CN219629862U

CN219629862U - Eustachian tube bracket

Info

Publication number: CN219629862U
Application number: CN202320494415.3U
Authority: CN
Inventors: 高尚; 董频; 刘钰莹; 陈歆维; 严敏珠
Original assignee: Shanghai First Peoples Hospital
Current assignee: Shanghai First Peoples Hospital
Priority date: 2023-03-15
Filing date: 2023-03-15
Publication date: 2023-09-05
Anticipated expiration: 2033-03-15

Abstract

The utility model provides a eustachian tube support, which is formed by encircling a medicine-carrying degradable material with a reticular structure into a cone shape, is provided with a first end and a second end which are opposite, adopts a degradable medicinal polyester material, can realize medicine carrying (carrying glucocorticoid medicine), is designed into the cone shape (the shape of the cone shape is similar to that of the part from the eustachian tube pharyngeal opening to the eustachian tube isthmus, namely the whole cartilage part), can adapt to the shape of eustachian tube, can continuously release glucocorticoid medicine, can treat eustachian tube mucosa, submucosa and cilia inflammation for a long time, and can prevent eustachian tube adhesion; and the eustachian tube bracket can be automatically degraded without taking out again, so that the pain and the economic pressure of a patient can be relieved.

Description

Eustachian tube bracket

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a eustachian tube bracket.

Background

The eustachian tube is a channel for communicating the tympanic cavity with the nasopharynx part, the total length is 31-38 mm, and the average length is 36mm, and the eustachian tube is composed of eustachian tube bone parts (outer 1/3) and cartilage parts (inner 2/3). The tympanic end opening of the eustachian tube is a tympanic opening, which is about 2mm wide and 5mm high. The opening in the nasopharynx, called the pharyngeal orifice, is located on the nasopharynx side wall, is triangular or oval in shape, is about 5mm wide and 9mm high. The eustachian tube is widest at the pharyngeal orifice, tapers outwardly, is narrowest at the juncture of the bony and cartilage portions, is about 1mm wide and 2mm high, and is known as the isthmus. The length of the bone part is about 11-12mm, and the length of the cartilage part is about 25mm, accounting for 2/3 of the total length. The cartilage part is full of elasticity, and in a normal resting state, the eustachian tube is closed due to the passive elasticity of cartilage and the pressure of surrounding tissues, and the lumen is in a slit shape, and only in swallowing and yawning, the cartilage part is opened and the eustachian tube is opened due to the operation of adjacent muscles. However, in pathological conditions, the eustachian tube cannot be opened normally, and eustachian tube dysfunction will occur.

The eustachian tube of the human body is a complex and viable organ with a long and narrow lumen and relatively weak dilated muscles, which results in eustachian tube being prone to dysfunction. Eustachian tube dysfunction is mainly caused by insufficient opening of a middle ear lumen, and eustachian tube expansion is not fully related to chronic negative middle ear pressure, difficulty in balancing middle ear pressure and tympanitis with effusion, and is easy to cause adhesive tympanitis, cholesteatoma and tympanic membrane perforation after long-term development.

For eustachian tube insufficiency, eustachian tube balloon dilatation (BET) is the latest treatment method, and the most effective dilatation part is the middle part of the cartilaginous part of the eustachian tube, so that the cartilaginous part caused by cartilage microfracture can be hardened and thinned, and the lumen is enlarged, especially the physiological isthmus lumen is enlarged. However, for inflammation and ciliated lesions of the eustachian tube mucosa and submucosa, the expansion does not produce a fundamental therapeutic effect, and the expansion itself may also produce new lesions and adhesions.

Studies show that dexamethasone is injected through eustachian tube and throat under the endoscope, has a certain curative effect on treating chronic secretory otitis media, can improve bone conduction threshold and aquaporin expression level of each frequency of patients, and effectively inhibits inflammatory response. But repeatedly injecting dexamethasone through the eustachian tube under the endoscope, the eustachian tube orifice is easy to damage and adhere, part of the medicine is easy to be discharged rapidly through the nasopharynx part, and the medicine cannot stay in the eustachian tube for a long time to exert the curative effect. The above drawbacks also limit the clinical application of dexamethasone and balloon dilation injected through the orifice of the eustachian tube.

Disclosure of Invention

The utility model aims to provide a eustachian tube support, which adopts degradable medicinal polyester materials, can realize medicine carrying (carrying glucocorticoid medicine), is designed into a cone-shaped (approximate cone-shaped, the shape of which is close to the part from eustachian tube pharyngeal opening to eustachian tube isthmus, namely the whole cartilage part), can adapt to the eustachian tube shape, can continuously release glucocorticoid medicine, can treat eustachian tube mucosa, submucosa and cilia inflammation for a long time, and can prevent eustachian tube adhesion; and the eustachian tube bracket can be automatically degraded without taking out again, so that the pain and the economic pressure of a patient can be relieved.

In order to achieve the above object, an embodiment of the present utility model is achieved by:

in a first aspect, an embodiment of the present utility model provides a eustachian tube stent, where the eustachian tube stent is formed by enclosing a drug-loaded degradable material with a mesh structure into a cone shape, and has a first end and a second end opposite to each other, where the first end is an oval opening, a first major axis has a size of 1.8mm to 2.2mm, and a first minor axis has a size of 0.9mm to 1.1mm; the second end is an oval opening, the second major axis is 8.5 mm-9.5 mm in size, and the second minor axis is 4.5 mm-5.5 mm in size; the distance between the first end and the second end is 23-27 mm.

With reference to the first aspect, in a first possible implementation manner of the first aspect, the first major axis dimension is 2mm, the first minor axis dimension is 1mm, the second major axis dimension is 9mm, the second minor axis dimension is 5mm, and a distance between the first end and the second end is 25mm.

With reference to the first aspect, in a second possible implementation manner of the first aspect, the first major axis dimension is 1.8mm, the first minor axis dimension is 0.9mm, the second major axis dimension is 8.5mm, the second minor axis dimension is 4.5mm, and a distance between the first end and the second end is 23mm.

With reference to the first aspect, in a third possible implementation manner of the first aspect, the first major axis dimension is 2.2mm, the first minor axis dimension is 1.1mm, the second major axis dimension is 9.5mm, the second minor axis dimension is 5.5mm, and a distance between the first end and the second end is 27mm.

With reference to the first aspect, in a fifth possible implementation manner of the first aspect, a first wire loop is disposed at the oval opening of the first end, and a second wire loop is disposed at the oval opening of the second end.

With reference to the fifth possible implementation manner of the first aspect, in a sixth possible implementation manner of the first aspect, the side surface of the first wire loop and the side surface of the second wire loop are looped with at least one groove.

With reference to the first aspect, in a seventh possible implementation manner of the first aspect, the eustachian tube stent has micro-elasticity or shape memory characteristics, and a supporting force of the eustachian tube stent is not less than 0.15N.

With reference to the first aspect, in an eighth possible implementation manner of the first aspect, the eustachian tube scaffold is made of a pharmaceutically-degradable polyester material loaded with a glucocorticoid drug.

The beneficial effects are that: the eustachian tube stent is designed to replace the existing saccule proposal, after the eustachian tube stent is placed in the cartilaginous part of the eustachian tube, the supporting force of the eustachian tube stent can maintain the cartilaginous part to form an open lumen shape, and the eustachian tube stent is carried with glucocorticoid medicines, can continuously release the medicines, can treat the mucous membrane, submucosa and cilia inflammation of the eustachian tube for a long time and prevent the adhesion of the eustachian tube; and the medical instrument can be automatically degraded without taking out again, and can relieve the pain and economic pressure of patients. The designed reticular structure can greatly reduce the contact surface of the eustachian tube bracket and the mucous membrane, and is beneficial to reducing the occurrence of eustachian tube mucous membrane, submucosa and cilia inflammation caused by the propping of the eustachian tube bracket. The oval opening part of first end is equipped with first silk circle, and the oval opening part of second end is equipped with the second silk circle, can reduce the stimulus (no edges and corners structure) to the mucosa, and the side of first silk circle and the side ring of second silk circle establish at least one slot, can increase again with the contact stability of mucosa to guarantee the stability of eustachian tube support installation.

In order to make the above objects, features and advantages of the present utility model more comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present utility model, the drawings that are needed in the embodiments of the present utility model will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present utility model and should not be considered as limiting the scope, and other related drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic view of a eustachian tube stent according to an embodiment of the present utility model.

Fig. 2 is a schematic view of a first wire loop according to an embodiment of the present utility model.

Icon: 10-eustachian tube stent; 11-a first wire loop; 12-a second wire loop; 13-network structure; 14-grooves.

Detailed Description

The technical solutions in the embodiments of the present utility model will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present utility model.

In the description of the present utility model, it should be noted that, the azimuth or positional relationship indicated by the terms "inner", "outer", etc. are based on the azimuth or positional relationship shown in the drawings, or the azimuth or positional relationship that is commonly put in use of the product of this application, are merely for convenience of describing the present utility model and simplifying the description, and do not indicate or imply that the device or element to be referred to must have a specific azimuth, be configured and operated in a specific azimuth, and therefore should not be construed as limiting the present utility model. Furthermore, the terms "first," "second," and the like, are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.

It should also be noted that the terms "disposed," "coupled," and "connected" are to be construed broadly, and may be, for example, fixedly coupled, detachably coupled, or integrally coupled, unless otherwise specifically defined and limited; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

Referring to fig. 1-2, fig. 1 is a schematic view of a eustachian tube stand 10 according to an embodiment of the present utility model; fig. 2 is a schematic view of a first wire loop (or a second wire loop) according to an embodiment of the present utility model.

In this embodiment, the eustachian tube stent 10 is formed by enclosing a drug-loaded degradable material of the mesh structure 13 into a cone-shape (essentially similar to a cone-shape, rather than an absolute cone-shape, and may be designed to have a certain curvature to adapt to the shape of the cartilage portion of the actual eustachian tube) and has opposite first and second ends. The first end is an oval opening (an approximate oval shape, which can be changed to adapt to the opening of the isthmus of the actual eustachian tube), the opening is provided with a first wire ring 11 (which can be understood as an oval ring), and at least one groove 14 (shown in fig. 2) is formed around the side surface of the first wire ring 11. The second end is also an oval opening (similar to an oval shape, which can be changed to adapt to the shape of the actual pharyngeal orifice of the eustachian tube), the oval opening of the second end is provided with a second wire ring 12, and at least one groove 14 (shown in fig. 2) is arranged on the side surface of the second wire ring 12 in a surrounding way.

The oval opening of the first end has a first major axis dimension of 1.8mm to 2.2mm (e.g., 1.8mm, 2.0mm, 2.2mm, etc.) and a first minor axis dimension of 0.9mm to 1.1mm (e.g., 0.9mm, 1.0mm, 1.1mm, etc.).

The oval opening of the second end has a second major axis dimension of 8.5mm to 9.5mm (e.g., 8.5mm, 9.0mm, 9.5mm, etc.) and a second minor axis dimension of 4.5mm to 5.5mm (e.g., 4.5mm, 5.0mm, 5.5mm, etc.).

The overall distance between the first end and the second end is 23-27 mm (e.g., 23mm, 25mm, 27mm, etc.).

Because the scheme adopts the mesh structure 13 (carrying glucocorticoid medicaments) prepared from the medicinal degradable polyester materials, the eustachian tube stent 10 can be designed into a staggered mesh structure in order to ensure that the supporting force of the eustachian tube stent 10 can be not less than 0.15N, and the required supporting force is met by adjusting the diameter of a mesh wire of the mesh structure. Also, the eustachian tube stent 10 has a slight elasticity (also referred to as shape memory properties) for ease of placement.

Taking a practical application as an example: the eustachian tube stent 10 adopts degradable medicinal polyester materials as important components of printing materials, and adopts solid homogeneous eutectic 3D printing technology to directly melt or disperse the medicines in the printing base material. The three-dimensional modeling is followed by printing and molding, so that the eustachian tube stent 10 and the drug (glucocorticoid drug) are perfectly fused, and the chemical behavior of degradation in the stent body and the physical behavior of drug release are blended.

Through researching a plurality of medicine carrying modes and three-dimensional structures, according to clinical requirements and actual use scenes of the eustachian tube stent 10, different hormone medicines can be designed to co-melt the formula, and the support strength, degradation speed and medicine release time of the eustachian tube stent 10 are adjusted:

specifically, in the degradable polyester stent slow-release system taking glucocorticoid as a main drug, the eustachian tube stent 10 is designed into a double-wire staggered net structure, the maintaining time of the eustachian tube stent 10 is between 7 days and 3 months, the stent supporting force is more than or equal to 0.15N, the elastic recovery rate of the eustachian tube stent 10 is more than or equal to 90%, and the total in-vitro real-time drug release for 21 days is more than or equal to 80% of the total drug amount.

Therefore, the eustachian tube bracket 10 designed according to the scheme can adapt to the form of eustachian tube, can continuously release glucocorticoid medicaments, can treat eustachian tube mucosa, submucosa and cilia inflammation for a long time, and can prevent eustachian tube adhesion; can be automatically degraded and discharged for about 3-4 weeks without being taken out again, and can relieve the pain and economic pressure of patients.

In summary, the embodiment of the present utility model provides a eustachian tube stent 10, which replaces the existing balloon scheme, after the eustachian tube stent 10 is placed in the cartilaginous part of the eustachian tube, the supporting force of the eustachian tube stent 10 can maintain the cartilage part to form an open lumen shape, and the eustachian tube stent 10 is loaded with glucocorticoid medicines, so that the medicines can be released continuously, and the eustachian tube mucosa, submucosa and cilia inflammation can be treated for a long time, so as to prevent adhesion of the eustachian tube; and the medical instrument can be automatically degraded without taking out again, and can relieve the pain and economic pressure of patients. The mesh structure 13 can greatly reduce the contact surface between the eustachian tube stent 10 and the mucous membrane, which is beneficial to reducing the occurrence of eustachian tube mucous membrane, submucosa and cilia inflammation caused by the supporting of the eustachian tube stent 10. The oval opening part of first end is equipped with first silk circle 11, and the oval opening part of second end is equipped with second silk circle 12, can reduce the stimulus (no edges and corners structure) to the mucosa, and the side of first silk circle 11 and the side of second silk circle 12 encircle and establish at least one slot 14, can increase again with the contact stability of mucosa to guarantee the stability of eustachian tube support 10 installation.

The above description is only an example of the present utility model and is not intended to limit the scope of the present utility model, and various modifications and variations will be apparent to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present utility model should be included in the protection scope of the present utility model.

Claims

1. A eustachian tube support is characterized in that the eustachian tube support is formed by enclosing a medicine-carrying degradable material with a net structure into a cone shape and is provided with a first end and a second end which are opposite,

the first end is an oval opening, the first major axis is 1.8 mm-2.2 mm in size, and the first minor axis is 0.9 mm-1.1 mm in size;

the second end is an oval opening, the second major axis is 8.5 mm-9.5 mm in size, and the second minor axis is 4.5 mm-5.5 mm in size;

the distance between the first end and the second end is 23-27 mm.

2. The eustachian tube stent of claim 1, wherein the first major axis is 2mm in size, the first minor axis is 1mm in size, the second major axis is 9mm in size, the second minor axis is 5mm in size, and the distance between the first end and the second end is 25mm.

3. The eustachian tube stent of claim 1, wherein the first major axis is 1.8mm in size, the first minor axis is 0.9mm in size, the second major axis is 8.5mm in size, the second minor axis is 4.5mm in size, and the distance between the first end and the second end is 23mm.

4. The eustachian tube stent of claim 1, wherein the first major axis is 2.2mm in size, the first minor axis is 1.1mm in size, the second major axis is 9.5mm in size, the second minor axis is 5.5mm in size, and the distance between the first end and the second end is 27mm.

5. The eustachian tube stent of claim 1, wherein the oval opening of the first end is provided with a first wire loop and the oval opening of the second end is provided with a second wire loop.

6. The eustachian tube stent of claim 5, wherein the side of the first wire loop and the side of the second wire loop are looped with at least one groove.

7. The eustachian tube stent according to claim 1, wherein the eustachian tube stent has micro-elastic or shape memory properties, and the supporting force of the eustachian tube stent is not less than 0.15N.

8. The eustachian tube stent of claim 1, wherein the eustachian tube stent is prepared from a pharmaceutically acceptable degradable polyester material carrying a glucocorticoid drug.