An integrated eustachian tube slow-release drainage device
By designing an integrated Eustachian tube slow-release drainage device, a drug-loadable and biodegradable elastic support and drainage mechanism are used to achieve drug slow release and effective drainage, solving the problem of the single function of existing devices and improving middle ear ventilation and treatment effects.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SHENZHEN NANSHAN DISTRICT PEOPLES HOSPITAL
- Filing Date
- 2025-04-07
- Publication Date
- 2026-06-12
AI Technical Summary
Existing Eustachian tube drainage devices have limited functionality, cannot simultaneously achieve sustained drug release therapy, and suffer from problems such as mucosal damage and high costs.
An integrated Eustachian tube sustained-release drainage device was designed, which uses a drug-loadable, biodegradable, and compressible elastic support, a drainage mechanism for drainage, and a biodegradable connecting line, combined with a hydrophilic layer, to achieve sustained drug release and effective drainage.
It effectively drains fluid from the Eustachian tube, improves middle ear ventilation, reduces mucosal damage, lowers the risk of infection, promotes mucosal repair, and treats Eustachian tube inflammation through sustained-release medication.
Smart Images
Figure CN224345075U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to an integrated Eustachian tube slow-release drainage device. Background Technology
[0002] Eustachian tube dysfunction is a complex eustachian tube abnormality that can lead to middle ear ventilation dysfunction and is also an important factor in the pathogenesis of middle ear diseases. Current treatment methods have many shortcomings. Drug treatment has limited effectiveness and some drugs have side effects. Surgical treatment, such as eustachian tube balloon dilation, has problems such as mucosal damage, pathogen invasion, high cost, and ineffectiveness in some patients.
[0003] Current simple drainage devices have limited functions. For example, the Eustachian tube indwelling tube positioning device and Eustachian tube indwelling drainage device disclosed in Chinese Patent Publication No. CN222075412U are used to position and fix the indwelling tube, including the fixation body. These drainage devices cannot simultaneously achieve sustained drug release therapy. With the advancement of sinus drug-elastic stent technology, new requirements and opportunities have been presented for the design and function of elastic stents, necessitating more precise and effective treatment solutions.
[0004] Therefore, it is essential to provide an integrated Eustachian tube slow-release drainage device to address the shortcomings of existing technologies. Utility Model Content
[0005] The purpose of this invention is to overcome the shortcomings of existing technologies and provide an integrated Eustachian tube sustained-release drainage device. This integrated Eustachian tube sustained-release drainage device can effectively drain fluid and secretions from the Eustachian tube, improve middle ear ventilation and drainage, and also has a drug-releasing sustained-release function.
[0006] The above-mentioned objectives of this utility model are achieved through the following technical measures:
[0007] An integrated Eustachian tube slow-release drainage device is provided, comprising a drug-loadable, biodegradable, and compressible elastic support, a drainage mechanism for draining fluid from the Eustachian tube, and a biodegradable connecting line, wherein the drainage mechanism is fixed to the front end of the elastic support via the connecting line.
[0008] Preferably, the above-mentioned elastic support is a cylindrical structure enclosed by a mesh structure.
[0009] Preferably, the drainage mechanism is a tubular structure, and the sidewall of the tubular structure is provided with multiple drainage holes for the entry of liquid from the Eustachian tube.
[0010] Preferably, the aforementioned elastic support is in communication with the drainage mechanism.
[0011] Preferably, the rear end of the above-mentioned drainage mechanism is provided with multiple connection holes, and the connection line passes through the connection holes and is fixed to the mesh structure of the elastic bracket.
[0012] The elastic support portion located inside the Eustachian tube is defined as the anterior sub-frame, and the elastic support portion protruding from the tympanic cavity orifice of the Eustachian tube is defined as the posterior sub-frame. The front end of the anterior sub-frame is fixed to the drainage mechanism via the connecting line.
[0013] When the elastic support is in its fully extended state, the diameter of the elastic support gradually increases from front to back.
[0014] The outer diameter of the front end of the front sub-frame is defined as d1, the outer diameter of the rear end of the rear sub-frame is defined as d2, and the outer diameter of the drainage mechanism is defined as d3. There exists a condition 1.0mm≤d1=d3≤1.5mm and 2d1≤d2≤4.0mm.
[0015] Preferably, the above-mentioned drainage mechanism is provided with a tube body and multiple eaves, each eave is integrally connected to the outer wall of the tube body, and all eaves are distributed at intervals on the outer wall of the tube body.
[0016] Preferably, the edge of the eaves bends toward the elastic support.
[0017] Each eave is equipped with multiple through holes for draining fluid from the Eustachian tube.
[0018] The length of the elastic support is defined as L1, and there exists a range of 30mm≤L1≤35mm.
[0019] The length of the drainage mechanism is defined as L2, where 15mm≤L2≤20mm.
[0020] The diameter of the drainage hole is 0.1mm to 0.2mm.
[0021] Preferably, the porosity of the above-mentioned mesh structure is 40% to 60%.
[0022] Preferably, the total length of the integrated Eustachian tube slow-release drainage device is 50 mm.
[0023] Preferably, the surface of the aforementioned drainage mechanism is further provided with a hydrophilic layer.
[0024] Preferably, the above-mentioned elastic scaffold is a chitosan elastic scaffold or a polycaprolactone elastic scaffold.
[0025] Preferably, the connecting wires are biodegradable protein wires;
[0026] Preferably, the above-mentioned drainage mechanism is a silicone drainage mechanism or a polylactic acid drainage mechanism.
[0027] This invention discloses an integrated Eustachian tube sustained-release drainage device, comprising a drug-loadable, biodegradable, and compressible elastic support, a drainage mechanism for draining fluid from the Eustachian tube, and a biodegradable connecting wire. The drainage mechanism is fixed to the front end of the elastic support via the connecting wire. This integrated Eustachian tube drainage device effectively drains fluid and secretions from the Eustachian tube, improving middle ear ventilation and drainage. The elastic support, made of biodegradable material, can carry drugs for continuous drug release, effectively treating Eustachian tube inflammation and other diseases, reducing inflammatory responses, and promoting mucosal repair. Furthermore, the biodegradable material of the elastic support reduces long-term impact on patients and lowers the risk of infection. Attached Figure Description
[0028] The present invention will be further described with reference to the accompanying drawings, but the content of the drawings does not constitute any limitation on the present invention.
[0029] Figure 1 This is a schematic diagram of an integrated Eustachian tube slow-release drainage device.
[0030] Figure 2 for Figure 1 Dimensioning diagram.
[0031] Figure 3 This is a schematic diagram of the structure inside the Eustachian tube in Example 1.
[0032] Figure 4 This is a schematic diagram of the integrated Eustachian tube slow-release drainage device in Example 2.
[0033] exist Figures 1 to 3 This includes:
[0034] Flexible support 100, front subframe 110, rear subframe 120.
[0035] 200 connecting cable
[0036] Drainage mechanism 300, drainage hole 310, connecting hole 320, pipe body 330, eaves 340, through hole 350. Detailed Implementation
[0037] The technical solution of this utility model will be further explained with reference to the following embodiments.
[0038] Example 1
[0039] An integrated Eustachian tube slow-release drainage device, such as Figures 1 to 3 As shown, the device includes a drug-loadable, biodegradable, and compressible elastic support 100, a drainage mechanism 300 for draining fluid from the Eustachian tube, and a biodegradable connecting wire 200. The drainage mechanism 300 is fixed to the front end of the elastic support 100 via the connecting wire 200. The surface of the drainage mechanism 300 is also provided with a hydrophilic layer.
[0040] It should be noted that the direction in which the integrated Eustachian tube drainage device of this utility model enters the Eustachian tube from outside the body is defined as the front end of the integrated Eustachian tube.
[0041] The elastic scaffold 100 is a chitosan elastic scaffold 100 or a polycaprolactone elastic scaffold 100; the connecting wire 200 is a biodegradable protein wire; the drainage mechanism 300 is a silicone drainage mechanism 300 or a polylactic acid drainage mechanism 300.
[0042] It should be noted that the elastic stent 100 in this invention is made of chitosan or polycaprolactone, both of which are common drug-loadable biodegradable materials. After being placed inside the body for a certain period, the elastic stent 100 degrades, releasing the drug loaded within it. Thus, the elastic stent 100 made from these materials possesses both drug-loaded sustained-release function and compressible elasticity. The material of the elastic stent 100 itself is not the subject of this invention. This invention protects the elastic stent 100 and its connection to the connecting wire 200 and the drainage mechanism 300 to form an integrated Eustachian tube drainage device. The connecting wire 200 is made of protein thread. After being placed inside the body for a certain period, the protein thread degrades and separates from the drainage mechanism 300, allowing the drainage mechanism 300 to be removed from the nasopharynx without needing to remove the Eustachian tube elastic stent 100. The silicone or polylactic acid drainage mechanism 300 is a biocompatible material that is unlikely to cause tissue reactions and possesses a certain degree of strength and flexibility, reducing friction and damage to the Eustachian tube mucosa. The hydrophilic layer facilitates the absorption of secretions by the drainage mechanism 300, further improving the drainage effect. The elastic support 100 of this invention is made of a biodegradable material, while the drainage mechanism 300 is made of a non-biodegradable material such as silicone or polylactic acid. This design ensures that after the elastic support 100 degrades, it adheres to the Eustachian tube mucosa and does not adequately support the Eustachian tube. Therefore, even after the elastic support 100 degrades, the drainage mechanism 300 can still provide drainage.
[0043] Because the Eustachian tube is physiologically curved, the chitosan elastic scaffold 100 or polycaprolactone elastic scaffold 100, and the silicone drainage mechanism 300 or polylactic acid drainage mechanism 300 of this invention all possess good flexibility while maintaining a certain strength, thus adapting to the natural curvature of the Eustachian tube and providing support. Furthermore, both the chitosan elastic scaffold 100 and the polycaprolactone elastic scaffold 100 are elastic, automatically opening and expanding after being inserted into the hydrophilic layer of the Eustachian tube, perfectly conforming to the surrounding structures. The hydrophilic layer of this invention is a layered structure composed of a hydrophilic material, that is, a substance with a strong affinity for water and capable of being wetted by water. The hydrophilic layer can be a hydrophilic polymer coating, a hyaluronic acid layer, etc.
[0044] It should also be noted that this integrated Eustachian tube drainage device is for patients with otitis media or cholesteatoma of the middle ear complicated by Eustachian tube dysfunction. The insertion method of this integrated Eustachian tube drainage device is as follows: the elastic support is radially compressed to a maximum outer diameter of no more than 1.5 mm. The integrated Eustachian tube drainage device is then inserted through the tympanic cavity orifice of the Eustachian tube, extending 1-1.5 cm beyond the pharyngeal orifice of the Eustachian tube. This length avoids causing a foreign body sensation or friction in the nasopharynx and facilitates later removal. After insertion, the elastic support naturally unfolds, the anterior support unfolds according to the inner diameter of the Eustachian tube and fits against the inner wall of the Eustachian tube, while the posterior support fully unfolds outside the tympanic cavity orifice of the Eustachian tube, thus preventing the integrated Eustachian tube drainage device from slipping outside the Eustachian tube. One month post-operation, the drainage tube is removed endoscopically through direct visualization of the nasopharynx. The elastic support partially dissolves and naturally detaches from the drainage device at this time.
[0045] The elastic stent 100 is a cylindrical structure enclosed by a mesh structure. The drainage mechanism 300 is a tubular structure, and the sidewalls of the tubular structure are provided with multiple drainage holes 310 for the entry of fluid from the Eustachian tube; the elastic stent 100 and the drainage mechanism 300 are interconnected. The diameter of the drainage holes 310 is 0.1 mm to 0.2 mm. The porosity of the mesh structure is 40% to 60%.
[0046] It should be noted that fluids such as effusion and secretions in the Eustachian tube can enter the drainage mechanism 300 through the drainage hole 310 and then flow out, thereby effectively draining the fluid from the Eustachian tube. It should also be noted that experiments have shown that when the porosity of the mesh structure of this invention is between 40% and 60%, controlled drug release can be achieved. When the porosity is less than this range, the effect is poor; when it is greater than the above range, the drug release rate increases. Only within the above range is the drug release rate slowed down, and the initial drug release amount is relatively small to avoid excessively high drug concentrations that could irritate the tissue. Later, as the elastic scaffold 100 degrades, the drug release rate gradually increases, ensuring that an effective drug concentration is maintained throughout the treatment process.
[0047] The rear end of the drainage mechanism 300 is provided with multiple connection holes 320, and the connecting line 200 passes through the connection holes 320 and is fixed to the mesh structure of the elastic support 100.
[0048] It should be noted that the connecting line 200 of this utility model fixes the drainage mechanism 300 and the elastic bracket 100 through the connecting hole 320.
[0049] The portion of the elastic support 100 located inside the Eustachian tube is defined as the anterior sub-support 110, and the portion of the elastic support 100 protruding from the tympanic cavity orifice of the Eustachian tube is defined as the posterior sub-support 120. The front end of the anterior sub-support 110 is fixed to the drainage mechanism 300 via the connecting line 200. When the elastic support 100 is in its fully deployed state, the diameter of the elastic support 100 gradually increases from front to back. The outer diameter of the front end of the anterior sub-support 110 is defined as d1, the outer diameter of the rear end of the posterior sub-support 120 is defined as d2, and the outer diameter of the drainage mechanism 300 is defined as d3. The following conditions exist: 10mm ≤ d1 = d3 ≤ 15mm, and 2d1 ≤ d2 ≤ 40mm.
[0050] It should be noted that this utility model prevents the integrated Eustachian tube drainage device from continuing to enter the human body by having the rear subframe 120 abut against the tympanic membrane and tympanic cavity opening mucosa.
[0051] The length of the elastic support 100 is defined as L1, where 30mm ≤ L1 ≤ 35mm. The length of the drainage mechanism 300 is defined as L2, where 15mm ≤ L2 ≤ 20mm. The total length of the integrated Eustachian tube slow-release drainage device is 50mm.
[0052] It should be noted that the Eustachian tube consists of a bony part of one-third of its length and a cartilaginous part of two-thirds of its length. The junction between the bony part and the cartilaginous part is the narrowest, with a diameter of about 1.5 mm. Therefore, the outer diameter of the drainage mechanism of this invention is set to be greater than 1.5 mm, so that it can pass smoothly through the junction.
[0053] This flexible stent 100 is made of biodegradable materials, enabling it to carry and continuously release medication for effective treatment of conditions such as eustachian tube inflammation, reducing inflammatory responses and promoting mucosal repair. Furthermore, the biodegradable materials in the flexible stent 100 minimize long-term impact on patients and reduce the risk of infection.
[0054] Example 2
[0055] An integrated Eustachian tube slow-release drainage device, such as Figure 4 As shown, other features are the same as in Embodiment 1, and it also has the following features: The drainage mechanism 300 is provided with a tube body 330 and multiple eaves 340, each eave 340 is integrally connected to the outer wall surface of the tube body 330, and all eaves 340 are distributed at intervals on the outer wall surface of the tube body 330. The edges of the eaves 340 are bent towards the elastic support 100. The diameter of the tube body 330 is 1mm to 2mm. Each eave 340 is provided with multiple through holes 350 for draining liquid from the Eustachian tube.
[0056] It should be noted that the bending of the edge of the eaves 340 towards the elastic support 100 in this embodiment facilitates the insertion of the integrated Eustachian tube drainage device into the Eustachian tube. Once in place, the eaves 340 and the rear sub-frame 120 cooperate to form two fixed points at the front and rear ends of the integrated Eustachian tube drainage device, effectively preventing overall displacement of the device. When the elastic support 100 and connecting line 200 degrade, the rear sub-frame 120 at the rear end of the integrated Eustachian tube drainage device disappears, allowing the drainage mechanism 300 to be easily removed from the nasopharynx. The through hole 350 on the eaves 340 allows fluid to pass through the Eustachian tube, further enhancing the drainage effect of the drainage mechanism 300.
[0057] Compared with Example 1, the integrated Eustachian tube drainage device of this embodiment can be more stably fixed in the Eustachian tube, thereby improving the reliability of treatment.
[0058] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model and are not intended to limit the scope of protection of this utility model. Although this utility model has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of this utility model without departing from the essence and scope of the technical solutions of this utility model.
Claims
1. An integrated Eustachian tube slow-release drainage device, characterized in that: The device is equipped with a drug-loadable, biodegradable, and compressible elastic stent, a drainage mechanism for draining fluid from the Eustachian tube, and a biodegradable connecting wire. The drainage mechanism is fixed to the front end of the elastic stent via the connecting wire.
2. The integrated Eustachian tube slow-release drainage device according to claim 1, characterized in that: The elastic support is a cylindrical structure enclosed by a mesh structure.
3. The integrated Eustachian tube slow-release drainage device according to claim 2, characterized in that: The drainage mechanism is a tubular structure, and the sidewall of the tubular structure is provided with multiple drainage holes for the entry of liquid from the Eustachian tube; The elastic support is connected to the drainage mechanism.
4. The integrated Eustachian tube slow-release drainage device according to claim 3, characterized in that: The rear end of the drainage mechanism is provided with multiple connection holes, and the connecting line passes through the connection holes and is fixed to the mesh structure of the elastic bracket.
5. The integrated Eustachian tube slow-release drainage device according to claim 4, characterized in that: The elastic support portion located inside the Eustachian tube is defined as the anterior subframe, and the elastic support portion protruding from the tympanic cavity orifice of the Eustachian tube is defined as the posterior subframe. The front end of the anterior subframe is fixed to the drainage mechanism via the connecting line. When the elastic support is in its fully extended state, the diameter of the elastic support gradually increases from front to back; The outer diameter of the front end of the front sub-frame is defined as d1, the outer diameter of the rear end of the rear sub-frame is defined as d2, and the outer diameter of the drainage mechanism is defined as d3. There exists a condition 1.0mm≤d1=d3≤1.5mm and 2d1≤d2≤4.0mm.
6. The integrated Eustachian tube slow-release drainage device according to claim 5, characterized in that: The drainage mechanism is provided with a tube body and multiple eaves, each eave is integrally connected to the outer wall of the tube body, and all eaves are distributed at intervals on the outer wall of the tube body; The edge of the eaves bends toward the elastic support.
7. The integrated Eustachian tube slow-release drainage device according to claim 6, characterized in that: Each eave is equipped with multiple through holes for draining fluid from the Eustachian tube.
8. The integrated Eustachian tube slow-release drainage device according to claim 6, characterized in that: The length of the elastic support is defined as L1, and there exists a range of 30mm ≤ L1 ≤ 35mm; The length of the drainage mechanism is defined as L2, where 15mm≤L2≤20mm; The diameter of the drainage hole is 0.1 mm to 0.2 mm; The porosity of the mesh structure is 40% to 60%; The total length of the integrated Eustachian tube slow-release drainage device is 50mm.
9. The integrated Eustachian tube slow-release drainage device according to any one of claims 1-8, characterized in that: The surface of the drainage mechanism is also provided with a hydrophilic layer.
10. The integrated Eustachian tube slow-release drainage device according to any one of claims 1-8, characterized in that: The elastic scaffold is a chitosan elastic scaffold or a polycaprolactone elastic scaffold; The connecting wires are biodegradable protein wires; The drainage mechanism is a silicone drainage mechanism or a polylactic acid drainage mechanism.