WO2003094694A2

WO2003094694A2 - Hand held device for inhalation therapy and method of use thereof

Info

Publication number: WO2003094694A2
Application number: PCT/IL2003/000359
Authority: WO
Inventors: Nimrod Lev; Eitan Landau; Shirit Aviram
Original assignee: Medihale Ltd.
Priority date: 2002-05-08
Filing date: 2003-05-04
Publication date: 2003-11-20
Also published as: AU2003223094A1; WO2003094694A3; AU2003223094A8

Abstract

A device 500 for symptomatic relief of croup includes a displacable compressed gas container 1, a gas release mechanism 3 designed and constructed to be operably connectable thereto and a mask 4 to cover a mouth and nose of a patient. Release of a gas mixture from container 1 by release mechanism 3 causes cooling of the released gas and routing of the cooled gas to mask 4 where it may be inhaled by the patient thereby relieving croup symptoms. The gas contains oxygen and may contain helium. Use of device 500 constitutes a method 600. Device 500 may be supplied as an article of manufacture including instructions for use in relief of croup symptoms.

Description

HAND HELD DEVICE FOR INHALATION THERAPY AND METHOD

OF USE THEREOF

FIELD AND BACKGROUND OF THE INVENTION The present invention relates to a hand held device for inhalation therapy and method of use thereof and, more particularly, to a device which relies upon delivery of cooled gases to an airway of a patient as a means of alleviating symptoms of croup.

V. Madden reports (Croup. Prof Care Mother Child 1997; 7:93-4) that as many as 3 percent of children under six years of age are affected by croup, usually at two to three years of age. Symptoms include a barking cough and inspiratory stridor. The preceding infection of the larynx is usually viral; bacterial infection can complicate the condition. J.A. Rosekrans confirms that (Mayo Clin. Proc 1998 Nov; 73(1 1): 1 102-6; discussion 1 107) Viral croup manifests with noisy, labored breathing and adds that parainfluenza viruses are the most common cause of croup with epiglottises and bacterial tracheitis contributing to the overall incidence.

It must be stressed that while recovery from croup is the most common outcome, the clinical episode of croup is generally an anxiety producing experience for both the patient (i.e. child) and the caregiver (i.e. parent or caregiver). Although most children eventually recover with minimal medical intervention, some are severely affected by laryngeal swelling and require respiratory support. In these more severe cases analgesics, cool mist, corticosteroids, nebulized epinephrine or hcliox are generally recommended. In some very severe cases intubation may be required. Drug treatments influences means are shown by Klassen TP, Watters LK, Feldman ME, Sutcliffe T, Rowe PC (Pediatrics 1996 Apr; 97(4): 463-6) and present that pediatric outpatients with mild to moderate croup have added, clinically important improvement in respiratory symptoms after treatment with budesonide. Other chemical interventions include use of nebulized racemic epinephrine and other corticosteroids. As with all drug intervention, use of steroids, especially in young children, should be undertaken with cautiuon due to the possibility of side effects.

United States Patens 6,171,611; 6,165,494 and 5,897,872 to Piccianno teach oral or nasal administration of saline solutions containing iodine to the nose/mouth of patients suffering from an infection. Piccianno fails to teach cooling of the airway as a means of providing symptomatic relief. Further, the teachings of Piccianno are not suited for use in patients with an allergy to iodine. Further, Picciano does not teach aerosol delivery using pressurized gas.

United States Patent 5,128,132 to Parnell teaches use of extracts of Yerba Santa plant (Eriodictyon californicum or Eriodictyon glutinosum) delivered by means of an aerosol propellant as a means of moisturizing mucous membranes in the airway and/or gastro-intestinal tract. As stated above, use of drugs, even plant extracts, in young children is to be avoided if other treatment alternatives are available. Further, the teachings of Parnell fail to ascribe a therapeutic value to the aerosol propellant.

United States Patent 5,925,334 to Rubin et al. teaches use of phospholipid surfactants delivered via an aerosol to relieve symptoms of a variety of respiratory conditions. As stated above, use of drugs, such as phospholipid surfactants, in young children is to be avoided if other treatment alternatives are available. Further, the teachings of Rubin fail to ascribe a therapeutic value to the aerosol propellant.

Previously, a common, "traditional" home treatment for children with croup symptoms has been to let them breathe cold air by placing the patient's airways openings (i.e. nose and mouth) near an open refrigerator door, or taking the patient outdoors, to the open cold air. Inhalation of the cold air provides symptomatic relief until the underlying clinical cause is resolved. J. T. McBride (Stridor in childhood. J Fam Pracr 1984 19:782-90) teaches that if the clinical picture is consistent with a diagnosis of croup and gas exchange is maintained, management with cool mist at home is appropriate. Unfortunately, a convenient source of cool air for inhalation is not always at hiind This is especially true when an attack occurs away from home or when the patient resides in a warm climate.

There is thus a widely recognized need for, and it would be highly advantageous to have, a hand held device for inhalation therapy which relies upon delivery of cooled gases to an airway of a patient and method of using same as a means of alleviating symptoms of croup devoid of the above limitations.

SUMMARY OF THE INVENTION According to one aspect of the present invention there is provided a device for symptomatic relief of croup. The device includes: (a) a disposable compressed gas container containing a mixture including oxygen and at least one additional gas, the mixture formulated to cool upon release from the container; (b) a gas release mechanism designed and constructed to be operably connectable to the gas container, the release mechanism capable of regulating a flow of the mixture from the container to a mask and (c) the mask designed and constructed to cover a mouth and nose of a patient suffering an attack of croup. Release by the release mechanism of at least a portion of the mixture from the container causes cooling of the at least a portion of the mixture and routing of the at least a portion of the mixture to the mask where the at least a portion of the mixture is in proximity to the mouth and nose and may be inhaled by the patient.

According to another aspect of the present invention there is provided a method of ameliorating acute symptoms of croup. The method includes; (a) providing a disposable compressed gas container containing a mixture including oxygen and at least one additional gas, the mixture formulated to cool upon release from the container; (b) operably attaching or connecting a gas release mechanism to the gas container, the release mechanism capable of regulating a flow of the mixture from the container to a mask capable of covering a mouth and nose of a patient suffering an attack of croup; (c) operating the release mechanism so that at least a portion of the mixture is released from the container, cooled and directed to the mask; and (d) covering the mouth and nose of the patient with the mask so that the at least a portion of the mixture which was released from the container and cooled is available for inhalation by the patient. The acute symptoms of croup are ameliorated by inhalation of at least a portion of the at least a portion of the mixture. According to yet another aspect of the present invention there is provided an article of manufacture which includes packaging material and a device identified for use in providing symptomatic relief of croup. The article of manufacture includes a device essentially as detailed hereinabove and hereinbelow together with instructions for use of the device in providing symptomatic relief from croup. According to further features in preferred embodiments of the invention described below, the device further includes a manually operable pressure reduction mechanism designed and configured to create a flow of the at least a portion of the mixture at ambient pressure.

According to still further features in the described preferred embodiments the device further includes a gas pressure indicator indicating a pressure of the mixture in the container.

According to still further features in the described preferred embodiments the mixture includes Helium.

The present invention successfully addresses the shortcomings of the presently known configurations by providing a hand held device for inhalation therapy which relies upon delivery of cooled gases to an airway of a patient and method of using same as a means of alleviating symptoms of croup.

BRIEF DESCRIPTION OF THE DRAWINGS The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

In the drawings:

FIG. 1 is an exploded view of components of one embodiment of a device according to the present invention.

FIG. 2 is a perspective view of the embodiment of figure 1 after assembly. . FIG. 3 illustrates an additional embodiment of a device according to the i present invention.

FIG. 4 illustrates in detail the components of one embodiment of a pressure release mechanism suited for use in the context of the present invention.

FIG. 5 is a simplified flow diagram of events associated with performance of a method according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is of a device for inhalation therapy which relies upon delivery of cooled gases to an airway of a patient and method of using same which can be employed as a means of alleviating symptoms of croup Specifically, the present invention can be used to provide a convenient portable (e.g. hand held) solution for an unexpected attack of croup. Methods of using the device are also claimed. The device and method obviate the need for a refrigerator or cool/moist climate which is not always available. Symptomatic relief provided by the invention reduces the level of stress and anxiety of both the patient and the caregiver. The principles and operation of a device and method according to the present invention may be better understood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. Referring now to the drawings, Figures 1, 2 and 3 illustrates a device 500 for symptomatic relief of croup according to the present invention. Device 500 includes a disposable compressed gas container containing a mixture including oxygen and at least one additional gas. The mixture is formulated to cool upon release from container 1. Preferably container 1 contains a Heliox mixture (20-30% oxygen, 80- 70% helium) at a pressure of 150 to 200 atmospheres or more. Preferably the volume of container 1 is small, most preferably 1 liter or less so that the device 500 is portable and easily deployed.

Device 500 further includes a gas release mechanism 3 designed and constructed to be operably connectable to gas container 1. Release mechanism 3 is capable of regulating a flow of the mixture from container 1 to a mask 4. Mask 4, further included in device 500, is designed and constructed to cover a mouth and nose of a patient suffering an attack of croup. Release by of at least a portion of the mixture from container 1 by release mechanism 3 causes cooling of the released portion of the mixture and routing of the cooled portion to mask 4 where at least part of the released cooled mixture is in proximity to the mouth and nose and may be inhaled by the patient.

The present invention is further embodied by a method 600 of ameliorating acute symptoms of croup. Method 600 includes providing 61 a disposable compressed gas container 1 containing a mixture including oxygen and at least one additional gas as detailed hereinabove. Method 600 further includes operably attaching or connecting 62 a gas release mechanism 3 to gas container 1. Release mechanism 3 is capable of regulating a flow of the mixture from container 1 to mask 4 designed and configured for covering a mouth and nose of a patient suffering an attack of croup. Method 600 further includes operating 63 release mechanism 3 so that at least a portion of the mixture is released from container 1, cooled and directed to mask 4. Method 600 further includes covering 64 the mouth and nose of the patient with mask 4 so that the at least a portion of the mixture which was released from container 1 and cooled is available for inhalation 65 by the patient. The acute symptoms of croup are ameliorated or relieved 66 by inhalation 65 of at least a portion of the at least a portion of the mixture which has been released and cooled.

According to yet another aspect of the present invention there is provided an article of manufacture which includes packaging material and device 500 identified for use in providing symptomatic relief of croup. The article of manufacture includes device 500 essentially as detailed hereinabove and hereinbelow together with instructions for use of device 500 in providing symptomatic relief from croup.

Optionally, but preferably, device 500 further includes a manually operable pressure reduction mechanism 70 (Figure 4) designed and configured to create a flow of the at least a portion of the mixture at ambient pressure (i.e. Approximately 1 atmosphere). Optionally, but preferably, device 500 further includes a gas pressure indicator

201 indicating a pressure of the mixture in the container. Most preferably indicator 201 indicates a reduction in pressure as container 1 is emptied.

As indicated hereinabove, it is preferable that the mixture stored in container 1 includes Helium as this gas cools to a great degree when it is released from container 1.

Thus, device 500 a portable or hand held device for inhalation therapy, particularly for first aid treatment for patients with viral croup or the like. Device 500 operates independently of external power sources or gas supplies.

As illustrated in figures 1-3, pressure release mechanism 3 may be operated by an activation handle 2 rotationally translatable through at least a portion of an arc about hinge 51.

Container 1 may be, for example cylindrical in form, with thread 25 and removable seal 24 in one end, to facilitate connection to release mechanism 3.

Removable seal 24 may be, for example, a thin metal, plastic or wax seal or a metal plastic or wax ball. Seal 24 may serve to contain pressure within container 1, or may cover a closure mechanism and serve as an indicator that container 1 has not been used. Closure mechanisms may be, for example, of the type used in carbon dioxide and nitrous oxide chargers employed to prepare soda water and whipped cream respectively. During operation of device 500 handle 2 is employed to facilitate opening of the valve 20 in pressure release mechanism 3. Optionally, but preferably, solid band 5 which engages container 1 serves to retain valve 20 in an open position by preventing handle 2 from returning to its original position (figures 2 and 3).

Optionally, but preferably, pressure release mechanism 3 (shown in detail in figure 3) includes a gas inlet 30, a valve 20 which is connected to the activation handle 2, a pressure reduction mechanism 70, an expansion chamber 21, a silencer 22, a venturi system 28 with a dedicated drug capsule 50 and a gas outlet 31.

Optionally, but also preferably, pressure release mechanism 3 further includes a small pressure sensor 200 and a display 201, indicating operational parameters such as mixture flow and/or pressure in container 1 during operation of device 500. Most preferably, display 201 further indicates low gas pressure in container 1, for example by means of a visible or audible indicator (e.g. light, flag, buzzer, bell.).

Pressure release mechanism 3 may further include internal thread 23 in one end, which is compatible to thread 25 of gas container 1, and a sharp edged insert 26 which serves to remove or puncture seal 24 of gas container 1 when connecting container 1 to pressure release mechanism 3. Preferably, pressure release mechanism 3 is designed and constructed at its distal end, 29 to engage or fit inlet 35 of mask 4.

Preferably mask 4 is equipped with at least one ventilation passage 33, for instance, unidirectional pressure sensitive leaf- valves which permit gas to exit but prevent ambient air 100 from entering internal volume 101 of mask 4. Alternately or additionally, mask 4 is equipped with an internal pipe 34 with gas inlet 103 and outlet 104, attached to its internal surface 101 and surrounding it, as shown in Fig. 3 . Internal pipe 34 may be connected, for example, to the mask air inlet 35 in one end, and open to internal volume 101 of mask 4 at its other end. One ordinarily skilled in the manufacturing arts, whether plastic or metal or a combination thereof, will be capable of manufacturing and assembling device 500 employing known production processes, such as parts molding and machinery, and gas compressing. The electronic parts may be of known components, such as LED, pressure switch, etc'. Alternately, or additionally, commercially available components may be assembled to produce device 500. For example pressure reduction mechanism 70 may be a "first degree regulator" employed in scuba diving or a miniaturized version thereof.

Different pressure areas along the "flow line" are High pressure 71, Medium pressure 72 and ambient pressure 73.

Device 500 is employed when an attack of croup (or similar episode) occurs. Use of Device 500 provides symptomatic relief and serves to decrease anxiety/stress of the patient and/or caregiver.

Activation of device 500 maybe by the patient or by another person acting on their behalf.

Screwing 62 gas container 1 to pressure release mechanism 3 serves to operably connect these components of device 500. During the last revolutions of screwing 62, sharp edged insert 26 may remove seal 24 from an outlet of gas container 1. Outlet of container 1 is then blocked by the valve 20. Device 500 is ready to use. Mask 4 should be attached now to the patient's face, in such way that it will cover its airway openings.

As an illustrative example of operation of the pictured embodiment of the invention, depression of handle 2 towards container 1 serves to open valve 20 of container 1. This permits at least a portion of the compressed gas mixture to flow through gas inlet 30 and pressure reduction mechanism 70 where the gas pressure is reduced to a constant lower pressure (preferably approximately 1 atmosphere) and into venturi system 28 and expansion chamber 21 where it expands and cools. The expanded cooled gas mixture then passes through silencer 22, which may also serve as a humidifier, and through gas outlet 31 into inlet 35 of mask 4. During expansion in the inlet and in internal pipe 34 the gas cools internal volume 101 of mask 4, allowing the patient to breath a cold oxygen mixture which is preferably also humidified.

Preferably, pushing of handle 2 towards the container 1 causes arms 5 to flex, engage and retain container 1 thereby retaining handle 2 in a position which keeps valve 20 open so that the mixture continues to flow from container 1 to internal volume 101 of mask 4.

Venturi system 28 allows addition of controlled amounts of a drug or medication into the 1. However, since croup is most prevalent among young children, it is often preferable to employ device 500 without adding any drug or using the venturi system option. In those cases where venturi system 28 is employed, a dedicated drug capsule 50 may be inserted so that its contents are sucked by the venturi system into the gas mixture released from container 1 as it flows past.

Preferably pressure sensor 200 indicates the decrease in gas pressure during operation of device 500. Below a certain pressure inside container 1, for example 30 atmospheres, an indication to the operator might appear. Such indication might be, for example a simple red LED. Unscrewing the gas container 1 from the pressure release mechanism 3 will, disconnect the electronic contact, for example, in order to save power. It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any. suitable sub-combination. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

WHAT IS CLAIMED IS:

1. A device for symptomatic relief of croup, the device comprising:

(a) a disposable compressed gas container containing a mixture including oxygen and at least one additional gas, said mixture formulated to cool upon release from said container;

(b) a gas release mechanism designed and constructed to be operably connectable to said gas container, said release mechanism capable of regulating a flow of said mixture from said container to a mask; and

(c) said mask designed and constructed to cover a mouth and nose of a patient suffering an attack of croup; wherein release by said release mechanism of at least a portion of said mixture from said container causes cooling of said at least a portion of said mixture and routing of said at least a portion of said mixture to said mask where said at least a portion of said mixture is in proximity to said mouth and nose and may be inhaled by said patient.

2. The device of claim 1, further comprising a manually operable pressure reduction mechanism designed and configured to create a flow of said at least a portion of said mixture at ambient pressure.

3. The device of claim 1, further comprising a gas pressure indicator indicating a pressure of said mixture in said container.

4. The device of claim 1, wherein said mixture includes Helium.

5. A method of ameliorating acute symptoms of croup, the method comprising;

(a) providing a disposable compressed gas container containing a mixture including oxygen and at least one additional gas, said mixture formulated to cool upon release from said container; (b) operably attaching or connecting a gas release mechanism to said gas container, said release mechanism capable of regulating a flow of said mixture from said container to a mask capable of covering a mouth and nose of a patient suffering an attack of croup;

(c) operating said release mechanism so that at least a portion of said mixture is released from said container, cooled and directed to said mask; and

(d) covering said mouth and nose of said patient with said mask so that said at least a portion of said mixture which was released from said container and cooled is available for inhalation by said patient; wherein the acute symptoms of croup are ameliorated by inhalation of at least a portion of said at least a portion of said mixture.

6. The method of claim 5, further comprising employing a manually operable pressure reduction mechanism to create a flow of said at least a portion of said mixture at ambient pressure.

7. The method of claim 5, further comprising displaying a pressure of said mixture in said container by means of a gas pressure indicator.

8. The method of claim 5, further comprising including Helium in said mixture.

9. An article of manufacture comprising packaging material and a device identified for use in providing symptomatic relief of croup, the article of manufacture comprising:

(a) said device comprising:

(i) a disposable compressed gas container containing a mixture including oxygen and at least one additional gas, said mixture formulated to cool upon release from said container;

(ii) a gas release mechanism designed and constructed to be operably connectable to said gas container, said release mechanism capable of regulating a flow of said mixture from said container to a mask,

(iii) said mask designed and constructed to cover a mouth and nose of a patient suffering an attack of croup; wherein release by said release mechanism of at least a portion of said mixture from said container causes cooling of said at least a portion of said mixture and routing of said at least a portion of said mixture to said mask where said at least a portion of said mixture is in proximity to said mouth and nose and may be inhaled by said patient and

(b) instructions for use of said device in providing symptomatic relief from croup.

10. The article of manufacture of claim 9, wherein said device further comprises a manually operable pressure reduction mechanism designed and configured to create a flow of said at least a portion of said mixture at ambient pressure.

1 1. The article of manufacture of claim 9, wherein said device further comprises a gas pressure indicator indicating a pressure of said mixture in said container.

12. The article of manufacture of claim 9, wherein said mixture includes Helium.