WO2019062366A1 - Heart valve prosthesis - Google Patents

Heart valve prosthesis Download PDF

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Publication number
WO2019062366A1
WO2019062366A1 PCT/CN2018/100645 CN2018100645W WO2019062366A1 WO 2019062366 A1 WO2019062366 A1 WO 2019062366A1 CN 2018100645 W CN2018100645 W CN 2018100645W WO 2019062366 A1 WO2019062366 A1 WO 2019062366A1
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WO
WIPO (PCT)
Prior art keywords
heart valve
valve prosthesis
stent body
arm
leaflet
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PCT/CN2018/100645
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French (fr)
Chinese (zh)
Inventor
刘明
阳明
陈国明
李�雨
Original Assignee
上海微创心通医疗科技有限公司
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Publication of WO2019062366A1 publication Critical patent/WO2019062366A1/en

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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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a heart valve prosthesis.
  • Aortic regurgitation refers to the flow of blood that has flowed into the aorta back to the left ventricle due to a loosely closed aortic valve during diastole. Mild to moderate aortic regurgitation may have no significant symptoms, and patients with moderate to severe aortic regurgitation may experience a cardiac compensatory period, with an average survival of only 2 to 5 years after loss of compensation.
  • TAVR valves Most of the existing TAVR valves are fixed by stent self-expansion (represented by Medtronic Core-Valve) or balloon-expandable stent (represented by Edwards Sapien), and the stent is fixed with calcified leaflets and annulus; In patients, after the stent itself expands, the calcified leaflets or annulus can hold the stent firmly, and the fixation is achieved by the calcified tissue and the radial support of the stent. From the anatomical features of aortic regurgitation, the primary valve leaf and the aortic root are often not necessarily accompanied by severe calcification, which is flexible, so the traditional TAVR valve cannot be fixed by radial support force.
  • TAVR valves radial support force fixation
  • the overall effect is not good, the valve is prone to ventricular turbulence, such as Medtronic Core-Valve, DFM , Lotus.
  • TAVR valves for the treatment of aortic regurgitation have become an industry challenge.
  • J-Valve uses the same concept, except that its clips are The valve body is not integral. All of them use transapical implantation, which has a disadvantage of being traumatic compared with the traditional TAVR valve transfemoral implantation.
  • the Edwards HELIO+XT system is based on the original Edwards Sapien-XT valve prosthesis, adding a rigid clamp (HELIO), the clamp is placed in the aortic sinus, and then the Sapien-XT valve is faked. Body release, clamps and valves clamp the native leaflets for fixation.
  • the prior art also discloses the treatment of aortic valve regurgitation by means of a transfemoral implant clamp and a transapical implanted Sapien-XT valve. It is expected that an implementation of simultaneous implantation of the clamp and the valve through the transfemoral approach may be proposed in the future. . It can be found that such a product system is complicated to operate and has high requirements for the operation of a doctor, and there are obvious deficiencies.
  • the mitral valve prosthesis is currently provided with a burr on the stent body, the valve is self-fixed by puncturing the leaflet, but for the aortic valve, the method of puncturing the leaflet is easy. Puncture the wall of the sinus, causing a risk of internal bleeding.
  • the mitral valve prosthesis is fixed by the lobular prosthesis. Can not be simply transplanted to the aortic annulus.
  • the present invention provides a heart valve prosthesis for replacing a pro-aortic valve located between an aorta and a ventricle, the pro-aortic valve including a native valve leaf, the heart
  • the valve prosthesis includes a stent body, a prosthetic leaflet fixed to the stent body, and at least one convex structure disposed on a sidewall of the stent body, wherein:
  • the at least one convex structure is configured to climb over the upper edge of the native leaflet.
  • the stent body is a mesh column structure
  • the pro-aortic valve further comprises an aortic annulus
  • the stent body comprises a first segment, the first region The segment is adapted to abut against the aortic annulus.
  • each of the protruding structures includes at least one arm structure, the arm structure includes a fixed end and a free end, and the fixed end is connected to the bracket body, The arm structure is configured to climb over the upper edge of the native leaflet.
  • each of the convex structures includes two of the arm structures
  • the free ends of the two arm structures are connected to each other
  • the arm structure forms a closed grid unit with the bracket body.
  • each of the convex structures further includes an anti-scratch structure, the anti-scratch structure is located at a free end of the arm structure for preventing the The arm structure stabs the blood vessels.
  • the anti-scratch structure is a straight rod or a curved rod, and is integrally formed with the arm structure.
  • the anti-scratch structure is a disc-shaped, spherical or curved rod-like structure connected to the arm structure.
  • the ratio of the length of the arm structure to the diameter of the stent body is 5% to 25%.
  • the distance from the fixed end of the arm structure to the root of the first section is 10 mm to 15 mm.
  • the heart valve prosthesis further comprises a skirt structure, the skirt structure is stitched on the inner wall of the bracket body, and the artificial leaflet is located near the first One side of a section.
  • the convex structure can be restrained in the mesh of the mesh column structure when the stent body is in a contracted state.
  • an angle between each of the convex structures and the axis of the stent body is 5° to 175°.
  • the material of the stent body is nickel titanium alloy.
  • the artificial leaflet comprises three single leaves, and the three single leaves are prepared by the anti-calcification treatment of the pig pericardium material, and are stitched or bonded.
  • the method is fixed on the bracket body.
  • the prosthetic leaflets when blood flows from the aorta to the ventricle, the prosthetic leaflets are closed, and the outer prosthetic structure is used to climb the upper edge of the native leaflets, and the native valve can be made
  • the leaf bears against the convex structure, which counteracts the pressure exerted by the returning blood on the artificial leaflet, prevents the stent body from pulsing toward the ventricle, and effectively achieves self-fixation, and has a better fixation effect.
  • the stent body and the convex structure of the present invention are small in size, and are suitable for a variety of transcatheter implantation such as transfemoral implantation, which has small trauma and simple operation.
  • the invention combines the radial supporting force of the stent body, can effectively solve the anchoring problem of the heart valve prosthesis at the root of the aorta, and achieve stable implantation of the stent body.
  • FIG. 1 is a schematic front elevational view of a heart valve prosthesis according to an embodiment of the present invention
  • FIG. 2 is a schematic top plan view of a heart valve prosthesis according to an embodiment of the present invention.
  • FIG. 3 is a schematic front elevational view of a heart valve prosthesis and an aorta according to an embodiment of the present invention
  • FIG. 4 is a top plan view of the heart valve prosthesis and the aorta according to an embodiment of the present invention
  • Figure 5 is a schematic front elevational view of a heart valve prosthesis according to another embodiment of the present invention.
  • FIG. 6 is a schematic top plan view of a heart valve prosthesis according to another embodiment of the present invention.
  • FIG. 7 is a schematic front elevational view of a heart valve prosthesis with an anti-scratch structure according to an embodiment of the present invention.
  • Figure 8 is a schematic view of the heart valve prosthesis of the embodiment of the present invention assembled in a sheath tube;
  • the figure shows: 1-stent body; 2-prosthetic leaflet; 3-convex structure; 31-arm structure; 32-scratch-resistant structure; 4-skirt structure; 5--prosthetic leaflet; Arterial annulus; 7-Valella sinus; 8-aorta; 9-sheath; 10-auxiliary unit.
  • the inventors of the present application have found that the use of a conventional valve that relies on radial support force for the treatment of aortic regurgitation has problems such as unstable anchoring and easy turbulence, and cannot achieve a good therapeutic effect.
  • the structure of the valve leaflets is clamped by the clip, and the overall size of the valve is large, and it needs to be implanted through the apex.
  • the trauma is larger, which is not conducive to the postoperative recovery of the elderly patients.
  • the use of the apex method to implant the clamp and the valve in succession in addition to the traumatic disadvantage of the transfemoral, is complicated to operate and requires high doctors.
  • the fixation of the mitral valve prosthesis with the leaflets creates a risk of internal bleeding.
  • the core idea of the present invention is to provide a heart valve prosthesis capable of effectively solving the anchoring problem of the interventional artificial heart valve prosthesis in the release position without significant calcification in the aortic root; and the prosthesis can be
  • the transfemoral implantation enables the heart valve prosthesis to be easily released, and can effectively improve the operation time and postoperative recovery time, so as to achieve self-fixation when treating aortic regurgitation, and the trauma is small and the operation is simple.
  • the present invention provides a heart valve prosthesis, in particular a heart valve prosthesis suitable for preventing prosthetic agitation when the aortic blood is returned to the ventricle.
  • the stent body of the valve prosthesis is designed with a convex structure, which can effectively fix the valve prosthesis and realize the expected function of the valve prosthesis.
  • the present invention provides a heart valve prosthesis for replacing a primary aortic valve between an aorta and a ventricle, the primary aortic valve including a native valve leaflet
  • the heart valve prosthesis includes a stent body 1 , a prosthetic leaflet 2 fixed to the stent body 1 , and a convex structure 3 disposed on a sidewall of the stent body 1 , wherein the prosthetic leaflet 2 is used Opened when blood flows from the ventricle to the aorta, and closed when blood flows from the aorta to the ventricle; the convex structure 3 is used to climb over the upper edge of the native leaflet.
  • the stent body 1 is a mesh column structure formed by a plurality of stent rods, and the mesh column structure includes a plurality of meshes.
  • the hole is defined by a stent rod, and the connection point between the stent rods is defined as a node of the columnar structure, and the mesh is formed by a node connection, and the primary aortic valve further includes an aortic annulus 6 and a sinus sinus 7
  • the native leaflet 5 extends from the aortic annulus 6, the length of the stent body 1 being greater than the distance from the aortic annulus 6 to the Watt's sinus 7, preferably greater than 10 mm to 15 mm, from the morphological structure
  • the stent body 1 includes a first section on the ventricular side, a transitional region and a second section on the aorta side along the longitudinal axis, and the convex structure may be disposed on the first section of the ventricular side, a transitional region and a second section
  • the stent body 1 After implantation of the prosthesis, the stent body 1 extends from the aortic annulus 6 to the sinus sinus 7 and further to the aorta 8, the stent body 1 having elasticity, The native leaflet 5 is pressed radially to the side of the sinus sinus 7 and the inner side of the native leaflet 5 is attached to the outside of the stent body 1.
  • the stent body 1 includes a first section, the first section (i.e., the inflow channel) for abutting against the aortic annulus 6 to provide a radial support force.
  • the prosthetic leaflet 2 is fixed to the inner side wall of the first section instead of the native leaflet 5, and the convex structure 3 is placed on the native leaflet 5.
  • each of the convex structures 3 includes at least one arm structure 31, and each of the arm structures 31 has a fixed end and freedom.
  • the fixed end of the arm structure 31 is connected to the bracket body 1, and the arm structure 31 is used to climb over the upper edge of the native leaflet 5, when blood flows back from the aorta 8 to the ventricle, The prosthetic leaflet 2 is closed and the native leaflet 5 bears against the arm structure 31 to counteract the pressure exerted by the returning blood on the prosthetic leaflet 2.
  • each of the convex structures 3 may include an arm structure 31 or a plurality of the arm structures 31, and each of the protrusions
  • the structure 3 includes a plurality of the arm structures 31, the free ends of the plurality of arm structures 31 are connected such that a plurality of the arm structures 31 form a closed grid unit with the bracket body, preferably
  • the arm structure 31 is two or two sets, and the two arm structures of each group form a U-shaped structure or a "V"-shaped structure after being connected at the free end.
  • 1 and 2 illustrate an embodiment of a convex structure including a first arm and a second arm, the fixed end of the first arm extending from a mesh node, And extending radially outward, the fixed end of the second arm protrudes from another mesh node and extends radially outward, and the first arm and the second arm intersect at the free end.
  • the first arm and the second arm are a straight rod or a curved rod.
  • the male structure including an arm structure 31 extending from the mesh of the bracket body 1 and radially Extend outside.
  • the arm structure 31 is a straight rod or a curved rod.
  • the convex structure 3 may further include an anti-scratch structure 32, which is located at the free end of the arm structure 31, and is connected to the arm structure 31.
  • the anti-scratch structure 32 is integrally formed with the arm structure 31, the anti-scratch structure 32 is a straight rod, the anti-scratch structure 32 extends toward the second section, and preferably,
  • the scraping structure 32 and the axis of the bracket body are parallel to each other, and the plurality of the protruding structures 3 may be arranged in a circumferentially uniform manner or may be arranged in a non-uniform manner.
  • the anti-scratch structure 32 extends in the direction of the second segment, and may also be 0-60° from the axis of the stent body 1.
  • the scratch-resistant structure 32 can also be a curved rod, and the tangent to the end point of the curved rod is 0 to 60°, preferably 30° to the axis of the stent body 1.
  • the anti-scratch structure 32 may be a disc-shaped, spherical or curved rod-like structure, and the arm structure 31 is connected by welding or the like.
  • the anti-scratch structures may be used for Any of the above-mentioned convex structures is not limited in the present invention.
  • the ratio of the length of the arm structure 31 to the diameter of the stent body 1 is 5% to 25%.
  • the vertical distance from the fixed end of the arm structure 31 to the root of the first section ie, the bottom end of the bracket body 1 in the perspective of FIG. 7) is 10 mm to 15 mm, which can well adapt to the height of the native leaflets.
  • the climbing structure of the convex structure 3 and the upper edge of the original leaflet 5 is realized.
  • the number of the convex structures 3 is plural, and the arm structures 31 included in all the convex structures are located in the same body of the bracket body 1.
  • the plurality of arm structures 31 are evenly or unevenly distributed, preferably, the plurality of arm structures 31 are evenly distributed on the cross section of the bracket body 1, and the cross section is to the main
  • the distance of the annulus 6 is 10 mm to 15 mm, which is slightly higher than the upper edge of the native leaflet 5.
  • the angle between the arm structure 31 and the axis of the bracket body 1 is 5° to 175°, that is, the angle of the eversion of the arm structure 31 is any angle of 5 to 90°, preferably 45°, 60°, 90°, in addition, the arm structure 31 can be everted outwardly toward the ventricle or outwardly toward the aorta, and the fixed end of the arm structure 31 is radially outward from the node of the stent body. Extending and extending toward the first segment or extending toward the second segment.
  • the material of the stent body 1 is nickel-titanium alloy, which has material memory function, and also has good elasticity, can prevent deformation of the stent body caused by blood pressure, and is preferably cut and fabricated by using nickel-titanium superelastic tube, through heat treatment, polishing, etc. After the process, it is formed into the unfolded form shown in the figure. Due to the shape memory characteristics of the nickel-titanium alloy, the stent body 1 has a self-expanding property, a contracted form of transport and a released form of release. As shown in Fig. 2, the artificial leaflets 2 are fixed on the stent body 1, mainly distributed on the first section.
  • the prosthetic leaflet comprises three or more single leaves (single-leaf valve), and the three single leaves are prepared from the calcified porcine pericardium material and fixed by suture or bonding.
  • the bracket body 1 is described.
  • the heart valve prosthesis further includes a skirt structure 4, the skirt structure 4 is sewn on the inner side wall of the bracket body 1, and is located at the The prosthetic leaflet 2 is adjacent to one side of the first section to prevent leakage of the valve.
  • the skirt structure 4 may be prepared from a homologous or heterologous biological material, or may be prepared from a synthetic material such as polyethylene terephthalate (PET).
  • the convex structures 3 extend from the nodes between the grids of the stent body 1. Therefore, when the stent body 1 is compressed into a contracted configuration, the above-mentioned convex structure 3 can be restrained in the space defined by the mesh unit, and the outer shape of the contracted body 1 is not significantly enlarged, and can be transported to the release position via the strand. .
  • the convex structure 3 is turned outward, and the contour diameter formed by the plurality of convex structures 3 around the bracket body 1 is increased compared to the contour diameter of the first section of the bracket body 1.
  • the profile diameter of the convex structure 3 is 10% to 50% larger than the diameter of the first segment in the unfolded state.
  • Figure 8 illustrates the contracted configuration of the stent body in a transport state.
  • the stent body 1 further has an auxiliary unit 10 near one end of the aorta. As shown in FIG. 8, the auxiliary unit 10 is used for combining and fixing the stent body 1 with the guiding rod in the sheath 9 to make the sheath 9
  • the heart valve prosthesis is delivered through the femoral artery into the blood vessel.
  • the stent body 1 is self-expanding and has a contracted configuration for delivery and a deployed configuration for release.
  • the heart valve prosthesis of the present invention is provided with a convex structure, which can be mounted on the upper edge of the native leaflet in the deployed state, and can effectively solve the anchoring problem of the valve prosthesis in the release position under the condition of no calcification of the aortic root.
  • the convex structure of the present invention can be restrained in the mesh shape of the mesh column structure in the contracted state, and the outer shape of the contraction shape is not significantly increased, and can be released through the femoral artery and released at the root of the aorta, compared with the transapical involvement. , small trauma, effectively improve postoperative recovery time.
  • the protruding structure of the present invention can be used to climb the upper edge of the native leaflet without adjusting the azimuth angle of the stent body, and the stent body release operation is simple, and the operation time can be effectively improved.
  • the above embodiments describe the different configurations of the heart valve prosthesis in detail.
  • the present invention includes, but is not limited to, the configurations listed in the above embodiments, and any of the configurations provided by the above embodiments are performed.
  • the contents of the transformation are all within the scope of protection of the present invention. Those skilled in the art can make the same according to the content of the above embodiments.

Abstract

A heart valve prosthesis, the heart valve prosthesis is used for replacing an original aortic valve located between the aorta and a ventricle; the original aortic valve comprises native leaflets, and the heart valve prosthesis comprises a stent body (1), artificial leaflets (2) that are fixed onto the stent body (1), and external convex structures (3) that are arranged on a side wall of the stent body (1), the external convex structures (3) being used to catch an upper edge of a native leaflet. By means of the external convex structures (3) catching an upper edge of a native leaflet, the native leaflet may abut against the external convex structures (3) so as to counteract the pressure that is exerted by returning blood on the artificial leaflets (2), preventing the stent body (1) from moving toward the ventricle, effectively achieving self-fixation; furthermore, the stent body (1) and the external convex structure (3) are small in size, being suitable for transfemoral implantation, causing little trauma while operation is simple.

Description

心脏瓣膜假体Heart valve prosthesis 技术领域Technical field
本发明涉及医疗器械技术领域，特别涉及一种心脏瓣膜假体。The present invention relates to the field of medical device technology, and in particular to a heart valve prosthesis.
背景技术Background technique
当前经导管主动脉瓣膜置换(简称TAVR)主要用于严重主动脉瓣狭窄的治疗，而主动脉瓣反流的TAVR治疗却处于探索之中。主动脉瓣反流是指心脏在舒张期时，主动脉瓣因闭合不严导致已流入主动脉的血液流回到左心室。轻中度的主动脉瓣反流可能无明显症状，中重度主动脉瓣反流患者可经历一个心脏代偿期，而失去代偿后平均存活仅为2到5年。Current transcatheter aortic valve replacement (TAVR) is mainly used for the treatment of severe aortic stenosis, while TAVR treatment of aortic regurgitation is under investigation. Aortic regurgitation refers to the flow of blood that has flowed into the aorta back to the left ventricle due to a loosely closed aortic valve during diastole. Mild to moderate aortic regurgitation may have no significant symptoms, and patients with moderate to severe aortic regurgitation may experience a cardiac compensatory period, with an average survival of only 2 to 5 years after loss of compensation.
现有的TAVR瓣膜大多是通过支架自膨胀方式(以Medtronic Core-Valve为代表)或者球囊扩张支架(以Edwards Sapien为代表)，将支架与钙化的瓣叶、瓣环固定；在主动脉狭窄患者中，支架自身扩张后，钙化的瓣叶或瓣环能够牢固地抱住支架，通过钙化组织以及支架的径向支撑力实现固定。而从主动脉瓣反流的解剖特点看，原生瓣叶以及主动脉根部往往不一定伴有严重钙化，呈一定柔性，因此传统TAVR瓣膜无法通过径向支撑力的方式实现固定。虽然有一些基于使用传统TAVR瓣膜(径向支撑力方式固定)用于主动脉瓣反流治疗的报道，但整体效果不佳，瓣膜易出现向心室窜动的现象，如Medtronic Core-Valve，DFM，Lotus。正因如此，用于治疗主动脉瓣反流的TAVR瓣膜成为行业难题。Most of the existing TAVR valves are fixed by stent self-expansion (represented by Medtronic Core-Valve) or balloon-expandable stent (represented by Edwards Sapien), and the stent is fixed with calcified leaflets and annulus; In patients, after the stent itself expands, the calcified leaflets or annulus can hold the stent firmly, and the fixation is achieved by the calcified tissue and the radial support of the stent. From the anatomical features of aortic regurgitation, the primary valve leaf and the aortic root are often not necessarily accompanied by severe calcification, which is flexible, so the traditional TAVR valve cannot be fixed by radial support force. Although there are some reports based on the use of traditional TAVR valves (radial support force fixation) for aortic regurgitation, the overall effect is not good, the valve is prone to ventricular turbulence, such as Medtronic Core-Valve, DFM , Lotus. For this reason, TAVR valves for the treatment of aortic regurgitation have become an industry challenge.
近年来，国内外开始对于主动脉瓣反流的TAVR治疗进行了研究，出现了一些可用于主动脉瓣反流治疗的新型瓣膜。如Jena Valve和Medtronic Engager，都是通过支架上的三个夹子将原生瓣叶夹紧于夹子和瓣膜本体之间，实现瓣膜固定；J-Valve采用了同样的概念，不同之处在于其夹子与瓣膜本体并非一体。三者均使用经心尖方式植入，相比于传统TAVR瓣膜经股动脉植入的方式，存在着创伤大的劣势。而Edwards HELIO+XT***则是在原有的Edwards Sapien-XT瓣膜假体基础上，添加一个刚性卡箍(HELIO)，植入时先将卡箍放置于主动脉窦，然后将Sapien-XT瓣膜假体释放，卡箍和瓣膜将原生瓣叶夹紧从而实现固定。现有技术中还公开了经股植入卡箍和经心尖植入Sapien-XT瓣膜 结合的方式治疗主动脉瓣反流，预计将来可能提出同时通过经股方式植入卡箍和瓣膜的实现方式。可以发现，这样的产品***操作复杂，并且对医生的操作要求较高，存在着明显的不足。In recent years, TAVR treatment for aortic regurgitation has been studied at home and abroad, and some new valves for aortic regurgitation have emerged. For example, Jena Valve and Medtronic Engager use the three clips on the bracket to clamp the native leaflets between the clip and the valve body to achieve valve fixation; J-Valve uses the same concept, except that its clips are The valve body is not integral. All of them use transapical implantation, which has a disadvantage of being traumatic compared with the traditional TAVR valve transfemoral implantation. The Edwards HELIO+XT system is based on the original Edwards Sapien-XT valve prosthesis, adding a rigid clamp (HELIO), the clamp is placed in the aortic sinus, and then the Sapien-XT valve is faked. Body release, clamps and valves clamp the native leaflets for fixation. The prior art also discloses the treatment of aortic valve regurgitation by means of a transfemoral implant clamp and a transapical implanted Sapien-XT valve. It is expected that an implementation of simultaneous implantation of the clamp and the valve through the transfemoral approach may be proposed in the future. . It can be found that such a product system is complicated to operate and has high requirements for the operation of a doctor, and there are obvious deficiencies.
虽然目前在二尖瓣瓣膜假体中有在支架主体上设置翻刺，通过翻刺刺扎瓣叶的方式实现瓣膜的自我固定，但对于主动脉瓣来说，刺扎瓣叶的方式很容易扎破瓦氏窦壁，造成内出血的风险。同时由于二尖瓣瓣环处的解剖结构与主动脉瓣瓣环的解剖结构存在明显的差异，瓣叶开合的机理以及瓣叶结构迥异，二尖瓣瓣膜假体刺扎瓣叶的固定方式不能简单的移植到主动脉瓣环处。Although the mitral valve prosthesis is currently provided with a burr on the stent body, the valve is self-fixed by puncturing the leaflet, but for the aortic valve, the method of puncturing the leaflet is easy. Puncture the wall of the sinus, causing a risk of internal bleeding. At the same time, due to the obvious difference between the anatomical structure of the mitral annulus and the anatomy of the aortic valve annulus, the mechanism of leaflet opening and closing and the structure of the leaflet are different, and the mitral valve prosthesis is fixed by the lobular prosthesis. Can not be simply transplanted to the aortic annulus.
发明内容Summary of the invention
本发明的目的在于提供一种心脏瓣膜假体，以使心脏瓣膜假体治疗主动脉瓣反流时，有效的实现自我固定，具有较佳的效果。It is an object of the present invention to provide a heart valve prosthesis for the purpose of effectively achieving self-fixation when a heart valve prosthesis is treated for aortic regurgitation, with better results.
本发明的目的还在于提供一种心脏瓣膜假体，以使心脏瓣膜假体治疗主动脉瓣反流创伤小。It is also an object of the present invention to provide a heart valve prosthesis such that the heart valve prosthesis treats aortic regurgitation with less trauma.
本发明的目的还在于提供一种心脏瓣膜假体，以使心脏瓣膜假体治疗主动脉瓣反流操作简单。It is also an object of the present invention to provide a heart valve prosthesis for the ease of operation of a heart valve prosthesis for aortic regurgitation.
为解决上述技术问题，本发明提供一种心脏瓣膜假体，所述心脏瓣膜假体用于替换位于主动脉和心室之间的原主动脉瓣膜，所述原主动脉瓣膜包括原生瓣叶，所述心脏瓣膜假体包括支架本体、固定于所述支架本体上的人工瓣叶以及设置于所述支架本体侧壁上的至少一个外凸结构，其中：In order to solve the above technical problems, the present invention provides a heart valve prosthesis for replacing a pro-aortic valve located between an aorta and a ventricle, the pro-aortic valve including a native valve leaf, the heart The valve prosthesis includes a stent body, a prosthetic leaflet fixed to the stent body, and at least one convex structure disposed on a sidewall of the stent body, wherein:
所述至少一个外凸结构用于攀搭在所述原生瓣叶的上沿。The at least one convex structure is configured to climb over the upper edge of the native leaflet.
可选的，在所述的心脏瓣膜假体中，所述支架本体为网柱状结构，所述原主动脉瓣膜还包括主动脉瓣环，所述支架本体包括第一区段，所述第一区段用于撑开后抵靠在所述主动脉瓣环上。Optionally, in the heart valve prosthesis, the stent body is a mesh column structure, the pro-aortic valve further comprises an aortic annulus, the stent body comprises a first segment, the first region The segment is adapted to abut against the aortic annulus.
可选的，在所述的心脏瓣膜假体中，每个所述外凸结构包括至少一个臂杆结构，所述臂杆结构包括固定端和自由端，所述固定端连接所述支架本体，所述臂杆结构用于攀搭在所述原生瓣叶的上沿。Optionally, in the heart valve prosthesis, each of the protruding structures includes at least one arm structure, the arm structure includes a fixed end and a free end, and the fixed end is connected to the bracket body, The arm structure is configured to climb over the upper edge of the native leaflet.
可选的，在所述的心脏瓣膜假体中，当每个所述外凸结构包括两个所述臂 杆结构时，两个所述臂杆结构的自由端相连接，以使两个所述臂杆结构与所述支架本体形成闭合网格单元。Optionally, in the heart valve prosthesis, when each of the convex structures includes two of the arm structures, the free ends of the two arm structures are connected to each other The arm structure forms a closed grid unit with the bracket body.
可选的，在所述的心脏瓣膜假体中，每个所述外凸结构还包括一防刮伤结构，所述防刮伤结构位于所述臂杆结构的自由端，用于防止所述臂杆结构刺伤血管。Optionally, in the heart valve prosthesis, each of the convex structures further includes an anti-scratch structure, the anti-scratch structure is located at a free end of the arm structure for preventing the The arm structure stabs the blood vessels.
可选的，在所述的心脏瓣膜假体中，所述防刮伤结构为一直杆或曲线杆，与所述臂杆结构一体成型。Optionally, in the heart valve prosthesis, the anti-scratch structure is a straight rod or a curved rod, and is integrally formed with the arm structure.
可选的，在所述的心脏瓣膜假体中，所述防刮伤结构为圆盘状、球状或曲杆状结构，与所述臂杆结构相连接。Optionally, in the heart valve prosthesis, the anti-scratch structure is a disc-shaped, spherical or curved rod-like structure connected to the arm structure.
可选的，在所述的心脏瓣膜假体中，所述臂杆结构的长度与所述支架本体的直径比值为5％～25％。Optionally, in the heart valve prosthesis, the ratio of the length of the arm structure to the diameter of the stent body is 5% to 25%.
可选的，在所述的心脏瓣膜假体中，所述臂杆结构的固定端到所述第一区段根部的距离为10mm～15mm。Optionally, in the heart valve prosthesis, the distance from the fixed end of the arm structure to the root of the first section is 10 mm to 15 mm.
可选的，在所述的心脏瓣膜假体中，所述心脏瓣膜假体还包括裙边结构，所述裙边结构缝合在所述支架本体内侧壁上，且位于所述人工瓣叶靠近第一区段的一侧。Optionally, in the heart valve prosthesis, the heart valve prosthesis further comprises a skirt structure, the skirt structure is stitched on the inner wall of the bracket body, and the artificial leaflet is located near the first One side of a section.
可选的，在所述的心脏瓣膜假体中，所述外凸结构在所述支架本体收缩状态时，能够束缚于所述网柱状结构的网孔中。Optionally, in the heart valve prosthesis, the convex structure can be restrained in the mesh of the mesh column structure when the stent body is in a contracted state.
可选的，在所述的心脏瓣膜假体中，每个所述外凸结构与所述支架本体轴线之间的夹角均为5°～175°。Optionally, in the heart valve prosthesis, an angle between each of the convex structures and the axis of the stent body is 5° to 175°.
可选的，在所述的心脏瓣膜假体中，所述支架本体的材料为镍钛合金。Optionally, in the heart valve prosthesis, the material of the stent body is nickel titanium alloy.
可选的，在所述的心脏瓣膜假体中，所述人工瓣叶包括三个单叶，所述三个单叶均由经过防钙化处理的猪心包材料制备，并通过缝合或粘接的方式固定在所述支架本体上。Optionally, in the heart valve prosthesis, the artificial leaflet comprises three single leaves, and the three single leaves are prepared by the anti-calcification treatment of the pig pericardium material, and are stitched or bonded. The method is fixed on the bracket body.
在本发明提供的心脏瓣膜假体中，当血液从主动脉向心室回流时，所述人工瓣叶关闭，通过外凸结构用于攀搭在原生瓣叶的上沿，可使所述原生瓣叶顶住外凸结构，抵消回流的血液施加在所述人工瓣叶上的压力，避免支架本体向心室方向窜动，有效的实现自我固定，具有较佳的固定效果。更进一步的，本 发明中的支架本体和外凸结构体积小，适用于经股方式植入等多种经导管植入术，创伤小，操作简单。本发明结合支架本体的径向支撑力，能够有效解决心脏瓣膜假体在主动脉根部的锚固问题，实现支架本体的稳定植入。In the heart valve prosthesis provided by the present invention, when blood flows from the aorta to the ventricle, the prosthetic leaflets are closed, and the outer prosthetic structure is used to climb the upper edge of the native leaflets, and the native valve can be made The leaf bears against the convex structure, which counteracts the pressure exerted by the returning blood on the artificial leaflet, prevents the stent body from pulsing toward the ventricle, and effectively achieves self-fixation, and has a better fixation effect. Furthermore, the stent body and the convex structure of the present invention are small in size, and are suitable for a variety of transcatheter implantation such as transfemoral implantation, which has small trauma and simple operation. The invention combines the radial supporting force of the stent body, can effectively solve the anchoring problem of the heart valve prosthesis at the root of the aorta, and achieve stable implantation of the stent body.
附图说明DRAWINGS
图1是本发明一实施例的心脏瓣膜假体整体正视示意图；1 is a schematic front elevational view of a heart valve prosthesis according to an embodiment of the present invention;
图2是本发明一实施例的心脏瓣膜假体整体俯视示意图；2 is a schematic top plan view of a heart valve prosthesis according to an embodiment of the present invention;
图3是本发明一实施例的心脏瓣膜假体与主动脉整体正视示意图；3 is a schematic front elevational view of a heart valve prosthesis and an aorta according to an embodiment of the present invention;
图4是本发明一实施例的心脏瓣膜假体与主动脉整体俯视示意图；4 is a top plan view of the heart valve prosthesis and the aorta according to an embodiment of the present invention;
图5是本发明另一实施例的心脏瓣膜假体整体正视示意图；Figure 5 is a schematic front elevational view of a heart valve prosthesis according to another embodiment of the present invention;
图6是本发明另一实施例的心脏瓣膜假体整体俯视示意图；6 is a schematic top plan view of a heart valve prosthesis according to another embodiment of the present invention;
图7是本发明实施例的带防刮伤结构的心脏瓣膜假体整体正视示意图；7 is a schematic front elevational view of a heart valve prosthesis with an anti-scratch structure according to an embodiment of the present invention;
图8是本发明实施例的心脏瓣膜假体装配在鞘管中的示意图；Figure 8 is a schematic view of the heart valve prosthesis of the embodiment of the present invention assembled in a sheath tube;
图中所示：1-支架本体；2-人工瓣叶；3-外凸结构；31-臂杆结构；32-防刮伤结构；4-裙边结构；5-原生瓣叶；6-主动脉瓣环；7-瓦氏窦；8-主动脉；9-鞘管；10-辅助单元。The figure shows: 1-stent body; 2-prosthetic leaflet; 3-convex structure; 31-arm structure; 32-scratch-resistant structure; 4-skirt structure; 5--prosthetic leaflet; Arterial annulus; 7-Valella sinus; 8-aorta; 9-sheath; 10-auxiliary unit.
具体实施方式Detailed ways
本申请的发明人研究发现，使用依赖径向支撑力的传统瓣膜治疗主动脉瓣反流，存在锚固不稳、易窜动等问题，不能达到良好的治疗效果。采用夹子夹合瓣叶的结构，瓣膜整体尺寸较大，需要采用经心尖方式植入，相比传统TAVR瓣膜经股植入而言，创伤较大，不利于高龄患者的术后恢复。使用经心尖方式先后将卡箍和瓣膜植入的方式，除相比经股的创伤劣势之外，其操作复杂，对医生要求较高。二尖瓣瓣膜假体刺扎瓣叶的固定方式造成内出血的风险。The inventors of the present application have found that the use of a conventional valve that relies on radial support force for the treatment of aortic regurgitation has problems such as unstable anchoring and easy turbulence, and cannot achieve a good therapeutic effect. The structure of the valve leaflets is clamped by the clip, and the overall size of the valve is large, and it needs to be implanted through the apex. Compared with the conventional TAVR valve, the trauma is larger, which is not conducive to the postoperative recovery of the elderly patients. The use of the apex method to implant the clamp and the valve in succession, in addition to the traumatic disadvantage of the transfemoral, is complicated to operate and requires high doctors. The fixation of the mitral valve prosthesis with the leaflets creates a risk of internal bleeding.
本发明核心思想在于提供了一种心脏瓣膜假体，所述心脏瓣膜假体能够有效解决主动脉根部无明显钙化条件下介入式人工心脏瓣膜假体在释放位置的锚固问题；同时该假体可经股植入，所述心脏瓣膜假体释放操作简单，能够有效改善手术操作时间及术后恢复时间，以实现治疗主动脉瓣反流时，能有效实现 自我固定，且创伤小，操作简单。The core idea of the present invention is to provide a heart valve prosthesis capable of effectively solving the anchoring problem of the interventional artificial heart valve prosthesis in the release position without significant calcification in the aortic root; and the prosthesis can be The transfemoral implantation enables the heart valve prosthesis to be easily released, and can effectively improve the operation time and postoperative recovery time, so as to achieve self-fixation when treating aortic regurgitation, and the trauma is small and the operation is simple.
本发明提供了一种心脏瓣膜假体，具体的为一种适用于防止主动脉血液回流心室时假体窜动的心脏瓣膜假体。该瓣膜假体的支架主体上设计有外凸结构，该外凸结构可以有效固定瓣膜假体，实现瓣膜假体的预期功能。The present invention provides a heart valve prosthesis, in particular a heart valve prosthesis suitable for preventing prosthetic agitation when the aortic blood is returned to the ventricle. The stent body of the valve prosthesis is designed with a convex structure, which can effectively fix the valve prosthesis and realize the expected function of the valve prosthesis.
以下结合附图和具体实施例对本发明提出的心脏瓣膜假体作进一步详细说明。根据下面说明和权利要求书，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。The heart valve prosthesis of the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. Advantages and features of the present invention will be apparent from the description and appended claims. It should be noted that the drawings are in a very simplified form and both use non-precise proportions, and are only for convenience and clarity to assist the purpose of the embodiments of the present invention.
如图1～7所示，本发明提供了一种心脏瓣膜假体，所述心脏瓣膜假体用于替换位于主动脉和心室之间的原主动脉瓣膜，所述原主动脉瓣膜包括原生瓣叶，所述心脏瓣膜假体包括支架本体1、固定于所述支架本体1上的人工瓣叶2以及设置于所述支架本体1侧壁上的外凸结构3，其中，所述人工瓣叶2用于在血液从心室流向主动脉时打开，在血液从主动脉流向心室时闭合；所述外凸结构3用于攀搭在所述原生瓣叶的上沿。1-7, the present invention provides a heart valve prosthesis for replacing a primary aortic valve between an aorta and a ventricle, the primary aortic valve including a native valve leaflet, The heart valve prosthesis includes a stent body 1 , a prosthetic leaflet 2 fixed to the stent body 1 , and a convex structure 3 disposed on a sidewall of the stent body 1 , wherein the prosthetic leaflet 2 is used Opened when blood flows from the ventricle to the aorta, and closed when blood flows from the aorta to the ventricle; the convex structure 3 is used to climb over the upper edge of the native leaflet.
如图3～4所示，在所述的心脏瓣膜假体中，所述支架本体1为由多个支架杆连接形成的网柱状结构，所述网柱状结构包括多个网孔，所述网孔由支架杆围成，将支架杆之间的连接点定义为网柱状结构的节点，则所述网孔由节点连接形成，所述原主动脉瓣膜还包括主动脉瓣环6和瓦氏窦7，原生瓣叶5从主动脉瓣环6延伸出，所述支架本体1的长度大于所述主动脉瓣环6处到所述瓦氏窦7的距离，优选的大于10mm～15mm，从形态结构上讲，支架本体1沿着纵向轴线包括心室侧的第一区段、过渡区域和主动脉侧的第二区段，外凸结构可以设置在心室侧的第一区段，也可以设置在过渡区域，本发明对此不做特别限制，外凸结构在支架本体1上的设置位置可以根据病人的原主动脉瓣膜的具体形态进行调整。所述假体植入后，所述支架本体1从所述主动脉瓣环6处延伸到所述瓦氏窦7，并进一步延伸到主动脉8，所述支架本体1具有弹性，将所述原生瓣叶5沿径向挤压到瓦氏窦7旁，并且原生瓣叶5的内侧依附于所述支架本体1的外侧。所述支架本体1包括第一区段，所述第一区段(即流入道)用于撑开后抵靠在所述主动脉瓣环6上，提供径向支撑力。所述人工瓣叶2固定于第一 区段的内侧壁上，替代原生瓣叶5，而外凸结构3攀搭在原生瓣叶5上。As shown in FIGS. 3 to 4, in the heart valve prosthesis, the stent body 1 is a mesh column structure formed by a plurality of stent rods, and the mesh column structure includes a plurality of meshes. The hole is defined by a stent rod, and the connection point between the stent rods is defined as a node of the columnar structure, and the mesh is formed by a node connection, and the primary aortic valve further includes an aortic annulus 6 and a sinus sinus 7 The native leaflet 5 extends from the aortic annulus 6, the length of the stent body 1 being greater than the distance from the aortic annulus 6 to the Watt's sinus 7, preferably greater than 10 mm to 15 mm, from the morphological structure In the above, the stent body 1 includes a first section on the ventricular side, a transitional region and a second section on the aorta side along the longitudinal axis, and the convex structure may be disposed on the first section of the ventricular side, or may be disposed in the transition In the region, the present invention is not particularly limited, and the position of the convex structure on the stent body 1 can be adjusted according to the specific shape of the patient's original aortic valve. After implantation of the prosthesis, the stent body 1 extends from the aortic annulus 6 to the sinus sinus 7 and further to the aorta 8, the stent body 1 having elasticity, The native leaflet 5 is pressed radially to the side of the sinus sinus 7 and the inner side of the native leaflet 5 is attached to the outside of the stent body 1. The stent body 1 includes a first section, the first section (i.e., the inflow channel) for abutting against the aortic annulus 6 to provide a radial support force. The prosthetic leaflet 2 is fixed to the inner side wall of the first section instead of the native leaflet 5, and the convex structure 3 is placed on the native leaflet 5.
具体的，如图1～7所示，在所述的心脏瓣膜假体中，每个所述外凸结构3包括至少一个臂杆结构31，每个所述臂杆结构31具有固定端和自由端，所述臂杆结构31的固定端连接所述支架本体1，所述臂杆结构31用于攀搭在所述原生瓣叶5的上沿，当血液从主动脉8向心室回流时，所述人工瓣叶2关闭，所述原生瓣叶5顶住所述臂杆结构31，以抵消回流的血液施加在所述人工瓣叶2上的压力。Specifically, as shown in FIGS. 1-7, in the heart valve prosthesis, each of the convex structures 3 includes at least one arm structure 31, and each of the arm structures 31 has a fixed end and freedom. The fixed end of the arm structure 31 is connected to the bracket body 1, and the arm structure 31 is used to climb over the upper edge of the native leaflet 5, when blood flows back from the aorta 8 to the ventricle, The prosthetic leaflet 2 is closed and the native leaflet 5 bears against the arm structure 31 to counteract the pressure exerted by the returning blood on the prosthetic leaflet 2.
如图1～4所示，在所述的心脏瓣膜假体中，每个所述外凸结构3可以包括一个臂杆结构31或多个所述臂杆结构31，当每个所述外凸结构3包括多个所述臂杆结构31时，多个所述臂杆结构31的自由端相连接，以使多个所述臂杆结构31与所述支架本体形成闭合网格单元，优选的，臂杆结构31两两一组，每一组的两个臂杆结构在自由端连接后形成“U”字形结构或“V”字形结构。As shown in FIGS. 1-4, in the heart valve prosthesis, each of the convex structures 3 may include an arm structure 31 or a plurality of the arm structures 31, and each of the protrusions When the structure 3 includes a plurality of the arm structures 31, the free ends of the plurality of arm structures 31 are connected such that a plurality of the arm structures 31 form a closed grid unit with the bracket body, preferably The arm structure 31 is two or two sets, and the two arm structures of each group form a U-shaped structure or a "V"-shaped structure after being connected at the free end.
图1、图2示意了一种外凸结构实施例，所述外凸结构3包括第一臂杆和第二臂杆，所述第一臂杆的固定端从一网格节点处伸出，并径向向外延伸，所述第二臂杆的固定端从另一网格节点处伸出，并径向向外延伸，第一臂杆与第二臂杆在自由端端处相交，所述第一臂杆和第二臂杆为一直杆或一曲杆。1 and 2 illustrate an embodiment of a convex structure including a first arm and a second arm, the fixed end of the first arm extending from a mesh node, And extending radially outward, the fixed end of the second arm protrudes from another mesh node and extends radially outward, and the first arm and the second arm intersect at the free end. The first arm and the second arm are a straight rod or a curved rod.
图5、图6示意了另一种外凸结构实施例，所述外凸结构包括一个臂杆结构31，所述臂杆结构31从支架本体1的网格处延伸而出，并径向向外延伸。所述臂杆结构31为一直杆或为一曲线杆。5 and 6 illustrate another embodiment of the male structure, the male structure including an arm structure 31 extending from the mesh of the bracket body 1 and radially Extend outside. The arm structure 31 is a straight rod or a curved rod.
较佳地，如图7所示，所述外凸结构3还可以包括防刮伤结构32，所述防刮伤结构32位于臂杆结构31的自由端，与所述臂杆结构31相连接；在本实施例中，防刮伤结构32与臂杆结构31一体成型，防刮伤结构32为一直杆，所述的防刮伤结构32向第二区段方向延伸，且优选的，防刮伤结构32与支架本体的轴线相互平行，多个所述外凸结构3可以为周向均布的设置方式，也可以非均匀布置方式。当然，在其他实施例中，所述的防刮伤结构32向第二区段方向延伸，也可以与支架本体1轴线成0～60°。防刮伤结构32也可以为一曲线杆，曲线杆的末端点的切线与支架本体1轴线成0～60°，优选的为30°。在其他实施例中，所述防刮伤结构32可以是圆盘状、球状或曲杆状等结构，与所述臂杆 结构31通过焊接等方式相连接，上述这些防刮伤结构可以用于上述任意一种外凸结构，本发明对此不做限制。Preferably, as shown in FIG. 7, the convex structure 3 may further include an anti-scratch structure 32, which is located at the free end of the arm structure 31, and is connected to the arm structure 31. In the present embodiment, the anti-scratch structure 32 is integrally formed with the arm structure 31, the anti-scratch structure 32 is a straight rod, the anti-scratch structure 32 extends toward the second section, and preferably, The scraping structure 32 and the axis of the bracket body are parallel to each other, and the plurality of the protruding structures 3 may be arranged in a circumferentially uniform manner or may be arranged in a non-uniform manner. Of course, in other embodiments, the anti-scratch structure 32 extends in the direction of the second segment, and may also be 0-60° from the axis of the stent body 1. The scratch-resistant structure 32 can also be a curved rod, and the tangent to the end point of the curved rod is 0 to 60°, preferably 30° to the axis of the stent body 1. In other embodiments, the anti-scratch structure 32 may be a disc-shaped, spherical or curved rod-like structure, and the arm structure 31 is connected by welding or the like. The anti-scratch structures may be used for Any of the above-mentioned convex structures is not limited in the present invention.
进一步的，在所述的心脏瓣膜假体中，所述臂杆结构31的长度与所述支架本体1的直径比值为5％～25％。所述臂杆结构31的固定端到所述第一区段根部(即图7视角下的支架本体1的最底端)的垂直距离均为10mm～15mm，能够良好的适应原生瓣叶的高度，实现外凸结构3与原生瓣叶5上沿的攀搭，一般的，外凸结构3的数量为多个，所有外凸结构所包括的臂杆结构31均位于所述支架本体1的同一径向平面(横切面)上，且多个臂杆结构31均匀或不均匀分布，优选的，多个臂杆结构31均匀地分布于支架本体1的横切面上，且所述横切面到主动脉瓣环6的距离为10mm～15mm，以稍稍高于原生瓣叶5的上沿为准。所述臂杆结构31与所述支架本体1的轴线之间的角度均为5°～175°，即所述的臂杆结构31的外翻角度为5～90°的任意角度，优选的为45°、60°、90°，另外，臂杆结构31既可以朝向心室方向外翻，也可以朝向主动脉方向外翻，该臂杆结构31的固定端从支架本体的节点处径向向外伸出，并向第一区段方向延伸，或向第二区段方向延伸。Further, in the heart valve prosthesis, the ratio of the length of the arm structure 31 to the diameter of the stent body 1 is 5% to 25%. The vertical distance from the fixed end of the arm structure 31 to the root of the first section (ie, the bottom end of the bracket body 1 in the perspective of FIG. 7) is 10 mm to 15 mm, which can well adapt to the height of the native leaflets. The climbing structure of the convex structure 3 and the upper edge of the original leaflet 5 is realized. Generally, the number of the convex structures 3 is plural, and the arm structures 31 included in all the convex structures are located in the same body of the bracket body 1. On the radial plane (cross section), and the plurality of arm structures 31 are evenly or unevenly distributed, preferably, the plurality of arm structures 31 are evenly distributed on the cross section of the bracket body 1, and the cross section is to the main The distance of the annulus 6 is 10 mm to 15 mm, which is slightly higher than the upper edge of the native leaflet 5. The angle between the arm structure 31 and the axis of the bracket body 1 is 5° to 175°, that is, the angle of the eversion of the arm structure 31 is any angle of 5 to 90°, preferably 45°, 60°, 90°, in addition, the arm structure 31 can be everted outwardly toward the ventricle or outwardly toward the aorta, and the fixed end of the arm structure 31 is radially outward from the node of the stent body. Extending and extending toward the first segment or extending toward the second segment.
所述支架本体1的材料为镍钛合金，具有材料记忆功能，另外也具有很好的弹性，可以防止血压造成的支架本体形变，优选的采用镍钛超弹性管材切割制作，通过热处理、抛光等工艺过程后成型为图示的展开形态。由于镍钛合金所具有的形状记忆特性，所述的支架本体1拥有自膨胀的特性，具有输送的收缩形态和释放的展开形态。如图2所示，人工瓣叶2固定在支架本体1上，主要分布在第一区段上。所述人工瓣叶包括三个或三个以上单叶(单叶式瓣膜)，所述三个单叶均由经过防钙化处理的猪心包材料制备，并通过缝合或粘接的方式固定在所述支架本体1上。如图1所示，在所述的心脏瓣膜假体中，所述心脏瓣膜假体还包括裙边结构4，所述裙边结构4缝合在所述支架本体1内侧壁上，且位于所述人工瓣叶2靠近第一区段的一侧，能够防止瓣周漏。裙边结构4可以为同源性或异源性的生物材料制备，也可以为人工合成材料制备，例如聚对苯二甲酸乙二醇酯(PET)。The material of the stent body 1 is nickel-titanium alloy, which has material memory function, and also has good elasticity, can prevent deformation of the stent body caused by blood pressure, and is preferably cut and fabricated by using nickel-titanium superelastic tube, through heat treatment, polishing, etc. After the process, it is formed into the unfolded form shown in the figure. Due to the shape memory characteristics of the nickel-titanium alloy, the stent body 1 has a self-expanding property, a contracted form of transport and a released form of release. As shown in Fig. 2, the artificial leaflets 2 are fixed on the stent body 1, mainly distributed on the first section. The prosthetic leaflet comprises three or more single leaves (single-leaf valve), and the three single leaves are prepared from the calcified porcine pericardium material and fixed by suture or bonding. The bracket body 1 is described. As shown in FIG. 1, in the heart valve prosthesis, the heart valve prosthesis further includes a skirt structure 4, the skirt structure 4 is sewn on the inner side wall of the bracket body 1, and is located at the The prosthetic leaflet 2 is adjacent to one side of the first section to prevent leakage of the valve. The skirt structure 4 may be prepared from a homologous or heterologous biological material, or may be prepared from a synthetic material such as polyethylene terephthalate (PET).
所述的外凸结构3从支架本体1的网格之间的节点处延伸而出。因而，在 支架本体1被压缩成收缩形态时，上述的外凸结构3能够束缚在网格单元限制的空间中，支架本体1收缩形态的外形尺寸无明显变大，能够经股输送到释放位置。在支架本体1处于展开形态时，外凸结构3向外翻，多个外凸结构3围绕支架本体1所形成的轮廓直径相比于支架本体1的第一区段的轮廓直径有所增大，例如，外凸结构3的轮廓直径比展开状态的第一区段直径大10％～50％。The convex structures 3 extend from the nodes between the grids of the stent body 1. Therefore, when the stent body 1 is compressed into a contracted configuration, the above-mentioned convex structure 3 can be restrained in the space defined by the mesh unit, and the outer shape of the contracted body 1 is not significantly enlarged, and can be transported to the release position via the strand. . When the bracket body 1 is in the deployed configuration, the convex structure 3 is turned outward, and the contour diameter formed by the plurality of convex structures 3 around the bracket body 1 is increased compared to the contour diameter of the first section of the bracket body 1. For example, the profile diameter of the convex structure 3 is 10% to 50% larger than the diameter of the first segment in the unfolded state.
图8示意了支架本体输送状态的收缩形态，外凸结构3被压缩收拢后，容纳在网柱状结构的网孔中，支架本体能够完好地束缚在输送***的鞘管中。所述支架本体1靠近主动脉的一端还具有辅助单元10，如图8所示，所述辅助单元10用于将支架本体1与鞘管9中的导引杆结合并固定，使鞘管9将心脏瓣膜假体通过股动脉输送到血管中。所述支架本体1是自膨胀式的，具有输送的收缩形态和释放的展开形态。Figure 8 illustrates the contracted configuration of the stent body in a transport state. After the convex structure 3 is compressed and gathered, it is accommodated in the mesh of the mesh column structure, and the stent body can be perfectly restrained in the sheath of the delivery system. The stent body 1 further has an auxiliary unit 10 near one end of the aorta. As shown in FIG. 8, the auxiliary unit 10 is used for combining and fixing the stent body 1 with the guiding rod in the sheath 9 to make the sheath 9 The heart valve prosthesis is delivered through the femoral artery into the blood vessel. The stent body 1 is self-expanding and has a contracted configuration for delivery and a deployed configuration for release.
本发明所述的心脏瓣膜假体设置有外凸结构，在展开形态能够攀搭挂载在原生瓣叶的上沿，可以有效解决主动脉根部无钙化条件下瓣膜假体在释放位置的锚固问题，实现瓣膜的稳定植入和正常功能。本发明所述的外凸结构在收缩形态能够束缚在网柱状结构的网孔中，收缩形态的外形尺寸未明显增大，能够经股介入，在主动脉根部进行释放，相比于经心尖介入，创伤小，有效改善术后恢复时间。相比于现有技术，本发明所述的外凸结构攀搭在原生瓣叶上沿，无需对支架本体的方位角度进行调整，支架本体释放操作简单，能够有效改善手术操作时间。The heart valve prosthesis of the present invention is provided with a convex structure, which can be mounted on the upper edge of the native leaflet in the deployed state, and can effectively solve the anchoring problem of the valve prosthesis in the release position under the condition of no calcification of the aortic root. To achieve stable implantation and normal function of the valve. The convex structure of the present invention can be restrained in the mesh shape of the mesh column structure in the contracted state, and the outer shape of the contraction shape is not significantly increased, and can be released through the femoral artery and released at the root of the aorta, compared with the transapical involvement. , small trauma, effectively improve postoperative recovery time. Compared with the prior art, the protruding structure of the present invention can be used to climb the upper edge of the native leaflet without adjusting the azimuth angle of the stent body, and the stent body release operation is simple, and the operation time can be effectively improved.
综上，上述实施例对心脏瓣膜假体的不同构型进行了详细说明，当然，本发明包括但不局限于上述实施中所列举的构型，任何在上述实施例提供的构型基础上进行变换的内容，均属于本发明所保护的范围。本领域技术人员可以根据上述实施例的内容举一反三。In summary, the above embodiments describe the different configurations of the heart valve prosthesis in detail. Of course, the present invention includes, but is not limited to, the configurations listed in the above embodiments, and any of the configurations provided by the above embodiments are performed. The contents of the transformation are all within the scope of protection of the present invention. Those skilled in the art can make the same according to the content of the above embodiments.

Claims (14)

  1. 一种心脏瓣膜假体，所述心脏瓣膜假体用于替换位于主动脉和心室之间的原主动脉瓣膜，所述原主动脉瓣膜包括原生瓣叶，其特征在于，所述心脏瓣膜假体包括支架本体、固定于所述支架本体上的人工瓣叶以及设置于所述支架本体侧壁上的至少一个外凸结构，其中：A heart valve prosthesis for replacing a proto-aortic valve located between an aorta and a ventricle, the pro-aortic valve comprising a native valve leaflet, characterized in that the heart valve prosthesis comprises a stent a body, a prosthetic leaflet fixed to the bracket body, and at least one convex structure disposed on a side wall of the bracket body, wherein:
    所述至少一个外凸结构用于攀搭在所述原生瓣叶的上沿。The at least one convex structure is configured to climb over the upper edge of the native leaflet.
  2. 如权利要求1所述的心脏瓣膜假体，其特征在于，所述支架本体为网柱状结构，所述原主动脉瓣膜还包括主动脉瓣环，所述支架本体包括第一区段，所述第一区段用于撑开后抵靠在所述主动脉瓣环上。The heart valve prosthesis of claim 1 wherein said stent body is a mesh-like structure, said primary aortic valve further comprising an aortic annulus, said stent body comprising a first section, said first A section is adapted to abut against the aortic annulus.
  3. 如权利要求2所述的心脏瓣膜假体，其特征在于，每个所述外凸结构包括至少一个臂杆结构，所述臂杆结构包括固定端和自由端，所述固定端连接所述支架本体，所述臂杆结构用于攀搭在所述原生瓣叶的上沿。The heart valve prosthesis of claim 2, wherein each of said convex structures comprises at least one arm structure, said arm structure comprising a fixed end and a free end, said fixed end connecting said bracket The body is configured to climb over the upper edge of the native leaflet.
  4. 如权利要求3所述的心脏瓣膜假体，其特征在于，当每个所述外凸结构包括两个所述臂杆结构时，两个所述臂杆结构的自由端相连接，以使两个所述臂杆结构与所述支架本体形成闭合网格单元。A heart valve prosthesis according to claim 3, wherein when each of said convex structures comprises two of said arm structures, the free ends of the two arm structures are connected such that The arm structure forms a closed grid unit with the bracket body.
  5. 如权利要求3所述的心脏瓣膜假体，其特征在于，每个所述外凸结构还包括一防刮伤结构，所述防刮伤结构位于所述臂杆结构的自由端，用于防止所述臂杆结构刺伤血管。The heart valve prosthesis of claim 3, wherein each of said convex structures further comprises an anti-scratch structure, said anti-scratch structure being located at a free end of said arm structure for preventing The arm structure stabs a blood vessel.
  6. 如权利要求5所述的心脏瓣膜假体，其特征在于，所述防刮伤结构为一直杆或曲线杆，与所述臂杆结构一体成型。The heart valve prosthesis of claim 5, wherein the anti-scratch structure is a straight rod or a curved rod integrally formed with the arm structure.
  7. 如权利要求5所述的心脏瓣膜假体，其特征在于，所述防刮伤结构为圆盘状、球状或曲杆状结构，与所述臂杆结构相连接。A heart valve prosthesis according to claim 5, wherein said anti-scratch structure is a disc-shaped, spherical or curved rod-like structure connected to said arm structure.
  8. 如权利要求3所述的心脏瓣膜假体，其特征在于，所述臂杆结构的长度与所述支架本体的直径比值为5％～25％。The heart valve prosthesis of claim 3 wherein the ratio of the length of the arm structure to the diameter of the stent body is between 5% and 25%.
  9. 如权利要求3所述的心脏瓣膜假体，其特征在于，所述臂杆结构的固定端到所述第一区段根部的距离为10mm～15mm。A heart valve prosthesis according to claim 3, wherein the fixed end of the arm structure has a distance from the root of the first section of 10 mm to 15 mm.
  10. 如权利要求2所述的心脏瓣膜假体，其特征在于，所述心脏瓣膜假体还包括裙边结构，所述裙边结构缝合在所述支架本体内侧壁上，且位于所述人 工瓣叶靠近第一区段的一侧。The heart valve prosthesis of claim 2, wherein the heart valve prosthesis further comprises a skirt structure stitched to the inner side wall of the stent body and located in the prosthetic leaflet Near the side of the first section.
  11. 如权利要求2所述的心脏瓣膜假体，其特征在于，当所述支架本体处于收缩状态时，所述外凸结构位于所述网柱状结构的网孔中。A heart valve prosthesis according to claim 2, wherein said convex structure is located in the mesh of said mesh column structure when said stent body is in a contracted state.
  12. 如权利要求1所述的心脏瓣膜假体，其特征在于，每个所述外凸结构与所述支架本体轴线之间的夹角均为5°～175°。The heart valve prosthesis of claim 1 wherein the angle between each of said convex structures and said stent body axis is between 5 and 175.
  13. 如权利要求1所述的心脏瓣膜假体，其特征在于，所述支架本体的材料为镍钛合金。The heart valve prosthesis of claim 1 wherein the stent body is made of a nickel titanium alloy.
  14. 如权利要求1所述的心脏瓣膜假体，其特征在于，所述人工瓣叶包括三个单叶，所述三个单叶均由经过防钙化处理的猪心包材料制备，并通过缝合或粘接的方式固定在所述支架本体上。The heart valve prosthesis of claim 1 wherein said prosthetic leaflet comprises three single leaves, said three single leaves being prepared from a calcified porcine pericardial material and stitched or viscous The connection is fixed to the bracket body.
PCT/CN2018/100645 2017-09-29 2018-08-15 Heart valve prosthesis WO2019062366A1 (en)

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