WO2018145249A1 - 用于治疗三尖瓣反流的装置及其植入方法 - Google Patents

用于治疗三尖瓣反流的装置及其植入方法 Download PDF

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Publication number
WO2018145249A1
WO2018145249A1 PCT/CN2017/073069 CN2017073069W WO2018145249A1 WO 2018145249 A1 WO2018145249 A1 WO 2018145249A1 CN 2017073069 W CN2017073069 W CN 2017073069W WO 2018145249 A1 WO2018145249 A1 WO 2018145249A1
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Prior art keywords
valve
stent
plug
tricuspid
guide wire
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PCT/CN2017/073069
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English (en)
French (fr)
Inventor
李守彦
南红霞
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上海甲悦医疗器械有限公司
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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 CN201780034645.9A priority Critical patent/CN109310497B/zh
Priority to US16/508,312 priority patent/US10932909B2/en
Priority to PCT/CN2017/073069 priority patent/WO2018145249A1/zh
Priority to PCT/CN2017/084157 priority patent/WO2018145365A1/zh
Priority to CN201780034704.2A priority patent/CN109414321B/zh
Priority to US16/468,286 priority patent/US20200069419A1/en
Publication of WO2018145249A1 publication Critical patent/WO2018145249A1/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
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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
    • A61F2/2412—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
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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
    • A61F2/2412—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
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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
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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
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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
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets 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
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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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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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 heart of a mammal contains four chambers, two of which are the atrium that fills the chamber, and two that are the chambers that are pumped out of the chamber.
  • the four main valves in the heart are the tarsal flaps representing the mitral valve, and the tricuspid valve, which is between the upper atrium and the lower ventricle, respectively, and is therefore referred to as the atrioventricular (AV) valve.
  • AV atrioventricular
  • AV atrioventricular
  • aortic and pulmonary valves in the arteries that leave the heart are aortic and pulmonary valves in the arteries that leave the heart.
  • the mitral and aortic valves are in the left heart, and the tricuspid and pulmonary valves are in the right heart.
  • the valve incorporates a leaflet or tip, wherein each valve has three tips in addition to having only two pointed mitral valves.
  • the mitral and tricuspid valves are located between the atria and the ventricle, respectively, and prevent backflow from the ventricles to the atria during the systole. They are anchored to the wall of the ventricle by a chord that prevents the valve from reversing. The chordae are attached to the papillary muscle, which causes tension to better maintain the valve.
  • Tricuspid regurgitation is a common heart disease. Functional tricuspid regurgitation is considered a fatal disease in patients with left heart disease. Tricus regurgitation is usually not treated alone. Synchronized with left heart disease. Especially patients with long-term mitral regurgitation. Severe tricuspid regurgitation can lead to decreased cardiac output and systemic congestion, which is a poor prognosis of many heart diseases, which seriously affects the prognosis of patients. It has been documented that moderate to severe tricuspid regurgitation is closely related to increased mortality.
  • the surgical treatment of tricuspid regurgitation includes annuloplasty, leaflet repair, papillary muscle or sacral cord adjustment, and marginal margin restoration.
  • the current moderate and severe tricuspid regurgitation is 1.6 million in the United States, China is estimated to be 5 million by population, of which only 0.5% can be operated, and the surgery is mainly based on annulus, and the remaining patients are not suitable for surgery. Therefore, there is no suitable treatment for such high-risk patients.
  • 74% The patient developed reflux after three years. Among the elderly over the age of 54 years, the incidence rate of males was 14.8% and that of females was 18.4%.
  • annuloplasty In addition to surgical treatment of tricuspid regurgitation, minimally invasive repair with annuloplasty and tricuspid valve plugging are currently in the research phase.
  • Annuloplasty such as the two-valve technique disclosed in the Mitralign system, simulating surgery through the jugular vein, implanting the suture repair technique to make the tricuspid valve two-lobed; and placing the stainless steel nut on the anterior and posterior trigone joints of the tricuspid valve Remodeling the tricuspid valve to make the tricuspid valve two-lobed TriCinch system.
  • Minimally invasive repair of the tricuspid valve is usually a tricuspid device placed at the orifice of the tricuspid valve leaflet to block the valve leakage orifice to prevent reflux, including balloon type
  • the tricuspid valve plug uses a liquid-filled balloon to bulge a cylindrical plug as a tricuspid plug; and a bell-shaped tricuspid plug.
  • the present invention implants a flap device with a prosthetic valve at the opening of the tricuspid valve, which can block the leakage orifice of the tricuspid valve during systole and prevent the tricuspid valve from closing.
  • Reflux, in the diastolic phase can also maximize the effective orifice area of blood from the tricuspid valve, prevent tricuspid stenosis, and provide an effective treatment for tricuspid regurgitation.
  • the first technical solution of the present invention provides a use Means for treating tricuspid regurgitation, the device comprising a compressible expanded flap, and a plug fixation device for anchoring the flap to the tricuspid orifice; the plug having an inflow end and an opposing The outflow end, and the inside of the valve plug is provided with a prosthetic valve that can be opened and closed.
  • the valve plug comprises a stent, a bushing and a prosthetic valve
  • the stent is a combination of any one or more of a tubular shape, a vertebral shape or a spherical shape, has a network structure, compressible expansion; Covering at least a portion of the inner and/or outer peripheral surface of the stent; the prosthetic valve is axially sewn within the stent, preferably axially sewn into the stent perpendicular to the stent.
  • the support is a mesh structure having diamond and/or hexagonal mesh, and the density of the diamond and/or hexagonal mesh structure is gradually reduced from the central portion to the both ends; the artificial valve is sewn on the support A diamond and/or hexagonal grid of relatively high density.
  • the stent is made by laser etching techniques, integrally formed 3D printing techniques or from woven crossed wires.
  • the bracket is made of an elastic alloy material having a strong restoring force, preferably a nickel-titanium alloy;
  • the bushing is any one selected from the group consisting of polyethylene materials, artificial blood vessel materials, polyurethane materials, pig or bovine pericardium materials.
  • the prosthetic valve is made of any one of a porcine or bovine animal valve, a biological tissue material, a polymeric material, or a tissue engineered valve.
  • the scaffold is a tubular tubular shape selected from a network, a truncated cone, or a combination of one or more of a cone, a sphere, a hemisphere, and an ellipsoid.
  • the shape of the bracket is a rounded table tubular shape and/or an inverted cone shape; the total length of the bracket is 20-80 mm, and the inner diameter is 0-50 mm.
  • the bracket is tubular or inverted conical in a round table, and the inner diameter of the bracket gradually increases from a small end to a distal end from a small end to a distal end; the total length of the bracket is 20-80 mm, and the inner diameter is 0-50 mm.
  • the inner diameter may vary from 0 to 50 mm.
  • the bracket is a truncated cone having a mesh structure, and the inner diameter of the truncated tubular bracket gradually decreases from the proximal end to the distal end, and the inner diameter can also be reduced to 0 to form an inverted cone.
  • the shape of the stent having the mesh structure is composed of a cone A and an inverted cone B from the proximal end to the distal end, and the inner diameter of the bottom surface of the cone A is the same as the inner diameter of the bottom surface of the inverted cone B, and the length of the cone A is smaller than The length of the inverted cone B.
  • the plug fixation device comprises a hollow cannula connecting the inflow or proximal end of the valve plug, and a guide wire passing through the center of the prosthetic valve and the hollow cannula; the distal end of the guide wire is provided with an anchor hook; The proximal end of the guidewire and the proximal end of the hollow cannula are anchored and positioned by the external control handle to adjust the relative position. After implantation of the device, the proximal end of the guidewire and the proximal end of the hollow cannula can be secured in the body tissue.
  • the anchor hook may be fixed to the apex or right ventricular inferior wall myocardium; the anchor hook is made of a shape memory alloy, preferably a nickel titanium alloy.
  • the hollow sleeve extends through the intermediate opening of the valve plug and the internal prosthetic valve such that a channel is formed inside the plug to facilitate sliding of the guide wire.
  • the second technical solution of the present invention provides a method for implanting a tricuspid regurgitation device, which comprises the following steps:
  • the present invention provides the use of any of the above-described devices for treating tricuspid 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 flow.
  • valve plug of the invention can block the leakage of the tricuspid valve to prevent backflow, and the plug itself has a plugging function
  • valve in the valve plug opens simultaneously at the diastolic phase and the tricuspid valve. After opening, the effective orifice area of the tricuspid valve inlet increases, and the tricuspid valve overcurrent resistance is reduced to prevent tricuspid stenosis;
  • the whole device can be recycled. After placing the device of the present invention, it can be withdrawn after discomfort, poor effect or repair is completed, such as recovering the compressible and expanded valve plug through the sheath tube, and recovering the anchor hook through the sheath tube.
  • the guide wire, etc. restore the preoperative state;
  • the device of the present invention preferably adopts minimally invasive percutaneous technique, does not require happy, thoracotomy, and is suitable for high-risk patients.
  • Figure 1 Schematic diagram of human heart anatomy: 1 is the superior vena cava, 2 is the inferior vena cava, 3 is the right atrium, 4 is the tricuspid valve, 5 is the right ventricle, 6 is the pulmonary valve, 7 is the pulmonary artery, 8 is Pulmonary vein, 9 is left atrium, 10 is mitral valve, 11 is left ventricle, 12 is aortic valve, 13 is aorta, 14 is descending aorta, 15 is oxygenated blood flow, 16 is hypoxic blood flow .
  • FIG. 2 Schematic diagram showing the correct placement of the device of one embodiment of the present invention in the heart: SVC is the superior vena cava, RV is the right ventricle; 21 is the valve plug, 22 is the hollow cannula, 23 is the guide wire, 24 As the anchor hook, 25 is an external control device, and 26 is a bushing that is wrapped around the outside of the plug bracket.
  • Fig. 3A is a schematic view showing the stent of the preferred occlusion device: 3A-1 is a top view, 3A-2 is a front view of 3A-1, and 3A-3 is a perspective view of 3A-1; wherein 31 is a cylindrical tube having a diamond mesh In the middle of the grid structure bracket, 32 is a truncated cone-shaped grid with a relatively low density of stent ends, 33 is a guide wire, 34, 35 are bases for fixing the grid structure bracket, and 34 is used to connect the hollow sleeve.
  • Fig. 3B is a schematic view showing the stent of the preferred occlusion device: 3B-1 is a plan view, 3B-2 is a front view of 3B-1, and 3B-3 is a perspective view of 3B-1; wherein 41 is a truncated cone shaped diamond In the middle of the grid structure bracket, 42 is a truncated cone shaped grid with a relatively low density of the inflow end of the bracket, and 47 is a truncated cone shaped grid with a relatively low density of the stent stream. At the end, 43 is a guide wire; 44 is a base for fixing the grid structure bracket, and is used for connecting the hollow sleeve.
  • FIG. 4 Schematic diagram of a preferred stent with a prosthetic valve: 4-1 is a top view, 4-2 is a front view of 4-1, and 4-3 is a perspective view of 4-1; 51 is a cylindrical tubular network The middle portion of the bracket, 52, 57 is the end (inflow end and outflow end) of the cone mesh bracket, 53 is the guide wire, 54 is the component for connecting the hollow sleeve, and 50 is the artificial trilobal valve, 58, 59 is a soft hoop-like component.
  • Fig. 5A is a schematic view showing a preferred prosthetic valve stent with an inner and outer bushing: 5A-1 is a top view, 5A-2 is a front view of 5A-1, and 5A-3 is a perspective view of 5A-1; wherein 41 is a circle The central portion has a diamond-shaped mesh structure in the middle of the bracket, 42 and 47 are truncated-shaped grids, and the relatively low density of the inflow and outflow ends of the bracket, 43 is a guide wire; 44 is a base for fixing the grid structure bracket, and is used For connecting the hollow sleeve; 48 is the outer bushing of the bracket, and 49 is the inner bushing of the bracket.
  • Fig. 5B is a schematic view showing a preferred artificial valve stent with an inner liner: 5B-1 is a top view, 5B-2 is a front view of 5B-1, 5B-3 is a perspective view, and 5B-4 is a bottom view; 41 is a trumpeter-shaped central portion having a diamond-shaped mesh structure bracket, 42 and 47 are truncated-shaped grids, and a relatively low density of the inflow and outflow ends of the stent, 43 is a guide wire; 44 is used for fixing the grid structure bracket.
  • the base is used to connect the hollow sleeve; 49 is the inner bushing of the bracket.
  • FIG. 6 Schematic diagram of anchor hook delivery of the preferred device shown: (a) ⁇ (b) ⁇ (c), 23 is the guide wire, 24 is the anchor hook, 27 is the sheath tube, and 28 is the automatic bending of the anchor hook Hook claws.
  • FIG. 7 Schematic diagram of the spring anchor hook of the preferred device shown: 7-1 is a bottom view, 7-2 is a front view of 7-1; wherein 61 is a helical spring anchor claw and 62 is an anchor base. 63 is a component that connects the guide wires.
  • FIG. 8 Schematic illustration of a preferred valve plug with an inner and outer liner and a prosthetic valve: 8-1 is a top view, 8-2 and 8-3 are perspective views at different angles; 70 is a manual trilobal valve, 72 is The truncated cone-shaped grid is relatively low in density of the stent inflow end, 77 is a truncated cone-shaped grid with a relatively low density of the stent outflow end, 73 is a guide wire; 74, 75 is a base for fixing the grid structure bracket, 74 It can also be used to connect hollow sleeves; 79 is the outer bushing of the bracket, and 78 is the inner bushing of the bracket.
  • inflow end shall be the end of the blood inflow and the "outflow end” shall be the end from which the blood flows.
  • sheath can also be described as a “catheter”, and thus these terms are used interchangeably.
  • network structure can also be described as a “mesh structure.”
  • the term "artificial tissue material” includes tissue manufactured by tissue engineering in a laboratory, for example, a combination of extracellular matrices, cells, and biologically active molecules from a design. It can prevent natural tissue materials from becoming calcified, leading to undesired hardening or degradation of the artificial heart valve.
  • the artificial tissue material can be any reasonable size kangaroo, ostrich, whale or any other suitable xenograft or allograft tissue.
  • the artificial tissue material also contains connective tissue proteins (ie, collagen and elastin) that serve as a support framework for the tissue material. To enhance the tissue protein compound, a chemical immobilization process can be performed to link the proteins together.
  • 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 and method of implantation of the present invention attempt to reduce or block the amount of blood flowing from the right ventricle to the right atrium during systole of the contraction of the heart, and to ensure blood flow from the right atrium to the right ventricle during diastole A sufficient amount.
  • the device for treating tricuspid regurgitation can reduce the size of these openings between the tricuspid valve leaflets, and in some cases completely eliminates the opening, allowing the tricuspid valve to seldom regulate Or function without any backflow.
  • by positioning the therapeutic reflux device between the tricuspid leaflets to close or fill the opening between the leaflets when closed This is achieved between the openings.
  • the reflux device does not reduce the effective flow area of the blood, ensuring blood flow from the right atrium to the right ventricle.
  • FIGS. 1 through 8 The following description refers to FIGS. 1 through 8. Those skilled in the art will recognize that the drawings and the drawings are intended to be illustrative of the various embodiments of the invention, and the scope of the appended claims BRIEF DESCRIPTION OF THE DRAWINGS
  • Figure 1 is a schematic illustration of the human heart anatomy, which consists of three approximately triangular valves or segments or leaflets (anterior tip, posterior tip and medial or septum tip). The bottom is attached to a fiber annulus (not shown in Figure 1) that surrounds the chamber opening and is also interconnected to form a continuous annulus membrane. Its atrial surface faces the blood flow from the atrium 3, while its ventricular surface faces the wall of the ventricle 5; it together with the apex and edge of the valve tip provides fixation for the chordae.
  • the function of the tricuspid valve is to prevent blood from flowing back into the right atrium 3; the arrows indicate the normal direction of blood flow. When the valve of the tricuspid valve 4 is not completely closed, causing blood to leak back into the right atrium 3, tricuspid regurgitation occurs.
  • a first aspect of the invention is a device for treating tricuspid regurgitation, the device comprising a compressible expanded flap, and a flap for anchoring the flap to the tricuspid orifice a plug fixation device; the valve plug having an inflow end and an opposite outflow end, the inside of the valve plug being provided with an artificial valve that can be opened and closed.
  • the prosthetic valve automatically closes when the tricuspid valve is closed; the prosthetic valve automatically opens when the tricuspid valve is opened, and blood flows in from the inflow end of the plug and flows out from the outflow end.
  • the occlusion plug can be anchored by the stenosis device at the orifice formed when the tricuspid valve is closed, and functions to block the orifice.
  • the opening and closing of the prosthetic valve is synchronized with the opening and closing of the tricuspid valve, i.e., in synchrony with diastolic contraction.
  • the tricuspid valve closes and the valve plug is blocked at the tricuspid orifice.
  • the prosthetic valve in the valve plug is also closed.
  • the closed valve plug effectively blocks blood reflux; when the heart is dilated, the tricuspid valve opens.
  • the traction of the valve plug is still in the vicinity of the original position due to the traction of the valve plug fixation device, and the blood flows from the right atrium to the right ventricle, and the artificial valve inside the valve plug is simultaneously opened to facilitate the flow of blood from the inflow end of the valve plug and flow out from the outflow end, avoiding the three tips The problem of narrow stenosis.
  • the compressible expanded flap can be transformed between a contracted first configuration and an expanded second configuration, the first configuration being a delivery configuration when the valve plug is delivered through a catheter, and the second configuration being the valve plug being implanted
  • Some embodiments of the present invention adopt the principle of self-expansion. In vitro, the device can be pressed into a strip-shaped first form, placed in the delivery device, and after reaching a predetermined position of the tricuspid orifice of the heart, through self-expansion, It returns to the original design and has a high hardness and is anchored inside the heart by the plug fixation device.
  • the plug comprises a stent, a liner, and a prosthetic valve;
  • the stent is tubular or a similar shape, and has a network structure, compressible expansion;
  • the liner covers at least the stent a portion of the inner and/or outer peripheral surface;
  • the prosthetic valve is axially sewn to the interior of the stent perpendicular to the stent.
  • the bushing is impervious to blood.
  • the stent, the stent of the present invention is a compressible and expandable upper and lower blood-permeable stent for use as a support skeleton for the valved prosthetic valve, and imparts contractile expansion characteristics to the valve plug.
  • the scaffold is any one or combination of tubular, vertebral or globular.
  • the shape of the stent having a mesh structure is selected from one or a combination of a cylinder, a cone, a truncated cone, a sphere, a hemisphere, and an ellipsoid.
  • the stent having a mesh structure may also be in the shape of a cage similar to a hemisphere and a cylinder.
  • the bracket is tubular or inverted conical in a rounded table, and the inner diameter of the bracket gradually decreases from the proximal end to the distal end.
  • a rounded tubular or inverted conical stent with a network structure acts as a stent for the valve plug, which is better fitted to the tricuspid valve when implanted at the tricuspid orifice Moving helps to limit backflow.
  • the stent having a mesh structure has a diamond-shaped mesh structure that is not unique in shape, and any shape that satisfies the requirements of blood flow and contraction expansion is feasible.
  • the support is a mesh structure having diamond and/or hexagonal mesh.
  • the mesh grid density of the mesh scaffold may be uniform or varied.
  • the density of the stent mesh (or mesh) is denser in the middle and less dense at both ends, which can be gradually reduced from the central portion to the both ends.
  • the higher density in the middle will not only facilitate the sewing of prosthetic valves and/or bushings, but also a stable prosthetic valve for better functioning and better shielding of the unnecessary blood flow from the bushing. The valve leaks around the valve.
  • the method for fabricating the occlusion stent for treating tricuspid regurgitation of the present embodiment is preferably a laser etching technique.
  • the method of preparation is not unique, and in other preferred embodiments it may be made using an integrally formed 3D printing technique or made of woven or otherwise crossed wires.
  • the bracket may be made of a metal material, or may be made of other materials having high supporting strength, preferably made of an elastic alloy material having a strong restoring force, such as a nickel titanium alloy or the like.
  • the occlusion stent in this embodiment can be designed into different sizes according to the actual situation of the patient, and specifically can refer to the size of the right atrium and the tricuspid orifice.
  • the plug stent can be designed to have an inner diameter of 0-50 mm and a total length of 20-80 mm.
  • the plug stent can be designed to have an inner diameter in the range of 5 to 45 mm and a total length of 20 to 80 mm.
  • the plug stent can be designed with a cylindrical tubular stent having an inner diameter of 0-40 mm or 5-35 mm and a length designed to be 20-80 mm.
  • the plug stent can be designed as a cylindrical tubular tube with a rectangular mesh in the middle of the stent, a triangular shape of a triangular mesh at both ends, and the middle and the ends are connected by a soft hoop type material, as shown in the figure. 4 is shown.
  • the differently shaped mesh portions of the stent can be joined by components made of a soft hoop-type material to meet the characteristics of expandable compression.
  • the plug stent is designed as a narrow-necked truncated cone at both ends, and the intermediate cylindrical tubular stent has an inner diameter of 5-50 mm and a length of 20-80 mm, and the inner radial ends are gradually reduced. To 5-40mm.
  • a preferred embodiment is shown in FIG. 3A, wherein 31 is a central portion of a cylindrical tubular stent having a diamond-shaped mesh structure, 32 is a truncated cone-shaped grid with a relatively low density of stent ends, 33 is a guidewire, and 34, 35 cylinders. It is a base for fixing the mesh structure bracket, and the cylinder 34 is located at the inflow end, and can be used to connect the hollow sleeve.
  • the occlusion stent is designed as a conical stent with a conical bottom at the proximal end and a diameter of 10-50 mm, and the inner diameter gradually tapers to the distal end to a tapered end with a total length of 20-80 mm.
  • the bottom of the cone also has an intersecting grid for easy attachment of the plug fixture.
  • the plug stent is designed as a truncated cone stent, the proximal end (inflow end) is the bottom of the truncated cone, the inner diameter is 5-50 mm, and the inner diameter gradually decreases toward the distal end (outflow end) to be reduced to an inner diameter of 5- 40mm, total length is 20-80mm.
  • the occlusion stent is designed as a combination of truncated cone shaped supports, a preferred embodiment is shown in Figure 3B, 3B-1 is a top view, 3B-2 is a front view of 3B-1, 3B-3 3D-1 is a three-dimensional diagram; wherein 41 is a truncated cone-shaped central portion with a diamond-shaped grid structure; 42 and 47 are truncated-shaped grids of relatively low density bracket ends (inflow end and outflow end), and When the valve plug is implanted into the tricuspid valve, 42 is the proximal end, 47 is the distal end; 43 is the guide wire, and 44 is the base for fixing the grid structure bracket, and is used for connecting the hollow sleeve.
  • 41, 42, and 47 constitute a combination of a truncated cone-shaped bracket, and the inner diameter gradually increases from small to large and then gradually decreases from the proximal end to the distal end.
  • the specific stent size can be adjusted and improved based on the patient's heart structure.
  • the preferred dimensions are, for example, an inner diameter of 10-15 mm at the narrowest point, 35-45 mm at the widest point, and a total length of 50-80 mm.
  • the stent can be divided into three parts from the inflow end to the outflow end, and the inner diameter of the first partial truncated stent is increased from 3-6 mm to 15-50 mm, and the length is 5- 10mm; then through the circular grid line transition to the second part of the circular table-shaped bracket, the inner diameter is reduced from 15-50mm to 0-40mm, the length is 20-60mm; then through the circular grid line transition to the third part, the inner diameter from 0-40mm Continue to reduce to 3-5mm, length 0-10mm. Wherein the diamond-shaped grid lines of the first part and the third part are lower in density than the second part.
  • the prosthetic valve of the present invention is a prosthetic valve that can be automatically opened and closed with the flow of blood, and its opening and closing is similar to the state in which the original tricuspid valve of the heart is working normally.
  • the prosthetic valve is axially sewn into the interior of the stent, preferably axially sewn to the interior of the stent perpendicular to the stent.
  • the prosthetic valve may be a common three-leaf valve or a two-leaf valve or a four-leaf valve.
  • the interlobular connection portion of the leaflets is fixed on the stent mesh, and the other edge portions are not sutured, and can be opened and closed at an angle to form three half-moon sinus shapes and the edges thereof can be completely closed. together.
  • the prosthetic valve is axially sewn perpendicular to the stent inside the stent to form a cross section.
  • 51 is the middle section of the cylindrical tubular network support
  • 52 is the end of the cone mesh stent
  • 53 is the guide wire
  • 54 is a spherical member for connecting the hollow cannula
  • 50 is a trifoliate valve
  • 52 is the proximal end (inflow end) and 57 is the distal end (outflow end).
  • 58, 59 are soft hoop members for attaching the proximal distal cone portion and the intermediate cylindrical tubular portion of the stent.
  • the soft hoop member can be made of the same material as the bushing of the present invention, preferably prepared from an artificial tissue material.
  • the middle of the bracket is a rectangular grid, and the two ends are triangular grids. Because they are connected by soft hoop type material components, the compression expansion characteristics can also be satisfied, and the requirements for catheter interventional surgery are met, and the preparation is simple and can be adopted. Obtained by the threading method.
  • the closed state of the trilobal valve 50 is shown in Figure 4-3.
  • the valve leaflet 50 opens toward the distal end (outflow end) of 57, that is, the three leaflets of the valve are folded toward the distal end of 57 to allow blood.
  • the stent shown in Fig. 4 is a mesh stent whose inner diameter and the inner diameter of the outflow end are gradually reduced, and the stent can be compressed; although the bushing is not indicated in the drawing, the bushing is preferably sewn in the middle portion of the 51 bracket. Preferably, both the inner and outer peripheral surfaces are sewn.
  • the prosthetic valve can be made from an animal (preferably porcine) valve, pig or bovine pericardium, or can be a biological tissue material, a polymeric material, or a tissue engineering valve.
  • the sewing position of the artificial valve inside the stent is not particularly limited.
  • the density of the mesh in the middle of the plug stent is high, the artificial valve is preferentially sewn at a higher density.
  • the bushing, the function of the bushing of the present invention is to ensure the sealing of the plug, and the bushing on the inner circumference and/or the outer peripheral surface of the bracket can prevent blood from flowing into the right atrium from the network gap of the plug bracket, thereby preventing the flap The role of the weekly leak.
  • a preferred bushing is provided as a bloodtight bushing.
  • the bushing may be disposed between the bracket and the prosthetic valve, or may cover the outer peripheral surface of the stent; most preferably, a bushing is disposed between the outer periphery of the stent and between the stent and the prosthetic valve (ie, the inner circumference) to form a double layer Bushing-covered bracket.
  • the liner covers at least a portion of the inner and/or outer peripheral surface of the stent.
  • the bushing can effectively prevent the prosthetic valve leakage and unnecessary backflow of blood; it can also greatly reduce or eliminate the coagulation of the internal prosthetic valve caused by the exposed stent components, while maintaining the benefits of the stent structure.
  • the bushing can be sewn to the bracket by sewing. If the liner is sewn inside the stent, the prosthetic valve can be sewn to both the liner and the stent at the same time.
  • the bushing may be made of a material such as polyethylene material, artificial tissue material, artificial blood vessel material, polyurethane material, pig or bovine pericard, or may be a polytetrafluoroethylene material, a woven fabric, a non-woven fabric, a woven polyester or the like.
  • the liner can be sewn to the inner and outer peripheral surface of the middle portion of the stent having the diamond-shaped lattice structure or only to the inner peripheral surface or only to be sewn. On the outer peripheral surface.
  • FIG. 5A is a schematic view of a preferred prosthetic valve stent with an inner and outer bushing as shown in FIG. 5A: 5A-1 is a top view, 5A-2 is a front view of 5A-1, and 5A-3 is a 3A-1 perspective view; wherein 41 is a circle The central portion has a diamond-shaped mesh structure in the middle of the bracket, 42 and 47 are truncated-shaped grids, and the relatively low density of the inflow and outflow ends of the bracket, 43 is a guide wire; 44 is a base for fixing the grid structure bracket, and is used For connecting the hollow sleeve; 48 is the outer bushing of the bracket, and 49 is the inner bushing of the bracket.
  • Figure 5B shows a schematic diagram of a preferred prosthetic valve stent with an inner liner: 5B-1 is a top view, 5B-2 is a front view of 5B-1, 5B-3 is a schematic view, 5B-4 A bottom view; wherein 41 is a trump-shaped central portion having a diamond-shaped lattice structure support, 42 and 47 are truncated-shaped grids having a relatively low density of the carrier inflow end and the outflow end, 43 is a guide wire; 44 is for fixing The base of the grid structure bracket is used to connect the hollow sleeve; 49 is the inner bushing of the bracket.
  • Valve plug fixing means said valve plug fixing means can be realized reliably anchor the valve plug and positioned within the heart.
  • the plug fixation device includes a hollow cannula that connects the proximal end of the valve plug, and an anchored guidewire that passes through the center of the prosthetic valve and the hollow cannula.
  • the distal end of the guide wire is provided with an anchor hook.
  • the anchor hook can be designed to be similar to the shape of the hook. It can be compressed into the sheath before delivery. After reaching the heart, the anchor hook is pushed out and the hook is inserted into the inner wall of the heart. The preferred insertion position is apex or right heart. Indoor lower wall myocardium.
  • the anchor hook may also be of other types, and a spring anchor hook type anchor hook as shown in Fig. 7 may be cited.
  • the anchor hook is connected to the guide wire by a thread or a slot.
  • the distal end of the guide wire with the anchor hook is implanted into the intraventricular fixation, and then the valve plug is implanted through the hollow cannula along the guide wire.
  • the proximal end of the guide wire and the proximal end of the hollow can be adjusted by the external control handle to adjust the relative position of the hollow cannula and the guide wire, and because the hollow catheter is connected to the proximal end of the valve plug, the relative movement of the hollow catheter and the guide wire is The orientation of the plug can be adjusted.
  • the proximal end of the guide wire and the proximal end of the hollow cannula can be fixed in the subclavian tissue capsular bag, similar to the placement method of the cardiac pacemaker, so as to facilitate the later withdrawal and adjustment of the position of the valve plug.
  • the hollow cannula and the plug can be connected by a threaded connection or a groove.
  • the inner diameter of the hollow sleeve is not too large, and the strength is sufficient to connect the plug, allow the guide wire to pass therethrough, and can move relative to each other.
  • the hollow sleeve has an inner diameter of from 1 to 3 mm.
  • the hollow sleeve can be attached to the inflow end base 34 on the bracket and can be connected by threads or grooves.
  • the hollow cannula can also extend through the valve plug and the prosthetic valve such that the interior of the plug also forms a passageway for relative movement of the guidewire therein.
  • the anchor is preferably made of a shape memory alloy such as Made of nickel-titanium alloy.
  • the alloy can also be selected such that its transition temperature is about 37 ° C and can initiate self-expansion when the transition temperature is reached.
  • the hollow cannula is selected from other implantable materials such as polymeric materials such as polyurethane materials.
  • the occlusion device of the present invention may be implanted by a surgical method or may be delivered by a transcatheter method.
  • the device of the present invention is loaded into a suitable deployment catheter where it is compressed by a retractable sheath or tube or the like.
  • the catheter is placed into the heart of the patient in need of support for the tricuspid valve.
  • an arrangement catheter loaded with a device according to the invention in a compressed state can be advanced through the jugular vein into the superior vena cava, into the right atrium, and re-expanded to the position of the tricuspid orifice .
  • the deployment catheter on which the device according to the invention is loaded in a compressed state can be advanced through the femoral vein into the inferior vena cava into the right atrium.
  • the device of the invention is implanted via a catheter in the subclavian vein or jugular vein opening.
  • a preferred embodiment of the present invention is a schematic representation of the correct placement of the plug in the heart: SVC is the superior vena cava, RV is the right ventricle; 21 is the valve plug, 22 is the hollow cannula, 23 is The guide wire, 24 is an anchor hook, 25 is an external control device, and 26 is a bushing that wraps around the periphery of the plug holder.
  • the device according to the invention is located in the heart of a person in an expanded state.
  • the valve plug 21 is just at the mouth of the tricuspid valve.
  • the occlusion stent is a network stent formed by a combination of a cone and a cylinder. The outer circumference is covered with a bushing 26.
  • the proximal end of the stencil holder is connected with the hollow sleeve 22, and the hollow sleeve 22 has a guide wire 23, which is guided.
  • the distal end of the wire 23 is provided with an anchor hook 24 and the anchor hook 24 has been anchored into the apex.
  • the proximal ends of the hollow cannula 22 and the guidewire 23 can be positionally adjusted and fixed at the external control device 25 to adjust the positioning of the petals 21.
  • a prosthetic valve is sewn into the valve plug 21 (not shown in Fig. 2, and specific reference is made to Fig. 8).
  • FIG 6 is a schematic view of the anchor hook transport of the preferred device of Figure 2: (1) ⁇ (2) ⁇ (3), wherein 23 is a guide wire, 24 is an anchor hook, and 27 is a sheath tube that can accommodate an anchor hook, 28 It is an automatically bendable hook on the anchor hook.
  • the anchor hook 24 can be compressed into the sheath tube 27 before delivery. After reaching the heart, the anchor hook 24 is pushed out, and the hook claw 28 is inserted into the apex, and the hook claw 28 is automatically bent after being inserted, thereby anchoring the guide wire.
  • a similar method can be used to anchor The hook 24 is removed from the heart and retracted to restore the preoperative state.
  • Figure 7 is an alternative type of anchor hook jaw that is helically spring-like and has the features of screw-in anchoring and screw-out withdrawal that can be anchored to the apex or inner wall of the heart.
  • Figure 8 is a schematic view of the preferred valve plug with the inner and outer bushings and the prosthetic valve shown in Figure 2: 8-1 is a top view, 8-2 and 8-3 are perspective views of different angles; 70 is a artificial trilobal valve, The middle of the bracket is cylindrical and has a diamond-shaped grid structure (not shown in the drawing, refer to FIG. 3A), 72 is a truncated-shaped grid with a relatively low density of the inflow end of the bracket, and 77 is a truncated grid.
  • Lower stent outflow end, 73 is the guide wire (corresponding to 23 in Figure 2); 74, 75 is the base for fixing the grid structure bracket, 74 can also be used to connect the hollow sleeve; 79 is the bracket outer bushing (corresponding to 26 in Fig. 2), 78 is the inner bushing of the bracket.
  • the artificial valve 70 is axially sewn on a tubular stent with an inner liner 78.
  • a "visualization element” may be attached or otherwise disposed 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, including any suitable The material, such as, for example, gold, bismuth, platinum, or consists of it.
  • a second aspect of the present invention provides a method of implanting a tricuspid regurgitation device, comprising the steps of:
  • proximal end of the guide wire and the proximal end of the hollow cannula are buried in the body tissue to complete the implantation of the tricuspid regurgitation device.
  • the embodiments disclosed in the present invention are specifically described as tricuspid valves for the heart, it is contemplated that these embodiments may be suitable for use with other heart valves.
  • the anchoring structure can be modified to press against different geometries within the heart, while a valve plug with a valve can change the existing shape to accommodate a valve of a different shape, such as a mitral valve.
  • a third technical solution of the present invention provides a method for treating a mitral regurgitation in a heart valve reflux therapy, the heart valve reflux being selected from the group consisting of mitral regurgitation and/or Or tricuspid regurgitation.
  • the device and the implantation method for treating tricuspid regurgitation provided by the invention can effectively treat tricuspid regurgitation, have no obstruction to blood flow in the heart, and the device can be recycled, and has minimally invasive repair, high operability and high safety. Features, with high clinical value.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种用于治疗三尖瓣(4)反流的装置，该装置包括可压缩扩张的瓣塞(21)，及用于锚定瓣塞(21)于三尖瓣(4)孔口的瓣塞固定装置；该瓣塞(21)具有流入端(42,52)和相对的流出端(47,57)，且瓣塞(21)的内部设置有可打开关闭的人工瓣膜(50,70)，三尖瓣(4)闭合时人工瓣膜(50,70)自动关闭，三尖瓣(4)打开时人工瓣膜(50,70)自动打开。该治疗三尖瓣(4)反流的装置及其植入方法能有效治疗三尖瓣(4)反流，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，具有较高的临床价值。

Description

用于治疗三尖瓣反流的装置及其植入方法 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，即两个是填充腔室的心房，和两个是泵出腔室的心室。在哺乳动物的心脏中，存在四个心脏瓣膜，它们通常允许血液在仅仅一个方向上流过心脏，在此，心脏瓣膜取决于在各侧上差别的血压打开或关闭。在心脏中的四个主瓣膜是表示二尖瓣的僧帽瓣，以及三尖瓣，它们分别在上方的心房和下方的心室之间，并且因此称作房室(AV)瓣。而且，在离开心脏的动脉中有主动脉瓣和肺动脉瓣。二尖瓣和主动脉瓣在左心中，且三尖瓣和肺动脉瓣在右心中。瓣膜合并有小叶或尖，其中，除了仅具有两个尖的二尖瓣之外，各瓣膜均具有三个尖。二尖瓣和三尖瓣分别位于心房和心室之间，并且防止在心缩期期间从心室向心房中的逆流。它们由防止瓣膜倒转的腱索锚定到心室的壁。腱索附接到乳头肌，其引起张力，以更好地保持瓣膜。
三尖瓣反流(TR)是常见的心脏疾病，功能性三尖瓣反流正在被认为左心疾病的病人所具有的致命的疾病，三尖瓣反流的治疗通常不单独手术，而是与左心疾病同步修复。特别是具有长期二尖瓣反流的病人。三尖瓣反流严重会导致心排量的下降以及体循环淤血，是很多心脏疾病预后不良的信号，严重影响着患者的预后。有文献记载，中重度三尖瓣反流与病死率升高密切相关。
目前三尖瓣反流的手术治疗方法有瓣环整形，瓣叶修复，乳头肌或腱索调整，缘到缘修复等。当前中度和重度三尖瓣反流在美国有160万人，中国按人口估计500万人，其中只有0.5％可以手术，而且手术以瓣环整形为主，其余的病人不适合做手术治疗，因此对这类高危病人没有合适的治疗方案。对于手术治疗的病人，74％的 病人三年后出现反流。54岁以上老年人口中，男性的发病率为14.8％和女性的发病率为18.4％。现有大量证据显示中重度三尖瓣反流在三尖瓣修复或置换术后需再次治疗，促使三尖瓣干预治疗的指征增多；但多数情况下三尖瓣的二次手术风险和病死率均较高。
除了手术治疗三尖瓣反流以外，微创修复有瓣环整形和三尖瓣塞，这两种方法目前都在研究阶段。瓣环整形如Mitralign系统公开的二瓣叶化技术，模拟外科手术经颈静脉途径，植入垫片缝合修复技术使三尖瓣二瓣叶化；以及在三尖瓣前后叶接合部安置不锈钢螺母重塑三尖瓣，使三尖瓣二瓣化的TriCinch系统。虽然这些手术可使三尖瓣反流轻度减轻，但目前还有很多技术的问题尚未解决。三尖瓣塞微创修复通常是设置一个三尖瓣塞装置，置于三尖瓣瓣叶形成的孔口处，用于堵住瓣膜泄露孔口，从而防止反流，常见的包括球囊型三尖瓣塞，使用充液气球鼓起圆柱形的塞子作为三尖瓣塞；以及钟型三尖瓣塞等。这些瓣膜塞子虽然能够减少血液反流的风险，但是因为塞子本身不允许血流通过，它们在三尖瓣中的使用会大大减小三尖瓣孔口的有效过流面积，造成瓣膜通路狭窄，增加了静脉压力和右心室负荷的风险，尤其是当塞子的直径过大时，还会产生不必要的并发症。
鉴于外科处理的三尖瓣反流或三尖瓣术后衰败而二次手术治疗的风险收益比，以及现有的三尖瓣瓣膜塞容易造成的瓣膜开口后血流通路狭窄的问题，因此需要探索更加有效的、侵入性更小的治疗三尖瓣反流的方式。
发明内容
针对上述技术问题，本发明通过在三尖瓣开口处植入带有人工瓣膜的瓣塞装置，该装置既能在心脏收缩期堵住三尖瓣的泄漏孔口，防止三尖瓣在关闭时反流，在心脏舒张期也能最大限度地保证血液从三尖瓣入流的有效孔口面积，防止三尖瓣狭窄，为三尖瓣反流提供有效的治疗方案。
由上所述，第一方面，本发明的第一项技术方案提供了一种用 于治疗三尖瓣反流的装置，所述装置包括可压缩扩张的瓣塞，及用于锚定瓣塞于三尖瓣孔口的瓣塞固定装置；所述瓣塞具有流入端和相对的流出端，且所述瓣塞的内部设置有可打开关闭的人工瓣膜。
优选地，所述瓣塞包含支架、衬套和人工瓣膜；所述支架为管状、椎体状或球状中的任一种或几种的组合，具有网络结构、可压缩扩张；所述衬套覆盖所述支架的至少一部分内周和/或外周表面；所述人工瓣膜轴向地缝制在支架内部，优选为被垂直于支架轴向地缝制在支架内部。
优选地，所述支架为具有菱形和/或六边形网眼的网格结构，且菱形和/或六边形网格结构的致密度从中部向两端逐渐降低；人工瓣膜缝制在支架上致密度相对高的菱形和/或六边形网格处。
优选地，所述支架通过激光刻蚀技术，一体成型的3D打印技术或由编织的交叉的丝制成。
优选地，所述支架由具有强回复力的弹性合金材料制成，优选镍钛合金；所述衬套由选自聚乙烯材料、人工血管材料、聚氨酯材料、猪或牛心包材料中的任意一种制成；所述人工瓣膜包括猪或牛的动物瓣膜、生物组织材料、高分子材料或组织工程瓣膜中的任意一种制成。
优选地，所述支架为选自网络状的圆柱体管状、圆台管状，或圆锥体、球体、半球体、椭球体中的一种或几种的组合。
优选地，所述支架的形状为倒圆台管状和/或倒圆锥状；支架的总长度为20-80mm，内径为0-50mm。
优选地，所述支架为倒圆台管状或倒圆锥状，支架的内径自近端向远端由小先逐渐变大再逐渐降低；支架的总长度为20-80mm，内径为0-50mm。所述内径可以在0-50mm的范围内变化。
优选地，所述支架为具有网状结构的圆台管状，圆台管状支架的内径自近端到远端逐渐降低，内径也可以降低至0形成倒圆锥体。
优选地，所述具有网状结构的支架的形状自近端到远端由圆锥体A、倒圆锥体B构成，且圆锥体A底面内径与倒圆锥B底面内径相同，圆锥体A的长度小于倒圆锥B的长度。
优选地，所述瓣塞固定装置包含连接瓣塞流入端或近端的中空套管，以及穿过人工瓣膜中心和中空套管的导丝；所述导丝远端设置有锚钩；所述导丝近端和中空套管近端通过体外控制把手调整相对位置来锚定和定位瓣塞。植入装置后，所述导丝近端和中空套管近端可以固定于体内组织中。
优选地，所述锚钩可固定在心尖或右心室内下壁心肌上；所述锚钩由形状记忆合金制成，优选镍钛合金。
优选地，所述中空套管贯穿所述瓣塞及内部人工瓣膜中间孔口，使瓣塞内部形成一个便于导丝滑动的通道。
第二方面，本发明的第二项技术方案提供了一种治疗三尖瓣反流装置的植入方法，其特征在于，包括如下步骤：
(1)首先在锁骨下静脉或颈静脉处开口，将远端设置有锚钩的导丝从开口处向内延伸至右心室，并使锚钩固定在心尖或右心室内下壁心肌上；
(2)然后将可压缩扩张、具有流入端和相对的流出端的瓣塞压缩进可收回的鞘、管或类似物的布置导管中，沿导丝将瓣塞送入到三尖瓣孔口处，释放三尖瓣塞，其自动扩张，撤出鞘、管或类似物的布置导管；所述瓣塞近端连接有中空套管，且导丝从所述中空套管中穿过；
(3)通过调整导丝近端和中空套管近端的相对位置，调整和固定瓣塞在三尖瓣孔口处的方位；
(4)将导丝近端和中空套管近端固定于体内组织，完成三尖瓣反流装置的植入。
第三方面，本发明提供了上述任意一项治疗三尖瓣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。
本发明提供的治疗三尖瓣反流装置及其植入方法具有如下优势：
(1)保证在心脏收缩期三尖瓣关闭时，本发明瓣塞能堵住三尖瓣泄漏孔口，防止反流，瓣塞本身具有堵漏功能；
(2)保证瓣塞中的瓣膜在舒张期与三尖瓣同时开启，开启后三尖瓣入口的有效孔口面积增加，减小三尖瓣过流阻力，防止三尖瓣狭窄；
(3)整套装置可回收，在放置本发明装置后，在放置不适、效果不佳或修复完成后都可以撤回，如通过鞘管回收可压缩扩张的瓣塞、通过鞘管回收带有锚钩的导丝等，恢复术前状态；
(4)本发明装置优选通过微创经皮技术，不需要开心、开胸手术，适合高危病人。
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为上腔静脉，2为下腔静脉，3为右心房，4为三尖瓣，5为右心室，6为肺动脉瓣，7为肺动脉，8为肺静脉，9为左心房，10为二尖瓣，11为左心室，12为主动脉瓣，13为主动脉，14为降主动脉，15为含氧血流向，16为缺氧血流向。
图2：显示本发明的一个实施例的装置放置在心脏中的正确位置的示意图：SVC为上腔静脉，RV为右心室；21为瓣塞，22为中空套管，23为导丝，24为锚钩，25为外部控制装置，26为包覆在瓣塞支架外周围的衬套。
图3A：所示优选的瓣塞装置的支架示意图：3A-1为俯视图，3A-2为3A-1的主视图，3A-3为3A-1的立体示意图；其中31为圆柱管状具有菱形网格结构支架的中部，32为圆台形的网格致密度相对较低的支架端部，33为导丝，34、35为用于固定网格结构支架的底座，且34用于连接中空套管。
图3B：所示优选的瓣塞装置的支架示意图：3B-1为俯视图，3B-2为3B-1的主视图，3B-3为3B-1的立体示意图；其中41为圆台形的具有菱形网格结构支架的中部，42为圆台形的网格致密度相对较低的支架流入端，47为圆台形的网格致密度相对较低的支架流 出端，43为导丝；44为用于固定网格结构支架的底座，并用于连接中空套管。
图4：所示优选的带有人工瓣膜的支架示意图：4-1为俯视图，4-2为4-1的主视图，4-3为4-1的立体示意图；其中51为圆柱体管状网络支架的中间部，52、57为圆锥体网状支架的端部(流入端和流出端)，53为导丝，54为用于连接中空套管的部件，50为人工三叶瓣膜，58、59为软质箍状部件。
图5A：所示优选的带有内外衬套的人工瓣膜支架示意图：5A-1为俯视图，5A-2为5A-1的主视图，5A-3为5A-1的立体示意图；其中41为圆台形的具有菱形网格结构支架的中部，42、47为圆台形的网格致密度相对较低的支架流入端和流出端，43为导丝；44为用于固定网格结构支架的底座，并用于连接中空套管；48为支架外衬套，49为支架内衬套。
图5B：所示优选的带有内衬套的人工瓣膜支架示意图：5B-1为俯视图，5B-2为5B-1的主视图，5B-3为立体示意图，5B-4为仰视图；其中41为圆台形的具有菱形网格结构支架的中部，42、47为圆台形的网格致密度相对较低的支架流入端和流出端，43为导丝；44为用于固定网格结构支架的底座，并用于连接中空套管；49为支架内衬套。
图6：所示优选的装置的锚钩输送示意图：(a)→(b)→(c)，23为导丝，24为锚钩，27为鞘管，28为锚钩上的可自动弯曲的钩爪。
图7：所示优选的装置的弹簧锚钩爪的示意图：7-1为仰视图，7-2为7-1的主视图；其中61为螺旋状弹簧锚钩爪，62为锚钩底座，63为连接导丝的部件。
图8：所示优选的带有内外衬套和人工瓣膜的瓣塞示意图：8-1为俯视图，8-2和8-3为不同角度的立体示意图；其中70为人工三叶瓣膜，72为圆台形的网格致密度相对较低的支架流入端，77为圆台形的网格致密度相对较低的支架流出端，73为导丝；74、75为用于固定网格结构支架的底座，74还可用于连接中空套管；79为支架外衬套，78为支架内衬套。
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。相关领域的普通技术人员将理解，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。虽然对各种过程的描述参考了以下公开内容中的步骤和顺序，但是不应认为这些步骤和步骤的顺序是实践本发明的所有实施方案所必需的。
如文中所用，术语“近端”应指靠近操作者(进入人体较少)，而“远端”应指远离操作者(进入人体较多)。
如文中所用，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。
如文中所用，术语“鞘”也可描述为“导管”，因此这些术语可互换使用。
如文中所用，术语“网络结构”也可描述成“网格结构”。
如文中所用，术语"人工组织材料"包括通过实验室中的组织工程制造的组织，例如，来自于设计的细胞外基质、细胞和生物活性分子的组合。其可避免天然组织材料可变为钙化的，导致人工心脏瓣的非所期望的变硬或退化等问题。所述人工组织材料可使用任何合理大小的袋鼠、鸵鸟、鲸或任何其它适合的异种移植物或同种移植物组织。所述人工组织材料也包含用作组织材料的支承构架的结缔组织蛋白质(即，胶原和弹性蛋白)。为了增强该组织蛋白质化合物，可执行化学固定工艺，将蛋白质链接在一起。
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。
本发明装置及植入方式试图减小或阻断在心脏收缩的心脏收缩期期间从右心室流动到右心房内的血液的量，并且保证在心脏舒张期期间从右心房流动到右心室的血液充足的量。
三尖瓣反流的大多数情况是因为瓣环扩张或三尖瓣瓣叶因右 室及容量负荷增加而受到牵拉引起，当三尖瓣闭合的时候，瓣叶之间会形成开口，关闭不全。本发明所述的治疗三尖瓣反流的装置能减小在三尖瓣瓣叶之间的这些开口的尺寸，而在一些情况下，完全消除开口，允许三尖瓣在很少发生反流或不发生任何反流的情况下发挥功能。在至少一些在本说明书中所描述的作为例子的实施例中，通过将治疗反流装置定位在三尖瓣小叶之间，以当闭合的时候，使在小叶之间的开口闭合或填充在小叶之间的开口，这得以实现。并且在一些情况下下，在至少一些在本说明书中所描述的作为例子的实施例中，反流装置不会减少血液有效过流面积，保证了血液从右心房流向右心室的血液流量。
以下描述参考图1至图8。本领域的普通技术人员将认识到，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。
图1是人的心脏解剖结构示意图，三尖瓣4由三个近似三角形的瓣膜或节段或小叶(前尖，后尖和中间或隔侧尖)组成。其底部连接至环绕房室口的纤维环(图1中未显示)且还相互连接从而形成连续的瓣膜环膜。其心房表面向着来自心房3的血流，而其心室表面向着心室5的壁；其与所述瓣膜尖的顶点和边缘一起为腱索提供固定。如上所述，三尖瓣的功能是阻止血液回流到右心房3中；箭头指示正常的血流方向。当三尖瓣4的瓣膜不完全关闭，导致血液向回渗漏进右心房3时，则出现三尖瓣反流。
第一方面，本发明的第一项技术方案是用于治疗三尖瓣反流的装置，所述装置包括可压缩扩张的瓣塞，及用于锚定瓣塞于三尖瓣孔口的瓣塞固定装置；所述瓣塞具有流入端和相对的流出端，所述瓣塞的内部设置有可打开关闭的人工瓣膜。三尖瓣闭合时人工瓣膜自动关闭；三尖瓣打开时人工瓣膜自动打开，血液从瓣塞流入端流进并从流出端流出。
瓣塞，所述瓣塞可以通过瓣塞固定装置锚定在三尖瓣闭合时形成的孔口处，起到堵住孔口的作用。人工瓣膜的打开和关闭与三尖 瓣的打开闭合同步，即与心脏舒张收缩同步。当心脏收缩，三尖瓣关闭，瓣塞堵在三尖瓣孔口处，瓣塞中的人工瓣膜亦处于关闭状态，封闭的瓣塞有效阻挡血液反流；当心脏舒张，三尖瓣打开，瓣塞因瓣塞固定装置的牵引作用仍处于原位置附近，血液从右心房流向右心室，瓣塞内部的人工瓣膜同时打开便于血液从瓣塞的流入端流入并从流出端流出，避免三尖瓣过流狭窄的问题。
所述可压缩扩张的瓣塞可在收缩的第一形态和扩张的第二形态之间变换，第一形态为该瓣塞被经导管输送时的输送形态，第二形态为该瓣塞被植入人体心脏后的工作形态。本发明一些实施方案采用自膨胀的原理，在体外，该装置可以被压迫成条状的第一形态，放置于输送装置中，到达心脏三尖瓣孔口的预定位置后，通过自膨胀，可以恢复到原始设计的形态且具有较高的硬度，并通过瓣塞固定装置锚定在心脏内部。
在本发明一些实施方案中，所述瓣塞包含支架、衬套和人工瓣膜；所述支架为管状或其类似形状，且具有网络结构、可压缩扩张；所述衬套覆盖所述支架的至少一部分内周和/或外周表面；所述人工瓣膜被垂直于支架轴向地缝制在支架内部。所述衬套不透血液。
支架，本发明所述支架为可压缩扩张的上下可通血液的支架，用于作为瓣塞人工瓣膜的支撑骨架，并且赋予瓣塞可收缩扩张的特性。
在本发明一些实施方案中，所述支架为管状、椎体状或球状中的任一种或几种的组合。所述具有网状结构的支架的形状为选自圆柱体、圆锥体、圆台、球体、半球体、椭球体中的一种或几种的组合。
即可以是圆柱体管状结构，也可以是圆柱体管状与圆台或圆锥体组合起来的结构。具有网状结构的支架也可以是类似于半球体与圆柱体构成的笼子的形状。
更优选的，所述支架为倒圆台管状或倒圆锥状，支架的内径自近端向远端逐渐降低。具有网络结构的倒圆台管状或倒圆锥状的支架作为瓣塞的支架，当植入三尖瓣孔口处会更好的与三尖瓣贴合和 移动，有利于限制反流。
在本发明一些实施方案中，所述具有网状结构的支架具有菱形网格结构，该网孔形状不唯一，任意满足血流流通和收缩扩张要求的形状都是可行的。优选的，所述支架为具有菱形和/或六边形网眼的网格结构。
在本发明一些优选的实施方案中，所述网状支架的网络网格致密度可以是统一的，也可以是变化的。作为优选，支架网格(或网眼)的致密度在中部较密，两端较疏，可以使其从中部向两端逐渐降低。中部致密度较高的部分将不仅便于缝制人工瓣膜和/或衬套，以获得稳固的人工瓣膜，让其更好的发挥作用，并使衬套更好的隔断不必要的血液流量，防止瓣周漏。
本实施例的用于治疗三尖瓣反流的瓣塞支架的制作方法优选为激光刻蚀技术。但该制备方法不唯一，在其它的优选实施方式中也可以采用一体成型的3D打印技术制作，或由编织的或以其他方式交叉的丝制成。
支架可由金属材料制成，也可由其它具有高支撑强度的材料制成，优选为由具有强回复力的弹性合金材料制成，如镍钛合金等。
本实施例中的瓣塞支架可根据患者的实际情况设计成不同的尺寸，具体可参考右心房室以及三尖瓣孔口的大小。
在一些实施方案中，所述瓣塞支架可设计内径为0-50mm，总长度为20-80mm。
在一些实施方案中，所述瓣塞支架可设计内径的范围为5-45mm，总长度为20-80mm。
在一些实施方案中，所述瓣塞支架可设计内径为0-40mm或5-35mm，长度可设计为20-80mm的圆柱体管状支架。
在一些实施方案中，所述瓣塞支架可设计为支架中部为长方形网格的圆柱体管状，两端为三角形网格的圆锥体状，中部与两端通过软质箍型材料连接，如图4所示。此外，支架的不同形状网格部分之间都可以通过软质箍型材料制成的部件连接，以满足可扩张压缩的特性。
在一些实施方案中，所述瓣塞支架设计成两端窄口圆台形，中间圆柱体的管状支架，中间圆柱体支架的内径为5-50mm，长度为20-80mm，内径向两端逐渐缩小至5-40mm。优选的实施例如图3A所示，其中31为圆柱管状具有菱形网格结构的支架的中部，32为圆台形的网格致密度相对较低的支架端部，33为导丝，34、35柱体为用于固定所述网格结构支架的底座，并且该柱体34位于流入端，可用于连接中空套管。
在一些实施方案中，所述瓣塞支架设计成圆锥体形支架，近端为圆锥底部，直径为10-50mm，内径逐渐向远端缩小成锥端，总长度为20-80mm。圆锥底部同样有交叉的网格，便于连接瓣塞固定装置。
在一些实施方案中，所述瓣塞支架设计成圆台形支架，近端(流入端)为圆台底部，内径为5-50mm，内径逐渐向远端(流出端)缩小，缩小至内径为5-40mm，总长度为20-80mm。
在一些实施方案中，所述瓣塞支架设计成类似圆台形的组合的支架，优选的实施例如图3B所示，3B-1为俯视图，3B-2为3B-1的主视图，3B-3为3B-1的立体示意图；其中41为圆台形的具有菱形网格结构支架的中部；42、47为圆台形的网格致密度相对较低的支架端部(流入端和流出端)，且当瓣塞植入三尖瓣时42为近端，47为远端；43为导丝，44为用于固定网格结构支架的底座，并用于连接中空套管。图中41、42、47构成了类似圆台形的组合的支架，内径自近端到远端先从小逐渐变大再逐渐变小。
具体的支架尺寸可以根据患者的心脏结构进行调整和改进。可优选的尺寸如：最窄处内径为10-15mm，最宽处内径为35-45mm，总长度为50-80mm。
在一些优选的实施方案中，如图3B所示的支架形状，支架从流入端到流出端可分为三部分，第一部分圆台状支架内径自3-6mm增加到15-50mm，长度为5-10mm；然后通过圆弧网格线过渡到第二部分圆台状支架，内径自15-50mm减少到0-40mm，长度为20-60mm；然后通过圆弧网格线过渡到第三部分，内径自0-40mm 继续减小到3-5mm，长度为0-10mm。其中，第一部分和第三部分的菱形网格线的致密度比第二部分低。
人工瓣膜，本发明所述人工瓣膜是可以随着血液的流动自动开启关闭的人工瓣膜，其开启关闭与心脏原三尖瓣正常工作时状态类似。所述人工瓣膜被轴向地缝制在支架内部，优选为垂直于支架轴向地缝制在支架内部。
所述人工瓣膜可以是普通的三叶瓣膜，也可以是二叶瓣膜、四叶瓣膜。作为本发明优选的三叶瓣膜，瓣叶的瓣叶间连接部分固定在支架网格上，其它边缘部分不缝合，可呈角度的开合，形成三个半月窦状并且其边缘能完全闭合在一起。
在一些实施方案中，如图4所示的带有人工瓣膜的支架，人工瓣膜被垂直于支架轴向地缝制在支架的内部，形成一个横截面。其中51为圆柱体管状网络支架的中间段部分，52、57为圆锥体网状支架的端部，53为导丝，54为用于连接中空套管的球状部件，50为三叶瓣膜，且52为近端(流入端)，57为远端(流出端)。58、59为软质箍状部件，所述软质箍状部件用于连接该支架的近端远端圆锥体部分和中间圆柱体管状部分。软质箍状部件可以与本发明所述衬套的制备材料相同，优选由人工组织材料制备获得。本实施方案中的支架中部为长方形网格，两端为三角形网格，因其通过软质箍型材料部件连接，同样可满足压缩扩张特性，符合导管介入手术的要求，而且制备简单，可通过穿丝方法获得。
三叶瓣膜50关闭状态如图4-3所示，当有血液从流入端流进，瓣膜小叶50朝57远端(流出端)打开，即瓣膜的三个小叶折向57远端以让血液流过；当血液从57远端流进支架，三叶瓣膜50处于关闭状态，阻挡血液返流。图4所示的支架为流入端和流出端内径逐渐减小的网状支架，该支架可以压缩；图中虽然没有标示出衬套，但是衬套优选的缝制在51支架的中间段部分，且优选内外周表面均缝制。
在一些实施方案中，所述人工瓣膜可由动物(优选猪)瓣膜，猪或牛心包制成，也可以为生物组织材料、高分子材料或组织工程 瓣膜。
人工瓣膜在所述支架内部的缝制位置没有特别限定，当瓣塞支架中部网格致密度较高时，人工瓣膜优先缝制在致密度较高处。
衬套，本发明所述衬套的作用是保证瓣塞的密封性，在支架的内周和/或外周表面的衬套可以阻止血液从瓣塞支架的网络缝隙流入右心房，起到防止瓣周漏的作用。优选的衬套设置为不透血液的衬套。
衬套可设置在支架和人工瓣膜之间，也可以覆盖在支架的外周围表面；最优选的，在支架外周围和支架与人工瓣膜之间(即内周围)均设置衬套，构成双层衬套包覆的支架。所述衬套覆盖所述支架的至少一部分内周和/或外周表面。
衬套能有效防止人工瓣周漏、以及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支架元件引起的内部人工瓣膜的促凝性，在保持支架结构利益的同时实现了促凝性的减小。所述衬套可以通过缝制的方法缝制在支架上。如果支架内部缝制有衬套，则上述人工瓣膜可以同时缝制在衬套和支架上。
衬套可以由聚乙烯材料、人工组织材料、人工血管材料、聚氨酯材料、猪或牛心包等材料制成，也可以是聚四氟乙烯材料、织造织物、非织造织物、织造聚酯等。
在一些优选的实施方案中，如附图5A、5B所示，所述衬套可缝制在具有菱形网格结构的支架的中部的内外周表面或仅缝制在内周表面或仅缝制在外周表面。
如图5A所示优选的带有内外衬套的人工瓣膜支架示意图：5A-1为俯视图，5A-2为5A-1的主视图，5A-3为5A-1的立体示意图；其中41为圆台形的具有菱形网格结构支架的中部，42、47为圆台形的网格致密度相对较低的支架流入端和流出端，43为导丝；44为用于固定网格结构支架的底座，并用于连接中空套管；48为支架外衬套，49为支架内衬套。
如图5B所示优选的带有内衬套的人工瓣膜支架示意图：5B-1为俯视图，5B-2为5B-1的主视图，5B-3为立体示意图，5B-4 为仰视图；其中41为圆台形的具有菱形网格结构支架的中部，42、47为圆台形的网格致密度相对较低的支架流入端和流出端，43为导丝；44为用于固定网格结构支架的底座，并用于连接中空套管；49为支架内衬套。
瓣塞固定装置，所述瓣塞固定装置可实现所述瓣塞在心脏内的可靠锚定和定位。
在本发明一些优选的实施方案中，瓣塞固定装置包含连接瓣塞近端的中空套管，以及穿过人工瓣膜中心和中空套管的带有锚钩的导丝。
所述导丝远端设置有锚钩。所述锚钩可以设计成类似于撑钩的形状，输送前可将其压缩在鞘管内，在到达心脏后，推出锚钩，使其钩爪插入心脏内壁，优选的插入位置为心尖或右心室内下壁心肌上。所述锚钩还可以选择其他类型，可以列举的如附图7所示的弹簧锚钩爪型锚钩。可选的，所述锚钩通过螺纹或插槽连接在导丝上。
当植入本发明装置时，先将远端带有锚钩的导丝植入心室内固定，然后再沿着导丝通过中空套管植入瓣塞。所述导丝近端和中空套管近端可以通过外部控制把手调整中空套管与导丝的相对位置，又因为中空导管与瓣塞近端连接，故通过中空导管和导丝的相对移动，可以调整瓣塞的方位。装置植入完毕，所述导丝近端和中空套管近端可以固定于锁骨下组织囊袋内，类似于心脏起搏器的放置方法，便于后期撤回取出及调整瓣塞方位。
所述中空套管和瓣塞可以通过螺纹连接或沟槽连接。
所述中空套管的内径不易过大，强度足以连接瓣塞、能够让导丝从其中穿过，并能发生相对移动即可。优选的，中空套管的内径为1-3mm。如图3A所示，所述中空套管可以连接在支架上的流入端底座34上，可以通过螺纹或者沟槽连接。
在本发明一些优选的实施方案中，所述中空套管还可以贯穿所述瓣塞及人工瓣膜，使瓣塞内部也形成一个能使导丝在其中发生相对移动的通道。
在本发明一些优选的实施方案中，锚钩优选由形状记忆合金如 镍钛合金制成。这种合金还可被选择成使得其转变温度为大约37℃，可在达到转变温度时起动自扩展。在本发明一些优选的实施方案中，所述中空套管选用聚合物材料，如聚氨酯材料等其他可植入材料。
本发明的瓣塞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。在优选的经导管的方法中，本发明的装置被加载到合适的布置导管，在那里被可收回的鞘或管或类似物压缩。布置导管被插入到三尖瓣需要支持的患者的心脏中。治疗三尖瓣反流时，其上加载有处于压缩状态的根据本发明的装置的布置导管，可以经由颈静脉前进到上腔静脉中，到右心房中，到达三尖瓣孔口位置再扩张。备选地，其上加载有处于压缩状态的根据本发明的装置的布置导管可以经由股静脉前进到下腔静脉中，到右心房中。
作为优选，本发明装置在锁骨下静脉或颈静脉开口经导管进行植入。
如图2所示，本发明优选的一个实施例中瓣塞放置在心脏中的正确位置的示意图：SVC为上腔静脉，RV为右心室；21为瓣塞，22为中空套管，23为导丝，24为锚钩，25为外部控制装置，26为包覆在瓣塞支架外周围的衬套。从图2中可见，根据本发明的装置以扩张状态位于人的心脏中。其中瓣塞21刚好处于三尖瓣孔口处。该瓣塞支架为圆锥体和圆柱体管状组合构成的网络支架，外周围包覆了衬套26，瓣塞支架近端与中空套管22连接，且中空套管22中有导丝23，导丝23远端设置有锚钩24，且锚钩24已经锚固进入心尖。中空套管22和导丝23的近端在外部控制装置25处可以进行相对位置调整和固定，以调整瓣塞21的定位。瓣塞21内缝制有人工瓣膜(图2中未标出，具体可参考图8)。
图6为图2所示优选的装置的锚钩输送示意图：(1)→(2)→(3)，其中23为导丝，24为锚钩，27为可容纳锚钩的鞘管，28为锚钩上的可自动弯曲的钩爪。输送前可将锚钩24压缩在鞘管27内，在到达心脏后，推出锚钩24，使其钩爪28插入心尖上，钩爪28插入后自动弯曲，以此锚定导丝。同时可采用类似的方法将锚 钩24从心脏中取出撤回，恢复术前状态。图7为锚钩钩爪的可选择的其他类型，为螺旋状弹簧状，具有旋入锚定和旋出撤回的特点，可锚固在心尖或心内壁上。
图8为图2所示优选的带有内外衬套和人工瓣膜的瓣塞示意图：8-1为俯视图，8-2和8-3为不同角度的立体示意图；其中70为人工三叶瓣膜，支架中部为圆柱管状的具有菱形网格结构(图中未标出，可参考附图3A)，72为圆台形的网格致密度相对较低的支架流入端，77为圆台形的网格致密度相对较低的支架流出端，73为导丝(对应于图2中的23)；74、75为用于固定网格结构支架的底座，74还可用于连接中空套管；79为支架外衬套(对应于图2中的26)，78为支架内衬套。所述人工瓣膜70垂直的轴向缝制在带有内衬套78的管状支架上。
在本发明一些实施方案中，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。
第二方面，本发明的第二项技术方案提供了一种治疗三尖瓣反流装置的植入方法，其包括如下步骤：
(1)首先在锁骨下静脉或颈静脉处开口，将远端设置有锚钩的导丝从开口处向内延伸至右心室，并使锚钩固定在心尖或右心室内下壁心肌上；
(2)然后将可压缩扩张、具有流入端和相对的流出端的瓣塞压缩进可收回的鞘、管或类似物的布置导管中，沿导丝将瓣塞送入到三尖瓣孔口处，释放三尖瓣并使其自动扩张，撤出鞘、管或类似物的布置导管；所述瓣塞近端连接有中空套管，且导丝从所述中空套管中穿过；
(3)通过调整导丝近端和中空套管近端的相对位置，调整和固定瓣塞在三尖瓣孔口处的方位；
(4)将导丝近端和中空套管近端埋入体内组织，完成三尖瓣反流装置的植入。
尽管在本发明中所披露的实施例特殊地描述为用于心脏的三尖瓣，但应该想到的是，这些实施例可以适合于用于其它心脏瓣膜。例如，锚定结构可以修改为在心脏内压靠在不同的几何形状上，而带有瓣膜的瓣塞可以改变现有的形状以适合于不同形状的瓣膜，例如二尖瓣。
第三方面，本发明的第三项技术方案是提供了一种治疗三尖瓣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。
本发明提供的治疗三尖瓣反流的装置和植入方法能有效治疗三尖瓣反流，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，具有较高的临床价值。
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 (11)

  1. 用于治疗三尖瓣反流的装置，其特征在于，所述装置包括可压缩扩张的瓣塞，及用于锚定瓣塞于三尖瓣孔口的瓣塞固定装置；所述瓣塞具有流入端和相对的流出端，且瓣塞的内部设置有可打开关闭的人工瓣膜。
  2. 权利要求1治疗三尖瓣反流的装置，其特征在于，所述瓣塞包含支架、衬套和人工瓣膜；所述支架为管状、椎体状或球状中的任一种或几种的组合，具有网络结构、可压缩扩张；所述衬套覆盖所述支架的至少一部分内周和/或外周表面；所述人工瓣膜被轴向地缝制在支架内部。
  3. 权利要求2治疗三尖瓣反流的装置，其特征在于，所述支架为具有菱形和/或六边形网眼的网格结构，且菱形和/或六边形网格结构的致密度从中部向两端逐渐降低；人工瓣膜缝制在支架上致密度相对高的菱形和/或六边形网格处。
  4. 权利要求2治疗三尖瓣反流的装置，其特征在于，所述支架通过激光刻蚀技术，一体成型的3D打印技术或由编织的交叉的丝制成。
  5. 权利要求2治疗三尖瓣反流的装置，其特征在于，所述支架由具有强回复力的弹性合金材料制成，优选镍钛合金；所述衬套由选自聚乙烯材料、人工血管材料、聚氨酯材料、猪或牛心包材料中的任意一种制成；所述人工瓣膜由选自包括猪或牛的动物瓣膜、生物组织材料、高分子材料或组织工程瓣膜中的任意一种制成。
  6. 权利要求2治疗三尖瓣反流的装置，其特征在于，所述支架的形状为倒圆台管状和/或倒圆锥状；支架的总长度为20-80mm，内径为0-50mm。
  7. 权利要求1治疗三尖瓣反流的装置，其特征在于，所述瓣塞固定装置包含连接瓣塞流入端或近端的中空套管，以及穿过人工瓣膜和中空套管的导丝；所述导丝远端设置有锚钩；所述导丝近端和中空套管近端通过体外控制把手调整相对位置来锚定和定位瓣塞。
  8. 权利要求6治疗三尖瓣反流的装置，其特征在于，所述锚钩固定在心尖或右心室内下壁心肌上；所述锚钩由形状记忆合金制 成，优选镍钛合金。
  9. 权利要求6治疗三尖瓣反流的装置，其特征在于，所述中空套管贯穿所述瓣塞及人工瓣膜孔口，使瓣塞内部形成一个便于导丝滑动的通道。
  10. 一种治疗三尖瓣反流装置的植入方法，其特征在于，包括如下步骤：
    (1)首先在锁骨下静脉或颈静脉处开口，将远端设置有锚钩的导丝从开口处向内延伸至右心室，并使锚钩固定在心尖或右心室内下壁心肌上；
    (2)然后将可压缩扩张、具有流入端和相对的流出端的瓣塞压缩进可收回的鞘、管或类似物的布置导管中，沿导丝将瓣塞送入到三尖瓣孔口处，释放三尖瓣塞，其自动扩张，撤出鞘、管或类似物的布置导管；所述瓣塞近端连接有中空套管，且导丝从所述中空套管中穿过；
    (3)通过调整导丝近端和中空套管近端的相对位置，调整和固定瓣塞在三尖瓣孔口处的方位；
    (4)将导丝近端和中空套管近端固定于体内组织，完成三尖瓣反流装置的植入。
  11. 权利要求1-9中任意一项治疗三尖瓣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。
PCT/CN2017/073069 2017-02-07 2017-02-07 用于治疗三尖瓣反流的装置及其植入方法 WO2018145249A1 (zh)

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