WO2020233598A1 - Tether for heart valve, and heart valve - Google Patents

Tether for heart valve, and heart valve Download PDF

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Publication number
WO2020233598A1
WO2020233598A1 PCT/CN2020/091289 CN2020091289W WO2020233598A1 WO 2020233598 A1 WO2020233598 A1 WO 2020233598A1 CN 2020091289 W CN2020091289 W CN 2020091289W WO 2020233598 A1 WO2020233598 A1 WO 2020233598A1
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WO
WIPO (PCT)
Prior art keywords
tether
stent
heart valve
valve
main body
Prior art date
Application number
PCT/CN2020/091289
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French (fr)
Chinese (zh)
Inventor
褚华磊
姚斌
刘香东
Original Assignee
先健科技(深圳)有限公司
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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 WO2020233598A1 publication Critical patent/WO2020233598A1/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

Definitions

  • the present invention relates to the field of medical equipment, in particular to a tether for heart valves and heart valves.
  • Valve replacement surgery generally can use interventional therapy, which has the advantages of less trauma and low surgical risk, and has a broader market demand.
  • the heart valve 1 includes a skirt stent 11, a valve leaf stent 12, a valve leaflet (not shown in the figure) and a tether 13.
  • the outer diameter of the skirt stent 11 is larger than the opening of the mitral valve MV.
  • the purpose of this application is to provide a tether for a heart valve and a heart valve.
  • a heart valve including:
  • valve stent includes a main body stent and a skirt stent disposed on the main body stent, the skirt stent extending outward along a radial direction of the main body stent;
  • valve leaflets are arranged in the main body stent.
  • the tether is connected with the main body support, and the tether is visible under X-rays.
  • a tether for heart valves including:
  • a core layer made of a polymer material doped with a developing material
  • a braided layer is wrapped around the core layer, and the braided layer is braided by polymer wires.
  • the state of the tether can be observed through DSA during the implantation process. If the tether is twisted or bent under X-rays, the tether can be tightened at this time To make it straight, ensure that the tension between the tether and the valve stent is appropriate, to ensure that the heart valve does not fit poorly under the impact of blood flow, and reduce the probability of paravalvular leakage.
  • the tether by setting the tether to be visible under X-rays, during follow-up, by observing the state of the tether, it can also be judged whether there will be a paravalvular leak.
  • Figure 1 is a schematic diagram of the structure of a heart valve after implantation in the heart in the prior art
  • FIG. 2 is a schematic diagram of the structure of a heart valve according to an embodiment of the application.
  • Fig. 3 is a schematic structural view of the heart valve shown in Fig. 2 from another perspective;
  • FIG. 4 is a schematic diagram of the structure of the heart valve shown in FIG. 2 after being implanted into the heart;
  • Figure 5 is an exploded view of the connector of the heart valve shown in Figure 2;
  • Figure 6 is a schematic structural diagram of the connecting member shown in Figure 5 after being connected to the tether;
  • Fig. 7 is a schematic structural diagram of a tether according to another embodiment of the application.
  • FIG. 8 is a schematic diagram of the structure of the tether shown in FIG. 7 after being knotted
  • Figure 9 is a schematic diagram of the structure of the tether shown in Figure 7 after being knotted;
  • FIG. 10 is a schematic structural diagram of a tether according to another embodiment of the application.
  • FIG. 11 is a schematic diagram of the structure of the tether weaving process shown in FIG. 10;
  • Figure 12 is a test structure diagram of the tether and core layer shown in Figure 10.
  • this application takes the replacement of a mitral valve as an example for description, and the concept of this application can also be used to replace a tricuspid valve, a pulmonary valve, or an aortic valve.
  • the heart valve tissue involved in the present invention refers to one or a combination of several of the body's own heart tissues such as valve annulus, valve leaflets, chordae, papillary muscles.
  • the heart valve In the delivery state, the heart valve is contracted in the delivery system to facilitate delivery; in the unfolded state, the heart valve is separated from the delivery system and is fixed to the heart tissue as a whole.
  • the heart valve 10 includes a valve stent 100, a tether 150, a baffle 170, and a valve leaflet 190.
  • the valve stent 100 includes a main body stent 110, a skirt stent 120 and a fixing part 130, and a skirt stent 120 and a fixing part. 130 are respectively arranged on the main body bracket 110, the skirt bracket 120 and the fixing member 130 are respectively used for fixing the heart tissue in two opposite cavities in the heart, and the tether 150 is connected to the main body bracket 110.
  • the skirt bracket 120 is used to fix the heart tissue on the left atrium side
  • the fixing member 130 is used to fix the heart tissue on the left ventricle side
  • the tether 150 extends from one side of the main body bracket 110 to the outside of the heart. Fixed at the apex of the heart. Specifically, the skirt support 120 extends radially outward from the leaflet support 112, and the skirt support 120 is farther away from the tether 150 than the fixing member 130.
  • the fixing member 130 may also be omitted.
  • the skirt stent 120 of the heart valve 10 can be stuck at the mitral valve annulus to prevent the heart valve 10 from falling into the left ventricle, and the tether 150 can be fixed outside the apex by knotting to prevent the heart valve 10 from moving to the left atrium.
  • the skirt support 120 and the tether 150 can prevent the heart valve 10 from being displaced after implantation.
  • the main body support 110 includes a leaflet support 112, a connecting rod 114, and a connecting piece 116.
  • the skirt support 120 and the fixing piece 130 are disposed on the leaflet support 112.
  • One end of the connecting rod 114 is connected to the leaflet support 112.
  • One end is fixedly connected, the other end is connected to the connecting piece 116, and the tether 150 is connected to the connecting piece 116.
  • the leaflet holder 112 is substantially cylindrical, and has an inflow end and an outflow end opposite to the inflow end.
  • the leaflet support 112 can provide radial support for the heart valve 10 and fix the leaflet 190.
  • the leaflet support 112 includes a wave ring 1121 and a connecting rod 1123.
  • the leaflet support 112 includes a plurality of wave rings 1121 spaced apart along the axial direction of the leaflet support 112.
  • the wave ring 1121 provides the radial support force of the leaflet support 112.
  • the leaflet support 112 includes three wave circles 1121.
  • the three wave rings 1121 are connected and fixed by a plurality of connecting rods 1123.
  • the number of connecting rods 1123 is the same as the number of troughs of the wave ring 1121, and one connecting rod 1123 is fixedly connected to the troughs of the three wave rings 1121 at the same time.
  • the connecting rod 1123 may also be fixedly connected to other positions of the wave ring 1121, such as wave crests.
  • the skirt bracket 120 includes a supporting portion 121 and a raised portion 122.
  • the support portion 121 extends outward from the leaflet support 112 along the radial direction of the leaflet support 112, and the upturned portion 122 is bent and extends from an end of the support portion 121 away from the leaflet support 112 toward the inflow end of the leaflet support 112.
  • the supporting portion 121 is used to fix the heart valve 10 in the human mitral valve annulus of the heart, and the upturned portion 122 is used to prevent the edge of the skirt stent 120 from abrading the left atrial tissue.
  • the distal edge of the radial support portion 121 directly contacts the atrial tissue, which will cause a cutting effect on the atrial tissue under long-term heart beats, causing damage to the atrial tissue.
  • the contact between the skirt stent 120 and the atrial tissue becomes surface contact, which increases the contact area, reduces the contact pressure, and avoids the cutting effect of the skirt stent 120 on the heart tissue and causes Abrasion.
  • the distance between the end of the support portion 121 of the skirt support 120 close to the leaflet support 112 and the inflow end is 1/4 to 1/2 of the axial length of the leaflet support 112.
  • the supporting portion 121 of the skirt bracket 120 is fixedly connected to the wave trough of the wave ring 1121 near the first end of the leaflet bracket 112. In this way, when the heart valve 10 is implanted into the heart, nearly one-third of the axial dimension of the leaflet stent 112 can be located in the left atrium, thereby avoiding excessive implantation of the left ventricle to cause stenosis or even obstruction of the left ventricular outflow tract.
  • the outer contour of the supporting portion 121 of the skirt stent 120 is circular when viewed from the inflow side of the valve blood flow.
  • the outer contour of the supporting portion 121 may also have other shapes, such as D-shaped, D-like, or elliptical.
  • the baffle 170 is used to block the blood flow from overflowing through the valve support 110, and cooperate with the valve leaflet 190 to ensure the unidirectional flow of blood in the heart valve 10.
  • the material of the baffle 170 is PTFE, PET, PU, casing or animal pericardium. Depending on the material, the baffle 170 may be laminated by a hot pressing process or fixed to the valve support 110 by suture. In this embodiment, the baffle 170 covers the surfaces of the leaflet holder 112 and the skirt holder 120. Specifically, the baffle 170 may only cover at least one of the inner surface and the outer surface of the leaflet holder 112.
  • a parylene layer is formed on the non-biological tissue surface of the heart valve 100.
  • a parylene layer is formed on the surface of the baffle 170.
  • the thickness of the parylene layer is 5 nanometers to 5 microns.
  • the material of the parylene layer is C-type parylene.
  • the leaflet 190 is located inside the leaflet support 112 and is fixed to the baffle 170 on the surface of the leaflet support 112.
  • the leaflet 190 is cut from the animal pericardium.
  • the leaflet 190 is roughly fan-shaped, and there are three pieces in total, which are sequentially arranged along the circumferential direction of the leaflet holder 112.
  • the ends of the two adjacent leaflets 190 close to the inner surface of the leaflet holder 112 are joined together to form a valve angle.
  • the peripheral edge of the leaflet 190 is fixed to the leaflet holder 112 and the baffle member 170 by suture, and the valve angle is fixed to the connecting piece.
  • the connecting rod 114 includes a proximal connecting rod 1141, a leaflet support connecting rod 1142, and a joint (not shown).
  • the proximal link 1141 is generally rod-shaped.
  • the leaflet support link 1142 is roughly V-shaped and includes two branch rods extending from one end of the proximal link 1141 to the leaflet support 112. The ends of the two branch rods away from the proximal link 1141 are connected to the leaflet support 112 respectively.
  • each wave trough is connected to a branch rod, so that a plurality of connecting rods 114 are evenly distributed along the outflow end, thereby playing a guiding role when the heart valve 10 is retracted into the sheath.
  • valve leaf support connecting rod 1142 can also have other shapes, for example, it can be in a straight shape, extending directly from one end of the proximal connecting rod 1141 to connect with the trough of the outflow end of the valve leaf support 112, that is, the branch rod The number is the same as that of the proximal link 1141.
  • valve support 100 can also be adjusted as needed.
  • the connecting member 116 includes a socket 1161 and a connecting cover 1163 fixedly connected to the socket 1161.
  • the connecting cover 1163 defines a limiting hole 1162.
  • the end of the connecting rod 114 away from the leaflet holder 112 passes through the limiting hole 1162 and is received in the limiting hole 1162.
  • the connection cover 1163 and the socket 1161 form a cavity.
  • the connecting cover 1163 includes a connecting sleeve 11631 and a spherical cap 11633 formed at one end of the connecting sleeve 11631.
  • the end of the connecting sleeve 11631 away from the spherical cap 11633 is sleeved and fixed with the socket 1161 to form a cavity, and the limiting hole 1162 is an edge connection
  • the sleeve 11631 has a strip hole extending axially.
  • the multiple limiting holes 1162 are evenly distributed along the circumferential direction of the connecting sleeve 11631.
  • the joint 1143 of each connecting rod 114 penetrates through a limiting hole 1162. .
  • the limiting hole 1162 extends from the end of the connecting sleeve 11631 away from the spherical crown 11633 to the middle of the spherical crown 11633, so that when the connecting rod 114 is connected to the connecting cover 1163, the angle of the connecting rod 114 can be reduced in the limiting hole 1162.
  • the angle of deflection, when the heart valve 10 is in a compressed state and an uncompressed state, the connecting rod 114 can adapt to different states of the heart valve 10 by changing the angle.
  • the socket 1161 includes a main body portion 11611 and a socket portion 11613.
  • the main body 11611 is approximately hemispherical and one end is flat.
  • the diameter of the main body 11611 is approximately the same as the diameter of the spherical cap 11633.
  • the plug-in portion 11613 protrudes from the plane of the main body portion 11611 and has a diameter smaller than that of the main body portion 11611.
  • the plug-in portion 11613 is received in the connecting sleeve 11631 and the two are fixed by welding.
  • the socket 1161 is provided with a screw hole 11614, and the screw hole 11614 penetrates the plug portion 11613 and the main body portion 11611.
  • the connecting member 116 further includes a blocking piece 1165.
  • the blocking piece 1165 is received in the connecting sleeve 11631 and is located at an end of the inserting portion 11613 close to the spherical crown 11633.
  • a through hole 11651 corresponding to the screw hole 11614 is opened in the middle of the blocking piece 1165.
  • the blocking piece 1165 can also be omitted.
  • Both ends of the connecting piece 116 are hemispherical, which can reduce the formation of thrombus and reduce the impact on hemodynamics.
  • One end of the tether 150 is inserted into the screw hole 11614 and is received in the cavity formed by the connecting cover 1163 and the socket 1161, and the other end extends out of the connecting piece 116 and passes through the apex of the heart and is knotted and fixed at the apex of the heart.
  • the heart valve 10 is pulled to prevent it from falling off in the left atrium.
  • the tether 150 is visible under X-rays.
  • the heart valve 10 may further include a gasket 180.
  • the material of the gasket 180 is selected from at least one of silica gel, polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium and stainless steel braided wire.
  • the gasket 180 can be a felt-like disc, a disc-like structure woven of titanium nickel wire, or a disc-like structure made of polymer injection molding.
  • the atria begin to contract, and blood in the atria is injected into the ventricles, causing the ventricular pressure to rise.
  • blood enters the aorta from the left ventricle through the aortic valve, and the pressure generated by the contraction of the left ventricle causes the blood to enter the capillaries.
  • the tether 150 exerts a pulling force on the heart valve 10 during ventricular diastole and systole.
  • the tension between the tether 150 and the heart valve 10 is weak, there will be gaps in the fit between the heart valve 10 and the mitral valve.
  • the tether 150 is not visible under X-rays, such as when the tether 150 is twisted or bent, during ventricular systole, the tether 150 is straightened under the impact of blood flow, so that the heart valve 10 and the mitral valve There is a gap between the fittings, which leads to paravalvular leakage, which affects heart function.
  • the tether 150 by setting the tether 150 to be visible under X-rays, during the follow-up process, by observing the state of the tether 150, it can also be determined whether there will be a paravalvular leak.
  • the tether 150 may be made of polymer doped with developing materials.
  • the developing material is dispersed in a polymer matrix with good biocompatibility to make the tether 150.
  • the polymer matrix can be silica gel, polypropylene (PP), polyurethane (PU), polyethylene (PE), polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), polyhydroxy fatty acid ester ( PHA), polydioxanone (PDO), polycaprolactone (PCL) or ultra-high molecular weight polyethylene (UHMWPE).
  • the developing material can be metal materials such as gold, tungsten, iron, platinum, titanium and its alloys, stainless steel, or non-metallic materials such as barium sulfate, bismuth subcarbonate, and iodides (such as iohexol and iopamidol).
  • the mass of the developing material in the tether 150 is not less than 10% of the mass of the tether 150 to improve the developability of the tether 150 under X-rays.
  • the wire diameter of the tether 150 is 0.02 mm to 5.0 mm, so that the tether 150 can be conveyed normally in the conveyor.
  • the tether 150 is made of polyurethane doped with barium sulfate, and its preparation can be divided into two steps.
  • the first step is melt granulation.
  • the drying temperature can be 60 ⁇ 140°C, and the drying time can be 2 ⁇ 8h.
  • the extruder temperature is 120 ⁇ 200 °C (the temperature of the feed section should not be too high, generally controlled at 120-150°C), the die temperature is 160-190°C, the polyurethane is plasticized and homogenized by the extruder, extruded from the die, and cut Knife cutting to complete granulation.
  • the feeding ratio of polyurethane and barium sulfate is 40:60, the temperature of the feeding section is 145°C, the temperature of the melting section is 165°C, the temperature of the homogenization section is 175°C, and the temperature of the die is 170°C.
  • the second step is extrusion molding.
  • the drying temperature can be 60 ⁇ 140°C
  • the drying time can be 2 ⁇ 8h
  • the screw speed is 0-60rpm
  • the traction speed is controlled at 0-200m/min
  • the tether 150 is obtained.
  • the temperature of the feeding section is controlled at 140°C
  • the temperature of the melting section is controlled at 160°C
  • the homogenization section is controlled at 180°C
  • the head temperature is controlled at 170°C
  • the screw speed is 30rpm
  • the traction speed is 10m/ min
  • the wire diameter of the final tether is 0.15mm.
  • the second embodiment of the present application differs from the first embodiment mainly in that the tether 250 includes a developing thread 251 and a non-developing thread 252.
  • the developing thread 251 and the non-developing thread 252 are woven to form a tether 250.
  • the developed yarn 251 and the non-developed yarn 252 are knitted by twisting.
  • the twist direction may be S, Z direction, or the like.
  • the twist should be moderately controlled, and the preferred twist is 1-100 per meter.
  • the developing thread 251 is a nickel-titanium wire with a diameter of 0.1mm;
  • the non-developing thread 252 is a nylon thread with a specification of 80D/20F; one developing thread 251 and three non-developing threads 252 are added along the S direction. Twist, the twist is 50 per meter, the tether 150 is made, and the wire diameter is 0.3mm.
  • the separate knot of the developed thread 251 will form a larger gap.
  • the knots are easy to unravel during the stretching process.
  • the gap formed after 250 knotting is smaller, and the knotting performance is greatly improved.
  • the developing wire 251 can also be made of other metal materials, such as gold, tungsten, iron, platinum, titanium and its alloys, stainless steel, etc., or can also be a polymer material doped with developing materials.
  • the material of the non-developing line 152 can also be silicone, polypropylene (PP), polyurethane (PU), polyethylene (PE), polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), poly Hydroxy fatty acid ester (PHA), polydioxanone (PDO), polycaprolactone (PCL) or ultra-high molecular weight polyethylene (UHMWPE).
  • the tether 350 includes a core layer 353 and a braided layer 354 wrapped around the core layer 353.
  • the core layer 353 is doped with
  • the material is made of polymer materials, and the braided layer 354 is knitted by polymer threads.
  • the above-mentioned tether can be seen under X-rays, and it can solve the problem that the metal tether is difficult to knot, and the mechanical properties of the polymer developing tether are reduced after the developer is added, so as to achieve better knotting and mechanical properties.
  • the developing material is dispersed in a polymer matrix with good biocompatibility to form the core layer 353.
  • the polymer matrix can be silica gel, polypropylene (PP), polyurethane (PU), polyethylene (PE), polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), polyhydroxy fatty acid ester ( PHA), polydioxanone (PDO), polycaprolactone (PCL) or ultra-high molecular weight polyethylene (UHMWPE).
  • the developing material can be metal materials such as gold, tungsten, iron, platinum, titanium and its alloys, stainless steel, or non-metallic materials such as barium sulfate, bismuth subcarbonate, and iodide (such as iohexol and iopamidol).
  • the mass of the developing material in the core layer 353 is not less than 10% of the mass of the core layer 353 to improve the developability of the tether 350 under X-rays.
  • the polymer thread of the braid 154 can be prepared by injection molding, extrusion, 3D printing, laser cutting, electrostatic spinning, etc.
  • the material can be various materials with good biocompatibility, including but not limited to ultra-high molecular weight polyethylene (UHMWPE).
  • UHMWPE ultra-high molecular weight polyethylene
  • polytetrafluoroethylene PTFE
  • nylon PA
  • PET polyethylene terephthalate
  • PP polypropylene
  • PU polyurethane
  • PE polyethylene
  • PEEK polyether ether ketone
  • PLA polylactic acid
  • PGA polyglycolic acid
  • PHA polyhydroxy fatty acid ester
  • PDO polydioxanone
  • PCL polycaprolactone
  • the core layer 353 is made of polypropylene doped with tungsten powder by 3D printing
  • the braided layer 354 is made of ultra-high molecular weight polyethylene yarns woven by pressing one by one.
  • the specific preparation method as follows. Firstly, the polypropylene and tungsten powder are dried. The drying temperature can be 60 ⁇ 140°C, and the drying time can be 2 ⁇ 8h.
  • the extruder temperature is 150 ⁇ 230°C (the temperature of the feed section should not be too high, generally controlled at 150 ⁇ 200°C), the die temperature is 190 ⁇ 230°C, the polypropylene is plasticized and homogenized by the extruder and extruded from the die. And after cutting with a cutter, granulation is completed.
  • the feeding ratio of polypropylene and tungsten powder is 80:20, the temperature of the feeding section is 190°C, the temperature of the melting section is 200°C, the temperature of the homogenization section is 210°C, and the temperature of the die is 200°C.
  • the printing filling density, printing temperature, printing speed and other process parameters should be properly controlled.
  • control the printing temperature of 170-250°C, the printing filling density of 50-90%, and the printing speed of 50-200mm/s.
  • the printing temperature is controlled to be 200°C, the printing filling density is 70%, and the printing speed is 50 mm/s.
  • the slicing software is used to generate the .stl model and process parameters into a 3D printing path file Gcode, and the 3D printer prints the core layer 353 under the control of the code, with a wire diameter of 0.1mm.
  • the core layer 353 is placed in the center of the yarn strands, and the yarn strands are woven around the core layer.
  • the yarn strands can be any number of double strands.
  • the knitting can be but not limited to compression knitting such as one pressing one, one pressing two, so that the yarn strands intersperse and weave , The braided rope is made.
  • the core layer 353 may also be made of a polymer material that is not doped with a developing material, and the braided layer is knitted by a polymer wire doped with a developing material.

Abstract

Disclosed are a heart valve (10), and a tether (150) for a heart valve (10). The heart valve (10) comprises: a valve stent (100), the valve stent (100) comprising a main body stent (110) and a skirt stent (120) arranged on the main body stent (110), the skirt stent (120) extending outwards in the radial direction of the main body stent (110); a valve leaflet (190), the valve leaflet (190) being arranged in the main body stent (110); and the tether (150), the tether (150) being connected to the main body stent (110), and the tether (150) being visible under X-rays. During an implantation process, the state of the tether (150) is observed under X-rays. If the tether (150) is in a state such as a twisted or bent state under X-rays, the tether (150) can be tightened to make same straight so as to guarantee that the tension of the tether (150) and the valve stent (100) is suitable and ensure that the heart valve (10) will not fit badly under the impact of blood flow, thereby reducing the probability of perivalvular leakage.

Description

用于心脏瓣膜的系绳及心脏瓣膜Tether for heart valve and heart valve 技术领域Technical field
本发明涉及医疗器械领域，特别是涉及一种用于心脏瓣膜的系绳及心脏瓣膜。The present invention relates to the field of medical equipment, in particular to a tether for heart valves and heart valves.
背景技术Background technique
本部分提供的仅仅是与本公开相关的背景信息，其并不必然是现有技术。This section provides only background information related to the present disclosure, which is not necessarily prior art.
随着人口老龄化加重，老年瓣膜相关疾病日渐突出。这些瓣膜病变不但危害生命安全、影响生活质量，同时给家庭和社会带来沉重的负担和压力。常见的治疗心脏瓣膜病的方法有两种：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。而瓣膜置换术一般可采用介入治疗的方法，具有创伤小、手术风险低等优点，具有更广阔的市场需求。With the aging of the population, senile valve-related diseases are becoming more prominent. These valvular diseases not only endanger life safety and quality of life, but also bring heavy burden and pressure to the family and society. There are two common methods for the treatment of heart valve disease: 1) Valvuloplasty, that is, repairing the damaged valve; 2) Valve replacement, replacing it with an artificial mechanical valve or a biological valve. Valve replacement surgery generally can use interventional therapy, which has the advantages of less trauma and low surgical risk, and has a broader market demand.
请参阅图1，心脏瓣膜1包括裙边支架11、瓣叶支架12、瓣叶(图中未示出)和系绳13，裙边支架11的外径大于二尖瓣MV的开口，当二尖瓣假体1植入心脏后裙边支架11位于左心房一侧，使得心脏瓣膜1整体“座”落于二尖瓣开口处的组织上，且不会从左心房一侧脱落至左心室中，瓣叶支架12位于原生二尖瓣位置，系绳13连接在瓣叶支架12的远端并固定在心尖的位置。然而将心脏瓣膜1固定在心尖位置时，由于系绳13与组织的相互作用、血液冲刷、连接线内部打结等影响，凭借力度感应和X射线下心脏瓣膜的位置并不能很好判断系绳13是否张紧及心脏瓣膜1是否已固定好。Please refer to Figure 1. The heart valve 1 includes a skirt stent 11, a valve leaf stent 12, a valve leaflet (not shown in the figure) and a tether 13. The outer diameter of the skirt stent 11 is larger than the opening of the mitral valve MV. After the cusp prosthesis 1 is implanted in the heart, the skirt stent 11 is located on the left atrium side, so that the heart valve 1 as a whole "seats" on the tissue at the opening of the mitral valve and will not fall off from the left atrium side to the left ventricle Among them, the leaflet holder 12 is located at the native mitral valve position, and the tether 13 is connected to the distal end of the leaflet holder 12 and fixed at the apex position. However, when the heart valve 1 is fixed at the apex position, due to the interaction between the tether 13 and the tissue, blood erosion, internal knotting of the connecting line, etc., the position of the heart valve under force sensing and X-ray cannot be used to determine the tether. 13 Whether it is tight and whether the heart valve 1 has been fixed.
发明内容Summary of the invention
本申请旨在提供一种用于心脏瓣膜的系绳及心脏瓣膜。The purpose of this application is to provide a tether for a heart valve and a heart valve.
一种心脏瓣膜，包括：A heart valve including:
瓣膜支架，所述瓣膜支架包括主体支架及设置于所述主体支架上的裙边支架，所述裙边支架沿所述主体支架的径向向外延伸；A valve stent, the valve stent includes a main body stent and a skirt stent disposed on the main body stent, the skirt stent extending outward along a radial direction of the main body stent;
瓣叶，所述瓣叶设置于所述主体支架内；及The valve leaflets are arranged in the main body stent; and
系绳，所述系绳与所述主体支架连接，所述系绳在X射线下可见。The tether is connected with the main body support, and the tether is visible under X-rays.
一种用于心脏瓣膜的系绳，包括：A tether for heart valves, including:
芯层，所述芯层由掺杂有显影材料的高分子材料制成，及A core layer made of a polymer material doped with a developing material, and
编织层，所述编织层包裹在所述芯层外，所述编织层由高分子线编织而成。A braided layer, the braided layer is wrapped around the core layer, and the braided layer is braided by polymer wires.
上述心脏瓣膜，通过将系绳设置成在X射线下可见，植入过程中通过DSA观察系绳的状态，假如在X射线下系绳出现扭曲或弯折等状态，此时可以拉紧系绳以使其呈直线状，确保系绳与瓣膜支架的张力适当，以保证心脏瓣膜在血流冲击下不会出现贴合不良，减小瓣周漏出现的概率。此外，通过将系绳设置成在X射线下可见，在随访过程中，通过观测系绳的状态，也可以判断出是否会出现瓣周漏。For the above-mentioned heart valve, by setting the tether to be visible under X-rays, the state of the tether can be observed through DSA during the implantation process. If the tether is twisted or bent under X-rays, the tether can be tightened at this time To make it straight, ensure that the tension between the tether and the valve stent is appropriate, to ensure that the heart valve does not fit poorly under the impact of blood flow, and reduce the probability of paravalvular leakage. In addition, by setting the tether to be visible under X-rays, during follow-up, by observing the state of the tether, it can also be judged whether there will be a paravalvular leak.
附图说明Description of the drawings
图1为现有技术中心脏瓣膜植入心脏后的结构示意图；Figure 1 is a schematic diagram of the structure of a heart valve after implantation in the heart in the prior art;
图2为本申请一实施例的心脏瓣膜的结构示意图；2 is a schematic diagram of the structure of a heart valve according to an embodiment of the application;
图3为图2所示的心脏瓣膜另一视角的结构示意图；Fig. 3 is a schematic structural view of the heart valve shown in Fig. 2 from another perspective;
图4为图2所示的心脏瓣膜植入心脏后的结构示意图；4 is a schematic diagram of the structure of the heart valve shown in FIG. 2 after being implanted into the heart;
图5为图2所示的心脏瓣膜的连接件的分解图；Figure 5 is an exploded view of the connector of the heart valve shown in Figure 2;
图6为图5所示的连接件与系绳连接后的结构示意图；Figure 6 is a schematic structural diagram of the connecting member shown in Figure 5 after being connected to the tether;
图7为本申请另一实施例的系绳的结构示意图；Fig. 7 is a schematic structural diagram of a tether according to another embodiment of the application;
图8为图7所示的系绳的显影线打结后的结构示意图；FIG. 8 is a schematic diagram of the structure of the tether shown in FIG. 7 after being knotted;
图9为图7所示的系绳打结后的结构示意图；Figure 9 is a schematic diagram of the structure of the tether shown in Figure 7 after being knotted;
图10为本申请又一实施例的系绳的结构示意图；FIG. 10 is a schematic structural diagram of a tether according to another embodiment of the application;
图11为图10所示的系绳编织过程中的结构示意图；FIG. 11 is a schematic diagram of the structure of the tether weaving process shown in FIG. 10;
图12为图10所示的系绳及芯层的测试结构图。Figure 12 is a test structure diagram of the tether and core layer shown in Figure 10.
具体实施方式Detailed ways
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对 本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。In order to make the above objectives, features and advantages of the present invention more obvious and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the following description, many specific details are explained in order to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific implementation disclosed below.
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or a central element may also be present. When an element is considered to be "connected" to another element, it can be directly connected to the other element or an intermediate element may be present at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not mean the only implementation.
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发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。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 terminology used in the description of the present invention herein is only for the purpose of describing specific embodiments, and is not intended to limit the present invention. The term "and/or" as used herein includes any and all combinations of one or more related listed items.
需要说明的是，本申请以置换二尖瓣的心脏瓣膜为例进行说明，而本申请的构思还可以用在置换三尖瓣、置换肺动脉瓣或者主动脉瓣的人工心脏瓣膜上。还需要说明的是，本发明所涉及的心脏瓣膜组织是指人体自身的瓣环、瓣叶、腱索、***肌等心脏组织中的一种或几种组织的组合。在输送状态下，心脏瓣膜收缩于输送***中，便于输送；在展开状态下，心脏瓣膜从输送***中脱离，并与心脏组织贴合固定为一体。It should be noted that this application takes the replacement of a mitral valve as an example for description, and the concept of this application can also be used to replace a tricuspid valve, a pulmonary valve, or an aortic valve. It should also be noted that the heart valve tissue involved in the present invention refers to one or a combination of several of the body's own heart tissues such as valve annulus, valve leaflets, chordae, papillary muscles. In the delivery state, the heart valve is contracted in the delivery system to facilitate delivery; in the unfolded state, the heart valve is separated from the delivery system and is fixed to the heart tissue as a whole.
请参阅图2，心脏瓣膜10包括瓣膜支架100、系绳150、阻流件170及瓣叶190，瓣膜支架100包括主体支架110、裙边支架120及固定件130，裙边支架120及固定件130分别设置于主体支架110上，裙边支架120及固定件130分别用于与心脏内两个相对设置的腔体内的心脏组织的固定，系绳150与主体支架110连接。在本实施例中，裙边支架120用于与左心房侧的心脏组织固定，固定件130用于与左心室侧的心脏组织固定，系绳150从主体支架110的一侧延伸到心脏外并固定在心尖处。具体的，裙边支架120自瓣叶支架112的径向向外延伸，裙边支架120比固定件130更远离系绳150。Please refer to FIG. 2, the heart valve 10 includes a valve stent 100, a tether 150, a baffle 170, and a valve leaflet 190. The valve stent 100 includes a main body stent 110, a skirt stent 120 and a fixing part 130, and a skirt stent 120 and a fixing part. 130 are respectively arranged on the main body bracket 110, the skirt bracket 120 and the fixing member 130 are respectively used for fixing the heart tissue in two opposite cavities in the heart, and the tether 150 is connected to the main body bracket 110. In this embodiment, the skirt bracket 120 is used to fix the heart tissue on the left atrium side, the fixing member 130 is used to fix the heart tissue on the left ventricle side, and the tether 150 extends from one side of the main body bracket 110 to the outside of the heart. Fixed at the apex of the heart. Specifically, the skirt support 120 extends radially outward from the leaflet support 112, and the skirt support 120 is farther away from the tether 150 than the fixing member 130.
需要说明的是，在其他实施例中，固定件130也可以省去。心脏瓣膜10的 裙边支架120可以卡在二尖瓣瓣环处，防止心脏瓣膜10掉落到左心室内，而系绳150通过打结固定在心尖外可以防止心脏瓣膜10向左心房移动，通过裙边支架120及系绳150可以防止心脏瓣膜10在植入后出现移位。It should be noted that in other embodiments, the fixing member 130 may also be omitted. The skirt stent 120 of the heart valve 10 can be stuck at the mitral valve annulus to prevent the heart valve 10 from falling into the left ventricle, and the tether 150 can be fixed outside the apex by knotting to prevent the heart valve 10 from moving to the left atrium. The skirt support 120 and the tether 150 can prevent the heart valve 10 from being displaced after implantation.
请继续参阅图3，主体支架110包括瓣叶支架112、连杆114及连接件116，裙边支架120及固定件130设置于瓣叶支架112上，连杆114的一端与瓣叶支架112的一端固定连接，另一端与连接件116连接，系绳150与连接件116连接。Please continue to refer to FIG. 3, the main body support 110 includes a leaflet support 112, a connecting rod 114, and a connecting piece 116. The skirt support 120 and the fixing piece 130 are disposed on the leaflet support 112. One end of the connecting rod 114 is connected to the leaflet support 112. One end is fixedly connected, the other end is connected to the connecting piece 116, and the tether 150 is connected to the connecting piece 116.
在图示的实施方式中，瓣叶支架112大致为圆筒形，具有流入端及与流入端相对的流出端。瓣叶支架112可以为心脏瓣膜10提供径向支撑力，并固定瓣叶190。请继续参阅图3，瓣叶支架112包括波圈1121及连接杆1123。瓣叶支架112包括多个沿瓣叶支架112的轴向间隔设置的波圈1121。波圈1121提供瓣叶支架112的径向支撑力。在图示的实施方式中，瓣叶支架112包括三个波圈1121。In the illustrated embodiment, the leaflet holder 112 is substantially cylindrical, and has an inflow end and an outflow end opposite to the inflow end. The leaflet support 112 can provide radial support for the heart valve 10 and fix the leaflet 190. Please continue to refer to FIG. 3, the leaflet support 112 includes a wave ring 1121 and a connecting rod 1123. The leaflet support 112 includes a plurality of wave rings 1121 spaced apart along the axial direction of the leaflet support 112. The wave ring 1121 provides the radial support force of the leaflet support 112. In the illustrated embodiment, the leaflet support 112 includes three wave circles 1121.
三个波圈1121通过多个连接杆1123连接固定。在图示的实施方式中，连接杆1123的数量与波圈1121的波谷的数量相同，一个连接杆1123同时与三个波圈1121的波谷固定连接。当然，在其他实施方式中，连接杆1123也可以与波圈1121的其他位置比如波峰固定连接。The three wave rings 1121 are connected and fixed by a plurality of connecting rods 1123. In the illustrated embodiment, the number of connecting rods 1123 is the same as the number of troughs of the wave ring 1121, and one connecting rod 1123 is fixedly connected to the troughs of the three wave rings 1121 at the same time. Of course, in other embodiments, the connecting rod 1123 may also be fixedly connected to other positions of the wave ring 1121, such as wave crests.
裙边支架120包括支撑部121及翘起部122。支撑部121自瓣叶支架112沿瓣叶支架112的径向向外延伸，翘起部122自支撑部121远离瓣叶支架112的一端向瓣叶支架112的流入端弯折延伸。支撑部121用于心脏瓣膜10在心脏的人体二尖瓣瓣环的固定，翘起部122用于防止裙边支架120的边缘对左心房组织的磨蚀。如果没有翘起部122则径向支撑部121的远端边缘直接和心房组织接触，在长期的心脏搏动下则会对心房组织形成切割效应，造成心房组织受损。而通过设置翘起部122，裙边支架120和心房组织接触就变成了面接触，增大了接触面积，降低了接触压强，避免了裙边支架120对心脏组织的切割效应，以及造成的磨蚀。The skirt bracket 120 includes a supporting portion 121 and a raised portion 122. The support portion 121 extends outward from the leaflet support 112 along the radial direction of the leaflet support 112, and the upturned portion 122 is bent and extends from an end of the support portion 121 away from the leaflet support 112 toward the inflow end of the leaflet support 112. The supporting portion 121 is used to fix the heart valve 10 in the human mitral valve annulus of the heart, and the upturned portion 122 is used to prevent the edge of the skirt stent 120 from abrading the left atrial tissue. If there is no upturned portion 122, the distal edge of the radial support portion 121 directly contacts the atrial tissue, which will cause a cutting effect on the atrial tissue under long-term heart beats, causing damage to the atrial tissue. By providing the upturned portion 122, the contact between the skirt stent 120 and the atrial tissue becomes surface contact, which increases the contact area, reduces the contact pressure, and avoids the cutting effect of the skirt stent 120 on the heart tissue and causes Abrasion.
裙边支架120的支撑部121靠近瓣叶支架112的一端与流入端的距离为瓣叶支架112轴向长度的1/4～1/2。在图示的实施例中，裙边支架120的支撑部121与靠近瓣叶支架112的第一端的波圈1121的波谷固接。如此，将心脏瓣膜10 植入心脏时，可以让瓣叶支架112近三分之一的轴向尺寸位于左心房，从而避免其过多植入左心室而造成左心室流出道狭窄甚至梗阻。The distance between the end of the support portion 121 of the skirt support 120 close to the leaflet support 112 and the inflow end is 1/4 to 1/2 of the axial length of the leaflet support 112. In the illustrated embodiment, the supporting portion 121 of the skirt bracket 120 is fixedly connected to the wave trough of the wave ring 1121 near the first end of the leaflet bracket 112. In this way, when the heart valve 10 is implanted into the heart, nearly one-third of the axial dimension of the leaflet stent 112 can be located in the left atrium, thereby avoiding excessive implantation of the left ventricle to cause stenosis or even obstruction of the left ventricular outflow tract.
在本实施例中，裙边支架120的支撑部121的外轮廓从瓣膜血流流入侧看为圆形。当然，其他实施例中，支撑部121的外轮廓还可以为其他形状，例如D型，类D型，或椭圆形。In this embodiment, the outer contour of the supporting portion 121 of the skirt stent 120 is circular when viewed from the inflow side of the valve blood flow. Of course, in other embodiments, the outer contour of the supporting portion 121 may also have other shapes, such as D-shaped, D-like, or elliptical.
阻流件170用于阻断血流通过瓣膜支架110外溢，与瓣叶190配合保证血液在心脏瓣膜10内的单向流动。阻流件170的材料为PTFE、PET、PU、肠衣或动物心包。阻流件170根据材质的不同，可以通过热压工艺覆合，或者通过缝合固定至瓣膜支架110。在本实施方式中，阻流件170覆盖瓣叶支架112及裙边支架120的表面。具体的，阻流件170也可以仅覆盖瓣叶支架112的内表面及外表面中的至少一个。在其中一个实施例中，为了加速心脏瓣膜100表面内皮组织的爬覆，心脏瓣膜100的非生物组织表面形成有派瑞林层。在其中一个实施例中，阻流件170表面形成有派瑞林层。派瑞林层的厚度为5纳米～5微米。优选的，派瑞林层的材料为C型派瑞林。The baffle 170 is used to block the blood flow from overflowing through the valve support 110, and cooperate with the valve leaflet 190 to ensure the unidirectional flow of blood in the heart valve 10. The material of the baffle 170 is PTFE, PET, PU, casing or animal pericardium. Depending on the material, the baffle 170 may be laminated by a hot pressing process or fixed to the valve support 110 by suture. In this embodiment, the baffle 170 covers the surfaces of the leaflet holder 112 and the skirt holder 120. Specifically, the baffle 170 may only cover at least one of the inner surface and the outer surface of the leaflet holder 112. In one of the embodiments, in order to accelerate the crawling of endothelial tissue on the surface of the heart valve 100, a parylene layer is formed on the non-biological tissue surface of the heart valve 100. In one of the embodiments, a parylene layer is formed on the surface of the baffle 170. The thickness of the parylene layer is 5 nanometers to 5 microns. Preferably, the material of the parylene layer is C-type parylene.
瓣叶190位于瓣叶支架112的内部且与瓣叶支架112表面的阻流件170固定。瓣叶190由动物心包切割而成。在本实施方式中，瓣叶190大致为扇形，共有三片，沿瓣叶支架112的周向依次排布。相邻的两片瓣叶190的靠近瓣叶支架112的内表面的一端结合在一起形成瓣角，瓣叶190的周缘通过缝合固定于瓣叶支架112和阻流件170，瓣角固定至连杆1123与瓣叶支架112的连接处。The leaflet 190 is located inside the leaflet support 112 and is fixed to the baffle 170 on the surface of the leaflet support 112. The leaflet 190 is cut from the animal pericardium. In this embodiment, the leaflet 190 is roughly fan-shaped, and there are three pieces in total, which are sequentially arranged along the circumferential direction of the leaflet holder 112. The ends of the two adjacent leaflets 190 close to the inner surface of the leaflet holder 112 are joined together to form a valve angle. The peripheral edge of the leaflet 190 is fixed to the leaflet holder 112 and the baffle member 170 by suture, and the valve angle is fixed to the connecting piece. The connection between the rod 1123 and the leaflet holder 112.
请参阅图2及图3，连杆114包括近端连杆1141、瓣叶支架连杆1142及接头(图未示)。近端连杆1141大致为杆状。瓣叶支架连杆1142大致为V型，包括两个从近端连杆1141的一端向瓣叶支架112延伸的分支杆，两个分支杆远离近端连杆1141的一端分别与瓣叶支架112靠近流出端的波圈相邻的两个波谷固接，每个波谷均与一个分支杆连接，使得多个连杆114沿流出端均匀分布，从而当心脏瓣膜10收入鞘管时起到导向作用，防止有波谷卡在鞘管外。如果瓣叶支架连杆1142连接到瓣叶支架112靠近流出端的波圈的波峰处，当心脏瓣膜10在入鞘时，波谷会卡在鞘管外。2 and 3, the connecting rod 114 includes a proximal connecting rod 1141, a leaflet support connecting rod 1142, and a joint (not shown). The proximal link 1141 is generally rod-shaped. The leaflet support link 1142 is roughly V-shaped and includes two branch rods extending from one end of the proximal link 1141 to the leaflet support 112. The ends of the two branch rods away from the proximal link 1141 are connected to the leaflet support 112 respectively. The two adjacent wave troughs of the wave circle near the outflow end are fixedly connected, and each wave trough is connected to a branch rod, so that a plurality of connecting rods 114 are evenly distributed along the outflow end, thereby playing a guiding role when the heart valve 10 is retracted into the sheath. Prevent wave troughs from getting stuck outside the sheath. If the leaflet stent link 1142 is connected to the wave crest of the leaflet stent 112 near the outflow end, when the heart valve 10 is sheathed, the wave trough will be stuck outside the sheath.
可以理解的是，瓣叶支架连杆1142还可以为其他形状，例如，可以为一字 型，从近端连杆1141的一端直接延伸与瓣叶支架112流出端的波谷连接，即，分支杆的数量与近端连杆1141的数量一致。It is understandable that the valve leaf support connecting rod 1142 can also have other shapes, for example, it can be in a straight shape, extending directly from one end of the proximal connecting rod 1141 to connect with the trough of the outflow end of the valve leaf support 112, that is, the branch rod The number is the same as that of the proximal link 1141.
需要说明的是，本申请中的瓣膜支架110的瓣叶支架112、连杆114、裙边支架120及固定件130的结构并不局限于与此，还可以根据需要对瓣膜支架100进行调整。It should be noted that the structure of the leaflet support 112, the connecting rod 114, the skirt support 120 and the fixing member 130 of the valve support 110 in the present application are not limited to this, and the valve support 100 can also be adjusted as needed.
请同时参阅图3、图5及图6，连杆114的接头与连接件116连接。连接件116包括插接座1161及与插接座1161固定连接的连接盖1163，连接盖1163开设有限位孔1162，连杆114远离瓣叶支架112的一端穿设于限位孔1162并收容于连接盖1163与插接座1161形成的空腔内。Please refer to FIG. 3, FIG. 5 and FIG. 6 at the same time, the joint of the connecting rod 114 is connected with the connecting piece 116. The connecting member 116 includes a socket 1161 and a connecting cover 1163 fixedly connected to the socket 1161. The connecting cover 1163 defines a limiting hole 1162. The end of the connecting rod 114 away from the leaflet holder 112 passes through the limiting hole 1162 and is received in the limiting hole 1162. The connection cover 1163 and the socket 1161 form a cavity.
连接盖1163包括连接套筒11631及形成于连接套筒11631一端的球冠11633，连接套筒11631远离球冠11633的一端与插接座1161套接固定形成空腔，限位孔1162为沿连接套筒11631轴向延伸的条形孔。连杆114为多个，限位孔1162也为多个，且多个限位孔1162沿连接套筒11631的周向均匀分布，每一连接杆114的接头1143穿设于一限位孔1162。限位孔1162自连接套筒11631远离球冠11633的一端延伸至球冠11633的中部，从而，将连杆114连接至连接盖1163时，连杆114的角度可以在限位孔1162内进行小角度的偏转，当心脏瓣膜10处于压缩状态和非压缩状态时，连杆114可以通过角度变化适应心脏瓣膜10的不同状态。The connecting cover 1163 includes a connecting sleeve 11631 and a spherical cap 11633 formed at one end of the connecting sleeve 11631. The end of the connecting sleeve 11631 away from the spherical cap 11633 is sleeved and fixed with the socket 1161 to form a cavity, and the limiting hole 1162 is an edge connection The sleeve 11631 has a strip hole extending axially. There are multiple connecting rods 114, and there are also multiple limiting holes 1162. The multiple limiting holes 1162 are evenly distributed along the circumferential direction of the connecting sleeve 11631. The joint 1143 of each connecting rod 114 penetrates through a limiting hole 1162. . The limiting hole 1162 extends from the end of the connecting sleeve 11631 away from the spherical crown 11633 to the middle of the spherical crown 11633, so that when the connecting rod 114 is connected to the connecting cover 1163, the angle of the connecting rod 114 can be reduced in the limiting hole 1162. The angle of deflection, when the heart valve 10 is in a compressed state and an uncompressed state, the connecting rod 114 can adapt to different states of the heart valve 10 by changing the angle.
在图示的实施方式中，插接座1161包括主体部11611及插接部11613。主体部11611大致为半球形且一端为平面，主体部11611的直径大致与球冠11633的直径相同。插接部11613凸设于主体部11611的平面，且直径小于主体部11611的直径。插接部11613收容于连接套筒11631且二者通过焊接固定。插接座1161上开设有螺孔11614，螺孔11614贯穿插接部11613及主体部11611。In the illustrated embodiment, the socket 1161 includes a main body portion 11611 and a socket portion 11613. The main body 11611 is approximately hemispherical and one end is flat. The diameter of the main body 11611 is approximately the same as the diameter of the spherical cap 11633. The plug-in portion 11613 protrudes from the plane of the main body portion 11611 and has a diameter smaller than that of the main body portion 11611. The plug-in portion 11613 is received in the connecting sleeve 11631 and the two are fixed by welding. The socket 1161 is provided with a screw hole 11614, and the screw hole 11614 penetrates the plug portion 11613 and the main body portion 11611.
在图示的实施方式中，连接件116还包括挡片1165。挡片1165收容于连接套筒11631内，且位于插接部11613靠近球冠11633的一端。挡片1165的中部开设有对应于螺孔11614的通孔11651。当然，挡片1165也可以省略。In the illustrated embodiment, the connecting member 116 further includes a blocking piece 1165. The blocking piece 1165 is received in the connecting sleeve 11631 and is located at an end of the inserting portion 11613 close to the spherical crown 11633. A through hole 11651 corresponding to the screw hole 11614 is opened in the middle of the blocking piece 1165. Of course, the blocking piece 1165 can also be omitted.
连接件116的两端均为半球形，可以减少血栓的形成以及减少对血液流体动力学的影响。Both ends of the connecting piece 116 are hemispherical, which can reduce the formation of thrombus and reduce the impact on hemodynamics.
系绳150的一端插设于螺孔11614且收容于连接盖1163与插接座1161形成的空腔内，另一端伸出连接件116并穿过心尖后打结固定在心尖的位置，起到牵拉住心脏瓣膜10作用，防止其在左心房脱落。系绳150在X射线下可见。One end of the tether 150 is inserted into the screw hole 11614 and is received in the cavity formed by the connecting cover 1163 and the socket 1161, and the other end extends out of the connecting piece 116 and passes through the apex of the heart and is knotted and fixed at the apex of the heart. The heart valve 10 is pulled to prevent it from falling off in the left atrium. The tether 150 is visible under X-rays.
在一实施例中，请参阅图4，心脏瓣膜10还可以包括垫片180。垫片180的材料选自硅胶，涤纶、尼龙、超高分子量聚乙烯、镍钛及不锈钢编织丝中的至少一种。垫片180可以为毛毡状的圆片、钛镍丝编织的盘状结构、高分子材料注塑的碟状结构。当心脏瓣膜10植入人体心脏后，系绳150远离连杆114的一端穿过心脏及垫片180后打结后与垫片180固定。In an embodiment, referring to FIG. 4, the heart valve 10 may further include a gasket 180. The material of the gasket 180 is selected from at least one of silica gel, polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium and stainless steel braided wire. The gasket 180 can be a felt-like disc, a disc-like structure woven of titanium nickel wire, or a disc-like structure made of polymer injection molding. After the heart valve 10 is implanted in the human heart, the end of the tether 150 away from the connecting rod 114 passes through the heart and the gasket 180 and is knotted and fixed with the gasket 180.
心脏瓣膜10的植入过程中，在心脏舒张期，心房开始收缩，心房内的血液射入心室，使得心室压力升高。而在心室收缩期，血液从左心室经主动脉瓣进入主动脉，靠左心室收缩产生的压力使血液进入到毛细血管中。系绳150在心室舒张和收缩期对心脏瓣膜10起到拉力作用，在心室收缩期，若系绳150与心脏瓣膜10的拉力较弱，使得心脏瓣膜10与二尖瓣的贴合出现缝隙，这将导致血液不经过心脏瓣膜10而直接从心脏瓣膜10与二尖瓣的缝隙中流入到心房，使得心脏功能异常。通过将系绳150设置成在X射线下可见，植入过程中通过X射线观察系绳150的状态，假如在X射线下系绳150出现扭曲或弯折等状态，此时可以拉紧系绳150以使其呈直线状，确保系绳150与瓣膜支架100的张力适当，以保证心脏瓣膜10在血流冲击下不会出现贴合不良，减小瓣周漏出现的概率。而若系绳150在X射线下不可见，如系绳150出现扭曲或弯折等状态时，在心室收缩期，系绳150在血流冲击下被拉直，使得心脏瓣膜10与二尖瓣的贴合之间出现缝隙而导致瓣周漏，影响心脏功能。此外，通过将系绳150设置成在X射线下可见，在随访过程中，通过观测系绳150的状态，也可以判断出是否会出现瓣周漏。During the implantation of the heart valve 10, during the diastole, the atria begin to contract, and blood in the atria is injected into the ventricles, causing the ventricular pressure to rise. During ventricular systole, blood enters the aorta from the left ventricle through the aortic valve, and the pressure generated by the contraction of the left ventricle causes the blood to enter the capillaries. The tether 150 exerts a pulling force on the heart valve 10 during ventricular diastole and systole. During ventricular systole, if the tension between the tether 150 and the heart valve 10 is weak, there will be gaps in the fit between the heart valve 10 and the mitral valve. This will cause blood to flow directly from the gap between the heart valve 10 and the mitral valve into the atrium without passing through the heart valve 10, causing abnormal heart function. By setting the tether 150 to be visible under X-rays, observe the state of the tether 150 through X-rays during the implantation process. If the tether 150 is twisted or bent under X-rays, the tether 150 can be tightened at this time 150 to make it linear, to ensure that the tension between the tether 150 and the valve stent 100 is appropriate, to ensure that the heart valve 10 does not fit poorly under the impact of blood flow, and to reduce the probability of paravalvular leakage. And if the tether 150 is not visible under X-rays, such as when the tether 150 is twisted or bent, during ventricular systole, the tether 150 is straightened under the impact of blood flow, so that the heart valve 10 and the mitral valve There is a gap between the fittings, which leads to paravalvular leakage, which affects heart function. In addition, by setting the tether 150 to be visible under X-rays, during the follow-up process, by observing the state of the tether 150, it can also be determined whether there will be a paravalvular leak.
具体的，系绳150可以由掺杂有显影材料的高分子制成。例如，将显影材料分散在生物相容性较好的高分子基质中，制作成系绳150。高分子基质可以为硅胶、聚丙烯(PP)、聚氨酯(PU)、聚乙烯(PE)、聚醚醚酮(PEEK)、聚乳酸(PLA)、聚乙醇酸(PGA)、聚羟基脂肪酸脂(PHA)、聚二氧环己酮(PDO)、聚己内酯(PCL)或超高分子量聚乙烯(UHMWPE)。显影材料可以为金、钨、 铁、铂金、钛及其合金、不锈钢等金属材料，也可以为硫酸钡、次碳酸铋、碘化物(如碘海醇、碘帕醇)等非金属材料。系绳150中显影材料的质量不小于系绳150质量的10％，以提高系绳150在X射线下的显影性。系绳150的线径为0.02mm～5.0mm，以使得系绳150能在输送器中正常输送。Specifically, the tether 150 may be made of polymer doped with developing materials. For example, the developing material is dispersed in a polymer matrix with good biocompatibility to make the tether 150. The polymer matrix can be silica gel, polypropylene (PP), polyurethane (PU), polyethylene (PE), polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), polyhydroxy fatty acid ester ( PHA), polydioxanone (PDO), polycaprolactone (PCL) or ultra-high molecular weight polyethylene (UHMWPE). The developing material can be metal materials such as gold, tungsten, iron, platinum, titanium and its alloys, stainless steel, or non-metallic materials such as barium sulfate, bismuth subcarbonate, and iodides (such as iohexol and iopamidol). The mass of the developing material in the tether 150 is not less than 10% of the mass of the tether 150 to improve the developability of the tether 150 under X-rays. The wire diameter of the tether 150 is 0.02 mm to 5.0 mm, so that the tether 150 can be conveyed normally in the conveyor.
在一个实施例中，系绳150由掺杂有硫酸钡的聚氨酯制成，其制备可以分为两步。第一步为熔融造粒。首先将聚氨酯和硫酸钡干燥，干燥温度可以为60～140℃，干燥时间可以为2～8h，将干燥后的聚氨酯和硫酸钡倒入单螺杆或双螺杆中，控制挤出机温度120～200℃(其中进料段的温度不宜过高，一般控制在120～150℃)，模头温度160～190℃，聚氨酯经过挤出机的塑化和均化，从模头挤出，并经过切刀切割，完成造粒。在本实施例中，聚氨酯和硫酸钡的投料比为40:60，进料段的温度为145℃，熔融段温度为165℃，均化段温度为175℃，机头温度170℃。第二步为挤出成型。将步骤一造出的颗粒烘干，干燥温度可以为60～140℃，干燥时间可以为2～8h，将干燥后的颗粒加入到单螺杆挤出机中，控制挤出机温度120～200℃，螺杆转速0～60rpm，牵引速率控制在0～200m/min,得到系绳150。在本实施例中，进料段的温度控制在140℃，熔融段温度控制在160℃，均化段控制在180℃，机头温度控制在170℃，螺杆转速为30rpm，牵引速度为10m/min，最终得到的系绳的线径为0.15mm。In one embodiment, the tether 150 is made of polyurethane doped with barium sulfate, and its preparation can be divided into two steps. The first step is melt granulation. First, dry the polyurethane and barium sulfate. The drying temperature can be 60～140℃, and the drying time can be 2～8h. Pour the dried polyurethane and barium sulfate into a single screw or twin screw, and control the extruder temperature to 120～200 ℃ (the temperature of the feed section should not be too high, generally controlled at 120-150℃), the die temperature is 160-190℃, the polyurethane is plasticized and homogenized by the extruder, extruded from the die, and cut Knife cutting to complete granulation. In this embodiment, the feeding ratio of polyurethane and barium sulfate is 40:60, the temperature of the feeding section is 145°C, the temperature of the melting section is 165°C, the temperature of the homogenization section is 175°C, and the temperature of the die is 170°C. The second step is extrusion molding. Dry the pellets produced in step 1, the drying temperature can be 60～140℃, the drying time can be 2～8h, add the dried pellets to the single screw extruder, and control the extruder temperature at 120～200℃ , The screw speed is 0-60rpm, the traction speed is controlled at 0-200m/min, and the tether 150 is obtained. In this embodiment, the temperature of the feeding section is controlled at 140°C, the temperature of the melting section is controlled at 160°C, the homogenization section is controlled at 180°C, the head temperature is controlled at 170°C, the screw speed is 30rpm, and the traction speed is 10m/ min, the wire diameter of the final tether is 0.15mm.
请参阅图7，本申请第二实施例与第一实施例的不同之处主要在于，系绳250包括显影线251及非显影线252，显影线251及非显影线252经过编织形成系绳250，例如加捻编织、经纬编织等。在图示的实施例中，显影线251及非显影线252通过加捻编织而成。显影线251及非显影线252至少各为1根，捻向可以为S、Z向等。为保证加捻的系绳250不易散开和内应力不太大，捻度应控制适中，优选的捻度为1～100个/米。本实施例中，显影线251为镍钛丝，直径为0.1mm；非显影线252为尼龙线，规格为80D/20F；1根显影线251和3根非显影线252沿着S向进行加捻，捻度为50个/米，制得系绳150，线径0.3mm。Referring to FIG. 7, the second embodiment of the present application differs from the first embodiment mainly in that the tether 250 includes a developing thread 251 and a non-developing thread 252. The developing thread 251 and the non-developing thread 252 are woven to form a tether 250. , Such as twisted knitting, warp and weft knitting. In the illustrated embodiment, the developed yarn 251 and the non-developed yarn 252 are knitted by twisting. There are at least one developing thread 251 and non-developing thread 252 each, and the twist direction may be S, Z direction, or the like. In order to ensure that the twisted tether 250 is not easy to spread out and the internal stress is not too large, the twist should be moderately controlled, and the preferred twist is 1-100 per meter. In this embodiment, the developing thread 251 is a nickel-titanium wire with a diameter of 0.1mm; the non-developing thread 252 is a nylon thread with a specification of 80D/20F; one developing thread 251 and three non-developing threads 252 are added along the S direction. Twist, the twist is 50 per meter, the tether 150 is made, and the wire diameter is 0.3mm.
将制备的系绳250进行打结，并对比显影线251，请参阅图8及9，显影线251单独打结会形成较大的空隙，线结在拉伸过程中容易散开，而系绳250打结后形成的空隙较小，打结性能具有较大地提高。Tie the prepared tether 250 and compare it with the developed thread 251. Please refer to Figures 8 and 9. The separate knot of the developed thread 251 will form a larger gap. The knots are easy to unravel during the stretching process. The gap formed after 250 knotting is smaller, and the knotting performance is greatly improved.
当然，在其他实施例中，显影线251还可以为其他金属材料，如金、钨、铁、铂金、钛及其合金、不锈钢等，还可以为掺杂有显影材料的高分子材料。非显影线152的材质还可以为硅胶、聚丙烯(PP)、聚氨酯(PU)、聚乙烯(PE)、聚醚醚酮(PEEK)、聚乳酸(PLA)、聚乙醇酸(PGA)、聚羟基脂肪酸脂(PHA)、聚二氧环己酮(PDO)、聚己内酯(PCL)或超高分子量聚乙烯(UHMWPE)。Of course, in other embodiments, the developing wire 251 can also be made of other metal materials, such as gold, tungsten, iron, platinum, titanium and its alloys, stainless steel, etc., or can also be a polymer material doped with developing materials. The material of the non-developing line 152 can also be silicone, polypropylene (PP), polyurethane (PU), polyethylene (PE), polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), poly Hydroxy fatty acid ester (PHA), polydioxanone (PDO), polycaprolactone (PCL) or ultra-high molecular weight polyethylene (UHMWPE).
请参阅图10，本申请第三实施例与第一实施例的不同之处主要在于，系绳350包括芯层353及包裹在芯层353外的编织层354，芯层353由掺杂有显影材料的高分子材料制成，编织层354由高分子线编织而成。上述系绳，可以在X射线下可见，而且可以解决金属系绳打结较难，高分子显影系绳由于加入显影剂后力学性能下降的缺陷，实现较优的打结性能和力学性能。10, the main difference between the third embodiment of this application and the first embodiment is that the tether 350 includes a core layer 353 and a braided layer 354 wrapped around the core layer 353. The core layer 353 is doped with The material is made of polymer materials, and the braided layer 354 is knitted by polymer threads. The above-mentioned tether can be seen under X-rays, and it can solve the problem that the metal tether is difficult to knot, and the mechanical properties of the polymer developing tether are reduced after the developer is added, so as to achieve better knotting and mechanical properties.
例如，将显影材料分散在生物相容性较好的高分子基质中，制作成芯层353。高分子基质可以为硅胶、聚丙烯(PP)、聚氨酯(PU)、聚乙烯(PE)、聚醚醚酮(PEEK)、聚乳酸(PLA)、聚乙醇酸(PGA)、聚羟基脂肪酸脂(PHA)、聚二氧环己酮(PDO)、聚己内酯(PCL)或超高分子量聚乙烯(UHMWPE)。显影材料可以为金、钨、铁、铂金、钛及其合金、不锈钢等金属材料，也可以为硫酸钡、次碳酸铋、碘化物(如碘海醇、碘帕醇)等非金属材料。芯层353中显影材料的质量不小于芯层353质量的10％，以提高系绳350在X射线下的显影性。编织层154的高分子线可以采用注塑、挤出、3D打印、激光切割、静电纺丝等制备，材质可以为各种生物相容性良好的材料，包括但不限于超高分子量聚乙烯(UHMWPE)、聚四氟乙烯(PTFE)、尼龙(PA)、聚对苯二甲酸乙二醇酯(PET)、聚丙烯(PP)、聚氨酯(PU)、聚乙烯(PE)、聚醚醚酮(PEEK)、聚乳酸(PLA)、聚乙醇酸(PGA)、聚羟基脂肪酸脂(PHA)、聚二氧环己酮(PDO)或聚己内酯(PCL)。高分子线可以通过经纬编织的方式在芯层353外侧形成编织层354。For example, the developing material is dispersed in a polymer matrix with good biocompatibility to form the core layer 353. The polymer matrix can be silica gel, polypropylene (PP), polyurethane (PU), polyethylene (PE), polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), polyhydroxy fatty acid ester ( PHA), polydioxanone (PDO), polycaprolactone (PCL) or ultra-high molecular weight polyethylene (UHMWPE). The developing material can be metal materials such as gold, tungsten, iron, platinum, titanium and its alloys, stainless steel, or non-metallic materials such as barium sulfate, bismuth subcarbonate, and iodide (such as iohexol and iopamidol). The mass of the developing material in the core layer 353 is not less than 10% of the mass of the core layer 353 to improve the developability of the tether 350 under X-rays. The polymer thread of the braid 154 can be prepared by injection molding, extrusion, 3D printing, laser cutting, electrostatic spinning, etc. The material can be various materials with good biocompatibility, including but not limited to ultra-high molecular weight polyethylene (UHMWPE). ), polytetrafluoroethylene (PTFE), nylon (PA), polyethylene terephthalate (PET), polypropylene (PP), polyurethane (PU), polyethylene (PE), polyether ether ketone ( PEEK), polylactic acid (PLA), polyglycolic acid (PGA), polyhydroxy fatty acid ester (PHA), polydioxanone (PDO) or polycaprolactone (PCL). The polymer yarn can form a braided layer 354 outside the core layer 353 by means of warp and weft knitting.
在一实施方式中，芯层353采用掺杂有钨粉的聚丙烯通过3D打印的方式制成，编织层354采用超高分子量聚乙烯纱股通过一压一的方式编织而成，具体制备方法如下。首先将聚丙烯和钨粉干燥，干燥温度可以为60～140℃，干燥时间可以为2～8h，将干燥后的聚丙烯和钨粉倒入单螺杆或双螺杆中，控制挤出机 温度150～230℃(其中进料段的温度不宜过高，一般控制在150～200℃)，模头温度190～230℃，聚丙烯经过挤出机的塑化和均化，从模头挤出，并经过切刀切割，完成造粒。在本实施例中，聚丙烯和钨粉的投料比为80:20，进料段的温度为190℃，熔融段温度为200℃，均化段温度为210℃，机头温度200℃。其次利用UG、Solidworks、Pro-E等三维设计软件绘制出显影高分子连接线81的三维实体模型，并保存为.stl格式，导入切片软件，并将干燥好的聚丙烯颗粒置于3D打印机的材料供料装置中，为保证打印出的连接线的完整性，应控制打印填充密度、打印温度、打印速度等工艺参数适当。例如，控制打印温度170～250℃，打印填充密度50～90％，打印速度50～200mm/s。本实施例中，控制打印温度200℃，打印填充密度70％，打印速度50mm/s。最后，利用切片软件将.stl模型和工艺参数生成为3D打印路径文件Gcode，3D打印机在代码的控制下打印出芯层353，线径0.1mm。将芯层353放于纱股中央，纱股绕着芯层进行编织，纱股可以为任意双股数，编织可以采用但不限于压编如一压一、一压二，使得纱股相互穿插交织，制得编织绳。请参阅图11，采用8股纱股编织，用一压一的编织方式，4股纱股(编号b、d、f、h)沿着同一方向，另4股纱股(编号a、c、e、g)沿着对称的方向，编织时将8股纱和芯层153一端固定在一起，将b纱股沿着与a纱线对称的方向压在a纱股上，c纱股沿着与b纱股对称的方向压在b纱股上，d纱股沿着与b纱股相同的方向压在c纱股上，最后将a压在h纱股上，重复操作，制得系绳，线径为0.5mm。In one embodiment, the core layer 353 is made of polypropylene doped with tungsten powder by 3D printing, and the braided layer 354 is made of ultra-high molecular weight polyethylene yarns woven by pressing one by one. The specific preparation method as follows. Firstly, the polypropylene and tungsten powder are dried. The drying temperature can be 60～140℃, and the drying time can be 2～8h. Pour the dried polypropylene and tungsten powder into a single screw or twin screw, and control the extruder temperature to 150 ～230℃ (the temperature of the feed section should not be too high, generally controlled at 150～200℃), the die temperature is 190～230℃, the polypropylene is plasticized and homogenized by the extruder and extruded from the die. And after cutting with a cutter, granulation is completed. In this embodiment, the feeding ratio of polypropylene and tungsten powder is 80:20, the temperature of the feeding section is 190°C, the temperature of the melting section is 200°C, the temperature of the homogenization section is 210°C, and the temperature of the die is 200°C. Secondly, use UG, Solidworks, Pro-E and other three-dimensional design software to draw the three-dimensional solid model of the developed polymer connecting line 81, and save it as .stl format, import the slicing software, and place the dried polypropylene particles in the 3D printer In the material feeding device, in order to ensure the integrity of the printed connecting lines, the printing filling density, printing temperature, printing speed and other process parameters should be properly controlled. For example, control the printing temperature of 170-250°C, the printing filling density of 50-90%, and the printing speed of 50-200mm/s. In this embodiment, the printing temperature is controlled to be 200°C, the printing filling density is 70%, and the printing speed is 50 mm/s. Finally, the slicing software is used to generate the .stl model and process parameters into a 3D printing path file Gcode, and the 3D printer prints the core layer 353 under the control of the code, with a wire diameter of 0.1mm. The core layer 353 is placed in the center of the yarn strands, and the yarn strands are woven around the core layer. The yarn strands can be any number of double strands. The knitting can be but not limited to compression knitting such as one pressing one, one pressing two, so that the yarn strands intersperse and weave , The braided rope is made. Please refer to Figure 11, using 8-ply yarn weaving, using one-press-one knitting method, 4 yarn strands (number b, d, f, h) along the same direction, the other 4 yarn strands (number a, c, e, g) Along the symmetrical direction, the 8-ply yarn and one end of the core layer 153 are fixed together when weaving, and the b yarn strand is pressed on the a yarn strand in a direction symmetrical to the a yarn, and the c yarn strand is along the The b yarn strand is pressed on the b yarn strand in a symmetrical direction, the d yarn strand is pressed on the c yarn strand in the same direction as the b yarn strand, and finally a is pressed on the h yarn strand, and the operation is repeated to obtain a tether. The wire diameter is 0.5mm.
将制备得到的系绳与芯层通过UTM-2460万能拉伸试验机，采用GB/T8834测试标准进行测试，结果如图12所示。可以得出，芯层的弹性模量仅为1.1GPa，而添加高分子聚乙烯编织线的系绳的弹性模量为107GPa。由此可知，The prepared tether and core layer were tested using the UTM-2460 universal tensile testing machine, using the GB/T8834 test standard, and the results are shown in Figure 12. It can be concluded that the elastic modulus of the core layer is only 1.1 GPa, while the elastic modulus of the tether with high molecular polyethylene braided wire is 107 GPa. It can be seen that
需要说明的是，在其他实施例中，芯层353也可以采用没有掺杂显影材料的高分子材料制成，编织层由掺杂由显影材料的高分子线编织而成。It should be noted that, in other embodiments, the core layer 353 may also be made of a polymer material that is not doped with a developing material, and the braided layer is knitted by a polymer wire doped with a developing material.
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发明的几种实施方式，其描述较为具体和详细， 但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明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 present invention, and their description is relatively specific and detailed, but they should not be understood as limiting the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can be made, and these all fall within the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims (10)

  1. 一种心脏瓣膜，其特征在于，包括：A heart valve, characterized in that it comprises:
    瓣膜支架，所述瓣膜支架包括主体支架及设置于所述主体支架上的裙边支架，所述裙边支架沿所述主体支架的径向向外延伸；A valve stent, the valve stent includes a main body stent and a skirt stent disposed on the main body stent, the skirt stent extending outward along a radial direction of the main body stent;
    瓣叶，所述瓣叶设置于所述主体支架内；及The valve leaflets are arranged in the main body stent; and
    系绳，所述系绳与所述主体支架连接，所述系绳在X射线下可见。The tether is connected with the main body support, and the tether is visible under X-rays.
  2. 根据权利要求1所述的心脏瓣膜，其特征在于，所述系绳由掺杂有显影材料的高分子材料制成。The heart valve of claim 1, wherein the tether is made of a polymer material doped with a developing material.
  3. 根据权利要求2所述的心脏瓣膜，其特征在于，所述显影材料的质量不小于所述系绳质量的10％。The heart valve according to claim 2, wherein the mass of the imaging material is not less than 10% of the mass of the tether.
  4. 根据权利要求1所述的心脏瓣膜，其特征在于，所述系绳包括：The heart valve of claim 1, wherein the tether comprises:
    芯层，所述芯层由掺杂有显影材料的高分子材料制成，及A core layer made of a polymer material doped with a developing material, and
    编织层，所述编织层包裹在所述芯层外，所述编织层由高分子线编织而成。A braided layer, the braided layer is wrapped around the core layer, and the braided layer is braided by polymer wires.
  5. 根据权利要求4所述的心脏瓣膜，其特征在于，所述显影材料的质量不小于所述芯层质量的10％。The heart valve according to claim 4, wherein the mass of the developing material is not less than 10% of the mass of the core layer.
  6. 根据权利要求1所述的心脏瓣膜，其特征在于，所述主体支架包括瓣叶支架、连杆及连接件，所述裙边支架设置于所述瓣叶支架上，所述连杆的一端与所述瓣叶支架的一端固定连接，另一端与所述连接件连接，所述系绳与所述连接件连接。The heart valve of claim 1, wherein the main body stent comprises a leaflet stent, a connecting rod and a connecting piece, the skirt stent is disposed on the leaflet stent, and one end of the connecting rod is connected to One end of the leaflet bracket is fixedly connected, the other end is connected with the connecting piece, and the tether is connected with the connecting piece.
  7. 根据权利要求1～6任一项所述的心脏瓣膜，其特征在于，所述系绳的线径为0.02mm～5.0mm。The heart valve according to any one of claims 1 to 6, wherein the wire diameter of the tether is 0.02 mm to 5.0 mm.
  8. 一种用于心脏瓣膜的系绳，其特征在于，包括：A tether for a heart valve, which is characterized in that it comprises:
    芯层，所述芯层由掺杂有显影材料的高分子材料制成，及A core layer made of a polymer material doped with a developing material, and
    编织层，所述编织层包裹在所述芯层外，所述编织层由高分子线编织而成。A braided layer, the braided layer is wrapped around the core layer, and the braided layer is braided by polymer wires.
  9. 根据权利要求8所述的系绳，其特征在于，所述显影材料的质量不小于所述芯层质量的10％。The tether according to claim 8, wherein the mass of the developing material is not less than 10% of the mass of the core layer.
  10. 根据权利要求8所述的系绳，其特征在于，所述系绳的线径为0.02mm～5.0mm。The tether according to claim 8, wherein the wire diameter of the tether is 0.02 mm to 5.0 mm.
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