CN113040975B

CN113040975B - Lumen stent

Info

Publication number: CN113040975B
Application number: CN201911383164.6A
Authority: CN
Inventors: 肖本好; 吴轩
Original assignee: Shenzhen Xianjian Changtong Medical Co ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-27
Filing date: 2019-12-27
Publication date: 2022-08-12
Anticipated expiration: 2039-12-27
Also published as: WO2021129298A1; CN113040975A

Abstract

The invention relates to a lumen stent, which comprises a tubular main body and at least one inner branch positioned in the tubular main body and respectively communicated with the tubular main body, wherein the inner branch is hollow and has two open ends, the inner branch comprises a branch main body and an expanding section connected with the near end of the branch main body, the near end of the expanding section is provided with an inclined opening, the inclined opening inclines from the inner wall of the tubular main body to the far end of the branch main body, and the position of the inclined opening is provided with an annular part with a smooth surface. According to the lumen stent, the oblique opening of the flaring section is utilized to enable the catheter to easily enter the inner branch, so that the blockage probability is reduced, and in addition, the smooth surface annular part is arranged at the position of the oblique opening, so that the smoothness of the catheter entering the inner branch is further improved, and the adverse effect caused by the blockage of the end part when the catheter enters the inner branch is effectively avoided.

Description

Lumen stent

Technical Field

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

Background

Aneurysms are common vascular diseases in clinic, and are mostly generated in the elderly, and the diseases easily cause rupture of the aortic aneurysm, thereby causing great threat to the life of patients. With the continuous development of the existing medical technology, the covered stent is implanted into the body by utilizing a minimally invasive surgery, and the treatment surgery for treating aortic aneurysm and dissecting aneurysm is used, so that the covered stent is widely applied due to small wound and quick recovery. The treatment mode is that the covered stent is compressed into the conveying device, is guided into a human body along a guide wire track implanted in advance, reaches a diseased position, and then is released to isolate blood flow and the diseased position, and simultaneously rebuilds a blood flow channel, after the aneurysm and the interlayer lose blood flow supply, residual blood in a tumor cavity gradually forms thrombus and becomes blood vessel tissues, the tumor wall in an expanded state shrinks due to pressure, and the original state is gradually recovered, so that the purpose of treating the aneurysm and the interlayer is achieved.

However, the vascular structure of the human body is complicated, and when a lesion occurs at a branch site, a stent graft capable of reconstructing a branch artery is required. At present, one type of covered stent for such a lesion is an internal covered stent, that is, a straight-tube type covered stent, generally called an internal branch, is connected inside the straight-tube type covered stent, and the two are connected together through a hole on the external covered stent and are in fluid communication through the hole. During practical use, the hole of the external covered stent is correspondingly placed at the position of the opening of the branch artery, and then a straight tube stent is implanted to communicate the internal branch and the branch artery, so that the purpose of reconstructing the branch artery is achieved. When reconstructing a branch artery by using the covered stent, a guide wire track from a hole on the covered stent to the branch artery needs to be established.

However, the guide wire channel of the inner branch is difficult to establish during the operation, in order to simplify the operation of the operation, the stent system can prepare the preset guide wire in the inner branch, in order to reduce the influence on the assembly and the release of the stent, the preset guide wire is often very thin, a guide wire with the diameter of 0.014 "or 0.018" is often used as the preset guide wire, when in practical use, a catheter is firstly conveyed into the inner branch along the channel established by the preset guide wire, then 0.035 "hard guide wire is exchanged, and the branch stent is implanted through the channel established by the hard guide wire.

As the lumen of the catheter can pass through the 0.035' hard guide wire, the lumen aperture of the catheter is adapted to the hard guide wire, and the preset guide wire is thinner than the hard guide wire, the lumen aperture of the catheter is larger relative to the preset guide wire, and the radial size difference of the preset guide wire and the catheter can form a step in the operation process of guiding the catheter by the preset guide wire, so that the end part of the catheter can be easily clamped at the end part of the inner branch when the catheter enters the inner branch along the preset guide wire.

Disclosure of Invention

Based on the technical scheme, the invention provides the lumen stent, which solves the technical problem that the catheter is easy to be stuck when entering the inner branch.

The utility model provides a lumen stent, includes the tubulose main part, and is located inside the tubulose main part and respectively with at least one interior branch of tubulose main part intercommunication, the inside cavity and the equal opening in both ends of interior branch, interior branch including the branch main part and with the flaring section that the near-end of branch main part is connected, the near-end of flaring section is equipped with the bevel connection, the bevel connection orientation the inside of tubulose main part is inclined to the distal end, just the position department at bevel connection place is equipped with the smooth cyclic annular piece in surface.

The invention provides a lumen stent, which comprises a tubular main body and an inner branch arranged in the tubular main body and communicated with the tubular main body, wherein the proximal end of the inner branch is provided with a flaring section so that a catheter can be more easily aligned with the proximal end of the inner branch; the proximal end of the flaring section is provided with an inclined opening, and the inclined opening inclines from the inner wall of the tubular main body to the distal end of the branch main body, so that the catheter can slide down along the inclined opening to enter the inner branch when being abutted against the inclined opening by utilizing the inclined opening of the flaring section, and the blocking probability is reduced. In addition, through set up the smooth cyclic annular piece in surface in bevel connection position department, make the pipe butt slide more easily when on the bevel connection, further improve the patency that the pipe entered interior branch to the tip appears blocking easily and produces harmful effects when effectively avoiding the pipe to enter interior branch.

Drawings

FIG. 1 is a schematic structural diagram of a luminal stent of an embodiment;

FIG. 2 is a schematic view of one embodiment of a luminal stent delivered to an aneurysm via a delivery device;

FIG. 3 is a schematic view of a delivery device in an embodiment showing a released state of a stent;

FIG. 4 is a schematic view of a catheter in an embodiment after delivery of the endoluminal stent to an aneurysm and before the catheter enters the endoluminal stent over a guidewire;

FIG. 5 is a schematic view of an embodiment of an inner branch of a catheter following a guidewire deployment into a stent, after the stent has been delivered to an aneurysm;

FIG. 6 is a schematic view showing the state where the end of the catheter abuts against the end of the inner branch when the catheter enters the inner branch;

FIG. 7 is a schematic view showing the end of the catheter abutting the end of the inner branch, the catheter compressing the inner branch to create a collapsed condition;

FIG. 8(a) is a partial structural view of a luminal stent of example 1; FIG. 8(b) is a partial view of the lumen stent shown in FIG. 8(a), wherein the normal of the oblique port intersects the central axis of the tubular body; FIG. 8(c) is a schematic view of an embodiment of a luminal stent with a catheter abutting against the oblique port of the inner branch under the guidance of a pre-placed guidewire; FIG. 8(d) is a schematic view of an embodiment of a luminal stent with the end of the catheter slid down the bevel to a position adjacent the bottom of the bevel;

FIG. 9 is a schematic view showing that the oblique ports of the inner branches of the luminal stent of example 1 are obliquely arranged toward the central axis of the tubular body;

FIG. 10 is a partial schematic structural view of an inner branch of a luminal stent of an embodiment;

FIG. 11 is a partial schematic structural view of an inner branch of another embodiment of a luminal stent;

FIG. 12 is a schematic axial top view of the luminal stent of example 2 having two inner branches showing the space formed between the two inner branches and the inner wall of the tubular body;

FIG. 13 is a schematic view showing that in the luminal stent of example 2, partial edges of the flaring segments of the two inner branches are connected to close the gap;

FIG. 14 is a schematic structural view of the luminal stent shown in FIG. 13;

FIG. 15 is an axial top view of another embodiment of a luminal stent showing the beveled edges of two inner branches within the tubular body both being scalloped;

FIG. 16 is a schematic structural view of the luminal stent shown in FIG. 15;

FIG. 17 is a partial structural view of an inner branch with a support member of the luminal stent of example 3;

FIG. 18 is a schematic view of a support member and a ring member of another embodiment of the luminal stent being integral;

FIG. 19 is a partial structural view of an inner branch with another support structure of another embodiment of a luminal stent;

FIG. 20 is a partial structural view of an inner branch of a luminal stent with another support structure according to yet another embodiment;

FIG. 21 is a schematic structural view of a support member of an embodiment of a luminal stent;

FIG. 22 is a schematic structural view of a support member of another embodiment of a luminal stent;

FIG. 23 is a schematic view of a luminal stent with a bare stent according to an embodiment;

FIG. 24 is a schematic view of the lumen stent of FIG. 23 in an anchoring configuration with a catheter passing through the bare stent;

FIG. 25 is a schematic structural view of the luminal stent provided with a bare stent of example 4;

FIG. 26 is a schematic view of the lumen stent of FIG. 25 in an anchoring configuration with a catheter passing through the bare stent.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

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 herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In the field of interventional medical devices, the end of a stent implanted in a human or animal body closer to the heart is generally called "proximal end", the end farther from the heart is called "distal end", and the "proximal end" and the "distal end" of any part of the stent are defined according to the principle; and the end of other medical apparatus implanted in the human or animal body closer to the operator is called "proximal end", the end farther from the operator is called "distal end", and the "proximal end" and the "distal end" of any one of the parts of the other medical apparatus are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.

The inner branch 12 of the luminal stent of the present invention can be used in luminal stents such as main thoraco-abdominal stent, arcus step stent, iliac bifurcation stent, suprarenal aneurysm stent, etc., and the application of the inner branch 12 to the main thoraco-abdominal stent will be described in detail below as an example, and the application of the inner branch 12 to other luminal stents is the same or similar, and will not be described again.

Example 1

Referring to fig. 1, embodiment 1 provides a lumen stent 10, where the lumen stent 10 includes a tubular main body 11 and at least one inner branch 12 located inside the tubular main body 11 and respectively communicated with the tubular main body 11. For example, the luminal stent 10 is shown in fig. 1 as having 2 inner branches 12 disposed within the tubular body 11. In other embodiments, the luminal stent 10 can be provided with one or more than 2 inner branches 12.

The tubular body 11 includes a tapered section 11a, a proximal section 11b, and a distal section 11 c. The proximal section 11b is connected to the proximal end of the tapered section 11a, and the distal section 11c is connected to the distal end of the tapered section 11 a. The tapered section 11a is located in the middle section of the tubular body 11, and the distal dimension of the tapered section 11a is smaller than the proximal dimension of the tapered section 11 a.

Specifically, the tapered section 11a is provided with an inner branch window 12a connected to the inner branch 12. When a plurality of inner branches 12 are provided inside the tubular body 11, a corresponding number of inner branch windows 12a are also provided on the tapered section 11a, the distal end of one inner branch 12 is connected to one inner branch window 12a, and the proximal end of the inner branch 12 is to be located inside the tubular body 11. In other embodiments, the tubular body 11 may not have the tapered section 11a, but only have the proximal section 11b and the distal section 11 c. The proximal section 11b may or may not have an outer diameter equal to the outer diameter of the distal section 11 c. One or more internal branch windows are provided on the proximal section 11b or the distal section 11c for communicating with the lumen of the internal branch 12 after connection to the distal end of the internal branch 12.

It should be noted that the inner branch 12 is hollow and open at both ends, so that the inner branch 12 will communicate with the tubular body 11 through the opening at its proximal end, and the catheter entering the tubular body 11 can be manipulated to enter the inner branch 12.

In some embodiments, the luminal stent 10 comprises at least one outer branch 101, the outer branch 101 being located outside the tubular body 11 and communicating with the interior of the tubular body 11 through its proximal end. For example, the proximal end of the outer branch 101 is connected to the tapered section 11a and communicates with the interior of the tubular body 11 through an outer branch window 101a provided on the tapered section 11 a.

For ease of understanding, the structure of the luminal stent 10 and its mechanism of action will be further described below with reference to fig. 2-5, taking as an example the operation of the luminal stent 10 in the application to an thoraco-abdominal aortic aneurysm.

Referring to fig. 2, the distribution of a thoraco-abdominal aortic aneurysm 100a and the branch vessels 100b in which it is located is schematically shown in fig. 2. The luminal stent 10 is accessed from the femoral artery by the delivery device 1 and delivered to the tumor site. As shown in connection with fig. 3, the luminal stent 10 is released at the tumor site and the pre-set guidewire 2 previously passed through the inner branch 12 is grabbed out by the grabber 3, wherein the grabber 3 can be delivered from the carotid or subclavian artery to the vicinity of the inner branch 12. Referring to fig. 4 and 5, 2 inner branches 12 are provided in the tubular main body 11, and preset guide wires 2 are pre-arranged in the 2 inner branches 12, so that the catheters 4 are guided to the corresponding inner branches 12 by the corresponding preset guide wires 2. Specifically, after the catcher 3 grabs out the preset guide wires 2, the 2 catheters 4 respectively enter the corresponding inner branches 12 under the guiding action of the respective preset guide wires 2, so as to establish the channels of the inner branches 12. At this time, the preset guide wire 2 is withdrawn while keeping the relative positions of the catheter 4 and the luminal stent 10 unchanged, and the other thicker guide wires are exchanged for the subsequent operation.

With the proximal flush-opening inner branch 12 configuration, the inventors have found that, due to the tapering of the guidewire 2, the end 4a of the catheter 4 tends to be offset from the lumen of the inner branch 12 and against the end 12b of the inner branch 12 as the catheter 4 is advanced along the guidewire 2 into the inner branch 12, as shown in fig. 6. The end 4a of the conduit 4 abuts the end 12b of the inner branch 12, which causes the conduit 4 to jam as it enters the inner branch 12 and thus cannot smoothly enter the inner branch 12. Referring to fig. 7, when the end 4a of the conduit 4 abuts against the end 12b of the inner branch 12, if the conduit 4 is pushed forcibly, the end 12b of the inner branch 12 will collapse, which will increase the jamming, and the conduit 4 will be further unable to penetrate the inner branch 12, which will affect the subsequent operation. In contrast, the inventor improves the structure of the luminal stent 10 to reduce the probability of seizure when the catheter 4 enters the inner branch 12, and to improve the smoothness of the catheter 4 entering the inner branch 12.

As shown in fig. 8(a), since the distal end of the inner branch 12 is connected to the inner branch window 12a of the tapered section 11a of the tubular body 11, and the proximal end of the inner branch 12 is located in the tubular body 11 and serves as the inlet end of the conduit 4 entering the inner branch 12, in one embodiment, the flaring structure is provided at the proximal end of the inner branch 12 so that the conduit 4 enters the inner branch 12 to reduce the occurrence of the seizure phenomenon.

In particular, the inner branch 12 comprises a branch body 121 and a flared section 122 connected to the proximal end 121a of the branch body 121. Thereby facilitating entry of the conduit 4 from the flared section 122 into the branch body 121. It will be appreciated that the flared section 122 is flared. In general, the proximal opening area of the flared section 122 is greater than the distal opening area of the flared section 122. Since the flared section 122 is connected to the proximal end 121a of the branch body 121, the flared section 122 serves as a pipe section for guiding the catheter 4 into the branch body 121, and when the catheter 4 enters the inner branch 12, the catheter 4 firstly enters the flared section 122 from the proximal end of the flared section 122 and then is guided to the branch body 121 by the flared section 122, so that the proximal opening area of the flared section 122 is larger than the distal opening area of the flared section 122, and thus the catheter 4 can be aligned with the cavity of the inner branch 12 with a greater probability. The flared section 122 has an inner diameter greater than the inner diameter of the branch body 121, wherein the inner diameter of the flared section 122 comprises the inner diameter of the flared section 122 as profiled in any cross-section thereof along its length.

In the inner branch 12, the branch body 121 is a substantially cylindrical tube, the distal end of the flared section 122 is connected to the proximal end 121a of the branch body 121, and the distal opening of the flared section 122 is then sized to be equal to the inner diameter of the branch body 121. At this time, the conduit 4 can enter the branch body 121 along the flared section 122, so as to reduce the jamming caused by the

end portions

4a and 12b abutting each other when the conduit 4 enters the inner branch 12, thereby improving the smoothness of the conduit 4 entering the inner branch 12.

Further, the proximal end of the flared section 122 is provided with a beveled opening 122a, the beveled opening 122a is inclined toward the inside of the tubular body 11 and toward the distal end, and a smooth-surfaced ring (not shown) is provided at the position of the beveled opening 122 a. Thus, when the conduit 4 enters the inner branch 12, even if the end 4a of the conduit 4 abuts against the end 12b of the inner branch 12, the end 4a of the conduit 4 slides down along the bevel 122a and falls into the flared section 122 and further enters the branch body 121 under the guidance of the bevel 122a and the ring.

Specifically, since the bevel 122a is disposed obliquely from the proximal end to the distal end, when the end 4a of the catheter 4 abuts against the bevel 122a, the abutting pressure of the catheter 4 against the bevel 122a is decomposed into a force F1 perpendicular to the plane of the bevel 122a and a force F2 along the plane of the bevel 122 a. The upper edge of the bevel 122a is connected to the inner wall 11b of the tubular main body 11, and since the force F2 along the surface of the bevel 122a is transmitted to the upper edge of the bevel 122a of the inner branch 12, the inner wall 11b of the tubular main body 11 can provide a better supporting effect for the bevel 122a, and the force F2 along the surface of the bevel 122a is weakened. Therefore, the possibility that the pipe 4 deforms the top of the end portion 12b of the inner branch 12 is greatly reduced, so that the bevel 122a can be maintained to have a larger opening area, which facilitates the pipe 4 to enter the flared section 122 from the bevel 122a, and then smoothly enter the interior of the branch body 121.

The supporting force of the ring is greater than the supporting force of the proximal end 121a of the branch body 121, specifically, the supporting force of the ring in the axial direction is greater than the supporting force of the proximal end 121a of the branch body 121 in the axial direction, and the supporting force of the ring in the radial direction is greater than the supporting force of the proximal end 121a of the branch body 121 in the radial direction, so that when the end 4a of the catheter 4 abuts against the ring, because the supporting property of the ring is higher relative to the proximal end 121a of the branch body 121, the flared section 122 supported by the ring is not easy to collapse, so that the flared section 122 at the bevel 122a can maintain a larger opening area, so that the end 4a of the catheter 4 has a greater probability of entering the flared section 122. And because the surface of the collar is smooth, the end 4a of the conduit 4 can be held against and slide down the collar into the flared section 122, with the collar providing sufficient support.

In some embodiments, the bevel 122a is inclined from the inner wall 11b of the tubular body 11 towards the central axis z of the tubular body 11, so that the catheter 4, when entering the interior of the tubular body 11, is more easily directed towards the opening at the proximal end of the inner branch 12, and thus can enter the inner branch 12 more smoothly.

For ease of understanding, as shown in fig. 8(a), in the extending direction along the central axis z of the tubular body 11, a portion of the bezel 122a closest to the proximal end of the tubular body 11 is referred to as a "top 1221", and correspondingly, a portion of the bezel 122a closest to the distal end of the tubular body 11 is referred to as a "bottom 1222". Since the bezel 122a is inclined toward the inside of the tubular body 11 and biased toward the distal end, the bottom 1222 of the bezel 122a is also the portion of the bezel 122a closest to the distal end of the branch body 121.

Referring to fig. 8(b), the bevel 122a is inclined from the inner wall 11b of the tubular body 11 toward the central axis z of the tubular body 11 and further toward the distal end, which can be understood as that the line m connecting the bottom 1222 of the bevel 122a and the top 1221 of the bevel 122a intersects with the central axis z of the tubular body 11 but is not perpendicular thereto, and meanwhile, the normal f intersecting the line connecting the bottom 1222 of the bevel 122a and the top 1221 of the bevel 122a in the normal f of the plane of the bevel 122a also intersects with the central axis z of the tubular body 11. Specifically, a straight line m connecting the bottom 1222 of the bezel 122a and the top 1221 of the bezel 122a, the central axis z of the tubular body 11, and a normal f intersecting a line connecting the bottom 1222 of the bezel 122a and the top 1221 of the bezel 122a in a normal of a plane in which the bezel 122a is located are coplanar. Under the structural arrangement, the bevel 122a not only can better receive the catheter 4 entering the tubular main body 11, and then is beneficial to operating the catheter 4 to enter the inner branch 12 from the bevel 122a along the preset guide wire 2, but also can keep the tubular main body 11 not to deform after the bevel 122a is fixed on the inner wall of the tubular main body 11, so that the part of the tubular main body 11 connected with the bevel 122a can be ensured to be well attached to the blood vessel wall.

Please refer to fig. 8(c) and 8(d) for a schematic illustration of the process of gradually advancing the catheter 4 into the inner branch 12 under the guidance of the preset guide wire 2. In the process shown in fig. 8(c), the catheter 4 is moved towards the proximal end of the inner branch 12, guided by the pre-guide wire 2, until the end 4a of the catheter 4 abuts against the bezel 122a of the inner branch 12, at a position intermediate the side edges between the bottom 1222 and the top 1221 of the bezel 122 a. The end 4a of the conduit 4 then slides down the ring along the bevel 122 a. Referring to the process shown in fig. 8(d), when the end 4a of the catheter 4 slides down to the position near the bottom 1222, since the preset guide wire 2 inserted into the inner branch 12 is limited by the inner wall of the inner branch 12, the farthest position of the preset guide wire 2 approaching to the central axis z can only abut against the position closest to the central axis z of the proximal end 121a of the branch body 121, and the bottom 1222 of the bevel 122a is closer to the central axis z than the position, so that the catheter 4 is subjected to a pulling force by the preset guide wire 2 that cannot approach the central axis z any more, and the end 4a of the catheter 4 can jump into the inside of the flared section 122 and enter the inside of the branch body 121 smoothly under the guidance of the preset guide wire 2, and the catheter 4 hardly catches up in these processes.

Further, referring to FIG. 9, the minimum angle a between the line m connecting the bottom 1222 of the bezel 122a and the top 1221 of the bezel 122a and the perpendicular line toward the distal end of the top 1221 of the bezel 122a is shown ₁ Is in the range of 45 degrees to 60 degrees, and for the cylindrical tubular body 11, the minimum included angle between the straight line m of the connecting line of the bottom 1222 of the bevel opening 122a and the top 1221 of the bevel opening 122a and the central axis z of the tubular body 11a ₁ Also in the range of 45 to 60 degrees. The angle is also the minimum angle a between the line m connecting the bottom 1222 of the bezel 122a and the top 1221 of the bezel 122a and the inner wall 11b of the tubular body 11 ₁ . Within this angular range, the bevel 122a will better decompose the force applied by the conduit 4 to prevent the flared section 122 from being deformed by the tip, thereby maintaining a larger opening of the flared section 122 for the conduit 4 to enter the inner branch 12 smoothly.

In other embodiments, the bevel 122a may also be inclined from the inner wall 11b of the tubular body 11 toward the inside of the tubular body 11 and not toward the central axis z of the tubular body 11, as long as the bevel 122a is inclined from the inner wall 11b of the tubular body 11 toward the distal end, that is, the top 1221 of the bevel 122a can be as close to the inner wall 11b of the tubular body 11 as possible, so as to sew the top 1221 of the bevel 122a or a portion adjacent to the top 1221 onto the tubular body 11, which can improve the crush-resistant and collapse-resistant performance of the bevel 122a, that is, when the conduit 4 enters the inner branch 12, even if the end 4a of the conduit 4 abuts against the bevel 122a, since the top 1221 of the bevel 122a or a portion adjacent to the top 1221 is sewed onto the tubular body 11, and thus when the end 4a of the conduit 4 continues to be pushed into the inner branch 12, the end 4a of the conduit 4 will slide down along the edge of the bevel 122a without causing the bevel 122a to collapse, the bevel 122a can still maintain a larger opening, so that the end 4a of the conduit 4 can smoothly enter the flared section 122 and then enter the branch body 121 along the flared section 122. At this time, the minimum angle a between the straight line m connecting the bottom 1222 of the bezel 122a and the top 1221 of the bezel 122a and the perpendicular line facing the distal end of the top 1221 of the bezel 122a ₁ Is in the range of 45 to 60 degrees.

The angle between the plane of the bevel 122a and the central axis z of the tubular body 11 is 45 to 60 degrees, so as to transmit the force of the conduit 4 pressing against the bevel 122a to the inner wall 11b of the tubular body 11, and prevent the bevel 122a from collapsing due to compression, thereby maintaining a large enough opening for the conduit 4 to enter the inner branch 12.

The bezel 122a is elliptical in shape. The shape of the bevel 122a may be a regular ellipse or an irregular ellipse, that is, the bevel 122a is substantially elliptical, so that the contour of the bevel 122a is rounded and the conduit 4 can enter the flared section 122.

In other embodiments, the bevel 122a may also have a fan shape, a "U" shape, or other shapes, so that the contour of the bevel 122a includes an arc-shaped section, thereby being more stably connected to the inner wall 11b of the tubular main body 11 by the arc-shaped section, and further improving the support of the bevel 122a by the inner wall 11b of the tubular main body 11, so that the bevel 122a is not easily deformed by being squeezed when the catheter 4 enters the inner branch 12.

In some embodiments, as shown in fig. 10, the loop is made of a metal coil 13a, so that the loop has enhanced compression resistance to provide greater support at the bevel 122a and prevent the bevel 122a from being crushed when the catheter 4 enters the inner branch 12. In other embodiments, as shown in FIG. 11, the ring member may be made of a covering film with stitches 13b densely stitched to the proximal edge of the flared section 122, and the stitches 13b may be made of metal wire to improve the stability of the stitched covering film.

As shown in FIG. 9, the shortest connecting line from the bottom 1222 of the bezel 122a to the proximal end 121a of the branch body 121 forms a smallest included angle a with the central axis z of the tubular body 11 ₂ Is in the range of 30 to 70 degrees. Since the extension direction of the branch body 121 of the inner branch 12 in the tubular body 11 is substantially parallel to the central axis Z of the tubular body 11, in this configuration, the shortest connecting line from the bottom 1222 of the bevel 122a to the proximal end 121a of the branch body 121 has a minimum included angle in the range of 30 degrees to 70 degrees with the central axis of the branch body 121. At this range of angles, the end 4a of the conduit 4 is less likely to jam against the lower edge of the bezel 122a and is more likely to enter the branch body 121 along the flared section 122. Effectively avoid the included angle a ₂ When the angle is too small, the side wall of the flared section 122 corresponding to the bottom 1222 of the bevel 122a is too vertical to achieve the guiding effect, and the end 4a of the guiding tube 4 is easily abutted against the lower edge of the bevel 122a to cause the seizure phenomenon. At the same time, the included angle a is also avoided ₂ If it is too large, the side wall of the flared section 122 corresponding to the bottom 1222 of the bevel 122a is too horizontal and the end 4a of the pipe 4 is not horizontalEasily enters the branch body 121 along the flared section 122.

Example 2

The same or similar parts of the luminal stent 10 of embodiment 2 and the luminal stent 10 of embodiment 1 are not repeated herein, and the main difference between the two parts is that in the luminal stent 10 of embodiment 2, please refer to fig. 12, the luminal stent 10 includes two inner branches 12, the structures of the two inner branches 12 are similar to the structures of the inner branches 12 of embodiment 1, that is, the inner branches 12 include a branch main body 121 and a flared section 122 connected to the proximal end 121a of the branch main body 121, the proximal end of the flared section 122 is provided with an oblique mouth 122a, and the oblique mouth 122a inclines from the inner wall 11b of the tubular main body 11 toward the inside of the tubular main body 11 and toward the distal end. The structure of the inner branch 12 will not be described in detail.

When the two inner branches 12 are connected to the inner wall 11b of the tubular body 11 adjacent to each other, the two inner branches 12 and the inner wall 11b of the tubular body 11 enclose a gap 10 a. If the blood flow at the gap 10a is not smooth, thrombus is easily formed at the gap 10 a. When the formed thrombus is flushed out by the blood flow, the thrombus can flow into the blood vessel along the blood flow to cause the blockage of the blood vessel. For this reason, the inventor proposes to reduce the gap 10a by using the combination structure of the flared sections 122 of the two inner branches 12 to improve the problem that thrombus is easily generated at the gap 10a to cause vessel occlusion. In particular, as shown in connection with fig. 13 and 14, a portion of the edge of the flared section 122 of each of the two inner branches 12 and the inner wall 11b of the tubular body 11 cooperate with each other to at least partially close off the interspace 10a between the two inner branches 12 and the inner wall 11b of the tubular body 11.

In this embodiment, since the two inner branches 12 are both disposed in the tubular body 11, and the respective flared sections 122 are fixed to the inner wall 11b of the tubular body 11, for example, by sewing or gluing, the flared sections 122 of the respective inner branches 12 are connected to the inner wall of the tubular body 11. When a part of the edges of the flared sections 122 of the two inner branches 12 are fitted to each other to close the gap 10a between the inner branch 12 and the inner wall 11b of the tubular body 11, the gap 10a can be reduced, and even the gap 10a can be completely closed, so as to prevent thrombus from being generated at the gap 10 a.

There are several possibilities for the construction of the closure of the interspace 10a with a mutual cooperation of a part of the edges of the flared section 122. For example, as shown in fig. 13 and 14, the flared sections 122 of the two inner branches 12 are connected to each other adjacent to and near the top 1221 of the bezel 122 a. Specifically, in one implementation, after the flaring segments 122 of the two inner branches 12 are respectively fixed to the inner wall 11b of the tubular main body 11, the flaring segments 122 of the two inner branches 12 are pressed against each other, so that the edge of the inclined opening 122a of the flaring segment 122 is closer to the inner wall 11b of the tubular main body 11, and at this time, the places where the flaring segments 122 are pressed against each other are connected, so that the gap 10a can be partially blocked, and the gap 10a is reduced as much as possible, so as to reduce the probability of thrombus at the gap 10 a.

Further, the top 1221 of the bezel 122a of one of the inner branches 12 is fixed, such as sewn or glued, to the top 1221 of the bezel 122a of the other inner branch 12, or other fixing means can be used. The structure of connecting the top 1221 of the bezel 122a of the two inner branches 12 to each other can improve the stability of the connection between the two inner branches 12 and the inner wall 11b of the tubular main body 11 by enhancing the stability of the connection between the two inner branches 12, thereby obtaining better support as a whole; on the other hand, the connection of the top 1221 of the inclined openings 122a of the two inner branches 12 can make the top 1221 approach the inner wall 11b of the tubular body 11 as much as possible, so as to better close the gap 10a between the two inner branches 12 and the inner wall 11b of the tubular body 11, thereby reducing the probability of generating thrombus.

With continued reference to fig. 13 and 14, in some embodiments, the bezel 122a of each of the two inner branches 12 includes a first edge 1201 and a second edge 1202, the first edge 1201 and the second edge 1202 respectively abut opposite sides of the top 1221 of the respective bezel 122a, wherein the first edge 1201 of the bezel 122a of one inner branch 12 is secured to the inner wall 11b of the tubular body 11, the second edge 1202 is connected to the first edge 1201 of the bezel 122a of the other inner branch 12, and the second edge 1202 of the bezel 122a of the other inner branch 12 is secured to the inner wall 11b of the tubular body 11. With this configuration, the gap 10a between the two inner branches 12 and the inner wall 11b of the tubular body 11 is effectively reduced under the plugging of the corresponding side walls of the flared section 122, thereby reducing the probability of thrombus.

Further, the top 1221 of the bezel 122a of each of the two inner branches 12 is fixed to the inner wall 11b of the tubular body 11. Thus, the first edge 1201 of the bevel 122a of one of the two inner branches 12 is completely fixed to the inner wall 11b of the tubular body 11, i.e., any one of the first edges 1201 of the bevel 122a of the inner branch 12 is fixedly connected to the inner wall 11b of the tubular body 11. The second edge 1202 of the bevel 122a of the other inner branch 12 is completely fixed to the inner wall 11b of the tubular body 11, i.e. any position of the second edge 1202 of the bevel 122a of the inner branch 12 is fixedly connected to the inner wall 11b of the tubular body 11. With this arrangement, the connection between the inclined openings 122a of the two inner branches 12 and the inner wall 11b of the tubular inner wall 11 will completely close the gap 10a between the two inner branches 12 and the inner wall 11b of the tubular main body 11, thereby effectively avoiding the generation of thrombus.

As shown in fig. 15 and 16, in some embodiments, the top portions 1221 of the bezel 122a of the two inner branches 12 are curved, and the curved top portions 1221 can be more tightly fixed to the inner wall 11b of the tubular body 11 to better close the gap 10 a. In particular, the top 1221 of the bezel 122a of both inner branches 12 is fixed to the inner wall 11b of the tubular body 11. Since the top 1221 of the bezel 122a is arc-shaped, when the top 1221 of the bezel 122a of the two inner branches 12 are fixed to each other, the top 1221 of the bezel 122a of the two inner branches 12 can completely fit the inner wall 11b of the tubular body 11, so that there is no gap between the inner wall 11b of the tubular body 11 and the top 1221 of the bezel 122a of the two inner branches 12. On the basis, the

edges

1221a, 1221b of the adjacent sides of the bezel 122a of the two inner branches 12 and the top 1221 near the bezel 122a are connected to each other, so that the gap 10a between the two inner branches 12 and the inner wall 11b of the tubular body 11 can be completely closed, thereby effectively preventing the formation of thrombus.

Further, in the embodiment that the top portions 1221 of the oblique openings 122a of the two inner branches 12 are both arc-shaped, the shape of the oblique openings 122a may be modified, so that the orthographic projection of the oblique openings 122a on the cross section of the tubular main body 11 is substantially fan-shaped, so that when the oblique openings 122a of the two inner branches 12 are connected, the oblique openings 122a of the structure can be tightly connected together to enhance the plugging effect, and at the same time, the connection stability of the two inner branches 12 and the tubular main body 11 is improved to obtain better support performance, and the catheter 4 is prevented from being easily jammed when entering the inner branches 12.

Example 3

The same or similar parts of the luminal stent 10 of embodiment 3 and the luminal stent 10 of embodiment 1 or embodiment 2 are not repeated herein, and the main difference is that in the luminal stent 10 of embodiment 3, a support is disposed on the side wall of the flared section 122, and the support is connected with the ring-shaped member, so that the ring-shaped member is stably supported on the inner wall 11b of the tubular main body 11 by the support, thereby further enhancing the supporting effect of the ring-shaped member at the bevel 122a and preventing the flared section 122 from collapsing after being pressed at the bevel 122 a.

In some embodiments, the flared section 122 is provided with a support part near the inner wall of the tubular body 11, so as to stably support the ring-shaped member, thereby enhancing the supporting force of the ring-shaped member on the bevel 122 a. The support member may be a unitary structure with the collar at the bezel 122 a. For example, as shown in fig. 17, after the ring-shaped member is wound into a ring shape by the metal wire 13c, a support rod 13d for connecting the inner wall of the tubular body 11 and/or the branch body 121 is led out, so that the support rod 13d can be used as a support member to provide a better support effect for the ring-shaped member, and further the ring-shaped member can enhance the anti-extrusion performance at the bevel 122a, that is, when the catheter 4 enters the inner branch 12, the flared section 122 is not easily extruded and collapsed by the support of the ring-shaped member and the support rod 13d, so that the bevel 122a has a larger opening, and thus the catheter 4 can enter the flared section 122 from the bevel 122a and enter the branch body 121 along the flared section 122.

In other embodiments, as shown in fig. 18, the ring member 13 and the supporting member 14 are integrally formed by cutting a pipe member. With the structure, the annular part 13 and the support part 14 do not need to be connected through other connection modes, the structure is simple, and the connection between the annular part and the support part is stable, so that the stable supporting effect is provided.

In some embodiments, the support may be an annular metal wave ring. For example, as shown in FIG. 19, the support member 14 is a zigzag-shaped wave ring adapted to the shape of the flared section 122, having peaks 14a and valleys 14b, wherein at least one peak 14a is connected to the base 1222 of the bezel 122a to provide better support.

Referring to fig. 20 and 21, two wave troughs 14b of the supporting member 14 are disposed adjacent to each other corresponding to the bottom 1222 of the bezel 122a, and in general, two adjacent wave troughs 14b corresponding to the bottom 1222 of the bezel 122a are closely adjacent to each other to better support the bottom 1222 of the bezel 122 a. For example, in some embodiments, two troughs 14b are positioned adjacent to each other, and a corner a is formed by a peak 14a between the two troughs 14b ₃ Close to 108 °, i.e. in the presence of an allowable error, the two wave bars 141 constituting the band are substantially parallel. With this arrangement, the two wave bars 141 near the bottom 1222 of the bezel 122a can better support the bezel 122 a. In some embodiments, as shown in fig. 22, two wave crests 14a are disposed adjacent to the bottom 1222 of the bezel 122a, which also provides better support.

It should be noted that, in this embodiment, two wave rods 141 corresponding to the two wave crests 14a may not be connected to each other through the wave trough 14 b. For example, as shown in fig. 22, two wave rods 141 supported at the bottom 1222 of the bevel opening 122a are connected by a steel sleeve 142, which still enables the support 14 to form a complete wave loop to obtain better radial anti-extrusion performance, and then the support 14 can be used to provide better support for the flared section 122, and at the same time, the radial anti-extrusion performance of the flared section 122 can also be improved, so that when the bevel opening 122a is extruded by the catheter 4, the flared section 122 is not easy to collapse, and the smoothness of the catheter 4 during entering is not affected. In other embodiments, the support member 14 may be an undulating ring in the shape of an M-wave, V-wave, sinusoidal wave, or the like.

Example 4

On the basis of the foregoing embodiments 1 to 3, the structure of the bare stent 111 at the proximal end of the lumen stent 10 is improved, so that the bare stent 111 pre-guides the catheter 4, so that the catheter 4 can enter the inner branch 12 more smoothly, and the probability of blockage is reduced.

Specifically, referring to fig. 5 and 23, in the luminal stent 10, a bare stent 111 is correspondingly disposed at the proximal end of the tubular main body 11, and the bare stent 111 is a portion of the tubular main body 11 where the proximal end is anchored with a fixing anchor 111a, and the bare stent 111 is an expandable and contractible structure with several wave rods 1111 connected end to end and in a wave ring shape in a natural state, and has opposite wave crests 1101 and wave troughs 1102. In the anchoring state, the wave crests 1101 of the bare stent 111 are locked to the anchor 111a, and at this time, the wave crests 1111 of the bare stent 111 are inwardly converged by the radial anchoring force of the anchor 111 a.

Referring to fig. 24, before entering the inner branch 12, the catheter 4 needs to pass through the gap 1112 between two adjacent wave bars 1111 and enter the tubular body 11. The inventors found that, after the catheter 4 enters the tubular body 11 through the gap 1112 between the adjacent two wave bars 1111, the position of the end portion 4a of the catheter 4 is difficult to control without guidance, so that the catheter 4 is easily stuck when entering the inner branch 12. In contrast, in the present embodiment, it is proposed to improve a portion of the wave rod 1111 of the bare stent 111, so that the bare stent 111 can pre-guide the catheter 4 in the anchoring state, so that the catheter 4 can enter the inner branch 12 more accurately, and the jamming probability is reduced. Specifically, as shown in fig. 25 and 26, two wave rods 1111 having arc-shaped sections are symmetrically disposed at a portion of the bare stent 111 corresponding to the inner branch 12 in the tubular body 11, and the arc-shaped sections of the adjacent wave rods 1111 form a larger gap 1112 therebetween, so that the wave rods 1111 can radially limit the catheter 4 in the gap 1112 in the anchoring state of the bare stent 111, and the movement space of the catheter 4 in the gap 1112 is larger than that of other linear wave rods.

Further, the spatial area of the gap 1112 formed between two adjacent wave rods 1111 having arc-shaped segments is larger than the gap formed between two other adjacent wave rods 111 of the bare stent 111 located at the same wave trough 1101, so that the catheter 4 can enter the gap 1112 with a larger probability and fall into the inner branch 12 with a larger probability under the guidance of the gap 1112, so as to avoid the end 4a of the catheter 4 from being stuck at the proximal end of the inner branch 12 and failing to enter the inner branch 12. Then, the guiding effect of the gap 1112 formed by the arc-shaped section of the wave rod 1111 on the conduit 4 is utilized to improve the smoothness of the conduit 4 entering the inner branch 12, so as to reduce the probability of jamming. It is understood that the inner branch 12 may be the inner branch 12 having the flared section 122 in any one of embodiments 1 to 3.

Further, the gap 1112 is close to the inner wall 11b of the tubular body 11, and the wave rod 1111 of the bare stent 111 above the inner branch 12 may be S-shaped, and the S-shaped wave rod 1111 includes an arc-shaped section 1111a and a reverse arc-shaped section 1111b connected to the arc-shaped section 1111a, and it is understood that the reverse arc-shaped section 1111b refers to a portion having a reverse bending direction to the arc-shaped section 1111 a. A gap 1112 formed by two arc-shaped segments 1111a arranged in mirror symmetry, close to the inner wall 11b of the tubular body 11, corresponding to the wave trough 1102; accordingly, two opposite arc segments 1111b arranged in mirror symmetry are close to the peak 1101.

In this configuration, when the bare stent 111 is in the anchored state, the reverse arc 1111b of the S-shaped wave rod 1111 adjacent to the wave crest 1101 will be squeezed, so that the two arc 1111a forming the gap 1112 are opened in opposite directions, so as to form a larger gap 1112 at the corresponding place of the wave trough 1102, and thus the catheter 4 passing through the gap 1112 is easier to enter the inner branch 12 close to the inner wall 11b of the tubular body 11 in a near vertical manner, so that there is less risk of being stuck when entering the inner branch 12.

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 various changes and modifications can be made by those skilled in the art without departing from the spirit of the invention, and these changes and modifications are all within the scope of the invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A lumen stent comprises a tubular main body and at least one inner branch which is positioned inside the tubular main body and is respectively communicated with the tubular main body, wherein the inner branch is hollow and has two open ends, and is characterized in that the inner branch comprises a branch main body and a flaring section connected with the near end of the branch main body, the near end of the flaring section is provided with an inclined opening, the inclined opening faces the inside of the tubular main body and inclines towards the far end, and the position of the inclined opening is provided with an annular part with a smooth surface; under the same external force, the supporting force of the annular part is larger than that of the proximal end of the branch main body.

2. The luminal stent of claim 1 wherein the oblique port is inclined distally from the inner wall of the tubular body toward the central axis of the tubular body.

3. The luminal stent of claim 1 wherein the minimum angle between the straight line where the bottom of the beveled edge is connected to the top of the beveled edge and the perpendicular to the distal end of the top of the beveled edge ranges from 45 degrees to 60 degrees.

4. The luminal stent of claim 1 wherein a support member is provided on the sidewall of the flaring segment, the support member being connected to the ring member.

5. A luminal stent as defined in claim 1, wherein the luminal stent comprises two of the inner branches, wherein a portion of the edge of the flared section of each of the two inner branches and the inner wall of the tubular body cooperate to at least partially close the gap between the two inner branches and the inner wall of the tubular body.

6. The luminal stent as defined in claim 5 wherein the top of the oblique mouth of one of the inner branches is secured with the top of the oblique mouth of the other of the inner branches.

7. A luminal stent as claimed in claim 5 or 6 wherein the respective mouths of the two inner branches each comprise a first edge and a second edge, the first edge and the second edge abutting respectively on opposite sides of the top of the respective mouth, wherein the first edge of the mouth of one of the inner branches is secured to the inner wall of the tubular body, the second edge is connected to the first edge of the mouth of the other of the inner branches, and the second edge of the mouth of the other of the inner branches is secured to the inner wall of the tubular body.

8. The luminal stent of claim 6 wherein the beveled edges of the two inner branches are each sector shaped, and the top of the beveled edges of the two inner branches are each secured to the inner wall of the tubular body; the adjacent sides of the oblique openings of the two inner branches are connected with each other by partial edges close to the tops of the oblique openings.

9. The luminal stent of claim 1, wherein the proximal end of the tubular body is provided with a bare stent comprising two adjacent wave bars symmetrically arranged and having arc-shaped segments, the two wave bars being arranged corresponding to the inner branches in the tubular body.

10. The luminal stent of claim 9 wherein the two wave bars are S-shaped and mirror-symmetrically disposed.