An individualized thoracic aortic stent system

Abstract

The present invention provides an individualized thoracic aortic stent system. The individualized thoracic aortic stent system includes an aortic arch stent and an ascending aortic stent. The anchoring area of the aortic arch stent is spliced and implanted into the ascending aortic stent, and the anchoring area of the ascending aortic stent is used as the anchoring area of the system. A first branch hole is pre-opened in the area of the aortic arch stent for connecting a branch stent, and the opening areas of the second branch hole and the third branch hole are locked with the first branch hole as a reference point, and the second branch hole and the third branch hole are opened in the opening areas. A movable, deformable or special-shaped framework structure is arranged in the opening area of the aortic arch stent. Through the splicing between the aortic arch stent and the ascending aortic stent, the anchoring area of the aortic arch stent is arranged in the ascending aortic arch stent, and the anchoring area of the ascending aortic stent is used as the anchoring area of the system, so that the anchoring area is moved forward to avoid the vascular branch fork, enabling the system to adapt to individuals who were previously unsuitable for anchoring.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and specifically to an individualized thoracic aortic stent system. Background Art

[0002] Existing thoracic aortic stents face the complex branch artery structure and individual differences in the aortic arch, and cannot completely solve the vascular diseases involving the aortic arch through stents. In 2024, the US FDA approved the registration of a bifurcated stent, indicating the direction for individualized solutions for the aortic arch.

[0003] In order to overcome the problems of the aortic arch and achieve the reconstruction of supra-aortic branches, various stents and supporting treatment plans have been developed at home and abroad, which can be mainly divided into: "chimney" or parallel stent technology, in-situ fenestration technology, pre-fenestration technology, branched stent technology, and pre-bypass bifurcated stent technology. For example, the improved aortic arch covered stent-graft with the patent number CN201810982118 makes the aortic stent easier to be compressed into a delivery system with a smaller diameter through the "chimney" or parallel stent technology; the aortic arch in-situ fenestration dedicated covered stent with the patent number CN202110212484 reduces the stenosis caused by the compression of the branched stent through the in-situ fenestration technology; a method for manufacturing a two-dimensional positioning template for aortic stent fenestration with the patent number CN202110784724 shortens the positioning time and reduces the cost through the pre-fenestration technology; the aortic arch stent-graft with the patent number CN200810110799 enables the aortic arch stent-grafts not to interfere with each other through the branched stent technology; Endospan Company pre-connects the left common carotid artery and the left subclavian artery with an artificial blood vessel, closes the blood flow of the left common carotid artery, and combines the treatment with the first branched stent, ascending aortic stent and the second branched stent to reduce the difficulty of vascular intervention surgery at the aortic arch.

[0004] However, in actual application, the influence brought by individual differences is far more than that. For example, the anchoring length of the branch fork range of some blood vessels is insufficient or there is no eligible area, which is not suitable for anchoring, increasing the difficulty of stent placement; in addition, due to individual differences, there are also differences in the hole positions of the branched stents. The hole positions of the three branched stents are different. If all are pre-opened at the same position, the adaptability is insufficient. However, if all are customized individually, it takes a long time and costs a lot. Moreover, since the aortic arch stent has a skeleton support, and most of the existing skeletons are fixed to the aortic arch stent, the position of the branch holes cannot completely avoid the skeleton, and the docking between the branch holes and the branched stents will be affected due to the obstruction of the skeleton. Summary of the Invention

[0005] Based on this, it is necessary to provide an individualized thoracic aortic stent system to address the existing problems of unsuitable anchoring and differences in branch stent hole positions due to individual differences.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] A personalized thoracic aorta stent system, comprising an aortic arch stent and an ascending aorta stent, wherein the anchoring region of the aortic arch stent is spliced ​​and implanted into the ascending aorta stent, and the anchoring region of the ascending aorta stent is used as the anchoring region of the system;

[0008] A first branch hole is pre-opened in the area on the aortic arch stent for connecting the branch stent, and the opening areas of the second branch hole and the third branch hole are locked with the first branch hole as a reference point, and the second branch hole and the third branch hole are opened in the opening area; the opening area of ​​the aortic arch stent is provided with a movable, deformable or irregular skeleton structure.

[0009] Furthermore, the skeleton structure includes a positioning bracket and an irregular wave-shaped bracket; the positioning bracket is arranged around the first branch hole, and the special-shaped bracket is arranged around the second branch hole and the third branch hole.

[0010] Furthermore, the peripheral surface of the opening area of ​​the aortic arch stent is covered with a double layer of film, and the skeleton structure is located in the interlayer gap of the double layer of film.

[0011] Furthermore, the skeleton structure is a notch bracket, which is annular as a whole and has a notch on one side that matches the opening area; the double-layer coating is sewn along its circumference to form an interlayer space that matches the notch bracket, and the notch bracket can be rotatably located in the interlayer space.

[0012] Furthermore, the skeleton structure is a small wave bracket, and a plurality of small wave brackets are slidably located in the interlayer gap of the double-layer coating.

[0013] Furthermore, the skeleton structure is a thin wave bracket with self-deformation, and multiple thin wave brackets are located in the interlayer gap of the double-layer coating. The half side of the thin wave bracket facing away from the hole area is sutured to the double-layer coating by sutures.

[0014] Furthermore, the peripheral surface of the opening area of ​​the aortic arch stent is covered with a single layer of film and presents an artificial blood vessel-like corrugated structure.

[0015] Further, the first branch hole, the second branch hole, and the third branch hole on the aortic arch stent are connected to branch stents correspondingly, and the branch stents include a brachiocephalic trunk branch stent, a left carotid common branch stent, and a left subclavian branch stent corresponding to the first branch hole, the second branch hole, and the third branch hole one by one; the brachiocephalic trunk branch stent, the left carotid common branch stent, and the left subclavian branch stent all include a covering and a branch skeleton arranged on the covering;

[0016] The film covering includes a straight tube film covering, a straight tube folding film covering provided on one end face of the straight tube film covering, and a semi-wrapping film covering wrapped around the outer surface of the straight tube film covering;

[0017] The branch skeleton includes a wavy bracket, a sealing bracket, and an inverted hanging bracket; the sealing bracket is located inside one end of the straight tube film covering close to the straight tube folding film covering, and the wavy brackets are evenly distributed in other parts inside the straight tube film covering; the inverted hanging bracket is arranged at the connection between the straight tube film covering and the straight tube folding film covering, and cooperates with the straight tube folding film covering to block the gap at the splicing part with the aortic arch stent.

[0018] Furthermore, the inverted hanging bracket includes a vertical part and an inclined part; the vertical part extends from the connection between the straight tube film covering and the straight tube folding film covering to the inside of the straight tube film covering and fits with the sealing bracket; the inclined part is connected to the vertical part, and the connection between the two forms an inverted hanging angle, and the inclined part closely adheres to the outer side of the straight tube folding film covering and extends obliquely upward.

[0019] Furthermore, both sides of the semi-wrapping film covering are in a staggered serrated shape, and the two sides of the semi-wrapping film covering are butted and wrapped around the straight tube film covering in the reverse direction to reduce the diameter of the branch stent.

[0020] Compared with the prior art, the beneficial effects of the present invention include:

[0021] 1. Through the splicing between the aortic arch stent and the ascending aorta stent, the present invention sets the anchoring area of the aortic arch stent inside the ascending aorta stent, makes the anchoring area of the ascending aorta stent serve as the anchoring area of the system, moves the anchoring area forward, avoids the vascular branch fork, and enables the system to adapt to individuals who were previously not suitable for anchoring;

[0022] 2. By setting a reserved, movable or deformable skeleton structure in the opening area of the aortic arch stent, the present invention can cooperate with the docking of the branch holes and the branch stent while ensuring the support of the aortic arch stent, without blocking the intervention of the branch stent, which is the basis for realizing targeted windowing and the premise for solving the standardization of the stent;

[0023] 3. Through the five parts of the ascending aorta, aortic arch, and three branch stents, the present invention can comprehensively solve the overall condition of the thoracic aorta or separately solve the local condition, improve the range of applicable diseases, and also solve the problem of difficult selection of the anchoring area in the case of complex conditions;

[0024] 4. Through the cooperation of the straight tube film covering, straight tube folding film covering, semi-wrapping film covering of the present invention and the branch skeleton including the wave support, the sealing support and the inverted hanging support, the problem of endoleakage at the splicing part of the branch support and the aortic arch support is avoided as much as possible; the inverted hanging structure realizes splicing limit, reduces the splicing difficulty, and the straight tube folding film covering realizes the sealing function similar to the sealing ring structure; the semi-wrapping structure can make the diameter of the branch support smaller than the inner diameter of the blood vessel. Without the semi-wrapping structure being untied, the branch support will not cause excessive frictional trauma to the inner wall of the blood vessel, greatly reducing the risk of blood vessel rupture. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The disclosure of the present invention will be described with reference to the accompanying drawings. It should be understood that the drawings are only for illustrative purposes and are not intended to limit the scope of protection of the present invention. Among them:

[0026] Figure 1 is a schematic structural diagram of an individualized thoracic aortic stent system introduced in the present invention;

[0027] Figure 2 is the first example diagram of the special-shaped stent introduced in Embodiment 1;

[0028] Figure 3 is the second example diagram of the special-shaped stent introduced in Embodiment 1;

[0029] Figure 4 is the third example diagram of the special-shaped stent introduced in Embodiment 1;

[0030] Figure 5 is the fourth example diagram of the special-shaped stent introduced in Embodiment 1;

[0031] Figure 6 is the fifth example diagram of the special-shaped stent introduced in Embodiment 1;

[0032] Figure 7 is the sixth example diagram of the special-shaped stent introduced in Embodiment 1;

[0033] Figure 8 is a schematic structural diagram of the branch stent introduced in Embodiment 1;

[0034] Figure 9 Based on Figure 8 is a semi-perspective view of the branch stent;

[0035] Figure 10 Based on Figure 8 is a schematic structural diagram of the inverted hanging stent.

[0036] Figure 11 is a schematic structural diagram of the notch stent introduced in Embodiment 2;

[0037] Figure 12 Based onFigure 11 Cross-sectional view of the aortic arch stent;

[0038] Figure 13 Schematic structural diagram of the small wave stent introduced in Example 3;

[0039] Figure 14 Stereogram of the fine wave stent introduced in Example 4;

[0040] Figure 15 Based on Figure 14 Cross-sectional view of the aortic arch stent;

[0041] Figure 16 Schematic structural diagram of the corrugated structure introduced in Example 5;

[0042] Figure 17 Schematic diagram for confirming the starting point of the ascending aortic stent release;

[0043] Figure 18 Schematic diagrams of each process for placing the brachiocephalic trunk branch stent;

[0044] Explanation of the markings in the figure: 1. Aortic arch stent; 11. First branch hole; 12. Second branch hole; 13. Third branch hole; 2. Ascending aortic stent; 3. Notch stent; 4. Small wave stent; 5. Fine wave stent; 6. Corrugated structure; 7. Branch stent; 71. Brachiocephalic trunk branch stent; 72. Left common carotid artery branch stent; 73. Left subclavian artery branch stent; 701. Straight tube covered membrane; 702. Straight tube folded covered membrane; 703. Semi-wrapped covered membrane; 704. Wave stent; 705. Sealing stent; 706. Inverted hanging stent; 81. Positioning stent; 82. Special-shaped stent. Detailed implementation manners

[0045] It is easy to understand that according to the technical solution of the present invention, without changing the essence of the present invention, those of ordinary skill in the art can propose various interchangeable structural manners and implementation manners. Therefore, the following detailed implementation manners and the accompanying drawings are only exemplary descriptions of the technical solution of the present invention, and should not be regarded as all of the present invention or as a limitation or restriction on the technical solution of the present invention.

[0046] Example 1

[0047] Please refer to Figure 1 , this example introduces an individualized thoracic aortic stent system, which mainly includes an aortic arch stent 1, an ascending aortic stent 2 and a branch stent 7; among them, the branch stent 7 includes a brachiocephalic trunk branch stent 71, a left common carotid artery branch stent 72, and a left subclavian artery branch stent 73.

[0048] The ascending aorta stent 2 and the branch stent 7 are selectively spliced ​​according to individual needs. When there is a complex vascular branch fork, that is, the anchoring area of ​​the branch fork is insufficient or there is no qualified area, the anchoring area of ​​the aortic arch stent 1 is spliced ​​into the ascending aorta stent 2. The anchoring area of ​​the ascending aorta stent 2 becomes the anchoring area of ​​the entire stent, and the entire anchoring area moves forward to avoid the original position of the complex vascular branch fork.

[0049] The aortic arch stent 1 has three branch holes, which are respectively used to connect with the brachiocephalic branch stent 71, the left common carotid branch stent 72, and the left subclavian branch stent 73. However, according to actual needs, if only two or one is needed, the other branch holes may not be opened and the branch stent 7 is not necessary.

[0050] The three branch holes are the first branch hole 11, the second branch hole 12 and the third branch hole 13. The three branch holes are opened before the aortic arch stent 1 enters the human body. The first branch hole 11 is opened at the factory, and the second branch hole 12 and the third branch hole 13 are opened adaptively according to the patient's arterial division before the operation.

[0051] The first branch hole 11 is first opened in the area of ​​the aortic arch stent 1 for connecting the branch stent 7, and the opening area of ​​the aortic arch stent 1 and the positions of the second branch hole 12 and the third branch hole 13 in the opening area are locked according to the pre-shot three-dimensional image and the position relationship of the first branch hole 11 on the aortic arch stent 1. Therefore, the first branch hole 11 is the reference point for opening the second branch hole 12 and the third branch hole 13.

[0052] Since the left carotid and left lock branch holes are customized by relevant personnel according to the three-dimensional blood vessel size of the disease, there are individual differences in the distribution of the hole positions. Generally, the skeleton of the stent is fixed, and the position of the hole cannot be guaranteed to avoid the skeleton. If the skeleton blocks the branch hole, the branch stent 7 cannot be spliced.

[0053] Therefore, a special-shaped skeleton structure is arranged on the circumferential surface where the opening area of ​​the aortic arch stent 1 is located. The skeleton structure is sutured to the aortic arch stent 1 by sutures. The skeleton structure includes a positioning stent 81 and an irregularly wavy special-shaped stent 82; the positioning stent 81 is arranged around the first branch hole 11, and the special-shaped stent 82 is arranged around the second branch hole 12 and the third branch hole 13, staggered from the first branch hole 11, the second branch hole 12 and the third branch hole 13. Figures 2 - 7 As shown, the special-shaped stents with different wave curvatures have the common feature of leaving a blank area on the left lock and left neck for doctors to make customized holes to meet personalized needs.

[0054] The operation method of the personalized thoracic aortic stent system of this embodiment is described below.

[0055] 1. Stent selection: Before the operation, measure the aortic data according to CTA. For aneurysms, select a stent with a diameter 15-20% larger than the vessel diameter; for aortic dissections, select a stent with a diameter 0-5% larger than the vessel diameter.

[0056] 2. Manual punching of the aortic arch stent 1: Take out the stent in the aortic arch delivery device. Based on the prefabricated first branch hole 11 (the branch hole connected to the brachiocephalic trunk branch stent 71), and according to the preoperative three-dimensional measurement, use a hole opener to complete the opening + sleeve suture of the second branch hole 12 and the third branch hole 13 (the branch holes connected to the left common carotid branch stent 72 and the left subclavian branch stent 73), and use an auxiliary device to reset the stent into the delivery device.

[0057] 3. Confirmation of the release starting point of the ascending aortic stent 2: As Figure 17 shown, through the femoral artery approach, a soft guide wire enters the ascending aorta, and a hard guide wire is guided by the soft guide wire into the ascending aorta. Angiography is used to determine the aortic valve and the left and right coronary arteries. The release range of the stent is 2 cm above the coronary arteries.

[0058] 4. Placement of the ascending aortic stent 2: The ascending aortic delivery device is guided by the guide wire and placed at the ascending aorta to place the ascending aortic stent 2 (the tail end of the stent cannot cover the first branch hole 11), and then the delivery device is withdrawn.

[0059] 5. Placement of the aortic arch stent 1: The aortic arch delivery device is guided by the guide wire and self-bent, and enters the aortic arch. First, partially release it (exposing the first branch hole 11 on the stent), and then through the carotid artery approach, insert a guide wire into the first branch hole 11 of the aortic arch stent 1, and adjust it by rotation to align the holes (imaging positioning and guide wire verification).

[0060] 6. Adjust the aortic arch stent 1 with a branch balloon: Through the carotid artery approach, the branch balloon catheter enters the hole position between the brachiocephalic artery and the aortic arch, aligns with the branch hole position on the aortic arch stent 1, expands the balloon to passively adjust the stent, and completely aligns the branch hole with the branch artery. Based on the first branch hole 11 (the brachiocephalic artery hole), completely release the aortic arch stent 1, and then withdraw the delivery device.

[0061] 7. Dilate the aortic arch stent 1 with a main balloon: Through the femoral artery approach, the main balloon catheter enters the aortic arch (the front end covers the folded part, and the end reaches the posterior segment of the arch), and completely dilates it to cause the secondary release of the aortic arch stent 1, so that the stent completely adheres to the aortic wall, and there is no gap between the folded parts of the ascending and arch stents. Withdraw the branch balloon and the main balloon.

[0062] 8. Placement of the brachiocephalic trunk branch stent 71: Through the carotid artery approach, the delivery device of the brachiocephalic trunk branch stent 71 is used. The tip enters the aortic arch. During the slow retraction process, the branch stent 7 is released (under fluoroscopic guidance, the bell mouth of the branch stent 7 is located within the main artery), and then it is withdrawn after completion.

[0063] 9. Branch balloon dilation of the brachiocephalic trunk stent: The branch balloon is guided by a guide wire into the hole position between the brachiocephalic trunk artery and the aortic arch. The balloon is dilated to make the interface between the branch stent 7 and the main stent fit tightly. Then the balloon is withdrawn, and angiography is performed to verify for endoleak.

[0064] 10. Placement of the left common carotid artery branch stent 72 and the left subclavian artery branch stent 73: The same steps as those for the brachiocephalic trunk branch stent 71 are followed, but with a different approach.

[0065] As shown in Fig. 18, it is a schematic diagram of the placement of the brachiocephalic trunk branch stent 71. Figure 18 (a) is a schematic diagram of fluoroscopic guidance and guide wire verification; Figure 18 (b) is a schematic diagram of using the branch balloon to correct the position of the hole in the brachiocephalic trunk artery (the first branch hole 11); Figure 18 (c) is a schematic diagram of dilating the main stent with a balloon; Figure 18 (d) is a schematic diagram of dilating the branch stent 7 with a branch balloon.

[0066] Therefore, the stent system in this embodiment's combined mode includes five parts: the ascending aorta, the aortic arch, and three branch arteries. It can comprehensively address the overall condition of the thoracic aorta, or separately address local conditions, expanding the scope of applicable diseases and solving the problem of difficult selection of the anchoring area in complex disease cases. Among them, the ascending aorta is placed first; the aortic arch is spliced with the ascending aorta during the operation.

[0067] The three corresponding fenestrations on the aortic arch stent are all opened before the aortic arch stent 1 enters the human body; among them, the fenestration of the brachiocephalic trunk branch stent 71 is opened at the factory, and the fenestrations of the left common carotid artery branch stent 72 and the left subclavian artery branch stent 73 are adaptively opened by the surgical staff according to the patient's arterial distribution before the operation.

[0068] The stent design of the aortic arch completely prevents interference problems and solves the problem of the skeleton affecting the docking of the branch hole and the branch stent 7. It is the basis for achieving targeted fenestration and the prerequisite for solving stent standardization.

[0069] The brachiocephalic trunk branch stent 71, the left common carotid artery branch stent 72, and the left subclavian artery branch stent 73 all include a membrane and branch skeletons arranged on the membrane.

[0070] As Figure 8As shown in the figure, the film covering includes a straight tube film covering 701, a straight tube folding film covering 702 arranged on one end face of the straight tube film covering 701, and a semi-wrapping film covering 703 wrapped around the outer surface of the straight tube film covering 701; the straight tube film covering 701 provides a basic sealing function. The straight tube folding film covering 702 is formed by folding a tubular film covering and is fixed at the head end. Since there will actually be a certain gap at the docking part of the hole and the stent after the branch stent 7 and the aortic arch stent 1 are spliced, this gap is caused by the suture and the imperfectly fitting splicing. Adding the straight tube folding film covering 702 can realize the sealing function of a structure similar to a sealing ring, and this structure of the film covering further seals to achieve a better splicing and sealing effect. The two sides of the semi-wrapping film covering 703 are in a staggered serrated shape. Through a wire, the serrated ends of the semi-wrapping film covering 703 are butted and the stent is wrapped in the reverse direction. The semi-wrapping structure will not be unfolded after the branch stent is pushed out by the conveyor during the intervention process. The diameter of the branch stent will be smaller than the inner diameter of the blood vessel, which means that during the process of rotating or telescoping to adjust the position or posture of the branch stent without the semi-wrapping structure being untied, the branch stent will not cause excessive frictional trauma to the inner wall of the blood vessel, greatly reducing the risk of blood vessel rupture.

[0071] As Figures 9 - 10 shown in the figure, the branch framework includes a wavy stent 704, a sealing stent 705, and an inverted hanging stent 706 arranged in sequence on the film covering; the sealing stent 705 is located inside one end of the straight tube film covering 701 close to the straight tube folding film covering 702, and the wavy stents 704 are evenly distributed in other parts inside the straight tube film covering 701; the inverted hanging stent 706 is arranged at the connection between the straight tube film covering 701 and the straight tube folding film covering 702; the wavy stent 704 is a common stent structure that provides support force and an end anchoring function. The wavy arc of the sealing stent 705 is different from that of the wavy stent 704. Close to the connection with the aortic arch stent 1, it provides enhanced support and a higher support density to achieve a better fitting effect to reach the splicing and sealing effect. The inverted hanging stent 706 includes a vertical part and an inclined part; the vertical part extends from the connection between the straight tube film covering 701 and the straight tube folding film covering 702 to the inside of the straight tube film covering 701 and fits with the sealing stent 705; the inclined part is connected to the vertical part, and the connection between the two forms an inverted hanging angle. The inclined part closely adheres to the outer side of the straight tube folding film covering 702 and extends obliquely upward. The inverted hanging stent 706 can provide a limiting function during the splicing process. In addition, a certain reverse inverted hanging angle ensures that during the splicing process, the branch stent film covering will extend into the hole by 2 - 3 mm, which means that the part in contact with the hole edge is always within the range of enhanced sealing, ensuring that the contact with the hole edge is at the height of the sealing structure and achieving a better splicing and sealing effect.

[0072] Therefore, the sealing stent 705, the inverted hanging stent 706, and the straight tube folding film covering 702 constitute the enhanced sealing area of the branch stent 7.

[0073] Embodiment 2

[0074] As shown Figures 11 - 12 in the figure, the framework structure of this embodiment adopts a notched stent 3. The notched stent 3 is in an overall ring shape, and there is a notch on one side of the notched stent 3. Therefore, the overall shape is similar to a columnar structure with a notch. As shown Figure 11 in the figure, the rectangular area is the opening area of the second branch hole 12 and the third branch hole 13. The circumferential surface where it is located is a double-layer film. Place the notched stent 3 in the sandwich gap of the double-layer film, and stitch the two layers of film together by suturing the end faces at both ends of the notched stent 3, so that the notched stent 3 can only rotate but not move in the sandwich space of the double-layer film, limiting the notched stent 3. After opening holes in the outer layer of the film, tools such as forceps can be used to move the notch of the notch to the opening position, and then open holes in the inner layer of the film. After opening the holes, stitch and fix the stent to the edge of the hole, so that the notched stent 3 is fixed.

[0075] This embodiment has the same beneficial effects as Embodiment 1.

[0076] Embodiment 3

[0077] As shown Figure 13 in the figure, this embodiment introduces an individualized thoracic aortic stent system, which has basically the same structure as the individualized thoracic aortic stent system introduced in Embodiment 1. The difference is that the framework structure of this embodiment is a small wavy stent 4, and multiple small wavy stents 4 slide in the sandwich gap of the double-layer film.

[0078] The small wavy stent 4 can move axially. When opening holes, place the stent beside it. After the doctor opens the holes, the small wavy stent 4 can be axially moved and fixed in position, so that it does not interfere with the hole position while ensuring a certain degree of support.

[0079] This embodiment has the same beneficial effects as Embodiment 1.

[0080] Embodiment 4

[0081] As shown Figures 14 - 15 in the figure, this embodiment introduces an individualized thoracic aortic stent system, which has basically the same structure as the individualized thoracic aortic stent system introduced in Embodiment 1. The difference is that the framework structure of this embodiment is a thin wavy stent 5 with self-deformability, and multiple thin wavy stents 5 are located in the sandwich gap of the double-layer film. Half of the thin wavy stent 5 away from the opening area is sutured to the double-layer film by sutures.

[0082] A longer thin wave stent 5 is used to cover the positions of the two branch holes. The non-opening half of the stent is sutured and fixed to the covering film, and the opening half is kept relaxed. After the doctor opens the hole, during the in vivo splicing process, the branch stent 7 enters the branch hole of the aortic arch stent 1 through the conveyor, and the relaxed stent is squeezed open by the self-expansion of the branch stent 7. This ensures that the metal stent does not block the intervention of the branch stent 7 and guarantees a certain support effect.

[0083] This embodiment has the same beneficial effects as Embodiment 1.

[0084] Example 5

[0085] like Figure 16 As shown, this embodiment introduces a personalized thoracic aortic stent system, which is basically the same in structure as the personalized thoracic aortic stent system introduced in Example 1. The difference is that the peripheral surface of the opening area of ​​the aortic arch stent 1 in this embodiment is a single-layer coating, and presents an artificial blood vessel-like corrugated structure 6.

[0086] The section where the second branch hole 12 and the third branch hole 13 are located adopts an artificial blood vessel-type corrugated structure 6, without the interference of a metal stent, and the opening position is free while having a certain degree of support.

[0087] This embodiment has the same beneficial effects as Embodiment 1.

[0088] Example 6

[0089] This embodiment introduces a personalized thoracic aorta stent system, which is basically the same in structure as the personalized thoracic aorta stent system introduced in Example 1. The difference is that the connecting ends of the brachiocephalic trunk branch stent 71, the left common carotid branch stent 72, and the left subclavian branch stent 73 in this embodiment gradually increase in diameter outward, forming a cone, and a double-layer brim is set on the end surface to form a double-layer brim structure. The double-layer brim structure includes a cone-shaped outer cap and an inner cap located inside the outer cap; the outer cap is continuously sutured to the inner wall of the connecting end of the branch stent 7 by sutures, and the inner cap is intermittently sutured to the inner wall of the connecting end of the branch stent 7 by sutures.

[0090] The double-brim structure has a taper that can fit the branch artery circular hole on the aortic arch stent 1 to the maximum extent. Since the sutures between the double-layer brims are sparse and there are interlayer gaps, blood will infiltrate and coagulate after splicing, causing the interlayer to bulge and the sealing of the interface to be reinforced for the second time.

[0091] The technical scope of the present invention is not limited to the contents in the above description. Those skilled in the art can make various deformations and modifications to the above embodiments without departing from the technical idea of ​​the present invention, and these deformations and modifications should all fall within the protection scope of the present invention.

Claims

1. A personalized thoracic aortic stent system, characterized in that: It comprises an aortic arch stent (1) and an ascending aorta stent (2); the anchoring region of the aortic arch stent (1) is spliced ​​and implanted into the ascending aorta stent (2), and the anchoring region of the ascending aorta stent (2) serves as the anchoring region of the entire stent system; A first branch hole (11) is pre-opened in an area on the aortic arch stent (1) for connecting the branch stent (7); the opening area of ​​the second branch hole (12) and the third branch hole (13) is locked with the first branch hole (11) as a reference point, and the second branch hole (12) and the third branch hole (13) are opened in the opening area; the opening area of ​​the aortic arch stent (1) is provided with a movable or deformable or shaped skeleton structure; The first branch hole (11), the second branch hole (12), and the third branch hole (13) on the aortic arch stent (1) are connected to branch stents (7) in correspondence thereto; the branch stent (7) comprises a brachiocephalic trunk branch stent (71), a left carotid common branch stent (72), and a left subclavian branch stent (73) corresponding one to the first branch hole (11), the second branch hole (12), and the third branch hole (13); the brachiocephalic trunk branch stent (71), the left carotid common branch stent (72), and the left subclavian branch stent (73) all comprise a coating and a branch skeleton arranged on the coating; The coating comprises a straight-tube coating (701), a straight-tube folded coating (702) arranged on one end surface of the straight-tube coating (701), and a semi-wrapped coating (703) wrapped around the outer surface of the straight-tube coating (701); The branch skeleton comprises a wave support (704), a sealing support (705) and an inverted hanging support (706); the sealing support (705) is located on the inner side of one end of the straight tube covering (701) close to the straight tube folding covering (702), and the wave support (704) is evenly distributed on other parts of the inner side of the straight tube covering (701); the inverted hanging support (706) is arranged at the connection between the straight tube covering (701) and the straight tube folding covering (702), and cooperates with the straight tube folding covering (702) to block the gap at the splicing part with the aortic arch support (1); The two sides of the semi-wrapped coating (703) are in a staggered sawtooth shape, and the two sides of the semi-wrapped coating (703) are butted against the reversely wrapped straight-tube coating (701) to reduce the diameter of the branch stent (7).

2. The personalized thoracic aortic stent system according to claim 1, characterized in that: The skeleton structure comprises a positioning bracket (81) and an irregularly wavy special-shaped bracket (82); the positioning bracket (81) is arranged around the first branch hole (11), and the special-shaped bracket (82) is arranged around the second branch hole (12) and the third branch hole (13).

3. The personalized thoracic aortic stent system according to claim 1, characterized in that: The peripheral surface of the opening area of ​​the aortic arch stent (1) is covered with a double layer of film, and the skeleton structure is located in the interlayer gap of the double layer of film.

4. The personalized thoracic aortic stent system according to claim 3, characterized in that: The skeleton structure is a notched bracket (3), the notched bracket (3) is annular as a whole, and a notch adapted to the opening area is opened on one side of the notched bracket (3); the double-layer covering is sewn along its circumference to form an interlayer space adapted to the notched bracket (3), and the notched bracket (3) can be rotatably located in the interlayer space.

5. The personalized thoracic aortic stent system according to claim 3, characterized in that: The skeleton structure is a small wave support (4), and a plurality of small wave supports (4) are slidably located in the interlayer gap of the double-layer coating.

6. The personalized thoracic aortic stent system according to claim 3, characterized in that: The skeleton structure is a thin wave support (5) with self-deformation, a plurality of thin wave supports (5) are located in the interlayer gap of the double-layer covering, and the half side of the thin wave support (5) away from the opening area is sutured to the double-layer covering by sutures.

7. The personalized thoracic aortic stent system according to claim 1, characterized in that: The peripheral surface of the opening area of ​​the aortic arch stent (1) is covered with a single layer of film and presents an artificial blood vessel-like corrugated structure (6).

8. The personalized thoracic aortic stent system according to claim 1, characterized in that: The inverted bracket (706) comprises a vertical portion and an inclined portion; the vertical portion extends from the connection between the straight-tube covering film (701) and the straight-tube folding covering film (702) to the inner side of the straight-tube covering film (701) and fits with the sealing bracket (705); The inclined portion is connected to the vertical portion, and the connection between the two forms an inverted angle. The inclined portion is closely attached to the outside of the straight-tube folded film (702) and extends obliquely upward.

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