Operation method of pressure vibration generation device

Abstract

To provide a novel therapy of sinusitis and an olfactory disorder without side effects and without troubles caused by manipulation such as respiratory distress.SOLUTION: An operation method of a device for generating pressure vibration so as to improve the symptoms of an aerial conduction olfactory disorder and / or sinusitis causes pressure vibration generated from a pressure vibration generation device to reach one or two or more places chosen from among the olfactory cleft, the middle nasal meatus, and the maxillary sinus through one-side nostril, without administration of a medicine.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a method of operating a pressure vibration generator.

Background Art

[0002] The nasal cavity and paranasal sinuses have a very complex structure with many intertwined passages. It has been considered that inhalation containing odorants reaches the olfactory epithelium present in the olfactory cleft in the upper part of the nasal cavity, enabling the perception of smell. However, exhalation is also known to be important. In addition, the natural ostia connecting the nasal cavity and paranasal sinuses are mainly present in the middle meatus. The pathological conditions of conductive olfactory disorders and rhinosinusitis are closely related to both airflow ventilation disorders and mucosal epithelial disorders.

[0003] The morbidity rate of olfactory disorders is said to be 1 - 3% in the United States, and is considered to be similar in Japan. Olfactory disorders due to COVID-19 have also come to be noticed. On the other hand, the morbidity rate of rhinosinusitis in Japan is said to be 5 - 6%. Various treatments have been carried out for conductive olfactory disorders and rhinosinusitis as drug therapies, but the effects have not been sufficient. It is considered that the factor is that the amount of drug transferred to the mucosa surrounded by the facial bones is insufficient in oral medications. Surgery is considered the last resort for treating inflammatory diseases of the complex paranasal sinuses, which are bone-mucosa complexes. In addition, in local administration, nasal drops or nebulizers have been used, but it is known that it is difficult for drugs to reach the lesion site due to the complex structure of the paranasal sinuses.

[0004] In such a situation, in order to improve drug delivery to the paranasal sinuses, a pressure vibration type nebulizer (manufactured by PARI Genus) has been developed and approved in Japan. This device aims to apply a fixed vibration of 44 Hz to allow more drugs such as steroids to reach the paranasal sinuses, which are the inflammatory sites. In addition, as improved versions of this pressure vibration type nebulizer, the nebulizers of Patent Documents 1 and 2 have also been reported.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] Special Publication No. 2013-524960 [Patent Document 2] Patent No. 6653000 [Overview of the project] [Problems that the invention aims to solve]

[0006] However, this pressurized vibration nebulizer device has drawbacks, such as requiring closure of the nostril on the opposite side of the vibration, making it cumbersome to operate and potentially causing shortness of breath. Furthermore, steroids, which are used to treat sinusitis, raise concerns about side effects such as thinning and atrophy of the skin, dilation of capillaries, increased susceptibility to infection due to a weakened immune system, and elevated blood sugar levels. Therefore, the object of the present invention is to provide a new treatment method for sinusitis and olfactory disorders that has no side effects and does not cause problems such as difficulty breathing due to the procedure. [Means for solving the problem]

[0007] Therefore, the inventors investigated ways to improve the symptoms of sinusitis and olfactory dysfunction without using drugs such as steroids. They found that by introducing pressure vibrations generated from a pressure vibration generator into one external nostril without administering drugs, the airflow and wall shear stress increased at one or more locations selected from the olfactory cleft, middle meatus, and maxillary sinus, both when the non-vibrating side was closed and when it was open, compared to normal breathing. This increased not only the inspiratory airflow but also the expiratory airflow, improving the symptoms of air-conducted olfactory dysfunction and sinusitis, thus completing the present invention.

[0008] In other words, the present invention provides the following inventions [1] to [4]. [1] A method for operating a pressure vibration generator to improve symptoms of air-conductive olfactory dysfunction and / or sinusitis, characterized in that pressure vibrations generated from the pressure vibration generator are sent to one or more locations selected from the olfactory cleft, middle meatus and maxillary sinus via one external nostril. [2] The operating method described in [1] wherein the frequency of the generated pressure vibration is 10 Hz to 80 Hz. [3] The method of operation according to [1] or [2], wherein when the generated pressure vibration is introduced into the nasal cavity through one external nostril, the pressure vibration generating device is operated without closing the external nostril that is not to which the pressure vibration is introduced. [4] The operating method according to any one of [1] to [3], wherein pressure vibrations are delivered to one or more locations selected from the olfactory cleft, middle nasal meatus and maxillary sinus via one external nostril, thereby increasing the flow rate and wall shear stress at one or more locations selected from the olfactory cleft, middle nasal meatus and maxillary sinus compared to normal breathing, and increasing not only the inspiratory flow rate but also the expiratory flow rate. [Effects of the Invention]

[0009] According to the present invention, without using drugs such as steroids, simply applying pressure vibration to the nasal cavity through one external nostril using a pressure vibration generator allows the vibration to reach one or more locations selected from the olfactory cleft, middle meatus, and maxillary sinus. In both cases, whether the non-vibrating side is closed or open, the airflow and wall shear stress increase at one or more locations selected from the olfactory cleft, middle meatus, and maxillary sinus compared to normal breathing. This increases not only the inspiratory flow rate but also the expiratory flow rate, improving the symptoms of air-conducted olfactory dysfunction and sinusitis. Therefore, compared to conventional nebulizer-based treatment, this method allows for safe and simple treatment of air-conducted olfactory dysfunction and sinusitis without the side effects of drugs and without the need to close the nostril on the side not receiving drug inhalation. Furthermore, numerous studies have recently reported the effectiveness of wound treatment using mechanical skin therapy (physical skin care) that does not rely on drugs. Mechanotherapy, which applies physical stimulation to the nasal mucosal epithelium using the method of the present invention, could become a pioneering treatment method that replaces expensive molecular targeted drugs. [Brief explanation of the drawing]

[0010] [Figure 1] This diagram shows the basic configuration of a pressure vibration device. [Figure 2]This diagram shows the airflow from the nostrils to the sinuses. The left side shows a view from the side of the face, and the right side shows a view from the front of the face. [Figure 3] This figure shows the relationship between pressure oscillation frequency and volumetric flow rate in the olfactory epithelium. The 0Hz line represents the flow rate during normal breathing. [Figure 4] This figure shows the relationship between pressure oscillation frequency and volumetric flow rate in the middle nasal meatus. The 0Hz line represents the flow rate during normal breathing. [Figure 5] This figure shows the relationship between pressure oscillation frequency and wall shear stress in the olfactory epithelium. The 0Hz line represents wall shear stress during normal respiration. [Figure 6] This figure shows the relationship between pressure oscillation frequency and airflow to the olfactory epithelium (comparison of maximum and minimum flow times). "Steady" represents airflow during normal breathing. [Figure 7] This figure shows the relationship between the frequency of pressure oscillations and the volumetric flow rate in the maxillary sinus (sinus floor) of the paranasal sinuses. [Modes for carrying out the invention]

[0011] The present invention relates to a method for operating a pressure vibration generator to improve symptoms of air-conductive olfactory dysfunction and / or sinusitis, characterized by causing pressure vibrations generated from the pressure vibration generator to reach one or more locations selected from the olfactory cleft, middle meatus, and maxillary sinus via one external nostril.

[0012] The pressure vibration generator used in this invention has the configuration shown in Figure 1. Air is drawn in by a blower, and vibrations are added to the airflow by a vibration generator containing a piston or diaphragm. This vibrating airflow is guided to a nozzle, its velocity is increased, and then it is introduced into the nostrils. The vibration generator can be any device capable of generating pressure vibrations with a frequency of 80 Hz or higher.

[0013] As described above, the nasal sinuses have a very complex structure with many intertwined passages. It has been assumed that an inhalation containing an odorant reaches the olfactory epithelium existing in the olfactory cleft in the upper part of the nasal cavity, and the odor is sensed. However, it is known that exhalation is also important. Further, the natural ostium connecting the nasal cavity and the paranasal sinuses mainly exists in the middle meatus. Usually, in drug administration by a nebulizer, since the inhalation cannot reach the olfactory cleft, the middle meatus, or the maxillary sinus, it is known that the drug does not reach the olfactory cleft, the middle meatus, or the maxillary sinus. On the other hand, if a pressure vibration is introduced into the upper part of the nasal cavity through one external nostril without drug administration, the pressure vibration can reach one or two or more locations selected from the olfactory cleft, the middle meatus, and the maxillary sinus. More specifically, the pressure vibration may be introduced from one external nostril into the upper part of the nasal cavity through an attachment capable of sending the pressure vibration generated from a pressure vibration generator to one external nostril (see FIG. 2).

[0014] The frequency of the pressure vibration introduced into the external nostril is not particularly limited. However, from the viewpoint of increasing the flow rate and the wall shear stress at one or two or more locations selected from the olfactory cleft, the middle meatus, and the maxillary sinus, and increasing not only the inhalation flow rate but also the exhalation flow rate as compared with normal breathing, it is preferably 10 Hz to 80 Hz, and more preferably 20 Hz to 60 Hz.

[0015] According to the method of the present invention, in both cases where the non-vibrating side is closed and where it is open, the flow rate and the wall shear stress increase at one or two or more locations selected from the olfactory cleft, the middle meatus, and the maxillary sinus as compared with normal breathing, and not only the inhalation flow rate but also the exhalation flow rate increases. When the non-vibrating side is closed, problems such as difficulty in breathing may occur. Therefore, when introducing the generated pressure vibration into the nasal cavity through one external nostril, the pressure vibration generator can be operated without closing the external nostril into which the pressure vibration is not introduced.

[0016] As described above, if pressure vibration is introduced into the upper part of the nasal cavity through one-sided external nostril, the pressure vibration can reach one or two or more locations selected from the olfactory cleft, middle nasal meatus, and maxillary sinus. Compared with normal breathing, the flow rate and wall shear stress increase at one or two or more locations selected from the olfactory cleft, middle nasal meatus, and maxillary sinus, and not only the inspiratory flow rate but also the expiratory flow rate increases. As a result, the flow rate and wall shear stress increase at one or two or more locations selected from the olfactory cleft, middle nasal meatus, and maxillary sinus, and not only the inspiratory flow rate but also the expiratory flow rate increases, so that the symptoms of conductive olfactory disorder and / or rhinosinusitis are improved without drug administration. In addition, olfactory rehabilitation for the symptoms or sequelae of novel coronavirus and olfactory disorders as prodromal symptoms of dementia is being carried out. The method of the present invention is useful as this olfactory rehabilitation.

Example

[0017] Next, the present invention will be described in more detail with reference to examples, but the present invention is not limited to these examples.

[0018] Example 1 Using a commercially available pressurized vibration type nebulizer (manufactured by PARI Genus), vibration aerosol therapy with physiological saline instead of a mixed solution of an antibiotic and a steroid agent, which has been commonly used, was performed on 3 patients with chronic rhinosinusitis accompanied by olfactory epithelial olfactory disorder showing moderate to severe olfactory loss 12 times a week for 3 months, and the effect was determined by symptoms and T&T olfactometry, which is a standard olfactory test. Under the condition of applying vibration from the external nostril, the changes in the airflow of the olfactory cleft, middle nasal meatus, and maxillary sinus, which are closely related to the onset of conductive olfactory disorder and rhinosinusitis, were analyzed by computational fluid dynamics (CFD). Specifically, images obtained from CT scans of three paranasal sinus cases were output as DICOM data. After creating a mesh, CFD analysis was performed using ANSYS CFX (ANSYS Inc.). The airflow velocity and wall shear stress in the olfactory cleft and middle meatus were analyzed under normal breathing conditions and with added vibrations at 25, 50, 75, and 100 Hz.

[0019] (result) As a result, it was confirmed that applying vibration to one nostril increased airflow and wall shear stress in the olfactory cleft and middle meatus compared to normal breathing in both the group with the non-vibrating side closed and the group with the left side open (Figures 3-6). Increased airflow was observed in the olfactory cleft at 25 and 50 Hz, and in the middle meatus at 25, 50, and 75 Hz, and both inspiratory and expiratory airflow increased. As a result, improvement in symptoms and loss of smell was observed in all cases. Furthermore, Figure 7 shows the relationship between the frequency of pressure oscillations and the volumetric flow rate within the maxillary sinus (sinus floor) of the paranasal sinuses. It was found that pressure oscillations cause airflow to reach not only the middle meatus but also the maxillary sinus.

Claims

1. A method for operating a pressure vibration generator to improve the symptoms of air conduction olfactory disorder and / or sinusitis, characterized in that pressure vibrations generated from the pressure vibration generator are delivered to one or more locations selected from the olfactory cleft, middle nasal meatus, and maxillary sinus via one external nostril without administering any medication.

2. 2. The method according to claim 1, wherein the frequency of the generated pressure vibration is 10 Hz to 80 Hz.

3. 3. The method of claim 1, wherein the pressure vibration generating device is operated without closing the nostril to which the pressure vibration is not introduced when the generated pressure vibration is introduced into the nasal cavity through one of the nostrils.

4. 3. The method according to claim 1 or 2, wherein the pressure vibration generator is operated so that the pressure vibration reaches one or more locations selected from the olfactory cleft, the middle nasal meatus, and the maxillary sinus via one external nostril, thereby increasing the airflow and wall shear stress at one or more locations selected from the olfactory cleft, the middle nasal meatus, and the maxillary sinus compared to normal breathing, thereby increasing not only the inhalation flow rate but also the exhalation flow rate.

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