CN111228000B

CN111228000B - Lumen stent

Info

Publication number: CN111228000B
Application number: CN201811347399.5A
Authority: CN
Inventors: 肖本好; 王逸斐
Original assignee: Shenzhen Xianjian Changtong Medical Co ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2018-11-13
Filing date: 2018-11-13
Publication date: 2022-12-16
Anticipated expiration: 2038-11-13
Also published as: CN111228000A

Abstract

The invention relates to a lumen bracket, which comprises a pipe body and a sealing structure sleeved on the pipe body, wherein the sealing structure comprises a sealing film and a plurality of first supporting rods, the pipe body comprises at least one wave-shaped ring, the plurality of first supporting rods are arranged at intervals along the circumferential direction of the pipe body, one end of each first supporting rod is connected with the wave-shaped ring in an integrated manner, the other end of each first supporting rod extends freely to enable the plurality of first supporting rods to be arranged in a radial manner, the sealing film is coated on the plurality of first supporting rods, and one end of the sealing film, which is far away from the free ends of the first supporting rods, is connected with the outer surface of the pipe body in a sealing manner. The lumen stent can better avoid intra-operative leakage.

Description

Lumen stent

Technical Field

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

Background

At present, the isolation of diseased regions in the body lumen by intraluminal isolation using luminal stents has become an increasingly important treatment modality. For example, luminal stents may be employed to isolate arterial dissections or aneurysms in blood vessels.

In the field of aortic intracavity treatment, when the anchoring area of the aortic stent graft is insufficient due to the fact that a dissection is too close to a branch blood vessel, the aims of isolating a diseased part and opening the branch blood vessel are achieved at the same time by generally adopting a chimney technology or an in-situ windowing technology. The chimney technique is to pass the stent graft 20 over and cover the opening of the branch vessel 1, and simultaneously axially and parallelly release a branch stent 10 in the aortic lumen 2, wherein the distal end of the branch stent 10 enters the branch vessel 1, and the proximal end is located on the surface of the stent graft 20 to ensure the blood supply of the branch vessel 1, as shown in fig. 1 a.

The chimney technique is limited by the fit relationship between the stent graft 20 and the branch stent 10, and the inter-stent gap 30 is often inevitably generated, as shown in fig. 1b, which may cause intra-operative leakage, and thus cause the operation to fail to achieve the desired effect.

Disclosure of Invention

Based on this, there is a need for a luminal stent which can better avoid intraoperative endoleaks.

The utility model provides a lumen support, locates including body and cover seal structure on the body, seal structure includes seal membrane and a plurality of first bracing piece, the body includes at least one wave form circle, a plurality of first bracing piece are followed the circumference interval of body is arranged, every the one end of first bracing piece with wave form circle formula as an organic whole is connected, and the other end freely extends and makes a plurality of first bracing pieces are radial arrangement, the seal membrane cladding in on a plurality of first bracing pieces, keeping away from of seal membrane the one end of the free end of first bracing piece with the surface sealing connection of body.

In one embodiment, the sealing structure further includes a plurality of second support rods, the plurality of second support rods correspond to the plurality of first support rods one to one, one end of each of the second support rods is connected to one end of the corresponding first support rod, which is far away from the pipe body, and the other end of each of the second support rods extends axially along the longitudinal central axis of the pipe body.

In one embodiment, the second support bar is parallel to the longitudinal central axis of the tube body.

In one embodiment, a plurality of branches are formed at one end of each second supporting rod far away from the corresponding first supporting rod.

In one embodiment, the sealing structure further includes a plurality of second support rods, the plurality of second support rods correspond to the plurality of first support rods one to one, one end of each of the second support rods is connected to one end of the corresponding first support rod, which is far away from the pipe body, and a distance from one end of each of the second support rods, which is far away from the corresponding first support rod, to the longitudinal central axis of the pipe body is greater than a distance from one end of each of the second support rods, which is connected to the corresponding first support rod, to the longitudinal central axis of the pipe body.

In one embodiment, the included angle between each second supporting rod and the corresponding first supporting rod is 20-90 degrees.

In one embodiment, each of the first support rods has a length of 2 to 25 mm.

In one embodiment, the number of the first supporting rods is 3 to 20.

In one embodiment, the included angle between each first support rod and the longitudinal central axis of the pipe body is 10-90 degrees.

In one embodiment, the width of the first supporting rod is 0.1-0.4 mm.

In one embodiment, the plurality of first support rods are arranged at equal intervals along the circumferential direction of the pipe body;

or, the plurality of first support rods are arranged at unequal intervals along the circumferential direction of the pipe body, and form a concentrated distribution area and a non-concentrated distribution area.

In one embodiment, each of the first support rods is coplanar with a longitudinal central axis of the pipe body; alternatively, the first and second liquid crystal display panels may be,

each first support rod is not coplanar with the longitudinal central axis of the pipe body; alternatively, the first and second electrodes may be,

in the plurality of first support rods, a part of the first support rods are coplanar with the longitudinal central axis of the pipe body, and the other part of the first support rods are not coplanar with the longitudinal central axis of the pipe body.

Above-mentioned lumen support's seal structure includes a plurality of first bracing pieces that are radial arrangement, and the one end and the wave form circle formula as an organic whole of every first bracing piece are connected, when releasing this lumen support to the appointed position in the blood vessel, seal structure and body are coaxial strictly, seal structure self-expanding expandes and laminates the tectorial membrane support in the aorta intracavity, can avoid leading to the shutoff effect not good because of seal structure's off-centre when the release form is relatively poor, thereby can block off the clearance between lumen support and the tectorial membrane support betterly, therefore can avoid interior hourglass in the art betterly.

Drawings

FIG. 1a is a schematic view of a state that a prior art covered stent and a branch stent are implanted into a specified part of a blood vessel;

FIG. 1b is a schematic view of a stent graft and a branch stent of the prior art implanted at another angle at a designated site of a blood vessel;

FIG. 2 is a schematic view of a configuration of an embodiment of a luminal stent;

FIG. 3 is a schematic view of the connection of the first support rod and the tube of the luminal stent shown in FIG. 2;

FIG. 4 is a schematic view showing a state where the lumen stent shown in FIG. 2 is inserted into a designated portion of a blood vessel and then a gap between the lumen stent and the stent-graft is sealed;

FIG. 5 is a schematic view of a configuration of an embodiment of a luminal stent;

FIG. 6 is a schematic view showing the construction of another embodiment of a luminal stent;

FIG. 7 is a schematic view showing the connection of the first support bar, the second support bar and the wave ring of the luminal stent shown in FIG. 6;

FIGS. 8 a-8 b are schematic views showing the gaps between the luminal stent occlusion and the covered stent shown in FIGS. 2 and 6;

FIG. 9 is a schematic view of the connection of the first support rod and the second support rod of the sealing structure of the luminal stent shown in FIG. 6 with the tube body;

FIG. 10 is a schematic view showing the connection of the first and second support rods of the sealing structure of the luminal stent to the tubular body according to another embodiment;

FIG. 11 is a schematic view of the overall construction of the luminal stent shown in FIG. 10;

FIG. 12 is a schematic view of the stent of FIG. 11 after implantation at a desired site in a blood vessel;

FIGS. 13a and 13b are schematic views of the lumen stent and the stent graft under force in situ fenestration;

FIG. 14 is a structural schematic view of a sealing structure of a luminal stent of yet another embodiment;

FIG. 15 is a schematic view of the sealing structure of FIG. 14 sealing a gap between the luminal stent and the stent graft.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention more comprehensible, embodiments accompanying figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, the "proximal end" of a luminal stent is defined as the end closer to the heart and the "distal end" of a luminal stent is defined as the end further away from the heart. "axial" refers to a direction parallel to the line connecting the proximal center and the distal center of the luminal stent, and "radial" refers to a direction perpendicular to the above-mentioned axial direction.

Referring to fig. 2, an embodiment of a luminal stent 100 includes a tube 110 and a sealing structure 120 sleeved on the tube 110.

Referring to fig. 3, the tube body 110 includes a coating film 112 and a plurality of corrugated rings 114, the plurality of corrugated rings 114 are arranged along an axial direction, and the coating film 112 is coated on the plurality of corrugated rings 114 to form a tube cavity structure.

The material of the covering film 112 may be plastic, dacron, polyester, or the like. For example, the plastic may be Polytetrafluoroethylene (PTFE), the polyester may be polyethylene terephthalate (PET) or Polyurethane (PU), and so forth.

In one embodiment, the material of the wave ring 114 is a shape memory metal material, including but not limited to nitinol, copper-based shape memory alloy, or iron-based shape memory alloy, among others. In other embodiments, the material of the wave ring 114 can be other materials with shape memory properties, such as shape memory polymer.

In the present embodiment, there is no additional connection member between the plurality of corrugated rings 114, and the plurality of corrugated rings 114 are connected integrally by the coating 112. The coating 112 may be a single layer of film covering the outer surfaces of the plurality of wave rings 114, or may be a double layer of film respectively disposed on the outer surface and the inner surface of the wave rings 114 so as to sandwich the wave rings 114 therebetween.

It is understood that in other embodiments, after the plurality of wave-shaped rings 114 can be connected to each other by additional connecting members to form a tube cavity, the covering film 112 is covered on the plurality of wave-shaped rings 114 to form a tube cavity structure. The connectors may be rod-like connectors, S-shaped connectors, or omega-shaped connectors, among others.

Referring again to FIG. 2, the sealing structure 120 includes a sealing membrane 122 and a plurality of first support posts 124. The plurality of first support rods 124 are arranged at intervals along the circumferential direction of the tube body 110, and one end of each first support rod 124 is connected to the tube body 110, and the other end of each first support rod 124 extends freely so that the plurality of first support rods 124 are arranged radially to form a support structure in a substantially truncated cone shape. In the supporting structure, an end of the supporting structure where the upper bottom surface (the bottom surface with the smaller diameter) is located is an end of the first supporting rod 124 connected to the tube 110. The sealing membrane 122 is wrapped over the plurality of first support rods 124 to form the sealing structure 120. Specifically, the sealing membrane 122 covers the outside of the support structure to form the frustoconical sealing structure 120. Also, one end of the sealing membrane 122 located at the upper bottom surface (bottom surface with smaller diameter) of the support structure is sealingly connected with the tube body 110, such that one end of the sealing structure 120 is a closed end and one end is an open end, and the radial width of the open end is greater than the radial width of the sealed end.

The material of the sealing film 122 may be plastic, dacron, polyester, or the like. For example, the plastic may be Polytetrafluoroethylene (PTFE), the polyester may be polyethylene terephthalate (PET) or Polyurethane (PU), and so forth.

In the supporting structure, the plurality of first supporting rods 124 are spaced apart from each other, and the plurality of first supporting rods 124 are not in contact with each other, that is, any two first supporting rods 124 are not in contact with each other. Moreover, any two first support rods 124 are not connected with any direct connection member or indirect connection member, and the plurality of first support rods 124 are kept independent. That is, in the sealing structure 120, any two first support rods 124 are not in contact with each other in the support structure itself, except that the sealing film 122 connects the plurality of first support rods 124 as a whole. Also, any two first support rods 124 are connected without any direct connection member and indirect connection member therebetween.

The material of the first support rod 124 is a shape memory metal material, including but not limited to nitinol, copper-based shape memory alloy, or iron-based shape memory alloy. In other embodiments, the material of the first support bar 124 may also be other materials with shape memory properties, such as shape memory polymers.

Referring to fig. 3, the first support rods 124 are integrated with one of the corrugated rings 114. The structure of the first supporting rods 124 integrated with one of the wave rings 114 refers to the following two ways:

the first method comprises the following steps: the wave ring 114 is an integral structure, and the first support rods 124 and the wave ring 114 are an integral structure;

and the second method comprises the following steps: the undulating ring 114 is not a unitary structure in itself, the undulating ring 114 comprising a plurality of arcuate segments joined end to form an annular undulating ring 114 comprising a plurality of peaks and a plurality of valleys, each first strut 124 being a unitary structure with each arcuate segment.

Specifically, for the first way, the shape memory tube material may be cut by, for example, laser cutting, plasma arc cutting, etc. to form the integrated first support rods 124 and the corrugated ring 114, i.e., the support structure of the sealing structure 120 and the corrugated ring 114 are integrated. In this embodiment, the wave ring 114 of the one-piece structure is still axially aligned with the other wave rings 114 of the tube body 110 to form a lumen structure. There is no connection between any two first support rods 124 except that the wave ring 114 connects the plurality of first support rods 124 into a whole.

For the second way, the plurality of integrated first supporting rods 124 and the wave ring 114 can be formed by weaving, for example, the integrated first supporting rods 124 and the arc-shaped segments are formed first, and then the plurality of integrated first supporting rods 124 and the arc-shaped segments are connected end to end.

The plurality of first support rods 124 and one of the wave rings 114 are of an integrated structure, so that the rebound resilience of the plurality of first support rods 124 is improved, the gap between the sealing structure 120 tightly attached to the lumen stent 100 and the covered stent 20 is facilitated, and the plugging effect is improved. Moreover, the consistency of manufacturing the sealing structure 120 is improved by means of laser cutting, plasma arc cutting and the like, the difficulty of winding the first support rod 124 on the corrugated ring 114 is reduced by integrating the first support rod 124 with the corrugated ring 114, and the process is easier to implement.

It will be appreciated that the outer diameter of the wave ring 114 in this one-piece construction is the same as the outer diameter of the other wave rings 114 of the tube body 110. The wave ring 114 of the one-piece construction may have parameters such as peak height, number of peaks and/or valleys, cross-sectional rod size, etc. that are equal to or different from the corresponding parameters of the other wave rings 114. When the corresponding parameters are equal or similar, it is beneficial to prevent the mechanical properties of the tube body 110 from being different.

It should be noted that in this embodiment, since the first support rod 124 is of a unitary structure with one of the wave rings 114, the total number of other wave rings 114 of the tubular body 110 should be 1 less than the total number of wave rings 114 designed for the luminal stent 100. For example, the total number of wave-shaped rings 114 in the design of the lumen stent 100 is 6, the number of wave-shaped rings 114 in the integrated structure is 1, and the total number of other wave-shaped rings 114 of the tube body 110 is 5.

The wave ring 114 to which the plurality of first support rods 124 are connected connects the plurality of first support rods 124 together. This way can guarantee that seal structure 120 and body 110 are strictly coaxial, can avoid when the release form is relatively poor because seal structure 120's off-centre leads to the shutoff effect not good.

When the luminal stent 100 is released to a designated part in a blood vessel, the sealing structure 120 can actively fit the gap between the luminal stent 100 and the stent graft 20 in the aortic lumen through self-expansion, and the sealing structure 120 can effectively seal the gap and avoid intra-operative leakage, as shown in fig. 4. In addition, since the plurality of first support rods 125 and one of the wave rings 114 of the tube body 110 are of an integral structure, the sealing structure 120 and the tube body 110 can be ensured to be strictly coaxial, and poor plugging effect caused by eccentricity of the sealing structure 120 when the release form is poor can be avoided. Therefore, the sealing structure 120 has a better sealing effect and a better effect of avoiding intra-operative leakage.

By properly designing the length of the first supporting rod 124 and the included angle between the first supporting rod 124 and the longitudinal central axis of the tube 110, the size of the sealing area of the sealing structure 120 can be properly adjusted to adapt to individual differences.

The longer the first support rod 124 is, the more the first support rod 124 is, the lower the resilience is, the less the sealing structure 120 is unfolded, and meanwhile, because the first support rod 124 of the sealing structure 120 is attached to the surface of the tube 110 in the sheathing state, the too long first support rod 124 may cause the conveyor to have poor flexibility and to be difficult to convey; however, if the length of the first support rod 124 is too small, the area covered by the seal structure 120 in the axial direction of the pipe body 110 is small, and it is difficult to obtain a good sealing effect. Thus, in one embodiment, as shown in FIG. 3, the length L of the first support bar 124 is in the range of 2 to 25 millimeters.

In one embodiment, the length L of the first support bar 124 is about 15 mm.

In one embodiment, the lengths L of the first support struts 124 are all equal.

In one embodiment, the lengths L of the plurality of first support struts 124 are not equal. Further, the length L of the plurality of first support bars 124 is regularly changed such that the open end of the sealing structure 120 is a slope. When the luminal stent 100 and the stent graft 20 are implanted at a designated site in a blood vessel, if there is an angle between the luminal stent 100 and the stent graft 20, a portion of the sealing structure 120 may be caused to extend beyond the stent graft 20, which may create a risk of obscuring other branch blood vessels. The open end of the sealing structure 120 is beveled, which can effectively avoid such a risk.

In one embodiment, the angle α (shown in fig. 3) between the first support rod 124 and the central longitudinal axisbase:Sub>A-base:Sub>A of the tube 110 is 10 ° to 90 °.

In one embodiment, the angle α between the first support rod 124 and the central longitudinal axis A-A of the tubular body 110 is 45 °.

The larger the number of the first supporting rods 124, the more difficult the sheathing, and the larger the inner diameter of the sheath tube required to be matched, which results in difficult or even impossible delivery. If the number of the first support rods 124 is too small, the support performance of the support structure formed by all the first support rods 124 is weak, so that the sealing structure 120 is difficult to be tightly attached to the stent graft 10, and thus a superior occlusion effect is difficult to obtain. Meanwhile, when the number of the first support rods 124 is small, it is difficult to maintain the sealing structure 120 in a desired contour shape for good sealing for a long time due to weak support performance of the support structure, thereby making it difficult to obtain a continuously good sealing effect. Therefore, in order to ensure the plugging effect while ensuring sheathing and delivery, the number of the first support rods 124 is 3 to 20 in one embodiment.

In one embodiment, the number of the first support rods 124 is 10.

When the number of the first supporting rods 124 is fixed, the larger the width (e.g., diameter, side length, etc.) of the first supporting rods 124 is, the greater the sheathing difficulty is, the larger the inner diameter of the sheath tube required to be matched is, and the difficulty or even incapability of conveying is caused. However, the width of the first supporting rod 124 is too small, which results in insufficient resilience of the first supporting rod 124 and thus affects the plugging effect. Therefore, in one embodiment, the width of the first support rod 124 is 0.1 mm to 0.4 mm for both the resilience of the first support rod 124 and the sheathing and delivery requirements.

In one embodiment, the first support bar 124 has a width of 0.2 millimeters.

It should be noted that the specific definition of the width varies with the shape of the first support bar 124. For example, when the first support bar 124 is a cylindrical bar, the width refers to the diameter of the cylindrical bar. When the first support bar 124 is a bar having a square cross section, the width refers to the side length of the square bar. When the first support bar 124 is a bar having a rectangular cross section, the width refers to the length of the side in the radial direction after sheathing. When the first support bar 124 is a bar having an irregular shape in cross section, the width refers to the width in the radial direction after sheathing.

The lumen stent 100 has simple structure and low sheath installation difficulty, and is beneficial to the assembly and the transportation of the whole conveying system.

In this embodiment, a plurality of first support rods 124 are arranged at equal intervals along the circumference of the tube body 110, so that the lumen stent 100 has no directivity, does not need to be rotated and aligned in the release process, and is beneficial to the release of the lumen stent 100, thereby being beneficial to reducing the operation time, reducing the blocking time for blood flow and improving the safety of the operation process.

In other embodiments, the plurality of first support rods 124 are arranged at unequal intervals in the circumferential direction of the pipe body 110, and form a concentrated distribution region and a non-concentrated distribution region. The concentrated distribution area refers to the area in which the number of the first support rods 124 is greater, but the first support rods 124 in the area may be arranged at equal intervals or at unequal intervals. The non-concentrated distribution region means that the number of the first support bars 124 in the region is less than that of the first support bars 124 in the concentrated distribution region, and the plurality of first support bars 124 in the region may be arranged at equal intervals or may be arranged at unequal intervals. A plurality of first supporting rods 124 are arranged according to the concentrated distribution area and the non-concentrated distribution area, so that the concentrated distribution area can better block special gaps, the blocking effect of the special area is improved, and intra-operative leakage can be better avoided.

For example, when there are many plaques in the blood vessel, which results in the inner wall of the blood vessel not being smooth enough, the concentrated distribution area of the first support rods 124 of the sealing structure 120 is attached to the inner wall of the blood vessel, and the first support rods 124 arranged densely are beneficial to fully attaching to the irregular surface of the inner wall of the blood vessel, thereby improving the plugging effect.

Referring again to fig. 2, in the present embodiment, each first supporting rod 124 is coplanar with the longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110.

In other embodiments, as shown in FIG. 5, each of the first support rods 124 is not coplanar with the longitudinal central axis A-A of the tubular body 110.

Each first support bar 124 is not coplanar with the longitudinal central axisbase:Sub>A-base:Sub>A of the tubular body 110 such that each first support bar 124 is more resilient. This is because the length of each of the first support bars 124 that are not coplanar is longer than the length of the coplanar first support bars 124 in the same natural state, and therefore, the sizing treatment for the longer first support bars 124 is more sufficient than for the shorter first support bars 124 in the heat treatment sizing. Each first support rod 124 is not coplanar with the longitudinal central axis A-A of the pipe body 110, so that after release, the sealing structure 120 has better resilience performance on the whole, opposite parts can be better sealed, and the plugging effect is improved.

In the embodiment shown in fig. 5, each first support rod 124 is a straight rod. In other embodiments where each of the first support rods 124 is not coplanar with the longitudinal central axisbase:Sub>A-base:Sub>A of the tubular body 110, the shape of each of the first support rods 124 is not limited tobase:Sub>A straight rod shape, and may be various shapes, such that the plurality of first support rods 124 are radially arranged and each of the first support rods 124 is not coplanar with the longitudinal central axisbase:Sub>A-base:Sub>A of the tubular body 110. For example, each of the first support bars 124 is an arc-shaped bar or a spiral-shaped bar, so that the plurality of first support bars 124 are flower-shaped as a whole.

It is understood that in other embodiments, the plurality of first support rods 124 can be arranged such that there are first support rods 124 that are coplanar with the longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110 and there are first support rods 124 that are not coplanar with the longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110.

Referring to fig. 6, in another embodiment, the sealing structure 120 further includes a plurality of second support rods 126. The plurality of first support bars 124 and the plurality of second support bars 126 correspond one to one. One end of each second support bar 126 is connected to an end of the corresponding first support bar 124 remote from the tube body 110, and the other end of each second support bar 126 extends alongbase:Sub>A longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110. And, the end of the second support rod 126 away from the first support rod 124 is a free end. In this embodiment, the sealing film 122 extends axially along the longitudinal central axis of the tube 110 to the free end of the second support rod 124 to completely cover the plurality of first support rods 124 and the plurality of second support rods 126. As shown in fig. 7, the first support bar 124 is of unitary construction with one of the wave rings 114. In this embodiment, the second support rod 126 and the first support rod 124 are also an integrated structure.

In this embodiment, the area covered by the sealing structure 120 along the longitudinal axis of the tube body 110 is increased due to the addition of the second support rods 126 extending axially along the longitudinal central axis of the tube body 110 by the luminal stent 100. When the anchoring distance between the luminal stent 100 and the stent graft 20 is long after the luminal stent 100 and the stent graft 20 are implanted at a designated site in a blood vessel, the area of the gap is small (as shown in fig. 8a and 8b, the coverage area of the gap 30 of fig. 8b is larger than the coverage area of the gap 30 of fig. 8 a), which is beneficial for avoiding endoleaks. Therefore, the sealing structure 120 has a larger covering area along the axial direction of the tube body 110, and the blocking effect of the lumen stent 100 is obviously better than that of the lumen stent 100 with a smaller covering area along the axial direction of the tube body 110. Therefore, the lumen stent 100 provided with the second support rod 126 has better plugging effect and better effect of avoiding inner leakage in the operation.

Moreover, the sealing structure 120 having the second support rod 126 extending axially along the longitudinal central axisbase:Sub>A-base:Sub>A of the tubular body 110 has the following advantages compared to simply extending the first support rod 124: because the second support bar 126 extends axially along the longitudinal central axisbase:Sub>A-base:Sub>A of the tubular body 110, the diameter or radial width of the open end of the sealing structure 120 is not too large, thereby increasing the axial coverage area along the tubular body 110 but avoiding the adverse effect on the resilience of the plurality of first support bars 124 caused by the excessive diameter or radial width of the open end of the sealing structure 120 simply extending the first support bars 124. Therefore, a plurality of second support rods 126 are arranged, so that the plugging area of the sealing structure 120 is obviously more attached to the edge of the gap, and a better effect of avoiding intraoperative leakage is obtained.

Referring again to fig. 6, each of the second support rods 126 is disposed parallel to the longitudinal central axisbase:Sub>A-base:Sub>A of the tube 110, such that the plurality of second support rods 126 and the sealing film 122 disposed on the plurality of second support rods 126 formbase:Sub>A tubular structure surrounding the tube 110. Under the condition, the coverage area along the axial direction is larger, and the plugging effect is better. It will be appreciated that when each second support bar 126 is disposed parallel to the longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110, the angle β between the second support bar 126 and the first support bar 124 is complementary to the angle α between the first support bar 124 and the longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110, as shown in fig. 9.

It should be noted that in other embodiments, each second support rod 126 is not required to be strictly parallel to the longitudinal central axis of the tube body 110, as long as the second support rod 126 extends axially along the longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110, and the second support rod 126 is substantially parallel to the longitudinal central axisbase:Sub>A-base:Sub>A of the tube body 110. And β is greater than α. Thus, compared to the solution of omitting the second support rod 126 and simply extending the first support rod 124 while omitting the second support rod 126, a better sealing effect can be obtained.

It is understood that the first support bar 124 and the second support bar 126 may be integrally formed. Alternatively, the first support bar 124 and the second support bar 126 may be connected in a manner known to those skilled in the art, such as welding, gluing, and the like.

In one embodiment, the shape and the width of the second supporting bar 126 are respectively consistent with the shape and the width of the first supporting bar 124. In other embodiments, the shape and width of the second support bar 126 may not correspond to the shape and width of the first support bar 124. Alternatively, the second support bar 126 may conform to the shape of the first support bar 124 but not to the width.

Referring to fig. 10, in another embodiment, each second support rod 126 does not extend axially along the longitudinal central axisbase:Sub>A-base:Sub>A of the tube 110, andbase:Sub>A distance D1 from an end of each second support rod 126 away from the corresponding first support rod 124 to the longitudinal central axisbase:Sub>A-base:Sub>A of the tube 110 is greater thanbase:Sub>A distance D2 from an end of the second support rod 126 connected to the corresponding first support rod 124 to the longitudinal central axisbase:Sub>A-base:Sub>A of the tube 110.

Referring to fig. 11, the seal 120 of this embodiment is generally a cuffed cap configuration. The plurality of first supporting rods 124 and the part of the sealing film 122 positioned on the plurality of first supporting rods 124 form the main body of the hat, and the plurality of second supporting rods 126 and the part of the sealing film 122 positioned on the plurality of second supporting rods 126 form the flanging structure of the hat.

In one embodiment of the sealing structure 120, which is a substantially flanged cap structure, the angle between each second support bar 126 and the corresponding first support bar 124 is γ, and γ is 20 ° to 90 °.

In another embodiment, γ is 80 °.

The first support bar 124 and the second support bar 126 may be integrally formed. For example, during the manufacturing process, one support rod may be bent away from the central longitudinal axis of the tube 110 to form the first support rod 124 and the second support rod 126. In other embodiments, the first support bar 124 and the second support bar 126 may be connected by other methods known to those skilled in the art, such as welding, gluing, etc., only by ensuring that the first support bar 124 and the second support bar 126 are securely connected and the first support bar 124 and the second support bar 126 are formed at an angle such that the sealing structure 120 is in a hat-over configuration.

In the in-situ windowing operation, the gaps cannot be completely filled due to the complex and changeable matching relationship between the branch supports and the windowing region, so that internal leakage occurs. The lumen stent 100 with the flanged cap structure can be used for in-situ windowing operation, the sealing structure 120 is in the flanged cap structure, and the lumen stent 100 is actively attached to the inner wall of the covered stent 20 used in a matched manner after releasing the designated part in the finger blood vessel, so that the gap is filled and blocked, as shown in fig. 12.

After the lumen stent 100 and the stent graft 20 are implanted into a specified lesion part in an in-situ fenestration operation, when the gamma is 80 degrees, under the action of force (such as the action force generated by buckling, stretching and even twisting due to vasoconstriction and relaxation), the first support rod 124 and the second support rod 126 can be ensured to have certain deformability, so that the lumen stent 100 can be more attached to the stent graft 20, thereby obtaining a continuous plugging effect even under the continuous action force of a blood vessel and effectively avoiding internal leakage. As shown in fig. 13a and 13b, when the aortic blood vessel 21 contracts and expands to bend, stretch, or even twist, the stent graft 20 changes its form accordingly, and due to the deformability of the first support rod 124 and the second support rod 126, the sealing structure 120 deforms accordingly to adapt to the deformation of the stent graft 20, so as to maintain a good occlusion effect.

In addition, because the first support rod 124 and the second support rod 126 have certain deformability, the device can adapt to the lesion sites of the branch blood vessels and the aorta blood vessels with different included angles, and can still effectively adhere to the wall in the lesion sites with different included angles to prevent inner leakage, so that the device has better adaptability to different individuals.

Since the connection manner of the second support bar 126 and the first support bar 124 is non-flexible connection, the included angle γ between the two can be changed only when a certain external force is applied, so the size design of γ has a certain relationship with the connection manner of the second support bar 126 and the first support bar 124. When the branched blood vessel 1 is nearly perpendicular to the aorta 21, i.e. the size of γ is nearly 90 °, the attaching effect of the luminal stent 100 and the stent graft 20 is the best, i.e. the blocking effect of the luminal stent 100 is the best. Therefore, when the second support rod 126 and the first support rod 124 have a larger rod diameter (or a larger width) and are connected by integral molding or welding, the design angle of γ should be as close to 90 ° as possible, so as to prevent the lumen stent 100 from tilting when the second support rod 126 contacts with the inner wall of the stent graft 20 after implantation, thereby preventing the lumen stent 100 from being unable to be attached. Further, in one embodiment, when the diameters of the first support bar 124 and the second support bar 126 are equal and the diameters of the first support bar 124 and the second support bar 126 are both greater than 0.15mm, γ has a value of 70 ° to 90 °.

When the rod diameters of the second support rod 126 and the first support rod 124 are smaller (or the widths are smaller), and the mutual mechanical relationship between the two is weaker, a smaller γ -angle design can be selected, and the smaller γ -angle can ensure that the second support rod 126 on the extrusion side of the luminal stent 100 in the condition of fig. 13b cannot be tilted. In one embodiment, when the diameters of the first support bar 124 and the second support bar 126 are equal, and the diameters of the first support bar 124 and the second support bar 126 are both greater than 0.05mm and less than 0.15mm, γ has a value of 20 ° to 80 °. In another embodiment, when the diameters of the first and second support bars 124 and 126 are not equal, and the diameter of one of the first and second support bars 124 and 126 is greater than 0.05mm and less than 0.015mm, γ has a value of 20 ° to 80 °.

In the embodiment where the sealing structure 120 is a cuff structure, the length of the second support rod 126 cannot be too small to ensure the abutting performance of the sealing structure 120 against the inner wall of the stent graft 20 so as to ensure the occlusion effect, but when the length of the second support rod 126 is too large, the sealing structure 120 may protrude out of the end of the stent graft 20 close to the heart to occlude other branch vessels. Therefore, the length of the second support bar 126 is 3 to 10 mm.

The lengths of the plurality of second support bars 126 are equal or unequal. Further, the lengths of the plurality of second support bars 126 are changed according to a certain rule such that the open end of the sealing structure 120 is an inclined surface.

In the in situ fenestration, as shown in fig. 12, the sealing structure 120 of the lumen stent 100 is located inside the stent graft 20 and the sealing structure 120 abuts against the inner wall of the stent graft 20, and the tube 110 protrudes from the fenestrated region (not labeled in fig. 12) of the stent graft 20 to the outside of the stent graft 20 and into the branch vessel 1. Because the fenestrated region is very close to the edge of the stent graft 20 at the end near the heart, the second support strut 126 may extend too far out of the end of the stent graft 20 near the heart, thereby affecting or obscuring other branch vessels in front of the anchor region of the stent graft 20. Therefore, the lengths of the second support rods 126 are not equal, so that the lumen stent 100 can be released without shielding other branch vessels and affecting the plugging performance in another direction in the in-situ windowing.

In the embodiment where the sealing structure 120 is in the form of a hat-flanging structure, the longer the length of the first supporting rod 124 is, the better the resilience is, and the sealing structure 120 is not unfolded well, and meanwhile, because the first supporting rod 124 of the sealing structure 120 is attached to the surface of the tube 110 in the sheathing state, the too long first supporting rod 124 may cause the conveyor to have poor flexibility and be difficult to convey; however, when the length of the first support rod 124 is too small, the operation requirements during the releasing process are extremely high, and when the clinical experience of the operator is insufficient, the deviation is easily generated, for example, the second support rod 126 may be placed in the through hole of the fenestrated area or the second support rod 126 is too far away from the fenestrated area, so that the second support rod 126 cannot be sufficiently attached to the inner wall of the stent graft 20. Thus, in one embodiment, the length L of the first support bar 124 is in the range of 2 mm to 10 mm. In another embodiment, the length L of the first support bar 124 is 3-5 mm.

Referring to fig. 14, in another embodiment of the sealing structure 120 of the luminal stent 100, a plurality of branches 1262 are formed at one end of the second support rod 126 away from the tube 110 (not shown in fig. 14). The plurality of branches 1262 may or may not be equal in width. Also, the width of each branch 1262 is less than the width of the second support bar 126.

The plurality of branches 1262 are formed at the free end of the second support rod 126 of the sealing structure 120 of the present embodiment, and the more complicated lumen occlusion with irregular shape can be realized by the respective resilience performance of more thinner branches 1262 while ensuring the stability of the second support rod 126, as shown in fig. 15, without increasing the sheathing size of the lumen stent 100.

Referring to fig. 14 again, in the present embodiment, each second support rod 126 is formed with 4 branches 1262, a free end of each branch 1262 extends axially along the tube 110 (not shown in fig. 14), and the four branches 1262 are on the same horizontal plane. The four branches 1262 are arranged at equal intervals in the circumferential direction of the pipe 110 (not shown in fig. 14). The end faces of the free ends of the branches 1262 on all of the second support bars 126 are in the same plane. With such an arrangement, the branches 1262 are distributed more densely, which is beneficial to improving the plugging effect of the sealing structure 120. Moreover, the branch 1262 is more stably connected with the second support rod 126, so that the branch 1262 is not easy to deform or incline, and a continuous plugging effect is favorably achieved. Meanwhile, the sheath is convenient to install, and the size of the sheath tube is not increased.

It is understood that in other embodiments, the number of branches on each second support bar 126 is not necessarily 4, and it is not required that the end surfaces of the free ends of all the branches 1262 on each second support bar 126 are located on the same plane, and it is not required that the branches 1262 are arranged at equal intervals along the circumference of the tube 110 (not shown in fig. 14), and the branches may also be arranged at non-equal intervals. At the same time, it is not required that the end surfaces of the free ends of the branches 1262 on all the second support bars 126 be on the same plane.

In the plurality of second support bars 126, the branches 1262 may be formed at the free ends of some second support bars 126, and the branches 1262 are not formed at the free ends of some second support bars 126. In the second support rods 126 formed with the branches 1262, the number of the branches 1262 on each second support rod 126 may be equal to or different from the number of the branches 1262 on the other second support rods 126. The shape, width and spacing of the branches 1262 on each second support bar 126 may or may not be the same as the shape, width and spacing of the branches 1262 on the other second support bars 126. In short, the specific arrangement of the branches 1262 is not limited as long as more complex lumen occlusion with irregular shape can be achieved without increasing the sheathing size of the luminal stent 100.

The greater the number of the second support bars 126 on which the branches 1262 are formed, the greater the number of the branches 1262 formed on each second support bar 126, that is, the greater the total number of the branches 1262, which means that the black spots of the branches 1262 are denser as shown in fig. 15, the better the sealing effect is. However, when the width of the branches 1262 is constant, the greater the number of branches 1262, the more difficult sheathing and delivery. Alternatively, when the width of branches 1262 is constant, the greater the number of branches 1262, the larger the size of the delivery sheath needed, resulting in delivery difficulties or difficulties in application to patients with smaller vessel diameters. When the number of branches 1262 is fixed, the larger the width of branches 1262, the same difficulties in sheathing and in delivery can occur; or may result in a larger size delivery sheath being required, resulting in delivery difficulties or difficulties in application to patients with smaller vessel diameters. However, as the width of the branches 1262 is smaller, i.e., the branches 1262 are thinner, the resilience of the branches 1262 is poor, resulting in poor sealing performance.

Therefore, when the number of the second support bars 126 forming the branches 1262 is small and the number of the branches on each second support bar 126 is small, for example, the number of the second support bars 126 forming the branches 1262 is 2 to 4 and the number of the branches on each second support bar 126 is 2 to 3, the width of the branches 1262 may be large to ensure a certain resilience. In one embodiment, branches 1262 have a width of 0.1 to 0.15 millimeters.

Therefore, when the number of the second support bars 126 forming the branches 1262 is large and the number of the branches on each second support bar 126 is large, for example, the number of the second support bars 126 forming the branches 1262 is 5 to 20 and the number of the branches on each second support bar 126 is 2 to 5, the width of the branches 1262 needs to be set small in order to ensure certain resilience without affecting the conveying performance. In one embodiment, branches 1262 have a width of 0.02 mm to 0.1 mm.

Therefore, in order to achieve the advantages of resilience, sheathing, and transportation, in one embodiment, the number of the second support rods 126 on which the branches 1262 are formed is 5, the number of the branches 1262 per second support rod 126 is 4, and the width of each branch 1262 is 0.05 to 0.1 mm.

In one embodiment, the end surfaces of the free ends of all the branches 1262 on all the second support bars 126 are on the same plane, and the end surfaces of the free ends of all the branches 1262 are inclined surfaces, that is, the end surface of the open end of the sealing structure 120 is an inclined surface. When the luminal stent 100 and the stent graft 20 are implanted at a desired location in a blood vessel, if there is an angle between the luminal stent 100 and the stent graft 20, a portion of the sealing structure 120 may be caused to extend out of the stent graft 20, which may create a risk of obscuring other branch vessels. The end surface of the open end of the sealing structure 120 is a slope, which can effectively avoid such a risk.

It should be noted that the end surface of the open end of the sealing structure 120 is a slope, and the length of the trunk and/or the branches 1262 of the first support rod 124 and the second support 126 can be adjusted. In one embodiment, in order to ensure a certain mechanical property, the lengths of the first support rods 124 are equal, the lengths of the stems of the second support rods 126 are equal, and the lengths of the branches 1262 are adjusted to make the end surface of the opening end of the sealing structure 120 an inclined surface.

It should be noted that, in the sealing structure 120 shown in fig. 14, the first support rod 124, the second support rod 126 and one of the wave rings 114 of the tube body 110 are of an integrated structure. It will be appreciated that in other embodiments where the free end of the second support post 126 is formed with a branch 1262, the first support post 124 and one of the wave rings 114 of the tubular body 110 are of a unitary construction, and the first support post 124 and the second support post 126 are not of a unitary construction. The first support bar 124 and the second support bar 126 are connected in a manner known to those skilled in the art, and a branch 1262 is formed at the free end of the second support bar 126.

It should be noted that, no matter whether the sealing structure 120 includes the second supporting rod 126, no matter the angle between the second supporting rod 126 and the first supporting rod 124 and the relative position relationship between the two, no matter the connection manner between the second supporting rod 126 and the first supporting rod 124 is an integrated connection or a non-integrated connection, and no matter whether the free end of the second supporting rod 126 is branched, the first supporting rod 124 and the corrugated ring 110 of the tube body 110 are an integrated structure.

In the embodiment where the sealing structure 120 is a flanged cap structure, when the plurality of first supporting rods 124 and one of the corrugated rings 114 of the tube body 110 are in an integrated structure, and the corrugated ring 114 in the integrated structure is the first corrugated ring 114 at the proximal end of the tube body 110, it is beneficial to simplify the corrugated ring structure of the tube body 110, and the lumen stent 100 can be used as a branch stent for the windowing technology.

It should also be noted that, regardless of whether the sealing structure 120 includes the second support bar 126, the included angle between the second support bar 126 and the first support bar 124 and the relative position relationship between the two, and regardless of whether the free end of the second support bar 126 is formed with a branch, the size of the included angle α between the first support bar 124 and the longitudinal central axis of the tube body 110, the greater the number of the first support bars 124, and the radial width of the first support bars 124 can be reasonably adjusted within the above-indicated range.

It should be noted that, no matter whether the sealing structure 120 includes the second supporting rod 126, no matter the included angle between the second supporting rod 126 and the first supporting rod 124 and the relative position relationship between the second supporting rod 126 and the first supporting rod 124, and no matter whether the free end of the second supporting rod 126 is formed with a branch, the plurality of first supporting rods 124 may be arranged at equal intervals along the circumferential direction of the tube body 110. Alternatively, the plurality of first support rods 124 may also be arranged at unequal intervals along the circumferential direction of the tube body 110, for example, the plurality of first support rods 124 are arranged in a concentrated distribution area and a non-concentrated distribution area.

In addition, no matter whether the sealing structure 120 comprises the second support rod 126, no matter the included angle between the second support rod 126 and the first support rod 124 and the relative position relationship between the second support rod 126 and the first support rod 124, and no matter whether the free end of the second support rod 126 is branched, the shapes of the first support rod 124 and the second support rod 126 are not limited as long as the first support rod 124 and the second support rod 126 are ensured to be rod-shaped structures with elasticity, and when the lumen stent 100 is released to a specified position in a blood vessel, the first support rod 124 and the second support rod 126 can rebound to enable the sealing structure 120 to better block the gap between the lumen stent 100 and the stent graft 20. Specifically, the first and second support bars 124 and 126 may be cylindrical bars, bars having a square cross section, bars having a rectangular cross section, profiled bars having an irregular cross section, threaded bars, or the like.

According to the lumen stent 100, the sealing structure 120 is arranged, when the lumen stent 100 is released to a specified part in a blood vessel, the plurality of first support rods 124 of the sealing structure 120 can rebound to enable the sealing structure 120 to block a gap between the lumen stent 100 and the covered stent 20, so that the lumen stent 100 and the covered stent 20 can be perfectly matched, and inner leakage is avoided.

Moreover, the sealing structure 120 has a simple structure, weak mechanical properties and small irritation to the vessel wall, and is beneficial to avoiding long-term clinical risks.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The utility model provides a lumen support, locates including body and cover seal structure on the body, a serial communication port, seal structure includes seal membrane and a plurality of first bracing piece, the body includes at least one wave form circle, a plurality of first bracing piece are followed the circumference interval of body is arranged, every the one end of first bracing piece with wave form circle formula as an organic whole is connected, and the other end freely extends and makes a plurality of first bracing pieces are radial arrangement, the seal membrane cladding in on a plurality of first bracing pieces, keeping away from of seal membrane the one end of the free end of first bracing piece with the surface sealing connection of body, arbitrary two first bracing piece is kept away from the one end of wave form circle does not have direct connection spare and indirect connection spare and links to each other, and is a plurality of keep independently between the first bracing piece.

2. The luminal stent of claim 1, wherein the sealing structure further comprises a plurality of second support rods, the plurality of second support rods correspond one-to-one with the plurality of first support rods, one end of each of the second support rods is connected with one end of the corresponding first support rod away from the tube body, and the other end of each of the second support rods extends axially along the longitudinal central axis of the tube body.

3. The luminal stent of claim 2 wherein the second support rod is parallel to the longitudinal central axis of the tubular body.

4. The luminal stent as defined in claim 2, wherein an end of each of the second support rods distal to the corresponding first support rod is formed with a plurality of branches.

5. The luminal stent of claim 1, wherein the sealing structure further comprises a plurality of second support rods, the plurality of second support rods correspond one-to-one to the plurality of first support rods, one end of each of the second support rods is connected to one end of the corresponding first support rod away from the tubular body, and the distance from one end of each of the second support rods away from the corresponding first support rod to the longitudinal central axis of the tubular body is greater than the distance from one end of the second support rod connected to the corresponding first support rod to the longitudinal central axis of the tubular body.

6. The luminal stent of claim 2 wherein the angle between each second support rod and the corresponding first support rod is from 20 ° to 90 °.

7. The luminal stent as claimed in any one of claims 1 to 5 wherein the length of each first supporting rod is 2 to 25 mm.

8. The luminal stent as defined in any one of claims 1 to 5 wherein the number of the first struts is 3 to 20.

9. The lumen stent as claimed in any one of claims 1 to 5, wherein an included angle between each first supporting rod and a longitudinal central axis of the tube body is 10-90 degrees.

10. The luminal stent as claimed in any one of claims 1 to 5 wherein the width of the first strut is 0.1 to 0.4 mm.

11. The luminal stent as claimed in any one of claims 1 to 5, wherein the plurality of first struts are arranged at equal intervals along the circumferential direction of the tube body;

12. The luminal stent of any one of claims 1 to 5, wherein each first support rod is coplanar with the longitudinal central axis of the tube body; alternatively, the first and second electrodes may be,