CN115887078A

CN115887078A - Airway stent for airway stenosis treatment

Info

Publication number: CN115887078A
Application number: CN202211449968.3A
Authority: CN
Inventors: 郭丽媛; 庄文娟
Original assignee: Beijing Saishute Medical Equipment Co ltd
Current assignee: Beijing Saishute Medical Equipment Co ltd
Priority date: 2022-11-19
Filing date: 2022-11-19
Publication date: 2023-04-04

Abstract

The invention discloses an airway stent for airway stenosis therapy, which comprises: at least one rack unit; the stand unit includes: the stent comprises a stent body with a tubular structure and an outer membrane covering the surface of the stent body, wherein the outer membrane extends towards an inner cavity of the stent body to form an inner cavity membrane; a through hole is formed in the cavity inner film, and the edge of the through hole is in a sawtooth shape; the outer membrane extends along the distal end of the stent body to form an elongated membrane. According to the stenosis degree and length of the clinical lesion segment, the combination form of the airway stent is selected, so that individuation is realized; the adjacent support units are formed by connecting the far-end support body and the extension membrane in a pressurizing manner, so that the flexibility and certain deformation capacity of the whole airway support are ensured; the serrated endoluminal structure can simulate mucociliary, and the serrated endoluminal structure can be moved during breathing, so that the mucus retention in the whole airway stent is reduced, and the limit of the whole stent on airway movement and sputum excretion is relieved.

Description

Airway stent for airway stenosis treatment

Technical Field

The invention relates to the technical field of medical instruments, in particular to an airway stent for airway stenosis treatment.

Background

Airway stenosis is a condition that is congenital or caused by infection, airway tumors, trauma, surgery, endobronchial tuberculosis, etc. The airway stent is an interventional treatment means for various benign or malignant airway stenoses, can relieve the tracheal obstruction symptom of a patient, and plays a role in temporary tracheal expansion or support. The current stents clinically used for treating airway stenosis include metal bare stents, metal covered stents, silicone stents and the like.

The metal bare stent is easy to place, has thin wall and large inner diameter, does not cause cough, is not easy to cause mucus retention, has large stimulation to air passages, is easy to cause restenosis due to over-stimulation of granulation tissue growth, and even causes that metal foreign bodies are permanently remained in a body and cannot be taken out. The metal covered stent overcomes the problem that the metal bare stent has restenosis caused by tumor and granulation growing into the cavity, and is easy to take out, but after the air passage is covered, mucociliary movement is inhibited, which easily causes difficulty in sputum excretion. The silicone support is small in wall thickness and inner diameter, adverse reactions such as irritative cough and phlegm discharge obstacle are easy to occur, the silicone support is not easy to place, the silicone support needs to be positioned by means of a hard bronchoscope in a general anesthesia state, the mode is complex, the wound is large, in addition, the radial supporting force of the silicone support is insufficient, the deformation capacity is poor, and the silicone support is difficult to be well attached to an air passage and is easy to move.

Therefore, the main problems of the current airway stent are that the structure is fixed, the stent is high in hardness and insufficient in flexibility, when the airway deforms, the stent cannot deform to a corresponding degree, shearing and friction between the stent and the airway are caused, the shearing friction which continuously occurs causes granulation tissue hyperplasia and stent displacement, mucociliary movement is influenced, mucus retention is easily caused to block the airway, sputum excretion during airway movement is limited, and the individualized requirements of different narrow lengths of the airway cannot be met.

Disclosure of Invention

In order to solve the technical problem, the invention provides an airway stent for airway stenosis treatment. The following presents a simplified summary in order to provide a basic understanding of some aspects of the disclosed embodiments. This summary is not an extensive overview and is intended to neither identify key/critical elements nor delineate the scope of such embodiments. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.

The invention adopts the following technical scheme:

in one embodiment, the present invention provides an airway stent for the treatment of airway stenosis, comprising: at least one rack unit;

the holder unit includes: the stent comprises a stent body with a tubular structure and an outer membrane covering the surface of the stent body, wherein the outer membrane extends towards an inner cavity of the stent body to form an inner cavity membrane; a through hole is formed in the cavity inner film, and the edge of the through hole is in a sawtooth shape; the outer membrane extends along the distal end of the stent body to form an elongated membrane.

In one embodiment, the stent body comprises: a proximal stent body and a distal stent body; the adventitia is followed near-end support body with this body hookup location department of distal end support extends in order to form the intracavity intima, the adventitia is followed distal end support body just to keeping away from one side of distal end support body extends in order to form the extension membrane.

In one embodiment, the stent body is a self-expanding stent.

In one embodiment, the stent body further comprises: the shoulder part is connected with the post rod; the near-end support body and the far-end support body are connected into a whole through the shoulder connecting post rod.

In one embodiment, the number of the saw teeth on the through hole formed in the cavity inner film is not less than 40, and the height of the saw teeth is 0.1-0.5 mm.

In one embodiment, the outer membrane, the inner cavity membrane and the extension membrane are made of silicone rubber or polyurethane.

In one embodiment, the inner surfaces of the outer membrane and the elongated membrane are coated with a hydrophilic coating, and the surface of the intraluminal membrane is coated with a hydrophilic coating.

In one embodiment, the adjacent stent units are assembled and connected by pressurizing the stent unit currently placed in the airway and the extension membranes of the adjacent stent units; the length of the extension membrane is 30-80% of the length of the distal stent unit of the stent unit pressed thereon, and the length of the extension membrane ranges from 3 to 8mm.

In one embodiment, the diameter of the proximal stent body is 40 to 70 percent of the diameter of the distal stent body, and the diameter of the distal stent body ranges from 5 to 25mm; the length of the near-end support body is 30% -80% of the length of the far-end support body, and the length range of the far-end support body is 4-10 mm.

In one embodiment, the thickness of the outer film and the thickness of the extension film are 0.01-0.1 mm.

The invention has the following beneficial effects:

1. according to the stenosis degree and length of the clinical lesion segment, the combination form of the airway stent is selected, namely the diameter, the length and the number of the stent units are selected to assemble the airway stent with different forms, so that uneven and irregular stenosis sections are opened, and the airway stent is better in recovery effect because the airway stent is more matched with an actual airway, namely the inner diameters of the stenosis airways can be recovered to the same state or a more ideal state after the stent units with different diameters are implanted;

2. the adjacent support units are formed by pressurizing and connecting the far-end support body and the extended flexible extension membrane, so that the flexibility and certain deformation capacity of the whole airway support are ensured, and the integral airway support can be further ensured to deform to a corresponding degree along with the airway deformation;

3. the structural design realizes the mutual restraint of all the support units, thereby avoiding the displacement of the whole air passage support and simultaneously reducing the granulation tissue hyperplasia caused by the shearing friction between the air passage support and the air passage;

4. the serrated endoluminal structure can simulate mucociliary, and the serrated endoluminal structure can be moved during breathing, so that the mucus retention in the whole airway stent is reduced, and the limit of the whole stent on airway movement and sputum excretion is relieved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic cross-sectional view of an airway stent of the present invention;

FIG. 2 is a schematic view of the configuration of the endoluminal membrane of the present invention;

fig. 3 is a schematic view of the combination of the stent unit of the present invention.

Detailed Description

Embodiments of the present invention are described in detail below with reference to the accompanying drawings. It should be understood that the described embodiments are only some embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

As mentioned above, the current airway stent has the technical problems that: firstly, the bracket has high hardness and insufficient flexibility, and when the air passage deforms, the bracket cannot deform to a corresponding degree, so that shearing and friction are caused between the bracket and the air passage, and the granulation tissue hyperplasia and bracket displacement are caused by the continuous shearing and friction; secondly, after the metal covered stent or the silicone stent is implanted into the air passage, mucociliary movement is influenced, mucus retention is easily caused to block the air passage, and meanwhile, the stent has high hardness, so that movement and sputum excretion of the air passage are limited; thirdly, the length of the airway stent should exceed the two ends of the narrow section by 5mm respectively, the airway stent is not too short, otherwise the narrow section cannot be completely expanded, the airway is not too long, the airway is covered too much, more mucociliary movement sputum excretion is influenced, the length specification of the current clinical airway stent is determined, and the personalized requirements of different narrow lengths of the airway cannot be met.

In order to solve the above technical problems existing in the current treatment of airway stenosis using airway stents, in some illustrative embodiments, as shown in fig. 1 to 3, the present invention provides an airway stent, which has a flexible structural design, can deform along with airway deformation, and reduces friction between the airway stent and the airway, thereby avoiding the occurrence of granulation tissue hyperplasia and stent displacement caused by shear friction, and has a respiratory assistance sputum excretion function, and a combination form of stent units can be selected according to the airway stenosis degree and length to meet personalized requirements of a treatment process.

The invention provides an airway stent for airway stenosis therapy, which comprises: at least one rack unit. The support unit can be used independently, and a plurality of support units can be combined for use to jointly assemble the airway support. The sizes of the stent units can be different, namely the stent units with different sizes can be selected to be sequentially implanted into the airway according to clinical lesion forms in practical application.

The holder unit includes: the stent comprises a stent body 1 and an outer film 2 covering the surface of the stent body 1.

The support body 1 is of a tubular structure, the outer membrane 2 extends towards the inner cavity 101 of the support body 1 to form an inner cavity membrane 3, a through hole 301 is formed in the inner cavity membrane 3, the support body 1 is internally provided with a communicating space due to the design of the through hole 301, breathing is guaranteed, and the edge of the through hole 301 is in a sawtooth shape.

The serrated endoluminal structure can simulate mucociliary, and the serrated endoluminal structure can be moved during breathing, so that the mucus retention in the whole airway stent is reduced, and the limit of the whole stent on airway movement and sputum excretion is relieved. In order to further reduce sputum excretion limitation and mucus retention, the number of the saw teeth on the through hole 301 arranged on the inner cavity membrane 3 is not less than 40, and the height of the saw teeth is 0.1-0.5 mm.

The inner surfaces of the outer membrane 2 and the extension membrane 4 are coated with hydrophilic coatings, and the surface of the cavity inner membrane 3 is coated with a hydrophilic coating, and particularly, a polyvinylpyrrolidone hydrophilic coating can be selected. The design of the hydrophilic coating may also further reduce the retention of mucus within the overall airway stent.

The stent body 1 is a self-expanding stent made of nickel-titanium alloy and formed by intersecting different struts. In order to clearly show the position and connection manner between the endosteal membrane, the adventitia, etc., a specific strut structure is not shown in fig. 1 and 3, but it is obvious that the stent body 1 formed by intersecting different struts can adopt any strut intersecting form, as long as the supporting function is achieved. The stent unit reaches the narrow part of the airway through the pressure-gripping type delivery catheter, and the self-expansion is carried out after the fixation is released, so that the disease position is unblocked. The outer membrane 2 covers the surface of the expansion bracket body 1 and extends out of a part to form an extension membrane 4, the inner cavity membrane 3 is positioned in the inner space of the bracket body 1 and is folded along with the compression of the bracket body 1, and the three have certain elasticity, are made of silicon rubber or polyurethane, and have the advantages of stable performance, good flexibility, good compatibility and the like.

The outer membrane 2 extends along the distal end of the stent body 1 to form an extension membrane 4, and the extension membrane 4 is used for realizing the assembly connection of adjacent stent units. When more than two bracket units are required to be assembled and used, the bracket unit currently placed in the air passage is pressurized to carry out the assembly connection of the adjacent bracket units with the extension membranes 4 of the adjacent bracket units, namely after the bracket unit currently placed in the air passage is released, radial pressure exists between the current bracket unit and the trachea or the bronchial wall, and the pressure just acts among the current bracket unit, the extension membranes 4 of the bracket unit adjacent to the current bracket unit and the trachea or the bronchial wall, so that the two adjacent bracket units are connected into a whole through the compression of the extension membranes 4.

According to the stenosis degree and length of clinical lesion sections, the combination form of the airway stent is selected, namely the diameter, the length and the number of the stent units are selected, the airway stent with different forms is assembled, uneven and irregular stenosis sections are opened, and the airway stent has better airway recovery effect because the airway stent is more matched with an actual airway when being used in a combination mode, namely the inner diameters of the stenosis airways can be recovered to the same state or a more ideal state after stent units with different diameters are implanted.

The stent body 1 includes: the shoulder connects the post 5, the proximal stent body 6, and the distal stent body 7.

The proximal stent body 6 and the distal stent body 7 are connected into a whole through the shoulder connecting post 5. The outer membrane 2 extends towards the inner cavity 101 along the connecting position of the proximal stent body 6 and the distal stent body 7 to form an inner cavity membrane 3, and the outer membrane 2 extends along the distal stent body 7 and towards the side far away from the distal stent body 7 to form an extension membrane 4. The structural design ensures that the structure of the stent unit is more stable, and the stent unit can ensure that the endocardium structure is not damaged in the process of compression implantation or use, namely, the serrated endocardium structure is protected to prevent excessive extrusion.

Since the membrane is too thick to be easily compressed for implantation and too thin membrane is too weak to be damaged, in some illustrative embodiments, the thickness of the outer membrane 2 and the thickness of the extension membrane 4 are limited to 0.01-0.1 mm, thereby ensuring the stability of the membrane structure during implantation.

The length of the extension membrane 4 is 30-80% of the length of the distal stent unit 7 pressed thereon, and the length range of the extension membrane 4 is 3-8 mm, which can ensure the connection stability of the adjacent stent units. The length of the extension film 4 may be cut as required. Because the distal stent unit 7 is required to be pressed against the extension membrane 4 during implantation, thereby realizing combination, the length of the distal stent unit 7 is larger than that of the extension membrane 4, so that the situation that implantation is difficult due to overlong extension membrane 4 can be avoided within the range, and the situation that the pressing effect cannot be realized due to overlong extension membrane 4 can also be avoided due to the size design.

The diameter of the near-end stent body 6 is 40 to 70 percent of the diameter of the far-end stent body 7, and the diameter range of the far-end stent body 7 is 5 to 25mm. The airway stent is used in a human airway, so the size of the airway stent meets the use requirement of the human airway, the diameter range of the proximal stent body 6 is given to protect an intima from being extruded, and the diameter range of the distal stent body 7 is given to ensure that the airway stent is compressed and released to be implanted into the airway, can be better attached to the wall of the airway and cannot be displaced. Because the wall of the bracket body is thin, compared with the diameter value, the wall thickness value can be ignored, and therefore, the diameter mentioned in the invention can be used as the inner diameter value and the outer diameter value.

The length of the near-end stent body 6 is 30-80% of the length of the far-end stent body 7, and the length range of the far-end stent body 7 is 4-10 mm. The length ranges of the proximal stent body 6 and the distal stent body 7 are given so that a single stent unit can function to open a narrow airway, and a shorter single stent unit can be combined into different lengths for use more flexibly.

The volume of the stent units inside the airway are compressed to 50% to 90% of the fully expanded volume. Because the stent unit is compressed and released to be implanted into the airway, the stent unit does not exist in the original heat-set diameter, but exists in a slightly compressed or semi-compressed state, and the diameter is smaller than the original size, because the stent unit has radial stretching force to support the wall of the trachea or the bronchus, the stent unit is not easy to displace.

When actually implanting, according to the narrow degree of air flue and length, select the diameter and the length of the distal end support body of support unit, the suitable major diameter support unit is implanted to the position that narrow degree is big, and the suitable minor diameter support unit is implanted to the position that narrow degree is little to guarantee in the different narrow section of narrow degree, narrow air flue internal diameter can resume the same state or the state of ideal behind the support unit of implanted different diameters. The following illustrates the use of the airway stent of the present invention in treating airway stenosis:

firstly, selecting a first support unit, wherein the diameter of a near-end support body is 5mm, the length of the near-end support body is 3mm, the diameter of a far-end support body is 10mm, and the length of the far-end support body is 5mm, cutting the length of the extension membrane to 3mm, implanting the selected first support unit into the near end (the end near the oral cavity) of the narrow airway, and enabling the near end of the support unit to face the near end of the airway.

The diameter of the distal stent body of the now-expanded first unit stent was measured after implantation to be 9mm.

Then, selecting a second bracket unit, wherein the selection needs to meet the following requirements: 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 being expanded. Therefore, the proximal stent body of the second selected stent unit has a diameter of 7.5mm and a length of 5mm, the distal stent body has a diameter of 12mm and a length of 10mm, and the extension membrane is cut to a length of 4mm. The compressed second stent unit is passed through the distal stent body of the first stent unit by the delivery catheter and released so that the upper portion of the distal stent body of the second stent unit presses against the elongate membrane of the first stent unit and approaches the distal edge of the first stent unit.

The diameter of the distal stent body of the second stent unit expanded at this time was measured after implantation to be 9.5mm.

And finally, selecting a third stent unit with the diameter of the near end smaller than that of the far end of the second stent unit, wherein the diameter of a near-end stent body of the third stent unit is 6.5mm and the length of the third stent unit is 3mm, the diameter of a far-end stent body of the third stent unit is 11mm and the length of the third stent unit is 8mm, cutting the length of the extension membrane to 1mm (the length of the extension membrane of the last stent unit is 1-2 mm), and implanting all the stent units by using the same implanting method as the second stent unit. The airway stent formed by combining the three stent units is used for treating an irregular stenosis section with a stenosis length of 13 mm.

The proximal end in the invention refers to the end close to the oral cavity, and the distal end refers to the end of the stent unit far away from the oral cavity when implanted.

The adjacent support units are formed by pressurizing and connecting the far-end support body and the extending flexible extension film, the overall flexibility and certain deformability of the airway support are guaranteed, and then the deformation of the overall airway support to the corresponding degree along with the airway deformation can be guaranteed. Structural design realizes each support unit's the system of pinning mutually to avoid whole air flue support's aversion, reduced the granulation tissue hyperplasia that the shearing friction between air flue support and air flue leads to simultaneously, alleviated air flue support in addition and moved the restriction of sputum discharging to the air flue. When the airway stenosis disease is treated, the length and the diameter of the support unit can be freely selected according to the stenosis degree and the stenosis length of the lesion segment of the airway, namely, the airway support is freely combined, the individual requirements are met, and meanwhile, the uneven and irregular stenosis segment can be better opened so as to ensure that the airway is expanded to a more ideal state.

The above description is only for the specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. An airway stent for treatment of airway stenosis, comprising: at least one rack unit;

2. The airway stent for airway constriction treatment as claimed in claim 1, wherein said stent body includes: a proximal stent body and a distal stent body; the adventitia is followed near-end support body with distal end support body hookup location department extends in order to form to the inner chamber the intracavity membrance, the adventitia is followed distal end support body just to keeping away from extend in order to form one side of distal end support body the extension membrane.

3. The airway stent for airway constriction of claim 2, wherein the stent body is a self-expanding stent.

4. The airway stent for airway constriction treatment as in claim 3, wherein said stent body further includes: the shoulder part is connected with the post rod; the near-end support body and the far-end support body are connected into a whole through the shoulder connecting post rod.

5. The airway stent for the treatment of airway stenosis according to claim 4, wherein the number of the saw teeth on the through hole formed on the inner lumen membrane is not less than 40, and the height of the saw teeth is 0.1 to 0.5mm.

6. The airway stent for airway stenosis treatment according to claim 5, wherein the outer membrane, the inner lumen membrane and the extension membrane are made of silicone rubber or polyurethane.

7. The airway stent for airway stenosis therapy as claimed in claim 6, wherein the inner surfaces of the outer membrane and the elongated membrane are coated with a hydrophilic coating, and the surface of the lumen inner membrane is coated with a hydrophilic coating.

8. The airway stent for airway stenosis treatment according to claim 7, wherein the adjacent stent units are assembled by pressurizing the stent unit currently inserted into the airway with the extension membrane of the adjacent stent unit; the length of the extension membrane is 30 to 80% of the length of the distal stent unit of the stent unit pressed thereon, and the length of the extension membrane ranges from 3 to 8mm.

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

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