CN117426808B - Skirt edge structure, self-adaptive skirt edge bracket, plugging device and skirt edge manufacturing method - Google Patents
Skirt edge structure, self-adaptive skirt edge bracket, plugging device and skirt edge manufacturing method Download PDFInfo
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- CN117426808B CN117426808B CN202311764301.7A CN202311764301A CN117426808B CN 117426808 B CN117426808 B CN 117426808B CN 202311764301 A CN202311764301 A CN 202311764301A CN 117426808 B CN117426808 B CN 117426808B
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Abstract
The invention provides a skirt edge structure, a self-adaptive skirt edge bracket, a plugging device and a skirt edge manufacturing method, and relates to the field of medical appliances; the skirt edge structure is in a saddle shape with high ends and low middle ends in the circumferential direction in a free state after being released, and the protruding and collapsing positions of the saddle shape formed by the skirt edge structure after being released can be adaptively rotated in the 360-degree range in the circumferential direction so as to be completely attached to the contacted surface; the adaptive skirt hanger and stopper both comprise the aforementioned skirt structure. The invention relieves the technical problems of easy internal leakage and easy abrasion of the existing branch bracket and the existing double-disc occluder after implantation.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a skirt edge structure, a self-adaptive skirt edge bracket, a plugging device and a skirt edge manufacturing method.
Background
The aortic vessel wall consists of three layers, called intima, media and adventitia, respectively; aortic dissection refers to that blood enters an aortic media from an aortic wall intima rupture (tearing port), blood in an aortic cavity separates the media and expands along the long axis direction of the aorta under the drive of pulse pressure, the aortic wall is separated into a true cavity and a false cavity, the true cavity refers to the original normal blood flow lumen, the false cavity refers to a newly torn pathological lumen, and the cavity wall of the aortic false cavity comprises the torn media and an outer film clung to the media. Currently, the method is mainly implemented by the following steps in interventional operations: (1) The method comprises the steps of (1) implanting a covered stent into an aorta, and pressing and closing the dissection openings by utilizing the radial supporting force of the covered stent to reconstruct a blood flow channel, or (2) inputting a plugging device into the aortic dissection openings to plug the aortic dissection openings so as to achieve the aim of treating aortic dissection, wherein when the dissection openings are more, the covered stent can be implanted into the aorta to press and close some openings, and simultaneously, implanting a plugging device into the dissection openings in the area where the covered stent cannot be pressed and closed to plug the dissection openings.
The current treatment methods above have the following problems:
(1) Because aortic dissection may involve branch vessels on the arch, and the stent graft cannot provide three branches of blood supply after implantation, and the integral stent implantation is difficult, the stent graft used is usually a split stent, including a main body stent and a branch stent, and the main body stent needs to be windowed and the branch stent is implanted from the windowed position to maintain branch blood supply when being implanted. However, after the split stent is implanted into the aorta, one end of the branch stent, which is close to the main body stent, is the proximal end of the branch stent, and one end of the branch stent extending into the branch vessel is the distal end of the branch stent: in the split-type support used in the prior art, the contact part of the proximal end part of the branch support and the windowing area of the main body support is in line contact, so that internal leakage is easy to occur (no closed slit leaks blood from the windowing area), although in the prior art, some branch supports with skirt structures connected with the proximal edges are provided, after the branch support is implanted into the windowing area of the main body support, the tightness of the butt joint part of the branch support and the windowing area of the main body support is expected to be improved through the skirt structures at the proximal ends of the branch supports, so that the internal leakage is reduced, however, the included angles of all parts of the skirt structures of the branch support in the prior art are constant angles (such as 90 degrees, acute angles or obtuse angles are kept with the peripheral surface of the main body of the branch support) in the circumferential direction, no difference exists in the circumferential direction, and when the split-type support is matched with the windowing area of the main body support, the problem of blood leakage exists (only internal leakage can be reduced, but the problem of internal leakage can be actually reduced still exist); for the gap here, the effect of reducing the gap is generally achieved to a certain extent by moving the branch stent in the distal direction and deforming the skirt structure by pressing the inside of the main body stent, but at this time, the adhesion force of the skirt structure to the main body stent in the circumferential direction is not uniform, the pressure is small or no at the circumferential angles 0 ° and 180 °, the pressure is maximum at the circumferential angles 90 ° and 270 °, and thus a series of problems such as inner leakage at the circumferential angles 0 ° and 180 °, excessive wear at the circumferential angles 90 ° and 270 ° may be brought about;
(2) The common structure of current plugging device is double-disc structure, including intermediate junction's interior dish and outer dish structure together, implants the back, and interior dish is located false chamber, and the waist of interior dish and outer dish intermediate junction passes aortic dissection breach, and outer dish is located true chamber, by interior dish and outer dish centre gripping aortic dissection breach, is applicable to the aortic dissection breach that the opening area is less. However, after the existing double-disc occluder is implanted, the clamping effect between the inner disc and the outer disc is poor, the problem of internal leakage exists, the edge of the disc body cannot be completely attached to the inner membrane of the cavity, and the problem that the edge of the disc body stimulates the inner membrane of the cavity and possibly causes a new rupture exists.
Disclosure of Invention
The invention aims to provide a skirt edge structure, a self-adaptive skirt edge bracket, an occluder and a skirt edge manufacturing method, so as to alleviate the technical problems in the prior art.
In order to achieve the above purpose, the embodiment of the present invention adopts the following technical scheme:
in a first aspect, embodiments of the present invention provide a skirt structure comprising an elastic framework and a skirt cover film connected to the elastic framework; the skirt edge structure is in a saddle shape with high ends and low middle ends in the circumferential direction in a free state after being released, and the protruding and collapsing positions of the saddle shape formed by the skirt edge structure after being released can be adaptively rotated in the 360-degree range in the circumferential direction so as to be completely attached to the contacted surface.
The skirt edge structure provided by the embodiment of the invention has a saddle-shaped natural state, and can be uniformly sealed with a main body bracket windowing area or an aortic dissection breach area in the circumferential direction after implantation, so that a complete sealing effect is achieved, internal leakage is fully prevented, and meanwhile, the edge part of the skirt edge structure is prevented from being worn or stimulating the vessel wall; in addition, as the skirt edge structure is not a fixed structure, but is a self-adaptive adjusting structure which can be self-adaptively and completely matched with a preset direction after implantation, implantation directivity is not required to be considered during implantation, implantation requirements are low, fault tolerance is high, and sealing effect after implantation is more stable compared with the prior art, and worry that the edge of the skirt edge structure is worn or stimulated after implantation is not required.
In an alternative implementation of this embodiment, it is preferable that the skirt cover film includes an annular film region; the skirt edge structure is formed by inwards pressing wave crests of the wavy annular elastic framework and then fixedly connecting one side of an inner ring of the annular membrane area, outwards turning wave troughs and then fixedly connecting one side of an outer ring of the annular membrane area; and the inner diameter of the annular membrane area is smaller than the inner diameter of the annular membrane area under the condition that all wave crests of the wavy annular elastic framework are inwards pressed and all wave troughs are outwards turned to form a flat polygonal star-shaped sheet-shaped state, and the annular membrane limits the elastic framework to rebound to an initial wavy annular shape.
In an alternative implementation of this embodiment, the elastic skeleton is made of nickel-titanium alloy or stainless steel material.
In an alternative implementation of this embodiment, the skirt cover film is made of polyester or polymer material.
In a second aspect, embodiments of the present invention provide an adaptive skirt hanger comprising a tubular hanger body and a skirt structure as described in any of the preceding embodiments of the first aspect, the skirt structure being attached to a membrane and/or a skeleton of a proximal edge of the tubular hanger body.
In an alternative implementation of this embodiment, it is preferable that the skirt structure is flexibly connected to the membrane and/or the skeleton of the proximal edge of the tubular hanger body.
In a third aspect, an embodiment of the present invention provides an occluder, including two skirt edge structures according to any one of the embodiments of the first aspect, where one of the skirt edge structures is used as an inner disc, and the other one of the skirt edge structures is used as an outer disc, the middle part of the inner disc and the middle part of the outer disc are connected together by a waist and are not communicated with each other, and at least one of the skirt edge film of the inner disc and the skirt edge film of the outer disc is a solid circular film.
In an alternative implementation manner of this embodiment, it is preferable that the diameter of the inner disc in the flat state is smaller than the diameter of the outer disc in the flat state; and/or, in the saddle-shaped structure of the inner disc and the outer disc in the free state, the curvature radius of the cross section taken by the center point of each disc and the midpoint of the two collapse parts of the saddle-shaped structure is the curvature radius of each, so that the following conditions are satisfied: the radius of curvature of the inner disc is smaller than the radius of curvature of the outer disc.
In a fourth aspect, an embodiment of the present invention provides a method for manufacturing a skirt, for manufacturing a skirt structure according to any one of the foregoing embodiments of the first aspect, including the following steps:
preparing a wavy annular elastic bare bracket as an elastic framework, and preparing a covering film with an annular film area as a skirt covering film;
and connecting the wave crests of the wavy annular elastic framework with the inner ring of the annular membrane area after inwards pressing, and connecting the wave troughs with the outer ring of the annular membrane area after outwards turning over, wherein the inner diameter of the annular membrane area is ensured to be smaller than the inner ring diameter of the wavy annular elastic framework in a flat polygonal star-shaped sheet state formed by inwards pressing all wave crests and outwards turning over all wave troughs, so that the annular membrane limits the elastic framework to rebound to an initial wavy annular shape.
In an alternative implementation manner of this embodiment, more preferably, the step of connecting the wave-shaped annular elastic skeleton peak to the annular membrane area inner ring after inward pressing and connecting the wave trough to the annular membrane area outer ring after outward turning includes: firstly, inwards pressing wave crests and wave troughs of the wavy annular elastic framework outwards to form a flat polygonal star-shaped sheet-shaped form; and connecting the sharp corners of the outer ring of the polygonal star-shaped sheet structure with the outer ring of the annular membrane area, and connecting the sharp corners of the inner ring of the polygonal star-shaped sheet structure with the inner ring of the annular membrane area.
In particular, in the context of the present invention, the foregoing "and/or" means "and/or" preceding structures are designed simultaneously or selectively with "and/or" following structures.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic illustration of a stent graft and a prior occluder for occluding a lesion in an aortic dissection when the lesion is at a dissection lesion site in an aortic dissection;
FIG. 2 is an enlarged view of the part of the structure of the portion A in FIG. 1;
FIG. 3 is a cross-sectional view of the plugging site of the prior art occluder of FIG. 1 taken along the radial direction of the vessel;
FIG. 4 is a diagram showing the state of fit between a branch stent and a main stent after implantation in a split stent for implantation in a branch vessel position in an aortic arch part according to the prior art;
FIG. 5 is a diagram showing a second state of fit of a branch stent and a main stent after implantation in a split stent for implantation in a branch vessel position of an aortic arch part in the prior art;
FIG. 6 is a schematic diagram showing the overall structure of a skirt structure according to the present embodiment;
FIG. 7 is a schematic diagram showing the overall structure of a skirt structure according to the present embodiment;
FIG. 8 is a schematic diagram of the whole structure of a skirt structure according to the present embodiment;
FIG. 9 is a schematic diagram showing the overall structure of a skirt structure according to the present embodiment;
FIG. 10 is a main step diagram of a method for manufacturing a skirt according to the present embodiment;
FIG. 11 is a diagram of the main steps of the method for manufacturing a skirt according to the present embodiment, and the direction indicated by the arrow indicates the rebound tendency of the elastic framework in the direction;
FIG. 12 is a third main step diagram of the method for manufacturing a skirt according to the present embodiment, wherein the direction indicated by the arrow indicates the rebound tendency of the elastic framework in the direction;
FIG. 13 is a diagram showing the main steps of the method for manufacturing a skirt according to the present embodiment, wherein the direction indicated by the arrow indicates the rebound tendency of the elastic framework in the direction;
FIG. 14 is a schematic view of the overall structure of the adaptive skirt hanger provided in this embodiment;
FIG. 15 is a schematic diagram showing the overall structure of the adaptive skirt hanger according to the present embodiment;
FIG. 16 is a schematic view of the overall structure of the adaptive skirt hanger provided in this embodiment;
FIG. 17 is a schematic view of the overall structure of the adaptive skirt hanger provided in this embodiment;
FIG. 18 is a top view of the overall structure of the adaptive skirt hanger provided in this embodiment;
FIG. 19 is a view showing the state of the implantation engagement of the adaptive skirt hanger and the body hanger according to the present embodiment;
FIG. 20 is a second view of an implanted engagement of the adaptive skirt hanger and the body hanger provided in this embodiment;
fig. 21 is a schematic overall structure of an alternative embodiment of the occluder provided in this embodiment;
fig. 22 is a schematic overall structure of another alternative embodiment of the occluder provided in this embodiment;
FIG. 23 is a cross-sectional view of the occluder of FIG. 22 in a radial cut through a blood vessel to occlude a lesion in the aortic dissection;
fig. 24 is a schematic view showing the morphology of the inner and outer discs of the occluder of fig. 23 in an adaptive attachment state.
Icon: 11-a main body support; 12-branch stent; 2-a double-disc occluder; 100-skirt structure; 200-adaptive skirt hanger; 210-a cylindrical stent body; 300-occluder; 310-inner disc; 320-outer disc; 330-waist.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
It should be noted that: like reference numerals and letters designate like items in the drawings, and thus once an item is defined in one drawing, no further definition or explanation thereof is necessary in the subsequent drawings.
In the description of the present invention, it should be noted that the terms "proximal," "distal," "inner," "outer," and the like indicate an orientation or a positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the inventive product is conventionally put in use, merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element in question must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.
In the description of the present invention, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally 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 will be understood in specific cases by those of ordinary skill in the art.
Some embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be combined with each other without conflict.
The aortic vessel wall consists of three layers, called intima, media and adventitia, respectively; aortic dissection refers to that blood enters an aortic media from an aortic wall intima rupture (tearing port), blood in an aortic cavity separates the media and expands along the long axis direction of the aorta under the drive of pulse pressure, the aortic wall is separated into a true cavity and a false cavity, the true cavity refers to the original normal blood flow lumen, the false cavity refers to a newly torn pathological lumen, and the cavity wall of the aortic false cavity comprises the torn media and an outer film clung to the media.
As shown in fig. 1, a schematic representation of a dissection breach site of an aortic arch dissection lesion is provided, and a schematic representation of the structure of the treatment of the aortic arch dissection lesion using a stent graft and an existing double disc occluder 2 is provided.
For the stent graft, the structure shown in fig. 1 uses a main body stent directly implanted into the true lumen of the aorta because the dissection breach is far away from the branch vessel, and closes a part of the dissection breach of the aorta without being matched with the branch stent, but when the dissection breach is near to the branch vessel, the split stent mentioned in the background art of the application is used, and the split stent structure is shown in fig. 4 and 5, and comprises a main body stent 11 and a branch stent 12, after the split stent is implanted into the aorta, one end of the branch stent 12 close to the main body stent 11 is the proximal end of the branch stent 12, and one end of the branch stent 12 extending into the branch vessel is the distal end of the branch stent 12: while the contact between the proximal end of the branch stent 12 and the fenestration area of the main stent 11 is in line contact, and thus internal leakage (leakage of blood from the gaps where the fenestration area is not closed) is liable to occur, in the prior art, providing the branch stent 12 with a skirt structure connected to the proximal edge as shown in fig. 4 and 5, it is expected that after the branch stent 12 is implanted into the fenestration area of the main stent 11, the seal at the junction between the branch stent 12 and the fenestration area of the main stent 11 is improved by the skirt at the proximal end of the branch stent 12, and the internal leakage is reduced, but in the mating relationship after the implantation, since the skirt structures of the existing branch stent 12 are at a fixed angle (e.g., kept 90 ° with respect to the main circumferential surface of the branch stent 12, acute angle or obtuse angle) in the circumferential direction, the skirt structure still has a gap when the skirt structure is mated with the fenestration of the main stent 11, and the problem of blood leakage is still present (can be reduced, but actually can be reduced, and the problem of internal leakage still remains); for the gap here, the above gap is generally reduced to some extent by moving the branch stent 12 in the distal direction, deforming its skirt structure by pressing the inside of the main body stent 11, but at this time, the fitting force of its skirt structure to the main body stent 11 in the circumferential direction is not uniform, the pressure is small or no at the circumferential angles 0 ° and 180 °, the pressure is maximum at the circumferential angles 90 ° and 270 °, whereby a series of problems such as inner leakage at the circumferential angles 0 ° and 180 °, excessive wear at the circumferential angles 90 ° and 270 ° may be brought about.
For the existing double-disc occluder 2, as shown in fig. 1 to 3, after implantation, the inner disc of the double-disc occluder 2 is positioned in a false cavity, the waist connected between the inner disc and the outer disc passes through an aortic dissection break, the outer disc is positioned in a true cavity, and the aortic dissection break is clamped by the inner disc and the outer disc, so that the double-disc occluder is suitable for the aortic dissection break with smaller opening area. However, referring to fig. 2 and 3 in detail, after the conventional double-disc occluder 2 is implanted, the clamping effect between the inner disc and the outer disc is poor, and there is a problem of internal leakage, and the edge of the disc cannot be completely attached to the inner membrane of the cavity, so that the edge of the disc stimulates the inner membrane of the cavity, which may cause a problem of new rupture.
In contrast, the embodiment of the present invention provides a skirt structure and a manufacturing method thereof, and provides an adaptive skirt bracket and an occluder according to the skirt structure, and the following description is given by way of specific embodiments respectively:
example 1
Referring to fig. 6 to 9, the present embodiment provides a skirt structure 100 including an elastic framework and a skirt cover film connected to the elastic framework. The skirt structure 100 is in a free state after being released, has a saddle shape with two high ends and a low middle end in the circumferential direction, and the protruding and collapsing positions of the saddle shape after being released of the skirt structure 100 can be adaptively rotated within 360 degrees in the circumferential direction so as to be completely attached to the contacted surface.
The skirt structure 100 according to this embodiment is not a fixed form in the free state, but can be self-adjusting within 360 ° of the implantation environment. The skirt structure 100 may be used to make a skirt of the branch stent 12, to mate with a fenestration area of the main body stent 11, or to make inner and outer discs of a double disc occluder, to occlude aortic dissection. When used as the skirt of the branch bracket 12, the skirt structure 100 can be self-adaptively attached to the inner peripheral surface of the main body bracket after the branch bracket 12 passes through the main body bracket 11, so that the window opening area is completely closed, the inner leakage is avoided, and the skirt abrasion can be avoided after the whole attachment; when the inner disc and the outer disc are used as the double-disc plugging device, after implantation, the skirt edge structures 100 used as the outer disc and the inner disc can be respectively and completely attached to two side surfaces of the inner membrane of the cavity, so that the aortic interlayer breach is completely closed, internal leakage is avoided, and after complete attachment, the phenomenon that the inner membrane of the cavity is stimulated by the edge of the disc body to cause a new breach can be avoided.
In summary, the skirt structure 100 provided in this embodiment has a "saddle shape" in nature, and after implantation, the skirt structure can be uniformly sealed with the fenestration area or the aortic dissection breach area of the main body stent 11 in the circumferential direction, so as to achieve a complete sealing effect, fully prevent internal leakage, and simultaneously avoid abrasion or irritation of the edge of the skirt structure 100 to the vessel wall; in addition, since the skirt structure 100 is not a fixed structure, but is a self-adaptive structure which can be self-adaptively and completely matched with a preset direction after implantation, the implantation direction is not required to be considered during implantation, the implantation requirement is low, the fault tolerance is high, the sealing effect after implantation is more stable compared with the prior art, and the worry that the edge of the skirt structure 100 is worn or irritated the vessel wall after implantation is not required.
With continued reference to fig. 6 to 9, in this embodiment, preferably, the elastic framework of the skirt structure 100 is made of nickel-titanium alloy or stainless steel, and has elasticity, and the skirt covering film is made of polyester or polymer material, including an annular film region, which may be annular as a whole or solid circular, and a concentric annular region is selected as the annular film region on the solid circular. The skirt structure 100 is formed by inwards pressing wave crests of a wavy annular elastic framework and then fixedly connecting the wave crests to one side of an annular membrane area inner ring, outwards turning wave troughs and then fixedly connecting the wave troughs to one side of the annular membrane area outer ring; and the inner diameter of the annular membrane area is smaller than the inner diameter of the annular membrane under the condition that all wave crests of the wavy annular elastic framework are inwards pressed and all wave troughs are outwards turned to form a flat polygonal star-shaped sheet shape, and the annular membrane limits the elastic framework to rebound to an initial wavy annular shape.
Example two
The present embodiment provides a method for fabricating a skirt structure 100 according to any one of the alternative embodiments of the present embodiment.
Referring to fig. 10 to 13, in combination with fig. 6 to 9, the skirt manufacturing method includes the steps of:
as shown in fig. 10, an elastic bare stent in a wavy annular shape is prepared as an elastic skeleton, and a coating film having an annular film region is prepared as a skirt coating film; the elastic framework can be formed by heat treatment and shaping of nickel-titanium alloy or stainless steel and other materials;
then, as shown in fig. 11 to 13, the wave crests of the wavy annular elastic framework are fixedly connected to one side of the inner ring of the annular membrane area of the skirt edge tectorial membrane after being inwards pressed, the wave troughs are outwards turned and fixedly connected to one side of the outer ring of the annular membrane area of the skirt edge tectorial membrane, and the inner diameter of the annular membrane area of the skirt edge tectorial membrane is ensured to be smaller than the inner ring diameter of the annular membrane area of the skirt edge tectorial membrane under the condition that all wave crests of the wavy annular elastic framework are inwards pressed and all wave troughs are outwards turned to form a flat polygonal star-shaped sheet state, so that the annular membrane area of the skirt edge tectorial membrane limits the elastic framework to rebound to an initial wavy annular state; the specific fixed connection steps can be as follows: as shown in FIG. 11, the wave crest of the wavy annular elastic skeleton is inwards pressed and the wave trough is outwards turned to form a flat polygonal star-shaped sheet shape; as shown in fig. 12, the outer ring sharp corners of the "polygonal star-shaped" sheet structure are connected to the outer ring of the skirt membrane annular membrane region, and the inner ring sharp corners of the "polygonal star-shaped" sheet structure are connected to the inner ring of the skirt membrane annular membrane region, and as shown in fig. 13, the skirt structure 100 is formed after all connection points are connected. Specifically, the elastic framework may be connected to one side surface of the annular membrane region of the skirt edge membrane, or may be slit in the annular membrane region of the skirt edge membrane, and after the elastic framework passes through the slit, a part of the sharp corners are connected to one side surface of the annular membrane region of the skirt edge membrane, and the other part of the sharp corners are connected to the other side surface of the annular membrane region of the skirt edge membrane. The connection mode of each connection part can be selected from the connection modes such as sewing or heat sealing, and the like, and is preferably but not limited to sewing connection.
In the above steps, referring to fig. 10 and 11, the diameter of the inner ring of the "multi-angle star-shaped" sheet structure shown in fig. 11 is smaller than the original diameter of the wavy annular structure shown in fig. 10, the diameter of the outer ring of the "multi-angle star-shaped" sheet structure is larger than the original diameter of the wavy annular structure shown in fig. 10, and the "multi-angle star-shaped" sheet structure itself has a tendency to return to the original natural state shown in fig. 10, so that the sharp angle of the inner ring of the "multi-angle star-shaped" sheet structure has a tendency to turn upwards and the sharp angle of the outer ring has a tendency to turn downwards. Referring to fig. 12, after the "multi-pointed star" sheet structure is connected to the skirt membrane annular membrane region, the "multi-pointed star" sheet structure is radially compressed because the inner diameter of the skirt membrane annular membrane region is smaller than the inner diameter of the "multi-pointed star" sheet structure; therefore, the elastic framework has a tendency to expand radially, but is limited by the annular membrane area of the skirt membrane, and meanwhile, the annular membrane area of the skirt membrane also limits the overturning tendency that the sharp angles of the inner ring and the sharp angles of the outer ring of the polygonal star-shaped sheet-shaped structure are overturned upwards and downwards as shown in the figure 11. Referring to fig. 13, after all the connection points are connected, the overturning trend and the radial expansion trend of the elastic framework are coupled with each other, so that the elastic framework reaches a relatively stable equilibrium state.
The final skirt structure 100 is shown in fig. 6 to 9, wherein each peak and trough of the elastic skeleton are in different forms in the circumferential direction, structurally, the structure comprises two convex parts and two collapse parts which are arranged at intervals, specifically, the inner ring of the skirt skeleton is projected to be elliptical, the two parts which are turned over and collapsed correspond to the minor axis of the ellipse, the two parts which are raised correspond to the major axis of the ellipse, the length dimension is larger than or equal to the major axis of the skirt tectorial membrane annular membrane area in the natural state, the convex parts release more energy in the radial direction, the collapse parts axially overturn, release more energy in the axial direction, self-consistent is formed, the shape of a saddle is shown in the free state, and the convex and collapse positions of the saddle can be self-adaptively rotated within 360 degrees in the circumferential direction and are completely attached to the contact surface.
Example III
Referring to fig. 14-18, the present embodiment provides an adaptive skirt hanger 200 comprising a tubular hanger body 210 and an embodiment-the skirt structure 100, the skirt structure 100 being attached to the membrane and/or the framework of the proximal edge of the tubular hanger body 210.
As shown in fig. 19 and 20, when the adaptive skirt hanger 200 is used in combination with the main body hanger 11, the skirt structure 100 of the adaptive skirt hanger 200 can be completely fitted to the inner peripheral surface of the window area of the main body hanger 11, and the window area is uniformly sealed in the circumferential direction to prevent inner leakage; after the skirt structure 100 is sufficiently attached, the edge portion of the main body holder 11 is not worn, and the state after implantation is stable and the effective time is long.
In this embodiment, the skirt structure 100 of the adaptive skirt hanger 200 is preferably flexibly connected to the coating and/or framework of the proximal edge of the tubular hanger body 210 by a flexible connection means including, but not limited to, heat sealing or suturing, etc., so that a wide range of angular adjustment can be maintained between the tubular hanger body 210 and the main hanger 11 to accommodate aortic arch multi-branch angles.
In addition, development marks made of gold, platinum iridium alloy, or the like are preferably provided at the proximal and distal ends of the body stent 11 or skirt structure 100, respectively, of the adaptive skirt stent 200 to help determine the implantation site at the time of surgery, making the implantation site more accurate.
Example IV
Referring to fig. 21 to 24, the present embodiment provides an occluder 300, where the occluder 300 includes two embodiments-the skirt structures 100, one skirt structure 100 is used as an inner disc 310 of the occluder 300, the other skirt structure 100 is used as an outer disc 320 of the occluder 300, the middle part of the inner disc 310 is connected with the middle part of the outer disc 320 through a waist 330, and the inner disc 310, the waist 330 and the outer disc 320 are not communicated with each other, and at least one of the skirt coating of the inner disc 310 and the skirt coating of the outer disc 320 is a solid circular coating.
After the occluder 300 is implanted, as shown in fig. 23 and 24, the inner disc 310 and the outer disc 320 are respectively and completely attached to two sides of the inner membrane of the aortic cavity, so as to achieve a uniform and completely sealed state in the circumferential direction and fully prevent internal leakage; meanwhile, the attaching state can avoid abrasion of the inner membrane of the cavity body at the edge of the disc body, and further avoid occurrence of a new crack.
In this embodiment, the diameters of the inner disc 310 and the outer disc 320 of the occluder 300 may be the same as shown in fig. 21 or different, wherein, preferably, as shown in fig. 22 to 24, the diameter of the inner disc 310 in the flat state is smaller than the diameter of the outer disc 320 in the flat state, and in the compressed state of the occluder 300, the inner disc 310 is easier to enter the false cavity from the interlayer breach; the outer disc 320 is slightly larger in size, so that the plugging effect can be enhanced;
in addition, in the "saddle-shaped" structure of the inner disc 310 and the outer disc 320 in the respective free states, the radius of curvature of the cross section taken through the center point of each disc and the midpoint of the two collapse portions of the "saddle-shape" is preferably the respective radius of curvature, so that: the radius of curvature of the inner disc 310 is smaller than that of the outer disc 320, so that after the occluder 300 is implanted, the deformation of the inner disc 310 is larger than that of the outer disc 320, the inner disc 310 presents a more obvious saddle shape relative to the outer disc 320, the inner disc 310 and the false cavity inner membrane are tightly attached while the outer disc 320 is ensured not to damage the true cavity inner membrane, and inner leakage is fully prevented. The curvature radius of each disc can be controlled by the interference fit of the elastic framework of each disc and the size of the annular membrane area of the skirt membrane in the specific design.
Finally, it should be noted that:
1. in the present specification, "and/or" means "and/or" preceding structure and "and/or" following structure are simultaneously or selectively designed;
2. in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described by differences from other embodiments, and identical and similar parts between the embodiments are only required to be seen with each other; the above embodiments in the present specification are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.
Claims (9)
1. A skirt structure (100), characterized in that: comprises an elastic framework and a skirt edge coating film connected with the elastic framework;
the skirt edge structure (100) is in a saddle shape with high ends and low middle ends in the circumferential direction in a free state after being released, and the protruding and collapsing positions of the saddle shape after being released can be adaptively rotated in the 360-degree range in the circumferential direction so as to be completely attached to the contacted surface; wherein:
the skirt cover film comprises an annular film area; the skirt edge structure (100) is manufactured by inwards pressing wave crests of a wavy annular elastic framework and then fixedly connecting one side of an inner ring of the annular membrane area, outwards turning wave troughs and then fixedly connecting one side of an outer ring of the annular membrane area; and the inner diameter of the annular membrane area is smaller than the inner diameter of the annular membrane area under the condition that all wave crests of the wavy annular elastic framework are inwards pressed and all wave troughs are outwards turned to form a flat polygonal star-shaped sheet-shaped state, and the annular membrane limits the elastic framework to rebound to an initial wavy annular shape.
2. The skirt structure (100) according to claim 1, wherein: the elastic framework is made of nickel-titanium alloy or stainless steel materials.
3. The skirt structure (100) according to claim 1, wherein: the skirt edge coating film is made of terylene or high polymer materials.
4. An adaptive skirt hanger (200), characterized by: comprising a tubular stent body (210) and a skirt structure (100) according to any of claims 1-3, said skirt structure (100) being connected to a membrane and/or a skeleton of a proximal edge of said tubular stent body (210).
5. The adaptive skirt hanger (200) according to claim 4, wherein: the skirt structure (100) is flexibly connected to the membrane and/or the framework of the proximal edge of the tubular stent body (210).
6. An occluder (300), characterized in that: comprising two skirt structures (100) according to any one of claims 1-3, one skirt structure (100) being an inner disc (310) and the other skirt structure (100) being an outer disc (320), the middle part of the inner disc (310) and the middle part of the outer disc (320) being connected together by a waist (330) and not being in communication with each other, at least one of the skirt film of the inner disc (310) and the skirt film of the outer disc (320) being a solid circular film.
7. The occluder (300) of claim 6, wherein: the diameter of the inner disc (310) in a flat state is smaller than the diameter of the outer disc (320) in a flat state;
and/or, in the saddle-shaped structure of the inner disc (310) and the outer disc (320) in the respective free states, the curvature radius of the cross section taken by the center point of each disc and the midpoints of the two collapse parts of the saddle-shaped is the respective curvature radius, so that the following conditions are satisfied: the radius of curvature of the inner disc (310) is smaller than the radius of curvature of the outer disc (320).
8. A method of making a skirt structure (100) according to any one of claims 1-3, wherein the method of making a skirt comprises the steps of:
preparing a wavy annular elastic bare bracket as an elastic framework, and preparing a covering film with an annular film area as a skirt covering film;
and connecting the wave crests of the wavy annular elastic framework with the inner ring of the annular membrane area after inwards pressing, and connecting the wave troughs with the outer ring of the annular membrane area after outwards turning over, wherein the inner diameter of the annular membrane area is ensured to be smaller than the inner ring diameter of the wavy annular elastic framework in a flat polygonal star-shaped sheet state formed by inwards pressing all wave crests and outwards turning over all wave troughs, so that the annular membrane limits the elastic framework to rebound to an initial wavy annular shape.
9. The method of manufacturing a skirt according to claim 8, wherein:
the step of connecting the wave crest of the wavy annular elastic framework to the inner ring of the annular membrane area after inwards pressing and connecting the wave trough to the outer ring of the annular membrane area after outwards turning comprises the following steps:
firstly, inwards pressing wave crests and wave troughs of the wavy annular elastic framework outwards to form a flat polygonal star-shaped sheet-shaped form; and then the sharp corners of the outer ring of the polygonal star-shaped sheet structure are fixedly connected to one side of the outer ring of the annular membrane area, and the sharp corners of the inner ring of the polygonal star-shaped sheet structure are fixedly connected to one side of the inner ring of the annular membrane area.
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| CN202311764301.7A CN117426808B (en) | 2023-12-21 | 2023-12-21 | Skirt edge structure, self-adaptive skirt edge bracket, plugging device and skirt edge manufacturing method |
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