WO2016004798A1 - 一种用于阻止瓣膜反流的假体 - Google Patents

一种用于阻止瓣膜反流的假体 Download PDF

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Publication number
WO2016004798A1
WO2016004798A1 PCT/CN2015/080173 CN2015080173W WO2016004798A1 WO 2016004798 A1 WO2016004798 A1 WO 2016004798A1 CN 2015080173 W CN2015080173 W CN 2015080173W WO 2016004798 A1 WO2016004798 A1 WO 2016004798A1
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WIPO (PCT)
Prior art keywords
prosthesis
valve
assisting
anchor
valve according
Prior art date
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PCT/CN2015/080173
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English (en)
French (fr)
Inventor
李毅斌
吕世文
徐志云
李佳楠
郑德源
陈志�
Original Assignee
宁波健世生物科技有限公司
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Application filed by 宁波健世生物科技有限公司 filed Critical 宁波健世生物科技有限公司
Priority to EP15819710.3A priority Critical patent/EP3167846B1/en
Publication of WO2016004798A1 publication Critical patent/WO2016004798A1/zh
Priority to US15/401,818 priority patent/US10449049B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483—Barbs
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • 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
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a prosthesis for preventing regurgitation of a valve.
  • the mitral valve is located at the left atrioventricular septum and consists of five parts: the annulus, the leaflet, the chordae, the papillary muscle, and the junction.
  • the anatomically accurate name is the mitral apparatus or the mitral valve complex. Mitral complex.
  • the tricuspid valve is located at the right atrioventricular opening and has three approximately triangular sail-shaped valves. The bottom of the valve is attached to the annulus of the atrioventricular canal. Functionally, the fibrous annulus, valve, chordae and papillary muscles are visible. Tricuspid valvar complex.
  • Mitral regurgitation can be divided into the following two types: 1.
  • Rheumatic heart mitral regurgitation mainly caused by mitral insufficiency, can cause reverse flow of blood, thus mixing different blood Causes the heart to pump blood and reduce oxygen delivery.
  • Non-rheumatic mitral regurgitation usually refers to different degrees of mitral regurgitation caused by abnormalities in the mitral valve itself and its surrounding anatomy in addition to rheumatic valvular lesions. There are many reasons for non-rheumatic mitral regurgitation.
  • Mitral regurgitation can also be divided into functional, degenerative or mixed. The most common are degenerative and functional mitral regurgitation. Functionality is generally secondary to left ventricular wall motor function impairment, left ventricular dilatation, papillary muscle dysfunction, generally seen in patients with heart failure. This part of the patient also included ischemic mitral regurgitation secondary to coronary heart disease and mitral regurgitation associated with nonischemic cardiomyopathy. Degenerative mitral regurgitation is generally considered to be a pathological change in the structure of the valve, or a pathological change in the subvalvular structure, including abnormal extension or rupture of the chordae.
  • Tricuspid regurgitation is generally pulmonary hypertension, right ventricular enlargement, tricuspid annulus dilatation, after tricuspid regurgitation, fatigue, ascites, edema, liver pain, indigestion, anorexia and other right heart failure symptoms.
  • Tricuspid regurgitation is mainly divided into functional tricuspid regurgitation and organic tricuspid regurgitation.
  • the organic closure of the valve caused by rheumatic fever is very small, most of which are functional insufficiency.
  • the most common cause is right ventricular dilatation caused by pulmonary hypertension, tricuspid annulus enlargement, resulting in tricuspid valve relative insufficiency.
  • the valve itself is structurally normal. Such as rheumatic mitral valve disease, congenital cardiovascular disease, pulmonary heart disease.
  • Conventional treatments for mitral and tricuspid valvular regurgitation include medications for mild to severe reflux, and surgical procedures with corresponding surgical indications.
  • surgical methods also include mitral valve, tricuspid valve replacement and mitral valve, tricuspid valve repair.
  • simple mitral regurgitation only 30% of patients requiring mitral valve replacement require only mitral valve repair.
  • the typical thoracotomy and open surgery are too invasive, and it is necessary to establish extracorporeal circulation, which has a high incidence of complications and infection.
  • transcatheter interventional replacement and repair surgery methods have been developed.
  • the transcatheter treatment of valvular regurgitation the current problems to be solved are as follows: as far as possible to ensure the effect of the anti-reflux effect, reduce the amount of implant implantation; the anti-reflux device must be accurately positioned and firmly It is fixed at the site where treatment is needed; the device for anti-reflux needs to minimally affect the movement of the remaining functional valve leaflets; the device for anti-reflux flow needs to adapt to the difference of the physiological structure of the annulus, which is listed in the prior art. , the technical points of different anti-reflux devices.
  • Patent WO 2006037073 A2 describes a treatment for mitral valve repair using a mitral clip, which sutures the center or corner of the mitral valve together, but this technique cannot be applied to two types of patients: contraction
  • the indirect suture gap of the valve leaflets is >10mm, which can not accurately synchronize the activity of the two leaflets; the other is the severe thickening and calcification of the structure under the annulus, due to the increase of the pressure of the chordae, valve leaflets and annulus The risk of breakage.
  • CN101902975 describes a device for repairing a valve leaflet in a beating heart of a patient, comprising a handle assembly, a capture assembly and a needle through which the leaflets are captured, the needle passing through the valve Lobules, to limit the movement of the prolapsed leaflets, to achieve anti-reflux effect, but this technology is In operation, it is necessary to grasp the moving leaflets, which is difficult and time-consuming to operate, and is liable to cause laceration to the native leaflets.
  • Patent US20130023985 describes an implant, implant system and method for treating valvular insufficiency and other valvular diseases, the implant comprising an auxiliary leaflet joint, the leaflet joint upper fit
  • the length of the native annulus portion is 25-35 mm, equal to the distance between the first and second joint junctions, the length of the upper to lower portion of the leaflet joint is 50-60 mm, and on the leaflet joint
  • an anchoring device is provided, and in the claims there is also limited that a portion of the joined body is conical, in another claim, except that the length of the upper abutting self-prosthetic annulus portion is defined as 25-35mm, further defining that the height of the leaflet joint portion and the annulus is 35-45mm in the vertical direction, which defines that the unconfined portion of the ventricle is 25-35mm in height perpendicular to the annulus, and the radius of curvature of the joint portion is defined at Within 35-45mm.
  • This system limits the length of the upper abutment to the native annulus portion and is only applicable to the overall repair of the mitral anterior or posterior valvular prolapse, as well as the prosthetic repair of the partial leaflets of the tricuspid valve, and indicates that The lower portion of the joined body covers at least a majority of the leaflets, the bonded portions having specific curvature requirements.
  • This technique does not accommodate the small prolapse of the valve or the repair of a smaller valve, such as the aortic valve, while sacrificing the rest of the normally working valve while repairing the incompletely closed position.
  • the disadvantages include: First, it is clearly described that the length of the upper portion of the joint is equal to the distance between the first and second joint junctions, and thus only applies to the overall repair of the leaflets, the repaired area includes both the petals
  • the leaf prolapse site also includes the normal part of the leaflet; second, the length of the annulus varies greatly from person to person, and the distance between the first and second joint junctions before the actual surgery is unpredictable, and it is difficult to
  • the design is precisely matched; thirdly, the shape of the joint body is tapered, and it is intended to match the taper of the human valve leaflets. It is also difficult to completely match due to human differences. Fourth, the design is not suitable for joint flap prolapse. Repair.
  • a method for treating a malocclusion of a heart valve of a patient comprising introducing the implant into the heart when the implant is in the first configuration, the implant The implant is deployed from the first configuration into a second configuration within the heart, the implant in the second configuration having a first and second opposing engagement surfaces, and a support
  • the deployed implant causes the joint assisting body to be offset from the axis of the heart valve along the joint region
  • the method further comprises: approaching the first joint The first joint selectively disposes the first anchor at a first target location of the first joint of the first and second leaflets of the heart valve, adjacent to the second joint
  • the second joint selectively disposes a second anchor at a second target location of the first junction of the first and second leaflets of the heart valve, introducing the engagement aid into the heart
  • the implant is described as comprising An auxiliary body, a first anchor and a second anchor, the joint auxiliary body having an axis and first and second opposite
  • the axis of the implant extends along the valve axis and the first and second sides of the engagement aid are required to be along the junction of the heart valve a curve extension wherein the engagement aid of the supported implant is sufficiently laterally conformed such that engagement between the implant and the heart causes the engagement aid between the edges to face the heart valve
  • the curve defined by the joint zone is curved laterally.
  • the "supporting the deployed implant” described in the invention allows the joint auxiliary body to be along
  • the engagement zone is offset from the axis of the heart valve, meaning that when the implant is naturally deployed, the engagement aid is reduced along the centerline, which requires the engagement aid to be tapered
  • the joint assisting body covers the normal valve that is not prolapsed, and is prone to adhesion during long-term exercise, at the expense of normal functioning of some normal valves; and third, self-centering toward the heart in the vicinity of the native annulus
  • the valve during the opening and closing process, has a smaller amplitude of movement than the leaflet near the tip of the cusps, and is easily adhered to the laterally conformal shape and adheres to the heart valve auxiliary body attached thereto.
  • the upper joint assisting body that is, the annulus, which is in the long-term implantation process, should be grown together with the self-body annulus to increase the effect of fixation, and the approaching
  • the native valve in the direction of the heart valve ring once caused by adhesion, will affect the movement effect of the leaflets, easily cause secondary reflux, leading to failure of the anti-reflux treatment; Fourth, due to the size of each individual annulus Different, resulting in more technical specifications in this technology.
  • Patent US20130325110 A1 describes a method for the treatment of mitral and tricuspid regurgitation by a beating device that assists in the delivery of a leaflet closure prosthesis, the method comprising using a flexible track to pass a ventricular fixation member from the atria through the native valve Feeding into the right ventricle for anchoring, using a catheter to deliver and adjust the position of the prosthesis at the tricuspid annulus until the reflux is reduced, the catheter is fixed relative to the flexible orbit, and is fixed to the inferior vena cava .
  • the delivery method can adjust the position of the prosthesis to adapt to different reflux positions, and has certain lesion adaptability
  • the fixed position of the inferior vena cava is far away from the annulus position, which tends to cause the fixation to be weak, and false.
  • the body is displaced after the fixation is completed.
  • the object of the present invention is to overcome the limitations of the prior art, and to provide a prosthesis for preventing valve regurgitation for partial valve prolapse.
  • the invention can realize position adjustment, accurate positioning and firm anchoring, and can be variously Different degrees and locations of lesions, adjust the position of the prosthesis, and then locate and anchor, and not easy to adhere to the tissue near the patient annulus.
  • a prosthesis for preventing regurgitation of a valve comprising a fixing unit, a connecting member and a assisting member, the fixing unit comprising a fixing member and an anchor, the distal end portion of the connecting member being close to the fixing member
  • the end portions are connected, the proximal end portion of the connector is coupled to the distal end portion of the assisting member, the connector member being flexible such that the connector member and the assisting closure member coupled thereto are capable of following the flap Movement of the leaf
  • the fixation member being fixed to the atrial wall of the patient or the annulus by the anchor, the width of the fixation member being less than two-thirds of the circumference of the valve tissue ring, the help
  • the closure is located between the patient's native leaflets in a free state, the maximum width of the closure member being less than the maximum width of a single native leaflet deployment, and the proximal end of the anchor is provided with a tip end.
  • the sum of the length of the assisting member and the length of the connector is greater than the height of the native leaflet deployment.
  • the assisting member is a single piece, a plurality of pieces, a cylinder, a bag, a column or a balloon, or the assisting member is a combination of a single piece and a plurality of pieces, or the assisting and closing
  • the piece is a combination of a single piece and a cylinder
  • the aid is a combination of a single piece and a bag
  • the combination is a combination of a single piece and a column
  • the aid is a single piece and a ball a combination of capsules.
  • the assisting member is a mesh structure
  • the protective film is a polymer material sheet or an animal-derived material sheet
  • the protective sheet is a polymer material sheet or animal origin In the case of a sheet of material, a hole is provided in the shutter.
  • the anchor is coupled to the fixture.
  • the fixture and the connector are of unitary construction.
  • the length of the assisting member along the axis of the plane of the annulus is greater than or equal to 10 mm and less than or equal to 60 mm.
  • the length of the connector along the axis of the plane of the annulus is greater than or equal to 1 mm and less than or equal to 25 mm.
  • the connector is in the form of a sheet, a strip, or a wire, or the connector is a combination of the above structures.
  • the connector is partially covered, and the portion of the connector that is not covered by the membrane is a passage through which blood flows.
  • the connector is fully coated, and a hole is provided in the film, the hole being a passage through which blood flows.
  • both sides of the connecting member are passages through which blood flows.
  • the fixing member is a flexible polymer sheet or a polymer mesh.
  • the fixing member has a skeleton structure composed of a plurality of support rods, or the skeleton structure is a wave-shaped structure or a zigzag structure in which a metal memory material is wound, or
  • the skeleton structure is a grid-like stent, or the skeleton structure is a combination of the above structures.
  • the crests and troughs of the undulating structure or the serrated tip of the zigzag structure are wound into a ring shape.
  • the skeletal structure is made of a shape memory material woven or integrally cut.
  • adjacent rods of the skeletal structure are intertwined to form a compact structure.
  • the distal end portion of the skeletal structure in the free state, is arcuate in the circumferential direction of the annulus.
  • the skeletal structure is coated with a film that is joined to the skeletal structure by sintering, welding, gluing or stitching, the film material comprising polytetrafluoroethylene, polyethylene, poly Acrylic, polyester or animal derived materials.
  • the distal end portion of the assisting member is sewn to the proximal end portion of the connector by a suture, or the distal end of the assisting member extends a plurality of rod wires to be wound around The proximal end portion of the connector or the distal end of the assisting member is attached to the proximal portion of the connector by sintering.
  • the distal end portion of the connector is sewn to the proximal portion of the fastener by a suture, or the distal end of the connector extends a plurality of rod wires around the The proximal portion of the fastener or the distal end of the connector is joined to the proximal portion of the fastener by sintering.
  • an adjustment device is disposed on the assisting member, the adjusting device is a wire or a polymer wire, and one end of the wire or the polymer wire is connected to the assisting member.
  • the wire or the other end of the polymer wire is connected to the ventricle or the apex.
  • the proximal end of the assisting member is provided with a deployment device made of a wire or a polymer wire, preventing the wrap from wrinkling or preventing the assisting member from being Compression causes the size to shrink.
  • the deployment device is a rod or the deployment device is a wavy or zigzag structure wound from a metal memory material.
  • the distal end of the anchor is sharp, the distal end portion of the anchor is predetermined, and the distal end portion of the anchor is predetermined to be in the following shape Combination of one or more of: spiral, circumferential, curved, combined arc and straight, bifurcated double hook, 3D curved, multi-segment curved, distal end of the anchor without barb Or with one or more barbs.
  • the present invention retains the function of the autologous valve leaflets and the leaflets, and prevents the prolapsed valve leaf from being reversed by the assisting member, thereby achieving the purpose of preventing valve regurgitation, which has less implants and blood. Good dynamics and other advantages.
  • the maximum width of the assisting member of the present invention is smaller than the maximum width of the single self-body leaflet, which not only avoids the influence of the width of the assisting member on the closing function of other adjacent leaflets, but also allows for circumferential adjustment.
  • the aid is placed at the most suitable prolapse site, with fewer implants, lower complications, and adaptability to different patient annulus sizes. The indications can be extended and manufacturers can reduce product specifications.
  • the maximum width of the assisting member of the present invention is smaller than the maximum width of the single self-body leaflet, and the self-leaf leaflet includes both the anterior-posterior valve leaflet and the combined valve leaflet, and the applicable range is higher than the prior art. More extensive.
  • the connector of the present invention is flexible such that the connector and the assisting closure associated therewith are movable with movement of the leaflets without affecting the motor function of the native leaflets.
  • the fixing member of the present invention adopts a non-closed loop structure (the width of the fixing member is less than two-thirds of the circumference of the valve tissue ring), which reduces the supporting force on the atrial wall and avoids the atrium and the phase. The effect of adjacent valve motor function.
  • the product of the invention has simple design structure and low manufacturing cost.
  • the present invention retains the function of the autologous valve leaflets, so the risk of surgery is low and the durability of the leaflets is good.
  • an adjustment device is also provided, and with image assistance, the effect of preventing valve leaf regurgitation can be controlled and adjusted until the effect is optimal, and the adjustment device is fixed to the apex and the ventricular wall.
  • FIGS 1a and 1b show schematic views of one embodiment of the invention.
  • Figures 2a and 2b show schematic views of another embodiment of the invention
  • Figures 2c and 2d show schematic views of two embodiments of the closure, respectively.
  • FIGS 3a-3d show schematic views of various embodiments of the invention, respectively.
  • FIGS 4a and 4b show schematic views of yet another embodiment of the present invention.
  • Figures 5a-5d show schematic views of the position of the fixation member being adjusted circumferentially along the patient annulus.
  • FIGS 6a-6p show schematic views of various embodiments of the invention, respectively.
  • Figures 7a-7c show schematic views of various embodiments of the closure member, respectively.
  • Figure 8a shows a schematic view of yet another embodiment of the present invention
  • Figures 8b-8d show schematic views of various embodiments of the present invention for use in tricuspid valve repair, respectively.
  • FIGS 9a-9h show schematic views of various embodiments of the invention, respectively.
  • FIGS 10a-10f show schematic views of various embodiments of the anchor, respectively.
  • the distal end of the present invention refers to the end away from the apex, and the proximal end refers to the end that is close to the apex.
  • a prosthesis 100 for preventing regurgitation of a valve includes a fixing unit 110, a connector 120 and a assisting member 130, the fixing unit 110 including a fixing member 111 and at least two anchors
  • the distal end portion of the connecting member 120 is connected to the proximal end portion of the fixing member 110, and the proximal end portion of the connecting member 120 is connected to the distal end portion of the assisting member 130, the connection
  • the member 120 is flexible such that the connector 120 and the assisting member 130 coupled thereto are movable with movement of the leaflets, and there is a blood supply between the assisting member 130 and the fixing member 111.
  • the fixing member 111 is a polymer sheet or the fixing member 111 has a skeleton structure, and the fixing member 111 is fixed to the patient's atrial wall or the annulus by the anchoring member 112,
  • the width of the fastener 111 is less than two-thirds of the circumference of the valve tissue ring, and the assisting member 130 is located between the patient's native leaflets in a free state, and the maximum width of the assisting member 130 is smaller than a single body.
  • the maximum width of the leaflet deployment, the distal end of the anchor 112 is pointed Sharply, the distal end portion of the anchor 112 is pre-shaped, and the proximal end of the anchor 112 is provided with a detachment end 1120.
  • the prosthesis 100 for preventing regurgitation of the valve is used to treat mitral valve prolapse
  • the length of the assisting member 130 along the axis of the plane of the annulus is about 50 mm, such that The benefit is that at least a portion of the assisting member 130 is located between the anterior and posterior lobes
  • the anterior and posterior flaps are respectively attached to both sides of the closure member 130, so that the mitral valve prolapse caused by the chordae rupture is treated to effectively prevent mitral regurgitation.
  • the fixing member 111 in the free state, is a flexible polymer sheet, and the distal end portion of the fixing member 111 is curved in the circumferential direction of the annulus, and thus designed.
  • the benefit is that the fastener 111 better conforms to the patient's atrial wall or annulus, assists the physician in positioning at the beginning of the release, and is less prone to displacement when the anchor 112 is anchored.
  • the length of the connector along the axis of the plane of the annulus is 15 mm.
  • the connecting member 120 is flexible, and the connecting member 120 is composed of two rods 1201 and 1202.
  • the rods 1201 and 1202 are in the shape of a straight strip, because the leaflets are close to the annulus during the opening and closing process.
  • the range of motion of the leaflets is small, the connector 120 is prone to adhesion due to prolonged contact with the native leaflets, and the gap formed between the rods 1201 and 1202 of the present invention allows blood to pass, and on the other hand increases the opening for blood supply.
  • the area prevents the connector 120 from sticking to the native leaflets.
  • the distal end of the assisting member 130 is connected to the proximal end portion of the connecting member 120 by sintering, and the distal end of the connecting member 120 is connected to the proximal end of the fixing member 111 by sintering.
  • the connecting member 120 is flexible, the connecting member 120 and the assisting member 130 connected thereto can As the movement of the leaflets moves, the assisting member 130 can still have sufficient space to adjust in the axial direction of the annulus, so that the closure piece 130 can better conform to the body when the leaflets are closed.
  • the leaflets enhance the effect of preventing valve regurgitation.
  • the assisting member 130 is a mesh structure (not shown) in which a wire (in some embodiments, a nickel-titanium memory alloy wire) is woven, or as shown in FIG. 2c.
  • the protective sheet 130 is a polymer material sheet or an animal-derived material sheet.
  • the assisting member 130 is provided with a hole 1303.
  • the hole 1303 has a circular shape.
  • the maximum width of the assisting member 130 is less than the maximum width of a single leaflet deployment, and the native leaflet includes both the anterior and posterior valve leaflets and the combined valve leaflets, and the scope of application is wider than in the prior art.
  • the sum of the length of the assisting member 130 and the length of the connector 120 is greater than the height at which the leaflets are deployed.
  • the rods 1201, 1202 of the connecting member 120 are partially covered with a film 1203, and the film is connected to the rods 1201, 1202 by welding, gluing or sewing, without being The part of the membrane is the passage through which blood flows.
  • the rods 1201, 1202 are coated with a membrane 1203, and the membrane 1203 is provided with a hole 1204, which is a passage through which blood flows, so as to further prevent the connection.
  • the piece 120 is adhered to the native leaflets.
  • the assisting member 130 is provided with a hole 1303, and the hole 1303 has a polygonal shape.
  • the rods 1201, 1202 are completely covered with a film 1203, and the film 1203 and the shutter member 130 are the same material and are connected to each other by sewing, welding or the like.
  • the fixing member 111 has a skeleton structure 1115, and in a free state, the skeleton knot
  • the distal end portion of the configuration 1115 is curved in the circumferential direction of the annulus, such that the design is advantageous in that the fixation member 111 better conforms to the patient's atrial wall or annulus, and the skeletal structure 1115 is coated with the membrane 114,
  • the film 114 is joined to the skeletal structure 1115 by sintering, welding, gluing or seaming, and the film 114 material comprises polytetrafluoroethylene, polyethylene, polypropylene, polyester or animal derived materials.
  • the skeleton structure 1115 is a grid-like bracket, and the skeleton structure 1115 is integrally cut by a metal memory alloy material, and the skeleton structure 1115 is partially covered.
  • the anchor member 112 secures the skeletal structure 1115 to the patient's atrial wall or an annulus through the membrane 114, the skeletal structure 1115 being located at the detachment end 1120 of the anchor 112 and the patient's tissue between.
  • the skeleton structure 1115 is a grid-like bracket, and the skeleton structure 1115 is integrally cut by a shape memory material, and the skeleton structure 1115 is provided with a hole 1111.
  • the proximal end of the anchor 112 is provided with a retaining end 1120 having a diameter larger than the diameter of the hole 1111 through which the anchor 112 secures the skeleton structure 1115.
  • the skeleton structure 1115 is made of a shape memory material, and the present invention can select the corresponding width of the shutter 130 according to the width of the prolapsed leaflets. , reducing the implantation amount of the implant, and does not affect the movement of the remaining normal function leaflets, reducing complications, as shown in FIG.
  • the width of the proximal end portion of the assisting member 130 is greater than the width of the distal end portion thereof, Suitable for a wide range of leaflet prolapse areas; as shown in Figure 3d, the width of the proximal portion of the assist member 130 is less than the width of its distal portion, suitable for a smaller range of leaflet prolapse areas, such as a combined flap region.
  • a prosthesis 200 for preventing regurgitation of a valve includes a fixation unit 210, a connector 220 and a assisting member 230, the fixation unit 210 including a fixture 211 and at least two anchors
  • the distal end portion of the connecting member 220 is connected to the proximal end portion of the fixing member 210, and the proximal end portion of the connecting member 220 is connected to the distal end portion of the assisting member 230, the connection
  • the member 220 is flexible such that the connector 220 and the assisting member 230 coupled thereto are movable with movement of the leaflets, and there is a blood supply between the assisting member 230 and the fixing member 211.
  • the through-flow passage, the fixing member 211 is a polymer mesh or the fixing member 211 has a skeleton structure, and the fixing member 211 is fixed on the patient's atrial wall or the annulus by the anchoring member 212,
  • the width of the fastener 211 is less than two-thirds of the circumference of the valve tissue ring.
  • the assisting member 230 is located between the patient's native leaflets in a free state, and the maximum width of the assisting member 230 is smaller than a single one.
  • the maximum width of the native leaflet deployment, the distal end of the anchor 212 is Sharply shaped, the distal end portion of the anchor 212 is pre-shaped, and the proximal end of the anchor 212 is provided with a detachment end 2120.
  • the prosthesis 200 for preventing regurgitation of the valve is used to treat mitral valve prolapse
  • the connector 220 is comprised of four rods 2201 that are curved in shape
  • the connector 220 can enhance the flexibility of the connector 220 such that the connector 220
  • the attached baffle 230 can move with the movement of the leaflets to prevent the connecting member 220 and the assisting member 230 from sticking to the annulus or the native leaflets for a long time.
  • the product of the complete annular structure is different from the prior art, and the fixing member 211 can be adjusted to adjust the position along the circumferential direction of the patient annulus, such as the combined flap position (Fig. 5a), the anterior leaflet Position (Fig. 5b) or posterior leaflet position (Fig. 5c) until anchor position is determined after the operator determines the most suitable position of the backflow according to the fitting of the assisting member 230 with the self-leaflet
  • the anchoring member 212 is released to achieve the fixation between the prosthesis 200 and the autologous tissue, which truly achieves the normal physiological function of the remaining heart valve while accurately treating the lesion, and reduces the function of the normal operating heart valve.
  • the fixing member 211 has a skeleton structure, and the skeleton structure is completely covered, and the skeleton structure is composed of a plurality of support rods 2114, the plurality of roots.
  • the support rods 2114 are arranged in an arc shape along the circumferential direction of the annulus, wherein the proximal ends of the two support rods 2114 extend all the way to form the connecting member 220, and the assisting member 230 is a single piece, and the assisting member The distal end of the 230 is attached to the proximal portion of the connector 220 by sintering.
  • the skeletal structure is a wavy or zigzag structure wound from a metal memory material.
  • the adjacent rods 2115, 2116 of the skeletal structure are intertwined with each other to form a compact structure, and the design is advantageous in that the expansion strength of the fixing member 211 is strengthened to maintain the expanded shape. It is not easy to wrinkle with blood wash and tissue movement.
  • the connecting member 220 is composed of two rods, and the connecting member 220 is entirely covered with a membrane 2203.
  • the membrane 2203 is provided with a hole 2204, which is a passage through which blood flows.
  • the distal end portion of the connector 220 is sewn to the proximal end portion of the fastener 211 by a suture, in some embodiments, the crests and troughs of the undulating structure or the serrations of the zigzag structure
  • the tip is wound into a ring 2117, which has the advantage of making the seam seam stronger, and the joint of the connector 220 with the fixture 211 is stronger.
  • the assisting member 230 is two pieces, which has the advantages of making it more complete with its own leaflets and preventing the reflux effect from being better.
  • the assisting member 230 and the film 2203 are made of the same material and are connected to each other by sintering.
  • the assisting member 230 is in the form of a bag, one end (distal end) of the bag mouth being connected together, and the other end (proximal end) being opened.
  • the bag-shaped assisting member bulges to increase the fit area with the native leaflets; when the blood flows from the atrium to the ventricle, the bag-shaped assisting member closes without affecting blood circulation.
  • the assisting member 230 is provided with a bag member 2302. The distal end of the bag 2302 and the two sides are sealed, and the proximal end is open.
  • the pocket 2302 bulges to increase the area of fit with the native leaflets; when blood flow from the atria to the ventricles, the pocket 2302 closes without affecting blood flow.
  • the assisting member 230 is cylindrical, and the connecting member 220 is composed of two rods, and the shape of the rod is curved, so that the design is advantageous for improving the position.
  • the flexibility of the connector 220 is described.
  • the fixing member 211 is a polymer sheet, and the design is advantageous for improving the softness of the fixing member 211 and facilitating adhesion to the atrial wall. A passage for blood to flow is formed between the two rods. As shown in FIGS.
  • the connecting member 220 is composed of a single wire having a shape of a straight line and a curved line so that the flexibility of each portion of the connecting member 220 can be made different. Both sides of the connecting member 220 are channels through which blood flows.
  • the assisting member 230 is a balloon, and the doctor can place the balloon into the patient's lesion, expand the balloon by flushing, and adjust the amount of flushing so that the degree of balloon inflation can adapt to the actual reflux of the patient's leaflets. As shown in FIGS.
  • the distal end of the connecting member 220 extends a plurality of rod wires around the proximal end portion of the fixing member 211, and the distal end of the assisting member 230 extends a plurality of rods.
  • a wire is wound around the proximal end portion of the connector 220, and in some embodiments, the bar wire extends from the closure member 230 up to the fixture 211.
  • the assisting member 230 is cylindrical and has an elliptical cross-section such that the assisting member 230 can maximize the fit of the patient's own leaflets 2401, 2402.
  • the assisting member 230 is filled with a light material, such as expanded polytetrafluoroethylene, and is wrapped with a relatively dense polymer material to prevent tissue growth from covering the assisting member. 230 to adhere to the leaflets.
  • the connecting member 220 is a polymer sheet, and the connecting member 220 is provided with a hole 2204, which is a passage through which blood flows, and is designed to improve the connecting member 220. Flexibility and prevent adhesion.
  • the assisting member 230 is a combination of a single piece and a double piece, and the proximal end of the single piece is fixedly connected with the distal end of the two pieces, which is also for the purpose of better fitting the assisting piece 230 with the leaflet itself. Combined, increase the fit area and improve the effect of preventing valve regurgitation.
  • the assisting device 230 is provided with an adjusting device 232.
  • the adjusting device 232 is a wire, and one end of the wire is connected to the assisting member 230.
  • the other end of the wire is connected to the ventricle or the apex, so that the design has the advantage that, under the aid of the image, the doctor can adjust and adjust the anti-flow effect of the leaflet by adjusting the wire during the operation to make the valve
  • the reflux reaches a minimum value (ie, when the effect of preventing backflow is optimal)
  • the other end of the wire is fixed to the ventricular wall or the apex, and the assisting member 230 can be prevented from turning during the movement of the leaflets.
  • the atrium On the atrium.
  • the proximal end of the assisting member 230 is provided with a deployment device 233, which is made of wire or polymer wire to prevent the sheet-like aid.
  • the closure 230 is wrinkled.
  • the deployment device 233 extends proximally from the distal end of the assist member 230, the stiffness of the deployment device 233 itself such that the closure member 230 is less susceptible to wrinkling under the impact of blood flow.
  • the unfolding device 233 is a rod or a metal memory material wire. The undulating or zigzag structure prevents the bailer 230 from wrinkling.
  • the deployment device is disposed at the proximal end of the tubular or bag-like closure member 230 to prevent the closure member 230 from being compressed resulting in a reduction in size.
  • a prosthesis 300 for preventing regurgitation of a valve includes a fixation unit 310, a connector 320 and a assisting member 330, the fixation unit 310 including a fixture 311 and at least two anchors
  • the distal end portion of the connecting member 320 is connected to the proximal end portion of the fixing member 310, and the proximal end portion of the connecting member 320 is connected to the distal end portion of the assisting member 330, the connection
  • the member 320 is flexible such that the connector 320 and the assisting member 330 coupled thereto are movable with the movement of the leaflets, and the blood is provided between the assisting member 330 and the fixing member 311.
  • the fixing member 311 is a polymer sheet or the fixing member 311 has a skeleton structure, and the fixing member 311 is fixed to the patient's atrial wall or the annulus by the anchoring member 312,
  • the width of the fastener 311 is less than two-thirds of the circumference of the valve tissue ring, and the assisting member 330 is partially or wholly between the patient's native leaflets in a free state, and the maximum width of the assisting member 330 is smaller than a single
  • the maximum width of the native leaflet deployment, the anchor 312 The distal end is sharply shaped, the distal end portion of the anchor 312 is shaped, and the proximal end of the anchor 312 is provided with a detachment end 3120.
  • the prosthesis 300 for preventing regurgitation of the valve is used to treat tricuspid prolapse.
  • the skeleton structure is composed of a plurality of support rods and a corrugated structure wound by a metal memory material wire, and the support rods on both sides of the skeleton structure are coated to form two sheets of film.
  • the regions 3118, 3119 are connected by a wavy metal memory material wire between the film-covering regions 3118, 3119, and the two anchor members 312 are respectively located on each of the film-covering regions 3118, 3119.
  • This design is particularly suitable for patients with multiple prolapses of the leaflets at different positions.
  • the anchor 312 is coupled to the fixture 311 as shown in Figures 9a-9h.
  • the advantage of such a design is that when the anchor 312 needs to be released to fix the fixing member 311 to the autogenous tissue, there is no need to consider the alignment problem between the anchor 312 and the fixing member 311. Ensure accurate alignment and anchoring, simplify the surgical procedure and save operation time. As shown in FIG.
  • the fixing member has a ring-shaped skeleton structure (not visible in the figure), the anchor 312 is fixedly connected to the annular skeleton structure, the distal end portion of the connecting member 320 is connected to the annular skeleton structure, and the proximal end portion of the connecting member 320 Connected to the distal end portion of the assist member 330.
  • the fixing member 311 has a skeleton structure, which is a grid-like bracket, the skeleton structure is covered with a film 3113, and the anchoring member 312 is connected to the film 3113.
  • the assisting member 330 is a combination of a single piece and a balloon, and the surface of the balloon is a porous material containing a water swellable material which can be attached to the patient's leaflets after being expanded in the blood.
  • the fixing member 311 is a polymer sheet
  • the anchoring member 312 is connected to the polymer sheet
  • a plurality of polymer wires 3302 are connected to the assisting member 330.
  • One end of the line 3302 is connected to the assisting member 330, and the other end is connected to the ventricle or the apex.
  • the doctor adjusts the polymer line 3302 so that the assisting member 330 does not affect the normal closing of the leaflets and prevents backflow.
  • the prosthesis 300 for preventing regurgitation of the valve includes two pieces of the aid member 330, and are respectively provided with a polymer wire 3302 for adjustment and anti-rolling action.
  • the connecting member 320 is two wires, and the distal end of the connecting member 320 is connected to the fixing member 311, and the fixing member 311 is a wire wound ring.
  • the fixing member 311 is integrated with the distal end of the connecting member 320 and is located in the retaining end 3120 of the anchor 312 at the same time.
  • the assisting member 330 is a combination of a single piece and a cylindrical shape. As shown in FIG.
  • the anchoring member 312 is connected to the fixing member 311 through two wires 3116, 3117.
  • the fixing member 311 is a polymer piece
  • the connecting member 320 is strip-shaped
  • the connecting member is Both sides of the 320 are channels through which blood flows.
  • the assisting member 330 is a combination of a single piece and a column. As shown in FIG. 9h, the assisting member 330 is a combination of a single piece and a bag shape, and the distal end of the bag member 3302 and the two sides are sealed, and the proximal end is open.
  • the fixing member 311 is a polymer sheet, and the fixing member 311 is connected to the assisting member 330 through the connecting member 320.
  • the connecting member 320 is three curved rods.
  • the distal end of the anchor 312 is sharp, and as shown in FIGS. 10b-10d, the distal end portion of the anchor 312 is predetermined to have the following shape.
  • the proximal end of the anchor 312 is provided with a detachment end 3120, and the distal end portion of the anchor 312 is further provided with a barb 3121 for enhancing the anchoring effect after piercing the patient's autologous tissue.
  • the distal portion of the anchor 312 has two bifurcations 3122, 3123 that enhance the anchoring effect. As shown in Figure 10f, the distal portion of the anchor 312 has three bifurcations 3122, 3123, 3124 that enhance the anchoring effect.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

一种用于阻止瓣膜反流的假体（100），包括固定单元（110）、连接件（120）和助闭件（130），固定单元（110）包括固定件（111）和锚定件（112），连接件（120）为柔性，其远端部分与所述固定件（111）的近端部分相连，其近端部分与所述助闭件（130）的远端部分相连，固定件（111）通过锚定件（112）被固定在患者心房壁上或者瓣环上，固定件（111）展开的宽度小于瓣膜组织环周长的2/3，助闭件（130）在自由状态时位于患者自体瓣叶之间，所述助闭件（130）的最大宽度小于单个所述自体瓣叶展开的最大宽度，锚定件（112）的近端设置有防脱端（1120）。所述假体（100）可实现位置可调、定位准确和牢固锚定，不易与患者瓣环附近的组织粘连。

Description

一种用于阻止瓣膜反流的假体
相关申请
本专利申请要求2014年7月7日申请的，申请号为201410322594.8，名称为“一种用于阻止瓣膜反流的假体”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本发明属于医疗器械领域，具体涉及一种用于阻止瓣膜反流的假体。
背景技术
二尖瓣位于左房室口，由瓣环、瓣叶、腱索、乳头肌、交界连接五部分组成，其在解剖学上的准确名称为二尖瓣装置(mitral apparatus)或者二尖瓣复合体(mitral complex)。
三尖瓣位于右房室口，具有三片近似三角形的帆状瓣膜，瓣膜底附着于房室口的纤维环上，在功能上可视纤维环、瓣膜、腱索和乳头肌，为三尖瓣复合体(tricuspid valvar complex)。
二尖瓣反流(mitral regurgitation)可以分为以下两种：1.风湿性心脏二尖瓣反流，主要由二尖瓣锁闭不全引起，可造成血液反向流动，从而使不同的血液混合，造成心脏泵血，输氧功能下降。2.非风湿性二尖瓣返流，通常指除风湿性瓣膜病变以外，二尖瓣本身及其周围解剖结构等的异常所导致的不同程度的二尖瓣返流。非风湿性二尖瓣关闭不全的原因很多，较常见的有：二尖瓣脱垂、乳头肌功能不全或腱索断裂、左心房粘液瘤、瓣膜环钙化、先天性瓣膜畸形、感染性心内膜炎等。二尖瓣反流还可以分为功能性、退行性或混合性三种。最常见的是退行性与功能性二尖瓣反流。功能性一般为继发于左室壁运动功能受损、左室扩张、乳头肌功能异常，一般见于心力衰竭患者中。此部份患者也包括继发于冠心病的缺血性二尖瓣反流及非缺血性心肌病有关的二尖瓣反流。退行性二尖瓣反流疾病一般被认为是瓣膜结构发生病理性变化，或瓣膜下结构病理性改变，包括腱索的异常延展或是断裂。
三尖瓣反流一般为肺动脉高压，右室扩大，三尖瓣环扩张引起，出现三尖瓣反流后，乏力、腹水、水肿肝区疼痛、消化不良、纳差等右心衰症状加重。三尖瓣关闭不全主要分为功能性三尖瓣关闭不全和器质性三尖瓣关闭不全。由风湿热引起的瓣膜的器质性关闭不全为数很少，多数为功能性关闭不全，其最常见的病因是由肺动脉高压造成右心室扩张，三尖瓣环扩大，导致三尖瓣相对关闭不全而瓣膜本身结构正常。如风湿性二尖瓣病、先天性心血管病、肺心病等。
二尖瓣和三尖瓣瓣膜反流的传统治疗手段包括适用于轻度至重度反流的药物治疗，和有相对应手术指征的外科手术方法。其中，外科手术方法还包括二尖瓣、三尖瓣置换和二尖瓣、三尖瓣修补。单纯的二尖瓣反流，需要二尖瓣置换的病人只有30％，余下的只需要二尖瓣修补。在外科手术方法中，典型的开胸、开心手术侵入性过大，需要建立体外循环，具有较高的并发症发生率和感染风险。而为了降低手术风险，经导管介入的置换和修补手术方法得以发展。
根据文献【Enriquez-Sarano M,Schaff HV,Orszulak TA,et al.Valve repair improves the outcome of surgery formitral regurgitation:a multivariate analysis[J].Circulation,1995,91(4):1022-1088】报导可见置换术具有较高的总手术的病死率和较低的生存率。
表1.二尖瓣成形术与二尖瓣置换术术后病死率及并发症的比较(多中心)
Figure PCTCN2015080173-appb-000001
而经导管治疗瓣膜反流，目前亟待解决的问题有如下几点：尽可能在保证阻反流效果的前提下，减少植入物的植入量；阻反流的器械必须被准确定位并牢固固定在需要治疗的部位；阻反流的器械需要最小程度的影响剩余具有正常功能瓣叶的运动；阻反流的器械需要适应瓣环的生理结构的差异性，下面列举了目前现有技术中，不同的阻反流器械的技术要点。
专利WO 2006037073 A2描述了一种使用二尖瓣夹(mitral clip)进行二尖瓣修补的治疗方法，将二尖瓣膜中心或者角落区域缝合在一起，但此技术无法应用于以下两类患者：收缩期瓣叶间接缝间隙＞10mm，无法准确同步两个瓣叶的活动；另一种是瓣环下结构有严重增厚与钙化，因腱索、瓣叶、瓣环压力的提高，有腱索断裂的风险。
专利US2009105751A1、CN101902975描述了一种用于修复在患者的搏动心脏中的瓣膜小叶的装置，其包括手柄组件、俘获组件和针头，通过所述俘获组件俘获瓣叶，所述针头穿过所述瓣膜小叶，来限制脱垂瓣叶的运动，达到阻反流的效果，但是此技术在 操作上，需要抓住正在运动的瓣叶，操作难度大且时间长，且对自体瓣叶容易造成撕裂伤。
专利US20130023985描述了一种用于治疗瓣膜关闭不全和其他瓣膜疾病的植入物、植入系统和方法，所述的植入物包括一个辅助瓣叶接合体，所述瓣叶接合体上部贴合自体瓣环部分的长度为25-35mm，等于第一和第二联合交界处之间的距离，所述瓣叶接合体上部到下部的长度为50-60mm，并且在所述瓣叶接合体上可选择的设置有锚定装置，在其权利要求中，还限制了所述接合体的某一部分为圆锥形，在另一个权利要求中，除了限定所述上部贴合自体瓣环部分的长度为25-35mm，还限定了所述瓣叶接合部分与瓣环垂直方向高度为35-45mm，限定了心室未接合部分在与瓣环垂直方向上高度为25-35mm，限定了接合部分弧度半径在35-45mm以内。该种系统对于上部贴合自体瓣环部分的长度限制，只适用于二尖瓣前瓣或者后瓣脱垂的整体修复，以及部分三尖瓣的整体瓣叶的脱垂修复，并且表明所述接合体下部长度至少覆盖了大部分瓣叶，所述结合部分具有特定的弧度要求。该种技术无法适应瓣膜小部分脱垂或者较小瓣膜例如主动脉瓣的修复，在修复关闭不全的位置时，同时牺牲了其余正常工作的瓣膜。综上所述，其缺点包括：第一，明确描述了接合体上部的长度等于第一和第二联合交界处之间的距离，因而只适用于瓣叶的整体修复，修复面积既包括了瓣叶脱垂部位也包括了瓣叶正常部位；第二，各人的瓣环长度差异很大，在实际手术之前第一和第二联合交界处之间的距离是无法预知的，很难在产品设计予以精确匹配；第三，接合体部分的形状为锥形，力求匹配人体瓣叶的锥形，同样由于人的差异性，很难完全匹配；第四，该设计不适合联合瓣叶脱垂的修复。
而在专利CN103338726A中，描述了一种用于治疗患者心脏瓣膜的接合不良的方法，所述方法包括在植入物处于第一构型时将所述植入物引入心脏中，将所述植入物在心脏内从所述第一构型展开成第二构型，处于所述第二构型的所述植入物具有第一和第二相反的接合表面的接合辅助体，以及支持所述展开的植入物使得所述接合辅助体沿所述接合区从所述心脏瓣膜的所述轴线偏移，在其权利要求中，所述方法还包括：在靠近所述第一联合(所述第一联合为在所述心脏瓣膜具有的第一和第二瓣叶的第一连接处)的第一目标位置处选择性地配置第一锚定件，在靠近所述第二联合(所述第二联合为在所述心脏瓣膜具有的第一和第二瓣叶的第二连接处)的第二目标位置处选择性地配置第二锚定件，将接合辅助体引入心脏中，在另一个权利要求中，描述了所述植入物包括接合辅助体、第一锚定件和第二锚定件，所述接合辅助体具有轴线以及第一和第二相反的主接合表面，各接合表面在所述接合辅助体的第一横向边缘与第二横向边缘之间横向延伸， 所述第一锚定件可选择性的配置在靠近所述第一联合的心脏的第一目标位置处，使得所述第一横向边缘朝向所述第一联合定向，其后还限定了所述第二锚定件的锚定位置在靠近所述第二联合处。在另一个权利要求中，还特别限定了所述植入物的轴线需沿所述瓣膜轴线延伸，并且所述接合辅助体的第一和第二侧边需沿所述心脏瓣膜的接合区的曲线延伸，其中被支持的植入物的所述接合辅助体充分横向适形，使得所述植入物与心脏之间的接合使得所述边缘之间的所述接合辅助体朝向所述心脏瓣膜的接合区所限定的曲线横向弯曲。上述权利要求，限定了所述锚定位置需要靠近所述第一以及第二联合处，还限定了整个所述接合辅助体需与所述心脏瓣膜充分横向适形。此种技术，无法适应部分的瓣膜脱垂症，在发挥阻反流效果的同时，具有以下缺点，第一，该发明中描述的“支持所述展开的植入物使得所述接合辅助体沿所述接合区从所述心脏瓣膜的所述轴线偏移”，即指当所述植入物自然展开时，接合辅助体沿中心线缩小，这就需要接合辅助体成形为锥形，第二，接合辅助体覆盖了未脱垂的正常瓣膜，在长期的运动过程中，容易造成粘连，牺牲了部分正常瓣膜的正常功能运作；第三，在靠近自体瓣环处的朝着心间方向的自体瓣膜，在开闭过程中，运动幅度比靠近瓣尖处的瓣叶的运动幅度小，容易与被充分横向适形，并与其相贴的所述心脏瓣膜辅助体发生粘连，此处不同于所述的上部接合辅助体即瓣环处，所述的瓣环处在长期的植入过程中，应该与所述的自体瓣环生长在一起，增加被固定的效果，而所述的靠近自体瓣环处朝着心间方向的自体瓣膜，一旦造成粘连，会影响瓣叶的运动效果，容易造成二次反流，导致阻反流治疗失败；第四，由于各人自体瓣环的尺寸各异，导致该技术中产品规格较多。
专利US20130325110 A1描述了一种不停跳输送助瓣叶关闭假体的治疗二尖瓣和三尖瓣反流的方法，所述的方法包括利用柔性轨道，将心室固定件从心房穿过自体瓣膜送入右心室进行锚定，利用导管输送并调整所述假体在三尖瓣环的位置，直至使反流减小，将所述导管与所述柔性轨道相对固定，并固定在下腔静脉上。该种输送方法虽可以调节所述假体的位置以适应不同的反流位置，有一定的病变适应性，但是所述的在下腔静脉的固定位置远离瓣环位置，容易导致固定不牢固，假体在固定完毕后位移。
目前临床结果表明，并未有一款理想的治疗瓣膜反流的产品。主要原因在于二尖瓣瓣环、三尖瓣瓣环等具有特殊的生理结构，且在瓣环下方有复杂的生理环境，造成产品准确定位和固定非常困难。另外，瓣膜脱垂病变的程度与位置不同，例如部分病人为前瓣脱垂导致的关闭不全，部分病人为联合瓣病变导致的关闭不全等，以上所述技术在治疗病变位置关闭不全的同时，还干涉到了剩余正常二尖瓣的生理结构，病变适应性不足。综上所述，尽管以上所描述的技术在瓣膜修复上分别都有一定的效果，但是，在治疗瓣 膜关闭不全的手术领域，亟需一种具备位置可调、定位准确和牢固锚定的假体，能够应对各种不同程度与位置的病变。
发明内容
本发明的目的是克服现有技术的限制，针对瓣膜部分脱垂，提出一种用于阻止瓣膜反流的假体，本发明可实现位置可调、定位准确和牢固锚定，能够根据各种不同程度与位置的病变，调节假体位置，再进行定位和锚定，同时不易与患者瓣环附近的组织粘连。
本发明的目的是通过以下技术方案实现的：
一种用于阻止瓣膜反流的假体，包括固定单元、连接件和助闭件，所述固定单元包括固定件和锚定件，所述连接件的远端部分与所述固定件的近端部分相连，所述连接件的近端部分与所述助闭件的远端部分相连，所述连接件为柔性，使得所述连接件以及与之相连的所述助闭件能够随着瓣叶的运动而运动，所述固定件通过所述锚定件被固定在患者心房壁上或者瓣环上，所述固定件展开的宽度小于瓣膜组织环周长的三分之二，所述助闭件在自由状态时位于患者自体瓣叶之间，所述助闭件的最大宽度小于单个所述自体瓣叶展开的最大宽度，所述锚定件的近端设置有防脱端。
本发明的目的还可以通过以下的技术方案来进一步实现：
在其中一些实施方式中，所述助闭件的长度与所述连接件的长度之和大于所述自体瓣叶展开的高度。
在其中一些实施方式中，所述助闭件为单片、多片、筒状、袋状、柱状或球囊，或者所述助闭件为单片与多片的组合，或者所述助闭件为单片与筒状的组合，或者所述助闭件为单片与袋状的组合，或者所述助闭件为单片与柱状的组合，或者所述助闭件为单片与球囊的组合。
在其中一些实施方式中，所述助闭件为网格结构，或者所述助闭片为高分子材料片或动物源性材料片，当所述助闭片为高分子材料片或动物源性材料片时，在所述助闭片上设置有孔。
在其中一些实施方式中，所述锚定件与所述固定件连接。
在其中一些实施方式中，所述固定件和所述连接件为一体结构。
在其中一些实施方式中，所述助闭件沿所述瓣环所在平面的轴线的长度大于等于10mm，小于等于60mm。
在其中一些实施方式中，所述连接件沿所述瓣环所在平面的轴线的长度大于等于1mm，小于等于25mm。
在其中一些实施方式中，在所述助闭件和所述固定件之间具有供血液流过的通道。
在其中一些实施方式中，所述连接件为片状、条状或丝状，或者所述连接件为上述结构的组合。
在其中一些实施方式中，所述连接件被部分覆膜，所述连接件没有被覆膜的部分为血液流过的通道。
在其中一些实施方式中，所述连接件被全部覆膜，在所述膜上设置有孔，所述孔为血液流过的通道。
在其中一些实施方式中，当所述连接件为单根的所述条状或者所述丝状的结构时，所述连接件的两侧为血液流过的通道。
在其中一些实施方式中，所述固定件为柔韧性的高分子片，或者为高分子网布。
在其中一些实施方式中，所述固定件具有骨架结构，所述骨架结构由多根支撑杆组成，或者所述骨架结构为金属记忆材料丝绕制而成的波浪形结构或锯齿形结构，或者所述骨架结构为网格状支架，或者所述骨架结构为上述结构的组合。
在其中一些实施方式中，所述波浪形结构的波峰和波谷或者所述锯齿形结构的锯齿尖处被绕制成环形。
在其中一些实施方式中，所述骨架结构为形状记忆材料编织制成或者一体切割制成。
在其中一些实施方式中，所述骨架结构的相邻的杆之间相互缠绕，形成紧密的结构。
在其中一些实施方式中，在自由状态下，所述骨架结构的远端部分沿所述瓣环的周向为弧形结构。
在其中一些实施方式中，所述骨架结构被覆膜，所述膜采用烧结、焊接、胶合或缝绑的方式与所述骨架结构连接，所述膜材料包括聚四氟乙烯、聚乙烯、聚丙烯、涤纶或动物源性材料。
在其中一些实施方式中，所述助闭件的远端部分通过缝线缝接在所述连接件的近端部分上，或者所述助闭件的远端延伸出多根杆线绕接在所述连接件的近端部分上，或者所述助闭件的远端通过烧结连接在所述连接件的近端部分上。
在其中一些实施方式中，所述连接件的远端部分通过缝线缝接在所述固定件的近端部分上，或者所述连接件的远端延伸出多根杆线绕接在所述固定件的近端部分上，或者所述连接件的远端通过烧结连接在所述固定件的近端部分上。
在其中一些实施方式中，在所述助闭件上设置有调整装置，所述调整装置为金属丝或高分子线，所述金属丝或所述高分子线的一端连接在所述助闭件上，所述金属丝或所述高分子线的另一端连接在心室或者心尖上。
在其中一些实施方式中，所述助闭件的近端设置有展开装置，所述展开装置由金属丝或高分子线制成，防止所述助闭件起皱或防止所述助闭件被压缩导致尺寸缩小。在其中一些实施方式中，所述展开装置为杆件或者所述展开装置为金属记忆材料丝绕制而成的波浪形结构或锯齿形结构。
在其中一些实施方式中，所述锚定件的最远端为尖锐状，所述锚定件的远端部分被预定形，所述锚定件的远端部分被预定形为以下形状中的一种或者多种的组合：螺旋形、圆周形、弧形、弧线与直线的组合形、分叉双钩形、3D弯曲形、多段弯曲形，所述锚定件的远端不带倒刺或者带有一个或者多个倒刺。
同现有技术相比，本发明的优点在于：
1、区别于整体瓣膜置换技术，本发明保留了自体瓣叶和瓣叶运动功能，通过助闭件防止脱垂瓣叶翻转，从而达到阻止瓣膜反流的目的，其具有植入物少，血液动力学好等优点。
2、本发明所述助闭件的最大宽度小于单个所述自体瓣叶展开的最大宽度，不仅可以避免助闭件过宽对其他相邻瓣叶关闭功能的影响，而且可以进行周向调整使助闭件放置在最合适的脱垂部位，不仅植入物较少，并发症低，而且适应于不同的患者的瓣环尺寸，适应证得以扩展，厂商可以减少产品规格。
3、本发明所述助闭件的最大宽度小于单个所述自体瓣叶展开的最大宽度，所述的自体瓣叶既包括前后瓣瓣叶，又包括联合瓣瓣叶，适用范围比现有技术更广。
4、本发明中所述连接件为柔性，使得所述连接件以及与之相连的所述助闭件能够随着瓣叶的运动而运动，而不致于影响自体瓣叶的运动功能。
5、本发明中在所述助闭件和所述固定件之间具有供血液流过的通道，能够避免假体与患者瓣环附近组织因长期接触而发生粘连。
6、本发明中所述固定件采用非闭环的结构(所述固定件展开的宽度小于瓣膜组织环周长的三分之二)，减少了对心房壁的支撑力，避免了对心房以及相邻瓣膜运动功能的影响。
7、本发明的产品设计结构简单，制造成本低。
8、本发明由于保留了自体瓣叶的功能，所以手术风险低，瓣叶的耐久性好。
9、在本发明的一些实施方式中，还设置了调整装置，在影像辅助下，可以控制和调整阻止瓣叶反流的效果，直至效果最佳时将调整装置固定于心尖和心室壁上。
附图说明
图1a和图1b示出了本发明的一种实施方式的示意图。
图2a和图2b示出了本发明的另一种实施方式的示意图，图2c和图2d分别示出了所述助闭件的两种实施方式的示意图。
图3a-3d分别示出了本发明的多种实施方式的示意图。
图4a和图4b示出了本发明的又一种实施方式的示意图。
图5a-5d示出了所述固定件展开后可沿患者瓣环周向调整位置的示意图。
图6a-6p分别示出了本发明的多种实施方式的示意图。
图7a-7c分别示出了所述助闭件的多种实施方式的示意图。
图8a示出了本发明的再一种实施方式的示意图，图8b-8d分别示出了本发明被用于三尖瓣修复的多种实施方式的示意图。
图9a-9h分别示出了本发明的多种实施方式的示意图。
图10a-10f分别示出了所述锚定件的多种实施方式的示意图。
具体实施方式
为使本发明的目的、技术方案及优点更加清楚明白，以下参照附图并举实施例，对本发明进一步详细说明。
本发明所述的远端是指远离心尖的一端，所述的近端是指接近心尖的一端。
具体实施例一：
如图1a和图1b所示，一种用于阻止瓣膜反流的假体100，包括固定单元110、连接件120和助闭件130，所述固定单元110包括固定件111和至少两个锚定件112，所述连接件120的远端部分与所述固定件110的近端部分相连，所述连接件120的近端部分与所述助闭件130的远端部分相连，所述连接件120为柔性，使得所述连接件120以及与之相连的所述助闭件130能够随着瓣叶的运动而运动，在所述助闭件130和所述固定件111之间具有供血液流过的通道，所述固定件111为高分子片或者所述固定件111具有骨架结构，所述固定件111通过所述锚定件112被固定在患者心房壁上或者瓣环上，所述固定件111展开的宽度小于瓣膜组织环周长的三分之二，所述助闭件130在自由状态时位于患者自体瓣叶之间，所述助闭件130的最大宽度小于单个所述自体瓣叶展开的最大宽度，所述锚定件112的最远端为尖锐状，所述锚定件112的远端部分被预定形，所述锚定件112的近端设置有防脱端1120。在一种实施方式中，所述用于阻止瓣膜反流的假体100被用于治疗二尖瓣脱垂，所述助闭件130沿瓣环所在平面的轴线的长度约为50mm，这样设计的好处在于保证助闭件130至少一部分位于前瓣和后瓣之间，所述助 闭件130的两面分别贴合前瓣和后瓣，使得原本因腱索断裂导致的二尖瓣脱垂得到治疗，有效阻止二尖瓣反流。
如图2a和图2b所示，在自由状态下，所述固定件111为柔韧性的高分子片，所述固定件111的远端部分沿瓣环的周向为弧形结构，这样设计的好处在于使得所述固定件111更好地贴合患者心房壁或者瓣环，在释放初期辅助医生进行定位，同时当所述的锚定件112实施锚定后不易产生移位。作为一种实施方式，所述连接件沿瓣环所在平面的轴线的长度为15mm。所述连接件120为柔性，所述连接件120由两根杆1201、1202组成，所述杆1201、1202的形状为直线条状，由于瓣叶在开闭过程中，在接近瓣环处的瓣叶的活动范围很小，所述连接件120因长期接触自体瓣叶容易产生粘连，而本发明在所述杆1201和1202之间形成的缝隙使得血液能够通过，一方面增加了供血的开口面积，另一方面可防止连接件120与自体瓣叶发生粘连。作为一种实施方式，所述助闭件130的远端通过烧结连接在所述连接件120的近端部分上，所述连接件120的远端通过烧结连接在所述固定件111的近端部分上，当所述固定件111被锚定在患者心房壁上或者瓣环上时，因为所述连接件120为柔性，使得所述连接件120以及与之相连的所述助闭件130能够随着瓣叶的运动而运动，同时所述助闭件130依然能够有足够的空间在瓣环的轴线方向进行调整，使得所述助闭片130在瓣叶关闭时能够更好地贴合自体瓣叶，提高阻止瓣膜反流的效果。作为另一种实施方式，所述助闭件130为金属丝(在其中一些实施方式中为镍钛记忆合金丝)编织而成的网格结构(未示出)，或者如图2c所示，所述助闭片130为高分子材料片或动物源性材料片，当所述助闭片130为高分子材料片或动物源性材料片时，所述的助闭件130上设置有孔1303，所述孔1303的形状为圆形。所述助闭件130的最大宽度小于单个瓣叶展开的最大宽度，所述的自体瓣叶既包括前后瓣瓣叶，又包括联合瓣瓣叶，适用范围比现有技术更广。所述助闭件130的长度与所述连接件120的长度之和大于瓣叶展开的高度。在其中一些实施方式中，所述连接件120的所述杆1201、1202之间被部分覆膜1203，所述膜采用焊接、胶合或缝绑的方式与所述杆1201、1202连接，没有被覆膜的部分为血液流过的通道。在其中一些实施方式中，所述杆1201、1202之间被覆膜1203，所述膜1203上设置有孔1204，所述孔1204为血液流过的通道，这样设计是为了进一步防止所述连接件120与自体瓣叶发生粘连。如图2d所示，所述的助闭件130上设置有孔1303，所述孔1303的形状为多边形。作为其中一种实施方式，所述杆1201、1202之间被全部覆膜1203，所述膜1203与所述助闭件130为同一材料并相互通过缝接和焊接等方式连接在一起。
如图3a-3d所示，所述固定件111具有骨架结构1115，在自由状态下，所述骨架结 构1115的远端部分沿瓣环的周向为弧形结构，这样设计的好处在于使得所述固定件111更好地贴合患者心房壁或者瓣环，所述骨架结构1115被覆膜114，所述膜114采用烧结、焊接、胶合或缝绑的方式与所述骨架结构1115连接，所述膜114材料包括聚四氟乙烯、聚乙烯、聚丙烯、涤纶或动物源性材料。作为一种实施方式，如图3a所示，所述骨架结构1115为网格状支架，所述骨架结构1115由金属记忆合金材料一体切割制成，所述骨架结构1115被部分覆膜，所述锚定件112穿过所述膜114将所述骨架结构1115固定在患者心房壁上或者瓣环上，所述骨架结构1115位于所述锚定件112的所述防脱端1120与患者组织之间。作为另一种实施方式，如图3b所示，所述骨架结构1115为网格状支架，所述骨架结构1115由形状记忆材料一体切割制成，所述骨架结构1115上设置有孔1111，所述锚定件112的近端设置有防脱端1120，所述防脱端1120的直径大于所述孔1111的直径，所述锚定件112穿过所述孔1111将所述骨架结构1115固定在患者心房壁上或者瓣环上。作为再一种实施方式，如图3c和图3d所示，所述骨架结构1115为形状记忆材料编织制成，本发明能根据脱垂的瓣叶宽度去选择所述助闭件130的相应宽度，减少植入物的植入量，而且不影响其余正常功能瓣叶运动，减少并发症发生，如图3c所示，所述助闭件130近端部分的宽度大于其远端部分的宽度，适合较大范围的瓣叶脱垂区域；如图3d所示，所述助闭件130近端部分的宽度小于其远端部分的宽度，适合较小范围的瓣叶脱垂区域，例如联合瓣区域。
具体实施例二：
如图4a和图4b所示，一种用于阻止瓣膜反流的假体200，包括固定单元210、连接件220和助闭件230，所述固定单元210包括固定件211和至少两个锚定件212，所述连接件220的远端部分与所述固定件210的近端部分相连，所述连接件220的近端部分与所述助闭件230的远端部分相连，所述连接件220为柔性，使得所述连接件220以及与之相连的所述助闭件230能够随着瓣叶的运动而运动，在所述助闭件230和所述固定件211之间具有供血液流过的通道，所述固定件211为高分子网布或者所述固定件211具有骨架结构，所述固定件211通过所述锚定件212被固定在患者心房壁上或者瓣环上，所述固定件211展开的宽度小于瓣膜组织环周长的三分之二，所述助闭件230在自由状态时位于患者自体瓣叶之间，所述助闭件230的最大宽度小于单个所述自体瓣叶展开的最大宽度，所述锚定件212的最远端为尖锐状，所述锚定件212的远端部分被预定形，所述锚定件212的近端设置有防脱端2120。在一种实施方式中，所述用于阻止瓣膜反流的假体200被用于治疗二尖瓣脱垂，所述连接件220由四根杆2201组成，所述杆2201的形状为曲线状，这样的设计能够提升所述连接件220的柔顺性，使得所述连接件220 及其相连的所述助闭片230能随瓣叶运动而运动，防止所述连接件220及所述助闭件230因长期接触瓣环或者自体瓣叶而与之发生粘连。
如图5a-5d所示，区别于现有技术中完整环状结构的产品，所述固定件211展开后可沿患者瓣环周向调整位置，如联合瓣位置(图5a)、前瓣叶位置(图5b)或者后瓣叶位置(图5c)，直至在手术操作者根据所述助闭件230与自身瓣叶贴合情况判断最合适的阻反流的位置后，再进行锚定定位，释放锚定件212，实现所述假体200与自体组织之间的固定，真正实现了在准确治疗病变的同时，保留了剩余心脏瓣膜的正常生理功能，减少了对正常运作的心脏瓣膜的干涉，实现位置可调、定位准确、牢固锚定和病变适应性，而且能够防止因压迫联合瓣导致新的瓣周漏。当患者出现多处不同位置的瓣叶脱垂时，传统的完整环状产品由于空间所限，若采用较大面积的助闭件则会压迫自身正常的瓣叶关闭，若采用较小面积的助闭件则无法取得良好疗效，而本发明所述固定件211展开的宽度较小，允许医生在不同病灶位置植入多枚器械，如图5d所示，增强阻止瓣膜反流的作用。
如图6a和图6b所示，作为另一种实施方式，所述固定件211具有骨架结构，所述骨架结构被全部覆膜，所述骨架结构由多根支撑杆2114组成，所述多根支撑杆2114沿瓣环的周向排布成弧形，其中两根所述支撑杆2114的近端一直延伸形成所述连接件220，所述助闭件230为单片，所述助闭件230的远端通过烧结连接在所述连接件220的近端部分上。如图6c-6h所示，在多种实施方式中，所述骨架结构为金属记忆材料丝绕制而成的波浪形结构或锯齿形结构。如图6c和图6d所示，所述骨架结构的相邻的杆2115、2116之间相互缠绕，形成紧密的结构，这样设计的好处在于加强所述固定件211的展开强度，维持展开的形状不容易随血液冲刷和组织运动起皱。所述连接件220由两根杆组成，所述连接件220被全部覆膜2203，所述膜2203上设置有孔2204，所述孔2204为血液流过的通道。所述连接件220的远端部分通过缝线缝接在所述固定件211的近端部分上，在其中一些实施方式中，所述波浪形结构的波峰和波谷或者所述锯齿形结构的锯齿尖处被绕制成环形2117，这样设计的好处在于使得缝线缝接强度更大，所述连接件220与所述固定件211的接合更牢固。所述助闭件230为两片，这样的好处在于使之与自身瓣叶贴合更完全，防止反流效果更好。所述助闭件230与所述膜2203为同一材料并相互通过烧结方式连接在一起。如图6e和6f所示，所述助闭件230为袋状，袋口的一端(远端)连接在一起，另外一端(近端)张开。当血流从心室流向心房时，袋状的助闭件鼓起，增加与自体瓣叶的贴合面积；当血流从心房流向心室时，袋状的助闭件闭合，不影响血液流通。如图6g和图6h所示，所述助闭件230上设置有袋状件2302，所 述袋状件2302的远端及两侧封口，近端开口。当血流从心室流向心房时，所述袋状件2302鼓起，增加与自体瓣叶的贴合面积；当血流从心房流向心室时，所述袋状件2302闭合，不影响血液流通。在其它实施方式中，如图6i和6j所示，所述助闭件230为筒状，所述连接件220由两根杆组成，所述杆的形状为曲线状，这样设计有利于提高所述连接件220的柔性。所述固定件211为高分子片，这样设计有利于提高所述固定件211的柔软性，有利于贴紧心房壁。所述两根杆之间形成供血液流过的通道。如图6k和6l所示，所述连接件220由单根丝组成，所述丝的形状为直线与曲线的结合，这样设计可以使所述连接件220的各个部位的柔顺性均不一样。所述连接件220的两侧为血液流过的通道。所述助闭件230为球囊，医生可以将球囊置入患者病灶处，通过冲液使球囊膨胀，调节冲液量使得球囊膨胀程度能够适应患者实际瓣叶的反流情况。如图6m和6n所示，所述连接件220的远端延伸出多根杆线绕接在所述固定件211的近端部分上，所述助闭件230的远端延伸出多根杆线绕接在所述连接件220的近端部分上，在其中一些实施方式中，所述杆线从所述助闭件230处一直延伸至所述固定件211上。在其中一些实施方式中，所述助闭件230为柱状，其横截面为椭圆形以使得所述助闭件230能够最大化地贴合患者自身瓣叶2401、2402。为了减轻所述助闭件230的重量，所述助闭件230里面填充有轻质材料，如膨体聚四氟乙烯等，外面再包裹比较致密的高分子材料，防止组织生长覆盖助闭件230而使之与瓣叶粘连。如图6o和6p所示，所述连接件220为高分子片，所述连接件220上设置有孔2204，所述孔2204为血液流过的通道，这样设计有利于提高所述连接件220的柔性并防止粘连。所述助闭件230为单片与双片的组合，所述单片的近端与所述双片的远端固定连接，这同样是为了使助闭件230更好地与自身瓣叶贴合，增加贴合面积，改善阻止瓣膜反流的效果。
如图7a所示，作为一种实施方式，所述助闭件230上设置有调整装置232，所述调整装置232为金属丝，所述金属丝的一端连接在所述助闭件230上，所述金属丝的另一端连接在心室或者心尖上，这样设计的好处在于，在影像辅助下，医生可以在术中通过调整所述金属丝来控制和调整阻止瓣叶反流的效果，使瓣膜反流达到最小值时(即阻止反流的效果最佳时)再将所述金属丝的另一端固定在心室壁或者心尖上，同时在瓣叶运动过程中能够防止所述助闭件230翻上心房。作为另一种实施方式，如图7b所示，所述助闭件230的近端设置有展开装置233，所述展开装置233由金属丝或高分子线制成，防止所述片状的助闭件230起皱。所述展开装置233从所述助闭件230的远端向近端延伸，所述展开装置233自身的刚度使得所述助闭件230在血流冲击下不易起皱。作为另一种实施方式，如图7c所示，所述展开装置233为杆件或者为金属记忆材料丝绕制而 成的波浪形结构或锯齿形结构，防止所述助闭件230起皱。在另一种实施方式中，所述展开装置被设置在筒状或袋状助闭件230的近端，防止所述助闭件230被压缩导致尺寸缩小。
具体实施例三：
如图8a和图8b所示，一种用于阻止瓣膜反流的假体300，包括固定单元310、连接件320和助闭件330，所述固定单元310包括固定件311和至少两个锚定件312，所述连接件320的远端部分与所述固定件310的近端部分相连，所述连接件320的近端部分与所述助闭件330的远端部分相连，所述连接件320为柔性，使得所述连接件320以及与之相连的所述助闭件330能够随着瓣叶的运动而运动，在所述助闭件330和所述固定件311之间具有供血液流过的通道，所述固定件311为高分子片或者所述固定件311具有骨架结构，所述固定件311通过所述锚定件312被固定在患者心房壁上或者瓣环上，所述固定件311展开的宽度小于瓣膜组织环周长的三分之二，所述助闭件330在自由状态时部分或者全部位于患者自体瓣叶之间，所述助闭件330的最大宽度小于单个所述自体瓣叶展开的最大宽度，所述锚定件312的最远端为尖锐状，所述锚定件312的远端部分被预定形，所述锚定件312的近端设置有防脱端3120。在一种实施方式中，所述用于阻止瓣膜反流的假体300用于治疗三尖瓣脱垂。如图8a所示，所述的骨架结构由多根支撑杆和金属记忆材料丝绕制而成的波浪形结构组成，所述骨架结构两侧的所述支撑杆被覆膜形成两片覆膜区3118、3119，所述覆膜区3118、3119之间通过波浪形的金属记忆材料丝连接，两个锚定件312分别位于每片覆膜区3118、3119上。这种设计尤其适合患者出现多处不同位置的瓣叶脱垂的情况，只需要调整所述锚定件312之间的距离，就能够使所述的助闭件330位于不同的目标位置，省去再次置入器械的时间，又区别于传统的较大面积的阻返片，防止压迫自身正常的瓣叶关闭，增强阻止瓣膜反流的作用。如图8c和图8d所示，手术操作者判断好最合适的阻反流的位置后，再进行锚定定位，释放锚定件312，实现所述固定件311与自体组织之间的固定，真正实现了在准确治疗病变的同时，保留了剩余心脏瓣膜的正常生理功能，减少了对正常运作的心脏瓣膜的干涉，实现位置可调、定位准确、牢固锚定和病变适应性，而且能够适应于不同的患者的瓣环尺寸，适用范围广。
在多种实施方式中，如图9a-9h所示，所述锚定件312与所述固定件311连接。这样设计的好处在于，当需要释放所述锚定件312将所述固定件311固定在自体组织的时候，不需要考虑所述锚定件312与所述固定件311之间的对位问题，保证对位和锚定的准确，简化手术流程，节省手术时间。如图9a所示，所述固定件具有环形的骨架结构 (图中未可见)，所述锚定件312与所述环状骨架结构固定连接，所述连接件320的远端部分与所述环状骨架结构连接，所述连接件320的近端部分与所述助闭件330的远端部分连接。如图9b所示，所述固定件311具有骨架结构，所述骨架结构为网格状支架，所述骨架结构被覆膜3113，所述锚定件312与所述膜3113连接。所述助闭件330为单片与球囊的组合，所述球囊表面为疏孔材料，里面含有吸水膨胀材料，其在血液中膨胀后能与患者瓣叶贴合。如图9c所示，所述固定件311为高分子片，所述锚定件312与所述高分子片连接，所述助闭件330上连接有多根高分子线3302，所述高分子线3302的一端连接在所述助闭件330上，另一端连接在心室或者心尖上，医生通过调整所述高分子线3302使得所述助闭件330不影响瓣叶正常关闭和防止反流。如图9d所示，所述用于阻止瓣膜反流的假体300包括两片助闭件330，并分别设置有高分子线3302，以便起到调整和防翻作用。如图9e和图9f所示，所述连接件320为两根丝，所述连接件320的远端连接在所述固定件311上，所述固定件311为金属丝绕制的环，所述固定件311与所述连接件320的远端成为一体结构并同时位于所述锚定件312的所述防脱端3120内。所述助闭件330为单片与筒状的组合。如图9g所示，所述锚定件312通过两个线3116、3117与所述固定件311连接，所述固定件311为高分子片，所述连接件320为条状，所述连接件320的两侧为血液流过的通道。所述助闭件330为单片与柱状的组合。如图9h所示，所述助闭件330为单片与袋状的组合，所述袋状件3302远端及两侧封口，近端开口。当血流从心室流向心房时，所述袋状件3302鼓起，增加与自体瓣叶的贴合面积；当血流从心房流向心室时，所述袋状件3302闭合，不影响血液流通。所述固定件311为高分子片，所述固定件311通过所述连接件320与所述助闭件330连接，所述连接件320为三根曲线状的杆。
作为一种实施方式，如图10a所示，所述锚定件312的最远端为尖锐状，如图10b-10d所示，所述锚定件312的远端部分被预定形为以下形状中的一种或者多种的组合：螺旋形、圆周形、弧形、弧线与直线的组合形、分叉双钩形、3D弯曲形、多段弯曲形。所述锚定件312的近端设置有防脱端3120，所述锚定件312的远端部分还设置有倒钩3121，用以在刺入患者自体组织后加强锚定效果。如图10e所示，所述锚定件312的远端部分具有两个分叉3122、3123，加强锚定效果。如图10f所示，所述锚定件312的远端部分具有三个分叉3122、3123、3124，加强锚定效果。
最后应当说明的是，以上所述仅为本发明的较佳的实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (17)

  1. 一种用于阻止瓣膜反流的假体，其特征在于，包括固定单元、连接件和助闭件，所述固定单元包括固定件和锚定件，所述连接件的远端部分与所述固定件的近端部分相连，所述连接件的近端部分与所述助闭件的远端部分相连，所述连接件为柔性，使得所述连接件以及与之相连的所述助闭件能够随着瓣叶的运动而运动，所述固定件通过所述锚定件被固定在患者心房壁上或者瓣环上，所述固定件展开的宽度小于瓣膜组织环周长的三分之二，所述助闭件在自由状态时位于患者自体瓣叶之间，所述助闭件的最大宽度小于单个所述自体瓣叶展开的最大宽度，所述锚定件的近端设置有防脱端。
  2. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述助闭件的长度与所述连接件的长度之和大于所述自体瓣叶展开的高度，所述助闭件为单片、多片、筒状、柱状或球囊，或者所述助闭件为单片与多片的组合，或者所述助闭件为单片与筒状的组合，或者所述助闭件为单片与柱状的组合，或者所述助闭件为单片与球囊的组合。
  3. 根据权利要求2所述的用于阻止瓣膜反流的假体，其特征在于，所述助闭件为网格结构，或者所述助闭片为高分子材料片或动物源性材料片，当所述助闭片为高分子材料片或动物源性材料片时，在所述的助闭片上设置有孔。
  4. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述锚定件与所述固定件连接。
  5. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述固定件和所述连接件为一体结构。
  6. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，在所述助闭件和所述固定件之间具有供血液流过的通道。
  7. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述连接件为片状、条状或丝状，或者所述连接件为上述结构的组合。
  8. 根据权利要求6或7所述的用于阻止瓣膜反流的假体，其特征在于，所述连接件被部分覆膜，所述连接件没有被覆膜的部分为血液流过的通道。
  9. 根据权利要求6或7所述的用于阻止瓣膜反流的假体，其特征在于，所述连接件被全部覆膜，在所述膜上设置有孔，所述孔为血液流过的通道。
  10. 根据权利要求6或7所述的用于阻止瓣膜反流的假体，其特征在于，当所述连接件为单根的所述条状或者所述丝状的结构时，所述连接件的两侧为血液流过的通道。
  11. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述固定件为 柔韧性的高分子片，或者为高分子网布。
  12. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述固定件具有骨架结构，所述骨架结构由多根支撑杆组成，或者所述骨架结构为金属记忆材料丝绕制而成的波浪形结构或锯齿形结构，或者所述骨架结构为网格状支架，或者所述骨架结构为上述结构的组合。
  13. 根据权利要求12所述的用于阻止瓣膜反流的假体，其特征在于，在自由状态下，所述骨架结构的远端部分沿所述瓣环的周向为弧形结构。
  14. 根据权利要求12所述的用于阻止瓣膜反流的假体，其特征在于，所述骨架结构被覆膜，所述膜采用烧结、焊接、胶合或缝绑的方式与所述骨架结构连接，所述膜材料包括聚四氟乙烯、聚乙烯、聚丙烯、涤纶或动物源性材料。
  15. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，在所述助闭件上设置有调整装置，所述调整装置为金属丝或高分子线，所述金属丝或所述高分子线的一端连接在所述助闭件上，所述金属丝或所述高分子线的另一端连接在心室或者心尖上。
  16. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述助闭件的近端设置有展开装置，所述的展开装置由金属丝或高分子线制成。
  17. 根据权利要求1所述的用于阻止瓣膜反流的假体，其特征在于，所述锚定件的最远端为尖锐状，所述锚定件的远端部分被预定形，所述锚定件的远端部分被预定形为以下形状中的一种或者多种的组合：螺旋形、圆周形、弧形、弧线与直线的组合形、分叉双钩形、3D弯曲形、多段弯曲形，所述锚定件的远端不带倒刺或者带有一个或者多个倒刺。
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