Patent Application
20150144133
The invention relates to an oxygen-rich gaseous composition produced on site, i.e. at the patient's home, and used for the management of chronic migraine attacks in patients at their home.
Chronic migraine is a frequent complication of conventional migraines, i.e. of conventional cephalalgia or headaches.
A chronic migraine is characterized by the occurrence of more than 15 cephalalgia attacks per month for at least 3 months with at least 8 days of migraine in total, according to the Société Francaise d'Etude des Migraines et des Céphalées [French Society for the Study of Migraines and Cephalalgia].
In order to attempt to soothe their chronic migraines, some patients suffering from chronic migraines have a tendency to increase the amount and/or the doses of drugs that they are taking, namely typically tablets of nonsteroidal anti-inflammatory (NSAID) type which decrease the inflammation of meningeal vessels, or of tryptan type, which are vasoconstrictors that reduce the diameter of dilated blood vessels.
However, the increase in the amount and/or in the doses of drugs absorbed causes a high risk of drug abuse in these patients and consequences on the health of these patients, in particular in terms of side effects, of drug interactions, of addiction, etc.
Conversely, some patients are frightened by the risk of drug abuse and attempt to reduce the doses of antimigraine drugs, which then occurs to the detriment of relief of their chronic migraine.
Moreover, some patients cannot be treated with these tablets owing to their side effects. Thus, drugs of NSAID type are contraindicated in patients with a history of gastroduodenal ulcer and advised against in those with a history of kidney diseases. In an analogous manner, tryptans are contraindicated in patients with a history of cardiovascular problems, such as infarction, arterial hypertension, stroke, etc.
In addition, the negative social impact of chronic migraines is very significant since it causes in particular repeated work interruptions, increased solitude of individuals, who have a tendency to isolate themselves, etc.
Moreover, document FR-A-2929513 proposes the use of oxygen gas for treating migraines without aura in pregnant women. The oxygen used comes from gas bottles. This solution is not practical since it requires the setting up of gas bottle management logistics and is not therefore easily applicable to the treatment of patients at their home.
The problem which then arises is that of providing an effective composition, without side effects and simple to administer, which makes it possible to treat, i.e. to at least reduce, the pain caused by cephalalgia in patients suffering from chronic migraines, and which, moreover, enables patients to rapidly treat themselves as soon as their attack occurs and without needing to go to a treatment centre, such as a physician, a hospital, or the like.
The solution of the invention relates to an inhalable gaseous composition, i.e. an inhalable gaseous medicament, containing oxygen (O2) in a proportion greater than 50% by volume, intended to treat, to minimize or to prevent a state of chronic migraine in a human being, said gaseous composition being produced on site, i.e. at the patient's home, by an oxygen-producing device designed so as to produce a gas stream containing more than 50% by volume of oxygen from air.
In the context of the present invention, the management of the migraine attacks is therefore carried out directly at home, which represents the ideal place for relieving the attacks since it offers patients a known environment, with the possibility of isolation and reduction of sound, of light or of other stressing or disturbing factors.
In the context of the present invention:
As appropriate, the inhalable gaseous composition of the invention may comprise one or more of the following technical characteristics:
Moreover, the invention also relates to a method for manufacturing an inhalable gaseous composition, i.e. an inhalable medicament, containing oxygen in a proportion greater than 50% by volume, intended to treat, to minimize or to prevent a chronic migraine attack in a human being, in which said gaseous composition is produced on site, i.e. at the patient's home, by an oxygen-producing device designed so as to produce a gas stream containing more than 50% by volume of oxygen from air, in particular an oxygen concentrator as described above.
In addition, the invention also relates to a therapeutic treatment method for treating, minimizing or preventing a state of chronic migraine in an individual, namely a man or a woman suffering from chronic migraines, in which:
i) an inhalable gaseous composition, i.e. an inhalable gaseous medicament, containing more than 50% of oxygen, typically more than 80% of oxygen, is produced on site, i.e. directly on the site where it is used, by means of an oxygen-producing device designed so as to produce a gas stream containing more than 50% of oxygen from air; and
ii) said gaseous composition containing oxygen in a proportion greater than 50% by volume, obtained in step i), is administered to said individual by inhalation.
As appropriate, the method of the invention may comprise one or more of the following technical characteristics:
Generally, the fact that said oxygen-rich gaseous composition, i.e. oxygen-rich gaseous medicament, is, in the context of the present invention, produced directly on site (in situ) by separation of ambient air by means of an oxygen-producing device, such as an oxygen concentrator, is particularly advantageous because:
this avoids laborious transportation logistics,
The present invention will now be described in greater detail with reference to the appended figures among which:
More specifically, the oxygen-producing device 1 is an oxygen concentrator which makes it possible to produce the gaseous composition acting as gaseous medicament according to the invention on site, i.e. directly at the patient's home, by separation of ambient air (O2 content approximately 21 vol. %) by preferential adsorption of nitrogen on one (or more) adsorbent material(s) and recovery of an oxygen-enriched gas stream, i.e. containing more than 50% by volume of oxygen, in particular more than 80 vol. % of oxygen, typically from 85% to 96% of oxygen, the rest being essentially nitrogen and other impurities, of the argon type, in minor amounts.
Advantageously, the adsorbent material is formed from zeolite particles or beads exchanged with metal cations. Preferentially, the zeolite is more than 80% exchanged with lithium cations. Typically, use is made of a zeolite between 88% and 98% exchanged with Li cations, the residual cations being mainly sodium and/or optionally potassium cations. Such a lithium-exchanged zeolite and the method of air separation and of oxygen production using it are described in particular by EP-A-0297542.
The particles of adsorbent material are arranged in one or more beds, preferably several beds, typically 2 or 3 beds, arranged in parallel and operating in alternating fashion. The nitrogen adsorption and the production of the oxygen stream used as inhalable gaseous composition according to the invention are then carried out via cycles of PSA or VSA type comprising one or more production phases and/or one or more regeneration phases performed at different pressures.
Once it has been produced in the oxygen concentrator 1, the gaseous stream constituting the gaseous composition according to the invention is conveyed, via a flexible pipe 18, to a patient interface 10, such as a respiratory mask, which makes it possible to administer it by continuous or fractional inhalation, to a human being 2, whether this is a man or a woman, and whatever his or her age, suffering from chronic migraines characterized by attacks of cephalalgia (headaches) occurring more than 15 times per month for at least 3 months with at least 8 days of migraine in total.
Advantageously, in the context of the present invention, a “high concentration” facial mask 10 is used to administer the gas to the patient. Such a mask 10 is represented diagrammatically in
This respiratory mask 10 comprises a shell 11 forming a mask body. The shell 11 includes a gas inhalation chamber 12 which is positioned on the nasal and buccal regions of the patient, when the latter is wearing the mask 10. The airtightness is provided by an edge formed from a flexible cushion 13, for example made of silicone, which moulds to the contours of the facial regions of the patient, in particular the bridge of the nose, the regions of the cheeks located on either side of the nose, and the region under the mouth, i.e. at the level of the patient's chin.
The inhalation chamber 12 is in fluidic communication with a flexible gas reservoir 14 formed from a flexible pouch typically made of polymer (volume approximately 0.5 litre) which is filled with oxygen produced by the oxygen concentrator.
A non-return valve 15 placed between the flexible reservoir 14 and the inhalation chamber 12 makes it possible to prevent the CO2 breathed out by the patient from mixing with the oxygen contained in the flexible reservoir 14. The CO2 breathed out is evacuated from the inhalation chamber 12 via an expiratory valve 16 placed in the body of the mask 10.
The mask 10 is held in position on the patient's face by means of a flexible strap or of an elastic band 17.
The flexible reservoir 14 is filled with the oxygen stream produced by the oxygen concentrator 1 (cf.
This type of facial mask 10 makes it possible to administer higher concentrations of oxygen to patients than the conventional respiratory masks, i.e. without a flexible reservoir, or higher oxygen flow rates at equal concentration of the sort to increase the patient's FiO2, in the context of a high flow rate, i.e. 9 l/min for example.
The duration of inhalation of the gaseous composition is chosen, case by case, so as to result in a decrease and preferably in total disappearance of the migraine pain in the patient under consideration. Typically, it is at least 15 minutes to 3 hours. The administration flow rate is, for its part, about 1 l/min to 30 l/min, typically about 9 to 11 l/min.
In order to verify the efficacy of the gaseous composition, i.e. of the gaseous medicament, according to the invention, an inhalable gaseous composition according to the invention was administered to a patient who had been suffering from chronic migraines for years, namely a 40-year-old woman.
The gaseous composition administered consisted of an oxygen-rich gaseous stream produced directly at the patient's home, i.e. in situ, by an oxygen-producing device of oxygen concentrator type operating via a cycle of PSA type.
In the present case, the oxygen concentrator having the brand name Platinum 9™ from the company Invacare™ was used, which fed a high-concentration respiratory mask from the company Intersurgical™, of the type of that represented in
This concentrator makes it possible to produce an oxygen-enriched gas stream at a flow rate ranging from 3 to 9 l/min and at an oxygen concentration of 87% to 93 vol. % of oxygen, depending on the flow rate selected.
In the context of the present example, the administration of the oxygen stream produced in situ is carried out at the time of the migraine attacks, for a period of 30 minutes and at a flow rate of 9 l/min.
The results obtained resulted in a relief of the attacks after 8 to 10 minutes in the patient thus treated.
This demonstrates the efficacy of the gaseous composition according to the invention in the treatment of chronic migraines when said gaseous composition is produced directly on site, i.e. directly at the patient's home and just before the inhalation thereof.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1361628 | Nov 2013 | FR | national |
This application claims the benefit of priority under 35 U.S.C. §119 (a) and (b) to French Patent Application No. 1361628, filed Nov. 26, 2013, the entire contents of which are incorporated herein by reference.
