WO2016169338A1 - 人工生物心脏瓣膜及其制作方法 - Google Patents

人工生物心脏瓣膜及其制作方法 Download PDF

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Publication number
WO2016169338A1
WO2016169338A1 PCT/CN2016/075359 CN2016075359W WO2016169338A1 WO 2016169338 A1 WO2016169338 A1 WO 2016169338A1 CN 2016075359 W CN2016075359 W CN 2016075359W WO 2016169338 A1 WO2016169338 A1 WO 2016169338A1
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WO
WIPO (PCT)
Prior art keywords
valve
wrap
sewing
heart valve
artificial biological
Prior art date
Application number
PCT/CN2016/075359
Other languages
English (en)
French (fr)
Inventor
赵益民
易定华
张�浩
Original Assignee
赵益民
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 赵益民 filed Critical 赵益民
Priority to MX2017013579A priority Critical patent/MX2017013579A/es
Priority to EP16782486.1A priority patent/EP3287100A4/en
Priority to US15/568,064 priority patent/US10470879B2/en
Publication of WO2016169338A1 publication Critical patent/WO2016169338A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—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
    • A61F2/2415—Manufacturing methods
    • 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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3625—Vascular tissue, e.g. heart valves

Definitions

  • the present invention relates to an artificial biological heart valve for use in cardiovascular surgery (heart surgery).
  • the invention describes an artificial biological heart valve. According to the presence or absence of a stent (valve) in the valve, the artificial biological heart valve is divided into a stent (valve) valve and a stentless (valve) valve.
  • the stentless (valve) valve is made only of biomaterial or only biomaterial plus polyester fabric.
  • the leaflets are made with a bovine pericardium or a horse pericardium or a pig pericardium.
  • the wrap and stitching edge ⁇ ring> are made of bovine pericardium, horse pericardium or polyester fabric.
  • the stented (valve) valve is usually made of three materials: metal or plastic, biomaterial and polyester (also known as polyester or polyethylene terephthalate or PET, hereinafter referred to as polyester) cloth. .
  • stent (valve) bioprostheses account for 95% of bioprostheses.
  • the advantage of having a stent valve is that it has a stent (valve), so it is easy to position during surgery and is easy for the doctor to implant accurately.
  • the current stented valves are made of three traditional materials: the leaflets are made of biomaterials, the petals are made of metal (alloy) or polymer materials, and the coverings and seaming edges are made of polyester fabric. ⁇ ring>.
  • This type of valve has the following disadvantages: 1) The polyester cloth exposed to the blood after implantation into the heart has a higher probability of producing a thrombus or increasing the attachment of the bacteria; 2) the valve is composed of a metal valve wire and a metal flap The structure of the seat is high in hardness, but the elasticity and compliance are poor, and the leaflets are easy to be strained.
  • valve frame is a combination of a metal valve wire and a metal leaf seat, the manufacturing process and structure are complicated, and There are welding points and casings in the valve wire, and there are hidden dangers in the fracture; 4) the overall height of the valve is high, after the heart is implanted, the aortic valve is easy to block the blood flow of the coronary artery opening, and the mitral valve easily obstructs the original subvalvular tissue of the heart. exercise.
  • polyester cloth is used to make the wrap and the suture edge.
  • the polyester fabric itself has good chemical inertness, sterilization resistance, good mechanical properties, low water absorption and good biocompatibility.
  • the polyester fabric can be sterilized by conventional techniques without changing its own properties, and has the advantages of high strength, good elasticity, good wear resistance, good fatigue resistance, and good dimensional stability.
  • polyester fabric has good biological inertness, can induce tissue growth, and has good fibrosis reactivity. It has been confirmed in the history of human body implantation for more than 50 years. On the other hand, due to its decades of application history, those skilled in the art typically use polyester cloth when designing the wrap and stitching edges.
  • the present invention has been devised in view of the fact that the conventional artificial biological heart valve design concept is obsolete, the structure is complicated, and there are many deficiencies in use and function.
  • an artificial biological heart valve including a valve holder, a leaflet, and a valve assisting structure, wherein the valve leaflet is coupled to the valve assist
  • the structure, the valve assisting structure is coupled to the valve holder, and the leaflet and the valve assisting structure are each made of a biomaterial.
  • the valve assisting structure can include a suture edge and a wrap, the leaflet being attached to the wrap, and the wrap and the suture edge being directly or indirectly secured to the crest .
  • the leaflets are sewn onto the wrap.
  • the wrap is secured to the flap and the stitching edge is attached to the wrap.
  • the valve holder includes an integral annulus and a ridge that is sewn to the outer edge of the annulus.
  • the wrap may include an inner flap of the flap and an outer wrap of the flap, wherein the flap is attached to the inner wrap, and the insert is built into the inner wrap Enclosed with the outer cladding Within the space.
  • the inner wrap and the outer wrap are stitched to form upper and lower edge wraps of the flap.
  • the leaflet is sewn to the top edge of the inner wrap
  • the top edge of the outer wrap is sewn to the top edge of the inner wrap to form the upper edge wrap
  • a lower edge of the inner wrap is sewn to a lower edge of the outer wrap to form the lower edge wrap, thereby wrapping the crest on the inner wrap,
  • the upper portion of the inner wrap is provided with three indentations that are shaped to match the leaflets, the lower contour matching the shape of the annulus of the valve holder; between each of the two notches, a shape and a flap are provided.
  • the ridges are matched with the protrusions, and the inner cladding is provided with two protrusions on both sides, and the combined shape of the two protrusions matches the shape of one ridge of the valve holder.
  • the upper portion of the outer wrap is provided with three protrusions that are shaped to match the ridges of the flap, the lower contour matching the shape of the annulus of the flap, and a shape is provided between each of the two projections.
  • the inner wrap, the outer wrap, and the stitching edge are integrally formed.
  • the outer wrap and the stitching edge are integrally formed.
  • the leaflet, the stitching edge and the covering are pre-set with a sewing mark, so that the artificial biological heart valve is completed along the sewing mark when sewing. Preparation.
  • valve holder can be integrally formed.
  • valve holder can be made of a resilient material.
  • the spacing between two adjacent sewing marks is between 0.5 mm and 3 mm.
  • valve holder may be made of polyoxymethylene (POM), polyetheretherketone (PEET), polysulfone (PSF), cobalt-based alloy, titanium-based alloy, or nickel-titanium alloy.
  • POM polyoxymethylene
  • PEET polyetheretherketone
  • PSF polysulfone
  • cobalt-based alloy titanium-based alloy
  • nickel-titanium alloy nickel-titanium alloy
  • the valve assisting structure can be made from an animal pericardium, and the leaflets can be made from an animal pericardium or a porcine aortic valve leaflet.
  • the animal pericardium is a bovine pericardium, a horse pericardium, a pig pericardium, a sheep pericardium, a pericardium, or a pericardium.
  • the sewing logo can be a sewing hole, a sewing point, or other indicia that is easily identifiable.
  • the sewn logo is preset at any location where sewing is required when making an artificial bio heart valve.
  • a sewn logo is pre-set along the perimeter of the inner wrap, the perimeter of the outer wrap, and the perimeter of the stitching edge.
  • an artificial biological heart valve comprising a valve holder, a leaflet and a valve assisting structure, the leaflet being coupled to the valve assisting structure, the valve assisting The structure is coupled to the valve holder, wherein the valve assisting structure is pre-set with a sewing marker such that upon sewing, the preparation of the artificial biological heart valve is completed along the sewing marker.
  • valve holder can be integrally formed.
  • valve holder can be made of a resilient material.
  • the valve assisting structure can include a suture edge and a wrap, the leaflet being attached to the wrap, and the wrap and the suture edge being directly or indirectly secured to the crest .
  • the wrap may include an inner wrap and an outer wrap, wherein the leaflet is attached to the inner wrap, the brace being built into the inner wrap and the outer side Within the space enclosed by the cladding.
  • the leaflet, the suture edge and the covering are pre-set with a sewing mark, so that the sewing of the artificial biological heart valve is completed along the sewing mark during sewing. .
  • the leaflet and valve assist structures can be made of a biomaterial.
  • the elastomeric material can be made of polyoxymethylene (POM), polyetheretherketone (PEET), polysulfone (PSF), cobalt-based alloy, titanium-based alloy, or nickel-titanium alloy.
  • POM polyoxymethylene
  • PEET polyetheretherketone
  • PSF polysulfone
  • cobalt-based alloy titanium-based alloy
  • nickel-titanium alloy nickel-titanium alloy
  • the sewing logo can be a sewing hole, a sewing point, or other indicia that is easily identifiable.
  • the wrap may include an inner wrap and an outer wrap
  • step (c) includes sewing the leaf blob to the inner wrap and then sewing the outer wrap
  • the inner cladding is coated with the upper and lower edge claddings.
  • step (c) comprises incorporating the valve holder in the inner wrap and the outer wrap Within the enclosed space.
  • the step (c) comprises sewing the leaflet to the top edge of the inner wrapper, and sewing the top edge of the outer wrap to the top edge of the inner wrap to form The upper edge wrap, and step (c) includes sewing a lower edge of the inner wrap to a lower edge of the outer wrap to form the lower edge wrap, thereby The flap is wrapped in a space surrounded by the inner wrap, the outer wrap, and the upper and lower edge wraps formed by stitching the two.
  • the valve holder includes an integral annulus and scallop, and step (d) includes sewing the suture edge to the outer edge of the annulus.
  • the leaflets are sewn onto the wrap by a patrolling stitching method and/or the upper edges of the inner and outer wraps are stitched by a seaming method.
  • the sewing indicia can be a sewing hole, a sewing point, or other indicia that is easily identifiable.
  • the artificial biological heart valve of the invention reduces the probability of thrombus or bacteria adhering thereto, and has a simple manufacturing process, good compliance with heart tissue, and prolongs the service life of the valve.
  • FIG. 1 is an exploded perspective view of an artificial bio heart valve in accordance with an embodiment of the present invention.
  • FIGS. 2-10 illustrate a method of making an artificial biological heart valve in accordance with an embodiment of the present invention.
  • 11 and 12 are views showing the structures of the inner wrap and the outer wrap of the artificial bio heart valve according to the second embodiment of the present invention, respectively.
  • FIGs 13-17 illustrate the steps of making an artificial bio heart valve of the embodiment of Figures 11 and 12.
  • FIG 18 and 19 are views showing the structures of the inner wrap and the outer wrap of the artificial bio heart valve according to the third embodiment of the present invention, respectively.
  • FIGs 20-24 illustrate the steps of making an artificial bio heart valve of the embodiment of Figures 18 and 19.
  • Fig. 25 is a view showing the structure of a coating of an artificial biological heart valve according to a fourth embodiment of the present invention.
  • 26-30 illustrate the steps of making an artificial bio heart valve of the embodiment of Fig. 25.
  • Flap An irregular ring consisting of an annulus (wavy or horizontal) and a ridge (three ridges).
  • the valve frame is composed of a valve wire and a valve seat, wherein the valve wire is an irregular ring composed of a ridge (three ridges), and the valve seat is wavy or horizontal. Ring.
  • the valve holder is integrally formed.
  • Leaflets Sewn from animal pericardium (bovine pericardium or horse pericardium or pig pericardium or sheep pericardium or pericardium or pericardium) or / and porcine aortic valve leaflets.
  • Stitching edge ⁇ or sewing ring> The suture edge is used to fix the heart valve to the heart tissue, which is placed on the outer edge of the valve frame and is usually sewn and usually in the shape of a ring (or other shape), so sometimes Also known as a sewing ring.
  • Valve assisted structure a general term for suture margins and wraps.
  • the artificial biological heart valve 100 includes a flap 1, a leaflet 2, an inner wrap 3, an outer wrap 4, and a sewing ring 5, wherein the leaflet 2 is sutured to the inner wrap 3, and the outer wrap
  • the covering 4 is stitched to the inner wrap 3, and then the leaflet 2, the inner wrap 3 and the outer wrap 4 are nested together in the flap 1 and sewn to the flap 1, that is, the flap is built in the inner side Within the space enclosed by the object 3 and the outer cladding 4.
  • the sewing ring 5 is fixed to the valve holder, thereby forming a complete artificial biological heart valve.
  • the inner wrap 3, the outer wrap 4, and the sewing ring 5 may be collectively referred to as a valve assisting structure.
  • the inner wrap 3 and the outer wrap 4 may be collectively referred to as a wrap.
  • the sewing ring can be fixed to the flap by sewing to the inner wrap and/or the outer wrap, or can be directly sewn to the flap.
  • the valve holder 1 comprises an integral annulus 11 and a ridge 12, wherein the annulus 11 is an irregular toroid and the ridge 12 is three ridges.
  • the valve holder 1 is preferably integrally formed of an elastic material.
  • the valve holder 1 is not provided with a hole or slit structure. More preferably, the valve holder is made of polyoxymethylene (POM), polyetheretherketone (PEET), polysulfone (PSF), cobalt-based alloy, titanium-based alloy or nickel-titanium alloy.
  • POM polyoxymethylene
  • PEET polyetheretherketone
  • PSF polysulfone
  • the leaflets 2 are generally semi-circular with pre-formed holes 21 for sewing the leaflets 2 onto the inner wrapper 3.
  • a heart valve typically includes three leaflets 2 .
  • the leaflets are made of biological material.
  • the valve assisting structure is made from an animal pericardium, and the leaflets are made of animal pericardium or porcine aortic valve leaflets.
  • Animal pericardium includes any suitable animal pericardium such as bovine pericardium, pig pericard or horse pericardium or sheep pericardium or pericardium or pericardium.
  • the upper portion of the inner wrap 3 is provided with three indentations 31 shaped to match the leaflets 2, the lower contours matching the annulus shape of the petals. Between each of the two notches 31, a projection 32 having a shape matching the ridge of the flap is provided.
  • the inner side cover 3 is further provided with protrusions 331 and protrusions 332 on both sides, and the shape of the combination of the protrusions 331 and the protrusions 332 is matched with the shape of one ridge of the valve holder.
  • the inner wrap is pre-formed with a slit hole 34 for sewing it together with the leaflet and the outer wrap 4. In this embodiment, the sewing holes are provided along the perimeter of the inner wrap and a row of stitching holes is also provided in the middle of the inner wrap.
  • the sewing apertures 34 can also be preset to any location that needs to be sewn on the inner wrap when making an artificial bio-heart valve.
  • the inner wrap is made of a biological material.
  • the biomaterial is an animal pericardium, such as a bovine pericardium, a pig pericardium or a horse pericardium or a sheep pericardium or a pericardium or a pericardium.
  • the upper portion of the outer wrap 4 is provided with three projections 41 shaped to match the ridges of the flap, the lower contour matching the shape of the annulus of the flap. Between each of the two projections 41, a notch 42 having a shape matching the leaflets 2 is provided.
  • the outer cover 4 is further provided with a notch 431 and a notch 432 on both sides, and the shape of the combination of the notch 431 and the notch 432 is matched with the shape of one of the leaflets 2.
  • the outer wrap is pre-set with a slit hole 44 for sewing it together with the inner wrapper 3. In this embodiment, the sewing holes are disposed along the perimeter of the outer wrap and a row of sewn holes is also provided in the middle of the outer wrap.
  • the sewing aperture 44 can also be predetermined anywhere that needs to be sewn on the outer wrap when making an artificial bio heart valve.
  • the outer wrap 4 is made of a biological material.
  • the biomaterial is an animal pericardium, such as a bovine pericardium, a pig pericardium or a horse pericardium or a sheep pericardium or a pericardium or a pericardium.
  • the sewing ring 5 is formed into a circular shape, and the inner edge and the outer edge are respectively provided with pre-sewn holes 51 and 52, wherein the pre-sewn holes 51 on the inner edge are used for sewing the outer coverings, The pre-sewn holes 52 on the outer edge are used to stitch the two sewing rings 5 together.
  • the sewing ring 5 is made of a biological material.
  • the biological material is an animal pericardium, such as a bovine pericardium, a pig pericardium or a horse pericardium or a sheep pericardium or a pericardium or a pericardium.
  • the pre-sewn holes provided on the leaflet 2, the inner wrapper 3, the outer wrap 4 and the sewing ring 5 may be replaced by other sewn marks, for example, at a position to be sewn or Set colored dots or other marks near it.
  • the operator can sew along these sewing marks when sewing the artificial heart valve.
  • the spacing between adjacent two sewing marks is from 0.5 mm to 3 mm, more preferably from 1.4 mm to 2 mm.
  • the way to set the sewing mark can include laser drilling and tooling (similar to the paper puncher principle) punching.
  • the sewing mark may be disposed at any position on one or more of the leaflet 2, the inner wrap 3, the outer wrap 4, and the sewing ring 5 that is to be sewn without being limited to the position disclosed herein. .
  • the artificial biological heart valve of the present invention increases the compliance with the heart and the human body by adopting special valve frames and biological material coverings, and by pre-set sewing marks.
  • the biocompatibility reduces the overall height of the valve, reduces the time of sewing, and reduces the probability of thrombus or bacteria adhering to it, as detailed in Table 1 below.
  • Table 1 compares several examples of artificial bio heart valves of the present invention with several examples of prior art artificial bio heart valves.
  • Level 1 is "the probability of bacterial adhesion or thrombosis is high, the ratio is less than 1.0%”.
  • Level 2 is "the probability of bacterial adhesion or thrombosis is low, the ratio is less than 0.1%".
  • Level 3 is "the probability of bacterial adhesion or thrombosis is very low, the ratio is less than 0.01%".
  • FIG. 2-10 illustrate a method of making an artificial biological heart valve in accordance with an embodiment of the present invention.
  • the method of the invention comprises the steps of:
  • the valve holder 1 is an integral piece, and the number of leaflets is three.
  • the wrap is composed of the inner wrap 3 and the outer wrap 4.
  • the number of sewing rings 5 is two.
  • the basic principle of the manufacturing method of the present invention is that a sewing hole is preliminarily provided on the leaflet, the covering and the suture edge, so that when the heart valve is made, it is only necessary to sew along the predetermined sewing hole. This makes the production simple and the product easy to standardize.
  • the suture 6 sews the leaflets 2 one after another along the sewing hole on the inner covering 3, that is, the leaflets are sewn to the top edge of the inner covering, as shown in FIGS. 2 and 3.
  • the valve leaflets are preferably sewn to the inner wrap by a patrol stitching method.
  • the inner wrap 3 is rolled into a cylindrical shape, and the both ends are sewn, as shown in Fig. 4-5.
  • the suture 6 sews the outer wrap 4 over the inner wrap 3 along the sewing hole, that is, the top edge of the outer wrap 4 is sewn to the top edge of the inner wrap 3, such as Figure 6 shows.
  • the upper edges of the inner and outer wraps are preferably stitched by a seaming method.
  • the sewn leaflets 2, the inner wraps 3 and the outer wraps 4 are put together on the flap 1 so that the flap 1 is built in the inner wrap 3 and the outer wrap 4 In the space, then suture the lower edge of the inner and outer wraps along the sewing hole, as shown in Figure 7-9.
  • the lower edges of the inner and outer wraps are preferably stitched by a seaming method.
  • the suture 6 sews the sewing ring 5 to the outer edge of the annulus of the valve holder along the sewing hole. Specifically, the inner edges of the two sewing rings are sewn on the outer covering by S-stitching, and then the outer edges of the two sewing rings are stitched by a spiral stitching method. After the suture ring is sewn, a certain outer edge is left for sewing in the heart or aorta during the valve replacement surgery.
  • the structure and shape of the covering of the artificial biological heart valve of the present invention are not limited to the above structures and shapes.
  • the inner covering and the outer covering may be integrally formed and sewn to the valve holder. The inner wrap and the outer wrap are then formed.
  • FIG. 11 and 12 are views showing the structures of the inner wrap 3' and the outer wrap 4' of the artificial biological heart valve according to the second embodiment of the present invention, respectively.
  • This embodiment differs from the embodiment shown in FIG. 1 in that, in this embodiment, the sewing ring is integrally formed on the inner wrap and the outer wrap, specifically, the inner wrap and the outer wrap.
  • the lower edges 35' and 45' are elongated such that after the sewing is completed, the inner edges 3' and the lower edges 35' and 45' of the outer wrap 4' form a stitching edge. Accordingly, in the present embodiment, the sewing ring of Fig. 1 is not separately provided.
  • the upper structure of the inner wrap 3' and the outer wrap 4' and the structure of the lobes are the same as those of the embodiment of Fig. 1, and will not be described in detail herein.
  • FIG. 18 and 19 are schematic views showing the structure of the inner wrap 3 and the outer wrap 4" of the artificial biological heart valve according to the third embodiment of the present invention.
  • This embodiment is different from the embodiment shown in Fig. 1.
  • the sewing ring is integrally formed on the outer wrap 4", specifically, the lower edge 45" of the outer wrap 4" is extended, so that after the sewing is completed, the outer wrap 4
  • the "lower edge 45" forms a seamed edge.
  • the sewing ring of Fig. 1 is not separately provided.
  • the structure of the inner wrap 3 is the same as that of the inner wrap 3 of FIG. 1, and the upper structure of the outer wrap 4" and the structure of the baffle 1 are the same as those of the embodiment of FIG. No longer detailed
  • Figure 25 is a schematic view showing the structure of an integral covering 7 of an artificial biological heart valve according to a fourth embodiment of the present invention.
  • This embodiment differs from the embodiment shown in Fig. 1 in that, in this embodiment, the inner wrap, the outer wrap, and the sewing ring are integrally formed.
  • the upper portion 71 of the covering 7 is an inner covering, and its structure is the same as that of the inner covering structure shown in FIG. 1 and will not be described in detail herein.
  • the lower portion 72 of the wrap 7 is an outer wrapper having the same structure as the outer wrap shown in Fig. 1, and will not be described in detail herein.
  • the middle portion 73 of the wrap 7 forms a stitching edge after the sewing is completed.
  • the structure of the valve holder is also the same as that of the embodiment of FIG. 1, and will not be described in detail herein.
  • the leaflet 2 is sewn to the upper portion 71 (i.e., the inner wrap) on the wrap 7 by a patrol stitching method, as shown in FIG.
  • valve-assisted structure is made of a biomaterial, including a valve-assisted structure (such as a wrap and a suture) that is internally made of other materials and wrapped with a layer of biomaterial in its outer layer.
  • a valve-assisted structure such as a wrap and a suture
  • the leaflets are made of biological materials, but also the auxiliary structures (claps and sewing rings, etc.) are basically made of biological materials, and the original artificial artificial heart valve is coated and covered.
  • the polyester cloth used for the suture edge makes the auxiliary structure of the heart valve of the present invention only made of biological material.
  • the Applicant has overcome the conventional practice of conventionally using a polyester cloth for the wrap and stitching edges (as mentioned in the background of this document, due to the many advantages of the polyester cloth, those skilled in the art will be taught by the prior art.
  • a stented prosthetic heart valve is made, usually only a polyester cloth is used to make the wrap and the suture edge.
  • the valve frame of the artificial biological heart valve of the invention is formed by one-time molding with high elasticity and good toughness, and has an integrated design, so that the artificial biological heart valve of the invention has the positioning of the traditional stent (valve) valve accurately.
  • the preparation process is simple, the compliance with the heart tissue is good, and the service life of the valve is prolonged. Accurate positioning during surgical implantation is easy for doctors to use and master.
  • the valve designed by the invention has a height which is 15-18% lower than the average height of the existing artificial biological heart valve in the market, and reduces the risk of the existing artificial biological heart valve being high.
  • the sewing between the leaflets, the suture margin and the covering of the present invention employs a new cutting form and a sewing method to standardize the valve sewing process.
  • the pre-punching technique of the sewing point is used to establish the standardization of the stitch length during the sewing process for the first time, so that the sewing process is more concise, accurate and standard.
  • Four kinds of stitching methods such as patrol stitching, seam stitching, S-stitching and spiral stitching, are adopted to ensure the firmness of the stitching, which makes the performance more superior and reliable than similar products.

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Abstract

一种人工生物心脏瓣膜（100）及其制作方法，人工生物心脏瓣膜（100）包括瓣架（1）、瓣叶（2）以及瓣膜辅助结构。瓣叶（2）连接于瓣膜辅助结构，瓣膜辅助结构连接于瓣架（1）。瓣叶（2）和瓣膜辅助结构均采用生物材料制成。瓣架（1）由弹性材料一体制成，且瓣膜辅助结构上预设有缝制标识。该人工生物心脏瓣膜增加了与人体的生物相容性，降低了瓣膜整体高度，减少了缝制时间，降低了血栓或细菌附着其上的概率。此外，该人工生物心脏瓣膜制作工艺简单，与心脏组织的顺应性好，延长了瓣膜的使用寿命。

Description

人工生物心脏瓣膜及其制作方法 技术领域
本发明涉及一种用于心血管外科(心脏外科)的人工生物心脏瓣膜。
背景技术
在医学心血管科领域，当心脏内部的瓣膜由于多种原因发生病变，导致心功能减退，而内科药物治疗无效时，往往需要外科医生采用植入的方法，用人工制成的瓣膜替换病变并失去功能的瓣膜。这种由外科植入的人工心脏瓣膜目前有二大类：人工机械心脏瓣膜和人工生物心脏瓣膜。本发明阐述的是人工生物心脏瓣膜。依据瓣膜内部有无支架(瓣架)，人工生物心脏瓣膜分为有支架(瓣架)瓣膜和无支架(瓣架)瓣膜。
无支架(瓣架)瓣膜仅由生物材料或仅由生物材料加涤纶布制作而成。瓣叶用牛心包或马心包或猪心包制作。包覆物和缝合缘<环>用牛心包、马心包或和涤纶布制作。无支架瓣膜优点是因为没有支架，所以植入心脏后与心脏的顺应性非常好，瓣叶各个部位所受的应力为最小，瓣叶受损小，使用寿命长。缺点也是因为没有支架(瓣架)，所以手术植入时定位难度高，对手术医生的技术要求很高，不便于医生准确植入，使用和推广量很少。
有支架(瓣架)瓣膜通常由三种材料制作而成，分别为金属或塑料、生物材料和涤纶(又称聚酯纤维或聚对苯二甲酸乙二醇酯或PET，以下简称涤纶)布。目前有支架(瓣架)生物瓣膜占生物瓣膜的95％。有支架瓣膜的优点是因为有支架(瓣架)，所以手术植入时定位方便，便于医生准确植入。然而，目前的有支架瓣膜都采用了传统的三种材料制作：由生物材料来制作瓣叶，由金属(合金)或高分子材料来制作瓣架，而由涤纶布制作包覆物和缝合缘<环>。这类型的瓣膜存在以下缺点：1)植入心脏后暴露于血液中的涤纶布，产生血栓或增加细菌着附其上的概率较高；2)瓣架是由金属瓣架丝和金属片瓣座组合而成的结构，硬度高，但弹性、顺应性差，瓣叶易劳损；3)因瓣架是由金属瓣架丝和金属片瓣座组合而成的结构，制作工艺和结构复杂，且瓣架丝有焊接点和套管，存在断裂隐患；4)瓣膜整体高度偏高，植入心脏后，主动脉瓣易阻碍冠状动脉开口的血流，二尖瓣易妨碍心脏原有瓣下组织的运动。
不论是无支架瓣膜还是有支架瓣膜，均采用了涤纶布来制作包覆物和缝合缘。这是因为一方面，涤纶布本身具有很好的化学惰性、耐灭菌性、良好的机械性能、低吸水性以及较好的生物相容性。具体地，涤纶布可以用传统技术来进行杀菌而不改变其本身性质，而且具有强度高、弹性好、耐磨性好、耐疲劳性好和尺寸稳定性好等优点。同时，涤纶布具有较好的生物惰性，能诱发组织生长，良好的纤维化反应性，在50多年的人体植入史中，已经证实了其安全性。另一方面，由于其已经有数十年的应用历史，本领域的技术人员在设计包覆物和缝合缘时，通常会采用涤纶布。
另外，无论何种生物瓣膜，在制作过程中，各部位的缝合均为手工缝合，缝合点和缝合间距全凭技术员工的经验，缝合的质量控制和培训难度较大。
鉴于传统的人工生物心脏瓣膜设计理念陈旧，结构复杂、存在诸多使用和功能上的不足，故设计和开发了本发明。
发明内容
本发明的目的是提供一种降低血栓或降低细菌着附于其上的人工生物心脏瓣膜。本发明的另一目的是解决传统瓣架的结构复杂、瓣架过硬、与心脏顺应性差的技术问题。本发明的另一目的是解决传统生物瓣膜在制作过程中，各部位的缝合全凭经验，无标准化的问题。
为实现上述各目的，根据本发明的一方面，提供了一种人工生物心脏瓣膜，所述人工生物心脏瓣膜包括瓣架、瓣叶以及瓣膜辅助结构，其中所述瓣叶连接于所述瓣膜辅助结构，所述瓣膜辅助结构连接于所述瓣架，以及所述瓣叶和所述瓣膜辅助结构均采用生物材料制成。
一实施例中，瓣膜辅助结构可包括缝合缘和包覆物，所述瓣叶连接于所述包覆物，以及所述包覆物和所述缝合缘直接或间接固定至所述瓣架上。
较佳地，所述瓣叶缝制于所述包覆物上。较佳地，所述包覆物固定至所述瓣架上，所述缝合缘连接于所述包覆物。
较佳地，所述瓣架包括一体的瓣环和瓣脊，所述缝合缘缝制于所述瓣环的外侧缘。
一实施例中，包覆物可包括瓣架内侧包覆物和瓣架外侧包覆物，其中所述瓣叶连接于所述内侧包覆物，所述瓣架内置于所述内侧包覆物和所述外侧包覆物所围成 的空间内。
所述内侧包覆物和外侧包覆物缝合而形成有瓣架的上、下缘包覆物。
较佳地，所述瓣叶缝制于所述内侧包覆物顶边缘，所述外侧包覆物的顶边缘缝制于所述内侧包覆物的顶边缘，形成所述上缘包覆物，且所述内侧包覆物的下边缘缝制于所述外侧包覆物的下边缘，形成所述下缘包覆物，从而将所述瓣架包裹于所述内侧包覆物、所述外侧包覆物和由二者缝合而形成的所述上、下缘包覆物所围成的空间内。
一实施例中，内侧包覆物的上部设有形状与瓣叶相匹配的三个缺口，下部轮廓与瓣架的瓣环形状相匹配；在每两个缺口之间，设有形状与瓣架的瓣脊相匹配的凸起，且内侧包覆物两侧还设有两个凸起，这两个凸起组合而成的形状与瓣架的一个瓣脊的形状相匹配。
一实施例中，外侧包覆物上部设有三个形状与瓣架的瓣脊相匹配的凸起，下部轮廓与瓣架的瓣环形状相匹配，在每两个凸起之间，设有形状与瓣叶相匹配的缺口，且外侧包覆物两侧还设有两个缺口，这两个缺口组合而成的形状与一个瓣叶的形状相匹配。
一实施例中，内侧包覆物、外侧包覆物和缝合缘一体形成。
一实施例中，外侧包覆物和缝合缘一体形成。
较佳地，所述瓣叶、所述缝合缘以及所述包覆物均预设有缝制标识，从而在缝制时，顺着所述缝制标识缝制而完成所述人工生物心脏瓣膜的制备。
一实施例中，瓣架可一体成型制成。
一实施例中，瓣架可由弹性材料制成。
一实施例中，相邻两个所述缝制标识之间的间距为0.5mm～3mm。
一实施例中，瓣架可由聚甲醛(POM)、聚醚醚酮(PEET)、聚砜(PSF)、钴基合金、钛基合金或镍钛合金制成。
一实施例中，瓣膜辅助结构可由动物心包制成，而瓣叶可由动物心包或猪主动脉瓣瓣叶制成。
较佳地，上述动物心包为牛心包、马心包、猪心包、羊心包、驴心包、或骡心包。
缝制标识可为缝制孔、缝制点或便于识别的其它标记。
较佳地，缝制标识预设于在制作人工生物心脏瓣膜时需要缝制的任何位置处。
较佳地，沿内侧包覆物的周界、外侧包覆物的周界以及缝合缘的周界均预设有缝制标识。
根据本发明的另一方面，提供了一种人工生物心脏瓣膜，所述人工生物心脏瓣膜包括瓣架、瓣叶以及瓣膜辅助结构，所述瓣叶连接于所述瓣膜辅助结构，所述瓣膜辅助结构连接于所述瓣架，其中所述瓣膜辅助结构预设有缝制标识，从而在缝制时，顺着所述缝制标识缝制而完成所述人工生物心脏瓣膜的制备。
一实施例中，瓣架可一体成型制成。
一实施例中，瓣架可由弹性材料制成。
一实施例中，瓣膜辅助结构可包括缝合缘和包覆物，所述瓣叶连接于所述包覆物，以及所述包覆物和所述缝合缘直接或间接固定至所述瓣架上。
一实施例中，包覆物可包括内侧包覆物和外侧包覆物，其中所述瓣叶连接于所述内侧包覆物，所述瓣架内置于所述内侧包覆物和所述外侧包覆物所围成的空间内。
较佳地，所述瓣叶、所述缝合缘以及所述包覆物均预设有缝制标识，从而在缝制时，顺着缝制标识缝制而完成所述人工生物心脏瓣膜的制备。
一实施例中，瓣叶和瓣膜辅助结构均可采用生物材料制成。
一实施例中，弹性材料可为聚甲醛(POM)、聚醚醚酮(PEET)、聚砜(PSF)、钴基合金、钛基合金或镍钛合金制成。
缝制标识可为缝制孔、缝制点或便于识别的其它标记。
根据本发明的另一方面，还提供了一种人工生物心脏瓣膜的制作方法，所述制作方法包括步骤：
(a)提供瓣架、瓣叶、缝合缘和包覆物；
(b)对所述瓣叶、缝合缘和包覆物预设缝制标识；
(c)顺着缝制标识将所述瓣叶缝制到所述包覆物，并将缝制好的所述瓣叶和所述包覆物固定至所述瓣架；
(d)将缝合缘固定至所述瓣架从而形成所述人工生物心脏瓣膜。
一实施例中，包覆物可包括内侧包覆物和外侧包覆物，步骤(c)包括将所述瓣叶缝制于所述内侧包覆物，然后将所述外侧包覆物缝制于所述内侧包覆物，并形成上、下缘包覆物。
较佳地，步骤(c)包括将所述瓣架内置于所述内侧包覆物和所述外侧包覆物 所围成的空间内。
较佳地，步骤(c)包括将所述瓣叶缝制于所述内侧包覆物顶边缘，将所述外侧包覆物的顶边缘缝制于所述内侧包覆物的顶边缘，形成所述上缘包覆物，且步骤(c)包括将所述内侧包覆物的下边缘缝制于所述外侧包覆物的下边缘，形成所述下缘包覆物，从而将所述瓣架包裹于所述内侧包覆物、所述外侧包覆物和由二者缝合而形成的上、下缘包覆物所围成的空间内。
较佳地，瓣架包括一体的瓣环和瓣脊，步骤(d)包括将所述缝合缘缝制于所述瓣环的外侧缘。
较佳地，采用巡回式缝合法将瓣叶缝制于包覆物上，和/或采用锁边式缝合法将内、外侧包覆物的上缘缝合。
该方法中，缝制标识可为缝制孔、缝制点或便于识别的其它标记。
本发明的人工生物心脏瓣膜降低了血栓或细菌附着其上的概率，而且制作工艺简单，与心脏组织的顺应性好，延长了瓣膜的使用寿命。
附图说明
图1是根据本发明的一实施例的人工生物心脏瓣膜的分解立体图。
图2-10示出根据本发明的一实施例的制作人工生物心脏瓣膜的方法。
图11和12分别示出根据本发明的第二实施例的人工生物心脏瓣膜的内侧包覆物和外侧包覆物的结构示意图。
图13-17示出图11和12所示实施例的人工生物心脏瓣膜的制作步骤。
图18和19分别示出根据本发明的第三实施例的人工生物心脏瓣膜的内侧包覆物和外侧包覆物的结构示意图。
图20-24示出图18和19所示实施例的人工生物心脏瓣膜的制作步骤。
图25示出根据本发明的第四实施例的人工生物心脏瓣膜的包覆物的结构示意图。
图26-30示出图25所示实施例的人工生物心脏瓣膜的制作步骤。
具体实施方式
以下将结合附图对本发明的较佳实施例进行详细说明，以便更清楚理解本发明的目的、特点和优点。应理解的是，附图所示的实施例并不是对本发明范围的限制， 而只是为了说明本发明技术方案的实质精神。
术语解释：
瓣架：为不规则圆环，由瓣环(波浪状或水平状)和瓣脊(三个脊状突起)构成。传统人工生物心脏瓣膜中，瓣架由瓣架丝和瓣座组合而成，其中瓣架丝为不规则圆环，由瓣脊(三个脊状突起)构成，而瓣座为波浪状或水平状圆环。本发明的人工生物心脏瓣膜中，瓣架一体制成。
瓣叶：由动物心包(牛心包或马心包或猪心包或羊心包或驴心包或骡心包)或/和猪主动脉瓣瓣叶缝制而成。
缝合缘<或称缝合环>：缝合缘用于将心脏瓣膜固定于心脏组织，其设置于瓣架外缘并通常通过缝制而成且形状通常为环形(也可为其它形状)，故有时也称为缝合环。
包覆物：缝制于瓣架内外缘和上、下缘的材料。
瓣膜辅助结构：缝合缘和包覆物的统称。
图1是根据本发明的一实施例的人工生物心脏瓣膜的分解立体图。如图1所示，人工生物心脏瓣膜100包括瓣架1、瓣叶2、内侧包覆物3、外侧包覆物4和缝合环5，其中瓣叶2缝合于内侧包覆物3，外侧包覆物4缝合于内侧包覆物3，然后瓣叶2、内侧包覆物3和外侧包覆物4一起套入瓣架1并缝合于瓣架1上，即瓣架内置于由内侧包覆物3和外侧包覆物4所围成的空间内。最后，缝合环5固定于瓣架上，由此形成完整的人工生物心脏瓣膜。这里，内侧包覆物3、外侧包覆物4和缝合环5可统称为瓣膜辅助结构。内侧包覆物3和外侧包覆物4可统称为包覆物。这里，缝合环可通过缝合于内侧包覆物和/或外侧包覆物而固定至瓣架上，也可直接缝制于瓣架上。
瓣架1包括一体的瓣环11和瓣脊12，其中瓣环11为不规则圆环形，瓣脊12为三个脊状突起。瓣架1较佳地由弹性材料一体成型制成。较佳地，瓣架1上不设有孔或缝结构。更佳地，瓣架由聚甲醛(POM)、聚醚醚酮(PEET)、聚砜(PSF)、钴基合金、钛基合金或镍钛合金制成。
瓣叶2为大致半圆形，其上预设有缝制孔21，用于将瓣叶2缝制到内侧包覆物3上。一个心脏瓣膜通常包括三片瓣叶2。瓣叶采用生物材料制成。较佳地，瓣膜辅助结构由动物心包制成，瓣叶由动物心包或猪主动脉瓣瓣叶制成。动物心包包括牛心包、猪心包或马心包或羊心包或驴心包或骡心包等任何合适的动物心包。
内侧包覆物3的上部设有形状与瓣叶2相匹配的三个缺口31，下部轮廓与瓣架的瓣环形状相匹配。在每两个缺口31之间，设有形状与瓣架的瓣脊相匹配的凸起32。内侧包覆物3两侧还设有凸起331和凸起332，凸起331和凸起332两者组合而成的形状与瓣架的一个瓣脊的形状相匹配。内侧包覆物预设有缝制孔34，用于将其与瓣叶及外侧包覆物4缝制在一起。本实施例中，缝制孔沿着内侧包覆物的周界设置并在内侧包覆物的中部也设有一排缝制孔。然而，应理解，缝制孔34也可预设于在制作人工生物心脏瓣膜时需要在内侧包覆物上缝制的任何地方。内侧包覆物采用生物材料制成，较佳地，生物材料为动物心包，诸如牛心包、猪心包或马心包或羊心包或驴心包或骡心包等任何合适的动物心包。
外侧包覆物4上部设有三个形状与瓣架的瓣脊相匹配的凸起41，下部轮廓与瓣架的瓣环形状相匹配。在每两个凸起41之间，设有形状与瓣叶2相匹配的缺口42。外侧包覆物4两侧还设有缺口431和缺口432，缺口431和缺口432两者组合而成的形状与一个瓣叶2的形状相匹配。外侧包覆物预设有缝制孔44，用于将其与内侧包覆物3缝制在一起。本实施例中，缝制孔沿着外侧包覆物的周界设置并在外侧包覆物的中部也设有一排缝制孔。然而，应理解，缝制孔44也可预设于在制作人工生物心脏瓣膜时需要在外侧包覆物上缝制的任何地方。外侧包覆物4采用生物材料制成，较佳地，生物材料为动物心包，诸如牛心包、猪心包或马心包或羊心包或驴心包或骡心包等任何合适的动物心包。
缝合环5由为圆环形，其内缘和外缘分别预设有预缝制孔51和52，其中内缘上的预缝制孔51用于将其缝制到外侧包覆物上，而外缘上的预缝制孔52用于将两片缝合环5缝合在一起。缝合环5采用生物材料制成，较佳地，生物材料为动物心包，诸如牛心包、猪心包或马心包或羊心包或驴心包或骡心包等任何合适的动物心包。
需要指出的是，设置在瓣叶2、内侧包覆物3、外侧包覆物4和缝合环5上的预缝制孔均可以由其它缝制标识来替代，例如在将要缝制的位置或其附近设置带颜色的点或其它标记。操作者在缝制人工心脏瓣膜时可顺着这些缝制标识缝制。较佳地，相邻两个缝制标识之间的间距为0.5mm-3mm，更佳地为1.4mm-2mm。设置缝制标识的方式可包括激光打孔及工装夹具(类似纸张打孔器原理)打孔等。另外，缝制标识可设置于瓣叶2、内侧包覆物3、外侧包覆物4和缝合环5中一个或多个上的任何需要缝制的位置处，而不限于本文所公开的位置。
相比于现有技术的人工生物心脏瓣膜，本实用新型的人工生物心脏瓣膜通过采用特制的瓣架和生物材料包覆物，以及通过预设缝制标识，增加了与心脏的顺应性和人体的生物相容性，降低了瓣膜整体高度，减少了缝制时间，降低了血栓或细菌附着其上的概率，详见下表1。
表1为本发明的人工生物心脏瓣膜的几个示例与现有技术的人工生物心脏瓣膜的几个示例的对比。
Figure PCTCN2016075359-appb-000001
注：血栓或细菌附着情况等级划分如下：
1级为“细菌附着或导致血栓的可能性较高，比例1.0％以下”。
2级为“细菌附着或导致血栓的可能性较低，比例0.1％以下”。
3级为“细菌附着或导致血栓的可能性非常低，比例0.01％以下”。
图2-10示出根据本发明的一实施例的制作人工生物心脏瓣膜的方法。本发明的该方法包括步骤：
(a)提供瓣架、瓣叶、包覆物以及缝合缘；
(b)对瓣叶、缝合缘和包覆物预设缝制孔；
(c)顺着缝制孔将所述瓣叶缝制到所述包覆物；
(d)将缝制好的所述瓣叶和所述包覆物固定至所述瓣架；
(e)将缝合缘固定至所述瓣架从而形成所述人工生物心脏瓣膜。
如图2-10所示，本实施例中，瓣架1为一体件，瓣叶数量为3片。包覆物由内侧包覆物3和外侧包覆物4构成。缝合环5数量为两片。应当理解的是，本发明 的制作方法也可适于其它类似的人工心脏瓣膜。本发明的制作方法的基本原理是在瓣叶、包覆物和缝合缘上预设有缝制孔，从而在制作心脏瓣膜时，只需顺着预先设定的缝制孔缝制即可，从而使得制作简单且产品容易标准化。
具体地，首先缝合线6顺着缝制孔将瓣叶2一片接着一片缝制于内侧包覆物3上，即，将瓣叶缝制于内侧包覆物顶边缘，如图2和3所示。该缝制过程中，较佳地采用巡回式缝合法将瓣叶缝制于内侧包覆物上。接着，将内侧包覆物3卷成筒状，并将其两端缝合，如图4-5所示。
然后，缝合线6顺着缝制孔将外侧包覆物4缝制于内侧包覆物3上，即，将外侧包覆物4的顶边缘缝制于内侧包覆物3的顶边缘，如图6所示。将外侧包覆物4缝制于内侧包覆物3上时，较佳地采用锁边式缝合法将内、外侧包覆物上缘缝合。
接下来，将缝制好的瓣叶2、内侧包覆物3和外侧包覆物4一起套上瓣架1，从而瓣架1内置于内侧包覆物3和外侧包覆物4所围成的空间内，然后顺着缝制孔将内、外侧包覆物下缘缝合，如图7-9所示。该过程中，较佳地采用锁边式缝合法将内、外侧包覆物下缘缝合。
最后，缝合线6顺着缝制孔将缝合环5缝制于瓣架的瓣环外侧缘。具体地，采用S式缝合法将两片缝合环内缘缝制在外侧包覆物上，然后采用螺旋式缝合法将两片缝合环外缘缝合。在缝合环缝制完成后，留出一定外缘，便于在瓣膜置换手术时缝制在心脏或主动脉内。
由此，完成本发明的人工生物心脏瓣膜的制作。
需要指出的是，本发明的人工生物心脏瓣膜的包覆物的结构和形状不限于上述结构和形状，例如，内侧包覆物和外侧包覆物可以一体制成，并在缝制至瓣架之后形成内侧包覆物和外侧包覆物。
图11和12分别示出根据本发明的第二实施例的人工生物心脏瓣膜的内侧包覆物3'和外侧包覆物4'的结构示意图。本实施例与图1所示的实施例不同之处在于，本实施例中，缝合环一体地形成于内侧包覆物和外侧包覆物上，具体地，内侧包覆物和外侧包覆物的下缘35'和45'延长,从而在缝制完成后，内侧包覆物3'和外侧包覆物4'的下缘35'和45'形成缝合缘。相应地，本实施例中，不单独设置图1中的缝合环。本实施例中，内侧包覆物3'和外侧包覆物4'的上部结构以及瓣架的结构与图1实施例相同，在此不再详述。
本实施例中，在缝制时，如图13-17所示，缝制步骤如下：
1)采用巡回式缝合法将瓣叶2缝制于内侧包覆物3'上，如图13所示。
2)将内侧包覆物3'卷成筒状，两端缝合，如图14所示。
3)采用锁边式缝合法将内、外侧包覆物3'和4'的上缘缝合，如图15所示。
4)将瓣架1置于内、外侧包覆物之间，如图16所示。
5)采用锁边式缝合法将内、外侧包覆物3'和4'的下缘缝合而形成人工生物心脏瓣膜200，如图17所示。
图18和19分别示出根据本发明的第三实施例的人工生物心脏瓣膜的内侧包覆物3和外侧包覆物4”的结构示意图。本实施例与图1所示的实施例不同之处在于，本实施例中，缝合环一体地形成于外侧包覆物4”上，具体地，外侧包覆物4”的下缘45”延长，从而在缝制完成后，外侧包覆物4”的下缘45”形成缝合缘。相应地，本实施例中，不单独设置图1中的缝合环。本实施例中，内侧包覆物3的结构与图1的内侧包覆物3的结构相同，且外侧包覆物4”的上部结构以及瓣架1的结构与图1实施例相同，在此不再详述
本实施例中，在缝制时，如图20-24所示，缝制步骤如下：
1)采用巡回式缝合法将瓣叶2缝制于内侧包覆物3上，如图20所示。
2)将内侧包覆物3卷成筒状，两端缝合，如图21所示。
3)采用锁边式缝合法将内、外侧包覆物3和4”的上缘缝合，如图22所示。
4)将瓣架1置于内、外侧包覆物之间，如图23所示。
5)采用锁边式缝合法将内、外侧包覆物3和4”的下缘缝合而形成人工生物心脏瓣膜300，如图24所示。
图25分别示出根据本发明的第四实施例的人工生物心脏瓣膜的一体的包覆物7的结构示意图。本实施例与图1所示的实施例不同之处在于，本实施例中，内侧包覆物、外侧包覆物和缝合环制成一体。具体地，本实施例中，包覆物7的上部71为内侧包覆物，其结构与图1所示的内侧包覆物结构相同，在此不再详述。包覆物7的下部72为外侧包覆物，其结构与图1所示的外侧包覆物相同，在此不再详述。包覆物7的中部73在缝制完成后形成缝合缘。本实施例中，瓣架的结构也与图1实施例的瓣架结构相同，在此不再详述
本实施例中，在缝制时，如图26-30所示，缝制步骤如下：
1)采用巡回式缝合法将瓣叶2缝制于包覆物7上的上部71(即内侧包覆物)，如图26所示。
2)将包覆物7卷成筒状，两端缝合，如图27所示。
3)将包覆物7的下部72(即外侧包覆物)向上折起与包覆物7的上部71(即内侧包覆物)重合对齐从而形成内、外侧包覆物，如图28所示。
4)将瓣架1置于内、外侧包覆物之间，如图29所示。
5)采用锁边式缝合法将内、外侧包覆物的上缘缝合而形成人工生物心脏瓣膜400，如图30所示。
本文中，瓣膜辅助结构采用生物材料制成，包含了瓣膜辅助结构(例如包覆物和缝合缘)内部由其它材料制成而在其外层再包裹一层生物材料，此种变型同样落入本发明的范围。
本发明的人工生物心脏瓣膜中，不仅瓣叶采用生物材料制作，其辅助结构(包覆物和缝合环等)也基本都采用生物材料制作，剔除了原有传统人工生物心脏瓣膜缝制包覆物、缝合缘采用的涤纶布，使得本发明的心脏瓣膜的辅助结构只采用生物材料制成。申请人克服了传统上包覆物和缝合缘采用涤纶布的常规做法(正如在本文背景技术中所提到的，由于涤纶布具有诸多优点，在现有技术的教导下，本领域的技术人员在制作有支架人工心脏瓣膜时，通常只会采用涤纶布来制作包覆物和缝合缘)，通过仅采用生物材料来直接接触血液，可降低血栓或细菌附着其上的概率。
本发明的人工生物心脏瓣膜的瓣架，选用弹性高、韧性好的材料一次性成型，呈一体式的设计，使本发明的人工生物心脏瓣膜，既有传统有支架(瓣架)瓣膜定位准确、易于植入的优点，也有传统无支架(瓣架)瓣膜顺应性好的优点；既消除了传统有支架(瓣架)瓣膜高强度、高硬度、瓣架结构复杂、有隐患的缺点，也消除了无支架(瓣架)瓣膜植入定位难的缺陷。其制作工艺简单，与心脏组织的顺应性好，延长了瓣膜的使用寿命。在手术植入时准确定位，易于医生使用和掌握。同时，本发明设计的瓣膜，其高度比市场现有人工生物心脏瓣膜的高度平均低15-18％，降低了现有人工生物心脏瓣膜高度偏高的风险。
另外，本发明的瓣叶、缝合缘和包覆物之间缝制采用了新的切割形态和缝制方法，使瓣膜缝制过程标准化。具体地，采用缝制点预先打孔技术，首次确立了缝制过程中针距的标准化，使缝制过程更为简洁、准确、标准。采用了巡回式缝合、锁边式缝合、S式缝合与螺旋式缝合4种缝合方法，保证了缝合的牢固度，使其性能比同类产品更加优越、可靠。
以上已详细描述了本发明的较佳实施例，但应理解到，在阅读了本发明的上述 讲授内容之后，本领域技术人员可以对本发明作各种改动或修改。这些等价形式同样落于本申请所附权利要求书所限定的范围。

Claims (26)

  1. 一种人工生物心脏瓣膜，其特征在于：所述人工生物心脏瓣膜包括瓣架、瓣叶以及瓣膜辅助结构，其中所述瓣叶连接于所述瓣膜辅助结构，所述瓣膜辅助结构连接于所述瓣架，以及所述瓣叶和所述瓣膜辅助结构均采用生物材料制成。
  2. 根据权利要求1所述的人工生物心脏瓣膜，其特征在于，所述瓣膜辅助结构包括缝合缘和包覆物，所述瓣叶连接于所述包覆物，以及所述包覆物和所述缝合缘直接或间接固定至所述瓣架上。
  3. 根据权利要求2所述的人工生物心脏瓣膜，其特征在于，所述包覆物包括内侧包覆物和外侧包覆物，其中所述瓣叶连接于所述内侧包覆物，所述瓣架内置于所述内侧包覆物和所述外侧包覆物所围成的空间内。
  4. 根据权利要求2所述的人工生物心脏瓣膜，其特征在于，所述瓣叶、所述缝合缘以及所述包覆物均预设有缝制标识，从而在缝制时，顺着所述缝制标识缝制而完成所述人工生物心脏瓣膜的制备。
  5. 根据权利要求4所述的人工生物心脏瓣膜，其特征在于，相邻两个所述缝制标识之间的间距为0.5mm～3mm。
  6. 根据权利要求4所述的人工生物心脏瓣膜，其特征在于，所述缝制标识为缝制孔。
  7. 根据权利要求1所述的人工生物心脏瓣膜，其特征在于，所述瓣架一体成型制成。
  8. 根据权利要求1所述的人工生物心脏瓣膜，其特征在于，所述瓣架由弹性材料制成。
  9. 根据权利要求1所述的人工生物心脏瓣膜，其特征在于，所述瓣架由聚甲醛(POM)、聚醚醚酮(PEET)、聚砜(PSF)、钴基合金、钛基合金或镍钛合金制成。
  10. 根据权利要求1所述的人工生物心脏瓣膜，其特征在于，所述瓣膜辅助结构由动物心包制成，且所述瓣叶由动物心包或猪主动脉瓣瓣叶制成。
  11. 根据权利要求10所述的人工生物心脏瓣膜，其特征在于，所述动物心包为牛心包、马心包、猪心包、羊心包、驴心包、或骡心包。
  12. 一种人工生物心脏瓣膜，其特征在于：所述人工生物心脏瓣膜包括瓣架、瓣叶以及瓣膜辅助结构，所述瓣叶连接于所述瓣膜辅助结构，所述瓣膜辅助结构连 接于所述瓣架，其中所述瓣膜辅助结构预设有缝制标识，从而在缝制时，顺着所述缝制标识缝制而完成所述人工生物心脏瓣膜的制备。
  13. 根据权利要求12所述的人工生物心脏瓣膜，其特征在于，所述瓣架一体成型制成。
  14. 根据权利要求12所述的人工生物心脏瓣膜，其特征在于，所述瓣架由弹性材料制成。
  15. 根据权利要求12所述的人工生物心脏瓣膜，其特征在于，所述瓣膜辅助结构包括缝合缘和包覆物，所述瓣叶连接于所述包覆物，以及所述包覆物和所述缝合缘直接或间接固定至所述瓣架上。
  16. 根据权利要求15所述的人工生物心脏瓣膜，其特征在于，所述包覆物包括瓣架内侧包覆物和外侧包覆物，其中所述瓣叶连接于所述内侧包覆物，所述瓣架内置于所述内侧包覆物和所述外侧包覆物所围成的空间内。
  17. 根据权利要求15所述的人工生物心脏瓣膜，其特征在于，所述瓣叶、所述缝合缘以及所述包覆物均预设有缝制标识，从而在缝制时，顺着缝制标识缝制而完成所述人工生物心脏瓣膜的制备。
  18. 根据权利要求12所述的人工生物心脏瓣膜，其特征在于，所述瓣叶和所述瓣膜辅助结构均采用生物材料制成。
  19. 根据权利要求12所述的人工生物心脏瓣膜，其特征在于，所述弹性材料为聚甲醛(POM)、聚醚醚酮(PEET)、聚砜(PSF)、钴基合金、钛基合金或镍钛合金。
  20. 根据权利要求12所述的人工生物心脏瓣膜，其特征在于，所述缝制标识为缝制孔。
  21. 一种人工生物心脏瓣膜的制作方法，其特征在于，所述制作方法包括步骤：
    (a)提供瓣架、瓣叶、缝合缘和包覆物；
    (b)对所述瓣叶、缝合缘和包覆物预设缝制标识；
    (c)顺着缝制标识将所述瓣叶缝制到所述包覆物，并将缝制好的所述瓣叶和所述包覆物固定至所述瓣架；
    (d)将缝合缘固定至所述瓣架从而形成所述人工生物心脏瓣膜。
  22. 根据权利要求21所述的制作方法，其特征在于，所述包覆物包括内侧包覆物和外侧包覆物，步骤(c)包括将所述瓣叶缝制于所述内侧包覆物，然后将所述外 侧包覆物缝制于所述内侧包覆物并形成上、下缘包覆物。
  23. 根据权利要求22所述的制作方法，其特征在于，步骤(c)包括将所述瓣架内置于所述内侧包覆物和所述外侧包覆物所围成的空间内。
  24. 根据权利要求22所述的制作方法，其特征在于，步骤(c)包括将所述瓣叶缝制于所述内侧包覆物顶边缘，将所述外侧包覆物的顶边缘缝制于所述内侧包覆物的顶边缘，形成所述上缘包覆物，且步骤(c)包括将所述内侧包覆物的下边缘缝制于所述外侧包覆物的下边缘，形成所述下缘包覆物，从而将所述瓣架包裹于所述内侧包覆物、所述外侧包覆物和所述上、下缘包覆物所围成的空间内。
  25. 根据权利要求21所述的制作方法，其特征在于，所述瓣架包括一体的瓣环和瓣脊，步骤(d)包括将所述缝合缘缝制于所述瓣环的外侧缘。
  26. 根据权利要求21所述的制作方法，其特征在于，所述缝制标识为缝制孔。
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