Covered stent and medical instrument assembly

Abstract

The invention discloses a covered stent and a medical instrument assembly. The covered stent comprises a stent body, an outer-layer covering film and an inner-layer covering film. The stent is of a hollow structure and comprises a covered section and a bare section which are communicated with each other. The outer layer covering film is arranged in the circumferential direction of the outer side of the covering film section and extends in the axial direction of the covering film section. The inner-layer covering film is arranged in the circumferential direction of the inner side of the covering film section and extends in the axial direction of the covering film section; the end, close to the bare section, of the inner-layer covering film is connected with the end, close to the bare section, of the outer-layer covering film in a sealed mode, and an adjusting cavity with an opening is formed between the inner-layer covering film and the outer-layer covering film. And the ductility of the outer-layer covering film is smaller than that of the inner-layer covering film. By injecting and extracting a medium into and from the adjusting cavity, the inner-layer covering film can move under the influence of the pressure of the medium, and deformation of the outer-layer covering film is reduced. When the covered stent is applied to connection of portal veins and hepatic veins of the liver, in the deformation process of the inner-layer covering film, the outer-layer covering film can be basically unchanged, so that liver parenchyma can be protected to the maximum extent, and damage to the liver parenchyma is reduced.

Description

Technical Field

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

[0002] When the liver functions abnormally, such as in cirrhosis, the blood flowing from the portal vein is blocked when entering the liver and cannot enter the liver normally. Over time, the portal vein pressure increases, causing portal hypertension, which in turn leads to phenomena such as gastroesophageal varices.

[0003] Transjugular intrahepatic portosystemic shunt (Tips) uses special interventional treatment devices, such as covered stents, to establish an artificial shunt channel in the liver between the hepatic vein and the main branches of the portal vein through the jugular vein under X-ray fluoroscopy guidance. The metal inner stent of the covered stent maintains its permanent patency, achieving the effect of reducing portal hypertension, controlling and preventing esophageal varicose vein rupture and bleeding, and promoting ascites absorption.

[0004] During stent graft use, the diameter of the stent graft needs to be adjusted to accommodate varying blood flow conditions. Currently, as the stent graft expands or contracts, both the inner and outer diameters of the stent graft change to a certain degree. Expansion of the outer diameter of the stent graft can squeeze the liver parenchyma, while contraction of the outer diameter can cause the liver parenchyma to simultaneously return to its original shape, impacting the liver parenchyma over time.

[0005] Therefore, how to provide a covered stent that reduces the change in outer diameter during the change in inner diameter to reduce the impact on the liver parenchyma is a technical problem that needs to be urgently solved by those skilled in the art. Summary of the Invention

[0006] In view of this, the present invention provides a stent graft that reduces the change in outer diameter during the change in inner diameter to reduce the impact on the liver parenchyma. In addition, the present invention also provides a medical device assembly having the above-mentioned stent graft.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] A coated stent comprises: a stent, which is a hollow structure and cylindrical, and includes a connected coated section and a bare section along the axial direction of the stent; an outer coating, which is arranged on the outside of the coated section, and the outer coating is arranged along the circumferential direction of the outer side of the coated section, and extends along the axial direction of the coated section; an inner coating, which is arranged on the inner side of the coated section, and the inner coating is arranged along the circumferential direction of the inner side of the coated section, and extends along the axial direction of the coated section; one end of the inner coating close to the bare section is sealed with one end of the outer coating close to the bare section, and an adjustment cavity with an opening is formed between the inner coating and the outer coating; the elongation of the outer coating is less than that of the inner coating.

[0009] Preferably, in the above-mentioned coated stent, the inner layer coating is connected to the coated segment at one end close to the bare segment, and the outer layer coating is connected to the coated segment at one end close to the bare segment; or, the outer layer coating is connected to the inner layer coating through the hollow part of the coated segment.

[0010] Preferably, the above-mentioned coated bracket also includes: a middle layer coating, the middle layer coating is located on the inner side of the coated segment, and the outer layer coating and the middle layer coating wrap the coated segment; one end of the inner layer coating close to the bare segment is sealed connected to one end of the middle layer coating close to the bare segment, and one end of the middle layer coating close to the bare segment is sealed connected to the outer layer coating.

[0011] Preferably, in the above-mentioned stent graft, the regulating cavity includes a plurality of sub-cavities along the circumference of the coated segment, and one end of the sub-cavities close to the opening of the regulating cavity is communicated with the opening.

[0012] Preferably, in the above-mentioned stent graft, the sub-cavity includes a plurality of sub-cavities along the axial direction of the graft segment, and the sub-cavities are connected along the axial direction.

[0013] Preferably, in the above-mentioned coated stent, the material of the inner layer coating and the outer layer coating is at least one of memory alloy, expanded polytetrafluoroethylene and fluorinated ethylene propylene copolymer; and the radial size of the inner layer coating along the stent is smaller than the radial size of the outer layer coating along the stent.

[0014] Preferably, in the above-mentioned coated stent, the inner coating is made of elastic material.

[0015] Preferably, the above-mentioned stent graft further includes: a sensor, which is arranged at the bare segment and detects at least one of the blood pressure, blood flow and blood flow velocity of the blood flowing through the bare segment.

[0016] A medical device assembly includes a coated stent, wherein the coated stent is any of the coated stents described above.

[0017] Preferably, the above-mentioned medical device assembly further includes: a medium container, which is used to store the medium; a catheter, one end of which is sealed and connected to the opening of the regulating chamber, and the other end of the catheter is sealed and connected to the medium container.

[0018] Preferably, the above-mentioned medical device assembly further includes: a controller, the medium container is integrated with a power pump; the controller is communicatively connected to the sensor of the coated stent, and the controller is communicatively connected to the power pump of the medium container; when the sensor detects that the blood pressure value flowing through the bare segment of the coated stent is less than a first preset value, the controller controls the medium container to inject medium into the regulating cavity; when the sensor detects that the blood pressure value flowing through the bare segment of the coated stent is greater than a second preset value, the controller controls the medium container to extract medium into the regulating cavity; the first preset value is less than the second preset value.

[0019] Disclosed in an embodiment of the present invention is a coated stent, in which an outer coating is provided on the outside of the coated section, and an inner coating is provided on the inside, and the elongation of the inner coating is greater than that of the outer coating. In the process of injecting or extracting a medium into the regulating cavity formed between the two, the inner coating can be deformed to achieve the size adjustment of the inner diameter of the coated stent. By adjusting the inner diameter of the coated stent, the blood pressure, blood flow and blood flow velocity flowing through the coated stent can be adjusted, thereby slowing down or avoiding the occurrence of complications. The elongation of the inner coating is greater than that of the outer coating. Under the influence of the medium pressure, the deformation of the outer coating can be reduced during the movement of the inner coating. When the coated stent is applied to connect the portal vein and the hepatic vein of the liver, the outer coating can remain basically unchanged during the deformation of the inner coating, thereby maximally protecting the liver parenchyma and reducing damage to the liver parenchyma. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention 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 invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0021] Figure 1 This is a schematic diagram of the application of the covered stent disclosed in an embodiment of the present invention on the liver;

[0022] Figure 2A schematic structural diagram of a stent graft disclosed in an embodiment of the present invention;

[0023] Figure 3 for Figure 2 Cross-sectional view in the AA direction;

[0024] Figure 4 for Figure 2 Cross-sectional view in the middle BB direction;

[0025] Figure 5 This is a side cross-sectional view of the stent graft disclosed in an embodiment of the present invention after adjusting the filling medium in the lumen;

[0026] Figure 6 This is a front cross-sectional view of the stent graft disclosed in an embodiment of the present invention after adjusting the filling medium in the lumen;

[0027] Figure 7 A side cross-sectional view of another structure of the stent graft disclosed in an embodiment of the present invention;

[0028] Figure 8 for Figure 8 A side cross-sectional view of the middle stent graft after the adjustment cavity is filled with medium;

[0029] Figure 9 A front cross-sectional view of another structure of the stent graft disclosed in an embodiment of the present invention;

[0030] Figure 10 This is a schematic structural diagram of a medical device assembly disclosed in an embodiment of the present invention. DETAILED DESCRIPTION

[0031] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0032] In the following, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the quantity of the technical features indicated. Therefore, a feature specified as "first" or "second" may explicitly or implicitly include one or more of the features.

[0033] The portal vein, as the liver's input venous system, is a blood vessel connecting the liver and the gastrointestinal capillaries; the hepatic vein, as the liver's output venous system, is a blood vessel that transports blood metabolized by the liver to the inferior vena cava of the human body through the hepatic vein.

[0034] When the liver functions abnormally, such as in cirrhosis, the blood flowing from the portal vein is blocked when entering the liver and cannot enter the liver normally. Over time, the portal vein pressure increases, causing portal hypertension, which in turn leads to phenomena such as gastroesophageal varices.

[0035] To address this issue, a transjugular intrahepatic portosystemic shunt (TIPS) is needed. During the Tips procedure, clinicians access the hepatic vein via the jugular vein and use a puncture needle to create an artificial blood flow channel from the hepatic vein through the liver parenchyma into the portal vein. After the channel is expanded to an appropriate size, a covered stent is implanted to maintain patency, thereby diverting blood flow from the portal vein to lower portal blood pressure.

[0036] Tips surgery uses special interventional treatment devices, such as covered stents, under the guidance of X-ray fluoroscopy, through the jugular vein to establish an artificial shunt channel in the liver between the hepatic vein and the main branches of the portal vein, and maintains its permanent patency with the metal inner stent of the covered stent, so as to achieve the effect of controlling and preventing rupture and bleeding of esophageal varicose veins and promoting ascites absorption after reducing portal hypertension.

[0037] like Figure 1 As shown, the covered stent 100 is located in the liver parenchyma 200 and is used to connect the hepatic vein 201 and the portal vein 202 to maintain smooth blood flow between the hepatic and portal veins, thereby achieving the purpose of lowering the blood pressure of the portal vein 202.

[0038] Many solutions have been proposed in the prior art to adjust the diameter of the coated stent 100 to adapt to different blood flow conditions, but most of them are changes in the diameter of the coated stent 100. When the coated stent 100 expands or shrinks to change its diameter, the inner diameter and outer diameter of the coated stent 100 will change to a certain extent. The expansion of the outer diameter of the coated stent 100 will squeeze the liver parenchyma 200, and the reduction of the outer diameter of the coated stent 100 will drive the liver parenchyma 200 to synchronously return to its original state, which will have a certain impact on the liver parenchyma 200 over time.

[0039] To address the aforementioned technical issues, the stent graft 100 disclosed in the embodiments of this application has a constant outer diameter and a variable inner diameter. This variation in the inner diameter allows the diameter of the stent's artificial blood flow channel to be adjusted to accommodate varying blood flow rates. The stent's outer diameter remains constant, or changes only slightly, minimizing its impact on the liver parenchyma 200.

[0040] It should be noted that the range of the variation of the outer diameter of the stent body can be set as needed and is not specifically limited here.

[0041] The following is combined with Figure 2The specific structure of the stent graft 100 disclosed in the embodiment of the present application is described.

[0042] like Figure 2 The stent graft 100 shown includes a stent 10 and a graft 20. The stent 10 includes a graft segment 101 and a bare segment 102.

[0043] The bare segment 102 is located at the distal end of the coated segment 101 , and the bare segment 102 and the coated segment 101 are arranged along the axial direction of the coated segment 101 .

[0044] The directional terms "proximal" and "distal" used herein are defined from the perspective of an operator operating stent graft 100. That is, the end of stent graft 100 closest to the operator is the "proximal end," and the end farther from the operator is the "distal end." It should be understood that the use of these directional terms is solely for clarity in describing the technical solution and does not constitute a substantial limitation on the stent graft 100 for which protection is sought.

[0045] The coated segment 101 is located in the liver parenchyma 200 and serves as the main structure of the artificial blood flow channel; the bare segment 102 is arranged at the portal vein 202 for communicating with the portal vein 202 .

[0046] In some embodiments, the stent 10 is a hollow structure, the coated segment 101 includes but is not limited to a cylindrical structure, and the bare segment 102 is a structure that gradually spreads from the coated segment 101 to a direction away from the coated segment 101 .

[0047] like Figures 3 to 6 As shown, the coating 20 includes an outer coating 23 and an inner coating 24 .

[0048] The outer coating 23 covers the outer side of the coating section 101 , and the inner coating 24 is disposed on the inner side of the coating section 101 .

[0049] The outer coating 23 is arranged along the circumferential direction of the outer side of the coating segment 101 and extends along the axial direction of the coating segment 101, so that the outer surface of the coating segment 101 is wrapped by the outer coating 23. Specifically, the outer coating 23 fills the hollow structure of the coating segment 101; the inner coating 24 is arranged along the circumferential direction of the inner side of the coating segment 101 and extends along the axial direction of the coating segment 101, so that the inner side of the coating segment 101 is wrapped by the inner coating 24, and the outer coating 23 and the inner coating 24 are both tubular structures that are sealed along the circumferential direction.

[0050] Combine Figure 3 and Figure 4As shown, along the axial direction of the coating segment 101, one end of the outer coating 23 is sealedly connected to one end of the inner coating 24, forming a sealed connection end. The outer coating 23 and the inner coating 24 are bonded together, including but not limited to bonding. An opening 21 is formed between the other end of the outer coating 23 and the other end of the inner coating 24. A gap is radially defined between the outer coating 23 and the inner coating 24 between the opening 21 and the sealed connection end, which serves as an adjustment cavity 22. This can be understood as follows: one end of the outer coating 23 is sealedly connected to one end of the inner coating 24, while the other ends are not connected, resulting in the coating 20 forming a structure with an adjustment cavity 22 having an opening at one end.

[0051] The terms "inside" and "outside" are defined relative to the artificial blood channel formed by the stent graft 100, i.e., the area close to the artificial blood channel is inside, and the area away from the artificial blood channel is outside. Alternatively, the area close to the axis of the graft segment 101 is inside, and the area away from the axis of the graft segment 101 is outside.

[0052] The inner coating 24 forms an artificial blood channel, i.e., the inner side of the inner coating 24 (away from the outer coating 23) is in contact with blood. The regulating cavity 22 formed between the inner coating 24 and the outer coating 23 is filled with a medium. The filling medium includes, but is not limited to, gas or liquid. The gas includes, but is not limited to, air, and the liquid includes, but is not limited to, saline.

[0053] The elongation of the inner coating 24 disclosed in the embodiment of the present application is greater than that of the outer coating 23. Optionally, the elongation of the outer coating 23 is 0% to 5%, preferably 3%; the elongation of the inner coating 24 is 6% to 9%, preferably 8%.

[0054] The elongation of the inner coating 24 is greater than that of the outer coating 23 , so that the inner coating 24 is more easily deformed than the outer coating 23 .

[0055] Combine Figure 5 and Figure 6During the process of filling the adjustment cavity 22 with medium, under the action of the medium pressure, the inner coating 24 moves away from the outer coating 23, that is, the inner coating 24 moves closer to the axis of the stent graft 100, causing the inner circumference of the inner coating 24 to decrease, and the inner diameter of the artificial blood channel formed by the stent graft 100 to decrease. Due to the low elongation of the outer coating 23, the outer coating 23 can be kept essentially motionless. During the process of withdrawing the medium from the adjustment cavity 22, the inner coating 24 elastically deforms, moving closer to the outer coating 23, that is, moving away from the axis of the stent graft 100, causing the inner circumference of the inner coating 24 to increase, and the inner diameter of the artificial blood channel formed by the stent graft 100 to increase. Due to the low elongation of the outer coating 23, the outer coating 23 can be kept essentially motionless. This achieves the purpose of changing the inner diameter while keeping the outer diameter of the stent graft 100 essentially unchanged.

[0056] The elongation of the inner coating 24 disclosed in the embodiment of the present application is greater than that of the outer coating 23, so that the radial dimension of the outer coating 23 forming the outer diameter of the coated stent 100 remains basically unchanged, and the radial dimension of the inner coating 24 forming the inner diameter of the coated stent 100 is adjustable.

[0057] The disclosed coated stent 100 implemented in the present application has an outer coating 23 provided on the outside of the coated section 101 and an inner coating 24 provided on the inside, and the elongation of the inner coating 24 is greater than that of the outer coating 23. During the process of injecting or extracting the medium into the regulating cavity 22 formed between the two, the inner coating 24 can be deformed to achieve the size adjustment of the inner diameter of the coated stent 100. By adjusting the inner diameter of the coated stent 100, the blood pressure, blood flow and blood flow velocity at the portal vein 202 can be adjusted, thereby slowing down or avoiding the occurrence of complications. The elongation of the inner coating 24 is greater than that of the outer coating 23. Under the influence of the medium pressure, the deformation of the outer coating 23 can be reduced during the movement of the inner coating 24, which can maximize the protection of the liver parenchyma 200 and reduce damage to the liver parenchyma 200.

[0058] In some embodiments, the inner coating 24 can have a greater elongation than the outer coating 23 by having the outer coating 23 have a greater thickness than the inner coating 24. Optionally, the outer coating 23 has a thickness ranging from 75 μm to 90 μm, preferably 80 μm, and the inner coating 24 has a thickness ranging from 55 μm to 70 μm, preferably 60 μm.

[0059] In other optional embodiments, the elongation of the inner coating 24 is greater than the elongation of the outer coating 23 by: the elastic modulus of the inner coating 24 is smaller than the elastic modulus of the outer coating 23. The elastic modulus of the inner coating 24 is smaller than the elastic modulus of the outer coating 23, so that when the inner coating 24 and the outer coating 23 are subjected to the same external force, the elastic deformation of the inner coating 24 is greater than the elastic deformation of the outer coating 23.

[0060] Optionally, the elastic material of the inner coating 24 and the outer coating 23 includes a composite material, and the composite material specifically includes a membrane structure formed by processing at least one of unsintered expanded polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene copolymer (FEP). Expanded PTFE is a medical polymer material. Because unsintered expanded PTFE is not heated to the level of sintered expanded PTFE, unsintered expanded PTFE has better compliance and ductility than sintered expanded PTFE, that is, expanded PTFE has elasticity and flexibility. It should be noted that when the inner coating 24 and the outer coating 23 are made of the same composite material, the elastic properties of the inner coating 24 are higher than those of the outer coating 23.

[0061] The inner coating 24 is made of elastic material, which can increase the space that can be filled with medium in the adjustment cavity 22 and increase the amplitude of the change in the inner diameter of the blood channel of the coated stent 100. The outer coating 23 is made of elastic material to facilitate the placement of the coated stent 100 in the corresponding position during the operation.

[0062] In some embodiments, the inner coating 24 is made of an elastic material, and the outer coating 23 is made of a plastic material. Optionally, the inner coating 24 includes, but is not limited to, an elastic or superelastic material (eg, shape memory alloy), and the outer coating 23 is made of silicone.

[0063] It should be noted that the material of the inner coating 24 and the material of the outer coating 23 can be set according to different needs. The two can be the same material or different materials. When the two are the same material, the thickness of the inner coating 24 (the radial dimension along the coating section 101) is smaller than the dimension of the outer coating 23.

[0064] like Figure 3 As shown, the outer coating 23 is attached to the outer periphery of the coating segment 101 . The connection between the outer coating 23 and the coating segment 101 can prevent the outer coating 23 from moving during the process of filling and extracting the medium into the regulating cavity 22 .

[0065] When the medium enters the adjustment cavity 22, the pressure of the medium can only move the inner coating 24 closer to the axis of the coated stent 100, and cannot move the outer coating 23 away from the axis of the coated stent 100 synchronously, thereby achieving a fixed outer diameter and adjustable inner diameter of the coated stent 100.

[0066] The material of the stent 10 includes, but is not limited to, metal materials, such as stainless steel, L605 steel, polymers, MP35N steel, stainless steel, polymer materials, cobalt, chromium, and nickel alloys. In some embodiments, the stent 10 may also be a polymer material, such as polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE); in other optional embodiments, the stent 10 may also be a biodegradable material, such as polylactic-co-glycolic acid (PLGA) or polylactic acid (PLA). Of course, the stent 10 may be a combination of the above materials. It should be noted that when the above materials are mixed, there is no chemical reaction between them. It can be understood that the stent 10 can be composed of a combination of structures formed by the above materials.

[0067] In some embodiments, both the outer coating 23 and the inner coating 24 are tubular membrane structures, and when connected, the adjustment cavity 22 is formed into an annular cavity. It should be noted that the annular arrangement of the adjustment cavity 22 allows for uniform changes in the overall amplitude of the inner coating 24 during the process of filling and withdrawing the medium from the adjustment cavity 22, thereby further reducing complications that may occur to the human body during the use of the stent graft 100.

[0068] In some possible embodiments, the coating 20 may also include a middle layer coating (not shown in the figure), and the middle layer coating covers the inner circle of the coating segment 101. Optionally, the middle layer coating and the inner circle of the coating segment 101 include but are not limited to being fitted together, and the outer layer coating 23 and the outer circle of the coating segment 101 include but are not limited to being fitted together, and the middle layer coating and the outer layer coating 23 wrap the stent 10 between the two.

[0069] The inner coating 24 is sealed to one end of the middle coating along the axial direction, and the other end forms the opening 21 . An adjustment cavity 22 is formed between the inner coating 24 and the middle coating, and the adjustment cavity 22 is communicated with the opening 21 .

[0070] Optionally, the elongation of the middle layer coating is smaller than that of the inner layer coating 24 , and the thickness of the middle layer coating is greater than that of the inner layer coating 24 .

[0071] During the process of filling and extracting the medium into the adjustment cavity 22 , the inner coating 24 can be moved relative to the axis of the stent graft 100 , but the middle coating cannot be moved relative to the axis of the stent graft 100 .

[0072] In summary, the inner coating 24 of the coated stent 100 disclosed in the embodiment of the present application is sealedly connected to the outer coating 23 at one axial end, and an adjustment cavity 22 with an opening 21 is formed between the inner coating 24 and the outer coating 23 at the other axial end.

[0073] Combine Figure 7 and Figure 8As shown, in other optional embodiments, the regulating chamber 22 is divided into a plurality of sub-cavities 221 along the circumferential direction, and is arranged at equal intervals along the circumference of the coating segment 101, including but not limited to. The proximal ends of all sub-cavities 221 are connected. It should be noted that there is an adhesive layer 25 extending along the axis of the coating segment 101 between the inner coating 24 and the outer coating 23, and the adhesive layer 25 bonds the inner coating 24 and the outer coating 23; and multiple adhesive layers 25 are arranged along the circumference of the coating segment 101. The inner coating 24 and the outer coating 23 are bonded by the adhesive layer 25, so that the coating segment 101 has multiple sub-cavities 221 in the circumferential direction. By changing the size of the adhesive layer 25 along the axial direction of the coating segment 101, the position where adjacent sub-cavities 221 are connected can be changed. The adhesive layer 25 is formed of adhesive glue.

[0074] The sub-cavities 221 are arranged at equal intervals, which helps to disperse blood pressure and ensure smooth blood flow. In addition, the proximal ends of the multiple sub-cavities 221 are connected, which can ensure that the circumferential deformation of the inner layer 24 is as consistent as possible during the process of simultaneously filling or extracting medium from multiple sub-cavities 221, and can also improve the efficiency of filling the regulating cavity 22 with medium.

[0075] Those skilled in the art will understand that the adhesive layer 25 arranged circumferentially between the inner coating 24 and the outer coating 23 can be arranged evenly or unevenly. A uniform arrangement of multiple adhesive layers 25 can form multiple sub-cavities 221 of equal volume, where the sub-cavities 221 of equal volume have the same circumferential cross-sectional area. An uneven arrangement of the adhesive layer 25 can form multiple sub-cavities 221 of different volumes, where the sub-cavities 221 of different volumes have different circumferential cross-sectional areas. Furthermore, the adhesive layer 25 can be tilted or bent along the axis of the coating segment 101 to form sub-cavities 221 of different cross-sectional areas. Those skilled in the art can select the arrangement of the adhesive layer 25 according to different usage scenarios, and all are within the scope of protection.

[0076] The number of the sub-cavities 221 can be set as required. In one application scenario, the multiple sub-cavities 221 are symmetrically arranged about the center of the stent 10 .

[0077] On the basis of the above technical solution, the sub-cavity 221 includes a plurality of sub-cavities 222 along the axial direction of the coating segment 101 , and the sub-cavities 222 are sequentially connected along the axial direction.

[0078] It should be noted that the sub-cavity 221 is provided with multiple sub-cavities 222, which facilitates effective control of blood flow after the sub-cavity 221 is expanded, while also ensuring the service life of the stent graft 100. The sub-cavities 222 are arranged in the same direction as the blood flow, and the outer walls of the sub-cavities 222 come into contact with the blood as the blood passes through the stent graft 100. This contact process can slow the blood flow rate, thereby regulating the blood flow rate and reducing or even eliminating the occurrence of complications during the use of the stent graft 100.

[0079] In an optional embodiment, the sub-cavities 222 in adjacent sub-cavities 221 are arranged circumferentially staggered. It should be noted that the sub-cavities 222 in adjacent sub-cavities 221 are arranged circumferentially staggered to achieve multi-dimensional regulation of blood flow velocity and slow down blood flow velocity.

[0080] like Figure 10 As shown, the coated support 100 also includes a sensor 30.

[0081] The sensor 30 is disposed on the inner wall of the bare segment 102 on the side close to the axis of the coated stent 100 and is used to collect at least one of the blood pressure, blood flow and blood flow velocity at the portal vein 202 .

[0082] By monitoring blood pressure, blood flow, and / or blood flow velocity through sensor 30, information such as blood pressure, blood flow, and blood flow velocity can be obtained in real time, facilitating adjustment of the radial dimension of the inner diameter of regulating cavity 22. Furthermore, based on the blood parameters detected by sensor 30, other complications caused by excessive blood pressure in portal vein 202, which could affect the patient's health, can be avoided.

[0083] It should be noted that blood pressure, blood flow, and blood velocity all reflect the blood pressure at portal vein 202, and their determination logic is the same, allowing for cross-reference. The following description uses sensor 30 used to monitor blood pressure at portal vein 202 as an example. When sensor 30 is used to monitor blood flow or blood velocity at portal vein 202, please refer to the following description and will not be further elaborated herein.

[0084] When the sensor 30 is used to monitor the blood pressure at the portal vein 202 , the sensor 30 on the bare segment 102 is configured to have a first preset threshold value and a second preset threshold value.

[0085] When the first preset threshold is smaller than the second preset threshold and the sensor 30 detects that the blood pressure value at the portal vein 202 is outside the first preset threshold and the second preset threshold, the sensor 30 sends a signal.

[0086] The sensor 30 operates as follows: It monitors the real-time blood pressure at the portal vein 202 and issues a signal when the blood pressure detected by the sensor 30 is less than a first preset threshold or when the blood pressure detected by the sensor 30 is greater than a second preset threshold. Specifically, when the blood pressure detected by the sensor 30 is less than the first preset threshold, the medium is injected into the regulating chamber 22; when the blood pressure detected by the sensor 40 is greater than the second preset threshold, the medium is withdrawn from the regulating chamber 22.

[0087] The coated stent 100 adjusts the filling or retraction of the regulating cavity 22 by controlling the injection and extraction volume of the filling medium, thereby adjusting the inner diameter of the coated section 101. This technical means can not only solve the clinical discomfort symptoms caused by high pressure in the portal vein 202, but also minimize the incidence of complications such as hepatic encephalopathy after TIPS surgery, so that more patients can benefit.

[0088] The setting ranges of the first and second preset thresholds set by sensor 30 are determined by the patient's clinical symptoms. Typically, the first preset threshold can be 5 mmHg, and the second preset threshold can be 10 mmHg. When the portal vein blood pressure is less than 5 mmHg, the medium is injected into the regulating chamber 22; when the portal vein blood pressure is greater than 10 mmHg, the medium is withdrawn from the regulating chamber 22.

[0089] In addition, an embodiment of the present application also discloses a medical device assembly, including a coated stent 100, and the coated stent 100 is the coated stent 100 disclosed in the above embodiment. Therefore, the medical device assembly with the coated stent 100 also has all the above technical effects, which will not be repeated here.

[0090] like Figure 10 The illustrated medical device assembly further includes a medium container 300 and a controller 400 .

[0091] Among them, the medium container 300 is used to accommodate the medium required in the regulating cavity 22. The outlet of the medium container 300 is sealed and connected to the opening 21 through the catheter 301, so that the medium in the medium container 300 can enter the regulating cavity 22 of the coated bracket 100 through the catheter 301, and the medium in the regulating cavity 22 can flow back to the medium container 300 through the catheter 301.

[0092] In some embodiments, the medium container 300 is a transfusion port, which is detachably connected to the catheter 301. The transfusion tube can be buried and fixed subcutaneously. Transfusion ports have good tissue compatibility, antioxidant properties, and solubility resistance, and are therefore preferred.

[0093] In some embodiments, the sensor 30 of the coated support 100 can be connected to the medium container 300 through the controller 400. Specifically, the sensor 30 is communicatively connected to the controller 400, a power pump is integrated in the medium container 300, and the controller 400 is communicatively connected to the power pump of the medium container 300.

[0094] When the blood pressure monitored by the sensor 30 is less than the first preset threshold, the sensor 30 sends a first signal. After receiving the first signal, the controller 400 controls the power pump of the medium container 300 to inject the medium into the regulating chamber 22. During the medium injection process, the inner layer coating 24 moves inward, reducing the inner diameter of the coated stent 100 to increase the blood flow rate, thereby increasing the blood pressure in the coated stent 100.

[0095] When the blood pressure monitored by the sensor 30 is greater than the second preset threshold, the sensor 30 sends a second signal. After receiving the second signal, the controller 400 controls the power pump of the medium container 300 to extract the medium into the regulating chamber 22. During the medium injection process, the inner layer coating 24 moves outward, increasing the inner diameter of the coated stent 100 to reduce the blood flow rate and thereby reduce the blood pressure in the coated stent 100.

[0096] Of course, the present application is not limited to controlling the medium container 300 to inject and extract the medium into the regulating chamber 22 through the controller 400. The medium container 300 can also be manually controlled by the operator to inject and extract the medium into the regulating chamber 22. For example, the operator can provide the medium container 300 with power to inject the medium into the regulating chamber 22 by pushing the syringe, and provide the medium container 300 with power to extract the medium into the regulating chamber 22 by pulling the syringe.

[0097] In some embodiments, the above-mentioned medical device assembly is used in Tips surgery.

[0098] The Tips surgical components include a catheter delivery system, a puncture kit, and a covered stent 100. The specific process of the Tips surgery is as follows: the catheter delivery system first reaches the target location via the jugular vein, then delivers the puncture needle and puncture catheter in the puncture kit to the target location, finds a suitable angle to puncture the hepatic vein, and establishes a blood pathway between the hepatic vein and the portal vein. This pathway is then dilated with a balloon, and the covered stent 100 is then delivered to this pathway to complete the implantation of the covered stent 100. The covered stent 100 directly penetrates the hepatic vein and portal vein, alleviating or relieving symptoms such as portal hypertension and gastroesophageal varices.

[0099] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0100] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A stent graft, characterized in that: include: A stent (10), the stent (10) being a hollow structure and cylindrical in shape, comprising a connected coated section (101) and a bare section (102) along the axial direction of the stent (10); An outer coating (23), the outer coating (23) being arranged on the outer side of the coating section (101), the outer coating (23) being arranged along the circumferential direction of the outer side of the coating section (101) and extending along the axial direction of the coating section (101); An inner coating (24), the inner coating (24) being arranged on the inner side of the coating section (101), and the inner coating (24) being arranged along the circumferential direction of the inner side of the coating section (101) and extending along the axial direction of the coating section (101); an end of the inner coating close to the bare section (102) is sealedly connected to an end of the outer coating (23) close to the bare section (102), and an adjustment cavity (22) having an opening (21) is formed between the inner coating and the outer coating (23); The elongation of the outer coating (23) is smaller than the elongation of the inner coating (24).

2. The stent graft according to claim 1, wherein: One end of the inner layer coating (24) close to the bare section (102) is connected to the coating section (101), and one end of the outer layer coating (23) close to the bare section (102) is connected to the coating section (101); or, The outer coating (23) is connected to the inner coating (24) through the hollow portion of the coating section (101).

3. The stent graft according to claim 1, wherein: Also includes: a middle layer of film, the middle layer of film being located inside the film section (101), the outer layer of film (23) and the middle layer of film wrapping the film section (101); One end of the inner layer coating (24) close to the bare section (102) is sealed to one end of the middle layer coating close to the bare section (102), and one end of the middle layer coating close to the bare section (102) is sealed to the outer layer coating (23).

4. The stent graft according to any one of claims 1 to 3, characterized in that: The regulating cavity (22) comprises a plurality of sub-cavities (221) along the circumference of the coating section (101), and one end of each of the sub-cavities (221) close to the opening (21) of the regulating cavity (22) is communicated with the opening (21).

5. The stent graft according to claim 4, characterized in that: The sub-cavity (221) includes a plurality of sub-cavities (222) along the axial direction of the coating section (101), and the sub-cavities (222) are connected along the axial direction.

6. The stent graft according to any one of claims 1 to 4, characterized in that: The material of the inner layer coating (24) and the outer layer coating (23) is at least one of memory alloy, expanded polytetrafluoroethylene and fluorinated ethylene propylene copolymer; Furthermore, the radial dimension of the inner coating (24) along the stent (10) is smaller than the radial dimension of the outer coating (23) along the stent (10).

7. The stent graft according to any one of claims 1 to 4, characterized in that: The inner coating (24) is made of elastic material.

8. The stent graft according to any one of claims 1 to 4, characterized in that: Also includes: A sensor (30) is provided on the bare segment (102) and detects at least one of the blood pressure, blood flow and blood flow velocity of the blood flowing through the bare segment (102).

9. A medical device assembly comprising a stent graft (100), characterized in that: The stent graft (100) is the stent graft (100) according to any one of claims 1 to 8.

10. The medical device assembly according to claim 9, wherein: Also includes: A medium container (300), the medium container (300) is used to store a medium; A conduit (301), one end of which is in sealed communication with the opening (21) of the regulating chamber (22), and the other end of which is in sealed communication with the medium container (300).

11. The medical device assembly according to claim 10, wherein: Also includes: A controller (400), wherein the medium container (300) is integrated with a power pump; The controller (400) is in communication connection with the sensor (30) of the stent graft (100), and the controller (400) is in communication connection with the power pump of the medium container (300); When the sensor (30) detects that the blood pressure value flowing through the bare section (102) of the coated stent (100) is less than a first preset value, the controller (400) controls the medium container (300) to inject the medium into the regulating cavity (22); when the sensor (30) detects that the blood pressure value flowing through the bare section (102) of the coated stent (100) is greater than a second preset value, the controller (400) controls the medium container (300) to extract the medium into the regulating cavity (22); The first preset value is smaller than the second preset value.

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