Stent graft

Abstract

The present invention provides a stent graft comprising a stent graft body and a docking device; the stent graft body has a flow space connected at both ends; the docking device is fixed to the stent graft body and located at one end of the stent graft body along the axial direction of the stent graft body. Compared with existing technologies, the stent graft provided by the present invention can facilitate docking with other medical devices, reducing the difficulty of docking.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a stent graft. Background Art

[0002] A covered stent is a metal stent coated with a special membrane material (such as polytetrafluoroethylene, Dacron, polyester, or polyurethane). This stent retains the functionality of a metal stent while also possessing the properties of the membrane material. Typically made of a nickel-titanium alloy, a covered stent is coated with a polymer membrane to form a self-expanding artificial conduit that is fixed within the body's blood vessels. It is used to treat conditions such as aneurysms, arterial dissections, and vascular ruptures.

[0003] Thoracic endovascular aortic stent graft repair (TEVAR) and abdominal endovascular aortic stent graft repair (EVAR) are minimally invasive procedures within the vascular lumen. Compared to traditional surgical methods, TEVAR and EVAR offer significant advantages such as less trauma, shorter recovery time, and fewer complications.

[0004] Currently, aortic stent grafts are increasingly being used to treat aortic dissection and aortic aneurysm, leading to the need for further endovascular intervention for long-term bleeding. Examples include long-term endoleaks after TEVAR and EVAR, and new lesions related to the proximal and distal ends of the stent.

[0005] The current clinical solution is a simple re-surgical intervention. If endoleaks occur after aortic stenting, doctors must insert new stent grafts proximal and distal to the stent graft based on the location of the endoleak. Alternatively, they can use a catheter and guidewire to penetrate the gap between the stent graft's outer wall and the vessel's inner wall for embolization.

[0006] However, in the prior art, it is very difficult for doctors to connect the catheter, guidewire and coated stent during the operation, which makes it very difficult and time-consuming to use the catheter and guidewire to enter the gap between the outer wall of the coated stent and the inner wall of the blood vessel for embolization. As a result, this surgical option is rarely chosen during clinical re-operation. This is also the reason why there are not many other convenient and simple methods for clinical re-operation except adding a new stent to the proximal and distal ends of the original stent. Summary of the Invention

[0007] In view of the technical problem in the prior art that the connection between the catheter, guidewire and stent graft during reoperation is very difficult, which increases the difficulty and time of the operation, the present invention provides a stent graft that facilitates connection, thereby reducing the difficulty and time of the operation.

[0008] A stent graft comprising a stent graft body and a docking device;

[0009] The stent graft body has a flow space with two ends connected;

[0010] The docking device is fixed on the stent graft body and is located at one end of the stent graft body along the axial direction of the stent graft body.

[0011] Preferably, the docking device includes a mounting portion and a docking portion:

[0012] The mounting portion is fixedly connected to the stent graft body;

[0013] The docking portion is fixed on the mounting portion.

[0014] Preferably, the mounting portion includes an outer sleeve, an interface tube and a hemostatic valve;

[0015] The interface tube is a hollow structure, a portion of the interface tube is disposed in the outer sleeve, another portion of the interface tube extends out of the outer sleeve and is connected to the stent graft body, and the portion of the interface tube located in the outer sleeve passes through the outer sleeve;

[0016] The hemostatic valve is arranged in the interface tube;

[0017] The docking portion is fixed on the outer sleeve.

[0018] Preferably, the interface pipe includes an inner pipe, an inner layer interface pipe, an outer layer interface pipe, a first connecting pipe and a second connecting pipe;

[0019] The inner tube is located in the outer tube;

[0020] The inner layer interface tube is in close contact with the inner surface of the stent graft body;

[0021] The outer interface tube is fitted and connected to the outer surface of the stent graft body;

[0022] The first connecting pipe connects the inner layer interface pipe and the inner pipe;

[0023] The second connecting pipe connects the outer interface pipe and the inner pipe.

[0024] Preferably, the central axis of the inner tube coincides with the central axis of the outer tube, and the docking portion and the inner tube are staggered.

[0025] Preferably, the outer sleeve is a soft silicone outer sleeve, and the interface tube is a soft silicone interface tube.

[0026] Preferably, the docking portion is a magnetic docking portion.

[0027] Preferably, the docking portion is arc-shaped.

[0028] Preferably, the opening direction of the docking portion is toward the center direction of the coated stent body.

[0029] Preferably, the docking device is fixedly connected to the metal support of the coated support body.

[0030] Compared to the prior art, the stent graft provided by the present invention includes a stent graft body and a docking device; the stent graft body has a flow space connected at both ends; the docking device is fixed to the stent graft body and is located at one end of the stent graft body along the axial direction of the stent graft body. The docking device can facilitate the docking between the stent graft and the catheter or guidewire, reducing the difficulty of docking, thereby reducing the difficulty and time of the operation, and providing more possibilities for the choice of surgical plan when the surgical intervention is repeated clinically. It also allows the stent graft to have more possibilities for use. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0032] Figure 1 A front view of a stent graft provided in one embodiment;

[0033] Figure 2 for Figure 1 A top view of the stent graft shown;

[0034] Figure 3 for Figure 1 A schematic diagram of the three-dimensional structure of the docking device shown;

[0035] Figure 4 for Figure 1 A schematic cross-sectional view of the docking device and the stent graft body; DETAILED DESCRIPTION

[0036] In order to help those skilled in the art better understand the technical solutions in this application, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without making any creative efforts shall fall within the scope of protection of this application.

[0037] It should be noted that when an element is referred to as being “fixed on,” “installed on,” or “set on” another element, it can be directly on the other element or indirectly set on the other element; when an element is referred to as being “connected to” another element, it can be directly connected to the other element or indirectly connected to the other element.

[0038] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions under which this application can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in this application without affecting the efficacy and purpose that can be achieved by this application.

[0039] The present invention provides a stent graft comprising a stent graft body and a docking device; the stent graft body has a flow space connected at both ends; the docking device is fixed to the stent graft body and located at one end of the stent graft body along the axial direction of the stent graft body. The stent graft can facilitate docking with a catheter or guidewire, reducing docking difficulty.

[0040] Please refer to Figures 1 to 4 . This embodiment provides a covered stent 100, specifically a large vessel covered stent. More specifically, the covered stent 100 in this embodiment is an ascending aorta covered stent. The covered stent 100 includes a covered stent body 10 and a docking device 20. The covered stent body 10 has a circulation space 11 connected at both ends, so that when the covered stent 100 is installed in the human body, blood can circulate well through the circulation space 11. The docking device 20 is fixed on the covered stent body 10, and along the axial direction of the covered stent body 10, the docking device 20 is located at one end of the covered stent body 10. Specifically, the covered stent body 10 is composed of a metal stent and a special coating material combined together to form a tubular structure, that is, the covered stent body 10 is composed of a metal stent 12 and a coating 13. In this embodiment, the metal stent 12 is made of nickel-titanium alloy, and the coating 13 is made of EPTFE (expanded polytetrafluoroethylene) film. The docking device 20 is arranged at the end of the coated stent body 10, so that when the coated stent 100 has been installed in the human body through surgery and subsequent surgical intervention is required, the docking device 20 can facilitate the docking between the coated stent 100 and other medical devices (such as catheters, guide wires), reduce the difficulty of docking, improve the docking efficiency, and thus reduce the difficulty and duration of the operation.

[0041] It is understandable that there are more and more cases in clinical practice where re-endovascular surgical intervention is needed, such as long-term endoleak after TEVAR (thoracic aortic stent graft endoluminal repair) and EVAR (abdominal aortic stent graft endoluminal repair), and new lesions related to the proximal and distal ends of the stent. There are roughly two options for re-surgical intervention in the existing technology: one is to add new stent grafts to the proximal and distal ends of the stent graft according to the location of the endoleak; the other is to use a catheter and a guide wire to enter through the gap between the outer wall of the stent graft and the inner wall of the blood vessel for embolization. However, since the stent graft installed in the body has completely fused with the vascular endothelium, it is very difficult to connect the catheter, guide wire and graft, which increases the difficulty of the operation. This is also the reason why there are not many convenient and simple methods other than adding new stents to the proximal and distal ends of the original stent when performing re-surgical intervention in clinical practice.

[0042] Furthermore, existing technologies for large vessel covered stents carry a risk of long-term infection, while small vessel covered stents carry a greater risk of restenosis and occlusion. Therefore, existing covered stents cannot be used in areas with existing infections or in situations with systemic infection. The restenosis prevention drugs used in small covered stents are mostly coatings, and the drugs are completely released after 3-6 months. Aortic lesions involving mediastinal and systemic infections are still relative contraindications to endovascular treatment, depriving many patients of the opportunity for minimally invasive treatment. Unable to undergo large-scale open surgery, these procedures could be life-threatening.

[0043] The stent graft 100 provided in this embodiment is provided with the docking device 20, so that the docking device 20 can facilitate docking with other medical devices. When clinical surgical intervention is required again, the docking device 20 can be used to dock with the catheter and guide wire more quickly, reducing the difficulty and time of the operation. In addition, the docking device 20 can also facilitate long-term multiple drug administration, so that the stent graft 100 has more possibilities for use. In other words, the stent graft 100 has a relatively convenient docking device 20 for providing long-term re-intervention (repair) or long-term multiple drug administration.

[0044] Preferably, the docking device 20 includes a mounting portion 21 and a docking portion 22, wherein the mounting portion 21 is fixedly connected to the stent graft body 10, and the docking portion 22 is fixed to the mounting portion 21. This can better ensure the fixing effect between the docking device 20 and the stent graft body 10, as well as the docking effect between the docking device 20 and other medical devices.

[0045] Preferably, the mounting portion 21 includes an outer sleeve 211, a mouthpiece 212, and a hemostatic valve 213. The mouthpiece 212 is a hollow structure, with a portion disposed within the outer sleeve 211, while another portion extends beyond the outer sleeve 211 and connects to the stent graft body 10. The portion of the mouthpiece 212 located within the outer sleeve 211 extends through the outer sleeve 211. Thus, the hollow mouthpiece 212 allows for easy guidance of catheters and guidewires into the area where the stent graft body 10 is located. Long-term, multiple drug administration can also be performed through the hollow mouthpiece 212. The hemostatic valve 213 is disposed within the mouthpiece 212, and the docking portion 22 is fixed to the outer sleeve 211. The hemostatic valve 213 prevents high-pressure blood flow within the blood vessel from entering the effective area of ​​the stent graft body 10 through the mouthpiece 212, causing bleeding.

[0046] Preferably, the interface tube 212 includes an inner tube 2121, an inner layer interface tube 2122, an outer layer interface tube 2123, a first connecting tube 2124, and a second connecting tube 2125. The inner tube 2121 is located in the outer tube 211. The inner layer interface tube 2122 is in close contact with the inner surface 14 of the stent graft body 10, and the outer layer interface tube 2123 is in close contact with the outer surface 15 of the stent graft body 10. The first connecting tube 2124 connects the inner layer interface tube 2122 and the inner tube 2121, and the second connecting tube 2125 connects the outer layer interface tube 2123 and the inner tube 2121. That is, the interface tube 212 is divided into two at the end near the stent graft body 10 and is respectively fixed to the inner and outer surfaces of the stent graft body 10, thereby better ensuring the connection stability between the docking device 20 and the stent graft body 10. Furthermore, the inner interface tube 2122 and the outer interface tube 2123 allow for the introduction of a catheter or guidewire into or out of the stent graft body 10 during surgery, as required. Alternatively, medication can be delivered into or out of the stent graft body 10, as required. In this embodiment, the interface tube 212 is a Y-shaped tube, i.e., the inner interface tube 2122 and the first connecting tube 2124 are symmetrically arranged with the outer interface tube 2123 and the second connecting tube 2125.

[0047] Preferably, the central axis of the inner tube 2121 coincides with the central axis of the outer tube 211, that is, the inner tube 2121 is disposed at the exact center of the outer tube 211. The docking portion 22 is offset from the inner tube 2121, so that the docking portion 22 does not block the inner tube 2121, does not affect the insertion of a catheter or guidewire into the inner tube 2121, or does not affect the delivery of drugs to the inner tube 2121.

[0048] Preferably, the outer sleeve 211 is a soft silicone outer sleeve, and the interface tube 212 is a soft silicone interface tube, thereby better ensuring safety and further avoiding damage to the human body.

[0049] Preferably, the docking portion 22 is a magnetic docking portion. That is, the docking portion 22 is made of magnetic material, so that it can dock with medical devices with magnetic structures (such as catheters and guidewires with magnetic structures), and complete the docking between other medical devices and the coated stent 100 by magnetic attraction. Of course, in other embodiments, the docking method between the docking portion 22 and other medical devices can also adopt a structural shape method, such as a groove or a protrusion can be provided on the docking portion 22, and other medical devices are correspondingly provided with a protrusion matching the groove or a groove matching the protrusion, to achieve the docking between the docking portion 22 and other medical devices. In this embodiment, the docking portion 22 is made of magnetic material, so that the docking between the coated stent 100 and other medical devices is completed by magnetic attraction, which can effectively improve the docking efficiency, reduce the difficulty of docking, make alignment easier, and better reduce the difficulty of surgery and surgery time.

[0050] Preferably, the docking portion 22 is in an arc shape, thereby better facilitating the docking between the docking portion 22 and other medical devices. Specifically, in this embodiment, the docking portion 22 is semicircular. More preferably, the opening direction of the docking portion 22 is toward the center direction of the stent graft body 10, that is, the docking portion 22 is located on the side away from the center direction of the stent graft body 10, so that the docking portion 22 does not block the normal circulation of blood inside the stent graft body 10.

[0051] Preferably, the docking device 20 is fixedly connected to the metal bracket 12 of the stent graft body 10, thereby further ensuring the connection and fixing effect between the docking device 20 and the stent graft body 10, and better ensuring the connection stability. Specifically, in this embodiment, the outer sleeve 211 is fixedly connected to the metal bracket 12 at the end of the stent graft body 10.

[0052] Preferably, the docking device 20 is provided with a heparin coating, and the docking device 20 is subjected to an anti-cell adhesion treatment, so as to prevent thrombosis and endothelial ingrowth as long as possible.

[0053] In this embodiment, one docking device 20 is provided at the end of the stent graft body 10. Of course, in other embodiments, the number of docking devices 20 may be greater depending on actual needs, and multiple docking devices 20 may be distributed in a circular array at one end of the stent graft body 10. In some embodiments, the docking devices 20 may be provided at both ends of the stent graft body 10, and the choice may be made based on actual needs.

[0054] The coated stent 100 provided in this embodiment is provided with the docking device 20, and the docking device 20 can be used for the docking inspection entrance for long-term re-intervention. The entrance is small in size and will not affect the structural stability of the coated stent body 10, nor does it have the risk of thrombosis in the long term. Through this entrance, convenient catheter guidewire operations can be performed between the coated stent body 10 and the blood vessel wall and in the cavity of the coated stent body 10 (such as sending substances such as spring coils and tissue glue between the outer layer of the aorta coated stent and the inner layer of the autologous blood vessel to prevent long-term internal leakage). Or it can be used to perfuse antibacterial drugs into the outer layer of the stent that is infected in the long term, etc. For small stents, anticoagulant or anti-intimal hyperplasia drugs can also be perfused into the inner layer of the stent.

[0055] The docking device 20 provided in this embodiment has the interface tube 212, which is a Y-shaped tube. After bifurcation, one tube leads to the inside of the coated stent body 10, and the other tube leads to the gap between the outside of the coated stent body 10 and the blood vessel wall. The lower half of the Y-shaped tube (the part before bifurcation) is connected to the outer sleeve 211, and the tube mouth is located at the end of the docking part 22. When the catheter with opposite magnetic poles is "connected" to the docking part 22, the catheter mouth is accurately aligned with the outer mouth of the interface tube 212. The guide wire can be introduced into the Y-shaped tube through the catheter, and the catheter can be followed up to choose whether to enter the stent or outside the stent for further processing under fluoroscopy.

[0056] It is understandable that in the prior art, it is difficult to re-intervene an already implanted covered stent, which is time-consuming, costly, and may not produce satisfactory results. The covered stent 100 provided in this embodiment can effectively reduce the difficulty of docking, thereby reducing the difficulty and time-consuming operation, facilitating long-term re-endovascular surgical intervention, and reducing the trauma and cost of re-operative intervention. In addition, in the prior art, it is impossible to implant a covered stent for infected lesions. For long-term infection of the covered stent, only systemic antibiotic treatment or open surgery for bypass and drainage can be performed, which is very traumatic. The covered stent 100 provided in this embodiment can serve as an interface device for drug administration in the long term. At the same time, the small-diameter covered stent used for peripheral arteries in the prior art has a high probability of restenosis and occlusion in the medium and long term, and can only be intervened by balloon expansion and covered stent intervention in the later stage. The current anticoagulant and anti-intimal hyperplasia drugs cannot provide long-term patency of the covered stent. An interface device that can be used for drug administration in the long term is also needed. The covered stent 100 provided in this embodiment can perfectly solve the above problems.

[0057] As the rate of long-term reoperation for endovascular treatment increases with the large number of endovascular surgeries, the efficiency of re-interventional procedures needs to be improved with the support of new concepts, technologies, and device innovations. The stent graft 100 provided in this embodiment is a concept that provides a long-term access port within the stent. The stent graft 100 facilitates magnetic navigation "docking" of an intraluminal catheter guidewire, facilitating docking for interventional procedures and drug delivery.

[0058] The above description is only an embodiment of the present invention. It should be pointed out that those skilled in the art can make improvements without departing from the creative concept of the present invention, but these improvements all fall within the scope of protection of the present invention.

Claims

1. A stent graft, characterized in that: The stent graft comprises a stent graft body and a docking device; The stent graft body has a flow space with two ends connected; The docking device is fixed to the stent graft body and is located at one end of the stent graft body along the axial direction of the stent graft body; The docking device includes a mounting portion and a docking portion: The mounting portion is fixedly connected to the stent graft body; The docking portion is fixed on the mounting portion; The mounting portion includes an outer sleeve, an interface tube and a hemostatic valve; The interface tube is a hollow structure, a portion of the interface tube is disposed in the outer sleeve, another portion of the interface tube extends out of the outer sleeve and is connected to the stent graft body, and the portion of the interface tube located in the outer sleeve passes through the outer sleeve; The hemostatic valve is arranged in the interface tube; The docking portion is fixed on the outer sleeve; The interface pipe includes an inner pipe, an inner layer interface pipe, an outer layer interface pipe, a first connecting pipe and a second connecting pipe; The inner tube is located in the outer tube; The inner layer interface tube is in close contact with the inner surface of the stent graft body; The outer interface tube is fitted and connected to the outer surface of the stent graft body; The first connecting pipe connects the inner layer interface pipe and the inner pipe; The second connecting pipe connects the outer interface pipe and the inner pipe; The docking portion is a magnetic docking portion.

2. The stent graft according to claim 1, wherein: The central axis of the inner tube coincides with the central axis of the outer tube, and the docking portion and the inner tube are staggered.

3. The stent graft according to claim 1, wherein: The outer sleeve is a soft silicone outer sleeve, and the interface tube is a soft silicone interface tube.

4. The stent graft according to claim 1, wherein: The docking portion is arc-shaped.

5. The stent graft according to claim 4, characterized in that: The opening direction of the docking portion is toward the center direction of the coated support body.

6. The stent graft according to claim 1, wherein: The docking device is fixedly connected to the metal support of the coated support body.

Images