CN116965993A

CN116965993A - Tectorial membrane support

Info

Publication number: CN116965993A
Application number: CN202311237029.7A
Authority: CN
Inventors: 董永贺; 朱明哲; 申宝胜; 罗静云; 刘颖
Original assignee: Beijing Huamai Taike Medical Instrument Co ltd
Current assignee: Beijing Huamai Taike Medical Instrument Co ltd
Priority date: 2023-09-25
Filing date: 2023-09-25
Publication date: 2023-10-31
Anticipated expiration: 2043-09-25
Also published as: CN116965993B

Abstract

The invention provides a tectorial membrane bracket, which relates to the field of medical appliances, and comprises a framework and a tectorial membrane connected with the framework, wherein the framework comprises N bracket rings, and each bracket ring is in a wavy shape; each bracket ring is formed by connecting at least one highest peak wave band, a plurality of first half side transition wave bands, at least one shortest peak wave band and a plurality of second half side transition wave bands end to end, and the wave peak of the transition wave band is smaller than the highest peak wave band and larger than the shortest peak wave band; along the axial direction of the tectorial membrane bracket, N is even, every two adjacent bracket rings are used as a bracket ring group, N is odd, one bracket ring at one axial end of the tectorial membrane bracket is independently arranged, the other bracket rings are used as a bracket ring group, and in each bracket ring group, the highest peak wave band of one bracket ring and the lowest peak wave band of the other bracket ring are arranged at the same side in the circumferential direction of the tectorial membrane bracket. The invention can simultaneously improve the flexibility, the anti-shrinkage property and the sealing property of the existing tectorial membrane bracket, has no directivity and is easier to operate.

Description

Tectorial membrane support

Technical Field

The invention relates to the field of medical instruments, in particular to a covered stent.

Background

The covered stent is used for treating aortic dissection or aneurysm, and the covered stent needs to have good flexibility, can reduce the return force, avoid stent source rupture to the aorta, and adapt to the physiological form of aortic vascular tortuosity. In the improvement process of the covered stent, in order to pursue better flexibility of the covered stent, a plurality of covered stents which are arranged at intervals in the axial direction of the wavy stent ring are preferably adopted, and the peak height of the wavy stent ring is properly reduced according to the rule that the peak height is shorter and the flexibility of the wavy stent ring is better, but for the wavy stent ring, the peak height of the wavy stent ring is positively correlated with the shrink resistance of the covered stent, namely: the shorter the peak height of the stent ring, the better the flexibility, but the worse the anti-shrink property, in order to balance the flexibility and anti-shrink property of the covered stent, in this regard, in the prior art, the covered stent in the technical scheme disclosed in patent publications 200520041828.8 and 202210531773.7, respectively, is adopted, so that the wavy stent ring is an unequal-height deflection stent ring comprising both the peak-high part and the peak-short part.

However, in the process of using the bracket ring, the novel problems of bending directivity, poor sealing performance, easy internal leakage and the like are found in the structure; the bending directivity is provided, so that the operation of the instrument is required to be higher in the using process, and the operation is not easy; the inner leakage is easy to occur between the outer peripheral surface of the large bending side of the covered stent and the inner wall of the blood vessel, so that an axial blood flow channel is formed.

Disclosure of Invention

The invention aims to provide a covered stent, which is non-directional and easy to operate, and can improve the flexibility, the anti-shrinkage performance and the sealing performance of the existing covered stent.

In order to achieve the above purpose, the embodiment of the present invention adopts the following technical scheme:

the embodiment of the invention provides a covered stent, which comprises a framework and a covered membrane connected with the framework, wherein the framework comprises N stent rings which are arranged at intervals along the axial direction of the covered stent, and each stent ring is respectively in a wavy shape.

Wherein: taking the part between every two adjacent wave troughs on each bracket ring as a wave band, wherein each bracket ring is formed by connecting at least one highest peak wave band, a plurality of first half side transition wave bands, at least one shortest peak wave band and a plurality of second half side transition wave bands end to end, and the wave crest of the first half side transition wave band and the wave crest of the second half side transition wave band are smaller than the wave crest of the highest peak wave band and larger than the wave crest of the shortest peak wave band;

along the axial direction of tectorial membrane support, if N is even, regard as a support ring group with every two adjacent support rings, if N is odd, one support ring of tectorial membrane support axial direction one end sets up alone, and other support rings regard as a support ring group with every two adjacent support rings, then, N the arrangement mode of support ring satisfies: in each stent ring group, the highest peak band of one stent ring and the lowest peak band of the other stent ring are arranged on the same side in the circumferential direction of the stent graft.

Indeed, the applicant carried out further studies and analyses on the stent graft obtained by modifying the traditional stent graft, published in the patent application numbers 200520041828.8 and 202210531773.7, respectively, which resulted in: for the existing covered stent with the wavy unequal-height deflection stent rings, the reason that the large bending side is easy to leak is mainly that the supporting force of the part with the shorter peak height of the wavy unequal-height deflection stent rings is large, the supporting force of the part with the higher peak height is small, the parts with the higher peak heights of the plurality of unequal-height deflection stent rings of the covered stent are all arranged on the same side in the circumferential direction of the covered stent, the large bending side corresponds to the large bending side after the covered stent is implanted into a blood vessel, when the size of the covered stent is larger than the inner diameter of the implanted blood vessel, the large bending side is extremely easy to form folds under certain circumferential angles, the folds enable gaps to be formed between the periphery of the covered stent and the inner wall of the blood vessel, the folds are more and are easy to be continuous in the axial direction, and the gaps are coherent to form a blood flow channel penetrating through the covered stent, so that the inner leak is caused.

According to the analysis, the applicant obtains the design thought of improving the existing tectorial membrane bracket according to the technical scheme of the embodiment of the invention, the concentration of folds of the tectorial membrane bracket after bending is reduced through structural improvement, the folds are discontinuous, so that a blood flow channel is not formed, and further, internal leakage is prevented, and the concrete improvement measures are that, as described in the technical scheme, each bracket ring is formed by connecting the head and the tail of a highest peak wave band, a plurality of first half side transition wave bands, a shortest peak wave band and a plurality of second half side transition wave bands respectively by taking the part between every two adjacent wave troughs on the bracket ring as a wave band, wherein the wave peak of the first half side transition wave band and the wave peak of the second half side transition wave band are smaller than the wave peak of the highest peak wave band and larger than the wave peak of the shortest peak wave band; along the axial direction of the tectorial membrane support, if N is even, regard every adjacent two support rings as a support ring group, if N is odd, one support ring of one axial end of tectorial membrane support sets up alone, and other support rings regard every adjacent two support rings as a support ring group, then, the arrangement mode of N support rings satisfies: in each stent ring group, the highest peak band of one stent ring and the lowest peak band of the other stent ring are arranged on the same side in the circumferential direction of the stent graft.

The flexibility of the traditional tectorial membrane bracket is improved by every two intervals between each bracket ring, each bracket ring comprises a peak position and a short peak position, the anti-shrinkage performance of the traditional tectorial membrane bracket is improved, the highest peak wave band and the shortest peak wave band between adjacent bracket rings are staggered at the same side of the tectorial membrane bracket in the circumferential direction along the axial direction of the tectorial membrane bracket, and the folds are peak wave bands after bending, so that the folds are separated by the low peak wave bands, the folds are not communicated with each other in the axial direction, a blood flow channel cannot be formed, and the effects of improving the tightness of the tectorial membrane bracket and preventing internal leakage are achieved.

In addition, for the existing covered stent, the parts with higher peak heights of the different-height deflection stent rings are arranged on the same side in the circumferential direction of the covered stent, which is also a main reason that the covered stent has strong directivity and is not easy to operate.

In an alternative implementation manner of this embodiment, it is preferable that one of every two adjacent stent ring sets is a proximal ring set, and the other is a distal ring set, and an arrangement manner between the proximal ring set and the distal ring set is as follows:

the highest peak wave band of the far-end bracket ring in the near-end ring group and the lowest peak wave band of the near-end bracket ring in the far-end ring group are arranged on the same side in the circumferential direction of the tectorial membrane bracket; alternatively, the highest peak band of the distal stent ring in the proximal ring set and the highest peak band of the proximal stent ring in the distal ring set are arranged on the same side in the circumferential direction of the stent graft.

In an alternative implementation of the present embodiment, it is preferable that the stent graft is axially: the proximal end face of the stent ring at the most-proximal end and the distal end face of the stent ring at the most-distal end are planes perpendicular to the axial direction of the stent graft respectively, and the distal end face of the stent ring at the most-proximal end and the proximal end face of the stent ring at the most-distal end are inclined planes inclined to the axial direction of the stent graft respectively; and the included angle between the end face of one side, close to each other, of each adjacent two bracket rings and the axial direction of the tectorial membrane bracket is the same.

In an alternative implementation of the present embodiment, it is preferable that, on the circumferential development plane of each of the stent rings:

the structural characteristics (1) are that a peak point of a highest peak wave band nearest to the first half side transition wave band is a first half side highest peak point, and a peak point of a shortest peak wave band nearest to the first half side transition wave band is a first half side shortest peak point: all the peak points of the first half side transition wave bands are positioned on a first auxiliary line which is formed by passing through the highest peak point of the first half side and the lowest peak point of the first half side; and taking the peak point of the highest peak wave band nearest to the second half side transition wave band as the highest peak point of the second half side, and taking the peak point of the shortest peak wave band nearest to the second half side transition wave band as the shortest peak point of the second half side: the peak points of all the second half-side transition wave bands are positioned on a second auxiliary line which is formed by passing through the highest peak point of the second half-side and the lowest peak point of the second half-side;

and/or, the structural feature (2) takes a trough point of the highest peak wave band nearest to the first half side transition wave band as a first half side lowest trough point, and takes a trough point of the shortest peak wave band nearest to the first half side transition wave band as a first half side highest trough point: all the wave trough points of the first half side transition wave band are positioned on a third auxiliary line which is formed by passing through the lowest wave trough point of the first half side and the highest wave trough point of the first half side; taking the trough point of the highest crest section nearest to the second half side transition wave band as the lowest trough point of the second half side, and taking the trough point of the shortest crest wave band nearest to the second half side transition wave band as the highest trough point of the second half side, then: and all trough points of the second half-side transition wave bands are positioned on a fourth auxiliary line which is formed by passing through the lowest trough point of the second half side and the highest trough point of the second half side.

The above-mentioned "and/or" means that the structural feature (1) is arranged simultaneously or alternatively with the structural feature (2).

In an alternative implementation manner of this embodiment, it is preferable that in each of the stent rings: the peaks of the plurality of first half-side transition bands decrease one by one from the highest peak band to the lowest peak band direction, and the peaks of the plurality of second half-side transition bands decrease one by one from the highest peak band to the lowest peak band direction.

Preferably, in each of the stent rings: the peak width of each band is proportional to the peak height.

Preferably, the peak width of the shortest peak band, the peak widths of the plurality of first half side transition band peaks, and the peak width of the highest peak band transition in an arithmetic progression, and the peak width of the shortest peak band, the peak width of the plurality of second half side transition band peaks, and the peak width of the highest peak band transition in an arithmetic progression.

In an alternative implementation manner of this embodiment, it is preferable that in each of the stent rings: the peak width of each wave is positively correlated with the peak height.

In an alternative implementation manner of this embodiment, it is preferable that in each of the stent rings: the peak included angles of all the wave bands are the same, or the peak included angle difference of the adjacent wave bands is not more than 5 degrees.

Preferably, in each stent ring, the bending radius of each wave is positively correlated with the peak height.

In an alternative implementation manner of this embodiment, it is preferable that in each of the stent rings: the peak widths of the individual waves are the same.

In an alternative implementation manner of the present embodiment, more preferably, the stent rings are made of wires, and in each of the stent rings, the wire diameter of each band is positively correlated with the peak height; or the bracket rings are formed by laser cutting, and in each bracket ring, the beam width of each wave band is positively correlated with the peak height.

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 view of the overall structure of a prior art stent graft in the form of a non-equal height deflection stent loop;

FIG. 2 is a radial cut view of a prior art stent graft of the form shown in FIG. 1 implanted in a vessel with endoleak;

fig. 3 is a schematic arrangement diagram of a proximal end face and a distal end face of each of N stent rings in a first alternative axial arrangement manner in the stent graft provided in this embodiment;

fig. 4 is a schematic layout view of a proximal end face and a distal end face of each of N stent rings in a second alternative axial arrangement manner in the stent graft provided in this embodiment;

fig. 5 is a schematic diagram illustrating the arrangement of the proximal end face and the distal end face of each of N stent rings in the third alternative axial arrangement manner in the stent graft according to the present embodiment;

fig. 6 is a schematic diagram showing a fold occurring in a peak band after the stent graft provided in the present embodiment is implanted in a blood vessel;

FIG. 7 is a schematic diagram showing the relative arrangement of the peaks of one stent ring and the troughs of another stent ring in the adjacent stent rings of the stent graft structure shown in FIG. 3;

FIG. 8 is a schematic view showing a staggered arrangement of peaks of one stent ring and peaks of another stent ring in adjacent stent rings under the stent graft structure shown in FIG. 3;

FIG. 9 is a circumferentially expanded plan view of each stent ring in one particular configuration of the stent graft shown in FIG. 3;

FIG. 10 is a schematic illustration of an alternative size configuration for each band in each stent ring;

FIG. 11 is a schematic view of alternative size and configuration of each band in each stent ring;

FIG. 12 is a graph of wire diameter versus peak height in a circumferentially expanded plan view of one embodiment of each stent ring.

Icon: 100-an existing stent graft; 200-vessel wall; 300-blood flow channel; 1-highest peak band; 2-the shortest band; 3-stent ring set.

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", "axial", "circumferential rear", and the like indicate an orientation or a positional relationship based on the orientation or the positional relationship shown in the drawings, or an orientation or a positional relationship in which the inventive product is conventionally put in use, merely for convenience of 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 particular, in the present invention, the term "proximal" refers to the end that is nearer to the patient's heart during surgery and "distal" refers to the other end that is opposite the "proximal".

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.

Based on the description of the background technology of the specification, the embodiment of the invention provides a covered stent, which comprises a framework and a covered film connected with the framework, wherein the framework comprises N stent rings which are arranged at intervals along the axial direction of the covered stent, and each stent ring is respectively in a wavy shape.

Among them, more particularly: referring to fig. 3 to 9, and particularly referring to fig. 9, with a portion between every two adjacent troughs on each stent ring as a wave band, each stent ring is formed by connecting at least one highest peak wave band 1, a plurality of first half side transition wave bands, at least one shortest peak wave band 2 and a plurality of second half side transition wave bands end to end, wherein the wave peak of the first half side transition wave band and the wave peak of the second half side transition wave band are smaller than the wave peak of the highest peak wave band 1 and larger than the wave peak of the shortest peak wave band 2. Referring to fig. 3 to 8, if N is an even number, two adjacent stent rings are used as a stent ring group 3 in the axial direction of the stent graft, if N is an odd number, one stent ring at one end of the axial direction of the stent graft is separately set, and the remaining stent rings are used as a stent ring group 3 in the axial direction of the stent graft, then the arrangement manner of the N stent rings satisfies: in each stent ring group 3, the highest peak band 1 of one stent ring and the lowest peak band 2 of the other stent ring are arranged on the same side in the circumferential direction of the stent graft, and it should be specifically explained that: the same side arrangement includes, but is not limited to, the arrangement of the peaks of one stent ring and the troughs of the other stent ring being opposite as shown in fig. 7, or the arrangement of the peaks of one stent ring and the troughs of the other stent ring being staggered as shown in fig. 8, and when the number of peaks of each stent ring is odd, the arrangement of the peaks of one stent ring and the troughs of the other stent ring being opposite as shown in fig. 7, the flexibility of the stent graft is optimal, but it is only a preferred arrangement form and not a necessary arrangement form.

In fact, referring to fig. 1 and 2, the applicant has further studied and analyzed the patent publications 200520041828.8 and 202210531773.7, respectively, for the improvement of conventional stent grafts, to obtain: for such a conventional stent graft 100 having wavy non-uniform-height stent rings, the reason why the large curved side is liable to leak is mainly that the supporting force of the part of the wavy non-uniform-height stent rings with shorter peak height is large, the supporting force of the part with higher peak height is small, the parts of the plurality of non-uniform-height stent rings of the stent graft with higher peak height are all arranged on the same side in the circumferential direction of the stent graft, corresponding to the large curved side of the stent graft after being implanted into the blood vessel, when the difference between the size of the stent graft and the inner diameter of the implanted blood vessel is large, the large curved side is liable to form wrinkles at some circumferential angles, the wrinkles make the gaps between the periphery of the stent graft and the blood vessel wall 200 exist, the wrinkles are liable to be continuous in the axial direction, and the gaps are coherent to form a blood flow channel 300 penetrating the stent graft, thereby causing leak.

Through this analysis, the applicant obtains the design thought of the improved existing stent graft 100 according to the above-mentioned technical solution of the present invention, and reduces the concentration of folds after bending the stent graft through some structural improvements, so that the folds are discontinuous, and thus the blood flow channel 300 is not formed, and further, the internal leakage is prevented, and the specific improvement measures are that, as described in the above-mentioned technical solution, the positions between every two adjacent troughs on the stent rings are used as a wave band, so that each stent ring is formed by connecting a highest peak wave band 1, a plurality of first half side transition wave bands, a shortest peak wave band 2 and a plurality of second half side transition wave bands end to end, and the wave peak of the first half side transition wave band and the wave peak of the second half side transition wave band are smaller than the wave peak of the highest peak wave band 1 and larger than the wave peak of the shortest peak wave band 2; along the axial direction of the tectorial membrane support, if N is even, regard every adjacent two support rings as a support ring group 3, if N is odd, one support ring of one axial end of tectorial membrane support sets up alone, and other support rings regard every adjacent two support rings as a support ring group 3, then, the arrangement mode of N support rings satisfies: in each stent ring group 3, the highest peak band 1 of one stent ring and the lowest peak band 2 of the other stent ring are arranged on the same side in the circumferential direction of the stent graft.

The flexibility of the traditional tectorial membrane bracket is improved by every two intervals between the bracket rings, each bracket ring comprises a peak position and a short peak position, the anti-shrinkage performance of the traditional tectorial membrane bracket is improved, the highest peak wave band 1 and the shortest peak wave band 2 between the adjacent bracket rings are staggered at the same side of the tectorial membrane bracket in the circumferential direction along the tectorial membrane bracket, and the folds are peak wave bands after bending, so as to separate the folds in the low peak wave band, so that the folds are not mutually communicated in the axial direction, and further the blood flow channel 300 cannot be formed, thereby achieving the effects of improving the tightness of the tectorial membrane bracket and preventing internal leakage.

In addition, for the existing stent graft 100, the positions with higher peak heights of the plurality of non-equal-height deflection stent rings are arranged on the same side in the circumferential direction of the stent graft, which is also a main reason that the stent graft has strong directivity and is not easy to operate.

For the arrangement of the adjacent stent ring sets 3 in the stent graft provided by the embodiment of the present invention, one of every two adjacent stent ring sets 3 is a proximal ring set, and the other is a distal ring set (the proximal and distal directions refer to the directions indicated in fig. 3), the arrangement between the proximal ring set and the distal ring set may, but is not limited to, satisfy: as shown in fig. 3 and 4, the highest peak band 1 near the distal stent ring in the proximal ring set and the lowest peak band 2 near the distal stent ring in the distal ring set are arranged on the same side in the circumferential direction of the stent graft; alternatively, as shown in fig. 5, the highest peak band 1 of the proximal ring set near the distal stent ring is aligned on the same side in the circumferential direction of the stent graft as the highest peak band 1 of the distal ring set near the distal stent ring. The arrangement modes between every two adjacent stent ring sets 3 can be the same or different, preferably the same, so as to further eliminate the directionality of the covered stent.

More preferably, as shown in fig. 3 to 5, in the stent graft provided in this embodiment, the axial direction of the stent graft is: the proximal end face of the stent ring at the nearest end and the distal end face of the stent ring at the farthest end are planes perpendicular to the axial direction of the stent graft respectively, and the distal end face of the stent ring at the nearest end and the proximal end face of the stent ring at the farthest end are inclined planes inclined to the axial direction of the stent graft respectively; and the included angle between the end face of one side, close to each other, of each two adjacent support rings and the axial direction of the tectorial membrane support is the same, so that the flexibility and the shrink resistance of the tectorial membrane support are both considered.

For each stent ring configuration, it is preferable that, as shown in fig. 9, on the circumferential deployment plane of each stent ring: the structural feature (1) is that the peak point of the highest peak wave band 1 nearest to the first half side transition wave band is the highest peak point of the first half side, and the peak point of the lowest peak wave band 2 nearest to the first half side transition wave band is the lowest peak point of the first half side, then: the peak points of all the first half side transition wave bands are positioned on a first auxiliary line which is formed by passing through the highest peak point of the first half side and the lowest peak point of the first half side; taking the peak point of the highest peak wave band 1 nearest to the second half side transition wave band as the highest peak point of the second half side, and the peak point of the lowest peak wave band 2 nearest to the second half side transition wave band as the lowest peak point of the second half side, then: the peak points of all the second half-side transition wave bands are positioned on a second auxiliary line which is formed by the highest peak point of the second half side and the lowest peak point of the second half side; and/or, the structural feature (2) takes the trough point of the highest peak wave band 1 nearest to the first half side transition wave band as the lowest trough point of the first half side, and the trough point of the shortest peak wave band 2 nearest to the first half side transition wave band as the highest trough point of the first half side, then: all the wave trough points of the first half side transition wave band are positioned on a third auxiliary line which is formed by passing through the lowest wave trough point of the first half side and the highest wave trough point of the first half side; taking the trough point of the highest crest segment 1 nearest to the second half side transition wave band as the lowest trough point of the second half side, and the trough point of the shortest crest wave band 2 nearest to the second half side transition wave band as the highest trough point of the second half side, then: the trough points of all the transition wave bands on the second half side are positioned on a fourth auxiliary line passing through the lowest trough point on the second half side and the highest trough point on the second half side, wherein 'and/or' means that the structural characteristic (1) and the structural characteristic (2) are arranged simultaneously or alternatively.

The structure can lead each bracket ring to respectively form a deflection bracket ring with uniform peak height transition and/or uniform trough height transition, so that the radial supporting force of each bracket ring is more uniform in the circumferential direction as much as possible.

For the spatial solid geometry of the respective carrier ring, the respective carrier ring preferably satisfies the following conditions: the wave peaks of the plurality of first half side transition wave bands are gradually reduced from the highest peak wave band 1 to the shortest peak wave band 2, and the wave peaks of the plurality of second half side transition wave bands are gradually reduced from the highest peak wave band 1 to the shortest peak wave band 2, namely, the wave bands of the bracket ring are further smoothly transited between the lowest peak and the highest peak, and the flexibility of the film-covered bracket is better.

In addition, the applicant further analyzes that the peak width, the peak angle and the bending radius of each band are also important factors capable of affecting the wrinkles, in this embodiment, the peak width L of each band may be set to be the same, the peak included angle θ of each band is made to be the same, or the difference between the peak included angles θ of adjacent bands is not greater than 5 degrees, and the structure of each optional and preferred embodiment is designed in cooperation with the above-mentioned fig. 6, and further, in addition to the above-mentioned fig. 6, the concentration of wrinkles after bending the film covered stent is reduced by some structural improvements, the wrinkles are discontinuous, so that the blood flow channel 300 is not formed, and further, the effect of preventing internal leakage is achieved, and further, the structure of the film covered stent is designed from the uniformity angle of the radial supporting force of each stent ring of the film covered stent in the circumferential direction, so that the wrinkles after bending the film covered stent is reduced, so that the effect of preventing internal leakage can be achieved, and the specific improvement measures mainly refer to fig. 10 and 11, from coupling the peak width L, peak included angle θ, radius R and peak height H of each band in each stent ring with the peak are adjusted, so that the supporting force of each stent ring is adjusted to have the same wave band, and the supporting force of each wave band is adjusted as close to the optimal as possible.

Specifically, as shown in fig. 9 to 11, H represents the peak height of each band, L represents the peak width of each band, θ represents the peak angle of each band, and R represents the bending radius of each band, then in the structure of this embodiment, the uniformity of the radial supporting force in the circumferential direction of each stent ring of the stent graft can be improved by setting in the following manner:

(1) In some alternative constructions, the individual stent rings are as shown in fig. 9: the peak width of each wave band is in direct proportion to the peak height, namely, the peak width of the high wave band is wider, and the peak width of the low wave band is narrower;

(2) In some alternative constructions, the peak width of the shortest band 2, the peak widths of the plurality of first half side transition band peaks, the peak width of the highest peak band 1 transition in an arithmetic progression, the peak width of the shortest band 2, the peak width of the plurality of second half side transition band peaks, the peak width of the highest peak band 1 transition in an arithmetic progression; for example, if the shortest peak height of the stent graft is 5mm and the highest peak height is 3 times the shortest peak height, that is, 15mm, the peak width of the highest peak height of the stent graft is also 3 times the peak width of the shortest peak, the peaks of each transition band are transited in an equi-differential number series, and the wire-wound stent with the diameter of 32mm and the 6 band is taken as an example, the shortest peak width is L1 and the highest peak width is l6=l1+5 Δ; l1+l2+l3+l4+l5+l6=6l1+15 Δ= 32pi, thereby determining the peak width of each band.

(3) In some alternative structures, the peak width of each wave in each stent ring is positively correlated with the peak height, that is, the peak width of the high-wave peak section is wider, and the peak width of the low-wave peak section is narrower, which is not necessarily in a proportional relationship as in the previous alternative structures.

In addition, in order to make the supporting force of the high peak and the low peak similar, the supporting force of the stent ring to the blood vessel after implantation is more uniform, parameter coupling debugging can be carried out on the peak width L, the peak included angle theta, the bending radius R and the peak height H of each wave band of the stent ring, wherein, the adjusting mode of the peak included angle theta can be realized by controlling the ratio of the peak width L to the peak height H and adjusting the bending radius R, and the adjusting rule follows: when the bending radius increases and the supporting force decreases beyond a certain range, for example, when R is adjusted from r1=1 shown in fig. 10 to r2=5 shown in fig. 11 under the condition that H/L is fixed as shown in fig. 10 and 11, the supporting force can be increased, but when R becomes large, the wave crest angle θ is reduced from θ1=50° shown in fig. 10 to θ2=42° and the supporting force can be reduced, wave heights H1 and H2 and wave crest widths L1 and L2 can be determined as required, and then other parameters can be adjusted appropriately so that the supporting forces in the circumferential direction of the stent are equal or tend to be equal, and radial supporting uniformity of the film-covered stent is improved.

In some preferred embodiments, in each stent ring: the bending radius of each wave is positively correlated with the peak height so as to increase the supporting force of higher peak wave bands and reduce wrinkles.

In addition, the structure of each stent ring can be designed from the third angle, so that the stent rings are made of wires by weaving or by a process of cutting metal or alloy tubes by laser, and in each stent ring, as shown in fig. 12, the wire diameters of each wave band are positively correlated with the peak heights, so that the supporting forces in the circumferential direction of the stent rings are equal or tend to be equal, and the radial supporting uniformity of the coated stent is improved.

Finally, it should be noted that: 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

1. The tectorial membrane bracket comprises a framework and tectorial membranes connected to the framework, wherein the framework comprises N bracket rings which are arranged at intervals along the axial direction of the tectorial membrane bracket, and each bracket ring is wavy; the method is characterized in that:

taking the part between every two adjacent wave troughs on each bracket ring as a wave band, wherein each bracket ring is formed by connecting at least one highest peak wave band (1), a plurality of first half side transition wave bands, at least one shortest peak wave band (2) and a plurality of second half side transition wave bands end to end, and the wave peaks of the first half side transition wave bands and the wave peaks of the second half side transition wave bands are smaller than the wave peak of the highest peak wave band (1) and larger than the wave peak of the shortest peak wave band (2);

along the axial direction of tectorial membrane support, if N is even, regard as a support ring group (3) with every adjacent two support rings, if N is odd, one support ring of tectorial membrane support axial direction one end sets up alone, and other support rings regard as a support ring group (3) with every adjacent two support rings, then, N the arrangement mode of support ring satisfies: in each stent ring group (3), the highest peak band (1) of one stent ring and the lowest peak band (2) of the other stent ring are arranged on the same side in the circumferential direction of the stent graft.

2. The stent graft as recited in claim 1, wherein: one of every two adjacent stent ring sets (3) is a proximal ring set, the other stent ring set is a distal ring set, and the arrangement mode between the proximal ring set and the distal ring set is as follows:

the highest peak wave band (1) of the far-end bracket ring in the near-end ring group and the lowest peak wave band (2) of the near-end bracket ring in the far-end ring group are arranged on the same side in the circumferential direction of the tectorial membrane bracket; alternatively, the highest peak band (1) of the distal stent ring in the proximal ring set and the highest peak band (1) of the proximal stent ring in the distal ring set are arranged on the same side in the circumferential direction of the stent graft.

3. The stent graft as recited in claim 1, wherein: along the axial direction of the covered stent: the proximal end face of the stent ring at the most-proximal end and the distal end face of the stent ring at the most-distal end are planes perpendicular to the axial direction of the stent graft respectively, and the distal end face of the stent ring at the most-proximal end and the proximal end face of the stent ring at the most-distal end are inclined planes inclined to the axial direction of the stent graft respectively; and the included angle between the end face of one side, close to each other, of each adjacent two bracket rings and the axial direction of the tectorial membrane bracket is the same.

4. The stent graft as recited in claim 1, wherein: on the circumferential development plane of each of the stent rings:

taking the peak point of the highest peak wave band (1) nearest to the first half side transition wave band as the highest peak point of the first half side, and the peak point of the lowest peak wave band (2) nearest to the first half side transition wave band as the lowest peak point of the first half side, then: all the peak points of the first half side transition wave bands are positioned on a first auxiliary line which is formed by passing through the highest peak point of the first half side and the lowest peak point of the first half side; taking the peak point of the highest peak wave band (1) nearest to the second half side transition wave band as the highest peak point of the second half side, and the peak point of the lowest peak wave band (2) nearest to the second half side transition wave band as the lowest peak point of the second half side, then: the peak points of all the second half-side transition wave bands are positioned on a second auxiliary line which is formed by passing through the highest peak point of the second half-side and the lowest peak point of the second half-side;

and/or, taking the trough point of the highest peak wave band (1) nearest to the first half side transition wave band as the lowest trough point of the first half side, and taking the trough point of the shortest peak wave band (2) nearest to the first half side transition wave band as the highest trough point of the first half side, wherein the steps are as follows: all the wave trough points of the first half side transition wave band are positioned on a third auxiliary line which is formed by passing through the lowest wave trough point of the first half side and the highest wave trough point of the first half side; taking the trough point of the highest crest section (1) nearest to the second half side transition wave band as the lowest trough point of the second half side, and the trough point of the shortest crest wave band (2) nearest to the second half side transition wave band as the highest trough point of the second half side, then: and all trough points of the second half-side transition wave bands are positioned on a fourth auxiliary line which is formed by passing through the lowest trough point of the second half side and the highest trough point of the second half side.

5. The stent graft as recited in claim 1, wherein: each of the stent rings:

the peaks of the plurality of first half-side transition bands decrease one by one from the highest peak band (1) to the lowest peak band (2), and the peaks of the plurality of second half-side transition bands decrease one by one from the highest peak band (1) to the lowest peak band (2).

6. The stent graft as recited in claim 5, wherein: each of the stent rings: the peak width of each band is proportional to the peak height.

7. The stent graft as recited in claim 5, wherein: the peak width of the shortest peak band (2), the peak widths of a plurality of first half side transition band peaks, and the peak width of the highest peak band (1) are transited in an arithmetic progression, and the peak width of the shortest peak band (2), the peak width of a plurality of second half side transition band peaks, and the peak width of the highest peak band (1) are transited in an arithmetic progression.

8. The stent graft as recited in claim 1, wherein: each of the stent rings: the peak width of each wave is positively correlated with the peak height.

9. The stent graft as recited in claim 1, wherein: each of the stent rings: the peak included angles of all the wave bands are the same, or the peak included angle difference of the adjacent wave bands is not more than 5 degrees.

10. The stent graft as recited in claim 1, wherein: each of the stent rings: the bending radius of each wave is positively correlated with the peak height.

11. The stent graft as recited in claim 1, wherein: each of the stent rings: the peak widths of the individual waves are the same.

12. A stent graft as claimed in any one of claims 1 to 11 wherein:

the bracket rings are made of wires, and in each bracket ring, the wire diameters of each wave band are positively correlated with the peak heights;

or the bracket rings are formed by laser cutting, and in each bracket ring, the beam width of each wave band is positively correlated with the peak height.