WO2009079915A1 - Prothèse endovasculaire rétractable pour valve - Google Patents

Prothèse endovasculaire rétractable pour valve Download PDF

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Publication number
WO2009079915A1
WO2009079915A1 PCT/CN2008/001941 CN2008001941W WO2009079915A1 WO 2009079915 A1 WO2009079915 A1 WO 2009079915A1 CN 2008001941 W CN2008001941 W CN 2008001941W WO 2009079915 A1 WO2009079915 A1 WO 2009079915A1
Authority
WO
WIPO (PCT)
Prior art keywords
cylindrical
support
stent
bracket
rear clamp
Prior art date
Application number
PCT/CN2008/001941
Other languages
English (en)
French (fr)
Inventor
Tao Wang
Kunling Tian
Original Assignee
Tao Wang
Kunling Tian
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 Tao Wang, Kunling Tian filed Critical Tao Wang
Publication of WO2009079915A1 publication Critical patent/WO2009079915A1/zh
Priority to US12/790,123 priority Critical patent/US8556958B2/en

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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
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • 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
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/043—Bronchi
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary

Definitions

  • the invention relates to a medical device, in particular to a valve stent for unidirectional circulation of a human body cavity for pulmonary diseases, bile ducts, blood aortic valves and obstructing anisotropic circulation in interventional therapy.
  • a medical device in particular to a valve stent for unidirectional circulation of a human body cavity for pulmonary diseases, bile ducts, blood aortic valves and obstructing anisotropic circulation in interventional therapy.
  • Emphysema, pulmonary bullae, and chronic obstructive pulmonary disease are common lung diseases.
  • surgery is generally based on lung volume reduction surgery. Due to the generally weak constitution and poor lung function, the patient cannot tolerate the surgical procedure, resulting in high mortality, which may result in some patients being unable to effectively treat or cure.
  • interventional therapy techniques it is possible to develop a stent and a check valve in the bronchus of the patient's lung target segment or below the segment, to achieve the one-way valve opening when exhaling, and one-way when inhaling.
  • the valve is closed, so that the amount of residual gas in the lungs of the lesion is reduced, and the secretion is discharged, eventually leading to collapse or fibrosis of the diseased lung.
  • the lungs gradually expand and play a compensatory role to improve the lung function of the patient; gallbladder, bile duct and blood aorta Valve lesions or abnormal circulation of the human lumen, also need to block the flow of anisotropic.
  • the above-mentioned bracket is provided with a hook body made of elastic metal. After being placed in the lumen, the hook body is inserted into the wall surface of the lumen to position the stent, which has the disadvantages that are difficult to overcome, such as the hook body has different degrees on the wall surface of the human lumen.
  • the injury is easy to cause complications such as perforation and long-term inflammation. In particular, it may cause a certain displacement of the stent to cause a certain displacement, which may cause the wall surface of the lumen to be scratched.
  • Another defect is that after the stent is positioned, such as stent damage, stent displacement or If the check valve is damaged, the bracket cannot be taken out directly from the human body, and it must be removed before surgery. When the stent is placed, it cannot be adjusted once released. Therefore, the existing interventional stent and check valve are urgently needed.
  • the object of the present invention is to disclose a unidirectional circulation of a human lumen which is recyclable and safe to use and which can be temporarily and permanently implanted for pulmonary diseases, bile ducts, blood aortic valves and obstructing anisotropic circulation. Valve stent.
  • a columnar bracket composed of a memory alloy material, in particular, a cylindrical sheet-shaped diaphragm is arranged in the columnar bracket, and at least one slit is formed on the diaphragm to form a flexible piece of the diaphragm.
  • One end of the columnar bracket is provided with a fixed fixture that fixes the alloy material of the column bracket, and the rear clamp has a thread connecting the conveyor.
  • the wire-shaped memory alloy material is woven into a columnar bracket, a two-strand alloy wire bundle is formed, and a rear clamp located at a pivotal position of the columnar support is fixed, and the columnar bracket is provided with two approximately elliptical openings at one end of the rear clamp; or braided
  • the alloy wire of the columnar support forms a three- or four-strand alloy tow and fixes the rear clamp at the axial position of the cylindrical support.
  • the cylindrical support is provided with three or four openings at one end of the rear clamp.
  • the columnar bracket is formed by laser etching of the alloy steel tube, and the part of the bracket is etched away from the diamond shape.
  • the support has at least three supports integrated with the bracket at one end, and the support is connected with the rear clamp.
  • the columnar bracket is formed by at least one wire spiral, and one end is provided with a rear clamp, preferably 2 to 4 alloy wires.
  • the other end of the columnar bracket is also provided with a front clamp, and the front and rear clamps can be symmetrically arranged or asymmetrically arranged.
  • the diaphragm has a cylindrical section adapted to the cylindrical bracket, and one end of the cylindrical section is integrally connected with a convex surface bulging toward the center of the circle, and the convex surface is provided with an unclosed circular slit; or two symmetric arcs are provided.
  • a slit having a linear slit between the two arcuate slits to form an approximate I-shaped slit; or a triangular slit extending from the center of the circle with an angle from the center of the circle; or a direction starting from the center of the circle
  • a cross gap extending around the circumference; respectively, forming one to four bendable elastic pieces.
  • Each of the elastic pieces of the diaphragm has a curved concave portion.
  • the thickness of the elastic piece gradually decreases from the circumferential edge to the center bulging position, and a cylindrical body is disposed at a position where the cylindrical section intersects the convex piece.
  • the inner or surface of the elastic piece is provided with a wire support body which can increase the elastic deformation and strength of the elastic piece.
  • the elastic piece is a piece whose diameter is adapted to the diameter of the columnar support and is rounded up by the center.
  • the elastic piece is connected with a clamp of the columnar support by a metal rod, and at least two slits are formed from the position close to the center of the circle to the edge of the elastic piece and form at least two Shrapnel; preferably three to four slits
  • the stent of the invention has a hook-free structure, which avoids the hook body of the prior art on the wall surface of the human lumen Injury and resulting complications, and accurate positioning adjustment of the stent, allowing the doctor to have at least one visible point during placement or recycling, enabling bidirectional insertion or recovery, safe and reliable, and the structure of the check valve Reasonable, with the characteristics of human heart valve, strong anti-reflux ability, reliable and durable, can be used for lung disease, bile duct, blood aortic valve and one-way valve stent that blocks the abnormal circulation of human lumen.
  • Figure 1 is a schematic view showing the structure of a first embodiment of a stent.
  • Figure 2 is a schematic view of the right side view of Figure 1.
  • Figure 3 is a schematic view showing the structure of a second embodiment of the stent.
  • Figure 4 is a schematic view of the right side view of Figure 3.
  • Fig. 5 is a schematic structural view of a third embodiment of the stent.
  • Figure 6 is a schematic view of the right side view of Figure 5.
  • Fig. 7 is a schematic structural view of a fourth embodiment of the bracket.
  • Figure 8 is a schematic view of the right side view of Figure 7.
  • Figure 9 is a schematic view showing the structure of a fifth embodiment of the stent.
  • Figure 10 is a schematic right side view of Figure 9.
  • Figure 11 is a schematic view showing the structure of a sixth embodiment of the stent.
  • Figure 12 is a schematic right side view of Figure 11;
  • Figure 13 is a schematic perspective view of Figure 11 .
  • Figure 14 is a cross-sectional structural view showing a first embodiment of the diaphragm.
  • Figure 15 is a schematic view showing the structure of the first embodiment of the elastic piece.
  • Figure 16 is a schematic view showing the structure of the second embodiment of the elastic piece.
  • Figure 17 is a schematic view showing the structure of a third embodiment of the elastic piece.
  • Figure 18 is a schematic view showing the structure of a fourth embodiment of the elastic piece.
  • Figure 19 is a cross-sectional view of a second embodiment of the diaphragm.
  • Figure 20 is a cross-sectional view showing a third embodiment of the diaphragm.
  • Figure 21 is a cross-sectional view showing a fourth embodiment of the diaphragm.
  • Figure 22 is a cross-sectional view showing a fifth embodiment of the diaphragm.
  • Figure 23 is a cross-sectional view showing a sixth embodiment of the diaphragm.
  • Figure 24 is a right side view of Figure 23 .
  • Figure 25 is a plan sectional view of Figure 23 .
  • Figure 26 is a cross-sectional view showing a seventh embodiment of the diaphragm.
  • Figure 27 is a right side view of Figure 26.
  • Figure 28 is a cross-sectional view showing an eighth embodiment of the diaphragm.
  • Figure 29 is a right side view of Figure 28.
  • Figure 30 is a cross-sectional view showing a ninth embodiment of the diaphragm.
  • Figure 31 is a right side view of Figure 30.
  • Figure 32 is a cross-sectional view showing a tenth embodiment of the diaphragm.
  • Figure 33 is a right side view of Figure 32.
  • Figure 34 is a schematic view showing the overall structure of a first embodiment of the product of the present invention.
  • Figure 35 is a right side view of Figure 34.
  • Figure 36 is a schematic view showing the entire structure of a second embodiment of the product of the present invention.
  • Figure 37 is a right side view of Figure 36.
  • Figure 38 is a schematic view showing the overall structure of a third embodiment of the product of the present invention.
  • Figure 39 is a right side view of Figure 38.
  • Figure 40 is a schematic view showing the overall structure of a fourth embodiment of the product of the present invention.
  • Figure 41 is a right side view of Figure 40.
  • Figure 42 is a schematic view showing the entire structure of a fifth embodiment of the product of the present invention.
  • Figure 43 is a right side view of Figure 42.
  • Figure 44 is a schematic view showing the overall structure of a sixth embodiment of the product of the present invention.
  • Figure 45 is a right side view of Figure 44.
  • Figure 46 is a schematic view showing the overall structure of a seventh embodiment of the product of the present invention.
  • Figure 47 is a right side view of Figure 46.
  • Figure 48 is a schematic view showing the overall structure of an eighth embodiment of the product of the present invention.
  • Figure 49 is a right side view of Figure 48.
  • Figure 50 is a perspective view of the state of Figure 48.
  • Figure 51 is a schematic view showing the overall structure of a ninth embodiment of the product of the present invention.
  • Figure 52 is a right side view of Figure 51.
  • Figure 53 is a schematic perspective view of Figure 51. detailed description: Referring to FIG. 1 to FIG. 53 , a specific embodiment of the present invention is as follows: Referring to FIG. 1 to FIG. 2 , a columnar bracket 1 composed of a memory alloy material is provided, and in particular, an elastic sheet-like diaphragm 2 is disposed in the columnar bracket 1 .
  • the diaphragm 2 is provided with at least one slit to form the flexible piece 15 of the diaphragm 2, and one end of the columnar bracket 1 is provided with a fixed fixture 3 for fixing the alloy material of the column bracket, and the rear clamp 3 has a thread connecting the conveyor;
  • the memory alloy material is a nickel-titanium alloy wire or an alloy steel pipe
  • the columnar bracket 1 is a cylindrical hollow simplified body, which may be woven from a plurality of alloy wires, or may be spirally formed from one or more alloy wires, or may be an alloy steel pipe.
  • the cylindrical stent 1 is provided with an elastic sheet-like membrane 2, which is made of polyester, polytetrafluoroethylene, polyurethane, medical silica gel or polyester cloth, and is provided on the membrane 2 There is at least one slit to form the flexible sheet 15 of the diaphragm 2, and one end of the columnar bracket 1 is provided with a fixed fixture 3 for fixing the alloy material of the columnar bracket.
  • an elastic sheet-like membrane 2 which is made of polyester, polytetrafluoroethylene, polyurethane, medical silica gel or polyester cloth, and is provided on the membrane 2
  • one end of the columnar bracket 1 is provided with a fixed fixture 3 for fixing the alloy material of the columnar bracket.
  • the rear clamp 3 is a cylinder, and the outer end surface of the cylinder has Internal thread or column
  • the body has a tapping thread
  • the columnar bracket 1 has a predetermined expanded shape and a relative elongation, which can be screwed with a guide wire in a tubular conveyor through the thread of the rear clamp 3, and the cylindrical bracket 1 is in a retracted state.
  • At least one alloy wire bundle 7 is formed and then fixed to the rear clamp 3, and the cylindrical support 1 is provided with a rear clamp 3 end forming at least one opening 5;
  • 1 is a plurality of nickel-titanium alloy wires woven into a cylindrical hollow mesh cylinder through a die, one end of which is open, and the mesh surface is a grid shape, and after forming a hollow mesh shape, the ends of the alloy wires at the other end of the simple body are self-aligned.
  • the ends are no longer mesh-woven, but are gathered together in a monofilament to form at least one alloy tow 7, and the alloy tow 7 is fixed to the rear clamp 3, and the cylindrical holder 1 is provided with at least one end of the rear clamp 3 An opening 5, the opening 5 allows gas or liquid to pass therethrough; see Fig. 1 and Fig.
  • the two alloy tows 7 are opposite to each other and are oriented obliquely to the center of the simple body, and the end lines are the same as one.
  • the rear clamp 3 of the axial position of the body is fixed to form an approximately tapered shape (shown in Fig. 1), and two oppositely elliptical openings 5 (shown in Fig. 2) are formed on the tapered surface, from the columnar shape
  • the airflow or liquid entering the end face of the bracket 1 is divided by the two openings 5 and passes therethrough.
  • the two alloy tows 7 form an integral structure with the columnar bracket 1 through the rear clamp 3, a support body is formed on the cylindrical bracket 1
  • the radial support force of the columnar support 1 can be enhanced, and the rear clamp 3 can make the cylindrical support 1 have a visible point where the axial position of the cylindrical support 1 is located; or the alloy wire of the cylindrical support 1 can be formed into a three- or four-strand alloy tow 7 and then fixed.
  • a rear clamp 3 located at the axial position of the cylindrical support 1 the cylindrical support 1 is provided with three or four openings 5 at the end of the rear clamp (shown in Figures 5 to 8); the plurality of alloy wires are equally divided into three alloy wires.
  • the end line of the three-strand alloy tow 7 is the same as the back clip 3 fixed, three approximately circular openings 5 (shown in Fig. 6) are formed in the tapered surface, and the three openings 5 can reduce the small flow cross section and reduce the flow amount, but form three columns for the columnar bracket 1.
  • the support body enhances the radial support force of the columnar support 1; the plurality of alloy wires described above may also be equally divided into four alloy wire bundles 7, and the four-strand alloy tow 7 forms four approximately circular openings 5 on the tapered surface (Fig.
  • the four openings 5 further reduce the small flow cross section and further reduce the flow amount, and form four support bodies for the columnar bracket 1 to enhance the radial supporting force of the bracket 1; the above-mentioned alloy wire can also be divided
  • the plurality of strands 7 are formed to form a plurality of openings 5, and the number of openings 5 is selected according to the amount of gas to be passed or the flow rate of the liquid.
  • the data obtained in the experiment indicates the number of openings 5. It is best to use 14 or more. If there are more than 4 openings, the effect of the amount of gas or liquid passed will decrease and the flow of liquid or liquid will be reduced excessively. Referring to FIG. 3 to FIG.
  • the other end of the columnar bracket 1 is also provided with a front clamp 4, and the front and rear clamps 4, 3 can be symmetrically arranged or asymmetrically arranged; in order to realize the bidirectional insertion of the cylindrical bracket 1 Or recycling, after knitting into a simple shape, the alloy wire at one end thereof is divided into the alloy tow 7 and fixed to the rear jig 3, and the alloy wire at the other end is also divided into the alloy tow 7 and fixed by the front jig 4, the columnar bracket 1 The two ends form opposite openings 5. If the alloy tow 7 has three strands, the two ends of the filament-shaped column holder 1 have three opposite openings 5 (shown in FIG.
  • the axis of the bracket 1 is symmetrical (shown in FIG. 40), and the symmetrically disposed front clamp 4 and rear clamp 3 are applied to the wire-like cylindrical support 1 of the alloy tow 7 more than one strand, and the mesh obtained by laser etching
  • the other end of the bracket 1 is also provided with a support 6 which is fixed to the front clamp 4 so that the laser etched bracket has a clamp at each end thereof; for the cylindrical bracket 1 having the largest diameter, the front clamp 4 and the rear clamp 3
  • the asymmetric setting is adopted, that is, the front and rear clamps are respectively disposed on opposite side walls of the columnar bracket 1, and the front clamp 4 and the rear clamp 3 are parallel to the axis of the cylindrical bracket 1 (shown in FIG.
  • each of the two ends of the bracket 1 is formed with a diameter close to the diameter of the cylindrical bracket 1
  • An approximately circular opening 5 shown in Figure 39
  • the outer end of the front clamp 4 is also provided with internal threads or tapped threads on the cylinder, threaded to connect or disengage the conveyor, front clamp 4 and rear clamp 3, the above-mentioned columnar bracket 1 has a fixture at each end, so that the columnar bracket 1 has two visible points, the doctor can release or retract the columnar bracket 1 through the front clamp 4 or the rear clamp 3, the viewpoint shown is Ultrasonic or X-ray can easily reflect the point. Under the direction of the viewpoint, the doctor can easily position it. According to the actual situation, the columnar bracket 1 can be placed or retracted through the front clamp 4 or through the rear clamp 3. The direction is selected to achieve double-direction insertion or recycling, making operation more convenient and safe.
  • the above-mentioned filamentary cylindrical stent 1 is provided with at least one concave ring 18 having a trapezoidal cross section (shown in FIG. 34), and the concave ring 18 can enhance the filament shape.
  • the radial support strength of the columnar bracket 1 can also cause the inner wall of the human body lumen to be squeezed into the ring 18 to form a bracket for the inner wall of the human body lumen, to maintain the stability of the positioning of the filamentous columnar bracket 1, and the oblique side 21 of the concave ring 18
  • the diaphragm 2 placed in the filamentary columnar stent 1 forms a support and a sealing effect.
  • the columnar bracket 1 is a mesh-shaped bracket obtained by laser etching of an alloy steel tube, and the etched portion has a shape resembling a diamond shape, and at least one support 6 is integrally formed at one end of the bracket, and the support 6 Connected to the rear jig 3;
  • the columnar support 1 is formed by laser etching of an alloy steel pipe, and the portion of the wall of the alloy steel that is laser-etched is shaped like a 'diamond shape, forming a rhombic column (shown in FIG. 9).
  • the radial support capability is large and has a good fit with the inner wall of the human body lumen.
  • a support of a straight section extending obliquely to the axis of the cylindrical support 1 is provided at one end of the cylindrical support 1
  • the support 6 is integrated with the columnar bracket 1 , and the support 6 is connected to the rear clamp 3 (shown in FIG. 10 ).
  • the support 6 is at least three, preferably four, and the other end of the cylindrical support 1
  • a support 6 may also be provided to provide a clamp at each end of the cylindrical support 1 so that the cylindrical support 1 can be placed or recovered in both directions.
  • the columnar bracket 1 is formed by at least one alloy wire spiral, and one end is provided with a rear clamp 3, preferably 2 to 4 alloy wires; the columnar support 1 is composed of one or more alloy wire spirals.
  • a spiral cylinder is formed, and the number of the alloy wires is preferably 2 to 4 alloy wires.
  • three alloy wires are taken as an example (shown in FIG.
  • the clamp 3 is centered and equiangularly distributed along the axial direction of the rear clamp 3, and each spiral ring is wound into a spiral cylinder in a diameter-increasing manner, and then the other end of the alloy wire is welded or fixed by a front clamp 4.
  • the diameter of the front clamp 4 of the formed spiral cylinder is slightly larger than the diameter of the portion of the proximal clamp 3 (shown in FIG. 11), forming a frustum shape, and the frustum-shaped spiral body has a good mosaic ability with the inner wall of the human lumen.
  • the spiral columnar bracket 1 can greatly reduce the amount of alloy wire used and has a high radial bearing force, because the spiral bracket can be made into a small diameter bracket and has great compression and extension. Deformation characteristics, so it can be installed in the conveyor of very small diameter, placed in the lumen of the human body with a small diameter, and the large-diameter spiral stent can be released or retracted through the small-diameter conveyor, avoiding the use.
  • the large-diameter conveyor may cause damage to the inner wall of the lumen, and the spiral bracket is in contact with the wall surface of the human lumen, so that the wall surface has a certain unevenness, and the stability is increased.
  • the diaphragm 2 has a cylindrical section 8 which is matched with the columnar bracket 1.
  • the cylindrical section 8 is integrally connected with a convex surface 9 which is convex toward the center of the circle, and the convex surface 9 is provided with an unclosed circular slit 10 Or two symmetric arc-shaped slits 11 are provided, and a linear slit 12 is connected between the two arc-shaped slits 11 to form an approximate I-shaped slit; or a triangle extending from the center of the circle with an equal angle from the center of the circle a slit 13; or a cross slit 14 extending from the center of the circle to the periphery of the circle; respectively, forming one to four bendable elastic pieces 15; see FIG.
  • the diaphragm 2 is a cylindrical shape, and the cylindrical section 8
  • the outer diameter of the cylindrical bracket 1 is matched with the inner diameter of the cylindrical bracket 1 and is placed in one end of the cylindrical bracket 1.
  • the cylindrical section 8 is integrally integrated with the cylindrical bracket 1, and one end of the cylindrical section 8 is open, and a circular center position is provided therein.
  • the base of the cone is integrally connected with the bottom edge of the cylindrical section 8, and the tapered side forms a convex surface 9, and the thickness of the convex surface 9 gradually decreases from the bottom edge of the circular cone to the center of the circular ridge, and the diaphragm 2
  • the cross-sectional shape approximates a vertical M shape (shown in Figure 14) 9 has the convex surface of a cutting tool by a very fine slit, the slit form 10, a circular annular gap unclosed gap 10, the convex surface 9 is formed with a sheet-like elastic piece 15 (shown in FIG.
  • the elastic piece 15 of approximately 3/4 circle, and the elastic shape of the elastic piece 15 is V-shaped; when the diaphragm 2 is not subjected to an external force, the elastic piece 15 and the convex surface are formed. 9 are bonded together to form a closed surface, and when the airflow or liquid enters from the bottom end A of the diaphragm 2, the airflow or liquid moves toward the slit along the inner wall of the tapered convex surface 9 toward the top of the cone, so that the elastic piece 15 is
  • the connecting portion with the diaphragm 2 is a fulcrum and is bent upward and opened at an angle, so that the convex surface 9 in the closed state forms an opening through which air or liquid can flow, and the elastic piece 15 can flow with the air or liquid.
  • the airflow or liquid reverses from the top end B of the diaphragm 2, the airflow or liquid is divided into two vortices by the tapered convex surface 9, and most of the pressure is transferred to the inner wall surface of the cylindrical section 8.
  • the elastic piece 15 is forced to be tightly clamped with the circular slit 10 to form a closed surface to block the passage of air or liquid;
  • the diaphragm 2 constitutes a one-way valve, has a one-way opening work, and can have a certain anti-reflux capability.
  • the slit on the convex surface 9 may be an approximate I-shaped slit, which is composed of two symmetric curved slits 11 and a straight slit 12, wherein the straight slit 12 is located between the two curved slits 11 and the two arcs
  • the slits 11 are connected, and the I-shaped slits form the convex surface 9 to form two opposite and approximately semi-circular elastic pieces 15 (shown in FIG.
  • the two elastic pieces 15 can be bent upward and downward, opening the opening, and the I-shaped slit
  • the anti-return ability is stronger than the anti-return ability of the circular slit 9; or the slit on the convex surface 9 is a triangular slit 13 which extends at an equal angle from the center of the circle to the periphery of the circle so that the convex surface 9 forms three
  • the triangular elastic piece 15 (shown in FIG.
  • the anti-backflow capability of the three elastic pieces 15 is greater than the anti-backflow capability of the I-shaped slit; or the slit on the convex surface 9 is a cross gap 14
  • Cross slit 14 makes the convex
  • the face 9 forms four springs 15 of four triangles in a top state (shown in FIG. 18), and the anti-backflow capability of the four triangular spring pieces 15 is greater than that of the triangular slits 13; It is in the shape of a meter to form a plurality of shrapnel, but the effect of excessive shrapnel is reduced.
  • the diaphragm 2 described above is composed of a cylindrical section 8 and a cone (shown in Fig. 19).
  • the diameter of the cone bottom of the cone is equal to the diameter of the cylindrical section 8, and the base of the cone-shaped convex surface 9 of the cone and the cylindrical section 8
  • the end edges of the structure are integrally connected, and the manufacturing process of the diaphragm 2 of the structure is relatively simple.
  • the diaphragm 2 described above is composed of a cylindrical section 8, a cylinder 21 and a cone (shown in Fig. 20), wherein the diameter of the cylinder 21 is smaller than the diameter of the cylinder section 8, and the diameter of the cone is smaller than that of the cylinder section 8.
  • the diameter is larger than the diameter of the cylinder 21, and the bottom edge of the convex surface 9 formed by the tapered side of the cone is One end of the cylinder 21 is connected, and the other end of the cylinder 21 is connected to one end of the cylindrical section 8.
  • the cylinder 21 forms a groove between the cylindrical section 8 and the cone, which makes the diaphragm 2 have a certain Deformation margin, due to the existence of the groove, the cylindrical bracket 1 may be deformed by compression after being placed in the human body, and the cylindrical segment 8 also has a certain deformation, since the diameter of the cylinder 21 is smaller than the diameter of the cylindrical segment 8, the cylinder The body 21 has only a slight deformation accompanying the deformation of the cylindrical section 8, and the deformation is reduced, so that the cone is substantially unaffected by the deformation, and the original shape is maintained, thereby preventing the cone from being deformed and causing the closure to be unsatisfactory, and Can increase the elasticity of the overall diaphragm.
  • the diaphragm 2 described above consists of a cylindrical section 8, a cylinder 22 and a cone (shown in Fig. 21), wherein the diameter of the cylinder 22 is smaller than the diameter of the cylindrical section 8, and the diameter of the cylinder 22 is conical with the cone.
  • the bottom diameter is equal, the cylinder 22 and the cone are placed in the cavity of the cylindrical section 8, the bottom edge of the convex surface 9 of the cone is connected to one end of the cylinder 22, and the other end of the cylinder 22 is opposite to the cylindrical section 8.
  • the bottom edge is connected, and the outer wall of the cylinder 22 and the inner wall surface of the cylindrical section 8 have a spacing 23 which has the same deformation margin as the aforementioned groove, and since the axial length of the cylindrical section 8 is long, The contact area with the stent is increased and the coverage with the stent is better.
  • the diaphragm 2 described above is composed of a cylindrical section 8, a cylinder 24, a cylinder 25 and a spherical cap 26 (shown in Fig. 22), wherein the diameter of the cylinder 24 is smaller than the diameter of the cylindrical section 8, and the diameter of the cylinder 25 is smaller than
  • the diameter of the cylindrical section 8 is larger than the diameter of the cylinder 24, the bottom diameter of the spherical crown 26 is equal to the diameter of the cylinder 25, and the cylindrical section 8, the cylinder 24, the cylinder 25 and the spherical crown 26 are sequentially connected in one body, and the cylinder
  • the body 24 forms a groove between the cylindrical section 8 and the cylinder 25, and the groove has the same effect as the aforementioned groove;
  • the convex surface 9 of the spherical crown 26 has a spherical surface, and there is also a spherical surface on the spherical surface 26
  • the cutter is cut into a very thin slit, which may be an unclosed
  • Each of the elastic pieces 15 of the diaphragm 2 has a curved concave portion 20; the thickness of the elastic piece 15 gradually decreases from the circumferential edge to the center of the ridge, and a cylindrical body is arranged at the intersection of the cylindrical portion and the convex piece; 23 to 25, the diaphragm 2 is composed of a cylindrical section 8 and a cylindrical body 27 (shown in FIG. 23), and a cylindrical concave portion 20 is formed at a near intermediate position of the cylindrical body 27, and the two curved concave portions 20 are opposed to each other. Close together (shown in Fig. 25), and a continuous slit 19 (shown in Fig.
  • the curved recess 20 on the cylinder 27 constitutes the elastic piece 15, when the gas or liquid enters the cylinder At 27 o'clock, it is compressed and concentrated toward its top slit 19, and the sheet-like elastic piece 15 having the curved recessed portion 20 is punched open, and the maximum opening degree of the elastic piece 15 can reach the diameter of the cylindrical body 27 ,
  • the opening degree can be automatically adjusted according to the size of the flow, and the sheet-like elastic piece 15 having the curved concave portion 20 facilitates the outflow of the forward airflow, further increases the flow of the gas blocking the reverse flow, and improves the one-way diaphragm.
  • the function of the check valve if the gas or liquid flows back, the pressure acts directly on the curved trap 20, forcing the edges of the two shrapnel to clamp each other, sealing the slit 19 to effectively prevent the backflow phenomenon;
  • the shrapnel of 20 is close to the structure of the human heart valve, and the one-way sealing effect is the best, and the anti-reflux ability is the strongest, and the spacing 28 formed by the combination of the cylinder 27 and the cylindrical section 8 causes the cylindrical section 8 to be subjected to the radial direction.
  • the cylinder 22 When the pressure may be deformed, the cylinder 22 is not affected by the deformation of the cylindrical segment 8, and remains in the original shape; the curved concave portion 20 of the cylindrical body 27 may be three, that is, the top end of the cylindrical body 22 is divided into three equal parts. The angles are kneaded together to form three curved recesses 20 (shown in Fig.
  • the top ends of the cylinders 27 are kneaded at four equal angles to form four curved recesses 20 in a state of apex angle, and the four curved recesses 20 constitute a total of four shrapnels.
  • Four straight slits 19 are formed (shown in FIG. 29); the above-mentioned curved recessed portions 20 may be provided in plurality, but more than four elastic sheets are practically meaningless, and the optimum range is 2 to 3 elastic pieces.
  • the elastic piece 15 is a piece whose diameter is adapted to the diameter of the columnar bracket 1 and is rounded up by the center.
  • the elastic piece 15 is connected to a clamp of the columnar support 1 through a metal rod 17, and at least two slits 29 are from the center of the circle to the position
  • the edge of the elastic piece 15 is formed with at least two elastic pieces, preferably three to four slits 29;
  • the diaphragm 2 is an umbrella body (or bowl shape) whose thickness gradually decreases from the center of the top of the umbrella body toward the edge of the umbrella body (shown in FIG.
  • the umbrella body has a plurality of slits 29 having a length smaller than the radius of the umbrella body from the edge toward the center of the circle.
  • the slits 29 are evenly distributed at the center of the center of the umbrella body, and the umbrella body surface connected between the two slits 29 is formed.
  • a elastic piece 15 is provided with a wire support body 16 (shown in FIG. 31) inside or on the surface of the elastic piece 15 for the purpose of imparting a certain strength to the elastic piece 15 and increasing the elastic deformation of the elastic piece and having a shape memory characteristic.
  • the wire support body 16 is provided. It is a memory alloy wire which can be wrapped in the elastic piece or disposed on the surface, and the support body is equivalent to the rib of the canopy surface, and is formed and fixed so that the elastic pieces maintain a curved shape and serve as a skeleton.
  • the elastic piece forms a support; in order to keep the diaphragm 2 in an umbrella shape, the center of the top of the umbrella body is fixed to a metal rod 17, and the metal rod 17 extends outward from the inside of the umbrella body and is fixed to the rear clamp 3 of the columnar bracket 1, and is shaped like an opening.
  • the umbrella, the metal rod 17 can make the elastic piece formed by the slit 29 open and close around it, and maintain the positioning position of the diaphragm 2; the above-mentioned metal rod 17 can also extend outward from the top surface of the umbrella and the columnar bracket 1
  • the front clamp 4 is fixed (shown in Fig. 32), and its function is the same as that described above, and the plurality of slits 29 can be formed with a plurality of elastic pieces I 5 , but
  • the three-to-west shrapnel 15 formed by three to four slits 29 is preferred.
  • one end of the columnar bracket 1 is open, and the other end is fixed by the rear clamp 3, and the two alloy wires 7 are formed with two openings 5, and the diaphragm 2 is placed in the columnar bracket 1, and the diaphragm 2 can be
  • the suture, the lamination or the method of directly forming the stent is integrated with the stent, and the bottom edge of the cylindrical section 8 of the membrane 2 is flush with the open edge of the cylindrical stent 1 and closely combined with the inner wall of the cylindrical stent 1
  • the bottom of the tapered convex surface 9 of the sheet 2 abuts against the invaginated wall surface formed by the concave ring 18 (shown in Fig.
  • each of the elastic pieces (shown in FIG. 35) on the convex surface 9 of the diaphragm 2 is provided with a support body 16 (shown in Fig. 35), which is a memory alloy wire.
  • the support body serves as a skeleton to support the elastic piece and maintains the shape of the convex surface 9 to increase its strength and to have shape recovery memory characteristics. When used, it is transported.
  • the guide wire in the lumen of the tube and the rear of the cylindrical stent 1 3 can be screwed with its single release or retraction direction.
  • one end of the above-mentioned columnar bracket 1 is fixed by the front clamp 4, two alloy tows 7 are formed with two openings 5, and the other ends of the two alloy strands 7 fixed by the rear clamp 3 are also formed with two The opening 5, the diaphragm 2 is placed in the columnar bracket 1, and the bottom edge thereof is abutted against the edge of the alloy bundle 7 (shown in Fig. 36) to which the front clamp 4 is fixed, and each of the elastic sheets on the convex surface 9 of the diaphragm 2 is placed thereon.
  • a support body 16 (shown in FIG. 37) may be provided, and the guide wire in the lumen of the conveyor may be screwed to the rear clamp 3 or screwed to the front clamp 4 to release or retract it in both directions.
  • the support body is a wire metal, and the support body 16 can be placed on the surface of the diaphragm, or can be placed inside the diaphragm, such as integrally processed, or the diaphragm 2 is composed of two layers of material, and the support 16 is placed in the second layer of material. between.
  • the columnar bracket 1 is an asymmetric arrangement of the front clamp 4 and the rear clamp 3.
  • the convex surface 9 of the diaphragm 2 is a spherical surface, and the gap on the cylindrical cover is an unclosed circular slit (FIG. 39
  • the unclosed circular slit is matched with the cylindrical bracket 1 in which the front clamp 4 and the rear clamp 3 are asymmetrically arranged, so that the flow cross section is increased, the flow rate is also increased, and the columnar shape can be obtained by the front clamp 4 or the rear clamp 3
  • the stent 1 is released or retracted in both directions.
  • the diaphragm 2 is placed in a cylindrical bracket 1 symmetrically disposed with a front clamp 4 and a rear clamp 3 (shown in FIG. 40).
  • the bracket has three openings 5, and the diaphragm 2 has a head.
  • the diaphragm 2 is placed in a cylindrical bracket 1 symmetrically disposed with a front clamp 5 and a rear clamp 4 (shown in FIG. 42).
  • the bracket has four openings 5, and the diaphragm 2 has a head.
  • Spherical The slit is a cross-shaped slit 12 which is staggered with the west opening 5 (shown in Fig. 43), and the cylindrical bracket 1 can be released or retracted in both directions by the front jig 4 or the rear jig 3.
  • one end of the columnar bracket 1 is fixed by the front clamp 4, and two alloy tows 7 are formed with two openings 5, and the other end is fixed by the rear clamp 3 to form two alloy tows 7 and two openings 5 are formed.
  • the diaphragm 2 is placed in the column holder 1, and one end of the metal rod 17 is connected to the front clamp 4, and the other end is connected to the center portion of the dome of the diaphragm 2, and the outer peripheral edge of the umbrella body abuts against the loop of the column holder 1.
  • 18 formed in the invagination wall surface shown in FIG.
  • the inset wall forms a sealing opening (similar to the valve edge) facing the diaphragm 2, and the metal rod 17 stretches the diaphragm 2 to maintain the umbrella shape.
  • the airflow or liquid enters from the front clamp 4, it is collected toward the periphery of the umbrella top of the diaphragm 2, so that the elastic piece 15 composed of the slit 29 is bent in the direction of the pressed rearward clamp 3, and the outer edge thereof is separated from the inner wall surface of the concave ring 18.
  • the umbrella diameter of the umbrella diaphragm 2 is reduced to form an annular opening, from which airflow or liquid flows out, and if it flows back, the airflow or liquid tightly seals the edge of the elastic piece 15 with the inner wall of the ring 18.
  • the metal rod 17 Press together to form a closed surface, Blocking airflow or liquid passage, and the metal rod 17 forms a tensile and topping action on the diaphragm 2 when the airflow or liquid is positive and backward; the metal rod 17 described above may extend outward from the interior of the umbrella body and with the cylindrical bracket 1
  • the rear clamp 3 is fixedly connected to an open umbrella shape, and the metal rod 17 forms a top support and a tensile action on the diaphragm 2 when the airflow or the liquid is flowing or flowing back (shown in FIG. 46), maintaining the shape of the diaphragm 2. .
  • the diaphragm 2 is placed in the spiral columnar bracket 1.
  • the shape of the diaphragm 2 can be selected from one of the diaphragms 2 described above, but the cylindrical section 8 of the diaphragm 2 is also The frustum shape is adapted to match the spiral cylinder. If the diaphragm 2 is in the shape of an umbrella, the diameter of the diaphragm 2 corresponds to the diameter of a spiral of the spiral cylinder, which may depend on the length of the metal rod 17.
  • the various diaphragms 2 described above are applicable to the above-mentioned filament-shaped columnar stent, laser-etched mesh columnar stent and spiral columnar stent, and can be selected according to the required airflow or liquid flux, and the elastic piece 15
  • the inner or surface may be provided with a wire support 16 that increases the elastic deformation and strength of the elastic.

Description

技术领域：
本发明涉及一种医疗器械， 具体是指一种介入治疗中用于对肺部疾病、 胆管、 血液主动脉瓣及阻挡异向流通的人体管腔单向流通的瓣膜支架。 背景技术：
肺气肿、 肺大泡和慢性阻塞性肺病等均是肺部常见病症， 除去以药物抗 感染的治疗方法外， 外科一般以肺减容手术为主。 由于患者一般体质较弱 和肺功能较差， 出现不能耐受手术过程， 导致死亡率高， 导致一部分患者 无法有效地治疗或根治。 随着介入性治疗手段技术的成熟， 发展出可在患 者的肺部靶区气管段或段以下支气管内置入一支架和一单向阀， 达到呼气 时单向阀开通， 吸气时单向阀关闭， 从而使病变肺部部位残气量减少， 使 分泌物流出， 最终导致病肺萎陷或纤维化， 健肺逐渐扩张发挥代偿作用， 改善患者肺功能； 胆囊、 胆管及血液主动脉瓣病变或人体管腔发生异向流 通， 同样需阻挡异向流通。 上述的支架设有弹性金属制成的钩体， 置入管 腔后， 钩体刺入管腔壁面后将支架定位， 其存在难以克服的缺点， 如钩体 对人体管腔壁面会有不同程度伤害易造成穿孔及长期炎症等并发症， 特别 是可能导致支架受力较大产生一定的位移， 进而导致管腔壁面被划伤； 另 一缺陷是支架定位后， 如支架损坏、 支架偏移或单向阀损坏， 无法将支架 从人体中直接取出， 须手术才可取出， 并且支架在置入时， 一旦释出便不 可进行调整， 因此， 现有的介入性的支架与单向阀急需进行改进。 发明内容：
本发明的发明目的是公开一种可回收且使用安全可靠的既可临时又可 长期植入的用于对肺部疾病、 胆管、 血液主动脉瓣及阻挡异向流通的人体 管腔单向流通的瓣膜支架。
实现本发明的技术解决方案如下： 包括记忆合金材料构成的柱状支架， 特别是柱状支架内设有一具弹性的片状膜片， 膜片上设有至少一个缝隙使 膜片形成可弯曲的弹片， 柱状支架的一端设有一固定构成柱状支架合金材 料的固定后夹具， 后夹具具有连接输送器的螺紋。 所述的丝状记忆合金材料编织为柱状支架后， 形成至少一股合金丝后再 固定于后夹具， 柱状支架的设有后夹具一端形成至少一个开口。
所述的丝状记忆合金材料编织为柱状支架后， 形成一股合金丝束后固定 位于柱状支架侧壁上缘的后夹具， 柱状支架的设有后夹具一端形成一个近 似圆形的开口。
所述的丝状记忆合金材料编织为柱状支架后， 形成二股合金丝束后固定 位于柱状支架轴心位置的后夹具， 柱状支架设有后夹具一端形成二个近似 椭圆形的开口； 或编成柱状支架的合金丝形成三股或四股合金丝束后固定 位于柱状支架轴心位置的后夹具， 柱状支架设有后夹具一端形成三个或四 个开口。
所述的柱状支架由合金钢管经激光刻蚀得到的网状支架， 蚀刻掉部分形 状近似菱形， 支架一端有与支架一体的至少三根支撑， 支撑与后夹具连接。
所述的柱状支架由至少一根合金丝螺旋形成，一端设有后夹具，优选 2 ~ 4根合金丝。
所述的柱状支架的另一端亦设有一前夹具， 前、 后夹具可对称设置或非 对称设置。
所述的膜片有一与柱状支架相适配的圆柱段， 由圆柱段一端一体连接有 一向圆心位置隆起的凸出面， 凸出面上设有一未封闭的圆形缝隙； 或设有 两对称的弧形缝隙， 两弧形缝隙的之间有一直线缝隙相连通形成一近似工 字形缝隙； 或设有以圆心为起点的等夹角向圆周边延伸的三角缝隙； 或设 有以圆心为起点的向圆周边延伸的十字缝隙； 分别设有形成一至四个可弯 曲的弹片。
所述的膜片的每一弹片均有一曲面凹陷部。
所述的弹片的厚度从圆周边缘向圆心隆起位置逐渐减小， 且圆柱段与凸 出片相交处设有一圆柱体。
所述的弹片内部或表面设有可增加弹片弹性变形和强度的金属丝支撑 体。
所述的弹片为一直径与柱状支架直径相适应并圆心隆起的片状物， 通过 一金属杆将弹片与柱状支架的一个夹具连接， 至少两条缝隙自接近圆心位 置至弹片边缘并形成至少两个弹片； 优选三〜四条缝隙
本发明的支架为无钩体结构， 避免了已有技术的钩体对人体管腔壁面的 伤害及导致的并发症， 并可对支架进行精确的定位调整， 在置入或回收时 使医生有至少一个可视点， 可实现双方向的置入或回收， 安全可靠， 并单 向阀的结构合理， 具有人体心脏瓣膜的特性， 抗返流能力强， 可靠耐用， 可用于对肺部疾病、 胆管、 血液主动脉瓣及阻挡人体管腔异向流通的单向 瓣膜支架。 附图说明：
图 1为支架的第一实施例的结构示意图。
图 2为图 1的右视结构示意图。
图 3为支架的第二实施例的结构示意图。
图 4为图 3的右视结构示意图。
图 5为支架的第三实施例的结构示意图。
图 6为图 5的右视结构示意图。
图 7为支架的第四实施例的结构示意图。
图 8为图 7的右视结构示意图。
图 9为支架的第五实施例的结构示意图。
图 10为图 9的右视结构示意图。
图 11为支架的第六实施例的结构示意图。
图 12为图 11的右视结构示意图。
图 13为图 11的立体状态示意图。
图 14为膜片的第一实施例的剖视结构示意图。
图 15为弹片第一实施例的结构示意图。
图 16为弹片第二实施例的结构示意图。
图 17为弹片第三实施例的结构示意图。
图 18为弹片第四实施例的结构示意图。
图 19为膜片的第二实施例的剖视图。
图 20为膜片的第三实施例的剖视图。
图 21为膜片的第四实施例的剖视图。
图 22为膜片的第五实施例的剖视图。
图 23为膜片的第六实施例的剖视图。
图 24为图 23的右视图。 图 25为图 23的俯视剖面图。
图 26为膜片的第七实施例的剖视图。
图 27为图 26的右视图。
图 28为膜片的第八实施例的剖视图。
图 29为图 28的右视图。
图 30为膜片的第九实施例的剖视图。
图 31为图 30的右视图。
图 32为膜片的第十实施例的剖视图。
图 33为图 32的右视图。
图 34为本发明产品的第一实施例的整体结构示意图。 图 35为图 34的右视图。
图 36为本发明产品的第二实施例的整体结构示意图。 图 37为图 36的右视图。
图 38为本发明产品的第三实施例的整体结构示意图。 图 39为图 38的右视图。
图 40为本发明产品的第四实施例的整体结构示意图。 图 41为图 40的右视图。
图 42为本发明产品的第五实施例的整体结构示意图。 图 43为图 42的右视图。
图 44为本发明产品的第六实施例的整体结构示意图。 图 45为图 44的右视图。
图 46为本发明产品的第七实施例的整体结构示意图。 图 47为图 46的右视图。
图 48为本发明产品的第八实施例的整体结构示意图。 图 49为图 48的右视图。
图 50为图 48的立体状态示意图。
图 51为本发明产品的第九实施例的整体结构示意图。 图 52为图 51的右视图。
图 53为图 51的立体状态示意图。 具体实施方式: 请参见图 1 ~图 53 , 本发明的具体实施例如下： 请参见图 1〜图 2, 包 括记忆合金材料构成的柱状支架 1 ,特别是柱状支架 1内设有一具弹性的片 状膜片 2 , 膜片 2上设有至少一个缝隙使膜片 2形成可弯曲的弹片 15， 柱 状支架 1的一端设有一固定构成柱状支架合金材料的固定后夹具 3 ,后夹具 3具有连接输送器的螺紋； 记忆合金材料为镍钛合金丝或合金钢管， 柱状支 架 1 为一圆柱形中空简体， 其可由多根合金丝编织而成， 也可由一根或多 根合金丝螺旋而成， 还可为合金钢管蚀刻而成， 柱状支架 1 的腔内设有一 具弹性的片状膜片 2 , 膜片 2为聚脂、 聚四氟乙烯、 聚氨脂、 医用硅胶或涤 纶布制成， 膜片 2上设有至少一个缝隙使膜片 2形成有可弯曲的弹片 15 , 柱状支架 1的一端设有一固定构成柱状支架合金材料的固定后夹具 3，后夹 具 3为一柱体， 其柱体的外端面有内螺紋或柱体上有攻丝螺紋， 柱状支架 1 具有预设的扩展形状及相对伸长率， 其可通过后夹具 3 的螺紋与一管状输 送器内的导丝螺接， 柱状支架 1 在缩回状态时收回输送器内， 在释出时自 输送器的端部伸出， 当柱状支架 1 全部从输送器释出后， 其预设的形状横 向伸展并与人体管腔内壁紧密结合定位， 此时膜片 2 上的由缝隙而形成的 弹性弹片 15在受到气体或液体的作用下产生单向弯曲以打开或关闭膜片 2 形成的开口， 使气体或液体单向通过或阻挡通过； 后夹具 3 与输送器内的 导丝螺接将柱状支架 1 以压缩拉伸状装入输送器内， 通过输送器将其置入 人体管腔， 或通过输送器内的导丝与后夹具 3 螺接将已置入人体管腔的柱 状支架 1收回， 后夹具 3并使柱状支架 1具有一可视点。
所述的丝状记忆合金材料编织为柱状支架 1后， 形成至少一股合金丝束 7后再固定于后夹具 3 , 柱状支架 1的设有后夹具 3—端形成至少一个开口 5; 柱状支架 1为多根镍钛合金丝经模具编织成一圆柱形中空网状筒体， 其 一端为敞口状， 网面为格栅形， 形成中空网状简体后， 简体另一端的合金 丝各端线自该端起不再进行网形编织， 而以单丝状聚集在一起形成至少一 股合金丝束 7 , 合金丝束 7则与后夹具 3固定， 柱状支架 1的设有后夹具 3 一端形成至少一个开口 5 , 开口 5可使气体或液体从其通过； 请参见图 1 图 2 , 上述的丝状记忆合金材料编织为柱状支架 1后， 形成二股合金丝束 7 后固定位于柱状支架 1轴心位置的后夹具 3 ,柱状支架 1设有后夹具 3—端 形成二个近似橢圆形的开口 5; 形成中空网状筒体后， 简体另一端的合金丝 各端线自该端起不再进行网形编织， 而被均分成二股合金丝束 7 , 每股合金 丝束 7 的合金丝以单丝状形式向筒状体圆心弯折并进行曲线过渡并聚拢， 该两股合金丝束 7相对并同向简状体圆心斜向， 其端线同由一位于简状体 的轴心位置的后夹具 3固定， 形成一近似锥状（图 1所示）， 并且在锥面上 形成了二个相对的近似椭圆形的开口 5 (图 2所示）， 从柱状支架 1端面敞 口处 A进入的气流或液体被两开口 5分流并从中通过，由于两股合金丝束 7 通过后夹具 3与柱状支架 1形成一体结构， 故对柱状支架 1构成一支承体, 可增强柱状支架 1的径向支撑力，后夹具 3使柱状支架 1具有一柱状支架 1 轴心位置所在的可视点； 或编成柱状支架 1 的合金丝形成三股或四股合金 丝束 7后固定位于柱状支架 1轴心位置的后夹具 3 ,柱状支架 1设有后夹具 3—端形成三个或四个开口 5 (图 5 ~图 8所示）； 多根合金丝被均分成三股 合金丝束 7 , 三股合金丝束 7的端线同由被后夹具 3固定， 在锥面等分形成 了三个近似圆形的开口 5 (图 6所示）， 该三个开口 5可减少小流通截面， 使流通量减少， 但并对柱状支架 1构成三个支承体， 增强柱状支架 1的径 向支撑力； 上述的多根合金丝还可均分成四股合金丝束 7 , 四股合金丝束 7 在锥面上形成了四个近似圆形开口 5 (图 8所示）， 该四个开口 5进一步减 少小流通截面， 亦使流通量进一步减少， 并对柱状支架 1构成四个支承体， 增强支架 1的径向支撑力； 上述的合金丝还可被分为多股合金丝束 7 , 以形 成个多个开口 5，而开口 5数量的多少则根据所需通过的气量或液体的流量 的大小选用，在实验中所获得的数据表明，开口 5的数量以 1 4个为最佳， 若开口 5多于 4个， 则通过的气量或液体的效果会随之增多而降低， 过多 的减少气流或液体的流通量巳无实际应用意义。 . 请参见图 3〜图 4, 所述的丝状记忆合金材料编织为柱状支架 1后， 形 成一股合金丝束 7后固定位于柱状支架 1侧壁上缘的后夹具 3 , 柱状支架 1 的设有后夹具 3—端形成一个近似圆形的开口 5;为使丝状柱状支架 1有最 大的通径， 丝状柱状支架 1 由多根合金丝编织为柱状后， 柱状支架 1一端 的合金丝均向该端的一侧壁上缘汇集， 汇成一股合金丝束 7 后再与设置于 侧壁上缘的后夹具 3固定（图 3所示）， 形成了一个直径接近于柱状支架 1 直径的近似圆形的开口 5 (图 4所示）， 该开口可使气流或液体以最大流量 通过， 形成柱状支架 1最大的通径， 对流量的影响最小。
请参见图 38〜图 41，所述的柱状支架 1的另一端亦设有一前夹具 4，前、 后夹具 4、 3可对称设置或非对称设置； 为使柱状支架 1实现双方向的置入 或回收， 其编织成简形后，其一端的合金丝被分成合金丝束 7后与后夹具 3 固定， 另一端的合金丝也被分成合金丝束 7并由前夹具 4固定， 柱状支架 1 的两端形成相对的开口 5 , 如合金丝束 7为三股， 则丝状柱状支架 1的两端 各有三个相对的开口 5 (图 41所示），前夹具 4与后夹具 3同处于柱状支架 1的轴线呈对称状态（图 40所示）， 对称设置的前夹具 4和后夹具 3适用于 合金丝束 7多于一股的丝状柱状支架 1 ,而由激光刻蚀得到的网状支架 1的 另一端也设有支撑 6 , 支撑 6与前夹具 4固定，使激光刻蚀的支架的两端各 有一夹具； 对于具有最大通径的柱状支架 1 , 则前夹具 4与后夹具 3釆用非 对称设置， 即前、 后夹具分别设置于柱状支架 1 的两端相对侧壁上， 前夹 具 4及后夹具 3与柱状支架 1的轴线呈平行状态 （图 38所示）， 使柱状支 架 1 两端各形成有一直径接近于柱状支架 1直径的近似圆形的开口 5 (图 39所示）， 前夹具 4的外端面也设有内螺紋或柱体上有攻丝螺紋， 螺紋使其 与输送器连接或脱开， 前夹具 4和后夹具 3使上述的柱状支架 1两端各具 有一夹具， 使柱状支架 1有两个可视点， 医生可通过前夹具 4或后夹具 3 将柱状支架 1释出或收回， 所示的视点是指在超声波或 X光线可易于反映 出的点， 在视点的指示下， 医生易于安置定位， 并可根据实际情况选择是 通过前夹具 4或是通过后夹具 3将柱状支架 1置入或收回， 进行不同的方 向选择， 实现双方向的置入或回收， 使操作更方便、 安全。
为增强丝状柱状支架 1的径向强度， 上述的丝状柱状支架 1上设有至少 一道凹环 18， 凹环 18的截面为梯形 （图 34所示）， 凹环 18既可增强丝状 柱状支架 1的径向支承强度， 又可使人体管腔内壁向 环 18挤入使支架对 人体管腔内壁形成嵌夹， 保持丝状柱状支架 1定位的稳固， 并且凹环 18的 斜边 21对置于丝状柱状支架 1内的膜片 2形成支撑及封闭作用。
请参见图 9〜图 10, 所述的柱状支架 1由合金钢管经激光刻蚀得到的网 状支架， 蚀刻掉的部分的形状近似菱形， 支架一端有与支架一体的至少三 根支撑 6， 支撑 6与后夹具 3连接； 柱状支架 1由一合金钢管经激光刻蚀制 成， 合金钢的管壁被激光蚀刻掉的部分的形状近似'菱形， 形成菱格状柱体 (图 9所示）， 其径向支承能力大并与人体管腔内壁有较好的嵌撑， 为使其 可置入或回收， 在柱状支架 1一端设有向柱状支架 1轴线斜向延伸的呈直 线段的支撑 6 , 支撑 6与柱状支架 1为一体结构， 支撑 6—端与后夹具 3连 接 （图 10所示）， 支撑 6至少为三根， 最好为四根， 柱状支架 1的另一端 也可设有支撑 6 , 使柱状支架 1的两端各设有一夹具， 以使柱状支架 1可进 行双方向的置入或回收。
请参见图 11 ~图 13 , 所述的柱状支架 1 由至少一根合金丝螺旋形成， 一端设有后夹具 3， 优选 2 ~ 4根合金丝； 柱状支架 1由一根或多根合金丝 螺旋形成一螺旋状柱体， 其合金丝的根数优选为 2 ~ 4根合金丝， 本实施例 以三根合金丝为例 （图 13所示）， 三根合金丝的一端均与后夹具 3固定， 并以后夹具 3为圆心并等角均布沿后夹具 3轴线方向进行螺旋， 各螺旋圈 以增径方式绕成一螺旋柱体， 然后合金丝的另一端焊固在一起或由一前夹 具 4固定， 所形成的螺旋柱体的近前夹具 4部分的直径略大于近后夹具 3 部分的直径 （图 11 所示）， 形成锥台状， 锥台状的螺旋体与人体管腔内壁 具有良好的镶嵌能力， 并且柱状支架 1 的后夹具 3固定的三根合金丝在该 端面形成有三个开口 5 ,该三个开口与前夹具 4所固定的合金丝所形成的三 个开口呈交错状（图 12所示）， 螺旋状的柱状支架 1可极大减少合金丝的 使用量并具有较高的径向支承力， 由于螺旋状支架可制成直径很小的支架 并有极大的缩压及展伸变形特性， 故可被装入极小直径的输送器内， 安置 于人体很小直径的管腔内， 并且可将大直径尺寸的螺旋状支架通过小直径 的输送器释出或收回， 避免使用大直径的输送器而对管腔内壁可能造成的 损伤， 螺旋状支架与人体管腔的壁面接触， 可使壁面有一定的凹凸， 使稳 定性增加。
所述的膜片 2有一与柱状支架 1相适配的圆柱段 8 ,由圆柱段 8—端一体 连接有一向圆心位置隆起的凸出面 9 ,凸出面 9上设有一未封闭的圆形缝隙 10; 或设有两对称的弧形缝隙 11 , 两弧形缝隙 11的之间有一直线缝隙 12 相连通形成一近似工字形缝隙； 或设有以圆心为起点的等夹角向圆周边延 伸的三角缝隙 13; 或设有以圆心为起点的向圆周边延伸的十字缝隙 14; 分 别设有形成一至四个可弯曲的弹片 15; 请参见图 14, 膜片 2为一圆柱形， 其圆柱段 8的外径与柱状支架 1的内径相适配且置于柱状支架 1一端内， 圆柱段 8用于与柱状支架 1结合为一体， 圆柱段 8的一端敞口， 其内设有 一向圆心位置隆起的圆锥体， 圆锥体的底边与圆柱段 8 的底边一体连接， 其锥边形成凸出面 9 ,凸出面 9的厚度自圆圆锥体的底边向圆心隆起位置逐 渐减小， 膜片 2的截面形状近似一竖直的 M形 （图 14所示）， 凸出面 9上 有一由刀具切割为极细的缝隙， 该缝隙呈未封闭的圆形缝隙 10, 圆形缝隙 10使凸出面 9形成有一近 3/4圆的薄片状的弹片 15 (图 15所示）， 弹片 15 的截面形状呈 V形； 当膜片 2未受到外力作用情况时， 弹片 15与凸出面 9 贴合在一起形成一封闭表面， 而当气流或液体自膜片 2的底端 A进入后， 气流或液体沿锥形凸出面 9的内壁面向锥顶部集中向缝口运动， 使弹片 15 以其与膜片 2连接部分为支点而向上发生弯曲并打开一个角度， 使处于封 闭状态的凸出面 9 形成了一个开口， 气流或液体便可从该开口中流出， 弹 片 15可随气流或液体流量的增大而使其开度增大； 若气流或液体反向自膜 片 2顶端 B进入， 气流或液体被锥形凸出面 9分成两股涡流， 将大部分压 力转至圆柱段 8内壁面， 同时挤压弹片 15迫使其与圆形缝隙 10紧密夹紧， 形成封闭表面， 阻挡气流或液体通过； 膜片 2构成一单向阀， 具有单向开 通功,能及一定的抗返流能力， 当压力很高时， 会有少许气流或液体经弹片 15与圆形缝隙 10之间的配合间隙中渗漏， 但不会产生影响， 另圆柱段 8的 长度（轴向长度） 可增长， 以增加与支架的结合面积； 上述的凸出面 9 上 的缝隙可为一近似工字形缝隙，其由两对称的弧形缝隙 11和一直线缝隙 12 构成， 其中直线缝隙 12位于两弧形缝隙 11的之间并将两弧形缝隙 11相连 通， 工字形缝隙使凸出面 9形成二个相对并近似于半圆的弹片 15 (图 16所 示）， 该两弹片 15 可各向上及下发生弯曲， 打开开口， 工字形缝隙的抗返 流能力较圆形缝隙 9的抗返流能力强；或凸出面 9上的缝隙为三角缝隙 13, 该三角缝隙以圆心为起点的等夹角向圆周边延伸使凸出面 9形成三个呈对 顶状态的三角形的弹片 15 (图 17所示）， 该三个弹片 15的抗返流能力大于 工字形缝隙的抗返流能力； 或上述的凸出面 9上的缝隙为十字缝隙 14 , 十 字缝隙 14使凸出面 9形成呈对顶状态的四个三角形的四个弹片 15 (图 18 所示；)，四个三角形弹片 15的抗返流能力又大于三角缝隙 13的抗返流能力； 上述的缝隙还可为米字形， 以形成多片弹片， 但过多的弹片其效果反而降 低。
上述的膜片 2 由一圆柱段 8和一圆锥体组成 （图 19所示）， 圆锥体的锥 底直径与圆柱段 8直径相等， 圆锥体的锥边凸出面 9的底边与圆柱段 8的 端边一体连接， 该结构的膜片 2制作工序较为简单。
上述的膜片 2由一圆柱段 8、 一圆柱体 21和圆锥体组成 （图 20所示）， 其中圆柱体 21的直径小于圆柱段 8的直径， 且圆锥体的底径小于圆柱段 8 的直径并大于圆柱体 21的直径， 圆锥体的錐边所形成的凸出面 9的底边与 圆柱体 21的一端边连接， 圆柱体 21另一端边则与圆柱段 8的一端边连接， 圆柱体 21使圆柱段 8与圆锥体之间形成一道 槽， 该凹槽使膜片 2具有一 定的变形余量， 由于该凹槽的存在， 故柱状支架 1 置入人体后可能因压缩 而产生一定变形， 圆柱段 8随之也产生一定变形， 由于圆柱体 21直径小于 圆柱段 8的直径， 圆柱体 21仅随圆柱段 8的变形而有微小的变形， 起到减 缓变形作用， 使圆锥体基本不受变形的影响， 仍保持原形状， 防止圆锥体 也随之变形而造成关闭不严， 并可增加整体膜片的弹力。
上述的膜片 2由圆柱段 8、一圆柱体 22和一圆锥体组成（图 21所示：)， 其 中圆柱体 22的直径小于圆柱段 8的直径， 且圆柱体 22的直径与圆锥体的 底径相等， 圆柱体 22和圆锥体同置于圆柱段 8腔内， 圆锥体的凸出面 9的 底边与圆柱体 22的一端边连接， 圆柱体 22的另一端边则与圆柱段 8的底 边连接， 圆柱体 22的外壁与圆柱段 8内壁面之间有一间距 23， 该间距 23 与前述的凹槽有相同的变形余量作用， 并且由于圆柱段 8的轴向长度较长， 其与支架的接触面积增大且与支架的覆合更好。
上述的膜片 2由一圆柱段 8、 圆柱体 24、 圆柱体 25和一球冠 26组成（图 22所示）， 其中圆柱体 24的直径小于圆柱段 8的直径， 圆柱体 25的直径小 于圆柱段 8的直径且大于圆柱体 24的直径， 球冠 26的底径与圆柱体 25的 直径相等， 圆柱段 8、 圆柱体 24、 圆柱体 25和球冠 26依次顺序连接为一 体， 且圆柱体 24使圆柱段 8和圆柱体 25之间形'成一道凹槽， 该凹槽与前 述的凹槽具相同的效果； 球冠 26的凸出面 9呈一球面， 在该球面上同样有 一由刀具切割为极细的缝隙， 其可为未封闭的圆形缝隙或工字形缝隙或三 角缝隙或十字缝隙以构成弹片 15，球冠 26可使气体或液体基本不被压缩而 将弹片 15打开一定角度， 同样具有良好的抗返流能力。
所述的膜片 2的每一弹片 15均有一曲面凹陷部 20; 弹片 15的厚度从圆 周边缘向圆心隆起位置逐渐减小， 且圆柱段与凸出片相交处设有一圆柱体; 请参见图 23〜图 25， 膜片 2由圆柱段 8和一圆柱体 27—体连接构成 （图 23所示）， 圆柱体 27近中间位置形成一曲面凹陷部 20， 两曲面凹陷部 20 相对， 其边缘紧贴在一起（图 25所示）， 并在该边缘结合处形成一直细缝 19 (图 24所示）， 圆柱体 27上的曲面凹陷部 20构成了弹片 15， 当气体或 液体进入圆柱体 27时被压缩并集中向其顶端细缝 19冲击， 将具曲面凹陷 部 20的片状弹片 15冲开， 弹片 15的最大开度可达到圆柱体 27的直径， 并可随流量的大小而自动调节开度， 该具曲面凹陷部 20的片状弹片 15 即 有利于顺向气流的流出， 更增加了阻挡反向流动的气体的流动， 提高了单 向膜片的单向阀的作用； 若气体或液体返流， 压力则直接作用在曲面 陷 部 20上， 迫使两弹片的边缘相互夹紧， 将细缝 19密闭， 有效防止返流现 象； 具曲面凹陷部 20的弹片接近于人体心瓣结构， 所形成的单向密封效果 最佳， 抗返流能力最强， 而圆柱体 27与圆柱段 8结合处所形成的间距 28 又使圆柱段 8在受径向压力可能产生一定变形时， 使圆柱体 22不受圆柱段 8的变形影响， 仍保持原形状； 上述圆柱体 27的曲面凹陷部 20可为三个， 即圆柱体 22的顶端按三四等分角度被捏合在一起， 形成三个呈对顶角状态 的曲面凹陷部 20 (图 27所示）， 构成了三个弹片 15 , 并形成有三条呈对顶 角状态的直细缝 19， 其单向密封效果及抗返流能力进一步提高； 或上述的 圆柱体 27的顶端按四等分角度被捏合在一起， 形成四个呈对顶角状态的曲 面凹陷部 20, 四个曲面凹陷部 20共构成了四个弹片， 形成有四条直细缝 19 (图 29所示）； 上述的曲面凹陷部 20还可设置多个， 但多于四个弹片则 实际意义不大， 其最佳范围为 2 ~ 3个弹片。
所述的弹片 15为一直径与柱状支架 1直径相适应并圆心隆起的片状物， 通过一金属杆 17将弹片 15与柱状支架 1的一个夹具连接， 至少两条缝隙 29自接近圆心位置至弹片 15边缘并形成至少两个弹片，优选三 ~四条缝隙 29; 膜片 2为一伞形体（或称碗形）， 其厚度自伞体顶部中心向伞体边缘逐 渐减小 （图 30所示）， 伞形体自边缘向其圆心方向开有多条长度小于伞体 半径的缝隙 29 , 缝隙 29 以伞形体中心为圆心按等分角度均布， 两条缝隙 29之间所连接的伞体面构成一弹片 15， 为使弹片 15具一定的强度及增加 弹片弹性变形并使之具有形状记忆特性， 在弹片 15内部或表面设有一金属 丝支撑体 16 (图 31所示）， 金属丝支撑体 16为一根记忆合金丝， 该合金丝 可包覆弹片内或设置在表面， 支撑体相当于伞面的肋筋， 起到成型固定作 用， 以使各弹片保持呈曲面形状， 并作为骨架对弹片形成支撑； 为保持膜 片 2呈伞形状态， 伞体顶部中心固接一金属杆 17 , 金属杆 17自伞体内部向 外延伸并与柱状支架 1的后夹具 3固接， 形似一打开的伞， 金属杆 17可使 由切缝 29构成的弹片环绕其进行开闭动作， 并保持膜片 2的定位位置； 上 述的金属杆 17也可自伞顶表面向外延伸并与柱状支架 1的前夹具 4固接（图 32所示）， 其作用与上述的相同， 而多道缝隙 29可形成有多个弹片 I5 , 但
1 ] 以三 ~四条缝隙 29所形成的三 ~西个弹片 15为最佳。
请参见图 34 ~图 35， 柱状支架 1的一端为敞口， 另一端由后夹具 3固 定两服合金丝 7形成有两开口 5 ,膜片 2被置于柱状支架 1内，膜片 2可釆 用缝合、 覆膜或直接在支架成型的方法与支架结合为一整体， 膜片 2 的圆 柱段 8的底边与柱状支架 1的敞口边缘平齐并与柱状支架 1内壁紧密结合, 膜片 2的锥形凸出面 9的底部紧抵于凹环 18所形成的内陷的壁面 （图 34 所示）， 凹环 18的内陷壁面对圆柱段 8形成一定位点及对凸出面 9形成一 支撑点，该支撑点在返流时可增强膜片 2的抗返流能力及封闭效果； 膜片 2 的凸出面 9上的每个弹片（图 35所示）上均设有一支撑体 16 (图 35所示）, 其为一根记忆合金丝， 支撑体作为骨架对弹片形成支撑， 并保持凸出面 9 的形状， 以增加其强度并使其具有形状恢复记忆特性， 使用时， 输送器管 腔内的导丝与柱状支架 1的后夹具 3螺接可将其进行单方向的释出或收回。 请参见图 36 图 37 , 上述的柱状支架 1的一端由前夹具 4固定两股合金 丝束 7形成有两开口 5 ,另一端由后夹具 3所固定的两股合金丝束 7也形成 有两开口 5 ,膜片 2被置于柱状支架 1内， 其底边抵至前夹具 4所固定的合 金束 7边缘（图 36所示）， 膜片 2的凸出面 9上的每个弹片上均可设有一 支撑体 16 (图 37所示）， 输送器管腔内的导丝或与后夹具 3螺接或与前夹 具 4 螺接以便将其进行双方向的释出或收回， 所述的支撑体为丝金属， 该 支撑体 16可置于膜片的表面， 亦可置于膜片内部， 如一体加工构成， 或膜 片 2为二层材料合成， 支撑体 16置于二层材料之间。
请参见图 38 ~图 39 ,柱状支架 1为前夹具 4与后夹具 3非对称设置结构， 膜片 2的凸出面 9为一球面，其上的缝隙为未封闭的圆形缝隙（图 39所示）, 未封闭的圆形缝隙与前夹具 4与后夹具 3非对称设置的柱状支架 1相配， 可使流通截面增大， 流量也增大， 并且通过前夹具 4或后夹具 3可将柱状 支架 1双方向释出或收回。
请参见图 40〜图 41 , 膜片 2置于一前夹具 4与后夹具 3对称设置的柱 状支架 1内（图 40所示）， 该支架具三个开口 5 , 膜片 2头部呈一球面， 其 上的缝隙为三角形缝隙 11 , 该三角形缝隙与四个开口 5呈交错状态（图 41 所示）， 柱状支架 1可通过前夹具 4或后夹具 3双方向的释出或收回。
请参见图 42 ~图 43, 膜片 2置于一前夹具 5与后夹具 4对称设置的柱状 支架 1内（图 42所示）， 该支架具四个开口 5， 膜片 2头部呈一球面， 其上 的缝隙为十字形缝隙 12 , 该十字形缝隙与西个开口 5呈交错状态（图 43所 示）， 柱状支架 1可通过前夹具 4或后夹具 3双方向的释出或收回。
请参见图 44 ~图 45 ,柱状支架 1的一端由前夹具 4固定两股合金丝束 7 形成有两开口 5 , 另一端由后夹具 3固定两股合金丝束 7形成有两开口 5 , 伞形膜片 2被置于柱状支架 1内， 金属杆 17的一端与前夹具 4连接， 另一 端与膜片 2伞顶中心部连接， 其伞体的外周缘边紧抵于柱状支架 1 的回环 18所形成的内陷壁面 （图 44所示）， 该内陷壁面对膜片 2形成密封口 （类 似阀门刃口）， 金属杆 17对膜片 2形成拉伸， 使其保持伞形状态， 当气流 或液体自前夹具 4处进入后， 向膜片 2的伞顶周缘汇集， 使由切缝 29构成 的弹片 15在受压向后夹具 3方向弯曲， 其外边缘与凹环 18 内壁面脱离接 触， 使伞形膜片 2 的伞径缩小而形成一环形开口， 气流或液体便自该环形 开口流出， 若返流时， 气流或液体则将弹片 15 的边缘与 环 18的内陷壁 面紧压在一起， 形成封闭面， 阻挡气流或液体通过， 并且金属杆 17在气流 或液体正、 返流时对膜片 2形成拉伸及顶撑作用； 上述的金属杆 17可自伞 体内部向外延伸并与柱状支架 1的后夹具 3固接， 呈一打开的伞状， 金属 杆 17在气流或液体正、 返流时对膜片 2形成顶撑及拉伸作用 （图 46所示 ) 保持膜片 2的命形状态。
请参见图 48〜图 53, 膜片 2置于螺旋状柱状支架 1 内， 膜片 2的形状 可选用以上所述的膜片 2其中的一种， 但膜片 2的圆柱段 8也同为锥台形， 以与螺旋柱体相适配， 若膜片 2为伞形时， 膜片 2的伞径要与螺旋柱体某 螺旋圈的直径相符， 可即依金属杆 17的长度而定。
以上所述的各种膜片 2均适用于以上所述的丝状柱状支架、 激光蚀刻网 状柱状支架和螺旋状柱状支架， 可根据所需的气流或液体流通量而选配， 并且弹片 15的内部或表面均可设有增加弹片弹性变形和强度的金属丝支撑 体 16。

Claims

权 利 要 求 书
1. 一种可回收的瓣膜支架， 包括记忆合金材料构成的柱状支架 （1), 其特 征在于柱状支架 （1) 内设有一具弹性的片状膜片 （2), 膜片 （2)上设 有至少一个缝隙使膜片（2)形成可弯曲的弹片 （15)， 柱状支架（1)的 一端设有一固定构成柱状支架合金材料的固定后夹具 （3), 后夹具 （3) 具有连接输送器的螺紋。
2. 按权利要求 1所述的可回收的瓣膜支架， 其特征在于所述的丝状记忆合 金材料编织为柱状支架后， 形成至少一股合金丝束（7)后再固定于后夹 具（3), 柱状支架（1)的设有后夹具 (3)一端形成至少一个开口 （5)。
3. 按杈利要求 2所述的可回收的瓣膜支架， 其特征在于所述的丝状记忆合 金材料编织为柱状支架 （1)后， 形成一股合金丝束 （7)后固定位于柱 状支架 （1)侧壁上缘的后夹具 （3)， 柱状支架 （1) 的设有后夹具 （3) 一端形成一个近似圆形的开口 （5)。
4. 按杈利要求 2所述的可回收的瓣膜支架， 其特征在于所述的丝状记忆合 金材料编织为柱状支架 (1)后, 形成二股合金丝束 (7)后固定位于柱 状支架（ 1 )轴心位置的后夹具（ 3 ), 柱状支架（ 1 )设有后夹具（ 3 )— 端形成二个近似椭圆形的开口 （5); 或编成柱状支架（1)的合金丝形成 三股或四股合金丝束（7)后固定位于柱状支架 （1) 轴心位置的后夹具
( 3), 柱状支架 (1)设有后夹具 (3) 一端形成三个或四个开口 (5)。
5. 按权利要求 所述的可回收的瓣膜支架，其特征在于所述的柱状支架（ 1 ) 由合金钢管经激光刻蚀得到的网状支架， 蚀刻掉部分形状近似菱形， 支 架一端有与支架一体的至少三根支撑（6), 支撑（6) 与后夹具 （3)连 接。
6. 按杈利要求 2所述的可回收的瓣膜支架，其特征在于所述的柱状支架（ 1 ) 由至少一根合金丝螺旋形成，一端设有后夹具（3),优选 2~ 4根合金丝。
7. 按杈利要求 1或 2或 3或 4或 5或 6所述的瓣膜支架， 其特征在于所述 的柱状支架（1) 的另一端亦设有一前夹具（4), 前、 后夹具（4、 3)可 对称设置或非对称设置。
8. 按杈利要求 1或 2或 3或 4或 5或 6或 7所述的可回收的瓣膜支架， 其 特征在于所述的膜片 （2)有一与柱状支架（1)相适配的圆柱段（8), 由圆柱段（8)—端一体连接有一向圆心位置隆起的凸出面（9), 凸出面 上（ 9 )设有一未封闭的圆形缝隙（ 10 ); 或设有两对称的弧形缝隙（ 11 ), 两弧形缝隙 (11) 的之间有一直线缝隙 (12)相连通形成一近似工字形 缝隙； 或设有以圆心为起点的等夹角向圆周边延伸的三角缝隙（13); 或 设有以圆心为起点的向圆周边延伸的十字缝隙（14); 分别设有形成一至 四个可弯曲的弹片 (15)。
9. 按权利要求 8所述的可回收的瓣膜支架， 其特征在于所述的膜片（2)的 每一弹片 （I5)均有一曲面凹陷部 （20)。
10. 按权利要求 9 所述的可回收的瓣膜支架， 其特征在于所述的弹片的厚 度从圆周边缘向圆心隆起位置逐渐减小， 且圆柱段（8)与凸出片相交 处设有一圆柱体。
11. 按权利要求 10所述的可回收的瓣膜支架，其特征在于所述的弹片（ 15 ) 内部或表面设有可增加弹片弹性变形和强度的金属丝支撑体（ 16 )。
12. 按权利要求 7所述的可回收的瓣膜支架， 其特征在于所述的弹片 （15) 为一直径与柱状支架 (1)直径相适应并圆心隆起的片状物， 通过一金 属杆（17)将弹片 （15) 与柱状支架（1) 的一个夹具连接， 至少两条 缝隙（ 29 )自接近圆心位置至弹片（ 15 )边缘并形成至少两个弹片（ 15 ); 优选三 四条缝隙 （29)。
PCT/CN2008/001941 2007-11-28 2008-11-28 Prothèse endovasculaire rétractable pour valve WO2009079915A1 (fr)

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