Vibrating device for treating nasal congestion and sinusitis symptoms and method thereof

A device for treating nasal congestion and/or relieving sinusitis symptoms in a patient comprises: a vibration generator, a fastener configured to attach the vibrator to a location adjacent to the patient's nasal cavity, nasal passageway or sinuses and a generator of a fluid stream which delivers the fluid stream to the respiratory tract of the patient. The vibration includes a motor, an eccentric member rotatable by the motor and an impact member mechanically linked to the eccentric member such that the impact member is vibratable by the eccentric member.

FIELD OF THE INVENTION

The present invention generally relates to a vibrating medical device and method for treating and relieving symptoms of nasal congestion and sinusitis.

BACKGROUND OF THE INVENTION

Sinusitis is a medical condition that affects the lives of many millions of people around the world. As much as 15 million people each year develop symptoms of sinusitis, which are often annoying and disturbing to a patient from conducting his everyday life. The symptoms of sinusitis usually comprise pain, tenderness, and swelling depending on the affected sinus. Known treatment for sinusitis comprises use of nasal sprays and medication that cause blood vessels to narrow and are aimed to improve sinuses drainage. Other types of sinusitis require the use of antibiotics. However, the known suggested treatments are often not useful. Furthermore, for the medications used often have short-term expediency and most of the medications have undesirable side-effects.

Upper respiratory disorders, such as viral upper respiratory tract infections or “common cold”, allergic rhinitis and rhinosinusitis, are associated with impairment in mucociliary clearance in the nasal passages. Although the causes of these disorders are varied, they share common nasal symptoms, such as rhinorrhea, nasal congestion/blockage, and post-nasal drip. In these conditions, the mucous membranes of the nose and paranasal sinuses become irritated, leading to these symptoms. In some patients, this irritation is sufficient to hinder the normal drainage of the sinuses into the nasal cavity, resulting in blockage that may lead to additional impaired ciliary activity, intense pressure/pain, and increased likelihood of infection.

Allergic rhinitis (AR) is a condition that results from exposure to allergens, either during specific times of the year (seasonal allergic rhinitis) or all the year-round (perennial allergic rhinitis). Up to one-half of AR patients suffer from both seasonal as well as perennial AR, approximately one-third suffer from seasonal AR alone and another one-third from perennial AR alone. In either seasonal or perennial AR, the symptoms and treatment approaches are similar. Symptoms mostly include nasal congestion or stuffiness, rhinorrhea and nasal itching. Allergic rhinitis affects nearly 150 million people. The world's seven major pharmaceutical markets' annual sales of medicaments for treating allergic rhinitis are estimated to total more than $4.5 billion worldwide. The medicaments currently available include primarily prescription and over-the-counter antihistamines, decongestants and nasal corticosteroids, delivered by nasal sprays, evaporation devices, and ointments.

Upper Respiratory Tract Infections (URTI) and the common cold affect all ages and are uncomfortable conditions, associated with lost work and school days.

There is, therefore, a requirement in the art for a simple, safe, relatively cheap, noninvasive treatment which is also devoid of side-effects. There is a further requirement for a treatment modality with a high efficacy and a long-term relief effect on the person suffering from nasal congestion and/or sinusitis symptoms.

SUMMARY OF THE PRESENT INVENTION

It is hence one object of the invention to disclose a device for treating nasal congestion and/or relieving sinusitis symptoms in a patient. The aforesaid device comprises: (a) means for generating vibrations; (b) attaching means configured attach the generating means to a location adjacent to the patient's nasal cavity, nasal passageway or sinuses; and (c) means for generating a fluid stream and delivering the fluid stream to the respiratory tract of the patient.

It is a core purpose of the invention to provide the vibration generating means comprising a motor, an eccentric member rotatable by the motor and an impact member mechanically linked to the eccentric member such that the impact member is vibratable by the eccentric member.

Another object of the invention is to disclose the attaching means selected from a group consisting of clips, fasteners, a vacuum means and any combination thereof.

A further object of the invention is to disclose the generating means generating vibrations at frequency ranging from 0.5 Hz to 1,000 Hz.

A further object of the invention is to disclose the device comprising a medicament dispenser configured to dispense predetermined doses a medicament into the fluid stream.

A further object of the invention is to disclose the medicament adapted to treat a respiratory disorder selected from a group consisting of nasal congestion, sinusitis symptoms, mucociliary clearance of secretions and any combination thereof.

A further object of the invention is to disclose the medicament dispenser comprising a medicament container accommodating the medicament and a medicament releasing mechanism configured to release the medicament from the container.

A further object of the invention is to disclose the device further comprising means for conditioning the mixture prior to or during delivering the mixture to the patient's respiratory tract; the conditioning means is selected from a group consisting of a heating labyrinth adapted to heat the mixture and a cooling Peltier device adapted to cool the mixture.

A further object of the invention is to disclose the device adapted to deliver the vibrations to the nasal cavity, nasal passageway or sinuses, selected from a group consisting of nasal passageway, sinus, sinuses, nasal bone, root of the nose, dorsum of the nose, bridge of the nose, nostrils, frontal bone, temporal bone, maxilla bone, superciliary arch and any combination thereof.

A further object of the invention is to disclose the heating labyrinth is configured to vaporize the medicament.

A further object of the invention is to disclose the means for generating and delivering the fluid stream to the respiratory tract of the patient comprising a chamber and a fluid propelling means.

A further object of the invention is to disclose the propelling means comprising a piston reciprocatively movable therewithin; the piston is mechanically driven by an eccentric member rotatable by an electric motor.

A further object of the invention is to disclose the propelling means comprising an air turbine wheel driven by an electric motor.

A further object of the invention is to disclose the chamber provided with a medicament capsule configured for gradually dispensing the medicament.

A further object of the invention is to disclose the chamber in fluid communication with a nebulizer.

A further object of the invention is to disclose the nebulizer adapted for atomizing medicaments in liquid and powder form. The nebulizer is selected from a group consisting of a dry powder nebulizer, a soft mist inhaler, a human powered nebulizer, a vibrating mesh nebulizer, a jet nebulizer, an ultrasonic wave nebulizer, a powder medicament capsule and any combination thereof.

A further object of the invention is to disclose the means for generating and delivering the fluid stream to the respiratory tract comprising a receptacle configured for receiving a patient's nose.

A further object of the invention is to disclose the means for generating and delivering the fluid stream to the respiratory tract comprising at least one pipe member configured to connect the chamber with a patient's nostril.

A further object of the invention is to disclose the device comprising at least one additional eccentric vibrator; rotation axes of the eccentric vibrators are orthogonal to each other.

A further object of the invention is to disclose a method of treating nasal congestion and/or relieving sinusitis symptoms in a patient. The aforesaid method comprises: (a) providing a device for treating nasal congestion and/or relieving sinusitis symptoms in the patient further comprising: (i) means for generating vibrations; (ii) attaching means configured attach the generating means to a location adjacent to the patient's nasal cavity, nasal passageway or sinuses; and (iii) means for generating a fluid stream and delivering the fluid stream to the respiratory tract of the patient; the vibration generating means comprises a motor, an eccentric member rotatable by the motor and an impact member mechanically linked to the eccentric member; (b) attaching the impact member to the patient's nasal cavity, nasal passageway or sinuses; and (c) vibrating the impact member.

It is another core purpose of the invention to provide the wherein the step of vibrating the impact member is performed by means rotating the eccentric member mechanically linked to the impact member.

A further object of the invention is to disclose the method comprising a step of dispensing a medicament into the fluid stream.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor for carrying-out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide means and method of treating nasal congestion and/or relieving sinusitis symptoms in the patient, comprising attaching a vibration generating means to the patient head, at a location adjacent to sinuses to be treated, generating vibrations by the vibration generating means, and delivering the vibrations to the patient.

The term ‘body portions adjacent to nasal cavity, nasal passageways sinus or sinuses’ refers hereinafter to any location on the head of the patient, and especially to locations selected from the nasal bone, root-, dorsum- or bridge- of the nose, nostrils, frontal bone, temporal bone, maxilla bone, superciliary arch and any combination thereof. The term is further related to the pulmonary system.

It is according to one embodiment of the present invention, wherein the hereto-disclosed method additionally comprises forcing a stream of fluid towards the patient's respiration tract. The term ‘forcing a stream of fluid’ refers hereinafter to the generation of a flowing fluid and its direction-flow, either as a continuous flow of fluid or as pulses of the flowing fluid, generated by means of vents, fans, jets, injectors, compressors, pumping means or other means known in the art adapted to force a fluid towards at least one predetermined location. Preferably, the aforesaid fluid is air. Alternatively, the aforesaid fluid is a mixture of air and at least a liquid or a gas other than air.

Dry powder nebulizers are also in the scope of the invention.

It is according to another embodiment of the present invention, wherein the medicament is introduced into the dispenser by means of a disposable capsule or the like. The capsule comprises an envelope adapted to be punctured, such that at least a limited measure of the medicament contained in the capsule is forced to flow towards the pulsed column of fluid with a predetermined flux.

According to a further embodiment of the present invention, the medicament is contained into an envelope (capsule). The insertion of this capsule initiates the medicament delivery by means of a micro-switch triggered by the insertion of the medicament capsule into the container. The capsule provides coded information for activating the dispensing of the medicament. It is another embodiment of the present invention in which the medicament delivery is provided by two dimensional or three dimensional specific and predetermined fitting mechanism, e.g., fitting by means of shape and size. In a further embodiment of the present invention, the shape of the capsule inside the inhaler envelope provides lock-in-key information for activating the inhaler.

It is according to another embodiment of the present invention, wherein the method additionally comprises heating the fluid before or in the process of forcing it towards the respiratory tract. Such a heating step provides for an effective dispersion or evaporation of the fluid and/or the medicaments. It is further acknowledged in this respect that the method may also comprise a step or steps of physical or chemical activation of a medicament by reacting it with one or more reactants before or during the process of forcing the same towards the respiratory tract.

A device for treating nasal congestion and/or relieving sinusitis symptoms in a patient is further presented. This novel device is comprised of both an attaching means and a vibration generating means being either incorporated therein or interconnected therewith.

While the description sets forth various embodiment specific details, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting the invention. Furthermore, various applications of the invention, and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein.

Reference is now made toFIG. 1, presenting a turbine embodiment of a vibrating inhaler100. The aforesaid inhaler100comprises a housing110accommodating a battery120, control unit130and an electric motor140. A sliding cover115is shown in the disengaged position serves for battery replacement. Dashed lines116/117and arrow118indicate the trajectory of mounting sliding cover115onto inhaler100. The electric motor140is mechanically connected with a turbine wheel160and an eccentric member147by means of shafts143and145, respectively. Attaching means (applicator)150providing vibrations to a patient body200(for example, to the nasal bone) is mechanically interconnected with the eccentric member147by means of a drag link149. Vibration frequency ranging between 0.5 and 1000 Hz is defined by rotation speed of the electric motor140.

A turbine wheel160is disposed within turbine chamber165having an input opening163and an output opening166. A medicament container175is configured for dispensing an accommodated medicament. The container175is actuated by a button170such that the medicament is dispensed into a chamber167. The dispensed medicament is blown out through the output opening169into the patient's nostrils.

Reference is now made toFIG. 2, presenting an enlarged view of an arrangement which comprises a fluid propelling mechanism and an eccentric vibrating mechanism driven by the common electric motor140. Specifically, the turbine wheel160is mechanically connected to the electric motor140by means of the shaft143. The eccentric member147connected to the motor140by means of shaft145. The applicator150is mechanically connected to the eccentric member147by the means of drag link149.

Reference is now made toFIG. 3, presenting a medicament dispensing arrangement. The turbine wheel160sucks in an ambient air through the input opening163into the chamber165and propels the air through the opening166into the chamber167. The medicament dispensed from the container175by means of the actuating button170is blown out by pneumatic pressure created by the turbine wheel160into the patient nostrils.

Reference is now made toFIG. 4, presenting a piston-based embodiment of the vibrating inhaler300. The aforesaid inhaler comprises an on-off switch310, a control unit320, a battery330and an electric motor340. The inhaler300includes two vibrators. An off-axis mass345is mechanically connected to the electric motor340by means of a shaft343a. Vibrations created by the off-axis mass345are applied to any location mentioned above.

The fluid propelling means is embodied by means of a piston347driven by an eccentric mechanism comprising a shaft343b, an eccentric member343c, levers343dand343e. InFIG. 5, an operation mode of the eccentric mechanism is depicted. Specifically, the eccentric member343creciprocatively moves the piston347by means of the levers343dand343e(not shown).

A numeral360refers to a direction of medicament injection into a chamber350. The reciprocative movement of the piston347within the chamber350creates pneumatic pulses which are provided into the patient's nostrils. An area marked by a dashed line350refers to a receptacle configured for receiving a patient's nose.

Reference is now made toFIGS. 6-8presenting alternative embodiments of the present invention. Specifically,FIG. 6presents an embodiment300aconfigured for applying the vibrations to the superciliary arch by means of an applicator370a. Alternatively, an embodiment300binFIG. 7is provided with an applicator370bdesigned for the nose bone. The embodiment300cinFIG. 8includes an applicator370cdesigned for the maxillary arch.

Reference is now made toFIG. 9, presenting an embodiment300dof the present invention comprising a medicament capsule380. The aforesaid capsule380gradually dispenses the medicament into pneumatic pulses created within the chamber350by the reciprocatively moving piston347.

Reference is now made toFIG. 10, presenting an embodiment300eof the present invention. According to a specific embodiment, a nebulizer390is fluidly connected to the chamber350, and aerosol droplets are injected into the chamber350.

Reference is now made toFIG. 11, presenting an embodiment300fof the present invention. For patient convenience, the vibrating inhaler300fis secured to the patient's head by means of a lashing strap370d.

Reference is now made toFIG. 12, presenting an embodiment300iof the present invention. The reciprocating piston347and off-axis mass345are driven by independent electric motors340aand340b, respectively. Thus, frequencies of nasal vibration stimulation and pneumatic pulses provided into the nasal nostrils can be controlled independently.

Reference is now made toFIG. 13, presenting an embodiment300jof the present invention comprising at least two off-axis masses345aand345bdriven by340band340c, respectively. The off-axis masses345aand345brotate around rotation axes which are orthogonal in an exemplary manner.

Reference is now made toFIG. 14, presenting an embodiment300gof the present invention provided with pipe members350afor connection to a patient's nostril.

According to the present invention, a device for treating nasal congestion and/or relieving sinusitis symptoms in a patient is disclosed. The aforesaid device comprises: (a) means for generating vibrations; (b) attaching means configured attach the generating means to a location adjacent to the patient's nasal cavity, nasal passageway or sinuses; and (c) means for generating a fluid stream and delivering the fluid stream to the respiratory tract of the patient.

It is a core feature of the invention to provide the vibration generating means comprising a motor, an eccentric member rotatable by the motor and an impact member mechanically linked to the eccentric member such that the impact member is vibratable by the eccentric member.

According to one embodiment of the present invention, the attaching means is selected from a group consisting of clips, fasteners, a vacuum means and any combination thereof.

According to one embodiment of the present invention, the generating means generates vibrations at frequency ranging from 0.5 Hz to 1,000 Hz.

According to a further embodiment of the present invention, the device comprises a medicament dispenser configured to dispense predetermined doses a medicament into the fluid stream.

According to a further embodiment of the present invention, the medicament is adapted to treat a respiratory disorder selected from a group consisting of nasal congestion, sinusitis symptoms, mucociliary clearance of secretions and any combination thereof.

According to a further embodiment of the present invention, the medicament dispenser comprises a medicament container accommodating the medicament and a medicament releasing mechanism configured to release the medicament from the container.

According to a further embodiment of the present invention, the device further comprises means for conditioning the mixture prior to or during delivering the mixture to the patient's respiratory tract; the conditioning means is selected from a group consisting of a heating labyrinth adapted to heat the mixture and a cooling Peltier device adapted to cool the mixture.

According to a further embodiment of the present invention, the device is adapted to deliver the vibrations to the nasal cavity, nasal passageway or sinuses, selected from a group consisting of nasal passageway, sinus, sinuses, nasal bone, root of the nose, dorsum of the nose, bridge of the nose, nostrils, frontal bone, temporal bone, maxilla bone, superciliary arch and any combination thereof.

According to a further embodiment of the present invention, the heating labyrinth is configured to vaporize the medicament.

According to a further embodiment of the present invention, the means for generating and delivering the fluid stream to the respiratory tract of the patient comprises a chamber and a fluid propelling means.

According to a further embodiment of the present invention, the propelling means comprises a piston reciprocatively movable therewithin; the piston is mechanically driven by an eccentric member rotatable by an electric motor.

According to a further embodiment of the present invention, the propelling means comprises an air turbine wheel driven by an electric motor.

According to a further embodiment of the present invention, the chamber is provided with a medicament capsule configured for gradually dispensing the medicament.

According to a further embodiment of the present invention, the chamber is in fluid communication with a nebulizer.

According to a further embodiment of the present invention, nebulizer is adapted for atomizing medicaments in liquid and powder form. The nebulizer is selected from a group consisting of a dry powder nebulizer, a soft mist inhaler, a human powered nebulizer, a vibrating mesh nebulizer, a jet nebulizer, an ultrasonic wave nebulizer, a powder medicament capsule and any combination thereof.

According to a further embodiment of the present invention, the means for generating and delivering the fluid stream to the respiratory tract comprises a receptacle configured for receiving a patient's nose.

According to a further embodiment of the present invention, the means for generating and delivering the fluid stream to the respiratory tract comprises at least one pipe member configured to connect the chamber with a patient's nostril.

According to a further embodiment of the present invention, the device comprises at least one additional eccentric vibrator; rotation axes of the eccentric vibrators are orthogonal to each other.

According to a further embodiment of the present invention, a method of treating nasal congestion and/or relieving sinusitis symptoms in a patient is disclosed. The aforesaid method comprises: (a) providing a device for treating nasal congestion and/or relieving sinusitis symptoms in the patient further comprising: (i) means for generating vibrations; (ii) attaching means configured attach the generating means to a location adjacent to the patient's nasal cavity, nasal passageway or sinuses; and (iii) means for generating a fluid stream and delivering the fluid stream to the respiratory tract of the patient; the vibration generating means comprises a motor, an eccentric member rotatable by the motor and an impact member mechanically linked to the eccentric member; (b) attaching the impact member to the patient's nasal cavity, nasal passageway or sinuses; and (c) vibrating the impact member.

It is another feature purpose of the invention to provide the wherein the step of vibrating the impact member is performed by means rotating the eccentric member mechanically linked to the impact member.

According to a further embodiment of the present invention, the method comprises a step of dispensing a medicament into the fluid stream.