms 52 are respectively and fixedly connected together by sequentially penetrating the corresponding clip fixing holes 421, substrate fixing holes 331, and clip arm fixing holes 5224 through the fixing rods. That is, the inner side walls of the bendable distal segments 5223 of the outer clip arms 52 are fixedly attached to the outer side walls of the distal segments of the first and second substrates 30a, 30 b. The outer clip arms 52 thus provide elastic force to the first and second substrates 30a, 30 b. The distal ends of the first and second substrates 30a, 30b are pulled by the first pull wire 924 of the conveying structure 92 to open, and the engagement ends 31 of the first and second substrates 30a, 30b are controllably moved proximally along the engagement section of the inner rod 10, and the flexible distal sections 5223 of the outer clip arms 52 are controllably and stably opened due to the fixed connection with the outer side walls of the first and second substrates 30a, 30 b. At this time, the bendable proximal segment 5221 and the bendable distal segment 5223 of the outer clamping arm 52 are bent at a transition angle θ with respect to the bendable middle segment 5222, and the angle θ is about 90 ° to 150 °. Of course, due to the elasticity of the outer clamping arm 52, the included angle θ may be further opened by a larger angle, for example, θ is 60 °. When the pulling force of the first pull wire 924 is removed, the bendable proximal segment 5221 and the bendable distal segment 5223 of the outer clip arm 52 return to the original natural state of the original material itself to be approximately linear, i.e., the θ angle is about 180 °. It is also possible to further fold the outer frame 50, assuming that there are no other components in the outer frame 50, only the folding component 53 and the outer frame 50 are shown in fig. 9A, and the bendable proximal segment 5221 and the bendable distal segment 5223 of the outer clip arm 52 can be further bent inward under the action of the folding component 53, so that the formed θ angle is about 190 ° or even 200 °, and thus the outer frame 50 can provide a larger clamping force for the first and second substrates 30a and 30b and the first and second clips 40a and 40b, so as to promote a more stable clamping of the native valve leaflet of the mitral valve. In one example, the width of the bendable proximal segment 5221, bendable middle segment 5222, and bendable distal segment 5223 is consistent with the width of the undeformed proximal arms 521. In another example, the width of the bendable proximal segment 5221 corresponds to the width of the non-deforming proximal arm 521; the width of the proximal end of the pliable middle section 5222 is the same as the width of the pliable proximal section 5221, with the width of the pliable middle section 5222 narrowing from the proximal end to the distal end; the width of the bendable distal section 5223 is the same as the distal width of the bendable middle section 5222, with the bendable distal section 5223 having a width of one-third to two-thirds of the bendable proximal section 5221.
In this example, the outer clip arm 52 has a mounting seat 523 extending from a side wall of the non-deforming proximal arm 521. Preferably, the mounting block 523 extends from the inner side wall of the non-deforming proximal arm 521. The mount 523 has at least one mounting hole 5231. For example, two mounting holes at different positions, for different native leaflets, the mounting hole 5231b is provided on the base, the mounting hole 5231b is closer to the distal direction of the middle part of the outer clip 50 than the mounting hole 5231a, and 5311a and fixing holes 5311b are provided at corresponding positions on the corresponding seat cover plate.
As shown in fig. 9A-9B, in this example, the outer clip 50 also has a tuck-in assembly 53. The tuck-in assembly 53 has a pair of parallel seat cover plates 531 and two pairs of clamping shafts 532. Two pairs of clamping shafts 532 are respectively clamped on the inner and outer side walls of the flexible middle section 5222 of the flexible distal arms 522 of the two outer clamping arms 52. The clamping shaft 532 is abutted against the inner side wall and the outer side wall of the bendable middle section 5222 respectively, and the clamping shaft 532 provides a fulcrum to provide bending deformation supporting force for the deformable distal arm 522, so that the included angle θ of bending of the deformable distal arm 522 in a natural state reaches 200 ° or more. The two ends of the clamping shaft 532 are respectively provided with an anti-falling cover, the anti-falling cover is a ring or a plate with the diameter larger than that of the sliding hole, and the anti-falling cover is fixed at the two ends of the clamping shaft 532, so that the clamping shaft 532 cannot slide out of the sliding hole.
In this example, the seat cover 531 is trapezoidal-like, and is adapted to the state of the mitral valve clamp after the native valve leaflet is clamped, the proximal side edge of the seat cover 531 is smaller than the distal side edge, and the distal side edge of the seat cover 531 is concave and arc-shaped, so as to avoid the limiting plate 25. The seat cover plate 531 is respectively installed on two sides of the non-deforming proximal arm 521 of the two outer clamping arms 52, and proximal side angles on two sides of the seat cover plate 531 are respectively provided with at least one fixing hole 5311 corresponding to the position of the mounting hole 5231 of the mounting seat 523; the seat cover 531 is mounted on both sides of the mounting seat 523 by the mounting rod penetrating into the fixing hole 5311 and the mounting hole 5231 of the mounting seat 523 of the non-deforming proximal arm 521. The distal side angles on both sides of the seat cover 531 are respectively provided with a sliding hole, the inner diameter of the sliding hole is gradually increased from the outside to the inside, and both ends of each pair of clamping shafts 532 are respectively arranged in the sliding holes in a sliding manner in a manner of leaning to slide inwards, so that the outer clamp is clamped and folded, meanwhile, both sides of the outer clamp are provided with the clamping shafts 532, the clamping shafts 532 correspond to the region with larger deformation of the outer clamp, and the torsion phenomenon caused by the outer clamp in the eversion process is prevented. Specifically, the slide aperture is L-shaped, having a proximal aperture 5312 and a distal aperture 5313. The proximal end of proximal aperture 5312 is inboard and the distal end of proximal aperture 5312 is outboard; the proximal end of distal aperture 5313 is communicatively coupled to the distal end of proximal aperture 5312, the proximal end of distal aperture 5313 being outboard and the distal end of distal aperture 5313 being inboard. The proximal hole 5312 has a progressively increasing hole pitch from the inside to the outside (equal to the diameter of the clamping shaft that can be accommodated between the slide holes); the distance between the distal end hole 5313 increases from the outside to the inside, and the distance between the holes inside the distal end hole 5313 is equal to the diameter of the clamping shaft 532; so that the clamping shaft 532 tends to slide inwardly under the force of the slide Kong Dan to clamp the outer clip together. The clamping shaft 532 is not so slid from the slide hole under the limit of the anti-drop cover (not shown) of the clamping shaft 532. Because the hole pitch gradually increases from the proximal end to the distal end, the included angle beta formed by the two side edges of the proximal hole 5312 is 3-10 degrees, the hole pitch of the proximal hole 5312 is changed greatly, the hole pitch is reduced rapidly, the clamping shaft 532 cannot fall into the proximal hole 5312 of the L-shaped sliding hole, but the narrow edge outside the proximal hole 5312 is reserved, the narrow edge has elasticity relatively, an L-shaped narrow edge can be formed with the narrow edge outside the distal hole 5312, and the deformed elastic force is utilized to provide acting force for the clamping shaft 532 together; the included angle alpha formed by the two side edges of the far-end hole 5313 is 1-5 degrees, so that a sliding hole with gradually-changed hole pitch is formed, and the clamping shaft 532 can slide in the sliding hole. The included angle gamma formed by the central line of the proximal hole 5312 and the axial line of the mitral valve clamp is 15-25 degrees; the included angle delta formed by the central line of the distal hole 5313 and the axial line of the mitral valve clamp is 60-70 degrees, the shape and the angle setting of the L-shaped sliding hole are controlled together by controlling the included angle gamma and the included angle delta, the specific values of the included angle gamma and the included angle delta can be flexibly adjusted according to the actual maximum bending point, the maximum deformation track and the like of the mitral valve clamp with different sizes in the opening and closing processes of the outer clamp, so that the sliding hole is more suitable for the opening and the closing of the outer clamp, and the specific values can be obtained by a person skilled in the art according to simple experiments. Since the hole distance of the distal hole 5313 gradually increases toward the inside, the deformable distal arm 522 springs back after the pulling force of the first pull wire is removed, and the outer clamping shaft 532 thereof loses the pushing pressure of the deformable distal arm 522 against it, the clamping shaft 532 moves toward the large hole distance, i.e., toward the inside distal end, under the elastic force of the slide hole, and the clamping shaft 532 located at the outside of the deformable distal arm 522 further pushes the deformable distal arm 522 to the inside, thereby completing the collapsing of the outer clamping arm 52 of the entire outer clamp 50.
As shown in fig. 10, in this example, two petal outer frames 60 are respectively located outside the outer clip arms. The petal casing 60 has a short bar 61 at the distal end; two long rods 62 extending proximally from both sides of the short rod 61, respectively; the two mounting rods 63 are linearly symmetrical with a certain interval in the middle and vertically connected to the proximal end of the long rod 62. The long bar 62 is slightly curved, resembling a lotus petal. The two mounting rods 63 are sequentially inserted into the fixing holes 5311 on the seat cover 531 and the mounting holes 5231 of the mounting seat 523 of the non-deforming proximal arm 521. The mounting rods 63 of the petal-shaped outer frame 60 are inserted into the mounting holes 5231 to be rotatable with each other, so that the petal-shaped outer frame 60 does not need to provide elastic force, but the first and second base plates are assisted to further clamp the native valve leaflets. Of course, the mounting rod 63 of the petal outer frame 60 may be fixed in the mounting hole 5231 to achieve the object of the present invention. The petal-shaped outer frames 60 and the corresponding outer clamping arms 52 are covered by a covering film (not shown), and the fixing sheets comprising the first and second base plates 30a, 30b and the first and second clamping sheets 40a, 40b fixed on the first and second base plates 30a, 30b are also covered together. The covered clamp can reduce secondary damage to the heart and promote endothelialization of the mitral valve clamp and heart valve leaflets.
The specific embodiments described herein are offered by way of example only to illustrate the spirit of the invention. Those skilled in the art may make various modifications or additions to the described embodiments or substitutions thereof without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.

Claims (20)

1. An outer clip for a mitral valve clip, comprising:
an outer holder end located at the proximal end;
two non-deforming proximal arms extending integrally from both sides of the outer holder end symmetrically toward the distal end;
two deformable distal arms respectively extend from the distal ends of the non-deformable proximal arms symmetrically and integrally towards the distal ends.
2. The outer clip for a mitral valve clip of claim 1, wherein the deformable distal arm comprises, in order from the proximal end to the distal end:
a bendable proximal segment integrally extending from the distal end of the non-deformable proximal arm;
a bendable middle section integrally extending from the distal end of the bendable proximal section;
a bendable distal section integrally extending from a distal end of the bendable middle section;
wherein, the included angle theta formed by the bendable near section and the bendable far section is 60-200 degrees.
3. An outer clip for a mitral valve clip as set forth in claim 2, wherein
And an included angle theta formed by the bendable near section and the bendable far section is 90-190 degrees.
4. An outer clip for a mitral valve clip as set forth in claim 2 or 3, wherein
The widths of the bendable proximal section, the bendable middle section and the bendable distal section are consistent with the width of the non-deforming proximal arm.
5. An outer clip for a mitral valve clip as set forth in claim 2 or 3, wherein
The width of the bendable proximal section is consistent with the width of the non-deformable proximal arm;
the width of the proximal end of the bendable middle section is consistent with the width of the bendable proximal section, and the width of the bendable middle section gradually narrows from the proximal end to the distal end;
the width of the bendable distal section is consistent with the distal width of the bendable distal section.
6. The outer clip for a mitral valve clip of claim 2, wherein the bendable distal segment has clip arm attachment holes.
7. The outer clip for a mitral valve clip of claim 1, wherein the non-deforming proximal arm comprises:
and a mounting seat extending from the side wall of the non-deformable proximal arm.
8. The outer clip for a mitral valve clip of claim 7, wherein the non-deforming proximal arm comprises:
The mounting seat extends from the inner side wall of the non-deforming near arm.
9. The outer clip for a mitral valve clip of claim 8, wherein the mount has at least one mounting hole.
10. The outer clip for a mitral valve clip of claim 1, further comprising a biasing assembly having:
two pairs of clamping shafts respectively clamped on the inner side wall and the outer side wall of the deformable far arm;
the two ends of each pair of clamping shafts are respectively arranged in the sliding holes in a sliding manner in the inward direction, so that the outer clamp is clamped and folded.
11. The outer clip for a mitral valve clip of claim 10, wherein the slide hole is L-shaped having:
a proximal aperture, the proximal end of the proximal aperture being inboard and the distal end of the proximal aperture being outboard;
the proximal end of the distal hole is connected with the distal end of the proximal hole in a communicating way, the proximal end of the distal hole is positioned on the outer side, and the distal end of the distal hole is positioned on the inner side.
12. An outer clip for a mitral valve clip as set forth in claim 11, wherein
The hole distance from the inner side to the outer side of the proximal hole is gradually increased;
the hole distance from the outer side to the inner side of the distal hole is gradually increased; so that the clamping shaft tends to slide inwardly, thereby clamping the outer clamp together.
13. An outer clip for a mitral valve clip as set forth in claim 12, wherein
The included angle beta formed by the two side edges of the near-end hole is 3-10 degrees;
the included angle alpha formed by the two side edges of the far-end hole is 1-5 degrees.
14. An outer clip for a mitral valve clip as set forth in claim 11, wherein
An included angle gamma formed by the central line of the proximal hole and the axial line of the mitral valve clamp is 15-25 degrees;
the included angle delta formed by the central line of the distal hole and the central line of the mitral valve clamp is 60-70 degrees.
15. An outer clip for a mitral valve clip as set forth in claim 10, wherein
The two ends of the clamping shaft are respectively provided with an anti-falling cover.
16. An outer clip for a mitral valve clip as set forth in claim 10, wherein
Proximal corners of both sides of the seat cover plate are provided with at least one fixation hole, respectively, for mounting the seat cover plate on an outer clip of the mitral valve clamp.
17. An outer clip for a mitral valve clip as set forth in claim 10, wherein
The seat cover plate is trapezoid-like, and the proximal side edge of the seat cover plate is smaller than the distal side edge.
18. An outer clip for a mitral valve clip as set forth in claim 10 or 17, wherein
The far-end side edge of the seat cover plate is in an inward concave arc shape.
19. An outer clip for a mitral valve clip as set forth in claim 10, wherein
Proximal side angles on two sides of the seat cover plate are respectively provided with at least one fixing hole;
the side wall of the non-deformable near arm is provided with a mounting seat, and the mounting seat is provided with at least one mounting hole corresponding to the fixing hole;
the mounting rod penetrates through the fixing hole and the mounting hole to mount the seat cover plate on two sides of the mounting seat.
20. An outer clip for a mitral valve clip as set forth in claim 10, wherein
The deformable distal arm has, in order from the proximal end to the distal end: a bendable proximal section, a bendable middle section, and a bendable distal section;
the clamping shafts are respectively abutted against the inner side wall and the outer side wall of the bendable middle section, and the supporting force for bending deformation is provided for the deformable far arm by providing a fulcrum through the clamping shafts, so that an included angle theta formed by bending of the deformable far arm is 60-200 degrees.
CN202210726066.3A 2022-06-24 2022-06-24 Outer clip for mitral valve clip Pending CN117297838A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210726066.3A CN117297838A (en) 2022-06-24 2022-06-24 Outer clip for mitral valve clip

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210726066.3A CN117297838A (en) 2022-06-24 2022-06-24 Outer clip for mitral valve clip

Publications (1)

Publication Number Publication Date
CN117297838A true CN117297838A (en) 2023-12-29

Family

ID=89245062

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210726066.3A Pending CN117297838A (en) 2022-06-24 2022-06-24 Outer clip for mitral valve clip

Country Status (1)

Country Link
CN (1) CN117297838A (en)

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