Degradable covered bifurcated stent

Abstract

The invention provides a degradable film-covered bifurcated stent, and belongs to the technical field of medical instruments, the degradable film-covered bifurcated stent comprises a main stent, a corrugated bent stent, a side stent and a film, the corrugated bent stent is arranged on the side face of the main stent in a penetrating mode, and the end of the corrugated bent stent is connected with the side stent; covering films are fixedly arranged on the outer side surfaces of the main stent, the corrugated bent stent and the side stents; by arranging the side stent, the side stent is branched from the main stent and can accurately correspond to a pulmonary artery branch, and when the main stent is installed in a pulmonary artery, the angle between the side stent and the main stent is adjusted through the corrugated bent stent according to the position of the pulmonary artery branch of a patient, so that the side stent extends into the pulmonary artery; the main stent and the side stent are better attached to the blood vessel, the treatment accuracy is improved, the blood flow of the branch blood vessel is not affected, and the influence on the normal blood vessel is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a degradable film-covered bifurcated stent. Background Art

[0002] Pulmonary artery stenosis is a disease that may exist congenitally or be caused by acquired factors. If the pulmonary artery stenosis is not treated in time, patients may face a series of serious consequences such as pulmonary hypertension, impaired cardiac systolic and diastolic functions, etc. Although balloon angioplasty has certain curative effects, it often leads to restenosis of blood vessels due to elastic recoil of the blood vessel wall and external compression. To solve this problem, pulmonary artery stent implantation came into being, and the application of this technology has significantly reduced the occurrence of restenosis events, thus improving the treatment effect.

[0003] Stent types:

[0004] 1. Self-expanding stent: Mostly made of nitinol alloy, it can be compressed to a very small volume, quickly restore its original shape after release, can be delivered with a smaller sheath tube, and has magnetic compatibility. However, it has problems such as severe intimal hyperplasia in the stent, high restenosis rate, and lack of expandability of diameter, and is not widely used in the treatment of pulmonary artery stenosis.

[0005] 2. Balloon-expandable stent: It can be implanted manually or pre-mounted on a balloon, and is placed in the blood vessel stenosis area through balloon dilation. The diameter is determined by the size of the dilating balloon;

[0006] Whether it is a self-expanding stent or a balloon-expandable stent, there is a possibility of restenosis. Restenosis occurs in the stent due to reasons such as vascular endothelial hyperplasia and thrombosis. Moreover, as a foreign body implanted in the body, the metal stent may cause immune responses and inflammatory responses of the body, affect the normal function of vascular endothelial cells, increase the probability of thrombosis and restenosis. Although some biodegradable stents have certain advantages in biocompatibility, they have problems such as poor mechanical strength and possible local inflammation caused by degradation products. After the metal stent is inserted into the pulmonary artery, it will affect the blood flow of the pulmonary artery branches and affect the normal blood flow. Therefore, a degradable film-covered bifurcated stent is designed to solve the above problems. Summary of the Invention

[0007] The purpose of the present invention is to solve the problems existing in the above background art, and to propose a degradable film-covered bifurcated stent.

[0008] The technical problem to be solved by the present invention is to provide a degradable film-covered bifurcated stent to solve the problem that after the metal stent is inserted into the pulmonary artery, it will affect the blood flow of the pulmonary artery branches and affect the normal blood flow.

[0009] The present invention provides a degradable film-covered bifurcated stent, which includes a main stent, a corrugated curved stent, a side stent and a film. A corrugated curved stent is disposed through the side surface of the main stent. The end of the corrugated curved stent is connected to a side stent. The outer surfaces of the main stent, the corrugated curved stent and the side stent are all fixedly provided with a film.

[0010] Preferably, the main stent, the corrugated curved stent and the side stent are all self-expanding stents, and the film has ductility.

[0011] Preferably, the metal keels of the main stent, the corrugated curved stent and the side stent are all made of degradable metal materials.

[0012] Preferably, the degradable metal material is one or more of degradable magnesium alloy, degradable iron alloy and degradable zinc alloy.

[0013] Preferably, the film is made of a degradable polymer material.

[0014] Preferably, the degradable polymer material is one or more of polylactic acid (PLA), polycaprolactone (PLC) and polyglycolide (PGA).

[0015] Preferably, the main stent, the corrugated curved stent, the side stent and the film are covered with the film by means of suture, sintering, lamination or fusion.

[0016] Preferably, the diameter of the main stent is 0.5 - 3 cm, and the length of the side stent is 2 - 5 cm.

[0017] Preferably, the diameter of the side stent is 0.3 - 2 cm, and the length of the side stent is 1 - 3 cm.

[0018] Preferably, the angle formed by the main stent and the side stent is 30 - 150°.

[0019] Preferably, a radiopaque marker is provided at the cross connection of the metal keels of the main stent and the side stent.

[0020] Compared with the prior art, the present invention has at least the following beneficial effects:

[0021] 1. By providing a film, the film can effectively prevent vascular endothelial hyperplasia and avoid vascular restenosis. At the same time, for patients with the invasion or rupture of the lower pulmonary artery, the pulmonary artery can be isolated to control pulmonary artery bleeding.

[0022] 2. The present invention is provided with side brackets, which branch out from the main bracket and can accurately correspond to the pulmonary artery branches. When the main bracket is installed in the pulmonary artery, according to the position of the patient's pulmonary artery branches, the angle between the side bracket and the main bracket is adjusted through the corrugated bending bracket, so that the side bracket extends in, enabling the main bracket and the side bracket to better fit the blood vessel, improving the treatment accuracy, not affecting the blood flow of the branch vessels, and reducing the impact on normal blood vessels.

[0023] 3. The metal skeleton of the covered bifurcated stent of the present invention is a biodegradable metal material, which is one or more of magnesium alloy, iron alloy, and zinc alloy. It has good tissue compatibility and can provide sufficient mechanical support in the early stage of implantation; it has biodegradability, and the degradation products are safe and harmless to the human body; the covering material is one or more of polylactic acid (PLA), polycaprolactone (PLC), and polyglycolide (PGA), which has good biocompatibility and can be naturally degraded in the human body. Therefore, it has more advantages in medical scenarios related to pediatric lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, the elements or parts are not necessarily drawn to scale.

[0025] Figure 1 Schematic three-dimensional view of the overall structure of the present invention Figure 1 .

[0026] Figure 2 Schematic cross-sectional view of the overall structure of the present invention.

[0027] Figure 3 For the present invention Figure 2 Schematic enlarged view of the structure at A.

[0028] Figure 4 Schematic three-dimensional view of the structure of the present invention Figure 2 .

[0029] [Reference Numerals]

[0030] 1. Main bracket; 2. Corrugated bending bracket; 3. Side bracket; 4. Covering; 5. Radiopaque marker.

[0031] As shown in the figure, in order to clearly show the structure of the embodiments of the present invention, specific structures and devices are marked in the figure, but this is only for schematic purposes and is not intended to limit the present invention to this specific structure, device, and environment. Those of ordinary skill in the art can adjust or modify these devices and environments according to specific needs. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0032] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts shall fall within the protection scope of the present invention.

[0033] In the description of the present invention, it should be understood that the orientation or positional relationships indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc. are based on the orientation or positional relationships shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present invention.

[0034] Embodiment:

[0035] As Figures 1-4 shown, an embodiment of the present invention provides a degradable film-covered bifurcated stent, which includes a main stent 1, a corrugated curved stent 2, a side stent 3 and a film 4. The side surface of the main stent 1 is penetrated with the corrugated curved stent 2, and the end of the corrugated curved stent 2 is connected with the side stent 3. The outer surfaces of the main stent 1, the corrugated curved stent 2 and the side stent 3 are all fixedly provided with the film 4.

[0036] By providing the film 4, the film can effectively prevent vascular endothelial hyperplasia and avoid vascular restenosis; at the same time, for patients with the invasion or rupture of the lower pulmonary artery, the pulmonary artery can be isolated to control pulmonary artery bleeding;

[0037] By providing the side stent 3, the side stent 3 branches out from the main stent 1, which can accurately correspond to the pulmonary artery branches. When the main stent 1 is installed in the pulmonary artery, according to the position of the patient's pulmonary artery branches, the angle between the side stent 3 and the main stent 1 is adjusted through the corrugated curved stent, so that the side stent extends in, making the main stent 1 and the side stent 3 better fit the blood vessel, improving the treatment accuracy, not affecting the blood flow of the branch blood vessels, and reducing the impact on the normal blood vessels.

[0038] In this embodiment, the main stent 1, the corrugated curved stent 2 and the side stent 3 are all self-expanding stents, and the film 4 has ductility, which is convenient for the expansion of the main stent 1, the corrugated curved stent 2 and the side stent 3.

[0039] In this embodiment, the metal keels of the main stent 1, the corrugated bending stent 2, and the side stent 3 are all made of degradable metal materials, and the main stent 1, the corrugated bending stent 2, and the side stent 3 can be degraded within the patient's blood vessels.

[0040] In this embodiment, the degradable metal material is one or more of degradable magnesium alloy, degradable iron alloy, and degradable zinc alloy, which has good tissue compatibility and can provide sufficient mechanical support in the early stage of implantation; it has biodegradability, and the degradation products are safe and harmless to the human body.

[0041] In this embodiment, the film 4 is made of degradable polymer material.

[0042] In this embodiment, the degradable polymer material is one or more of polylactic acid (PLA), polycaprolactone (PLC), and polyglycolic acid (PGA), which has good biocompatibility and can be naturally degraded in the human body. Therefore, it has more advantages in medical scenarios related to pediatric lesions.

[0043] The metal skeleton of the film-covered bifurcated stent of the present invention is a degradable metal material, one or more of magnesium alloy, iron alloy, and zinc alloy, which has good tissue compatibility and can provide sufficient mechanical support in the early stage of implantation; it has biodegradability, and the degradation products are safe and harmless to the human body; the film material is one or more of polylactic acid (PLA), polycaprolactone (PLC), and polyglycolic acid (PGA), which has good biocompatibility and can be naturally degraded in the human body. Therefore, it has more advantages in medical scenarios related to pediatric lesions.

[0044] In this embodiment, the main stent 1, the corrugated bending stent 2, the side stent 3 and the film 4 are covered with the film by suture, sintering, lamination or fusion.

[0045] In this embodiment, the diameter of the main stent 1 is 0.5 - 3 cm, and the length of the main stent 1 is 2 - 5 cm.

[0046] In this embodiment, the diameter of the side stent 3 is 0.3 - 2 cm, and the length of the side stent 3 is 1 - 3 cm.

[0047] In this embodiment, the angle formed by the main stent 1 and the side stent 3 is 30 - 150°.

[0048] In this embodiment, a radiopaque point 5 is provided at the cross connection of the metal keels of the main stent 1 and the side stent 3. By providing the radiopaque point 5, it is convenient to observe and locate the positions of the main stent 1 and the side stent 3.

[0049] The present invention encompasses any alternatives, modifications, equivalent methods, and solutions that are made within the spirit and scope of the present invention. To enable the public to have a thorough understanding of the present invention, specific details are described in detail in the following preferred embodiments of the present invention. However, those skilled in the art can fully understand the present invention even without the description of these details. Additionally, well-known methods, processes, procedures, components, and circuits are not described in detail to avoid unnecessary confusion with the essence of the present invention.

[0050] The above description is only a preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A biodegradable coated bifurcated stent, characterized in that: The invention comprises a main support (1), a corrugated curved support (2), a side support (3) and a coating (4); the side of the main support (1) is penetrated by the corrugated curved support (2); the end of the corrugated curved support (2) is connected to the side support (3); and the outer surfaces of the main support (1), the corrugated curved support (2) and the side support (3) are all fixedly provided with a coating (4).

2. The degradable coated bifurcation stent according to claim 1, characterized in that: The main stent (1), the corrugated bending stent (2), and the side stent (3) are all self-expanding stents, and the coating (4) has ductility.

3. The degradable coated bifurcation stent according to claim 2, characterized in that: The metal keels of the main support (1), the corrugated curved support (2) and the side support (3) are all made of degradable metal materials.

4. The degradable coated bifurcation stent according to claim 3, characterized in that: The degradable metal material is one or more of a degradable magnesium alloy, a degradable iron alloy, and a degradable zinc alloy.

5. The degradable coated bifurcation stent according to claim 2, characterized in that: The coating (4) is made of a degradable polymer material.

6. The degradable coated bifurcation stent according to claim 5, characterized in that: The degradable polymer material is one or more of polylactic acid PLA, polycaprolactone PLC, and polyglycolide PGA.

7. The degradable coated bifurcation stent according to claim 2, characterized in that: The main support (1), the corrugated bending support (2), the side support (3) and the film (4) are coated by sewing, sintering, laminating or fusing.

8. The degradable coated bifurcation stent according to claim 2, characterized in that: The diameter of the main stent (1) is 0.5-3 cm, and the length of the main stent (1) is 2-5 cm.

9. The degradable coated bifurcation stent according to claim 2, characterized in that: The diameter of the side bracket (3) is 0.3-2 cm, and the length of the side bracket (3) is 1-3 cm.

10. The degradable coated bifurcation stent according to claim 2, characterized in that: The angle between the main support (1) and the side support (3) is 30-150°.

11. The degradable coated bifurcation stent according to claim 2, characterized in that: A developing point (5) is provided at the cross-connection of the metal keels of the main support (1) and the side support (3).

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