CN115770126B - Bracket for fixing artificial valve and fixing method thereof - Google Patents
Bracket for fixing artificial valve and fixing method thereof Download PDFInfo
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- CN115770126B CN115770126B CN202310092725.7A CN202310092725A CN115770126B CN 115770126 B CN115770126 B CN 115770126B CN 202310092725 A CN202310092725 A CN 202310092725A CN 115770126 B CN115770126 B CN 115770126B
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- 238000000034 method Methods 0.000 title abstract description 13
- 230000007704 transition Effects 0.000 claims description 34
- -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
- 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
- 238000009954 braiding Methods 0.000 claims description 2
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 239000000463 material Substances 0.000 description 6
- 230000000903 blocking effect Effects 0.000 description 3
- 238000009958 sewing Methods 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 2
- 210000004351 coronary vessel Anatomy 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000004891 communication Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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Abstract
The invention provides a bracket for fixing a prosthetic valve and a fixing method thereof, wherein the bracket comprises a tubular bracket main body, a folding structure and a valve supporting structure are sequentially arranged in the bracket main body along the axial direction, and the folding structure and the valve supporting structure are arranged along the circumferential direction of the bracket 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 folded along the direction of being close to the central shaft of the support main body in the circumferential direction, 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 direction of being close to the central shaft of the support main body in the circumferential direction; the artificial valve is sent into the bracket main body, the supporting part supports the artificial valve, and the tightening part is folded towards the direction close to the artificial valve and is clung to the artificial valve. The invention adopts the support structure capable of being closed to connect and fix the artificial valve, is firm and simple, and is beneficial to reducing the risk of paravalvular leakage.
Description
Technical Field
The invention belongs to the technical field of medical appliances, and relates to a bracket for fixing a prosthetic valve and a fixing method thereof.
Background
The connecting part of the artificial valve and the self-body valve ring (namely the suture ring of the artificial valve) is usually circular, a cylindrical tube is selected as the bracket for fixing the artificial valve, and the artificial valve and the bracket are connected and fixed after the artificial valve and the self-body valve ring are implanted in the body.
At present, the annular part of the artificial valve is fixed mainly by using 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 buckling structure on the stent is easy to be extruded by the native valve annulus and surrounding tissues, tends to be non-circular, greatly increases the difficulty of connecting the artificial valve and the stent, and easily causes the risk of paravalvular leakage due to the problem of insufficient matching degree or sealing degree after the connection is completed. In addition, the contour portion of the stent at the aortic end is not sufficiently adhered to surrounding biological tissues, and the stent rods are too dense to easily block the coronary openings.
Therefore, it is very important to provide a valve stent which is easy to operate and firm in connection.
Disclosure of Invention
Aiming at the defects existing in the prior art, the invention aims to provide a bracket for fixing a prosthetic valve and a fixing method thereof, wherein the bracket profile of the aortic end part is optimized, a support structure capable of being closed is adopted for connection and fixation with the prosthetic valve, the bracket is firm and simple, and the risk of blocking coronary artery openings and paravalvular leakage is reduced.
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, the stent for fixing a prosthetic valve including a tubular stent body, in which a collapsible structure and a valve support structure are sequentially disposed in an axial direction, and the collapsible structure and the valve support structure are disposed along a circumferential direction of the stent 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 folded along the circumferential direction in the direction close to the central shaft of the support main body, the valve support 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 shaft of the support main body;
the artificial valve is sent into the bracket main body, the supporting part supports the artificial valve, and the tightening part is folded towards the direction close to the artificial valve and is clung to the artificial valve.
According to the bracket 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 artificial valve placed in the bracket main body is supported by the valve supporting structure, meanwhile, the folding structure is utilized to tighten up one end of the artificial valve, so that the connection and fixation of the bracket main body and the artificial valve are realized, in addition, the tightening part and the artificial valve sewing ring are mutually extruded, and the risk of paravalvular leakage caused by gaps between the bracket main body and the artificial valve is effectively reduced.
The support part of the valve support structure extends along the circumferential direction and is close to the central shaft of the support main body to form an adduction structure, so that the support main body is prevented from being pressed and slipped after being connected with the artificial valve.
In the present invention, the tightening part 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 is sent 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 preferable aspect of the present invention, an inner diameter of the orthographic projection of the support portion of the valve support structure in a direction perpendicular to the central axis of the stent body is smaller than an inner diameter of the orthographic projection of the tightening portion of the tightening structure in a direction perpendicular to the central axis of the stent body.
Preferably, the inner diameter of the orthographic projection of the supporting portion in the direction perpendicular to the central axis of the support body is 19-27 mm.
In the stent body of the present invention, the support portion of the valve support structure forms a support surface for supporting the bottom of the prosthetic valve, and the tightening portion of the folding structure is folded in a direction approaching the prosthetic valve, covers a part of the surface of the prosthetic valve, and is mutually pressed to achieve connection.
As a preferable technical scheme of the invention, the bracket main body comprises an outflow part, a transition section and an inflow part which are sequentially arranged along the axial direction.
The outflow portion, the transition section and the inflow portion are sequentially arranged along the pushing direction of the artificial valve. The folding structure is arranged along the axial direction and is close to the outflow part, and in the using process, the artificial valve is pushed from the outflow part to the inflow part along the axial direction of the bracket 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 is contracted towards the direction close to the artificial valve and covers the artificial valve seam 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, respectively extend towards directions which are far away from each other 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 outward folding of the outflow portion and the inflow portion in the circumferential direction means folding 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 the direction perpendicular to the central axis of the stent body is greater than that of the transition section, and the structure is formed such that both ends of the outflow portion and the inflow portion expand radially and widen, and the middle of the inflow portion is narrow, so that the stent body is firmly fixed at the 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 bracket main body can be firmly fixed after being implanted into a human body, and can be prevented from deviating along with the movement of a heart.
As a preferable technical scheme of the invention, the transition section is formed by sequentially arranging and surrounding a plurality of supporting bars along the circumferential direction, the supporting bars are arranged in parallel on the central shaft of the bracket main body, the outflow part is formed by sequentially arranging and surrounding a plurality of first frame bodies along the circumferential direction, the inflow part is formed by sequentially arranging and surrounding a plurality of second frame bodies along the circumferential direction, and two ends of each supporting bar are respectively connected with the first frame bodies and the second frame bodies.
It should be noted that, the outflow part of the invention is a hollow network structure formed by sequentially arranging a plurality of first frames, and the inflow part 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, and the hollowed-out grids are sparse, so that the risk of blocking the coronary artery opening is reduced.
In a preferred embodiment of the present invention, the angle between the first housing and the central axis of the holder body is 30 ° to 90 °, for example, 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, 70 °, 75 °, 80 °, 85 ° or 90 °, but the present invention is not limited to the recited values, and other non-recited values within the range of values are equally applicable.
The angle between the second housing and the central axis of the holder main body may be 30 ° to 90 °, for example, 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, 70 °, 75 °, 80 °, 85 °, or 90 °, but the present invention is not limited to the recited values, and other values not recited in the numerical range are equally applicable.
The length of the support bar is 30-60% 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 meet the requirement of the stent body for flexibility in the blood vessel, so that the stent body can be smoothly implanted into the set position.
The material of the bracket main body comprises memory alloy.
Preferably, the material of the bracket main body is nickel-titanium alloy.
The maximum linear distance of orthographic projection of the support main body in the direction perpendicular to the central axis of the support main body is 22-35 mm.
As a preferable technical scheme of the invention, one end of the supporting bar is connected with the first frame body through a first connecting joint, and the other end of the supporting bar is connected with the second frame body through a second connecting joint.
Two adjacent first frame bodies are connected through a first fixed joint, and two adjacent second frame bodies are connected through a second fixed joint.
The width of orthographic projection of the first frame body in the axial direction of the support main body gradually expands from the first connecting joint to the direction of the first fixing joint, and gradually reduces from the first fixing joint to the direction far away from the support bar.
The width of orthographic projection of the second frame body in the axial direction of the support main body gradually expands from the second connecting joint to the second fixing joint, and gradually reduces from the second fixing joint to the direction far away from the support bar.
Preferably, the first frame is similar to the second frame in shape.
In the invention, the outer contour of each of the first frame body and the second frame body adopts a structure that the outer contour of the first frame body and the outer contour of the second frame body are gradually expanded along the radial direction and then gradually contracted along the radial direction in the direction away from the transition section, so that the damage to the primary tissue can be reduced.
As a preferred embodiment of the present invention, the valve support structure is connected to a connection portion between 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 aspect of the present invention, the material of the valve support structure includes 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 mode, the supporting frame bodies are in the width of orthographic projection of the axial direction of the support main body, the connecting portions gradually taper towards the supporting portions, and the supporting frame bodies are in circular arc transition from the connecting portions to the supporting portions.
As a preferable technical scheme of the invention, the folding structure is made of a high polymer material braiding body, and the folding structure is sewed and fixed on the inner side surface of the bracket main body.
The polymer material comprises any one of polyurethane, polyethylene terephthalate, polytetrafluoroethylene or polypropylene.
It should be noted that, the folding structure in the invention is a polymer material woven body, which is placed in the bracket main body, the fixing part of the folding structure is tightly attached to the surface of the transition section part of the bracket main body along the circumferential direction, the tightening part forms a closing-up, and the closing-up is mutually extruded with the artificial valve to cover the joint ring of the artificial valve, so as to realize the connection between the artificial valve and the bracket main body.
In a second aspect, 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 is sent into the bracket main body and props against the supporting part of the valve supporting structure, the tightening part of the folding structure contracts towards the direction close to the central axis of the bracket main body and covers part of the surface of the artificial valve, so that the artificial valve is fixed.
The numerical ranges recited herein include not only the above-listed point values, but also any point values between the above-listed numerical ranges that are not listed, and are limited in space and for the sake of brevity, the present invention is not intended to be exhaustive of the specific point values that the stated ranges include.
Compared with the prior art, the invention has the beneficial effects that:
according to the bracket for fixing the artificial valve and the fixing method thereof, the artificial valve placed in the bracket main body from the bottom is supported by the valve supporting structure, so that the artificial valve is prevented from slipping after being pressed, meanwhile, the folding structure is used for being tightened near one end of the artificial valve, the bracket main body is connected with the artificial valve, the tightening part and the artificial valve sewing ring are mutually extruded, and the risk of paravalvular leakage caused by gaps between the bracket main body and the artificial valve is effectively reduced.
Drawings
FIG. 1 is a schematic illustration 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 view of a bracket 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 one embodiment of the present invention.
Wherein, 10-outflow part; 101-a first frame; 102-a first connection node; 103-a first fixed knot; 20-transition section; 201-supporting bars; 30-valve support structure; 40-inflow; 401-a second frame; 402-a second connection section; 403-second fixed knot; 50-folding structure; 501-a fixing part; 502-a tightening part; 60-prosthetic valve.
Description of the embodiments
It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus are not to be construed 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 a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may explicitly or implicitly include one or more such feature. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.
It should be noted that, in the description of the present invention, unless explicitly specified and limited otherwise, the terms "disposed," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art in a specific case.
The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings.
In one embodiment, the present invention provides a stent for fixing a prosthetic valve, which comprises a tubular stent body, as shown in fig. 1, 2, 3 and 4, wherein a folding structure 50 and a valve supporting structure 30 are sequentially arranged in the stent body along the axial direction, and the folding structure 50 and the valve supporting structure 30 are arranged along the circumferential direction of the stent body.
The folding structure 50 comprises a fixing portion 501 and a tightening portion 502, the fixing portion 501 is connected with the support main body, the tightening portion 502 is folded along the circumferential direction and is close to the direction of the central axis of the support main body, the valve support structure 30 comprises a connecting portion and a supporting portion, the connecting portion is used for connecting the support main body, the supporting portion extends along the circumferential direction and is close to the direction of the central axis of the support main body, the artificial valve 60 is sent into the support main body, the supporting portion supports the artificial valve 60, and the tightening portion 502 is folded along the direction close to the artificial valve 60 and is clung 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 stent main body forms an adduction structure in the stent main body to prevent the stent main body from being pressed and slipped off after being connected with the artificial valve 60, and simultaneously, one end, close to the artificial valve 60, of the folding structure 50 is utilized to shrink and mutually extrude the joint ring of the artificial valve 60, so that the connection between the stent main body and the artificial valve 60 is realized.
In the present invention, the tightening part 502 is a free end, and in its initial state, extends along the stent body and is attached to the inner side surface of the stent body, and after the prosthetic valve 60 is sent into the stent body, the tightening part 502 is gradually contracted in the circumferential direction in the direction approaching the prosthetic valve 60 to be connected and fixed.
In some embodiments, the inner diameter of the orthographic projection of the support portion of the valve support structure 30 in the direction perpendicular to the central axis of the stent body is smaller than the inner diameter of the orthographic projection of the cinching portion 502 of the cinching structure 50 in the direction perpendicular to the central axis of the stent body.
Specifically, the inner diameter of the orthographic projection of the support portion in the direction perpendicular to the central axis of the support main body is 19-27 mm.
The support part of the invention is a free end, forms a support surface for supporting the bottom of the artificial valve 60, and the tightening part 502 is also a free end, is contracted and folded in the direction approaching the artificial valve 60, and is mutually extruded and connected with the artificial valve 60.
The inner diameter of the orthographic projection of the support part in the axial direction of the stent 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 stent 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 stent body, and the tightening part 502 is contracted to cover part of the slit ring of the artificial valve 60, so that the fixation of the artificial valve 60 is completed.
In some embodiments, the stent body includes an outflow portion 10, a transition section 20, and an inflow portion 40 that are disposed in sequence in an axial direction. The outflow portion 10, the transition portion 20 and the inflow portion 40 are disposed in sequence along the pushing direction of the prosthetic valve 60. The collapsible structure 50 of the present invention is disposed axially adjacent to the outflow portion 10, and during use, the prosthetic valve 60 is pushed from the outflow portion 10 to the inflow portion 40 in the axial direction of the stent body until the bottom of the prosthetic valve 60 is supported on the support portion of the valve support structure 30, and then the cinching portion 502 of the collapsible structure 50 is contracted in a direction adjacent to the prosthetic valve 60, covering the slit ring of the prosthetic valve 60.
The two ends of the transition section 20 are respectively connected with the outflow portion 10 and the inflow portion 40, and one ends of the outflow portion 10 and the inflow portion 40, which are far away from the transition section 20, respectively extend in directions far away from each other and are turned outwards along the circumferential direction. In the invention, the outflow part 10 and the inflow part 40 are folded in a 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 perpendicular to the central axis of the stent body is larger than that of the transition section 20, the radial expansion and widening of the two ends are formed, the middle is narrow, and the stent body is firmly fixed at the valve annulus of the primary valve in a shape fit mode. In addition, the outflow portion 10 and the inflow portion 40 of the present invention have an outwardly expanded structure with respect to the transition section 20, so that the stent body can be firmly fixed after being implanted in a human body, and can be prevented from being deviated along with the movement of the heart.
Specifically, the support portion of the valve support structure 30 extends in a direction opposite to the direction of extension of the inflow portion 40.
In some embodiments, the transition section 20 is formed by sequentially arranging a plurality of support bars 201 along the circumferential direction, the support bars 201 are arranged in parallel to the central shaft of the support body, the outflow portion 10 is formed by sequentially arranging a plurality of first frames 101 along the circumferential direction, the inflow portion 40 is formed by sequentially arranging a plurality of second frames 401 along the circumferential direction, and two ends of the support bars 201 are respectively connected with the first frames 101 and the second frames 401. The outflow part 10 of the invention is a hollow network structure formed by sequentially arranging a plurality of first frames 101, the inflow part 40 is a hollow network structure formed by sequentially arranging a plurality of second frames 401, and the hollow grids are sparse, so that the risk of blocking coronary openings is reduced.
In some embodiments, the included angle between the first frame 101 and the central axis of the stand body is 30-90 °, and the included angle between the second frame 401 and the central axis of the stand body is 30-90 °.
In some embodiments, the length of the supporting strip 201 is 30-60% of the maximum linear distance of the bracket main body in the axial orthographic projection. The transition section 20 of a specific length in the present invention can satisfy the requirement of the stent body for flexibility in a blood vessel so that the stent body can be smoothly implanted in a set position.
In some embodiments, the material of the stent body comprises a memory alloy.
Specifically, the material of the bracket main body is nickel-titanium alloy.
In some embodiments, the maximum linear distance of the bracket main body in the direction perpendicular to the central axis of the bracket main body is 22-35 mm.
In some embodiments, one end of the supporting bar 201 is connected to the first frame 101 through a first connection joint 102, and the other end of the supporting bar 201 is connected to the second frame 401 through a second connection joint 402.
In some embodiments, two adjacent first frames 101 are connected by a first fixing joint 103, and two adjacent second frames 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 bracket main body gradually expands from the first connecting joint 102 to the first fixing joint 103, and gradually tapers from the first fixing joint 103 to a direction away from the supporting bar 201. The width of the orthographic projection of the second frame 401 in the axial direction of the bracket main body gradually expands from the second connecting section 402 to the second fixing section 403, and gradually tapers from the second fixing section 403 to a direction away from the supporting bar 201.
The first frame 101 is in arc transition from the first connecting joint 102 to the first fixing joint 103. The first frame 101 is in arc transition from the first fixed joint 103 to the other end, the second frame 401 is in arc transition from the first connecting joint 102 to the first fixed joint 103, and the second frame 401 is in arc transition from the second fixed joint 403 to the other end. The first housing 101 may have a petal shape, for example, similar to the second housing 401. In the invention, the outer contour of each of the first frame 101 and the second frame 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 primary tissue can be reduced.
In some embodiments, the valve support structure 30 is attached to the junction of the transition section 20 and the inflow 40. The connection of the valve support structure 30 accesses the second connection node 402.
In some embodiments, the valve support structure 30 comprises 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 sequentially arranging a plurality of support frames along the circumferential direction, and the width of orthographic projection of the support frames in the direction perpendicular to the central axis of the stent main body is gradually reduced from the connecting portion to the direction of the support portion.
The supporting frame body is in arc transition from the connecting part to the supporting part. According to the invention, the supporting frame body is retracted from the connecting part to the supporting part, and is similar to a triangular hollow structure.
In some embodiments, the folding structure 50 is made of a polymer material woven body, and the fixing portion 501 of the folding structure 50 is stitched and fixed on the inner side surface of the bracket body. The folding structure 50 is arranged in the bracket main body, the fixing part 501 of the folding structure is tightly attached to the surface of the transition section 20 of the bracket main body along the circumferential direction for fixing, the tightening part 502 forms a closing-in, and the closing-in and the artificial valve 60 are mutually extruded and cover the joint ring of the artificial valve 60, so that the artificial valve 60 is connected with the bracket main body.
In some embodiments, the polymeric material comprises any one of polyurethane, polyethylene terephthalate, polytetrafluoroethylene, or polypropylene.
The present invention is not limited to the manner of shrinking the tightening part 502 of the folding structure 50, and any method known to those skilled in the art for shrinking the tightening part 502 may be used, for example, pulling wires for tightening and shrinking, or elastic bands for tightening.
In another 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 bracket main body and abuts against the supporting part of the valve supporting structure 30, the tightening part 502 of the folding structure 50 is contracted towards the direction close to the central axis of the bracket main body, and part of the surface of the artificial valve 60 is covered, so that the artificial valve 60 is fixed.
Illustratively, the method of implantation of the prosthetic valve 60 using the stent for securing a prosthetic valve provided by the present invention is as follows:
the artificial valve 60 is pushed from the outflow portion 10 to the inflow portion 40 along the axial direction of the stent body until the bottom of the artificial valve 60 is supported on the supporting portion of the valve supporting structure 30, and the tightening portion 502 of the folding structure 50 is contracted in the direction approaching the artificial valve 60 and covers the slit ring of the artificial valve 60, thereby completing the fixation of the artificial valve 60.
The bracket for fixing the artificial valve 60 adopts the valve supporting structure 30 to support the artificial valve 60 which is placed in the bracket main body from the bottom, so as to prevent the artificial valve 60 from slipping after being pressed; simultaneously, the folding structure 50 is used for tightening one end close to the artificial valve 60, and the connection between the bracket main body and the artificial valve 60 can be realized without suture, so that the operation is simplified. In addition, the tightening part 502 and the sewing ring of the artificial valve 60 are mutually extruded, so that the risk of paravalvular leakage caused by a gap between the bracket main body and the artificial valve 60 is effectively reduced.
The applicant declares that the above is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be apparent to those skilled in the art that any changes or substitutions that are easily conceivable within the technical scope of the present invention disclosed by the present invention fall within the scope of the present invention and the disclosure.
The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited to the specific details of the above embodiments, and various simple modifications can be made to the technical solution of the present invention within the scope of the technical concept of the present invention, and all the simple modifications belong to the protection scope of the present invention.
Claims (7)
1. The bracket for fixing the artificial valve is characterized by comprising a tubular bracket main body, wherein a folding structure and a valve supporting structure are sequentially arranged in the bracket main body along the axial direction, and the folding structure and the valve supporting structure are arranged along the circumferential direction of the bracket main body;
the folding structure comprises a fixing part and a tightening part, the fixing part is connected with the bracket main body, the tightening part is folded along the circumferential direction in the direction close to the central shaft of the bracket main body and covers a suture ring of the artificial valve, and the tightening part and the suture ring of the artificial valve are mutually extruded so as to reduce the risk of paravalvular leakage caused by a gap between the bracket main body and the artificial valve;
the folding structure is made of a high polymer material braiding body and is sewn and fixed on the inner side surface of the bracket main body; the high polymer material comprises any one of polyurethane, polyethylene terephthalate, polytetrafluoroethylene or polypropylene;
the valve support structure comprises a connecting part and a supporting part, wherein the connecting part is used for connecting the bracket main body, the supporting part extends along the circumferential direction and is close to the central axis of the bracket main body, and the inner diameter of orthographic projection of the supporting part of the valve support structure in the direction vertical to the central axis of the bracket main body is smaller than the inner diameter of orthographic projection of the tightening part of the folding structure in the direction vertical to the central axis of the bracket main body;
the artificial valve is sent into the bracket main body, the supporting part supports the artificial valve, and the tightening part is folded towards the direction close to the artificial valve and is clung to the artificial valve.
2. The stent for securing a prosthetic valve of claim 1, wherein the stent body comprises an outflow portion, a transition section, and an inflow portion disposed 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, respectively extend towards directions which are far away from each other 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.
3. The stent for fixing a prosthetic valve according to claim 2, wherein the transition section is formed by arranging a plurality of support bars in turn in the circumferential direction, the support bars are arranged in parallel to the central axis of the stent body, the outflow portion is formed by arranging a plurality of first frame bodies in turn in the circumferential direction, the inflow portion is formed by arranging a plurality of second frame bodies in turn in the circumferential direction, and both ends of the support bars are respectively connected with the first frame bodies and the second frame bodies.
4. The stent for fixing a prosthetic valve according to claim 3, wherein an included angle between the first frame body and a central axis of the stent body is 30-90 °;
the included angle between the second frame body and the central shaft of the support main body is 30-90 degrees;
the length of the support bar is 30-60% of the maximum linear distance of the axial orthographic projection of the support main body;
the bracket main body is made of memory alloy;
the maximum linear distance of orthographic projection of the support main body in the direction perpendicular to the central axis of the support main body is 22-35 mm.
5. A stent for securing a prosthetic valve according to claim 3, wherein one end of the support bar is connected to the first frame body by a first connection joint and the other end of the support bar is connected to the second frame body by a second connection joint;
two adjacent first frames are connected through a first fixed joint, and two adjacent second frames are connected through a second fixed joint;
the width of orthographic projection of the first frame body in the axial direction of the bracket main body gradually expands from the first connecting joint to the first fixing joint, and gradually reduces from the first fixing joint to a direction far away from the supporting bar;
the width of orthographic projection of the second frame body in the axial direction of the support main body gradually expands from the second connecting joint to the second fixing joint, and gradually reduces from the second fixing joint to the direction far away from the support bar.
6. The stent for securing a prosthetic valve of claim 5, wherein the valve support structure is attached to a junction of the transition section and the inflow portion, the junction of the valve support structure being attached to the second connection node.
7. The stent for securing a prosthetic valve of claim 1, wherein the valve support structure comprises any one of platinum iridium alloy, cobalt chromium alloy, nickel titanium alloy, cobalt chromium alloy, or tantalum metal;
the valve support structure and the bracket main body are integrally formed;
the valve supporting structure is formed by sequentially arranging a plurality of supporting frame bodies along the circumferential direction in a surrounding mode, the supporting frame bodies are in the width of orthographic projection of the axial direction of the support main body, the connecting portions gradually taper towards the supporting portions, and the supporting frame bodies are in circular arc transition from the connecting portions to the supporting portions.
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Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
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US6676699B2 (en) * | 2002-04-26 | 2004-01-13 | Medtronic Ave, Inc | Stent graft with integrated valve device and method |
CN101180010B (en) * | 2005-05-24 | 2010-12-01 | 爱德华兹生命科学公司 | Rapid deployment prosthetic heart valve |
WO2007071436A2 (en) * | 2005-12-22 | 2007-06-28 | Symetis Sa | Stent-valves for valve replacement and associated methods and systems for surgery |
US8308798B2 (en) * | 2008-12-19 | 2012-11-13 | Edwards Lifesciences Corporation | Quick-connect prosthetic heart valve and methods |
US11207176B2 (en) * | 2012-03-22 | 2021-12-28 | Boston Scientific Scimed, Inc. | Transcatheter stent-valves and methods, systems and devices for addressing para-valve leakage |
US10646333B2 (en) * | 2013-10-24 | 2020-05-12 | Medtronic, Inc. | Two-piece valve prosthesis with anchor stent and valve component |
US20150209141A1 (en) * | 2014-01-24 | 2015-07-30 | St. Jude Medical, Cardiology Division, Inc. | Stationary intra-annular halo designs for paravalvular leak (pvl) reduction-passive channel filling cuff designs |
CN107252363B (en) * | 2015-03-26 | 2020-04-28 | 杭州启明医疗器械股份有限公司 | Valve stent with reduced compressed length and valve replacement device with same |
EP3917454A1 (en) * | 2019-01-30 | 2021-12-08 | Edwards Lifesciences Corporation | Heart valve sealing assemblies |
CN112089507B (en) * | 2020-08-28 | 2022-12-16 | 江苏大学 | Balloon expansion type aortic valve stent |
CN113855333A (en) * | 2021-10-18 | 2021-12-31 | 上海欣吉特生物科技有限公司 | Split type valve support reaches intervention mitral valve replacement system including it |
CN216294352U (en) * | 2021-11-15 | 2022-04-15 | 南京圣德医疗科技有限公司 | Self-expanding biological valve |
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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 |
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