CN109717986B - Branch type tectorial membrane support and branch type tectorial membrane support system - Google Patents

Branch type tectorial membrane support and branch type tectorial membrane support system Download PDF

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CN109717986B
CN109717986B CN201711045140.0A CN201711045140A CN109717986B CN 109717986 B CN109717986 B CN 109717986B CN 201711045140 A CN201711045140 A CN 201711045140A CN 109717986 B CN109717986 B CN 109717986B
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stent
window
branch
section
branched
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CN109717986A (en
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邓筱娟
严冬梅
袁振宇
朱清
苗铮华
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Shanghai Microport Endovascular Medtech Co Ltd
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Shanghai Microport Endovascular Medtech Co Ltd
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Abstract

The invention provides an abdominal aorta covered stent and an abdominal aorta covered stent system, which comprise a stent main body and a covering membrane, wherein the stent main body comprises a plurality of stent rings which are sequentially connected, and the covering membrane is covered on the stent main body; the branched covered stent sequentially comprises a main body upper section, a windowing section and a main body lower section from a near end to a far end, wherein the windowing section is provided with at least one first branched window; the first branch window is provided with a support frame, the support frame is formed by surrounding two adjacent complete support frames, the coating film coated on the support frame is provided with an opening, the opening is used for being communicated with a branch blood vessel, and the coating film in the range of the support frame is sunken towards the inside of the support. The aorta abdominalis covered stent and the aorta abdominalis covered stent system provided by the invention can be used as the aorta abdominalis covered stent and the aorta abdominalis covered stent system for interventional therapy of the perirenal aorta with short tumor neck, and can have excellent anchoring stability.

Description

Branch type tectorial membrane support and branch type tectorial membrane support system
Technical Field
The invention relates to the technical field of medical instruments, in particular to a branch type covered stent and a branch type covered stent system.
Background
Abdominal aortic aneurysms are among the most fatal and most difficult to treat vascular surgical diseases. Since the conventional surgical operation is difficult to implement and has a large surgical wound, an intravascular interventional therapy method implemented by using an abdominal aorta stent graft has been widely used for clinical treatment in recent years. In the interventional therapy operation, the aorta abdominalis covered stent is conveyed to the aorta abdominalis diseased position through a conveying system through a femoral artery incision, so that diseased blood vessels are protected, and the aorta abdominalis diseased is repaired.
The abdominal aorta covered stent for the interventional therapy of the abdominal aortic aneurysm in the current market is various in types, various products have respective characteristics, and the scope of indications is also different. Most of the products of the aorta abdominalis covered stent are usually fixed on the tumor neck through an anchoring area at the proximal end of the aorta abdominalis covered stent when treating the aorta abdominalis. In order to meet the requirements of good wall adhesion and long-term displacement prevention of the proximal end of the covered stent for the abdominal aorta, the covered stent for the abdominal aorta has good anchoring stability, and the shortest length of a proximal anchoring area of a suitable case is more than or equal to 15 mm. However, the tumor neck length of abdominal aortic aneurysms varies from case to case. Generally, clinically, when the neck of the abdominal aortic aneurysm is greater than or equal to 15mm, a doctor can implant the abdominal aortic stent graft to isolate the abdominal aortic aneurysm by an interventional method under the condition that the patient's own physical conditions are satisfied. When the tumor neck of the abdominal aortic aneurysm is less than 15mm (the tumor body starting position is closer to the renal artery), the common abdominal aortic stent graft requires an anchoring area with the diameter of 15mm or more at the proximal end, so that a doctor can difficultly implant the common abdominal aortic stent graft by an interventional method. Therefore, the current solutions can only be transferred to open surgical treatment, or treatment with a special customized abdominal aortic fenestration stent, or treatment with in-situ fenestration or pre-fenestration on the spot by the physician.
However, the open surgery is not only extremely complicated to operate and prone to cause various serious complications, but also is not tolerated by every patient's physical condition. For the mode of using the abdominal aortic windowing stent, only one customized abdominal aortic windowing stent needs 4-6 weeks of customized time in China at present, and if the abdominal aortic windowing stent is used for treatment, the patient may not wait for 4-6 weeks. For the mode of in-situ windowing or pre-windowing, the in-situ windowing or pre-windowing has high requirements on the experience and technical level of doctors, if the aorta abdominalis covered stent system is not suitable for being reinstalled after being released, the doctors cannot perform self-windowing, and the in-situ windowing has a successful case, but the feasibility of the in-situ windowing still has a dispute due to the defects of the mechanical and laser in-situ windowing. In addition, in europe and america, there are a few non-customized branched stent systems for the treatment of perirenal abdominal aortic aneurysms in pre-market research. From the anatomical analysis of human abdominal aorta, the lower edge of the superior mesenteric artery is usually just about 8.4mm above the upper edge of the double renal arteries on average, and the superior mesenteric artery cannot be shielded and needs to be provided with a notch or a window, and under the severe anatomical condition, the longer the anchoring area of the tectorial membrane is, the more stable the anchoring is generally considered. However, some of the branched stents in these studies did not leave space for the renal artery stent near the perirenal border, thereby causing the renal artery stent to be at risk of being squeezed; some double kidney branch stents are designed into a waisted form for reserving positions for extending, and the waisted position has no anchoring function. Namely, the latter has the disadvantages that the overlap of the anchoring area of the multi-branch aorta abdominalis covered stent and the reserved position of the double-kidney branch stent can not be realized, so that the anchoring area is shortened, and the aorta abdominalis covered stent is unstable in anchoring, or the anchoring area is prolonged to increase the anchoring effect of the aorta abdominalis covered stent, so that the proximal end of the aorta abdominalis covered stent is mainly anchored on the trunk vessels of the abdominal cavity, thus, the structural complexity and the operation difficulty of the stent are increased, and the trunk vessels of the abdominal cavity are easily affected.
Disclosure of Invention
The invention aims to provide a branch type covered stent and a branch type covered stent system, which can be used as an abdominal aorta covered stent and an abdominal aorta covered stent system for interventional therapy of abdominal aortic aneurysm around short neck and kidney, have excellent anchoring stability, do not need to be anchored above an abdominal trunk vessel, have simple structure and small influence range of operation, do not need to be customized, and can be used for treating emergency cases.
In order to solve the technical problems, the invention provides an abdominal aorta covered stent, which comprises a stent main body and a covering membrane, wherein the stent main body comprises a plurality of stent rings which are sequentially connected, and the covering membrane is covered on the stent main body; the branched covered stent sequentially comprises a main body upper section, a windowing section and a main body lower section from a near end to a far end, wherein the windowing section is provided with at least one first branched window; the first branch window is provided with a support frame, the support frame is formed by surrounding two adjacent complete support frames, the coating film coated on the support frame is provided with an opening, the opening is used for being communicated with a branch blood vessel, and the coating film in the range of the support frame is sunken towards the inside of the support.
Optionally, a U-shaped groove is formed in the upper section of the main body, and provides a channel for the branch blood vessel.
Optionally, the two sides of the U-shaped groove are connected with support rods, and the support rods are connected with the complete bracket ring.
Optionally, the branched stent graft further comprises a bare section, and a distal end of the bare section is connected with a proximal end of the main body upper section.
Optionally, the bare section comprises a plurality of barbs for anchoring the bifurcated stent graft.
Optionally, the bare section is provided with a window, and when the bare section is not completely released, the width of the window is 2-5 times that of other non-window areas.
Optionally, the windowing section is provided with at least one second branch window; the part of the stent ring in the second branch window and the lower stent frame of the first branch window belong to the same stent ring, the part of the stent ring in the second branch window is in a concave shape, the coating film in the second branch window is provided with an opening, the opening is used for being communicated with a branch blood vessel, and the coating film in the second branch window is connected with the coating film outside the second branch window through a suture line.
Optionally, a plurality of developing members are respectively fixed to the edges of the first branch window and/or the second branch window and/or the U-shaped groove.
Optionally, a built-in channel is arranged in the first branch window and/or the second branch window, and the built-in channel extends towards the inside of the stent main body with the opening as a starting point.
Optionally, the branched stent graft further comprises a bifurcated section, a proximal end of the bifurcated section is connected with a distal end of the lower section of the main body, and the bifurcated section is divided into two tubular leg structures from the proximal end to the distal end.
The invention also provides a branch type covered stent system which comprises the branch type covered stent and a branch stent, wherein the branch stent is connected with the open pores of the first branch window and/or the second branch window.
The invention provides an aorta abdominalis covered stent and an aorta abdominalis covered stent system, which comprises the following components
Has the advantages that:
compared with the prior art, the branch type covered stent disclosed by the invention is only inwards recessed at the branch window, and other areas of the windowing section outside the branch window still have radial supporting force, so that the adherence of the stent is increased, and the branch type covered stent can be used for anchoring an abdominal aorta. Moreover, because the range of the branch window is inwards sunken, the position of the bracket is reserved for the branch bracket while the bracket is anchored, and the branch window has a certain area, so that the bracket can be applied to cases as long as the branch blood vessel is positioned in the windowing range of the branch window. Therefore, the stent is not customized, the patient does not need to wait for customization, and the patient and the doctor do not need to bear the risk of worsening the disease caused by waiting, so that the stent can be used for emergency cases.
In addition, the upper section of the main body of the covered stent can comprise a U-shaped groove for providing a channel for a branch blood vessel, and because the two sides of the U-shaped groove are connected with the supporting rods which are connected with the complete stent ring, the radial supporting force can be transmitted to the periphery of the U-shaped groove from the stent ring, thereby ensuring the anchoring force and the adherence of the upper section of the main body. The complete stent ring means that the stent ring is in a closed shape, such as a circle, and the complete stent ring has strong radial supporting force.
Furthermore, one V-shaped section of the bare section of the covered stent is larger than other V-shaped sections, so that a bare section window is formed. This can be achieved by means of heat setting. When the naked segment is not released later, the width of the window of the naked segment is 2-5 times of the width of other non-window regions. The main body stent can penetrate through the naked section window under the condition of not releasing, and the outer sheath tube of the branch stent can penetrate through the naked section window, so that the following effects are realized: when the stent is not released, the branch stent can pass through the bare section from the proximal section of the main stent and is led into the branch vessel, and the bare section can not influence the sheath vessel before and after the release and at the moment of the release. This greatly increases the success rate of the introduction of the branch stent.
Drawings
FIG. 1 is a schematic view of an aorta abdominalis covered stent according to a first embodiment of the present invention;
FIG. 2 is a schematic view of a bare section of a covered stent for abdominal aorta according to a first embodiment of the present invention in an unreleased state;
FIG. 3 is a schematic view of a bare section of a covered stent for abdominal aorta according to a first embodiment of the present invention in a post-release state;
FIG. 4 is a partial schematic view of an aorta abdominalis covered stent in accordance with a first embodiment of the present invention;
FIG. 5 is a schematic view of a fenestrated section of a stent graft for the abdominal aorta in accordance with a first embodiment of the invention;
FIG. 6a is a partial schematic view of a fenestrated section of a stent graft for the abdominal aorta in accordance with a first embodiment of the invention;
FIG. 6b is a schematic view of a further portion of the fenestrated section of the stent graft for the abdominal aorta in accordance with one embodiment of the invention;
FIG. 7 is another partial schematic view of a fenestration section of a stent graft for the abdominal aorta in accordance with one embodiment of the invention,
FIG. 8 is a schematic view of a covered stent for aorta abdominalis according to a second embodiment of the present invention;
FIG. 9 is a schematic view of a stent graft system for aorta abdominalis according to a third embodiment of the present invention;
FIG. 10 is a partial schematic view of an aorta abdominalis stent graft system in accordance with a third embodiment of the present invention.
Description of reference numerals:
100-aorta abdominalis covered stent;
200-a stent body; 300-coating a film;
400-a bare section; 410-sheath window; 411-barbs;
500-a film covering section;
510-a body upper section; 511-U type groove; 512-support rods; 513-a scaffolding ring;
520-a windowing section; 521-high kidney segment; 522-lower kidney segment;
530-high kidney window; 531-support frame; 532-upper bracket frame; 533-lower support frame; 534-opening of high kidney;
540-low kidney window; 541-suture frame; 542-a suture thread; 543-a suture thread; 544-opening of the lower kidney;
550-concave structure;
560-high renal indwelling channel; 570-low renal intrinsic pathway;
580-lower body section;
590-a bifurcated segment; 591-a tubular leg structure;
600-high kidney stent; 700-Low Kidney Stent.
Detailed Description
Unless otherwise indicated, the terms "distal" and "proximal" refer herein to the direction of blood flow from the heart during use of the abdominal aorta stent graft in the abdominal aorta: "distal" refers to the portion of the device that faces away from the heart or a direction away from the heart, while "proximal" refers to the portion of the device that is closer to the heart or a direction toward the heart.
The invention provides a multi-branch non-customized covered stent system which can be used for interventional therapy of perirenal abdominal aortic aneurysm with short tumor neck, has excellent anchoring stability and does not need to be anchored above an abdominal trunk vessel. The stent graft of the present invention can be used for interventional treatment of aorta with multiple branches, and the abdominal aorta stent graft is used as an example in this specification, but the structure can also be used for aorta with similar anatomical structure, such as the stent graft of thoracic aorta, or other stent grafts with similar structure, which can be understood by those skilled in the art.
The aorta abdominalis covered stent and the aorta abdominalis covered stent system proposed by the present invention will be further described in detail with reference to the accompanying drawings and specific examples. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.
Example one
The present embodiment provides an abdominal aorta stent graft, and referring to fig. 1, fig. 1 is a schematic view of an abdominal aorta stent graft according to a first embodiment of the present invention. The aorta abdominalis covered stent 100 comprises a stent main body 200 and a covering membrane 300, wherein the covering membrane 300 is covered on part of the stent main body 200. The stent body 200 is in the shape of a mesh tube. The stent body 200 includes a bare segment 400 and a covered segment 500. The distal end of the bare segment 400 is connected to the proximal end of the cover segment 500. The bare segment 400 is used to anchor the aorta abdominalis stent graft 100. The film 300 is coated on the film coating section 500. The graft segment 500 serves to isolate the aneurysm from blood flow and to allow blood flow from within the abdominal aorta stent graft 100. The membrane segment 500 includes a body upper segment 510, a fenestration segment 520, and a body lower segment 580 connected in series. The proximal end of the main body upper section 510 is connected to the distal end of the bare section 400. The window opening section 520 is provided with a high kidney window 530 and a low kidney window 540 which are recessed towards the interior of the stent main body. The high renal window 530 is adjacent to the upper body section 510, the low renal window 540 is adjacent to the lower body section 580, the high renal window 530 is adapted to communicate with a high renal artery (the higher side renal artery), and the low renal window 540 is adapted to communicate with a low renal artery (the lower side renal artery). The abdominal aorta stent graft 100 in this embodiment provides radial support for anchoring the abdominal aorta stent graft 100 from the bare section 400 to the main body superior section 510 to the inferior border stent section of the high renal window 530.
In this embodiment, the aorta abdominalis stent graft 100 has a deployed state and a crimped state. In the deployed state, the abdominal aortic stent graft 100 has a tendency to radially deploy. Specifically, the bare section 400, the upper body section 510, the fenestration section 520, and the lower body section 580 all have a tendency to radially expand. In this embodiment, in the expanded state, the radial cross-sections of the bare section 400, the upper body section 510, the fenestration section 520, and the lower body section 580 are annular.
In order to ensure that the bare segment 400 is attached to the normal blood vessel sufficiently, the bare segment 400 needs to have sufficient radial supporting force, and the implementation manner of the bare segment 400 is not limited to that the bare segment 400 is formed by weaving metal wires or engraving metal tubes.
To further enhance the anchoring effect of the bare section 400, the bare section 400 has a plurality of barbs 411, and the plurality of barbs 411 are used for anchoring the abdominal aorta stent graft 100. As shown in fig. 1, the bare section 400 is carved out of a metal tube, and the bare section 400 has 5 barbs 411 in total. The bare section comprises a support ring in a wavy shape, in one embodiment, the barb is arranged on the wave crest of the support ring close to the proximal end of the bare section, and in another embodiment, the barb is not arranged on the wave crest but arranged on the side surface of the wave as long as the function of anchoring can be achieved. In other embodiments, the number of barbs 411 is at least one, for example, the bare segment 400 has one, two or three barbs 411, and the bare segment 400 may not have barbs 411.
In this embodiment, the bare section 400 is provided with a sheath window 410. Referring to fig. 2 and 3, fig. 2 is a schematic view of a bare section of an abdominal aorta stent graft in a first embodiment of the invention in an unreleased state, and fig. 3 is a schematic view of the bare section of the abdominal aorta stent graft in a second embodiment of the invention in a released state. The stent ring of the bare section is regarded as a wave-shaped graph, the sheath window 410 is an inverted peak, and when the bare section 400 is in a non-post-release state, the width of the sheath window 410 is 3 times that of other non-window areas. The width of the sheath window 410 is a half-peak width of an inverted peak corresponding to the sheath window 410 when the release is not performed. The other non-window region widths refer to the half-peak widths of the peaks of the other non-sheath windows without post-release. The sheath window 410 may be achieved by heat setting. In other embodiments, the width of the sheath window 410 is 2-5 times the width of the other non-window regions when the bare segment 400 is not released afterwards. The bare segment 400 is in a non-expanded configuration before release within the body, and other tubular objects such as catheters or sheaths may pass through the sheath window 410 of the bare segment 400 but not through other portions of the bare segment 400. The outer diameter of other tubular objects such as a catheter or a sheath is not more than 11F, wherein the outer diameter of the other tubular objects is preferably 7F. The sheath window 410 is arranged, so that other outer sheaths of the abdominal aorta covered stent 100 can pass through the sheath window 410 under the condition that the abdominal aorta covered stent 100 is not released, the outer sheaths of the high renal artery branch stents can be conveniently led into the renal artery through the sheath window 410 before the abdominal aorta covered stent 100 is completely released, and the success rate of leading other stents into the high renal artery is greatly increased.
The proximal end of the covered section 500 is connected with the distal end of the bare section 400, the covered membrane 300 is covered on the covered section 500, the covered section 500 is used for isolating the aneurysm from blood flow and enabling the blood flow to flow through the covered stent 100 of the abdominal aorta, and the covered section 500 comprises an upper main body section 510, a windowing section 520 and a lower main body section 580 which are sequentially connected.
The film covering section 500 is connected with the bare section 400 by sewing or hot melting.
The main body upper section 510 has radial supporting force and can be used for anchoring the aorta abdominalis covered stent 100, and the main body upper section 510 is not limited to be woven by metal wires or carved by metal tubes.
Further, referring to fig. 1 and 4, fig. 4 is a partial schematic view of the aorta abdominalis covered stent 100 according to the first embodiment of the present invention, wherein the main body upper section 510 is provided with a U-shaped groove 511, and the U-shaped groove 511 is used for providing a channel for a branch port of an superior mesenteric artery.
Specifically, referring to fig. 4, the main body upper section 510 includes a plurality of support rings 513, and the plurality of support rings 513 are sequentially connected. A U-shaped slot 511 is formed in a plurality of bracket rings 513 adjacent the proximal end of the upper body section 510. Two sides of the U-shaped groove 511 are respectively fixed with a support rod 512, and the distal end of each support rod 512 is fixedly connected with a support ring 513 at the distal end of the support rod 512, and the implementation manner is as follows: stitching, heat staking, welding, or mechanical attachment, etc. Since the distal stent ring 513 of the main body upper section 510 is a complete ring, the main body upper section 510 can provide radial support force after being deployed, and the support force is transmitted from the distal stent ring of the main body upper section 510 to the U-shaped groove 511, so that the entire main body upper section 510 has good radial support force and can act as an anchoring region on the vessel wall. After the covered stent 100 is implanted into a human body, the supporting rods 512 can be anchored and sealed at two sides of a branch blood vessel, so that the risk of I-type internal leakage is reduced.
The U-shaped groove 511 may be fixed with a plurality of developing members for assisting the positioning of the U-shaped groove 511. During operation, the U-shaped slot 511 under X-ray can be clearly shown. The developing material may be provided by, but not limited to, connecting a developing part to the coating film 300 around the U-shaped groove 511, or connecting a developing part to a supporting rod. The way to attach the development member may be, but is not limited to, sewing, heat staking, welding, etc.
Referring to fig. 5, fig. 5 is a schematic view of the fenestrated section 520 of the aorta abdominalis stent graft 100 according to the first embodiment of the present invention, wherein the proximal end of the fenestrated section 520 is connected to the distal end of the main body upper section 510. The fenestration section 520 includes a high renal section 521 and a low renal section 522. The high kidney segment 521 is adjacent the body upper end 510 and the low kidney segment 522 is adjacent the body lower segment 580. The high kidney segment 521 and the low kidney segment 522 partially overlap, the high kidney window 530 is located within the high kidney segment 521, and the low kidney window 540 is located within the low kidney segment 522. Both the high renal window 530 and the low renal window 540 are recessed inwardly of the stent body. The high renal window 530 is used for communicating with the low renal artery, the low renal window 540 is used for communicating with the low renal artery, and the part above the lower edge of the high renal window 530 in the fenestration section 520 has radial supporting force and can be used as an anchoring area.
Referring to fig. 5, the high kidney segment 521 includes a high kidney window 530 and a non-window region. The low kidney segment 522 includes a low kidney window 540 and a non-window region. There is an overlap between the high kidney segment 521 and the low kidney segment 522. The high renal window 530 and the low renal window 540 are of concave structures, and the concave structures ensure that the main body support adheres to the inner wall of the abdominal aorta, and simultaneously reserve spaces for other supports arranged at the high renal artery and the low renal artery, so that the other supports arranged at the high renal artery and the low renal artery are prevented from being extruded. In other embodiments, the high renal segment 521 and the low renal segment 522 may also be free of overlapping regions.
Specifically, referring to fig. 6a, fig. 6a is a partial schematic view of the fenestration section 520 of the aorta abdominalis covered stent 100 according to the first embodiment of the present invention, where the hyperrenal window 530 includes a stent frame 531 and a hyperrenal opening 534, the stent frame 531 is located at the hyperrenal section 521, the cover membrane 300 is covered on the stent frame 531, the cover membrane 300 located on the stent frame 531 is provided with the hyperrenal opening 534, and the hyperrenal opening 534 is used for communicating with the ostium of the hyperrenal artery blood vessel.
The windowing section 520 comprises a plurality of bracket rings connected in sequence, and the bracket frame 531 is formed by two adjacent bracket rings. Specifically, referring to fig. 6a, the support frame 531 is composed of an upper support frame 532 and a lower support frame 533, and the upper support frame 532 and the lower support frame 533 are respectively a part of two adjacent support rings. Because the stent rings are all complete ring structures, the stent frame 531 can cling to the vessel wall, providing a supporting force to anchor the abdominal aorta stent graft 100.
The stent frame 531 of the reniform window 530 has a stent body with a coating portion that is recessed inward because of its unsupported structure. The concave shape leaves a position for the branch support, so that the branch structure is not extruded. The high renal artery in the operation only needs to be located within the range of the support frame 531, so that the smoothness of the high renal artery is ensured, and the abdominal aorta covered stent 100 can adapt to the anatomical morphology of different people, namely the abdominal aorta covered stent 100 does not need to be customized, and the change range of the high renal artery openings of different people is considered to be applicable if the change range is within the range of the support frame 531.
Referring to fig. 6b, fig. 6b is a partial schematic view of the fenestration section 520 of the aorta abdominalis stent graft 100 according to the first embodiment of the present invention, wherein the low renal window 540 comprises a suture frame 541 formed by sutures 542 and 543 and a low renal opening 544, the suture frame 541 is located at the low renal section 522, the stent graft in the low renal window 540 is connected with the stent graft 300 outside the low renal window 540 by the sutures 542 and 543, the low renal opening 544 is formed in the low renal window 540, and the low renal opening 544 is used for communicating with the ostium of the low renal artery.
Referring to fig. 7, in the present embodiment, the low-kidney window 540 is designed to be a concave structure, and the implementation manner may be: through the heat treatment method, the stent ring of the low kidney segment 522 is partially recessed inwards to form an inner concave structure 550, the inner concave structure 550 reserves a space for the branch stent at the low kidney artery, and because the stent ring part in the low kidney window 540 and the lower stent frame 533 of the high kidney window 530 belong to the same stent ring, the part of the stent ring in the low kidney window 540 is in an inner concave shape, so that the inward recessed stent ring is still a closed-loop stent and can still provide radial support force, namely the stent ring not only reserves a space for the branch stent, but also has the function of riveting. The concave structure 550 is mechanically or welded to the low kidney segment 522 to form a unitary body. Such a design ensures that the anchoring zone of the stent graft 100 of the present invention is sufficiently long. The low-kidney window 540 is not limited by the stent frame, can be set to be larger (larger than the area of the high-kidney window 530), is more flexible in shape, can be rectangular, circular, elliptical, rhombic and the like, can further improve the adaptability of the abdominal aorta covered stent 100 to the anatomical morphology of different people, and achieves the purpose of no need of customization. It should be noted that the present application presents the anatomical features that the right renal artery is slightly higher than the left renal artery, but in practice, there are cases where the left renal artery is slightly higher than the right renal artery, or the left and right renal arteries are almost as high. For patients with left renal artery higher than right renal artery, the same method is adopted, and the design of mirror image exchange of the naked section 400, the upper main body section 510 and the windowing section 520 can be applied, and for patients with the same height of the left and right renal arteries, the low renal window 540 of the product is large in area and flexible in shape, so that the product can also be applied.
In this embodiment, a plurality of developing members are fixed to the support frame 531 and the suture frame 541, and the developing members are used for assisting positioning of the support frame 531 and the suture frame 541 during the operation. In other embodiments, a plurality of developing devices may be fixed to only the support frame 531 and not the suture frame 541, or a plurality of developing devices may be fixed to only the suture frame 541 and not the support frame 531, or no developing devices may be fixed to both the support frame 531 and the suture frame 541.
In this embodiment, the circumferential orientation of the high renal window 530 and the low renal window 540 may vary. The variation range is as follows: setting the midpoint of the U-shaped groove 511 to be 12 points, setting the high kidney window 530 to be 8-10 points, and setting the low kidney window 540 to be 1-4 points; or the midpoint of the U-shaped groove 511 is set to be 12 points, and the high kidney window 530 is 2: 30-4 o 'clock, low kidney window 540 is 8 o' clock-10: 30.
in the present embodiment, the high-kidney window 530 formed by the stent frame and the low-kidney window 540 surrounded by only the suture without the stent frame are provided, but the present invention is not limited to this form. In the embodiment suitable for other blood vessel shapes, only one branch window formed by the support frame can be provided, a plurality of branch windows formed by the support frame can be provided, or a branch window formed by the support frame and a plurality of branch windows without the support frame and only surrounded by the suture line can be provided at the same time, or a plurality of branch windows formed by the support frame and one or more branch windows without the support frame and only surrounded by the suture line can be provided at the same time, and the like.
The abdominal aorta covered stent 100 described with reference to FIGS. 6a and 6b further includes a high renal indwelling channel 560 and a low renal indwelling channel 570 that are indwelling within the stent body. The high-kidney built-in channel 560 and the low-kidney built-in channel 570 are channels coated with a coating film, the high-kidney built-in channel 560 is fixedly connected with the high-kidney opening 534, and the low-kidney built-in channel 570 is fixedly connected with the low-kidney opening 544. The high renal indwelling channel 560 and the low renal indwelling channel 570 are inside the stent of the cover 300 and can be used to direct blood flow through the high renal indwelling channel 560 or the low renal indwelling channel 570 into the high renal artery and the low renal artery. The high-kidney built-in channel 560 and the low-kidney built-in channel 570 are respectively used for being connected with branch stents implanted in renal arteries on two sides, specifically, the branch stents can be respectively sleeved in the high-kidney built-in channel 560 and the low-kidney built-in channel 570, and the high-kidney built-in channel 560 and the low-kidney built-in channel 570 comprise a stent section (or a plurality of stent sections), so that the branch stents are tightly connected with the high-kidney built-in channel 560 or the low-kidney built-in channel 570, and the high-kidney auxiliary stent 560 or the low-kidney auxiliary stent 570 is partially overlapped with the branch stents. In conclusion, the sealing performance and the matching force of the other stents connected with the high renal stent 560 or the low renal stent 570 are improved.
The high-renal built-in channel 560 may extend from the high-renal window 530 in a direction toward the proximal end of the fenestrated section 520, and the low-renal built-in channel 570 may extend from the low-renal window 540 in a direction toward the distal end of the fenestrated section 520. In other embodiments, the direction of extension of the high-renal built-in channel 560 and the low-renal built-in channel 570 may be other ways, such as, for example, the high-renal built-in channel 560 and the low-renal built-in channel 570 each extending in a direction toward the distal end of the fenestrated section 520, or the high-renal built-in channel 570 extending in a direction toward the proximal end of the fenestrated section 520, or the high-renal built-in channel 560 extending in a direction toward the distal end of the fenestrated section 520, or the low-renal built-in channel 570 extending in a direction toward the proximal end of the fenestrated section 520. In a specific operation, the aorta abdominalis covered stent 100 in that orientation is selected according to different anatomical morphology.
The proximal end of the body lower section 580 is connected to the distal end of the fenestrated section 520.
In this embodiment, the coating 300 coated on the coating segment 500 is made of PET, and the coating 300 coated on the high renal stent 560 and the low renal stent 570 is made of EPTFE. The stent body of the graft section 500 is connected to the graft 300 by suturing.
In this embodiment, the release process of the aorta abdominalis covered stent 100 is as follows:
first, the abdominal aorta covered stent 100 is crimped within the delivery device.
Secondly, the aorta abdominalis covered stent 100 is guided to the lesion position through a conveyer, and the position is adjusted up and down, so that the anchoring area of the covered stent 300 can be the same as the normal blood vessel near the lesion position after being released.
And thirdly, releasing the aorta abdominalis covered stent 100, wherein after the aorta abdominalis covered stent 100 is released, the stent main body supports the covered membrane 300 on the normal blood vessel wall, and the joint between the aorta abdominalis covered stent 100 and the normal blood vessel is ensured.
Example two
The difference between this embodiment and the first embodiment is that, in this embodiment, the film covering section 500 further includes a bifurcated section 590. Referring to fig. 8, fig. 8 is a schematic view of an aorta abdominalis stent graft in the second embodiment of the present invention, wherein the stent graft 500 further includes a bifurcation 590, a proximal end of the bifurcation 590 is connected to a distal end of the lower body section 580, and the bifurcation 590 is divided into two tubular leg structures 591 in a proximal-to-distal direction.
In this embodiment, the midpoint of the U-shaped groove 511 is set as 12-point adjustment, and the high kidney window 530 is set at 14: 30-15: 30, low renal window 540 at 8: 00-10: 30.
in this embodiment, the bare section 400 has three barbs, and the three barbs are fixed on the bare section 400 by welding. The bare section 400 includes a stent ring that is corrugated, with the barbs being fixed to the proximal end of the stent ring at the peaks of the stent ring. Of course, in other embodiments, the barbs may be located at other positions on the stent rings, and the bare segment 400 may also include multiple stent rings connected in series.
In this embodiment, a gold wire for developing is welded on an end of the high kidney auxiliary support 560 away from the high kidney opening 534. Four tantalum tubes for development are welded on the stent frame 531, so that the position of the aorta abdominalis covered stent 100 can be conveniently adjusted in the operation, and the opening of the high renal blood vessel is positioned in the range of the high renal window 530. The four tantalum tubes were sutured next to the upper, lower, left and right coatings 300 of the window. The upper direction refers to a direction close to the proximal end of the fenestrated section 520, and the distal direction refers to a direction close to the distal end of the fenestrated section 520. Correspondingly, four tantalum tubes for visualization are sewn into the suture frame 541 of the low kidney window 540. During manufacturing, the PtNi alloy wire is wound into a circle with the diameter of 6mm, and is hot-melted with the built-in channel 560 of the high kidney, and then the PtNi circle is sewn with the coating 300 of the high kidney window 530 and the low kidney window 540.
Gold wires are wound on the supporting rods on the two sides of the U-shaped groove 511, and the supporting rods, the gold wires and the PET covering film 300 are sewn together by using sewing threads, so that the width and the depth of the U-shaped groove 511 can be clearly seen through X-rays in the operation. The width of the U-shaped groove 511 refers to the length of the U-shaped groove 511 along the circumferential direction, and the depth of the U-shaped groove 511 refers to the length of the U-shaped groove 511 along the axial direction.
EXAMPLE III
The present embodiment provides an abdominal aorta stent graft system including a high renal stent 600 and a low renal stent 700. Referring to fig. 9 and 10, fig. 9 is a schematic view of an abdominal aorta stent graft system in a third embodiment of the invention, and fig. 10 is a partial schematic view of the abdominal aorta stent graft system in the third embodiment of the invention, in which the high-renal stent 600 is sleeved with the high-renal built-in channel 560, and the low-renal stent 700 is sleeved with the low-renal built-in channel 570.
Specifically, the high renal built-in channel 560 is fixedly connected to the high renal window 530, and the low renal built-in channel 570 is fixedly connected to the low renal window 540.
Because the high kidney support 600 and the low kidney support 700 can be respectively sleeved in the high kidney auxiliary support 560 and the low kidney auxiliary support 570, when the high kidney support 600 and the low kidney support 700 are connected with the high kidney built-in channel 560 or the low kidney built-in channel 570, the high kidney built-in channel 560 or the low kidney built-in channel 570 is partially overlapped with the high kidney support 600 and the low kidney support 700, and the sealing property and the matching force of the connection of the high kidney support 600 and the low kidney support 700 with the high kidney built-in channel 560 or the low kidney built-in channel 570 are improved.
The release process of the aorta abdominalis covered stent 100 is as follows:
first, the abdominal aorta covered stent 100 is crimped within the delivery device.
Then, the abdominal aorta covered stent 100 is guided to the lesion position by a conveyor, the position is adjusted up and down, and the anchoring position of the covered stent 300 is adjusted.
And thirdly, the abdominal aorta covered stent 100 is partially released, and after the abdominal aorta covered stent 100 is partially released, the stent main body supports the covered membrane 300 on the normal blood vessel wall, so that the fit between the abdominal aorta covered stent 100 and the normal blood vessel is ensured.
Next, the high renal stent 600 and the low renal stent 700 are introduced through the high renal built-in channel 560 and the low renal built-in channel 570 of the abdominal aorta stent graft 100, respectively, and blood flow channels of the abdominal aorta and the branch vessels are established. Finally, the covered stent 100 and the high and low kidney stents 600 and 700 are completely released, so that the normal blood supply of the abdominal aorta and the branch vessels is ensured while the risk of aneurysm rupture is eliminated, and the purpose of maintaining the smooth blood flow of the abdominal aorta and the important branch vessels is achieved.
The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims (9)

1. A branch type covered stent is characterized by comprising a stent main body and a covering membrane, wherein the stent main body comprises a plurality of stent rings which are sequentially connected, and the covering membrane is covered on the stent main body;
the branched covered stent sequentially comprises a main body upper section, a windowing section and a main body lower section from a near end to a far end, wherein the windowing section is provided with at least one first branched window;
the upper section of the main body is provided with a U-shaped groove, the U-shaped groove provides a channel for a branch blood vessel, two sides of the U-shaped groove are connected with supporting rods, and the supporting rods are connected with a complete bracket ring so as to transmit the radial supporting force of the bracket ring to the U-shaped groove;
the first branch window is provided with a support frame, the support frame is formed by surrounding two adjacent complete support frames, the coating film coated on the support frame is provided with an opening, the opening is used for being communicated with a branch blood vessel, and the coating film in the range of the support frame is sunken towards the inside of the support.
2. The branched stent graft of claim 1, further comprising a bare segment, a distal end of the bare segment being connected to a proximal end of the main body upper segment.
3. The branched stent graft of claim 2, wherein the bare section comprises a plurality of barbs for anchoring the branched stent graft.
4. The branched stent graft of claim 2, wherein the bare segment is windowed, and when the bare segment is not fully released, the window has a width 2-5 times the width of the other non-window regions.
5. The branched stent graft of claim 1, wherein the fenestration section is provided with at least one second branched window;
the part of the bracket ring in the second branch window and the lower bracket frame of the first branch window belong to the same bracket ring, the part of the bracket ring in the second branch window is in a concave shape,
the film inside the second branch window is provided with an opening which is used for being communicated with a branch blood vessel,
the coating film inside the second branch window is connected with the coating film outside the second branch window through a suture line.
6. The branched stent graft of claim 5, wherein a plurality of developers are respectively fixed to edges of said first branch window and/or said second branch window and/or said U-shaped groove.
7. The branched stent graft of claim 5, wherein said first and/or said second branch windows have an internal channel therein, said internal channel extending from said opening into the interior of the stent body.
8. The branched stent graft of claim 1, further comprising a bifurcated segment, a proximal end of which is connected to a distal end of the lower body segment, the bifurcated segment diverging in a proximal to distal direction into two tubular leg structures.
9. A branched stent-graft system comprising the branched stent-graft according to any one of claims 1 to 8 and a branched stent, wherein the branched stent-graft is connected to the opening of the first branched window and/or the second branched window.
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