WO2015100857A1 - 人工心脏瓣膜成形环 - Google Patents

人工心脏瓣膜成形环 Download PDF

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Publication number
WO2015100857A1
WO2015100857A1 PCT/CN2014/073973 CN2014073973W WO2015100857A1 WO 2015100857 A1 WO2015100857 A1 WO 2015100857A1 CN 2014073973 W CN2014073973 W CN 2014073973W WO 2015100857 A1 WO2015100857 A1 WO 2015100857A1
Authority
WO
WIPO (PCT)
Prior art keywords
artificial heart
spiral structure
ring
tubular spiral
ring according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2014/073973
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English (en)
French (fr)
Inventor
金昌�
钟生平
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kingstronbio Technology Changshu Co Ltd
Original Assignee
Kingstronbio Technology Changshu Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kingstronbio Technology Changshu Co Ltd filed Critical Kingstronbio Technology Changshu Co Ltd
Priority to EP14877467.2A priority Critical patent/EP3090703B1/en
Priority to JP2016544092A priority patent/JP6251402B2/ja
Publication of WO2015100857A1 publication Critical patent/WO2015100857A1/zh
Priority to US15/197,649 priority patent/US20160310275A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61F2/2442—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
    • A61F2/02—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
    • A61F2/2448—D-shaped rings
    • 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
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0015—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity

Definitions

  • the invention relates to a prosthetic heart valve forming ring, belonging to the technical field of medical instruments. Background technique
  • the mitral and tricuspid valves When the heart contracts, the mitral and tricuspid valves close, allowing blood in the ventricles to flow into the artery while preventing blood in the ventricles from flowing back into the atria. Valve sinus dilatation, subvalvular chordae rupture, leaflet perforation, leaflet prolapse and other diseases, so that when the ventricle contracts, the valve leaflets can not completely close, causing blood to return to the atria.
  • the formation of the annulus is an important means of clinically remodeling the diseased mitral and tricuspid valves to maintain normal shape and contour, repairing the mitral and tricuspid valve closure and incompleteness caused by disease. Problems such as ventricular reflux.
  • the forming rings that have been applied in clinical practice mainly include soft ring, hard ring and semi-hard ring.
  • the soft ring is mostly of two-dimensional structure, and the main body is mostly made of polymer material, so that it can fit well with the annulus of the valve, but the material of the soft ring is too soft, which is not conducive to effective locking of the leaflet and effective shaping of the annulus.
  • the hard ring and the semi-hard ring are two-dimensional planar structures or three-dimensional saddle structures designed according to the annulus of the valve.
  • the saddle structure has many advantages in reducing leaflet stress and improving tolerance.
  • the hard ring is made of metal and has good support strength, but the hard ring is not easy to bend, and the coordinated movement with the cardiac cycle cannot be achieved.
  • the semi-rigid ring combines the advantages of both the soft ring and the hard ring. By adjusting the rigidity of the forming ring body, it can effectively adapt to the change of the valve annulus caused by systole and relaxation while providing better supporting strength. So began to get attention.
  • the patent US Pat. No. 5,607,741 discloses a forming ring whose annular main body structure is a variable diameter wire material, and the rigidity of each ring segment is adjusted by adjusting the wire diameter.
  • the design and manufacture of the mold is very cumbersome and the manufacturing process is complicated; the forming ring disclosed in the patent of US6908482, the annular main structure adopts the metal strip directly to form the contour of the forming ring, and the number of strip layers is adjusted to achieve the demand for different rigidity.
  • the forming ring made by this method has a large deformation rigidity in the vertical toroidal direction at the joint of the front and rear rings.
  • the forming ring disclosed in the patent US Pat. No. 7,220,277 has an annular main body structure adopting a pipe material, and a circular or other shaped hole is hollowed out on the pipe, and the rigidity of the forming ring is adjusted according to the shape and position of the hole, but the forming ring is subjected to a certain force. In the case of easy breakage and cracking.
  • a ring body that adjusts the rigidity of the entire forming ring by means of a combination of metal and polymer. It is necessary to match the metal ring segment with the polymer ring segment according to the rigidity requirement, because of the very special application environment requirements, for the metal.
  • the invention provides a prosthetic heart valve forming ring, which can easily adjust the rigidity, has a simple structure, is easy to manufacture, and can maintain a stable forming effect for a long time, while satisfying the application requirements.
  • the present invention provides a prosthetic heart valve forming ring comprising an outer layer and an annular body structure, the outer layer enclosing an outer circumference of the annular body structure, wherein the annular body structure has a curl formed by a sheet metal strip At least one layer of tubular helical structure that adjusts the rigidity of the forming ring.
  • the shape of the main body of the forming ring may be the same as that of the prior art, and the gP may be integrally formed by a plurality of ring segments, and may include, for example, a front ring segment, a rear ring segment, a left ring segment, a right ring segment, and a connection disposed therebetween. Segments, each ring segment is a unitary structure that together form a closed or open annular body.
  • the outer body of the annular body is coated with a biocompatible fibrous fabric layer, which is a medical material conforming to medical standards, such as medical polyester fabric.
  • the tubular spiral structure is a structure formed by crimping a strip of sheet material in the axial direction, and has a substantially tubular structure.
  • a prosthetic heart valve forming ring according to the present invention, the tubular spiral structure having a single helix structure formed by crimping a single strip of the sheet material, or the tubular spiral structure having a multi-helical structure formed by crimping a plurality of the strips of sheet material .
  • the multi-helical structure may be composed of a plurality of single-helical structures having the same or different directions of rotation.
  • pitches of the respective portions of the single spiral structure are not all the same; or the pitches between the respective spiral structures in the multi-helical structure are not all the same.
  • the material of the plurality of sheet metal strips may not be the same, or the width of the plurality of sheet metal strips It may not be identical, which is advantageous for further changing and adjusting the rigidity of the annular body.
  • the widths of the strips are not all the same, and the widths may be connected by a step or a gradual transition.
  • the tubular spiral structure has a multi-helical structure formed by crimping a plurality of the strips, and a plurality of the strips are connected by at least one joint.
  • the connection may be direct welding or reinforced welding, etc., in order to increase the local strength and the coordination between the plurality of said strips during movement.
  • the sheet metal strip may have a hollow structure to achieve the purpose of changing and adjusting the rigidity of the annular body, and there is no special requirement for the specific arrangement of the hollow structure.
  • the through holes of different shapes may be, for example, circular, elliptical, or other shapes such as triangles, square polygons, and combinations of the above various shapes.
  • the hollow structures of different portions of the same strip are not identical; or the hollow structures between the different strips are not all the same.
  • the tubular spiral structure is formed by at least two layers, and each layer of the tubular spiral structure is respectively formed by curling of the sheet metal strip.
  • the tubular spiral structure as the annular body may be a single layer, or a tubular spiral structure having a smaller outer diameter may be inserted into the tubular spiral structure having a larger inner diameter to form a double or multi-layer tubular spiral structure.
  • Ring body For an annular body having a double or multi-layer tubular spiral structure, the same or different hollow ratios, pitches or strip widths may be used for the same portion of each layer to achieve different rigidity requirements of different ring segments, so that the entire forming ring satisfies A good match for the cardiac cycle.
  • the tubular spiral structure is internally provided with a wire material which can assist in adjusting the rigidity of the forming ring.
  • a wire may be provided inside the annular body structure to assist in adjusting the rigidity of the forming ring.
  • the length of the wire is generally no greater than the length of the tubular helical structure and may be disposed within the tubular helical structure, which may be continuous or spaced apart within the tubular helical structure.
  • the use of the wire can effectively prevent the structural change of the tubular spiral structure during three-dimensional shaping and use, limit the length of expansion of the forming ring, and prevent the valve leaf from being effectively restrained after prolonged use.
  • the material of the wire material may be a medical metal material or a medical polymer material, and the arrangement is also a conventional method, which is not limited in the present invention.
  • a heat shrinkable tube is further disposed between the outer layer and the tubular spiral structure.
  • the arrangement of the heat-shrink tubing is more advantageous for three-dimensional shaping of the tubular spiral structure and prevention of structural changes during use.
  • the material can usually be a polymer material, and is sleeved on the outer circumference of the tubular spiral structure by a heat shrinking process.
  • the prosthetic heart valve forming ring is filled with a polymer material at the gap of the sheet metal strip of the tubular spiral structure.
  • the injection molding or the method of immersing the tubular spiral structure in the solution or the glue of the polymer and then drying the polymer material of a material different from the material of the sheet metal can be filled in the gap between the strips of the tubular spiral structure to form different materials.
  • the tubular spiral structure may have an outer diameter of 0.6 to 3 mm.
  • the outer diameter is understood to be the outer diameter of the outermost tubular helical structure.
  • the sheet thickness may be 0.1-lmm.
  • the above thickness can be understood as the sum of the thicknesses of the strips of the multilayer tubular spiral structure.
  • the width, the hollowness, the thickness of the plurality of ring segments of the annular body, and the pitch, the number of layers and the outer diameter of the tubular spiral structure may be adjusted individually or in combination to obtain different rigidity.
  • Forming ring For example, while selecting and determining the appropriate strip width, thickness, tubular helical pitch, number of layers, and tube diameter to obtain the overall rigidity of the forming ring, the sheet metal strip forming the tubular spiral structure is hollowed out, and the hollowing rate is adjusted. (ie, adjustment of the hollow structure pattern, position and/or density) to achieve a further adjustment of the rigidity of the annular body.
  • the hollow structure may be disposed in each ring segment, or may have a hollow structure in one or several ring segments, and the hollowing rate of the hollow structure may be the same or different on different ring segments.
  • the rings of the forming ring are The stiffness between the segments is not the same or not the same, which is more conducive to clinical application.
  • the adjustment of the pitch can be combined to meet the different stiffness requirements of the forming ring for each ring segment. For example, for ring segments with higher rigidity requirements, the strips are made with a lower hollowing rate or without hollowing and a smaller pitch; the ring segments with lower stiffness requirements, the strips with high voiding ratio and a larger pitch achieve.
  • the "hollowing rate" used in the present invention means the percentage of the area of the sheet metal formed on the sheet metal to occupy the area of the sheet strip, which can be satisfied by the design of the shape, size, distribution, and the like of the opening.
  • the formation of the hollow structure on the strip of sheet material can be by any feasible method, for example For sheet metal strips, laser cutting is preferred.
  • the strip of the desired length may be first cut, the pattern of the desired density and structure may be cut on the strip of sheet by laser cutting or other methods, and then shaped into a final structure by the mold; or shaped into After the final structure, a hollow pattern of the desired density and structure is processed by three-dimensional flexible laser cutting or other methods.
  • the sheet metal strip may be various medical alloys or polymers, including medical nickel-titanium alloy sheet strips, cobalt-chromium alloy sheet strips, titanium alloy sheet strips, stainless steel sheet strips or polymerization. Sheet metal strips, etc.
  • a strip of sheet material made of 316L stainless steel, a sheet of strip made of cobalt-chromium alloy of MP35, L605, Elgiloy or Phynox, a strip of sheet made of titanium alloy Ti6A14V, made of Ni-Ti nickel-titanium alloy can be used.
  • the polymer sheet strip can be, for example, a strip of material made of a material such as polyethylene, polytetrafluoroethylene, polyacetal resin or polyethylene terephthalate.
  • an intermediate layer may be disposed between the outer layer and the annular body.
  • the material of the intermediate layer is generally silica gel, which facilitates the sewing of the forming ring and the heart, and also makes the internal pipe structure more elastic and resilient, and plays a role in fixing and effectively stabilizing the pipe structure.
  • the intermediate layer may be directly sheathed to the outside of the annular body by a circular tube, or may be fixed to the outside of the annular body by means of a coating, a heat shrinkable tube or a heat shrinkable film.
  • the artificial heart valve forming ring provided by the invention adopts a tubular spiral structure formed by curling of a strip of sheet material as a ring main body, which can make the ring segments have different rigidity, at the same time, the structure is simple, the rigidity is easily adjusted, and the second tip can be better adapted. Movement characteristics of the valve or tricuspid valve;
  • the forming ring for prosthetic heart valve repair of the present invention does not need to redesign and process the main body mold of the forming ring when adjusting the rigidity of the forming ring, the processing method is simple and convenient, the yield rate is high, and the durability is better. . DRAWINGS
  • FIG. 1 is a schematic view of a mitral annuloplasty ring provided by an embodiment of the present invention.
  • FIG. 2 is a schematic exploded view of a tubular spiral structure of a mitral annuloplasty ring body according to an embodiment of the present invention.
  • 3 is a schematic cross-sectional view of a mitral annuloplasty ring according to an embodiment of the present invention.
  • 4 is a schematic view of a sheet metal strip forming the tubular spiral structure of FIG. 2.
  • Figure 5 is a schematic illustration of a tubular helical structure of a mitral annuloplasty ring provided by another embodiment of the present invention.
  • Figure 6 is a schematic view of a sheet metal strip forming the tubular spiral structure of Figure 5.
  • Figure 7 is a schematic illustration of a tubular helical structure of a mitral annuloplasty ring provided by another embodiment of the present invention.
  • Fig. 8 is a schematic cross-sectional view showing a mitral annuloplasty ring according to still another embodiment of the present invention.
  • Figure 9 is a longitudinal cross-sectional view of a closed loop junction of a mitral annuloplasty ring in accordance with yet another embodiment of the present invention.
  • Figure 10 is a schematic view of a sheet metal strip forming the tubular spiral structure of Figure 7.
  • FIG. 11A and 11B are partial enlarged views of the tubular spiral structure of Fig. 7.
  • FIG. 12 is a schematic view of a tricuspid annuloplasty ring according to still another embodiment of the present invention.
  • Figure 13 is a schematic view showing the tubular spiral structure of the main body of the tricuspid valve forming ring according to still another embodiment of the present invention.
  • Figure 14 is a schematic view of a sheet metal strip forming the tubular spiral structure of Figure 13.
  • the invention provides a forming ring with different rigidity at different parts, which can better conform to the movement of the mitral or tricuspid valve in a direction perpendicular to the toric surface and parallel to the toric surface, and has better durability; Moreover, the manufacturing equipment and process are simple, and the adjustment of the rigidity is convenient.
  • the contour of the shaped ring of the present invention may be indistinguishable from the currently used or already documented prosthetic heart valve forming ring, for example, with the publication number CN101374478A, entitled "Valve forming ring for mitral valve prolapse"
  • the forming rings disclosed in the patent have the same contour.
  • the annular body structure can be formed into an open or closed annular structure having a planar or three-dimensional structure as needed. When the forming ring is of a closed structure, it can be realized by fixing, such as stitching, bonding, welding or ferrules of the closed joint portion of the forming ring.
  • the forming ring typically includes an outer layer and a body structure.
  • the outer layer is usually coated with a cloth-like material woven from a material such as polyester fiber or polytetrafluoroethylene on the outer periphery of the main body structure; the annular main body structure is crimped into a tubular spiral structure by a sheet metal strip; and then the curled tubular spiral structure is formed into a desired Planar or three-dimensional opening or closed loop structure.
  • the forming ring may further comprise an intermediate layer covering the outer layer of the main body.
  • the material of the intermediate layer is mostly made of silica gel to facilitate stitching with the heart.
  • the forming ring may also have no intermediate layer and is directly sutured with the heart through the outer layer.
  • the width of different parts of the strip used for rolling by adjusting the width of different parts of the strip used for rolling, the thickness of the strip, the pattern and density of the hollow on the strip, the pitch after rolling, and the diameter of the tubular spiral structure
  • the formed ring formed by the roll is subjected to rigidity adjustment.
  • the width of the strip when the coil is of equal pitch, by adjusting the width of the strip, the harder forming ring segment has a larger width, the softer forming ring segment has a smaller width, and then the rolled tubular spiral
  • the structure is formed into the desired contour of the forming ring to obtain the forming ring of the required rigidity; the pattern and density of the hollow strips can be adjusted, so that the rigid ring forming ring has less material to be removed.
  • the soft forming ring segment removes more material; or adjusts the thickness of the strip used and the diameter of the tubular spiral after rolling; it can also directly adjust the pitch so that the softer forming ring segment has a larger
  • the pitch of the harder forming ring segment has a smaller pitch to adjust the rigidity of the forming ring; the different ring segments of the forming ring have different stiffnesses by adjusting the wall thickness of the plate and the diameter of the tubular spiral structure after crimping;
  • the stiffness of the forming ring can also be adjusted in combination with the above several factors.
  • the annular main body structure can simultaneously adopt a plurality of strips of the same or different materials, and curl at the same time to form a double helix or a multi-spiral structure.
  • the direction of rotation of the sheet strip after crimping may be the same or different.
  • double helix or multi-spiral there may be direct welding or reinforcement at some points to weld, etc. in order to increase the local strength and increase the coordination of motion between the double helix or the multi-helix.
  • the strips used at the same time may be of the same material or different materials; and the strips used at the same time may have the same or different strip width structure and pattern structure. Wall thickness structure.
  • the material used for the main structure is usually a metal material such as medical stainless steel, cobalt-based alloy or nickel-titanium alloy; or a polymer material such as polytetrafluoroethylene or polypropylene.
  • the strips can be made into two tubular spiral structures with smaller and larger diameters as needed, and then the small tubular spiral structure is placed in a tubular spiral structure with a larger diameter, and then made into a plane or three-dimensional Open or closed annular structure.
  • the wire may be incorporated into the tubular structure that is crimped according to stiffness or other needs, and the wire used may be the same or different than the material of the sheet material.
  • a silica gel wire is installed in a tubular spiral structure made of stainless steel.
  • the mitral annuloplasty ring is a closed three-dimensional saddle structure, and the annular body is composed of a front ring segment 1, a rear ring segment 2, a left ring segment 3 and a right ring segment 4.
  • the upper arcuate protrusion of the forming ring is the front ring section 1, and the lower one is the rear ring section 2, and the two recessed sections are the left ring segment 3 and the right ring segment 4, respectively, the front ring segment 1 and the left ring segment 3
  • a connecting section 5 is provided between adjacent ring segments in the right ring segment 4, respectively.
  • the midpoint of the ring segment 2 is a joint point, and the forming ring is developed into a flat tubular spiral structure in the circumferential direction, and the outer diameter thereof can be l-3 mm, and the pitch is uniform.
  • the strips forming the spiral are unequal in width, and the strips used are usually 0.1-0.6 mm thick and are formed by laser cutting or stamping.
  • the middle portion of the sheet metal strip has a large width, a small width at both ends, and a gradual transition between the widths.
  • the loop segments of the forming ring are adjusted by the width of the sheet strip to facilitate coordinated movement of the forming ring with the cardiac contraction and diastolic cardiac cycle.
  • the rear ring segment 2, the left ring segment 3, and the right ring segment 4 are flexible ring segments, and the strip width is the smallest; the front ring segment 1 is opposite to the rear ring segment 2, the left ring segment 3, and the right ring segment 4.
  • the width of the strip is the largest; the width of the strip of the connecting section 5 is the two connected to it. Between the widths of the strips of the ring segments.
  • Fig. 3 is a cross-sectional view of the forming ring, using a tubular spiral structure in which a medical cobalt-chromium alloy sheet strip is crimped as a main body 8.
  • the outer layer 6 is a biocompatible polyester polyester fiber fabric that can be used to suture the heart during surgery.
  • the closed connection end of the medical cobalt-chromium alloy tubular spiral structure as the main body 8 is welded and connected to realize the closing of the forming ring; the medical polyester fiber fabric of the outer layer 6 is directly coated on the medical cobalt-chromium alloy by the sewing method.
  • the tubular spiral structure 8 is outside.
  • a heat shrinkable tube (not shown) may be additionally disposed between the outer layer 6 and the tubular spiral structure.
  • the arrangement of the heat-shrink tubing is more advantageous for three-dimensional shaping of the tubular spiral structure and prevention of structural changes during use.
  • the material may be usually a polymer material such as polytetrafluoroethylene, and is sheathed on the outer circumference of the tubular spiral structure by a heat shrinking process.
  • the artificial mitral annuloplasty ring provided by the embodiment realizes that the artificial mitral annuloplasty ring forms four motion units in front, back, left and right respectively due to different stiffness.
  • the front ring segment 1 with a large strip width (high stiffness) is mainly used to maintain the curvature of the artificial mitral annuloplasty ring to simulate the physiological mitral annulus structure, while the strip width is small (smaller stiffness)
  • the posterior ring segment 2, the left ring segment 3 and the right ring segment 4 correspond to the movement pattern of the artificial mitral annuloplasty ring to the physiological mitral annulus movement mode and requirements, and the connecting segment 5 is between them To the transition.
  • the artificial mitral annuloplasty ring of the present embodiment can coordinate movement with each cardiac cycle of the heart beat.
  • the present embodiment provides an artificial mitral valve forming ring
  • Fig. 5 is a tubular spiral structure in which the annular body of the forming ring is flattened in a circumferential direction.
  • Figure 6 is a strip of sheet material forming the tubular spiral structure of Figure 5.
  • the sheet metal strip in the embodiment is processed from a medical stainless steel sheet, and has a width larger than that of the sheet metal strip in the embodiment 1, and has a plurality of elongated hollow structures thereon.
  • the remaining shape and structure of the artificial mitral annuloplasty ring provided by this embodiment are the same as those of the artificial mitral annuloplasty ring in the first embodiment.
  • the invention achieves the purpose of adjusting the rigidity of each ring segment by the arrangement of the hollow structure.
  • This embodiment provides an artificial mitral annuloplasty ring having a shape as shown in Fig. 1, which is the same shape as the artificial mitral annuloplasty ring in the first embodiment.
  • the midpoint of the subsequent ring segment 2 is a closed connection point, and the forming ring body 8 is along the circumference of the ring.
  • the tubular spiral structure developed into a flat shape may have an outer diameter of l-3 mm and a uniform pitch.
  • the strips forming the spiral are unequal in width, and may have a thickness of usually 0.1 to 0.6 mm and formed by other methods such as laser cutting or stamping.
  • Fig. 10 is a strip of sheet material wound with the main structure.
  • the main structure is formed into a double-spiral structure by means of a double-plate strip as shown in the figure, so as to increase the resistance of the strip to fatigue. As shown in Fig.
  • Figure 11A is a partial schematic view of a double helix structure after rolling. It is also possible to weld the connecting ribs at certain locations of the two spiral structures with reference to Fig. 11B to promote the coordination of the motion between the different helical structures.
  • the front ring segment 1, the left ring segment 3 and the right ring segment 4 are flexible, and the strip width is the smallest; the rear ring segment 4 is rigid with respect to the front ring segment 1, the left ring segment 3 and the right ring segment 4, and the strip width is the highest;
  • the width of the strip of strip 5 is between the widths of the strips of the two loop segments to which it is attached.
  • the outermost layer 6 of the artificial mitral annuloplasty ring provided in this embodiment is a polyester fiber fabric, and has an intermediate layer 7, which is made of a silicone tube, and the main body 8 is curled by a medical cobalt-chromium alloy sheet strip. Formed, a cobalt-chromium alloy wire 9 is disposed in the tubular spiral structure.
  • Figure 9 is a longitudinal cross-sectional view of the closed junction of the forming ring.
  • the main body 8 medical cobalt-chromium alloy tubular spiral structure is directly welded to the cobalt-chromium alloy wire 9; the silicone tube as the intermediate layer 7 is tightly sleeved outside the medical nickel-titanium tubular spiral structure 8, and the joint is biocompatible.
  • the adhesive is bonded to the joint, and the outer layer 6 is a medical polyester fabric which is directly coated on the silicone tube 7 by a sewing method.
  • the mitral annuloplasty ring provided by the embodiment not only helps to maintain the physiological saddle shape with the change of the cardiac cycle, but also ensures the quality of the valve leaf, and the use of the wire can effectively prevent the three-dimensional shaping process and use after the forming ring is cut.
  • the structural changes in the process limit the maximum retractable length of the forming ring and prevent the valve leaf from being effectively restrained after prolonged use.
  • the present embodiment provides an artificial tricuspid annuloplasty ring having a three-dimensional structure conforming to the physiological shape of the tricuspid valve, as shown in Fig. 12, comprising a front ring segment 1, a rear ring segment 2 and a side ring segment 10.
  • the forming ring is developed into a flat tubular spiral structure in the circumferential direction of the ring.
  • the strips of the sheet material which are crimped to form the tubular spiral structure are uniform in width, and the rigidity of the strip segments of the tubular spiral structure is adjusted by adjusting the pitch of the different loop segments.
  • the front ring segment 1 has a larger pitch and a lower rigidity
  • the rear ring segment 2 and a portion of the side ring segment 10 have a smaller pitch and rigidity. Higher.
  • the outer layer 6 of the artificial tricuspid annulus provided by the embodiment is a polyester fiber fabric
  • the intermediate layer 7 is a silicone tube having an inner diameter larger than the outer diameter of the main tubular spiral structure
  • the main body 8 is a medical nickel-titanium tubular spiral structure. Both ends of the intermediate layer 7 and the outer layer 6 are directly sewn in such a manner that the main tubular spiral structure 8 is wrapped therein.
  • a polymer material such as silica gel may be filled in the gap of the sheet metal strip of the tubular spiral structure.
  • the arrangement may be, for example,: the tubular structure is detachably filled with a columnar material, and then the tubular spiral is immersed in the glue of the silica gel, and after drying, the internally filled columnar material is extracted to form a gap between the silica gel and the medical nickel-titanium alloy.
  • Tubular spiral structure It is also possible to immerse the tubular material in the glue of the silica gel without filling the columnar material, and after drying, form a tubular spiral structure in which the interior is filled with silica gel and the outer part is silica gel and medical nickel-titanium alloy.
  • the tricuspid annuloplasty ring provided in this embodiment is advantageous for maintaining the physiological three-dimensional shape with the change of the cardiac cycle, ensuring the quality of the valve leaf, and is applied in the clinical tricuspid valvuloplasty operation, so that it can coordinate with the cardiac cycle.
  • the above embodiments are merely illustrative of the technical solutions of the present invention, and are not intended to be limiting; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art The technical solutions described in the foregoing embodiments may be modified, or some or all of the technical features may be equivalently replaced; and the modifications or substitutions do not deviate from the technical solutions of the embodiments of the present invention. range.

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Abstract

一种人工心脏瓣膜成形环，包括外层（6）和内层主体结构（8），所述外层（6）包覆在内层主体结构（8）外，用于与心脏组织的缝合。所述内层主体结构（8）具有由板材条卷曲形成的管状螺旋结构，所述管状螺旋结构能调节该成形环刚性。该人工心脏瓣膜成形环结构简单，刚度容易调节，制作加工方便。

Description

人工心脏瓣膜成形环
技术领域
本发明涉及一种人工心脏瓣膜成形环， 属于医疗器械技术领域。 背景技术
心脏收缩时， 心脏二尖瓣和三尖瓣闭合， 使心室内的血液流入动脉， 同 时防止心室内的血液反流至心房。 瓣窦扩张， 瓣下腱索断裂， 瓣叶穿孔， 瓣 叶脱垂等疾病， 使得心室收缩时， 瓣叶不能够完全闭合， 造成血液回流心房。 成形环植入是临床上对病变二尖瓣和三尖瓣进行重塑以维持正常形状和轮廓 的重要手段， 可修复因疾病导致的二尖瓣和三尖瓣瓣叶闭和不完全造成的心 室反流等问题。
目前临床已经有应用的成形环主要有软环、 硬环和半硬环三类。 软环多 为二维结构， 主体多采用聚合物材料， 以能与瓣膜环面较好的贴合， 但软环 的材质过软， 不利于瓣叶的有效闭锁和瓣环的有效塑形。 硬环和半硬环为二 维平面结构或根据瓣膜环面设计的三维鞍形结构，鞍形结构在减少瓣叶应力， 提高耐受性方面有诸多优势。 硬环多采用金属材质， 具有较好的支撑强度， 但硬环不易弯曲， 无法实现与心动周期的协调运动。 半硬环结合软环和硬环 两者的优点， 通过对成形环主体的刚性调节， 使之在提供较好支撑强度的同 时， 能够有效地适应心脏收缩和舒张引起的瓣膜环面的变化， 因此开始受到 关注。
目前对于半硬环， 为达到调节刚性的目的， 如专利 US5607471公开了一 种成形环， 其环形主体结构为变直径的丝材， 通过调整丝材直径来调节各环 段的刚性，此种结构模具的设计和制造非常繁琐，制造工艺复杂； US6908482 等一族专利公开的成形环， 其环形主体结构采用金属带材直接制成成形环的 轮廓， 通过调节带材层数以实现对不同刚性的需求， 此方法制成的成形环在 前后环的接合处垂直环面方向的变形刚度很大。专利 US7220277公开的成形 环， 其环形主体结构采用管材， 且管材上镂空出圆形或其它形状的孔洞， 根 据孔的形状尺寸和位置来调整成形环的刚度， 然而该成形环在承受一定力的 情况下容易产生折断和开裂。 或者， 也有环形主体采用金属与聚合物结合的 方式调整整个成形环的刚性， 需要将金属环段与聚合物环段按刚度需要进行 匹配后再进行连接， 由于非常特殊的应用环境要求， 对于金属环段和聚合物 环段的加工， 以及二者的连接工序， 都必须有很严格的控制， 工序复杂， 也 增加了不良率， 同时， 对于部分这种结构设计在使用过程中， 金属与聚合物 接头处容易产生磨损， 会影响长期使用效果。 发明内容
本发明提供一种人工心脏瓣膜成形环， 在满足应用需求的同时， 刚性 易于调节， 结构简单， 便于制造， 并能够长期保持稳定的成形效果。
本发明提供一种人工心脏瓣膜成形环， 包括外层和环形主体结构， 所述 外层包覆在所述环形主体结构的外周， 其特征在于， 所述环形主体结构具有 由板材条卷曲形成的至少一层的管状螺旋结构， 所述管状螺旋结构能调节该 成形环刚性。
所述成形环的主体形状可以与现有技术相同， gP， 可由多个环段一体形 成， 例如可包括前环段、 后环段、 左环段、 右环段以及设置于他们之间的连 接段， 各个环段为一体结构， 共同形成闭合或开口的环形主体。 环形主体外 包覆了具有生物相容性的纤维织物层， 为符合医用标准的聚合物材料， 例如 医用聚酯织物。 所述管状螺旋结构为将板材条沿轴向卷曲后形成的结构， 其 结构大体为管状。
根据本发明提供的人工心脏瓣膜成形环， 所述管状螺旋结构具有由单个 所述板材条卷曲形成的单螺旋结构， 或者所述管状螺旋结构具有由多个所述 板材条卷曲形成的多螺旋结构。 其中多螺旋结构可以由多个旋向相同或不同 的单螺旋结构组成。
所述单螺旋结构各部位的螺距不全相同； 或者所述多螺旋结构中各个螺 旋结构之间的螺距不全相同。
根据本发明提供的人工心脏瓣膜成形环， 对于管状螺旋结构具有多个所 述板材条卷曲形成的多螺旋结构的情况， 所述多个板材条的材质可以不全相 同， 或者多个板材条的宽度可以不全相同， 这有利于进一歩改变和调节环形 主体的刚性。 根据本发明提供的人工心脏瓣膜成形环， 所述板材条的各处的宽度不全 相同， 不同宽度间可以采用阶梯或逐渐过渡的形式连接。
根据本发明提供的人工心脏瓣膜成形环， 所述管状螺旋结构具有由多个 所述板材条卷曲形成的多螺旋结构， 且多个所述板材条之间通过至少一个连 接部两两连接。 其连接方式可为直接焊接或加筋进行焊接等， 以便于增加局 部强度和多个所述板材条之间在运动时的协调一致性。
根据本发明提供的人工心脏瓣膜成形环， 所述板材条上可以具有镂空结 构， 以达到进一歩改变和调节环形主体的刚性的目的， 而对于所述镂空结构 的具体设置方式没有特别要求， 可以为不同形状的通孔， 例如可以是圆形、 椭圆形、 或例如三角形、 方形的多边形等其他形状及上述各种形状的组合。 当然， 从加工的便利以及保证管状螺旋结构的特性考虑， 也可以选择设置一 种确定形状的孔或者形状差异不大的孔。 根据本发明提供的人工心脏瓣膜成 形环， 同一所述板材条的不同部位的镂空结构不全相同； 或不同板条间的镂 空结构不全相同。
根据本发明提供的人工心脏瓣膜成形环， 所述管状螺旋结构由至少二层 套设而成， 每层管状螺旋结构分别由所述板材条卷曲形成。 在本发明中， 作 为环形主体的管状螺旋结构可以为单层， 也可以将外径较细的管状螺旋结构 插入内径较粗的管状螺旋结构内， 形成为具有双层或多层管状螺旋结构的环 形主体。 对于具有双层或多层管状螺旋结构的环形主体， 各层相同部位可采 用相同或不同的镂空率、 螺距或板材条宽度， 以实现不同环段对刚性的不同 需求， 使整个成形环满足与心动周期的良好匹配。
根据本发明提供的人工心脏瓣膜成形环， 所述管状螺旋结构内部设置有 能辅助调节所述成形环刚性的丝材。尤其是当环形主体结构的镂空率较高时， 为了使其长度和形状相对固定， 可以在环形主体结构的内部设置丝材， 辅助 调节成形环的刚性。 丝材的长度一般不大于管状螺旋结构的长度， 从而可设 置在管状螺旋结构的内部， 所述丝材可以是连续的、 也可以是间隔设置在管 状螺旋结构内。 丝材的使用可有效防止管状螺旋结构在三维定型和使用过程 中结构的变化， 限制成形环的伸缩长度， 防止发生长时间使用后不能有效的 对瓣叶进行限制的情况。丝材的材料可以为医用金属材料或医用聚合物材料， 设置方式也是常规方法， 本发明中不做限制。 根据本发明提供的人工心脏瓣膜成形环， 所述外层和所述管状螺旋结构 之间还设置有热缩管。 所述热缩管的设置更有利于管状螺旋结构的三维定型 和防止使用过程中结构的变化。 其材质通常可以为聚合物材料， 采用热缩工 艺套设于管状螺旋结构外周。
根据本发明提供的人工心脏瓣膜成形环， 在所述管状螺旋结构的板材条 间隙处填充有聚合物材料。 例如可使用注塑成型或者将管状螺旋结构浸泡于 聚合物的溶液或胶液中然后干燥的方法，在所述管状螺旋结构的板材条间隙 处填充与板材条不同材质的聚合物材料， 形成不同材料间隔设置的管状螺旋 结构。
根据本发明提供的人工心脏瓣膜成形环， 所述管状螺旋结构的外径可以 为 0.6-3mm。 对于具有多层管状螺旋结构的成形环， 所述外径可理解为最外 层管状螺旋结构的外径。
根据本发明提供的人工心脏瓣膜成形环， 板材厚度可以为 0.1-lmm。 对 于具有多层管状螺旋结构的成形环， 上述厚度可理解为多层管状螺旋结构的 板材条厚度之和。
本发明中， 所述环形主体多个环段板材条的宽度、 镂空率、 厚度、 以及 所述管状螺旋结构的螺距、 层数和外径可单独或相互结合进行调节以获得不 同刚性的所述成形环。 例如， 在选择和确定具有适当板材条宽度、 厚度、 管 状螺旋结构螺距、 层数和管径来获得成形环整体刚性的同时， 对形成管状螺 旋结构的板材条进行镂空， 通过对镂空率的调整 （即对镂空结构图案、 位置 和 /或密度的调整） ， 实现对环形主体刚性的进一歩调节。 该镂空结构可以设 置在每个环段， 或者选择在某个或某几个环段具有镂空结构， 而镂空结构在 不同环段上的镂空率可以相同或不同， 可以理解， 成形环的各环段之间的刚 度不相同或不全相同， 更利于临床应用。 或者还可以结合螺距的调整来满足 成形环对各环段的不同刚度需求。 例如对刚度要求较高的环段， 板材条采用 较低的镂空率或不进行镂空以及较小的螺距来实现； 刚度要求较低的环段， 板材条采用高镂空率以及较大的螺距来实现。
本发明中所使用的"镂空率"， 是指板材条上形成镂空的区域面积占板材 条面积的百分率， 可以通过开孔的形状、 大小、 分布情况等的设计来满足。
本发明中， 板材条上形成镂空结构可以通过任何可行的方法， 例如对于 金属板材条， 首选采用激光切割的方法。 在制备本发明中的成形环时， 可以 先截取所需长度的板材条， 通过激光切割或其他方法在板材条上切割出所需 要密度和结构的图案， 然后通过模具定形为最终结构； 或者定形为最终结构 后， 再通过三维柔性的激光切割或其他方法加工出所需密度和结构的镂空图 案。 上述加工方法在对成形环刚度进行调整时， 不需要重新设计和加工制作 成形环的主体模具， 简单方便。
根据本发明提供的人工心脏瓣膜成形环， 所述板材条可以为各种医用合 金或聚合物， 包括医用的镍钛合金板材条、 钴铬合金板材条、 钛合金板材条、 不锈钢板材条或聚合物板材条等。例如可以使用例如牌号为 316L不锈钢制成 的板材条，牌号为 MP35 , L605 , Elgiloy或 Phynox的钴铬合金制成的板材条， 钛合金 Ti6A14V制成的板材条， 镍钛合金 Ni-Ti制成的板材条， 聚合物板材 条例如可以使用聚乙烯、 聚四氟乙烯、 聚甲醛树脂或聚对苯二甲酸乙二醇酯 等材料制成的板材条。
根据本发明提供的人工心脏瓣膜成形环， 其外层与所述环形主体之间还 可以设置有中间层。 所述中间层的材料一般为硅胶， 便于将成形环与心脏缝 合的同时， 还可以使内部的管材结构更易于弯曲回弹， 起到对管材结构的固 定和有效稳定作用。 所述中间层可以采用圆管直接套至环形主体的外部， 也 可以以涂层、 热缩管或热缩膜的方式固定到环形主体外部。
本发明方案的实施， 至少具有以下优势：
1、本发明提供的人工心脏瓣膜成形环采用由板材条卷曲形成的管状螺旋 结构作为环形主体， 能够使各环段具有不同的刚度， 同时结构简单， 刚度容 易调节， 能够更好地适应二尖瓣或三尖瓣的运动特点；
2、 本发明人工心脏瓣膜修复用成形环， 在对成形环刚度进行调整时， 不需要重新设计和加工制作成形环的主体模具， 加工方法简单方便， 良品 率高， 且具有更好的耐久性。 附图说明
图 1为本发明的一个实施例提供的二尖瓣成形环示意图。
图 2为本发明的一个实施例提供的二尖瓣成形环主体管状螺旋结构的 展开示意图。 图 3为本发明的一个实施例提供的二尖瓣成形环横断面结构示意图。 图 4为形成图 2中管状螺旋结构的板材条的示意图。
图 5为本发明的另一实施例提供的二尖瓣成形环主体管状螺旋结构示 意图。
图 6为形成图 5中管状螺旋结构的板材条的示意图。
图 7为本发明的另一实施例提供的二尖瓣成形环主体管状螺旋结构示 意图。
图 8为本发明的又一实施例提供的二尖瓣成形环的横断面结构示意 图。
图 9为本发明的又一实施例提供的二尖瓣成形环闭环连接处的纵向剖 面图。
图 10为形成图 7中管状螺旋结构的板材条的示意图。
图 11A和图 11B为图 7中管状螺旋结构的局部放大图。
图 12为本发明的又一实施例提供的三尖瓣成形环示意图。
图 13为本发明的又一实施例提供的三尖瓣成形环主体管状螺旋结构 示意图。
图 14为形成图 13中管状螺旋结构的板材条的示意图。
附图标记说明
1 前环段
2 后环段
3 左环段
4 右环段
5 连接段
6 外层
7 中间层
8 环形主体结
9 丝材
10侧环段 具体实施方式 下面结合具体实施方案和实施例对本发明进行进一歩详细阐述， 旨在 帮助阅读者更好地理解本发明的实质内容， 不能理解为对本发明实施范围 的任何限定。
本发明提供一种不同部位具有不同刚度的成形环， 其在垂直于环面方 向和平行于环面方向均能够较好地符合二尖瓣或三尖瓣的运动， 具有更好 的耐久性； 且其制造设备和工艺简单， 刚度的调节方便。
本发明成形环的外形轮廓可以与目前临床使用的或已经有记载的人工心 脏瓣膜成形环没有区别， 例如， 与公开号为 CN101374478A、 发明名称为"用 于二尖瓣脱垂的瓣膜成形环"的专利中公开的成形环的外形轮廓相同。所述环 形主体结构可根据需要制成具有平面或三维结构的开口或闭合的环状结构。 当成形环为闭合结构时， 可以通过对成形环闭合连接部位的缝合、 粘接、 焊 接或卡套等固定方式实现。
成形环通常包括外层和主体结构。 外层通常采用聚酯纤维或聚四氟乙 烯等材料编织的布状材料包覆在主体结构外周； 环形主体结构采用板材条 卷曲成管状螺旋结构； 然后将卷曲成的管状螺旋结构制成所需的平面或三维 的开口或闭合的环状结构。成形环还可以包括中间层包覆在主体层外， 中间 层的材质多采用硅胶， 以便于与心脏的缝合， 成形环也可不具有中间层， 直接通过外层与心脏进行缝合。
对于卷制后管状螺旋结构，通过调整卷制所采用板材条不同部位的宽度、 板材条的厚度、 板材条上镂空的花型及密度、 卷制后的螺距， 以及管状螺旋 结构的直径等对卷制成的成形环进行刚度调整。 例如卷制后为等螺距时， 通 过调整板材条的宽度， 使较硬的成形环环段具有较大的宽度， 较软的成形环 环段具有较小的宽度， 然后将卷成的管状螺旋结构制成所需的成形环轮廓， 即可获得所需刚度的成形环；也可以对板材条上镂空的花型和密度进行调整， 使刚性较大的成形环环段去掉材料较少， 较软的成形环环段去掉材料较多； 或对所使用的板材条的厚度及卷制后管状螺旋结构的直径进行调整； 还可以 直接通过调整螺距， 使得较软的成形环环段具有较大的螺距， 较硬的成形环 环段具有较小的螺距来调整成形环的刚度； 也可通过板材壁厚及卷曲后管状 螺旋结构直径等的调整， 使成形环的不同环段具有不同刚度； 也可结合上面 上述几个因素对成形环的刚度进行调节。 环形主体结构可同时采用多个具有相同或不同材质的板材条， 同时卷曲， 制成双螺旋或多螺旋结构管材。板材条卷曲后的旋向可以相同， 亦可以不同。 对于双螺旋或多螺旋， 之间可在某些部位点直接焊接或加筋进行焊接等方式 以便于增加局部强度增加双螺旋或多螺旋之间的运动协调性。 当采用多个板 材条制成双旋或多旋结构， 同时采用的板材条可以为同种材质， 也可以为不 同材质； 同时采用的板材条可以具有相同或不同的条宽结构， 图案结构， 壁 厚结构。 主体结构所采用的材料通常为医用不锈钢、 钴基合金、 镍钛合金等 金属材料； 或聚四氟乙烯、 聚丙烯等高分子材料。
根据需要可以将板材条分别制成管径较小和较大的两个管状螺旋结构， 然后将小的管状螺旋结构在置于管径较大的管状螺旋结构内， 再制成平面或 三维的开口或闭合的环状结构。
另外可以根据刚度或其他需要， 在卷曲成的所述管型结构内部可以加入 丝材， 所使用的丝材可以为与板材条材料相同或不同。 比如在采用不锈钢制 的管状螺旋结构内装有硅胶丝。
以下结合附图对本发明的具体实施方式进行说明。
实施例 1
本实施例提供了一种人工二尖瓣成形环。 如图 1所示， 该二尖瓣成形环 为闭合的三维鞍形结构， 其环状主体由前环段 1、 后环段 2、 左环段 3和右环 段 4组成。 成形环较高的弓形凸起为前环段 1， 较低的凸起为后环段 2， 两个 凹陷段分别为左环段 3和右环段 4， 前环段 1、左环段 3和右环段 4中的相邻 环段之间分别设置有连接段 5。
如图 2所示， 以后环段 2的中点为连接点， 将该成形环沿环周方向展开 成平直状的管状螺旋结构， 其外径可以为 l-3mm， 且螺距一致。 形成该螺旋 状的板材条各处宽度不等，其所采用的板材条的厚度通常可为 0.1-0.6mm， 并 使用激光切割或冲压等方法加工形成。 如图 4所示， 该板材条的中间部分宽 度较大， 两端宽度较小， 不同宽度间逐渐过渡。
该成形环的各环段通过板材条宽度调整为有利于使得成形环随着心脏收 缩和舒张的心动周期协调运动。 如图 2所示， 后环段 2、 左环段 3和右环段 4 为柔性环段， 板材条宽度最小； 前环段 1相对于后环段 2、 左环段 3和右环 段 4为刚性环段， 板材条宽度最大； 连接段 5的板材条宽度在其所连接的两 个环段的板材条宽度之间。
图 3为该成形环的断面图， 使用医用钴铬合金板材条卷曲成的管状螺旋 结构作为主体 8。 外层 6为生物相容性良好的医用聚酯纤维织物， 可用于在 手术中与心脏缝合连接。
作为主体 8的医用钴铬合金管状螺旋结构的闭合连接端采用焊接的方式 进行连接， 实现成形环的闭合； 外层 6的医用聚酯纤维织物直接采用缝制的 方法包覆在医用钴铬合金管状螺旋结构 8外。
另外， 外层 6和管状螺旋结构之间还可以另外设置热缩管 （未图示） 。 所述热缩管的设置更有利于管状螺旋结构的三维定型和防止使用过程中结构 的变化。 其材质通常可以为聚合物材料， 例如聚四氟乙烯等， 采用热缩工艺 套设于管状螺旋结构外周。
本实施例提供的人工二尖瓣成形环实现了人工二尖瓣成形环在前、 后、 左和右分别因刚度的不同而形成四个运动单元。 板材条宽度较大 （刚 度较大） 的前环段 1主要用于维持人工二尖瓣成形环模拟生理性二尖瓣环 鞍形结构的曲度， 而板材条宽度较小 （刚度较小） 的后环段 2、 左环段 3 和右环段 4则与之呼应使得人工二尖瓣成形环的运动模式趋于生理性二尖 瓣环运动方式和要求， 连接段 5在他们之间起到过渡作用。 因此本实施例 的人工二尖瓣成形环可随心脏搏动的每个心动周期协调运动。
实施例 2
本实施例提供一种人工二尖瓣成形环， 图 5为将该成形环的环形主体 沿环周方向展开成平直状的管状螺旋结构。 图 6为形成图 5中管状螺旋结 构的板材条。 其中本实施例中的板材条由医用不锈钢板加工而成， 其宽度 大于实施例 1中的板材条， 且其上有多个长条形的镂空结构。 除此之外， 本实施例提供的人工二尖瓣成形环的其余形状及结构与实施例 1中的人工 二尖瓣成形环相同。 本发明通过镂空结构的设置来实现进一歩调节各环段 刚性的目的。
实施例 3
本实施例提供一种人工二尖瓣成形环， 其形状如图 1所示， 与实施例 1中的人工二尖瓣成形环形状相同。
如图 7所示， 以后环段 2的中点为闭合连接点， 该成形环主体 8沿环周 向展开成平直状的管状螺旋结构， 其外径可以为 l-3mm， 且螺距一致。 形成 该螺旋状的板材条各处宽度不等，其厚度通常可为 0.1-0.6mm， 并使用激光切 割或冲压等其他方法加工形成。 图 10为卷制该主体结构的板材条， 该主体 结构采用图示的双板材条方式， 卷制成双螺旋的结构， 以便于增加板材条 抵抗疲劳的能力。 如图 10所示， 该板材条的中间部分宽度较小， 两端宽度 较大， 不同宽度间逐渐过渡。 图 11A为卷制后双螺旋结构的局部示意图。 也可以参照图 11B对两个螺旋结构在某些部位焊接连接筋， 以促进不同螺 旋结构间的运动的协调性。
前环段 1、 左环段 3和右环段 4为柔性， 板材条宽度最小； 后环段 4相 对前环段 1、 左环段 3和右环段 4为刚性， 板材条宽度最高； 连接段 5的板 材条宽度为其所连接的两个环段的板材条宽度之间。
如图 8所示， 本实施例提供的人工二尖瓣成形环最外层 6为聚酯纤维织 物， 且具有中间层 7， 其材质为硅胶管， 主体 8为由医用钴铬合金板材条卷 曲形成， 管状螺旋结构内设置钴铬合金丝材 9。
图 9 为该成形环闭口连接处的纵向剖面图。作为主体 8医用钴铬合金 管状螺旋结构直接焊接到钴铬合金丝材 9上； 作为中间层 7的硅胶管紧密 套设在医用镍钛合金管状螺旋结构 8外， 接头处采用具有生物相容性的胶 粘剂进行对合粘接， 外层 6为医用的聚酯纤维织物， 直接采用缝制的方法 包覆在硅胶管 7外。
本实施例提供的二尖瓣成形环不仅利于维持随心动周期变化的生理 鞍状塑型， 保证瓣叶对合质量， 而且丝材的使用可有效防止成形环切割完 成后三维定型过程中和使用过程中结构的变化， 限制成形环最大可伸缩长 度， 防止长时间使用后不能有效的对瓣叶进行限制。
实施例 4
本实施例提供一种人工三尖瓣成形环， 其具有符合三尖瓣生理塑型的 三维结构， 如图 12所示， 由前环段 1、 后环段 2和侧环段 10组成。
如图 13所示， 将该成形环沿环周向展开成平直状的管状螺旋结构。 如图 14所示， 卷曲形成该管状螺旋结构的板材条各处宽度一致， 通过调 整该管状螺旋结构不同环段的螺距来进一歩调整其刚性。 其中， 前环段 1 的螺距较大， 刚性较低， 后环段 2和部分的侧环段 10的螺距较小， 刚性 较高。
本实施例提供的人工三尖瓣成形环外层 6为聚酯纤维织物， 中间层 7 为内径大于主体管状螺旋结构外径的硅胶管， 主体 8为医用镍钛合金管状 螺旋结构。 中间层 7和外层 6的两端采用直接缝合的方法以使主体管状螺 旋结构 8包裹在其中。
另外， 在所述管状螺旋结构的板材条间隙处还可以填充有聚合物材 料， 例如硅胶。 其设置方式可例如： 将管状螺旋结构内部可拆卸的填充柱 状材料， 然后将管状螺旋浸泡于硅胶的胶液中， 干燥后将内部填充的柱状 材料抽出， 形成硅胶和医用镍钛合金间隔设置的管状螺旋结构。 也可以不 填充柱状材料， 直接将管状螺旋浸泡于硅胶的胶液中， 干燥后形成内部填 充硅胶、 外部为硅胶和医用镍钛合金间隔设置的管状螺旋结构。
本实施例提供的三尖瓣成形环利于维持随心动周期变化的生理三维 塑型， 保证瓣叶对合质量， 应用于临床三尖瓣成形修复手术中， 使其能随 心动周期协调运动。 最后应说明的是： 以上各实施例仅用以说明本发明的技术方案， 而非 对其限制； 尽管参照前述各实施例对本发明进行了详细的说明， 本领域的 普通技术人员应当理解： 其依然可以对前述各实施例所记载的技术方案进 行修改， 或者对其中部分或者全部技术特征进行等同替换； 而这些修改或 者替换， 并不使相应技术方案的本质脱离本发明各实施例技术方案的范 围。

Claims

权 利 要 求 书
1、 一种人工心脏瓣膜成形环， 包括外层和环形主体结构， 所述外层包覆 在所述环形主体结构的外周， 其特征在于， 所述环形主体结构具有由板材条 卷曲形成的至少一层的管状螺旋结构， 所述管状螺旋结构能调节该成形环刚 性。
2、 根据权利要求 1所述的人工心脏瓣膜成形环， 其特征在于， 所述管状 螺旋结构具有由单个所述板材条卷曲形成的单螺旋结构， 或者所述管状螺旋 结构具有由多个所述板材条卷曲形成的多螺旋结构。
3、 根据权利要求 2所述的人工心脏瓣膜成形环， 其特征在于， 所述单螺 旋结构各部位的螺距不全相同； 或者所述多螺旋结构中各个螺旋结构之间的 螺距不全相同。
4、 根据权利要求 1-3任一项所述的人工心脏瓣膜成形环， 其特征在于， 所述管状螺旋结构具有由多个所述板材条卷曲形成的多螺旋结构， 且所述多 个板材条的材质不全相同。
5、 根据权利要求 1-3任一项所述的人工心脏瓣膜成形环， 其特征在于， 所述管状螺旋结构具有由多个所述板材条卷曲形成的多螺旋结构， 且所述多 个板材条的宽度不全相同。
6、 根据权利要求 1-3任一项所述的人工心脏瓣膜成形环， 其特征在于， 所述管状螺旋结构由至少二层套设而成， 每层管状螺旋结构分别由所述板材 条卷曲形成。
7、 根据权利要求 1-3任一项所述的人工心脏瓣膜成形环， 其特征在于， 所述的板条的各部位具有不同宽度， 且不同宽度间采用阶梯或逐渐过渡的形 式连接。
8、 根据权利要求 1-3任一项所述的人工心脏瓣膜成形环， 其特征在于， 所述管状螺旋结构具有由多个所述板材条卷曲形成的多螺旋结构， 且多个所 述板材条之间通过至少一个连接部两两连接。
9、 根据权利要求 1-3任一项所述的人工心脏瓣膜成形环， 其特征在于， 所述板材条上具有镂空结构。
10、 根据权利要求 9所述的人工心脏瓣膜成形环， 其特征在于， 同一所 述板材条的不同部位的镂空结构不全相同； 或不同板条间的镂空结构不全相 同。
11、 根据权利要求 1所述的人工心脏瓣膜成形环， 其特征在于， 所述管 状螺旋结构内部设置有能辅助调节所述成形环刚性的丝材。
12、 根据权利要求 1所述的人工心脏瓣膜成形环， 其特征在于， 所述外 层和所述管状螺旋结构之间还设置有热缩管。
13、 根据权利要求 1所述的人工心脏瓣膜成形环， 其特征在于， 在所述 管状螺旋结构的板材条间隙处填充有聚合物材料。
14、 根据权利要求 1所述的人工心脏瓣膜成形环， 其特征在于， 所述管 状螺旋结构的外径为 0.6-3mm。
15、 根据权利要求 1所述的人工心脏瓣膜成形环， 其特征在于， 所述板 材条的厚度为 0.1-lmm。
PCT/CN2014/073973 2013-12-31 2014-03-24 人工心脏瓣膜成形环 Ceased WO2015100857A1 (zh)

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