CN115770126A - Support for fixing artificial valve and fixing method thereof - Google Patents
Support for fixing artificial valve and fixing method thereof Download PDFInfo
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- CN115770126A CN115770126A CN202310092725.7A CN202310092725A CN115770126A CN 115770126 A CN115770126 A CN 115770126A CN 202310092725 A CN202310092725 A CN 202310092725A CN 115770126 A CN115770126 A CN 115770126A
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- 238000000034 method Methods 0.000 title claims abstract description 16
- 230000007704 transition Effects 0.000 claims description 35
- -1 polyethylene terephthalate Polymers 0.000 claims description 9
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 claims description 6
- 239000002861 polymer material Substances 0.000 claims description 6
- 230000008602 contraction Effects 0.000 claims description 5
- 239000000463 material Substances 0.000 claims description 5
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 5
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 claims description 3
- 239000004743 Polypropylene Substances 0.000 claims description 3
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 claims description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 3
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 3
- 229920002635 polyurethane Polymers 0.000 claims description 3
- 239000004814 polyurethane Substances 0.000 claims description 3
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 3
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 claims description 3
- 230000001174 ascending effect Effects 0.000 claims 1
- 230000009286 beneficial effect Effects 0.000 abstract description 3
- 238000009958 sewing Methods 0.000 description 10
- 230000000903 blocking effect Effects 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000000709 aorta Anatomy 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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Abstract
The invention provides a stent for fixing a prosthetic valve and a fixing method thereof, wherein the stent comprises a tubular stent main body, a folding structure and a valve supporting structure are sequentially arranged in the stent main body along the axial direction, and the folding structure and the valve supporting structure are arranged along the circumferential direction of the stent main body; the folding structure comprises a fixing part and a tightening part, the fixing part is connected with the support main body, the tightening part is turned over along the circumferential direction to the direction close to the central axis of the support main body, the valve supporting structure comprises a connecting part and a supporting part, the connecting part is used for connecting the support main body, and the supporting part extends along the circumferential direction to the direction close to the central axis of the support main body; the artificial valve is sent into the support main body, the supporting part supports the artificial valve, and the tightening part is turned over towards the direction close to the artificial valve and clings to the artificial valve. The invention adopts a foldable bracket structure to connect and fix the artificial valve, is firm, simple and convenient and is beneficial to reducing the risk of perivalvular leakage.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and relates to a stent for fixing a prosthetic valve and a fixing method thereof.
Background
The connecting part of the artificial valve and the autologous valve ring (namely a sewing ring of the artificial valve) is usually circular, a cylindrical tubular object is selected for the suitability of a bracket for fixing the artificial valve, and the artificial valve and the bracket are connected and fixed after the bracket is implanted into the position of the autologous valve ring in the body.
At present, the valve ring part of the artificial valve is mainly fixed by utilizing the buckling structures of the upper layer and the lower layer on the bracket. However, after the stent is implanted into a human body, the buckle structure on the stent is easily extruded by the native valve ring and surrounding tissues and tends to be non-circular, so that the connection difficulty of the artificial valve and the stent is greatly increased, and the risk of perivalvular leakage is easily caused due to the problem of insufficient matching degree or tightness after the connection is completed. In addition, the contour part of the stent at the end of the aorta is not attached to the surrounding biological tissues, and the stent rod is too dense, so that the coronary opening is easily blocked.
Therefore, it is very important to provide a valve stent which is simple to operate and is firmly connected.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a stent for fixing a prosthetic valve and a fixing method thereof, which optimize the stent profile of the aortic end part, adopt a foldable stent structure to connect and fix the stent with the prosthetic valve, are firm and simple and are beneficial to reducing the risks of blocking coronary ostia and paravalvular leakage.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the present invention provides a stent for fixing a prosthetic valve, including a tubular stent main body, in which a folding structure and a valve support structure are sequentially arranged along an axial direction, and the folding structure and the valve support structure are arranged along a circumferential direction of the stent main body;
the folding structure comprises a fixing part and a tightening part, the fixing part is connected with the support main body, the tightening part is turned over along the circumferential direction in the direction close to the central axis of the support main body, the valve supporting structure comprises a connecting part and a supporting part, the connecting part is used for connecting the support main body, and the supporting part extends along the circumferential direction in the direction close to the central axis of the support main body;
and the artificial valve is sent into the support main body, the support part supports the artificial valve, and the tightening part is turned over towards the direction close to the artificial valve and is tightly attached to the artificial valve.
According to the support for fixing the artificial valve, the folding structure and the valve supporting structure are sequentially arranged along the pushing direction of the artificial valve, the valve supporting structure is adopted to support the artificial valve placed in the support main body, meanwhile, the folding structure is used for tightening one end close to the artificial valve, the support main body is connected and fixed with the artificial valve, in addition, the tightening part and the artificial valve sewing ring are mutually extruded, and the risk of valve leakage caused by the gap generated between the support main body and the artificial valve is effectively reduced.
The support part of the valve support structure of the invention extends along the circumferential direction to the direction close to the central shaft of the bracket main body to form an inward contraction structure, thereby preventing the bracket main body from being pressed and slipping after being connected with the artificial valve.
It should be noted that the tightening part in the present invention is a free end, and the tightening part extends along the stent main body in an initial state and is attached to the inner side surface of the stent main body, and after the prosthetic valve is delivered into the stent main body, the tightening part gradually contracts in a direction approaching the prosthetic valve along the circumferential direction to be connected and fixed.
As a preferred embodiment of the present invention, an inner diameter of an orthogonal projection of the support portion of the valve support structure in a direction perpendicular to the central axis of the holder main body is smaller than an inner diameter of an orthogonal projection of the tightening portion of the collapsible structure in a direction perpendicular to the central axis of the holder main body.
Preferably, the inner diameter of the orthographic projection of the support part in the direction perpendicular to the central axis of the bracket main body is 19 to 27mm.
In the stent main body of the present invention, the supporting portion of the valve supporting structure forms a supporting surface for supporting the bottom of the artificial valve, and the tightening portion of the folding structure is folded toward the direction close to the artificial valve, covers part of the surface of the artificial valve, and is mutually squeezed to realize connection.
As a preferred technical solution of the present invention, the stent main body includes an outflow portion, a transition section, and an inflow portion, which are sequentially arranged along an axial direction.
It should be noted that the outflow portion, the transition section, and the inflow portion are sequentially arranged along the pushing direction of the prosthetic valve. The folding structure is arranged close to the outflow part along the axial direction, in the using process, the artificial valve is pushed to the direction of the inflow part from the outflow part along the axial direction of the support main body until the artificial valve is supported on the supporting part of the valve supporting structure, and then the tightening part of the folding structure contracts towards the direction close to the artificial valve and covers the artificial valve sewing ring.
The two ends of the transition section are respectively connected with the outflow part and the inflow part, one ends of the outflow part and the inflow part, which are far away from the transition section, extend towards the directions far away from each other respectively and are turned outwards along the circumferential direction, and the extending direction of the supporting part of the valve supporting structure is opposite to the extending direction of the inflow part.
In the present invention, the outflow portion and the inflow portion are folded outward in the circumferential direction, which means that the outflow portion and the inflow portion are folded in a direction away from the central axis of the stent body, so that the maximum linear distance between the outflow portion and the inflow portion in a direction perpendicular to the central axis of the stent body is greater than that of the transition section, and a structure is formed in which both ends expand radially and widen and the middle is narrow, and the stent body is firmly fixed at the valve annulus of the native valve in a shape fitting manner. The outflow part and the inflow part of the invention are in outward expansion structures relative to the transition section, so that the stent main body can be firmly fixed after being implanted into a human body, and the displacement along with the movement of the heart is prevented.
As a preferred technical scheme of the present invention, the transition section is formed by sequentially arranging and enclosing a plurality of support bars along the circumferential direction, the support bars are arranged in parallel on a central shaft of the support main body, the outflow portion is formed by sequentially arranging and enclosing a plurality of first frame bodies along the circumferential direction, the inflow portion is formed by sequentially arranging and enclosing a plurality of second frame bodies along the circumferential direction, and two ends of each support bar are respectively connected to the first frame bodies and the second frame bodies.
In the present invention, the outflow portion is a hollow network structure formed by sequentially arranging a plurality of first frames, and the inflow portion is a hollow network structure formed by sequentially arranging a plurality of second frames. The outflow part of the stent main body is formed by splicing a plurality of first frame bodies, the hollowed grids are sparse, and the risk of blocking coronary openings is favorably reduced.
As a preferred embodiment of the present invention, an included angle between the first frame and the central axis of the holder body is 30 to 90 °, and may be, for example, 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, 70 °, 75 °, 80 °, 85 °, or 90 °, but is not limited to the enumerated values, and other non-enumerated values within the numerical range are also applicable.
The included angle between the second frame and the central axis of the bracket body is 30 to 90 degrees, and may be, for example, 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, 70 °, 75 °, 80 °, 85 ° or 90 °, but is not limited to the enumerated values, and other unrecited values in the numerical range are also applicable.
The length of the supporting strip is 30 to 60 percent of the maximum linear distance of the axial orthographic projection of the support main body.
It should be noted that the transition section with a specific length in the present invention can satisfy the requirement of the flexibility of the stent body in the blood vessel, so that the stent body can be implanted into the set position smoothly.
The material of the bracket main body comprises memory alloy.
Preferably, the stent main body is made of nickel titanium alloy.
The maximum linear distance of the orthogonal projection of the support main body in the direction vertical to the central axis of the support main body is 22 to 35mm.
As a preferred technical solution of the present invention, one end of the supporting bar is connected to the first frame body through a first connecting joint, and the other end of the supporting bar is connected to the second frame body through a second connecting joint.
Two adjacent first frameworks pass through first fixed knot and connect, and two adjacent second frameworks pass through the second fixed knot and connect.
The width of the orthographic projection of the first frame body in the axial direction of the support main body is gradually enlarged from the first connecting section to the first fixing section, and gradually reduced from the first fixing section to the direction far away from the support bar.
The width of the orthographic projection of the second frame body in the axial direction of the support main body is gradually enlarged from the second connecting joint to the second fixing joint, and gradually reduced from the second fixing joint to the direction far away from the support bar.
Preferably, the first frame body is similar in shape to the second frame body.
It should be noted that, in the present invention, the outer contour of each of the first frame and the second frame adopts a structure that gradually expands along the radial direction and then gradually contracts along the radial direction in the direction away from the transition section, so that the damage to the native tissue can be reduced.
As a preferred technical solution of the present invention, the valve support structure is connected to a connection point of the transition section and the inflow portion, and the connection portion of the valve support structure is connected to the second connection node.
As a preferable technical solution of the present invention, the valve support structure is made of any one of platinum-iridium alloy, cobalt-chromium alloy, nickel-titanium alloy, cobalt-chromium alloy, and tantalum metal.
The valve support structure is integrally formed with the stent body.
The valve supporting structure is formed by sequentially arranging a plurality of supporting frame bodies along the circumferential direction in a surrounding manner, the supporting frame bodies are arranged on the width of the axial upward orthographic projection of the support main body, the width of the orthographic projection of the support main body is gradually enlarged from the connecting parts to the supporting parts, and the supporting frame bodies are in arc transition from the connecting parts to the supporting parts.
As a preferred technical solution of the present invention, the folding structure is made of a woven polymer material, and the folding structure is sewn and fixed on the inner side surface of the stent main body.
The high polymer material comprises any one of polyurethane, polyethylene terephthalate, polytetrafluoroethylene or polypropylene.
It should be noted that the folding structure in the present invention is a high polymer material woven body, and is placed in the stent main body, the fixing portion of the folding structure is fixed by being tightly attached to the surface of the transition section portion of the stent main body along the circumferential direction, and the tightening portion forms a closed opening and is mutually extruded with the artificial valve to cover the artificial valve sewing ring, so as to realize the connection between the artificial valve and the stent main body.
In a second aspect, the present invention provides a method of fixing a stent for fixing a prosthetic valve according to the first aspect, the method comprising:
the artificial valve is sent into the support body and is propped against the supporting part of the valve supporting structure, the tightening part of the folding structure shrinks towards the direction close to the central shaft of the support body and covers part of the surface of the artificial valve, and the fixation of the artificial valve is realized.
The recitation of numerical ranges herein includes not only the above-recited numerical values, but also any numerical values between non-recited numerical ranges, and is not intended to be exhaustive or to limit the invention to the precise numerical values encompassed within the range for brevity and clarity.
Compared with the prior art, the invention has the following beneficial effects:
the invention provides a stent for fixing a prosthetic valve and a fixing method thereof.A valve supporting structure is adopted to support the prosthetic valve which is placed in a stent main body from the bottom, the prosthetic valve is prevented from slipping after being pressed, meanwhile, one end of a folding structure close to the prosthetic valve is used for tightening, the connection between the stent main body and the prosthetic valve is realized, and a tightening part and a prosthetic valve sewing ring are mutually extruded, so that the risk of valve perivalvular leakage caused by a gap between the stent main body and the prosthetic valve is effectively reduced.
Drawings
FIG. 1 is a schematic diagram of a prosthetic valve according to one embodiment of the present invention;
FIG. 2 is a schematic view of a prosthetic valve according to one embodiment of the present invention extending into a stent body;
FIG. 3 is a schematic structural diagram of a stent body according to an embodiment of the present invention;
fig. 4 is a top view of a stent for securing a prosthetic valve according to an embodiment of the present invention.
Wherein, 10-the outflow portion; 101-a first frame; 102-a first connection; 103-a first fixed joint; 20-a transition section; 201-supporting strips; 30-a valve support structure; 40-an inflow portion; 401-a second frame; 402-a second connecting joint; 403-a second fixed knot; 50-a folding structure; 501-a fixed part; 502-a tightening part; 60-artificial valve.
Detailed Description
It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate a number of the indicated technical features. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.
It should be noted that, unless explicitly stated or limited otherwise, the terms "disposed," "connected" and "connected" in the description of the present invention are to be construed broadly and may include, for example, a fixed connection, a detachable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.
The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.
In one embodiment, the present invention provides a stent for fixing a prosthetic valve, including a tubular stent main body, as shown in fig. 1, 2, 3 and 4, a collapsible structure 50 and a valve support structure 30 are sequentially disposed in the stent main body along an axial direction, and the collapsible structure 50 and the valve support structure 30 are disposed along a circumferential direction of the stent main body.
The folding structure 50 comprises a fixing part 501 and a tightening part 502, the fixing part 501 is connected with the support body, the tightening part 502 is circumferentially folded towards the direction close to the central axis of the support body, the valve supporting structure 30 comprises a connecting part and a supporting part, the connecting part is used for connecting the support body, the supporting part is circumferentially extended towards the direction close to the central axis of the support body, the artificial valve 60 is fed into the support body, the supporting part supports the artificial valve 60, and the tightening part 502 is folded towards the direction close to the artificial valve 60 and tightly attached to the artificial valve 60.
The folding structure 50 and the valve supporting structure 30 are sequentially arranged along the pushing direction of the artificial valve 60, the valve supporting structure 30 in the support main body forms a folding structure in the support main body, the support main body is prevented from being pressed and slipping after being connected with the artificial valve 60, one end of the folding structure 50, which is close to the artificial valve 60, is used for shrinking, the folding structure and the artificial valve 60 are mutually extruded, and the support main body and the artificial valve 60 are connected.
The tightening part 502 in the present invention is a free end, and in an initial state, the tightening part extends along the stent main body and is attached to the inner side surface of the stent main body, and after the prosthetic valve 60 is sent into the stent main body, the tightening part 502 gradually contracts in the circumferential direction toward the prosthetic valve 60 for connection and fixation.
In some embodiments, an inner diameter of an orthographic projection of the support portion of the valve support structure 30 in a direction perpendicular to the central axis of the stent body is smaller than an inner diameter of an orthographic projection of the contraction portion 502 of the collapsible structure 50 in a direction perpendicular to the central axis of the stent body.
Specifically, the inner diameter of the orthographic projection of the support part in the direction perpendicular to the central axis of the bracket main body is 19 to 27mm.
The supporting part of the invention is a free end to form a supporting surface for supporting the bottom of the artificial valve 60, and the tightening part 502 is also a free end, is folded and contracted towards the direction close to the artificial valve 60, and is mutually extruded with the artificial valve 60 to realize connection.
The inner diameter of the orthographic projection of the support part in the axial direction of the support main body is smaller than the maximum linear distance of the orthographic projection of the bottom of the artificial valve 60 in the axial direction of the support main body, the inner diameter of the orthographic projection of the tightening part 502 is larger than or equal to the maximum linear distance of the orthographic projection of the bottom of the artificial valve 60 in the axial direction of the support main body, and the tightening part 502 is covered on part of the sewing ring of the artificial valve 60 through the contraction action of the tightening part 502 to complete the fixation of the artificial valve 60.
In some embodiments, the stent body comprises an outflow portion 10, a transition section 20, and an inflow portion 40 arranged in axial sequence. The outflow part 10, the transition section 20 and the inflow part 40 are arranged in sequence along the pushing direction of the prosthetic valve 60. The collapsible structure 50 of the present invention is disposed close to the outflow portion 10 in the axial direction, and in the using process, the artificial valve 60 is pushed from the outflow portion 10 to the inflow portion 40 in the axial direction of the stent main body until the bottom of the artificial valve 60 is supported on the supporting portion of the valve supporting structure 30, and then the tightening portion 502 of the collapsible structure 50 is contracted in the direction close to the artificial valve 60 to cover the sewing ring of the artificial valve 60.
The two ends of the transition section 20 are respectively connected with the outflow part 10 and the inflow part 40, and the ends of the outflow part 10 and the inflow part 40 far away from the transition section 20 extend towards the directions far away from each other and are turned outwards along the circumferential direction. The outflow part 10 and the inflow part 40 are folded towards the direction far away from the central axis of the stent body, so that the maximum linear distance between the outflow part 10 and the inflow part 40 in the direction vertical to the central axis of the stent body is larger than that of the transition section 20, a structure with two ends expanded radially and a narrow middle is formed, and the stent body is firmly fixed at the valve ring of the native valve in a shape fitting manner. In addition, the outflow part 10 and the inflow part 40 of the present invention have an outward expansion structure relative to the transition section 20, so that the stent main body can be firmly fixed after being implanted into a human body, and can be prevented from shifting along with the movement of the heart.
In particular, the support portion of the valve support structure 30 extends in a direction opposite to the direction in which the inflow portion 40 extends.
In some embodiments, the transition section 20 is arranged in proper order along circumference by a plurality of support bars 201 and encloses and establish and form, support bar 201 parallel arrangement in the center pin of support main body, the outflow portion 10 is arranged in proper order along circumference by a plurality of first framework 101 and encloses and establish and form, the inflow portion 40 is arranged in proper order along circumference by a plurality of second frameworks 401 and encloses and establish and form, the both ends of support bar 201 are connected respectively first framework 101 with second framework 401. The outflow part 10 is a hollow network structure formed by sequentially arranging a plurality of first frame bodies 101, the inflow part 40 is a hollow network structure formed by sequentially arranging a plurality of second frame bodies 401, hollow grids are sparse, and the risk of blocking coronary openings is reduced.
In some embodiments, an included angle between the first frame 101 and a central axis of the stent body is 30 to 90 °, and an included angle between the second frame 401 and the central axis of the stent body is 30 to 90 °.
In some embodiments, the length of the supporting strip 201 is 30 to 60% of the maximum linear distance of the axial orthogonal projection of the stent main body. The transition section 20 with a specific length in the present invention can satisfy the requirement of the flexibility of the stent body in the blood vessel, so that the stent body can be implanted into the set position smoothly.
In some embodiments, the material of the stent body comprises a memory alloy.
Specifically, the stent main body is made of nickel titanium alloy.
In some embodiments, the maximum linear distance of the stent main body in the direction perpendicular to the central axis of the stent main body is 22 to 35mm.
In some embodiments, one end of the supporting bar 201 is connected to the first frame 101 through a first connecting joint 102, and the other end of the supporting bar 201 is connected to the second frame 401 through a second connecting joint 402.
In some embodiments, two adjacent first frame bodies 101 are connected by a first fixing joint 103, and two adjacent second frame bodies 401 are connected by a second fixing joint 403. The width of the orthographic projection of the first frame 101 in the axial direction of the stent main body is gradually enlarged from the first connecting joint 102 to the first fixing joint 103, and gradually reduced from the first fixing joint 103 to the direction away from the supporting strip 201. The width of the orthographic projection of the second frame 401 in the axial direction of the stent main body is gradually expanded from the second connecting joint 402 to the second fixing joint 403, and gradually reduced from the second fixing joint 403 to the direction far away from the support strip 201.
The first frame 101 is in arc transition from the first connecting joint 102 to the first fixing joint 103. The first frame body 101 is in arc transition from the first fixed joint 103 to the other end, the second frame body 401 is in arc transition from the first connecting joint 102 to the first fixed joint 103, and the second frame body 401 is in arc transition from the second fixed joint 403 to the other end. The first frame 101 and the second frame 401 have similar shapes, and may have, for example, a petal shape. In the invention, the outer contour of each of the first frame body 101 and the second frame body 401 adopts a structure that the outer contour gradually expands along the radial direction and then gradually contracts along the radial direction in the direction away from the transition section 20, so that the damage to the native tissue can be reduced.
In some embodiments, the valve support structure 30 is joined to the transition section 20 at the inflow 40. The connecting portion of the valve support structure 30 is coupled to the second connecting joint 402.
In some embodiments, the material of the valve support structure 30 includes any one of platinum-iridium alloy, cobalt-chromium alloy, nickel-titanium alloy, cobalt-chromium alloy, or tantalum metal.
In some embodiments, the valve support structure 30 is integrally formed with the stent body.
In some embodiments, the valve support structure 30 is formed by a plurality of support frames arranged in a circumferential direction, and the width of the support frames in the orthographic projection perpendicular to the central axis direction of the stent body is gradually enlarged from the connecting portion to the support portion.
The support frame body is in arc transition from the connecting part to the support part. The supporting frame body is inwardly folded from the connecting part to the supporting part and has a triangular hollow structure.
In some embodiments, the folding structure 50 is made of a woven polymer material, and the fixing portion 501 of the folding structure 50 is sewn and fixed on the inner surface of the stent body. The collapsible structure 50 is placed in the stent body, the fixing portion 501 is fixed to the surface of the transition section 20 of the stent body along the circumferential direction, and the tightening portion 502 forms a closed end and presses against the prosthetic valve 60 to cover the sewing ring of the prosthetic valve 60, so as to connect the prosthetic valve 60 and the stent body.
In some embodiments, the polymeric material comprises any of polyurethane, polyethylene terephthalate, polytetrafluoroethylene, or polypropylene.
The present invention is not limited to the manner of contracting the tightening part 502 of the collapsible structure 50, and any method known to those skilled in the art that can be used to contract the tightening part 502 can be used, such as tightening and contracting with a string, or tightening with an elastic band.
In another specific embodiment, the present invention provides a method for fixing a stent for fixing a prosthetic valve according to the first aspect, the method comprising:
the artificial valve 60 is sent into the stent main body and abuts against the supporting part of the valve supporting structure 30, and the tightening part 502 of the folding structure 50 is contracted towards the direction close to the central axis of the stent main body and covers part of the surface of the artificial valve 60, so that the fixation of the artificial valve 60 is realized.
Illustratively, the method of implanting the prosthetic valve 60 using the stent for fixing a prosthetic valve provided by the present invention is as follows:
the artificial valve 60 is pushed from the outflow part 10 to the inflow part 40 along the axial direction of the stent main body until the bottom of the artificial valve 60 is supported on the support part of the valve support structure 30, and the tightening part 502 of the folding structure 50 is contracted towards the direction close to the artificial valve 60 and covers the sewing ring of the artificial valve 60, so that the fixation of the artificial valve 60 is completed.
The stent for fixing the artificial valve 60 provided by the invention adopts the valve supporting structure 30 to support the artificial valve 60 which is placed in the stent main body from the bottom, so as to prevent the artificial valve 60 from slipping after being pressed; meanwhile, one end of the folding structure 50 close to the artificial valve 60 is used for tightening, and the connection between the stent main body and the artificial valve 60 can be realized without sewing, so that the operation is simplified. In addition, the tightening part 502 and the artificial valve 60 are mutually extruded, so that the risk of paravalvular leakage caused by clearance generated between the stent main body and the artificial valve 60 is effectively reduced.
The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention disclosed herein fall within the scope and disclosure of the present invention.
The preferred embodiments of the present invention have been described in detail, however, the present invention is not limited to the specific details of the above embodiments, and various simple modifications may be made to the technical solution of the present invention within the technical idea of the present invention, and these simple modifications are within the protective scope of the present invention.
Claims (10)
1. A stent for fixing a prosthetic valve is characterized by comprising a tubular stent main body, wherein a folding structure and a valve supporting structure are sequentially arranged in the stent main body along the axial direction, and the folding structure and the valve supporting structure are arranged along the circumferential direction of the stent main body;
the folding structure comprises a fixing part and a tightening part, the fixing part is connected with the support main body, the tightening part is turned over along the circumferential direction in the direction close to the central axis of the support main body, the valve supporting structure comprises a connecting part and a supporting part, the connecting part is used for connecting the support main body, and the supporting part extends along the circumferential direction in the direction close to the central axis of the support main body;
and the artificial valve is sent into the support main body, the support part supports the artificial valve, and the tightening part is turned over towards the direction close to the artificial valve and is tightly attached to the artificial valve.
2. The stent for fixing a prosthetic valve according to claim 1, wherein an inner diameter of an orthographic projection of the support portion of the valve support structure in a direction perpendicular to a central axis of the stent main body is smaller than an inner diameter of an orthographic projection of the contraction portion of the contraction structure in a direction perpendicular to a central axis of the stent main body.
3. The stent for fixing a prosthetic valve according to claim 1, wherein the stent body comprises an outflow part, a transition section and an inflow part which are arranged in sequence along an axial direction;
the two ends of the transition section are respectively connected with the outflow part and the inflow part, one ends of the outflow part and the inflow part, which are far away from the transition section, extend towards the directions far away from each other respectively and are folded outwards along the circumferential direction, and the extending direction of the supporting part of the valve supporting structure is opposite to the extending direction of the inflow part.
4. The stent for fixing a prosthetic valve of claim 3, wherein the transition section is formed by sequentially arranging and enclosing a plurality of support bars along a circumferential direction, the support bars are arranged in parallel on a central axis of the stent body, the outflow portion is formed by sequentially arranging and enclosing a plurality of first frame bodies along the circumferential direction, the inflow portion is formed by sequentially arranging and enclosing a plurality of second frame bodies along the circumferential direction, and two ends of the support bars are respectively connected with the first frame bodies and the second frame bodies.
5. The stent for fixing the artificial valve as claimed in claim 4, wherein the included angle between the first frame and the central axis of the stent main body is 30 to 90 °;
the included angle between the second frame and the central shaft of the bracket main body is 30 to 90 degrees;
the length of the supporting strip is 30 to 60 percent of the maximum linear distance of the axial orthographic projection of the bracket main body;
the material of the bracket main body comprises memory alloy;
the maximum linear distance of the orthogonal projection of the support main body in the direction vertical to the central axis of the support main body is 22 to 35mm.
6. The holder of claim 4, wherein one end of the support bar is connected to the first frame via a first connecting joint, and the other end of the support bar is connected to the second frame via a second connecting joint;
two adjacent first frame bodies are connected through a first fixing joint, and two adjacent second frame bodies are connected through a second fixing joint;
the width of the orthographic projection of the first frame body in the axial direction of the support main body is gradually enlarged from the first connecting joint to the first fixing joint, and gradually reduced from the first fixing joint to the direction far away from the support bar;
the second framework is in the width of the ascending orthographic projection of support subject axial, by the second connecting node to the direction of second fixed knot is gradually enlarged, and by the second fixed knot to keeping away from the direction convergent of support bar.
7. The stent for securing a prosthetic valve according to claim 6, wherein the valve support structure accesses a junction of the transition section and the inflow portion, the junction portion of the valve support structure accessing the second connecting node.
8. The stent for securing a prosthetic valve according to claim 1, wherein the valve support structure is made of any one of platinum-iridium alloy, cobalt-chromium alloy, nickel-titanium alloy, cobalt-chromium alloy, or tantalum metal;
the valve support structure is integrally formed with the stent body;
the valve supporting structure is formed by sequentially arranging a plurality of supporting frame bodies along the circumferential direction in a surrounding manner, the supporting frame bodies are arranged on the width of the axial upward orthographic projection of the support main body, the width of the orthographic projection of the support main body is gradually enlarged from the connecting parts to the supporting parts, and the supporting frame bodies are in arc transition from the connecting parts to the supporting parts.
9. The stent for fixing a prosthetic valve according to claim 1, wherein the folding structure is made of a woven body of a polymer material, and the folding structure is sewn and fixed on the inner side surface of the stent main body;
the high polymer material comprises any one of polyurethane, polyethylene terephthalate, polytetrafluoroethylene or polypropylene.
10. A method of fixing a stent for fixing a prosthetic valve according to any one of claims 1 to 9, characterized in that the method of fixing comprises:
the artificial valve is sent into the support body and is abutted against the supporting part of the valve supporting structure, the tightening part of the folding structure contracts towards the direction close to the central shaft of the support body and covers part of the surface of the artificial valve, and the fixation of the artificial valve is realized.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202310092725.7A CN115770126B (en) | 2023-02-10 | 2023-02-10 | Bracket for fixing artificial valve and fixing method thereof |
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| CN202310092725.7A CN115770126B (en) | 2023-02-10 | 2023-02-10 | Bracket for fixing artificial valve and fixing method thereof |
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| CN115770126B CN115770126B (en) | 2023-06-02 |
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| Publication number | Publication date |
|---|---|
| CN115770126B (en) | 2023-06-02 |
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Denomination of invention: A stent and its fixation method for fixing artificial valves Granted publication date: 20230602 Pledgee: Shanghai Rural Commercial Bank Co.,Ltd. Pudong branch Pledgor: SHANGHAI CINGULAR BIOTECH Corp. Registration number: Y2024310000135 |