CN115969571A - Vascular implant and luminal stent - Google Patents

Vascular implant and luminal stent Download PDF

Info

Publication number
CN115969571A
CN115969571A CN202211419206.9A CN202211419206A CN115969571A CN 115969571 A CN115969571 A CN 115969571A CN 202211419206 A CN202211419206 A CN 202211419206A CN 115969571 A CN115969571 A CN 115969571A
Authority
CN
China
Prior art keywords
branch
vascular implant
support
stent
windowing
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
CN202211419206.9A
Other languages
Chinese (zh)
Inventor
郭伟
吴雅莎
尹玉杨
王永胜
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.)
Hangzhou Wei Qiang Medical Technology Co ltd
Original Assignee
Hangzhou Wei Qiang Medical Technology 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 Hangzhou Wei Qiang Medical Technology Co ltd filed Critical Hangzhou Wei Qiang Medical Technology Co ltd
Priority to CN202211419206.9A priority Critical patent/CN115969571A/en
Publication of CN115969571A publication Critical patent/CN115969571A/en
Pending legal-status Critical Current

Links

Images

Landscapes

  • Prostheses (AREA)

Abstract

The application discloses a vascular implant and a luminal stent. The vascular implant comprises a connecting bracket which is enclosed into a tubular connecting cavity, and an embedded branch which is fixed on the connecting bracket and is contained in the connecting cavity, wherein the embedded branch is communicated with the connecting cavity; the transition covering film is hermetically connected with one port of the embedded branch; the windowing structure is arranged on the connecting support, the transition covering film is connected to the windowing structure in a sealing mode, so that the windowing structure is communicated with the communicating cavity, and the axial length of the windowing structure is larger than the maximum axial length of at least one port of the embedded branch in the axial direction of the connecting support; the circumferential length of the windowing structure is greater than the maximum circumferential length of at least one port of the embedded branch in the circumferential direction of the connecting support, and the circumferential length of the windowing structure on the connecting support is 20% -40% of the circumferential length of the connecting support, so that the circumferential caliber of the windowing structure on the vascular implant is larger, and the positioning precision of the windowing structure on the branch blood vessel is improved.

Description

Vascular implant and luminal stent
Technical Field
The application relates to the technical field of medical instruments, in particular to a vascular implant and a lumen stent.
Background
The aortic arch diseases include aortic aneurysm, pseudo aneurysm, aortic dissection, aortic ulcer and mural hematoma which affect aortic arch. Methods for treating aortic arch diseases include surgical procedures, hybrid procedures, and full-lumen techniques.
The aortic arch part has a complex anatomical structure, and the main blood vessel of the aortic arch part is in a bent shape and is a main artery for blood supply of internal organs and lower limbs. The branch vessels on the aortic arch are the channels for maintaining blood supply to the brain and upper limbs, and the diameter difference of the branch vessels of different individuals is large, and the distance difference among a plurality of branch vessels is also large. The difficulty of the intervention treatment in the aortic cavity is that when the aortic arch part diseases are isolated, the smoothness of branch vessels on the aortic arch part is ensured; the long ischemia time of the brain blood supply will cause fatal harm to the patients. The existing intracavity products in the current market are difficult to realize and mainly adopt a surgical (full arch replacement) treatment mode. However, the total arch replacement surgery has great difficulty and trauma, needs to be completed under the condition of deep low-temperature extracorporeal circulation, and has more postoperative complications. At present, the reconstruction of double embedded branches (namely at least two branch vessels) needs bypass surgery, the trauma is relatively large, the surgery time is long, and the bridge vessel stenosis or occlusion is easy to occur at the middle and long term. Patients who have bypass blood vessels between the left common carotid artery and the left subclavian artery have 25% of phrenic nerve paralysis complications, so that the three branch endovascular surgeries are advantageous.
The current technology has the problem of difficult branch positioning of branch blood vessels, for example, three main artery important branch blood vessels, namely a brachiocephalic trunk, a left common carotid artery and a left subclavian artery, are arranged on an aortic arch, and how to establish the important branch blood vessels on the aorta is a great problem in the current aortic aneurysm endoluminal repair.
Disclosure of Invention
The application provides a vascular implant and a lumen stent which can improve the positioning accuracy of a branch blood vessel so as to solve the problem of difficult branch positioning of the branch blood vessel.
In a first aspect, embodiments of the present application provide a vascular implant, comprising:
the connecting bracket surrounds a tubular connecting cavity;
the embedded branch is fixed on the connecting bracket and is contained in the connecting cavity, the embedded branch is enclosed into a tubular communicating cavity, and the communicating cavity is communicated with the connecting cavity;
the transition covering film is connected to one port of the embedded branch in a sealing manner;
the windowing structure is arranged on the connecting support, the transition covering film is connected to the windowing structure in a sealing mode so as to enable the windowing structure to be communicated with the communicating cavity, and the windowing structure is used for being in splicing fit with a branch support for reconstructing a branch blood vessel so as to enable the branch support to be communicated with the connecting cavity through the communicating cavity; in the axial direction of the connecting bracket, the axial length of the windowing structure is greater than the maximum axial length of at least one port of the embedded branch; in the circumferential direction of the connecting support, the circumferential length of the windowing structure is greater than the maximum circumferential length of at least one port of the embedded branch, and the circumferential length of the windowing structure along the circumferential direction of the connecting support is 20% -40% of the circumferential length of the connecting support.
In some other embodiments, the axial length of the fenestration along the connecting stent is at least 40% of the circumferential length of the fenestration along the connecting stent.
In a second aspect, an embodiment of the present application provides a lumen stent, which includes a main body stent and the vascular implant as described above, where the main body stent encloses a main body lumen, and the vascular implant is inserted into the main body lumen.
The utility model provides a vascular implant and lumen stent, because the axial length of windowing structure is greater than the maximum axial length of at least one port of embedded branch, the circumference length of windowing structure is greater than the maximum circumference length of at least one port of embedded branch, the size of windowing structure promptly is greater than the size of at least one port of embedded branch than the correlation technique, combines embedded branch's intercommunication chamber to be used for with the branch support grafting cooperation of rebuilding branch's blood vessel, the size of windowing structure promptly is greater than the root opening size of target branch's blood vessel than the correlation technique, the windowing structure is followed circumference length on the linking bridge does 20% ~ 40% of the circumference length of linking bridge for the size of windowing structure is greater than the root opening size of target branch's blood vessel more than the correlation technique, even the near-end mouth of embedded branch is difficult to be completely central with the root opening of target branch's blood vessel, the windowing structure that the size is bigger also can guarantee to cover the root opening of branch's blood vessel to improve the fault-tolerant rate of vascular in-process of rebuilding branch, improved the windowing structure to the positioning accuracy of target blood vessel, be convenient for the branch support is assembled in the branch and the operation in the branch not greatly reduced the operation size of branch.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the embodiments or the prior art descriptions will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a perspective view of a lumen stent provided in accordance with a first embodiment of the present application;
FIG. 2 is a perspective view of the luminal stent with the vascular implant removed;
FIG. 3a is a perspective view of FIG. 2 from another perspective;
FIG. 3B is a schematic diagram of an included angle B formed by the surface PL of the sealing coating and the central axis AX of the main stent;
FIG. 4 is a side view of a vascular implant provided in accordance with an embodiment of the present application;
FIG. 5 isbase:Sub>A cross-sectional view of the vascular implant of FIG. 4 taken along line A-A;
FIG. 6 is a schematic view of a vessel implant in expanded configuration;
FIG. 7a is an enlarged schematic view at a localized area A of the vascular implant of FIG. 6;
FIG. 7b is a schematic projection view of the first portion of the second skeleton and the windowing structure along the central axis of the connecting cover film on the projection plane P-P shown in FIG. 6;
FIG. 8a is a schematic perspective view of the vascular implant of FIG. 4;
FIG. 8B is an enlarged schematic view of the vascular implant of FIG. 8a at localized area B;
FIG. 9a is a perspective view of an inset branch of a vascular implant;
FIG. 9b is a perspective view of the inset branch of FIG. 9a from another perspective;
FIG. 10 is a schematic view of a scenario in which a vascular implant is used to reconstruct the left subclavian artery of the aortic arch;
FIG. 11 is a schematic view of a vascular implant used to reconstruct the renal arteries of the abdominal aorta;
FIG. 12 is a schematic view of a luminal stent applied to reconstruct three branch vessels of an aortic arch;
FIG. 13 is a schematic view of a luminal stent applied to reconstruct two branch vessels of an aortic arch
FIG. 14 is a schematic plan expanded view of a vascular implant provided in accordance with a second embodiment of the present application;
FIG. 15 is a schematic view of a possible implementation of the proximal port of the embedded branch in the vascular implant of FIG. 8a as a beveled port;
FIG. 16 is a schematic diagram of the structure of the inset branch of FIG. 15;
FIG. 17 is a schematic diagram of one possible implementation of an angle between a plane of a proximal port of the embedded branch, a plane of a distal port of the embedded branch, and a central axis of the embedded branch;
fig. 18 is a schematic diagram of another possible implementation of an angle between a plane of a proximal port of the embedded branch, a plane of a distal port of the embedded branch, and a central axis of the embedded branch.
Description of the reference numerals: 1000. a lumen stent; 100. a vascular implant; 50. a windowing structure; 52. a first windowing portion; 54. a second windowing portion; 56. a ring-shaped member; 70. embedding branches; 72. branch film covering; 726. a breach; 720. a communicating cavity; 722. a proximal port; 724. a distal port; 74. transition film covering; 76. a support ring; 77. a positioning ring; 78. sewing a stitch; 20. connecting and laminating; 22. a connecting cavity; 30. a support framework; 31. a support bar; 31a, a peak; 312a, high wave; 314a, low wave; 31b, a wave trough; 32. a proximal support armature; 34. a distal support armature; 36. a first skeleton; 38. a second skeleton; 382. a first portion; 384. a second portion; 40. a first support section; 42. a second support portion; 420. an anchoring hook; 44. a third support frame; 200. a main body support; 201. covering a film on the main body; 203. a body support structure; 205. a main lumen channel; 210. a body cavity; 300. the root is opened; 400. a partition bracket; 410. a separation chamber; 401. separating and laminating; 4012. a proximal end opening; 4014. a distal opening; 403. a separation support structure; 404. a separation positioning structure; 405. developing the mark; 500. sealing and laminating; 501. a main lumen port; 503. a sub-cavity opening; 700. a leakage-proof frame; 800. positioning a rod; 2000. a branch support; 3000. the aortic arch; 3001. the left subclavian artery; 3002. the left common carotid artery; 3003. the brachiocephalic trunk; 4000. the abdominal aorta; 4001. the renal artery.
Detailed Description
The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art without any inventive work based on the embodiments in the present application are within the scope of protection of the present application.
For a vascular implant, proximal refers to the end of the vascular implant that is closer to the human heart after it is used for interventional therapy, and distal refers to the end of the vascular implant that is further from the human heart after it is used for interventional therapy. The direction of the rotation center axis of an object such as a cylinder or a pipe is defined as an axial direction, and the direction perpendicular to the axial direction is defined as a radial direction. Circumferential is defined as "circumferential", i.e., about the axis of the cylinder, tube, etc. (perpendicular to the axis and perpendicular to the radius of the section). "circumferential", "axial" and "radial" together constitute the three orthogonal directions of the cylindrical coordinates. Circumferential length refers to the extension of a structure or element in the circumferential direction of a cylinder, tube, or the like. Axial length refers to the extension of a structure or element in the axial direction of a cylinder, tube, etc. The definitions are for convenience only and do not limit the present application.
Referring to fig. 1, a lumen stent 1000 for isolating a lesion region in a lumen by performing an endoluminal isolation procedure in a lumen is provided in a first embodiment of the present application, for example, the lumen stent 1000 may be used to isolate an arterial dissection or an aneurysm in a lumen of a blood vessel. It is understood that the vessel may be the aortic arch, thoracic aorta, or abdominal aorta, etc. It will be appreciated by those of ordinary skill in the art that the use of blood vessels is illustrated by way of example only and not as a limitation of the present application, and that the concepts of the present application are applicable to a variety of human or animal lumens, such as digestive tract lumens and the like.
Referring to fig. 2 and 3a, the luminal stent 1000 comprises a vascular implant 100, a main stent 200 and at least one separation stent 400. The main body stent 200 encloses a tubular main body cavity 210 for receiving the separation stent 400 and the vascular implant 100. A partition bracket 400 is provided in the body cavity 210. The separation stent 400 encloses a tubular separation cavity 410 for inserting the branch stent so that the lumen stent 1000 is used in cooperation with the branch stent to reconstruct a branch vessel through the branch stent. The outer wall of the separation frame 400 and the inner wall of the main body frame 200 form a main lumen channel 205, and the main lumen channel 205 is used for inserting the vascular implant 100. The vascular implant 100 is inserted into the main lumen channel 205.
The vascular implant 100 is inserted into the main lumen channel 205, including the following possible implementations: the vascular implant 100 may be inserted in both end openings in the axial direction of the main lumen channel 205; the side wall of the main body bracket 200 can be provided with a socket, and the blood vessel implant 100 can be inserted into the main cavity channel 205 from the socket of the side wall of the main body bracket 200; alternatively, an external branch (not shown) may be disposed on the outer sidewall of the main body frame 200, and the vascular implant 100 may be communicated with the main lumen channel 205 through the external branch.
The blood vessel includes a main blood vessel and a branch blood vessel. When the lumen stent 1000 is implanted into a blood vessel, the main body stent 200 and the vascular implant 100 are positioned in the main body blood vessel, the vascular implant 100 can be communicated with the main body blood vessel, and the branch stents inserted into the separation chambers 410 can be communicated with the corresponding branch blood vessels. For example, when the luminal stent 1000 is used for reconstructing an aortic arch, the main stent 200 and the vascular implant 100 are positioned in the main vessel of the aortic arch, and the branch stent inserted into the separation chamber 410 can be communicated with the corresponding branch vessel on the aortic arch.
In this embodiment, the main body bracket 200 is a tubular structure with two open ends. The main body stent 200 has a radial expansion ability that is compressed by an external force and self-expands after the external force is removed or returns to an original shape by mechanical expansion and maintains the original shape, thereby being attached to a vessel wall by its radial supporting force after being implanted into a vessel.
The main body stent 200 comprises a tubular main body cover 201 and a main body support structure 203 arranged on the main body cover 201. The body covering membrane 201 encloses a body cavity 210. The body support structure 203 is used to provide radial support for the body support 200. The main body support structure 203 is capable of contracting or expanding in the radial direction of the main body cover film 201. The main body support structure 203 may be a wavy ring, a mesh structure formed by weaving metal wires, or a cut mesh structure formed by cutting a metal tube, and the structure of the main body support structure 203 is not limited in the present application.
The separation stent 400 has a radial expansion ability, and can be compressed by an external force and self-expanded after the external force is removed or restored to an original shape by mechanical expansion and maintain the original shape, thereby being attached to a vessel wall by its radial supporting force after being implanted into a vessel.
The separation stent 400 includes a separation coating 401 and a separation support structure 403 fixed to the separation coating 401. The separation support structure 403 may be a plurality of wavy rings arranged in the axial direction of the separation coating film 401, may be a mesh structure formed by weaving metal wires, or may be a cut mesh structure formed by cutting a metal tube, and the structure of the separation support structure 403 is not limited in the present application.
A partition membrane 401 is secured to the body membrane 201 and is located within the body lumen 210. The separation coating 401 encloses a tubular separation chamber 410. The outer wall of the separation membrane 401 and the inner wall of the main body cavity 210 together form the main cavity channel 205. The partition coating 401 includes a proximal opening 4012 and a distal opening 4014 that are oppositely disposed in the axial direction of the partition coating 401. The surface where the proximal opening 4012 is located is obliquely arranged, that is, an included angle formed between the central axis of the separation bracket 400 and the surface where the proximal opening 4012 is located is a non-right angle; the plane of the far-end opening 4014 is obliquely arranged, that is, an included angle formed between the central axis of the separation bracket 400 and the plane of the far-end opening 4014 is a non-right angle; that is, the proximal opening 4012 and the distal opening 4014 of the separation support 400 are both designed as oblique openings, which is beneficial to avoid the stress concentration of the proximal opening 4012 and the distal opening 4014 of the separation support 400, which is not beneficial to radial shrinkage transportation, and also facilitates the entry of the branch support into the separation support 400.
It is appreciated that in other embodiments, the included angle formed between the central axis of separation support 400 and the plane of proximal opening 4012 may be a right angle, and the included angle formed between the central axis of separation support 400 and the plane of distal opening 4014 may be a right angle, i.e., proximal opening 4012 and distal opening 4014 may both be of a flat design.
The proximal opening 4012 and the distal opening 4014 may each be provided with an annular separation positioning structure 404. The partition positioning structure 404 can contract or expand in the radial direction of the partition coating film 401. The separation positioning structure 404 may be a ring adapted to the proximal opening 4012 and the distal opening 4014, which is beneficial to avoiding wrinkles of the proximal opening 4012 and the distal opening 4014, contact between the separation positioning structure 404 and the outer surface of the branch support, and improvement of sealing performance of the branch support after being inserted into the separation support 400, thereby being beneficial to preventing inner leakage.
The partition bracket 400 may further include a development mark 405, and the development mark 405 is disposed on the partition positioning structure 404 for indicating the position of the partition bracket 400. In this example, the development mark 405 may be a ring-shaped structure wound on the separation positioning structure 404. In other embodiments, the separation positioning structure 404 may have a developing material. The material of the visualization marker 405 and the visualization material in the separation positioning structure 404 may be made of materials with good X-ray opacity, strong corrosion resistance and good biocompatibility, and may be gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium, or the like, or an alloy of at least two of these materials.
The luminal stent 1000 further comprises a sealing membrane 500, the sealing membrane 500 being located within the main body lumen 210, the sealing membrane 500 being secured to the distal end of the main body stent 200. One side of the sealing membrane 500 and the main body membrane 201 are provided with a space so that the inner walls of the sealing membrane 500 and the main body membrane 201 form a main lumen 501. The main lumen port 501 is placed in communication with the main lumen channel 205 for insertion of the vascular implant 100. The diameter of the main cavity opening 501 is smaller than that of the blood vessel implant 100, and in the release state, the blood vessel implant 100 is tightly inserted and matched with the main cavity opening 501 so as to connect the blood vessel implant 100 and the main body bracket 200 together. The vascular implant 100 and the sealing coating 500 are in close contact, which is beneficial to reducing the possibility of internal leakage.
The sealing coating 500 may further include at least one sub-cavity opening 503. The branch stent can be inserted into the compartment 410 through the sub-cavity opening 503. One partition bracket 400 corresponds to one sub-cavity opening 503, i.e. the number of sub-cavities 503 is the same as the number of partition brackets 400. In this embodiment, the number of the partition brackets 400 is two as an example. The sealing coating 500 is hermetically fixed at the distal opening 4014 of the partition stent 400 through the sub-lumen opening 503 so that the sub-lumen opening 503 and the corresponding partition lumen 410 in the partition coating 401 are communicated. Referring to fig. 3B, an included angle B between the surface PL of the sealing coating 500 and the central axis AX of the body stent 200 is a non-right angle, i.e., the included angle B between the surface PL of the sealing coating 500 and the central axis AX of the body stent 200 is an acute angle or an obtuse angle, and in the embodiment, the included angle B between the surface PL of the sealing coating 500 and the central axis AX of the body stent 200 is preferably an acute angle. The sealing coating film 500 is obliquely arranged relative to the central axis of the main body stent 200, so that the branched stent is conveniently inserted and matched with the separation stent 400 through the sub-cavity opening 503 and the distal opening 4014 of the separation coating film 401 in sequence, and the positioning accuracy is improved. In other embodiments, the lying surface PL of the sealing coating 500 may form a right angle with the central axis AX of the body stent 200, i.e., the lying surface PL of the sealing coating 500 is perpendicular to the central axis AX of the body stent 200.
The luminal stent 1000 further comprises a leakage-proof frame 700 (shown in fig. 2 and 3 a) disposed at both sides of the separation stent 400. The distal end surfaces of the leakage preventing frames 700 are fixed to the sealing membranes 500, and the proximal end surface edges of the leakage preventing frames 700 are sealingly connected to the peripheries of the proximal opening 4012 of the corresponding partition membrane 401 and the main body membrane 201. When the vascular implant 100 is inserted into the main cavity 501, the edge of the main cavity 501 of the sealing coating 500 can be tightly attached to the outer surface of the main body stent 200, and the leakage-proof frame 700 can be tightly attached to the outer surface of the main body stent 200, so that the distal end and the proximal end of the luminal stent 1000 can be tightly attached to the outer surface of the vascular implant 100 inserted into the main cavity 501, and internal leakage can be further effectively prevented. In other embodiments, if the number of the partition brackets 400 is multiple, the multiple partition brackets 400 are regarded as an integral partition bracket, the number of the leakage preventing frames 700 may still be set to two, and two leakage preventing frames 700 are respectively located at two sides of the integral partition bracket 400.
The luminal stent 1000 further comprises a positioning rod 800 (as shown in fig. 2 and 3 a) arranged at one side of the sealing covering membrane 500 close to the main lumen 501, wherein the positioning rod 800 is used for positioning the vascular implant 100 when the vascular implant 100 is inserted into the main lumen channel 205. Rings (not shown) may also be provided at both ends of positioning rod 800. The positioning rod 800 may also be provided with a visualization mark (not shown) for indicating the position of the positioning rod 800, so as to facilitate the insertion and engagement of the vascular implant 100 with the main lumen channel 205. The positioning rod 800 has both ends fixed to the main body stent 200 (on the main body cover 201 or the main body support structure 203), respectively. In a release state, when the vascular implant 100 is inserted into and matched with the main cavity 501, the positioning rod 800 can be tightly attached to the outer surface of the vascular implant 100, so that the sealing coating 500 is tightly attached to the outer surface of the vascular implant 100, which is beneficial to preventing the inner leakage, and the vascular implant 100 can be conveniently inserted into the main cavity 501, thereby increasing the compatibility between the vascular implant 100 and the lumen stent 1000, and enabling the engagement between the vascular implant 100 and the main stent 200 to be more stable.
It is understood that in other embodiments of the present application, the sealing coating 500, the leakage-proof frame 700 and the positioning rod 800 may be omitted, the separation stent 400 encloses the separation lumen 410, the separation stent 400 and the inner wall of the main stent 200 form the main lumen channel 205, and the vascular implant 100 is inserted into the main lumen channel 205.
It should be understood that, in other embodiments of the present application, the separation stent 400, the sealing coating 500, the leakage-proof frame 700 and the positioning rod 800 may be omitted, the main body stent 200 defines the main body cavity 210, and the vascular implant 100 is inserted into the main body cavity 210.
The vascular implant 100 is a straight tubular or tapered structure, as illustrated in fig. 4 and 5, with the vascular implant being a straight tubular structure. The vascular implant 100 includes a connecting stent, a fenestration 50, embedded branches 70, and a transitional covering membrane 74. The connecting struts enclose a tubular connecting chamber 22. The embedded branch 70 is enclosed into a tubular communication cavity 720, the embedded branch 70 is fixed on the connecting bracket and is contained in the connecting cavity 22, and the communication cavity 720 is communicated with the connecting cavity 22. The windowing structure 50 is arranged on the connecting support, the transition covering film 74 is connected to one end of the embedded branch 70 in a sealing mode, the transition covering film 74 is connected to the windowing structure 50 in a sealing mode, the windowing structure 50 is communicated with the communicating cavity 720, and the windowing structure 50 is used for being in splicing fit with the branch supports of the reconstructed branch blood vessels so that the branch supports are communicated with the connecting cavity 22 through the communicating cavity 720. When the vascular implant 100 is inserted into the primary lumen channel 205, the connecting lumen 22 is in communication with the primary lumen channel 205 (as shown in FIG. 2).
This embodiment is illustrated with a transition coating 74 sealingly attached to the proximal end of the inset branch 70. It will be appreciated that depending upon the location of the embedded branch 70, the transitional coating 74 may also be sealingly attached to the distal end of the embedded branch 70, such as where the embedded branch 70 is located on the proximal side of the fenestration structure 50.
The axial extension direction of the embedded branch 70 is the same as the axial extension direction of the vascular implant 100, which can also be understood as the axial extension direction of the embedded branch 70 is the same as the axial extension direction of the connecting stent, i.e. the central axis of the embedded branch 70 is parallel to the central axis of the vascular implant 100. In other embodiments, the inset branch 70 is angled, i.e., a central axis of the inset branch 70 may be angled with respect to a central axis of the vascular implant 100.
The connecting stent comprises a connecting covering film 20 and a plurality of supporting skeletons 30, a connecting cavity 22 is defined by the connecting covering film 20, the supporting skeletons 30 are fixed on the wall surface of the connecting covering film 20 and are arranged at intervals along the axial direction of the connecting covering film 20, each supporting skeleton 30 is an integrally formed independent closed-loop structure, namely, each supporting skeleton 30 does not depend on a windowing structure 50 to form a closed-loop structure, in other words, the arrangement of the windowing structure 50 does not damage the integrally formed closed-loop independence of each supporting skeleton 30. Each supporting framework 30 comprises a plurality of supporting rods 31 which are connected in sequence at included angles, and two adjacent included angles in the circumferential direction of the connecting coating film 20 are respectively a wave crest 31a and a wave trough 31b. The peaks 31a are closer to the proximal end of the attachment film 20 than the valleys 31b. In this embodiment, the rounded corners are disposed at the peaks 31a and the valleys 31b, which is beneficial to reduce the risk of damage to the vascular implant 100 during radial contraction.
Referring to fig. 6, the embedded branch 70 includes a proximal port 722 and a distal port 724 disposed axially opposite the embedded branch 70. In the circumferential direction of the connecting bracket, the circumferential length of the fenestration structure 50 is greater than the maximum circumferential length of at least one port of the embedded branch 70. The fenestration 50 has a greater circumferential length along the connecting stent than the proximal aperture 722 of the embedded branch 70. The circumferential length L1 of the fenestration 50 on the connection coating 20 is 20% to 40% of the circumferential length of the connection stent. The axial length of the window structure 50 along the axial direction of the connecting bracket is greater than the maximum axial length of at least one port of the inset branch 70. The axial length of the fenestration structure 50 along the linking bridge is at least 40% of the circumferential length of the fenestration structure 50 along the linking bridge.
The circumferential length L1 of the window structure 50 is 25mm to 35mm, the axial length of the window structure 50 along the connection film 20 is in the range of 15mm to 25mm, preferably, the circumferential length L1 of the window structure 50 is 28 mm to 32mm, and the axial length L2 of the window structure 50 along the connection film 20 is 18 mm to 22mm. In the present embodiment, the circumferential length L1 of the window structure 50 is 30mm, and the axial length L2 of the window structure 50 along the connection film 20 is 20 mm.
The axial length of the windowing structure 50 along the connecting stent is at least 40% of the circumferential length of the windowing structure 50 along the connecting stent, the circumferential length L1 of the windowing structure 50 on the connecting stent 20 is 20% -40% of the circumferential length of the connecting stent, so that the caliber of the windowing structure 50 on the connecting stent is larger, the size of the windowing structure 50 is larger than the size of the root opening 300 of the target branch vessel (the root opening 300 can refer to the positions shown in fig. 11-14), even if the proximal end 722 of the embedded branch 70 is difficult to be completely aligned with the root opening 300 of the target branch vessel (complete alignment means that the central axis of the embedded branch 70 coincides with the central axis of the root opening 300 of the target branch vessel), the windowing structure 50 with larger size can also ensure to cover the root opening 300 of the branch vessel, thereby improving the fault tolerance of the vascular implant 100 in the process of reconstructing the branch vessel, improving the positioning accuracy of the windowing structure 50 on the target branch vessel, facilitating the assembly of the branch stent in the embedded branch 70 without affecting the radial compression size of the vascular implant 100, and greatly reducing the operation time and operation difficulty of a patient.
The support frame 30 includes a proximal support frame 32, a distal support frame 34, a first frame 36, a second frame 38, a first support portion 40, and a second support portion 42, depending on the position of the support frame 30 in the axial direction of the connection cover 20. The first bobbin 36 is disposed adjacent to the second bobbin 38 in the axial direction. The first backbone 36 is farther from the proximal end of the connecting stent than the second backbone 38. The fenestration 50 is disposed adjacent to the first frame 36 and the second frame 38.
The distal support backbone 34 is located on a distal end side of the first backbone 36, the first backbone 36 is disposed adjacent to the distal support backbone 34 in the axial direction of the connection cover 20, and the first support section 40 is located on a distal end side of the distal support backbone 34. The proximal support armature 32 is located on a proximal side of the second armature 38, the second armature 38 is disposed adjacent to the proximal support armature 32 in the axial direction of the connection cover 20, and the second support portion 42 is located on a proximal side of the proximal support armature 32. The maximum axial length of the fenestration 50 on the connecting covering film 20 is less than or equal to the maximum axial length between the proximal support framework 32 and the distal support framework 34, so that the axial extension length of the fenestration 50 on the connecting covering film 20 is relatively large, in other words, the circumferential and axial dimensions of the fenestration 50 are relatively large, and thus the dimension of the fenestration 50 is larger than the dimension of the root opening 300 of the branch vessel, so as to further improve the positioning accuracy and fault tolerance of the fenestration 50 on the branch vessel.
In the embodiment of the application, the first supporting portion 40 is arranged in an equal-altitude-wave manner, that is, the axial lengths of the multiple wave crests 31a of the first supporting portion 40 on the connecting coating film 20 are approximately equal, so that the radial supporting force of the vascular implant 100 is increased, the adherence between the vascular implant 100 and a blood vessel is improved, and the prevention of internal leakage is facilitated. It is understood that the plurality of crests 31a of the first support 40 may not have equal axial lengths on the connecting coating 20. In the embodiment of the present application, the axial lengths of the partial wave crests 31a of the second supporting portion 42 on the connecting coating 20 are substantially equal, so as to increase the radial supporting force of the vascular implant 100, improve the adherence to the blood vessel, and facilitate preventing the inner leakage. The axial length of the peak 31a in the connection coating 20 as referred to herein means the maximum axial length between the proximal end of the peak 31a and the distal end of the vascular implant 100. Part of the wave crests 31a in the second support portion 42 protrude to connect with the proximal end of the graft film 20 to form anchoring hooks 420, facilitating the post-release process of the proximal end of the vascular implant 100. It is understood that the plurality of peaks 31a of the second support portion 42 may be equal or unequal in axial length of the connection coating 20.
The plurality of peaks 31a on the first framework 36 include a high wave 312a and a low wave 314a, the plurality of peaks 31a on the second framework 38 also include a high wave 312a and a low wave 314a, the proximal support framework 32 also includes a high wave 312a and a low wave 314a, and the distal support framework 34 also includes a high wave 312a and a low wave 314a. The axial length of the high wave 312a along the connection cover 20 is greater than the axial length of the low wave 314a along the connection cover 20, and the proximal end of the high wave 312a is closer to the proximal end of the connection cover 20 than the proximal end of the low wave 314a. The axial length of the high wave 312a along the connection cover 20 as referred to herein means the maximum axial length between the proximal end of the high wave 312a and the distal end of the connection stent; the axial length of the low wave 314a along the connecting stent 20 is defined as the maximum axial length between the proximal end of the low wave 314a and the distal end of the connecting stent. The first framework 36, the second framework 38, the near side supporting framework 32 and the far side supporting framework 34 are all arranged in a high-low wave mode, so that the flexibility of the blood vessel implant 100 is improved, the blood vessel implant 100 can better conform to the bending form of a blood vessel, and the better bending of the windowing structure 50 can be favorably attached to the root openings 300 of the branch blood vessels on the blood vessel in different bending forms tightly.
In this embodiment, it is preferable that the first framework 36, the proximal support framework 32 and the distal support framework 34 are arranged alternately with high and low waves periodically, so that the compliance of the vascular implant 100 is more uniform, and the vascular implant 100 better conforms to the curved shape of the blood vessel.
It is understood that, in other embodiments, the high waves 312a and the low waves 314a on the first framework 36, the proximal support framework 32 and the distal support framework 34 may be disposed in a periodic mixed manner or a non-periodic mixed manner, that is, the high waves 312a and the low waves 314a on the first framework 36, the proximal support framework 32 and the distal support framework 34 are disposed in a non-alternating manner, for example, at least two adjacent peaks 31a are both high waves 312a, or at least two adjacent peaks 31a are both low waves 314a, or the arrangement number of the high waves 312a and the low waves 314a in the circumferential direction of the connection cover 20 may be varied randomly, and the like.
At least one high wave 312a is respectively arranged at two sides adjacent to the windowing structure 50 along the circumferential direction of the connecting covering film 20, and the high waves 312a are positioned on a supporting framework integrally arranged with the windowing structure 50; that is, at least one high wave 312a is respectively disposed on two sides of the windowing structure 50 along the circumferential direction of the connecting coating film 20, and the high wave 312a is located on the first skeleton 36 to improve the radial supporting force around the windowing structure 50, which is beneficial to preventing the windowing structure 50 from sinking. Preferably, at least two adjacent high waves 312a are respectively arranged on two sides of the window structure 50 along the circumferential direction of the connecting covering film 20, and the high waves 312a are positioned on a supporting framework integrally arranged with the window structure 50; that is, at least four peaks 31a adjacent to the fenestration structure 50 in the plurality of peaks 31a on the first framework 36 are high waves 312a, that is, preferably, at least four high waves 312a adjacent to the fenestration structure 50 are provided, two of the high waves 312a are located at one end of the fenestration structure 50 in the circumferential direction, and the other two high waves 312a are located at the other end of the fenestration structure 50 in the circumferential direction, so that the requirement of radial support force around the fenestration structure 50 can be better ensured, and the requirement of better flexibility can be simultaneously considered.
The second skeleton 38 includes a first portion 382 and a second portion 384 that are disposed in a connected manner along the circumferential direction of the connection cover 20. The first portion 382 is closer to the proximal end of the connecting cover 20 than the second portion 384 to facilitate the solution of the protrusion of the valleys 31b of the first portion 382 when assembled, while reducing the radial support force of the first portion 382 on the proximal side of the fenestration structure 50 to facilitate the radially compressive assembly of the vascular implant 100 in the delivery device. Specifically, the proximal ends of the peaks 31a of the first portion 382 are closer to the proximal end of the connection coating 20 than the proximal ends of the peaks 31a of the second portion 384, the distal ends of the valleys 31b of the first portion 382 are closer to the proximal end of the connection coating 20 than the distal ends of the valleys 31b of the second portion 384, and the distal ends of the valleys 31b of the first portion 382 are farther from the proximal end of the connection coating 20 than the distal ends of the peaks 31a of the second portion 384, so as to better reduce the risk of outward bulging of the valleys 31b of the first portion 382 during assembly, and simultaneously better reduce the radial supporting force of the first portion 382 at the proximal side of the fenestration structure 50, thereby facilitating the radial compressive assembly of the vascular implant 100 in the delivery device. Peaks 31a of first portion 382 are all high waves 312a. Peaks 31a of second portion 384 preferably alternate with periodic high waves 312a and low waves 314a.
It is understood that in other embodiments, peak 31a of first portion 382 may be a mixture of high wave 312a and low wave 314a.
Referring to fig. 7a and 7b, in the present embodiment, the first portion 382 is formed by six support rods 31 connected in sequence at an included angle (the range within the dashed rectangle in fig. 7 a), so as to facilitate the determination of the range of the first portion 382, but not limit the number of the support rods 31 on the first portion 382. With the central axis 101 of the connecting bracket as the projection direction and P-P as the projection plane (orthographic projection), the projection of the first portion 382 along the central axis 101 of the connecting bracket (the central axis 101 being the axial extension direction of the connecting bracket) at least partially coincides with the projection of the fenestration structure 50 along the central axis 101 of the connecting bracket. In this embodiment, it is preferable that the projection of the first portion 382 along the central axis 101 of the connecting bracket completely coincides with the projection of the windowing structure 50 along the central axis 101 of the connecting bracket, so as to better ensure the structural stability of the windowing structure 50. In other embodiments, the projection width of the first portion 382 along the central axis 101 of the connecting bracket may be greater than the projection width of the window structure 50 along the central axis 101 of the connecting bracket (the width refers to the circumferential length on the connecting bracket), so as to better ensure the structural stability of the window structure 50.
The support frame 30 further includes a plurality of third support frames 44 (shown in fig. 6). A portion of the third support armature 44 is located between the proximal support armature 32 and the second support portion 42, and the remaining portion of the third support armature 44 is located between the distal support armature 34 and the first support portion 40. The third supporting frame 44 is arranged in a periodic alternating high-low wave. The provision of a plurality of third support backbones 44 can further enhance compliance around fenestration 50. It is understood that the third support frame 44 may not be disposed between the first support portion 40 and the second support portion 42.
In the axial direction of the connecting stent, the wave crests 31a of every two adjacent supporting skeletons 30 are opposite, and the wave troughs 31b of every two adjacent supporting skeletons 30 are opposite in the proximal supporting skeleton 32, the distal supporting skeleton 34, the first supporting skeleton 40, the second supporting skeleton 42 and the plurality of third supporting skeletons 44, so as to further improve the flexibility of the blood vessel implant 100 on the side close to the small curve side of the blood vessel.
Referring to fig. 6 and 7a, the window structure 50 includes a first window portion 52 and a second window portion 54 connected along the axial direction of the connecting bracket. The first fenestration 52 and the second fenestration 54 may enclose a closed loop structure. The first fenestration 52 is further from the proximal end of the vascular implant 100 than the second fenestration 54. The first fenestration 52 generally defines a concave arc structure (i.e., the first fenestration 52 is concave in the proximal direction away from the connection coating 20), and the second fenestration 54 generally defines an arc structure that is convex toward the proximal end of the connection coating 20 (i.e., the second fenestration 54 is convex in the proximal direction toward the connection coating 20), and for example, the second fenestration 54 may have an arc structure of 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, and the like. The first fenestration 52 and the second fenestration 54 enclose an irregular window shape. It is understood that the structure and shape of the window opening structure 50 are not limited in the present application, for example, the first window opening portion 52 may have an arc structure, etc., the second window opening portion 54 may have a multi-segment arc structure, etc., and the window opening structure 50 may also have some regular shape, such as a circle, an ellipse, etc.
At least a portion of the embedded branch 70 proximate to the port of the fenestration 50 is secured to the fenestration 50, and in this embodiment, the proximal port 722 of the embedded branch 70 is partially secured to the first fenestration 52. At least a portion of the embedded branch 70 near the port of the fenestration 50 is fixed to the fenestration 50, which allows the embedded branch 70 to be more stably inserted into the branch bracket.
The first portion 382 is located on the proximal side of the second fenestration 54, in other words, the second fenestration 54 is located between the first portion 364 and the first fenestration 52.
At least a portion of the fenestration 50 is integral with at least one of the support skeletons 30. It should be noted that the integral arrangement may mean that at least a part of the window structure 50 is a part of at least one supporting framework 30, or may mean that at least a part of the window structure 50 is a framework bar fixed on the supporting framework 30, so as not to destroy the independent closed loop structure of each supporting framework 30.
In this embodiment, the first windowing portion 52 and the first framework 36 are integrally arranged, so that the first framework 36 is still an independent closed-loop structure, and each supporting framework 30 connected to the coating film 20 is an independent closed-loop structure, which is beneficial to greatly improving the supporting force of the windowing structure 50 in the radial direction. When the blood vessel is calcified or intercalated to compress the blood vessel implant 100, the radial supporting force formed by each supporting skeleton 30 in the independent closed loop structure can slow down the compression of the calcified area or intercalated area on the blood vessel implant 100, which leads to the reduction of the radial size of the connecting cavity 22 of the blood vessel implant 100 and even the occlusion, thereby being beneficial to reducing the blood flux loss caused by the compression of the blood vessel implant 100. The first framework 36 and the first windowing part 52 are integrally arranged, and the radial size of the vascular implant 100 is favorably reduced, so that the vascular implant 100 is more conveniently and radially compressed to be assembled in a conveyor, and the release success rate of interventional therapy of the vascular implant 100 is improved; the problem that the windowing structure 50 is deformed or even cannot be restored to a preset shape to cause inaccurate positioning and further cause failure in reconstructing the branch vessel due to the fact that the windowing structure 50 is extruded when the axially adjacent supporting framework is radially compressed and assembled in the transporter for the vascular implant 100 is also favorably avoided.
Note that the first window opening portion 52 may be provided integrally with the first frame 36, which means that the first window opening portion 52 is a part of the first frame 36, or the first window opening portion 52 may be a frame bar fixed to the first frame 36 so as not to damage the closed loop structure of the first frame 36.
Referring to fig. 8a and 8b, the window structure 50 further includes two ring-shaped members 56, and the two ring-shaped members 56 are respectively fixed at two ends of the second window portion 54 along the circumferential direction of the connecting bracket; the provision of the loop 56 facilitates preventing the second fenestration 54 from shifting on the connecting stent while also facilitating avoiding both ends of the second fenestration 54 from abrading the vascular implant 100 when sutures suture the second fenestration 54 to the connecting stent.
Referring to fig. 8a, 9a and 9b, the embedded branch 70 includes a branch coating 72 and a support ring 76, the branch coating 72 is hermetically connected to the connection coating 20, and the support ring 76 is disposed on the branch coating 72 for providing radial support force for the embedded branch 70. The transition tectorial membrane 74 is located the connection chamber 22, and transition tectorial membrane 74 sealing connection is in the near end of branch tectorial membrane 72, and transition tectorial membrane 74 sealing connection is on windowing structure 50 to make windowing structure 50 loop through near end mouth 722 of branch tectorial membrane 72, intercommunication chamber 720 and connect the chamber 22 intercommunication, make the leak protection performance of windowing structure 50 better. In this embodiment, the transitional coating 74 is integrally formed with the branch coating 72 to enhance the anti-endoleak effect of the vascular implant 100.
The term "hermetically sealed connection" as used herein may mean that both are integrally provided, that one of them is fixed to the other by a sewing thread, and that one of them is fixed to the other by means of adhesion, heat sealing, pressure welding, or the like.
In this embodiment, the support ring 76 is an open-loop wave ring (i.e., the support ring 76 is preferably an open-loop structure), which is beneficial to avoid the problem that the support ring 76 is difficult to recover to the preset shape due to stress concentration on the surface of the support ring 76 when the embedded branch 70 is contracted in the delivery device after being radially compressed, and is also beneficial to reduce the problem of large resistance when the vascular implant 100 is released from the delivery device, and improve the smoothness when the vascular implant 100 is released in the blood vessel. Specifically, the side of the support ring 76 provided with the opening is fixed to the branch coating film 72.
The support rings 76 may be structurally identical to the support frame 30, that is, each support ring 76 may also include a plurality of support rods 31 connected in sequence at included angles, and two included angles adjacent to each other in the circumferential direction of the branched coating film 72 are a wave crest 31a and a wave trough 31b, respectively. The peaks 31a are closer to the proximal ends of the branched overlaminates 72 than the valleys 31b. Along the axial direction of the embedded branch 70, the wave crests 31a of every two adjacent support rings 76 are opposite, and the wave troughs 31b of every two adjacent support rings 76 are opposite.
For two support rings 76 adjacent to each other in the axial direction of the embedded branch 70, the wave trough 31b of one support ring 76 and the wave crest 31a of the other adjacent support ring 76 can be fixedly connected to each other, which is beneficial to avoid the embedded branch 70 from being shortened (i.e. the axial length of the embedded branch 70 is shortened), thereby being beneficial to ensure the required anchoring length of the branch stent released in the embedded branch 70.
Referring to fig. 6 and 7a, the circumferential length L1 of the window structure 50 on the connecting bracket is 1-5 times the maximum diameter of the embedded branch 70. The diameter of the embedded branch 70 can be 6mm, 8mm, 10mm, 12mm, 14mm or 16mm according to the diameter of the branch vessel to be reconstructed of different patients.
Because the circumferential length of the windowing structure 50 on the connecting support is 1-5 times of the diameter of the embedded branch 70, the circumferential caliber of the windowing structure 50 on the connecting support is larger, and the positioning accuracy and the fault tolerance rate of the windowing structure 50 on the branch blood vessel are improved, for example, when the vascular implant 100 is applied to aortic arch interventional therapy, the windowing structure 50 can improve the alignment accuracy of the vascular implant 100 on the root opening 300 of the branch blood vessel, and is convenient for the assembly of the branch support without affecting the radial compression size of the vascular implant 100.
In the related art, since the size of the fenestration structure is relatively small, for example, the fenestration structure is the proximal port of the embedded branch (for example, the fenestration in CN111227990A in the related art), the fenestration structure may be directly used as the proximal port of the embedded branch to align with the root opening of the target branch vessel, and a beam diameter design (for example, at least two rows of connectors in CN109984862A in the related art) may be required to make the vascular implant radially contract to assume a half-deployed state, so that an operator may adjust the position of the vascular implant many times until the fenestration structure and the root opening of the target branch vessel are aligned, that is, after the fenestration structure and the root opening of the target branch vessel are accurately aligned, the beam diameter design is released from binding the vascular implant, and then the branch stent is released in the embedded branch to reconstruct the blood circulation of the target vessel. The design of the fenestration structure 50 of the present embodiment can eliminate the beam diameter design in the related art, reduce the size and structure of the transporter, reduce the learning curve and the operation difficulty of the operator, and facilitate the improvement of the release success rate of the vascular implant 100.
Taking the reconstruction of the left subclavian artery of the aortic arch as an example, when the root openings 300 of the left subclavian artery and the innominate artery or the left common carotid artery are not in the same cross section, the windowing structure 50 is more easily positioned at the root opening 300 of any branch vessel, and the fault tolerance is higher.
The main covering membrane 201, the separating covering membrane 401, the sealing covering membrane 500, the connecting covering membrane 20, the branch covering membrane 72 and the transition covering membrane 74 are all biocompatible fabrics including, but not limited to, woven or knitted polyester, such as polyethylene terephthalate, polylactide, polyglycolide and copolymers thereof; fluorinated polymers such as polytetrafluoroethylene, expanded or electrospun polytetrafluoroethylene, and polyvinylidene fluoride; polysiloxanes, such as polydimethylsiloxane; polyurethanes such as polyether polyurethanes, polyurethane ureas, polyether polyurethane ureas, polyurethanes containing carbonate linkages, braided nickel titanium containing siloxane segments, and polyurethanes; silicone, ultra high molecular weight polyethylene, or other suitable material. The materials of the main body coating 201, the partition coating 401, the connection coating 20, the branch coating 72, and the transition coating 74 are not limited in the present application.
The main body support structure 203, the separation support structure 403, the support frame 30, the support ring 76, and the positioning rod 800 are made of elastic materials, including but not limited to one or more of nitinol, cobalt-chromium-nickel-molybdenum alloy, copper-based shape memory alloy, iron-based shape memory alloy, medical stainless steel alloy, or various polymers (such as polynorbornene, polyurethane, polylactic acid copolymer, etc.), and the like.
Referring to fig. 6, 8a and 8b, the proximal end of the branched covering film 72 is provided with a slit 726. The split 726 is located on a distal side of the fenestration 50 (i.e., a distal side of the first fenestration 52). The slit 726 is fixed to the connection film 20, and is used for reducing the risk of wrinkles at the joint of the transition film 74 and the connection film 20, and ensuring that enough space is available when a branch blood vessel is inserted into the embedded branch 70, so that the risk of internal leakage is reduced. The length of the proximal end of the slit 726 is greater than the length of the distal end of the slit 726 in the circumferential direction of the connection cover 20, for example, the length of the slit 726 in the circumferential direction of the connection stent may be gradually increased from the distal end of the slit 726 to the proximal end of the slit 726. In other embodiments, split 726 may be in the shape of a T, V, inverted V, dumbbell, or the like.
The branch coating 72 is formed with a sewing stitch 78 at the junction with the inner wall of the connecting coating 20. Suture stitch 78 is attached to the distal end of split 726. A suture stitch 78 extends axially along embedded branch 70. The length of the sewing stitches 78 extending in the axial direction of the embedded branch 70 is not less than 15mm to improve the stability of the connection between the branch coating film 72 and the connection coating film 20.
As shown in fig. 10, the blood vessel may be an aortic arch 3000, for example, to reconstruct the left subclavian artery 3001 of the aortic arch 3000, the vascular implant 100 is released into the aortic arch 3000, and the branch stent 2000 is released into the embedded branch 70, since the length of the suture thread 78 extending along the axial direction of the branch covering film 72 is not less than 15mm, the branch stent 2000 can be stably inserted into the embedded branch 70 of the vascular implant 100 and the risk of internal leakage of the branch stent 2000 is reduced.
As shown in fig. 11, the blood vessel may be an abdominal aorta 4000, and taking a renal artery 4001 for reconstructing the abdominal aorta 4000 as an example, the branch stent 2000 is released in the embedded branch 70, and since the length of the suture stitches 78 along the axial direction of the branch covering film 72 is not less than 15mm, the branch stent 2000 can be stably inserted into the embedded branch 70 of the blood vessel implant 100 and the risk of internal leakage of the branch stent 2000 is reduced.
In other embodiments, a plurality of nested branches 70 and a corresponding number of fenestrations 50 may be provided in the vascular implant 100 to enable the reconstruction of multiple branch vessels.
Referring to fig. 6, 8a and 8b again, in the present embodiment, the distance L3 between the suture thread 78 and the first windowing portion 52 is in the range of 2.5-3.5 mm, so as to reduce the possibility of wrinkling of the transitional covering film 74, ensure blood supply to the branch vessels, and reduce the risk of internal leakage. Too small a distance between the proximal end of the suture stitch 78 and the distal end of the first fenestration 52 may tend to cause the transitional coating 74 near the fenestration 50 to wrinkle. Too large a distance between the proximal end of the suture stitch 78 and the distal end of the first fenestration 52 tends to cause the position of the support ring 76 on the branched coating 72 to move downward, which in turn causes the axial length of the branched coating 72 to be too long. The blood flow enters the embedded branch 70 from the distal port 724 of the embedded branch 70, and then the blood supply of the branch vessel is ensured through the branch stent inserted into the embedded branch 70, and the lengthening of the axial length of the embedded branch 70 will result in the lengthening of the retrograde distance of the blood flow, which is not favorable for ensuring the blood supply of the branch vessel. In addition, if the axial length of the embedded branch 70 is too long, the radial supporting force at the branch coating 72 between the proximal end side of the support ring 76 and the distal end of the first fenestration 52 tends to be insufficient, and the branch stent is likely to leak inward after being inserted into the embedded branch 70 through the fenestration 50.
The proximal port 722 of the embedded branch 70 and the distal port 724 of the embedded branch 70 are each provided with a positioning ring 77, and the embedded branch 70 is provided with a visualization mark on the positioning ring 77 of the proximal port 722 for indicating the position of the embedded branch 70 for over-selecting the position. A visualization marker may also be provided on fixation ring 77 of distal port 724. Wherein retaining ring 77 at proximal port 722 may be generally semi-annular in configuration. It will be appreciated that retaining ring 77 may have other shapes, for example, retaining ring 77 may be a closed loop structure. When the positioning ring 77 is substantially a semi-ring structure, the two ends of the positioning ring 77 along the circumferential direction of the embedded branch 70 can be respectively fixed with a ring member 56 (not shown), when the positioning ring 77 is sutured and fixed on the transitional coating 74 by a suture, the rings at the two ends of the positioning ring 77 are beneficial to preventing the positioning ring 77 from being displaced and also beneficial to preventing the two ends of the positioning ring from wearing the transitional coating 74.
The developing marker material can be made of materials with good X-ray impermeability, strong corrosion resistance and good biocompatibility, and can be gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and other materials or alloys of the materials.
It is understood that the development mark may also be understood that at least one of the retainer rings 77 has development material such that the retainer ring 77 need not be provided with a development mark; alternatively, at least one of the support rings 76 may be provided with a visualization mark disposed around at least a portion of the positioning ring 77.
Referring to fig. 12, in an application scenario of a luminal stent 1000, taking reconstruction of three branch vessels on the aortic arch 3000 as an example, the three branch vessels may be a left subclavian artery 3001, a left common carotid artery 3002 and a brachiocephalic artery 3003. The two stent separators 400 are provided, the vascular implant 100 is released into the main lumen channel 205 through the main lumen port 501, and then the branch stent 2000 is released into the embedded branch 70 and the two stent separators 400, respectively, and the state of the main stent 200, the stent separators 400, and the branch stent 2000 released in the aortic arch 3000 is shown in fig. 12.
Referring to fig. 13, in other embodiments of the present application, the number of the separation stents 400 may also be one, taking reconstruction of two branch vessels of the aortic arch 3000 as an example, such as reconstruction of the left subclavian artery 3001 and the left common carotid artery 3002, or reconstruction of the left subclavian artery 3001 and the brachiocephalic artery 3003, the separation stents 400 are configured as one, the vessel implant 100 is released into the main lumen channel 205 through the main lumen port 501, and then the branch stents 2000 are released in the embedded branch 70 and the separation stent 400 respectively, and the state of the main body stent 200, the separation stent 400 and the branch stent 2000 released in the aortic arch 3000 is shown in fig. 13.
Referring to fig. 14, the vascular implant 100 provided in the second embodiment of the present application has substantially the same structure as the vascular implant 100 provided in the first embodiment of the present application, and the vascular implant 100 provided in the second embodiment of the present application has a structure different from the vascular implant 100 provided in the first embodiment of the present application in that the arrangement of the fenestration structure 50 and the structure of the partial support scaffold are different.
In this embodiment, the first frame 36 and the first window 52 are integrally disposed, and the second frame 38 and the second window 54 are integrally disposed, so that the first frame 36 and the second frame 38 are still independent closed-loop structures, respectively, so that each support frame 30 connected to the covering film 20 is an independent closed-loop structure, which is beneficial to greatly improving the radial support force of the window 50. When the blood vessel is calcified or intercalated to compress the blood vessel implant 100, the radial supporting force formed by each supporting skeleton 30 in the independent closed loop structure can slow down the compression of the calcified area or intercalated area on the blood vessel implant 100, which leads to the reduction of the radial size of the connecting cavity 22 of the blood vessel implant 100 and even the occlusion, thereby being beneficial to reducing the blood flux loss caused by the compression of the blood vessel implant 100. The first framework 36 and the first windowing part 52 are integrally arranged, and the second framework 38 and the second windowing part 54 are integrally arranged, so that the radial size of the vascular implant 100 is favorably reduced, the vascular implant 100 is more conveniently radially compressed and assembled in a conveyor, and the release success rate of interventional therapy of the vascular implant 100 is improved; the problem that the windowing structure 50 is deformed or even cannot be restored to a preset shape to cause inaccurate positioning and further cause failure in reconstruction of the branch blood vessel due to the fact that the windowing structure 50 is extruded when the blood vessel implant 100 which is adjacent in the axial direction is radially compressed and assembled in the conveyor is avoided.
Note that, the first window 52 may be provided integrally with the first frame 36, that is, the first window 52 may be a part of the first frame 36, or the first window 52 may be a frame strip fixed to the first frame 36, so that the closed loop structure of the first frame 36 is not damaged. The second frame 38 and the second window-opening portion 54 may be integrally provided, that is, the second window-opening portion 54 is a part of the second frame 38, or that the second window-opening portion 54 is a frame strip fixed to the second frame 38, so that the closed-loop structure of the second frame 38 is not damaged. Ultimately ensuring that each support armature 30 is an integrally formed, independent closed loop structure.
The first frame 36 and the second frame 38 may be axially spaced apart, and two circumferential ends of the first window portion 52 are fixed to two circumferential ends of the second window portion 54 by means of sutures, respectively, so that the window structure 50 forms a closed loop structure.
The plurality of peaks 31a on the first skeleton 36 include a high wave 312a and a low wave 314a, and the plurality of peaks 31a on the second skeleton 38 also include a high wave 312a and a low wave 314a. The high wave 312a has a greater axial length along the connecting stent than the low wave 314a, and the proximal end of the high wave 312a is closer to the proximal end of the connecting stent than the proximal end of the low wave 314a. The first and second frameworks 36 and 38 are configured in a high-low wave configuration to improve the flexibility of the vascular implant 100, so that the vascular implant 100 can better conform to the curved shape of the blood vessel.
At least one high wave 312a is respectively arranged at two sides adjacent to the windowing structure 50 along the circumferential direction of the connecting covering film 20, and the high waves 312a are positioned on the supporting framework 30 integrally arranged with the windowing structure 50; that is, at least one high wave 312a is respectively arranged on two sides of the window structure 50 along the circumferential direction of the connecting coating film 20, and the high waves 312a are positioned on the first framework 36 and the second framework 38; in other words, at least one of the plurality of peaks 31a of the first skeleton 36 adjacent to the peak 31a of the window structure 50 is a high wave 312a, and at least one of the plurality of peaks 31a of the second skeleton 38 adjacent to the peak 31a of the window structure 50 is a high wave 312a, so as to improve the radial supporting force around the window structure 50, which is beneficial to preventing the window structure 50 from sinking.
Preferably, at least two high waves 312a are respectively arranged along the circumferential direction of the connecting coating film 20 and adjacent to two sides of the windowing structure 50, and the high waves 312a are positioned on the supporting framework 30 integrally arranged with the windowing structure 50; that is, at least two high waves 312a are respectively disposed along the circumferential direction of the connection coating film 20 and adjacent to two sides of the windowing structure 50, and the high waves 312a are located on the first framework 36 and the second framework 38; in other words, at least four wave crests 31a adjacent to the windowing structure 50 among the plurality of wave crests 31a on the first framework 36 are high waves 312a, wherein two high waves 312a are located at one end of the windowing structure 50 in the circumferential direction, and the other two high waves 312a are located at the other end of the windowing structure 50 in the circumferential direction; preferably, at least four wave crests 31a adjacent to the fenestration structure 50 in the plurality of wave crests 31a on the second framework 38 are high waves 312a, two of the high waves 312a are located at one end of the fenestration structure 50 in the circumferential direction, and the other two high waves 312a are located at the other end of the fenestration structure 50 in the circumferential direction, so that the requirement of radial support force around the fenestration structure 50 can be better ensured.
The vascular implant 100b provided in the third embodiment of the present application has substantially the same structure as the vascular implant 100 provided in the first or second embodiment of the present application, and referring to fig. 15, the vascular implant 100 provided in the third embodiment of the present application has a structure different from the vascular implant 100 provided in the first or second embodiment of the present application in that at least one of the proximal port 722 and the distal port 724 of the embedded branch 70 may be a beveled port.
Referring to fig. 15 and 16, fig. 15 is a schematic view of a possible implementation of the proximal port 722 of the embedded branch 70 of the vascular implant 100 shown in fig. 8a as a beveled port; fig. 16 is a schematic diagram of the structure of the inset branch 70 of fig. 15. The proximal port 722 of the embedded branch 70 is an oblique port, and one side of the proximal port 722, which is close to the central axis 101 of the connecting stent, can correspondingly extend towards the proximal direction of the vascular implant 100, which is favorable for improving the visibility of the proximal port 722, facilitating the better insertion of the branch stent into the corresponding embedded branch 70, and improving the positioning accuracy of the branch vessel; the supporting force of the transition covering film 74 is improved, the problem that the transition covering film 74 is folded is solved, the blood flow in the connecting cavity 22 of the connecting support is smooth, the thrombus is reduced, and the branch support can be inserted into the embedded branch 70 more tightly. Accordingly, the proximal ports 722 of the embedded branches 70 are beveled, and the side of the support ring 76 adjacent to the proximal ports 722 that is adjacent to the central axis 101 of the stent graft may correspondingly extend in the proximal direction of the stent graft to increase the radial support near the proximal ports 722, which may help reduce the wrinkling of the branch graft 72.
Referring to fig. 17, a first included angle C is formed between the plane of the proximal port 722 and the central axis 101 of the connecting bracket, so that the proximal port 722 of the embedded branch 70 is located in the connecting cavity 22, that is, the proximal port 722 of the embedded branch 70 is not disposed on the circumferential surface of the connecting bracket, so that the plane of the proximal port 722 and the central axis 101 of the embedded branch 70 form the first included angle C. The proximal port 722 of the embedded branch 70 is positioned in the connecting cavity 22, so that more sufficient space is provided for the branch stent for reconstructing the target branch blood vessel, and the blood supply of the branch blood vessel is influenced by preventing the blood vessel implant 100 from extruding the branch stent to cause stenosis and even occlusion of the branch stent; meanwhile, the sufficient space provided for reconstructing the branch stent of the target branch vessel is also beneficial to providing a larger pivot angle for the branch stent, namely, the branch stent can be twisted by a certain angle in the circumferential direction and the axial direction of the windowing structure 50, so that the branch stent can better adapt to vessels with different anatomical forms.
In this embodiment, the surface of the proximal port 722 may be disposed obliquely with respect to the central axis 101 of the connecting bracket, that is, the first included angle C may be disposed at a non-right angle, in other words, the proximal port 722 of the embedded branch 70 may be an oblique port; with the distal end of the connecting stent as a bottom point, the inclination direction of the plane of the proximal port 722 may be that the side of the proximal port 722 away from the central axis 101 of the connecting stent is settled toward the distal end of the connecting stent relative to the side of the proximal port 722 close to the central axis 101 of the connecting stent (i.e., the side of the proximal port 722 away from the central axis 101 of the connecting stent is closer to the distal end of the connecting stent than the side of the proximal port 722 close to the central axis 101 of the connecting stent), or that the side of the proximal port 722 close to the central axis 101 of the connecting stent is settled toward the distal end of the connecting stent relative to the side of the proximal port 722 away from the central axis 101 of the connecting stent relative to the side of the proximal port 722 close to the central axis 101 of the connecting stent is farther from the distal end of the connecting stent.
Referring to fig. 18, in other embodiments of the present application, the first included angle C is substantially a right angle, i.e., the proximal port 722 of the embedded branch 70 may be a flat port.
Referring to fig. 17 and 18, a second included angle D is formed between the plane of the distal end 724 of the embedded branch 70 and the central axis 101 of the connecting bracket. In this embodiment, the second included angle D is greater than 0 degrees and smaller than 90 degrees, i.e., the distal opening 724 of the embedded branch 70 may also be a bevel opening. With the proximal end of the connecting bracket as the bottom point, the slope of the face of distal opening 724 is preferably oriented such that the side of distal opening 724 distal from fenestration 50 is recessed from the side of distal opening 724 proximal to fenestration 50 (i.e., the side of distal opening 724 distal from fenestration 50 is closer to the proximal end of the connecting bracket than the side of distal opening 724 proximal to fenestration 50). In other embodiments of the present application, the second included angle D may be a right angle, i.e., the distal opening 724 of the embedded branch 70 may also be a flat opening.
The above disclosure is only for the purpose of illustrating the preferred embodiments of the present application and is not to be construed as limiting the scope of the present application, so that the present application is not limited thereto, and all equivalent variations and modifications can be made to the present application.

Claims (20)

1. A vascular implant, comprising:
the connecting bracket surrounds a tubular connecting cavity;
the embedded branch is fixed on the connecting bracket and is contained in the connecting cavity, the embedded branch is enclosed into a tubular communicating cavity, and the communicating cavity is communicated with the connecting cavity;
the transition covering film is connected to one port of the embedded branch in a sealing manner;
the windowing structure is arranged on the connecting support, the transition covering film is connected to the windowing structure in a sealing mode so as to enable the windowing structure to be communicated with the communicating cavity, and the windowing structure is used for being in splicing fit with a branch support for reconstructing a branch blood vessel so as to enable the branch support to be communicated with the connecting cavity through the communicating cavity; in the axial direction of the connecting bracket, the axial length of the windowing structure is greater than the maximum axial length of at least one port of the embedded branch; in the circumferential direction of the connecting support, the circumferential length of the windowing structure is greater than the maximum circumferential length of at least one port of the embedded branch, and the circumferential length of the windowing structure along the circumferential direction of the connecting support is 20% -40% of the circumferential length of the connecting support.
2. The vascular implant of claim 1, wherein the fenestration has an axial length along the linking stent that is at least 40% of the circumferential length of the fenestration along the linking stent.
3. The vascular implant of claim 1, wherein at least a portion of the embedded branch proximate to the port of the fenestration is secured to the fenestration.
4. The vascular implant of claim 1, wherein the connection stent comprises a connection coating and a plurality of support skeletons having a wave-shaped ring structure, wherein the plurality of support skeletons having a ring structure are fixed on the wall surface of the connection coating and are arranged along the axial direction of the connection coating;
at least part of the windowing structure and at least one of the supporting frameworks are integrally arranged.
5. The vascular implant of claim 4, wherein each of the support scaffolds is an integrally formed independent closed-loop structure.
6. The vascular implant of claim 5, wherein the support scaffold comprises a plurality of support rods connected in sequence at included angles, two of the included angles adjacent in the circumferential direction of the support scaffold are respectively a peak and a trough, and the peak is closer to the proximal end of the connection coating than the trough;
the plurality of wave crests on at least one of the support frames include high waves and low waves, the axial length of the high waves along the connection coating film is greater than the axial length of the low waves along the connection coating film, and the high waves are closer to the proximal end of the connection coating film than the low waves.
7. The vascular implant of claim 6, wherein at least one high wave is provided adjacent to each of both sides of the fenestration in the circumferential direction of the connection coating, the high wave being located on the support scaffold integrally provided with the fenestration.
8. The vascular implant of claim 6, wherein the fenestration is integral with one to two of the support scaffolds.
9. The vascular implant of claim 8, wherein the fenestration is integral with one of the support scaffolds: the plurality of supporting frameworks comprise a first framework and a second framework, the first framework and the second framework are arranged adjacently along the axial direction of the connecting covering film, and the first framework is farther away from the near end of the connecting support than the second framework;
the windowing structure comprises a first windowing part and a second windowing part which are connected and arranged along the axial direction of the connecting coating, and the first windowing part is farther away from the near end of the connecting bracket than the second windowing part;
the first framework and the first windowing part are integrally arranged, and the second windowing part is located on the far end side of the second framework.
10. The vascular implant of claim 9, wherein ring-shaped members are fixed to both ends of the second fenestrated section, respectively, in a circumferential direction of the connection coating.
11. The vascular implant of claim 9, wherein the second skeleton comprises, in a circumferential direction of the connection cover, a first portion and a second portion arranged in a connection, the first portion being closer to a proximal end of the connection cover than the second portion, a projection of the first portion in an axial direction of the connection cover at least partially coinciding with a projection of the fenestration in the axial direction of the connection cover.
12. The vascular implant of claim 8, wherein the fenestration structure is integral with both of the support scaffolds: the plurality of support skeletons comprise a first skeleton and a second skeleton, the first skeleton and the second skeleton are arranged adjacently along the axial direction of the connecting covering film, and the first skeleton is farther away from the near end of the vascular implant than the second skeleton;
the windowing structure comprises a first windowing part and a second windowing part which are connected and arranged along the axial direction of the connecting covering film, and the first windowing part is farther away from the proximal end of the vascular implant than the second windowing part;
the first framework and the first windowing part are integrally arranged, and the second framework and the second windowing part are integrally arranged.
13. The vascular implant of claim 1, wherein the embedded branch comprises a proximal port and a distal port disposed opposite each other along an axial direction of the embedded branch, and a plane of the proximal port forms an angle with a central axis of the embedded branch, so that the proximal port of the embedded branch is located in the connection cavity.
14. The vascular implant of claim 13, wherein at least one of the proximal and distal ports of the embedded branches is a beveled port.
15. The vascular implant of claim 13, wherein at least one of the proximal and distal ports of the embedded branch is provided with a positioning ring.
16. The vascular implant of claim 15, wherein at least one of the positioning rings is provided with a visualization marker.
17. The vascular implant of any of claims 13-16, wherein the embedded branches comprise branch membranes and at least one support ring, the at least one support ring being secured to the branch membranes;
the transition coating and the branch coating are integrally formed.
18. The vascular implant of claim 15, wherein the bifurcated cover has a split at a proximal end thereof, the split being located at a distal side of the fenestration, the split being secured to the connecting cover;
the circumferential length of the proximal end of the split is greater than the circumferential length of the distal end of the split in the circumferential direction of the connection coating.
19. A lumen stent comprising a main stent and the vascular implant according to any one of claims 1 to 18, wherein the main stent defines a tubular main lumen, and the vascular implant is inserted into the main lumen.
20. The luminal stent of claim 19 wherein a separation stent is arranged in the main body lumen, the separation stent encloses a tubular separation lumen, the separation stent and the inner wall of the main body stent form a main lumen channel, the vascular implant is inserted into the main lumen channel, and the fenestration structure is located outside the main lumen channel.
CN202211419206.9A 2022-11-14 2022-11-14 Vascular implant and luminal stent Pending CN115969571A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202211419206.9A CN115969571A (en) 2022-11-14 2022-11-14 Vascular implant and luminal stent

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202211419206.9A CN115969571A (en) 2022-11-14 2022-11-14 Vascular implant and luminal stent

Publications (1)

Publication Number Publication Date
CN115969571A true CN115969571A (en) 2023-04-18

Family

ID=85960115

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202211419206.9A Pending CN115969571A (en) 2022-11-14 2022-11-14 Vascular implant and luminal stent

Country Status (1)

Country Link
CN (1) CN115969571A (en)

Similar Documents

Publication Publication Date Title
JP6353593B2 (en) Endoluminal prosthesis with a bifurcated section that can be turned
US7862609B2 (en) Stent graft having a pleated graft member
US6482227B1 (en) Stent graft having improved attachment within a body vessel
US6843802B1 (en) Delivery apparatus for a self expanding retractable stent
CA2415972C (en) Supra-renal prosthesis and renal artery bypass
JP4209054B2 (en) Improved stent recaptured and repositioned
EP1356788A2 (en) Modular aneurysm repair system
ES2278699T3 (en) ENDOVASCULAR PROTESIS FOR USE IN AN ENDOVASCULAR PROTESIS GRAFT.
US20030130724A1 (en) Supra-renal anchoring prosthesis
CA2646055C (en) Iliac leg extension stent graft
CN115836928A (en) Interventional stent and interventional prosthesis
MXPA03000282A (en) Stent graft with branch leg.
JP2008023334A (en) Abdominal aortic aneurysm treatment apparatus equipped with aortic aneurysm sac access port
US9398964B2 (en) Device for securing a prosthesis to the internal wall of a body lumen
JP2006525063A (en) Blood vessel replacement and deployment system
CN219207502U (en) Endoluminal prosthesis and endoluminal implant
CN115969571A (en) Vascular implant and luminal stent
CN219207503U (en) Implant stent and implant prosthesis
CN219629863U (en) Vascular implant and lumen stent
CN115919504B (en) Split type single embedded branch tectorial membrane support
CN219184347U (en) Lumen graft and anchor graft
CN116370144A (en) Vascular stent and system
CN116407338A (en) Vascular stent and stent system
CN118217065A (en) Lumen graft and anchor graft
CN116370143A (en) Wall-attached vascular stent and tectorial stent system

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination