WO2018113333A1 - 人工瓣膜成形环及其缝合方法 - Google Patents

人工瓣膜成形环及其缝合方法 Download PDF

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Publication number
WO2018113333A1
WO2018113333A1 PCT/CN2017/099029 CN2017099029W WO2018113333A1 WO 2018113333 A1 WO2018113333 A1 WO 2018113333A1 CN 2017099029 W CN2017099029 W CN 2017099029W WO 2018113333 A1 WO2018113333 A1 WO 2018113333A1
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WO
WIPO (PCT)
Prior art keywords
fabric layer
layer
suture
flexible material
forming ring
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Ceased
Application number
PCT/CN2017/099029
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English (en)
French (fr)
Inventor
付明娟
陈文俊
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Publication of WO2018113333A1 publication Critical patent/WO2018113333A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the invention relates to a cardiovascular medical device, in particular to a prosthetic valve forming ring and a suturing method thereof.
  • the existing prosthetic valve forming ring generally has a three-layer structure, the innermost layer is a metal or polymer material support body, the middle layer is a silica gel layer, and the outermost layer is a polyester cloth tube.
  • the silica gel layer is sleeved on the outer surface of the support body, and then the polyester cloth tube is sleeved on the silica gel layer, and finally the two ends of the polyester cloth tube are laminated on the same.
  • the stitches with stitches are stitched together along the circumferential direction of the polyester tube to stitch the ends of the polyester tube together.
  • the overlapping ends of the polyester cloth tube are thicker than the other parts of the polyester cloth tube, and the sutures are formed at the stitching overlap, a plurality of protrusions are formed, so the surface of the polyester cloth on the artificial valve forming ring is
  • the protrusions formed by stitching the ends of the polyester cloth tube are thicker than the other parts of the polyester cloth, and the protrusions are more.
  • the thick and more convex polyester cloth not only hinders the flow of blood flow, but also reduces the blood flow.
  • the flow rate also increases the probability of thrombus formation on the surface of the polyester fabric.
  • the technical problem to be solved by the present invention is to provide a prosthetic valve forming ring and a suturing method thereof in view of the defects of the prior art.
  • the technical solution adopted by the present invention to solve the technical problem is to construct a prosthetic valve forming ring, which comprises a core tube, a layer of flexible material wrapped around the core tube, and a fabric layer wrapped around the layer of flexible material.
  • the fabric layer is a closed loop structure having two ends stitched by a suture, each of the ends having a plurality of spaced annular structures, one end of the suture alternately passing through the two ends
  • the annular structure of the portion is to stitch the ends together.
  • the annular structures of the two ends are opposite and alternately arranged.
  • the forming ring is provided with marking points, and the positions of the sutures at both ends of the fabric layer coincide with the positions of the marking points.
  • the forming ring is provided with marking lines circumferentially along the forming ring, the marking lines stitching the layer of flexible material and the fabric layer together and separated from the core tube.
  • the cross section of the prosthetic annuloplasty ring includes a first portion and a second portion connected to the first portion, the contour of the first portion being curved and having a first end point and a second end point, the The contour of the two portions includes a first segment connected to the first end point and extending away from the first portion, and an end portion away from the first end point from the first segment and bent toward a second segment extending from the second end and connected to the second end;
  • a tangent to the first end of the contour of the first portion, a tangent to the second end of the first partial contour, and the first segment enclose a triangle, and wherein the triangle An angle between the tangent to the first end point of the first partial contour line and the first segment is an acute angle, and the second segment and the first partial contour line pass the second end point Tangent coincidence
  • the core tube is made of a metal or polymer material.
  • the flexible material layer is a silica gel layer.
  • the fabric layer is a polyester cloth.
  • Another technical solution adopted by the present invention to solve the technical problem thereof is to provide a suture method for a prosthetic valve forming ring as described above, which comprises the following steps:
  • annuloplasty semi-finished product comprising a non-closed inner core tube and a layer of flexible material wrapped around the outer circumference of the inner core tube; wherein one end of the inner core tube is provided with a connecting piece, the connecting piece Exposed from the end;
  • One end of the suture is alternately passed through the annular structure at both ends of the fabric layer, and the suture is tensioned.
  • the stitching method further comprises a stitching method of the marking line, and the stitching method of the marking line comprises the following steps:
  • the angle of the other end of the suture needle is adjusted, and then the suture needle is pushed from the position where the suture needle is pierced at one end, and It moves in the direction indicated by the other end of the suture needle, avoiding the inner core tube and sequentially passing through the layer of flexible material and fabric until the suture needle is fully exposed.
  • the needle tail of the suture needle is tapered, and the tapered needle tail is inserted from the fabric layer in step 2).
  • the angle of the suture needle is adjusted within the layer of flexible material.
  • the cross section of the prosthetic annuloplasty ring includes a first portion and a second portion connected to the first portion, the contour of the first portion being arcuate and having a first end point and a second end point,
  • the contour of the second portion includes a first segment connected to the first end point and extending away from the first portion, and an end portion away from the first end point from the first segment and facing a second segment of the second end extending and connected to the second end;
  • a tangent to the first end of the contour of the first portion, a tangent to the second end of the first partial contour, and the first segment enclose a triangle, and wherein the triangle An angle between the tangent to the first end point of the first partial contour line and the first segment is an acute angle, and the second segment and the first partial contour line pass the second end point The tangent coincides.
  • the stitching method further includes a stitching method of the marking point, which specifically includes the following steps:
  • the suture needle is inserted from the junction of the first portion and the second portion, avoiding the inner core tube and completely passing through the fabric layer and the layer of flexible material, surrounding the outer portion of the first portion Contour Returning to the junction;
  • the suture needle is threaded from the junction and through the fabric layer and layer of flexible material, surrounding the outer contour of the second portion and back to the junction.
  • the connecting member is a nickel titanium sleeve.
  • the stitching portion can extend between the two loop structures adjacent to each other due to the annular structure of one end portion.
  • the flatness is more thin, and the resulting protrusions are thinner. Therefore, obtaining the fabric layer of the prosthetic valve forming ring by this method not only has less influence on the flow velocity of the blood flow, but also reduces the probability of thrombus formation.
  • Figure 1 is a schematic view showing the structure of a preferred embodiment of a prosthetic valve ring of the present invention
  • Figure 2 is a cross-sectional view of the prosthetic valve ring of Figure 1 taken along the line A-A of Figure 1;
  • Figure 3 is a schematic view showing the structure of the artificial valve annulus shown in Figure 1 when the two ends of the fabric layer are not sewn;
  • Figure 4 is a schematic view showing the structure of the two ends of the fabric layer in the prosthetic valve ring shown in Figure 1;
  • Figure 5 is a schematic view showing the structure of the end portions of the fabric layer in the artificial valve annulus shown in Figure 1;
  • Figure 6 is a schematic view showing another embodiment of the artificial valve annulus shown in Figure 1 when both ends of the fabric layer are not sewn;
  • FIG. 7 is a schematic structural view of a semi-finished annulus provided in step S1 of a suture method of a prosthetic valve forming ring of the present invention.
  • Figure 8 is a schematic view showing the operation of the step S2 of the suturing method of the prosthetic valve forming ring of the present invention.
  • 9-11 are schematic views showing the operation of the step S3 of the suturing method of the prosthetic valve forming ring of the present invention.
  • Figure 12 is a schematic view showing the operation of steps S4 and S5 of the suturing method of the prosthetic valve forming ring of the present invention.
  • Figure 13 is a schematic view showing the operation of the step S6 of the suturing method of the prosthetic valve forming ring of the present invention.
  • Figure 14 is an enlarged view of a portion B in Figure 13;
  • Figure 15 is a schematic view showing the structure of a suture needle provided in the method for suturing a marker thread of the present invention.
  • 16 to 20 are schematic views showing a suturing process using the marking line stitching method of the present invention.
  • Figure 21 is a schematic view showing the structure after suturing by the marking thread stitching method of the present invention.
  • Figure 22 is a schematic view showing the operation of a point stitching method using the present invention.
  • Figure 23 is a schematic illustration of the process of stitching the marked points using the stitching method shown in Figure 22.
  • a prosthetic valve forming ring 10 includes a core tube 11, a layer of flexible material 12 wrapped around the outer periphery of the core tube 11, and a fabric layer 13 wrapped around the layer 12 of flexible material.
  • the prosthetic valve forming ring 10 is a flexible non-planar ring body, the core tube 11 is made of a metal or polymer material, the flexible material layer 12 is preferably a silica gel, and the fabric layer 13 is preferably a polyester cloth.
  • the artificial valve forming ring 10 is further provided with marking lines 14 disposed along the circumference of the forming ring 10, and left triangular marking points 15, right triangular marking points 16, and rear marking points 17 spaced apart from the forming ring 10.
  • the fabric layer 13 is a closed woven loop structure having two ends 131 and 132 sewn by sutures 18. Both end portions 131 and 132 have a plurality of spaced-apart annular structures 131A and 132A, respectively. Since the fabric layer 13 is a woven fabric, the annular structures 131A and 132A are a part of themselves, and in the preferred embodiment, the annular structures 131A and 132A are opposite and alternately disposed.
  • the relative and alternate arrangement means that the plurality of annular structures 131A are opposite to the plurality of annular structures 132A, and when the both end portions 131 and 132 are aligned, there is only between each two adjacent annular structures 131A There is an annular structure 132A with one and only one annular structure 131A between each two adjacent annular structures 132A.
  • the sutures 18 alternately pass through the annular structures 131A and 132A in sequence, and finally the suture 18 is tightened to complete the suture.
  • the annular structures 131A and 132A are arranged alternately so that after the suture 18 is tensioned, one end of the annular structure can extend between the two annular structures adjacent to the other end.
  • the stitching portion can extend between the two annular structures adjacent to the other end due to the annular structure of one end portion. It is flatter and produces fewer bulges. Therefore, obtaining the fabric layer of the prosthetic valve forming ring by this method not only has less influence on the flow velocity of the blood flow, but also reduces the probability of thrombus formation.
  • the positions of the plurality of annular structures 131A' and 132A' at the two ends may also be one-to-one correspondence. Since the one end of the suture 18' alternately passes through the annular structure at both ends of the fabric layer, the suture 18' is pulled, and an annular structure 132A' shown in Fig. 6 is pulled under the traction of the suture 18'. Pull in between the two adjacent annular structures 132A'. The stitching thus obtained is also flatter due to the fact that one end annular structure can extend between the two adjacent annular structures, and the resulting projections are thinner and less.
  • the position of the suture 18 is merged with one of the three markers described above and hidden beneath the marker point. Hiding the position of the suture 18 beneath one of the marked points can further reduce the unevenness of the surface of the annulus, making the annulus more aesthetic while reducing the probability of thrombosis.
  • the cross section of the forming ring 10 includes a first portion 101 and a second portion 102 that is coupled to the first portion 101.
  • the outline of the first portion 101 has a circular arc shape and has a first end point 101A and a second end point 101B.
  • the outline of the second portion 102 has a first segment 102A that is coupled to the first end point 101A and extends away from the first portion 101, and is bent from an end of the first segment 102A away from the first end point 101A and A second segment 102B that extends toward the second endpoint 101B and is coupled to the second endpoint 101B.
  • the tangent of the first portion 101 contour line past the first end point 101A, the tangent line of the second portion end point 101B of the first portion 101 contour line, and the first segment 102A enclose a triangle, and the first portion 101 contour line of the triangle portion
  • the angle between the tangent to the first end 101A and the first segment 102A is an acute angle; the second segment 102B coincides with the tangent of the second portion 101B of the first portion 101 contour.
  • the marking line 14 penetrates the fabric layer 13 and the flexible material layer 12 from the first end 101A and the first segment 102A and avoids the core tube 11, thereby suturing the fabric layer 13 and the flexible material layer 12.
  • the relative position of the marking line 14 and the flexible material layer 12 is fixed, and is located at the junction of the first end point 101A and the first section 102A.
  • the relative position of the marking line 14 to the flexible material layer 12 is fixed so that the doctor does not poke the core tube 11 due to the relative sliding between the fabric layer 13 and the flexible material layer 12 during the surgical operation, thereby avoiding surgical failure and improving the operation. Success rate.
  • the invention also proposes a suture method for the above artificial valve forming ring, the method comprising the following steps:
  • the annulus semi-finished product 20 includes a non-closed The core tube 21 and the flexible material layer 22 wrapped around the outer circumference of the core tube 21.
  • the core tube 21 is a hollow tubular structure, and one end portion of the core tube 21 is provided with a connecting member 23 which is exposed from the end of the core tube 21.
  • the connector 23 is a nickel-titanium tube.
  • a tube 30 and a tubular fabric layer 24 are provided.
  • the tubing 30 has a tail portion 31 and a tapered head portion 32.
  • Fabric layer 24 has a tube entry end 241.
  • the end of the annulus semi-finished product 20 having the connector 23 is pushed into the interior of the tube 30 from the opening of the tail 31 of the tube 30, and the end of the annulus semi-finished product 20 remote from the connector 23 is exposed, and the head of the tube 30 is again 32 is pushed through the tube entry end 241 of the fabric layer 24 into the interior of the fabric layer 24.
  • the surface of the tube 30 is smooth and its head 32 is tapered to facilitate entry into the interior of the fabric layer 24.
  • the tubing of the fabric layer 24 is moved into the end 241 to cause the fabric layer 24 to move relative to the tubing 30 until the tubing of the fabric layer 24 enters the end 241 near the tail 31 of the tubing 30.
  • the tubing 30 reveals its head 32, the tubing 30 is pulled until the tubing 30 is fully withdrawn from the fabric layer 24.
  • the inner wall surface of the fabric layer 24 is bonded to the outer wall surface of the flexible material layer 22.
  • One end of the suture is alternately passed through the annular structure at both ends of the fabric layer 24 (see Fig. 4). The ends of the suture are then tightened and the ends of the suture are tied together, and the ends of the knotted suture are hidden between the fabric layer 24 and the layer of flexible material 22, thus completing the stitching.
  • one end of the suture line alternately passing through the annular structure at both ends of the fabric layer 24 can be completed in the following manners:
  • one end of the suture can be sequentially from right to left.
  • the third annular structure 131A, the third annular structure 132A from right to left passes through until the end of the suture passes through the last annular structure on the right side;
  • One end can be from left to right in turn
  • the third annular structure 132A to the right, the third annular structure 131A... from left to right passes through until the end of the suture passes out from the last annul
  • one end of the suture is alternately passed through the annular structure at both ends of the fabric layer, and after the ends of the suture are stretched, one end of the loop structure can extend into the other end.
  • this stitching method not only does not overlap the two ends of the fabric layer, but also the stitching portion can be extended by an end ring structure. It is flatter between the two annular structures adjacent to the other end, and the resulting protrusions are thinner and less. Therefore, the fabric layer of the artificial valve forming ring obtained by the method not only has less influence on the flow velocity of the blood flow. It also reduces the probability of thrombosis formation.
  • the suturing method of the prosthetic valve forming ring further includes a suture method of the marking line and a suturing method of the marking point.
  • the stitching method of the marking line includes the following steps:
  • a suture needle 40 having a needle tip 41 and a needle tail 43 opposite to the needle tip 41 is provided.
  • the needle tail 43 has a function of a needle tip and is provided with a threading hole 42.
  • the needle tail 43 is tapered.
  • the threading hole 42 can receive the suture, that is, the suture can be connected to the needle tail 43 via the threading hole 42.
  • the stitching of the marking line can be completed by repeating steps 2) and 3).
  • the needle tip 41 can also be inserted from the top surface 241 of the fabric layer 24 in step 2, avoiding the core tube 21, and sequentially passing through the top surface 241 of the fabric layer 24 and the flexible material layer 22.
  • the angle of the needle tail 43 of the suture needle 40 is adjusted, and then the needle 40 is pushed out from the needle tip 41 of the fabric layer 24.
  • the position S is inserted and moved in the direction indicated by the needle tail 41, avoiding the core tube 21 and sequentially passing through the flexible material layer 22 and the fabric layer 24 until the needle 40 is completely exposed, and the marking line can also be completed. Stitching.
  • the sutures are not stitched to the bottom surface 242 of the fabric layer 24 and the flexible material layer 22 by the stitches stitched between the top surface 241 of the fabric layer 24 and the flexible material layer 22. Interspersed. Due to the tensioning action of the suture and the material properties of the flexible material layer 22, the position of the fabric layer 24 through which the suture needle 40 passes and the adjacent position between the positions will inevitably produce small depressions, and the suture method described above is employed. The advantage is that the absence of such depressions on the bottom surface 242 minimizes unevenness and bulging on the surface of the fabric layer and reduces the probability of thrombosis.
  • the marking line stitched by the above method is stitched together with the flexible material layer 22, and the suture avoids the inner tube 21, and the doctor does not poke the core tube 21 under the guidance of the suture during the operation. Improve the safety and effectiveness of surgery.
  • the marking points may continue to be sewn on the fabric layer, and the stitching of the marking points includes the following steps:
  • the suture needle 40 is inserted from the junction of the first segment 102A and the first end point 101A in the cross section of the forming ring, avoiding the core tube 21 and completely passing through the fabric layer 24 and the flexible material layer 22.
  • the outer contour of the first portion 101 is clockwise returned to the first segment 102A where it is connected to the first end point 101A.
  • the suture needle 40 is inserted from the first segment 102A at the junction with the first end point 101A and through the fabric layer 24 and the layer of flexible material 22, counterclockwise around the outer contour of the second portion 102 and back to the first segment 102A is connected to the first endpoint 101A.
  • the core tube 21 is avoided and completely passes through the fabric layer 24 and the flexible material layer 22.
  • the second segment 102B is connected to the second end point 101B; the second segment 102B is connected to the second end point 101B, and passes through the fabric layer 24 and the flexible material layer. 22, clockwise around the outer contour of the second portion 102 and return to the second segment 102B and the second end point 101B; finally knot the ends of the suture and hide the knot into the fabric layer 24, Form a marker point.
  • the three marking points and the marking lines can also be completed by one knotting.
  • the marking line can be first stitched by the stitching method of the marking line until the first At a mark point, the first point is then stitched in a manner substantially similar to the stitching method of the above-mentioned point (of course, the first point is stitched without knotting), and the first point is stitched.
  • the stitching line of the above-mentioned marking line is continued to suture the marking line up to the second marking point, and then the second marking point is stitched by a method substantially similar to the stitching method of the above-mentioned marking point (of course, the second marking point is stitched at this time) No need to tie knots, and then use the stitching method of the above marking line to suture the marking line until the third marking point (of course, when the first marking point is stitched at this time, no knotting is required), after the third marking point is finished Then, the stitching method of the above-mentioned marking line is continued to suture the marking line until it merges with the other end of the marking line to tie the knot together, thus completing the marking line and the marking point once.
  • junction formation process For another example, first stitch the first marker, but do not tie, then sew the marker line to the second marker point, then sew the second marker point, still not knotted, and then sew the marker line to the third marker At the point, still not knotted, then sew the marking line to the first marking point, knot the ends of the suture at the first marking point, and complete the marking line and the three marking points.
  • the knot formation process For another example, first stitch the first marker, but do not tie, then sew the marker line to the second marker point, then sew the second marker point, still not knotted, and then sew the marker line to the third marker At the point, still not knotted, then sew the marking line to the first marking point, knot the ends of the suture at the first marking point, and complete the marking line and the three marking points.
  • the mark line is stitched according to the stitching method of the mark line of the present invention, and when stitching to the position of the next mark point, the stitching is completed according to the stitching method of the mark point, and then the mark line is stitched until the line is stitched.
  • the next point is marked so that the suture of the prosthetic valve forming ring is completed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Oral & Maxillofacial Surgery (AREA)
  • Prostheses (AREA)

Abstract

一种人工瓣膜成形环（10）及其缝合方法，该人工瓣膜成形环（10）包括内核管（11）、包裹于内核管（11）外的柔性材料层（12）以及包裹于柔性材料层（12）外的织物层（13）。织物层（13）为闭环结构，其具有通过缝合线缝合的两端部（131,132），两端部（131,132）均具有多个间隔设置的环状结构（131A,132A），缝合线（18）依次交替穿过两端部（131,132）的环状结构（131A,132A）从而将两端部缝合。该人工瓣膜成形环（10）的织物层（13）不仅对血流的流速影响较小，也降低了血栓的形成概率。

Description

人工瓣膜成形环及其缝合方法 技术领域
本发明涉及心血管医疗器械，尤其涉及一种人工瓣膜成形环及其缝合方法。
背景技术
现有的人工瓣膜成形环一般具有三层结构，最内层为金属或高分子材料支撑体，中间层为硅胶层，最外层是涤纶布管。在制备人工瓣膜成形环的过程中，通常是，先将硅胶层套设于支撑体的外表面上，再将涤纶布管套设于硅胶层上，最后将涤纶布管的两端叠合在一起，并用连有缝线的缝针沿涤纶布管的周向一进一出的将涤纶布管两端的叠合之处缝合在一起。然而，因涤纶布管两端叠合处相对涤纶布管其他之处较厚，且缝线在缝合叠合处时也会形成多个凸起，故，人工瓣膜成形环上的涤纶布表面因缝合涤纶布管两端而形成的凸起相对涤纶布的其他之处较厚，且凸起较多，有较厚且较多凸起的涤纶布不仅会阻碍血流的流动，降低了血流的流速，还增加了涤纶布表面形成血栓的概率。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种人工瓣膜成形环及其缝合方法。
本发明解决其技术问题所采用的技术方案是：构造一种人工瓣膜成形环，其包括内核管、包裹于所述内核管外的柔性材料层以及包裹于所述柔性材料层外的织物层，所述织物层为闭环结构，其具有通过缝合线缝合的两端部，每个所述端部均具有多个间隔设置的环状结构，所述缝合线的一端依次交替穿过两所述端部的环状结构以将两所述端部缝合在一起。
优选的，两所述端部的环状结构相对且交替设置。
优选的，所述成形环上设有标记点，所述织物层两端部的缝合线的位置与所述标记点的位置重合。
优选的，所述成形环上设有沿所述成形环周向设置的标记线，所述标记线将所述柔性材料层与所述织物层缝合在一起，且与所述内核管相分离。
优选的，该人工瓣膜成形环的横截面包括第一部分和与所述第一部分相连的第二部分，所述第一部分的轮廓线呈弧形且具有第一端点和第二端点，所述第二部分的轮廓线包括与所述第一端点相连且向远离所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段；
所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形，且所述三角形中，所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角，所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合
优选的，所述内核管由金属或高分子材料制成。
优选的，所述柔性材料层为硅胶层。
优选的，所述织物层为涤纶布。
本发明解决其技术问题采用的另一技术方案是：提出一种如上述所述的人工瓣膜成形环的缝合方法，其包括以下步骤：
S1、提供一瓣环半成品，所述瓣环半成品包括非封闭的内核管以及包裹于所述内核管外周的柔性材料层；所述内核管的其中一端部内容置有连接件，所述连接件自所述端部露出；
S2、提供一管材和织物层，所述管材具有尾部以及头部，将所述瓣环半成品的具有所述连接件的端部从所述管材的尾部推入，所述管材的头部从所述织物层的一端进入所述织物层的内部；
S3、移动所述织物层，使所述织物层与所述管材做相对运动，直至所述织物层的一端靠近所述管材的尾部，此时将所述管材全部从所述织物层中抽出，使所述织物层与所述柔性材料层贴合；
S4、将所述织物层远离所述尾部的端部回折，直至将所述连接件露出；
S5、将所述内核管的两端对接并通过连接件固定形成对接处；
S6、将所述织物层回折的所述端部摊平并覆盖住所述内核管的对接处；
S7、将缝合线的一端依次从所述织物层两端部的环状结构中交替穿过，并拉紧所述缝合线。
优选的，该缝合方法还包括所述标记线的缝合方法，所述标记线的缝合方法包括以下步骤：
1)、将连接有缝合线的缝合针的一端从所述织物层扎入，避开所述内核管，并依次穿过所述织物层和柔性材料层；
2)、所述缝合针的一端自所述织物层穿出后，先调整所述缝合针另一端的角度，再推动所述缝合针自所述缝合针一端穿出的位置扎入，并使其朝所述缝合针另一端所指的方向移动，避开所述内核管并依次穿过所述柔性材料层和织物层，直至所述缝合针全部露出。
3)、重复步骤1)和步骤2)完成所述标记线的缝合。
优选的，所述缝合针的针尾呈锥形，且步骤2)中所述锥形的针尾从所述织物层扎入。
优选的，所述缝合针的角度在所述柔性材料层内调整。
优选的，该人工瓣膜成形环的横截面包括第一部分和与所述第一部分相连的第二部分，所述第一部分的轮廓线呈圆弧形且具有第一端点和第二端点，所述第二部分的轮廓线包括与所述第一端点相连且向远离所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段；
所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形，且所述三角形中，所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角，所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合。
优选的，该缝合方法还包括所述标记点的缝合方法，其具体包括以下步骤：
①、所述缝合针从所述第一部分与所述第二部分相连处扎入，避开所述内核管并完全穿过所述织物层以及所述柔性材料层，围绕所述第一部分的外轮廓 回到所述相连处；
②、所述缝合针从所述相连处扎入并穿过所述织物层和柔性材料层，围绕所述第二部分的外轮廓并回到所述相连处。
优选的，所述连接件为镍钛套管。
相较现有的缝合方式，不仅未将织物层的两端叠合在一起，而且缝合处由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整，产生的凸起较薄也较少，因此通过该方法获得人工瓣膜成形环的织物层不仅对血流的流速影响较小，也降低了血栓的形成概率。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明一种人工瓣膜环优选实施例的结构示意图；
图2是图1所示的人工瓣膜环沿图1中A-A方向的剖面图；
图3是图1所示的人工瓣膜环中织物层两端部未被缝合时的结构示意图；
图4是图1所示的人工瓣膜环中织物层两端部缝合过程中的结构示意图；
图5是图1所示的人工瓣膜环中织物层两端部缝合完的结构示意图；
图6是图1所示的人工瓣膜环中织物层两端部未被缝合时另一实施例的示意图；
图7是本发明一种人工瓣膜成形环的缝合方法步骤S1中提供的瓣环半成品的结构示意图；
图8是本发明的人工瓣膜成形环的缝合方法步骤S2的操作示意图；
图9-图11是本发明的人工瓣膜成形环的缝合方法步骤S3的操作示意图；
图12是本发明的人工瓣膜成形环的缝合方法步骤S4和步骤S5的操作示意图；
图13是本发明的人工瓣膜成形环的缝合方法步骤S6的操作示意图；
图14是图13中B部位的放大图；
图15是本发明的标记线缝合方法中提供的缝合针的结构示意图；
图16-图20是采用本发明的标记线缝合方法的缝合过程示意图；
图21是采用本发明的标记线缝合方法缝合完之后的结构示意图；
图22是采用本发明的一种标记点缝合方法的操作示意图；
图23是采用图22所示的缝合方法缝合标记点的过程示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
如图1和图2所示，一种人工瓣膜成形环10包括内核管11、包裹于内核管11外周的柔性材料层12以及包裹于柔性材料层12外的织物层13。人工瓣膜成形环10为一具有柔性的非平面环体，内核管11由金属或高分子材料制成，柔性材料层12优选硅胶，织物层13优选涤纶布。此外，人工瓣膜成形环10上还设有沿成形环10周向设置的标记线14以及间隔设置在成形环10上的左三角标记点15、右三角标记点16以及后标记点17。
如图3-图5所示，织物层13为一封闭的编织环状结构，其具有通过缝合线18缝合的两端部131和132。两端部131和132分别具有若干个间隔设置的环状结构131A和132A。由于织物层13为编织物，因此环状结构131A和132A为其自身的一部分，且在本优选实施例中，环状结构131A和132A相对且交替设置。所述相对且交替设置是指，若干个环状结构131A与若干个环状结构132A相对，且当两端部131和132对齐时，每两个相邻的环状结构131A之间有且仅有一个环状结构132A，每两个相邻的环状结构132A之间有且仅有一个环状结构131A。缝合线18依次交替穿过环状结构131A和132A，最后再拉紧缝合线18完成缝合。
环状结构131A和132A相对交替设置使得缝合线18在拉紧后，其中一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间，这种缝合方式相较现有的缝合方式，不仅未将织物层的两端叠合在一起，而且缝合处由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整，产生的凸起较薄也较少，因此通过该方法获得人工瓣膜成形环的织物层不仅对血流的流速影响较小，也降低了血栓的形成概率。
如图6所示，在其他可能的实施例中，两个端部的若干个环状结构131A’和132A’的位置也可以是一一对应的。由于缝合线18’一端依次从织物层两端部的环状结构中交替穿过，因此拉动缝合线18’，图6中所示的一个环状结构132A’在缝合线18’的牵引下被拉入两个相邻的环状结构132A’中间。这样所获的缝合处也由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整，产生的凸起较薄也较少。
进一步的，在本发明的优选实施例中，缝合线18的位置与上述三个标记点中的其中一个重合并隐藏在该标记点下面。将缝合线18的位置隐藏在其中一个标记点下面可以进一步减少瓣膜环表面的不平整处，在降低血栓形成概率的同时，使得瓣环更加美观。
如图2所示，该成形环10的横截面包括第一部分101和与第一部分101相连的第二部分102。第一部分101的轮廓线呈圆弧形且具有第一端点101A和第二端点101B。第二部分102的轮廓线具有与第一端点101A相连的且向远离所述第一部分101方向延伸的第一段102A，和自第一段102A远离第一端点101A的端部弯折且朝第二端点101B延伸并与第二端点101B相连的第二段102B。其中，第一部分101轮廓线的过第一端点101A的切线、第一部分101轮廓线的过第二端点101B的切线及第一段102A围成一个三角形，且该三角形中，第一部分101轮廓线的过第一端点101A的切线与第一段102A之间的夹角为锐角；第二段102B与第一部分101轮廓线的过第二端点101B的切线重合。
标记线14自第一端点101A和第一段102A相连处穿入织物层13和柔性材料层12并避开内核管11，从而将织物层13和柔性材料层12缝合固定。此时，标记线14与柔性材料层12的相对位置是固定的，且位于第一端点101A和第一段102A相连处。标记线14与柔性材料层12的相对位置固定使得医生在手术操作过程中不会因为织物层13与柔性材料层12之间的相对滑动而戳到内核管11，避免了手术失败，提高了手术的成功率。
本发明还提出了一种上述人工瓣膜成形环的缝合方法，该方法包括以下步骤：
S1、如图7所述，提供一瓣环半成品20。该瓣环半成品20包括非封闭的 内核管21以及包裹于内核管21外周的柔性材料层22。内核管21为空心的管状结构，且内核管21其中一端部内容置有连接件23，该连接件23自内核管21的端部露出。在本优选实施例中，连接件23为镍钛管。
S2、如图8所示，提供一管材30和管状的织物层24。管材30具有尾部31以及锥形的头部32。织物层24具有管材进入端241。将瓣环半成品20的具有连接件23的端部从管材30的尾部31开口处推入管材30内部，且瓣环半成品20的远离连接件23的端部裸露在外，再将管材30的头部32经织物层24的管材进入端241推入织物层24的内部。管材30的表面光滑，且其头部32被设计成锥形，以有利于进入织物层24的内部。
S3、如图9所示，移动织物层24的管材进入端241，使织物层24与管材30做相对运动，直至将织物层24的管材进入端241靠近管材30的尾部31。如图10所述，当管材30露出其头部32时，拉动管材30，直至将管材30全部从织物层24中抽出。如图11所示，此时，织物层24的内壁面与柔性材料层22的外壁面贴合。
S4、如图12所示，将织物层24靠近连接件23的端部回折，直至将连接件23露出。
S5、将内核管21的两端对接并通过连接件23焊接固定形成对接处。
S6、如图13和图14所示，将织物层24回折的端部摊平并覆盖住内核管21的对接处。
S7、将缝合线的一端依次从织物层24两端部的环状结构中交替穿过(参阅图4)。再拉紧缝合线的两端，并将缝合线的两端打结成一体，打结后的缝合线的端部隐藏于织物层24与柔性材料层22之间，如此，完成缝合。
本发明中，所述缝合线的一端依次从织物层24两端部的环状结构中交替穿过可以通过以下多种方式完成：方式一，缝合线的一端可以依次从从右至左数的第一个环形结构131A、从右至左数第一个环状结构132A、从右至左数第二个环状结构131A、从右至左数第二个环状结构132A、从右至左数第三个环状结构131A、从右至左数第三个环状结构132A……穿过，直至缝合线的端部从右侧的最后一个环状结构穿出；方式二，缝合线的一端可以依次从从左至右 数的第一个环形结构132A、从左至右数第一个环状结构131A、从左至右数第二个环状结构132A、从左至右数第二个环状结构131A、从左至右数第三个环状结构132A、从左至右数第三个环状结构131A……穿过，直至缝合线的端部从右侧的最后一个环状结构穿出。
该缝合方法中，缝合线的一端依次从织物层两端部的环状结构中交替穿过，待拉紧缝合线两端后，其中一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间，这种缝合方式相较现有的缝合方式，不仅未将织物层的两端叠合在一起，而且缝合处由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整，产生的凸起较薄也较少，因此通过该方法获得人工瓣膜成形环的织物层不仅对血流的流速影响较小，也降低了血栓的形成概率。该人工瓣膜成形环的缝合方法还进一步包括标记线的缝合方法和标记点的缝合方法。其中标记线的缝合方法包括以下步骤：
1)、如图15所示，提供一缝合针40，该缝合针40具有针尖41、与针尖41相对的针尾43。针尾43具有针尖的功能，其设有一个穿线孔42。本实施例中，针尾43呈锥形。穿线孔42可收容缝线，即缝线可经穿线孔42与针尾43相连。
2)、如图16和图17所示，将连有缝线50的缝合针40的针尾43从织物层24的顶面241扎入，避开内核管21，并依次穿过织物层24的顶面241和柔性材料层22。
3)、如图18-20所示，缝合针40的针尾43自织物层24的底面242穿出后，先调整缝合针40针尖41的角度，再推动缝合针40自织物层24上针尾43穿出的位置S扎入，并使其朝针尖41所指的方向移动，避开内核管21并依次穿过柔性材料层22和织物层24，直至缝合针40全部露出。
4)、如图21所示，重复步骤2)和步骤3)即可完成标记线的缝合。
可以理解的是，其他实施例中，步骤2中也可以针尖41从织物层24的顶面241扎入，避开内核管21，并依次穿过织物层24的顶面241和柔性材料层22，此种情况下，待缝合针40的针尖41自织物层24的底面242穿出后，先调整缝合针40针尾43的角度，再推动缝合针40自织物层24上针尖41穿出 的位置S扎入，并使其朝针尾41所指的方向移动，避开内核管21并依次穿过柔性材料层22和织物层24，直至缝合针40全部露出，也可以完成标记线的缝合。
由图21可以看到，采用上述方法缝合的标记线，缝合线并未将织物层24的底面242与柔性材料层22缝合，缝合线在织物层24的顶面241与柔性材料层22之间穿插。由于缝合线的拉紧作用以及柔性材料层22的材料特性，织物层24的被缝合针40穿过的位置以及相邻的该位置之间会不可避免的产生小的凹陷，而采用上述缝合方式的好处是，底面242上不存在这样的凹陷，就能最大限度地减少织物层表面的不平整和凸起，降低了血栓发生的概率。此外，采用上述方法缝合的标记线与柔性材料层22缝合在一起，且缝合线避开了内核管21，医生在手术时，缝合针在缝合线的指引下，不会戳到内核管21，提高了手术的安全有效性。
当完成织物层两端的缝合后，可以在织物层上继续缝制标记点，而标记点的缝合包括以下步骤：
①、请参阅图22，缝合针40从成形环横截面上的第一段102A与第一端点101A的相连处扎入，避开内核管21并完全穿过织物层24以及柔性材料层22，顺时针围绕第一部分101的外轮廓回到第一段102A与第一端点101A相连处。
②、缝合针40从第一段102A与所述第一端点101A相连处扎入并穿过织物层24和柔性材料层22，逆时针围绕第二部分102的外轮廓并回到第一段102A与第一端点101A的相连处。
③、将缝合线的两端打结，并将结头隐藏至织物层24里面。
可以理解的是，其他实施例中，若从成形环横截面上的第二段102B与第二端点101B相连处入针，则避开内核管21并完全穿过织物层24以及柔性材料层22，逆时针围绕第一部分101的外轮廓回到第二段102B与第二端点101B相连处；再从第二段102B与第二端点101B相连处入针，并穿过织物层24和柔性材料层22，顺时针围绕第二部分102的外轮廓并回到第二段102B与第二端点101B相连处；最后将缝合线的两端打结，并将结头隐藏至织物层24里面，也能形成标记点。
如图23所示，还可以理解的是，其他实施例中，三个标记点及标记线之间还可以通过一次打结来完成，例如可以先采用上述标记线的缝合方法缝合标记线直至第一标记点处，然后采用与上述标记点的缝合方法大体上类似的方法缝合第一个标记点(当然，此时缝合第一个标记点时无需打结)，待第一个标记点缝完之后继续采用上述标记线的缝合方法缝合标记线直至第二个标记点处，然后采用与上述标记点的缝合方法大体上类似的方法缝合第二个标记点(当然，此时缝合第二标记点时无需打结)，接着再采用上述标记线的缝合方法缝合标记线直至第三个标记点处(当然，此时缝合第一个标记点时无需打结)，待第三个标记点缝完之后继续采用上述标记线的缝合方法缝合标记线直至与标记线的另一端头汇合而打结结合在一起，如此，完成了标记线及标记点的一次打结形成过程。再例如，先缝第一个标记点，但是不打结，接着缝标记线至第二个标记点处，再缝第二个标记点，仍然不打结，接着缝标记线至第三个标记点处，仍然不打结，接着缝标记线至第一个标记点处，将缝合线的两端在第一个标记点处打结，也可以完成了标记线及三个标记点的一次打结形成过程。
依照上述缝合方法完成一个标记点的缝合后，再依照本发明标记线的缝合方法缝合标记线，当缝合至下一个标记点位置时再依照标记点的缝合方法完成缝合，接着再缝合标记线直至再下一个标记点，如此即可完成人工瓣膜成形环的缝合。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (14)

  1. 一种人工瓣膜成形环，其包括内核管、包裹于所述内核管外的柔性材料层以及包裹于所述柔性材料层外的织物层，其特征在于，所述织物层为闭环结构，其具有通过缝合线缝合的两端部，每个所述端部均具有多个间隔设置的环状结构，所述缝合线的一端依次交替穿过两所述端部的环状结构以将两所述端部结合在一起。
  2. 根据权利要求1所述的人工瓣膜成形环，其特征在于，两所述端部的环状结构相对且交替设置。
  3. 根据权利要求2所述的人工瓣膜成形环，其特征在于，所述成形环上设有标记点，所述织物层两端部的缝合线的位置与所述标记点的位置重合。
  4. 根据权利要求1所述的人工瓣膜成形环，其特征在于，所述成形环上设有沿所述成形环周向设置的标记线，所述标记线将所述柔性材料层与所述织物层缝合在一起，且与所述内核管相分离。
  5. 根据权利要求4所述的人工瓣膜成形环，其特征在于，该成形环的横截面包括第一部分和与所述第一部分相连的第二部分，所述第一部分的轮廓线呈弧形且具有第一端点和第二端点，所述第二部分的轮廓线包括与所述第一端点相连且向远离所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段；
    所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形，且所述三角形中，所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角，所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合。
  6. 根据权利要求1所述的人工瓣膜成形环，其特征在于，所述内核管由金属或高分子材料制成。
  7. 根据权利要求1所述的人工瓣膜成形环，其特征在于，所述柔性材料层为硅胶层。
  8. 根据权利要求1所述的人工瓣膜成形环，其特征在于，所述织物层为涤纶布。
  9. 一种如权利要求1-8任一项所述的人工瓣膜成形环的缝合方法，其特征在于，其包括以下步骤：
    S1、提供一瓣环半成品，所述瓣环半成品包括非封闭的内核管以及包裹于所述内核管外周的柔性材料层；所述内核管的其中一端部内容置有连接件，所述连接件自所述端部露出；
    S2、提供一管材和织物层，所述管材具有尾部以及头部，将所述瓣环半成品的具有所述连接件的端部从所述管材的尾部推入，所述管材的头部从所述织物层的一端进入所述织物层的内部；
    S3、移动所述织物层，使所述织物层与所述管材做相对运动，直至所述织物层的一端靠近所述管材的尾部，此时将所述管材全部从所述织物层中抽出，使所述织物层与所述柔性材料层贴合；
    S4、将所述织物层远离所述尾部的端部回折，直至将所述连接件露出；
    S5、将所述内核管的两端对接并通过连接件固定形成对接处；
    S6、将所述织物层回折的所述端部摊平并覆盖住所述内核管的对接处；
    S7、将缝合线的一端依次从所述织物层两端部的环状结构中交替穿过，并拉紧所述缝合线。
  10. 根据权利要求9所述的缝合方法，其特征在于，该缝合方法还包括所述标记线的缝合方法，所述标记线的缝合方法包括以下步骤：
    1)、将连接有缝合线的缝合针的一端从所述织物层扎入，避开所述内核管，并依次穿过所述织物层和柔性材料层；
    2)、所述缝合针的一端自所述织物层穿出后，先调整所述缝合针另一端的角度，再推动所述缝合针自所述缝合针一端穿出的位置扎入，并使其朝所述缝合针另一端所指的方向移动，避开所述内核管并依次穿过所述柔性材料层和织物层，直至所述缝合针全部露出；
    3)、重复步骤1)和步骤2)完成所述标记线的缝合。
  11. 根据权利要求10所述的缝合方法，其特征在于，所述缝合针具有相 对的针尖及针尾，所述针尾连接有缝合线且步骤1)中所述针尾从所述织物层扎入。
  12. 根据权利要求11所述的缝合方法，其特征在于，该人工瓣膜成形环的横截面包括第一部分和与所述第一部分相连的第二部分，所述第一部分的轮廓线呈圆弧形且具有第一端点和第二端点，所述第二部分的轮廓线包括与所述第一端点相连且向远离所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段；
    所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形，且所述三角形中，所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角，所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合。
  13. 根据权利要求10或12所述的缝合方法，其特征在于，该缝合方法还包括所述标记点的缝合方法，其具体包括以下步骤：
    ①、所述缝合针从所述第一部分与第二部分相连处扎入，避开所述内核管并完全穿过所述织物层以及所述柔性材料层，围绕所述第一部分的外轮廓回到所述相连处；
    ②、所述缝合针从所述相连处扎入并穿过所述织物层和柔性材料层，围绕所述第二部分的外轮廓并回到所述相连处。
  14. 根据权利要求10所述的缝合方法，其特征在于，所述连接件为镍钛套管。
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