Aerosol administration device cooperating with eustachian tube insufflation

Abstract

This invention relates to a nebulized drug delivery device for use with Eustachian tube insufflation, belonging to the field of medical device technology. Addressing the limitations of clinical treatment for secretory otitis media and Eustachian tube dysfunction, this invention comprises a nasal plug assembly, a nebulized drug cup, a Eustachian tube insulator, and a nebulizer. The nebulized drug cup is connected to the nasal plug assembly, and the Eustachian tube insulator is connected to one end of the nasal plug assembly's air inlet. The nebulized drug cup is connected to the nebulizer via a tubing. The nasal plug assembly includes dual nasal plug heads and a delivery tube, with the nebulized drug cup integrally connected to the sidewall of the delivery tube. This invention combines Eustachian tube insufflation with nebulized drug delivery, directly delivering medication to the Eustachian tube and middle ear cavity while the Eustachian tube is dilated. Furthermore, the dual nasal plug heads can simultaneously insulate and deliver medication to both nasal cavities and the Eustachian tube, ensuring safety and effectiveness during use while improving ease of operation and efficiency.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a nebulized drug delivery device that works in conjunction with Eustachian tube inflation. Background Technology

[0002] Otitis media with effusion (OME) is a common ear disease with an incidence rate as high as 5.2% to 21.6% in the general population. Clinically, hearing loss and a feeling of fullness or blockage in the ear are the primary symptoms, and it is one of the most common causes of hearing loss. The disease is prone to recurrence, and some acute OME patients may experience prolonged or recurrent episodes that can develop into chronic OME. Long-term chronic OME can lead to many complications, resulting in severe hearing loss. Eustachian tube dysfunction is currently considered an important cause of OME.

[0003] The Eustachian tube is a tubular structure connecting the middle ear cavity and the lateral wall of the nasopharynx. The segment of the Eustachian tube near the tympanic cavity is usually open, while the segment near the nasopharynx can narrow or widen. Normally closed, it only opens when swallowing, yawning, singing, or forcefully blowing the nose. The Eustachian tube plays a crucial role in maintaining middle ear pressure balance and drainage. Abnormal Eustachian tube function can lead to middle ear pressure imbalance and impaired drainage, causing symptoms such as a feeling of fullness in the ear, popping or cracking sounds in the ear, hearing loss, tinnitus, and increased self-hearing. It can also lead to complications such as secretory otitis media, chronic otitis media, tympanic adhesions, and tympanic sclerosis.

[0004] Currently, the main clinical treatments for secretory otitis media (OME) include medication, surgery, and conservative treatments such as Eustachian tube inflation. Surgical treatment is not currently the first-line treatment for OME due to its invasiveness, difficulty in operation, and poor patient tolerance. Clinically, Eustachian tube inflation is also a commonly used treatment method. Compared to surgery, it is non-invasive, has good compliance, and high safety, and is currently recognized as an effective non-invasive treatment for OME. Eustachian tube inflation involves actively or passively pressurizing the nasopharynx to open the Eustachian tube, allowing air to be blown into the middle ear, thereby improving Eustachian tube function, improving middle ear ventilation, and relieving negative pressure in the middle ear. Traditional inflation methods include the Valsalva maneuver, the Politzer maneuver, the catheter method, and the electric pressure pump method, but these methods may have complications such as tympanic membrane congestion and perforation, and some patients cannot cooperate with the procedure. The latest eustachian tube inflators are now used as one of the main methods of eustachian tube inflator treatment because of their controllable airflow, ease of operation, high safety, and ability to assist passive inflator in addition to active swallowing. They are suitable for adults and children over 2 years old.

[0005] However, the therapeutic effect of simple Eustachian tube inflation is limited. Simply opening the Eustachian tube to balance the pressure in the tympanic cavity is insufficient to relieve or eliminate middle ear inflammation. Therefore, there is an urgent need for a device that can both relieve the negative pressure in the middle ear, restore the ciliary system's movement, and promote the drainage of mucus into the nasopharynx, while simultaneously reducing inflammatory lesions and restoring normal gas exchange in the middle ear mucosa. This would allow for better treatment of conditions such as Eustachian tube dysfunction and secretory otitis media. Utility Model Content

[0006] In view of the shortcomings of the existing surgical techniques, such as tympanic membrane perforation and tympanic cavity sclerosis, and the inability of simple Eustachian tube inflation to eliminate inflammation, this utility model aims to provide a nebulized drug delivery device that works in conjunction with Eustachian tube inflation. By combining Eustachian tube inflation with nebulized drugs into a nasal nebulization component, the therapeutic effect on Eustachian tube dysfunction and secretory otitis media is improved. Furthermore, by setting up double nasal plugs that can be inserted into both nostrils simultaneously, the ease and efficiency of Eustachian tube inflation and drug delivery can be effectively improved, thereby solving the problems existing in the background technology.

[0007] This utility model achieves the above-mentioned technical objectives by adopting the following technical solutions: A nebulized drug delivery device for use with Eustachian tube inflator includes a nasal plug assembly, a nebulizing cup, an Eustachian tube inflator, and a nebulizer. The nebulizing cup is connected to the nasal plug assembly, and the Eustachian tube inflator is connected to one end of the air inlet of the nasal plug assembly. The nebulizing cup is connected to the nebulizer via a conduit. The nasal plug assembly includes two nasal plug heads and a delivery tube. The air outlet of the delivery tube is connected to the rear end of the two nasal plug heads, and the delivery tube communicates with the interior of the two nasal plug heads. The nebulizing cup is connected to the side wall of the delivery tube, and the nebulizing cup is at an angle of 30° to 45° to the delivery tube.

[0008] As a further preferred option of the above solution: the dual nose plugs are made of a flexible U-shaped structure, and the front end of the dual nose plugs is provided with a sealing cap.

[0009] Based on the above technical solution, the sealing cap is further shaped into a conical structure, and the front end of the sealing cap is provided with a vent hole, which communicates with the inner cavity of the double-nostril plug.

[0010] As a further preferred embodiment of the above solution: the outlet of the nebulizer cup is equipped with a shielding cover, which is hinged to the nebulizer cup.

[0011] As a further preferred embodiment of the above solution: the Eustachian tube inflator is detachably connected to the delivery tube via a connecting assembly.

[0012] Based on the above technical solution, the connecting assembly further includes a connecting pipe 1 disposed on the delivery pipe and a connecting pipe 2 disposed on the Eustachian tube inflator, and the connecting pipe 1 and the connecting pipe 2 are threadedly engaged.

[0013] Compared with the prior art, the present invention has the following beneficial effects: 1. This utility model combines eustachian tube inflation with nebulized drug delivery. Based on the traditional single physical therapy method of eustachian tube inflation device, it integrates drug delivery operation in the eustachian tube dilation state. It can allow nebulized drugs to directly enter the middle ear cavity through the dilated eustachian tube channel, eliminate inflammation in the eustachian tube and middle ear cavity, achieve better treatment effect, and is safer and more efficient than the invasive drug delivery method through catheter in clinical practice.

[0014] 2. By setting up dual nasal plugs, which connect to the Eustachian tube inflator, simultaneous inflation of both nostrils can be achieved. Compared to the currently used single-sided inflation, this is more efficient and easier to operate. In addition, the dual nasal plugs lengthen the Eustachian tube inflation path, effectively avoiding the drawbacks of excessive force that may occur when using the Eustachian tube inflator directly, which could lead to aggravation of middle ear inflammation, tympanic membrane congestion, or even tympanic membrane perforation. This makes it safer to use.

[0015] 3. By integrating the nebulizer cup into both nasal plugs, the nebulized medication can enter the nasal plugs before inflation, making it easier to directly blow the nebulized medication into the patient's Eustachian tube during inflation. This facilitates the combined treatment of inflation and nebulized medication, thereby doubling the therapeutic effect. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the embodiments will be briefly introduced below.

[0017] Figure 1 This is a schematic diagram of the overall structure of a nebulized drug delivery device that works in conjunction with Eustachian tube inflation according to this utility model. Figure 2 This is a schematic diagram showing the connection relationship between the nasal plug assembly, the nebulizer cup, and the Eustachian tube inflator of this utility model. Figure 3 This is a schematic diagram showing the connection between the nasal plug assembly and the nebulizer cup of this utility model; Figure 4 This is a schematic diagram of the nasal plug assembly of this utility model; Figure 5 This is a schematic diagram showing the connection relationship between the atomizing medicine cup and the shielding cover of this utility model; Figure 6 This is an enlarged view of the structure of the connecting component of this utility model; In the diagram: 1. Nasal plug assembly; 11. Double nasal plug head; 12. Delivery tube; 13. Occlusion cap; 14. Vent hole; 2. Nebulizer cup; 21. Masking cap; 3. Eustachian tube inflator; 4. Nebulizer; 5. Connecting assembly; 51. Connecting tube one; 52. Connecting tube two; 6. Catheter. Detailed Implementation

[0018] The technical solutions in the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments, not all embodiments. For those skilled in the art, other embodiments can be obtained without creative effort.

[0019] In the description of this utility model, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0020] Currently, for the treatment of Eustachian tube dysfunction and secretory otitis media, clinical practice often involves either Eustachian tube inflators or catheter-based drug delivery. However, both methods have drawbacks to varying degrees, making it impossible to ensure patient safety. Based on the currently used Eustachian tube inflators, the inventors sought to add drug delivery functionality, namely, administering medication simultaneously with Eustachian tube dilation. Inspired by the commonly used nebulized drug delivery method, they designed the device combining an Eustachian tube inflator and nebulized drug delivery, as described in this application. Furthermore, improvements were made to the single-nose inflator technique of current Eustachian tube inflators, resulting in the technical solution of this application: a nebulized drug delivery device for Eustachian tube inflator.

[0021] The following is in conjunction with the appendix Figure 1-6 The technical solution of this utility model is described in detail below.

[0022] Example 1: Reference Figure 1 This utility model proposes a nebulized drug delivery device for use with Eustachian tube inflator, including a nasal plug assembly 1, a nebulized drug cup 2, an Eustachian tube inflator 3, and a nebulizer 4. The nebulized drug cup 2 is connected to the nasal plug assembly 1, the Eustachian tube inflator 3 is connected to one end of the air inlet of the nasal plug assembly 1, and the nebulized drug cup 2 is connected to the nebulizer 4 through a conduit 6.

[0023] In this embodiment, both the Eustachian tube inflator 3 and the nebulizer 4 adopt existing technologies without any improvements. The Eustachian tube inflator 3 preferably uses the clinically commonly used brand, BonySy, and the nebulizer 4 is selected from clinically commonly used brands such as Omron and Yuwell.

[0024] like Figures 2-4As shown, the nasal plug assembly 1 includes a double nasal plug head 11 and a delivery tube 12. The air outlet of the delivery tube 12 is connected to the rear end of the double nasal plug head 11, and the delivery tube 12 communicates with the interior of the double nasal plug head 11. The nebulizer cup 2 is integrally connected to the side wall of the delivery tube 12, and the nebulizer cup 2 and the delivery tube 12 are at an angle of 30° to 45°. In this embodiment, the double nasal plug head 11 is made of a flexible material, preferably medical-grade silicone rubber, and the double nasal plug head 11 has an overall U-shaped structure with an arc, which conforms to ergonomic and aesthetic design. The delivery tube 12 is made of medical-grade hard plastic, and the connection between the delivery tube 12 and the double nasal plug head 11 is made by heat fusion.

[0025] In some preferred embodiments, a sealing cap 13 is provided at the front end of the dual nasal plug 11. The sealing cap 13 is also made of a flexible material, using the same material as the dual nasal plug 11 or other materials suitable for clinical use; such as Figure 4 As shown, the occlusion cap 13 has a conical structure. When the conical occlusion cap 13 is inserted into the patient's nostril, it can fully cover and block the patient's nostril opening. In addition, a ventilation hole 14 is provided at the front end of the occlusion cap 13. The ventilation hole 14 communicates with the inner cavity of the double nasal plug head 11. The nebulized medicine entering the double nasal plug head 11 is blown into the patient's eustachian tube passage through the ventilation hole 14 using the eustachian tube inflator 3.

[0026] like Figure 5 As shown, the nebulizer cup 2 has a cover 21 at its outlet. The cover 21 is hinged to the nebulizer cup 2. The connection between the cover 21 and the nebulizer cup 2 is through a hinge (similar to the hinge of a door / window). In its natural state, the hinge allows the cover 21 to be slightly open, so that the nebulized medication can enter the nasal plug 11 through the gap between the cover 21 and the nebulizer cup 2. When the eustachian tube inflator 3 is opened, the cover 21 rotates under the inflating pressure, thus blocking the outlet of the nebulizer cup 2. The patient's swallowing action opens the eustachian tube, and the eustachian tube inflator 3 blows the nebulized medication into the patient's eustachian tube passage and then into the middle ear cavity.

[0027] Specifically, the eustachian tube inflator 3 and the air inlet end of the delivery tube 12 are detachably connected via a connecting assembly 5, allowing for separate storage when not in use; for example Figure 6 As shown, the connecting assembly 5 includes a first connecting pipe 51 and a second connecting pipe 52. The first connecting pipe 51 is fixedly connected to one end of the air inlet of the delivery pipe 12 and has an internal thread. The second connecting pipe 52 is fixedly connected to the air outlet of the Eustachian tube inflator 3 and has an external thread. The internal thread and the external thread are compatible. The Eustachian tube inflator 3 and the delivery pipe 12 are detachably connected by the cooperation of the first connecting pipe 51 and the second connecting pipe 52.

[0028] Example 2: A nebulized drug delivery device that works in conjunction with Eustachian tube inflation, in practical clinical applications: Fill the nebulizer cup 2 with nebulized medication, connect the nebulizer cup 2 to the nebulizer 4 through the tubing 6, and connect the Eustachian tube inflator 3 to the delivery tube 12 by using the cooperation of connecting tube 1 51 and connecting tube 2 52. Swallowing a small sip of water beforehand (especially helpful for children) can aid in the swallowing process. Turn on the nebulizer 4. After the nebulized medication is expelled as mist, plug the nostrils with the double nasal plugs 11. Ensure the outer wall of the sealing cap 13 is tightly against the patient's nostrils to achieve a seal. Then, the patient begins to hold their breath while simultaneously activating the Eustachian tube inflator 3. After five seconds, the patient swallows. The Eustachian tube inflator 3 continues to operate. During swallowing, the patient's Eustachian tube passage opens, and the nebulized medication that has entered the double nasal plugs 11 is blown into the patient's Eustachian tube through the vent 14 and into the middle ear cavity via the Eustachian tube inflator 3. This treatment occurs at the moment the Eustachian tube passage opens during swallowing, so the above steps need to be repeated multiple times for medication administration. This can effectively treat inflammation in the middle ear cavity.

[0029] It should be noted that when eustachian tube inflator treatment is effective, a popping sound or a feeling of fullness in the ear can be felt. If the symptoms are severe or no popping sound or feeling of fullness is felt, the machine can be run for 8-10 seconds. When using a eustachian tube inflator, please note the following: 1) For those with severe ear infections, respiratory infections, severe nasal congestion, or cold symptoms, the infection should be eliminated before use to prevent bacteria from entering the middle ear; 2) If there is a tympanic membrane perforation, eustachian tube inflator treatment should be performed only after the perforation has healed; 3) If the patient has rhinitis or sinusitis, the nasal cavity should be cleaned before treatment. When children use the device, parents can try it themselves first and then guide the child to operate it to ensure accuracy.

[0030] It should be understood that the above detailed description of the embodiments of the present invention provided in the accompanying drawings is only for further explanation of the present invention and is not intended to limit the scope of the claimed present invention. Based on the embodiments of the present invention, any non-essential improvements and adjustments made by those skilled in the art based on the above description of the present invention are all within the protection scope of the present invention.

Claims

1. A nebulized drug delivery device for use with Eustachian tube inflation, characterized in that, The device includes a nasal plug assembly (1), a nebulizer cup (2), a Eustachian tube inflator (3), and a nebulizer (4). The nebulizer cup (2) is connected to the nasal plug assembly (1), and the Eustachian tube inflator (3) is connected to one end of the air inlet of the nasal plug assembly (1). The nebulizer cup (2) is connected to the nebulizer (4) via a tubing (6). The nasal plug assembly (1) includes a double nasal plug head (11) and a delivery tube (12). The air outlet of the delivery tube (12) is connected to the rear end of the double nasal plug head (11), and the delivery tube (12) is connected to the interior of the double nasal plug head (11). The nebulizer cup (2) is connected to the side wall of the delivery tube (12), and the nebulizer cup (2) and the delivery tube (12) are at an angle of 30° to 45°.

2. The nebulized drug delivery device for use with Eustachian tube inflation according to claim 1, characterized in that, The double nose plug (11) is a U-shaped structure made of flexible material.

3. The nebulized drug delivery device for use with Eustachian tube inflation according to claim 2, characterized in that, The front end of the double nose plug (11) is provided with a sealing cap (13).

4. The nebulized drug delivery device for use with Eustachian tube inflation according to claim 3, characterized in that, The sealing cap (13) has a conical structure, and the front end of the sealing cap (13) is provided with a vent hole (14), which is connected to the inner cavity of the double nose plug (11).

5. The nebulized drug delivery device for use with Eustachian tube inflation according to claim 1, characterized in that, The outlet of the nebulizer cup (2) is equipped with a shielding cover (21), which is hinged to the nebulizer cup (2).

6. The nebulized drug delivery device for use with Eustachian tube inflation according to claim 1, characterized in that, The Eustachian tube inflator (3) is detachably connected to the delivery tube (12) via the connecting assembly (5).

7. A nebulized drug delivery device for use with Eustachian tube inflatation according to claim 6, characterized in that, The connecting assembly (5) includes a first connecting pipe (51) disposed on the delivery pipe (12) and a second connecting pipe (52) disposed on the Eustachian tube inflator (3), and the first connecting pipe (51) and the second connecting pipe (52) are threaded together.

Images