Disclosure of Invention
Aims at solving the technical problems of easy infection and low anti-infection capability of the covered stent in the prior art. The invention provides a covered stent which can effectively improve the anti-infection capability.
A covered stent, which comprises a covered stent body and a medicine storage device;
The inside of the tectorial membrane bracket body is provided with a circulation space with two communicated ends;
The medicine storage device is fixed on the tectorial membrane support body, just the medicine storage device is at least partially located the outside of tectorial membrane support body, medicine storage space has in the medicine storage device inside, just medicine administration hole has been seted up on the medicine storage device, medicine administration hole will medicine storage space and external environment intercommunication.
Preferably, the medicine storage device is embedded in the coating of the coating bracket body.
Preferably, the medicine storage device comprises an axial medicine storage tube and a circumferential medicine storage tube;
The axial medicine storage tube is arranged along the axial direction of the tectorial membrane bracket body;
the circumferential medicine storage tube is connected with the axial medicine storage tube, and the circumferential medicine storage tube is arranged along the circumferential direction of the tectorial membrane bracket body;
The medicine storage space comprises a first medicine storage space and a second medicine storage space, the first medicine storage space is arranged in the axial medicine storage tube, the second medicine storage space is arranged in the circumferential medicine storage tube, and the second medicine storage space is communicated with the first medicine storage space;
the medicine feeding holes are formed in the axial medicine storage pipe and the circumferential medicine storage pipe.
Preferably, the axial medicine storage tubes are provided with a plurality of medicine storage tubes, the axial medicine storage tubes are distributed along the circumference of the tectorial membrane bracket body in sequence, and two adjacent medicine storage tubes are arranged at intervals.
Preferably, the circumference medicine storage pipe is provided with a plurality of, and is a plurality of circumference medicine storage pipe is followed the axial of tectorial membrane support body distributes in proper order, and adjacent two circumference medicine storage pipe is mutual interval setting.
Preferably, the device further comprises a docking device;
The docking device is fixed on the tectorial membrane support body, and the medicine supplementing channel is arranged on the docking device, and the medicine supplementing channel is communicated with the medicine storage space.
Preferably, the docking device includes a mounting portion and a docking portion:
The mounting part is fixedly connected with the tectorial membrane bracket body, and is positioned at one end of the tectorial membrane bracket body along the axial direction of the tectorial membrane bracket body;
the butt joint part is fixed on the mounting part;
The medicine supplementing channel is arranged in the mounting part.
Preferably, the mounting part comprises an outer sleeve, a connector tube and a hemostatic valve;
The medicine supplementing channel is surrounded by the interface tube, one part of the interface tube is arranged on the outer sleeve, the other part of the interface tube extends out of the outer sleeve and is connected with the tectorial membrane bracket body, and the part of the interface tube positioned in the outer sleeve penetrates through the outer sleeve;
the hemostatic valve is arranged in the interface tube;
the butt joint part is fixed on the outer sleeve.
Preferably, the interface tube comprises an inner tube, an inner interface tube, an outer interface tube, a first connecting tube and a second connecting tube;
The inner tube is positioned in the outer sleeve;
the inner layer interface tube is in fit connection with the inner surface of the tectorial membrane bracket body;
The outer layer interface tube is connected with the outer surface of the tectorial membrane bracket body in a fitting way, and the outer layer interface tube is connected with the medicine storage device;
The first connecting pipe is connected with the inner layer interface pipe and the inner pipe;
the second connecting pipe is connected with the outer layer interface pipe and the inner pipe;
The medicine supplementing channel is surrounded by the inner pipe, the second connecting pipe and the outer layer interface pipe.
Preferably, the abutting portion is a magnetic abutting portion.
Compared with the prior art, the tectorial membrane support comprises a tectorial membrane support body and a medicine storage device, wherein a circulation space with two ends communicated is formed in the tectorial membrane support body, the medicine storage device is fixed on the tectorial membrane support body and is at least partially positioned on the outer side of the tectorial membrane support body, a medicine storage space is formed in the medicine storage device, a medicine feeding hole is formed in the medicine storage device, and the medicine feeding hole is used for communicating the medicine storage space with the external environment. The medicine storage device can store antibacterial and anti-infection medicines in the covered stent, and the medicine administration holes can release the antibacterial and anti-infection medicines stored in the medicine storage device outwards, so that the anti-infection capacity of the covered stent after being installed in a human body can be effectively improved, and the covered stent has more use possibility.
Detailed Description
In order to enable those skilled in the art to better understand the technical solutions of the present application, the technical solutions of the embodiments of the present application will be clearly and completely described below, and it is obvious that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
It will be understood that when an element is referred to as being "mounted" or "fixed" to another element, it can be directly on the other element or be indirectly on the other element, or be directly connected or indirectly connected to the other element.
It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for the purpose of understanding and reading the disclosure, and are not intended to limit the scope of the application, which is defined by the claims, but rather by the claims, unless otherwise indicated, and that any structural modifications, proportional changes, or dimensional adjustments, which would otherwise be apparent to those skilled in the art, would be made without departing from the spirit and scope of the application.
The invention provides a covered stent which comprises a covered stent body and a medicine storage device, wherein a circulation space with two communicated ends is formed in the covered stent body, the medicine storage device is fixed on the covered stent body and at least partially positioned on the outer side of the covered stent body, a medicine storage space is formed in the medicine storage device, a medicine feeding hole is formed in the medicine storage device, and the medicine feeding hole communicates the medicine storage space with the external environment. The medicine storage device can store antibacterial and anti-infective medicines and can release the medicines outwards through the medicine feeding holes, so that the tectorial membrane bracket has better anti-infective capacity.
Please refer to fig. 1 to fig. 4 in combination. The present embodiment provides a stent graft 100, and in particular, the stent graft 100 is an ascending aortic stent graft in the present embodiment. The stent graft 100 comprises a stent graft body 10 and a drug storage device 20, wherein a circulation space 11 with two ends communicated is provided in the stent graft body 10, so that when the stent graft 100 is mounted in a human body, blood can be circulated well through the circulation space 11. The medicine storage device 20 is fixed on the stent graft body 10, and the medicine storage device 20 is at least partially located at the outer side of the stent graft body 10, i.e. the medicine storage device 20 is at least partially located at one side of the outer surface of the stent graft body 10, so that the medicine can be conveniently administered to the inner wall of the blood vessel through the portion of the medicine storage device 20 located at the outer side of the stent graft body 10. Specifically, in the present embodiment, the drug storage device 20 is integrally disposed outside the stent graft body 10. The medicine storage device 20 has a medicine storage space inside, that is, the medicine storage device 20 has a hollow structure, and the medicine storage device 20 can accommodate and store medicine. The drug storage device 20 is provided with a drug administration hole 21, and the drug administration hole 21 communicates the drug storage space with the external environment. Therefore, when the stent graft 100 is mounted in a human body, the medicine stored in the medicine storage space can be released outwards through the medicine administration hole 21, so that infection after the stent graft 100 is mounted in the human body can be better avoided. Specifically, the stent graft body 10 is formed by combining a metal stent and a special stent graft material to form a tubular structure, that is, the stent graft body 10 is formed by a metal stent 12 and a stent graft 13, in this embodiment, the metal stent 12 is made of a nickel-titanium alloy, and the stent graft 13 is made of an EPTFE (expanded polytetrafluoroethylene) film.
It can be appreciated that the current aortic stent graft is contraindicated in the case of treating infectious aneurysms, aortic trauma with severe infection of the lungs or mediastinum, and damage of the aorta by foreign bodies from the esophagus, etc., because of the high infection probability of the stent graft, which causes many patients to lose the opportunity for minimally invasive surgery, and the patients who cannot tolerate the macroinvasive surgery under extracorporeal circulation are likely to die. And as TEVAR (stented endoluminal prosthesis for thoracic aortic arch) has become more and more widely used in clinical applications, stent infection has occurred in long term. The treatment of such long-term stent infections is also quite tricky, and patient mortality is also very high.
The film-covered stent 100 provided in this embodiment is provided with the drug storage device 20, and the drug delivery hole 21 is formed on the drug storage device 20, so that the antibacterial and anti-infective drugs can be stored in the drug storage device 20. After the stent graft 100 is installed in a human body, the stored antibacterial and anti-infective drugs can be gradually released through the drug administration holes 21, so that the anti-infective ability of the stent graft 100 can be effectively improved, and the stent graft 100 has more application possibilities.
Preferably, the medicine storage device 20 is embedded in the film coating 13, so that the connection stability between the medicine storage device 20 and the film coating bracket body 10 can be better ensured, and the anti-seepage performance of the film coating bracket body 10 is also better ensured. And the drug-storage device 20 does not need to be installed in the metal bracket 12, and the manufacturing process flow is simpler.
Preferably, the medicine storage device 20 includes an axial medicine storage tube 22 and a circumferential medicine storage tube 23, the axial medicine storage tube 22 is disposed along the axial direction of the stent graft body 10, the circumferential medicine storage tube 23 is connected with the axial medicine storage tube 22, and the circumferential medicine storage tube 23 is disposed along the circumferential direction of the stent graft body 10. The medicine storage space comprises a first medicine storage space and a second medicine storage space, the first medicine storage space is arranged in the axial medicine storage tube 22, the second medicine storage space is arranged in the circumferential medicine storage tube 23, and the second medicine storage space is mutually communicated with the first medicine storage space. Namely, the axial medicine storage tube 22 and the circumferential medicine storage tube 23 are hollow structures, medicines can be stored in the axial medicine storage tube 22 and the circumferential medicine storage tube 23, and the medicines can circulate between the axial medicine storage tube 22 and the circumferential medicine storage tube 23. The medicine feeding holes 21 are respectively formed in the axial medicine storage tube 22 and the circumferential medicine storage tube 23, namely, the medicine can be outwards released from the axial medicine storage tube 22 and the circumferential medicine storage tube 23. Thereby, the medicine can be better released to the outside through the axial medicine storage tube 22 and the circumferential medicine storage tube 23, and the anti-infection capability of the covered stent 100 is better ensured. More preferably, the axial medicine storage tube 22 and the circumferential medicine storage tube 23 are respectively provided with a plurality of medicine feeding holes 21, and the medicine feeding holes 21 are uniformly distributed on the axial medicine storage tube 22 and the circumferential medicine storage tube 23. Thus, when the medicine is released, the medicine is released more uniformly in each area. Specifically, in this embodiment, the circumferential medicine storage tube 23 has an arc shape. Of course, in other embodiments, the circumferential medicine storage tube 23 may be annular, which is selected according to the size of the actually required administration area.
Preferably, the axial medicine storage tubes 22 are provided with a plurality of axial medicine storage tubes 22, and the axial medicine storage tubes 22 are sequentially distributed along the circumferential direction of the stent graft body 10, and two adjacent axial medicine storage tubes 22 are mutually spaced, so that the stent graft 100 is more uniform in administration. In this embodiment, three of the axial drug storage tubes 22 are exemplified.
Preferably, the plurality of circumferential medicine storage tubes 23 are provided, and the plurality of circumferential medicine storage tubes 23 are sequentially distributed along the axial direction of the stent graft body 10, and two adjacent circumferential medicine storage tubes 23 are arranged at intervals, so that the stent graft 100 is further even in administration. In the present embodiment, five of the circumferential medicine storage tubes 23 are exemplified.
Preferably, the drug storage device 20 is a 2.6-3F microcatheter.
Preferably, the stent graft 100 further includes a docking device 30, the docking device 30 is fixed on the stent graft body 10, and the docking device 30 is provided with a medicine supplementing channel 40, and the medicine supplementing channel 40 is communicated with the medicine storage space. Thereby facilitating docking of the stent graft 100 with other medical devices by the docking device 30. When the covered stent 100 is installed in a human body and then the operation is performed again, the butt joint efficiency between other medical instruments and the covered stent 100 can be effectively improved, the operation difficulty is reduced, and the operation time is shortened. And the docking device 30 can also realize long-term medicine replenishment in the medicine storage device 20, so that the long-term anti-infection capability of the covered stent 100 is better ensured.
Preferably, the docking device 30 includes a mounting portion 31 and a docking portion 32, where the mounting portion 31 is fixedly connected with the stent graft body 10, and is located at one end of the stent graft body 10 along the axial direction of the stent graft body 10, so as to more facilitate docking of other medical devices. The abutting portion 32 is fixed to the mounting portion 31, and the medicine supplementing passage 40 is provided in the mounting portion 31.
Preferably, the mounting portion 31 includes an outer sleeve 311, a mouthpiece 312, and a hemostatic valve 313, and the drug supplementing channel 40 is surrounded by the mouthpiece 312, i.e. the mouthpiece 312 is of a hollow structure. The part of the interface tube 312 is disposed on the outer sleeve 311, the other part of the interface tube 312 extends out of the outer sleeve 311 and is connected with the stent graft body 10, and the part of the interface tube 312 located in the outer sleeve 311 is disposed through the outer sleeve 311. Thus, the hollow interface tube 312 can well guide a catheter and a guide wire to penetrate into the area where the stent graft body 10 is located, and long-term repeated administration can be performed through the hollow interface tube 312 and the area where the stent graft body 10 is located. The hemostatic valve 313 is disposed in the mouthpiece 312, and the docking portion 32 is fixed on the outer sleeve 311. So that the hemostatic valve 313 can prevent high pressure blood flow in the blood vessel from leaking through the interface tube 312 into the effective region of the stent graft body 10.
Preferably, the interface tube 312 includes an inner tube 3121, an inner interface tube 3122, an outer interface tube 3123, a first connection tube 3124, and a second connection tube 3125, and the inner tube 3121 is positioned within the outer sleeve 311. The inner interface tube 3122 is in contact with the inner surface 14 of the stent graft body 10, the outer interface tube 3123 is in contact with the outer surface 15 of the stent graft body 10, and the outer interface tube 3123 is connected with the drug storage device 20. The first connection pipe 3124 connects the inner interface pipe 3122 and the inner pipe 3121, and the second connection pipe 3125 connects the outer interface pipe 3123 and the inner pipe 3121. The medicine supplementing passage 40 is surrounded by the inner tube 3121, the second connection tube 3125, and the outer layer interface tube 3123. That is, the end of the interface tube 312, which is close to the stent graft body 10, is divided into two parts and is respectively fixed on the inner and outer surfaces of the stent graft body 10, so that the connection stability between the docking device 30 and the stent graft body 10 can be better ensured. And the inner interface tube 3122 and the outer interface tube 3123 also enable the introduction of catheters and guide wires into the stent graft body 10 or outside thereof according to actual needs during the operation. Or the medicine can be fed into the inside or the outside of the stent graft body 10 according to actual requirements. In this embodiment, the interface tube 312 is a Y-shaped tube, that is, the inner interface tube 3122 and the first connection tube 3124 are symmetrically arranged with the outer interface tube 3123 and the second connection tube 3125.
Preferably, the central axis of the inner tube 3121 coincides with the central axis of the outer sleeve 311, that is, the inner tube 3121 is disposed at the center of the outer sleeve 311. The butt joint part 32 is arranged in a dislocation with the inner tube 3121, so that the butt joint part 32 does not block the inner tube 3121, not affect the insertion of a catheter or a guide wire into the inner tube 3121, or not affect the delivery of a drug to the inner tube 3121.
Preferably, the outer sleeve 311 is a soft silica gel outer sleeve, and the interface tube 312 is a soft silica gel interface tube, so that the safety is better ensured, and the damage to the human body is further avoided.
Preferably, the docking portion 32 is a magnetic docking portion. That is, the docking portion 32 is made of a magnetic material, so that it can dock with a medical apparatus with a magnetic structure (such as a catheter with a magnetic structure, a guide wire, etc.), and the docking between other medical apparatuses and the stent graft 100 is completed by means of magnetic attraction. Of course, in other embodiments, the docking mode between the docking portion 32 and other medical devices may also be a structural shape mode, for example, a groove or a protrusion may be formed on the docking portion 32, and protrusions matching with the groove or grooves matching with the protrusions are correspondingly formed on other medical devices, so as to achieve docking between the docking portion 32 and other medical devices. In this embodiment, the docking portion 32 is made of a magnetic material, so that docking between the stent graft 100 and other medical devices is completed by means of magnetic attraction, so that docking efficiency can be effectively improved, docking difficulty is reduced, alignment is easier, and operation difficulty and operation time are better reduced.
Preferably, the docking portion 32 is circular arc-shaped, so that docking between the docking portion 32 and other medical devices is better facilitated. Specifically, in the present embodiment, the abutting portion 32 is semicircular. More preferably, the opening direction of the abutting portion 32 faces the direction close to the center of the stent graft body 10, that is, the abutting portion 32 is located at the side far from the center of the stent graft body 10, so that the abutting portion 32 does not block the normal circulation of blood inside the stent graft body 10.
Preferably, the docking device 30 is fixedly connected with the metal bracket 12 of the stent graft body 10, so that the connection fixing effect between the docking device 30 and the stent graft body 10 can be further ensured, and the connection stability is better ensured. Specifically, in this embodiment, the outer sleeve 311 is fixedly connected to the metal bracket 12 at the end of the stent graft body 10.
Preferably, the docking device 30 is provided with a heparin coating, and the docking device 30 is subjected to an anti-cell adhesion treatment, so that thrombus formation and endothelial ingrowth can be prevented as long as possible.
Preferably, the coated stent 100 is coated with a silver nitrate drug coating, so that sterilization of the coated stent 100 during initial implantation can be improved. It is understood that existing drug coating techniques are used for antiproliferative drugs to prevent intimal hyperplasia in stents. In this embodiment, silver nitrate, which is a sterilizing agent, is used as a coating layer in the stent graft 100, so that the stent graft is safer and more effective, and the anti-infection capability is better ensured.
In this embodiment, two docking devices 30 are provided at the end of the stent graft body 10. Of course, in other embodiments, the number of the docking devices 30 may be greater, and a plurality of the docking devices 30 may be distributed in an annular array at one end of the stent graft body 10 according to actual needs. Even in some embodiments, the docking device 30 may be disposed at two ends of the stent graft body 10, and may be selected according to actual requirements.
The stent graft 100 provided in this embodiment is provided with the drug storage device 20 and the docking device 30, and the drug storage device 20 and the docking device 30 may be used for reperfusion of the antibacterial drug during long-term infection. The drug filling interface is a long-term interface (i.e. the docking device 30) special for the intra-cavity stent, the drug storage device 20 forms a network shape at the inner layer and the outer layer of the covered stent body 10, and can comprehensively provide an antibacterial drug spraying tank around the stent. This allows for easier infusion of sensitive antibiotics after docking of the stent graft 100 with the docking device 30 via the catheter guidewire (magnetically) if infection occurs at a long time, greatly improving the anti-infective ability of the stent graft 100. And solves the problem that the surrounding (such as the mediastinum) of the covered stent 100 is difficult to effectively resist infection at the deep anatomical part. Meanwhile, the problem that different antibiotics are needed for different bacterial infections is solved conveniently, and sensitive antibiotics can be poured according to the culture result, so that deep administration can be completed rapidly.
The docking device 30 can be used for a docking access portal with a small size that does not affect the structural stability of the stent graft body 10, nor the risk of thrombus formation at a long time. Through the inlet, convenient catheter guide wire operation (such as feeding materials such as spring rings and tissue glue between the outer layer of the aortic stent graft and the inner layer of the autologous blood vessel to prevent leakage in long term) can be performed between the stent graft body 10 and the blood vessel wall and in the cavity of the stent graft body 10. Or the outer layer of the bracket for long-term infection is used for the perfusion of antibacterial drugs and the like. For small-sized stents, anticoagulant or anti-intimal hyperplasia drugs can be infused into the inner layer of the stent. That is, in one embodiment, some of the docking devices 30 may not be connected to the drug storage device 20 among the plurality of docking devices 30.
The docking device 30 provided in this embodiment has the interface tube 312, where the interface tube 312 is a Y-shaped tube, one tube after bifurcation is led into the stent graft body 10, and the other tube is led into a gap between the outside of the stent graft body 10 and the vessel wall. The lower half part (before bifurcation) of the Y-shaped pipe is communicated with the outer sleeve 311, and the pipe orifice is positioned at the tail end of the abutting part 32. When the catheter with the opposite magnetic pole is connected with the butt joint part 32, the catheter port is accurately matched with the outer port of the interface tube 312. The guide wire can be introduced into the Y-shaped tube through the catheter, and the catheter is followed, and whether the guide wire enters the stent or is out of the stent is selected for further treatment under perspective.
It can be appreciated that, in the prior art, re-intervention on the implanted stent graft is difficult, time-consuming, expensive and may not achieve a satisfactory effect, while the stent graft 100 provided in this embodiment can effectively reduce the docking difficulty, thereby reducing the operation difficulty and time-consuming, facilitating long-term re-endoluminal operation intervention, and reducing the trauma and cost of re-operation intervention. In addition, the stent graft cannot be placed in the prior art for infection lesions, bypass and drainage can only be performed for long-term infection of the stent graft by systemic antibiotic treatment or open surgery, so that the wound is huge, and the stent graft 100 provided by the embodiment can serve as an interface device for administration in a long term. Meanwhile, the probability of middle-long term restenosis and occlusion is high in the small-diameter stent graft for peripheral artery in the prior art, and the stent graft intervention can only be performed once again in the later period, so that the current anticoagulation and anti-intimal hyperplasia drugs can not provide long-term smooth guarantee for the stent graft, and an interface device capable of performing drug delivery in the long term is also needed, and the stent graft 100 provided in this embodiment can perfectly solve the above problems.
Because the probability of long-term re-operation of endovascular treatments increases as a number of endovascular procedures proceed, the efficiency of re-intervention procedures needs to be increased with the assistance of new concepts, technological and instrument innovations. The stent graft 100 provided in this embodiment is a concept of reserving a long-term access hole in an in-vivo stent, and the stent graft 100 is convenient for the magnetic navigation "connection" technology of an endoluminal catheter guide wire, and is convenient for docking to perform interventional operation and drug administration operation.
While the invention has been described with respect to the above embodiments, it should be noted that modifications can be made by those skilled in the art without departing from the inventive concept, and these are all within the scope of the invention.