An airway stent

Abstract

The application discloses an airway stent, 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 separating the inner cavity into two independent spaces, a tear line is arranged on the intracavity membrane, and the outer membrane extends along the distal end of the stent body to form an extension membrane. Different combination forms of the airway stent are selected to adapt to different types of airway diseases; adjacent stent units are connected by the distal stent body and the extension membrane under pressure to ensure the flexibility and certain deformation capacity of the whole airway stent; mutual restraint of each stent unit is realized, so that the displacement of the whole airway stent is avoided, and the granulation tissue proliferation caused by the shearing friction between the airway stent and the airway is reduced.

Description

TECHNICAL FIELD

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

[0002] In recent years, airway diseases caused by various benign and malignant diseases, trauma, tracheotomy or intubation, etc. are increasing, such as airway stenosis, bronchial fistula and intractable hemoptysis in the lung, etc. At present, various stents are commonly used in clinical treatment of airway diseases, but the existing airway stents have single function and can only treat one type of airway disease, which cannot simultaneously meet the treatment of various complex airway diseases. Clinicians need to repeatedly try various interventional devices in combination according to the operation effect, which brings great difficulty and challenge to clinicians. SUMMARY

[0003] To solve the above technical problems, the present application provides an airway stent. 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 is it intended to determine the key / important elements or delineate the scope of protection of these embodiments. Its only purpose is to present some concepts in a simple form as a prelude to the detailed description that follows.

[0004] The present application adopts the following technical solutions:

[0005] In an embodiment, the present application provides an airway stent, comprising: at least one stent unit;

[0006] The stent unit comprises: a stent body of a tubular structure and an outer membrane covering the surface of the stent body, the outer membrane extending to the inner cavity of the stent body to form an intracavity membrane separating the inner cavity into two independent spaces;

[0007] A tear line is provided on the intracavity membrane;

[0008] 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 rod; the proximal stent body and the distal stent body are connected as a whole through the shoulder connecting column rod.

[0012] In an embodiment, the stent unit further comprises a cylindrical protrusion; the cylindrical protrusion is connected with the inner membrane of the cavity defined by the tear line.

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

[0014] In an embodiment, the thickness of the outer membrane and the extension membrane is 0.01-0.5mm; the thickness of the inner membrane is 0.01-0.1mm.

[0015] In an embodiment, the adjacent stent unit is assembled by pressurizing the extension membrane of the stent unit currently placed in the airway and the adjacent stent unit; the length of the extension membrane is 30%-80% of the length of the distal stent unit on which the pressurization is performed, and the length of the extension membrane ranges from 3mm to 8mm.

[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 4mm to 25mm; 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 4mm to 10mm.

[0017] In an embodiment, the tear line on the surface of the inner membrane is a circular indentation, and the diameter of the circular indentation is 60%-95% of the diameter of the proximal stent body.

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

[0019] 1. According to the type of airway disease, the combination form of the airway stent is selected, that is, the diameter, length, number of the stent unit and the use mode of the inner membrane are selected according to the specific disease, so as to realize the assembly of the airway stent in different forms to adapt to different types of airway diseases.

[0020] 2. The adjacent stent units are connected by the pressurization of the distal stent body and the flexible extension membrane extending therefrom, which ensures the flexibility and deformation ability of the whole airway stent, and further ensures that the whole airway stent deforms to a corresponding degree along with the deformation of the airway.

[0021] 3. The structure design realizes the mutual restraint of each stent unit, thereby avoiding the displacement of the whole airway stent, reducing the granuloma proliferation caused by the shear friction between the airway stent and the airway, and relieving the limitation of the airway stent on the airway movement and sputum discharge. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to make the technical solutions in the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description only aim to explain some of the embodiments of the present application, and all other embodiments obtained by those of ordinary skill in the art without creative effort based on the embodiments of the present application shall fall within the protection scope of the present application.

[0023] Figure 1 is a schematic view of a cross section of the airway stent of the present application;

[0024] Figure 2 is a schematic view of the structure of the intracavity membrane of the present application;

[0025] Figure 3 is a schematic view of the combination of the stent units of the present application. DETAILED DESCRIPTION

[0026] The embodiments of the present application will be described in detail below with reference to the accompanying drawings. It should be noted that the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments of the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort shall fall within the protection scope of the present application.

[0027] In some illustrative embodiments, as shown in Figures 1-3 the present application provides an airway stent, comprising: at least one stent unit. The stent unit can be used alone, or multiple stent units can be combined and assembled to form an airway stent. Wherein, the size of each stent unit can be different, that is, different sizes of stent units can be selected according to the morphology of the clinical lesion and implanted into the airway in sequence in actual application.

[0028] The stent unit comprises: a stent body 1 and an outer membrane 2 covering the surface of the stent body 1.

[0029] 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, which separates the inner cavity 101 into two independent spaces, and a tear line 301 is provided on the intracavity membrane 3. In actual operation, part of the intracavity membrane 3 can be torn along the tear line 301 according to the actual disease to be treated, so that the internal space of the stent body 1 is communicated and does not affect breathing, for example, treating airway stenosis; or all of the intracavity membrane 3 can be left in the inner cavity 101 to achieve the effect of plugging, for example, treating bronchial fistula and intractable hemoptysis.

[0030] The stent unit further comprises a cylindrical protrusion 8 for facilitating the communication of the interior space of the stent body 1. The tear line 301 defines a portion of the lumen membrane 3, and the cylindrical protrusion 8 is connected to the portion of the lumen membrane defined by the tear line 301. Thus, pulling the cylindrical protrusion 8 can tear a portion of the lumen membrane 3 along the tear line 301, so as to communicate the interior space of the stent body 1.

[0031] The stent body 1 is a self-expandable stent made of different columnar rods and is made of nickel-titanium alloy. In order to clearly show the positions and connection modes of the lumen membrane, the outer membrane and other structures, Figure 1 and Figure 3 The specific columnar rod structure is not shown in the drawings, but it is obvious that the stent body 1 made of different columnar rods can adopt any existing columnar rod intersection form as long as it can support. The stent unit reaches the lesion site through a compression-gripping delivery catheter, and expands to unblock or fix the lesion site after being released. The outer membrane 2 is covered on the surface of the expanded stent body 1 and extends a portion to form an extended membrane 4. The lumen membrane 3 is located in the interior space of the stent body 1, and 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, good biocompatibility, etc.

[0032] The outer membrane 2 extends along the distal end of the stent body 1 to form an extended membrane 4. The function of the extended 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 extended membrane 4 of the adjacent stent unit is connected by the stent unit currently placed in the airway. When the stent unit is released, the radial pressure exists between the current stent unit and the tracheal or bronchial wall, which acts on the current stent unit, the extended membrane 4 of the adjacent stent unit and the tracheal or bronchial wall, so that the two adjacent stent units are connected by the pressure of the extended membrane 4.

[0033] According to the type of airway disease, the combination form of the airway stent is selected, that is, the diameter, length, number of the stent unit and the use mode of the lumen membrane are selected according to the specific disease, so as to realize the assembly of the airway stent in different forms to adapt to different types of airway diseases. The stent unit can be used alone or in combination to treat various airway diseases such as airway stenosis, bronchial fistula and intractable hemoptysis, which has the advantage of functional diversification.

[0034] The stent body 1 comprises a shoulder connecting columnar rod 5, a proximal stent body 6 and a distal stent body 7.

[0035] The proximal stent body 6 and the distal stent body 7 are connected by the shoulder connecting column 5 to form an integrated whole. 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 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, and can play a better sealing effect after placement, such as fistula plugging and hemoptysis, and is also convenient to operate.

[0036] 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 thickness of the outer membrane 2 and the extension membrane 4 is limited to 0.01-0.5mm; the thickness of the intracavity membrane 3 is 0.01-0.1mm, which ensures the stability of the membrane structure during implantation.

[0037] 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. Because the distal stent unit 7 needs to be pressed on the extension membrane 4 during implantation, thereby realizing combination, the length of the distal stent unit 7 is greater than the length of the extension membrane 4, and within the above range, it 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.

[0038] 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 4-25mm. 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, and the given diameter range of the proximal stent body 6 and the distal stent body 7 is to enable the airway stent to better fit the wall of the airway and not to be displaced after being compressed and released and implanted in the airway. Among them, because the stent body wall is thin, compared with the diameter value, the wall thickness value can be ignored, so the diameter mentioned in the present application can be used as the inner diameter value or the outer diameter value.

[0039] 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 diameter range of the proximal stent body 6 is to protect the intracavity membrane from being extruded, and the given length range of the distal stent body 7 is to enable a single stent unit to play the role of dilating a narrow airway, plugging a fistula and plugging hemoptysis, and a shorter single stent unit can be more flexible to be combined into different lengths for use.

[0040] The tear line 301 on the surface of the cavity membrane 3 is a circular indentation, and the diameter of the circular indentation is 60% to 95% of the diameter of the proximal stent body 6. The minimum diameter of the circular indentation is to provide a larger channel in the cavity after tearing for the discharge of secretions, and the maximum diameter is to facilitate the indentation.

[0041] The volume of the stent unit inside the airway is compressed to 50% to 90% of the volume when fully expanded. Since the stent unit is released into the airway by compression, it does not exist in the original heat-set diameter, but in a slightly compressed or semi-compressed state with a diameter smaller than the original size. Because of this state, the stent unit has radial expansion force to support the tracheal or bronchial wall and ensure that it is not easily displaced.

[0042] The following illustrates the use of the airway stent of the present application in treating airway stenosis, bronchial fistula and intractable hemoptysis in the lung.

[0043] First, treat airway stenosis:

[0044] When used to treat airway stenosis, according to the degree and length of airway stenosis, a stent unit is selected, or multiple stent units of different diameters and lengths are selected for combination to ensure that in a stenosis section with different degrees of stenosis, the diameter of the stenosis airway after implanting stent units of different diameters can be restored to the same state or an ideal state. The number of stent units and the length of each stent unit can be selected according to the actual length of the stenosis section.

[0045] For example, during actual implantation, a first stent unit is first selected, the proximal stent body of the first stent unit has a diameter of 5 mm and a length of 3 mm, the distal stent body has a diameter of 10 mm and a length of 5 mm, the length of the extension film is cut to 3 mm, a portion of the cavity membrane is torn along the tear line, and the first stent unit is implanted in the proximal end of the stenosis airway (the end closer to the oral cavity). In the present application, the proximal end refers to the end closer to the oral cavity, and the distal end refers to the end of the stent unit away from the oral cavity during implantation.

[0046] After implantation, the diameter of the expanded distal stent body of the first stent unit is measured to be 9 mm.

[0047] Then, the second stent unit is selected, and the selection needs to meet: the diameter of the proximal stent body of the second stent unit is smaller than the diameter of the distal stent body of the first stent unit after expansion. Therefore, the diameter of the proximal stent body of the selected second stent unit is 7.5 mm, and the length is 5 mm, the diameter of the distal stent body is 12 mm, and the length is 10 mm, the length of the extension film is cut to 4 mm, a part of the intracavity film is torn along the tear line, the compressed second stent unit is sent through the distal stent body of the first stent unit by the delivery catheter, and then released, so that the upper part of the distal stent body of the second stent unit is pressed on the extension film of the first stent unit, and close to the distal edge of the first stent unit.

[0048] After implantation, the diameter of the distal stent body of the expanded second stent unit is measured to be 9.5 mm.

[0049] Finally, the third stent unit with a smaller proximal diameter than the distal diameter of the expanded second stent unit is selected, the diameter of the proximal stent body of the third stent unit is 6.5 mm, and the length is 3 mm, the diameter of the distal stent body is 11 mm, and the length is 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 same implantation method as the second stent unit is used to complete the implantation of all stent units. The airway stent formed by the three stent units is used for the treatment of irregular stenosis with a stenosis length of 13 mm.

[0050] Second, treatment of bronchial fistula disease:

[0051] When used for the treatment of bronchial fistula disease, the fistula is a broken opening in the airway, and the proximal bronchus of the bronchial fistula needs to be blocked by a stent unit to prevent pus from entering the airway or gas from flowing into the pleural cavity. This treatment method does not tear the intracavity film, and the proximal bronchus of the fistula needs to be blocked by a stent unit that meets the diameter and length of the bronchus, in order to have a suitable radial expansion force to support the airway stent from moving or falling.

[0052] For example, during actual implantation, a stent unit is selected, the diameter of the proximal stent body of the stent unit is 4 mm, and the length is 2 mm, the diameter of the distal stent body is 8 mm, and the length is 5 mm, and the length of the extension film is 3 mm. The extension film of the stent unit is cut off, the compressed stent unit is sent to the proximal bronchus of the bronchial fistula by the delivery catheter, and then released, the distal end of the stent unit faces the fistula, and the 6 mm fistula is blocked by the intracavity film of the stent unit. This fistula can be compared to a pipe with a 6 mm diameter at one end, and the stent unit can be compared to a plug with a diameter of 8 mm, which blocks the fistula. Therefore, the diameter of the distal stent body needs to be larger than the diameter of the pipe to be tightly plugged, and it will not fall due to slight peristalsis.

[0053] Third, treatment of intractable hemoptysis disease in the lung:

[0054] When used for treating lung intractable hemoptysis disease, the principle is to block the proximal end (the end close to the oral cavity) of the bleeding airway by airway stent to prevent blood from flowing to the main airway, causing choking and suffocation, and the blood blocked is self-coagulated to stop bleeding in the closed space.

[0055] For example, when actually implanted, a stent unit is selected, the diameter of the proximal stent body of the stent unit is 3 mm, the length is 4 mm, the diameter of the distal stent body is 8 mm, the length is 7 mm, and the length of the extension film is 8 mm. The extension film is cut off, the compressed stent unit is sent into the proximal bronchus of the bleeding site by a delivery catheter, and the stent unit is released, the distal end of the stent unit faces the bleeding site, and the proximal bronchus with a diameter of 7 mm is blocked to stop bleeding. The above example uses a single stent unit as an airway stent for implantation, and the intracavity membrane is not torn off to block.

[0056] Other airway diseases can be freely selected in terms of airway lesions, the diameter, length and number of stent units.

[0057] The intracavity membrane of the airway stent can be selected to be torn off or not torn off. When not torn off, the airway stent can block in the radial and axial directions, and when torn off, the airway stent blocks in the axial direction and supports the airway in the radial direction. The stent unit with the torn-off intracavity membrane can be used to treat stenosis after assembly. Adjacent stent units are connected by the distal stent body and the flexible extension film extending out to pressurize, 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 with the deformation of the airway.

[0058] 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 expectoration.

[0059] In the treatment of airway stenosis disease, the length and diameter of the stent unit can be freely selected according to the stenosis degree and length of the airway lesion segment, that is, the airway stent can be freely combined to meet the individual needs and better open the uneven and irregular stenosis segment to ensure that the airway is expanded to a more ideal state.

[0060] The airway stent has various uses and can be used to treat various airway diseases.

[0061] 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 of 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, characterized by, The application relates to a stent unit for airway stent. The stent unit comprises a tubular stent body and an outer membrane covering the surface of the stent body, the outer membrane extending to the inner cavity of the stent body to form an intracavity membrane separating the inner cavity into two independent spaces. A tear line is arranged on the intracavity membrane. The outer membrane extends along the distal end of the stent body to form an extended membrane. 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 extends along the distal stent body and to the side away from the distal stent body to form the extended membrane; 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 4 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. The intracavity membrane of the airway stent can be selected to be torn or not torn; when the intracavity membrane is not torn, the airway stent plays a plugging role in the radial and axial directions; when the intracavity membrane is torn along the tear line, the airway stent plays a plugging role in the axial direction and a supporting role in the radial direction; the stent unit with the torn intracavity membrane is used for treating stenosis after assembly; adjacent stent units are connected by the distal stent body and the extended membrane; the airway stent deforms to a corresponding degree along with the deformation of the airway. The stent body is a self-expanding stent.

2. An airway tube according to claim 1, 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.

3. An airway tube according to claim 2, wherein, The stent unit further comprises a cylindrical protrusion; the cylindrical protrusion is connected to the intracavity membrane defined by the tear line.

4. An airway tube according to claim 3, wherein, The outer membrane is made of silicone rubber or polyurethane.

5. An airway tube according to claim 4, wherein The thickness of the outer membrane and the extended membrane is 0.01-0.5 mm; and the thickness of the intracavity membrane is 0.01-0.1 mm.

6. An airway tube according to claim 5, wherein, The extended membrane of the adjacent stent unit is connected by pressurizing 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.

7. An airway tube according to claim 6, wherein The tear line on the surface of the intracavity membrane is a circular indentation, and the diameter of the circular indentation is 60-95% of the diameter of the proximal stent body.

8. An airway tube according to claim 7, wherein, ​

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