CN219184335U - Tectorial membrane support - Google Patents

Abstract

The utility model provides a tectorial membrane bracket, which comprises a main body supporting part and a connecting wave ring; the distal end opening of the main body supporting part is in an oblique incision shape, so that the supporting position of the distal end of the main body supporting part on the large bending side and the supporting position of the main body supporting part on the small bending side deviate to a certain extent, the change of the inside of the main body supporting part during bending of the blood vessel is adapted, and the adherence of the covered stent on the distal end is enhanced; the main body supporting part comprises a main body bracket and a coating film which is coated on the main body bracket; at least part of the proximal wave rods connected with the wave ring extend into the covering film of the main body supporting part and are overlapped with the main body wave ring of the main body bracket at the most distal end in a crossing way, so that the supportability at the edge of the opening is enhanced; the distal end of the part connected with the wave ring extends out of the distal end opening of the main body supporting part, the extending part forms a hooking structure, and when the hooking structure is released, the hooking structure close to the large curved side of the blood vessel can be preferentially released to be abutted and anchored with the blood vessel wall, so that the stability of the tectorial membrane bracket is ensured during subsequent release.

Description

Tectorial membrane support

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a covered stent.

Background

Chest aortic endoluminal repair (thoracic endovascular aortic repair, TEVAR) is one method of treating aortic disease. The TEVAR aims to seal a primary intima breach of a blood vessel by using a covered stent, expand a true cavity, compress a false cavity, promote thrombosis of the false cavity, prevent interlayer rupture, achieve aortic reconstruction and improve blood supply of a proximal branch blood vessel. With the development of TEVAR for more than 10 years and with the improvement of the bracket and the perfection of the technology, the minimally invasive technology is widely applied, the near-term and mid-term results are satisfactory, and the open surgery is replaced in a certain range. Compared with surgery, TEVAR has the advantages of relatively simple operation, high success rate of surgery, small trauma, quick recovery of patients and the like.

TEVAR can have the problem of poor adhesion of the distal end of the stent in some cases, and is easy to cause I-type internal leakage. For example, because the physiological radian of the ascending aorta is large, the far end of the implanted stent is poor in adhesion property at the small-bending side of the ascending aorta, so that a new stent structure is necessary to be provided, so that the released stent has good adhesion property in a region with large bending degree in the blood vessel of the ascending aorta, and meanwhile, the position accuracy and stability of the stent during release can be ensured.

Disclosure of Invention

Aiming at the defects in the technology, the utility model provides a tectorial membrane bracket which comprises a main body supporting part and a connecting wave ring; the far-end opening of the main body supporting part is in an inclined notch shape, and the main body supporting part comprises a main body bracket with a far-end main body wave ring and a coating film which is coated on the main body bracket; the proximal ends of at least part of the wave rods of the connecting wave ring extend into the covering film of the main body supporting part, the at least part of the wave rods of the connecting wave ring extend into the covering film and are overlapped with the part of the wave rods of the far-end main body wave ring of the main body supporting part in a one-to-one crossing manner, and at least part of wave peaks of the connecting wave ring extend out of a far-end opening of the main body supporting part and are used for being detachably connected with a conveyer.

In one embodiment, the connection wave ring includes a first high wave and a first low wave, the axial dimension of the first high wave is greater than that of the first low wave, the peak of the first high wave extends out of the opening edge of the covering film, and the wave rod of the first low wave is overlapped with the wave rod of the main body wave ring in a crossing manner.

In one embodiment, the connection wave ring comprises a first wave ring section which is closer to the large bending side of the tectorial membrane bracket in the circumferential direction, and a plurality of first high waves are arranged in the first wave ring section at intervals.

In one embodiment, a plurality of the first high waves are arranged at intervals along the circumferential direction of the connection wave ring.

In one embodiment, the peaks of the first low waves are flush with the oblique cut of the main body support portion at the distal end, and the plane of the connecting line of the peaks of the first high waves in the circumferential direction is parallel to the plane of the oblique cut.

In one embodiment, the peaks of the first low waves are flush with the oblique cut of the main body support portion at the distal end, and an included angle formed by a plane where the connecting lines of the peaks of the first high waves in the circumferential direction are located and a plane where the oblique cut is located is in a range of 0 ° to 45 °.

In one embodiment, the body band includes a second high wave and a second low wave, the second high wave having an axial dimension greater than an axial dimension of the second low wave, the second high wave being closer to a vessel macrobend side than the second low wave in a circumferential direction of the body band.

In one embodiment, the oblique incision is in the form of an arcuate incision that curves in the sagittal and/or coronal plane.

In one embodiment, a part of the peak of the connecting wave ring extending out of the distal opening of the main body supporting part is bent towards the axis direction of the connecting wave ring to form an inwardly folded hooking structure.

In one embodiment, the inclined angle of the plane where the inclined incision is located relative to the plane where the cross section of the stent graft along the circumferential direction is in the range of 5 ° to 25 °.

The beneficial effects of the utility model are as follows: compared with the prior art, the utility model provides a tectorial membrane bracket, which comprises a main body supporting part and a connecting wave ring; the distal end opening of the main body supporting part is in an oblique incision shape, so that the supporting position of the distal end of the main body supporting part on the large bending side and the supporting position of the main body supporting part on the small bending side deviate to a certain extent, the change of the inside of the main body supporting part during bending of the blood vessel is adapted, and the adherence of the covered stent on the distal end is enhanced; the main body supporting part comprises a main body bracket and a coating film which is coated on the main body bracket; at least part of the proximal wave rods connected with the wave ring extend into the covering film of the main body supporting part and are overlapped with the main body wave ring of the main body bracket at the most distal end in a crossing way, so that the supportability at the edge of the opening is enhanced; the distal end of the part connected with the wave ring extends out of the distal end opening of the main body supporting part, the extending part forms a hooking structure, and when the hooking structure is released, the hooking structure close to the large curved side of the blood vessel can be preferentially released to be abutted and anchored with the blood vessel wall, so that the stability of the tectorial membrane bracket is ensured during subsequent release.

Drawings

FIG. 1 is a schematic structural view of a stent graft of the present utility model;

FIG. 2 is a schematic view of the stent graft of FIG. 1 installed in the ascending aorta vessel;

FIG. 3 is a schematic view of the structure of a distal section of an stent graft according to the first embodiment of the present utility model;

FIG. 4 is a schematic view of a construction of another embodiment of a distal section of an stent graft according to the first embodiment of the present utility model;

FIG. 5 is an exploded view of a stent band and a main body band of a distal section of a stent graft according to an embodiment of the present utility model;

FIG. 6 is a side view of a connecting band structure according to a first embodiment of the present utility model;

FIG. 7 is a schematic diagram showing a first high wave connected to a band of waves in a first band of waves according to an embodiment of the present utility model;

FIG. 8 is a schematic diagram illustrating radian occupied by a first high wave connected to a band in a first band according to an embodiment of the present utility model;

FIG. 9 is a perspective view showing a structure of a connection wave ring according to the first embodiment of the present utility model;

fig. 10 is a schematic diagram of a first high-frequency wave of a connection wave ring arranged at intervals along a circumferential direction of the connection wave ring in the second embodiment of the utility model;

FIG. 11 is a schematic illustration of a first high-wave vertical alignment of a connection band in a second embodiment of the present utility model;

FIG. 12 is a schematic view illustrating a first high-wave tilt alignment of a connection band in a second embodiment of the present utility model;

FIG. 13 is a structural side view of a body wave ring of the present utility model;

fig. 14 is a schematic structural view of a second high wave duty ratio of a main body wave band gradually decreasing toward a distal end along an axial direction in a third embodiment of the present utility model;

FIG. 15 is a simplified view of a diagonal slit in a fourth embodiment of the utility model being an arcuate slit;

FIG. 16 is a schematic view showing the structure of a fifth embodiment of the present utility model wherein the oblique incision is curved in the sagittal and coronal planes;

FIG. 17 is a schematic diagram of a second high-wave duty cycle of a body wave band in a third embodiment of the present utility model;

FIG. 18 is a side view of a distal rivet connection of the connecting band of the present utility model;

FIG. 19 is a simplified view of a connection collar of the present utility model riveted on the distal end;

FIG. 20 is a schematic view of the suture points connecting the band and the cover film according to the present utility model;

FIG. 21 is a schematic view of the present utility model after the connecting band is cross-laminated with the proximal body band.

Detailed Description

For a better understanding of the inventive concept, embodiments of the present utility model will be described in detail below with reference to the drawings, the following specific examples are only some of the examples of the present utility model and are not limiting of the present utility model.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

For purposes of more clarity in describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical arts. For ease of description, the following description uses the terms "proximal" and "distal," where "proximal" refers to the end proximal to the operator and "distal" refers to the end distal to the operator, the phrase "axial direction" in the present utility model refers to the direction in which the device is pushed in and out, and the phrase "circumferential direction" in the present utility model refers to the direction about the axial direction.

In the utility model, a wave ring (also called a wave ring) is a closed ring structure, and a wave unit is an arc structure. The wave ring and the wave unit are made of metal elastic material or polymer material through weaving or cutting. The metallic elastic material includes known materials or combinations of various biocompatible materials implanted in medical devices, such as alloys of two or more single metals of cobalt, chromium, nickel, titanium, magnesium, iron, and 316L stainless steel, nitinol, tantalum alloys, etc., or other biocompatible metallic elastic materials. The polymer material includes biocompatible material such as polylactic acid. The wave ring and the wave unit have radial expansion capability, can realize radial contraction under the action of external force, and can recover to an original shape and maintain the original shape by self-expansion or mechanical expansion (for example, expansion by a balloon) after the external force is removed, thereby being capable of being tightly attached to the inner wall of the lumen through the radial supporting force after being implanted into the lumen. The waveforms of the waves in the "wave ring" and the "wave unit" are not limited, and include Z-shaped waves, M-shaped waves, V-shaped waves, sine waves and the like. The "wave ring" and "wave unit" each include a plurality of wave crests (also known as distal peaks), a plurality of wave troughs (also known as proximal peaks), and wave rods connecting adjacent wave crests and wave troughs. Wherein one vertex (distal vertex or distal vertex) and two wavebars connected to the vertex form one wave.

The 'coating film' in the utility model can isolate liquid to a certain extent, and can be made of high polymer materials with good biocompatibility, such as polytetrafluoroethylene (Poly tetra fluoroethylene, PTFE for short), polyethylene terephthalate (Polyethylene terephthalate, PET for short) and the like.

Referring to fig. 1 and 2, the stent graft 1 provided by the present utility model is a hollow tubular structure with openings at two ends, and the stent graft 1 includes a distal section 11, a proximal section 12 and an intermediate section 14 between the distal section 11 and the proximal section 12 along the axial direction; the distal end section 11 includes a tubular main body support portion 111 and a connection collar 112, the main body support portion 111 includes a main body stent 16 and a coating 1112, and the coating 1112 may be applied to the inside and/or outside of the main body stent 16 by sewing, bonding, heat-fusing, or the like. Referring to fig. 3, the main body support 16 includes a plurality of main body wave rings 1111 axially arranged, and it is understood that the plurality of main body wave rings 1111 may be disposed at intervals or may be connected by a connecting rod and then disposed at intervals; the proximal section 12 includes a tubular proximal support and a proximal body cover that may also be sewn, adhered, heat fused, etc. to the inside and/or outside of the proximal support. The proximal support portion includes a plurality of axially spaced apart body collars. The intermediate section 14 includes an intermediate unit that includes an intermediate body cover and an intermediate support (omitted in other embodiments). The inner cavity formed by the enclosing of the middle main body coating is communicated with the inner cavity formed by the enclosing of the far-end coating 1112 and the inner cavity formed by the enclosing of the near-end main body coating; wherein the surface of the intermediate unit is provided with a window 13.

Example 1

Referring to fig. 1 and 2, when the stent graft 1 enters the ascending aorta vessel 2, the bending radian of the small curved side 22 is often larger than that of the large curved side 21, and when the stent is manufactured by adopting the main body wave ring with the existing symmetrical structure, referring to fig. 2, the position of the small curved side 22 corresponding to the position of the vessel 2 of the large curved side 21 is already offset, but the stent itself is not offset suitable for the position, so that the problem of poor adhesion at the opening of the small curved side 22 occurs when the large curved side 21 is adhered to the wall, thereby causing internal leakage; the covered stent 1 is provided with an oblique incision 15 at the distal section 11; the distal body stent 16 comprises a plurality of body wave rings 1111, the body wave rings 1111 have a plurality of wave structures distributed along the circumferential direction, and the wave crest connecting lines of the plurality of wave structures of the distal body wave rings 1111 at the side close to the edge of the distal opening form oblique cuts 15, and the distal cover 1112 covers the body wave rings 1111 to form oblique cuts 15 as well;

in the present embodiment, referring to fig. 2, 4 and 5, the notch of the distal coating 1112 on the side near the edge of the opening is flush with the notch of the main body band 1111; it will be appreciated that a flush arrangement does not mean that the peaks of the body band 1111 are perfectly aligned with the edges of the cover 1112, where a gap distance should be left for the stitching or bonding of the peaks of the body band 1111, preferably a gap distance of at least 1mm to 2mm in a flush position, and a distance between the body band 1111 and the cut-out of the cover 1112 within 2mm can be considered as aligned; when the stent main body enters the blood vessel 2, the position close to the large curved side of the blood vessel 2 is a large curved side 21 of the covered stent 1, and the opposite side is a small curved side 22; the oblique incision 15 is specifically an oblique structure in which the bracket main body protrudes obliquely towards the distal direction near the large curved side 21 and is folded obliquely towards the proximal direction near the small curved side 22; the plane of the inclined notch 15 forms an inclined angle theta with respect to the plane of the cross section of the film-covered bracket along the circumferential direction, and the angle theta is 5-25 degrees; the angle formed in one embodiment is 10 °;

referring to fig. 3, the oblique incision 15 is specifically shown as an oblique structure in which the major curved side 21 main body band 1111 protrudes obliquely in the distal direction and the minor curved side 22 main body band 1111 is folded obliquely in the proximal direction; the supporting positions of the main body wave rings 1111 on the large bending side 21 and the small bending side 22 can be offset to a certain extent, so that the change in the blood vessel 2 is adapted, and the adherence of the whole stent main body is enhanced; it will be appreciated that the body stent 16 further comprises a plurality of body bands 1111 at the distal open rear end, the body stent 16 is formed by axially arranging the body bands 1111, the body bands 1111 may have the same structure or different structures, so that the stent graft itself has a better effect of adapting to the intravascular environment, and in one embodiment, other body bands 1111 at the rear end of the body band 1111 at the distal open position of the body stent 16 have the same oblique cut as the body band 1111 to form a parallel oblique structure, so that both the large curved side 21 and the small curved side 22 of the overall stent graft 1 in the curved position can conform better to the curved structure and shape of the ascending aortic vessel 2, so that the stent graft 1 has a better adhesion.

Preferably, referring to fig. 5 and 6, a wave structure connecting the wave ring 112 and the body wave ring 1111 having a larger axial dimension is defined as a high wave, and a wave structure having a smaller axial dimension is defined as a low wave; specifically, the high wave of the connection wave ring 112 is defined as a first high wave 1121, and the low wave is defined as a first low wave 1122; defining the high wave of the body band 1111 as a second high wave 11111, and the low wave as a second low wave 11112; when the axial dimension of the second high wave 11111 of the body band 1111 is equal to the axial dimension of the second low wave 11112, the projection of the body band 1111 in the sagittal plane is specifically expressed as: a parallelogram is formed by a connection line between the peak of the top of the second high wave 11111 and the peak of the second low wave 11112 and a connection line between the trough of the second high wave 11111 and the trough of the second low wave 11112; the parallelogram shape can better form the structure of the deflection of the upper high wave and the lower high wave supporting position, adapt to the change in the blood vessel 2 and strengthen the adherence of the whole stent main body.

When the axial dimension of the second high wave 11111 of the body band 1111 is greater than the axial dimension of the second low wave 11112, the projection of the body band 1111 in the sagittal plane is specifically expressed as: a connection line between the peak of the top of the second high wave 11111 and the peak of the second low wave 11112, and a connection line between the trough of the second high wave 11111 and the trough of the second low wave 11112 form a trapezoid-like shape with the length of the upper bottom edge being longer than that of the lower bottom edge; the trapezoid-like shape can also form a structure that the supporting position of the upper second high wave 11111 relative to the lower second low wave 11112 of the main body wave ring 1111 is relatively shifted, adapt to the change in the blood vessel 2, and enhance the adherence of the whole stent main body.

In the present embodiment, referring to fig. 5-9, a plurality of wave structures in the same body wave ring 1111 have a plurality of axial dimensions; in the circumferential direction, the axial dimension a of the second high waves 11111 of the plurality of main body wave rings 1111 is greater than or equal to the axial dimension B of the second low waves 11112, and the axial dimension is specifically the vertical distance from the top of the crest to the bottom of the trough of the single wave structure of the main body wave ring 1111; wherein the second high wave 11111 in the same body band 1111 is disposed above the second low wave 11112 in the circumferential direction, that is, on the side closer to the macrocurvature side of the blood vessel in the circumferential direction; because the length of the bending part of the large bending side of the blood vessel is larger than that of the bending part of the small bending side, the length of the covered stent covering the blood vessel on the small bending side is smaller than that of the large bending side in the actual relative blood vessel position, and the adoption of the existing covered stent can lead the covered stent to generate a protruding section with one end tilted and protruding out of the blood vessel on the small bending side; the axial dimension of the second low wave 11112 is smaller than the axial dimension of the second high wave 11111, the second high wave 11111 in the same body wave ring 1111 is arranged above the second low wave 11112 in the circumferential direction, the position of the second high wave 11111 can be ensured to be closer to the large curved side of the blood vessel, the position of the second low wave 11112 is closer to the small curved side of the blood vessel, the number of the body wave rings 1111 is not required to be reduced, and the laminating degree of the film covered stent is improved while the whole radial supporting force is not reduced.

In this embodiment, referring to fig. 3, the connection collar 112 is disposed at the distal end opening of the main body supporting portion 111, the connection collar 112 is also in a collar structure, the connection collar 112 is disposed at the edge of the opening and is overlapped with the main body collar 1111 at the position, the peak of at least the first low wave 1122 of the connection collar 112 is flush with the main body coating 1112 to form an oblique notch 15, the connection collar 112 is provided with a first high wave 1121 and a first low wave 1122, the peak edge of the first low wave 1122 is flush with the peak edge of the main body collar 1111, the axial dimension of the first high wave 1121 is greater than the axial dimension of the first low wave 1122, and the axial dimension of the first high wave 1121 of the connection collar 112 is greater than the axial dimension of the second high wave 11111 of the main body collar 1111 at the same position, so that the peak of the first high wave 1121 of the connection collar 112 protrudes from the oblique notch edge of the distal end coating 1112 and is exposed to form a hooking structure 1123 for detachably connecting with the distal end 3 device of the conveyor, where the hooking connection is detachably riveted.

Referring to fig. 4, in another embodiment, the peak of the first high wave 1121 connected to the wave ring 112 is not exposed at but flush with the bevel edge of the distal coating 1112, and the peak of the first low wave 1122 is retracted and not flush with the bevel edge of the distal coating 1112; the connecting bead 112 thus arranged, the sewing point for fixedly connecting the coating 1112 and the connecting bead 112 is not arranged at the peak of the first high wave 1121 of the connecting bead 112, so that the peak position can be used as the hooking position of the distal rivet 3.

In a preferred embodiment, referring to fig. 6-9, a portion of the first high wave 1121 peak of the connection wave ring 112 extending out of the coating 1112 is bent radially toward the axial direction of the coating bracket 1 to form a concave bent hooking structure 1123; the first high wave 1121 thus provided can reduce the abrasion or the stimulation of the stent to the blood vessel 2, in particular, the stimulation to the blood vessel 2 wall of the greater curvature side 21 of the ascending aorta blood vessel 2.

Preferably, the hooking structure 1123 is bent at an angle of about 30 to 60, and in one embodiment, is bent at an angle of 45.

In one embodiment, referring to fig. 3, the position of the connection wave ring 112 overlaps the position of the main wave ring 1111 at the edge of the opening, and the peaks and valleys of at least part of the wave structure of the connection wave ring 112 are staggered with the peaks and valleys of the main wave ring 1111 at the position, that is, the part of the wave rods of the connection wave ring 112 are overlapped with the wave rods of the main wave ring in a staggered manner; this is because, in the case where only a single body wave band 1111 or a connection wave band 112 is provided or the positions of the peaks and valleys of the body wave band 1111 are completely overlapped, since there is a gap between the peaks and the adjacent peaks, the film at the gap position may be tilted under the impact of blood flow, thereby causing an internal leakage, i.e., a "bird's beak" phenomenon; the wave crest of the connecting wave ring 112 is arranged opposite to the wave trough of the main wave ring 114, and the wave crest of the connecting wave ring 112 fills the gap position of the main wave ring 1111, so that the covering film at the position can play a supporting role, when the covering film bracket 1 is unfolded, the adherence of the covering film at the gap position is ensured, the bird's beak phenomenon is avoided, and the adherence of the bracket at the far end position is improved.

In a preferred embodiment, the wavebars of the first low wave 1122 connected to the wave ring 112 are all disposed to overlap the wavebars of the body wave ring 1111 at the most distal end of the body mount 16, and the wavebars of the first high wave 1121 connected to the wave ring 112 are disposed to overlap the peaks of the body wave ring 1111 at the same position.

In a preferred embodiment, referring to fig. 7 and 8, the first high wave 1121 is disposed in a first band of the connection band 112 closer to the macrobending side of the blood vessel in the circumferential direction, and the first high waves 1121 are disposed at intervals in the first band; preferably, referring to fig. 9, the arc length of the first high wave 1121 of the connection wave ring 112 in the first wave ring segment in the circumferential direction occupies at least 1/3-1/2 of the circumference of the connection wave ring 112, that is, the included angle α formed by two first high waves 1121 of the first high wave 1121 of the connection wave ring 112 closest to the first low wave 1122 in the circumferential direction is 120 ° to 180 °; further preferably, at least 3 first high waves 1121 are provided, and an included angle α formed by two first high waves 1121 on both sides is 120 °.

Referring to fig. 18-19, in other embodiments, the number of fingers of the distal rivet 3 of the conveyor is at least 3 fingers, and the three fingers form a three-jaw structure with a corresponding angle α; preferably, the length of the hook claw closest to the major curved side 21 of the blood vessel 2, namely the top hook claw 31, of the 3 hook claws of the distal riveting 3 is smaller than that of the hook claws 32 on two sides, and when the stent is released, the connecting wave ring 112 near the major curved side 21 is released first, contacts the inner wall of the blood vessel 2 preferentially and is anchored in an abutting manner, so that the stability of the position of the stent in the subsequent release is ensured.

In a preferred embodiment, referring to fig. 20 and 21, the connection mode of the main body band 1111 and the cover film 1112 is performed by stitching; the main body wave ring 1111 of the asymmetric oblique incision 15 provided in the present application has a waveform structure in the same wave ring, the deformation degree of the second high wave 11111 is different from that of the second low wave 11112, so that when the film 1112 on the surface of the main body wave ring 1111 is assembled by the film coated bracket 1, the deformation degree of the film 1112 corresponding to the different waveform structures is different due to the different deformation degrees of the wave ring, so that corresponding wrinkles are generated on the film 1112, and for this reason, the stitching site 4 is specifically arranged at the crest and trough positions of the main body wave ring 1111 and the middle position of the wave rod for connecting the crest and the trough; through the optimized suture sites, when the covered stent 1 is assembled in a compression mode, relative displacement to a certain degree can be generated between the main body wave ring 1111 and the covered film 1112, acting force generated between the main body wave ring 1111 and the covered film 1112 due to different deformation degrees can be reduced, and therefore wrinkles of the covered film 1112 are reduced or even avoided, and the covered stent 1 can be restored to a normal state to the greatest extent after being released.

Further preferably, referring to fig. 21, the suture structure connecting the intersection point of the band 112 and the body band 1111 at the edge of the opening of the distal end section 11 adopts a cross suture structure 41.

Example two

In this embodiment, referring to fig. 10, the structure of the stent graft 1 is substantially the same as that of the stent graft 1 in the first embodiment, except that the first high waves 1121 of the connecting band 112 are not only disposed in the first band, but the first high waves 1121 of the connecting band 112 are disposed at intervals along the circumferential direction of the connecting band 112; the first high waves 1121 are preferably arranged at the same distance from each other, and compared with the arrangement mode of only being arranged in the upper half circle, the first high waves 1121 used for hooking are uniformly distributed when the film-covered stent 1 is released, so that the distribution of unhooked parts formed during hooking is uniform, the impact on blood is also uniform, and the problem that the release stability is not affected by uneven stress is avoided.

In one embodiment, the connection wave ring 112 includes at least three first high waves 1121, one first high wave 1121 of the connection wave ring 112 is disposed at the lowest point in the circumferential direction of the connection wave ring 112, and the remaining two first high waves 1121 have the same interval with the first high wave 1121 at the lowest point, that is, the angle rotated at intervals in the circumferential direction of the connection wave ring 112 is 120 °, so as to form three hooking structures 1123 at equally divided positions.

Preferably, as shown in fig. 12, in the present embodiment, the peak of the first low wave 1122 of the connection band 112 is flush with the opening edge of the main body cover at the distal end section, and the plane on which the line of the peak of the first high wave 1121 in the circumferential direction is located is parallel to the plane on which the oblique cut 15 is located; it will be appreciated that the same diagonal cuts can be made parallel to the plane in which the diagonal cuts 15 lie, thereby forming a positional offset structure between the major curved side 21 and the minor curved side 22 as with the main body band 1111 at that location, more adapting the morphology of the vessel at these two locations, and thus better conforming to the curved structure and shape of the ascending aortic vessel 2, resulting in a better apposition of the stent.

Preferably, as shown in fig. 11, the peak of the first low wave 1122 connected to the wave ring 112 is flush with the opening edge of the distal end section of the main body cover film, and the angle formed by the plane on which the peak of the first high wave 1121 is connected in the circumferential direction and the plane on which the oblique cut 15 is located is 0 ° to 45 °, it is understood that the plane on which the peak of the first high wave 1121 is connected in the circumferential direction is parallel to the cross section of the cover film bracket along the circumferential direction, that is, forms an angle of 10 ° with the plane on which the oblique cut 15 is located; therefore, the first high waves 1121 are flush in the vertical plane, and when the distal rivet 3 releases the bracket, the first high waves 1121 can be released simultaneously, and the unstable release caused by the blood flow impact of the released end due to different release time is avoided.

In a third embodiment of the present utility model,

in this embodiment, referring to fig. 13 and 14, the ratio of the arc length of the second high wave 11111 of each of the plurality of body wave bands 1111 to the circumference of the complete wave band is C; the proportion C gradually decreases in the axial direction of the distal section 11 of the stent graft 1 in the distal-to-proximal direction; the aim of this arrangement is to provide better compliance for the stent graft 1 in order to better accommodate the ascending main vessel 2; the proportion of the second high waves 11111 of each main body wave ring 1111 axially arranged is in a stepped distribution, in the axial direction, a larger gap is generated between the second high waves 11111 of the main body wave ring 1111 which is closer to the proximal direction and the second low waves 11112 of the previous main body wave ring 1111, and as the gap is covered by the coating 1112 only, the flexibility is better, so that a larger deformation amount can be provided, and better bending performance is provided, and a flexible position is formed; the second high wave 11111 with the step-shaped change duty ratio can form a flexible section with arc-shaped distribution in the axial direction, so that when the distal end position with larger bending degree of the blood vessel 2 is located, the flexible section with arc-shaped distribution can provide better bending performance for the distal end of the covered stent 1, thereby further providing better adherence.

In a preferred embodiment, a plurality of body wave bands 1111 in the axial direction are spaced apart by the same distance between the second high waves 11111 of the adjacent body wave bands 1111, and the spaced apart distance between the second low waves 11112 is equal;

in one embodiment that has been implemented, referring to FIG. 17, the body band 1111-01 at the open edge of the distal segment 11 has an arc length of the second high wave 11111 that is 1/2 of the circumference of its full band; the other main wave rings 1111-02, 03, 04, 05 are sequentially arranged at the rear part in the proximal direction, and the ratio of the arc length of each second high wave 11111 to the perimeter of the complete wave ring is sequentially as follows: 2/5,3/10,1/4 and 1/5; the second high wave 11111 arc length ratio provided above is only one embodiment of the present application set for a structure of a certain ascending aortic blood vessel 2, which is beneficial to achieve a better adherence effect, and the claimed solution is not limited thereto.

Example IV

In this embodiment, referring to fig. 15, the structure of the stent graft 1 is substantially the same as that of the stent graft 1 in the first embodiment, except that the oblique slit 15 formed by the connection line of the peaks of the main body wave band 1111 at the opening edge of the distal end section 11 is specifically in the shape of an arc slit on the sagittal plane, and the connection lines of the peaks of the main body wave band 1111 are all arranged parallel to each other in the circumferential direction; this is arranged to accommodate the characteristic of the ascending aortic vessel 2 being curved in the human body primarily in the sagittal plane;

preferably, the spacing distances between the second high waves 11111 between the plurality of body wave rings 1111 in the axial direction are equal, the spacing distances between the second low waves 11112 are unequal, the spacing distance between the second low waves 11112 can be selected according to the actual bending condition of the blood vessel 2, the spacing distance between the second low waves 11112 between the body wave rings 1111 is slightly larger than the spacing distances between the body wave rings 1111 at other positions at the position of greater bending degree, and the spacing distance between the second low waves 11112 between the body wave rings 1111 is slightly smaller than the spacing distances between the other body wave rings 1111 at the position of lesser bending degree; the arrangement can ensure that the supporting force of the main body wave ring 1111 is reduced at a position with larger bending degree, and the separated gap position is covered only by the coating film 1112, so that the support has better flexibility, and better bending performance can be realized at the position, and the adherence of the support main body is ensured;

it is further preferable that the spacing distance between the second low waves 11112 of the plurality of body bands 1111 is made gradually smaller from the intermediate position toward both ends in the axial direction, that is, the spacing of the second low waves 11112 between the body bands 1111 at the intermediate position is made large, and the spacing of the second low waves 11112 between the body bands 1111 at both sides is made small, so as to accommodate the situation where the body bands 1111 at the intermediate position are opposed in the ascending aorta vessel 2 in general, that is, the portion where the degree of bending of the ascending aorta vessel 2 is the largest; thus, the main body wave rings 1111 have good flexibility at large intervals, better bending performance and better adaptability to larger bending angles.

Example five

In this embodiment, referring to fig. 16, the structure of the stent graft 1 is substantially the same as that of the stent graft 1 in the third embodiment, except that the oblique incision 15 is in a curved oblique posture at least in two different planes, and the oblique incision 15 formed by connecting the peaks of the main body wave ring 1111 and other main body wave rings 1111 at the opening edge of the distal end section 11 is curved obliquely in any plane which is not parallel to and coincident with the sagittal plane, so as to form a spatially curved incision shape; the plane is determined by the specific curved structure of the ascending aortic vessel 2 in the human body which is actually acquired; since the specific bending mode and structure of the blood vessel 2 in the human body are complex and changeable, the bending direction is usually not only bent in a single plane, so that the bending direction and bending plane of the main body wave ring 1111 are determined after the bending form of the blood vessel 2 is determined according to the actual situation of the blood vessel 2, the adherence of the stent graft 1 can be ensured, and the stent graft 1 more suitable for the form of the blood vessel 2 is obtained.

In a preferred embodiment, the oblique incision 15 formed by the crest line of the body band 1111 of the distal end section 11 has an arc-shaped bending structure not only on the sagittal plane, but also on the coronal plane perpendicular to the sagittal plane, and simultaneously achieves bending and tilting on the sagittal plane and the coronal plane, so that the stent graft 1 formed by the body band 1111 achieving bending and tilting on the sagittal plane and the coronal plane simultaneously conforms to the shape of the blood vessel 2 when the ascending aortic blood vessel 2 bends or even twists in the human body, thereby ensuring the adherence of the stent graft 1 to the distal blood vessel 2.

It is further preferred that the body band 1111 at the opening edge of the distal section 11 and the rear body band 1111 at the rear thereof are spaced apart by the same distance between each two body bands 1111.

In one embodiment that has been implemented, the oblique cuts 15 have a bend angle of inclination of 10 ° in the sagittal and coronal planes, respectively, and the second high waves 11111 and the second low waves 11112 of the body band 1111 are equal in axial dimension.

Example six

In this embodiment, referring to fig. 3 and 4, the structure of the stent graft 1 is substantially the same as that of the stent graft 1 in the first to fifth embodiments, except that two main body wave rings 1111 of the distal end section 11 near the middle section 14 have the same structure, and the wave crests of the two main body wave rings 1111 extend in opposite directions, and the wave troughs are near and opposite to each other; further, the two main body wave rings 1111 are respectively provided with at least two peaks of the second high waves 11111 at the top in the circumferential direction, two supporting rings with diamond structures are formed between the peaks of the four second high waves 11111, and the two supporting rings are just covered on two branch brackets of which the distal end sections are arranged side by side to form a supporting structure, so that the supportability of the branch brackets is improved, and the radial shrinkage of the branch brackets is prevented.

Preferably, the wire diameter of the body band 1111 at the edge of the opening is smaller than the wire diameter of the connection band 112; and is smaller than the wire diameter of the rear end body band 1111 behind the distal end section 11, having the smallest wire diameter; the wire diameter of the connecting wave ring 112 is larger than the wire diameters of all the main wave rings 1111 of the distal end section 11, so that the aim of the arrangement is that the main wave ring 1111 at the edge of the opening has the minimum wire diameter, so that the main wave ring 1111 can be ensured to have better flexibility, and the adherence of the covered stent at the position in the blood vessel is ensured; further, in order to ensure the adherence and the supporting force, the connecting wave ring 112 has a larger wire diameter, so as to provide a better supporting force for the edge of the opening, and avoid side leakage.

The utility model has the advantages that:

1. the main body wave ring is arranged in parallel and forms oblique cuts, so that the supporting position of the main body wave ring on the large bending side and the supporting position of the small bending side are offset to a certain extent, the internal change during bending of the blood vessel is adapted, and the adherence of the whole stent is enhanced.

2. The connecting wave ring is further arranged at the opening edge of the distal end section, and the connecting wave ring can fill a supporting gap generated by the wavy structure of the main body wave ring at the opening edge, so that the adherence of the support after the opening of the distal end section is released is improved.

3. The wave crest is bent towards the axial direction to form an inwards folded hooking structure, so that the abrasion or the stimulation effect of the bracket on the blood vessel can be reduced, and particularly the stimulation effect on the large curved side of the ascending aorta blood vessel can be reduced.

4. The distal end of the part connected with the wave ring extends out of the distal end opening of the main body supporting part, the extending part forms a hooking structure, and when the hooking structure is released, the hooking structure close to the large curved side of the blood vessel can be preferentially released to be abutted and anchored with the blood vessel wall, so that the stability of the tectorial membrane bracket is ensured during subsequent release.

The above disclosure is only a few specific embodiments of the present utility model, but the present utility model is not limited thereto, and any changes that can be thought by those skilled in the art should fall within the protection scope of the present utility model.

Claims (10)

1. The tectorial membrane support is characterized by comprising a main body supporting part and a connecting wave ring; the far-end opening of the main body supporting part is in an inclined notch shape, and the main body supporting part comprises a main body bracket with a far-end main body wave ring and a coating film which is coated on the main body bracket; the proximal ends of at least part of the wave rods of the connecting wave ring extend into the covering film of the main body supporting part, the at least part of the wave rods of the connecting wave ring extend into the covering film and are overlapped with the part of the wave rods of the far-end main body wave ring of the main body supporting part in a one-to-one crossing manner, and at least part of wave peaks of the connecting wave ring extend out of a far-end opening of the main body supporting part and are used for being detachably connected with a conveyer.

2. The stent graft of claim 1, wherein said connecting band comprises a first high wave and a first low wave, said first high wave having an axial dimension greater than an axial dimension of said first low wave, a peak of said first high wave extending beyond an open edge of said stent, a wave rod of said first low wave being cross-plied with a wave rod of said body band.

3. The stent graft of claim 2, wherein said connecting band comprises a first band segment circumferentially closer to the greater curvature of said stent graft, and wherein a plurality of said first high waves are disposed within and spaced apart from said first band segment.

4. The stent graft of claim 2, wherein a plurality of said first high waves are spaced apart along the circumferential direction of said connecting band.

5. The stent graft of claim 3 or 4, wherein the peaks of said first low waves are flush with the diagonal cuts of said main body support at the distal end, and the plane in which the lines of the peaks of said first high waves in the circumferential direction lie is parallel to the plane in which said diagonal cuts lie.

6. The stent graft of claim 3 or 4, wherein the peaks of said first low waves are flush with the oblique cut of said main body support portion at the distal end, and the angle formed by the plane in which the lines of the peaks of said first high waves in the circumferential direction lie and the plane in which said oblique cut lies is in the range of 0 ° to 45 °.

7. The stent graft of claim 1, wherein said body band comprises a second high wave and a second low wave, said second high wave having an axial dimension greater than an axial dimension of said second low wave, said second high wave being closer to a vessel macrobend side than said second low wave in a circumferential direction of said body band.

8. The stent graft according to any one of claims 1-7, wherein said oblique incision is in the form of an arcuate incision curved in the sagittal and/or coronal plane.

9. The stent graft of any one of claims 1-7, wherein the peak of the portion of said connecting band extending beyond the distal opening of said main body support is folded toward the axis of said connecting band to form an inwardly tapered hook.

10. The stent graft of claim 1, wherein the oblique cut has a plane that is inclined at an angle in the range of 5 ° to 25 ° relative to the plane of the stent graft in the circumferential cross section.

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