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WO2018145365A1 - 治疗瓣膜反流的装置 - Google Patents

治疗瓣膜反流的装置 Download PDF

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Publication number
WO2018145365A1
WO2018145365A1 PCT/CN2017/084157 CN2017084157W WO2018145365A1 WO 2018145365 A1 WO2018145365 A1 WO 2018145365A1 CN 2017084157 W CN2017084157 W CN 2017084157W WO 2018145365 A1 WO2018145365 A1 WO 2018145365A1
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WO
WIPO (PCT)
Prior art keywords
frame
valve
heart
apex
valvular regurgitation
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Application number
PCT/CN2017/084157
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English (en)
French (fr)
Inventor
李守彦
南红霞
Original Assignee
上海甲悦医疗器械有限公司
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 上海甲悦医疗器械有限公司 filed Critical 上海甲悦医疗器械有限公司
Priority to US16/468,286 priority Critical patent/US20200069419A1/en
Priority to CN201780034704.2A priority patent/CN109414321B/zh
Publication of WO2018145365A1 publication Critical patent/WO2018145365A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0015—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
    • A61F2250/0017—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight differing in yarn density
    • 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
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    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
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Definitions

  • the invention belongs to the field of cardiac repair technology and medical device, and particularly relates to an implantable device for treating heart valve reflux and an implantation method thereof.
  • the mammalian heart contains four chambers as shown in Figure 1, ie two are the atrium filling the chamber, and two are the ventricles that are pumped out of the chamber.
  • the left ventricle 3 is located at the upper left of the apex 5, and the mitral valve 2 is located between the left atrium 1 and the left ventricle 3, and the mitral valve 2 controls the flow of blood from the left atrium 1 into the left ventricle 3 in one direction.
  • the dysfunctional mitral valve 2 causes the two leaflets of the mitral valve 2 to be incompletely closed, causing blood to flow back from the left ventricle 3 back to the left atrium during systole.
  • Mitral regurgitation will cause pulmonary congestion and left ventricular 3 hypertrophy, which ultimately leads to heart failure and death in the patient.
  • the structure of the mitral valve is shown in Figure 2.
  • the mitral valve is a complex one-way valve structure that withstands blood pressure, consisting of an annulus 2.1, a anterior leaflet 2.2, a posterior leaflet 2.3, a chordae 2.4, a papillary muscle 2.5, and a left Myocardium on the ventricular wall.
  • the papillary muscle 2.5 is attached to the left ventricular wall
  • the anterior leaflet 2.2 and the posterior leaflet 2.3 are attached to the annulus 2.1.
  • the annulus 2.1 is an internal tissue structure that connects the anterior leaflet 2.2, the posterior leaflet 2.3, and the left ventricular wall.
  • tissue structure of the annulus 2.1 it is divided into a fibrous layer of the anterior medial segment and a muscle layer of the posterolateral segment.
  • the chordae 2.4 starts from the papillary muscle 2.5 and attaches to the leaflets to prevent the anterior leaflet 2.2 and the posterior leaflet 2.3 from collapsing into the left atrium when the heart contracts.
  • the dysfunctional mitral valve causes the two lobes of the mitral valve to be incompletely closed, causing blood to flow back from the left ventricle back to the left atrium during systole. Mitral regurgitation will cause pulmonary congestion and left heart Hypertrophy of the room eventually leads to heart failure and death, so mitral regurgitation is a major health condition.
  • the number of patients is large, with a conservative estimate of more than 100 million people.
  • Current treatments are surgical repair of the valve or, in some cases, valve replacement when it is not possible to repair.
  • MitraClip mitral valve clip on the market is a proven prosthetic device for the treatment of mitral regurgitation, but it can only be used in relatively few patients, usually patients with regurgitation caused by mitral valve prolapse, There is still residual reflux, which is not effective for patients with ischemic mitral regurgitation.
  • the structure under the annulus will increase weight and calcification, and there is a risk of chordae rupture.
  • More mitral valve repair techniques use minimally invasive instruments to simulate surgical valve repair, such as experimental instruments that limit the mitral annulus or use instruments to limit papillary muscle dislocation and chordae repair.
  • Invasive prosthetic valve replacement methods also encounter difficulties, such as the placement of anchoring devices on the enlarged native valve annulus, which sometimes causes the annulus to continue to expand, and large valves often result in greatly reduced prosthetic valve life.
  • the invasive annuloplasty ring is not as robust in use as a minimally invasive repair device as in a happy procedure. Therefore, suitable replacement/anchoring devices are highly challenging and affect the efficiency of this device application. All of the devices described above have one thing in common: these minimally invasive methods of treating valvular regurgitation have significant, unpredictable effects on native valve and annulus structures.
  • the minimally invasive mitral or tricuspid plug technique has the advantage of minimal interference with the native valve structure, ie, a plug or plate is placed in the reflux region where the autologous mitral or tricuspid leaflets cannot be closed to prevent the Flow, however, the plug or plate will increase blood flow resistance when the valve is open, resulting in a narrow valve passage. More serious is the risk of increased thrombosis in patients due to blocked blood flow.
  • transcatheter prosthetic valve replacement requires a large anchoring ring, which affects the life of the prosthetic valve and affects the function of the annulus; Although the technique is effective in reducing reflux, it restricts blood flow when the valve is opened, resulting in a mitral valve. Or tricuspid stenosis, increasing the risk of thrombosis in patients, so it is necessary to explore a more effective and safe technique for the treatment of mitral or tricuspid atresia.
  • the present invention can prevent the blood from flowing back during the systole of the valve by implanting a device with a prosthetic valve leaflet at the opening of the valve to ensure maximum blood flow during diastole.
  • the effective orifice area of the blood inflow prevents mitral or tricuspid stenosis, and the device is positioned accurately and firmly, does not adhere to the native annulus, has good durability, and is used for treating valvular regurgitation, especially mitral valve Or tricuspid regurgitation provides an effective treatment option.
  • a first aspect of the present invention provides a device for treating valvular regurgitation, comprising a frame and an anchoring device, the anchoring device being coupled to a frame; the frame being expandable and compressible, having an inflow end and an opposite outflow end; The interior of the frame is provided with valve leaflets that can be opened and closed in the blood flow; the anchoring device is capable of maintaining the position of the frame in the expanded state at the orifice of the native valve of the heart.
  • the anchoring device Under the action of the anchoring device, when the primary valve is closed, the outer periphery of the frame in the expanded state can contact or conform to the native valve; when the primary valve is opened, the frame in the expanded state can be freed in the orifice of the native valve of the heart, Will arbitrarily move in the heart.
  • the frame When the device is applied to the mitral or tricuspid valve, the frame can maintain the posture of the blood flowing from the atrium into the ventricle in the direction of the long axis of the heart, conforming to the joint of the native valve leaflet and the frame in the short axis direction.
  • the frame has an expandable and compressible mesh structure, and at least a portion of the inner and/or outer peripheral surface of the frame is provided with a cover film; the cover film covers at least the outer periphery of the frame where the valve leaflets and the frame are joined .
  • the frame has an expandable and compressible mesh structure having a diamond-shaped and/or hexagonal mesh; or the mesh structure is formed by intersecting straight lines and arcs with irregular arcs The mesh of the side.
  • the material of the frame includes an elastic metal material, an elastic polymer material or a memory alloy material.
  • the frame may be woven by integral laser lithography, 3D printing or by filamentary material.
  • the frame is internally provided with all or part of the reinforcing member;
  • the reinforcing member comprises a plate member, a column member, or a plate member having a mesh structure and a column member.
  • the length of the frame from the inflow end to the outflow end in the longitudinal direction of the heart is 20-80 mm.
  • the cross-section inside the frame, or the in-plane cross-section of the short axis of the heart is perpendicular to the long axis of the heart.
  • the frame has a cross-sectional thickness of 3-30 mm in the plane of the short axis of the heart when the frame is expanded, and a width of 1-50 mm.
  • the frame length, width, and thickness can be adjusted according to the patient's heart size.
  • the shape of the cross section of the short axis of the heart when the frame is expanded includes a circular shape, an elliptical shape, a rectangular shape or a rounded rectangular shape, a crescent shape or a crescent shape with rounded corners, a dumbbell shape, and a rectangular shape of two sides and a semicircle.
  • the combined shape, trapezoidal or trapezoidal with rounded corners, and their combined shape, or the overall shape resembles a crescent shape with an arc in the middle and a smaller thickness in the middle than at both ends.
  • the shape of the cross section in the plane of the short axis of the heart is bilaterally symmetrical or asymmetrical.
  • the shape of the cross section of the short axis of the heart when the frame is expanded continuously changes continuously or in stages from the inflow end to the outflow end of the frame.
  • the cover film is joined to the frame by sintering, welding, gluing or stitching; the cover film covers the outer periphery of the frame at the junction of the valve leaflets and the frame and the inner circumference of the frame.
  • the cover film is an outer cover film
  • the length of the outer cover film is less than or equal to the length of the frame
  • the coverage area of the inner cover film is less than or equal to the coverage area of the outer cover film.
  • the inner cover film preferably covers the inner circumference of the frame near the side of the ventricle where the frame and the valve leaflet are joined.
  • the length of the cover film from the inflow end to the outflow end along the expanded frame is 5-60 mm.
  • Materials for the cover film include blood compatible materials, artificial blood vessel materials, animal valves, animal pericardium, and high molecular polymers.
  • the valve leaflets comprise a single leaf valve, a bilobal valve, a trilobal valve or a four leaf valve; the valve leaflets are combined with a frame having a mesh structure by means of stitching, gluing.
  • the material of the valve leaflet includes an animal valve, an animal pericardium, an artificial chordae, a high molecular polymer, an artificial blood vessel material.
  • the valve leaflet root is connected to the cover film disposed on the frame and/or the frame, the valve leaflet opening and closing portion is connected with the connecting body; the connecting body is connected with the cover film disposed on the frame and/or the frame; the connecting body comprises a strip Shape, filament, sheet, column, mesh or a combination of these structures.
  • the valve leaflets are placed inside the frame by being pulled by the connecting body unit.
  • the linker can be obtained by cutting an animal valve, an animal pericardium, an artificial chordae, a polymer or an artificial blood vessel material. Artificial chordae can be cut from animal valves and/or pericardium, and can be cut from the valve leaflets.
  • the anchoring device maintains the frame at an orifice location of the native valve, preferably the anchoring device includes a connector and an anchor; the anchor is coupled to the frame by a connector; the anchor comprises An anchoring member disposed on the annulus, an intra-tissue anchor between the two papillary muscles disposed at or near the apex, a stent disposed on the surface of the intraventricular wall, and/or an intra-tissue anchor, disposed in the atrial lumen An open cup-shaped stent, an intra-tissue anchor disposed on the inner wall surface of the atrium, a frame having a mesh structure disposed in the atrial lumen, or a combination of the above anchors; the connector includes a rod shape, a wire shape, A sheet, column or tube connector, or a combination of these structures.
  • the material of the connecting member comprises an elastic metal material, a memory alloy material or an elastic polymer material.
  • the connector may be obtained by an integral molding technique extending from the outflow end of the frame.
  • a cover film may be provided on the outer periphery of the connector, preferably a cover film prepared from a blood compatible material.
  • the connector is coupled to the anchor by an elastic or hinge capable of operating a particular degree of freedom; the anchoring device is capable of swinging or rotating the frame at the location of the orifice of the native valve.
  • the apex is provided with an apex snap ring that prevents the anchor from swaying, and the snap ring can withstand the tension and pressure from the connector.
  • the anchoring device comprises a support rod, a positioning sleeve, a apex snap ring and a fixing plug; the proximal end of the support rod is connected with the outflow end of the frame; the distal end of the support rod is connected with the positioning sleeve; the apex card
  • the ring is fixed between the apex of the apex or the apex of the apex;
  • the positioning sleeve is fixed on the apex clasp;
  • the fixed plug is connected with the apex clasp and located outside the apex for positioning the apex clasp; the positioning sleeve and the support
  • the rod can move or slide relative to each other.
  • the connection manner of the support rod with the anchor and the frame comprises an elastic connection or a hinge connection.
  • the support rod is partially bent from 0 to 30 degrees from the proximal end to the distal end, and then connected to the anchor, and the angle of the partial bending may also be 1-20 degrees, 5-10 degrees.
  • a second technical solution of the present invention provides a method for implanting a valvular regurgitation device, wherein the expandable and compressible frame is compressed and placed in a sleeve, and then passed through Minimally invasive technique implants the heart to bring the frame into an expanded state, and uses an anchoring device attached to the frame to position the frame at the native valve orifice such that the closed heart native valve fits the outer surface of the frame; anchoring The device is introduced into the heart by compression into the cannula, which is introduced simultaneously or not simultaneously with the frame; the frame and anchoring device are fully recovered or partially recovered using the original introduction method after failure or completion of treatment.
  • a method of implanting a therapeutic valve regurgitation device comprises the following steps:
  • the expandable and compressed frame and the connector connected to the frame are assembled and compressed into the puncture catheter in vitro, and the piercing catheter tail is provided with an anchor and an operating rod connected with the connecting member; Opening a closed valve leaflet in blood flow; the frame having an inflow end and an opposite outflow end, the outer periphery of the frame being provided with a cover film at the junction of the valve leaflet and the frame;
  • the present invention provides the use of any of the above-described devices for treating valvular regurgitation in the treatment of heart valve reflux, the heart valve reflux being selected from the group consisting of mitral regurgitation and/or tricuspid regurgitation.
  • the device of the present invention with artificial valve leaflets can reduce the overcurrent resistance when the native valve is opened, effectively reduce the thrombus and the internal biological risk;
  • the device of the invention has simple structure, accurate positioning and size Small, suitable for a variety of pathological mitral / tricuspid regurgitation patients, the choice of a suitable frame, or a small modification of the anchoring device and frame size can be applied to children to high-risk elderly patients, and valve prolapse The treatment is also applicable;
  • the anchoring device of the invention can be disposed not on the native annulus, has less interference to the structure of the native valve annulus, reduces the correct positioning process and knowledge requirements of the surgeon, and has simple operation and high success rate;
  • the device of the present invention has less consumables, is more suitable for intervention through a catheter, has more durable durability, and is recyclable, and has extremely high clinical value compared with a replacement/displacement prosthetic valve.
  • Figure 1 Schematic diagram of human heart anatomy: 1 is the left atrium, 2 is the mitral valve, 3 is the left ventricle, 4 is the aortic valve, and 5 is the apex.
  • Figure 2 Schematic diagram of the tissue structure of the mitral valve 2 in Figure 1: 2.1 annulus, 2.2 anterior leaflet, 2.3 posterior leaflet, 2.4 chordae, 2.5 papillary muscle.
  • Figure 3 Schematic diagram of the mitral valve shown in Figure 2 when the systole is normally closed and closed.
  • Figure 3a1 is the right side view of the mitral valve when it is normally closed;
  • Figure 3a2 is the atrial side of the mitral valve when it is normally closed.
  • Figure 3b1 is the right side view of the mitral regurgitation when the mitral regurgitation is incomplete;
  • Figure 3b2 is a partial enlarged view of the atrial side of the mitral regurgitation when the mitral regurgitation is incomplete;
  • Figure 4 Schematic diagram of the frame of Embodiment 1:
  • Figure 4a1 is a perspective view of the frame
  • Figure 4a2 is a front view of Figure 4a1
  • Figure 4a3 is a side view of 4a1
  • Figure 4a4 is a top view of Figure 4a1
  • Figure 4b1 is a change of the shape of the frame mesh
  • 411 is the frame length
  • 412 is the frame thickness
  • 413 is the frame width
  • 421 is the inflow end
  • 422 is the outflow end.
  • Fig. 5 is a schematic view of the frame of the embodiment 1 provided with a reinforcing member: 5a1 is a perspective view with one central reinforcing member, and 5a2 is a front view of 5a1.
  • Figure 6 Schematic diagram of the frame of the embodiment 1 with the valve leaflets:
  • Figure 6a1 is a schematic view of the single leaf valve leaflet directly sewn on the frame,
  • Figure 6a2 is a top view of Figure 6a1;
  • Figure 6b1 single leaf valve leaflet is pulled by the artificial tendon
  • Figure 6b2 is a front view of Figure 6b1
  • Figure 6b3 is a top view of Figure 6b1
  • Figure 6b4 is a side view of Figure 6b1; wherein 611 is the valve leaflet root, 612 is the valve leaflet opening and closing, 621 is the valve leaflet body 622 is a columnar artificial chord.
  • Figure 7 is a schematic view and a cross-sectional view of a frame 1 provided with a cover film and a valve leaflet:
  • Figure 7a1 is a perspective view of the frame provided with an outer cover film
  • Figure 7a2 is a front view of Figure 7a1;
  • Figures 7a3, 7a4, 7b1 and 7b2 A cross-sectional view of the valve leaflets and the covering membrane in the frame under different states of diastolic contraction, and
  • Figures 7a3 and 7a4 show single leaf valve leaflets, and
  • Figures 7b1 and 7b2 show double leaf valve leaflets;
  • Figure 7c1 shows For people The single leaf valve leaflets of the work scorpion;
  • 7d1 shows the double leaf valve leaflets pulled by the artificial chordae; the arrow indicates the direction of blood flow; 701 is the frame body, 711 and 741 are the roots of the valve leaflets, 712 and 742
  • 701 is the frame body
  • 711 and 741 are the roots of the valve leaflets
  • 712 and 742 For valve leaflet opening and closing, 721 is a single-leaf valve leaflet body, 751 is a double-leaf valve leaflet body, 731 is an outer covering surface, 732 is an inner covering film, and 761, 762, and 763 are artificial chordae.
  • Figure 8 is a schematic view of the mitral regurgitation device of the first embodiment:
  • Figure 8a is a schematic view of the device when the support rod is a linear rod;
  • Figure 8b is a schematic view of the device when the support rod is bent at an angle ⁇ ;
  • 811 is a cover film, 812, 821
  • 813 is a linear support rod
  • 814 is a positioning sleeve
  • 815 is a apex snap ring
  • 816 is a fixed plug
  • 817 is a plug
  • 822 is a support rod bent at an angle ⁇
  • a broken line indicates a longitudinal direction of the frame.
  • FIG. 9 is a schematic view showing the integral molding of the frame and the support rod connecting member of Embodiment 1, wherein 911 is a frame portion and 912 is a supporting rod portion;
  • Figure 10 is a schematic plan view showing the cross-sectional plane of the short axis of the frame of the embodiment 2;
  • Fig. 10a is a schematic view showing the combination of different shapes and shapes in Fig. 10a;
  • Fig. 10b is the position of the frame in the leaflets of the native valve when the cross section is 105.
  • Figure 11 is a schematic view of the anchoring device of Embodiment 3, wherein 132 is a grid-like anchoring cage in the atrium, 133 is a mesh frame, and 134 is an intracardiac connector supporting rod.
  • Figure 12 is a schematic view of a device for treating tricuspid regurgitation in Example 4, wherein 141 is a frame, 142 is a trifoliate valve leaflet, and 143 is a perforated support rod.
  • proximal shall mean the end closer to the atria or in the atria
  • distal shall mean the end closer to or in the ventricle.
  • inflow end shall be the end of the blood inflow and the “outflow end” shall be the end from which the blood flows out.
  • sheath can also be described as a “catheter.”
  • messages structure can also be described as “network structure”, referring to a structure having a mesh or a mesh.
  • long axis of the heart shall mean the axis from the atrium to the ventricle, through the orifice of the native valve, or the long axis of the frame in this direction, and the “short axis of the heart” shall mean the axis perpendicular to the long axis of the heart.
  • a patient or subject in need of treatment i.e., a patient or subject suffering from valvular heart valves, is a mammal, preferably a human.
  • the device of the present invention and its method of implantation attempt to reduce or block the amount of blood flowing from the ventricle into the atria during systole and to ensure a sufficient amount of blood flowing from the atria to the ventricle during diastole and to reduce Thrombosis.
  • the device of the present invention reduces or eliminates the size of the native valve opening, allowing the valve to function with little or no backflow.
  • the treatment between the native valve is closed or filled between the native valves by positioning the therapeutic reflux device between the mitral or tricuspid native valve leaflets. The opening.
  • the reflux device does not reduce the effective flow area of the blood, ensuring blood flow from the atria to the ventricles.
  • FIGS. 1 through 12 The following description refers to FIGS. 1 through 12. Those skilled in the art will recognize that the drawings and the accompanying drawings are to be construed in accordance with the accompanying drawings. description.
  • a device for treating mitral regurgitation comprising a frame and an anchoring device, the anchoring device being coupled to the frame.
  • the frame has an inflow end and an opposite outflow end.
  • the frame acts as a support skeleton for the valve leaflets and imparts a contractile expansion characteristic to the entire device.
  • the device In vitro, the device is compressed into a strip or plate-like contraction state, placed in the catheter, after reaching a predetermined position of the heart valve orifice, the ejection device is self-expanded to the original designed expanded configuration and anchored by the anchoring device. Inside the heart.
  • the outflow end of the frame is preferably an outflow end that contracts with respect to the inflow end, which occupies in the heart
  • the space is smaller, and it is advantageous to apply a pulling force at the outflow end to re-shrink the entire frame, which is convenient for device recovery.
  • the contracted outflow end is more easily attached to the anchoring device disposed in the ventricle, and the reflux can be more effectively and widely restricted.
  • the frame of the present embodiment is a mesh structure having a diamond mesh and/or an irregular mesh with a curved edge.
  • the frame is made of an elastic alloy material such as a nickel titanium alloy by an integral laser etching technique.
  • the mesh at the outflow end of the frame is larger, and the blood outflow resistance is small, which is more conducive to blood circulation.
  • the mesh density of the frame with the diamond mesh gradually decreases from the inflow end to the outflow end, and the mesh has an irregular arcuate shape near the outflow end.
  • the length, width, and thickness of the frame can be reasonably set according to the actual physiological condition of the patient's heart.
  • the length 411 of the frame from the inflow end (proximal end) to the outflow end (distal end) is 20-80 mm, and further preferably the frame length is 35-65 mm, and may also be 25 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm.
  • the frame has a short-axis in-plane cross-sectional maximum thickness 412 of 30 mm, a thickness in the range of 0.1-30 mm, 5-25 mm, 10-20 mm or 5-15 mm; a maximum width 413 of 50 mm, and a range of widths.
  • the width of the cross section is more than one time the thickness.
  • the frame has a width of 38-42 mm, a thickness of 7-9 mm, and a length of 50-60 mm.
  • the cross-sectional shape of the short axis of the heart is a combined shape of two semicircular intermediate rectangles and is bilaterally symmetrical.
  • the shape of the cross section may vary continuously or in stages from the inflow end to the outflow end of the frame.
  • the length, width, and the like of the cross-section corresponding to the continuous change are continuously reduced or increased, for example, the cross-sectional shape is gradually deformed and reduced along the long axis of the heart, and is reduced to an elliptical or circular shape having a smaller area at the outflow end.
  • the stepwise change means that the shape of the cross section is maintained for a length under a certain shape, and then gradually changes shape and reduces the area along the outflow end of the long axial frame of the heart.
  • the shape and area of the cross section of the frame from the inflow end to the entire frame One-half of the length remains unchanged, and then the area is continuously reduced and the shape is changed.
  • the mesh of the frame is also expanding, and the cross-sectional shape gradually changes to a smaller circle and a small circle until the outflow end. It can better connect with the intracardiac anchoring device and save consumables.
  • the varying frame cross-section will have a wider range of applications, enabling the same device to be used simultaneously for patients of different ages or different types of disease.
  • the varying cross-section can correspond to different orifice slits, making the frame more closely conformable to the native valve leaflets, more effective and adequately limiting. Reflux.
  • the frame is internally provided with all reinforcing plate members as shown in Figs. 5a1 and 5a2; the reinforcing plate members are disposed in the middle of the frame or in the direction of the long axis of the heart, and are capable of retaining the frame during compression of the frame. Symmetric compression becomes smaller.
  • the reinforcing member is used for improving the supporting strength of the frame, and may be integrally formed with the frame, or may be separately formed and connected to the frame by welding, rivet or the like.
  • the reinforcement member preferably takes the same material as the frame.
  • the stiffeners can also be configured as a mesh structure to conserve consumables and make them easier to compress inside the frame.
  • Valve leaflet the valve leaflet can control the one-way flow of blood in the frame, when the heart contracts, the mitral valve closes, the device is blocked at the mitral valve orifice, and the valve leaflets in the frame are closed, effectively blocking blood reflux
  • the mitral valve is opened, the frame can still be in the original orifice position by the traction of the anchoring device connected thereto, blood flows from the right atrium to the right ventricle, and the valve leaflets inside the frame are opened to facilitate blood from the frame. Both the inside and the outside flow out at the same time to avoid stenosis of the mitral valve.
  • the single-lobe valve leaflets 621 are directly sewn on the frame, the valve leaflet roots 611 are sealingly attached to the frame, and the valve leaflet opening and closing portion 612 can be opened or closed as the blood flow direction changes, the valve Both the leaflet root 611 and the opening and closing portion 612 belong to the junction of the valve leaflet and the frame. If the cross-section of the frame is relatively narrow and the longest axis to shortest axis ratio is greater than 2:1, the valve leaflets are preferably single leaf, bilobal or quadrilateral valves.
  • the interlobular junction of the multilobed valve can be attached to the frame grid, and the other marginal portions are not sutured, can be angularly opened and closed, forming a semilunar sinus shape and the edges can be completely closed together.
  • the valve leaflet opening and closing portion is connected by a column
  • the columnar connector may be an artificial chord cut from an animal valve and/or a pericardium; one end of the artificial chord 622 is connected to the valve leaflet opening and the other end is connected to the inside of the frame opposite the valve leaflet root .
  • the directly sewed valve leaflets are easily stressed unevenly on the frame or the cover film, and the opening and closing portions of the valve leaflets are pulled by the connecting body, so that the force of the valve leaflet root and the opening and closing part can be better balanced, so that the whole device has Better durability, which is more conducive to the smooth opening of the valve leaflets with blood flow.
  • the position of the valve leaflets in the frame is not particularly limited.
  • the valve leaflets can be expanded into a circular shape on the jig before being sewn.
  • the valve leaflets are preferred bovine pericardium or porcine aortic valves.
  • the cover film functions to provide a seal of the frame of the mesh structure, prevent blood from flowing into the atrium from the mesh or mesh of the frame, and prevent leakage of the valve.
  • the cover film can help prevent unnecessary reflux of the blood; it can also greatly reduce or eliminate the coagulating property of the internal valve leaflets caused by the exposed frame elements, and achieve the reduction of the coagulation property while maintaining the benefits of the frame structure. small.
  • the cover film covers at least a portion of the inner and/or outer peripheral surface of the frame. If the cover film completely covers the inner and/or outer periphery of the frame, the cover film is provided with a blood-permeable hole at the inflow end and the outflow end of the frame to keep blood flowing from both ends of the frame.
  • the cover film may be disposed between the frame and the valve leaflets; preferably covering the outer peripheral surface of the frame; more preferably, a cover film is provided on the outer circumference of the frame.
  • the inner cover film covers at least the inner circumference of the frame near the ventricle side of the frame at the junction with the valve leaflets.
  • Fig. 7a3, 7a4 show the opening and closing of the leaflet leaflet in the frame with the direction of blood flow
  • Fig. 7b1, Fig. 7b2 show the direction of blood flow in the frame of the double leaf valve leaflet.
  • the opening and closing pattern 732 is disposed on the inner circumference of the frame near the side of the ventricle, and the outer cover film 731 and the inner cover film 732 can better maintain the blood pressure balance inside and outside the frame.
  • the single leaf valve leaflet root 711 and the bilobal valve leaflet root 741 can be sewn onto the cover film and the frame. As shown in Figures 7a3, 7b2, as the heart expands, blood flows from the open valve leaflets; as shown in Figures 7a4, 7b1, when the heart contracts, the valve leaflets close, preventing blood from flowing back.
  • FIG. 7c1 shows that the chord 761 pulls the opening and closing portion of the single-lobe valve leaflet 721 when the heart is dilated;
  • FIG. 7d1 shows the artificial chord 762 when the heart is dilated.
  • 763 pulled the opening and closing of the double-leaf valve leaflet 751.
  • the artificial chordae shown does not impede the flow of blood while balancing the roots of the valve leaflets and the opening and closing of the opening, and the artificial chordae can be sutured on the cover film.
  • the cover film is attached to the frame by stitching;
  • the material of the cover film is preferably a kind of biological material that does not cause blood coagulation by contact with blood, including polytetrafluoroethylene, nylon, polyester, polyurethane, Polyester, animal valve and/or pericardium, such as pig, bovine valve and/or pericardium.
  • the length of the cover film from the inflow end to the outflow end along the expanded frame is less than or equal to the length of the frame, and the length ranges from 5 to 60 mm. Further, it is 10-50 mm, 15-40 mm, and 20-35 mm.
  • An anchoring device comprising a connector and an anchor; the anchor being coupled to the frame by a connector.
  • the native mitral valve leaflets and the valvular lobules in the frame are open, and the frame is freed in the orifice of the valve by the anchoring device, so there is only a small blood flow resistance when the blood fills the ventricle, and the blood flow can simultaneously clean the frame.
  • the medial and lateral side significantly reduces the formation of blood clots.
  • the anchoring device includes a connector support rod 813, a positioning sleeve 814, an anchor apex snap ring 815, a fixed plug 816, a plug 817; and the support rod 813.
  • the proximal end is connected to the outflow end of the frame 812;
  • the apex snap ring 815 is fixed in the apex of the ventricle as shown in Fig. 8b, or near the apex of the apex;
  • the positioning sleeve 814 is fixed on the apex snap ring;
  • the distal end of the rod 813 is coupled to the positioning sleeve 814.
  • the positioning sleeve supports the rod and can be moved relative to the support rod to fix the length of the connecting member by adjusting the distance of the relative movement to adapt to different patients.
  • the fixing plug is located outside the apex for positioning of the apex clasp; the plug is mounted on the outside of the positioning sleeve to further assist in positioning, and to improve the airtightness of the device and prevent blood in the ventricle from leaking from the apex clasp.
  • the distal end of the apex snap ring is provided with a pointed tip, which is easy to penetrate into the apical tissue and fixed.
  • the above connection may be a threaded connection or a card slot connection.
  • the support rod may be a sleeve made of a plurality of strands of nickel-titanium alloy wire, and the sleeve surface is covered with a blood compatible material such as PTFE.
  • the connector is coupled to the anchor by an elastic or hinge; the anchoring device is capable of swinging or rotating the frame at the orifice location of the native valve to accommodate the shape of the orifice for different valve leaks and position.
  • the frame's forward flow shear stress produces a small axial load that can be withstood by the anchoring device, the frame is free within the annulus, and the radial force is borne by the native annulus.
  • the anchoring device is placed at the apex, the pressure difference between the ventricular contraction and the frame is transmitted to the apex, which promotes the contraction of the ventricle, which also helps the left systolic function to recover.
  • the anchoring device is preferably disposed between the nipple muscles; if the anchoring device anchoring member is disposed at the apex of the apex, the support rod needs to be bent toward the anchoring member, and the angle ⁇ is bent from the proximal end to the distal end.
  • the angle ⁇ of the bending of the support rod 822 ranges from 0 to 30 degrees.
  • the ⁇ angle may also range from 0.1-25 degrees, 0.5-20 degrees, 5-15 degrees depending on the needs of the different patient and anchor mounting locations.
  • the support rod is an elastic material, the elastic support rod having a bending angle is more easily compressed into the sleeve.
  • a “visualization element” can be attached to or otherwise provided on the device of the present invention to monitor the correct placement of the device, for example, the optional visualization element is a radiopaque marker comprising any suitable material, such as For example, gold, bismuth, platinum, or consist of it.
  • the frame and the support rod of the embodiment can be integrally formed by laser etching, and the support rod portion can be a sleeve shape with a mesh, which is lighter and easier to produce as shown in FIG.
  • the device of the present embodiment may be implanted by a surgical method or may be delivered by a catheter.
  • Specific transcatheter implantation includes the following steps:
  • the device and the implantation method for treating mitral regurgitation provided by the embodiment can effectively treat mitral regurgitation, the device is positioned accurately and firmly, and can move with the apex of the heart, and does not adhere to the native annulus, and is in the heart.
  • the blood flow is non-blocking, the device can be recycled, and the minimally invasive repair is characterized by high operability and high safety.
  • the pressure difference generated on the frame when the ventricle contracts is transmitted to the anchoring device at the apex, and the ventricular contraction is also promoted. Function can help the recovery of left systolic function.
  • the cross-sectional shape of the short-axis plane of the heart of the frame is a combination of irregular arc-shaped shapes, and can continuously change from the inflow end to the outflow end of the frame. To apply different barriers to the defect of the incomplete native valve.
  • the cross-section of the frame in the native valve leaflets 2.2 is the anterior leaflet, 2.3 is the posterior leaflet, and the gap 116 is unevenly distributed during the mitral insufficiency, the middle gap Narrower, the gaps on both sides may be irregular and will become larger.
  • the preferred frame cross-sectional shape 105 of the present embodiment has a crescent-like shape as a whole, an arc-shaped portion in the middle portion and a narrower thickness than the two ends, and the two ends are larger in circle, and the frame is fitted with the native valve leaflets.
  • the closed line has a certain degree of curvature.
  • 111 and 112 are the possible areas of engagement of the leaflets with the frame 114, and 113 is a possible conforming line or called a closed line.
  • the frame shown in this embodiment can be nearly completely integrated with the valve leaflets of the native insufficiency, and the treatment of mitral regurgitation is particularly remarkable.
  • the anchor further includes a frame anchor having a mesh structure disposed inside the atrium, similar to the shape of the anchor cage, and when the shape is expanded, the shape can be determined to be better.
  • the ground conforms to the geometry of the left atrium, so the frame is positioned more accurately and accurately at the desired location.
  • the frame is a cylindrical grid structure that replaces the native damaged valve as a replacement flap when the cylindrical inner diameter is sufficiently large.
  • the anchoring device can also be placed in the ventricle at the same time, including components such as the connector support rods and anchors as shown in Embodiment 1.
  • the anchoring device has a mesh anchoring cage 132, a cylindrical mesh frame 133, and an intracardiac connector supporting rod 134.
  • the anchoring device and the frame can be integrally formed by laser etching.
  • the preparation process is simple, the preparation process is simple, the device is light, and the application is wide.
  • This embodiment is a device for treating tricuspid regurgitation, comprising a frame and an anchoring device, the anchoring device being coupled to the frame.
  • the anchoring device refers to the anchoring member and the support rod connecting member disposed in the right ventricle of the present embodiment 1.
  • the valve leaflets are preferably trilobal in the device for treating tricuspid regurgitation, and the cross-section of the frame is preferably circular.
  • the support rod is a support rod having a lattice structure.

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Abstract

一种用于治疗瓣膜反流的装置，包括框架（114,133,141,701,812,821,911）和锚定装置（132），锚定装置（132）与框架（114,133,141,701,812,821,911）连接；框架（114,133,141,701,812,821,911）可扩张压缩，具有流入端（421）和相对的流出端（422）；框架（114,133,141,701,812,821,911）的内部设置有可在血液流动中打开关闭的瓣膜小叶（142,621,721,751）；锚定装置（132）能够保持扩张状态下的框架（114，133,141,701,812,821,911）在心脏原生瓣膜的孔口位置。治疗瓣膜反流的装置及其植入方法能有效治疗瓣膜反流，装置定位准确且牢固，不会与原生瓣环发生粘连，对心脏内血液流动无阻塞，而且装置可回收，具有微创修复可操作性强、安全性高的特点，具有极高的临床价值。

Description

治疗瓣膜反流的装置 技术领域
本发明属于心脏修复技术和医疗器械领域，具体涉及一种用于治疗心脏瓣膜反流的可植入装置，及其植入方法。
背景技术
哺乳动物的心脏包含四个腔室如图1所示，即两个是填充腔室的心房，和两个是泵出腔室的心室。左心室3位于心尖5左上方，二尖瓣2位于左心房1和左心室3之间，二尖瓣2控制血液从左心房1单向流入左心室3。功能失调的二尖瓣2会导致二尖瓣2的两瓣叶关闭不全，使血液在心脏收缩期从左心室3反流回左心房1。二尖瓣反流将引起肺充血和左心室3肥大，最终导致病人的心衰和死亡。二尖瓣的结构如图2所示，二尖瓣是一个复杂的承受血压的单向阀结构，由瓣环2.1、前瓣叶2.2、后瓣叶2.3、腱索2.4、乳头肌2.5和左心室壁上的心肌组成。乳头肌2.5附着于左心室壁上，前瓣叶2.2、后瓣叶2.3附着在瓣环2.1上。瓣环2.1是一个连接前瓣叶2.2、后瓣叶2.3和左心室壁的内部组织结构。根据瓣环2.1的组织结构，它被分成前内侧段的纤维层和后外侧段的肌肉层。腱索2.4起始于乳头肌2.5，附着于瓣叶上，能够防止心脏收缩时前瓣叶2.2、后瓣叶2.3塌陷进入左心房。
功能正常的二尖瓣闭合时的状态如图3a1和3a2所示，二尖瓣关闭后前瓣叶2.2、后瓣叶2.3之间没有间隙，前后瓣叶结合处2.6之间完全闭合，不会产生反流现象。当二尖瓣2闭合时的状态如图3b1和3b2所示所示时，二尖瓣2的前后瓣叶结合处2.6之间有间隙出现，前后瓣叶结合处2.6间的间隙使血液在心脏收缩时从左心室3回流到左心房1(如图3b1中的箭头所示的反流方向)，这种回流称为二尖瓣反流。
功能失调的二尖瓣导致二尖瓣的两瓣叶关闭不全，使血液在心脏收缩期从左心室反流回左心房。二尖瓣反流将引起肺充血和左心 室肥大，最终导致病人的心衰和死亡，所以二尖瓣反流是一个重大的健康疾患。患者数量众多，据保守估计超过1亿人。目前的治疗方法是通过外科手术修复瓣膜，或在某些情况下,当无法修复时，进行瓣膜置换。然而，对于不适合开胸和开心手术的病人，没有切实可行的方法来治疗二尖瓣反流。
近年来，有许多新技术正在开发以满足这一需求。市场上的MitraClip二尖瓣夹是一项经过检验的用于治疗二尖瓣返流的修复器械，但是只能适用于相对较少的患者，通常是二尖瓣脱垂造成反流的病人，仍有有残余反流，对于缺血性二尖瓣反流的病人治疗效果不佳。而且瓣环下结构会增重与钙化，有腱索断裂的风险。较多的二尖瓣修复技术借助于微创器械来模拟外科瓣膜修复，如实验器械限制二尖瓣环或使用器械限制乳头肌错位和腱索修复。
介入式人工瓣膜置换方法同时也遭遇到重重困难，如在扩大的原生瓣膜环上安置锚定装置，有时可导致瓣环继续扩张，大型瓣膜通常会导致人工瓣膜使用寿命大大降低。对于那些减小扩大瓣环的方法，介入式瓣整形环在微创修复器械使用中并不如在开心手术中那样稳固。因此，合适的置换/锚定装置均具有很大的挑战性、并且影响这设备应用的效率。上面所述的所有装置有个共同点：这些微创的治疗瓣膜反流的方法对于原生的瓣膜和瓣膜环结构都具有显著的、难以预期的影响。微创二尖瓣或三尖瓣塞技术解决办法具有对原生瓣膜结构最小干扰的优点，即在自体二尖瓣或三尖瓣小叶不能闭合的返流区放入塞子或板状件来阻止反流，然而，瓣塞或板状件将会增加瓣膜打开时的血流阻力，导致瓣膜通道狭窄。更严重的是，血流受阻所导致的患者血栓增加的风险。
二尖瓣瓣环、三尖瓣瓣环等因特殊的生理结构、复杂的生理环境，使相关的治疗产品在同时具备较佳的治疗效果、定位及固定方面造成很大困难。鉴于现有技术在解决二尖瓣、三尖瓣闭锁不全的问题时，经导管人工瓣膜置换技术需要大型锚定环，影响人工瓣膜使用寿命并会影响自身瓣环的功能；瓣塞或闭合板状件技术虽然可有效减少回流，但是它在瓣膜打开时会限制血液流动，导致二尖瓣 或三尖瓣狭窄，增加患者血栓形成的风险等问题，因此需要探索更加有效、安全的治疗二尖瓣或三尖瓣闭锁不全的技术。
发明内容
针对上述技术问题，本发明通过在瓣膜开口处植入带有人工瓣膜小叶的装置，既能在心脏收缩期堵住瓣膜的泄漏孔口，防止血液反流，在心脏舒张期也能最大限度保证血液入流的有效孔口面积，防止二尖瓣或三尖瓣狭窄，而且该装置定位准确、牢固，不会与原生瓣环发生粘连，耐久性好，为治疗瓣膜反流、尤其是二尖瓣或三尖瓣反流提供了有效的治疗方案。
本发明第一项技术方案提供了一种治疗瓣膜反流的装置，包括框架和锚定装置，所述锚定装置与框架连接；所述框架可扩张压缩，具有流入端和相对的流出端；所述框架的内部设置有可在血液流动中打开关闭的瓣膜小叶；所述锚定装置能够保持扩张状态下的框架在心脏原生瓣膜的孔口位置。在锚定装置的作用下，原生瓣膜闭合时，扩张状态下的框架的外周能与原生瓣膜接触或贴合；原生瓣膜打开时，扩张状态下的框架能游离在心脏原生瓣膜的孔口内，不会在心脏内任意窜动。当装置适用于二尖瓣或三尖瓣，框架能保持在心脏长轴方向顺应血液从心房流入心室、在短轴方向顺应原生瓣膜小叶与框架结合处的姿态。
优选的，所述框架具有可扩张压缩的网格结构，且框架的至少一部分内周和/或外周表面设置有覆盖膜；所述覆盖膜至少覆盖所述瓣膜小叶与框架的结合处的框架外周。
优选的，所述框架具有可扩张压缩的网格结构，其具有菱形和/或六边形的网眼；或者所述网格结构为直线和弧线交叉绕制而成，具有不规则带有弧边的网眼。所述框架的材料包括弹性金属材料、弹性高分子材料或记忆合金材料。所述框架可以通过一体成型的激光刻蚀技术、3D打印技术或由丝状材料编织而成。
优选的，所述框架内部设置有全部或局部加强件；所述加强件包括板状件、柱体件，或具有网格结构的板状件、柱体件。
优选的，所述框架自流入端到流出端的心脏长轴方向长度为20-80mm。
所述框架在瓣膜孔口处扩张时，框架内部的横截面或称为心脏短轴平面内横截面，与心脏长轴垂直。优选的，所述框架扩张时的心脏短轴平面内横截面厚度为3-30毫米、宽度为1-50毫米。框架长度、宽度、厚度可以根据患者心脏尺寸进行调整。
优选的，所述框架扩张时的心脏短轴平面内横截面的形状包括圆形、椭圆形、矩形或圆角矩形、月牙形或带圆角的月牙形、哑铃形、两边半圆形中间长方形的组合形状、梯形或带圆角的梯形、以及他们的组合形状，或者形状整体类似月牙形、中间带有弧边且中间的厚度比两头小。所述心脏短轴平面内横截面的形状左右对称或不对称。
优选的，所述框架扩张时的心脏短轴平面内横截面的形状自框架的流入端到流出端连续变化或分阶段变化。
优选的，所述覆盖膜通过烧结、焊接、胶合或者缝合的方式与所述框架连接；所述覆盖膜覆盖瓣膜小叶与框架的结合处的框架外周以及框架内周。所述覆盖膜为外覆盖膜时，外覆盖膜的长度小于或者等于框架的长度；所述覆盖膜为内覆盖膜时，内覆盖膜的覆盖面积小于或者等于外覆盖膜的覆盖面积。内覆盖膜优选覆盖框架与瓣膜小叶结合处的靠近心室一侧的框架内周。覆盖膜沿着扩张的框架自流入端到流出端的长度为5-60mm。覆盖膜的材料包括血液相容性材料、人工血管材料、动物瓣膜、动物心包、高分子聚合物。
优选的，所述瓣膜小叶包括单叶瓣膜、双叶瓣膜、三叶瓣膜或四叶瓣膜；所述瓣膜小叶通过包括缝合、胶合的方式与具有网格结构的框架相结合。瓣膜小叶的材料包括动物瓣膜、动物心包、人工腱索、高分子聚合物、人工血管材料。
优选的，瓣膜小叶根部与框架和/或框架上设置的覆盖膜连接，瓣膜小叶开合部与连接体连接；连接体与框架和/或框架上设置的覆盖膜连接；所述连接体包括条状、丝状、片状、柱状、网状或这些结构的组合。瓣膜小叶通过被连接体拉住的方式设置在框架的内 部。所述连接体可以通过对动物瓣膜、动物心包、人工腱索、高分子聚合物或人工血管材料进行剪裁后获得。人工腱索可以由动物瓣膜和/或心包剪裁制成，可由瓣膜小叶一体剪裁制成。
所述锚定装置保持所述框架在原生瓣膜的孔口位置处，优选的，所述锚定装置包括连接件和锚定件；所述锚定件通过连接件与框架连接；锚定件包括设置在瓣环上的锚定件、设置在心尖处或靠近心尖处两乳头肌间的组织内锚定件、设置在心室内壁表面的支架和/或组织内锚定件、设置在心房内腔的开口杯状支架、设置在心房内壁表面的组织内锚定件、设置在心房内腔的具有网格结构的框架，或者以上锚定件的组合；所述连接件包括杆状、线状、片状、柱状或筒状连接件，或者为这些结构的组合。所述连接件的材料包括弹性金属材料、记忆合金材料或弹性高分子材料。所述连接件可以由框架流出端延伸经一体成型技术获得。所述连接件外周可以设置覆盖膜，优选血液相容性材料制备的覆盖膜。
优选的，所述连接件与锚定件通过能够运行特定自由度的弹性或铰链连接；所述锚定装置能够使框架在原生瓣膜的孔口位置处摆动或转动。当锚定件设置在心尖处或靠近心尖处两乳头肌间时，心尖外设有防止锚定件窜动的心尖卡环，所述卡环能够承受来自连接件的拉、压力。
优选的，所述锚定装置包括支撑杆、定位轴套、心尖卡环和固定塞；所述支撑杆的近端与框架的流出端连接；支撑杆的远端与定位轴套连接；心尖卡环固定在心尖位置或靠近心尖处两乳头肌间；定位轴套固定在心尖卡环上；固定塞与心尖卡环连接并位于心尖外面，用于定位心尖卡环；所述定位轴套与支撑杆可以发生相对移动或滑动。优选的，所述支撑杆与锚定件及框架的连接方式包括弹性连接，或铰链连接。
优选的，所述支撑杆自近端到远端设置有部分弯曲0-30度，再与锚定件连接，所述部分弯曲的角度还可以是1-20度、5-10度。
第二方面，本发明的第二项技术方案提供了一种治疗瓣膜反流装置的植入方法，将可扩张压缩的框架压缩放置在套管内，再通过 微创技术植入心脏使框架达到扩张状态，并使用与框架连接的锚定装置将框架定位在原生瓣膜孔口处，使闭合时的心脏原生瓣膜与所述框架的外表面贴合；锚定装置通过压缩在套管内再导入进心脏，其与框架同时或者不同时导入；所述框架和锚定装置在失效或者完成治疗后采用原先导入方式进行全部回收或者部分回收。
优选的，一种治疗瓣膜反流装置的植入方法包括如下步骤：
A、在体外将可扩张压缩的框架、与框架连接的连接件装配好压缩进穿刺导管中，穿刺导管尾部设置有与连接件连接的锚定件和操作杆；所述框架的内部设置有可在血液流动中打开关闭的瓣膜小叶；所述框架具有流入端和相对的流出端，框架外周在瓣膜小叶与框架的结合处设置有覆盖膜；
B、将穿刺导管经左侧胸部切口从心尖位置穿刺进入左心室或右心室，到达二尖瓣或三尖瓣孔口处，用操作杆将锚定件固定在心尖位置；再将框架和连接件推出；
C、撤出穿刺套管。
第三方面，本发明提供了上述任意一项治疗瓣膜反流的装置在心脏瓣膜反流治疗中的应用，所述心脏瓣膜反流选自二尖瓣反流和/或三尖瓣反流。
本发明的有益技术效果：(1)本发明装置带有人工瓣膜小叶能减少原生瓣膜打开时的过流阻力、有效降低血栓和内生物风险；(2)本发明装置结构简单、定位准确、尺寸小，适用多种病理的二尖瓣/三尖瓣反流患者，对选择合适的框架，或对锚定装置和框架尺寸稍作修改就能适用儿童到高风险老年患者，而且对瓣膜脱垂治疗也适用；(3)本发明锚定装置可以不设置在原生瓣环上，对原生瓣膜瓣环结构干扰小，减少了外科医生正确定位学习过程和知识要求，手术简单，成功率高；(4)本发明装置与替换/置换型人工瓣膜相比，具有更少的耗材、更适合通过导管介入、并具有更持久的耐久性，而且能够回收，具有极高的临床价值。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果。
附图说明
图1：人的心脏解剖结构示意图：其中1为左心房，2为二尖瓣，3为左心室，4为主动脉瓣，5为心尖。
图2：图1中二尖瓣2的组织结构放大示意图：其中2.1瓣环、2.2前瓣叶、2.3后瓣叶、2.4腱索、2.5乳头肌。
图3：图2所示的二尖瓣在心脏收缩时正常关闭和关闭不全的示意图：图3a1为二尖瓣正常关闭时的右侧视图；图3a2为二尖瓣正常关闭时的心房侧局部放大图；图3b1为二尖瓣关闭不全时二尖瓣反流的右侧视图；图3b2为二尖瓣关闭不全时的二尖瓣反流的心房侧局部放大图；其中2.1瓣环、2.2前瓣叶、2.3后瓣叶、2.4腱索、2.5乳头肌、2.6前后瓣叶闭合/孔口处。
图4：实施例1框架示意图：图4a1为框架立体示意图，图4a2为图4a1的正视图，图4a3为4a1的侧视图，图4a4为图4a1的俯视图；图4b1为改变了框架网眼形状的框架立体示意图；其中，411为框架长度、412为框架厚度、413为框架宽度、421为流入端、422为流出端。
图5：实施例1设置有加强件的框架示意图：5a1为带有1个中部加强件的立体示意图，5a2为5a1的正视图。
图6：实施例1带有瓣膜小叶的框架的示意图：图6a1为单叶瓣膜小叶直接缝在框架上的示意图，图6a2为图6a1的俯视图；图6b1单叶瓣膜小叶被人工腱索拉住的示意图，图6b2为图6b1的正视图、图6b3为图6b1的俯视图，图6b4为图6b1的侧视图；其中，611为瓣膜小叶根部、612为瓣膜小叶开合部、621为瓣膜小叶本体、622为柱状人工腱索。
图7：实施例1设置有覆盖膜、瓣膜小叶的框架示意图及剖视图：图7a1为框架上设置有外覆盖膜的立体示意图，图7a2为图7a1的正视图；图7a3、7a4、7b1和7b2为框架在心脏舒张收缩不同状态下框架内瓣膜小叶和覆盖膜的剖视图，且图7a3、图7a4所示为单叶瓣膜小叶，图7b1、图7b2所示为双叶瓣膜小叶；图7c1所示为人 工腱索拉住的单叶瓣膜小叶；图7d1所示为人工腱索拉住的双叶瓣膜小叶；箭头指代血液流动方向；701为框架本体，711和741为瓣膜小叶根部，712和742为瓣膜小叶开合部，721为单叶瓣膜小叶本体，751为双叶瓣膜小叶本体，731为外覆盖面，732为内覆盖膜，761、762、763为人工腱索。
图8：实施例1治疗二尖瓣反流装置的整体示意图：图8a支撑杆为直线杆时装置示意图；图8b支撑杆弯曲θ角度时的装置示意图；其中：811为覆盖膜，812、821为框架，813为直线支撑杆，814为定位轴套，815为心尖卡环，816为固定塞，817为堵头，822为弯曲θ角的支撑杆，虚线表示框架长轴方向。
图9：实施例1框架和支撑杆连接件一体成型的示意图，其中，911为框架部分、912为支撑杆部分；
图10：实施例2框架心脏短轴平面内横截面示意图；图10a中101～106为不同的形状及形状的组合的示意图；图10b为横截面为105时框架在原生瓣膜小叶中的位置的横截面示意图，其中2.2为前瓣叶、2.3为后瓣叶，111和112为瓣叶与框架114贴合的部分，113为可能的贴合线或闭合线。
图11：实施例3锚定装置示意图，其中，132为心房内网格状锚定笼、133为网格框架、134为心室内连接件支撑杆。
图12：实施例4治疗三尖瓣反流的装置示意图，其中141为框架，142为三叶瓣膜小叶，143为刻孔的支撑杆。
具体实施方式
以下描述和附图中阐述了某些具体细节，以便理解本发明的各种实施方案。本领域技术人员将理解，他们能够实践本发明的其它实施方案而无需本文描述的一个或多个细节。因此，申请人并非意在以任何方式将所附权利要求书的范围限制于这种细节。
如文中所用，术语“近端”应指更靠近心房或在心房中的端部，而“远端”应指更靠近心室或在心室中的端部。术语“流入端”应为血液流入的端部，而“流出端”应为血液流出的端部。
术语“鞘”也可描述为“导管”。术语“网格结构”也可描述成“网络结构”，指具有网眼或网孔的结构。
术语“心脏长轴”应指从心房到心室、穿过原生瓣膜孔口的轴，或这个方向上的框架的长轴，“心脏短轴”应指与心脏长轴垂直的轴。
本发明需要治疗的患者或对象，即患有心脏瓣膜反流的患者或对象是哺乳动物，优选是人类。
本发明装置及其植入方式试图减小或阻断在心脏收缩期期间从心室流到心房内的血液的量，并且保证在心脏舒张期期间从心房流动到心室的血液充足的量，并减少血栓产生。本发明装置能减小或消除在原生瓣膜开口的尺寸，允许瓣膜在很少发生反流或不发生任何反流的情况下发挥功能。在至少一些实施例中，通过将治疗反流装置定位在二尖瓣或三尖瓣原生瓣膜小叶之间，以当闭合的时候，使在原生瓣膜之间的开口闭合或填充在原生瓣膜之间的开口。本说明书中所描述的实施例中，反流装置不会减少血液有效过流面积，保证了血液从心房流向心室的血液流量。
以下描述参考图1至图12。本领域技术人员将认识到，附图和附图描述是针对本发明的各种实施方案，除非上下文另有说明，否则其并非是将所附权利要求的范围限制于附图和/或附图描述。
实施例1：
用于治疗二尖瓣反流的装置，包括框架和锚定装置，所述锚定装置与框架连接。
框架，所述框架通过锚定装置锚定在二尖瓣闭合时形成的孔口处，所述框架在孔口处扩张，心脏原生瓣膜在闭合时与所述框架的外表面贴合。所述框架具有流入端和相对的流出端。所述框架作为瓣膜小叶的支撑骨架，并且赋予整个装置可收缩扩张的特性。
在体外，该装置被压缩成条状或板状的收缩状态，放置于导管中，到达心脏瓣膜孔口的预定位置后，推出装置自膨胀恢复到原始设计的扩张形态并通过锚定装置锚定在心脏内部。
框架流出端优选为相对流入端收缩的流出端，其在心脏中占有 空间更小，而且有利于在流出端施加拉力重新收缩整个框架，便于装置回收。收缩的流出端更易与设置在心室内的锚定装置连接固定，能够更有效也更广泛的限制反流。
框架网眼的形状不唯一，任意满足血流流通和收缩扩张要求的形状都可行。如图4所示，本实施例框架是具有菱形网眼和/或不规则的带有弧边的网眼的网格结构。所述框架通过一体成型的激光刻蚀技术由弹性合金材料制成，如镍钛合金等。优选的，框架流出端的网眼更大，此时血液流出阻力小，更利于血液流通。如图4a1所示，带有菱形网眼的框架的网眼致密度从流入端向流出端逐渐降低，且接近流出端时网眼为不规则的带有弧边的形状。
因人类具有较大的个体差异，所述框架的长度、宽度、厚度均可以根据患者心脏的实际生理状况进行合理设置。所述框架自流入端(近端)到流出端(远端)的长度411为20-80mm，进而优选框架长度为35-65mm，还可以是25mm、30mm、40mm、50mm、60mm、70mm。所述框架的心脏短轴平面内横截面最大厚度412为30毫米，厚度的范围可以是0.1-30mm，5-25mm，10-20mm或5-15mm；最大宽度413为50毫米，宽度的范围可以是0.1-50mm，1-45mm，5-40mm，10-35mm，15-30mm，30-45mm或8-25mm。尺寸较大的适合成年患者、尺寸小的适合未成年患者，更小的尺寸则适合婴幼儿患者。优选的所述横截面的宽度是厚度的一倍以上。本实施例中框架的宽度为38-42mm，厚度为7-9mm，长度为50-60mm。
如图4a4所示，所述心脏短轴平面内横截面形状为两边半圆形中间长方形的组合形状且左右对称。所述横截面的形状自框架的流入端到流出端可以连续变化或分阶段变化。所述连续变化对应的横截面的长度、宽度等尺寸是连续减小或增加，例如横截面形状沿着心脏长轴逐渐变形并缩小，到了流出端缩小成为面积更小的椭圆或圆形。所述分阶段变化指的是横截面的形状在某一个特定形状下保持一段长度，然后再沿着心脏长轴向框架流出端逐渐改变形状并缩小面积。
如图4a2所示，框架横截面的形状和面积从流入端到整个框架 长度的二分之一处保持不变，之后再逐渐连续缩小面积和改变形状，框架网眼也在不断扩大，一直到流出端，横截面形状逐渐变化成了更小的圆形，小的圆形能更好的与心室内锚定装置连接，节约耗材。变化的框架横截面将具有更广泛的应用范围，使同一个装置能同时适用不同年龄段或不同患病类型的患者。例如，在植入本发明装置时，通过调整框架在孔口的位置，变化的横截面可以对应于不同的孔口缝隙，使框架与原生瓣膜小叶贴合地更密切，更有效和充分的限制反流。
在本实施例中，框架内部设置有全部加强板状件如图5a1和5a2所示；所述加强板状件设置在框架的中部或心脏长轴方向上，能够在框架压缩过程中保持框架的对称压缩变小。所述加强件用于提高框架的支撑强度，可以与框架一体成型，也可以单独成型再通过焊接、铆钉等连接方式与框架连接部。所述加强件优选采用与框架相同的材料。加强件还可以设置为网状结构，以节约耗材、并使其在框架内部更容易被压缩。
瓣膜小叶，所述瓣膜小叶能够控制框架内血液的单向流动，当心脏收缩，二尖瓣关闭，所述装置堵在二尖瓣孔口处，框架中的瓣膜小叶关闭，有效阻挡血液反流；当心脏舒张，二尖瓣打开，所述框架可以通过与其连接的锚定装置的牵引作用仍处于原孔口位置，血液从右心房流向右心室，框架内部的瓣膜小叶打开便于血液从框架的内部和外部同时流出，避免二尖瓣过流狭窄。
如图6a1、6a2所示单叶瓣膜小叶621直接缝在框架上的示意图，瓣膜小叶根部611密封连接固定在框架上、瓣膜小叶开合部612可以随着血液流动方向的改变打开或关闭，瓣膜小叶根部611和开合部612都属于瓣膜小叶与框架的结合部。如果框架的横截面比较狭长，最长轴和最短轴比大于2：1，则瓣膜小叶优选单叶、双叶或四叶瓣膜。如果是多叶瓣膜，则多叶瓣膜的瓣叶间连接部分可以固定在框架网格上，其它边缘部分不缝合，可呈角度的开合，形成半月窦状并且其边缘能完全闭合在一起。
在本实施例中，如图6b1-6b4所示，瓣膜小叶开合部由柱状连 接体辅助固定，柱状连接体可以是由动物瓣膜和/或心包剪裁制成的人工腱索；人工腱索622的一端与瓣膜小叶开合部连接，另一端与瓣膜小叶根部对面的框架内侧连接。直接缝制瓣膜小叶在框架或覆盖膜上容易受力不均，而通过连接体拉住瓣膜小叶的开合部，能更好地平衡瓣膜小叶根部和开合部的受力，使整个装置具备更好地耐久性，更利于瓣膜小叶随着血液流动顺利开合。
所述瓣膜小叶在框架中位置没有特别限制。所述瓣膜小叶可在夹具上扩成圆形后再进行缝制。本实施例中，所述瓣膜小叶为优选的牛心包或猪主动脉瓣。
覆盖膜，所述覆盖膜的作用是提供网格结构的框架的密封性，防止血液从框架的网眼或网孔流入心房，防止瓣周漏。覆盖膜能协助防止血液发生不必要的反流；还能极大地减小或消除由于露出的框架元件引起的内部瓣膜小叶的促凝性，在保持框架结构利益的同时实现了促凝性的减小。
所述覆盖膜覆盖所述框架的至少一部分内周和/或外周表面。所述覆盖膜若将框架的内和/或外周全部覆盖，那么覆盖膜在框架流入端和流出端需设置有可通血液的孔，保持血液可从框架两端流过。
覆盖膜可设置在框架和瓣膜小叶之间；优选的覆盖在框架的外周围表面；更优选在框架内外周均设置覆盖膜。内覆盖膜至少覆盖框架上与瓣膜小叶结合处的框架靠近心室一侧的框架内周。如图7所示，图7a3、7a4所示为单叶瓣膜小叶在框架内随着血液流动方向的开合示意图；图7b1、图7b2所示为双叶瓣膜小叶在框架内随着血液流动方向的开合示意图；内覆盖膜732均设置在了靠近心室一侧的框架内周，此时外覆盖膜731和内覆盖膜732能较佳地保持框架内外的血液压力平衡。
单叶瓣膜小叶根部711、双叶瓣膜小叶根部741可以缝制在覆盖膜和框架上。如图7a3、7b2所示，当心脏扩张，血液从打开的瓣膜小叶流过；如图7a4、7b1所示，当心脏收缩，瓣膜小叶闭合，阻止血液反流。
优选的，瓣膜小叶被人工腱索拉住时，图7c1示出了心脏扩张时工腱索761拉住了单叶瓣膜小叶721的开合部；图7d1示出了心脏扩张时人工腱索762、763拉住了双叶瓣膜小叶751的开合部。所示人工腱索在平衡瓣膜小叶根部和开合部拉力的同时不会对血液的流动造成阻碍，此时的人工腱索可以缝合在覆盖膜上。
本实施例中，覆盖膜通过缝合的方式与所述框架连接；所述覆盖膜的材料优选与血液接触不会导致血液凝固的一类生物材料，包括聚四氟乙烯、尼龙、涤纶、聚氨酯、聚酯、动物瓣膜和/或心包，如猪、牛瓣膜和/或心包等。
所述覆盖膜沿着扩张的框架自流入端到流出端的长度小于或者等于框架的长度，长度范围为5-60mm。进而为10-50mm，15-40mm，20-35mm。
锚定装置，所述锚定装置包括连接件和锚定件；所述锚定件通过连接件与框架连接。在心脏舒张期，原生二尖瓣小叶和框架内瓣膜小叶都打开，框架因锚定装置作用而游离在瓣膜孔口内，因此在血液充盈心室时只有很小血流阻力，血流可以同时清洗框架内外侧，显著降低血栓的形成。
在本实施例中，如图8所示，所述锚定装置包括连接件支撑杆813、定位轴套814；锚定件心尖卡环815、固定塞816、堵头817；所述支撑杆813的近端与框架812的流出端连接；心尖卡环815固定在心室内的心尖位置如图8b所示，或靠近心尖处两乳头肌间；所述定位轴套814固定在心尖卡环上；支撑杆813的远端和定位轴套814连接，所述定位轴套支撑杆，并可以与支撑杆发生相对移动再固定，通过调整相对移动的距离来调整连接件整体的长度，以适应不同的患者心脏大小。所述固定塞位于心尖外面，用于心尖卡环的定位；所示堵头安装在定位轴套外上，进一步辅助定位，并且提高装置气密性、防止心室中血液从心尖卡环泄露。心尖卡环远端设置有尖头，容易刺入心尖组织并固定。上述连接可以是螺纹连接或卡槽连接。
所述支撑杆可以是多股镍钛合金金属丝制成的套管，且所述套管表面覆盖有血液相容性材料，如PTFE。
在其他实施例中，所述连接件与锚定件通过弹性或铰链连接；所述锚定装置能够使框架在原生瓣膜的孔口位置处摆动或转动，以适应不同瓣膜泄漏的孔口形状和位置。
在心脏舒张期，框架正向血流剪切应力产生的轴向负载较小，能够被锚定装置承受，框架游离在瓣环内，径向力由原生瓣环承担。当用锚定装置设置在心尖时，心室收缩产生框架上的压差力会传递到心尖，对心室收缩有推动作用，这还能帮助左心收缩功能恢复。
所述支撑杆为直线支撑杆时，锚定装置优选设置在乳头肌间；如果锚定装置锚定件设置在心尖，支撑杆则需弯向锚定件，自近端到远端弯曲θ角度，如图8b2所示，支撑杆822弯曲的θ角范围为0-30度。根据不同患者和锚定件安装位置的需要，所述θ角度范围还可以是0.1-25度、0.5-20度、5-15度。支撑杆为弹性材料时，具有弯曲角度的弹性支撑杆更容易被压缩进套管中。
优选的，可以在本发明装置上附于或以其他方式设置“可视化元件”来监测装置的正确放置，例如可选择的可视化元件是不透射线的标记物，其包含任何合适的材料，如，例如，金，钽，铂，或由其组成。
更优选的，本实施例所述框架和支撑杆可以通过激光刻蚀一体成型，支撑杆部分可以是带有网孔的套管形状，如图9所示更加轻便并易于生产制备。
本实施例装置可以通过手术方法植入或可以通过经导管的方法递送。具体的经导管植入包括如下步骤：
A、在胸部左心心尖位置做切口；
B、在体外，将框架、与框架连接的支撑杆、定位轴套装配好后，压缩放置到穿刺导管中，导管外装配心尖卡环，尾部连接有操作杆；
C、将上述穿刺导管经左侧胸部切口，到达心尖位置并穿刺进入左心室，通过调节操作杆将心尖卡环固定在心尖；
D、将框架、定位轴套从穿刺导管中推出，调节定位轴套与支撑杆相对位置；撤出穿刺导管，将固定塞安装在心尖卡环下端，撤 除操作杆；
E、将堵头安装在定位轴套外端，缝合胸部切口，完毕。
本实施例提供的治疗二尖瓣反流的装置和植入方法能有效治疗二尖瓣反流，装置定位准确且牢固，且可以随心尖运动，不会与原生瓣环发生粘连，对心脏内血液流动无阻塞，装置可回收，具有微创修复可操作性强、安全性高的特点，而且心室收缩时在框架上产生的压力差会传递到心尖处锚定装置，对心室收缩还具有推动作用，能帮助左心收缩功能的恢复。
实施例2：
如图10所示的101～106，所述框架的心脏短轴平面内横截面形状为不规则的带有弧边的形状的组合，且自所述框架的流入端到流出端连续可以变化，以适用不同的闭锁不全原生瓣膜的缺陷缝隙。
如图10b所示，框架在原生瓣膜小叶中的位置的横截面，图中2.2为前瓣叶、2.3为后瓣叶，此时二尖瓣闭锁不全时的间隙116分布的不均匀，中部间隙较窄，两侧缝隙可能不规则而且会变得较大。与实施例1不同的是，本实施例优选的框架横截面形状105，整体类似月牙状，中部带有弧边且厚度比两头窄，两头较圆较大，框架与原生瓣膜小叶贴合时的闭合线有一定弧度。图中111和112为瓣叶与框架114可能的贴合区域，113为可能的贴合线或称为闭合线。本实施例所示的框架能够与该类原生闭锁不全的瓣膜小叶进行近乎完整的贴合，治疗二尖瓣反流效果尤为显著。
实施例3：
与实施例1不同的是，所述锚定件还包括了设置在心房内部的具有网格结构的框架锚定件，类似于锚定笼的形状，其扩张形状时，可以确定形状为更好地符合于左心房的几何形状，因此更好准确地将框架定位在想要的部位。所述框架为圆柱形网格结构，当圆柱形内径足够大时即可以替换原生受损瓣膜起到替换瓣的作用。所述锚 定笼的远端与框架的流入端连接，可以通过线状的弹性金属丝连接，如镍钛合金金属丝。锚定装置还可以同时设置在心室内，包括如实施例1所示的连接件支撑杆和锚定件等部件。如图11所示，锚定装置心房内网格状锚定笼132、圆柱形网格框架133、以及心室内连接件支撑杆134，此时锚定装置及框架均可以通过激光刻蚀一体成型制备获得，制备工艺简单，装置轻便，应用广泛。
实施例4：
本实施例用于治疗三尖瓣反流的装置，包括框架和锚定装置，所述锚定装置与框架连接。锚定装置参考本实施例1设置在右心室内的锚定件和支撑杆连接件。如图12所示，用于治疗三尖瓣反流的装置中瓣膜小叶优选为三叶瓣膜，且框架的横截面优选为圆形。所述支撑杆为具有网格结构的支撑杆。
虽然就特别的实施例和应用描述了本发明，但基于本教示，在本领域中的普通技术人员可以在不偏离本发明的主旨或不超越本发明的范围的情况下，实施额外的实施例，并且进行额外的修改。因此，应该理解的是，附图和描述在这里作为例子提供以有助于理解本发明，而不应该用来限制其范围。

Claims (20)

  1. 治疗瓣膜反流的装置，其特征在于，包括框架和锚定装置，所述锚定装置与框架连接；所述框架可扩张压缩，具有流入端和相对的流出端；所述框架的内部设置有可在血液流动中打开关闭的瓣膜小叶；所述锚定装置能够保持扩张状态下的框架在心脏原生瓣膜的孔口位置。
  2. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架具有可扩张压缩的网格结构，且框架的至少一部分内周和/或外周表面设置有覆盖膜；所述覆盖膜至少覆盖所述瓣膜小叶与框架的结合处的框架外周。
  3. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架具有可扩张压缩的网格结构，其具有菱形和/或六边形的网眼；或者所述网格结构为直线和弧线交叉绕制而成，具有不规则带有弧边的网眼。
  4. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架的内部设置有全部或局部加强件；所述加强件包括板状件、柱体件，或具有网格结构的板状件、柱体件。
  5. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架扩张时自流入端到流出端的心脏长轴方向长度为20-80mm。
  6. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架扩张时的心脏短轴平面内横截面的厚度为3-30毫米；宽度为1-50毫米。
  7. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架扩张时的心脏短轴平面内横截面的形状包括圆形、椭圆形、矩形或圆角矩形、月牙形或带圆角的月牙形、哑铃形、两边半圆形中间长方形的组合形状、梯形或带圆角的梯形、以及他们的组合形状，或者形状整体类似月牙形、中间带有弧边且中间的厚度比两头小。
  8. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架扩张时的心脏短轴平面内横截面的形状自框架的流入端到流出端连续变化或分阶段变化。
  9. 权利要求2治疗瓣膜反流的装置，其特征在于，所述覆盖膜 通过包括烧结、焊接、胶合或者缝合的方式与所述框架连接；所述覆盖膜覆盖瓣膜小叶与框架的结合处的框架外周以及框架内周。
  10. 权利要求2治疗瓣膜反流的装置，其特征在于，所述覆盖膜的材料包括血液相容性材料、人工血管材料、动物瓣膜、动物心包、高分子聚合物。
  11. 权利要求1治疗瓣膜反流的装置，其特征在于，所述瓣膜小叶包括单叶瓣膜、双叶瓣膜、三叶瓣膜或四叶瓣膜；所述瓣膜小叶通过包括缝合、胶合的方式与具有网格结构的框架相结合。
  12. 权利要求2治疗瓣膜反流的装置，其特征在于，瓣膜小叶根部与框架和/或框架上设置的覆盖膜连接，瓣膜小叶开合部与连接体连接；连接体与框架和/或框架上设置的覆盖膜连接；所述连接体包括条状、丝状、片状、柱状、网状或这些结构的组合。
  13. 权利要求1治疗瓣膜反流的装置，其特征在于，所述框架的材料包括金属材料、高分子材料或记忆合金材料；所述瓣膜小叶的材料包括动物瓣膜、动物心包、人工腱索、高分子聚合物、人工血管材料。
  14. 权利要求1治疗瓣膜反流的装置，其特征在于，所述锚定装置包括连接件和锚定件；所述锚定件通过连接件与框架连接；锚定件包括设置在瓣环上的锚定件、设置在心尖处或靠近心尖处两乳头肌间的组织内锚定件、设置在心室内壁表面的支架和/或组织内锚定件、设置在心房内腔的开口杯状支架、设置在心房内壁表面的组织内锚定件、设置在心房内腔的具有网格结构的框架，或者以上锚定件的组合；所述连接件包括杆状、线状、片状、柱状或筒状连接件，或者为这些结构的组合。
  15. 权利要求14治疗瓣膜反流的装置，其特征在于，所述连接件的材料包括金属材料、记忆合金材料或高分子材料。
  16. 权利要求14治疗瓣膜反流的装置，其特征在于，所述连接件与锚定件通过弹性或铰链连接；所述锚定装置能够使框架在原生瓣膜的孔口位置处摆动或转动。
  17. 权利要求1治疗瓣膜反流的装置，其特征在于，所述锚定 装置包括支撑杆、定位轴套、心尖卡环和固定塞；所述支撑杆的近端与框架的流出端连接；支撑杆的远端与定位轴套连接；心尖卡环固定在心尖位置或靠近心尖处两乳头肌间；定位轴套固定在心尖卡环上；固定塞与心尖卡环连接并位于心尖外面，用于定位心尖卡环；所述定位轴套与支撑杆可以发生相对移动或滑动。
  18. 权利要求17治疗瓣膜反流的装置，其特征在于，所述支撑杆自近端到远端设置有部分弯曲0-30度。
  19. 权利要求1治疗瓣膜反流装置的植入方法，其特征在于，将可扩张压缩的框架压缩放置在套管内，再通过微创技术植入心脏使框架达到扩张状态，并使用与框架连接的锚定装置将框架定位在原生瓣膜孔口处，使闭合时的心脏原生瓣膜与所述框架的外表面贴合；锚定装置通过压缩在套管内再导入进心脏，其与框架同时或者不同时导入；所述框架和锚定装置在失效或者完成治疗后采用原先导入方式进行全部回收或者部分回收。
  20. 一种治疗瓣膜反流装置的植入方法，其特征在于，包括如下步骤：
    A、在体外将可扩张压缩的框架、与框架连接的连接件装配好压缩进穿刺导管中，穿刺导管尾部设置有与连接件连接的锚定件和操作杆；所述框架的内部设置有可在血液流动中打开关闭的瓣膜小叶；所述框架具有流入端和相对的流出端，框架外周在瓣膜小叶与框架的结合处设置有覆盖膜；
    B、将穿刺导管经左侧胸部切口从心尖位置穿刺进入左心室或右心室，到达二尖瓣或三尖瓣孔口处，用操作杆将锚定件固定在心尖位置；再将框架和连接件推出；
    C、撤出穿刺套管。
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