A covered stent with an embedded branch and its delivery system

Abstract

This utility model relates to a covered stent with embedded branches and its delivery system, including an aortic covered stent, at least one embedded branch covered stent, and at least one independent branch covered stent. The aortic covered stent includes a main metal skeleton, a main PTFE membrane pressed onto the surface of the main metal skeleton, and at least one branch opening in the main PTFE membrane. The edge of each branch opening is sutured with the embedded branch covered stent. In this utility model, the central guidewire catheter and the branch catheters provide movement channels for the central guidewire and the corresponding branch guidewire, respectively. Compared with the absence of branch catheters, this reduces or avoids the problem of guidewire entanglement. In particular, with two or more embedded branch covered stents, it ensures that each guidewire maintains an independent movement channel, making it less prone to guidewire entanglement, thus facilitating the application of multi-branch stents.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a covered stent with embedded branches and its delivery system. Background Technology

[0002] Aortic dissection and aortic aneurysm are serious diseases that threaten human life and health. With social development, the incidence of these diseases is on the rise. If these diseases are not treated in time, they can lead to rupture of blood vessels and death. In addition, aortic dissection can also cause occlusion of branch vessels, leading to ischemia of the supplied organs and causing complications such as myocardial infarction, cerebral infarction, and renal infarction. Therefore, aortic dissection and aortic aneurysm should be treated actively.

[0003] In recent years, endovascular interventional techniques have flourished, and endovascular aortic stent graft resection (TEVAR) has become a common treatment for aortic dissection and aortic aneurysm. This procedure involves placing an aortic stent graft into the aorta, isolating the diseased portion of the aorta outside the stent. Blood flow passes through the stent graft, eliminating the impact of blood flow on the diseased vessel wall and protecting the vessel wall at the lesion site, thus treating aortic dissection and aortic aneurysm. However, TEVAR application has certain conditions: the stent needs to be placed beyond the lesion into a relatively normal vessel, a specific anchoring zone is required, and the stent cannot obstruct important branches of the aorta. To address these issues, branched stents are now used clinically. These stents, in addition to the main straight stent, also have branched stents. During application, the branched stent is placed into the branch, and then the main stent and branched stent are released separately. Currently, only single-branched stents (one main stent and one branched stent) are available on the market. During their release, the main stent guidewire and the branched stent guidewire converge in the same central guidewire catheter, which can easily lead to the following problems:

[0004] 1. Guidewire entanglement: Single-branch stent deployment requires two guidewires, which may become entangled in the body. If entanglement occurs, the stent needs to be rotated within the body to untangle it. This requires experienced surgeons and takes time, increasing the workload for both patients and doctors. If the entanglement is not clearly identified, premature deployment may result in the stent failing to deploy, leading to surgical failure and potential dangers. 2. Stent torsion: Since deployment is often performed under two-dimensional imaging such as DSA, stents may become torsion after deployment, leading to long-term stent occlusion and endoleak. 3. Difficulty in implementing multi-branch stents (one main stent and two or more branch stents): This design often results in multiple guidewire entanglements (two or more), which are almost impossible to untangle within the body, limiting the application of multi-branch stents. Utility Model Content

[0005] The purpose of this invention is to provide a film-coated support with embedded branches and its delivery system in order to solve the above-mentioned problems.

[0006] This utility model achieves the above objectives through the following technical solutions:

[0007] A covered stent with an embedded branch includes an aortic covered stent, at least one embedded branch covered stent, and at least one independent branch covered stent.

[0008] The aortic endovascular stent graft includes a main metal skeleton, a main PTFE membrane pressed onto the surface of the main metal skeleton, and at least one branch opening formed in the main PTFE membrane; each branch opening edge is sutured with the embedded branch endovascular stent graft.

[0009] The outer surface of the aortic endovascular stent graft is covered with a main soft membrane for restricting the release of the aortic endovascular stent graft. The embedded branch endovascular stent graft has a branch catheter inside. The tip of the branch catheter is flush with the branch opening and the outer wall of the branch catheter extending out of the tail end of the embedded branch endovascular stent graft is covered with a branch soft membrane. The branch soft membrane is used to wrap the embedded branch endovascular stent graft and restrict the release of the embedded branch endovascular stent graft.

[0010] As a further optimization of this utility model, the embedded branched film-coated support is conical, with a wide end at the front and a narrow end at the rear. The embedded branched film-coated support includes a branched metal skeleton and a branched PTFE membrane pressed onto the surface of the branched metal skeleton.

[0011] As a further optimization of this utility model, the independent branch film-coated support is cylindrical, and the independent branch film-coated support includes an independent branch metal skeleton and an independent branch PTFE membrane pressed onto the surface of the independent branch metal skeleton.

[0012] As a further optimization of this utility model, the suture connection between the aortic endovascular stent graft and the embedded branch endovascular stent graft is covered with a pressure membrane, and the embedded branch endovascular stent graft is located inside the aortic endovascular stent graft, and can be bent along the suture connection with the aortic endovascular stent graft, and after release, it adheres to the inner wall surface of the aortic endovascular stent graft.

[0013] As a further optimization of this utility model, the diameter of the embedded branch covered stent is smaller than that of the aortic covered stent.

[0014] As a further optimization of this utility model, the aortic endovascular stent graft is also provided with a release lead.

[0015] A delivery system for delivering the aforementioned covered stent with embedded branches, the delivery system comprising an outer sheath, a central guidewire catheter disposed inside the outer sheath, a tapered head connected to the central guidewire catheter, a main diaphragm controller for connection to a main diaphragm, a central guidewire catheter controller for connection to the central guidewire catheter, and a branch catheter controller for connection to a branch catheter.

[0016] As a further optimization of this utility model, a flushing pipe is provided inside the outer sheath tube, and the outlet of the flushing pipe extends to the surface of the outer sheath tube.

[0017] As a further optimization of this utility model, the outer surface of the outer sheath is provided with a hydrophilic coating.

[0018] As a further optimization of this utility model, the outer sheath tube is connected to an outer sheath tube controller.

[0019] The beneficial effects of this utility model are as follows:

[0020] 1) In this utility model, the central guidewire catheter and the branch catheter provide movement channels for the central guidewire and the corresponding branch guidewire, respectively. Compared with the absence of branch catheters, the problem of guidewires getting tangled can be reduced or avoided. In particular, in the case of two or more embedded branch covered stents, each guidewire can be guaranteed to maintain an independent movement channel, so as to facilitate the application of multi-branch stents.

[0021] 2) The branch catheter and branch diaphragm in this utility model can compress the embedded branch diaphragm by wrapping it with the branch diaphragm. Removing the branch diaphragm facilitates the release of the embedded branch diaphragm. Wrapping the embedded branch diaphragm with the branch diaphragm can also make the branch catheter and the embedded branch diaphragm tightly connected, preventing the branch catheter from falling off. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall structure of the film-coated support and conveying system with embedded branches of this utility model.

[0023] Figure 2 This is a schematic diagram of the structure of the film-coated support with embedded branches of this utility model.

[0024] Figure 3 This is a schematic diagram of the embedded branched covered stent and branched conduit of this utility model.

[0025] Figure 4 This is a diagram showing the state of the delivery system of the present invention, which includes a compressed aortic stent graft and an embedded branch stent graft, placed inside the aorta.

[0026] Figure 5This is a diagram showing the state of the aortic endovascular stent graft of this utility model after complete release and removal of the branch pia mater to release the embedded branch endovascular stent graft (without delivery of the independent branch endovascular stent graft).

[0027] Figure 6 This is a schematic diagram of the structure of the independent branch film-coated support of this utility model.

[0028] Figure 7 These are diagrams showing the state of the aortic endovascular stent graft, the embedded branch endovascular stent graft, and the independent branch endovascular stent graft after placement, according to this utility model.

[0029] In the diagram: 1. Aortic endovascular stent graft; 2. Embedded branched endovascular stent graft; 3. Branch catheter; 4. Release lead; 5. Outer sheath; 6. Central guidewire catheter; 7. Conical tip; 8. Main pia mater controller; 9. Central guidewire catheter controller; 10. Branch catheter controller; 11. Flushing tube; 12. Central guidewire; 13. Branch guidewire; 14. Independently branched endovascular stent graft; 101. Main metal skeleton; 102. Main PTFE membrane; 103. Main pia mater; 104. Branch opening; 201. Branch metal skeleton; 202. Branch PTFE membrane; 203. Branch pia mater. Detailed Implementation

[0030] The present application will now be described in further detail with reference to the accompanying drawings. It should be noted that the following specific embodiments are only used to further illustrate the present application and should not be construed as limiting the scope of protection of the present application. Those skilled in the art can make some non-essential improvements and adjustments to the present application based on the above application content.

[0031] Example 1

[0032] like Figure 1-7 As shown, a covered stent with embedded branches includes an aortic covered stent 1, at least one embedded branch covered stent 2, and at least one independent branch covered stent 14.

[0033] The aortic endovascular stent graft 1 includes a main metal skeleton 101, a main PTFE membrane 102 pressed onto the surface of the main metal skeleton 101, and at least one branch opening 104 formed on the main PTFE membrane 102; each of the branch openings 104 is sutured with the embedded branch endovascular stent graft 2 at its edge.

[0034] The outer surface of the aortic stent graft 1 is covered with a main body lamina 103 for restricting the release of the aortic stent graft 1. The embedded branch stent graft 2 is provided with a branch catheter 3 inside. The tip of the branch catheter 3 is flush with the branch opening 104 and the outer wall of the branch catheter 3 extending out of the tail end of the embedded branch stent graft 2 is provided with a branch lamina 203. The branch lamina 203 is used to wrap the embedded branch stent graft 2 and restrict the release of the embedded branch stent graft 2.

[0035] Preferably, the embedded branched film-coated support 2 is conical, with a wide end at the front and a narrow end at the rear. The embedded branched film-coated support 2 includes a branched metal skeleton 201 and a branched PTFE membrane 202 pressed onto the surface of the branched metal skeleton 201.

[0036] Preferably, the independent branched film-coated support 14 is cylindrical, and the independent branched film-coated support 14 includes an independent branched metal skeleton and an independent branched PTFE membrane pressed onto the surface of the independent branched metal skeleton.

[0037] Preferably, the suture connection between the aortic stent graft 1 and the embedded branch stent graft 2 is covered with a pressure membrane, and the embedded branch stent graft 2 is located inside the aortic stent graft 1, and can be bent along the suture connection with the aortic stent graft 1, and after release, it adheres to the inner wall surface of the aortic stent graft 1.

[0038] Preferably, the diameter of the embedded branch covered stent 2 is smaller than the diameter of the aortic covered stent 1.

[0039] Preferably, the aortic endovascular stent graft 1 is further provided with a release lead 4.

[0040] Example 2

[0041] like Figure 1-7 As shown, a delivery system for delivering the covered stent with embedded branches of Embodiment 1 is provided. The delivery system includes an outer sheath 5, a central guidewire catheter 6 disposed inside the outer sheath 5, a tapered head 7 connected to the central guidewire catheter 6, a main diaphragm controller 8 for connecting to the main diaphragm 103, a central guidewire catheter controller 9 for connecting to the central guidewire catheter 6, and a branch catheter controller 10 for connecting to the branch catheter 3.

[0042] Preferably, the outer sheath 5 is provided with a flushing pipe 11 inside, and the outlet of the flushing pipe 11 extends to the surface of the outer sheath 5 to facilitate external flushing of the outer sheath 5.

[0043] Preferably, the outer surface of the outer sheath 5 is provided with a hydrophilic coating.

[0044] Preferably, the outer sheath 5 is connected to an outer sheath controller.

[0045] The delivery method for the covered stent with embedded branches in Example 1 using the delivery system is as follows: The aortic covered stent 1 and the covered stent with embedded branches 2 are placed inside the outer sheath 5, and the aortic covered stent 1 is fitted over the central guidewire catheter 6. The corresponding controllers are then connected. The femoral artery of the patient with aortic dissection is exposed by incision. An angiography guidewire and an angiography catheter are placed via femoral artery puncture. Angiography confirms that the angiography catheter is located within the true lumen of the aorta. The central guidewire 12 is placed, and the angiography catheter is removed. The stent is then delivered along the central guidewire 12... The delivery system, containing the aortic endovascular stent graft 1 and the embedded branch endovascular stent graft 2, is placed at the predetermined position in the aortic arch to be repaired. Based on the stent mark, the outer sheath 5 is pulled backward via the outer sheath controller, and the position of the endovascular stent graft is adjusted. The main endovascular membrane 103 is gradually removed backward via the main endovascular membrane controller 8, exposing the branch openings 104. At this point, the aortic endovascular stent graft 1 is in a semi-released state. A branch guidewire 13 is placed inside the branch catheter 3, extending into the corresponding branch of the arch. The branch guidewire 13 is used to align the opening of the embedded branch endovascular stent graft 2 with the corresponding arch opening. The position of the endovascular stent graft is adjusted again, and the release lead 4 is pulled to completely release the aortic endovascular stent graft 1. At this point, the embedded branch endovascular stent graft 2 is wrapped by the branch endovascular membrane 203 on the branch catheter 3 and is in an unreleased state. The branch catheter 3 is pulled back via the branch catheter controller 10 to open the branch endovascular membrane 203, releasing the embedded branch endovascular stent graft 2. It is then removed via the central guidewire catheter controller 9. The central guidewire catheter 6 and the conical tip 7 are used to select an appropriate size of independent branch covered stent 14 according to the diameter of the branch vessel. The independent branch covered stent 14 is placed along the corresponding branch guidewire 13, with the head end of the independent branch covered stent 14 located in the branch vessel and the tail end of the independent branch covered stent 14 located in the embedded branch covered stent 2, with the tail end flush with the tail end of the embedded branch covered stent 2. The independent branch covered stent 14 is then released, the branch guidewire 13 is removed, and the procedure is completed after angiography to assess the stent placement.

[0046] The embodiments described above are merely examples of several implementations of this utility model, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of this utility model patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this utility model, and these modifications and improvements all fall within the protection scope of this utility model.

Claims

1. A covered scaffold with embedded branches, characterized in that: It includes an aortic endovascular stent graft (1), at least one inlaid branch endovascular stent graft (2), and at least one independent branch endovascular stent graft (14); The aortic endovascular stent graft (1) includes a main metal skeleton (101), a main PTFE membrane (102) pressed onto the surface of the main metal skeleton (101), and at least one branch opening (104) formed on the main PTFE membrane (102); each of the branch openings (104) is sutured with the embedded branch endovascular stent graft (2) at its edge; The outer surface of the aortic endovascular stent graft (1) is covered with a main body lamina (103) for restricting the release of the aortic endovascular stent graft (1). The embedded branch endovascular stent graft (2) is provided with a branch catheter (3) inside. The head end of the branch catheter (3) is flush with the branch opening (104), and the outer wall of the branch catheter (3) extending out of the tail end of the embedded branch endovascular stent graft (2) is provided with a branch lamina (203). The branch lamina (203) is used to wrap the embedded branch endovascular stent graft (2) and restrict the release of the embedded branch endovascular stent graft (2).

2. The covered scaffold with embedded branches according to claim 1, characterized in that: The embedded branched membrane stent (2) is conical with a wide end at the front and a narrow end at the rear. The embedded branched membrane stent (2) includes a branched metal skeleton (201) and a branched PTFE membrane (202) pressed onto the surface of the branched metal skeleton (201).

3. A covered scaffold with embedded branches according to claim 1, characterized in that: The aortic endovascular stent graft (1) and the embedded branch endovascular stent graft (2) are covered with a pressure membrane at the suture connection point. The embedded branch endovascular stent graft (2) is located inside the aortic endovascular stent graft (1) and can be bent along the suture point with the aortic endovascular stent graft (1). After release, it adheres to the inner wall surface of the aortic endovascular stent graft (1).

4. A covered scaffold with embedded branches according to claim 1, characterized in that: The diameter of the embedded branch covered stent (2) is smaller than that of the aortic covered stent (1).

5. A covered scaffold with embedded branches according to claim 1, characterized in that: The aortic endovascular stent graft (1) is also provided with a release lead (4).

6. A conveying system for conveying a film-coated stent with embedded branches as described in any one of claims 1-5, characterized in that: The delivery system includes an outer sheath (5), a central guidewire catheter (6) located inside the outer sheath (5), a conical head (7) connected to the central guidewire catheter (6), a main body soft membrane controller (8) for connection to the main body soft membrane (103), a central guidewire catheter controller (9) for connection to the central guidewire catheter (6), and a branch catheter controller (10) for connection to the branch catheter (3).

7. The delivery system for a film-coated scaffold with embedded branches according to claim 6, characterized in that: The outer sheath (5) is provided with a flushing pipe (11), and the outlet of the flushing pipe (11) extends to the surface of the outer sheath (5).

8. The delivery system for a film-coated scaffold with embedded branches according to claim 6, characterized in that: The outer surface of the outer sheath (5) is provided with a hydrophilic coating.

9. A delivery system for a film-coated stent with embedded branches according to claim 6, characterized in that: The outer sheath (5) is connected to an outer sheath controller.

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