Airway stent for airway stenosis treatment

Abstract

The application discloses an airway stent for airway stenosis treatment, which comprises at least one stent unit, wherein the stent unit comprises a tubular stent body and an outer membrane covering the surface of the stent body, the outer membrane extends to the inner cavity of the stent body to form an intracavity membrane, a through hole is formed on the intracavity membrane, and the edge of the through hole is serrated, and the outer membrane extends along the distal end of the stent body to form an extension membrane. According to the stenosis degree and length of the clinical lesion section, the combination form of the airway stent is selected, and the airway stent is more personalized. Adjacent stent units are connected through the distal stent body and the extension membrane under pressure, so that the flexibility and deformation ability of the whole airway stent are ensured. The serrated intracavity membrane structure can simulate the mucociliary, when breathing, the serrated intracavity membrane is dragged, the mucus retention in the whole airway stent is reduced, and the restriction of the whole stent on the airway movement and sputum discharge is relieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an airway stent for treating airway stenosis. BACKGROUND

[0002] Airway stenosis is a disease caused by infection, airway tumor, trauma, postoperative, endobronchial tuberculosis, etc. Airway stent is an interventional treatment for various benign or malignant airway stenosis, which can relieve the symptoms of airway obstruction and play a temporary role in airway expansion or support. The stents currently used in clinical treatment of airway stenosis include metal bare stents, metal covered stents and silicone stents.

[0003] Metal bare stents are easy to place, thin-walled and large in diameter, do not cause coughing and are not easy to cause mucus retention, but they cause great airway irritation and can easily cause restenosis due to excessive stimulation of granulation tissue growth, and even cause permanent retention of metal foreign bodies in the body. The metal covered stent overcomes the problem of restenosis caused by tumor and granulation growth into the lumen, and is easy to remove, but the covered airway can inhibit the movement of mucociliary, which can easily cause difficulty in expectoration. Silicone stents are thin-walled and small in diameter, which can easily cause adverse reactions such as irritating cough and expectoration disorders, and are not easy to place, and need to be positioned under general anesthesia with the help of a rigid bronchoscope. This method is complex and traumatic, and in addition, the radial support of the silicone stent is not enough and the deformation ability is poor, which makes it difficult to fit the airway and thus easy to displace.

[0004] Therefore, the main problem of the current airway stent is that the structure is fixed, the stent is hard and not flexible enough, when the airway deforms, the stent cannot deform to the corresponding degree, thereby causing shear and friction between the stent and the airway, and the continuous shear and friction causes the proliferation of granulation tissue and the displacement of the stent, and affects the movement of mucociliary, which can easily cause mucus retention and block the airway, limit the airway movement and expectoration, and cannot meet the individual needs of different stenosis lengths of the airway. SUMMARY

[0005] To solve the above technical problems, the present application provides an airway stent for treating airway stenosis. In order to have a basic understanding of some aspects of the disclosed embodiments, a brief summary is given below. This part is not a general review, nor does it determine the key / important elements or delineate the protection scope of these embodiments. Its only purpose is to present some concepts in a simple form as a prelude to the detailed description that follows.

[0006] The present application adopts the following technical solutions:

[0007] In an embodiment, the present application provides an airway stent for treating airway stenosis, comprising: at least one stent unit;

[0008] The stent unit comprises a tubular stent body and an outer membrane covering the surface of the stent body, the outer membrane extends to the inner cavity of the stent body to form an intracavity membrane, a through hole is formed on the intracavity membrane, and the edge of the through hole is serrated, and the outer membrane extends along the distal end of the stent body to form an extended membrane.

[0009] In an embodiment, the stent body comprises a proximal stent body and a distal stent body, the outer membrane extends to the inner cavity at the connection position of the proximal stent body and the distal stent body to form the intracavity membrane, and the outer membrane extends along the distal stent body and to the side away from the distal stent body to form the extended membrane.

[0010] In an embodiment, the stent body is a self-expanding stent.

[0011] In an embodiment, the stent body further comprises a shoulder connecting column, and the proximal stent body and the distal stent body are connected into one body through the shoulder connecting column.

[0012] In an embodiment, the number of serrations on the through hole of the intracavity membrane is not less than 40, and the serration height is 0.1-0.5 mm.

[0013] In an embodiment, the material of the outer membrane, the intracavity membrane and the extended membrane is silicone rubber or polyurethane.

[0014] In an embodiment, the inner surface of the outer membrane and the extended membrane is coated with a hydrophilic coating, and the surface of the intracavity membrane is coated with a hydrophilic coating.

[0015] In an embodiment, the assembly and connection of adjacent stent units are achieved by pressurizing the extended membrane of the stent unit adjacent to the stent unit currently placed in the airway, the length of the extended membrane is 30%-80% of the length of the distal stent unit of the stent unit subjected to pressurization, and the length of the extended membrane ranges from 3 to 8 mm.

[0016] In an embodiment, the diameter of the proximal stent body is 40%-70% of the diameter of the distal stent body, and the diameter of the distal stent body ranges from 5 to 25 mm, the length of the proximal stent body is 30%-80% of the length of the distal stent body, and the length of the distal stent body ranges from 4 to 10 mm.

[0017] In an embodiment, the thickness of the outer membrane and the extended membrane is 0.01-0.1 mm.

[0018] The beneficial effects brought by the present application are as follows:

[0019] 1. According to the clinical lesion segment stenosis degree and length, the combination form of the airway stent is selected, that is, the diameter, length and number of the stent unit are selected, and different forms of airway stents are assembled to realize opening of uneven and irregular stenosis segment, and since the airway is more matched with the actual airway, the airway recovery effect is better, that is, after implanting stent units with different diameters, the inner diameter of the stenosis airway can be restored to the same state or a more ideal state;

[0020] 2. Adjacent stent units are connected by the distal stent body and the flexible extension film extending therefrom under pressure, which ensures the flexibility and certain deformation ability of the overall airway stent, and thus the overall airway stent can deform to a corresponding degree with the deformation of the airway;

[0021] 3. The structure design realizes mutual restraint of each stent unit, thereby avoiding displacement of the overall airway stent, and reducing the proliferation of granulation tissue caused by shear friction between the airway stent and the airway;

[0022] 4. The sawtooth-shaped intracavity membrane structure can simulate mucociliary, and when breathing, the sawtooth-shaped intracavity membrane is dragged, reducing the mucus retention in the overall airway stent, and relieving the restriction of the overall stent on airway movement and expectoration. BRIEF DESCRIPTION OF DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description only constitute some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0024] Figure 1 is a cross-sectional schematic view of the airway stent of the present application;

[0025] Figure 2 is a structural schematic view of the intracavity membrane of the present application;

[0026] Figure 3 is a combination schematic view of the stent unit of the present application. DETAILED DESCRIPTION

[0027] The embodiments of the present application will be described in detail below with reference to the drawings. It should be clear that the described embodiments are only some of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0028] As described above, the current airway stent has the following technical problems: first, the stent has large hardness and insufficient flexibility, and when the airway deforms, the stent cannot deform to a corresponding degree, thereby causing shear and friction between the stent and the airway, and the continuous shear and friction causes granulation tissue proliferation and stent displacement; second, after the metal covered stent or the silicone stent is implanted into the airway, the mucociliary movement is affected, which easily causes mucus retention to block the airway, and the large hardness of the stent limits the airway movement for expectoration; third, the length of the airway stent should be more than 5 mm at both ends of the stenosis section, and should not be too short, otherwise the stenosis section cannot be completely expanded, and should not be too long, otherwise more mucociliary movement for expectoration is affected, and the length specification of the current clinical airway stent cannot meet the individual needs of different stenosis lengths of the airway.

[0029] To solve the above technical problems in the treatment of airway stenosis by using the airway stent, in some illustrative embodiments, as shown in Figures 1-3 the present application provides an airway stent which has good flexibility in structural design, can deform with the deformation of the airway, reduces the friction between the airway stent and the airway, thereby avoiding the occurrence of granulation tissue proliferation and stent displacement caused by shear and friction, and has a respiratory assistance expectoration function, and the combination form of the stent unit can be selected according to the degree and length of the airway stenosis to meet the individual needs of the treatment process.

[0030] The airway stent for treating airway stenosis provided by the present application comprises at least one stent unit. The stent unit can be used alone or in combination with multiple stent units to form an airway stent by assembly. The size of each stent unit can be different, that is, different sizes of stent units can be selected according to the clinical lesion morphology for implantation into the airway in sequence.

[0031] The stent unit comprises a stent body 1 and an outer membrane 2 covering the surface of the stent body 1.

[0032] The stent body 1 is in a tubular structure, and the outer membrane 2 extends to the inner cavity 101 of the stent body 1 to form an intracavity membrane 3. A through hole 301 is formed on the intracavity membrane 3, and the design of the through hole 301 makes the inside of the stent body 1 a continuous space to ensure breathing, and the edge of the through hole 301 is serrated.

[0033] The serrated intracavity membrane structure can simulate the mucociliary movement. When breathing, the serrated intracavity membrane moves to reduce the mucus retention in the overall airway stent, and the restriction of the overall stent on the airway movement for expectoration is relieved. To further reduce the expectoration restriction and mucus retention, the number of serrations on the through hole 301 of the intracavity membrane 3 is not less than 40, and the height of the serrations is 0.1-0.5 mm.

[0034] The outer membrane 2 and the inner surface of the extension membrane 4 are coated with a hydrophilic coating, and the surface of the intraluminal membrane 3 is coated with a hydrophilic coating, which can be polyvinylpyrrolidone hydrophilic coating. The design of the hydrophilic coating can further reduce the mucus retention in the overall airway stent.

[0035] The stent body 1 is a self-expanding stent made of different column rods. In order to clearly show the position and connection mode between the intraluminal membrane, the outer membrane and the like, Figure 1 and Figure 3 The specific column rod structure is not shown in the figure, but it is obvious that the stent body 1 formed by different column rods can adopt any existing column cross form as long as it can support. The stent unit reaches the airway stenosis through a compression grip type delivery catheter, and is self-expanded after being released to make the disease position unobstructed. The outer membrane 2 is covered on the surface of the expanded stent body 1 and extends out a part to form the extension membrane 4. The intraluminal membrane 3 is located in the internal space of the stent body 1. The three are folded when the stent body 1 is compressed and have a certain elasticity. The material is silicone rubber or polyurethane, which has the advantages of stable performance, good softness and good compatibility.

[0036] The outer membrane 2 extends along the distal end of the stent body 1 to form the extension membrane 4. The function of the extension membrane 4 is to realize the assembly connection of adjacent stent units. When two or more stent units need to be assembled and used, the extension membrane 4 of the adjacent stent unit is assembled and connected through the pressurization of the stent unit currently placed in the airway. After the stent unit currently placed in the airway is released, there is a radial pressure between the current stent unit and the tracheal or bronchial wall. This pressure acts between the current stent unit, the extension membrane 4 of the stent unit adjacent to the current stent unit and the tracheal or bronchial wall, so that the two adjacent stent units are connected into one through the compression of the extension membrane 4.

[0037] According to the stenosis degree and length of the clinical lesion segment, the combination form of the airway stent is selected, that is, the diameter, length and number of the stent unit are selected to assemble the airway stent in different forms to open the concave-convex and irregular stenosis segment. Since the airway stent of the application is more matched with the actual airway when used in combination, the airway recovery effect is better, that is, the inner diameter of the stenosis airway can be restored to the same state or a more ideal state after implanting stent units with different diameters.

[0038] The stent body 1 includes a shoulder connecting column rod 5, a proximal stent body 6 and a distal stent body 7.

[0039] The proximal stent body 6 and the distal stent body 7 are connected by the shoulder connecting column 5. The outer membrane 2 extends to the inner cavity 101 at the connection position of the proximal stent body 6 and the distal stent body 7 to form the intracavity membrane 3, and extends along the distal stent body 7 and to the side away from the distal stent body 7 to form the extension membrane 4. The above structure design makes the stent unit structure more stable, and can ensure that the intracavity membrane structure is not damaged during compression implantation or use, that is, the jagged intracavity membrane structure is protected from excessive extrusion.

[0040] Because the membrane is too thick and not easy to compress and implant, and the membrane is too thin and easy to break, in some illustrative embodiments, the present application limits the thickness of the outer membrane 2 and the extension membrane 4 to 0.01-0.1mm, ensuring the stability of the membrane structure during implantation.

[0041] The length of the extension membrane 4 is 30%-80% of the length of the distal stent unit 7 on which it is pressed, and the length of the extension membrane 4 is 3-8mm, which can ensure the stability of the connection of adjacent stent units. The length of the extension membrane 4 can be cut according to needs. Because the distal stent unit 7 needs to be pressed on the extension membrane 4 during implantation, thereby achieving combination, the length of the distal stent unit 7 is greater than the length of the extension membrane 4, which can avoid the extension membrane 4 being too long to be implanted, and the above size design can also avoid the extension membrane 4 being too short to play a pressing role.

[0042] The diameter of the proximal stent body 6 is 40%-70% of the diameter of the distal stent body 7, and the diameter of the distal stent body 7 is 5-25mm. The airway stent of the present application is used in the human airway, so the size should meet the use requirements of the human airway. The given diameter range of the proximal stent body 6 is to protect the intracavity membrane from being extruded, and the given diameter range of the distal stent body 7 is to enable the airway stent to better fit the wall and not to be displaced after being compressed and released and implanted in the airway. Since the stent body wall is thin, the wall thickness value can be ignored compared to the diameter value, so the diameter mentioned in the present application can be used as the inner diameter value or the outer diameter value.

[0043] The length of the proximal stent body 6 is 30%-80% of the length of the distal stent body 7, and the length of the distal stent body 7 is 4-10mm. The given length range of the proximal stent body 6 and the distal stent body 7 is to enable a single stent unit to play a role in opening a narrow airway, and a shorter single stent unit can be more flexible in combination to different lengths for use.

[0044] The volume of the stent unit inside the airway is compressed to 50% to 90% of the volume when fully expanded. The stent unit is released for implantation into the airway in a compressed state, not in the original heat-set diameter, but in a slightly compressed or semi-compressed state, with a diameter smaller than the original size. In this state, the stent unit has radial expansion force to support the tracheal or bronchial wall, ensuring that it is not easily displaced.

[0045] In actual implantation, according to the degree and length of the airway stenosis, the diameter and length of the distal stent body of the stent unit are selected. A large-diameter stent unit is implanted at a position with a large degree of stenosis, and a small-diameter stent unit is implanted at a position with a small degree of stenosis, to ensure that after implantation of stent units of different diameters in a stenosis section with different degrees of stenosis, the inner diameter of the stenotic airway can be restored to the same or ideal state. The following is an example to illustrate the use of the airway stent of the present application in treating airway stenosis:

[0046] First, a first stent unit is selected, with a proximal stent body of 5 mm in diameter and 3 mm in length, and a distal stent body of 10 mm in diameter and 5 mm in length. The length of the extension film is cut to 3 mm, and the selected first stent unit is implanted into the proximal end of the stenotic airway (the end closer to the oral cavity), with the proximal end of the stent unit facing the proximal end of the airway.

[0047] After implantation, the diameter of the distal stent body of the expanded first stent unit is measured to be 9 mm.

[0048] Then, a second stent unit is selected, with the selection satisfying that the diameter of the proximal stent body of the second stent unit is smaller than the diameter of the distal stent body of the expanded first stent unit. Therefore, the selected second stent unit has a proximal stent body of 7.5 mm in diameter and 5 mm in length, and a distal stent body of 12 mm in diameter and 10 mm in length. The length of the extension film is cut to 4 mm. The compressed second stent unit is passed through the distal stent body of the first stent unit through the delivery catheter and released, so that the upper part of the distal stent body of the second stent unit is pressed against the extension film of the first stent unit and approaches the distal edge of the first stent unit.

[0049] After implantation, the diameter of the distal stent body of the expanded second stent unit is measured to be 9.5 mm.

[0050] Finally, a third stent unit with a proximal diameter less than the distal diameter of the second stent unit is selected, the proximal stent body of the third stent unit has a diameter of 6.5 mm and a length of 3 mm, and the distal stent body has a diameter of 11 mm and a length of 8 mm, the length of the extension film is cut to 1 mm (the length of the extension film of the last stent unit is 1-2 mm), and the implantation of all stent units is completed by using the same implantation method as the second stent unit. The airway stent formed by the three stent units is used for the treatment of an irregular narrow section with a narrow length of 13 mm.

[0051] In the present application, the proximal end refers to the end close to the oral cavity, and the distal end refers to the end away from the oral cavity during implantation.

[0052] The adjacent stent units are connected by the distal stent body and the flexible extension film extending therefrom under pressure, which ensures the flexibility and deformation ability of the overall airway stent, and further ensures that the overall airway stent deforms to a corresponding degree when the airway deforms. The structure design realizes mutual restraint of each stent unit, thereby avoiding displacement of the overall airway stent, reducing the proliferation of granulation tissue caused by shear friction between the airway stent and the airway, and relieving the restriction of the airway stent on airway movement and sputum discharge. When treating airway stenosis, the length and diameter of the stent unit can be freely selected according to the stenosis degree and length of the airway lesion section, that is, the airway stent can be freely combined to meet the individual needs, and the uneven and irregular narrow section can be better opened to ensure that the airway is expanded to a more ideal state.

[0053] The above is only a specific embodiment of the present application, but the protection scope of the present application is not limited thereto, any changes or replacements within the technical range disclosed by the present application can be easily thought by those skilled in the art, which should be covered within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. An airway stent for treating airway stenosis, characterized by, The application relates to a tracheal stent, which comprises: at least one stent unit; the stent unit comprises a tubular stent body and an outer membrane covering the surface of the stent body, the outer membrane extends to the inner cavity of the stent body to form an intracavity membrane; a through hole is formed on the intracavity membrane, and the edge of the through hole is serrated; the outer membrane extends along the distal end of the stent body to form an extension membrane; the serrated intracavity membrane structure is used for simulating mucociliary, and when breathing, the serrated intracavity membrane is dragged to reduce mucus retention in the whole airway stent; the extension membrane is used for realizing the assembly connection of adjacent stent units; the assembly connection of adjacent stent units is realized by pressurizing the stent unit currently implanted in the airway and the extension membrane of the adjacent stent unit.

2. The airway stent for treating airway stenosis according to claim 1, wherein the stent body comprises a proximal stent body and a distal stent body; the outer membrane extends to the inner cavity at the connecting position of the proximal stent body and the distal stent body to form the intracavity membrane, and the outer membrane extends along the distal stent body and to the side away from the distal stent body to form the extension membrane.

3. The airway stent for treating airway stenosis according to claim 2, wherein the stent body is a self-expanding stent.

4. The airway stent for treating airway stenosis according to claim 3, wherein the stent body further comprises a shoulder connecting column rod; the proximal stent body and the distal stent body are connected into an integrated whole through the shoulder connecting column rod.

5. The airway stent for treating airway stenosis according to claim 4, wherein the number of serrations on the through hole of the intracavity membrane is not less than 40, and the serration height is 0.1-0.5 mm.

6. The airway stent for treating airway stenosis according to claim 5, wherein the material of the outer membrane, the intracavity membrane and the extension membrane is silicone rubber or polyurethane.

7. The airway stent for treating airway stenosis according to claim 6, wherein the inner surface of the outer membrane and the extension membrane is coated with a hydrophilic coating, and the surface of the intracavity membrane is coated with a hydrophilic coating.

8. The airway stent for treating airway stenosis according to claim 7, wherein the length of the extension membrane is 30%-80% of the length of the distal stent unit of the stent unit subjected to pressurization, and the length of the extension membrane ranges from 3 mm to 8 mm.

9. The airway stent for treating airway stenosis according to claim 8, wherein the diameter of the proximal stent body is 40%-70% of the diameter of the distal stent body, and the diameter of the distal stent body ranges from 5 mm to 25 mm; the length of the proximal stent body is 30%-80% of the length of the distal stent body, and the length of the distal stent body ranges from 4 mm to 10 mm.

10. The airway stent for treating airway stenosis according to claim 9, wherein the thickness of the outer membrane and the extension membrane is 0.01-0.1 mm.

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