CN116407371A - Lumen stent - Google Patents

Lumen stent Download PDF

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Publication number
CN116407371A
CN116407371A CN202111677226.1A CN202111677226A CN116407371A CN 116407371 A CN116407371 A CN 116407371A CN 202111677226 A CN202111677226 A CN 202111677226A CN 116407371 A CN116407371 A CN 116407371A
Authority
CN
China
Prior art keywords
stent
branch
wave
main body
proximal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202111677226.1A
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Chinese (zh)
Inventor
肖本好
明廷伯
杨武龙
阎晋
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to CN202111677226.1A priority Critical patent/CN116407371A/en
Priority to PCT/CN2022/137946 priority patent/WO2023124903A1/en
Publication of CN116407371A publication Critical patent/CN116407371A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A61F2/885Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

The present invention provides a lumen stent comprising: the tubular main body support comprises an anchoring part, the branch support is arranged in a lumen of the main body support and comprises a free end which can move relative to the main body support, and the connecting part is respectively connected with the free end of the branch support and the anchoring part. The lumen stent can reduce the degree of shortening the main body stent driven by the branch stent.

Description

Lumen stent
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a lumen stent.
Background
At present, the vascular diseases can be treated by adopting a minimally invasive interventional technique, and the method has small trauma to patients, high safety and high effectiveness, so that the method is affirmed by doctors and patients, and becomes an important treatment method for the vascular diseases. The interventional treatment method is to implant the vascular stent into the lesion section of the blood vessel of the patient by using a conveying system, the implanted vascular stent can support the blood vessel of the narrow occlusion section or block the interlayer rupture of the blood vessel by expanding, the elastic retraction and the reshaping of the blood vessel are reduced, the lumen blood flow is kept smooth, and the interventional treatment method also has the function of preventing restenosis.
For the intra-luminal treatment of aortic aneurysms or aortic dissection accumulated to branch arteries, the bridging stent technology has the advantages of low intra-operative leakage, good stent integrity, continuous blood supply of the branch arteries during implantation and the like, and becomes a trend of the current treatment of aortic dissection or aortic aneurysms of the branch arteries involved. The bridging support technology can be divided into: branch stent and outer bridging stent technology, wherein branch stent technology has advantages such as convenient assembly, the operation degree of difficulty is relatively low, becomes the hot spot of current research.
The existing branch stent is fixedly connected to the inner wall of the main body stent coating through a suture, for example, the suture is routed from one end of the branch stent to the other end, so that the whole branch stent is ensured to be clung to the inner wall of the main body stent coating. After the stent is implanted to the target position, certain components (e.g., tip) of the conveyor may hook the branch stent during the process of retracting the conveyor from the proximal end to the distal end, so that the branch stent drives the main body stent to shrink.
Disclosure of Invention
The invention provides a lumen stent, which aims to reduce the degree of shortening of a main body stent driven by a branch stent. This object is achieved by:
the invention provides a lumen stent, comprising:
a tubular body stent comprising an anchoring portion;
the branch bracket is arranged in the lumen of the main body bracket and comprises a free end which can move relative to the main body bracket;
the connecting pieces are respectively connected with the free ends of the branch brackets and the anchoring parts.
In one embodiment, the main body support comprises a covering film and a plurality of main body wave rings which are connected with the covering film and are arranged at intervals in the axial direction, the anchoring part comprises a bare wave ring and/or anchor, and the radial supporting force of the bare wave ring is larger than that of the main body wave ring.
In one embodiment, the free end of the branch stent is located at the proximal end of the branch stent and the anchor is located at the proximal end of the main body stent; alternatively, the free end of the branch stent is located at the distal end of the branch stent, and the anchoring portion is located at the distal end of the main body stent.
In one embodiment, the connecting member includes a linear or curved support rod having one end connected to the anchoring portion and the other end connected to the free end of the branch stent.
In one embodiment, the connecting piece comprises an elastic section, and two ends of the elastic section are respectively connected with the anchoring part and the free end of the branch bracket; the elastic segment comprises one or more of a coil spring structure, a planar folded structure, and an elastomeric member.
In one embodiment, the planar folding structure comprises a saw tooth wave comprising saw teeth inclined towards the anchoring portion or towards the branch stent.
In one embodiment, the connector includes a helical segment that extends helically about the axis of the body support entirely, and the helical segment at least partially conforms to and is movable relative to the inner surface of the body support.
In one embodiment, the helical segment comprises a helical structure formed by one or more of a helical spring structure, a planar folded structure, and a helical wrap of elastomeric members.
In one embodiment, the connecting piece is fixedly connected or movably connected with the anchoring portion, and the connecting piece is fixedly connected or movably connected with the free end of the branch bracket.
In one embodiment, the lumen stent comprises two connectors, and the two connectors are respectively arranged at two sides of the branch stent.
In one embodiment, the luminal stent further comprises an intermediate member movably coupled to the anchor member and coupled to at least one connector.
In one embodiment, the luminal stent comprises a first connector and a second connector, the second connector is closer to the axis of the body stent than the first connector, and the second connector has a stiffness less than the stiffness of the first connector.
In the invention, even if the free end of the branch bracket is hooked by the conveyor and pulled in the proximal direction in the process of withdrawing the conveyor from the proximal end to the distal end, the free end can move relative to the main bracket, and the free end is connected with the anchoring part through the connecting piece, so that the force of the conveyor hooking the branch bracket is transferred to the anchoring part with stronger anchoring capability along the connecting piece, and the main bracket is not shortened or shifted due to direct acting on the main tectorial membrane or the main wave ring.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Wherein:
FIG. 1 is a schematic view of a lumen stent according to an embodiment of the present invention;
FIG. 2 is a top view of an attachment section in an embodiment of the invention;
FIG. 3 is a front view of an attachment section in an embodiment of the invention;
FIG. 4 is a schematic plan view of a pair of body bands of the attachment section of FIG. 2;
FIG. 5 is a schematic plan view of a pair of body bands of an attachment segment according to another embodiment of the present invention;
FIG. 6 is a schematic view illustrating a structure of a branch stent according to an embodiment of the present invention;
FIG. 7 is a side view of a transition section of the branch stent of FIG. 6;
FIG. 8 is a front view of an attachment section in another embodiment of the invention;
FIG. 9 is a schematic plan view of a pair of body bands of the attachment section of FIG. 8;
FIG. 10 is a schematic plan view of a pair of body bands of an attachment segment according to yet another embodiment of the present invention;
FIG. 11 is a schematic view showing the structure of a branch stent according to another embodiment of the present invention;
fig. 12 is a schematic structural view of a keel of a branch stent according to another embodiment of the invention;
FIG. 13 is a schematic view of an elastic member according to an embodiment of the present invention;
FIG. 14 is a schematic view of an elastic member according to another embodiment of the present invention;
FIG. 15 is a schematic view of a lumen stent according to an embodiment of the present invention;
FIG. 16 is a schematic view of a lumen stent according to another embodiment of the present invention;
FIG. 17 is a schematic view of the connector of FIG. 16;
fig. 18a and 18b are schematic structural views of a connector according to another embodiment of the present invention;
FIG. 19 is a schematic view showing a structure of a connecting member according to another embodiment of the present invention;
FIG. 20 is a schematic view of a connecting member with a middle piece according to an embodiment of the present invention;
FIG. 21 is a schematic view of a connecting member with an intermediate member according to another embodiment of the present invention;
FIG. 22 is a schematic view of a connector with helical segments according to an embodiment of the present invention;
fig. 23 is a schematic structural view of a connector with helical segments according to another embodiment of the present invention.
Detailed Description
Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of the invention to those skilled in the art.
It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.
Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.
For purposes of more clarity in describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical arts. Specifically, "distal" means the end from which blood flows, and "proximal" means the end from which blood flows, for example, after implantation of a stent, blood flows from the proximal end toward the distal end of the stent; "axial" means its lengthwise direction and "radial" means a direction perpendicular to the "axial direction".
The wave ring is a closed ring structure, also called a wave ring, and can be made of metal elastic material or polymer material by weaving or cutting. The metallic elastic material includes known materials or combinations of various biocompatible materials implanted in medical devices, such as alloys of two or more single metals of cobalt, chromium, nickel, titanium, magnesium, iron, and 316L stainless steel, nitinol, tantalum alloys, etc., or other biocompatible metallic elastic materials. The wave ring has radial expansion capability, can realize radial contraction under the action of external force, and can restore to the original shape and maintain the original shape by self-expansion or mechanical expansion (for example, balloon expansion) after the external force is removed, thereby being capable of being tightly attached to the inner wall of the lumen through the radial supporting force after being implanted into the lumen. The waveform of the wave ring is not limited, and includes Z-shaped wave, M-shaped wave, V-shaped wave, sine wave, etc. The wave ring comprises a plurality of wave crests (also known as proximal peaks), a plurality of wave troughs (also known as distal peaks), and wave rods connecting adjacent wave crests and wave troughs. Wherein one vertex (proximal or distal) and two wavebars connected to the vertex form one wave.
The wave number refers to the number of wave crests or wave troughs, and the number of wave crests and wave troughs in the same wave ring are the same. The wave height refers to the vertical distance between a wave crest and the connecting line of two adjacent wave troughs.
For the shortest axial distance between adjacent waveform units, the waveform unit a and the waveform unit B are taken as an example for illustration, the waveform unit a is located at the proximal end of the waveform unit B, and if the waveform unit a is to be abutted against the waveform unit B, the shortest axial distance required to be moved is the shortest axial distance.
Example 1
As shown in fig. 1 to 3, the lumen stent 100 of the present embodiment includes a main body stent 1 and a branch stent 2.
The main body bracket 1 is of a tubular structure with openings at two ends, and comprises a main body wave ring 11 and a main body coating film 12, wherein a plurality of main body wave rings 11 are axially arranged and connected through the tubular main body coating film 12.
The main body stent 1 comprises at least one attachment section 13, the attachment section 13 is tubular, and the branch stent 2 is arranged in the lumen of the attachment section 13. In the present embodiment, the body band 11 is disposed outside the body cover 12 in the attachment section 13, so as to enhance the friction between the attachment section 13 and the inner wall of the lumen, which is beneficial to prevent the body stent 1 from being displaced and contracted relative to the lumen. In other embodiments, the body wave ring 11 may be disposed inside the body coating 12, or the body coating 12 may be disposed on both the inner and outer sides of the body wave ring 11.
In this embodiment, the cross-sectional shape of the attachment section 13 is generally circular for better fitting to the inner wall of the lumen, and in other embodiments, the cross-sectional shape of the attachment section 13 may be any other suitable shape such as oval.
Referring to fig. 4, in the present embodiment, the attachment section 13 includes a first region 14 and a second region 16 connected to the first region 14 in the circumferential direction. The first region 14 includes a plurality of first waveform elements 15 arranged axially. The second region 16 includes a plurality of second waveform elements 17 arranged axially. The first waveform element 15 and the second waveform element 17 are each part of the body wave band 11. In this embodiment, the first region 14 includes two first waveform units 15 axially arranged, namely a proximal first waveform unit 15a closer to the proximal end and a distal first waveform unit 15b closer to the distal end. The second region 16 also includes two second waveform elements 17, a proximal second waveform element 17a closer to the proximal end and a distal second waveform element 17b closer to the distal end.
Wherein the first waveform element 15 comprises a plurality of high waves with substantially uniform wave heights. The second waveform unit 17 includes a plurality of short waves having substantially uniform wave heights. The ratio of the wave height of the first waveform unit 15 to the wave height of the second waveform unit 17 is 1.2 to 1.8.
The proximal first wave unit 15a comprises a first proximal wave trough 151 and a first proximal wave crest 153, and the distal first wave unit 15b comprises a first distal wave trough 152 and a first distal wave crest 154. The proximal second wave unit 17a comprises a second proximal wave trough 171 and a second proximal wave crest 173, and the distal second wave unit 17b comprises a second distal wave trough 172 and a second distal wave crest 174.
The proximal and distal first wave units 15a, 15b are in opposite phase, i.e. the first proximal wave trough 151 is opposite (close to) the first distal wave trough 154, and the first proximal wave trough 153 is distant (far from) from the first distal wave trough 152, the line connecting at least one first proximal wave trough 151 and the first distal wave trough 154 being substantially parallel to the axis of the main body stent 1.
The proximal and distal second wave units 17a, 17b are opposite in phase, i.e. the second proximal wave trough 171 is opposite to the second distal wave trough 174, and the second proximal wave trough 173 is separated from the second distal wave trough 172, and the line connecting at least one of the second proximal wave trough 171 and the second distal wave trough 174 is substantially parallel to the axis of the main body stent 1. Alternatively, the proximal second waveform element 17a and the distal second waveform element 17b have a phase difference, that is, the second proximal trough 171 is opposite to the second distal peak 174, and the connection line between any second proximal trough 171 and the second distal peak 174 has an included angle with the axis of the main body stent 1.
Referring to fig. 4, in this embodiment, first proximal valleys 151 and second proximal valleys 171 lie in substantially the same radial plane, and first distal valleys 152 and second distal valleys 172 also lie in substantially the same radial plane.
Referring to fig. 5, in other embodiments, the first proximal peaks 153 and the second proximal peaks 173 lie in substantially the same radial plane, as do the first distal valleys 152 and the second distal valleys 172. This arrangement is advantageous in increasing the axial distance between adjacent second undulating units 17, making the second region 16 more flexible, and when the second region 16 is implanted on the small curved side of the aortic arch (i.e., the side with a larger degree of curvature and a smaller radius of curvature), it can conform to the curved shape of the small curved side more, thereby increasing the friction between the main body stent 1 and the inner wall of the lumen, and further preventing foreshortening; in addition, in fig. 5, the proximal first waveform unit 15 and the distal first waveform unit 15b can be manufactured by the same mold (or tooling), and the proximal second waveform unit 17a and the distal second waveform unit 17b can also be manufactured by the same mold (or tooling), so that the manufacturing process is simpler and more efficient.
In the present embodiment, the shortest axial distance (also called axial pitch) between two adjacent first waveform units 15 is smaller than the shortest axial distance between two adjacent second waveform units 17. For example, the shortest axial distance between adjacent first waveform units 15 is 0 to 2 mm. In other embodiments, the first region 14 includes more than two first waveform elements 15, and the second region 16 includes more than two second waveform elements 17, so that the shortest axial distance between any two adjacent first waveform elements 15 is smaller than the shortest axial distance between any two adjacent second waveform elements 17.
Since the shortest axial distance between two adjacent first waveform elements 15 in the first region 14 is smaller than the shortest axial distance between two adjacent second waveform elements 17, and the wave height of the first waveform elements 15 is larger than the wave height of the second waveform elements 17. Therefore, when the first region 14 is axially contractible by an external force, the axial contractible amount of the first region 14 is smaller than the axial contractible amount of the second region 16, and the axial lengths of the first region 14 and the second region 16 are the same in the present embodiment, so that the axial contractible rate of the first region 14 is smaller than the axial contractible rate of the second region 16. The axially contractible rate refers to the ratio of the length of the axially contractible rate to the axial length of the naturally expanding state when the axially contractible rate is not contracted any more under the action of an axial pressure F (for example, F is more than or equal to 1N and less than or equal to 2N). The axial shortness of the first and second regions 14, 16 can be measured by the following method: in the natural expansion state, the length of the region to be measured (the first region 14 or the second region 16) is a, the diameter is d, the attachment section 13 is sleeved in an inner tube (for example, a smoother inner tube) with the diameter of 0.9d, axial pressure (for example, 1N-2N) is uniformly applied to two ends of the region to be measured, once the region to be measured has a position where the region to be measured cannot be contracted any more, the application of the axial pressure is stopped, the axial length of the region to be measured is b, and the axial contraction rate of the region to be measured is (a-b)/a x 100%.
It should be noted that the shortest axial distance between the adjacent first waveform elements 15 is suitable, and the excessively long shortest axial distance makes the axial shortability of the first region 14 excessively large, and when the excessively short shortest axial distance makes the first waveform elements 15 extend to both ends due to radial compression, opposite peaks and valleys on the adjacent first waveform elements 15 are easily stacked together, thereby increasing the difficulty of assembling the lumen stent 100 and increasing the assembling force.
The surface of the attachment section 13 is provided with a window 131, and the window 131 is opened at a position without a wave ring on the main body covering film 12. For example, the surface of the main body holder 1 may form a recessed section 18, the attachment section 13 is provided with a slope 132 connected to the recessed section 18, the slope 132 is formed by a part of the main body cover 12, and the slope 132 may be provided with a window 131. The concave section 18 can provide a larger expansion space for the bridging stent at the connecting position of the bridging stent and the main body stent 1 when the bridging stent (not shown) is implanted, so that the bridging stent is not easy to block when and after being implanted.
The branch stent 2 is arranged in the lumen of the attachment section 13, and the inner cavity of the branch stent 2 is communicated with the window 131, so that the implanted bridging stent can be smoothly inserted into the branch stent 2 through the window 131. In other embodiments, the body stent 1 may omit the window, the lumen of the branch stent 2 may be in communication with the lumen of the body stent 1, and the bridging stent may enter the body stent 1 from the distal end of the body stent 1 and plug onto the branch stent 2.
Referring to fig. 6, the branched stent 2 includes a branched wave ring 21 and a branched coating film 22, and a plurality of branched wave rings 21 are connected by the branched coating film 22. The branch stent 2 comprises two branch vessels 23 and a transition piece 24. The distal end of the transition section 24 is sealingly connected to the window 131 (see fig. 1), and the distal ends of the two branch pipe bodies 23 are connected to the proximal end of the transition section 24, and the proximal ends of the branch pipe bodies 23 are free ends and are disposed toward the proximal end of the main body holder 1. The branch pipe body 23 and the transition section 24 may be in an integral structure, and are formed by arranging a plurality of branch wave rings 21 at intervals and coating the inner side and/or the outer side thereof. In the natural deployment state, the axis of the branch pipe body 23 is approximately parallel to the axis of the main body stent 1, so that the difficulty of implantation of the bridging stent can be reduced to a certain extent and the blood flow in the lumen of the main body stent 1 is not greatly influenced. In other embodiments, the angle between the axial direction of the branch pipe body 23 and the axial direction of the main body bracket 1 may be any other angle in the range of 0 ° to 15 °. In addition, the number of the branch pipe bodies 23 is not limited, and one or more than two branch pipe bodies can be used, and the number and the positions of the bridging supports can be correspondingly set and selected according to the needs, so that the requirements of emergency operation can be met in clinical use, and the situation that the optimal treatment opportunity is missed due to long waiting time for customization can be avoided. The branch film 22 on the branch stent 2 may be formed by joining a plurality of films by stitching, adhesion, or the like.
Referring to fig. 7, the transition section 24 includes an arc-shaped sheet 241 and a relatively flat bottom plate 242, wherein the arc-shaped sheet 241 and the bottom plate 242 enclose a tubular structure with a substantially crescent-shaped cross section, and the arc-shaped sheet 241 is disposed closer to the inner wall of the attachment section 13 than the bottom plate 242, so that the transition section 24 is better adhered to the inner wall of the attachment section 13. In addition, the transition section 24 includes a small diameter end connected to the distal end of the branch pipe body 23 and a large diameter end connected to the window 131. The radial dimension of the small diameter end is matched with the radial dimension of the branch pipe body 23, and the radial dimension of the large diameter end is matched with the dimension of the window 131, so that the small diameter end is in sealing connection with the branch pipe body 23, and the transition section 24 is in sealing connection with the window 131. The transition section 24, the window 131 and the branch pipe body 23 can be connected by sewing, bonding, etc. The edge of the large diameter end of the transition section 24 or the edge of the window 131 may also be provided with a first annular support to keep the form of the window 131 stable.
The window 131 of the present invention is not limited in shape and may be circular, oval, crescent-shaped, or any other shape, and the radial dimension of the window 131 is larger than the radial dimension (e.g., diameter) of the branch pipe body 23, thereby facilitating the implantation of the bridging stent. In other embodiments, a plurality of windows 131 and a plurality of branch stents 2 may be further disposed on the surface of the main body stent 1, where the plurality of windows 131 are disposed at intervals along the axial direction of the main body stent 1, so that a specific fixing position of the main body stent 1 may be adjusted according to the structure of an arterial vessel, thereby performing the reconstruction of the blood vessel of a plurality of branch vessels. It will be appreciated that in this embodiment, the branch pipe body 23 of the branch stent 2 is closer to the proximal end of the main stent 1 than the transition section 24, and in other embodiments, the branch pipe body 23 of the branch stent 2 may be closer to the distal end of the main stent 1 than the transition section 24, or when a plurality of branch stents 2 are provided, a part of the branch pipe bodies 23 of the branch stents 2 are closer to the proximal end of the main stent 1 and a part of the branch stents 2 are closer to the distal end of the main stent 1.
Referring to fig. 1-3, in the present embodiment, the branch stent 2 is connected to the first region 14, and the distance from the branch stent 2 to the first region 14 is smaller than the distance from the branch stent 2 to the second region 16. Because the branch bracket 2 is connected with the first area 14 with lower axial shortening rate, even if the branch bracket 2 is hooked by the conveyor and drives the main bracket 1 to deform, the first area 14 connected with the branch bracket 2 can greatly reduce the shortening rate of the main bracket 1.
In this embodiment, the branch stent 2 is attached to the inner wall of the first region 14, and the tangential region of the branch stent 2 and the first region 14 is sewn and fixed with each other by a suture. For example, a tangent line extending approximately along the axial direction is arranged between the branch pipe body 23 and the inner wall of the first region 14, the tangent point (i.e. along the tangent line) between the branch pipe body 23 and the inner wall of the first region 14 is used for sewing and fixing the branch pipe body 23 and the first region 14 by a suture, so that a plurality of fixing points are formed on the tangent line between the branch pipe body 23 and the inner wall of the first region 14, wherein the fixing points are arranged on the proximal end port (i.e. the free end 20 a) and the distal end port of the branch pipe body 23, and a second annular supporting piece can be arranged on the free end 20a of the branch pipe support 2, so that the form of the branch pipe support 2 is not greatly changed under the impact of blood flow or when the branch pipe support 2 is hooked by a conveyer, and the branch pipe support 2 is effectively prevented from shrinking. In addition, the side of the transition section 24 that is attached to the first region 14 (i.e., the arcuate sheet 241) may be connected to the first region 14 by a suture to provide a better attachment of the transition section 24 to the inner wall of the first region 14, and to minimize the gap between the transition section 24 and the first region 14, thereby avoiding blood pooling in the gap and thrombosis. In other embodiments, the transition section 24 is connected to the window 131 at only one end and the branch pipe body 23 at the other end, and the other area may not be fixed to the first area 14. In other embodiments, the branch stent 2 and the first region 14 may be fixedly connected by adhesion or the like.
Referring to fig. 1 and 4, the length and position of the branch pipe 23 have an effect on performance. In this embodiment, the ratio of the length of the branch pipe body 23 to the wave height of the first waveform unit 15 may be 0.5-2.2, where the proximal end port of the branch pipe body 23 and the peak of the proximal first waveform unit 15a are located on the same radial plane, or the proximal end port of the branch pipe body 23 is located between the first proximal end peak 153 and the first distal end trough 152. The purpose of this is to locate the branch pipe body 23 in the first region 14 where the first wave unit 15 is supported, so that it is more difficult for the branch pipe bracket 2 to drive the main body bracket 1 to contract.
Example 2
Referring to fig. 8 and 9, the present embodiment is substantially the same as the lumen stent 100 of embodiment 1, except for the structures of the first and second wave units 35 and 37 in the attachment section 13 and the connection manner of the branch stent 2 and the first region 14.
As shown in fig. 9, the first waveform unit 35 and the second waveform unit 37 are each a part of the body wave band 11. In this embodiment, the first region 14 includes two first waveform units 35 axially arranged, a proximal first waveform unit 35a closer to the proximal end and a distal first waveform unit 35b closer to the distal end. The second region 16 also includes two second waveform elements 37, a proximal second waveform element 37a closer to the proximal end and a distal second waveform element 37b closer to the distal end.
Wherein the phases of the proximal first waveform element 35a and the distal first waveform element 35b are opposite. The phases of the proximal second waveform element 37a and the distal second waveform element 37b are opposite; alternatively, the proximal second waveform element 37a and the distal second waveform element 37b have a phase difference. Wherein the wave height of the first waveform element 35 is greater than the wave height of the second waveform element 37. The proximal first wave unit 35a comprises a plurality of first proximal wave crests 353 lying in substantially the same radial plane and a plurality of first proximal wave troughs 351 lying in substantially the same radial plane, and the distal first wave unit 35b likewise comprises a plurality of first distal wave crests 354 lying in substantially the same radial plane and a plurality of first distal wave troughs 352 lying in substantially the same radial plane. The proximal second wave unit 37a comprises a plurality of second proximal wave crests 373 lying in substantially the same radial plane, and a plurality of second proximal wave troughs 371 lying in different radial planes. The distal second wave unit 37b includes a plurality of second distal wave troughs 372 lying in substantially the same radial plane and a plurality of second distal wave crests 374 lying in different radial planes. The second proximal valleys 371 circumferentially closer to the first area 14 are axially closer to the proximal end of the body stent 1 and/or the second distal peaks 374 circumferentially closer to the first area 14 are axially closer to the distal end of the body stent 1. For example, in the present embodiment, in the proximal second waveform units 37a, the second proximal peaks 373 are each closer to the distal end than the first proximal peaks 353, the second proximal valleys 371 are each closer to the proximal end than the first proximal valleys 351, and the second proximal valleys 371, which are farther from the proximal first waveform units 35a, are offset more proximally with respect to the first proximal valleys 351. As shown in FIG. 9, the line connecting the second proximal valleys 371 forms an angle α with the radial plane of 0 < α.ltoreq.20°. In other embodiments, the line connecting the second proximal valleys 371 may not be straight, for example, may be stepped. In the distal second waveform element 37b, the second distal valleys 372 are each closer to the proximal end than the first distal valleys 352, the second distal peaks 374 are each closer to the distal end than the first proximal peaks 353, and the second distal peaks 374 farther from the distal first waveform element 35b are offset distally from the first distal peaks 354 by a greater distance. For example, the line connecting the second distal peaks 374 forms an angle β with the radial plane, 0 < β+.20°. In other embodiments, the line connecting the second distal peaks 374 may not be straight, for example, may be stepped. Because the second proximal valleys 371 are distributed on different radial planes and the second distal peaks 374 are distributed on different radial planes, when the second wave unit 37 is radially compressed, the second proximal valleys 371 and the second distal peaks 374 will not be stacked on the same radial plane, thereby reducing the radial compression size and assembly difficulty of the lumen stent 100 while ensuring the same radial force; in addition, when the second wave unit 37 is implanted to the small curve side of the aortic arch, the curved shape of the small curve side can be more fitted, thereby increasing the friction force of the main body stent 1 and the inner wall of the lumen, further preventing shortening.
In the present embodiment, the shortest axial distance (also called axial pitch) between two adjacent first waveform units 35 is smaller than the shortest axial distance between two adjacent second waveform units 37. For example, the shortest axial distance between adjacent first waveform units 35 is 0 to 2 mm. In other embodiments, the first region 14 includes more than two first waveform elements 35, and the second region 16 includes more than two second waveform elements 37, such that the shortest axial distance between any two adjacent first waveform elements 35 is less than the shortest axial distance between any two adjacent second waveform elements 37.
Since the shortest axial distance between two adjacent first waveform cells 35 in the first region 14 is smaller than the shortest axial distance between two adjacent second waveform cells 37, and the wave height of the first waveform cells 35 is larger than that of the second waveform cells 37. The first region 14 is axially collapsible by a smaller amount than the second region 16 when it is subjected to an external force. Thus, the axial shortness of the first zone 14 is less than the axial shortness of the second zone 16. The first region 14 enables the degree of shortening of the main body stent 1 to be greatly reduced even if the main body stent 1 is driven by the branch stent 2.
Referring to fig. 8, in the present embodiment, the branch pipe body 23 can be connected to the first region 14 by sewing as well. For example, a tangential line extending in a substantially axial direction is provided between the branch pipe body 23 and the inner wall of the first region 14, and the suture can be routed from the distal end of the branch pipe body 23 in a proximal direction (or from the proximal end to the distal end) along the tangential line, and the suture is ended at a position close to the proximal end of the branch pipe body 23, so that the branch pipe body 23 has a fixed section fixed to the first region 14 in a suture manner and located at the distal end and a movable section (at least including the free end 20a of the branch pipe support 2) movable relative to the main body support 1 and located at the proximal end, wherein the ratio of the length of the movable section to the length of the fixed end is 0.1-1, so as to ensure that the movable section can move relatively flexibly relative to the main body support 1, and avoid unstable form of the branch pipe body 23 under the impact of blood flow. For the transition section 24, the side of the transition section 24 that is attached to the first region 14 (i.e., the arcuate sheet 241) may be connected to the first region 14 by a suture, so that the transition section 24 may better attach to the inner wall of the first region 14, and the gap between the transition section 24 and the first region 14 may be reduced as much as possible, so as to avoid blood from accumulating in the gap and causing thrombosis. In other embodiments, the transition section 24 is connected to the window 131 (see fig. 1) at only one end and the branch pipe body 23 at the other end, and the other region may not be fixed to the first region 14. In other embodiments, the branch stent 2 and the first region 14 may be fixedly connected by adhesion or the like.
In this embodiment, by providing the branch stent 2 with the movable free end 20a, even if the free end 20a of the branch stent 2 is hooked by the conveyor and pulled in the proximal direction during the process of withdrawing the conveyor from the proximal end to the distal end, the free end 20a can move relative to the main body stent 1, so that the force of the branch stent 2 driving the main body stent 1 to move in the distal direction can be weakened to a certain extent, and the risk that the branch stent 2 driving the main body stent 1 to shrink is reduced.
The position at which the branch stent 2 is disposed and the position of the fixing point of the branch stent 2 to the first region 14 also have an influence on the shrink-proof performance. In this embodiment, the free end 20a of the branch stent 2 is substantially flush with the first proximal peak 353, or, alternatively, the free end 20a of the branch stent 2 is located between the first proximal peak 353 and the first proximal trough 351; and the most proximal fixation point between the branch stent 2 and the first region 14 is located between the first proximal crest 353 and the first proximal trough 351. Even if the main body stent 1 is driven to move distally by the branch stent 2 of the present embodiment, only the region near the proximal first waveform unit 35a is driven to move distally, and the shortest axial distance between the proximal first waveform unit 35a and the distal first waveform unit 35b is small, so that the shortening degree of the main body stent 1 is greatly reduced.
Example 3
Referring to fig. 10 and 11, the present embodiment is substantially the same as the lumen stent 100 of embodiment 1 and embodiment 2, except for the structures of the first wave unit 45, the second wave unit 47 and the branch stent 2, and the connection manner of the branch stent 2 and the first region 14.
Referring to fig. 10, the first proximal crest 453 of the proximal first wave unit 45a is substantially in the same radial plane as the second distal crest 473 of the proximal second wave unit 47a, the first proximal trough 451 of the proximal first wave unit 45a is substantially in the same radial plane as the second proximal trough 471 of the proximal second wave unit 47a, the first distal crest 454 of the distal first wave unit 45b is substantially in the same radial plane as the second distal crest 474 of the distal second wave unit 47b, and the first distal trough 452 of the distal first wave unit 45b is substantially in the same radial plane as the second distal trough 472 of the distal second wave unit 47 b. I.e. the wave height of the first wave unit 45 is approximately equal to the wave height of the second wave unit 47. Further, the phases of the proximal first waveform element 45a and the distal first waveform element 45b are opposite. The proximal second wave shaped elements 47a and the distal second wave shaped elements 47b are in the same phase, i.e. the line connecting the second proximal wave troughs 471 and the second distal wave troughs 472 is substantially parallel to the axis of the main body stent 1, and the line connecting the second proximal wave crests 473 and the second distal wave crests 474 is substantially parallel to the axis of the main body stent 1. In other embodiments, there may be a phase difference between the proximal second waveform element 47a and the distal second waveform element 47 b.
In the present embodiment, the shortest axial distance (also called axial pitch) between two adjacent first waveform units 45 is smaller than the shortest axial distance between two adjacent second waveform units 47. For example, the shortest axial distance between adjacent first waveform units 45 is 1 to 2 mm. In other embodiments, the first region 14 includes more than two first waveform elements 45, and the second region 16 includes more than two second waveform elements 47, such that the shortest axial distance between any two adjacent first waveform elements 45 is less than the shortest axial distance between any two adjacent second waveform elements 47.
Since the shortest axial distance between two adjacent first waveform elements 45 in the first region 14 is smaller than the shortest axial distance between two adjacent second waveform elements 47, the wave height of the first waveform elements 45 is substantially equal to the wave height of the second waveform elements 47. Therefore, when the first region 14 is axially contractible by an external force, the first region is axially contractible by a smaller amount than the second region 16, and thus the first region 14 is axially contractible by a smaller amount than the second region 16. The first region 14 enables the degree of shortening of the main body stent 1 to be greatly reduced even if the main body stent 1 is driven by the branch stent 2. In addition, in the present embodiment, the wave height of the first wave unit 45 is approximately equal to the wave height of the second wave unit 47, and compared with the design of the high-low wave, the hollow membrane region (i.e., the region where the main body membrane 12 is not covered on the wave unit) in the attachment section 13 of the present embodiment is more uniform and round in the circumferential direction, and in the bending state, a large amount of membrane accumulation on one side is not easy to be caused.
Referring to fig. 11, in this embodiment, the branch pipe body 23 of the branch bracket 2 is further provided with a linear or curved keel 25, and the keel 25 may be of a rigid or flexible structure, and may be made of an alloy of two or more of cobalt, chromium, nickel, titanium, magnesium, iron, 316L stainless steel, nickel-titanium-tantalum alloy, or other biocompatible metal elastic materials. The keel 25 connects the most proximal branch loop 21 and the most distal branch loop 21 to prevent the branch stent 2 from collapsing to some extent. In other embodiments, the keel 25 may also extend to the transition piece 24 of the branch stent 2.
Referring to fig. 12, in other embodiments, the keel 25 is provided on the outer surface of the branch stent 2, and the branch stent 2 is connected to the main body stent 1 through the keel 25, so that the main body stent 1 is prevented from being contracted to some extent because the keel 25 is connected to the main body stent 1. The proximal end of the keel 25 may pass over the proximal end port of the branch stent 2 to improve resistance to foreshortening. Further, the proximal end of the keel 25 may further extend proximally and abut against the bare wave 11a, thereby more effectively preventing the branch stent 2 and the main body stent 1 from shrinking. In other embodiments, the proximal end of the keel 25 may also be located between the proximal port of the branch stent 2 and the bare eye 11a, not abutting the bare eye 11 a.
Example 4
Referring to fig. 13, this embodiment is substantially identical to the luminal stent 100 of embodiments 1-3, except that one or more elastic members 56 are provided between adjacent first undulating units 55. The elastic member 56 may be integrally woven or cut with the first wave unit 55, or may be connected to the first wave unit 55 by bonding, welding, or the like.
The first waveform unit 55 and the second waveform unit 57 shown in fig. 13 are substantially the same as those of embodiment 1. The elastic member 56 includes a spring section having one end connected to the trough of the proximal first wave unit 55a and the other end connected to the peak of the distal first wave unit 55b, and having opposite peaks and troughs connected thereto.
The first waveform unit 55 and the second waveform unit 57 shown in fig. 14 are substantially the same as the first waveform unit 55 and the second waveform unit 57 of embodiment 1, except that the phases of adjacent first waveform units 55 are the same. The spring 56 is a wire of biocompatible metallic spring material that includes at least one wave including a Z-shape, an M-shape, a V-shape, a sinusoidal shape, etc. One end of the elastic member 56 is connected to the wave rod of the proximal first wave unit 55a, and the other end is connected to the wave rod of the distal first wave unit 55 b.
In this embodiment, the elastic member 56 is provided, and the elastic member 56 has a certain elasticity in the axial direction. Referring to fig. 1, when the branch stent 2 applies a force to the first region 14 for moving distally, the elasticity of the elastic member 56 can play a role of buffering to a certain extent, and thus the main body stent 1 can be effectively prevented from shrinking regardless of the structure of the first waveform unit 55. Furthermore, the resilient members 56 may prevent opposing peaks and valleys on adjacent first wave units 55 from stacking together when the attachment segments 13 are in a radially compressed state.
Example 5
Referring to fig. 15, this embodiment is substantially the same as the lumen stent 100 of embodiments 1 to 4, except that the lumen stent 100 of this embodiment further includes a connector 19, and the main body stent 1 includes an anchor portion 10.
In this embodiment, the anchoring portion 10 is disposed at the proximal end of the main body stent 1, and after the lumen stent 100 is implanted in the lumen of a human body, the anchoring portion 10 and the inner wall of the lumen of the human body form an anchor, so that the main body stent 1 can be prevented from being displaced during surgery and in a long term to some extent.
In this embodiment, the anchoring portion 10 includes one or more bare wave rings 11a disposed at the proximal end of the main body support 1, where the bare wave rings 11a are fixedly connected to the proximal end of the main body covering film 12, and at least part of the bare wave rings 11a are exposed, that is, the main body covering film 12 only partially covers the bare wave rings 11a or does not cover the bare wave rings 11a.
In other embodiments, the anchoring portion 10 may further include one or more anchors (not shown) provided on the bare eye 11a, for example, the plurality of peaks of the bare eye 11a may extend proximally with anchor posts provided with anchors integrally formed with the anchor posts, and the anchors may extend outwardly from the anchor posts at which they are located and may be directed distally. After the lumen stent 100 is implanted in the lumen of the human body, the anchor points can form reliable fixed connection between the proximal end of the main body stent 1 and the inner wall of the lumen of the human body, thereby further improving the anchoring force between the anchoring portion 10 and the inner wall of the lumen of the human body. It will be appreciated that in other embodiments, the anchoring portion 10 may omit the nude eyelet 11a, and the anchoring thorns in the anchoring portion 10 may be directly connected to the proximal edge of the body stent 1, as well as provide an anchoring effect.
In the present embodiment, the radial supporting force of the bare wave 11a is greater than the radial supporting force of the main body wave 11. For example, the ratio of the radial supporting force of the single bare wave 11a to the radial supporting force of the single body wave 11 ranges from 1.1 to 2. The radial supporting force of the bare wave ring 11a and the main wave ring 11 can be adjusted by adjusting parameters such as materials, wire diameters, wave angles, wave heights, wave numbers and the like of the bare wave ring 11a and the main wave ring 11. For example, when other parameters of the bare wave ring 11a and the main body wave ring 11 are the same, the rigidity of the material of the bare wave ring 11a may be made larger than the rigidity of the material adopted by the main body wave ring 11, so that the radial supporting force of the bare wave ring 11a is made larger than the radial supporting force of the main body wave ring 11; when the bare wave ring 11a and the main wave ring 11 are made of the same material, other waveform parameters can be kept the same, so that the wire diameter of the bare wave ring 11a is larger than that of the main wave ring 11, and the radial supporting force of the bare wave ring 11a is larger than that of the main wave ring 11.
Since the bare wave ring 11a is at least partially exposed, and the radial supporting force of the bare wave ring 11a is relatively large, the bare wave ring 11a can have better anchoring capability, i.e. can better resist the capability of generating axial relative displacement after the lumen stent 100 is implanted into the lumen of a human body.
In this embodiment, the free end 20a of the branch pipe body 23 is movable relative to the main body bracket 1. For example, a tangential line extending approximately axially is provided between the branch pipe body 23 and the inner wall of the main body support 1, the distal end of the branch pipe body 23 can be stitched along the tangential line in a proximal direction (or in a proximal-to-distal direction), and the stitching is finished at a position close to the proximal end of the branch pipe body 23, so that the branch pipe body 23 is provided with a fixed section which is stitched to the main body support 1 and is positioned at the distal end, and a movable section (at least comprising the free end 20a of the branch support 2) which is movable relative to the main body support 1 and is positioned at the proximal end, wherein the ratio of the length of the movable section to the length of the fixed end is 0.1-1, so that the movable section can move relatively flexibly relative to the main body support 1, and unstable form of the branch pipe body 23 under the impact of blood flow can be avoided. For the transition section 24, the side of the transition section 24, which is attached to the main body support 1, can be connected with the main body support 1 through a suture, so that the transition section 24 is attached to the inner wall of the main body support 1 better, and the gap between the transition section 24 and the main body support 1 can be reduced as much as possible, and the thrombus formation caused by blood accumulation in the gap can be avoided. In other embodiments, the transition section 24 is connected to the window 131 (see fig. 1) at only one end, and the branch pipe body 23 at the other end, and other areas may not be fixed to the main body bracket 1. In addition, in other embodiments, the fixing connection manner of the branch bracket 2 and the main body bracket 1 may be adhesion, hot melting, or the like.
The free end 20a of the branch pipe body 23 is connected to the anchor portion 10 via a connector 19. In this embodiment, the connection member 19 includes a support rod, one end of which is connected to the anchoring portion 10 (for example, the bare wave 11a of the anchoring portion 10), and the other end of which is connected to the free end 20a of the branch stent. For example, one end of the support rod is fixedly connected to the anchoring portion 10 by welding, bonding, hot melting, sewing, winding, or the like, and the other end of the support rod may be fixedly connected to one or more of the branching wave ring 21 at the proximal end of the branching pipe body 23, the branching coating film 22 at the free end 20a, and the second annular support.
The supporting rod can be made of biocompatible polymer materials, metal materials and the like, the diameter of the supporting rod is 0.05-0.3 mm, the specific shape of the supporting rod is not required, and the supporting rod can be linear and/or curved.
In this embodiment, the support rod is integrally attached to the surface of the main body support 1, and the support rod can move relative to the main body cover 12, so that at least a part of the area of the branch support 2 (for example, the free end 20a of the branch support 2) can move relative to the main body support 1 under the action of an external force, can deform within a certain range, and can be restored to the original position after the external force is removed. During the withdrawal of the conveyor from the proximal end to the distal end, even if the free end 20a of the branch stent 2 is hooked by the conveyor and pulled in the proximal direction, the free end 20a can move relative to the main body stent 1, and the free end 20a is connected to the anchoring portion 10 by the connecting member 19, so that the force of the conveyor hooking the branch stent 2 is transmitted to the anchoring portion 10 having a stronger anchoring capability along the connecting member 19 without causing the main body stent 1 to be shortened or displaced by directly acting on the main body stent graft 12. When the force of hooking the conveyor is removed, the free end 20a of the branch stent 2 can be restored to the original position again.
In other embodiments, the support rod may be movably coupled to the anchor 10 and/or the free end 20 a. For example, a movable connection may be provided at the end of the support rod, the movable connection comprising a collar and/or a winding (e.g., the winding comprising a helically wound filament) that is movably connected to the anchor 10 and/or free end 20a such that the support rod is movable in a longitudinal or circumferential direction relative to the anchor 10 and/or free end 20 a. The advantage of this arrangement is that when the luminal stent 100 is in a radially compressed state or when the luminal stent 100 is impacted by blood, the distance between the free ends 20a of the main stent 1 and the branch stent 2 may change, since the movably connected support bars may move in their length direction to some extent, the support bars are prevented from restricting the distance between the main stent 1 and the branch stent 2 from changing, and further from damaging the main stent 1 or the branch stent 2 by pulling the main stent 1 or the branch stent 2 in a radially compressed state or when the luminal stent 100 is impacted by blood. In addition, the support bar movably connects the anchor portion 10 and/or the free end 20a to allow the free end 20a to move more flexibly with respect to the main body support 1, and the conveyor can be separated from the free end 20a when the free end 20a is bent to a certain degree.
Example 6
Referring to fig. 16 and 17, the lumen stent 100 of the present embodiment is substantially the same as that of embodiment 5, except that the connecting member 19 of the present embodiment has elasticity and includes an elastic section 192 and connecting sections (hereinafter referred to as a first connecting section 191 and a second connecting section 193 for convenience of description) disposed at two ends of the elastic section 192, wherein the first connecting section 191 is connected to the main body stent 1 and the second connecting section 193 is connected to the branch stent 2. On the same longitudinal section, the range of the included angle between the length extending direction of the connecting piece 19 and the outer surface of the branch bracket 2 is 0-60 degrees, namely the range of the included angle between the stress direction of the connecting piece 19 and the outer surface of the branch bracket 2 is 0-60 degrees.
The resilient segment 192 includes one or more of a coil spring structure, an elastomeric member, a planar folded structure. The spiral spring structure comprises one or more of an extension spring, a progressive spring and a linear spring. The elastic body member includes a member made of a material having elasticity itself, for example, an elastic cord made of an elastic polymer material, an elastic wire or an elastic rod made of a super elastic metal material (such as nickel-titanium alloy or the like), or the like. The planar folding structure can be elongated and shortened along the length direction, and comprises one or more of Z-shaped waves, M-shaped waves, V-shaped waves and sine waves. As shown in fig. 18, to further reduce the radial compression dimension of the luminal stent 100, the planar folding structure comprises a sawtooth wave 192a comprising one or more sawtooth 1921 inclined toward the anchoring portion 10 or toward the free end 20a of the branched stent 2, such sawtooth wave 192a can be folded in the transverse direction (direction perpendicular to the length direction) to some extent, whereby the radial compression dimension of the luminal stent 100 can be reduced.
In this embodiment, when the main body stent 1 and the branch stent 2 are both in the natural unfolding state, the elastic section 192 of the connecting piece 19 is in a stretched state, so that a certain tensile force is provided to the branch stent 2 through the connecting piece 19, so that the branch stent 2 is tightly attached to the inner wall of the main body stent 1, and a certain movable space of the branch stent 2 relative to the main body stent 1 is provided, so that the branch stent 2 is prevented from shaking under the impact of blood, and the normal flow of blood is further affected. It will be appreciated that in other embodiments, the connector 19 may be in a naturally relaxed state when both the main body stent 1 and the branch stent 2 are in a naturally deployed state.
In this embodiment, the first connecting section 191 and the second connecting section 193 of the connecting member 19 may be connected to one or more of the anchor portion 10 and the branching wave ring 21 of the branching bracket 2, the branching coating 22 at the free end 20a (refer to fig. 6), and the second annular supporting member, respectively. For example, the connecting piece 19 is connected with the branching wave ring 21 or the second annular supporting piece, so that the branching coating film 22 is prevented from being damaged under the tensile force of the connecting piece 19, and the internal leakage phenomenon is avoided.
It will be appreciated that in other embodiments, the connector 19 may be provided with only one connecting section, in which case the other end of the resilient section 192 is directly connected to the branch stent 2 or the main body stent 1.
In particular, the connector 19 may be made of single or multi-strand nickel titanium wire or stainless steel wire spirals, etc. In order to ensure that the connecting element 19 is fully stretched when subjected to a suitable pulling force, and returns to its original state after the force is removed and maintains a certain stability, the stiffness coefficient K of the elastic section 192 of the connecting element 19 ranges from 0 < K < 100N/M.
The first connecting section 191 of the connecting member 19 may be disposed closer to the anchoring portion 10 than the second connecting section 193 (i.e., the stress direction of the connecting member 19 and the outer surface of the branch stent 2 have an included angle greater than 0 degrees), so that the branch stent 2 is always disposed toward the anchoring portion 10 under the tensile force of the connecting member 19, and further the branch stent 2 is sufficiently close to the inner surface of the main stent 1, thereby reducing or eliminating the gap between the main stent 1 and the branch stent 2, and further minimizing the influence of the branch stent 2 on the blood flow in the main stent 1 and reducing the formation of thrombus.
In other embodiments, the first connecting section 191 and the second connecting section 193 can be omitted, and two ends of the elastic section 192 are respectively connected to the anchoring portion 10 and the free end 20a of the branch stent 2.
The connector of the present embodiment has elasticity, which enables the free end 20a of the branch stent 2 to move more flexibly relative to the main body stent 1, even if the free end 20a of the branch stent 2 is hooked by the conveyor and pulled in the proximal direction, the free end 20a can be easily bent, and when the bending is to a certain extent, the conveyor can be separated from the free end 20 a. In addition, the elastic connection member can adapt to the change of the distance between the main body stent 1 and the free end 20a of the branch stent 2 when the lumen stent 100 is in a radially compressed state or when the lumen stent 100 is impacted by blood, thereby preventing damage to the main body stent 1 or the branch stent 2 due to excessive pulling of the main body stent 1 or the branch stent 2 when the lumen stent 100 is in a radially compressed state or is impacted by blood.
Example 7
Referring to fig. 19, the lumen stent 100 of this embodiment is substantially the same as the lumen stent 100 of embodiment 6, except that the lumen stent 100 of this embodiment includes a first connecting member 19a and a second connecting member 19b. For example, the first connection member 19a connects a first side surface (a side toward the inner wall of the main body bracket 1 and close to the inner wall of the main body bracket 1) of the branch bracket 2, and the second connection member 19b connects a second side surface (a side toward the central axis of the main body bracket 1 and close to the central axis of the main body bracket 1) of the branch bracket 2. The first connecting piece 19a and the second connecting piece 19b are respectively connected with the first side surface and the second side surface of the branch bracket 2, so that the stress of the branch bracket 2 is more balanced, and the stability of the branch bracket 2 is further improved. Further, the rigidity of the first and second connection members 19a and 19b may be different. For example, if the conveyor is easier to hook on the second side surface, the rigidity (for example, the axial rigidity, i.e., the ability to resist deformation in the longitudinal direction) of the second connection member 19b connected to the second side surface may be made smaller than the rigidity of the first connection member 19a connected to the first side surface, and if the conveyor is easier to hook on the first side surface, the rigidity of the first connection member 19a connected to the first side surface may be made smaller than the rigidity of the second connection member 19b connected to the second side surface. This facilitates a more flexible movement of the free end 20a of the branch stent 2. In other embodiments, both connectors 19 may be provided on the first side or on the second side. In other embodiments, more than two connectors 19 may be provided.
Referring to fig. 20, in other embodiments, an intermediate member 194 is provided between the first and second connection members 19a and 19b, and the intermediate member 194 is connected to the proximal end portions of the first and second connection members 19a and 19b, respectively, and is connected to the bare wave ring 11 a. In this embodiment, the intermediate member 194 is movably connected with the trough of the bare wave 11 a. For example, the intermediate piece 194 is arc-shaped and is movably connected with the bare wave ring 11a (such as the trough of the bare wave ring 11 a) through a hook connection or a winding connection; alternatively, the intermediate member 194 includes a limiter 1941 (such as an elastic elongated filament or rod), at least one sliding connector 1942 (such as a ring or a tube) is disposed on the limiter 1941, the sliding connector 1942 is sleeved on the wave rod of the bare wave ring 11a and can slide along the length direction of the wave rod of the bare wave ring 11a, the limiter 1941 is used for limiting the sliding range of the sliding connector 1942, for example, both ends of the elongated limiter 1941 are provided with sliding connectors 1942, and the two sliding connectors 1942 are respectively connected to the proximal ends of the two connectors 19; alternatively, one end of the elongated limiter 1941 is fixedly connected to the bare wave 11a, and the other end is provided with the sliding connector 1942, wherein the proximal end of the first connector 19a is connected to the sliding connector 1942, and the proximal end of the second connector 19b is connected to the limiter 1941 or the bare wave 11 a. The sliding connection between the intermediate member 194 and the bare wave ring 11a has the effect that when one side of the branch stent 2 where one of the connecting members is located is hooked by the conveyor, the intermediate member 194 can move relative to the anchoring portion 10, so as to adapt to the change of the distance between the proximal end of the connecting member and the anchoring portion 10 to a certain extent, so that the proximal end port 20a of the branch stent 2 moves more flexibly relative to the main stent 1, and after the conveyor and the branch stent 2 are separated, the intermediate member 194 can drive the connecting member to return to the initial position. In other embodiments, the intermediate member 194 may be fixedly coupled to the valleys of the bare wave 11 a.
Example 8
This embodiment is substantially the same as embodiment 5, except that, referring to fig. 22, the connecting member 19 includes a spiral section 195, the spiral section 195 extends spirally around the central axis of the main body support 1, and the spiral section 195 at least partially abuts against the inner surface of the main body support 1 and is movable relative to the inner surface of the main body support 1, for example, only two ends of the connecting member 19 are respectively connected to the anchoring portion 10 and the branch support 2, and the rest of the area including the spiral section 195 is only abutted against the inner surface of the main body support 1 without connecting points with the main body support 1.
The helical segment 195 may extend helically around the central axis of the body support 1 one or more turns, and in other embodiments, the helical segment 195 may extend helically around the central axis of the body support 1 less than one turn. Because the spiral segment 195 itself is spiral, and the spiral structure itself has elastic recovery capability (i.e., the capability of being deformed by external force and recovering after removing the external force), the material of the spiral segment 195 is not required to have good elasticity, and may be made of various biocompatible materials, such as a polymer material or a metal material. Referring to fig. 23, to further increase the elasticity of the helical segment 195, the helical segment 195 further includes a helical structure formed by one or more of a helical spring structure, a planar folded structure, an elastomer member, for example, the helical spring structure includes one or more of an extension spring, a progressive spring, a linear spring, and the helical segment 195 includes a helical structure formed by one or more of the above-described helical windings. The elastomeric member comprises a member made of a material that is inherently elastic, for example, the helical segment 195 comprises a helical structure formed by helically encircling an elastic cord made of an elastic polymeric material, an elastic wire or rod made of a superelastic metallic material (e.g., nitinol, etc.), or the like. The planar folding structure comprises one or more of Z-shaped wave, M-shaped wave, V-shaped wave and sine wave, can be radially compressed, has radial expansion capacity, can realize radial contraction under the action of external force, and can be self-expanded or restored to an original shape through mechanical expansion after the external force is withdrawn and maintain the original shape. The helical segment 195 includes a helical structure formed by helically winding the planar folded structure described above.
The helical segment 195 of the present embodiment has elastic restoring ability, which allows more flexible movement of the free end 20a of the branch stent 2 with respect to the main body stent 1. In addition, the connector with the helical segment 195 can also accommodate the change in distance between the main body stent 1 and the free end 20a of the branch stent 2 when the lumen stent 100 is in a radially compressed state or when the lumen stent 100 is impacted by blood, thereby avoiding damage to the main body stent 1 or the branch stent 2 by excessively pulling the main body stent 1 or the branch stent 2 when the lumen stent 100 is in a radially compressed state or impacted by blood. Furthermore, since the spiral segment 195 at least partially conforms to the inner surface of the main body stent 1, the adherence, displacement resistance and shortening resistance of the main body stent 1 in the region of the spiral segment 195 can be increased.
Further, the connecting members in the above embodiments 5 to 8 may be made of biodegradable materials, for example, degradable polymers such as degradable polyesters and/or degradable polyanhydrides, and degradable metal materials such as magnesium-based, iron-based, and zinc-based alloys. The arrangement has the advantages that the problems of restenosis in the middle and later stages of blood vessels, late thrombosis and the like can be avoided, and the biological safety is improved.
It will be appreciated by those skilled in the art that the anchoring portion 10 of the above embodiments 5 to 8 is located at the proximal end of the main body stent 1, and the free end 20a of the branch stent 2 is located at the proximal end of the branch stent 2. In other embodiments, the anchor 10 may be located at the distal end of the main body stent 1, and the free end 20a of the branch stent 2 is located at the distal end of the branch stent 2. The present invention is not limited to the specific positions of the anchor portion 10 and the free end 20 of the branch stent 2, as long as the technical effects of the present invention can be achieved.
The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention are intended to be included in the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims (12)

1. A lumen stent, comprising:
a tubular body stent comprising an anchoring portion;
the branch bracket is arranged in the lumen of the main body bracket and comprises a free end which can move relative to the main body bracket;
The connecting pieces are respectively connected with the free ends of the branch brackets and the anchoring parts.
2. The lumen stent of claim 1, wherein the body stent comprises a cover and a plurality of axially spaced apart body bands connected to the cover, the anchoring portion comprises a bare band and/or an anchor, and a radial support force of the bare band is greater than a radial support force of the body band.
3. The luminal stent of claim 1, wherein the free end of the branched stent is located at the proximal end of the branched stent and the anchor is located at the proximal end of the main body stent; alternatively, the free end of the branch stent is located at the distal end of the branch stent, and the anchoring portion is located at the distal end of the main body stent.
4. A luminal stent according to any one of claims 1 to 3 wherein the connector comprises a rectilinear or curvilinear strut connected at one end to the anchoring portion and at the other end to the free end of the branched stent.
5. A lumen stent according to any one of claims 1 to 3 wherein the connector comprises an elastic section, the ends of the elastic section being connected to the anchor portion and the free end of the branch stent respectively; the elastic segment comprises one or more of a coil spring structure, a planar folded structure, and an elastomeric member.
6. The luminal stent of claim 5, wherein the planar folding structure comprises a saw tooth wave comprising saw teeth that slope toward the anchoring portion or toward the branched stent.
7. A luminal stent according to any of claims 1 to 3 wherein the connector comprises a helical section which extends helically around the axis of the body stent entirely and which at least partially conforms to and is moveable relative to the inner surface of the body stent.
8. The luminal stent of claim 7, wherein the helical segments comprise a helical structure formed by one or more of a helical spring structure, a planar folded structure, an elastomeric member, and a helical wrap.
9. A luminal stent according to any of claims 1 to 3 wherein the connector is fixedly or movably connected to the anchoring portion and the connector is fixedly or movably connected to the free end of the branch stent.
10. A luminal stent according to any one of claims 1 to 3 comprising two connectors, one on each side of the branched stent.
11. The luminal stent of claim 10, further comprising an intermediate member movably coupled to the anchor and coupled to at least one connector.
12. The luminal stent of claim 10, comprising a first connector and a second connector, the second connector being closer to the axis of the body stent than the first connector, and the second connector having a stiffness less than the first connector.
CN202111677226.1A 2021-12-31 2021-12-31 Lumen stent Pending CN116407371A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202111677226.1A CN116407371A (en) 2021-12-31 2021-12-31 Lumen stent
PCT/CN2022/137946 WO2023124903A1 (en) 2021-12-31 2022-12-09 Endoluminal stent

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202111677226.1A CN116407371A (en) 2021-12-31 2021-12-31 Lumen stent

Publications (1)

Publication Number Publication Date
CN116407371A true CN116407371A (en) 2023-07-11

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN202111677226.1A Pending CN116407371A (en) 2021-12-31 2021-12-31 Lumen stent

Country Status (1)

Country Link
CN (1) CN116407371A (en)

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