WO2023246278A1 - 一种人工心脏瓣膜 - Google Patents

一种人工心脏瓣膜 Download PDF

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Publication number
WO2023246278A1
WO2023246278A1 PCT/CN2023/090094 CN2023090094W WO2023246278A1 WO 2023246278 A1 WO2023246278 A1 WO 2023246278A1 CN 2023090094 W CN2023090094 W CN 2023090094W WO 2023246278 A1 WO2023246278 A1 WO 2023246278A1
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WO
WIPO (PCT)
Prior art keywords
valve
section
anchoring
artificial heart
heart valve
Prior art date
Application number
PCT/CN2023/090094
Other languages
English (en)
French (fr)
Inventor
徐亚鹏
曹海涛
刘羽飞
虞奇峰
Original Assignee
上海纽脉医疗科技股份有限公司
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Application filed by 上海纽脉医疗科技股份有限公司 filed Critical 上海纽脉医疗科技股份有限公司
Publication of WO2023246278A1 publication Critical patent/WO2023246278A1/zh

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Classifications

    • 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
    • A61F2/2421—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 non-pivoting rigid closure members
    • 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

Definitions

  • the present invention relates to the field of medical devices for cardiac surgery, and in particular to an artificial heart valve.
  • the heart consists of four pumping chambers, each with a valve that controls its unidirectional outflow.
  • the mitral valve is located between the left atrium and the left ventricle. When the ventricle contracts, the mitral valve tightly closes the atrioventricular orifice to prevent blood from flowing back into the left atrium; the mitral valve is located between the right atrium and the right ventricle.
  • the tricuspid valve (tricuspid valve), when the right ventricle contracts, squeezes the blood in the chamber and impacts the tricuspid valve to close, preventing blood from flowing back into the right atrium.
  • a well-functioning mitral or tricuspid valve ensures correct blood circulation throughout the heart cycle, but mitral regurgitation occurs when the leaflets of the valve are unable to fully contact (couple) due to disease.
  • MR tricuspid regurgitation
  • TR tricuspid regurgitation
  • MR mitral regurgitation MR
  • the incidence of MR is more than 5 times that of patients with aortic stenosis. It is estimated that there are more than 10 million patients with severe MR in my country.
  • surgery is still the gold standard for the treatment of MR, but for many high-risk patients who are elderly and have multiple system diseases, surgery has high risks and little survival benefit.
  • Only 2% of MR patients in the United States receive surgery, 49% of patients do not receive surgery because the surgical risks are too high, and another 49% of patients do not go to the hospital despite having MR symptoms.
  • the 1-year and 5-year overall mortality rates of patients with severe MR without prompt treatment are 20% and 50%, respectively.
  • Transcatheter mitral valve replacement can benefit high-risk MR patients who have lost the chance of surgery.
  • TMVR valves under development around the world. Due to the complex D-shaped three-dimensional saddle annulus anatomical structure of the mitral valve, there are chordae tendineae and papillary muscles under the valve, which is not easy to anchor the valve. Moreover, due to the large pressure difference at the MR, the implanted valve prosthesis and the original mitral valve Poor fit of the valve annulus and valve leaflets can easily cause paravalvular leakage, which in turn can cause a series of complications and adverse reactions such as hemolysis.
  • TMVR products that have entered the clinical stage and are progressing rapidly include two series: ball-expanded valves and self-expanding valves; the overall system profile of ball-expanded valves is relatively large, and ball-expanded anchoring can easily damage the native valve leaflets and cause paravalvular leakage; self-expanding valves
  • the valve profile value is relatively small, but it is difficult to anchor the native valve leaflets, has a high risk of displacement, requires a long learning curve, and is not easy to operate.
  • the invention discloses an artificial heart valve and aims to solve the technical problems existing in the prior art.
  • An artificial heart valve is provided, the structure of which includes a valve leaflet anchor and a valve stent;
  • the leaflet anchoring member is spiral-shaped and can be coiled outside the chordae tendineae of the mitral valve/tricuspid valve and interacts with the valve stent implanted in the mitral valve/tricuspid valve; the leaflet anchoring member is formed from the proximal
  • the atrial segment, the functional segment and the ventricular segment are sequentially arranged from end to distal; the functional segment includes several turns of coils positioned at the native valve annulus for supporting the implanted artificial heart valve stent;
  • the valve stent includes an inflow section and an outflow section; the outflow section is provided with at least one row of anchoring arms along the circumferential direction.
  • the anchoring arms include a fixed end and an anchoring section. The fixed end is fixed to the outflow section, and the anchoring section moves away from the valve stent from the fixed end.
  • the anchor arm is extended in the direction of insertion, and the anchor arm is attached to the peripheral wall of the valve stent in a compressed state.
  • the anchor arm is tilted toward the radial outside of the valve stent in a released state, passing through the native leaflet and penetrating into the leaflet anchor. Fix the gap between adjacent coils in the functional section.
  • the angle between the anchor arm and the peripheral wall of the outflow section in the released state is ⁇ 1, 30° ⁇ 1 ⁇ 90°.
  • the length of the anchor arm is not less than the cross-sectional diameter of the coil.
  • the anchoring section is roughly I-shaped and radially turned outward;
  • the anchoring section is roughly I-shaped, with the free end of the anchoring section tilted clockwise or counterclockwise and turned radially outward, and the tilting angle is ⁇ 2, 0 ⁇ 2 ⁇ 45°.
  • the bending arc length or the bending section length of the free end of the anchoring segment is greater than the cross-sectional radius of the coil.
  • the anchoring section is also provided with at least one arc-shaped barb; the angle between the arc-shaped barb and the anchoring section is ⁇ 3, 30° ⁇ 3 ⁇ 90°.
  • the arc-shaped barbs are arranged on the inside or outside of the anchoring section.
  • the anchor arms are arranged in 2-7 rows along the axial direction of the outflow section, with 4-24 anchor arms in each row; adjacent anchor arms in each row are spaced or arranged continuously.
  • anchoring arms of adjacent rows penetrate adjacent or spaced coil gaps of the functional segments.
  • the anchor arm is cut integrally with the valve stent; alternatively, the anchor arm is fixed to the valve stent by welding, crimping or riveting.
  • the inflow section has a trumpet-shaped structure
  • the outflow section has a cylindrical shape
  • the small diameter end of the inflow section is connected to the outflow section.
  • the free end of the outflow section is tapered to reduce outflow tract obstruction.
  • the outflow section includes several interconnected diamond grid structures, and the areas on the outflow section where anchor arms are not provided have a higher elastic coefficient than the areas where anchor arms are provided.
  • the atrial segment is configured to extend from the functional segment into the atrium and generally follow the curvature of the atrial wall;
  • the ventricular segment extends the ventricle from the functional segment and is configured in a curve that generally follows the curvature of the native chordee plexus.
  • the distance between adjacent coils in the functional section is equal to 0 to 2 times the thickness of the anchor arm.
  • the diameter of the coil gradually decreases from the proximal end to the distal end in the ventricular segment.
  • the present invention provides an artificial heart valve, whose structure includes a leaflet anchor and a valve stent; the leaflet anchor is implanted through the femoral vein through the interatrial septum, and the native valve leaflets are captured to form a subsequent valve stent.
  • the valve leaflet anchoring member can directly cooperate with the implanted valve stent to prevent the valve stent from being deformed or displaced during the contraction or relaxation process of the native tissue, thereby effectively ensuring the fixed position of the valve stent.
  • the valve stent is equipped with one or several rows of anchor arms at the position where it interacts with the valve leaflet anchors.
  • the anchor arms are in a compressed state when the stent is transported and are attached to the peripheral wall of the valve stent. After the stent is released, the anchoring arm tilts toward the radial outside of the valve stent, penetrates the native valve leaflet and penetrates into the gap between the adjacent coils of the valve leaflet anchoring component, so that the gap between the valve stent and the valve leaflet anchoring component is Tightly combines and generates solid anchoring force to prevent valve displacement during the cardiac phase.
  • a barb is also provided at the free end of the anchoring arm, and the arc length of the barb is greater than the cross-sectional radius of the coil constituting the leaflet anchoring member, so that the anchoring Once the arm penetrates into the gap between the adjacent coils of the valve leaflet anchoring member, the valve stent cannot be easily separated from the valve leaflet anchoring member. Even if the heart occurs or is subjected to substantial tremors, or the valve undergoes organic disease again, this application The artificial heart valve can still function normally.
  • the inflow section of the valve stent has a trumpet-shaped structure, and a sealing membrane is sutured on the outside, which can effectively prevent paravalvular leakage and reduce surgical risks.
  • Figure 1 is a schematic structural diagram of an artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present invention
  • Figure 2 is a schematic structural diagram of a leaflet anchoring member in a preferred embodiment disclosed in Embodiment 1 of the present invention
  • Figure 3 is a bottom view of the leaflet anchoring member in a preferred embodiment disclosed in Embodiment 1 of the present invention
  • Figure 4 is a schematic structural diagram of a valve stent in a preferred embodiment disclosed in Embodiment 1 of the present invention
  • Figure 5 is a schematic structural diagram of a valve stent in a preferred embodiment disclosed in Embodiment 1 of the present invention.
  • Figure 6 is a view of the cooperation state between the valve stent and the valve leaflet anchoring member in Figure 5;
  • Figure 7 is a schematic structural diagram of a valve stent in a preferred embodiment disclosed in Embodiment 1 of the present invention.
  • Figure 8 is a view of the cooperation state between the valve stent and the valve leaflet anchoring member in Figure 7;
  • Figure 9 is a schematic structural diagram of a valve stent in a preferred embodiment disclosed in Embodiment 1 of the present invention.
  • Figure 10 is a view of the cooperation state between the valve stent and the valve leaflet anchoring member in Figure 9;
  • Figure 11a is a schematic structural diagram of a J-shaped anchor arm in a preferred embodiment disclosed in Embodiment 1 of the present invention.
  • Figure 11b is a schematic structural diagram of an L-shaped anchor arm in a preferred embodiment disclosed in Embodiment 1 of the present invention.
  • Figure 12 is a diagram of the use status of the artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present invention.
  • Figure 13 is a schematic structural diagram of a valve stent in a preferred embodiment disclosed in Embodiment 2 of the present invention.
  • Figure 14 is a view of the cooperation state between the valve stent and the valve leaflet anchoring member in Figure 13;
  • Figure 15a is a schematic structural diagram of an anchor arm in a preferred embodiment disclosed in Embodiment 2 of the present invention.
  • Figure 15b is a schematic structural diagram of the anchor arm in a preferred embodiment disclosed in Embodiment 2 of the present invention.
  • Figure 16 is a schematic structural diagram of a valve stent in a preferred embodiment disclosed in Embodiment 2 of the present invention.
  • Figure 17 is a view of the cooperation state of the valve stent and the valve leaflet anchoring member in Figure 16;
  • Figure 18a is a schematic structural diagram of an anchor arm in a preferred embodiment disclosed in Embodiment 2 of the present invention.
  • Figure 18b is a schematic structural diagram of the anchor arm in a preferred embodiment disclosed in Embodiment 2 of the present invention.
  • Figure 19 is a schematic structural diagram of a valve stent in a preferred embodiment disclosed in Embodiment 3 of the present invention.
  • Figure 20 is a schematic structural diagram of a valve stent in another preferred embodiment disclosed in Embodiment 3 of the present invention.
  • Figure 21 is a diagram of the mating state of the valve leaflet anchoring members of the valve stent in a preferred embodiment disclosed in Embodiment 3 of the present invention.
  • Valve stent 100 inflow section 110, outflow section 120, diamond grid 121, wave rod 122, node 123, anchoring arm 130, anchoring section 131, free end 132, arc-shaped barb 140;
  • Leaflet anchor 200 atrial segment 210, functional segment 220, ventricular segment 230; Left atrium 300; left ventricle 400.
  • connection should be understood in a broad sense.
  • connection or integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two components.
  • connection or integral connection
  • connection or integral connection
  • connection can be a mechanical connection or an electrical connection
  • it can be a direct connection or an indirect connection through an intermediate medium
  • it can be an internal connection between two components.
  • first, “second”, etc. are only used to differentiate the description and cannot be understood as indicating or implying relative importance.
  • the main structure includes a leaflet anchor 200 and a valve stent 100; wherein, the leaflet anchor 200 is spiral-shaped and can be coiled. Outside the mitral valve/tricuspid valve chordae tendineae, and interacts with the valve stent 100 implanted in the mitral valve/tricuspid valve; the valve leaflet anchoring members 200 are arranged as atrial segments in sequence from the proximal end to the distal end. 210.
  • the anchoring arm 130 includes a fixed end and an anchoring section 132. The fixed end is fixed to the outflow section 120. The anchoring section 132 is inserted from the fixed end away from the valve stent 100.
  • the anchor arm 130 is extended in the direction, and the anchor arm 130 is attached to the peripheral wall of the valve stent 100 in a compressed state.
  • the anchor arm 130 is tilted toward the radial outside of the valve stent 100 in a released state, passing out of the native valve leaflets and penetrating into the valve leaflets.
  • the anchor 200 is in the gap between adjacent coils of the functional section 220 .
  • the artificial heart valve provided in this embodiment can be used in the mitral valve or the tricuspid valve.
  • this embodiment 1 provides an artificial heart valve to solve the existing problems.
  • Technical problems in technology are known in the art.
  • the above-mentioned artificial heart valve includes a valve stent 100 and a leaflet anchoring member 200.
  • the valve stent 100 includes an inflow section 110 and an outflow section 120; preferably, valve leaflets are also sewn inside the valve stent 100.
  • a sealing membrane is sutured on the outer wall of the inflow section 110 to prevent paravalvular leakage.
  • the above-mentioned valve leaflet anchoring member 200 is generally spiral-shaped and can be implanted in the chordae tendineae of the human mitral valve, and provides axial and radial forces to cooperate with the valve stent 100 implanted in the mitral valve and with it.
  • the leaflet anchoring member 200 can anchor the position of the valve stent 100 more tightly, effectively preventing the valve stent 100 from being in the myocardium. Displacement occurs during movement.
  • valve leaflet anchor 200 is provided with an atrial segment 210, a functional segment 220 and a ventricular segment 230 in sequence from the proximal end to the distal end, wherein: the functional segment 220 is coiled.
  • the ventricular segment 230 extends downwardly from the functional segment 220 to and joins the left ventricle 400 and is configured to generally follow The curvature of the native mitral valve chordae tendineae plexus; preferably, the functional segment 220 and the ventricular segment 230 are configured as 1.5-5.5 turns of coils, and the distance between adjacent turns of the coils is 0.2-2.0 mm; the atrial segment 210 is configured as The functional segment 220 spirals upward through the leaflet space, extends to the left atrium 300 and is curved and coiled in the left atrium 300, and its curvature is approximately the same as the curvature of the atrial wall to ensure that the atrial segment 210 can be closer to the left atrium 300.
  • the atrial segment 210 is configured as a coil of 0.5-2.5 turns, and the distance between coils of adjacent turns is 0-2.0 mm.
  • the diameter d of the coil constituting the leaflet anchor 200 is 0.2-2 mm.
  • the diameter of the coil is designed to be variable in the ventricular segment 230 (at the tip) to reduce damage to the myocardium and valve leaflets during valve leaflet harvesting and improve the success rate of valve leaflet harvesting; preferably, the diameter is variable.
  • the diameter length is 10-100mm, specifically the diameter gradually decreases from the proximal end to the distal end, and the most distal diameter ranges from 0.1-1.0mm.
  • the shape and size of the atria/valves/ventriculars will be different.
  • the specific bending curvature, size and number of coil turns of each section of the valve leaf anchor 200 It can be changed adaptively according to the patient's condition.
  • the atrial segment 210 is used to provide a radially outward expansion force to ensure that the segment can be stably positioned.
  • the functional segment 220 and the ventricular segment 230 provide a radially inward tightening force to anchor the valve stent 100 positioned in the mitral valve to simultaneously fix the valve stent 100 and itself, while The mitral valve can also be tightened to reduce mitral regurgitation.
  • the substantially spiral leaflet anchor 200 can also provide axial deformation capability to comply with the morphological changes of the myocardial tissue throughout the cardiac cycle, and is also more convenient during surgical insertion.
  • the mitral valve annulus is the narrowest, and the chordae tendineae under the mitral valve gradually expand, so in a preferred embodiment, in multiple areas of the valve leaflet anchoring member 200 Among the segments, the diameter d1 of the functional segment 220 is smaller than the diameter d2 of the ventricular segment 230, and the diameter d2 of the ventricular segment 230 is smaller than the diameter d3 of the atrial segment 210, in order to obtain the best fixation position.
  • the diameter d1 of the functional segment 220 is 15-40 mm
  • the diameter d2 of the ventricular segment 230 is 20-50 mm
  • the diameter d3 of the atrial segment 210 is 30-70 mm.
  • the height L1 of the atrial segment 210 is 10-20 mm, and the total height L2 of the leaflet anchor 200 is 15-30 mm.
  • a more appropriate size and proportion can be selected according to the actual situation.
  • the coils that make up the leaflet anchor 200 include a core and a wrapping layer from the inside to the outside; the core is spirally coiled from preformed memory metal, preferably nickel-titanium alloy, which can at least Elastic deformation occurs in the radial and axial directions to adapt to changes in the shape of the myocardial tissue; the wrapping layer is used to provide friction for the leaflet anchoring member 200.
  • the material of the wrapping layer can be selected from a braided material with larger pores and a Polymer materials with high friction coefficient or polymer materials with patterned hollows.
  • the valve stent 100 is a self-expanding stent.
  • the self-expanding stent has a smaller profile value (the profile value is the cross-sectional diameter in the pressed state). , thereby improving the ability of the valve stent 100 to pass through the diseased area.
  • the valve stent 100 is made of metal or polymer materials, such as nickel-titanium alloy memory materials or other memory polymer materials or alloys. In this embodiment, by processing nickel-titanium alloy memory materials, etc. Processing to form several interconnected rhombus grid 121 structures; optionally, the above processing methods include but are not limited to weaving, laser cutting, welding, rivet connection, threaded connection, etc.
  • the outflow section 120 is located downstream of the inflow section 110.
  • the inflow section 110 corresponds to the part where the blood flows into the valve stent 100 after the artificial heart valve is implanted.
  • the outflow section 120 corresponds to the part where the blood flows out of the valve stent 100 after the artificial heart valve is implanted. part; preferably, the inflow section 110 is positioned at the annulus of the native mitral valve and has a roughly trumpet-shaped structure, and the outflow section 120 is positioned at the connection transition area between the leaflets and the chordae tendineae of the native mitral valve and has a cylindrical structure.
  • the inflow segment 110 has a higher elastic coefficient than the outflow segment 120 and can elastically deform at least in the radial and axial directions after being implanted in the mitral valve to conform to the native mitral valve annulus. Changes in form.
  • the outflow section 120 of the valve stent 100 includes several interconnected polygonal mesh structures, and adjacent mesh structures are connected through wave rods 122 or nodes 123 with certain elasticity, wherein the polygonal mesh can be a rhombus mesh.
  • the grid 121 or the hexagonal grid, preferably the rhombus grid 121 has a V-shaped structure at the upper and lower diagonal corners of the rhombus grid 121; preferably, the rhombus grid 121 of the outflow section 120 has a V-shaped structure in the axial and circumferential directions.
  • the number of circumferential rhombus grids 121 of the valve stent 100 is 8 —24, the number of V-shaped structures is 3-8.
  • At least one row of anchor arms 130 is provided along the circumferential direction between some adjacent rhombus grids 121 of the outflow section 120.
  • the anchor arms 130 are attached to the outer periphery of the valve stent 100 in a compressed state.
  • the wall, in the released state, is tilted toward the radial outside of the valve stent 100, passing through the native leaflets and penetrating into the gap between the adjacent coils of the leaflet anchoring member 200, so that the valve stent 100 and the leaflet anchoring member 200 They are tightly combined and generate a stable anchoring force to prevent the valve from displacement during the cardiac period.
  • the area where the anchor arm 130 is not provided in the outflow section 120 has a higher elastic coefficient than the area where the anchor arm 130 is provided, so that the area where the anchor arm 130 is not provided has a certain degree of flexibility to conform to the shape of the myocardium.
  • the region where the anchor arm 130 is disposed has sufficient stiffness to securely anchor with the leaflet anchor 200 .
  • the rhombus mesh 121 without the anchor arm 130 has a small axial diagonal angle ⁇ 4, preferably 30° ⁇ 4 ⁇ 70°; while the rhombus mesh with the anchor arm 130 Grid 121 has a larger axial diagonal angle ⁇ 5, preferably 70° ⁇ 5 ⁇ 90°.
  • the anchor arm 130 can be made of memory alloy, polymer, fiber or other polymer materials, and is fixed to the valve stent 100 by welding, crimping or riveting; in a more preferred embodiment, the anchor arm 130 It is made of the same material as the valve stent 100, that is, nickel-titanium alloy, and the two are cut and formed in one piece; those skilled in the art should understand that since nickel-titanium alloy has a stretch rate of more than 20%, it has high damping, high elasticity and high The fatigue life can ensure that the contracted state is maintained during delivery to the human body, and after the valve stent 100 is released, it expands and penetrates into the gap between adjacent coils of the leaflet anchor 200, and then maintains a stable shape; more importantly, As a biocompatible material, nickel-titanium alloy is safer, has wear-resistant and corrosion-resistant properties, and will not produce rejection reactions.
  • the anchoring arm 130 includes a fixed end and an anchoring section 132.
  • the fixed end is fixed to the outflow section 120 of the valve stent 100, and is preferably arranged outside the wave rod 122 or node 123 between adjacent rhombus grids 121; the anchoring section 132 It extends from the fixed end to the direction away from the insertion of the valve stent 100 and is tilted; the anchoring section 132 also has a free end 132.
  • the free end 132 has a blunt structure, such as approximately a fan shape or an arc shape.
  • the anchoring arm 130 pierces the native valve annulus through the pressure of the expansion of the valve stent 100 when it expands, the blunt structure can avoid the exposed part of the native valve leaflet after it penetrates to a certain extent. Damage other myocardial tissue; in another preferred embodiment, the anchoring segment 132 It is a variable diameter design, and the diameter becomes smaller as it approaches the free end 132. On the one hand, it can further enhance the puncture ability of the anchor arm 130 on the native leaflets, and on the other hand, it can improve the deformation ability of the free end 132, allowing it to penetrate smoothly. Coil gap.
  • the angle between the anchor arm 130 and the peripheral wall of the outflow section 120 in the released state is ⁇ 1, 30° ⁇ 1 ⁇ 60°, to ensure that the anchor arm 130 can smoothly penetrate into the valve leaflet after the valve stent 100 is released.
  • the functional section 220 of the anchor 200 is between adjacent coils and is clamped by the adjacent coils. At the same time, the exposed part after passing through the coils can extend obliquely upward to avoid large-scale impact on other surrounding tissue structures.
  • the anchoring arm 130 has a flat structure and is roughly I-shaped and radially turned outward; preferably, the thickness of the anchoring arm 130 is not less than that of the leaflet anchor.
  • the gap between the adjacent coils of the functional section 220 of the component 200 is to ensure that the anchoring arm 130 forms a stable interference connection with the coil after passing through the coil gap, thereby increasing the friction between the two and preventing the leaflet anchoring component 200 is separated from the anchor arm 130; in another preferred embodiment, the gap between adjacent coils of the functional section 220 of the leaflet anchor 200 is 0 to 2 times the thickness of the anchor arm 130, which can make the anchor
  • the fixed arm 130 can more easily pass through the gap of the coil, and at the same time, it can ensure a certain degree of relative movement between the valve leaflet anchor 200 and the valve stent 100 to prevent the two from being too tight and causing the native valve leaflets to tear during the cardiac cycle.
  • the length of the anchor arm 130 is not less than
  • the anchoring arm 130 is a flat structure, roughly I-shaped, tilted clockwise or counterclockwise from the free end 132 and tilted radially outward.
  • the inclined structure can further increase the contact area between the anchor arm 130 and the coil, thereby further increasing the friction and ensuring the tightness of the combination between the two.
  • the inclination directions of the anchoring arms 130 arranged in the same row are consistent, but the inclination angles may be different, in order to provide more angles/larger radiation range friction with the leaflet anchors 200, making the combination of the two more efficient. Stablize.
  • the inclination directions of the anchor arms 130 arranged in the same row are consistent, and the inclination directions of the anchor arms 130 arranged in different rows may be inconsistent, so as to prevent the valve leaf anchor 200 from following the inclination trend of a certain row and the valve stent 100 Detachment occurs.
  • the anchoring arm 130 is a flat structure with a certain curvature, and is roughly J-shaped and radially tilted outwards.
  • the anchoring section 132 is still a flat straight structure or a relatively straight arc structure, and the free end 132 is in an arc shape bent toward the inflow section 110 or the outflow section 120; preferably, the bending arc length of the free end 132 is greater than the cross-sectional radius of the coil,
  • the anchoring arm 130 passes through the coil gap, its arcuate free end 132 can fit against the outer wall of the coil. On the one hand, it can prevent the leaflet anchor 200 from being separated from the anchoring arm 130. On the other hand, it can prevent the anchor from being separated.
  • the free end 132 of the fixed arm 130 extends outward to damage other myocardial tissues.
  • the anchoring arm 130 is roughly L-shaped, in which the free end 132 of the anchoring section 132 is in a straight shape that is bent toward the inflow section 110 or the outflow section 120.
  • the angle of the bend is ⁇ 7, ⁇ 7>90°, and more preferably, ⁇ 7 ⁇ 135° to avoid the bending angle being too small to penetrate the native valve annulus; after the anchoring arm 130 passes through the native valve leaflet, the bending part can fit the outer wall of the coil,
  • the inner side of the bend can be set to a smooth transition instead of a hard transition in the inner angular shape, which can not only better fit the coil, but also provide a certain deformation performance; while the outer side of the bend can be set in an outer angular shape. Hard transition rather than smooth transition in order to obtain better puncture performance.
  • the anchor arms 130 are arranged in 2-7 rows along the axial direction of the outflow section 120, with 4-24 anchor arms 130 in each row; adjacent anchor arms 130 in each row are spaced or continuously arranged in an annular shape.
  • the design of multiple rows of anchoring arms 130 can also increase the contact area between the valve leaflet anchors 200 and the valve stent 100, thereby increasing friction.
  • multiple leaflets are sewn on the frame of the valve stent 100, and the leaflets are preferably porcine pericardial or bovine pericardial leaflets; preferably, the sealing membrane sewn on the outer wall of the inflow section 110 is made of biocompatible fabric.
  • the biocompatible fabric is preferably but not limited to any one or a combination of at least two of PET, PTFE, e-PTFE or PU.
  • the valve stent 100 also has multiple development points. After the artificial heart valve is implanted in the human body, usually the doctor needs to determine whether the implantation position is accurate through the imaging point set on the implanted valve stent 100. Moreover, since the heart valve is a three-dimensional structure, it usually needs to determine whether the implantation position is accurate. Whether its spatial position is accurate, it is necessary to judge whether its spatial position is accurate through the positions of multiple development points.
  • the above artificial heart valve is used as follows:
  • the arc-shaped barb 140 is provided on the inside of the anchoring section 132; in a preferred embodiment, the arc-shaped barb 140 is provided on the free end 132 on the inside of the anchoring section 132; in another preferred embodiment, the arc-shaped barb 140 is disposed at any position inside the anchoring section 132.
  • the anchor arm 130 and the arc-shaped barb 140 are released, the arc-shaped barb 140 can fit the upper coil. , and clamp the coil between them together with the anchor arm 130 of the previous row.
  • multiple arc-shaped barbs 140 can also be provided inside the anchoring section 132 to further increase the stability of the combination with the upper row of coils.
  • the arc-shaped barb 140 is provided on the outside of the anchoring section 132; in a preferred embodiment, the arc-shaped barb 140 is provided on the free end 132 on the outside of the anchoring section 132; in another preferred embodiment, the arc-shaped barb 140 is disposed at any position outside the anchoring section 132.
  • the anchor arm 130 and the arc-shaped barb 140 are released, the arc-shaped barb 140 can block the coil below from moving upward. The movement occurs to disengage, and together with the anchor arm 130 of the next row, the coil between them is clamped.
  • multiple arc-shaped barbs 140 can also be provided on the outside of the anchoring section 132 to further increase the stability of the combination with the lower row of coils.
  • At least one arc-shaped barb 140 is provided on both the inner and outer sides of the anchoring section 132.
  • the inner arc-shaped barb 140 can jointly clamp the coil between the anchor arms 130 of the previous row, and the outer arc-shaped barb 140 can clamp the coil between them.
  • the arc-shaped barbs 140 can jointly clamp the coils between the anchor arms 130 of the next row.
  • the bending arc length or bending section length of the free end 132 of the anchoring arm 130 is greater than the cross-sectional radius of the coil.
  • the anchoring arm 130 passes through the coil gap, its free end 132 can fit the coil above it.
  • the coils below are kept at a certain distance to provide a certain buffer space to avoid tearing the leaflets, making the cooperation between the mitral valve leaflets and the artificial heart valve safer and more stable.
  • the angle between the arc-shaped barb 140 and the anchoring section 132 after release is ⁇ 3, 30° ⁇ 3 ⁇ 90°, to ensure that the arc-shaped barb 140 can block the coil above or below it. , when the upper or lower coil is displaced in the vertical direction, it can be caught by the arc-shaped barb 140 to prevent falling off.
  • the anchor arms 130 can be provided in only one row, and the adjacent anchor arms 130 in the row are spaced or continuously arranged in an annular shape, and the number is set to 4-24; those skilled in the art will understand that,
  • the free end 132 of the anchoring arm 130 is also provided with barbs, it is possible to ensure that it is difficult to separate the leaflet anchoring member 200 from the valve stent 100 when only one row is provided, ensuring that the two The stability of the cooperation between them.
  • an artificial heart valve is provided, the structure of which includes a valve stent 100 and a valve leaflet anchor 200; in this embodiment, the valve stent 100 is anchored
  • the structure of the arm 130 is the same as that of the above-mentioned Embodiment 1 or Embodiment 2, and will not be described again here.
  • anchor arms 130 are provided on the outflow section 120 of the valve stent 100.
  • the anchor arms 130 are spaced outside the wave rods 122 or nodes 123 between adjacent rhombus grids 121. , is no longer limited to an annular arrangement, but a hashed arrangement, which can achieve three-dimensional fixation of the valve stent 100 to the leaflet anchoring member 200 in multiple directions to ensure the stability of the cooperation between the two.
  • the anchor arms 130 that are roughly in a row can be partially arranged outside the corrugated rods 122 between the rhombus grids 121, and partially arranged outside the nodes 123, as shown in Figures 20-21; or they can all be arranged outside the corrugated rods 122. Or they are all arranged outside node 123, as shown in Figure 19.
  • the anchoring arms 130 arranged at different positions may have the same shape, size, inclination angle, presence or absence of barbs, and other settings, or they may be different.

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Abstract

本发明涉及一种人工心脏瓣膜，其结构包括瓣叶锚定件及瓣膜支架；瓣叶锚定件呈螺旋状，能够与被植入二尖瓣/三尖瓣内的瓣膜支架互相作用；瓣叶锚定件包括功能段；功能段包括定位于原生瓣环处的数匝线圈，用于支撑植入的人工心脏瓣膜支架；瓣膜支架包括流入段和流出段；流出段沿周向设有至少一排锚定臂，锚定臂在压缩状态下贴附于瓣膜支架的外周壁，锚定臂在释放状态下朝瓣膜支架径向的外侧翻翘，穿出原生瓣叶并穿入瓣叶锚定件在功能段的相邻线圈的间隙，使得瓣膜支架与瓣叶锚定件之间紧密结合并产生稳固的锚定力，防止瓣膜支架在心动期内发生位移。

Description

一种人工心脏瓣膜 技术领域
本发明涉及心脏术用医疗器械领域，尤其涉及一种人工心脏瓣膜。
背景技术
心脏包括四个泵腔，每个泵腔都具有控制其单向流出的瓣膜。其中位于左心房和左心室之间的是二尖瓣(mitral valve)，心室收缩时，二尖瓣即严密关闭房室口，防止血液逆流入左心房；位于右心房和右心室之间的是三尖瓣(tr icuspid valve)，当右心室收缩时，挤压室内血液冲击三尖瓣使其关闭，防止血液倒流入右心房。功能完善的二尖瓣或三尖瓣能够保证在心脏周期中保持正确的血液循环，但是在瓣膜的叶瓣因为疾病而无法达到完全接触(接合)的时候，就会发生二尖瓣反流(MR)或三尖瓣反流(TR)。
以二尖瓣反流MR为例，根据美国等西方发达国家的流行病学调查数据显示，大于65岁以上的老年人群发病率占首位的瓣膜病类型是MR。MR发病率是主动脉瓣狭窄患者的5倍以上。据估测，我国重度MR患者超过1000万。目前，外科手术仍是治疗MR的金标准，但对于很多高龄合并多系统疾病的高危患者，手术风险高，生存获益少。在美国仅有2％的MR患者接受外科手术，49％的患者因手术风险过高而未接受外科手术，另有49％的患者虽存在MR症状但未到医院就诊。严重MR患者未进行及时治疗1年和5年的总死亡率分别为20％和50％。
经导管二尖瓣置换(Transcatheter mitral valve replacement，TMVR)可以使失去手术机会的高危MR患者获益，目前全球有多款TMVR的瓣膜正在研发中。二尖瓣由于复杂的D形三维马鞍瓣环解剖结构，瓣下有腱索与乳头肌，不易于瓣膜的锚定，而且由于MR处压差较大，植入瓣膜假体与二尖瓣原始瓣环、瓣叶贴合不好极易造成瓣周漏，继而会引起溶血等一系列并发症与不良反应。目前进入到临床阶段进展较快的TMVR产品有球扩瓣以及自膨瓣两大系列；球扩瓣的整体系统profile值较大，球扩锚定易损伤原生瓣叶导致瓣周漏；自膨瓣profile值相对较小，但是其锚定原生瓣叶困难，位移风险高，需要较长的学习曲线，不易于操作。
发明内容
本发明公开了一种人工心脏瓣膜，旨在解决现有技术中存在的技术问题。
本发明采用下述技术方案：
提供一种人工心脏瓣膜，其结构包括瓣叶锚定件及瓣膜支架；
瓣叶锚定件呈螺旋状，能够盘绕于二尖瓣/三尖瓣腱索丛外，并与被植入二尖瓣/三尖瓣内的瓣膜支架互相作用；瓣叶锚定件由近端至远端依次设置为心房段、功能段及心室段；功能段包括定位于原生瓣环处的数匝线圈，用于支撑植入的人工心脏瓣膜支架；
瓣膜支架包括流入段和流出段；流出段沿周向设有至少一排锚定臂，锚定臂包括固定端与锚定段，固定端固接于流出段，锚定段由固定端向背离瓣膜支架置入的方向延伸，锚定臂在压缩状态下贴附于瓣膜支架的外周壁，锚定臂在释放状态下朝瓣膜支架径向的外侧翻翘，穿出原生瓣叶并穿入瓣叶锚定件在功能段的相邻线圈的间隙。
作为优选的技术方案，锚定臂在释放状态下与流出段外周壁的夹角为α1，30°≤α1≤90°。
作为优选的技术方案，锚定臂的长度不小于线圈的横截面直径。
作为优选的技术方案，锚定段呈大致I字形径向向外翻翘；
或者，锚定段呈大致I字形，由锚定段的自由端顺时针或逆时针倾斜并径向向外翻翘，倾斜的角度为α2，0＜α2≤45°。
作为优选的技术方案，锚定段呈大致J字形或L形径向向外翻翘，锚定段的自由端呈朝向流入段或流出段的弯曲或弯折。
作为优选的技术方案，锚定段的自由端的弯曲弧长或弯折段长度大于线圈的横截面半径。
作为优选的技术方案，锚定段还设有至少一个弧形倒刺；弧形倒刺与锚定段的夹角为α3，30°≤α3≤90°。
作为优选的技术方案，弧形倒刺设置于锚定段的内侧或外侧。
作为优选的技术方案，锚定臂沿流出段的轴向设置2-7排，每排设置锚定臂4-24个；每排中相邻的锚定臂间隔或连续排布。
作为优选的技术方案，相邻排的锚定臂穿入功能段相邻或间隔的线圈间隙。
作为优选的技术方案，锚定臂与瓣膜支架一体切割；或者，锚定臂通过焊接、压接或铆接固定于瓣膜支架。
作为优选的技术方案，流入段呈喇叭状结构，流出段呈圆筒状，流入段的小直径端连接流出段。
作为优选的技术方案，流出段的自由端呈收口状，以降低流出道梗阻。
作为优选的技术方案，流出段包括若干相互连接的菱形网格结构，流出段上未设置锚定臂的区域具有比设有锚定臂的区域更高的弹性系数。
作为优选的技术方案，未设置锚定臂的菱形网格的轴向对角为α4，30°≤α4≤70°；设有锚定臂的菱形网格的轴向对角为α5，70°＜α5≤90°。
作为优选的技术方案，瓣膜支架的内侧缝合有瓣叶，瓣叶用于控制血液单向流动；流入段外侧设有密封膜，密封膜用于防止瓣周漏。
作为优选的技术方案，在瓣叶锚定件中：
心房段被配置为由功能段延伸至位于心房，并大致遵循心房壁曲率的弯曲状；
心室段由功能段延伸心室，并被配置为大致遵循原生腱索丛曲率的弯曲状。
作为优选的技术方案，心房段被配置为0.5—2.5匝线圈；功能段及心室段被配置为1.5—5.5匝线圈。
作为优选的技术方案，功能段中相邻的线圈之间的距离等于0～2倍锚定臂的厚度。
作为优选的技术方案，线圈的直径在心室段由近端至远端的渐次减小。
作为优选的技术方案，瓣叶锚定件由内向外包括芯体及包裹层；芯体由预成形的记忆金属制成，其至少能够在径向和轴向发生弹性形变，以顺应心肌组织形状的改变；包裹层用于为瓣叶锚定件提供摩擦力
本发明采用的技术方案能够达到以下有益效果：
(1)本发明提供了一种人工心脏瓣膜，其结构包括瓣叶锚定件及瓣膜支架；瓣叶锚定件经股静脉穿越房间隔植入，对原生瓣叶进行捕获后为后续瓣膜支架的植入提供位点，瓣叶锚定件能够与植入的瓣膜支架直接配合，避免瓣膜支架在原生组织的收缩或舒张过程中发生变形或移位，以有效的保证瓣膜支架的固定位置，减少其移位风险；瓣膜支架在与瓣叶锚定件相互作用的位置设有一排或数排锚定臂，锚定臂在支架输送时处于压缩状态，并贴附于瓣膜支架的外周壁，待支架释放后，锚定臂朝瓣膜支架径向的外侧翻翘，穿出原生瓣叶并穿入瓣叶锚定件的相邻线圈的间隙中，使得瓣膜支架与瓣叶锚定件之间紧密结合并产生稳固的锚定力，防止瓣膜在心动期内发生位移。
(2)在本发明一种优选实施方式中，在锚定臂的自由端还设有一个倒刺，且倒刺的弧长大于构成瓣叶锚定件的线圈的横截面半径，使得锚定臂一旦穿入瓣叶锚定件的相邻线圈的间隙中，瓣膜支架便无法轻易与瓣叶锚定件脱离，即使心脏发生或受到大幅度震颤，或瓣膜再次发生器质性病变，本申请的人工心脏瓣膜仍能够正常发挥作用。
(3)在本发明一种优选实施方式中，瓣膜支架为自膨胀支架，能够有效降低profile值；更进一步地，瓣膜支架由若干相互连接的菱形网格结构组成，其中设置有锚定臂的菱形网格，其轴向的对角角度较大，以保证足够的刚度以便和瓣叶锚定件进行稳固锚定，而 没有设置锚定臂的菱形网格，其轴向的对角角度较小，以保证一定的柔性，以顺应心肌形态的改变。
(4)瓣膜支架的流入段呈喇叭形结构，其外侧缝合有密封膜，能够效防止瓣周漏，降低手术风险。
(5)瓣膜支架流出段的自由端呈收口状，以防止流出道梗阻。
附图说明
为了更清楚地说明本发明实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，构成本发明的一部分，本发明的示意性实施例及其说明解释本发明，并不构成对本发明的不当限定。在附图中：
图1为本发明实施例1公开的一种优选实施方式中人工心脏瓣膜的结构示意图；
图2为本发明实施例1公开的一种优选实施方式中瓣叶锚定件的结构示意图；
图3为本发明实施例1公开的一种优选实施方式中瓣叶锚定件的底面视图；
图4为本发明实施例1公开的一种优选实施方式中瓣膜支架的结构示意图；
图5为本发明实施例1公开的一种优选实施方式中瓣膜支架的结构示意图；
图6为图5中的瓣膜支架与瓣叶锚定件的配合状态图；
图7为本发明实施例1公开的一种优选实施方式中瓣膜支架的结构示意图；
图8为图7中的瓣膜支架与瓣叶锚定件的配合状态图；
图9为本发明实施例1公开的一种优选实施方式中瓣膜支架的结构示意图；
图10为图9中的瓣膜支架与瓣叶锚定件的配合状态图；
图11a为本发明实施例1公开的一种优选实施方式中J字形锚定臂的结构示意图；
图11b为本发明实施例1公开的一种优选实施方式中L字形锚定臂的结构示意图；
图12为本发明实施例1公开的一种优选实施方式中人工心脏瓣膜的使用状态图；
图13为本发明实施例2公开的一种优选实施方式中瓣膜支架的结构示意图；
图14为图13中的瓣膜支架与瓣叶锚定件的配合状态图；
图15a为本发明实施例2公开的一种优选实施方式中锚定臂的结构示意图；
图15b为本发明实施例2公开的一种优选实施方式中锚定臂的结构示意图；
图16为本发明实施例2公开的一种优选实施方式中瓣膜支架的结构示意图；
图17为图16中的瓣膜支架与瓣叶锚定件的配合状态图；
图18a为本发明实施例2公开的一种优选实施方式中锚定臂的结构示意图；
图18b为本发明实施例2公开的一种优选实施方式中锚定臂的结构示意图；
图19为本发明实施例3公开的一种优选实施方式中瓣膜支架的结构示意图；
图20为本发明实施例3公开的另一种优选实施方式中瓣膜支架的结构示意图；
图21为本发明实施例3公开的一种优选实施方式中瓣膜支架瓣叶锚定件的配合状态图。
附图标记说明：
瓣膜支架100，流入段110，流出段120，菱形网格121，波杆122，节点123，锚定臂
130，锚定段131，自由端132，弧形倒刺140；
瓣叶锚定件200，心房段210，功能段220，心室段230；
左心房300；左心室400。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明具体实施例及相应的附图对本发明技术方案进行清楚、完整地描述。在本发明的描述中，需要说明的是，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。另外，在本申请的描述中，术语“第一”、“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。
显然，所描述的实施例仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
为解决现有技术中存在的问题，本申请实施例提供了一种人工心脏瓣膜，主要结构包括瓣叶锚定件200及瓣膜支架100；其中，瓣叶锚定件200呈螺旋状，能够盘绕于二尖瓣/三尖瓣腱索丛外，并与被植入二尖瓣/三尖瓣内的瓣膜支架100互相作用；瓣叶锚定件200由近端至远端依次设置为心房段210、功能段220及心室段230；功能段220包括定位于原生瓣环处的数匝线圈，用于支撑植入的人工心脏瓣膜支架100；瓣膜支架100包括流入段110和流出段120；流出段120沿周向设有至少一排锚定臂130，锚定臂130包括固定端与锚定段132，固定端固接于流出段120，锚定段132由固定端向背离瓣膜支架100置入的方向延伸，锚定臂130在压缩状态下贴附于瓣膜支架100的外周壁，锚定臂130在释放状态下朝瓣膜支架100径向的外侧翻翘，穿出原生瓣叶并穿入瓣叶锚定件200在功能段220的相邻线圈的间隙。
实施例1
本实施例所提供的人工心脏瓣膜，可用于二尖瓣或三尖瓣内，优选的，以二尖瓣植入为例，本实施例1提供了一种人工心脏瓣膜，用来解决现有技术中存在的技术问题。
根据图1-图12，上述人工心脏瓣膜包括瓣膜支架100及瓣叶锚定件200，瓣膜支架100包括流入段110及流出段120；优选地，在瓣膜支架100内还缝合有瓣叶，用于控制血液单向流；在流入段110的外侧壁缝合有密封膜，用于防止瓣周漏。上述瓣叶锚定件200大致呈螺旋状，可植入人体二尖瓣的腱索丛处，并提供轴向和径向的作用力，以配合植入二尖瓣内的瓣膜支架100并与其相互作用，二者的配合能够缩小天然二尖瓣的尺寸、减少二尖瓣反流，同时瓣叶锚定件200可以更紧固的锚定瓣膜支架100的位置，有效避免瓣膜支架100在心肌运动过程中发生移位。
参考图2-图3，在一种优选实施方式中，瓣叶锚定件200近端向远端依次设置有心房段210、功能段220及心室段230，其中：功能段220呈盘卷状定位于原生二尖瓣的瓣环处，用于支撑被植入二尖瓣内的瓣膜支架100；心室段230由功能段220向下延伸至并接合至左心室400，并被配置为大致遵循原生二尖瓣腱索丛曲率的弯曲状；优选地，功能段220及心室段230被配置为1.5—5.5匝线圈，相邻匝的线圈间距离为0.2-2.0mm；心房段210被配置为由功能段220穿过瓣叶间隙螺旋上升，延伸至左心房300并弯曲盘绕于左心房300中，且其弯曲的曲率与心房壁的曲率大致相同，以保证心房段210可以与左心房300更加匹配，优选地，心房段210被配置为0.5—2.5匝线圈，相邻匝的线圈间距离为0-2.0mm。优选地，组成瓣叶锚定件200的线圈的直径d为0.2—2mm。
在一种优选实施方式中，线圈的直径在心室段230(Tip头处)为变径设计，以减少瓣叶捕捞时对心肌、瓣叶的损伤，提升瓣叶捕捞成功率；优选地，变径长度为10—100mm，具体为其直径由近端至远端的渐次减小，最远端直径范围为0.1—1.0mm。
进一步地，对于不同的患者，其心房/瓣膜/心室的形状、尺寸会有所不同，本领域技术人员可以理解的是，瓣叶锚定件200各区段的具体弯曲曲率、尺寸及线圈匝数可以根据患者的情况而适应性的改变。
优选地，由于心房段210定位于心房中，而功能段220及心室段230放置于二尖瓣外，因此心房段210用于提供径向向外扩张的力，以保证该段可以稳定的定位于左心房300中，而功能段220及心室段230则提供径向向内收紧的力，以锚定位于二尖瓣内的瓣膜支架100，以同时对瓣膜支架100和自身进行固定，同时也可以对二尖瓣进行收紧，以减少二尖瓣反流。
优选地，呈大致螺旋状的瓣叶锚定件200还可以提供轴向变形能力，以顺应心肌组织在整个心动周期中形态的改变，同时在进行手术置入时也更加便利。
优选地，由于心房的空间较大，二尖瓣瓣环处最狭窄，二尖瓣下的腱索丛逐渐扩张，因此在一种优选实施例中，在瓣叶锚定件200的多个区段中，功能段220的直径d1小于心室段230的直径d2，心室段230的直径d2小于心房段210的直径d3，以期获得最佳的固定位点。优选地，功能段220的直径d1为15—40mm，心室段230直径d2为20—50mm，心房段210直径d3为30—70mm。优选地，心房段210的高度L1为10—20mm，瓣叶锚定件200的总高度L2为15—30mm。在其他实施例中，若术前对患者的心脏进行影像学检查后发现上述实施例中的比例关系不适用，则可以根据实际情况选择更加合适的尺寸及比例。
在一种优选实施方式中，组成瓣叶锚定件200的线圈由内向外包括芯体及包裹层；芯体由预成形的记忆金属螺旋盘绕而成，优选为镍钛合金，其至少能够在径向和轴向发生弹性形变，以顺应心肌组织形状的改变；包裹层用于为瓣叶锚定件200提供摩擦力，优选的，包裹层的材料可选择具有较大孔隙的编织材料、具备高摩擦系数的高分子材料或者设有图案化镂空的高分子材料。
参考图4-图5，优选的，瓣膜支架100为自膨胀式支架，相对于球囊扩张式支架，自膨胀式支架具有更小的profile值(profile值即是压握状态下的截面直径)，从而提升了瓣膜支架100通过病变区域的能力。
在一种优选实施方式中，瓣膜支架100由金属或高分子材料制成，如镍钛合金记忆材料或其他记忆高分子材料或者合金，在本实施例中，通过对镍钛合金记忆材料等进行处理，形成若干互相连接的菱形网格121结构；可选的，上述处理方式包括但不限于编织、激光切割、焊接、铆钉连接、螺纹连接等。
根据血流的方向，流出段120位于流入段110的下游，流入段110对应人工心脏瓣膜植入后血液流入瓣膜支架100的部分，流出段120对应于人工心脏瓣膜植入后血液流出瓣膜支架100的部分；优选地，流入段110定位于原生二尖瓣的瓣环处，大致呈喇叭状结构，流出段120定位于原生二尖瓣的瓣叶与腱索的连接过渡区域，呈圆柱形结构或类似圆柱形的结构，且流入段110的小直径端连接流出段120；瓣膜支架100的流出段120和/或流入段110够径向扩展及压缩，保证其在血管中输送时呈压缩状态，而到达原生二尖瓣的瓣环后再通过自膨胀扩张打开。
参考图5，在一种优选实施方式中，流出段120的出口处呈收口状，以降低流出道梗阻；优选的，流出段120的出口处相对于其中间段向内弯折的角度为α6，α6≤45°。
在一种优选实施方式中，流入段110具有比流出段120更高的弹性系数，在植入二尖瓣内后能够至少在径向和轴向发生弹性形变，以顺应原生二尖瓣瓣环形态的改变。
优选地，瓣膜支架100的流出段120包括若干互相连接的多边形网格结构，相邻的网格结构间通过具有一定弹性的波杆122或及节点123相连，其中多边形网格可选为菱形网格121或六边形网格，优选为菱形网格121，在菱形网格121的上下两个对角均呈V形结构；优选地，流出段120的菱形网格121在轴向及周向上均呈连续完整分布，从而不影响径向的支撑力，避免瓣膜支架100在植入二尖瓣后发生不期望的移位；优选地，瓣膜支架100的周向菱形网格121的数量为8—24个，V形结构的数量为3—8个。
在一种优选实施方式中，在流出段120的部分相邻的菱形网格121间，沿周向设有至少一排锚定臂130，锚定臂130在压缩状态下贴附于瓣膜支架100的外周壁，在释放状态下朝瓣膜支架100径向的外侧翻翘，穿出原生瓣叶并穿入瓣叶锚定件200的相邻线圈的间隙中，使得瓣膜支架100与瓣叶锚定件200之间紧密结合并产生稳固的锚定力，防止瓣膜在心动期内发生位移。
优选地，在流出段120未设置锚定臂130的区域具有比设有锚定臂130的区域更高的弹性系数，使得未设置锚定臂130的区域具有一定的柔性，以顺应心肌形态的改变，而设置锚定臂130的区域具有足够的刚度，以便和瓣叶锚定件200进行稳固锚定。
在一种优选实施方式中，没有设置锚定臂130的菱形网格121，其轴向的对角α4角度较小，优选30°≤α4≤70°；而设置有锚定臂130的菱形网格121，其轴向的对角α5角度较大，优选70°＜α5≤90°。
优选地，锚定臂130可选择记忆合金、聚合物、纤维或其他高分子材料，并通过焊接、压接或铆接固定于瓣膜支架100；在一种更优选地实施方式中，锚定臂130采用与瓣膜支架100相同的材料制作，也即镍钛合金，且二者一体切割成型；本领域技术人员应理解，由于镍钛合金具备20％以上的伸缩率，具有高阻尼、高弹性和高疲劳寿命，能够保证在向人体递送过程中保持收缩状态，而在瓣膜支架100释放后扩张并穿入瓣叶锚定件200的相邻线圈的间隙中，之后保持稳定形状；更重要的是，镍钛合金作为生物相容性材料会更加安全，及具备耐磨和抗腐蚀的性能，还不会产生排异反应。
锚定臂130包括固定端与锚定段132，固定端固接于瓣膜支架100的流出段120，优选地设置于相邻菱形网格121间的波杆122或节点123外侧；锚定段132由固定端向背离瓣膜支架100置入的方向延伸并翻翘；锚定段132还具有自由端132，在一种优选实施方式中，自由端132呈钝性结构，如近似于扇形、弧形、椭圆形或半圆形，由于锚定臂130通过瓣膜支架100膨胀时外扩的压力刺穿原生瓣环，因此钝性结构能够在一定程度上避免在穿出原生瓣叶后其外露的部分损伤其他的心肌组织；在另外一种优选实施例当中，锚定段132 为变径设计，且越靠近自由端132其直径越小，一方面能够进一步增强锚定臂130对于原生瓣叶的穿刺能力，另一方面能够提升自由端132的变形能力，使其顺利穿入线圈间隙。
优选地，锚定臂130在释放状态下与流出段120外周壁的夹角为α1，30°≤α1≤60°，以保证瓣膜支架100在释放后，锚定臂130能够顺利穿入瓣叶锚定件200功能段220相邻线圈之间，并被相邻的线圈夹紧，同时穿过线圈后外露的部分能够斜向上延伸，避免大面积影响周围的其他组织结构。
参考图5-图6，在一种优选实施方式中，锚定臂130为扁平结构，呈大致的I字形径向向外翻翘；优选地，锚定臂130的厚度不小于瓣叶锚定件200功能段220相邻线圈之间的间隙，以保证锚定臂130在穿过线圈间隙后与线圈之间形成稳定的过盈连接，增加二者之间摩擦力，防止瓣叶锚定件200与锚定臂130相脱离；在另一种优选实施方式中，瓣叶锚定件200的功能段220相邻线圈之间的间隙为锚定臂130厚度的0～2倍，能够使得锚定臂130更容易穿越线圈的间隙，同时能够保证瓣叶锚定件200与瓣膜支架100之间能够存在一定程度的相对移动，以避免二者过于紧固致使原生瓣叶在心动周期中撕裂。优选地，锚定臂130的长度不小于线圈的横截面直径，以保证二者之间存在足够的接触面积。
参考图7-图8，在另一种优选实施方式中，锚定臂130为扁平结构，呈大致I字形，由自由端132顺时针或逆时针倾斜并径向向外翻翘，倾斜的角度为α2，0＜α2≤45°，倾斜式结构能够进一步增大锚定臂130与线圈之间的接触面积，以此进一步增大摩擦力，保证二者结合的紧密性。
优选地，设置于同一排的锚定臂130的倾斜方向一致，但倾斜角度可以不同，以期提供与瓣叶锚定件200更多角度/更大辐射范围的摩擦力，使得二者的结合更加稳定。
优选地，设置于相同排的锚定臂130的倾斜方向一致，设置于不同排的锚定臂130的倾斜方向可以不一致，以避免瓣叶锚定件200顺应某排的倾斜趋势与瓣膜支架100发生脱离。
参考图9-图11a，在另一种更优选的实施方式中，锚定臂130为扁平且带有一定弧度的结构，呈大致的J字形径向向外翻翘，优选地，锚定段132仍为扁平直形结构或较为平直的弧形结构，而自由端132呈朝向流入段110或流出段120弯曲的弧状；优选地，自由端132的弯曲弧长大于线圈的横截面半径，在锚定臂130在穿过线圈间隙后，其弧状的自由端132能够贴合于线圈的外壁，一方面能够防止瓣叶锚定件200与锚定臂130相脱离，另一方面能够避免锚定臂130自由端132向外延伸损伤其他的心肌组织。
参考图11b，在另一种优选实施方式中，锚定臂130呈大致的L字型，其中锚定段132的自由端132呈朝向流入段110或流出段120弯折的直形，优选的，弯折处的角度为α7， α7＞90°，更优选的，α7≥135°，以避免弯折角度过小难以穿刺原生瓣环；待锚定臂130穿过原生瓣叶后，弯折处能够贴合于线圈的外壁，优选的，弯折的内侧可以设置为平滑过渡而非内角形的硬过渡，不仅能够更好的与线圈贴合，还能提供一定的形变性能；而弯折处的外侧可以设置为外角形的硬过渡而非平滑过渡，以期获得更加优异的穿刺性能。
优选地，锚定臂130沿流出段120的轴向设置2-7排，每排锚定臂130设置4-24个；每排中相邻的锚定臂130间隔或连续呈环形排布，多排锚定臂130的设计同样能够增大瓣叶锚定件200与瓣膜支架100之间的接触面积，从而增大摩擦。
本领域技术人员应理解，由于瓣叶锚定件200中成匝的线圈宽度并不与瓣膜支架100中菱形网格121的轴向长度一致，因此当设置多排锚定臂130时，邻排的锚定臂130穿入功能段220相邻或间隔的线圈间隙中。
优选地，多片瓣叶缝制在瓣膜支架100的框架上，瓣叶优选为猪心包或牛心包瓣叶；优选地，缝制在流入段110外侧壁的密封膜由生物相容性织物制成，生物相容性织物优选但不限于PET、PTFE、e-PTFE或PU中的任意一种或至少两种的组合。
优选的，在瓣膜支架100上还具有多个显影点。当人工心脏瓣膜植入人体内之后，通常情况下，医生需要通过设置于所植入的瓣膜支架100上的显影点来确定植入位置是否准确，而且，由于心脏瓣膜是立体结构，通常需要确定其空间位置是否准确，因此需要通过多个显影点的位置判断其空间位置是否准确。
优选地，瓣膜支架100的总高度H为20—30mm，其中流出段120的高度h为10—20mm；优选地，流出段120的直径D1为25—40mm，流入段110大直径端的直径D2为35—60mm；优选地，流出段120与流入段110的内夹角为30°—90°；优选地，瓣膜支架100的壁厚0.2—2mm。
本领域技术人员应理解，不同的患者具有不同的年龄、性别、身高、体重、病变位置及病变状况等，为了保证瓣膜支架100与病变的原生瓣膜能够良好贴合以发挥作用，瓣膜支架100流出段120与流入段110的尺寸及二者角度可做出适应性调整或选择，在此不再赘述。
参照图12，在本实施例中，上述人工心脏瓣膜的使用方法如下：
通过输送装置将瓣叶锚定件200经股静脉穿越房间隔置入二尖瓣腱索丛，以尽可能减小对人体的创伤，在置入时，瓣叶锚定件200的功能段220及心室段230将瓣叶进行捕捉，为后续瓣膜支架100的植入提供位点，瓣叶捕捞完毕后延伸到心房侧，将整个瓣叶锚定件200进行定位。
将带有锚定臂130的瓣膜支架100经输送器压缩后由股静脉入路，在穿越房间隔到达瓣叶锚定件200的心室段230内进行释放，瓣膜支架100上的锚定臂130打开后与瓣叶锚定件200的功能段220结合，产生稳固的锚定力，防止瓣膜支架100在心动期内发生位移，使得瓣膜与原生的组织结构配合更加安全和稳定。瓣膜支架100在植入后其流入段110会在心房中形成一个法兰盘样结构，流入段110外侧缝有密封膜，能有效防止瓣周漏，降低手术风险。
实施例2
仍以二尖瓣植入为例，在本实施例中，提供了一种人工心脏瓣膜，其结构包括瓣膜支架100及瓣叶锚定件200；在本实施例中，瓣叶锚定件200的结构与实施例1相同，在此不再赘述。
在一种优选实施方式中，锚定臂130的主体为扁平且带有一定弧度或弯折的结构，呈大致的J字形或L字形径向向外翻翘，其中，锚定段132仍为扁平直形结构，而自由端132呈朝向流入段110或流出段120弯曲的弧状，或者，自由端132呈朝向流入段110弯折的直形结构；优选地，在锚定段132还设有至少一个弧形倒刺140，用于避免位于锚定臂130上方或下方的线圈在心肌运动过程中相上发生脱离。
参考图13-图15a，优选地，弧形倒刺140设置于锚定段132的内侧；在一种优选实施方式中，弧形倒刺140设置于锚定段132内侧的自由端132；在另一种优选实施方式中，弧形倒刺140设置于锚定段132内侧的任一位置，当锚定臂130及弧形倒刺140释放后，弧形倒刺140能够贴合上方的线圈，并与上一排的锚定臂130共同夹紧二者之间的线圈。
参考图15b，在另一优选实施方式中，在锚定段132内侧也可以设置多个弧形倒刺140，以进一步增加与上排线圈结合的稳定性。
参考图16-图18a，优选的，弧形倒刺140设置于锚定段132的外侧；在一种优选实施方式中，弧形倒刺140设置于锚定段132外侧的自由端132；在另一种优选实施方式中，弧形倒刺140设置于锚定段132外侧的任一位置，当锚定臂130及弧形倒刺140释放后，弧形倒刺140能够阻挡下方的线圈向上运动发生脱离，并与下一排的锚定臂130共同夹紧二者之间的线圈。
参考图18b，在另一种优选实施方式中，在锚定段132的外侧也可以设置多个弧形倒刺140，以进一步增加与下排线圈结合的稳定性。
优选的，在锚定段132内侧及外侧均设有至少一个弧形倒刺140，内侧的弧形倒刺140能够与上一排的锚定臂130共同夹紧二者之间的线圈，外侧的弧形倒刺140能够与下一排的锚定臂130共同夹紧二者之间的线圈。
优选的，锚定臂130自由端132的弯曲弧长或弯折段长度大于线圈的横截面半径，在锚定臂130在穿过线圈间隙后，其自由端132能够贴合于其上方的线圈的外壁；优选地，弧形倒刺140的弯曲弧长大于线圈的横截面半径，以贴合其上方或下方的线圈的外壁；更优选地，弧形倒刺140在扩张后仍与上方或下方的线圈保持一定间距，以提供一定的缓冲空间，避免撕裂瓣叶，使得二尖瓣的瓣叶与人工心脏瓣膜间的配合更加安全和稳定。
在一种优选实施方式中，弧形倒刺140在释放后与锚定段132的夹角为α3，30°≤α3≤90°，以保证弧形倒刺140能够阻挡其上方或下方的线圈，当上方或下方线圈发生竖直方向的位移时能够被弧形倒刺140卡住，防止脱落。
优选地，在本实施例中，锚定臂130可仅设置一排，排中相邻的锚定臂130间隔或连续呈环形排布，数量设置4-24个；本领域技术人员应理解，在本实施例中，由于锚定臂130的自由端132还设有倒刺，因此在仅设置一排的情况下即可保证瓣叶锚定件200与瓣膜支架100之间难以脱离，保证二者之间配合的稳定性。
在本实施例中，上述人工心脏瓣膜的使用方式与实施例1相同，在此不再赘述。
实施例3
仍以二尖瓣植入为例，在本实施例中，提供了一种人工心脏瓣膜，其结构包括瓣膜支架100及瓣叶锚定件200；在本实施例中，瓣膜支架100上锚定臂130的结构与上述实施例1或实施例2相同，在此不再赘述。
在一种优选实施方式中，在瓣膜支架100的流出段120设置数个锚定臂130，优选地，锚定臂130间隔设置于相邻菱形网格121间的波杆122或或节点123外侧，不再限定呈环形排布，而是呈散列排布状，能够实现瓣膜支架100在多个方向上对瓣叶锚定件200的立体固定，以保证二者之间配合的稳定性。
优选地，大致呈一排的锚定臂130可以部分设置于菱形网格121间的波杆122外侧，而部分设置于节点123外侧，如图20-图21；也可以均设置于波杆122外侧或均设置于节点123外侧，如图19。
优选地，设置于不同位置的锚定臂130，每一个的形状、尺寸、倾斜角度、有无倒刺等设置均可以相同，也可以不同。
上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，均属于本发明的保护之内。

Claims (21)

  1. 一种人工心脏瓣膜，其特征在于，包括瓣叶锚定件及瓣膜支架；
    所述瓣叶锚定件呈螺旋状，能够盘绕于二尖瓣/三尖瓣腱索丛外，并与被植入二尖瓣/三尖瓣内的所述瓣膜支架互相作用；所述瓣叶锚定件由近端至远端依次设置为心房段、功能段及心室段；所述功能段包括定位于原生瓣环处的数匝线圈，用于支撑植入的人工心脏瓣膜支架；
    所述瓣膜支架包括流入段和流出段；所述流出段沿周向设有至少一排锚定臂，所述锚定臂包括固定端与锚定段，所述固定端固接于所述流出段，所述锚定段由所述固定端向背离所述瓣膜支架置入的方向延伸；所述锚定臂在压缩状态下贴附于所述瓣膜支架的外周壁，所述锚定臂在释放状态下朝所述瓣膜支架径向的外侧翻翘，穿出原生瓣叶并穿入所述瓣叶锚定件在所述功能段的相邻所述线圈的间隙。
  2. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚定臂在释放状态下与所述流出段外周壁的夹角为α1，30°≤α1≤90°。
  3. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚定臂的长度不小于所述线圈的横截面直径。
  4. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚定段呈大致I字形径向向外翻翘；
    或者，所述锚定段呈大致I字形，自所述锚定段的自由端顺时针或逆时针倾斜并径向向外翻翘，所述倾斜的角度为α2，0＜α2≤45°。
  5. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚定段呈大致J字形或L形径向向外翻翘，所述锚定段的自由端呈朝向所述流入段或所述流出段的弯曲或弯折。
  6. 根据权利要求5所述的人工心脏瓣膜，其特征在于，所述锚定段的自由端的弯曲弧长或弯折段长度大于所述线圈的横截面半径。
  7. 根据权利要求5所述的人工心脏瓣膜，其特征在于，所述锚定段还设有至少一个弧形倒刺；所述弧形倒刺与所述锚定段的夹角为α3，30°≤α3≤90°。
  8. 根据权利要求7所述的人工心脏瓣膜，其特征在于，所述弧形倒刺设置于所述锚定段的内侧或外侧。
  9. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚定臂沿所述流出段的轴向设置2-7排，每排设置所述锚定臂4-24个；每排中相邻的所述锚定臂间隔或连续排布。
  10. 根据权利要求9所述的人工心脏瓣膜，其特征在于，相邻排的所述锚定臂穿入所述功能段相邻或间隔的线圈间隙。
  11. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚定臂与所述瓣膜支架一体切割；
    或者，所述锚定臂通过焊接、压接或铆接固定于所述瓣膜支架。
  12. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述流入段呈喇叭状结构，所述流出段呈圆筒状，所述流入段的小直径端连接所述流出段。
  13. 根据权利要求12所述的人工心脏瓣膜，其特征在于，所述流出段的自由端呈收口状，以降低流出道梗阻。
  14. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述流出段包括若干相互连接的菱形网格结构，所述流出段上未设置所述锚定臂的区域具有比设有所述锚定臂的区域更高的弹性系数。
  15. 根据权利要求14所述的人工心脏瓣膜，其特征在于，未设置所述锚定臂的所述菱形网格的轴向对角为α4，30°≤α4≤70°；设有所述锚定臂的所述菱形网格的轴向对角为α5，70°＜α5≤90°。
  16. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述瓣膜支架的内侧缝合有瓣叶，所述瓣叶用于控制血液单向流动；所述流入段外侧设有密封膜，所述密封膜用于防止瓣周漏。
  17. 根据权利要求1所述的人工心脏瓣膜，其特征在于，在所述瓣叶锚定件中：
    所述心房段被配置为由所述功能段延伸至位于心房，并大致遵循心房壁曲率的弯曲状；
    所述心室段由所述功能段延伸心室，并被配置为大致遵循原生腱索丛曲率的弯曲状。
  18. 根据权利要求17所述的人工心脏瓣膜，其特征在于，所述心房段被配置为0.5—2.5匝所述线圈；所述功能段及所述心室段被配置为1.5—5.5匝所述线圈。
  19. 根据权利要求17所述的人工心脏瓣膜，其特征在于，所述功能段中相邻的所述线圈之间的距离等于0～2倍所述锚定臂的厚度。
  20. 根据权利要求17所述的人工心脏瓣膜，其特征在于，所述线圈的直径在所述心室段由近端至远端的渐次减小。
  21. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述瓣叶锚定件由内向外包括芯体及包裹层；所述芯体由预成形的记忆金属制成，其至少能够在径向和轴向发生弹性形变，以顺应心肌组织形状的改变；所述包裹层用于为所述瓣叶锚定件提供摩擦力。
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