Airway implantation instrument

By designing a coated support skeleton and multiple rows of pointed bodies in the airway implantation device, the secretion retention problem caused by the airway stent is solved, complications are reduced, and airway health is improved.

CN222889070UActive Publication Date: 2025-05-23HANSTAR MEDICAL TECHNOLOGY (SHENZHEN) CO LTD
View PDF 0 Cites 0 Cited by

Patent Information

Application Number
CN202421379675.7
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-06-18
Publication Date
2025-05-23
Estimated Expiration
2034-06-18

AI Technical Summary

Technical Problem

The existing metal stents in the airway are prone to restenosis after long-term use. The coated stent is closely connected to the tracheal wall, which prevents the movement of the mucocilia in the airway, resulting in secretion retention and complications such as cough and pneumonia.

Method used

An airway implantation device is designed, including a coated support frame and a plurality of pointed bodies, which are arranged around the axis of the coated support frame to form a channel extending axially to ensure that the secretions in the airway can be effectively discharged.

Benefits of technology

By setting up multiple rows of sharp bodies and channels in the airway implantation device, secretion retention is avoided, complications such as cough and pneumonia are reduced, and the efficiency of discharge of secretions in the airway is improved.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN222889070U_ABST
    Figure CN222889070U_ABST
Patent Text Reader

Abstract

The airway implantation instrument provided by the utility model comprises a film-covered supporting framework and a plurality of pointed bodies arranged on the film-covered supporting framework. And the plurality of pointed bodies are arranged in n rows on the outer surface of the film-covered supporting framework around the axis of the film-covered supporting framework, wherein the n rows are separated from each other. A channel extending in the axial direction X is formed between any two adjacent rows of pointed bodies, and projections of any two adjacent rows of pointed bodies in a plane perpendicular to the axial direction X of the film-covered supporting framework are separated from each other. The far end of at least part of the pointed body is used for being inserted into tracheal tissue, so that the instrument is fixed to the lesion position, and a gap is formed between the outer surface of the covered supporting skeleton and the tracheal tissue. After the device is implanted into the trachea, the movement of mucosa cilia on the inner wall of the trachea cannot be stopped, and secreta can be discharged from a channel.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The utility model relates to an implantable medical device, in particular to an airway implantable device. Background Art

[0002] With the aging of the population and changes in dietary structure, the incidence of some diseases such as tracheal stenosis, rupture, and tumors is increasing year by year.

[0003] Airway metal stents are an important means of treating tracheal and bronchial stenosis. They can quickly rebuild the airway and relieve symptoms such as dyspnea. According to the material, airway stents can be divided into metal stents and non-metal stents. According to whether they are covered or not, metal stents can be divided into covered stents and bare stents.

[0004] Early airway stents mainly used bare metal stents. Bare metal stents mainly use nickel-titanium memory alloy mesh stents. Implanting bare metal stents into the airway has the advantages of not being easily displaced and airway secretions not being easily retained. However, due to the large mesh space of bare metal stents, it cannot prevent tumors or granulation tissue from growing along the mesh of the trachea. Malignant tumors are prone to grow into the inner cavity of the stent and cause airway restenosis. Therefore, bare metal stents can only be placed for a short period of time to relieve airway obstruction and should not be placed for too long.

[0005] Based on the above problems, a covered stent has appeared in the prior art. A covered stent has a layer of coating added to the bare stent. After the covered stent is implanted in the airway, the coating will prevent the tumor from growing into the stent. However, because the covered stent fits tightly to the tracheal wall, the coating will prevent the movement of the mucociliary cells in the airway, causing secretions to accumulate at both ends of the airway and unable to be discharged from the body, leading to complications such as coughing and pneumonia in patients. Utility Model Content

[0006] In order to overcome the above technical problems, the utility model provides an airway implant device which can effectively discharge secretions from diseased trachea.

[0007] As conceived above, the technical solution adopted by the utility model is: an airway implant device, comprising a membrane supporting frame and a plurality of pointed bodies arranged on the membrane supporting frame, the plurality of pointed bodies are arranged into n mutually separated columns on the outer surface of the membrane supporting frame around the axis of the membrane supporting frame, and n is an integer; a channel extending along the axial direction is formed between any two adjacent columns of the pointed bodies; and the projections of any two adjacent columns of the pointed bodies in a plane perpendicular to the axial direction of the membrane supporting frame are separated from each other, and the distal ends of at least some of the pointed bodies are used to insert into tracheal tissue, thereby fixing the device at the lesion site and forming a gap between the outer surface of the membrane supporting frame and the tracheal tissue.

[0008] In one embodiment of the instrument provided by the present invention, the value of n satisfies 2≤n≤12, and the height H of each of the pointed bodies satisfies: 450um≤H≤3000um.

[0009] In one embodiment of the instrument provided by the present invention, the center points of the proximal ends of at least some of the pointed bodies in each row are in the same plane.

[0010] In one embodiment of the instrument provided by the utility model, the spacing between the projections of any two adjacent rows of the pointed bodies in a plane perpendicular to the axial direction of the membrane support frame is equal.

[0011] In one embodiment of the instrument provided by the present invention, the membrane support frame includes a support frame and a membrane fixed on the support frame, and at least part of the plurality of pointed bodies are arranged on the surface of the membrane.

[0012] In one embodiment of the instrument provided by the present invention, the plurality of spikes are non-degradable spikes.

[0013] In one embodiment of the device provided by the present invention, the plurality of spikes include degradable spikes and non-degradable spikes, wherein the proportion of the non-degradable spikes is greater than or equal to 40% and less than 100%.

[0014] In one embodiment of the instrument provided by the present invention, the coating has a first covering portion, the first covering portion is provided with an opening, the proximal end of the pointed body is accommodated in the first covering portion and the distal end extends out of the opening.

[0015] In one embodiment of the instrument provided by the present invention, the pointed body includes a second covering portion, and the second covering portion covers at least a portion of the supporting frame.

[0016] The airway implant device of the utility model is provided with multiple rows of pointed bodies on the membrane support frame, and there is a channel for secretion flow between any two adjacent rows of pointed bodies. After the device is implanted into the diseased trachea, at least the distal ends of some of the pointed bodies are inserted into the diseased tracheal tissue, so that there is a gap between the outer wall of the device and the diseased tracheal tissue, so that the movement of the mucociliary hairs on the inner wall of the trachea is not blocked, and the secretion can be discharged from the channel, thereby reducing the retention of secretions in the trachea and reducing the discomfort caused to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a stereoscopic diagram of an embodiment of the airway implant device provided by the utility model;

[0018] Figure 2 yes Figure 1 A top view of the airway implant device is shown;

[0019] Figure 3 yes Figure 2 A cross-sectional view of the airway implant device shown implanted in the trachea;

[0020] Figure 4 yes Figure 1 A partial enlarged view of the A portion of the airway implant device shown;

[0021] Figure 5 yes Figure 4 A cross-sectional view along line CC of the first embodiment of the airway implant device shown;

[0022] Figure 6 yes Figure 4 A cross-sectional view along line CC of a second embodiment of the airway implant device shown;

[0023] Figure 7 yes Figure 4 A cross-sectional view along line CC of the third embodiment of the airway implant device shown;

[0024] Figure 8 yes Figure 1 A partial enlarged view of the B portion of the airway implant device shown;

[0025] Fig. 9 yes Figure 8 A cross-sectional view along line DD of the airway implant device is shown.

[0026] Explanation of the reference numerals: 1-wave ring; 2-connecting rod; 3-hollowing; 4-film; 41-first covering portion; 5-pointed body; 51-distal end; 52-proximal end; 53-second covering portion; 54-separation layer; 6-channel; 7-trachea. DETAILED DESCRIPTION

[0027] The airway implant device provided by the present invention is clearly and completely described below in conjunction with the accompanying drawings. It can be understood that the described embodiments are only some embodiments of the present invention, not all embodiments, and the present invention can be implemented in many other ways different from those described herein.

[0028] Unless otherwise defined, all technical terms and scientific terms used in this specification have the same meanings as those commonly understood by ordinary technicians in the technical field to which the utility model belongs. The terms used in this specification are only for describing specific embodiments and are not intended to limit the utility model.

[0029] It should be noted that all directional indications in the embodiments of this specification are only used to explain the relative position relationship, movement status, etc. between the components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0030] In addition, in the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this specification, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0031] The technical solutions of the various embodiments of the present utility model can be combined with each other, but it must be based on the fact that ordinary technicians in the field can implement it. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by the present utility model.

[0032] In this specification, "axial" refers to the direction parallel to the line connecting the distal center and the proximal center of the instrument; "radial" refers to the direction perpendicular to the above-mentioned axial direction, and the end of the pointed body close to the membrane support frame is defined as the proximal end, and the end away from the membrane support frame is defined as the distal end.

[0033] like Figures 1 to 9 As shown, the airway implant device provided by the utility model includes a membrane support frame and a plurality of spikes 5 arranged on the membrane support frame, and the plurality of spikes 5 are arranged in n rows separated from each other around the axis of the membrane support frame on the outer surface of the membrane support frame. A channel 6 extending along the axial direction X is formed between any two adjacent rows of the spikes 5, and the projections of any two adjacent rows of the spikes 5 in a plane perpendicular to the axial direction X of the membrane support frame are separated from each other, and the distal ends of at least some of the spikes 5 are used to insert into the tracheal tissue so as to fix the device in a predetermined position and to allow a gap to exist between the outer surface of the membrane support frame and the tracheal tissue. Alternatively, a portion of the spikes 5 is longer, and the remaining spikes 5 are shorter, and the longer portion of the spikes 5 can be inserted into the tracheal tissue to fix the device on the inner wall of the trachea 7, and the remaining spikes 5 form a support between the device and the trachea 7, and the gap between the two can be maintained during the breathing movement.

[0034] Specifically, the coated support frame is used to be implanted in the diseased trachea to support the trachea 7 and improve its stenosis effect, thereby ensuring the normal flow of gas. At least part of the distal end of the pointed body 5 penetrates into the inner wall of the diseased trachea 7, which can prevent the device from moving in the trachea 7. When the pointed body 5 is a drug-carrying pointed body, it can also perform drug treatment on the diseased trachea 7 after being partially inserted into the diseased trachea 7, and a gap can be formed between the outer surface of the coated support frame and the wall of the trachea 7. Figure 3The gap shown. The gap cooperates with the channel 6 to provide a flow channel for the secretions of the diseased trachea 7, so that the secretions can be discharged from the body under the movement of the villi.

[0035] The film support frame is preferably a tubular structure, such as a cylindrical structure, an elliptical cylindrical structure, a frustum structure, etc. In this embodiment, the film support frame is preferably cylindrical, and in other embodiments, the film support frame may also be a combination of one or more of the above structures.

[0036] In a preferred embodiment, the film-covering support frame includes a support frame and a film-covering. Figure 1 At least two corrugations 1 are shown and a connecting rod 2 is located between two adjacent corrugations 1. The corrugations 1 are composed of Z-shaped corrugations, and may also be made of other structures, which will not be described in detail here.

[0037] Preferably, one end of the connecting rod 2 is fixedly connected to the corrugated ring 1 at one end thereof, and the other end of the connecting rod 2 is fixedly connected to the corrugated ring 1 at the other end thereof, thereby connecting and fixing two adjacent corrugated rings 1. The corrugated ring 1 and the connecting rod 2 can be fixedly welded to each other or integrally formed, and the user can select the fixed connection method of the two as needed.

[0038] Preferably, the wave ring 1 and / or the connecting rod 2 are made of materials with good biocompatibility, such as nickel-titanium alloy, iron, magnesium alloy, stainless steel, polylactic acid, etc., which can be selected and set according to needs, so they are not described here in detail.

[0039] In a preferred embodiment, Figure 5 As shown, the end of the pointed body 5 close to the membrane support frame (indicated by the wave circle 1) is the proximal end 52, and the end away from the membrane support frame is the distal end 51. The cross-sectional area of ​​the distal end 51 of the pointed body 5 is smaller than the cross-sectional area of ​​the proximal end 52, thereby ensuring that the pointed body 5 can penetrate the trachea 7. Further, the pointed body 5 is preferably a cone, or a polygonal pyramid, etc. The shape of the pointed body 5 can be selected and set according to needs, which will not be repeated here.

[0040] In one embodiment, in the axial direction X, Figure 1 and Figure 2 As shown, the multiple spikes 5 in each column of spikes 5 are arranged in sequence at intervals, and the line connecting the proximal ends of the spikes 5 in each column on the coating support frame extends along the axial direction X, thereby enhancing the fixation and treatment effects on the linear distribution area and facilitating the formation of a channel 6 on the surface of the coating support frame between two adjacent columns of spikes 5.

[0041] Preferably, in each row of the spikes 5, the first and last two spikes 5 are respectively located at the two end ends of the coating support frame, and the remaining spikes 5 are distributed at equal intervals, thereby fixing the ends of the coating support frame, making them more firmly fixed and preventing them from detaching from the inner wall of the trachea 7.

[0042] In one embodiment, the plurality of pointed bodies 5 are arranged on the membrane support frame. Figure 1 Multiple rows spaced from each other are formed in the circumferential direction Y. As a preferred embodiment, the line connecting the proximal ends of all the spikes 5 in each row on the outer surface of the membrane support frame is located in a plane perpendicular to the axial direction X of the membrane support frame.

[0043] More preferably, the channel 6 extends in a direction parallel to the axial direction X and is consistent with the axial direction of the trachea 7, that is, the line connecting the proximal ends of the plurality of spikes in any row of spikes 5 is parallel to the axis of the instrument, so that Figure 3 The secretions and the like in the trachea 7 shown can be discharged smoothly along the channel 6 .

[0044] In one embodiment, the spikes 5 have n rows, where 2≤n≤12, and n is an integer. The user can select and set it according to the needs, and no specific limitation is made here.

[0045] When n is large, the number of channels 6 increases, and the width of channels 6 decreases, making it difficult for secretions to pass through channels 6, affecting the discharge of secretions. When n is small, the pointed body 5 cannot effectively open the trachea 7, making the gap between the inner wall of the trachea 7 and the outer wall of the membrane support frame small, thus affecting the discharge of secretions. n is limited to between 2 and 12, which can not only effectively open the trachea 7, but also maintain an appropriate width of the channel 6, ensuring that secretions are discharged in a timely and rapid manner, reducing the discomfort of the patient.

[0046] Preferably, if Figure 1 and Figure 2 As shown, in each row of pointed bodies 5, when a plurality of pointed bodies 5 are arranged in sequence and equidistantly along the axial direction X, it can be ensured that the pointed bodies 5 are subjected to uniform force when piercing the inner wall of the trachea 7, thereby extending their service life.

[0047] More preferably, the distance between two adjacent pointed bodies 5 can be selected and set as needed, and is not specifically limited here.

[0048] In one embodiment, in each row of spikes 5, the center points of the proximal ends 52 of at least some of the spikes 5 are in the same plane, thereby ensuring the width of the channel 6 and preventing some of the spikes 5 from being in the channel 6 to affect the flow of secretions in the channel 6.

[0049] In a preferred embodiment, the center points of the proximal ends 52 of all the spikes 5 in each column of spikes 5 are in the same plane, so that all the spikes 5 in the column of spikes 5 are neatly arranged in a row, which helps to reduce the impact on the outflow of secretions from the channel 6.

[0050] Preferably, any two adjacent rows of pointed bodies 5 are equidistantly arranged in the circumferential direction Y, that is, the spacing between the projections of any two adjacent rows of pointed bodies in a plane perpendicular to the axial direction X of the membrane support skeleton is equal, thereby ensuring that the width of each channel 6 is equal, and further ensuring the discharge effect of secretions, etc. at various positions in the circumferential direction, thereby minimizing the patient's discomfort.

[0051] In one embodiment, the pointed body 5 is disposed on the corrugated ring 1, or on the connecting rod 2, or the pointed body 5 is disposed on both the corrugated ring 1 and the connecting rod 2. The pointed body 5 can be disposed at any position on the corrugated ring 1 or the connecting rod 2 as required, and is not specifically limited here, as long as it can provide a stable supporting effect on the film support frame.

[0052] In one embodiment, if Figure 1 As shown, the pointed body 5 is also fixed on the surface of the coating 4. Preferably, the coating support skeleton has a hollow 3, and the hollow 3 is formed by the corrugated ring 1, or the connecting rod 2, or the combination of the corrugated ring 1 and the connecting rod 2. When the hollow 3 is formed by the corrugated ring 1, the corrugated ring 1 is preferably a wave or other geometric shape, and when the hollow 3 is formed by the connecting rod 2, the connecting rod 2 is preferably a wave or other geometric shape, and the user can select and set it according to needs, and no specific limitation is made here.

[0053] More preferably, a coating 4 is also fixed to the inner surface of the coated support frame and covers the hollow area 3, thereby preventing granulation tissue or tumors from entering the interior of the coated support frame and preventing the airway implant device from failing in function.

[0054] In such Figure 1 In the embodiment shown, the outer surface of the coating 4 is provided with a plurality of spikes 5. Furthermore, the inner surface of the coating 4 may also be provided with a plurality of drug-carrying spikes 5. The coating 4 is made of a material with good biocompatibility, such as ePTFE (clothing fabric laminated with a polytetrafluoroethylene microporous membrane and ordinary fabric), PET (polyethylene terephthalate), silk fibroin, silicone, etc.

[0055] In one embodiment, a portion of the pointed body 5 is a degradable pointed body. For example, the solvent of the raw material liquid of the pointed body 5 is water, and the solute is at least one of chitosan, sodium alginate, polyethylene glycol, PLGA (polylactic acid-hydroxy acid), PCL (polycaprolactone), PMMA (polymethyl methacrylate), PGA (polyglycolic acid), PLA (polylactic acid), PEA (polyetheramine), gelatin, hyaluronic acid, silk protein, etc., and the pointed body 5 can further be dispersed with liposomes, which are prepared from phosphatidylcholine and cholesterol. The raw material liquid and liposomes of the pointed body 5 can carry different drugs, and the added drugs are for preventing hyperplasia, therapeutic drugs and antibacterial drugs, etc. Common drugs are paclitaxel, rapamycin and its derivatives (such as sirolimus, zotarolimus, everolimus, tacrolimus and pimecrolimus), amine-coupled polyurethane (SA-PU) polymers, etc. Therefore, the pointed body 5 can be degraded after piercing the trachea 7 , so that the drug can have a therapeutic effect on the trachea 7 .

[0056] More preferably, the drug can be added to the raw material liquid to form the pointed body 5, and the drug content in the raw material liquid of the pointed body 5 is 1% to 10%, and more preferably, the drug content in the raw material liquid of the pointed body 5 is 1% to 5%. The surface of the pointed body 5 can also be coated with a drug content of 1% to 20%, and more preferably, the drug content is 10% to 15%, and the above ratio ranges are all mass percentages. Further, the total drug content of the implant is 30 to 300ug. The above-mentioned total amount and percentage of the drug can ensure the therapeutic effect of the drug and reduce the occurrence of diseases such as intimal hyperplasia.

[0057] More preferably, in order to meet the clinical needs of the target site, the spikes can be designed with appropriate height, diameter, number, drug concentration, drug type, degradation rate, etc. For example, in the place where the film support frame exerts too much pressure on the trachea 7, it is easier to cause hyperplasia due to stimulation of the trachea 7, so more spikes can be set at this position. For another example, there is a shear force at the position where the film support frame contacts the trachea 7, so it is easier to cause hyperplasia or form granulomas, and more drug-loaded spikes 5 can also be set to achieve a certain amount of drug to achieve the effect of preventing hyperplasia and granulomas.

[0058] Furthermore, the multiple pointed bodies 5 can carry different medicines, so as to achieve the treatment of different diseases. The user can set it according to needs, which will not be repeated here.

[0059] In one embodiment, the plurality of spikes 5 are all non-degradable spikes. Preferably, the spikes 5 are made of nickel-titanium alloy, stainless steel, iron alloy, PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), PTFE (tetrafluoroethylene), etc., and the connection between the spikes 5 and the membrane support frame can be welding or bonding.

[0060] More preferably, the pointed body 5 is made of non-degradable material and forms a long-term stable connection with the supporting frame or the coating 4, so that after the pointed body 5 penetrates into the trachea 7, it can be firmly connected with the trachea 7, thereby preventing the risk of the airway implant device slipping out of the trachea 7 and improving the structural stability.

[0061] In one embodiment, the total number of spikes in each column of spikes 5 is a, including degradable spikes and non-degradable spikes, the number of non-degradable spikes is b, and the ratio of non-degradable spikes b / a satisfies: b / a is greater than or equal to 40% and less than 100%. By limiting the number of non-degradable spikes, the fixing effect of the coating support frame can be ensured to prevent the device from slipping and displacing from the inside of the trachea 7.

[0062] When the pointed body 5 is in a conical shape, it is easier to penetrate the trachea 7. The pointed body 5 may also be in other shapes, such as a multi-faceted pyramid. The height H of the pointed body 5 satisfies: 450um≤H≤3000um. If the height of the pointed body is too small, after the device is implanted, the gap between the membrane 4 and the wall of the trachea 7 is too small, which is not conducive to the discharge of secretions. If the height of the pointed body is too large, the device needs to be transported by a conveyor with a larger diameter, which makes it difficult to implant.

[0063] In one embodiment, if Figure 5 As shown, the proximal end 52 of the pointed body 5 is attached to the membrane support frame and fixedly connected thereto.

[0064] Preferably, the proximal end 52 of the pointed body 5 can be attached to the wave ring 1 or to the connecting rod 2. The user can choose the setting according to the needs, and no specific limitation is made here.

[0065] In one embodiment, if Figure 6 As shown, the pointed body 5 includes a second covering portion 53, which can be a closed ring or an unclosed arc. The second covering portion 53 covers the membrane support frame to achieve a fixed connection with the membrane support frame.

[0066] Preferably, the second covering portion 53 and the pointed body 5 can be integrally formed, or fixedly connected by bonding or other methods.

[0067] More preferably, the second covering portion 53 covering the membrane support frame specifically means that the second covering portion 53 covers the wave ring 1 or covers the connecting rod 2 .

[0068] In one embodiment, if Figure 7 As shown, the pointed body 5 further includes a water-soluble separation layer 54 , and the water-soluble separation layer 54 is located between the pointed body 5 and the second covering portion 53 .

[0069] Preferably, the water-soluble separation layer 54 is made of an easily separable material, preferably a water-soluble adhesive, such as polyethylene glycol hydrogel, so that the device will quickly dissolve after encountering water or other liquids at a predetermined position, thereby achieving the separation of the pointed body 5 and the second covering portion 53; it can also be composed of hyaluronic acid and sucrose, with the mass ratio of hyaluronic acid to sucrose being 4:1, which can also play a role in separation.

[0070] More preferably, the provision of the water-soluble separation layer 54 can play a specific separation role, such as withdrawing an airway implant device, and the second covering portion 54 and the pointed body 5 can be separated only when the water-soluble separation layer 54 is dissolved after contacting water.

[0071] In one embodiment, if Figure 8 and Fig. 9 As shown, the pointed body 5 is connected to the coating 4 by being covered.

[0072] Preferably, a first covering portion 41 is provided on the coating 4, and a covering space is provided inside the first covering portion 41, and the covering space has an opening. The first covering portion 41 can be formed when the coating 4 is formed, thereby simplifying the process and improving the product yield.

[0073] More preferably, the proximal end 52 of the pointed body 5 is accommodated in the covering space of the first covering portion 41, and the distal end 51 extends from the opening of the covering space, and the area of ​​the proximal end 52 is larger than the area of ​​the opening, so that the proximal end 52 is movably restricted in the covering space of the first covering portion 41, thereby achieving a stable connection between the coating 4 and the pointed body 5 and preventing the pointed body 5 from detaching from the coating 4.

[0074] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the utility model, rather than to limit it. Although the utility model has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the utility model.

Claims

1. An airway implant device, characterized in that: It comprises a membrane support frame and a plurality of pointed bodies (5) arranged on the membrane support frame, wherein the plurality of pointed bodies (5) are arranged in n mutually separated rows around the axis of the membrane support frame on the outer surface of the membrane support frame, where n is an integer; a channel (6) extending along the axial direction (X) is formed between any two adjacent rows of the pointed bodies (5); and the projections of any two adjacent rows of the pointed bodies (5) in a plane perpendicular to the axial direction (X) of the membrane support frame are separated from each other, and the distal ends of at least some of the pointed bodies are used to insert into tracheal tissue, thereby fixing the device at the lesion site and forming a gap between the outer surface of the membrane support frame and the tracheal tissue.

2. The airway implant device according to claim 1, characterized in that: The value of n satisfies 2≤n≤12, and the height H of each of the pointed bodies satisfies: 450um≤H≤3000um.

3. The airway implant device according to claim 1, characterized in that: The center points of the proximal ends of at least some of the pointed bodies (5) in each row of the pointed bodies (5) are located in the same plane.

4. The airway implant device according to claim 1, characterized in that: The spacing between the projections of any two adjacent rows of the pointed bodies (5) in a plane perpendicular to the axial direction (X) of the membrane support frame is equal.

5. The airway implant device according to claim 1, characterized in that: The coating support frame comprises a support frame and a coating (4) fixed on the support frame, and at least part of the plurality of pointed bodies (5) are arranged on the surface of the coating (4).

6. The airway implant device according to claim 1, characterized in that: The plurality of pointed bodies (5) are non-degradable pointed bodies.

7. The airway implant device according to claim 1, characterized in that: The plurality of pointed bodies (5) include degradable pointed bodies and non-degradable pointed bodies, wherein the proportion of the non-degradable pointed bodies is greater than or equal to 40% and less than 100%.

8. The airway implant device according to claim 5, characterized in that: The coating (4) has a first covering portion (41), the first covering portion (41) is provided with an opening, the proximal end (52) of the pointed body (5) is received in the first covering portion (41) and the distal end extends out of the opening.

9. The airway implant device according to claim 5, characterized in that: The pointed body (5) comprises a second covering portion (53), wherein the second covering portion (53) covers at least a portion of the supporting frame.