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WO2016101529A1 - Valve-clamping device for artificial mitral valve - Google Patents

Valve-clamping device for artificial mitral valve Download PDF

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Publication number
WO2016101529A1
WO2016101529A1 PCT/CN2015/080209 CN2015080209W WO2016101529A1 WO 2016101529 A1 WO2016101529 A1 WO 2016101529A1 CN 2015080209 W CN2015080209 W CN 2015080209W WO 2016101529 A1 WO2016101529 A1 WO 2016101529A1
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WO
WIPO (PCT)
Prior art keywords
valve
mitral valve
artificial mitral
core rod
barrel
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.)
Ceased
Application number
PCT/CN2015/080209
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French (fr)
Chinese (zh)
Inventor
钟生平
靳永富
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.)
Kingstronbio (changshu) Co Ltd
Original Assignee
Kingstronbio (changshu) 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 Kingstronbio (changshu) Co Ltd filed Critical Kingstronbio (changshu) Co Ltd
Publication of WO2016101529A1 publication Critical patent/WO2016101529A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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

Definitions

  • the invention relates to an artificial mitral valve valve holder, belonging to the technical field of medical instruments.
  • Heart valve disease is currently one of the major types of heart disease, and valvular disease can cause major cardiac dysfunction and ultimately requires replacement of the native heart valve with a prosthetic heart valve.
  • the heart valve is mainly divided into aortic valve, pulmonary valve, tricuspid valve and mitral valve.
  • the mitral valve is also called the sacral flap, which is like a “one-way valve” between the left atrium and the left ventricle, ensuring blood circulation from the left atrium to the left ventricle and a certain blood flow.
  • the artificial heart valve is mostly surgically implanted into the body.
  • the artificial mitral valve is made of biological tissue, metal frame, silica gel, polyester thread and polyester fabric. It is stored and transported in antiseptic solution after production. During this time, the function of the mitral valve valve is to firmly fix the mitral valve in the preservation bottle containing the antiseptic solution, and the valve holder is required to be fixed in the preservation bottle and the valve hanger in the preservation bottle. Connected, the mitral valve is not separated from the antiseptic solution, and does not collide with other utensils, resulting in product safety problems. And during the operation, the surgeon will suture the valve and the human tissue by grasping the valve with the aid of the valve holder.
  • the three valve angles of the valve should be retracted before implantation, which is also the valve flap One of the functions of the device.
  • the clinically used holders are generally designed to have a structure capable of axially pushing and tightening the line to retract the flap angle, or to fix the non-retracted flap angle, which is too large for the deformation of the flap angle, and The way of axial tightening requires the mold to be integrally formed, so that the cost of producing the mold is greatly increased.
  • the mitral valve of different sizes needs to be replaced by the corresponding size of the valve holder, and the operation cost is too high.
  • the present invention provides an artificial mitral valve valve holder which can achieve radial fixation of the flap angle of the artificial mitral valve, thereby avoiding the flap when the flap angle is retracted
  • the damage caused by the excessive deformation of the horn in addition, the artificial mitral valve holder is a split type, which greatly reduces the production cost and the use cost.
  • the invention provides an artificial mitral valve valve holder, comprising: a handle portion, a core rod, a ratchet wheel and a flap portion; wherein
  • the holding portion has a barrel-shaped cavity with an upper opening and a through hole at the bottom, the inner wall of the barrel-shaped cavity is provided with a ratchet groove and a sliding groove, and the outer side of the holding valve portion is provided with three valves in the circumferential direction of the barrel-shaped cavity a support portion, a lower outer edge of each of the valve support portions forms a support surface for supporting the artificial mitral valve, and the three support surfaces are circumferentially encircled along the circumferential direction of the retaining flap and are supported by the radial dimension
  • the inner diameter of the suture edge of the artificial mitral valve is the same, and the upper part of the support surface is provided with a wire holding portion, and the wire holding portion can pass the tightening wire from the inner side of the wire holding portion to the lower side of the wire holding portion;
  • the top end of the core rod has a positioning plate, the lower end surface of the positioning plate is provided with a positioning core rod, and the upper portion of the positioning core rod forms a clamping portion with an increased outer diameter, and the lower edge of the clamping portion forms a hook structure, and the ratchet can be sleeved on the
  • the latching portion enables the combination of the ratchet and the retaining portion to be received in the upper opening of the barrel-shaped cavity of the retaining flap, and the lower portion of the positioning stem can pass from the bottom of the barrel-shaped cavity
  • the hole protrudes, and the ratchet and the hook structure respectively cooperate with the ratchet groove and the chute of the inner wall of the barrel cavity to realize one-way rotation;
  • the handle portion is detachably disposed on a positioning plate of the core rod, and the handle portion is capable of driving the core rod to rotate.
  • the handle portion includes a handle base and a detachable handle.
  • the handle seat is provided with a first threading hole
  • the positioning plate of the core rod is provided with a second threading hole corresponding to the first threading hole.
  • first threading hole and the second threading hole are both two, and a first tangential groove is disposed between the first threading holes.
  • a fixing hole is formed on a positioning plate portion of the core rod, and a fixing rod capable of engaging with the fixing hole is disposed at a lower portion of the handle seat, and the card is realized by a card slot structure between the fixing rod and the fixing hole. Fixed.
  • the retaining portion of the upper outer diameter of the positioning mandrel is a cage structure having three center pillars whose upper ends are fixed to the lower end surface of the positioning plate, and the center is standing
  • the lower ends of the columns are respectively connected to the outer ends of a beam, the inner ends of the beams meet at the positioning core rod, the lower end edges of the center columns form the hook structure, and the three beams are respectively provided with a line for threading the tightening line Through hole.
  • the lower portion of the positioning core rod is a columnar body, one end of which is connected to the intersection of the beam and the other end of which protrudes from the through hole at the bottom of the barrel cavity.
  • At least one elastic tooth tangential to the outer circumference of the ratchet is disposed on the outer circumference of the ratchet.
  • the wire holding portion is a two-stage stepped structure
  • the first step is fixed on a lower outer circumference of the barrel-shaped cavity of the lobed portion, and the supporting surface for forming a support for the artificial mitral valve
  • three spaced-aperture threading holes are circumferentially opened on the second step, and a step of extending the tightening wire from the positioning core is provided on the first step Pass through the threaded passage to the threading hole.
  • a second tangential groove is formed between the two threading holes of the three spaced-aperture threading holes.
  • a pair of two axially distributed protrusions are respectively disposed in the corresponding regions of the outer circumference of the barrel-shaped cavity of the lobed portion, and the pair of protrusions are disposed to fix the valve pylon to the pair of protrusions Between.
  • the artificial mitral valve valve holder provided by the invention realizes one-way rotation in the barrel-shaped cavity of the flap portion by matching the handle portion, the core rod and the ratchet wheel, and further passes the thread holding portion while the handle portion rotates.
  • the tightening wire that is passed from the inner side to the lower side thereof is tightened, thereby achieving radial fixation of the flap angle of the artificial mitral valve;
  • the artificial mitral valve retaining device is a split structure, not only The mold structure is greatly simplified and the mold manufacturing cost is reduced, and the corresponding flap members are only required to be replaced for different sizes of the mitral valve, thereby reducing the cost of use.
  • FIG. 1 is a schematic view showing the structure of a manual mitral valve valve holder in a separated state according to the present invention
  • FIG. 2 is a schematic structural view of a flap portion of a prosthetic valvular valve holder according to the present invention
  • FIG. 3 is a schematic structural view of a handle seat and a core rod of the artificial mitral valve valve holder of the present invention
  • Figure 4 is a bottom plan view of the mandrel of the artificial mitral valve valve holder of the present invention.
  • FIG. 5 is a schematic view showing the artificial mitral valve valve holder and the artificial mitral valve connected and fixed according to the present invention.
  • handle part 2 core rod
  • fixing groove 25 columnar body
  • FIG. 1 is a schematic view showing the structure of the artificial mitral valve valve holder in a separated state according to the present invention.
  • 2 is a schematic view showing the structure of a flap portion of an artificial mitral valve holder according to the present invention.
  • 3 is a schematic view showing the structure of a handle seat and a core rod of the artificial mitral valve valve holder of the present invention.
  • Figure 4 is the hair A bottom view of the mandrel of the artificial mitral valve holder.
  • FIG. 5 is a schematic view showing the artificial mitral valve valve holder and the artificial mitral valve connected and fixed according to the present invention.
  • the artificial mitral valve valve holder of the present invention comprises: a handle portion 1, a core rod 2, a ratchet 3 and a holding portion 4.
  • the holding portion 4 has a barrel-shaped cavity 41 having an upper opening and a through hole at the bottom thereof.
  • the inner wall of the barrel-shaped cavity is provided with a ratchet groove 42 and a sliding groove 43.
  • the outside of the holding valve portion 4 is circumferentially along the barrel-shaped cavity 41.
  • Three valve support portions 44 are provided, and a lower outer edge of each of the valve support portions 44 forms a support surface 45 for supporting the artificial mitral valve, and three support surfaces 45 are circumferentially formed along the valve portion 4
  • the radial dimension of the ring coincides with the inner diameter of the suture edge of the supported artificial mitral valve, and the upper portion of the support surface 45 is provided with a wire holding portion 46, which can pass the tightening wire from the inner side of the wire holding portion. To the bottom of the line.
  • the top end of the core rod 2 has a positioning plate 21, and the lower end surface of the positioning plate 21 is provided with a positioning core rod 22.
  • the upper portion of the positioning core rod 22 forms a holding portion 23 with an increased outer diameter, and the lower edge of the holding portion 23 forms a hook structure 24,
  • the ratchet wheel 3 can be sleeved on the latching portion 23, so that the combination of the ratchet wheel 3 and the latching portion 23 can be accommodated in the upper opening of the barrel-shaped cavity 41 of the flap portion, and the lower portion of the positioning core rod 22 can be
  • the through hole at the bottom of the barrel cavity 41 protrudes, and the ratchet wheel 3 and the hook 24 structure respectively cooperate with the ratchet groove 42 and the chute 43 of the inner wall of the barrel cavity to realize one-way rotation.
  • the handle portion 1 is detachably provided on the positioning plate 21 of the core rod 2, and the handle portion 1 can drive the core rod 2 to rotate.
  • the handle portion 1 is used for the operator to hold and rotate in a clockwise or counterclockwise direction to form a driving force for tightening the flap angle b of the artificial mitral valve, and the handle
  • the core rod 2 connected to the portion 1 is matched with the ratchet wheel 3 and transmits the driving force from the handle portion 1 to the ratchet wheel 3, and the ratchet wheel 3 is matched with the ratchet groove 42 of the inner wall of the barrel-shaped cavity and the ratchet wheel 3 can only be single in the ratchet groove 42.
  • the handle portion 1 may include a handle base 12 and a detachable handle 13.
  • the handle seat may be provided with a first threading hole
  • the positioning plate 21 of the core rod 2 may be provided with a second corresponding to the first threading hole. needle.
  • the first threading hole and the second threading hole may have the same diameter, for example, each of 0.3-1.5 mm; the opposite first threading hole and the second threading hole may be used to form a binding between the handle seat 12 and the core rod positioning plate 21, thereby The relative fixing of the handle base 12 and the core positioning plate 21 is achieved.
  • the detachable handle 13 can be screwed to the handle base 12, for example, and an axially disposed internally threaded hole can be formed in the handle base 12, and an external thread matching the internal threaded hole can be formed on the handle 13. Thereby, the mounting and dismounting of the handle 13 on the handle base 12 is facilitated.
  • an axially disposed internal threaded hole may be formed in an upper portion of the handle base 12, and a guide hole coaxial with the internally threaded hole and having no thread is formed below the internally threaded hole, and the size of the guide hole may be
  • the handles 13 are mated and the guide holes facilitate axial orientation of the handle, thereby preventing the handle 13 from being axially offset and unable to simultaneously tighten the three flap angles of the artificial mitral valve to a predetermined position.
  • first threading hole and the second threading hole may be two, and a first tangential groove 123 is disposed between the first threading holes.
  • the diameters of the two first threading holes 121a, 121b may be the same, and the diameters of the two second threading holes 214a, 214b may be the same.
  • the two threading holes are provided to facilitate fixing the ends of the wire, the first tangential groove 123 The arrangement facilitates cutting of the wire that binds the handle base 12 and the core positioning plate 21, thereby facilitating separation of the handle base 12 from the core positioning plate 21.
  • the first wire groove 123 may be longitudinally penetrated and may have a width of 0.3-2.0 mm; in addition, the first tangential groove may be disposed to be biased toward one of the two first threading holes, thereby effectively preventing the wire end from being fixedly formed.
  • the line junction interferes with the tangential process.
  • a fixing hole 212 is defined in an upper portion of the positioning plate 21 of the core rod 2.
  • the lower portion of the handle base 12 is provided with a fixing rod 14 that can cooperate with the fixing hole 212, and the fixing rod 14 and the fixing hole 212 pass the card.
  • the groove structure realizes the holding and fixing.
  • At least one radial fixing rib 15 may be disposed on an outer circumference of the upper portion of the fixing rod, and a fixing groove 213 matching the fixing rib is disposed at a position corresponding to the fixing rib of the core rod positioning plate, the fixing rib 15
  • the width can be 0-0.2 mm larger than the width of the fixing groove 213, and the height of the fixing rib can be 0-0.2 mm smaller than the depth of the fixing groove, that is, When the fixing ribs are placed in the fixing groove, a gap of 0-0.2 mm is formed between each other.
  • the diameter of the fixing rod 14 may be equal to or slightly smaller than the diameter of the fixing hole 212.
  • the holding portion of the upper outer diameter of the positioning core rod 22 is a cage structure 23 having three center pillars 231 fixed at the lower end surface of the positioning plate, and the lower ends of the center pillars 231 are respectively The outer ends of the beams 232 are connected to each other. The inner ends of the beams 232 are joined to the positioning core rods 22. The lower end edges of the central columns 231 form a hook structure 24, and the three beams 232 are respectively provided with a through-line through holes for threading the tightening lines. 233.
  • the hook structure 24 can be, for example, a protrusion extending outward from the outer end of the beam 232, and can cooperate with the sliding groove 43 of the inner wall of the barrel cavity to achieve relative rotation, and the length of the protrusion extending from the outer end of the beam can be It is 0.1-2 mm; at the same time, the sliding groove 43 provided in the inner wall of the barrel cavity may be an annular sliding groove.
  • the positioning mandrel 22 of the above structure can realize the fixing of one end of the tightening wire a.
  • one end of the three tightening wires a can be respectively wound from the upper one of the three beams 232 from below, and the wire a is tightened.
  • the ends are tightened and then threaded out of the tether through holes 233 and wound around the projecting core 22 from the projecting portion of the through hole at the bottom of the barrel.
  • the diameter of the through hole of the tie can be 0.3-2.0 mm.
  • the lower portion of the positioning mandrel is a columnar body 25, one end of which is connected to the junction of the beam and the other end of which protrudes from the through hole at the bottom of the barrel-shaped cavity.
  • the columnar body may have a length of 2-10 mm and a diameter of 0.5-5 mm.
  • the outer circumference of the ratchet wheel 3 is provided with at least one elastic tooth tangential to the outer circumference of the ratchet wheel, for example, 1-8; in particular, when a plurality of elastic teeth are provided, the orientations of the plurality of elastic tooth extending ends are the same, for example, Orient clockwise or counterclockwise.
  • the outer circumference of the ratchet is provided with three elastic teeth which are tangential to the outer circumference of the ratchet and extend counterclockwise, which can be rotated when the handle rotates clockwise, and when the handle rotates counterclockwise and barrel shape
  • the ratchet groove of the inner wall of the chamber is locked without rotation.
  • the setting method can avoid the re-opening of the flap angle after tightening the flap angle of the artificial mitral valve, so that the fixing effect on the flap angle is good.
  • the wire holding portion 46 may be a two-stage stepped structure, and the first step is fixed on the outer periphery of the lower portion of the barrel-shaped cavity 41 for holding the supporting surface of the artificial mitral valve c. 45 is located below the inner side of the second step, and three spaced-apart threading holes 461a, 461b, 461c are circumferentially opened on the second step, and the first step is provided with the tightening line from the positioning core
  • the rod extension portion is threaded through the wire passage 47 of the threading hole.
  • the line passage 47 can be axially disposed on the outer side of the first stage.
  • the lower width of the valve support portion is limited to be in contact with the artificial mitral valve without touching the leaflet, and the diameter of the threading hole is 0.3-2 mm.
  • One end of the three tightening wires is fixed to the positioning mandrel 22, and the other end can be respectively passed through the wire passage 47 of the first wire holding portion (which may be any one of the three wire holding portions), since the first The threading hole 461a of the thread holding portion (the threading hole at the end portion) penetrates from the lower portion of the flap angle b located below the first thread holding portion to the lower portion of the adjacent flap corner, and then is threaded from the first thread holding portion.
  • the hole 461b (the threading hole adjacent to the threading hole 461a) is pierced, and then penetrates from the threading hole 461c of the first wire holding portion (the threading hole adjacent to the threading hole 461b) and fastens the end of the flap corner.
  • the threading hole 461c penetrates the tightening line.
  • a second tangential groove 462 is defined between two of the three spaced-aperture-threaded holes.
  • the second tangential groove is disposed between the threading hole 461b and the threading hole 461c, and the depth thereof is not limited to the axial penetration, and the width may be 0.3-2 mm, and the length may be 2-10 mm.
  • the arrangement of the second tangential groove facilitates the cutting of the tightening line, so that the flap angle of the artificial mitral valve can be conveniently opened.
  • the wire holding portion is configured to achieve radial tightening of the flap angle of the artificial mitral valve by three tightening wires when the handle is rotated, and to stably position the valve in the radial and axial directions on the retainer In order to avoid damage caused by excessive deformation of the flap angle.
  • the tightening resistance when the flap angle is tightened is greatly reduced, thereby making the operation more convenient.
  • two pairs of protrusions distributed along the axial direction are respectively disposed in the corresponding regions of the outer circumference of the barrel-shaped cavity of the flap portion, and the pair of protrusions are disposed to fix the valve hanger to the pair of protrusions between.
  • the pair of projections facilitate securing the valve holder in the valve bottle.
  • the lower protrusion 52 may be larger than the upper protrusion 51, and a shaped hole matching the upper protrusion 51 or slightly larger than the upper protrusion 51 may be formed at a position corresponding to the upper protrusion 52 of the lower protrusion 52, thereby It is advantageous for the formation of the upper protrusions 51 during the mold making.
  • the handle portion 1 is connected to the core rod 2 by a tightening line.
  • the specific operation mode is that one end of the tightening line first enters the corresponding second threading hole 214a of the core rod through the first threading hole 121a of the handle seat, and passes through the positioning.
  • the plate 21 enters the first threading hole 121b through the second threading hole 214b toward the handle portion 1, the other end of the tightening line is knotted and fixed at the first threading hole 121b.
  • the above step completes the handle portion 1 It is fixed to the connection with the core rod 2.
  • one end of one of the tightening lines can be respectively first After winding the beam from below one of the three beams 232, it is fastened to the end of the tightening wire, and then passes out from the wire through hole 233 and is wound around the through hole of the positioning mandrel 22 from the bottom of the barrel cavity.
  • the upper portion, that is, the columnar body 25, is then pierced from the line passage 47, and is inserted from the first thread holding portion after the threading hole 461a (the threading hole at the end) of the first wire holding portion is inserted.
  • the lower corner of the flap is passed to the lower portion of the adjacent flap, and then passes through the threading hole 461b from the first wire holding portion, and then penetrates from the threading hole 461c of the first wire holding portion and fastens the end of the tightening wire.
  • the tightening line penetrated from the third threading hole 461c. The remaining two flap angles are then tightened together with the other two tightening lines in the same operation.
  • connection method of the artificial mitral valve holding device is to fix the handle portion 1 and the core rod 2 through a tightening line, and then realize the artificial mitral valve holding device and the artificial two through the other three tightening lines.
  • the combination of the components of the embodiment of the invention and the over-line channel on the wire-holding portion achieves radial contraction of the mitral valve leaflet angle, and the mold structure is simple, and the combination and disassembly are easy, which greatly reduces the manufacturing cost. . When it is used for different types of mitral valve, it is only necessary to replace the flap of the corresponding model, which greatly reduces the cost of use.

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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)
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  • Prostheses (AREA)

Abstract

A valve-clamping device for artificial mitral valve, comprising a handle portion (1), a core rod (2), a ratchet wheel(3) and a valve-clamping portion (4); the valve-clamping portion (4) has a barrel-shaped cavity (41) with an opening at an upper portion and a through hole at a bottom portion, a ratchet wheel groove (42) and a sliding groove (43) being disposed on an inner wall of the barrel-shaped cavity (41) to connect the core rod (2) and the ratchet wheel(3), three line clamping portions (46) being circumferentially disposed along the barrel-shaped cavity (41) on an outer side of the valve-clamping portion (4), the tightening line enabling a valve corner and the valve-clamping device to be fixedly connected via the line clamping portions (46); when the handle portion (1) is rotated, an engagement between the handle portion (1), the core rod (2) and the ratchet wheel(3) enables the core rod (2) to be uni-directionally rotated to tighten the tightening line so as to tighten the valve corner. The valve-clamping device for the artificial mitral valve can radially fix the valve corner of the artificial mitral valve, thus avoiding an injury caused by extra distortion of the valve corner when being closed; furthermore, the valve-clamping device for artificial mitral valve is of a split-type, thereby considerably reducing manufacturing cost and operation cost.

Description

人工二尖瓣瓣膜持瓣器Artificial mitral valve valve holder 技术领域Technical field

本发明涉及一种人工二尖瓣瓣膜持瓣器,属于医疗器械技术领域。The invention relates to an artificial mitral valve valve holder, belonging to the technical field of medical instruments.

背景技术Background technique

心脏瓣膜疾病目前是心脏病的主要种类之一,瓣膜疾病可以导致心脏重大功能障碍并且最终需要用人工心脏瓣膜替换自体心脏瓣膜。心脏瓣膜主要分为主动脉瓣、肺动脉瓣、三尖瓣以及二尖瓣。其中二尖瓣瓣膜又叫僧帽瓣,如同一个左房和左室之间的“单向活门”,保证血液循环由左心房一定向左心室方向流动和通过一定的血流量。对于多数需要更换心脏瓣膜的病人,大都采用外科手术的方式将人工心脏瓣膜植入体内。Heart valve disease is currently one of the major types of heart disease, and valvular disease can cause major cardiac dysfunction and ultimately requires replacement of the native heart valve with a prosthetic heart valve. The heart valve is mainly divided into aortic valve, pulmonary valve, tricuspid valve and mitral valve. The mitral valve is also called the sacral flap, which is like a “one-way valve” between the left atrium and the left ventricle, ensuring blood circulation from the left atrium to the left ventricle and a certain blood flow. For most patients who need to replace the heart valve, the artificial heart valve is mostly surgically implanted into the body.

人工二尖瓣瓣膜是由生物组织、金属架、硅胶及涤纶线和涤纶布制造而成的,在生产完成后要放在防腐液中存储、运输。在这期间,二尖瓣瓣膜持瓣器的作用是将二尖瓣瓣膜牢固地固定在盛有防腐液的保存瓶中,要求瓣膜持瓣器固定在保存瓶中与保存瓶中的瓣膜挂架相连,使二尖瓣瓣膜既不脱离开防腐液,又不与其他器物相碰撞而导致产品安全问题。并且在手术过程中,术者会借助持瓣器对瓣膜的把握而将瓣膜与人体组织进行缝合。The artificial mitral valve is made of biological tissue, metal frame, silica gel, polyester thread and polyester fabric. It is stored and transported in antiseptic solution after production. During this time, the function of the mitral valve valve is to firmly fix the mitral valve in the preservation bottle containing the antiseptic solution, and the valve holder is required to be fixed in the preservation bottle and the valve hanger in the preservation bottle. Connected, the mitral valve is not separated from the antiseptic solution, and does not collide with other utensils, resulting in product safety problems. And during the operation, the surgeon will suture the valve and the human tissue by grasping the valve with the aid of the valve holder.

在二尖瓣瓣膜临床植入过程中,为了防止瓣膜瓣角与组织发生干涉而影响手术效果和/或手术进程,在植入前需将瓣膜的三个瓣角收起,这也是瓣膜持瓣器的作用之一。目前临床使用的持瓣器一般设计为具有能实现轴向推收紧线的结构来收起瓣角,或者对不收起的瓣角进行固定,这种方式对于瓣角的形变过大,并且轴向收紧的方式要求模具一体成型,使生产模具的费用大大增加,同时针对不同尺寸的二尖瓣瓣膜需要相对应尺寸的持瓣器的整体更换,手术成本过高。In the clinical implantation of the mitral valve, in order to prevent the valve flap angle and tissue interference and affect the surgical effect and / or the surgical process, the three valve angles of the valve should be retracted before implantation, which is also the valve flap One of the functions of the device. Currently, the clinically used holders are generally designed to have a structure capable of axially pushing and tightening the line to retract the flap angle, or to fix the non-retracted flap angle, which is too large for the deformation of the flap angle, and The way of axial tightening requires the mold to be integrally formed, so that the cost of producing the mold is greatly increased. At the same time, the mitral valve of different sizes needs to be replaced by the corresponding size of the valve holder, and the operation cost is too high.

发明内容 Summary of the invention

针对现有技术中的上述缺陷,本发明提供一种人工二尖瓣瓣膜持瓣器,其能够实现对人工二尖瓣瓣膜的瓣角的径向固定,从而在收起瓣角时可避免瓣角因形变过大所带来的损伤;此外,该人工二尖瓣瓣膜持瓣器为分体式,大大降低了生产成本以及使用成本。In view of the above-mentioned drawbacks in the prior art, the present invention provides an artificial mitral valve valve holder which can achieve radial fixation of the flap angle of the artificial mitral valve, thereby avoiding the flap when the flap angle is retracted The damage caused by the excessive deformation of the horn; in addition, the artificial mitral valve holder is a split type, which greatly reduces the production cost and the use cost.

本发明提供一种人工二尖瓣瓣膜持瓣器,包括:手柄部、芯杆、棘轮和持瓣部;其中,The invention provides an artificial mitral valve valve holder, comprising: a handle portion, a core rod, a ratchet wheel and a flap portion; wherein

所述持瓣部具有上部开口且底部设有通孔的桶形腔体,该桶形腔体内壁设有棘轮槽和滑槽,该持瓣部外侧沿桶形腔体周向设置有三个瓣膜支撑部,每个瓣膜支撑部的下部外缘均形成用于对人工二尖瓣瓣膜形成支撑的支撑面,且三个支撑面沿持瓣部周向围成环形的径向尺寸与所支撑的人工二尖瓣瓣膜的缝合缘内径一致,所述支撑面的上部设有持线部,该持线部能够使收紧线从持线部的内侧穿设至持线部的下方;The holding portion has a barrel-shaped cavity with an upper opening and a through hole at the bottom, the inner wall of the barrel-shaped cavity is provided with a ratchet groove and a sliding groove, and the outer side of the holding valve portion is provided with three valves in the circumferential direction of the barrel-shaped cavity a support portion, a lower outer edge of each of the valve support portions forms a support surface for supporting the artificial mitral valve, and the three support surfaces are circumferentially encircled along the circumferential direction of the retaining flap and are supported by the radial dimension The inner diameter of the suture edge of the artificial mitral valve is the same, and the upper part of the support surface is provided with a wire holding portion, and the wire holding portion can pass the tightening wire from the inner side of the wire holding portion to the lower side of the wire holding portion;

所述芯杆顶端具有定位板,该定位板下端面设有定位芯杆,定位芯杆上部形成外径增大的卡持部,该卡持部下沿形成挂钩结构,所述棘轮能套设于所述卡持部,从而使棘轮与卡持部的结合体能容置于所述持瓣部的桶形腔体的上部开口内,而定位芯杆的下部则能从桶形腔体底部的通孔伸出,且棘轮和挂钩结构分别与桶形腔体内壁的棘轮槽和滑槽相配合并实现单向转动;The top end of the core rod has a positioning plate, the lower end surface of the positioning plate is provided with a positioning core rod, and the upper portion of the positioning core rod forms a clamping portion with an increased outer diameter, and the lower edge of the clamping portion forms a hook structure, and the ratchet can be sleeved on the The latching portion enables the combination of the ratchet and the retaining portion to be received in the upper opening of the barrel-shaped cavity of the retaining flap, and the lower portion of the positioning stem can pass from the bottom of the barrel-shaped cavity The hole protrudes, and the ratchet and the hook structure respectively cooperate with the ratchet groove and the chute of the inner wall of the barrel cavity to realize one-way rotation;

所述手柄部可拆卸地设于芯杆的定位板上,该手柄部能够驱动芯杆转动。The handle portion is detachably disposed on a positioning plate of the core rod, and the handle portion is capable of driving the core rod to rotate.

在一实施方式中,所述手柄部包括手柄座和可拆卸的手柄,手柄座上设有第一穿线孔,所述芯杆的定位板对应于所述第一穿线孔设有第二穿线孔。In an embodiment, the handle portion includes a handle base and a detachable handle. The handle seat is provided with a first threading hole, and the positioning plate of the core rod is provided with a second threading hole corresponding to the first threading hole. .

进一步地,所述第一穿线孔和第二穿线孔均为二个,且所述第一穿线孔之间设有第一切线槽。Further, the first threading hole and the second threading hole are both two, and a first tangential groove is disposed between the first threading holes.

在一实施方式中,所述芯杆的定位板上部开设有固定孔,手柄座下部设有能与固定孔相配合的固定杆,且所述固定杆与固定孔之间通过卡槽结构实现卡持固定。In an embodiment, a fixing hole is formed on a positioning plate portion of the core rod, and a fixing rod capable of engaging with the fixing hole is disposed at a lower portion of the handle seat, and the card is realized by a card slot structure between the fixing rod and the fixing hole. Fixed.

在一实施方式中,所述定位芯杆上部外径增大的卡持部为笼形结构,该笼形结构具有三个上端固定于定位板下端面的中心立柱,中心立 柱的下端分别与一横梁的外端连接,该横梁的内端汇合于定位芯杆,中心立柱的下端缘形成所述挂钩结构,三个横梁上分别开设有用于穿系收紧线的系线通孔。In one embodiment, the retaining portion of the upper outer diameter of the positioning mandrel is a cage structure having three center pillars whose upper ends are fixed to the lower end surface of the positioning plate, and the center is standing The lower ends of the columns are respectively connected to the outer ends of a beam, the inner ends of the beams meet at the positioning core rod, the lower end edges of the center columns form the hook structure, and the three beams are respectively provided with a line for threading the tightening line Through hole.

进一步地,所述定位芯杆的下部为柱状体,其一端与所述横梁汇合处相连,另一端从桶形腔体底部的通孔伸出。Further, the lower portion of the positioning core rod is a columnar body, one end of which is connected to the intersection of the beam and the other end of which protrudes from the through hole at the bottom of the barrel cavity.

进一步地,所述棘轮的外周上设有至少一个与该棘轮外周相切的弹性齿。Further, at least one elastic tooth tangential to the outer circumference of the ratchet is disposed on the outer circumference of the ratchet.

在一实施方式中,所述持线部为两级阶梯结构,第一级阶梯固定在持瓣部桶形腔体的下部外周上,所述用于对人工二尖瓣瓣膜形成支撑的支撑面位于第二级阶梯的内侧下方,在所述第二级阶梯上沿周向开设有三个间隔分布的穿线孔,且在第一级阶梯上设有能够使收紧线从定位芯杆伸出部分穿设至穿线孔的过线通道。In an embodiment, the wire holding portion is a two-stage stepped structure, and the first step is fixed on a lower outer circumference of the barrel-shaped cavity of the lobed portion, and the supporting surface for forming a support for the artificial mitral valve Located below the inner side of the second step, three spaced-aperture threading holes are circumferentially opened on the second step, and a step of extending the tightening wire from the positioning core is provided on the first step Pass through the threaded passage to the threading hole.

进一步地,在三个间隔分布的穿线孔中的二个穿线孔间开设有第二切线槽。Further, a second tangential groove is formed between the two threading holes of the three spaced-aperture threading holes.

进一步地,在持瓣部桶形腔体外周相对应的区域分别设有两组沿轴向分布的一对凸起,且该一对凸起的设置能够使瓣膜挂架固定于该一对凸起之间。Further, a pair of two axially distributed protrusions are respectively disposed in the corresponding regions of the outer circumference of the barrel-shaped cavity of the lobed portion, and the pair of protrusions are disposed to fix the valve pylon to the pair of protrusions Between.

本发明提供的人工二尖瓣瓣膜持瓣器,通过手柄部、芯杆、棘轮的相互匹配来实现在持瓣部桶形腔体内的单向转动,此外在手柄部转动的同时通过持线部使从其内侧穿设至其下方的收紧线收紧,由此实现对人工二尖瓣瓣膜的瓣角的径向固定;此外,该人工二尖瓣瓣膜持瓣器为分体式结构,不仅大大简化了模具结构并降低了模具制造成本,同时在针对不同尺寸的二尖瓣瓣膜时只需更换相应的持瓣部件,从而降低了使用成本。The artificial mitral valve valve holder provided by the invention realizes one-way rotation in the barrel-shaped cavity of the flap portion by matching the handle portion, the core rod and the ratchet wheel, and further passes the thread holding portion while the handle portion rotates. The tightening wire that is passed from the inner side to the lower side thereof is tightened, thereby achieving radial fixation of the flap angle of the artificial mitral valve; in addition, the artificial mitral valve retaining device is a split structure, not only The mold structure is greatly simplified and the mold manufacturing cost is reduced, and the corresponding flap members are only required to be replaced for different sizes of the mitral valve, thereby reducing the cost of use.

附图说明DRAWINGS

图1为本发明的人工二尖瓣瓣膜持瓣器在分体状态下的结构示意图;1 is a schematic view showing the structure of a manual mitral valve valve holder in a separated state according to the present invention;

图2为本发明的人工二尖瓣瓣膜持瓣器的持瓣部的结构示意图;2 is a schematic structural view of a flap portion of a prosthetic valvular valve holder according to the present invention;

图3为本发明的人工二尖瓣瓣膜持瓣器的手柄座与芯杆的结构示意图; 3 is a schematic structural view of a handle seat and a core rod of the artificial mitral valve valve holder of the present invention;

图4为本发明的人工二尖瓣瓣膜持瓣器的芯杆的仰视图;Figure 4 is a bottom plan view of the mandrel of the artificial mitral valve valve holder of the present invention;

图5为本发明的人工二尖瓣瓣膜持瓣器与人工二尖瓣瓣膜连接固定后的示意图。FIG. 5 is a schematic view showing the artificial mitral valve valve holder and the artificial mitral valve connected and fixed according to the present invention.

附图标记:Reference mark:

1:手柄部                         2:芯杆1: handle part 2: core rod

3:棘轮                           4:持瓣部3: Ratchet 4: Holding the flap

12:手柄座                        13:手柄12: Handle seat 13: Handle

14:固定杆                        15:固定筋14: Fixed rod 15: Fixed rib

123:第一切线槽                   121a、121b:第一穿线孔123: first tangential groove 121a, 121b: first threading hole

21:定位板                        22:定位芯杆21: positioning plate 22: positioning mandrel

23:卡持部                        24:挂钩结构23: Holder 24: Hook structure

212:固定孔                       214a、214b:第二穿线孔212: fixing holes 214a, 214b: second threading holes

213:固定槽                       25:柱状体213: fixing groove 25: columnar body

231:中心立柱                     232:横梁231: Center column 232: Beam

233:系线通孔                     41:桶形腔体233: Line through hole 41: barrel cavity

42:棘轮槽                        43:滑槽42: ratchet slot 43: chute

45:支撑面                        46:持线部45: support surface 46: line support

47:过线通道                      461a、461b、461c:穿线孔47: Overpass channel 461a, 461b, 461c: Threading hole

462:第二切线槽                   a:收紧线462: second tangential groove a: tightening line

b:瓣角                            c:人工二尖瓣瓣膜b: flap angle c: artificial mitral valve

具体实施方式detailed description

为使本发明的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention are clearly and completely described in the following with reference to the accompanying drawings in the embodiments of the present invention. Some embodiments, rather than all of the embodiments, are invented. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.

图1为本发明的人工二尖瓣瓣膜持瓣器在分体状态下的结构示意图。图2为本发明的人工二尖瓣瓣膜持瓣器的持瓣部的结构示意图。图3为本发明的人工二尖瓣瓣膜持瓣器的手柄座与芯杆的结构示意图。图4为本发 明的人工二尖瓣瓣膜持瓣器的芯杆的仰视图。图5为本发明的人工二尖瓣瓣膜持瓣器与人工二尖瓣瓣膜连接固定后的示意图。1 is a schematic view showing the structure of the artificial mitral valve valve holder in a separated state according to the present invention. 2 is a schematic view showing the structure of a flap portion of an artificial mitral valve holder according to the present invention. 3 is a schematic view showing the structure of a handle seat and a core rod of the artificial mitral valve valve holder of the present invention. Figure 4 is the hair A bottom view of the mandrel of the artificial mitral valve holder. FIG. 5 is a schematic view showing the artificial mitral valve valve holder and the artificial mitral valve connected and fixed according to the present invention.

请同时参考图1-图5,本发明的人工二尖瓣瓣膜持瓣器包括:手柄部1、芯杆2、棘轮3和持瓣部4。Referring to FIG. 1 to FIG. 5 simultaneously, the artificial mitral valve valve holder of the present invention comprises: a handle portion 1, a core rod 2, a ratchet 3 and a holding portion 4.

持瓣部4具有上部开口且底部设有通孔的桶形腔体41,该桶形腔体内壁设有棘轮槽42和滑槽43,该持瓣部4外侧沿桶形腔体41周向设置有三个瓣膜支撑部44,每个瓣膜支撑部44的下部外缘均形成用于对人工二尖瓣瓣膜形成支撑的支撑面45,且三个支撑面45沿持瓣部4周向围成环形的径向尺寸与所支撑的人工二尖瓣瓣膜的缝合缘内径一致,支撑面45的上部设有持线部46,该持线部46能够使收紧线从持线部的内侧穿设至持线部的下方。The holding portion 4 has a barrel-shaped cavity 41 having an upper opening and a through hole at the bottom thereof. The inner wall of the barrel-shaped cavity is provided with a ratchet groove 42 and a sliding groove 43. The outside of the holding valve portion 4 is circumferentially along the barrel-shaped cavity 41. Three valve support portions 44 are provided, and a lower outer edge of each of the valve support portions 44 forms a support surface 45 for supporting the artificial mitral valve, and three support surfaces 45 are circumferentially formed along the valve portion 4 The radial dimension of the ring coincides with the inner diameter of the suture edge of the supported artificial mitral valve, and the upper portion of the support surface 45 is provided with a wire holding portion 46, which can pass the tightening wire from the inner side of the wire holding portion. To the bottom of the line.

芯杆2顶端具有定位板21,该定位板21下端面设有定位芯杆22,定位芯杆22上部形成外径增大的卡持部23,该卡持部23下沿形成挂钩结构24,棘轮3能套设于卡持部23,从而使棘轮3与卡持部23的结合体能容置于持瓣部的桶形腔体41的上部开口内,而定位芯杆22的下部则能从桶形腔体41底部的通孔伸出,且棘轮3和挂钩24结构分别与桶形腔体内壁的棘轮槽42和滑槽43相配合并实现单向转动。The top end of the core rod 2 has a positioning plate 21, and the lower end surface of the positioning plate 21 is provided with a positioning core rod 22. The upper portion of the positioning core rod 22 forms a holding portion 23 with an increased outer diameter, and the lower edge of the holding portion 23 forms a hook structure 24, The ratchet wheel 3 can be sleeved on the latching portion 23, so that the combination of the ratchet wheel 3 and the latching portion 23 can be accommodated in the upper opening of the barrel-shaped cavity 41 of the flap portion, and the lower portion of the positioning core rod 22 can be The through hole at the bottom of the barrel cavity 41 protrudes, and the ratchet wheel 3 and the hook 24 structure respectively cooperate with the ratchet groove 42 and the chute 43 of the inner wall of the barrel cavity to realize one-way rotation.

手柄部1可拆卸地设于芯杆2的定位板21上,该手柄部1能够驱动芯杆2转动。The handle portion 1 is detachably provided on the positioning plate 21 of the core rod 2, and the handle portion 1 can drive the core rod 2 to rotate.

本发明的人工二尖瓣瓣膜持瓣器中,手柄部1用于操作者握持并在顺时针或逆时针转动时形成对人工二尖瓣瓣膜的瓣角b收紧的驱动力,与手柄部1连接的芯杆2与棘轮3匹配并将来自手柄部1的驱动力传递至棘轮3,棘轮3与桶形腔体内壁的棘轮槽42匹配并使棘轮3仅能在棘轮槽42内单向转动;在放置人工二尖瓣瓣膜并使其被支撑于瓣膜支撑部的下部外缘时,通过收紧线a对其进行径向和轴向固定,其中可使收紧线a的一端固定在定位芯杆2上,另一端从持线部46的内侧(具体可从定位芯杆22自桶形腔体底部通孔伸出的部分)穿设至持线部46的下方,进而从位于持线部46下方的人工二尖瓣瓣膜的瓣角b穿过后被固定,从而在转动手柄部1时通过带动收紧线a来实现对人工二尖瓣瓣膜的瓣角b的收紧;由于棘轮3仅能在棘轮槽42内单向转动,因此瓣角c在收紧后不会重新 张开,从而可使瓣膜在径向和轴向上稳固地固定在持瓣器上,可在存储、运输和手术过程中给人工二尖瓣瓣膜提供良好的固定、支撑和把持作用。In the artificial mitral valve valve holder of the present invention, the handle portion 1 is used for the operator to hold and rotate in a clockwise or counterclockwise direction to form a driving force for tightening the flap angle b of the artificial mitral valve, and the handle The core rod 2 connected to the portion 1 is matched with the ratchet wheel 3 and transmits the driving force from the handle portion 1 to the ratchet wheel 3, and the ratchet wheel 3 is matched with the ratchet groove 42 of the inner wall of the barrel-shaped cavity and the ratchet wheel 3 can only be single in the ratchet groove 42. Rotating; when the artificial mitral valve is placed and supported on the lower outer edge of the valve support portion, it is radially and axially fixed by the tightening wire a, wherein one end of the tightening wire a can be fixed On the positioning mandrel 2, the other end is penetrated from the inner side of the wire holding portion 46 (particularly from the portion of the positioning mandrel 22 protruding from the bottom hole of the barrel cavity) to the lower side of the wire holding portion 46, thereby being located The flap angle b of the artificial mitral valve below the wire holding portion 46 is fixed after passing through, thereby tightening the flap angle b of the artificial mitral valve by driving the tightening line a when the handle portion 1 is rotated; The ratchet 3 can only rotate in one direction in the ratchet groove 42, so the flap angle c does not reappear after tightening The opening allows the valve to be securely attached to the holder in both the radial and axial directions, providing a good fixation, support and holding action for the artificial mitral valve during storage, transport and surgery.

在一实施方式中,手柄部1可以包括手柄座12和可拆卸的手柄13,手柄座上可设有第一穿线孔,芯杆2的定位板21对应于第一穿线孔可设有第二穿线孔。第一穿线孔和第二穿线孔的直径可以相同,例如均为0.3-1.5mm;相对设置的第一穿线孔和第二穿线孔可用于对手柄座12与芯杆定位板21形成捆绑,从而实现手柄座12与芯杆定位板21的相对固定。此外,可拆卸的手柄13例如可以螺纹连接在手柄座12上,此时可以在手柄座12上形成轴向设置的内螺纹孔,并在手柄13上形成与该内螺纹孔相匹配的外螺纹,从而方便手柄13在手柄座12上的安装和拆卸。特别是,还可以在手柄座12的上部形成轴向设置的内螺纹孔,并且在该内螺纹孔的下方形成与内螺纹孔同轴且不具有螺纹的导向孔,该导向孔的尺寸可与手柄13匹配,导向孔有利于对手柄进行轴向定向,从而防止手柄13因发生轴向偏移而导致无法将人工二尖瓣瓣膜的三个瓣角同时收紧至预定位置。In an embodiment, the handle portion 1 may include a handle base 12 and a detachable handle 13. The handle seat may be provided with a first threading hole, and the positioning plate 21 of the core rod 2 may be provided with a second corresponding to the first threading hole. needle. The first threading hole and the second threading hole may have the same diameter, for example, each of 0.3-1.5 mm; the opposite first threading hole and the second threading hole may be used to form a binding between the handle seat 12 and the core rod positioning plate 21, thereby The relative fixing of the handle base 12 and the core positioning plate 21 is achieved. In addition, the detachable handle 13 can be screwed to the handle base 12, for example, and an axially disposed internally threaded hole can be formed in the handle base 12, and an external thread matching the internal threaded hole can be formed on the handle 13. Thereby, the mounting and dismounting of the handle 13 on the handle base 12 is facilitated. In particular, an axially disposed internal threaded hole may be formed in an upper portion of the handle base 12, and a guide hole coaxial with the internally threaded hole and having no thread is formed below the internally threaded hole, and the size of the guide hole may be The handles 13 are mated and the guide holes facilitate axial orientation of the handle, thereby preventing the handle 13 from being axially offset and unable to simultaneously tighten the three flap angles of the artificial mitral valve to a predetermined position.

进一步地,第一穿线孔和第二穿线孔可以均为二个,且第一穿线孔之间设有第一切线槽123。两个第一穿线孔121a、121b的直径可以相同,两个第二穿线孔214a、214b的直径也可以相同,设置两个穿线孔有利于对线的端部进行固定,第一切线槽123的设置有利于对捆绑手柄座12与芯杆定位板21的线进行切断,从而方便地使手柄座12与芯杆定位板21形成分离。第一切线槽123可纵向贯通,并且宽度可为0.3-2.0mm;此外第一切线槽可偏向两个第一穿线孔中的一个而设置,从而可有效地防止线端部固定形成的线结对切线过程造成干扰。Further, the first threading hole and the second threading hole may be two, and a first tangential groove 123 is disposed between the first threading holes. The diameters of the two first threading holes 121a, 121b may be the same, and the diameters of the two second threading holes 214a, 214b may be the same. The two threading holes are provided to facilitate fixing the ends of the wire, the first tangential groove 123 The arrangement facilitates cutting of the wire that binds the handle base 12 and the core positioning plate 21, thereby facilitating separation of the handle base 12 from the core positioning plate 21. The first wire groove 123 may be longitudinally penetrated and may have a width of 0.3-2.0 mm; in addition, the first tangential groove may be disposed to be biased toward one of the two first threading holes, thereby effectively preventing the wire end from being fixedly formed. The line junction interferes with the tangential process.

在一实施方式中,芯杆2的定位板21上部开设有固定孔212,手柄座12下部设有能与固定孔212相配合的固定杆14,且固定杆14与固定孔212之间通过卡槽结构实现卡持固定。具体地,可以在固定杆的上部外周上设置至少一个径向的固定筋15,并在芯杆定位板对应于该固定筋的位置设置与该固定筋相匹配的固定槽213,该固定筋15的宽度可比固定槽213的宽度大0-0.2mm,固定筋的高度可比固定槽的深度小0-0.2mm,即 使固定筋放置在固定槽中时彼此之间形成0-0.2mm的间隙。此外,固定杆14的直径可与固定孔212的直径相等或略小于固定孔的直径。In an embodiment, a fixing hole 212 is defined in an upper portion of the positioning plate 21 of the core rod 2. The lower portion of the handle base 12 is provided with a fixing rod 14 that can cooperate with the fixing hole 212, and the fixing rod 14 and the fixing hole 212 pass the card. The groove structure realizes the holding and fixing. Specifically, at least one radial fixing rib 15 may be disposed on an outer circumference of the upper portion of the fixing rod, and a fixing groove 213 matching the fixing rib is disposed at a position corresponding to the fixing rib of the core rod positioning plate, the fixing rib 15 The width can be 0-0.2 mm larger than the width of the fixing groove 213, and the height of the fixing rib can be 0-0.2 mm smaller than the depth of the fixing groove, that is, When the fixing ribs are placed in the fixing groove, a gap of 0-0.2 mm is formed between each other. Further, the diameter of the fixing rod 14 may be equal to or slightly smaller than the diameter of the fixing hole 212.

进一步地,定位芯杆22上部外径增大的卡持部为笼形结构23,该笼形结构23具有三个上端固定于定位板下端面的中心立柱231,中心立柱231的下端分别与一横梁232的外端连接,该横梁232的内端汇合于定位芯杆22,中心立柱231的下端缘形成挂钩结构24,三个横梁232上分别开设有用于穿系收紧线的系线通孔233。具体地,挂钩结构24例如可以为自横梁232外端向外延伸的凸起,其可与桶形腔体内壁的滑槽43相配合并实现相对转动,该凸起自横梁外端延伸的长度可为0.1-2mm;同时,桶形腔体内壁设置的滑槽43可以为环形滑槽。Further, the holding portion of the upper outer diameter of the positioning core rod 22 is a cage structure 23 having three center pillars 231 fixed at the lower end surface of the positioning plate, and the lower ends of the center pillars 231 are respectively The outer ends of the beams 232 are connected to each other. The inner ends of the beams 232 are joined to the positioning core rods 22. The lower end edges of the central columns 231 form a hook structure 24, and the three beams 232 are respectively provided with a through-line through holes for threading the tightening lines. 233. Specifically, the hook structure 24 can be, for example, a protrusion extending outward from the outer end of the beam 232, and can cooperate with the sliding groove 43 of the inner wall of the barrel cavity to achieve relative rotation, and the length of the protrusion extending from the outer end of the beam can be It is 0.1-2 mm; at the same time, the sliding groove 43 provided in the inner wall of the barrel cavity may be an annular sliding groove.

上述结构的定位芯杆22可实现对收紧线a一端的固定,例如三根收紧线a的一端可分别先自三个横梁232中的一个上方从下缠绕横梁后,与收紧线a的端部紧系,然后从系线通孔233穿出并缠绕在定位芯杆22从桶形腔体底部通孔的伸出部分上。系线通孔的直径可为0.3-2.0mm。进一步地,定位芯杆的下部为柱状体25,其一端与横梁汇合处相连,另一端从桶形腔体底部的通孔伸出。该柱状体的长度可为2-10mm,直径可为0.5-5mm。The positioning mandrel 22 of the above structure can realize the fixing of one end of the tightening wire a. For example, one end of the three tightening wires a can be respectively wound from the upper one of the three beams 232 from below, and the wire a is tightened. The ends are tightened and then threaded out of the tether through holes 233 and wound around the projecting core 22 from the projecting portion of the through hole at the bottom of the barrel. The diameter of the through hole of the tie can be 0.3-2.0 mm. Further, the lower portion of the positioning mandrel is a columnar body 25, one end of which is connected to the junction of the beam and the other end of which protrudes from the through hole at the bottom of the barrel-shaped cavity. The columnar body may have a length of 2-10 mm and a diameter of 0.5-5 mm.

进一步地,棘轮3的外周上设有至少一个与该棘轮外周相切的弹性齿,例如1-8个;特别是在设置有多个弹性齿时,多个弹性齿延伸端的朝向相同,例如同时朝向顺时针方向或逆时针方向。在一实施方式中,棘轮的外周上设有三个与该棘轮外周相切并朝逆时针方向延伸的弹性齿,其可以在手柄顺时针转动时进行转动,而在手柄逆时针转动时与桶形腔体内壁的棘轮槽形成卡止而不发生转动。该设置方式可避免在对人工二尖瓣瓣膜的瓣角收紧后瓣角重新张开,从而对瓣角的固定效果良好。Further, the outer circumference of the ratchet wheel 3 is provided with at least one elastic tooth tangential to the outer circumference of the ratchet wheel, for example, 1-8; in particular, when a plurality of elastic teeth are provided, the orientations of the plurality of elastic tooth extending ends are the same, for example, Orient clockwise or counterclockwise. In one embodiment, the outer circumference of the ratchet is provided with three elastic teeth which are tangential to the outer circumference of the ratchet and extend counterclockwise, which can be rotated when the handle rotates clockwise, and when the handle rotates counterclockwise and barrel shape The ratchet groove of the inner wall of the chamber is locked without rotation. The setting method can avoid the re-opening of the flap angle after tightening the flap angle of the artificial mitral valve, so that the fixing effect on the flap angle is good.

在一实施方式中,持线部46可以为两级阶梯结构,第一级阶梯固定在持瓣部桶形腔体41的下部外周上,用于对人工二尖瓣瓣膜c形成支撑的支撑面45位于第二级阶梯的内侧下方,在第二级阶梯上沿周向开设有三个间隔分布的穿线孔461a、461b、461c,且在第一级阶梯上设有能够使收紧线从定位芯杆伸出部分穿设至穿线孔的过线通道47。具体地,该过线通道47可轴向设置在第一级阶段的外侧边部上。 In an embodiment, the wire holding portion 46 may be a two-stage stepped structure, and the first step is fixed on the outer periphery of the lower portion of the barrel-shaped cavity 41 for holding the supporting surface of the artificial mitral valve c. 45 is located below the inner side of the second step, and three spaced-apart threading holes 461a, 461b, 461c are circumferentially opened on the second step, and the first step is provided with the tightening line from the positioning core The rod extension portion is threaded through the wire passage 47 of the threading hole. Specifically, the line passage 47 can be axially disposed on the outer side of the first stage.

进一步地,瓣膜支撑部的下部宽度以与人工二尖瓣瓣膜组装后不触及瓣叶为限,并且穿线孔的孔径为0.3-2mm。三根收紧线的一端固定于定位芯杆22后,另一端可分别从第一持线部(可为三个持线部中的任一个)的过线通道47中穿出,在自第一持线部的穿线孔461a(位于端部的穿线孔)穿入后从位于第一持线部下方的瓣角b下部穿至相邻的瓣角下部,随后从与第一持线部的穿线孔461b(与穿线孔461a相邻的穿线孔)穿出,再从第一持线部的穿线孔461c(与穿线孔461b相邻的穿线孔)穿入并将瓣角的端部系于从穿线孔461c穿入的收紧线上。Further, the lower width of the valve support portion is limited to be in contact with the artificial mitral valve without touching the leaflet, and the diameter of the threading hole is 0.3-2 mm. One end of the three tightening wires is fixed to the positioning mandrel 22, and the other end can be respectively passed through the wire passage 47 of the first wire holding portion (which may be any one of the three wire holding portions), since the first The threading hole 461a of the thread holding portion (the threading hole at the end portion) penetrates from the lower portion of the flap angle b located below the first thread holding portion to the lower portion of the adjacent flap corner, and then is threaded from the first thread holding portion. The hole 461b (the threading hole adjacent to the threading hole 461a) is pierced, and then penetrates from the threading hole 461c of the first wire holding portion (the threading hole adjacent to the threading hole 461b) and fastens the end of the flap corner. The threading hole 461c penetrates the tightening line.

进一步地,在三个间隔分布的穿线孔中的二个穿线孔间开设有第二切线槽462。具体地,第二切线槽设置在穿线孔461b和穿线孔461c之间,其深度以不形成轴向贯通为限,宽度可为0.3-2mm,长度可为2-10mm。该第二切线槽的设置有利于对收紧线进行切断,从而可方便地使人工二尖瓣瓣膜的瓣角张开。Further, a second tangential groove 462 is defined between two of the three spaced-aperture-threaded holes. Specifically, the second tangential groove is disposed between the threading hole 461b and the threading hole 461c, and the depth thereof is not limited to the axial penetration, and the width may be 0.3-2 mm, and the length may be 2-10 mm. The arrangement of the second tangential groove facilitates the cutting of the tightening line, so that the flap angle of the artificial mitral valve can be conveniently opened.

该持线部的设置可以在手柄转动时通过三根收紧线实现对人工二尖瓣瓣膜的瓣角的径向收紧,并使瓣膜在径向和轴向上稳固地定位在持瓣器上,从而避免瓣角因形变过大而造成损伤。此外,在对瓣角收紧时的收紧阻力大大降低,从而操作更加方便。The wire holding portion is configured to achieve radial tightening of the flap angle of the artificial mitral valve by three tightening wires when the handle is rotated, and to stably position the valve in the radial and axial directions on the retainer In order to avoid damage caused by excessive deformation of the flap angle. In addition, the tightening resistance when the flap angle is tightened is greatly reduced, thereby making the operation more convenient.

此外,在持瓣部桶形腔体外周相对应的区域分别设有两组沿轴向分布的一对凸起,且该一对凸起的设置能够使瓣膜挂架固定于该一对凸起之间。该一对凸起有利于将持瓣器固定在瓣膜瓶中。特别是,下部凸起52可大于上部凸起51,并且在下部凸起52相应于上部凸起的位置上可开设与上部凸起51尺寸匹配或略大于上部凸起51的成形孔,从而有利于模具制作时对上部凸起51的成形。In addition, two pairs of protrusions distributed along the axial direction are respectively disposed in the corresponding regions of the outer circumference of the barrel-shaped cavity of the flap portion, and the pair of protrusions are disposed to fix the valve hanger to the pair of protrusions between. The pair of projections facilitate securing the valve holder in the valve bottle. In particular, the lower protrusion 52 may be larger than the upper protrusion 51, and a shaped hole matching the upper protrusion 51 or slightly larger than the upper protrusion 51 may be formed at a position corresponding to the upper protrusion 52 of the lower protrusion 52, thereby It is advantageous for the formation of the upper protrusions 51 during the mold making.

以下为本发明实施例的具体使用方法。首先,通过收紧线将手柄部1与芯杆2连接,具体操作方式为,收紧线的一端先通过手柄座的第一穿线孔121a进入芯杆相应的第二穿线孔214a,穿过定位板21,再朝向手柄部1的方向穿过第二穿线孔214b进入第一穿线孔121b后,与收紧线的另一端在第一穿线孔121b处打结固定,上述步骤完成了手柄部1与与芯杆2的连接固定。接着,进行芯杆与瓣角的连接,由于具有三个瓣角所以该过程需要三根收紧线a。具体步骤为:将其中一根收紧线的一端可分别先 自三个横梁232中的一个上方从下缠绕横梁后与收紧线的端部紧系,然后从系线通孔233穿出并缠绕在定位芯杆22从桶形腔体底部通孔的伸出部分上,即柱状体25上,再从过线通道47穿射出,在自第一持线部的穿线孔461a(位于端部的穿线孔)穿入后从位于第一持线部下方的瓣角下部穿至相邻的瓣角下部,随后从与第一持线部的穿线孔461b穿出,再从第一持线部的穿线孔461c穿入并将收紧线的端部系于从第三穿线孔461c穿入的收紧线上。随后以相同操作用另外两根收紧线对剩余两个瓣角进行收紧连接。The following is a specific method of using the embodiments of the present invention. First, the handle portion 1 is connected to the core rod 2 by a tightening line. The specific operation mode is that one end of the tightening line first enters the corresponding second threading hole 214a of the core rod through the first threading hole 121a of the handle seat, and passes through the positioning. After the plate 21 enters the first threading hole 121b through the second threading hole 214b toward the handle portion 1, the other end of the tightening line is knotted and fixed at the first threading hole 121b. The above step completes the handle portion 1 It is fixed to the connection with the core rod 2. Next, the connection of the core rod to the flap angle is performed, and since there are three flap angles, the process requires three tightening lines a. The specific steps are as follows: one end of one of the tightening lines can be respectively first After winding the beam from below one of the three beams 232, it is fastened to the end of the tightening wire, and then passes out from the wire through hole 233 and is wound around the through hole of the positioning mandrel 22 from the bottom of the barrel cavity. The upper portion, that is, the columnar body 25, is then pierced from the line passage 47, and is inserted from the first thread holding portion after the threading hole 461a (the threading hole at the end) of the first wire holding portion is inserted. The lower corner of the flap is passed to the lower portion of the adjacent flap, and then passes through the threading hole 461b from the first wire holding portion, and then penetrates from the threading hole 461c of the first wire holding portion and fastens the end of the tightening wire. The tightening line penetrated from the third threading hole 461c. The remaining two flap angles are then tightened together with the other two tightening lines in the same operation.

上述人工二尖瓣瓣膜持瓣器的连接方法,通过一根收紧线将手柄部1与芯杆2进行固定连接,再通过另外三根收紧线实现人工二尖瓣瓣膜持瓣器与人工二尖瓣瓣角的连接,当在运输或手术过程中要实现瓣角的收缩时,由于棘轮3与棘轮槽42的卡合只能实现单向转动,在本实施例中如图1所示,只能实现顺时针转动,因此通过对手柄13的顺时针旋转,驱动芯杆2的挂钩结构24在桶形腔体41中的滑槽43中顺时针滑动,带动柱状体25顺时针旋转将从柱状体到瓣角的一段收紧线缠绕收缩至柱状体上,从而使瓣角进行收缩。当需要将人工二尖瓣瓣膜持瓣器与人工二尖瓣瓣膜分离时,先在第一切线槽将收紧线切断,实现手柄部与芯杆的分离,再通过第二切线槽切断其余三根连接线实现持线部与人工二尖瓣瓣膜的分离。The connection method of the artificial mitral valve holding device is to fix the handle portion 1 and the core rod 2 through a tightening line, and then realize the artificial mitral valve holding device and the artificial two through the other three tightening lines. The connection of the cusp valve angle, when the flap angle is to be contracted during transportation or surgery, since the engagement of the ratchet wheel 3 and the ratchet groove 42 can only achieve one-way rotation, as shown in FIG. 1 in this embodiment, Only clockwise rotation can be achieved, so by the clockwise rotation of the handle 13, the hook structure 24 of the drive mandrel 2 slides clockwise in the chute 43 in the barrel cavity 41, causing the columnar body 25 to rotate clockwise from A section of the columnar body to the angle of the flap is wound and contracted onto the columnar body, thereby causing the flap angle to contract. When it is necessary to separate the artificial mitral valve valve from the artificial mitral valve, the tightening line is first cut in the first tangential groove to separate the handle portion from the core rod, and then the second tangential groove is used to cut off the rest. Three connecting wires realize the separation of the wire holding portion from the artificial mitral valve.

通过本发明实施例各部件的组合关系以及持线部上的过线通道实现了对二尖瓣瓣膜瓣角的径向收缩,并且模具结构简单,极易进行组合与拆卸,大大降低了制造成本。当针对不同型号的二尖瓣瓣膜时,只需更换相应型号的持瓣部,大大降低了使用成本。The combination of the components of the embodiment of the invention and the over-line channel on the wire-holding portion achieves radial contraction of the mitral valve leaflet angle, and the mold structure is simple, and the combination and disassembly are easy, which greatly reduces the manufacturing cost. . When it is used for different types of mitral valve, it is only necessary to replace the flap of the corresponding model, which greatly reduces the cost of use.

最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。 Finally, it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention, and are not intended to be limiting; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art will understand that The technical solutions described in the foregoing embodiments may be modified, or some or all of the technical features may be equivalently replaced; and the modifications or substitutions do not deviate from the technical solutions of the embodiments of the present invention. range.

Claims (10)

一种人工二尖瓣瓣膜持瓣器,其特征在于,包括:手柄部、芯杆、棘轮和持瓣部;其中,An artificial mitral valve valve holder, comprising: a handle portion, a core rod, a ratchet wheel and a flap portion; wherein 所述持瓣部具有上部开口且底部设有通孔的桶形腔体,该桶形腔体内壁设有棘轮槽和滑槽,该持瓣部外侧沿桶形腔体周向设置有三个瓣膜支撑部,每个瓣膜支撑部的下部外缘均形成用于对人工二尖瓣瓣膜形成支撑的支撑面,且三个支撑面沿持瓣部周向围成环形的径向尺寸与所支撑的人工二尖瓣瓣膜的缝合缘内径一致,所述支撑面的上部设有持线部,该持线部能够使收紧线从持线部的内侧穿设至持线部的下方;The holding portion has a barrel-shaped cavity with an upper opening and a through hole at the bottom, the inner wall of the barrel-shaped cavity is provided with a ratchet groove and a sliding groove, and the outer side of the holding valve portion is provided with three valves in the circumferential direction of the barrel-shaped cavity a support portion, a lower outer edge of each of the valve support portions forms a support surface for supporting the artificial mitral valve, and the three support surfaces are circumferentially encircled along the circumferential direction of the retaining flap and are supported by the radial dimension The inner diameter of the suture edge of the artificial mitral valve is the same, and the upper part of the support surface is provided with a wire holding portion, and the wire holding portion can pass the tightening wire from the inner side of the wire holding portion to the lower side of the wire holding portion; 所述芯杆顶端具有定位板,该定位板下端面设有定位芯杆,定位芯杆上部形成外径增大的卡持部,该卡持部下沿形成挂钩结构,所述棘轮能套设于所述卡持部,从而使棘轮与卡持部的结合体能容置于所述持瓣部的桶形腔体的上部开口内,而定位芯杆的下部则能从桶形腔体底部的通孔伸出,且棘轮和挂钩结构分别与桶形腔体内壁的棘轮槽和滑槽相配合并实现单向转动;The top end of the core rod has a positioning plate, the lower end surface of the positioning plate is provided with a positioning core rod, and the upper portion of the positioning core rod forms a clamping portion with an increased outer diameter, and the lower edge of the clamping portion forms a hook structure, and the ratchet can be sleeved on the The latching portion enables the combination of the ratchet and the retaining portion to be received in the upper opening of the barrel-shaped cavity of the retaining flap, and the lower portion of the positioning stem can pass from the bottom of the barrel-shaped cavity The hole protrudes, and the ratchet and the hook structure respectively cooperate with the ratchet groove and the chute of the inner wall of the barrel cavity to realize one-way rotation; 所述手柄部可拆卸地设于芯杆的定位板上,该手柄部能够驱动芯杆转动。The handle portion is detachably disposed on a positioning plate of the core rod, and the handle portion is capable of driving the core rod to rotate. 根据权利要求1所述的人工二尖瓣瓣膜持瓣器,其特征在于,所述手柄部包括手柄座和可拆卸的手柄,手柄座上设有第一穿线孔,所述芯杆的定位板对应于所述第一穿线孔设有第二穿线孔。The artificial mitral valve valve holder according to claim 1, wherein the handle portion comprises a handle seat and a detachable handle, and the handle seat is provided with a first threading hole, and the positioning plate of the core rod A second threading hole is provided corresponding to the first threading hole. 根据权利要求2所述的人工二尖瓣瓣膜持瓣器,其特征在于,所述第一穿线孔和第二穿线孔均为二个,且所述第一穿线孔之间设有第一切线槽。The artificial mitral valve valve holder according to claim 2, wherein the first threading hole and the second threading hole are two, and the first threading hole is provided with a first cut. Trunking. 根据权利要求2所述的人工二尖瓣瓣膜持瓣器,其特征在于,所述芯杆的定位板上部开设有固定孔,手柄座下部设有能与固定孔相配合的固定杆,且所述固定杆与固定孔之间通过卡槽结构实现卡持固定。The artificial mitral valve valve holder according to claim 2, wherein the positioning portion on the positioning plate of the core rod is provided with a fixing hole, and the lower portion of the handle seat is provided with a fixing rod capable of cooperating with the fixing hole, and The fixing rod and the fixing hole are locked by the card slot structure. 根据权利要求1所述的人工二尖瓣瓣膜持瓣器,其特征在于,所述定位芯杆上部外径增大的卡持部为笼形结构,该笼形结构具有三个上端固定于定位板下端面的中心立柱,中心立柱的下端分别与一横梁的外端连接,该横梁的内端汇合于定位芯杆,中心立柱的下端缘形成所述挂 钩结构,三个横梁上分别开设有用于穿系收紧线的系线通孔。The artificial mitral valve valve holder according to claim 1, wherein the clamping portion of the upper outer diameter of the positioning core rod is a cage structure, and the cage structure has three upper ends fixed to the positioning. a central column of the lower end surface of the plate, the lower end of the center column is respectively connected with the outer end of a beam, the inner end of the beam meets the positioning core rod, and the lower end edge of the center column forms the hanging The hook structure has three through-holes for threading the fastening lines. 根据权利要求5所述的人工二尖瓣瓣膜持瓣器,其特征在于,所述定位芯杆的下部为柱状体,其一端与所述横梁汇合处相连,另一端从桶形腔体底部的通孔伸出。The artificial mitral valve valve holder according to claim 5, wherein the lower portion of the positioning mandrel is a columnar body, one end of which is connected to the junction of the beam, and the other end is from the bottom of the barrel cavity. The through hole extends. 根据权利要求1所述的人工二尖瓣瓣膜持瓣器,其特征在于,所述棘轮的外周上设有至少一个与该棘轮外周相切的弹性齿。The artificial mitral valve valve holder according to claim 1, wherein at least one elastic tooth tangential to the outer circumference of the ratchet is provided on the outer circumference of the ratchet. 根据权利要求1所述的人工二尖瓣瓣膜持瓣器,其特征在于,所述持线部为两级阶梯结构,第一级阶梯固定在持瓣部桶形腔体的下部外周上,所述用于对人工二尖瓣瓣膜形成支撑的支撑面位于第二级阶梯的内侧下方,在所述第二级阶梯上沿周向开设有三个间隔分布的穿线孔,且在第一级阶梯上设有能够使收紧线从定位芯杆伸出部分穿设至穿线孔的过线通道。The artificial mitral valve valve holder according to claim 1, wherein the wire holding portion is a two-stage stepped structure, and the first step is fixed on the outer periphery of the lower portion of the barrel-shaped cavity of the valve holding portion. The support surface for forming support for the artificial mitral valve is located below the inner side of the second step, and three spaced-aperture holes are circumferentially opened on the second step, and on the first step A through-line passage is provided which can pass the tightening wire from the protruding portion of the positioning core to the threading hole. 根据权利要求8所述的人工二尖瓣瓣膜持瓣器,其特征在于,在三个间隔分布的穿线孔中的二个穿线孔间开设有第二切线槽。The artificial mitral valve valve holder according to claim 8, wherein a second tangential groove is defined between two of the three spaced-aperture threading holes. 根据权利要求1所述的人工二尖瓣瓣膜持瓣器,其特征在于,在持瓣部桶形腔体外周相对应的区域分别设有两组沿轴向分布的一对凸起,且该一对凸起的设置能够使瓣膜挂架固定于该一对凸起之间。 The artificial mitral valve valve holder according to claim 1, wherein two pairs of protrusions distributed along the axial direction are respectively disposed in corresponding regions of the outer circumference of the barrel-shaped cavity of the lobes, and A pair of raised arrangements enable the valve hanger to be secured between the pair of projections.
PCT/CN2015/080209 2014-12-24 2015-05-29 Valve-clamping device for artificial mitral valve Ceased WO2016101529A1 (en)

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