Device for treatment of valve regurgitation

Abstract

A device for treatment of valve regurgitation is described, comprising frameworks ( 114, 133, 141, 701, 812, 821, 911 ) and an anchoring unit ( 132 ). The anchoring unit ( 132 ) is connected to the frameworks ( 114, 133, 141, 701, 812, 821, 911 ); the frameworks ( 114, 133, 141, 701, 812, 821, 911 ) can be expanded and compressed and have an inflow end ( 421 ) and an opposite outflow end ( 422 ); valve leaflets ( 142, 621, 721, 751 ) capable of opening and closing in blood flow are provided inside the frameworks ( 114, 133, 141, 701, 812, 821, 911 ); the anchoring unit ( 132 ) can keep the frameworks ( 114, 133, 141, 701, 812, 821, 911 ) in an expanded state at the orifice position of a natural heart valve. The device for treatment of valve regurgitation and an implantation method therefor can effectively treat valve regurgitation.

1 . A device for treating valve regurgitation, characterized in that it comprises a frame and an anchoring device, the anchoring device is connected to the frame, the frame is expandable and compressible, having an inflow end and an opposite outflow end, a prosthetic valve, which opens and closes in the blood flow is provided inside the frame; and the anchoring device is capable of positioning the frame in an expanded state at the native heart valve orifice. 
     
     
         2 . The device for treating valve regurgitation according to  claim 1 , characterized in that, the frame has a covering film on at least part of the inner and/or outer circumferential surface of the frame; the covering film at least covers the outer circumference of the frame at the junction of the valve leaflets of the frame. 
     
     
         3 . The device for treating valve regurgitation according to  claim 1 , characterized in that, the frame has an expandable and compressible lattice structure with rhombic and/or hexagonal meshes, or the lattice structure is made of irregular meshes with curved edge by cross-wrapping straight and arc lines. 
     
     
         4 . The device for treating valve regurgitation according to  claim 1 , characterized in that, reinforcement is provided in at least part of an interior of the frame; the reinforcement includes a plate-like member, a column-like member, or a plate-like member or a column-like member with a lattice structure. 
     
     
         5 . The device for treating valve regurgitation according to  claim 1 , characterized in that, the length in the cardiac long-axis direction from the inflow end to the outflow end of the frame when the frame is expanded to 20-80 mm. 
     
     
         6 . The device for treating valve regurgitation according to  claim 1 , characterized in that, a cross-section at the cardiac short axis plane of the frame, when the frame is expanded, has a thickness of 3-30 mm and a width of 1-50 mm. 
     
     
         7 . The device for treating valve regurgitation according to  claim 1 , characterized in that, a cross-section at the cardiac short axis plane of the frame, when the frame is expanded, has a shape including a circular, oval, rectangular or rounded rectangle, crescent or rounded crescent, dumbbell-shaped, a combination of rectangle in the middle with semi-circular on two opposite ends, a trapezoid or rounded trapezoid, and their combined shapes, or an overall shape similar to crescent as a whole with arc in the middle and thicker in the middle than in two ends. 
     
     
         8 . The device for treating valve regurgitation according to  claim 1 , characterized in that, shape of a cross-section at the cardiac short-axis plane of the frame, when the frame is expanded, changes continuously or in stages from the inflow end to the outflow end of the frame. 
     
     
         9 . The device for treating valve regurgitation according to  claim 2 , characterized in that, the covering film is connected to the frame by means of sintering, welding, gluing or sewing; the covering film covers outer and inner circumference of the frame at the junction of the valve leaflets of the frame. 
     
     
         10 . The device for treating valve regurgitation according to  claim 2 , characterized in that, the material of the covering film comprises a blood-compatible material, an artificial blood vessel material, an animal valve, an animal pericardium, and a polymer. 
     
     
         11 . The device for treating valve regurgitation according to  claim 1 , characterized in that, the device has a prosthetic valve inside with which the prosthetic valve leaflets include a uni-leaflet valve, a bi-leaflet valve, a tri-leaflet valve or a tetra-leaflet valve; the valve leaflet is connected to a frame having a lattice structure by means including sewing or gluing. 
     
     
         12 . The device for treating valve regurgitation according to  claim 2 , characterized in that, end of the prosthetic valve leaflet is connected to the frame and/or the covering film on the frame, the free edge of the prosthetic valve leaflet is connected to the frame and/or the covering membrane through a connector; structure of the connector includes strip, filament, sheet, column, net, or a combination thereof, can be an integral part of the leaflet or separate element. 
     
     
         13 . The device for treating valve regurgitation according to  claim 1 , characterized in that, the material of the frame comprises a metal material, polymer material or memory alloy material; the material of the valve leaflet includes animal valve, animal pericardium, artificial chordae, polymer, and artificial blood vessel material. 
     
     
         14 . The device for treating valve regurgitation according to  claim 1 , characterized in that, the anchoring device comprises a linker and an anchor; the anchor is connected to the frame through the linker; the anchor may be arranged on the valve annulus, at apex or between the papillary muscle near the apex, or a stent and/or an intra-tissue anchor arranged on the surface of inner wall of ventricle, an open cup-shaped stent arranged in the inner chamber of atrium, on the surface of inner wall of atrium, a frame having a lattice structure arranged in the inner chamber of atrium, or a combination of the above anchors. 
     
     
         15 . The device for treating valve regurgitation according to  claim 14 , characterized in that, a linker is used to connect the anchor and the frame, said linker includes a rod, a wire, a sheet, a column, or a tube, or a combination thereof and the material of the linker comprises metal material, memory alloy material or polymer material. 
     
     
         16 . The device for treating valve regurgitation according to  claim 14 , characterized in that, the linker and the anchor are connected by an elastic material or a hinge; so to allow the frame to swing or rotate in the native valve orifice. 
     
     
         17 . The device for treating valve regurgitation according to  claim 1 , characterized in that, the anchoring device comprises a supporting rod, a positioning sleeve, an apex snap ring and a fixation plug; the proximal end of the supporting rod is connected to the outflow end of the frame; the distal end of the supporting rod is connected to the positioning sleeve; the apex snap ring is fixed at the apex or the papillary muscle near the apex; the positioning sleeve is fixed on the apex snap ring; the fixation plug is connected to the apex snap ring and is located outside the apex to position apex snap ring; the positioning sleeve can be moved or slide relative to the supporting rod. 
     
     
         18 . The device for treating valve regurgitation according to  claim 17 , characterized in that, the supporting rod is provided with a partial bend in a range of 0-30 degrees from the proximal end to the distal end. 
     
     
         19 . A method for implanting the device for treating valve regurgitation according to  claim 1 , characterized in that,
 loading in a cannula the expandable and compressible frame after being compressed   implanting the expandable and compressible frame into a native valve position through a minimally invasive technique to make the frame reach an expanded state, the frame is positioned in the native valve orifice by means of the anchoring device connected to the frame, such that the native heart valve leaflets coaptate on the outer surface of the frame during systole;   compressing the anchoring device into the cannula and implanting it into the heart, either simultaneously with the frame or not; the frame and the anchoring device are configured to be completely retracted or partially retracted by an original implantation method.   
     
     
         20 . A method for implanting a device for treating valve regurgitation, characterized in that, comprising the steps of:
 A. providing the implanting device of  claim 1 , wherein an expandable and compressible frame, the linker and the anchor are collectively or partly assembled in vitro, whole assembly or subassembly are configured to be compressed into a puncturing catheter;   B. placing a puncturing catheter from the apex position through an incision on left chest into a left ventricle or right ventricle, to a mitral or tricuspid valve orifice, the whole assembly or subassembly is then pushed out, the puncturing catheter is withdrawn.   C. attaching the anchor to the apex position.