CN117224296B - Window opening bracket - Google Patents

Abstract

The invention discloses a windowing bracket, which relates to the technical field of medical appliances and comprises a bracket main body and a bracket film attached to the bracket main body; the support film is provided with wave-shaped support rod pairs which are axially arranged side by side at intervals, and the endpoints on the same side of the wave-shaped support rod pairs are arranged in opposite directions and close to each other; defining a region without bracket main body interference, which is surrounded by connecting lines of the same side endpoints of the waveform support rod pairs, as a windowing region part; the windowing area part comprises a redundant area and a window area for connecting the branch brackets, and the area ratio of the redundant area to the window area is 1.5-35; the length value of the connecting line of the folding point pair is more than or equal to 6mm and less than or equal to 40mm; two end points of each waveform supporting rod in the waveform supporting rod pair are connected with two end points of the semi-ring unit to form two closed ring bodies with radial supporting capability. The invention can adapt to the treatment of patients with different conditions, improves the application range and adapts to more cases.

Description

Window opening bracket

Technical Field

The invention relates to the technical field of medical equipment, in particular to a windowing bracket.

Background

Because the damage to the human body caused by the intracavity repair is small, the complications are less, the stent graft is widely applied and popularized in the field of cardiovascular diseases, wherein the stent graft is mainly used as a main instrument for the operation, and is mainly used for treating arterial interlayers and aneurysms, and the stent graft is used for shielding the arterial interlayers or the aneurysms to replace the vascular wall so as to enable blood to circulate, thereby reducing the pressure of the affected parts and playing roles of relieving and treating.

The aortic dissection proximal ostium is often located in the thoracic aorta, and the distal ostium is located in the four branch region (i.e., the region where the superior mesenteric artery, the trunk abdominal artery, and the left and right renal arteries are located in the aorta) requiring reconstruction of the branch vessels of the patient. For the sandwich patient, the aortic vacuum cavity is extruded by the false cavity, so that the space is narrower, the operation space reserved for the operator is smaller, and the operation difficulty is extremely high. The operation space required by the windowing bracket is smaller than that of the branch bracket, and the windowing bracket is more suitable for the treatment of the interlayer patient. Meanwhile, for the abdominal aortic aneurysm of the near kidney and the abdominal aortic aneurysm with the aneurysm-like lesion range becoming widely involved in the renal artery, the traditional infrarenal abdominal aortic stent is difficult to achieve a good treatment effect when being singly used, and the intracavity reconstruction of the branch artery of the patient is also required.

Different from the branch stent technology, the windowing technology needs smaller intracavity space, the window faces to the branch artery to be protected after the stent is released, and blood flow can flow into the branch artery through the windows; a small bracket can be placed in the window to bridge the bracket window and the opening of the branch artery, and meanwhile, the patency of the branch artery can be ensured and the displacement can be prevented. This technique also suffers from certain drawbacks such as tightness in the fenestration area; when the aorta is severely bent, the window is difficult to be closed; only 1-2 target blood vessels can be protected; there is a risk of target vessel stenosis after surgery; the existing window opening support is mainly a customized support, the window opening support is customized according to the condition of each patient, the universality of the customized support is poor, the customized support cannot be suitable for treatment of different patients, and the application range is extremely limited.

Disclosure of Invention

The invention aims to provide a windowing bracket so as to solve the problems in the prior art, adapt to the treatment of patients with different conditions, improve the application range and adapt to more cases.

In order to achieve the above object, the present invention provides the following solutions:

the invention provides a windowing bracket, which comprises a bracket main body in a shape of a cylinder or a round table and a bracket film attached to the bracket main body; the support film is provided with waveform support rod pairs which are axially arranged side by side at intervals, the endpoints of the same side of the waveform support rod pairs are opposite or approximately close to each other (namely, the endpoints of the waveform support rod are closer to the gap of the waveform support rod pairs relative to the waveform support rod), or the endpoints of the waveform support rod pairs are approximately away from each other (namely, the endpoints of the waveform support rod are farther away from the gap of the waveform support rod pairs relative to the waveform support rod) or the endpoints of the waveform support rod pairs are arranged in the same direction (namely, one of the endpoints of the waveform support rod pairs is farther away from the gap of the waveform support rod pairs relative to the waveform support rod, and the other endpoint of the waveform support rod pairs is closer to the gap of the waveform support rod pairs); defining a region without bracket main body interference, which is surrounded by connecting lines of the same side endpoints of the waveform support rod pairs and the waveform support rod pairs, as a windowing region part; the windowing region part is used for adapting to windowing of a differential hollow anatomical structure; the windowing area part comprises a redundant area and a window area used for connecting the branch brackets, and the area ratio of the redundant area to the window area is 1.5-35. It can be understood that the same side end points of the waveform support rod pair are designed to be opposite or approximately opposite and close to each other, so that the development of collapse grooves along the circumferential direction of the windowing support can be effectively restrained due to the radial (windowing support) force of the branching support on the support film of the redundant area in the windowing area part, and the support film of the windowing support is prevented from being wrinkled in a large range due to the acting force of the branching support; the endpoints of the same side of the waveform support rod pair are approximately opposite and far away from each other, and the radial support performance of the windowing area part on the support membrane can be ensured by increasing the waveform period number of the unit length in the circumferential direction and reducing the amplitude length; although the universality of the windowing bracket is positively related to the area of the redundant area of the windowing area part, the fatigue resistance of the redundant area which is not constrained by the bracket main body, namely radial supporting performance, pulse blood pressure impact resistance or window area sealing performance after being extruded by a hollow anatomical structure/branch bracket is obviously reduced, the area ratio of the redundant area to the window area is 1.5-35, the performances are effectively considered and ensured, and meanwhile, the windowing bracket can be ensured to have wider universality; the window of the windowing bracket is a window/hole area which is formed by a doctor after windowing/perforating operation is carried out on the bracket film of the windowing area part according to the actual three-dimensional structural characteristics of the hollow anatomical structure of the patient and can be connected with/overlapped with the branch bracket.

Preferably, the wave-shaped supporting rod pair is provided with a folding point pair which is opposite or approximately opposite and close to each other except for the end points, and the length value of a connecting line of the folding point pair is more than or equal to 6mm and less than or equal to 40mm; the two end points of the waveform supporting rod are connected by the semi-ring units to form a closed ring body with radial supporting capacity. It will be appreciated that the pair of opposite or substantially opposite fold points except the end points can provide support and support for the fenestration area portion and support the stent membrane to avoid collapse and wrinkling of the stent membrane in the redundant area, but also affect the fenestration of the fenestration area portion, so that the area where the fenestration operation cannot be performed in the fenestration area portion is increased, and further the ineffective redundant area is increased, so that even if the redundant area has a better area ratio to the fenestration area, the fenestration area portion cannot achieve optimal universality, and meanwhile, the redundant ineffective redundant area brings adverse dimensional changes to the grasping loading of the fenestration stent; the wave-shaped supporting rod pair is provided with a folding point pair which is opposite to or approximately opposite to each other and is close to the end point, the connecting line length value of the folding point pair is more than or equal to 6mm and less than or equal to 40mm, the influence factors can be effectively considered, and the wide universality of the windowing area part is ensured.

Preferably, the support film in the windowing region part is arranged in a redundant way relative to the projection surface of the windowing region part, so that a redundant film is formed, part or all of the windowing region can displace relative to the windowing region part under the restraint of the redundant film, and the matching applicability of the windowing support and the differentiated hollow anatomical structure of a wider patient is further improved. It can be understood that the support film is arranged in a redundant manner relative to the projection surface of the windowed region, so that the geometric dimensions of the length, width, area and the like of the support film in the windowed region are larger than those of the projection surface of the windowed region, and form a relatively redundant geometric dimension; the redundant geometric dimension of the bracket film relative to the projection surface of the windowing area part ensures that the window area after windowing on the bracket film in the area has displacement capacity with vector property, for example, the window area is subjected to the dragging/limiting/restraining/controlling action of the redundant film, the redundant film at the edge of one side of the window area, which is close to the proximal end of the windowing bracket, is subjected to the fixed-length loitering movement along the radial direction of the windowing bracket, and the window area can realize the loitering movement towards the proximal end or the distal end of the windowing bracket in the axial direction of the windowing bracket under the dragging/pushing action of the redundant film; the ability to convert the radial displacement of the redundant membrane into axial/circumferential displacement of the window region further improves/enhances/facilitates the versatility of the fenestration stent to patient populations with differentiated hollow anatomy, significantly reduces the probability of custom-making fenestration stents, and significantly reduces the cost of surgery.

Preferably, the number of the window area parts is 3, and the window area parts are arranged in a roughly inverted V shape.

Preferably, the ratio of the projection area of the redundant film to the projection area of the windowed area is 1.05-2; the ratio of the redundant membrane to the projection area of the windowed area can be set to ensure good lumen acquisition rate after the hollow anatomical structure operation and inhibit lumen loss.

Preferably, a sealing elastic film is attached to the inside and/or the outside of the windowed region, the sealing elastic film is arranged in a redundant manner relative to the projection surface of the windowed region, the ratio of the projection area of the sealing elastic film to the projection area of the windowed region is 1.05-3, and the outer edge of the sealing elastic film is connected with the support film to form a hollow cavity. It can be appreciated that the redundant arrangement of the sealing elastic membrane relative to the projection surface of the fenestration area portion, such that the length/width/area of the sealing elastic membrane in the fenestration area portion is greater than the geometry of the projection surface of the fenestration area portion, resulting in a relatively redundant geometry; the sealing elastic membrane has relative redundant geometric dimensions, so that the sealing reinforcing hole after the sealing reinforcing hole is formed in the sealing elastic membrane in the area has vector displacement capability, for example, the sealing reinforcing hole can move along the radial direction of the windowing support in a fixed length loitering manner by the redundant sealing elastic membrane which is close to the edge of one side of the proximal end of the windowing support under the action of the dragging/limiting/controlling of the redundant sealing elastic membrane, and then the sealing reinforcing hole can move towards the proximal end or the distal end of the windowing support in the axial direction of the windowing support in a loitering manner under the action of the dragging/pushing of the redundant sealing elastic membrane; the ability to convert the radial displacement of the redundant sealing elastic membrane into the axial/circumferential displacement of the sealing reinforcing hole further improves/enhances/promotes the universality of the fenestration stent facing the patient group with the differentiated hollow anatomical structure, obviously reduces the probability of customizing the fenestration stent and obviously reduces the operation cost.

Preferably, a sealing elastic film is attached to the inside and/or the outside of the window area part, a sealing reinforcing hole is formed in the sealing elastic film, the outer edge of the sealing elastic film is connected with the support film to form a hollow cavity, and the window area is aligned with the sealing reinforcing hole along the circumferential direction and not aligned with the sealing reinforcing hole along the axial direction to form space dislocation arrangement.

Preferably, the size of the sealing reinforcing hole is smaller than the size of the opened window, and the diameter of the sealing reinforcing hole is smaller than the outer diameter of the branch bracket.

Preferably, the two ends of the stent film and the edges of the window area are respectively provided with a radio-opaque mark for marking the start and stop of the stent film and the position of the opened window. The radiopaque marker is made of a radiopaque metal.

The invention provides a windowing bracket, which comprises a bracket main body in a shape of a cylinder or a round table and a bracket film attached to the bracket main body; the support film is provided with wave-shaped support rod pairs which are axially arranged side by side at intervals, and the same side endpoints of the wave-shaped support rod pairs are opposite or approximately close to each other; defining a region without bracket main body interference, which is surrounded by connecting lines of the same side endpoints of the waveform support rod pairs and the waveform support rod pairs, as a windowing region part; the windowing region part is used for adapting to windowing of a differential hollow anatomical structure; the support film of the windowing region part comprises a redundant region and a window region for connecting a branch support, and the area ratio of the redundant region to the window region is 1.5-35; the sealing elastic membrane is arranged in a redundant mode relative to the projection surface of the windowing area, sealing reinforcing holes are formed in the sealing elastic membrane, and the window area and the sealing reinforcing holes are aligned along the circumferential direction and are not aligned along the axial direction, so that axial space dislocation arrangement is formed.

Preferably, the radiopaque marker includes a development point and a development ring; a circle of developing points are arranged at both ends of the support film, or a circle of developing rings are arranged at both ends of the support film; and one circle of developing points are arranged on the edge of the window area, or one circle of developing rings are arranged on the edge of the window area.

Preferably, the material of the support membrane is terylene, expanded polytetrafluoroethylene or fluorinated ethylene propylene copolymer, and the material of the sealing elastic membrane is expanded polytetrafluoroethylene or fluorinated ethylene propylene copolymer.

Preferably, the material of the bracket film is one or more of expanded polytetrafluoroethylene, terylene, fluorinated ethylene propylene copolymer and the like.

Preferably, the stent body comprises a bare section, a sealing section, a windowing region section and a transition section, wherein the bare section is an annular wavy stent with incomplete covering at two ends, the sealing section is an annular wavy stent which is close to the bare section and is positioned between the two bare sections, the windowing region section is an annular wavy stent which is positioned between the two sealing sections, and the transition section is an annular wavy stent which is positioned between the windowing region section and the sealing section. The windowing region is positioned between two adjacent windowing region sections.

Preferably, the bare segment has a plurality of first vertexes without covering film, and at least one second vertex with covering film is arranged between two adjacent first vertexes, and the height of the first vertexes is higher than that of the second vertexes; the sealing section is provided with a plurality of third vertexes, every two third vertexes are continuously arranged to form a third vertex group, at least one fourth vertex is arranged between every two adjacent third vertex groups, the height of each third vertex is higher than that of each fourth vertex, and the third vertexes are flush with the second vertexes; the transition section has a plurality of fifth vertexes of equal height or has a plurality of the fifth vertexes and sixth vertexes alternately arranged, and the height of the fifth vertexes is higher than that of the sixth vertexes.

Preferably, the fenestration area portion includes a dry abdominal fenestration area portion, a left renal artery fenestration area portion and a right renal artery fenestration area portion, the fenestration area includes a dry abdominal fenestration area, an upper mesenteric fenestration area, a left renal artery fenestration area and a right renal artery fenestration area portion, the dry abdominal fenestration area portion, the left renal artery fenestration area and the right renal artery fenestration area portion are respectively opened based on the upper mesenteric fenestration area, the dry abdominal fenestration area portion is provided with the dry abdominal fenestration area portion, and the left renal artery fenestration area portion is provided with the right renal artery fenestration area portion.

Preferably, the two adjacent windowing region sections at the two ends of the windowing region part are connected through a connecting rod; the support body is last to be equipped with reinforcing fiber, reinforcing fiber connects bare section, sealed section, open window regional section and at least two in the changeover portion.

Preferably, the window region is disposed non-coaxially with the seal-enhancing aperture.

Preferably, a sealant coating surrounding the outer periphery of the window area is arranged on the stent film in the window area, and the sealant coating is formed by mixing at least one of fibrin glue, medical cyanoacrylate, radiopaque medical cyanoacrylate composition, modified poly (cinnamyl alcohol) foam hardener and gel dry powder. The sealant coating is used for further enhancing the tightness and the connection strength of the windowing bracket and the branch bracket; the sealant coating can also act directly on the wall of the hollow anatomical structure to adhesively seal the outer edge of the window region of the fenestration support with the wall of the hollow anatomical structure.

Preferably, the sealant coating has an operable time to trigger gelation, avoiding undesired gelation behavior when the fenestration stent is disposed in the hollow anatomical structure.

Compared with the prior art, the invention has the following technical effects:

the invention provides a windowing bracket, which is characterized in that a windowing area part capable of adaptively matching a differential hollow anatomical structure is arranged on a bracket film, and a window area for connecting a branch bracket is arranged on the windowing area part, so that the bracket film has a large enough area to select the windowing window position, the bracket film can adapt to the treatment of patients under different conditions, the application range is improved, more cases are adapted, and the windowing area part is positioned in a gap in a bracket main body, after the branch bracket is connected, the branch bracket cannot generate friction with the bracket main body, and the use safety is improved.

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 embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic perspective view of a window bracket according to the present invention;

FIG. 2 is a view showing the development of the window bracket according to the present invention;

FIG. 3 is a schematic view of a fenestration area section of the fenestration support of the present invention;

FIG. 4 is a schematic view of a pair of wave-shaped supporting rods of the window bracket according to the present invention;

FIG. 5 is a schematic view of another fenestration area section of the fenestration support of the present invention;

FIG. 6 is a schematic diagram of a structure in which two ends of a wave-shaped supporting rod of a window bracket are connected by a half ring unit to form a ring body;

FIG. 7 is a schematic view of a redundant arrangement of a frame membrane of a fenestration frame of the present invention with respect to a projection plane of a fenestration area;

FIG. 8 is a cross-sectional view A-a of FIG. 7;

FIG. 9 is a schematic view of a redundant arrangement of sealing elastic membranes of a fenestration support of the present invention with respect to a projection plane of a fenestration area;

FIG. 10 is a cross-sectional view B-B of FIG. 9;

FIG. 11 is a schematic perspective view of a redundant arrangement of a frame membrane of a fenestration frame of the present invention with respect to a projection plane of a fenestration area;

FIG. 12 is a schematic perspective view of a redundant arrangement of sealing elastic membranes of a fenestration area portion of a fenestration support of the present invention;

FIG. 13 is a developed view of the fenestration product of the present invention with reinforcing fibers disposed therein;

fig. 14 is a schematic structural view of the fenestration stent provided in the present invention when the sealing elastic membrane is positioned inside the stent membrane;

FIG. 15 is a schematic view of the structure of the fenestration product of the present invention when the sealing elastic membrane is located outside the support membrane;

FIG. 16 is a schematic elevation view of the azimuthal arrangement of the window area and seal reinforcing aperture in a fenestration support provided by the present invention;

FIG. 17 is a schematic view in partial cross section of an azimuthal arrangement of a window region and seal reinforcing holes in a fenestration support provided in the present invention;

FIG. 18 is a schematic view of a partial cross section of a branched stent and stent membrane arrangement in an axial angle in a fenestration stent provided in the present invention;

FIG. 19 is a schematic view of the structure of the sealing elastic membrane of the fenestration stent of the present invention connected to the branch stent when the sealing elastic membrane is located outside the stent membrane;

fig. 20 is a schematic structural view of the windowing bracket according to the present invention when a bracket film or a sealing elastic film in a windowing region is arranged in a redundant manner with respect to a projection plane of the windowing region;

FIG. 21 is a schematic view showing the connection structure with the branch stent in FIG. 20 with the window area or seal enhancing hole in the middle position;

FIG. 22 is a schematic view showing the connection structure with the branch stent when the window area or the seal reinforcing hole is located on the upper side in FIG. 20;

FIG. 23 is a schematic view showing the connection structure with the branch stent when the window area is located at the lower side in FIG. 20;

FIG. 24 is a view showing the release process of a branched stent in the present invention, wherein the window area or seal reinforcement hole of the window area part is arranged in a redundant manner after the release of the fenestration stent is opposite to the branched vessel;

FIG. 25 is a view showing the release process of a branched stent when a window area or a seal reinforcing hole of a fenestration area part of the redundant arrangement is offset from a branched vessel after the release of the fenestration stent in the present invention;

FIG. 26 is a schematic view of the structure of the development points at the ends of the stent membrane according to the present invention;

FIG. 27 is a schematic view of a stent membrane end development ring according to the present invention;

FIG. 28 is a schematic view of a window area edge development point structure in accordance with the present invention;

fig. 29 is a schematic view showing a structure of a window area edge developing ring in the present invention.

In the figure: 1-fenestration stent, 2-stent body, 3-stent membrane, 4-branch stent, 5-fenestration area, 6-seal elastic membrane, 7-seal reinforcement hole, 8-fenestration area boundary, 9-redundancy membrane or redundancy seal elastic membrane, 10-visualization point, 11-visualization ring, 12-bare segment, 13-seal segment, 14-fenestration area segment, 15-transition segment, 16-fenestration area segment, 17-first vertex, 18-second vertex, 19-third vertex, 20-third vertex set, 21-fourth vertex, 22-fifth vertex, 23-sixth vertex, 24-peritoneal dry window, 25-mesenteric upper window, 26-left renal artery window, 27-right renal artery window, 28-peritoneal dry fenestration area segment 29-left renal artery fenestration area section, 30-right renal artery fenestration area section, 31-connecting rod, 32-reinforcing fiber, 33-branch vessel, Y-axis, X-circumference, 1610-first waveform support bar, 1620-second waveform support bar, 1630-waveform support bar pair, 1640-redundant area, 1611-first ipsilateral end point, 1621-second ipsilateral end point, 1622-intersection diagonal bar, 1612-first oppositely approaching break point, 1623-second oppositely approaching break point, 1650-oppositely approaching break point pair, 1660-oppositely away break point pair, 1670-projection plane, 1680-hollow cavity, 310-redundant film, 510-window center, 710-seal reinforcing hole center, the length value of the L-break point pair connecting line, the axial interval of the La-waveform supporting rod pair, the length value of the projection surface of the Lb-windowing area part, the width value of the projection surface of the Lc-windowing area part, the length value of the Ld-spreading plane and the width value of the Le-spreading plane.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. 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.

In the present invention, the definition is: the axial direction is parallel to the side surface of the windowing bracket and is marked as Y; "circumferential" means horizontally encircling the window bracket along the side of the window bracket for a circle (i.e. 360 degrees ^o ) Is denoted as X.

In the present invention, the definition is: the folding point is the intersection point of the two inclined rod endpoints to form a V or inverted V, namely the peak top point or the trough bottom point of the waveform folding line; the 'folding point pair' is two 'folding points' of a common bus (a bus of a substantially cylindrical or round table-shaped windowing bracket) on two side-by-side waveform folding lines; the "pair of folding points which are opposite or approximately opposite and close to each other" is a "pair of folding points" of a gap, in which an approximately common bus (an approximately cylindrical or circular table-shaped bus of the window bracket) is arranged on two side-by-side wavy folding lines of the gap, and the diagonal bar is closer to the two side-by-side wavy folding lines relative to the intersection point of the approximately cylindrical or circular table-shaped bus; the "pair of folding points which are opposite or substantially away from each other" is a "pair of folding points" of a gap which is substantially common to bus lines (bus lines of a substantially cylindrical or truncated cone-shaped window bracket) on two side-by-side wavy folding lines of the gap, and is further away from the two side-by-side wavy folding lines with respect to the intersecting diagonal bar thereof.

In the present invention, the definition is: the window is a regular or irregular hole which is formed on the side wall surface of the complete stent membrane according to the actual three-dimensional parameter conditions of the arterial interlayer and the aneurysm of the patient before operation; the windowing is to plan and arrange holes on a bracket film of a windowing bracket according to actual three-dimensional parameters.

The invention aims to provide a windowing bracket so as to solve the problems in the prior art, adapt to the treatment of patients with different conditions, improve the application range and adapt to more cases.

In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description.

As shown in fig. 1 to 29, the present embodiment provides a fenestration support 1, the fenestration support 1 includes a support main body 2 and a support film 3 attached to the support main body, the support main body 2 is substantially cylindrical or circular-table-shaped; the support film 3 is provided with a pair of waveform support rods 1630 which are axially arranged side by side at intervals, the same side end points of the pair of waveform support rods 1630 (as shown in the pair of same side end points of fig. 3, the first same side end point 1611 and the second same side end point 1621) are opposite or approximately close to each other (namely, the end points of the waveform support rods are closer to the gap La of the pair of waveform support rods 1630 relative to the waveform support rods), or the same side end points of the pair of waveform support rods 1630 are approximately far away from each other (namely, the end points of the waveform support rods are farther from the gap of the pair of waveform support rods relative to the waveform support rods) or the same side end points of the pair of waveform support rods 1630 are arranged in the same direction (namely, one of the same side end points of the pair of waveform support rods are farther from the gap of the pair of waveform support rods relative to the waveform support rods and the other same side end points of the pair of waveform support rods are closer to the gap of the pair of waveform support rods); defining a region without bracket body interference surrounded by connecting lines of the waveform support rod pair 1630 and the same-side end points (a first same-side end point 1611 and a second same-side end point 1621) of the waveform support rod pair as a windowing region part 16; the fenestration area section 16 is for accommodating fenestration of a differentiated hollow anatomical structure; the windowed region 16 includes a redundant region 1640 and a windowed region 5 for connecting the branch brackets, and the area ratio of the redundant region 1640 to the windowed region 5 is 1.5 to 35.

Through setting up the regional portion 16 of windowing that adaptable matches differential hollow anatomical structure on support membrane 3, set up the window region 5 that is used for connecting branch support 4 on regional portion 16 of windowing to make there is enough large enough area on the support membrane 3 to carry out the selection of windowing window position, can adapt to the treatment of matching different situation patients, improve application scope, adapt to more cases, moreover, because regional portion 16 of windowing is arranged in the clearance in support main part 2, after connecting branch support 4, branch support 4 can not produce the interference with support main part 2. By designing the area ratio of the redundant area 1640 to the window area 5, the ratio is within a limited range, so that the radial support of the window area 16 and the fatigue resistance against the impact of blood flow and blood pressure pulses can be ensured, and the window area 16 has wider universality.

The use of the windowing bracket 1 of the invention: before the bracket is arranged on a human body, three-dimensional data and simulation results are collected according to medical imaging equipment, and a region which is optimally matched with three-dimensional parameters of a hollow anatomical structure of a patient is selected on a windowing region part 16 for windowing arrangement in an in-vitro environment; further overlapping the branch stent 4 at the window region 5 if necessary; the window area 5 or the branch stent 4 is in the optimal matching state with each branch artery in the three-dimensional space, so that the influence of implantation of the window stent 1 on the environment of a patient vein is inhibited, and the occurrence of adverse events after implantation is reduced.

In some embodiments, as shown in fig. 3-6, the pair of folding points 1650 on the pair of wave-shaped supporting rods 1630, except for the end points, are opposite or approximately opposite and close, and the length value of the connecting line of the pair of folding points is more than or equal to 6mm and less than or equal to 40mm; the two end points of the wave-shaped support bars (the first wave-shaped support bar 1610 and the second wave-shaped support bar 1620) are connected by a half ring unit to form a ring body with radial support capability.

In some embodiments, as shown in fig. 7-8 and 11, the stent film 3 positioned in the fenestration area 16 is arranged in a redundant manner relative to the projection surface 1670 of the fenestration area 16, forming the redundant film 310 such that part or all of the fenestration area 5 can be displaced relative to the fenestration area 16 under the drag of the redundant film 310, weakening the spatial rigidity constraint of the fenestration area boundary 8 formed by the pair of wave shaped support rods 1630, enabling the fenestration area 5 to be radially adaptively tilted and twisted relative to the fenestration stent (e.g., folding and expanding the redundant film 310 having root portions of the branch stent 4 overlapping the fenestration area 5 to shift the branch stent 4 toward), further improving the suitability of the fenestration stent for matching a differentiated hollow anatomical structure of a wider patient.

In some embodiments, as in fig. 2 and 6, the number of fenestration area portions is 3, arranged in a generally chevron shape.

In some embodiments, as shown in fig. 7-8 and 11, the area ratio of the redundant film 310 to the windowed region 16 is 1.05-2; the ratio of the redundant membrane 310 to the area of the fenestration area portion 16 is set to ensure good lumen access after the hollow anatomical surgery and to suppress lumen loss.

In some embodiments, the fenestration area: clinically, the positions of other branches are generally determined by taking the position of an upper mesenteric artery as an origin, the positions of the other branches are expressed by the center distance from the upper mesenteric artery along the axial direction, and the circumferential direction is expressed by a clock angle; and (3) design: the diameter of the left and right renal arteries is about 5mm, and the fenestration stent hole is generally 5mm. The bell angle is 9:00 to 10:30, -5mm to-30 mm,2:00 to 3:30, -10mm to-35 mm; the dry diameter of the abdominal cavity is 10mm, and the distance is 10mm-20mm; the left and right renal artery fenestration areas are about (the length value Lb of the projection surface of the fenestration area) 25mm long and the width (the width value Lc of the projection surface of the fenestration area) about 15mm; the length of the abdominal cavity dry-cut window area is about 20mm, and the width is about 10mm.

In some embodiments, as shown in fig. 9-10 and 12, a sealing elastic film 6 is attached to the inside and/or the outside of the fenestration area portion 16, the sealing elastic film 6 is arranged in a redundant manner relative to a projection surface 1670 of the fenestration area portion 16, the area ratio of the sealing elastic film 6 to the fenestration area portion 16 is 1.05-3, and the outer edge of the sealing elastic film 6 is connected with the stent film 3 to form a hollow cavity 1680.

In some embodiments, as shown in fig. 16 to 17, a sealing elastic membrane 6 is attached to the inside and/or the outside of the window area portion 16, a sealing reinforcing hole 7 is provided on the sealing elastic membrane 6, the outer edge of the sealing elastic membrane 6 is connected with the support membrane 3 to form a hollow cavity 1680, and the window area 5 and the sealing reinforcing hole 7 are aligned circumferentially and not aligned axially to form a space dislocation arrangement. For example, in fig. 16, the window center 510 of the window region 5 is aligned and collinear with the seal reinforcing hole center 710 of the seal reinforcing hole 7 in the circumferential direction and is axially offset.

In some embodiments, as shown in fig. 16-18, the fenestration support 1 includes a generally cylindrical or frustoconical support body 2 and a support membrane 3 attached to the support body; the bracket film 3 is provided with a pair 1630 of waveform supporting rods which are axially spaced and close to each other in opposite directions or approximately in opposite directions at the same side end points; defining a region without bracket body interference, which is surrounded by connecting lines of the waveform supporting rod pairs 1630 and the endpoints of the same side of the waveform supporting rod pairs, as a windowing region part 16; the fenestration area section 16 is for accommodating fenestration of a differentiated hollow anatomical structure; the bracket film 3 of the windowing area part 16 comprises a redundant area 1640 and a window area 5 for connecting the branch bracket, wherein the area ratio of the redundant area 1640 to the window area 5 is 1.5-35; the outside of the windowing region is attached with a sealing elastic film which is arranged in a redundant way relative to the projection surface 1670 of the windowing region, the sealing elastic film is provided with a sealing reinforcing hole 7, and the window region 5 and the sealing reinforcing hole 7 are aligned along the circumferential direction and not aligned along the axial direction, so that the axial space dislocation arrangement is formed. It will be appreciated that this arrangement of the window region 5 and seal-reinforcing aperture 7 being circumferentially aligned and axially misaligned greatly facilitates, on the one hand, deployment of the branch stent 4 in vivo following the anatomic luminal aspect of the physician's procedure, avoiding the complex manipulation of right angle overlapping of the branch stent 4 with the fenestration stent 1; on the other hand, the branch stent 4 overlaps the stent membrane 3 at an angle to conform to the hollow anatomical structure, and the occurrence of unexpected folds in the membrane in the redundant area 1640 near the window area 5 of the stent membrane 3 due to the acting force of the branch stent 4 is greatly suppressed, and such folds affect the tightness of the connection area of the branch stent 4 and the stent membrane 3, so that the tightness is weakened.

In some embodiments, the seal stiffener bore 7 is smaller in size than the window region 5 and the seal stiffener bore 7 is smaller in diameter than the outer diameter of the branch stent 4. When in use, the sealing elastic membrane 6 can be attached to the outside (shown in fig. 15) or the inside (shown in fig. 14) of the support membrane 3, or both the inside and the outside are arranged, when the branch support 4 is connected (shown in fig. 16), after the branch support 4 passes through the window area 5 and the sealing reinforcing hole 7, the branch support 4 is extruded under the elastic action of the sealing reinforcing hole 7, so that the connection tightness of the branch support 4 and the sealing elastic membrane 6 is ensured, the connection tightness between the windowing support 1 and the branch support 4 is enhanced, the blood leakage is reduced, the fatigue influence caused by friction is reduced, and the treatment effect is ensured. The stent body 2 may be made of a metal material, and the metal material may be nickel-titanium alloy wire, 316L or L605, or the like. The sealing elastic membrane 6 and the bracket membrane 3 can be bonded, thermally compounded or sewn.

As shown in fig. 20-25, in some embodiments, the redundant film or redundant seal elastic film 9 on the fenestration area section 16 with the fenestration area section boundary 8, the end port of the redundant film or redundant seal elastic film 9 that is away from the fenestration area section boundary 8 is a fenestration area 5, the fenestration area 5 being free to move within the fenestration area section boundary 8. The mutual traction behavior of the branch bracket 4 and the windowing bracket can enable the wall surface of the redundant film or the redundant sealing elastic film 9 to incline into a slope/cone table surface, so that the redundant film or the redundant sealing elastic film is more attached to the branch blood vessel 33, and the window area 5 freely moves within the scope of the boundary 8 of the windowing area, so that the window area 5 and the branch blood vessel 33 can be more conveniently aligned accurately, the application range is improved, more cases are adapted, the adverse effect caused by inaccurate windowing position is reduced, the risk of inaccurate alignment in operation is reduced, and the treatment effect is ensured. As shown in fig. 24, when the window area 5 of the redundant membrane or the redundant sealing elastic membrane 9 is opposite to the branch vessel 33 after the fenestration stent 1 is released, the position of the window area 5 is not required to be adjusted, and the branch stent 4 is released; as shown in fig. 25, when the window area 5 of the redundant membrane or the redundant sealing elastic membrane 9 is offset from the branch vessel 33 to some extent after the release of the fenestration stent 1, the position of the window area 5 is adjusted so that the window area 5 faces the branch vessel 33, and then the branch stent 4 is released.

In some embodiments, the redundant membrane or redundant seal elastic membrane 9 is sized: the length Ld of the flattening surface is 26-30mm, and the width Le of the flattening surface is 16-20mm. The size of the window area portion 16 is designed: the length Lb of the projection surface of the window area is 25mm, and the width Lc of the projection surface of the window area is 15mm.

In some embodiments, both ends of the stent membrane 3 and the edges of the window region 5 are provided with radiopaque markers, made of a radiopaque metal, such as platinum iridium alloy, gold, tantalum, etc., for marking the start and stop of the stent membrane 3 and the position of the window region 5, respectively. The radiopaque markers may be "6", "9", "g", "infinity", "e", "not", "excellent" or "very good" in shape, or may be other shapes such as bands. These radiopaque markers have a directional and positional identification effect; when the windowing bracket is deployed, a user can identify the real-time azimuth change and the relative position change of the windowing bracket, so that the deployment efficiency of the windowing bracket is improved.

26-29, in some embodiments, the radiopaque marker includes a development point 10 and a development ring 11, with one development point 10 at each end of the stent membrane 3, or one development ring 11 at each end of the stent membrane 3, one development point 10 at the edge of the window region 5, or one development ring 11 at the edge of the window region 5. The start and stop of the stent film 3 and the position of the window region 5 are marked by the development dot 10 or the development ring 11.

In some embodiments, the stent membrane 3 is made of terylene, expanded polytetrafluoroethylene or fluorinated ethylene propylene copolymer, and the sealing elastic membrane 6 is made of expanded polytetrafluoroethylene or fluorinated ethylene propylene copolymer, but is not limited to the above materials. The terylene material has high strength, and ensures the structural strength of the bracket film 3. When the sealing elastic membrane 6 is made of expanded polytetrafluoroethylene or fluorinated ethylene propylene copolymer, the sealing elastic membrane is softer, and has better sealing performance and certain activity when being connected with the branch bracket 4.

As shown in fig. 1, 2 and 13, in some embodiments, the stent body 2 includes a bare segment 12, a seal segment 13, a fenestrated region segment 14, and a transition segment 15, the bare segment 12 being an annular corrugated stent with incomplete coverage at both ends, the seal segment 13 being an annular corrugated stent immediately adjacent to the bare segment 12 and between two bare segments 12, the fenestrated region segment 14 being an annular corrugated stent between two seal segments 13, the transition segment 15 being an annular corrugated stent between the fenestrated region segment 14 and the seal segments 13; the fenestration area sections 16 are located between adjacent two fenestration area sections 14. The part of the bare segment 12, which is not covered by the film, is used for being fixed on a matched conveying system so as to convey the windowed bracket 1 to a designated position, the sealing segment 13 and the bare segment 12 are jointly used for supporting two ends of the bracket film 3, the windowed region segment 14 is shaped so that a sufficient space is reserved between two adjacent windowed region segments 14 to arrange the windowed region part 16, and the transition segment 15 is used for supporting the corresponding part of the bracket film 3 so as to ensure the roundness of the bracket film 3.

As shown in fig. 2, in some embodiments, the bare segment 12 has a plurality of first apexes 17 without a film, at least one second apexes 18 with a film between two adjacent first apexes 17, the first apexes 17 have a height higher than the height of the second apexes 18, specifically, three first apexes 17 and three or six second apexes 18 are provided, and the three first apexes 17 are used for being fixed on a matched conveying system; the sealing section 13 is provided with a plurality of third vertexes 19, each two third vertexes 19 are continuously arranged to form a third vertex group 20, at least one fourth vertex 21 is arranged between every two adjacent third vertex groups 20, the height of each third vertex 19 is higher than that of each fourth vertex 21, and the third vertexes 19 are flush with the second vertexes 18, so that two ends of the stent membrane 3 are more round and the uniformity of the whole supporting force is ensured; the transition section 15 has a plurality of fifth vertexes 22 of equal height or has a plurality of fifth vertexes 22 and sixth vertexes 23 alternately arranged, and the height of the fifth vertexes 22 is higher than the height of the sixth vertexes 23, so that the corresponding portion of the stent film 3 can be uniformly supported.

As shown in fig. 1-2, in some embodiments, fenestration area section 16 includes a dry abdominal fenestration area section 28, a left renal artery fenestration area section 29, and a right renal artery fenestration area section 30, and fenestration area 5 includes a dry abdominal fenestration 24, an superior mesenteric fenestration 25, a left renal artery fenestration 26, and a right renal artery fenestration 27, with superior mesenteric fenestration 25 being used as a reference for the dry abdominal fenestration 24, the left renal artery fenestration 26, and the right renal artery fenestration 27, respectively, and dry abdominal fenestration 24 is disposed on the dry abdominal fenestration area section 28, and left renal artery fenestration 26 and right renal artery fenestration 27 are disposed on the left renal artery fenestration area section 29 and the right renal artery fenestration area section 30, respectively. Can be used for treating aneurysms or arterial dissection of accumulated abdominal trunk (CA), renal Arteries (RA) or Superior Mesenteric Arteries (SMA). The abdominal cavity trunk window 24, the left renal artery window 26 and the right renal artery window 27 are respectively arranged at different positions of the abdominal cavity trunk window area part 28, the left renal artery window area part 29 and the right renal artery window area part 30 so as to adapt to branch blood vessels in different conditions, improve the application range and adapt to more cases.

As shown in fig. 2 and 13, in some embodiments, the adjacent fenestration area sections 14 at two ends of the fenestration area section 16 are connected by a connecting rod 31, so as to increase the overall strength of the bracket main body 2; the support main body 2 is provided with the reinforcing fiber 32, and the reinforcing fiber 32 is connected with at least two of the bare section 12, the sealing section 13, the windowing area section 14 and the transition section 15, so that the overall strength of the support main body 2 is improved. Wherein the reinforcing fibers 32 may be disposed longitudinally.

The principles and embodiments of the present invention have been described in detail with reference to specific examples, which are provided to facilitate understanding of the method and core ideas of the present invention; also, it is within the scope of the present invention to be modified by those of ordinary skill in the art in light of the present teachings. In view of the foregoing, this description should not be construed as limiting the invention.

Claims (9)

1. A support of windowing, its characterized in that: comprises a bracket main body and a bracket film attached to the bracket main body; the support film is provided with wave-shaped support rod pairs which are axially arranged side by side at intervals, and the endpoints on the same side of the wave-shaped support rod pairs are oppositely and closely arranged; defining a region without bracket main body interference surrounded by connecting lines of the waveform supporting rod pairs and the same side endpoints of the waveform supporting rod pairs as a windowing region part; the windowing region part is used for adapting to windowing of a differential hollow anatomical structure; the windowing area part comprises a redundant area and a window area for connecting a branch bracket, and the area ratio of the redundant area to the window area is 1.5-35; the length value of the connecting line of the folding point pairs is more than or equal to 6mm and less than or equal to 40mm; two end points of each waveform supporting rod in the pair of waveform supporting rods are connected with two end points of the semi-ring unit to form two closed ring bodies with radial supporting capacity;

The sealing elastic membrane is attached to the inside and/or the outside of the window opening area part, a sealing reinforcing hole is formed in the sealing elastic membrane, the outer edge of the sealing elastic membrane is connected with the support membrane to form a hollow cavity, and the window area is aligned with the sealing reinforcing hole along the circumferential direction and not aligned with the sealing reinforcing hole along the axial direction to form space dislocation arrangement.

2. A fenestration support as defined in claim 1 wherein: the redundant area is arranged around the window area, the support film in the window area part is arranged in a redundant mode relative to the projection surface of the window area part, and the redundant film is formed, so that part or all of the window area can be displaced relative to the window area part under the restraint of the redundant film.

3. A fenestration support as defined in claim 2 wherein: the ratio of the area of the redundant film to the projected area of the windowed area is 1.05-2.

4. A fenestration support as defined in claim 1 wherein: the support main body comprises a bare section, a sealing section, a windowing area section and a transition section, wherein the bare section is an annular wavy support which is positioned at two ends and is not completely covered, the sealing section is an annular wavy support which is close to the bare section and is positioned between the two bare sections, the windowing area section is an annular wavy support which is positioned between the two sealing sections, and the transition section is an annular wavy support which is positioned between the windowing area section and the sealing section; the windowing region is positioned between two adjacent windowing region sections.

5. The fenestration holder of claim 4 wherein: the fenestration area part comprises an abdominal cavity trunk fenestration area part, a left renal artery fenestration area part and a right renal artery fenestration area part, the fenestration area comprises an abdominal cavity trunk fenestration, an upper mesenteric window, a left renal artery fenestration and a right renal artery fenestration, the abdominal cavity trunk fenestration, the left renal artery fenestration and the right renal artery fenestration are respectively opened by taking the upper mesenteric window as a reference, the abdominal cavity trunk fenestration is arranged on the abdominal cavity trunk fenestration area part, and the left renal artery fenestration and the right renal artery fenestration are respectively arranged on the left renal artery fenestration area part and the right renal artery fenestration area part.

6. The fenestration holder of claim 4 wherein: the two adjacent windowing region sections at the two ends of the windowing region part are connected through a connecting rod; the support body is last to be equipped with reinforcing fiber, reinforcing fiber connects bare section, sealed section, open window regional section and at least two in the changeover portion.

7. A support of windowing, its characterized in that: comprises a bracket main body and a bracket film attached to the bracket main body; the support film is provided with wave-shaped support rod pairs which are axially arranged side by side at intervals, and the same-side endpoints of the wave-shaped support rod pairs are close to each other or are far away from each other or are arranged in the same direction; defining a region without bracket main body interference surrounded by connecting lines of the waveform supporting rod pairs and the same side endpoints of the waveform supporting rod pairs as a windowing region part; the windowing region part is used for adapting to windowing of a differential hollow anatomical structure; the windowing area part comprises a redundant area and a window area for connecting a branch bracket, and the area ratio of the redundant area to the window area is 1.5-35; the sealing elastic membrane is arranged in a redundant mode relative to the projection area of the windowing area, the ratio of the projection area of the sealing elastic membrane to the projection area of the windowing area is 1.05-3, the outer edge of the sealing elastic membrane is connected with the support membrane to form a hollow cavity, sealing reinforcing holes are formed in the sealing elastic membrane, and the window area is circumferentially aligned and axially misaligned with the sealing reinforcing holes to form space dislocation arrangement.

8. The fenestration holder of claim 7 wherein: the number of the window area parts is 3, and the window area parts are arranged in a delta shape; the support main body comprises a bare section, a sealing section, a windowing area section and a transition section, wherein the bare section is an annular wavy support with incomplete covering films at two ends, the sealing section is an annular wavy support which is close to the bare section and is positioned between the two bare sections, the windowing area section is an annular wavy support which is positioned between the two sealing sections, and the transition section is an annular wavy support which is positioned between the windowing area section and the sealing section.

9. A support of windowing, its characterized in that: comprises a bracket main body and a bracket film attached to the bracket main body; the support film is provided with wave-shaped support rod pairs which are axially arranged side by side at intervals, and the endpoints on the same side of the wave-shaped support rod pairs are oppositely and closely arranged; defining a region without bracket main body interference surrounded by connecting lines of the waveform supporting rod pairs and the same side endpoints of the waveform supporting rod pairs as a windowing region part; the windowing region part is used for adapting to windowing of a differential hollow anatomical structure; the support film of the windowing region part comprises a redundant region and a window region for connecting a branch support, wherein the area ratio of the redundant region to the window region is 1.5-35; the sealing elastic membrane is arranged in a redundant mode relative to the projection surface of the windowing area, sealing reinforcing holes are formed in the sealing elastic membrane, and the window area and the sealing reinforcing holes are aligned along the circumferential direction and are not aligned along the axial direction, so that axial space dislocation arrangement is formed.