WO2020238725A1 - Heart valve prosthesis and system - Google Patents

Heart valve prosthesis and system Download PDF

Info

Publication number
WO2020238725A1
WO2020238725A1 PCT/CN2020/091290 CN2020091290W WO2020238725A1 WO 2020238725 A1 WO2020238725 A1 WO 2020238725A1 CN 2020091290 W CN2020091290 W CN 2020091290W WO 2020238725 A1 WO2020238725 A1 WO 2020238725A1
Authority
WO
WIPO (PCT)
Prior art keywords
heart valve
valve prosthesis
protective tube
tube
tether
Prior art date
Application number
PCT/CN2020/091290
Other languages
French (fr)
Chinese (zh)
Inventor
姚斌
Original Assignee
先健科技(深圳)有限公司
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 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Publication of WO2020238725A1 publication Critical patent/WO2020238725A1/en

Links

Images

Classifications

    • 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

Definitions

  • the utility model relates to the field of implantable medical devices, in particular to a heart valve prosthesis and a heart system.
  • the human heart is divided into four heart chambers: left atrium, left ventricle, right atrium, and right ventricle.
  • the two atria are connected to two ventricles, and the two ventricles are connected to two aorta.
  • the heart valve functions as a one-way valve to move the blood flow in one direction.
  • the four heart valves are the mitral valve, tricuspid valve, aortic valve and pulmonary valve. If these heart valves are diseased, it will affect the movement of blood flow, resulting in abnormal heart function and eventually heart failure.
  • heart valve disease has become a more common heart disease.
  • senile valvular disease and valvular disease caused by coronary heart disease and myocardial infarction are becoming more and more common.
  • These heart valve diseases not only affect the quality of life, but also bring a heavy burden and pressure to the family and society, and seriously endanger life safety.
  • valve replacement surgery generally uses delivery devices to implant heart valve prostheses through interventional and minimally invasive methods. During the delivery process, the delivery device is detachably connected to the heart valve prosthesis.
  • the heart valve prosthesis is disconnected from the delivery device, and the heart valve prosthesis is connected to the heart tissue through a tether , To prevent the heart valve prosthesis from shifting.
  • the connection between the heart valve prosthesis and the delivery device is generally a flexible connection or a rigid connection.
  • a flexible connection is adopted, there is no supporting force when the heart valve prosthesis is pushed out of the sheath, and another device is needed, which makes the implantation operation more troublesome. ;
  • a rigid connection it is limited by the way the heart valve prosthesis is connected to the delivery device.
  • the tether is easily broken due to friction, which may cause the heart valve to shift and make it difficult to reach treatment effect.
  • a heart valve prosthesis comprising a stent, a connecting piece, and a tether.
  • the connecting piece includes a connecting cover and a connecting seat connected to the connecting cover.
  • the connecting cover is connected to the stent, and the connecting seat is opened
  • the heart valve prosthesis also includes a hollow protection tube, the protection tube is at least partially received in the screw hole and the outer wall of the protection tube forms a gap with the inner wall of the screw hole, the protection The tube has a first open end and a second open end opposite to the first open end, the tether passes through the protective tube, and one end of the tether is accommodated in the connecting cover or the connecting seat internal.
  • the protective tube and the connecting seat are of an integrated structure; or, the protective tube and the connecting seat are of non-integrated structure, and the protective tube is fixedly connected to the connecting seat .
  • the tether is provided with a resisting portion, the end surface of the first open end of the protective tube resists the inner wall of the connecting seat, and the end surface of the second open end of the protective tube is against the inner wall of the connecting seat. The resisting department resisted.
  • the protective tube is coated on the tether, and the protective tube is fixedly connected to the tether.
  • the protection tube is partially received in the screw hole, and one end of the protection tube extends to the outside of the connecting seat.
  • the stent includes a leaflet stent and a plurality of links, the leaflet stent has a first end and a second end opposite to the first end, and each link includes a first end.
  • a rod part, a second rod part and a joint the second rod part is connected to the first rod part, and the joint is connected to an end of the second rod part away from the first rod part, the The end of the first rod portion away from the second rod portion is connected to the second end of the valve leaflet support, the joint is connected to the connecting cover, and the second rod portion is connected to the longitudinal direction of the valve leaflet support
  • the included angle of the central axis is 40°-60°.
  • the connecting cover has an inner cavity, and the connecting cover is provided with a plurality of limiting holes arranged at intervals and all communicating with the inner cavity, and the plurality of joints respectively pass through the In the limiting hole, the plurality of joints respectively shield the plurality of limiting holes to prevent the joint from coming out of the limiting hole.
  • the connecting seat includes a connecting portion and an inserting portion connected to the connecting portion, the connecting cover is sleeved on the inserting portion, and the connecting cover and the connecting portion Abut.
  • a receiving groove is formed at one end of the plug-in portion away from the connecting portion
  • the protective tube includes a tube body and a fixing part connected to the tube body, and the fixing part is accommodated in the housing.
  • the tube body extends from the receiving groove along the axial direction of the connecting portion.
  • a heart valve prosthesis system comprising a delivery device and the above-mentioned heart valve prosthesis.
  • the delivery device includes a delivery sheath and a push tube slidably received in the delivery sheath.
  • One end of the push tube is provided with External thread, the external thread cooperates with the screw hole on the connecting seat to make the push tube and the heart valve prosthesis detachably connected.
  • the axial length of the screw hole is greater than or equal to the axial length of the external thread.
  • the push tube of the delivery device is threadedly connected with the screw hole of the connecting seat, and the heart valve prosthesis is pushed out of the delivery sheath by pushing the push tube.
  • the tether is pierced with a protective tube to avoid direct contact between the tether and the inner wall of the screw hole, and effectively prevent the tether from breaking, thereby helping to prevent the heart valve prosthesis from shifting.
  • Fig. 1 is a schematic structural diagram of a heart valve prosthesis system according to an embodiment
  • FIG. 2 is a perspective exploded view of the heart valve prosthesis system shown in FIG. 1 with the delivery sheath omitted;
  • Fig. 3 is a schematic structural diagram of the heart valve prosthesis system shown in Fig. 1 after the delivery sheath is omitted;
  • FIG. 4 is a three-dimensional exploded view of the connecting piece and the push tube of the heart valve prosthesis system shown in FIG. 1;
  • Fig. 5 is a schematic structural diagram of the connector of the heart valve prosthesis system shown in Fig. 1;
  • Fig. 6 is a schematic diagram of the connection state of the connector and the push tube of the heart valve prosthesis system shown in Fig. 1;
  • Fig. 7 is a three-dimensional exploded view of a connector, a protective tube, and a push tube of a heart valve prosthesis system according to another embodiment
  • Figure 8 is a cross-sectional view of Figure 7;
  • FIG. 9 is a schematic diagram of the connection state between the push tube of the heart valve prosthesis system shown in FIG. 1 and the heart valve prosthesis;
  • FIG. 10 is a schematic diagram of a state of a heart valve prosthesis after implantation in a heart disease site of an embodiment
  • Fig. 11 is a schematic diagram of the connection state of the connector, the protective tube and the coefficient in another embodiment.
  • a heart valve prosthesis system 100 includes a heart valve prosthesis 20 and a delivery device 40.
  • the delivery device 40 is detachably connected to the heart valve prosthesis 20. After the delivery device 40 is used to deliver the heart valve prosthesis 20 to the diseased site, the delivery device 40 is disconnected from the heart valve prosthesis 20, and the delivery device 40 is removed from the biological Withdraw from the body and complete the operation.
  • the heart valve prosthesis 20 includes a stent 210, a connecting piece 230, a tether 250, and a protective tube 270.
  • the support 210 includes a leaflet support 211 and a plurality of connecting rods 213.
  • the leaflet stent 211 is roughly a lumen structure surrounded by mesh metal or mesh polymer.
  • the leaflet holder 211 has a first end 2111 and a second end 2113 opposite to the first end 2111.
  • One end of each link 213 is fixedly connected to the second end 2113 of the leaflet holder 211.
  • the structure of the leaflet stent 211 is not limited to the manner shown in FIGS. 2 and 3, and the leaflet stent 211 can be loaded in the delivery device 40 to meet the requirements of compression, and can provide Other ways required for sufficient radial force.
  • the leaflet stent 211 is a lumen structure formed by a plurality of annular wave rings connected axially through a connector.
  • valve leaflet holder 211 is also used to support and fix the valve leaflets (not shown in the figure), so that the heart valve prosthesis 20 can function as a one-way valve and obtain the functions of a natural heart valve.
  • each connecting rod 213 includes a first rod portion 2131, a second rod portion 2133 and a joint 2135.
  • One end of the first rod portion 2131 is fixedly connected to the second end 2113 of the leaflet holder 211, and the end of the second rod portion 2133 away from the first rod portion 2131 is fixedly connected to the joint 2135.
  • the first rod portion 2131, the second rod portion 2133 and the joint 2135 are integrally formed to form the connecting rod 213, or the first rod portion 2131, the second rod portion 2133 and the joint 2135 are fixedly connected by welding, gluing, or the like.
  • the first rod portion 2131 is substantially a U-shaped rod with an open end, and the width of the open end of the U-shaped rod is greater than the width of the closed end.
  • the two open ends of the U-shaped rod are fixedly connected to the second end 2113 of the leaflet holder 211.
  • the second rod portion 2133 is substantially a straight rod, and one end of the second rod portion 2133 is connected to the middle of the closed end of the U-shaped rod.
  • the joint 2135 is substantially rod-shaped, and the extension direction of the joint 2135 is perpendicular to the second rod 2133. Along the extension direction of the joint 2135, the size of the joint 2135 is larger than the size of the second rod portion 2133.
  • the shape of the first rod portion 2131 is not limited to a U-shaped rod with an open end
  • the shape of the second rod portion 21 is not limited to a straight rod shape
  • the shape of the joint 2135 is not limited to a rod shape.
  • the connecting rod 213 can be connected to the leaflet support 211 and the connecting piece 230, and the shape of the leaflet support 211 can be easily stored in the delivery device 40.
  • the first rod portion 2131 is a V-shaped rod
  • the second rod portion 2133 is a special-shaped rod
  • the joint 2135 is spherical or disc-shaped.
  • the leaflet holder 211 and the plurality of connecting rods 213 are integrally formed to form the holder 210.
  • the bracket 210 is formed by integrally cutting a metal pipe.
  • the bracket 210 is assembled from a plurality of parts. Compared with the assembly of multiple parts, the integral molding has the advantages of small radial size after compression and easy sheathing. At the same time, the welding or splicing structure of each part of the stent 210 is eliminated, which is beneficial to improve the fatigue resistance of the stent 210.
  • the connecting member 230 is used to connect the stent 210 and the delivery device 40. Please refer to FIG. 2 again.
  • the connecting member 230 includes a connecting cover 231 and a connecting seat 233 connected to the connecting cover 231. Please refer back to FIG. 3, the connecting cover 231 has an inner cavity 2311.
  • the connecting cover 231 is provided with a plurality of limiting holes 2313 arranged at intervals, and each limiting hole 2313 communicates with the inner cavity 2311.
  • the plurality of joints 2135 of the plurality of connecting rods 213 respectively pass through the plurality of limiting holes 2313, and the plurality of joints 2135 respectively block the plurality of limiting holes 2313 to prevent the joints 2135 from coming out of the limiting holes 2313, thereby making the
  • the two connectors 2135 are received in the inner cavity 2311 of the connecting cover 231. It can be understood that the number of limit holes 2313 is equal to the number of joints 2135.
  • the connecting seat 233 includes a connecting portion 2331 and a plug portion 2333 connected to the connecting portion 2331.
  • the connecting cover 231 is sleeved on the plug portion 2333, and the connecting cover 231 abuts and is fixedly connected to the connecting portion 2331. .
  • the state of the connecting cover 231 and the connecting seat 233 fixedly connected is shown in FIG. 5.
  • the connecting portion 2331 and the plug-in portion 2333 are fixedly connected, and the fixed connection can be realized by a connection method mastered by those skilled in the art, for example, welding.
  • the connecting portion 2331 and the plug-in portion 2333 are integrally formed. Referring to FIG. 6, a screw hole 2335 is opened in the middle of the connecting seat 233, and the threaded hole 2335 extends along the axial direction of the connecting seat 233 and extends from the connecting portion 2331 to the inserting portion 2333.
  • the connecting cover 231 and the connecting portion 2331 are fixedly connected, and the joint 2135 of the connecting rod 213 is further restricted to the inside of the connecting piece 230 to realize the reliable connection between the connecting piece 230 and the bracket 210.
  • the angle between the second rod portion 2133 and the axis of the valve leaflet holder 211 is ⁇ , and ⁇ is 40°-60°.
  • ⁇ is 40°-60°
  • the sheath resistance of the heart valve prosthesis 20 can be better controlled to facilitate loading.
  • the joint 2135 of the connecting rod 213 is limited to the inside of the connecting piece 230, but the joint 2135 is not fixedly connected to the connecting piece 230.
  • the connecting rod 213 will surround the connecting cover 231 The geometric center rotates to adapt to stress changes and improve the fatigue resistance of the heart valve prosthesis 100.
  • the protection tube 270 is a hollow tube body. Please refer to FIG. 3, the protection tube 270 is at least partially received in the screw hole 2335. The outer wall of the protective tube 270 and the inner wall of the screw hole 2335 form a gap (not shown). The extending direction of the protection tube 270 is the same as the extending direction of the screw hole 2335. Please also refer to FIG. 6, the protection tube 270 has a first open end 271 and a second open end 273 opposite to the first open end 271. In this embodiment, one end of the protective tube 270 is located inside the screw hole 2335, and the other end extends from the screw hole 2335 and is located outside the connecting portion 2331. Or, in another embodiment, one end of the protective tube 270 is flush with one end of the screw hole 2335, and the other end is flush with the other end of the screw hole 2335.
  • the protective tube 270 and the connecting seat 233 may be an integral structure or a non-integrated structure, and the protective tube 270 and the connecting seat 233 are fixedly connected by a connection method mastered by those skilled in the art.
  • the protective tube 270 is a hollow straight tube extending axially from the inner wall of the end of the inserting portion 2333 toward the connecting portion 2331.
  • the protection tube 270 and the connecting seat 233 are of a non-integral structure, the protection tube 270 is also a hollow straight tube extending axially from the inner wall of the end of the insertion part 2333 to the connection part 2331, and the first part of the protection tube 270 The end surface of the open end 271 is fixedly connected to the inner wall of the end of the insertion portion 2333.
  • the protective tube 270 includes a tube body 275 and a fixing part 277.
  • the tube body 275 is a hollow lumen structure
  • the fixing part 277 is a hollow cylinder
  • the fixing part 277 and the tube body 275 The inner cavity of the fixing part 277 is connected with the inner cavity of the tube body 275.
  • the end of the fixing portion 277 away from the tube body 275 is the first open end 271 of the protection tube 270, and the end of the tube body 275 that is away from the fixing portion 277 is the second open end 273 of the protection tube 270.
  • the outer diameter of the fixing portion 277 is greater than the outer diameter of the pipe body 275. Referring to FIGS.
  • a receiving groove 2337 is formed at one end of the insertion portion 2333 away from the connecting portion 2331, and a through hole 2339 is formed at the bottom of the receiving groove 2337 (not shown in FIG. 8).
  • the pipe body 275 passes through the through hole 2339, and the fixing portion 277 is received in the receiving groove 2337. Further, the fixing portion 277 is fixed in the receiving groove 2337 by welding, gluing, etc., so as to realize the protection tube 270 and the insertion portion 2333 Fixed connection.
  • the protection tube 270 including the tube body 275 and the fixing portion 277 facilitates assembly, so that the protection tube 70 and the connecting seat 233 are fixedly connected more conveniently and the connection is more reliable.
  • the tether 250 is used to prevent the heart valve prosthesis 20 from being displaced.
  • the tether 250 is provided with a protective tube 270 through it. Referring to FIG. 9, one end of the tether 250 is accommodated in the connecting cover 231 or the connecting seat 233, and the other end extends from the protective tube 270.
  • the end protruding from the protective tube 270 is fixed to the heart tissue. For example, one end protruding from the protective tube 270 passes through the apex of the heart and is fixed.
  • One end of the tether 250 is formed with a blocking portion 252, and the blocking portion 252 is provided to keep one end of the tether 250 and the connecting cover 231 or the connecting seat 233 relatively fixed.
  • the blocking portion 252 is spherical, and the diameter of the blocking portion 252 is larger than the inner diameter of the fixing portion 277 to prevent the blocking portion 252 from falling off the protection tube 270.
  • one end of the tether 250 may extend into the connecting cover 231, and the blocking portion 252 is stuck to prevent the blocking portion 252 from falling off the connecting cover 231.
  • one end of the tether 250 extends from any limiting hole 2313 of the connecting cover 231 to the connecting cover 231, and at least one-dimensional size of the blocking portion 252 is larger than the size of the limiting hole 2313 so that the blocking portion 252 is blocked in the connecting cover 231 outside.
  • the blocking portion 252 is not limited to a spherical shape, and may have any shape provided that the blocking portion 252 is blocked.
  • the blocking portion 252 has a sheet shape, a rod shape, or the like.
  • the blocking portion 252 may also be a structure formed by knotting one end of the tether 250.
  • the material of the tether 250 includes but is not limited to metal and polymer materials. In one embodiment, the material of the tether 250 is polyethylene.
  • the delivery device 40 includes a delivery sheath 41 and a push tube 43.
  • An external thread 431 is provided at one end of the push tube 43. Extend the end of the push tube 43 with the external thread 431 into the gap formed by the outer wall of the protective tube 270 in the connecting seat 233 and the inner wall of the screw hole 2335.
  • the external thread 431 matches the internal thread of the screw hole 2335 to make the push tube 43 and the heart valve prosthesis 20 are detachably connected, and the connected state of the two is shown in FIG. 9.
  • the push tube 43 is slidably received in the delivery sheath 41. By sliding the push tube 43 in two opposite directions along the axis of the delivery sheath 41, the heart valve prosthesis 20 can be stored in the delivery sheath 41 or the heart The valve prosthesis 20 is pushed out from the delivery sheath 41.
  • the axial length of the screw hole 2335 is greater than or equal to the axial length of the external thread 431.
  • the threaded connection part has a sufficient length to make the push tube 43 and the heart valve prosthesis 20 reliably connected; on the other hand, it is to prevent the external thread 431 from being exposed and causing damage to human tissues.
  • the axial length of the external thread 431 refers to the axial length of the portion of the push tube 43 where the external thread 431 is provided.
  • the push tube 43 is composed of hard material or soft material.
  • Hard materials are metal materials such as stainless steel, and soft materials are polymer materials.
  • the push tube 43 is a hollow stainless steel tube.
  • the push tube 43 and the heart valve prosthesis 20 are connected by threads, wherein the end of the tether 250 of the heart valve prosthesis 20 away from the blocking portion 252 extends into the inner cavity of the push tube 43, as shown in FIG. 9 .
  • a small gap is formed in the apex of the heart, and then the heart valve prosthesis 20 is delivered to the diseased site through the delivery sheath 41, and then the push tube 43 is pushed to make the push tube 43 Sliding axially in the lumen of the delivery sheath 41, the sliding direction is opposite to the sliding direction when loading, so that the heart valve prosthesis 20 is pushed out of the delivery sheath 41, and the heart valve prosthesis 20 is self-expanded and positioned in the heart After the valve is affected, the push tube 43 is rotated to disconnect the push tube 43 and the heart valve prosthesis 20, and the push tube 43 and the delivery sheath 41 are withdrawn. At this time, as shown in FIG.
  • the end of the tether 250 away from the blocking portion 252 is located outside the heart 30, and the end of the tether 250 away from the blocking portion 252 is fixed to the outside of the heart 30, and the valve stent 211 is radially supported
  • the force and the pulling action of the tether 250 make the heart valve prosthesis 20 reliably fixed at the position of the mitral valve.
  • the above-mentioned heart valve prosthesis 20 is connected to the push tube 43 by a rigid connector 230, and the heart valve prosthesis 20 is pushed through the push tube 43, without the need for additional equipment to push the heart valve prosthesis 20, and the implantation is more convenient.
  • the line determined by the connection point between the tether 250 and the stent 210 and the connection point between the tether 250 and the apex is not collinear with the longitudinal center axis of the heart valve prosthesis 20 (two lines The angle formed is neither 0° nor 180°), that is, the straight line determined by the connection point between the tether 250 and the stent 210 and the connection point between the tether 250 and the apex is relative to the heart valve prosthesis 20
  • the longitudinal center axis is inclined. In this way, when the protective tube 270 is omitted, the tether 250 directly contacts and rubs with the thread of the inner wall of the screw hole 2335, which is likely to break.
  • the tether 250 is constantly rubbing with the thread, which is more likely to break.
  • the tether 250 is provided with a protective tube 270, it is avoided that the tether 250 directly contacts and rubs against the thread of the inner wall of the screw hole 2335, which effectively prevents the tether 250 from breaking, thereby helping to avoid the heart valve prosthesis 20 shifted.
  • the heart valve prosthesis 20 After the heart valve prosthesis 20 is released, if the release position is not the expected position, the heart valve prosthesis 20 needs to be retracted into the delivery sheath 41 through the delivery device 40, repositioned and released.
  • the specific operation is as follows: under the guidance of the tether 250, after the push tube 43 slides in the delivery sheath 41 close to the heart valve prosthesis 20, rotate the push tube 43 to re-thread the push tube 43 with the heart valve prosthesis 20 to achieve Recovery of the heart valve prosthesis 20.
  • the protection tube 270 is provided to prevent the tether 250 from contacting the thread, effectively prevent the tether 250 from breaking, and avoid device failure during the recovery process.
  • the protection tube 270 and the connecting seat 233 are an integral structure. It can be understood that, in other embodiments, the two are non-integrated structures, but are fixedly connected by a connection method mastered by those skilled in the art, such as welding and gluing.
  • the protection tube 270 and the connecting seat 233 are neither integrated nor fixedly connected.
  • the protective tube 270 is sleeved on the tether 250, and the protective tube 270 is at least partially received in the screw hole 2335, and the other part extends out of the connecting seat 233 or the end of the other end is flush with the end of the connecting seat 233.
  • the tether 250 is provided with a resisting portion 254, and the resisting portion 254 is disposed opposite to the blocking portion 252.
  • the end of the first open end 271 of the protective tube 270 resists the inner wall of the connecting seat 233, and the end of the second open end 273 of the protective tube 270 resists the resisting portion and is blocked by the resisting portion, so that the protective tube 270 is at least partially received in the screw hole 2335.
  • the protective tube 270 is coated on the tether 250, and the protective tube 270 is fixedly connected to the tether 250.
  • the protective tube 270 is a silicone tube, and the protective tube 270 is directly fixedly connected to the tether 250, which can also better protect the tether 250.
  • the axial length of the protective tube 270 is greater than or equal to the axial length of the screw hole 2335.
  • the protective tube 270 is only partially received in the screw hole 2335, and the other part extends from the connecting seat 233 and is located outside the connecting seat 233.
  • the axial length of the protective tube 270 is greater than the axial length of the screw hole 2335.
  • the part of the protective tube 270 protruding from the connecting seat 233 can align the coaxiality between the push tube 43 and the screw hole 2335 in advance to guide the push tube 43 to quickly align with the screw hole 2335.
  • the heart valve prosthesis 20 is not limited to a mitral valve heart valve prosthesis, and can also be a tricuspid heart valve prosthesis. , Aortic valve heart valve prosthesis or pulmonary valve heart valve prosthesis.
  • the stent 210 of the heart valve prosthesis 20 in the above embodiment is a self-expanding stent. In other embodiments, it is not limited to a self-expanding stent.
  • the stent 210 may be a balloon-expandable stent.

Abstract

A heart valve prosthesis (20) and a system (100), the heart valve prosthesis (20) comprising a support frame (210), a connector (230) and a tether (250), the connector (230) comprising a connecting cover (231) and a connection base (233) connected to the connecting cover (231), the connecting cover (231) being connected to the support frame (210), and the connection base (233) being provided with a threaded hole (2335); the heart valve prosthesis (20) also comprises a hollow protective tube (270), the protective tube (270) being at least partially accommodated in the threaded hole (2335), a gap being formed by an outer wall of the protective tube (270) and an inner wall of the threaded hole (2335), the protective tube (270) having a first open end (271) and a second open end (273) opposite the first open end (271), the tether (250) penetrating the protective tube (270), and one end of the tether (50) being accommodated in the connecting cover (231) or the connection base (233). The present heart valve prosthesis (20) is convenient to implant and does not move easily.

Description

心脏瓣膜假体及***Heart valve prosthesis and system 技术领域Technical field
本实用新型涉及植入式医疗器械领域，特别是涉及一种心脏瓣膜假体及心***。The utility model relates to the field of implantable medical devices, in particular to a heart valve prosthesis and a heart system.
背景技术Background technique
人体的心脏分为左心房、左心室和右心房、右心室四个心腔，两个心房分别和两个心室相连，两个心室和两个大动脉相连。在心房和心室之间以及心室和大动脉之间存在共四个心脏瓣膜，心脏瓣膜起到单向阀门的作用，使血流单方向运动。四个心脏瓣膜分别为二尖瓣、三尖瓣、主动脉瓣和肺动脉瓣。这些心脏瓣膜如果出现了病变，就会影响血流的运动，从而造成心脏功能异常，最终导致心功能衰竭。The human heart is divided into four heart chambers: left atrium, left ventricle, right atrium, and right ventricle. The two atria are connected to two ventricles, and the two ventricles are connected to two aorta. There are a total of four heart valves between the atrium and the ventricle and between the ventricle and the aorta. The heart valve functions as a one-way valve to move the blood flow in one direction. The four heart valves are the mitral valve, tricuspid valve, aortic valve and pulmonary valve. If these heart valves are diseased, it will affect the movement of blood flow, resulting in abnormal heart function and eventually heart failure.
目前，心脏瓣膜疾病已经成为较为普遍的心脏疾患。随着人口老龄化加重，老年性瓣膜病以及冠心病心肌梗死后引起的瓣膜病变也越来越常见。这些心脏瓣膜病变不但影响生活质量，同时给家庭和社会带来沉重的负担和压力，严重的还危害生命安全。At present, heart valve disease has become a more common heart disease. With the aging of the population, senile valvular disease and valvular disease caused by coronary heart disease and myocardial infarction are becoming more and more common. These heart valve diseases not only affect the quality of life, but also bring a heavy burden and pressure to the family and society, and seriously endanger life safety.
目前治疗心脏瓣膜病的外科手术治疗主要分两种方法：1)瓣膜成形术，即对损害的瓣膜进行修理；2)瓣膜置换术，用人工机械瓣或生物瓣进行替换。瓣膜成形术通常用于病变轻微的二尖瓣或三尖瓣，而对于严重的心脏瓣膜病变，特别是风湿性心脏瓣膜病，多选择瓣膜置换术。瓣膜置换术一般借助输送器械，通过介入、微创的方法植入心脏瓣膜假体。在输送过程中，输送器械与心脏瓣膜假体可拆卸连接，心脏瓣膜假体植入病变部位后，心脏瓣膜假体与输送器械断开连接，并通过系绳将心脏瓣膜假体与心脏组织相连，以防止心脏瓣膜假体移位。然而，心脏瓣膜假体与输送器械连接一般是柔性连接或刚性连接，当采用柔性连接时，在将心脏瓣膜假体推出鞘管时没有任何支撑力，需要借助另外的器械，植入操作较为麻烦；当采用刚性连接时，受限于心脏瓣膜假体与输送器械的连接方式，心脏瓣膜假体在植入后，系绳容易因摩擦而断裂，这可能会 导致心脏瓣膜移位，从而难以达到治疗效果。The current surgical treatment of heart valve disease is mainly divided into two methods: 1) valvuloplasty, that is, repairing the damaged valve; 2) valve replacement, replacing it with an artificial mechanical valve or a biological valve. Valvuloplasty is usually used for mitral valve or tricuspid valve with mild disease. For severe heart valve disease, especially rheumatic heart valve disease, valve replacement is more of choice. Valve replacement surgery generally uses delivery devices to implant heart valve prostheses through interventional and minimally invasive methods. During the delivery process, the delivery device is detachably connected to the heart valve prosthesis. After the heart valve prosthesis is implanted in the diseased part, the heart valve prosthesis is disconnected from the delivery device, and the heart valve prosthesis is connected to the heart tissue through a tether , To prevent the heart valve prosthesis from shifting. However, the connection between the heart valve prosthesis and the delivery device is generally a flexible connection or a rigid connection. When a flexible connection is adopted, there is no supporting force when the heart valve prosthesis is pushed out of the sheath, and another device is needed, which makes the implantation operation more troublesome. ; When a rigid connection is used, it is limited by the way the heart valve prosthesis is connected to the delivery device. After the heart valve prosthesis is implanted, the tether is easily broken due to friction, which may cause the heart valve to shift and make it difficult to reach treatment effect.
实用新型内容Utility model content
基于此，有必要提供一种方便植入且不易移位的心脏瓣膜假体。Based on this, it is necessary to provide a heart valve prosthesis that is convenient for implantation and not easily displaced.
一种心脏瓣膜假体，包括支架、连接件和系绳，所述连接件包括连接盖及与所述连接盖相连的连接座，所述连接盖与所述支架相连，所述连接座上开设有螺孔，所述心脏瓣膜假体还包括中空的保护管，所述保护管至少部分收容于所述螺孔中且所述保护管的外壁与所述螺孔的内壁形成间隙，所述保护管具有第一开口端以及与所述第一开口端相对的第二开口端，所述系绳穿设所述保护管，且所述系绳的一端收容于所述连接盖或所述连接座内部。A heart valve prosthesis, comprising a stent, a connecting piece, and a tether. The connecting piece includes a connecting cover and a connecting seat connected to the connecting cover. The connecting cover is connected to the stent, and the connecting seat is opened There is a screw hole, the heart valve prosthesis also includes a hollow protection tube, the protection tube is at least partially received in the screw hole and the outer wall of the protection tube forms a gap with the inner wall of the screw hole, the protection The tube has a first open end and a second open end opposite to the first open end, the tether passes through the protective tube, and one end of the tether is accommodated in the connecting cover or the connecting seat internal.
在其中一个实施方式中，所述保护管与所述连接座为一体式结构；或者，所述保护管与所述连接座为非一体式结构，且所述保护管与所述连接座固定连接。In one of the embodiments, the protective tube and the connecting seat are of an integrated structure; or, the protective tube and the connecting seat are of non-integrated structure, and the protective tube is fixedly connected to the connecting seat .
在其中一个实施方式中，所述系绳上设置有抵持部，所述保护管的第一开口端的端面与所述连接座的内壁抵持，所述保护管的第二开口端的端面与所述抵持部抵持。In one of the embodiments, the tether is provided with a resisting portion, the end surface of the first open end of the protective tube resists the inner wall of the connecting seat, and the end surface of the second open end of the protective tube is against the inner wall of the connecting seat. The resisting department resisted.
在其中一个实施方式中，所述保护管包覆于所述系绳上，且所述保护管与所述系绳固定相连。In one of the embodiments, the protective tube is coated on the tether, and the protective tube is fixedly connected to the tether.
在其中一个实施方式中，所述保护管部分收容于所述螺孔中，且所述保护管的一端伸出至所述连接座的外部。In one of the embodiments, the protection tube is partially received in the screw hole, and one end of the protection tube extends to the outside of the connecting seat.
在其中一个实施方式中，所述支架包括瓣叶支架和多个连杆，所述瓣叶支架具有第一端及与所述第一端相对的第二端，每个所述连杆包括第一杆部、第二杆部及接头，所述第二杆部与所述第一杆部连接，所述接头与所述第二杆部的远离所述第一杆部的一端连接，所述第一杆部的远离所述第二杆部的一端与所述瓣叶支架的第二端连接，所述接头与所述连接盖连接，所述第二杆部与所述瓣叶支架的纵向中心轴线的夹角为40°～60°。In one of the embodiments, the stent includes a leaflet stent and a plurality of links, the leaflet stent has a first end and a second end opposite to the first end, and each link includes a first end. A rod part, a second rod part and a joint, the second rod part is connected to the first rod part, and the joint is connected to an end of the second rod part away from the first rod part, the The end of the first rod portion away from the second rod portion is connected to the second end of the valve leaflet support, the joint is connected to the connecting cover, and the second rod portion is connected to the longitudinal direction of the valve leaflet support The included angle of the central axis is 40°-60°.
在其中一个实施方式中，所述连接盖具有内腔，且所述连接盖上开设多个间隔设置且均与所述内腔连通的限位孔，所述多个接头分别穿过所述多个限位 孔中，且多个所述接头分别遮挡多个所述限位孔，以阻止所述接头从所述限位孔内脱出。In one of the embodiments, the connecting cover has an inner cavity, and the connecting cover is provided with a plurality of limiting holes arranged at intervals and all communicating with the inner cavity, and the plurality of joints respectively pass through the In the limiting hole, the plurality of joints respectively shield the plurality of limiting holes to prevent the joint from coming out of the limiting hole.
在其中一个实施方式中，所述连接座包括连接部及与所述连接部相连的插接部，所述连接盖套设于所述插接部上，且所述连接盖与所述连接部抵接。In one of the embodiments, the connecting seat includes a connecting portion and an inserting portion connected to the connecting portion, the connecting cover is sleeved on the inserting portion, and the connecting cover and the connecting portion Abut.
在其中一个实施方式中，所述插接部的远离所述连接部的一端形成有收容槽，所述保护管包括管体及与所述管体连接的固定部，所述固定部收容于所述收容槽中，且所述管体自所述收容槽沿所述连接部的轴向延伸。In one of the embodiments, a receiving groove is formed at one end of the plug-in portion away from the connecting portion, the protective tube includes a tube body and a fixing part connected to the tube body, and the fixing part is accommodated in the housing. In the receiving groove, and the tube body extends from the receiving groove along the axial direction of the connecting portion.
一种心脏瓣膜假体***，包括输送器械及上述心脏瓣膜假体，所述输送器械包括输送鞘管及可滑动地收容于所述输送鞘管中的推送管，所述推送管的一端设有外螺纹，所述外螺纹与所述连接座上的所述螺孔配合使所述推送管与所述心脏瓣膜假体可拆卸连接。A heart valve prosthesis system, comprising a delivery device and the above-mentioned heart valve prosthesis. The delivery device includes a delivery sheath and a push tube slidably received in the delivery sheath. One end of the push tube is provided with External thread, the external thread cooperates with the screw hole on the connecting seat to make the push tube and the heart valve prosthesis detachably connected.
在其中一个实施方式中，所述螺孔的轴向长度大于或等于所述外螺纹的轴向长度。In one of the embodiments, the axial length of the screw hole is greater than or equal to the axial length of the external thread.
在输送过程中，将输送器械的推送管与连接座的螺孔螺纹连接，通过推动推送管将心脏瓣膜假体推出输送鞘管，无需借助额外的器械推送心脏瓣膜假体，植入较为方便；并且，系绳穿设保护管，避免了系绳与螺孔内壁直接接触，有效防止系绳断裂，从而有利于避免心脏瓣膜假体移位。During the delivery process, the push tube of the delivery device is threadedly connected with the screw hole of the connecting seat, and the heart valve prosthesis is pushed out of the delivery sheath by pushing the push tube. There is no need to use additional equipment to push the heart valve prosthesis, making it easier to implant; In addition, the tether is pierced with a protective tube to avoid direct contact between the tether and the inner wall of the screw hole, and effectively prevent the tether from breaking, thereby helping to prevent the heart valve prosthesis from shifting.
附图说明Description of the drawings
图1为一实施方式的心脏瓣膜假体***的结构示意图；Fig. 1 is a schematic structural diagram of a heart valve prosthesis system according to an embodiment;
图2为图1所示的心脏瓣膜假体***的省略输送鞘管后的立体分解图；2 is a perspective exploded view of the heart valve prosthesis system shown in FIG. 1 with the delivery sheath omitted;
图3为图1所示的心脏瓣膜假体***的省略输送鞘管后的结构示意图；Fig. 3 is a schematic structural diagram of the heart valve prosthesis system shown in Fig. 1 after the delivery sheath is omitted;
图4为图1所示的心脏瓣膜假体***的连接件与推送管的立体分解图；4 is a three-dimensional exploded view of the connecting piece and the push tube of the heart valve prosthesis system shown in FIG. 1;
图5为图1所示的心脏瓣膜假体***的连接件的结构示意图；Fig. 5 is a schematic structural diagram of the connector of the heart valve prosthesis system shown in Fig. 1;
图6为图1所示的心脏瓣膜假体***的连接件与推送管连接状态示意图；Fig. 6 is a schematic diagram of the connection state of the connector and the push tube of the heart valve prosthesis system shown in Fig. 1;
图7为另一实施方式的心脏瓣膜假体***的连接件、保护管与推送管的立体分解图；Fig. 7 is a three-dimensional exploded view of a connector, a protective tube, and a push tube of a heart valve prosthesis system according to another embodiment;
图8为图7的剖面图；Figure 8 is a cross-sectional view of Figure 7;
图9为图1所示的心脏瓣膜假体***的推送管与心脏瓣膜假体连接状态示意图；9 is a schematic diagram of the connection state between the push tube of the heart valve prosthesis system shown in FIG. 1 and the heart valve prosthesis;
图10为一实施方式的心脏瓣膜假体植入心脏病变部位后的状态示意图；FIG. 10 is a schematic diagram of a state of a heart valve prosthesis after implantation in a heart disease site of an embodiment;
图11为另一实施方式的连接件、保护管与系数的连接状态示意图。Fig. 11 is a schematic diagram of the connection state of the connector, the protective tube and the coefficient in another embodiment.
具体实施方式Detailed ways
为了便于理解本实用新型，下面将参照相关附图对本实用新型进行更全面的描述。附图中给出了本实用新型的较佳的实施例。但是，本实用新型可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本实用新型的公开内容的理解更加透彻全面。In order to facilitate the understanding of the utility model, the utility model will be described in a more comprehensive manner with reference to the relevant drawings. The preferred embodiments of the invention are shown in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present utility model more thorough and comprehensive.
除非另有定义，本文所使用的所有的技术和科学术语与属于本实用新型的技术领域的技术人员通常理解的含义相同。本文中在本实用新型的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本实用新型。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of the present invention. The terms used in the description of the utility model herein are only for the purpose of describing specific embodiments, and are not intended to limit the utility model. The term "and/or" as used herein includes any and all combinations of one or more related listed items.
请参阅图1，一实施方式的心脏瓣膜假体***100，包括心脏瓣膜假体20和输送器械40。输送器械40与心脏瓣膜假体20可拆卸连接，借助输送器械40将心脏瓣膜假体20输送至病变部位后，断开输送器械40与心脏瓣膜假体20的连接，并将输送器械40从生物体体内撤回，完成手术。Please refer to FIG. 1, a heart valve prosthesis system 100 according to an embodiment includes a heart valve prosthesis 20 and a delivery device 40. The delivery device 40 is detachably connected to the heart valve prosthesis 20. After the delivery device 40 is used to deliver the heart valve prosthesis 20 to the diseased site, the delivery device 40 is disconnected from the heart valve prosthesis 20, and the delivery device 40 is removed from the biological Withdraw from the body and complete the operation.
请一并参阅图2和图3，心脏瓣膜假体20包括支架210、连接件230、系绳250和保护管270。Please refer to FIGS. 2 and 3 together. The heart valve prosthesis 20 includes a stent 210, a connecting piece 230, a tether 250, and a protective tube 270.
支架210包括瓣叶支架211和多个连杆213。本实施方式中，瓣叶支架211大致为由网状金属或网状聚合物等围成的呈管腔结构。如图3所示，瓣叶支架211具有第一端2111及与第一端2111相对的第二端2113。每个连杆213的一端与瓣叶支架211的第二端2113固定连接。可以理解，在其他实施方式中，瓣叶支架211的结构不限于图2和图3所示的方式，瓣叶支架211可以为满足能够压缩而装载于输送器械40中，且在释放后能够提供足够的径向力的要求的其他方式。例如，在一实施方式中，瓣叶支架211为由多个环状波圈通过连接件轴 向相连形成的管腔结构。The support 210 includes a leaflet support 211 and a plurality of connecting rods 213. In this embodiment, the leaflet stent 211 is roughly a lumen structure surrounded by mesh metal or mesh polymer. As shown in FIG. 3, the leaflet holder 211 has a first end 2111 and a second end 2113 opposite to the first end 2111. One end of each link 213 is fixedly connected to the second end 2113 of the leaflet holder 211. It can be understood that in other embodiments, the structure of the leaflet stent 211 is not limited to the manner shown in FIGS. 2 and 3, and the leaflet stent 211 can be loaded in the delivery device 40 to meet the requirements of compression, and can provide Other ways required for sufficient radial force. For example, in one embodiment, the leaflet stent 211 is a lumen structure formed by a plurality of annular wave rings connected axially through a connector.
可以理解，瓣叶支架211还用于支撑和固定瓣叶(图未示)，以使心脏瓣膜假体20能够起到单向阀门的作用，获得天然心脏瓣膜具有的功能。It can be understood that the valve leaflet holder 211 is also used to support and fix the valve leaflets (not shown in the figure), so that the heart valve prosthesis 20 can function as a one-way valve and obtain the functions of a natural heart valve.
请再次参阅图3，在一实施例中，每个连杆213包括第一杆部2131、第二杆部2133和接头2135。第一杆部2131的一端与瓣叶支架211的第二端2113固定连接，第二杆部2133的远离第一杆部2131的一端与接头2135固定连接。第一杆部2131、第二杆部2133和接头2135一体成型形成连杆213，或者，第一杆部2131、第二杆部2133和接头2135通过焊接、胶粘等方式固定连接。Please refer to FIG. 3 again. In one embodiment, each connecting rod 213 includes a first rod portion 2131, a second rod portion 2133 and a joint 2135. One end of the first rod portion 2131 is fixedly connected to the second end 2113 of the leaflet holder 211, and the end of the second rod portion 2133 away from the first rod portion 2131 is fixedly connected to the joint 2135. The first rod portion 2131, the second rod portion 2133 and the joint 2135 are integrally formed to form the connecting rod 213, or the first rod portion 2131, the second rod portion 2133 and the joint 2135 are fixedly connected by welding, gluing, or the like.
本实施方式中，第一杆部2131大致为一端开口的U形杆，并且，U形杆的开口端的宽度大于封闭端的宽度。U形杆的两个开口端与瓣叶支架211的第二端2113固定连接。第二杆部2133大致为直杆，第二杆部2133的一端连接于U形杆的封闭端的中部。接头2135大致为杆状，且接头2135的延伸方向与第二杆部2133垂直。沿接头2135的延伸方向，接头2135的尺寸大于第二杆部2133的尺寸。In this embodiment, the first rod portion 2131 is substantially a U-shaped rod with an open end, and the width of the open end of the U-shaped rod is greater than the width of the closed end. The two open ends of the U-shaped rod are fixedly connected to the second end 2113 of the leaflet holder 211. The second rod portion 2133 is substantially a straight rod, and one end of the second rod portion 2133 is connected to the middle of the closed end of the U-shaped rod. The joint 2135 is substantially rod-shaped, and the extension direction of the joint 2135 is perpendicular to the second rod 2133. Along the extension direction of the joint 2135, the size of the joint 2135 is larger than the size of the second rod portion 2133.
可以理解，在其他实施方式中，第一杆部2131的形状不限于一端开口的U形杆，第二杆部21的形状也不限于直杆状，接头2135的形状亦不限于杆状，其他满足连杆213能够与瓣叶支架211和连接件230连接，且方便将瓣叶支架211收入输送器械40中的形状均可。例如，在其他实施方式中，第一杆部2131为V形杆，第二杆部2133为异形杆，接头2135为球形、圆片形等。It can be understood that in other embodiments, the shape of the first rod portion 2131 is not limited to a U-shaped rod with an open end, and the shape of the second rod portion 21 is not limited to a straight rod shape, and the shape of the joint 2135 is not limited to a rod shape. The connecting rod 213 can be connected to the leaflet support 211 and the connecting piece 230, and the shape of the leaflet support 211 can be easily stored in the delivery device 40. For example, in other embodiments, the first rod portion 2131 is a V-shaped rod, the second rod portion 2133 is a special-shaped rod, and the joint 2135 is spherical or disc-shaped.
在本实施方式中，瓣叶支架211和多个连杆213一体成型形成支架210。例如，通过金属管材一体切割而成形成支架210。在另外的实施方式中，由多个零配件组装构成支架210。一体成型相对多个零配件组装，具有压缩后径向尺寸小、容易入鞘的优点，同时支架210的各部分取消焊接或拼接结构，有利于提高支架210的抗疲劳性能。In this embodiment, the leaflet holder 211 and the plurality of connecting rods 213 are integrally formed to form the holder 210. For example, the bracket 210 is formed by integrally cutting a metal pipe. In another embodiment, the bracket 210 is assembled from a plurality of parts. Compared with the assembly of multiple parts, the integral molding has the advantages of small radial size after compression and easy sheathing. At the same time, the welding or splicing structure of each part of the stent 210 is eliminated, which is beneficial to improve the fatigue resistance of the stent 210.
连接件230用于连接支架210和输送器械40。请再次参阅图2，连接件230包括连接盖231及与连接盖231相连的连接座233。请回到参阅图3，连接盖231具有内腔2311。请一并参阅图4，连接盖231上开设多个间隔设置的限位孔2313，每个限位孔2313均与内腔2311连通。多个连杆213的多个接头2135分别穿过 多个限位孔2313中，且多个接头2135分别遮挡多个限位孔2313，以阻止接头2135从限位孔2313内脱出，从而使多个接头2135收容于连接盖231的内腔2311中。可以理解，限位孔2313的数量与接头2135的数量相等。The connecting member 230 is used to connect the stent 210 and the delivery device 40. Please refer to FIG. 2 again. The connecting member 230 includes a connecting cover 231 and a connecting seat 233 connected to the connecting cover 231. Please refer back to FIG. 3, the connecting cover 231 has an inner cavity 2311. Please also refer to FIG. 4, the connecting cover 231 is provided with a plurality of limiting holes 2313 arranged at intervals, and each limiting hole 2313 communicates with the inner cavity 2311. The plurality of joints 2135 of the plurality of connecting rods 213 respectively pass through the plurality of limiting holes 2313, and the plurality of joints 2135 respectively block the plurality of limiting holes 2313 to prevent the joints 2135 from coming out of the limiting holes 2313, thereby making the The two connectors 2135 are received in the inner cavity 2311 of the connecting cover 231. It can be understood that the number of limit holes 2313 is equal to the number of joints 2135.
如图4所示，连接座233包括连接部2331及与连接部2331相连的插接部2333，连接盖231套设于插接部2333上，且连接盖231与连接部2331抵接且固定相连。连接盖231与连接座233固定相连的状态如图5所示。连接部2331与插接部2333固定连接，可以通过本领域技术人员掌握的连接方式实现固定连接，例如，焊接。或者，连接部2331与插接部2333一体成型。请对照图6，连接座233的中部开设有螺孔2335，螺孔2335沿连接座233的轴向延伸，并从连接部2331延伸至插接部2333。As shown in FIG. 4, the connecting seat 233 includes a connecting portion 2331 and a plug portion 2333 connected to the connecting portion 2331. The connecting cover 231 is sleeved on the plug portion 2333, and the connecting cover 231 abuts and is fixedly connected to the connecting portion 2331. . The state of the connecting cover 231 and the connecting seat 233 fixedly connected is shown in FIG. 5. The connecting portion 2331 and the plug-in portion 2333 are fixedly connected, and the fixed connection can be realized by a connection method mastered by those skilled in the art, for example, welding. Alternatively, the connecting portion 2331 and the plug-in portion 2333 are integrally formed. Referring to FIG. 6, a screw hole 2335 is opened in the middle of the connecting seat 233, and the threaded hole 2335 extends along the axial direction of the connecting seat 233 and extends from the connecting portion 2331 to the inserting portion 2333.
连接盖231和连接部2331固定连接，进一步将连杆213的接头2135限制在连接件230的内部，实现连接件230与支架210的可靠连接。在一实施方式中，当心脏瓣膜假体20处于打开状态下，第二杆部2133与瓣叶支架211的轴线的夹角为α，α为40°～60°。α为40°～60°时，能够较好地控制心脏瓣膜假体20的入鞘阻力，以方便装载。同时，能够保证瓣叶支架211具有一定的支撑强度，以在植入后瓣叶支架211能够可靠地抵接心脏组织。The connecting cover 231 and the connecting portion 2331 are fixedly connected, and the joint 2135 of the connecting rod 213 is further restricted to the inside of the connecting piece 230 to realize the reliable connection between the connecting piece 230 and the bracket 210. In one embodiment, when the heart valve prosthesis 20 is in the open state, the angle between the second rod portion 2133 and the axis of the valve leaflet holder 211 is α, and α is 40°-60°. When α is 40°-60°, the sheath resistance of the heart valve prosthesis 20 can be better controlled to facilitate loading. At the same time, it can be ensured that the leaflet stent 211 has a certain supporting strength, so that the leaflet stent 211 can reliably abut the heart tissue after implantation.
连杆213的接头2135限制在连接件230的内部，但接头2135并没有与连接件230固定连接，当任意一个连杆213的受到较大的局部应力时，连杆213会围绕连接接盖231的几何中心旋转，从而自适应应力变化，提高心脏瓣膜假体100的抗疲劳性能。The joint 2135 of the connecting rod 213 is limited to the inside of the connecting piece 230, but the joint 2135 is not fixedly connected to the connecting piece 230. When any one of the connecting rods 213 is subjected to a large local stress, the connecting rod 213 will surround the connecting cover 231 The geometric center rotates to adapt to stress changes and improve the fatigue resistance of the heart valve prosthesis 100.
保护管270为中空管体。请参阅图3，保护管270至少部分收容于螺孔2335中。保护管270的外壁与螺孔2335的内壁形成间隙(图未示)。保护管270的延伸方向与螺孔2335的延伸方向相同。请一并参阅图6，保护管270具有第一开口端271以及与第一开口端271相对设置的第二开口端273。本实施方式中，保护管270的一端位于螺孔2335的内部，另一端从螺孔2335中伸出而位于连接部2331的外部。或者，在另一实施方式中，保护管270的一端与螺孔2335的一端平齐，另一端与螺孔2335的另一端平齐。The protection tube 270 is a hollow tube body. Please refer to FIG. 3, the protection tube 270 is at least partially received in the screw hole 2335. The outer wall of the protective tube 270 and the inner wall of the screw hole 2335 form a gap (not shown). The extending direction of the protection tube 270 is the same as the extending direction of the screw hole 2335. Please also refer to FIG. 6, the protection tube 270 has a first open end 271 and a second open end 273 opposite to the first open end 271. In this embodiment, one end of the protective tube 270 is located inside the screw hole 2335, and the other end extends from the screw hole 2335 and is located outside the connecting portion 2331. Or, in another embodiment, one end of the protective tube 270 is flush with one end of the screw hole 2335, and the other end is flush with the other end of the screw hole 2335.
保护管270与连接座233可以为一体式结构，也可以为非一体式结构，并 且通过本领域技术人员掌握的连接方法，将保护管270与连接座233固定相连。The protective tube 270 and the connecting seat 233 may be an integral structure or a non-integrated structure, and the protective tube 270 and the connecting seat 233 are fixedly connected by a connection method mastered by those skilled in the art.
请参阅图6，当保护管270与连接座233为一体式结构时，保护管270为自插接部2333的端部的内壁向连接部2331轴向延伸的中空直管。当保护管270与连接座233为非一体式结构时，保护管270亦为自插接部2333的端部的内壁向连接部2331轴向延伸的中空直管，并且，保护管270的第一开口端271的端面与插接部2333的端部的内壁固定相连。Please refer to FIG. 6, when the protective tube 270 and the connecting seat 233 are an integral structure, the protective tube 270 is a hollow straight tube extending axially from the inner wall of the end of the inserting portion 2333 toward the connecting portion 2331. When the protection tube 270 and the connecting seat 233 are of a non-integral structure, the protection tube 270 is also a hollow straight tube extending axially from the inner wall of the end of the insertion part 2333 to the connection part 2331, and the first part of the protection tube 270 The end surface of the open end 271 is fixedly connected to the inner wall of the end of the insertion portion 2333.
在一实施方式中，如图7所示，保护管270包括管体275和固定部277，管体275为中空的管腔结构，固定部277为中空的圆柱体，固定部277与管体275的一端连接，且固定部277的内腔与管体275的内腔连通。固定部277的远离管体275的一端为保护管270的第一开口端271，管体275的远离固定部277的一端为保护管270的第二开口端273。固定部277的外径大于管体275的外径。请一并参阅图7和图8，插接部2333的远离连接部2331的一端形成有收容槽2337，且收容槽2337的槽底形成有通孔2339(图8未示)。管体275穿过通孔2339，且固定部277收容于收容槽2337中，进一步，通过焊接、胶粘等方式将固定部277固定于收容槽2337中，从而实现保护管270与插接部2333固定连接。In one embodiment, as shown in FIG. 7, the protective tube 270 includes a tube body 275 and a fixing part 277. The tube body 275 is a hollow lumen structure, the fixing part 277 is a hollow cylinder, and the fixing part 277 and the tube body 275 The inner cavity of the fixing part 277 is connected with the inner cavity of the tube body 275. The end of the fixing portion 277 away from the tube body 275 is the first open end 271 of the protection tube 270, and the end of the tube body 275 that is away from the fixing portion 277 is the second open end 273 of the protection tube 270. The outer diameter of the fixing portion 277 is greater than the outer diameter of the pipe body 275. Referring to FIGS. 7 and 8 together, a receiving groove 2337 is formed at one end of the insertion portion 2333 away from the connecting portion 2331, and a through hole 2339 is formed at the bottom of the receiving groove 2337 (not shown in FIG. 8). The pipe body 275 passes through the through hole 2339, and the fixing portion 277 is received in the receiving groove 2337. Further, the fixing portion 277 is fixed in the receiving groove 2337 by welding, gluing, etc., so as to realize the protection tube 270 and the insertion portion 2333 Fixed connection.
包括管体275和固定部277的保护管270有利于装配，使保护管70与连接座233固定连接较为方便，且连接较为可靠。The protection tube 270 including the tube body 275 and the fixing portion 277 facilitates assembly, so that the protection tube 70 and the connecting seat 233 are fixedly connected more conveniently and the connection is more reliable.
系绳250用于避免心脏瓣膜假体20移位。系绳250穿设保护管270。请参阅图9，系绳250的一端收容于连接盖231或连接座233内部，另一端从保护管270从伸出。从保护管270中伸出的一端与心脏组织固定。例如，从保护管270中伸出的一端穿过心尖并固定。请再次参阅图8，系绳250的一端形成有阻挡部252，设置阻挡部252以使系绳250的一端与连接盖231或连接座233保持相对固定。具体地，本实施方式中，阻挡部252呈球状，且阻挡部252的直径大于固定部277的内径，防止阻挡部252自保护管270中脱落。The tether 250 is used to prevent the heart valve prosthesis 20 from being displaced. The tether 250 is provided with a protective tube 270 through it. Referring to FIG. 9, one end of the tether 250 is accommodated in the connecting cover 231 or the connecting seat 233, and the other end extends from the protective tube 270. The end protruding from the protective tube 270 is fixed to the heart tissue. For example, one end protruding from the protective tube 270 passes through the apex of the heart and is fixed. Please refer to FIG. 8 again. One end of the tether 250 is formed with a blocking portion 252, and the blocking portion 252 is provided to keep one end of the tether 250 and the connecting cover 231 or the connecting seat 233 relatively fixed. Specifically, in this embodiment, the blocking portion 252 is spherical, and the diameter of the blocking portion 252 is larger than the inner diameter of the fixing portion 277 to prevent the blocking portion 252 from falling off the protection tube 270.
可以理解，在其他实施方式中，系绳250的一端可以伸入连接盖231中，且阻挡部252被卡住而防止阻挡部252自连接盖231中脱落。例如，系绳250的一端从连接盖231的任一限位孔2313中伸出连接盖231，并且阻挡部252的 至少一维尺寸大于限位孔2313的尺寸使得阻挡部252被阻挡在连接盖231的外部。It can be understood that in other embodiments, one end of the tether 250 may extend into the connecting cover 231, and the blocking portion 252 is stuck to prevent the blocking portion 252 from falling off the connecting cover 231. For example, one end of the tether 250 extends from any limiting hole 2313 of the connecting cover 231 to the connecting cover 231, and at least one-dimensional size of the blocking portion 252 is larger than the size of the limiting hole 2313 so that the blocking portion 252 is blocked in the connecting cover 231 outside.
可以理解，在其他实施方式中，阻挡部252不限于球状，在满足阻挡部252被阻挡的前提下，可以为任意形状。例如，阻挡部252为片状、杆状等等。或者，阻挡部252也可以为系绳250的一端打结形成的结构。It can be understood that, in other embodiments, the blocking portion 252 is not limited to a spherical shape, and may have any shape provided that the blocking portion 252 is blocked. For example, the blocking portion 252 has a sheet shape, a rod shape, or the like. Alternatively, the blocking portion 252 may also be a structure formed by knotting one end of the tether 250.
系绳250的材料包括但不限于金属和高分子材料。在一实施方式中，系绳250的材料为聚乙烯。The material of the tether 250 includes but is not limited to metal and polymer materials. In one embodiment, the material of the tether 250 is polyethylene.
请再次参阅图1，输送器械40包括输送鞘管41及推送管43。推送管43的一端设有外螺纹431。将推送管43的设有外螺纹431的一端伸入连接座233中的保护管270的外壁与螺孔2335的内壁形成的间隙中，外螺纹431与螺孔2335的内螺纹配合，使推送管43与心脏瓣膜假体20可拆卸连接，两者连接的状态如图9所示。推送管43可滑动地收容于输送鞘管41中，通过使推送管43往相反的两个方向沿输送鞘管41轴向滑动，实现将心脏瓣膜假体20收入输送鞘管41内部或将心脏瓣膜假体20从输送鞘管41中推出。Please refer to FIG. 1 again, the delivery device 40 includes a delivery sheath 41 and a push tube 43. An external thread 431 is provided at one end of the push tube 43. Extend the end of the push tube 43 with the external thread 431 into the gap formed by the outer wall of the protective tube 270 in the connecting seat 233 and the inner wall of the screw hole 2335. The external thread 431 matches the internal thread of the screw hole 2335 to make the push tube 43 and the heart valve prosthesis 20 are detachably connected, and the connected state of the two is shown in FIG. 9. The push tube 43 is slidably received in the delivery sheath 41. By sliding the push tube 43 in two opposite directions along the axis of the delivery sheath 41, the heart valve prosthesis 20 can be stored in the delivery sheath 41 or the heart The valve prosthesis 20 is pushed out from the delivery sheath 41.
在一实施方式中，螺孔2335的轴向长度大于或等于外螺纹431的轴向长度。一方面，保证螺纹连接部位具有足够长度，以使推送管43与心脏瓣膜假体20可靠连接；另一方面，避免外螺纹431裸露在外，对人体组织造成损伤。其中，外螺纹431的轴向长度是指推送管43的设有外螺纹431的部分的轴向长度。In one embodiment, the axial length of the screw hole 2335 is greater than or equal to the axial length of the external thread 431. On the one hand, it is ensured that the threaded connection part has a sufficient length to make the push tube 43 and the heart valve prosthesis 20 reliably connected; on the other hand, it is to prevent the external thread 431 from being exposed and causing damage to human tissues. The axial length of the external thread 431 refers to the axial length of the portion of the push tube 43 where the external thread 431 is provided.
推送管43由硬质材料或者软质材料组成。硬质材料为不锈钢等金属材料，软质材料为高分子材等。例如，在一实施方式中，推送管43为空心的不锈钢管。The push tube 43 is composed of hard material or soft material. Hard materials are metal materials such as stainless steel, and soft materials are polymer materials. For example, in one embodiment, the push tube 43 is a hollow stainless steel tube.
使用时，将推送管43与心脏瓣膜假体20通过螺纹连接，其中，心脏瓣膜假体20的系绳250的远离阻挡部252的一端伸入推送管43的内腔中，如图9所示。沿轴向拉动推送管43，使推送管43在输送鞘管41的内腔中轴向滑动，从而将心脏瓣膜假体20装载于输送鞘管41的内腔中。以植入二尖瓣心脏瓣膜假体为例进行说明，在心尖部位穿刺形成小缺口，然后通过输送鞘管41将心脏瓣膜假体20输送至病变部位后，推动推送管43，使推送管43在输送鞘管41的内腔中轴向滑动，滑动的方向与装载时的滑动方向相反，从而将心脏瓣膜假体20推出至输送鞘管41外，心脏瓣膜假体20自膨胀并定位于心脏瓣膜病变部位 后，旋转推送管43，以断开推送管43与心脏瓣膜假体20的连接，并撤回推送管43和输送鞘管41。此时，如图10所示，系绳250的远离阻挡部252的一端位于心脏30的外部，将系绳250的远离阻挡部252的一端固定在心脏30的外部，瓣膜支架211的径向支撑力及系绳250的拉动作用使得心脏瓣膜假体20可靠地固定在二尖瓣位置。When in use, the push tube 43 and the heart valve prosthesis 20 are connected by threads, wherein the end of the tether 250 of the heart valve prosthesis 20 away from the blocking portion 252 extends into the inner cavity of the push tube 43, as shown in FIG. 9 . Pull the push tube 43 in the axial direction to make the push tube 43 slide axially in the lumen of the delivery sheath 41 so that the heart valve prosthesis 20 is loaded in the lumen of the delivery sheath 41. Taking the implantation of a mitral valve prosthesis as an example, a small gap is formed in the apex of the heart, and then the heart valve prosthesis 20 is delivered to the diseased site through the delivery sheath 41, and then the push tube 43 is pushed to make the push tube 43 Sliding axially in the lumen of the delivery sheath 41, the sliding direction is opposite to the sliding direction when loading, so that the heart valve prosthesis 20 is pushed out of the delivery sheath 41, and the heart valve prosthesis 20 is self-expanded and positioned in the heart After the valve is affected, the push tube 43 is rotated to disconnect the push tube 43 and the heart valve prosthesis 20, and the push tube 43 and the delivery sheath 41 are withdrawn. At this time, as shown in FIG. 10, the end of the tether 250 away from the blocking portion 252 is located outside the heart 30, and the end of the tether 250 away from the blocking portion 252 is fixed to the outside of the heart 30, and the valve stent 211 is radially supported The force and the pulling action of the tether 250 make the heart valve prosthesis 20 reliably fixed at the position of the mitral valve.
上述心脏瓣膜假体20采用刚性的连接件230与推送管43相连，并借助推送管43推送心脏瓣膜假体20，无需借助额外的器械推送心脏瓣膜假体20，植入较为方便。The above-mentioned heart valve prosthesis 20 is connected to the push tube 43 by a rigid connector 230, and the heart valve prosthesis 20 is pushed through the push tube 43, without the need for additional equipment to push the heart valve prosthesis 20, and the implantation is more convenient.
并且，在植入后，可能会出现系绳250与支架210的连接点与系绳250与心尖部位的连接点所确定的直线与心脏瓣膜假体20的纵向中心轴线不共线(两条线所形成的角度即不为0°，也不为180°)的情况，即系绳250与支架210的连接点与系绳250与心尖部位的连接点所确定的直线相对心脏瓣膜假体20的纵向中心轴线倾斜。如此，当省略保护管270时，系绳250与螺孔2335的内壁的螺纹直接接触、摩擦，容易断裂。尤其是在心脏不断地收缩和舒张运动中，系绳250与螺纹不断地摩擦，更容易断裂。上述心脏瓣膜假体20，由于系绳250穿设保护管270，避免了系绳250直接与螺孔2335内壁的螺纹直接接触、摩擦，有效防止系绳250断裂，从而有利于避免心脏瓣膜假体20移位。Moreover, after implantation, it may appear that the line determined by the connection point between the tether 250 and the stent 210 and the connection point between the tether 250 and the apex is not collinear with the longitudinal center axis of the heart valve prosthesis 20 (two lines The angle formed is neither 0° nor 180°), that is, the straight line determined by the connection point between the tether 250 and the stent 210 and the connection point between the tether 250 and the apex is relative to the heart valve prosthesis 20 The longitudinal center axis is inclined. In this way, when the protective tube 270 is omitted, the tether 250 directly contacts and rubs with the thread of the inner wall of the screw hole 2335, which is likely to break. Especially in the continuous contraction and diastole of the heart, the tether 250 is constantly rubbing with the thread, which is more likely to break. In the above-mentioned heart valve prosthesis 20, since the tether 250 is provided with a protective tube 270, it is avoided that the tether 250 directly contacts and rubs against the thread of the inner wall of the screw hole 2335, which effectively prevents the tether 250 from breaking, thereby helping to avoid the heart valve prosthesis 20 shifted.
当心脏瓣膜假体20释放后，若释放位置并非预期的位置，需要通过输送器械40将心脏瓣膜假体20收回至输送鞘管41中，重新定位并释放。具体操作如下：在系绳250的引导下，推送管43在输送鞘管41内滑动至靠近心脏瓣膜假体20后，旋转推送管43使推送管43重新与心脏瓣膜假体20螺纹连接以实现心脏瓣膜假体20的回收。然而，在此过程中，由于操作者在体外操作，在推送管43向靠近心脏瓣膜假体20移动的过程中，推送管43的外螺纹会很容易切断系绳250，导致器械失效。设置有保护管270，有利于避免系绳250与螺纹接触，有效防止系绳250断裂，避免在回收过程中器械失效。After the heart valve prosthesis 20 is released, if the release position is not the expected position, the heart valve prosthesis 20 needs to be retracted into the delivery sheath 41 through the delivery device 40, repositioned and released. The specific operation is as follows: under the guidance of the tether 250, after the push tube 43 slides in the delivery sheath 41 close to the heart valve prosthesis 20, rotate the push tube 43 to re-thread the push tube 43 with the heart valve prosthesis 20 to achieve Recovery of the heart valve prosthesis 20. However, in this process, because the operator operates outside the body, when the push tube 43 moves closer to the heart valve prosthesis 20, the external thread of the push tube 43 will easily cut off the tether 250, causing the device to fail. The protection tube 270 is provided to prevent the tether 250 from contacting the thread, effectively prevent the tether 250 from breaking, and avoid device failure during the recovery process.
在一实施方式中，保护管270与连接座233为一体式结构。可以理解，在其他实施方式中，两者为非一体式结构，而是通过焊接、胶粘等本领域技术人员掌握的连接方法固定相连。In one embodiment, the protection tube 270 and the connecting seat 233 are an integral structure. It can be understood that, in other embodiments, the two are non-integrated structures, but are fixedly connected by a connection method mastered by those skilled in the art, such as welding and gluing.
在另一实施方式中，保护管270与连接座233即不是一体式结构，也不固定相连。保护管270套设于系绳250上，且保护管270至少部分收容于螺孔2335中，另一部分伸出连接座233或另一端的端部与连接座233的端部平齐。请参阅图11，此种情况下，系绳250上设有抵持部254，抵持部254与阻挡部252相对设置。保护管270的第一开口端271的端部与连接座233的内壁抵持，保护管270的第二开口端273的端部与抵持部抵持而被抵持部所阻挡，使得保护管270至少部分收容于螺孔2335的内部。In another embodiment, the protection tube 270 and the connecting seat 233 are neither integrated nor fixedly connected. The protective tube 270 is sleeved on the tether 250, and the protective tube 270 is at least partially received in the screw hole 2335, and the other part extends out of the connecting seat 233 or the end of the other end is flush with the end of the connecting seat 233. Please refer to FIG. 11. In this case, the tether 250 is provided with a resisting portion 254, and the resisting portion 254 is disposed opposite to the blocking portion 252. The end of the first open end 271 of the protective tube 270 resists the inner wall of the connecting seat 233, and the end of the second open end 273 of the protective tube 270 resists the resisting portion and is blocked by the resisting portion, so that the protective tube 270 is at least partially received in the screw hole 2335.
在另一实施方式中，保护管270包覆于系绳250上，且保护管270与系绳250固定相连。例如，保护管270为硅胶管，保护管270与系绳250直接固定相连，亦可较好地保护系绳250。In another embodiment, the protective tube 270 is coated on the tether 250, and the protective tube 270 is fixedly connected to the tether 250. For example, the protective tube 270 is a silicone tube, and the protective tube 270 is directly fixedly connected to the tether 250, which can also better protect the tether 250.
无论保护管270与连接座233为一体式结构，还是保护管270通过其他连接方式与连接座233固定相连，亦或是保护管270与连接座233不固定相连，而是被系绳250的抵持部所阻挡，保护管270的轴向长度大于或等于螺孔2335的轴向长度。当保护管270的轴向长度大于螺孔2335的轴向长度时，保护管270仅有部分收容于螺孔2335中，另一部分从连接座233中伸出而位于连接座233的外部。保护管270的轴向长度大于螺孔2335的轴向长度，一方面提供裕量，以在异常情况下(如保护管270异常缩短)也能保证有效隔离螺纹和系绳250；另一方面，在装载过程或在回收过程中，保护管270的伸出连接座233的部分能够提前校准推送管43与螺孔2335的同轴性，以引导推送管43快速地与螺孔2335对齐。Regardless of whether the protective tube 270 and the connecting seat 233 are an integral structure, or the protective tube 270 is fixedly connected to the connecting seat 233 through other connection methods, or the protective tube 270 is not fixedly connected to the connecting seat 233, but is resisted by the tether 250 Blocked by the holding portion, the axial length of the protective tube 270 is greater than or equal to the axial length of the screw hole 2335. When the axial length of the protective tube 270 is greater than the axial length of the screw hole 2335, the protective tube 270 is only partially received in the screw hole 2335, and the other part extends from the connecting seat 233 and is located outside the connecting seat 233. The axial length of the protective tube 270 is greater than the axial length of the screw hole 2335. On the one hand, it provides a margin to ensure that the thread and the tether 250 can be effectively separated under abnormal conditions (such as abnormal shortening of the protective tube 270); on the other hand, During the loading process or the recovery process, the part of the protective tube 270 protruding from the connecting seat 233 can align the coaxiality between the push tube 43 and the screw hole 2335 in advance to guide the push tube 43 to quickly align with the screw hole 2335.
需要说明的是，上述以植入二尖瓣心脏瓣膜假体为例阐述了植入过程，但心脏瓣膜假体20不限于二尖瓣心脏瓣膜假体，还可以为三尖瓣心脏瓣膜假体、主动脉瓣心脏瓣膜假体或肺动脉瓣心脏瓣膜假体。上述实施方式中的心脏瓣膜假体20的支架210为自膨胀支架，在其他实施方式中，不限于自膨胀支架，例如，支架210可以为球囊扩张支架。It should be noted that the above-mentioned implantation of a mitral valve heart valve prosthesis is used as an example to illustrate the implantation process, but the heart valve prosthesis 20 is not limited to a mitral valve heart valve prosthesis, and can also be a tricuspid heart valve prosthesis. , Aortic valve heart valve prosthesis or pulmonary valve heart valve prosthesis. The stent 210 of the heart valve prosthesis 20 in the above embodiment is a self-expanding stent. In other embodiments, it is not limited to a self-expanding stent. For example, the stent 210 may be a balloon-expandable stent.
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, All should be considered as the scope of this specification.
以上所述实施例仅表达了本实用新型的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对实用新型专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本实用新型构思的前提下，还可以做出若干变形和改进，这些都属于本实用新型的保护范围。因此，本实用新型专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the utility model, and the description is relatively specific and detailed, but it should not be understood as a limitation to the scope of the utility model patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the utility model, several modifications and improvements can be made, and these all fall within the protection scope of the utility model. Therefore, the protection scope of the utility model patent should be subject to the appended claims.

Claims (11)

  1. 一种心脏瓣膜假体，包括支架、连接件和系绳，其特征在于，所述连接件包括连接盖及与所述连接盖相连的连接座，所述连接盖与所述支架相连，所述连接座上开设有螺孔，所述心脏瓣膜假体还包括中空的保护管，所述保护管至少部分收容于所述螺孔中且所述保护管的外壁与所述螺孔的内壁形成间隙，所述保护管具有第一开口端以及与所述第一开口端相对的第二开口端，所述系绳穿设所述保护管，且所述系绳的一端收容于所述连接盖或所述连接座内部。A heart valve prosthesis, comprising a stent, a connecting piece, and a tether, wherein the connecting piece includes a connecting cover and a connecting seat connected to the connecting cover, the connecting cover is connected to the stent, the The connecting seat is provided with a screw hole, the heart valve prosthesis further includes a hollow protective tube, the protective tube is at least partially received in the screw hole, and the outer wall of the protective tube forms a gap with the inner wall of the screw hole The protective tube has a first open end and a second open end opposite to the first open end, the tether passes through the protective tube, and one end of the tether is accommodated in the connecting cover or Inside the connecting seat.
  2. 根据权利要求1所述的心脏瓣膜假体，其特征在于，所述保护管与所述连接座为一体式结构；或者，所述保护管与所述连接座为非一体式结构，且所述保护管与所述连接座固定连接。The heart valve prosthesis according to claim 1, wherein the protective tube and the connecting seat are of an integrated structure; or the protective tube and the connecting seat are of non-integrated structure, and the The protection tube is fixedly connected with the connecting seat.
  3. 根据权利要求1所述的心脏瓣膜假体，其特征在于，所述系绳上设置有抵持部，所述保护管的第一开口端的端面与所述连接座的内壁抵持，所述保护管的第二开口端的端面与所述抵持部抵持。The heart valve prosthesis according to claim 1, wherein the tether is provided with a resisting portion, the end surface of the first open end of the protective tube resists the inner wall of the connecting seat, and the protective The end surface of the second open end of the tube resists the resisting portion.
  4. 根据权利要求1所述的心脏瓣膜假体，其特征在于，所述保护管包覆于所述系绳上，且所述保护管与所述系绳固定相连。The heart valve prosthesis according to claim 1, wherein the protective tube is wrapped on the tether, and the protective tube is fixedly connected to the tether.
  5. 根据权利要求1所述的心脏瓣膜假体，其特征在于，所述保护管部分收容于所述螺孔中，且所述保护管的一端伸出至所述连接座的外部。The heart valve prosthesis according to claim 1, wherein the protective tube is partially received in the screw hole, and one end of the protective tube extends to the outside of the connecting seat.
  6. 根据权利要求1所述的心脏瓣膜假体，其特征在于，所述支架包括瓣叶支架和多个连杆，所述瓣叶支架具有第一端及与所述第一端相对的第二端，每个所述连杆包括第一杆部、第二杆部及接头，所述第二杆部与所述第一杆部连接，所述接头与所述第二杆部的远离所述第一杆部的一端连接，所述第一杆部的远离所述第二杆部的一端与所述瓣叶支架的第二端连接，所述接头与所述连接盖连接，所述第二杆部与所述瓣叶支架的纵向中心轴线的夹角为40°～60°。The heart valve prosthesis according to claim 1, wherein the stent comprises a leaflet stent and a plurality of links, the leaflet stent has a first end and a second end opposite to the first end Each of the connecting rods includes a first rod part, a second rod part and a joint, the second rod part is connected to the first rod part, and the joint and the second rod part are away from the first rod part. One end of a rod is connected, an end of the first rod away from the second rod is connected with the second end of the leaflet holder, the joint is connected with the connecting cover, the second rod The included angle between the part and the longitudinal center axis of the valve leaf support is 40°-60°.
  7. 根据权利要求6所述的心脏瓣膜假体，其特征在于，所述连接盖具有内腔，且所述连接盖上开设多个间隔设置且均与所述内腔连通的限位孔，所述多个接头分别穿过所述多个限位孔中，且多个所述接头分别遮挡多个所述限位孔，以阻止所述接头从所述限位孔内脱出。The heart valve prosthesis according to claim 6, wherein the connecting cover has an inner cavity, and the connecting cover is provided with a plurality of limiting holes arranged at intervals and all communicating with the inner cavity, the A plurality of joints respectively pass through the plurality of limiting holes, and the plurality of joints respectively block the plurality of limiting holes to prevent the joints from falling out of the limiting holes.
  8. 根据权利要求1所述的心脏瓣膜假体，其特征在于，所述连接座包括连接部及与所述连接部相连的插接部，所述连接盖套设于所述插接部上，且所述 连接盖与所述连接部抵接。The heart valve prosthesis according to claim 1, wherein the connecting seat comprises a connecting part and an inserting part connected to the connecting part, and the connecting cover is sleeved on the inserting part, and The connecting cover abuts against the connecting portion.
  9. 根据权利要求8所述的心脏瓣膜假体，其特征在于，所述插接部的远离所述连接部的一端形成有收容槽，所述保护管包括管体及与所述管体连接的固定部，所述固定部收容于所述收容槽中，且所述管体自所述收容槽沿所述连接部的轴向延伸。The heart valve prosthesis according to claim 8, wherein a receiving groove is formed at one end of the insertion portion away from the connecting portion, and the protective tube includes a tube body and a fixing device connected to the tube body. Part, the fixing part is received in the receiving groove, and the tube body extends from the receiving groove along the axial direction of the connecting portion.
  10. 一种心脏瓣膜假体***，其特征在于，包括输送器械及如权利要求1～9任一项所述的心脏瓣膜假体，所述输送器械包括输送鞘管及可滑动地收容于所述输送鞘管中的推送管，所述推送管的一端设有外螺纹，所述外螺纹与所述连接座上的所述螺孔配合使所述推送管与所述心脏瓣膜假体可拆卸连接。A heart valve prosthesis system, comprising a delivery device and the heart valve prosthesis according to any one of claims 1-9, the delivery device comprising a delivery sheath and slidably received in the delivery The push tube in the sheath, one end of the push tube is provided with an external thread, and the external thread cooperates with the screw hole on the connecting seat to make the push tube and the heart valve prosthesis detachably connected.
  11. 根据权利要求10所述心脏瓣膜假体***，其特征在于，所述螺孔的轴向长度大于或等于所述外螺纹的轴向长度。The heart valve prosthesis system according to claim 10, wherein the axial length of the screw hole is greater than or equal to the axial length of the external thread.
PCT/CN2020/091290 2019-05-31 2020-05-20 Heart valve prosthesis and system WO2020238725A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201920819376.3 2019-05-31
CN201920819376.3U CN211049720U (en) 2019-05-31 2019-05-31 Heart valve prosthesis and system

Publications (1)

Publication Number Publication Date
WO2020238725A1 true WO2020238725A1 (en) 2020-12-03

Family

ID=71583943

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2020/091290 WO2020238725A1 (en) 2019-05-31 2020-05-20 Heart valve prosthesis and system

Country Status (2)

Country Link
CN (1) CN211049720U (en)
WO (1) WO2020238725A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023284663A1 (en) * 2021-07-12 2023-01-19 上海易桥医疗器械有限公司 Valve stent, valve prosthesis and valve prosthesis system

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110004296A1 (en) * 2007-09-13 2011-01-06 Georg Lutter Heart Valve Stent
US20150223934A1 (en) * 2014-02-11 2015-08-13 Tendyne Holdings, Inc. Adjustable tether and epicardial pad system for prosthetic heart valve
US20160074160A1 (en) * 2013-05-30 2016-03-17 Tendyne Holdings, Inc. Structural members for prosthetic mitral valves
CN105682611A (en) * 2013-10-28 2016-06-15 坦迪尼控股股份有限公司 Prosthetic heart valve and systems and methods for delivering the same
CN106420114A (en) * 2016-10-24 2017-02-22 宁波健世生物科技有限公司 Heart valve prosthesis
CN106963519A (en) * 2015-12-22 2017-07-21 Nvt股份公司 Prosthetic mitral valve engages intensifier
CN109069272A (en) * 2016-04-29 2018-12-21 美敦力瓦斯科尔勒公司 Prosthetic heart valve equipment and associated system and method with the anchor log with tether
CN109549752A (en) * 2017-09-25 2019-04-02 先健科技(深圳)有限公司 Heart valve

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110004296A1 (en) * 2007-09-13 2011-01-06 Georg Lutter Heart Valve Stent
US20160074160A1 (en) * 2013-05-30 2016-03-17 Tendyne Holdings, Inc. Structural members for prosthetic mitral valves
CN105682611A (en) * 2013-10-28 2016-06-15 坦迪尼控股股份有限公司 Prosthetic heart valve and systems and methods for delivering the same
US20150223934A1 (en) * 2014-02-11 2015-08-13 Tendyne Holdings, Inc. Adjustable tether and epicardial pad system for prosthetic heart valve
CN106963519A (en) * 2015-12-22 2017-07-21 Nvt股份公司 Prosthetic mitral valve engages intensifier
CN109069272A (en) * 2016-04-29 2018-12-21 美敦力瓦斯科尔勒公司 Prosthetic heart valve equipment and associated system and method with the anchor log with tether
CN106420114A (en) * 2016-10-24 2017-02-22 宁波健世生物科技有限公司 Heart valve prosthesis
CN109549752A (en) * 2017-09-25 2019-04-02 先健科技(深圳)有限公司 Heart valve

Also Published As

Publication number Publication date
CN211049720U (en) 2020-07-21

Similar Documents

Publication Publication Date Title
US11712337B2 (en) Delivery systems and methods of implantation for prosthetic heart valves
US11896482B2 (en) Stent-valves for valve replacement and associated methods and systems for surgery
US10398546B2 (en) Mitral prosthesis and methods for implantation
US10080658B2 (en) Devices and methods for collapsing prosthetic heart valves
US9326850B2 (en) Sutureless prosthetic device
US9119717B2 (en) Retainers for transcatheter heart valve delivery systems
EP3302362B1 (en) System for loading a collapsible heart valve having a leaflet restraining member
EP2717803B1 (en) Systems and delivery handles for delivering prosthetic heart valves disposed on valve holders
US20140371844A1 (en) Transcatheter mitral valve and delivery system
CN105342724A (en) Treatment device for a blood circulation conduit
FR3006884A1 (en) ATRAUMATIC DEVICE FOR INTRODUCING A HOLLOW TUBULAR ELEMENT IN A BIOLOGICAL ORGAN
CN110897763B (en) Medical instrument conveying device
WO2020238725A1 (en) Heart valve prosthesis and system
CN109925095B (en) Heart valve
US20230125281A1 (en) Improvements in or relating to the delivery and unsheathing of prosthetic heart valves
US11779462B2 (en) Conveyor and conveyor system
WO2020134025A1 (en) Intervention guidance device
US20220331106A1 (en) Anchor designs with adaptable length control
CN211049721U (en) Prosthetic valve apparatus and system
CN114762635A (en) Valve clamping device and valve clamping system with full fitting
CN114903651A (en) On-demand valve clamping device and valve clamping system

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20815326

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20815326

Country of ref document: EP

Kind code of ref document: A1

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205 DATED 25.01.2022)

122 Ep: pct application non-entry in european phase

Ref document number: 20815326

Country of ref document: EP

Kind code of ref document: A1