Middle ear stent and middle ear stent system

Abstract

The invention provides a middle ear stent and a middle ear stent system.The middle ear stent is used for being supported in a cut tympanic membrane in the axial direction of a middle ear, in the axial direction of the middle ear stent, the middle of the middle ear stent is necked down, the two ends of the middle ear stent are flared so that the position, placed in the tympanic membrane, of the middle ear stent can be fixed, and the middle ear stent is in a grid shape; therefore, the middle ear bracket is arranged in the middle ear so as to be convenient for ventilation and liquid ventilation. In this way, foreign body sensation of a patient is small, meanwhile, compression into a conveying system is facilitated, and the incision of the tympanic membrane cannot be damaged during implantation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a middle ear support and a middle ear support system. Background Technology

[0002] Secretory otitis media (SOM) is a non-suppurative inflammatory disease of the middle ear characterized by middle ear effusion and hearing loss; it is also known as catarrhal otitis media or exudative otitis media. This disease is common and frequently occurring in otolaryngology. Previous treatments, including oral antibiotics, corticosteroids, antihistamines, and mucolytics, have been largely ineffective. Patients with refractory otitis media often require surgical intervention to fully relieve their symptoms. Tympanostomy tube insertion is suitable for patients with recurrent and persistent refractory otitis media. It can balance the air pressure inside and outside the ear, promote ciliary movement of the tympanic tube, and drain middle ear effusion.

[0003] However, some studies have found that simple tympanotomy and tube insertion is difficult to completely improve the inflammatory response in patients with refractory otitis media. Intratympanic drug instillation is a novel route of drug delivery that allows drugs to act directly on the local lesion and exert a rapid anti-inflammatory effect.

[0004] Currently, most tympanotomy tube placement procedures use silicone or metal ventilation tubes for physical support of the tympanic incision. A significant clinical problem is that these instruments cause a strong foreign body sensation, leading to poor patient experience and impacting treatment outcomes. Furthermore, these instruments are inconvenient to deliver and implant.

[0005] In addition, these devices have the following shortcomings: (1) They are non-degradable and need to be removed twice; after a long period of contact with the tympanic membrane, some mucous membrane has adhered to the tube, and the removal during the second surgery will cause secondary damage to the already healed surgical site; some patients forget to remove them, and long-term retention in the ear canal may lead to infection, causing permanent perforation of the tympanic membrane, which in turn affects hearing.

[0006] (2) Without drug delivery, it cannot suppress middle ear inflammation; the current clinical intratympanic drug instillation technique requires patients to come to the hospital for drug instillation every day for 7 consecutive days, which requires patients to spend a lot of time and energy, and the patient compliance is low. Moreover, the drug instillation technique cannot guarantee that the amount of drug absorbed by the affected site can be controlled, which poses certain risks. Summary of the Invention

[0007] The purpose of this invention is to provide a middle ear support to solve the problems of current devices causing a strong foreign body sensation, poor patient experience, and affecting treatment effectiveness, as well as being inconvenient for delivery and implantation.

[0008] To solve the above-mentioned technical problems, the present invention provides a middle ear support for supporting the incised tympanic membrane along the axial direction of the middle ear. Along the axial direction of the middle ear support, the middle part of the middle ear support is constricted and the two ends are expanded to facilitate fixing the position of the middle ear support in the tympanic membrane. The middle ear support is mesh-shaped to facilitate the ventilation and fluid passage of the middle ear support in the middle ear.

[0009] Optionally, the middle ear support is made of a biodegradable material and is maintained for 14-60 days to prevent the cut tympanic membrane from reclosing.

[0010] Optionally, the biodegradable material includes: polylactic acid, polybutylene adipate / terephthalate, polybutylene succinate, polybutylene adipate, polycaprolactone, polypropylene carbonate, polyglycolic acid, or polydioxanone; or blends, copolymers, or homologues of polylactic acid, polybutylene adipate / terephthalate, polybutylene succinate, polybutylene adipate, polycaprolactone, polypropylene carbonate, polyglycolic acid, or polydioxanone.

[0011] Optionally, the elastic recovery rate of the middle ear support is not less than 90%, so that the middle ear support can have 90% rebound at the incision site of the tympanic membrane.

[0012] Optionally, the middle ear support is woven from at least one thread, and the mesh in the middle ear support has a diamond-shaped structure.

[0013] Optionally, the radial dimension of the middle ear support in its naturally released state is larger than the size of the cut tympanic membrane, so that the middle ear support is snapped onto the cut tympanic membrane, and the middle ear support is placed at a position on the tympanic membrane that is lower along the direction of gravity.

[0014] Optionally, when the middle ear support is formed by weaving silk threads, the number of intersections of the middle ear support is 1-3; the diameter of the silk threads of the middle ear support is 0.1-0.3mm;

[0015] Alternatively, the radial dimension of the middle ear support is 3-5 mm; the longitudinal length of the middle ear support is 1-3 mm; and the number of vertices of the middle ear support is 3-5.

[0016] Preferably, the middle ear support has a support body and a drug release layer, the drug release layer includes a drug, and the drug release layer is attached to the outside of the support body to achieve sustained release;

[0017] Alternatively, the drug release period of the drug sustained-release layer is 1-60 days;

[0018] Alternatively, the drug sustained-release layer can be applied by ultrasonic spraying;

[0019] Alternatively, the drug may include prednisone, methylprednisone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone, or mometasone furoate, or the drug may be a combination of prednisone, methylprednisone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone, or mometasone furoate.

[0020] Alternatively, the drug sustained-release layer comprises a drug and a biodegradable polymer, wherein the drug is one or more drugs, and when there are multiple drugs, the different drugs have different or the same sustained-release period; the biodegradable polymer is a biodegradable material or a mixture of multiple biodegradable materials.

[0021] The present invention also provides a middle ear support system, comprising: a delivery device and a middle ear support as described above, wherein the delivery device is for implantation from one side of the outer ear, and the middle ear support is placed through an incision in the tympanic membrane.

[0022] Optionally, the delivery device includes: a push rod and a hose, the push rod being located inside the hose and movable within the hose, the distal end of the hose having a bend with a radial curvature of 0-10°, the end of the bend being positioned in the middle ear to release the middle ear support, the inner diameter of the hose matching the radial dimension of the compressed middle ear support; the inner diameter of the hose is 1-3 mm.

[0023] This invention provides a middle ear support and a middle ear support system. The middle ear support is used to support the incised tympanic membrane along the axial direction of the middle ear. Along the axial direction of the middle ear support, the middle portion of the support is constricted while the two ends are flared to facilitate fixing the position of the middle ear support within the tympanic membrane. The middle ear support is mesh-like to facilitate air and fluid permeability within the middle ear. This reduces the patient's foreign body sensation and facilitates compression into the delivery system without damaging the tympanic membrane incision during implantation. Attached Figure Description

[0024] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0025] Figure 1 This is a perspective view of the middle ear support provided in an embodiment of the present invention.

[0026] Figure 2 This is a schematic diagram of the middle ear support implanted into the middle ear tissue according to an embodiment of the present invention.

[0027] Figure 3 for Figure 2 A cross-sectional view of the middle ear support after it has been implanted into the middle ear tissue.

[0028] Figure 4 This is a schematic diagram of the delivery device for the middle ear support provided in an embodiment of the present invention.

[0029] In the attached image:

[0030] 10-Middle ear support;

[0031] 20-Conveyor, 21-Push rod, 22-Hose. Detailed Implementation

[0032] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention.

[0033] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or” unless otherwise expressly indicated. Furthermore, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. It should be noted that the following detailed description is illustrative and intended to provide further explanation of the application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0034] A middle ear support and a middle ear support system are disclosed. The middle ear support is used to support the incised tympanic membrane along the axial direction of the middle ear. Along the axial direction of the middle ear support, the middle ear support has a constricted middle section and flared ends to facilitate fixing the position of the middle ear support within the tympanic membrane. The middle ear support is mesh-like to facilitate air and fluid permeability within the middle ear. This design minimizes the patient's foreign body sensation and facilitates compression into the delivery system without damaging the tympanic membrane incision during implantation.

[0035] The following will describe this embodiment in detail.

[0036] Figure 1 A perspective view of the middle ear support provided in an embodiment of the present invention; Figure 2 This is a schematic diagram of the middle ear support implanted into the middle ear tissue according to an embodiment of the present invention; Figure 3 for Figure 2 Cross-sectional view of the middle ear support after implantation into the middle ear tissue; Figure 4 This is a schematic diagram of the delivery device for the middle ear support provided in an embodiment of the present invention.

[0037] like Figures 1 to 3 As shown, this embodiment provides a middle ear support 10 for supporting the incised tympanic membrane along the axial direction of the middle ear. Along the axial direction of the middle ear support 10, the middle ear support 10 has a constricted middle section and flared ends to facilitate fixing its position within the tympanic membrane. The middle ear support 10 is mesh-like to facilitate air and fluid circulation within the middle ear. The constricted middle section and flared ends of the middle ear support 10 represent a longitudinal section along the middle ear support 10. The middle ear support 10 is hourglass-shaped or I-shaped (the I-shaped section has a cylindrical middle section and flared ends, meaning the radial dimension of the middle section is smaller than that of the ends). The constricted middle section is fixed at the incision site of the tympanic membrane, and the flared ends have a radial dimension larger than the incision site, ensuring the middle ear support 10 does not dislodge. The mesh-like design minimizes the contact area between the main body of the middle ear support 10 and the tympanic membrane, thus reducing the patient's foreign body sensation and achieving good support with a smaller proportion of material in the same space. Simultaneously, the mesh-like design facilitates compression into the delivery system. When the distal end of the delivery system is implanted into the tympanic membrane incision, the middle ear support 10 is released, allowing it to be directly placed at the tympanic membrane incision site without damaging it. In contrast, silicone or metal ventilation tubes are directly inserted during implantation, which can damage the tympanic membrane incision.

[0038] Preferably, the middle ear support 10 is made of biodegradable material. After fulfilling its supporting function, the middle ear support 10 degrades within a predetermined time, with some being absorbed by the body and some being expelled from the external auditory canal. This eliminates the need for a second surgery, avoiding damage to the tympanic membrane. The middle ear support 10 lasts for 14-60 days to prevent the incisional tympanic membrane from re-closing. Compared to silicone and metal airways, the biodegradable design allows for biodegradation after the tympanic membrane incision has healed, eliminating the need for a second surgery. The biodegradable material middle ear support 10 can degrade within two months and will not remain in the tympanic membrane incision for an extended period. In practice, after a period of time following surgery, the doctor can determine whether removal is necessary based on the actual situation.

[0039] Preferably, the biodegradable material includes: polylactic acid, polybutylene adipate / terephthalate, polybutylene succinate, polybutylene succinate-adipate, polycaprolactone, polypropylene carbonate, polyglycolic acid, or polydioxanone; or blends, copolymers, or homologues of polylactic acid, polybutylene adipate / terephthalate, polybutylene succinate, polybutylene succinate-adipate, polycaprolactone, polypropylene carbonate, polyglycolic acid, or polydioxanone.

[0040] Preferably, the elastic recovery rate of the middle ear support 10 is not less than 90%. This ensures that the middle ear support 10 can have 90% rebound at the incision site of the tympanic membrane. It should be understood that because the incision site of the tympanic membrane is very fragile, the middle ear support 10 only needs to open the incision site. The middle ear support 10 is compressed in the delivery system, and when it is implanted into the incision site of the tympanic membrane, the high elastic recovery rate of the middle ear support 10 allows the entire middle ear support 10 to be implanted into the incision site of the tympanic membrane.

[0041] Preferably, the middle ear support 10 is woven from at least one thread, and the mesh in the middle ear support 10 has a diamond-shaped structure. The diamond-shaped structure ensures the stability of the support structure.

[0042] Preferably, the radial dimension of the middle ear support 10 in its naturally released, constricted state is larger than the size of the cut tympanic membrane, so that the middle ear support 10 is snapped into the cut tympanic membrane, and the middle ear support 10 is positioned lower on the tympanic membrane along the direction of gravity. This ensures that the middle ear support 10 is securely snapped into the tympanic membrane, and also facilitates better drainage of fluid.

[0043] Preferably, when the middle ear support 10 is formed by weaving silk threads, the number of intersections of the middle ear support 10 is 1-3, for example, 1, 2, or 3; the diameter of the silk threads of the middle ear support 10 is 0.1-0.3 mm, for example, 0.1, 0.2, or 0.3 mm; the number of vertices of the middle ear support 10 can represent the density of the middle ear support 10, and this density can also directly create different elastic recovery rates for the tympanic membrane.

[0044] Alternatively, the radial dimension of the middle ear support 10 is 3-5 mm, for example, 3, 4, or 5; the longitudinal length of the middle ear support 10 is 1-3 mm, for example, 1, 2, or 3; and the number of vertices of the middle ear support 10 is 3-5, for example, 3, 4, or 5. The combination of the number of intersections and the diameter of the wires allows the patient to experience different sensations with the middle ear support 10, resulting in different elastic recovery rates.

[0045] Preferably, the middle ear support 10 has a support body and a drug-releasing layer, the drug-releasing layer comprising a drug, and the drug-releasing layer is attached to the outside of the support body to achieve sustained release. The drug contained in the middle ear support 10 can also be absorbed by the middle ear, exerting a targeted therapeutic effect and inhibiting middle ear inflammation.

[0046] Alternatively, the drug release period of the sustained-release layer is 1-60 days; for example, 10, 20, 30, 40, 50, or 60 days.

[0047] Alternatively, the drug sustained-release layer can be applied by ultrasonic spraying;

[0048] Alternatively, the medication may include prednisone, methylprednisone, betamethasone, beclomethasone dipropionate, prednisolone, hydrocortisone, dexamethasone, or mometasone furoate, or a combination of prednisone, methylprednisone, betamethasone, beclomethasone dipropionate, prednisolone, hydrocortisone, dexamethasone, or mometasone furoate. This allows the medication to directly diffuse to the incision site of the tympanic membrane, be absorbed by the surgical site, and directly contact the lesion site over a large area, achieving targeted drug delivery and improving the efficiency of drug treatment. This results in better treatment outcomes, avoids the harm of oral administration or re-implantation of medication, and eliminates the need for postoperative nasal spray treatment. The medication may possess antibacterial, anti-inflammatory, or anti-granulation scarring properties, thereby inhibiting scar growth at the tympanic membrane, ensuring rapid healing of the tympanic membrane, and maintaining long-term patency of the ear canal.

[0049] Alternatively, the drug-release layer comprises a drug and a biodegradable polymer, wherein the drug is one or more drugs, and when multiple drugs are used, different drugs have different or the same release period; the biodegradable polymer is a single biodegradable material or a mixture of multiple biodegradable materials. This drug-loaded design effectively prevents the suppression of otitis media after implantation of the middle ear stent 10, thus avoiding secondary infection.

[0050] The present invention also provides a middle ear support system 10, comprising: a delivery device and a middle ear support 10 as described above, wherein the delivery device is for implantation from one side of the outer ear, and the middle ear support 10 is placed through an incision in the tympanic membrane.

[0051] Preferably, the delivery device includes a push rod and a hose, the push rod being located inside the hose and movable within the hose, the distal end of the hose having a bend with a radial curvature of 0-10°, the end of the bend being positioned in the middle ear to release the middle ear support 10, the inner diameter of the hose matching the radial dimension of the compressed middle ear support 10; the inner diameter of the hose is 1-3 mm, for example 1, 2, or 3 mm.

[0052] In summary, this application provides a middle ear support and a middle ear support system. The middle ear support is used to support the incised tympanic membrane along the axial direction of the middle ear. Along the axial direction of the middle ear support, the middle portion of the support is constricted while the two ends are expanded to facilitate fixing the position of the middle ear support within the tympanic membrane. The middle ear support is mesh-like to facilitate ventilation and fluid permeation within the middle ear. This minimizes the patient's foreign body sensation and facilitates compression into the delivery system, preventing damage to the tympanic membrane incision during implantation. The middle ear support provides good support for the tympanic membrane incision, drains middle ear effusion, and balances the air pressure inside and outside the ear. The support minimizes foreign body sensation and provides good comfort after implantation. The support allows for targeted drug treatment of the lesion site, directly contacting the lesion site over a large area, eliminating the need for postoperative middle ear drug instillation. The middle ear support is completely biodegradable and does not require removal after surgery, avoiding repeated visits to the patient and preventing secondary damage to the surgical site.

[0053] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the claims.

Claims

1. A middle ear support, characterized in that, The middle ear support is used to support the incised tympanic membrane along the axial direction of the middle ear. The middle ear support has a constricted middle section and flared ends to facilitate fixing the position of the middle ear support in the tympanic membrane. The middle ear support is mesh-shaped to facilitate ventilation and fluid passage in the middle ear.

2. The middle ear support according to claim 1, characterized in that, The middle ear support is made of biodegradable material and lasts for 14-60 days to prevent the cut tympanic membrane from reclosing.

3. The middle ear support according to claim 2, characterized in that, The biodegradable materials include: polylactic acid, polybutylene adipate / terephthalate, polybutylene succinate, polybutylene adipate-succinate, polycaprolactone, polypropylene carbonate, polyglycolic acid, or polydioxanone; or blends, copolymers, or homologues of polylactic acid, polybutylene adipate / terephthalate, polybutylene succinate, polybutylene adipate-succinate, polycaprolactone, polypropylene carbonate, polyglycolic acid, or polydioxanone.

4. The middle ear support according to claim 1, characterized in that, The elastic recovery rate of the middle ear support is not less than 90%, which allows the middle ear support to have 90% rebound at the incision site of the tympanic membrane.

5. The middle ear support according to claim 1, characterized in that, The middle ear support is woven from at least one thread, and the mesh in the middle ear support has a diamond-shaped structure.

6. The middle ear support according to claim 1, characterized in that, The radial dimension of the middle ear support in its naturally released state is larger than the size of the cut tympanic membrane, so that the middle ear support can be snapped onto the cut tympanic membrane. The middle ear support is placed at a position on the tympanic membrane that is lower along the direction of gravity.

7. The middle ear support according to claim 1, characterized in that, When the middle ear support is formed by weaving silk threads, the number of intersections in the middle ear support is 1-3; the diameter of the silk threads in the middle ear support is 0.1-0.3mm. Alternatively, the radial dimension of the middle ear support is 3-5 mm; the longitudinal length of the middle ear support is 1-3 mm; and the number of vertices of the middle ear support is 3-5.

8. The middle ear support according to claim 1, characterized in that, The middle ear support has a support body and a drug release layer, the drug release layer includes a drug, and the drug release layer is attached to the outside of the support body to achieve sustained release; Alternatively, the drug release period of the drug sustained-release layer is 1-60 days; Alternatively, the drug sustained-release layer can be applied by ultrasonic spraying; Alternatively, the drug may include prednisone, methylprednisone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone, or mometasone furoate, or the drug may be a combination of prednisone, methylprednisone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone, or mometasone furoate. Alternatively, the drug sustained-release layer comprises a drug and a biodegradable polymer, wherein the drug is one or more drugs, and when there are multiple drugs, the different drugs have different or the same sustained-release period; the biodegradable polymer is a biodegradable material or a mixture of multiple biodegradable materials.

9. A middle ear support system, characterized in that, include: The delivery device and the middle ear support according to any one of claims 1-8, the delivery device being for implantation from the outer ear side, the middle ear support being placed through a tympanic membrane incision.

10. The middle ear support system according to claim 9, characterized in that, The delivery device includes a push rod and a hose. The push rod is located inside the hose and is movable within the hose. The distal end of the hose has a bend with a radial curvature of 0-10°. The end of the bend is positioned in the middle ear to release the middle ear support. The inner diameter of the hose matches the radial dimension of the compressed middle ear support; the inner diameter of the hose is 1-3 mm.

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