GB2567844A

GB2567844A - Device for treatment of chronic respiratory diseases

Info

Publication number: GB2567844A
Application number: GB1717625.6A
Authority: GB
Inventors: Drott Kenth; Schmehl Wolfgang; Geoffrey Senior Peter
Original assignee: Linde GmbH
Current assignee: Linde GmbH
Priority date: 2017-10-26
Filing date: 2017-10-26
Publication date: 2019-05-01
Also published as: GB201717625D0

Abstract

A device 1 for the delivery of a medical gas to a patient 50, device 1 comprising: a connection 3 for receiving a vessel 2, where vessel 2 is activated to produce the medical-gas; a gas outlet 4 in fluid communication with both connection 3 and a downstream patient interface 5; and an actuation means 6 to activate vessel 2 into producing the medical-gas for delivery to the patient-interface 5. Device 1 may be a portable inhaler and comprise a demand valve. Activation means 6 may comprise a mechanical element 60, which when operated engages vessel 2 to structurally modify it into activation. Activation means 6 may comprise a light source 60, which when operated activates vessel 2. Other preferable features may include: predefined dosage based upon a characteristic of vessel 2; wireless communication with a monitoring device; a physiological measurement device; use of patient data to control activation means 6; identifying a patient through barcode, fingerprint, or RFID scanning. A vessel 2 for producing a medical-gas, vessel 2 comprising: a semi-permeable membrane 25 that’s permeable only to gas; and a gas releasing molecule 26 activated by an activation means 6. Medical-gas may be carbon monoxide or nitric oxide.

Description

The following terms are registered trade marks and should be read as such wherever they occur in this document:

Bluetooth, P.g 10, 11, 20,26

Zigbee, P.g 10, 11,20, 26

Intellectual Property Office is an operating name of the Patent Office www.gov.uk/ipo

Device for treatment of chronic respiratory diseases

Technical Field

The invention relates to a device for the application and administration of a medical gas to a patient, in particular for the treatment of respiratory disorders in hospital settings or in a non-hospital or homecare environment.

Technological Background

A number of gaseous molecules have been described to be beneficial as therapeutic compounds in various diseases, in particular as an inhalable medical gas for the treatment of respiratory disorders. Amongst these are, for example, nitric oxide (NO), carbon monoxide (CO), and hydrogen sulfide (H2S). Whereas inhalable nitric oxide (iNO) is recognized and approved as a drug to treat Persistent Pulmonary Hypertension of the Newborn (PPHN) or - in some parts of the world cardiac surgery related pulmonary hypertension of adults, the administration and application of carbon monoxide is discussed to have therapeutic potential. However, no medical indication for carbon monoxide has yet been established or approved.

Furthermore, the therapeutic application of gaseous molecules is technically challenging. As a gas, the drug substance is generally contained in pressurized gas cylinders that are bulky and have considerable weight, such that they are difficult to carry and transport. In addition, gas cylinders most often comprise a complex container closure requiring a valve as well as a pressure regulator fora safe release of the gas from the pressurized cylinder. For the medical application or administration of the gas, the pressurized gas in many cases needs to be diluted to therapeutic concentrations and the application of the pressurized medical gas furthermore requires a medical device, which often requires calibration and specific configuration by medical personnel.

Accordingly, the combination of both a gas cylinder and a medical device is too complex or cumbersome to be used by a patient on its own, which may reduce patient compliance, in particular in situations where a patient is suffering from chronic diseases, such that the application of gaseous molecules as a medical gas is limited to clinical settings and hospital wards, thereby limiting the mobility and flexibility of the patient and increasing the burden on the patient. To increase the mobility and compliance of the patient, e.g. by enabling the application of the medical gas at home, at least a dedicated logistics chain for pressurized gas cylinders is required, which is both expensive in terms of production and shipping. Furthermore, this would still require a patient to handle and operate pressurized gas cylinders and corresponding medical devices, which poses handling and safety concerns and limits the usage of medical gas.

An alternative to the use of pressurized gas cylinders could be the implementation of gas releasing molecules for producing the therapeutic amount of gas where and when needed. However, most gas releasing molecules pose health hazards, for example, due to the production of therapeutically irrelevant or even toxic by-products. Although the use of such molecules has been tested in laboratory settings, e.g. in the field of extracorporeal transplants, extracorporeal cells, brain-dead transplant donors, and foodstuff, these settings are not ad hoc translatable into a clinical setting due to the complexity of such laboratory devices, issues regarding stability and shelf life of such molecules, and the required training and technical skill of personnel operating such laboratory devices. Accordingly, the applicability of such gas releasing molecules in in vivo applications and, in particular, to produce an inhalable medicament for patient administrations still poses many technical problems.

Summary of the invention

It is an object of the present invention to provide an improved device for the application of a medical gas to a patient.

In a first aspect, a device for the application of a medical gas to a patient is suggested, which comprises a connecting means for receiving an activatable vessel, wherein the vessel is configured to produce the medical gas, preferably comprising nitric oxide or carbon monoxide, when activated. For delivering the medical gas to the patient, the device comprises a gas outlet, which is in fluid communication with the connecting means as well as a patient interface, which is in fluid communication with the gas outlet and is arranged downstream of the gas outlet. To start production of the medical gas, the device furthermore comprises an activation means, which is configured to activate the vessel for providing the medical gas to the patient interface via the gas outlet.

The connecting means may comprise any means capable of receiving the vessel and may hence be configured to support, hold and/or fix the vessel and is preferably configured to sealingly engage the vessel and/or its gas outlet and/or provide a gas tight connection with the gas outlet. In order to provide a gas tight connection between the connecting means and the vessel, the connecting means may comprise a sealing element, e.g. an elastomeric ring orO-ring. Such sealing element provides a seal upon connecting or coupling the connecting means to the vessel, e.g. by providing a required tensile or compression force with respect to the vessel.

For example, the connecting means may be formed to provide a screwing connection, e.g. by providing a thread corresponding to a thread provided on the vessel, a positive locking, an interference fit, a bayonet-like connection, a lever closure, a compression fit, e.g. by providing a spring retainer, a hinge, or an elastic element, or the like. In order to allow a gas flow between the vessel and the gas outlet, e.g. upon activation, the connecting means may furthermore comprise an opening that fluidly connects the vessel with the gas outlet and/or the activation means. Alternatively, the connecting means may comprise the gas outlet such that the gas outlet forms the opening to or connection with the vessel.

The device and/or the connecting means may furthermore comprise one or more structural grooves or protrusions that facilitate the coupling or connection of the device to the vessel. For example, such grooves may guide the vessel upon insertion or coupling of the vessel. Accordingly, the insertion of the vessel may be fool-proof and further structural stability of the connected vessel is provided, e.g. by preventing or reducing a lateral movement or generally a movement away from the connecting means of the vessel. The one or more grooves are preferably formed as a recess for receiving a corresponding shape of the vessel or as elongated grooves, which are dimensioned to engage at least one corresponding protrusion provided on the vessel. For example, the grooves may be formed as a recess having a substantial cylindrical or rectangular shape or as slots, to slideably couple the vessel to the connecting means of the device.

The connecting means may furthermore provide a feedback signal relating to the correct and complete coupling or insertion of the vessel, preferably by means of a haptic, acoustic, and/or visual feedback signal. For example, the connecting means may require a predefined resistance, a partial or complete resistance release, and/or a snap-in modification as a haptic signal to notify the user about a correct or incorrect insertion of the vessel. Alternatively, or in addition, the connecting means may provide an acoustic feedback signal, e.g., by providing a clicking sound when the vessel is fully and correctly inserted into the connecting means, for example, by means of an elastic metal element engaging the vessel. Furthermore, a visual feedback may be provided, for example, by covering a warning indication when the vessel is fully and correctly inserted.

A fluid communication between the vessel and the patient interface is provided by the gas outlet. In its simplest form, the gas outlet may be formed as an opening. Preferably, the gas outlet comprises a conduit. This has the advantage that a continuous fluid connection between the vessel and the patient interface is provided when these are spaced apart and/or are arranged at different regions of the device. The gas outlet may hence comprise a conduit or tube, wherein preferably the connecting means and/or the activation means are arranged at an upstream end of the gas outlet and the patient interface is arranged at a downstream end of the gas outlet. Preferably, the connecting means comprises an opening such that, upon coupling of the vessel to the device, the vessel may be brought into fluid communication with the gas outlet. Although the opening may be provided such that the vessel is in fluid communication with the gas outlet independent of the activation of the activation means, which may be provided since the gas production, i.e. the gas flow is only provided when the vessel is activated, the activation means is preferably configured such that it blocks a gas flow from the vessel via the opening, when the activation means is not activated and enables a gas flow from the vessel via the opening and gas outlet to the patient interface upon activation of the activation means.

Furthermore, the downstream end of the gas outlet connecting the patient interface to the gas outlet may be formed and/or dimensioned to receive the patient interface. For example, the gas outlet may comprise a substantially cylindrical shape, which forms a sleeve, bushing, or nozzle to receive a corresponding geometry of the patient interface. The patient interface may hence be mounted on the gas outlet by means of e.g. an interference fit or positive locking. Alternatively, the downstream end of the gas outlet may comprise a thread to provide a screwing engagement with a corresponding end of the patient interface. Accordingly, the patient interface may be releasably coupled to the gas outlet and, for example, may be formed as a disposable. Alternative, the patient interface may be integrally formed with the gas outlet and/or be formed of a single piece.

In order to provide the medical gas, the vessel is configured to produce gas upon activation by the activation means. The gas may be provided by e.g. a predefined amount of gas releasing molecules or gas releasing compound contained within the vessel, wherein the gas releasing compound and the gas releasing molecules are preferably non-toxic. Accordingly, the vessel may comprise or be configured as a reservoir, preferably small-sized reservoir, comprising gas releasing molecules or a gas releasing compound. Said gas releasing molecules may be provided as a mixture of substances comprising a pre-molecule or precursor molecule, which produces the required gas product upon activation. For example, the gas releasing molecules may comprise metal-based gas releasing molecules, encapsulated gas releasing molecules, enzyme-triggered gas releasing molecules, and/or photo-sensitive organic gas releasing molecules. Preferably, the gas releasing molecules are provided as a solid, semi-solid, or liquid medium, and/or may be provided in or on a substrate to provide a mechanical or physical structure retaining said molecules. Preferably, the vessel furthermore comprises a semi-permeable membrane, which facilitates the transfer of the required or desirable medical gas components across the membrane while preventing other molecules and aqueous components to cross the membrane. Accordingly, upon activation, only the required medical gas is provided via the gas outlet and the patient interface to the patient and potential toxic and waste and/or non-gaseous degradation products are retained in the vessel and are not exposed to the patient.

In addition, the activation means is preferably configured to be specific for the gas releasing molecule to be activated and comprised in the vessel. Accordingly, the medium comprising the gas releasing molecules or gas releasing compound in the vessel may only be triggered to produce the medical gas upon the activation of the activation means. In other words, absent of any activation of the activation means, no activation of the vessel occurs. The activation means may furthermore be configured to block the gas outlet prior to activation and/or be configured to open the vessel, e.g. by modifying the vessel.

The provision of the activation means hence has the advantage that the production of the medical gas from the respective vessel may occur only on demand and the gas may not be produced before activation. Accordingly, the risk of the occurrence of any inadvertent activation is minimized while the patient may immediately be provided with the required medical gas when required by activation of the activation means. The safety of the patient is hence improved while the amount of medical gas provided is controlled and can be adapted to a predefined or required amount.

Accordingly, the device is not dependent on the provision of large gas containers, but instead may be operated with comparatively small-size vessels. The vessels may be generally provided in any form and may furthermore also be provided in a packaging comprising multiple vessels, e.g. each according to a prescribed dose. As the operation of the device does not require medical personnel and may be handled by the patient, the device and therefore the patient are essentially autonomous, such that the patients may treat themselves at locations that are remote from a hospital or any other clinical setting, preferably at home. The device hence enables selfadministration of the therapeutic or medical gas.

The device is preferably a portable device, preferably configured as a portable inhaler. For example, the device may be dimensioned in size and weight to be operated as a hand-held device, preferably by one hand, wherein the activation means may be activated by one or more fingers. To facilitate the application of the medical gas to the patient, the patient interface preferably comprises a mouthpiece, face mask, nasal mask, ora nasal cannula. Accordingly, the inhalation of the gas is facilitated and it is ensured that the medical gas is applied to the patient, thereby also reducing the amount of gas entering the surroundings. Alternatively, or in addition, the device may comprise a demand valve. This has the advantage that the produced gas is only supplied upon inhalation and is not entering the surroundings upon an inadvertent activation of the activation means. Furthermore, this may enable that a predefined amount of medical gas may be produced prior to inhalation, wherein the device preferably comprises a safety valve to avoid an unwanted pressure build-up in the vessel or device.

To further assist the inhalation of the medical gas by a patient, the device preferably comprises a positive airway pressure device. This is particularly advantageous for patients suffering from respiratory diseases and/or having difficulties in breathing, wherein the positive pressure ensures that the medical gas is also delivered to the lower respiratory system, bronchi, and alveoli. It may also be provided in a way that the produced medical gas is mixed with air from the environment. In a further embodiment, the produced medical gas may be mixed with oxygen from an external oxygen source suitable for homecare patients (compressed gas oxygen, liquid oxygen, oxygen concentrators). Accordingly, the device may comprise a gas inlet arranged either upstream or downstream of said positive airway pressure device. Such gas inlet may hence allow the suction of oxygen or air into the device, which is then mixed with the produced gas from the vessel and is applied to the patient as a medical gas or gaseous mixture. The mixture with air has the advantage that the temperature of the applied medical gas is normalized to the ambient temperature and furthermore provides a dilution the produced gas. Such dilation may have the advantage that a larger volume may be inhaled, thereby reaching other areas in the respiratory system and the patient may continue a substantially normal breathing pattern while at the same time the concentration of the medical gas may be further controlled by the amount of air intake by the device. The mixture with oxygen can be useful as many patients who might benefit from the therapeutic gas also get a prescription for home oxygen therapy. In such a case, both gases, therapeutic gas and oxygen, may either be mixed in the device or applied to the patient interface via a double lumen cannula or conduit.

The vessel may be connected directly to the connecting means. However, the connecting means may alternatively comprise a container having a cavity with a sealable opening and which is in fluid communication with the gas outlet, wherein the cavity and opening are dimensioned to receive the vessel. Accordingly, the vessel may be inserted into the container, wherein the activation means is coupled to the container to activate the vessel and produce the gas. This has the advantage that the container may provide the structural and mechanical features required for the activation, whereas the vessel may be dimensioned only to comprise the gas releasing molecules or compound. Hence, the vessel may be formed substantially smaller.

For example, the vessel may be sized and/or dimensioned to provide a single predetermined dose or a volume corresponding to said dose. By the same token, the dose may correspond to a specific medical indication, such that the provided single dose forms a therapeutic dose or therapeutic range for a specific disorder.

Furthermore, the vessel may be sized and/or dimensioned to be portable, preferably hand-held, such that the vessel can be easily carried and mounted to the device by a user. Accordingly, the vessel may comprise a volume in the range of one or more microliters up to several milliliters. The reduced size and/or dimensions of the vessel thereby facilitate the production, transportation, and shipment of the vessel.

To activate the vessel, the activation means of the device preferably comprises a mechanical element, which is configured to engage the vessel when the activation means is operated and which is configured to mechanically and/or structurally modify the vessel to activate the vessel. For example, the mechanical element may be formed as a protrusion or tab which engages the vessel and causes a sealing membrane to deform by means of e.g. compression, twisting, or puncture of said membrane. Accordingly, a chemical reaction may occur in the vessel, thereby producing the required gas. Instead of causing a membrane deformation, the mechanical element may also comprise or be formed as at least one electrically conductive element, e.g. an electrode arrangement, to provide an electrically conducting circuit with the vessel or provide electromagnetic radiation upon activation of the activation means.

Alternatively, the activation means may comprise a light source, preferably at least one light emitting diode, which is configured to activate the vessel when the activation means is operated and wherein an intensity and/or spectral range of the light source is preferably adaptable to a predefined production of the medical gas. Accordingly, the intensity of the light source may be increased to provide a larger production of the gas and a corresponding higher dose of medical gas to the patient. By the same token, the wavelength or spectral range of the light may be adaptable, e.g. by means of a band-pass filter arrangement, to control the gas production and provide a more specific gas according to the gas releasing compound or molecules provided in the vessel. For example, the gas production may be configured to only occur with light in a specific wavelength, for example, UVlight. Preferably, the activation means comprises an indicator and the activation means may be set to predefined values that correspond to a specific dose and/or vessel.

The activation means may be configured to be operable by the patient, e.g. by turning, depressing, or pushing a knob or button. Furthermore, the activation means may be coupled to the patient interface and may also be configured to activate the vessel upon suction, e.g. upon inhalation of the patient, or merely by engagement of the patient interface by the patient, e.g. combined with a depression of the activation means, thereby increasing the pressure exerted on the vessel and causing a deformation or structural modification of said vessel. Accordingly, the medical gas may be provided to the patient by an active operation of the patient, which has the advantage that the patient may control the application of the medical gas and the risk of inadvertently activating the vessel is furthermore reduced. By the same token, the activation means may be configured such that the gas production only requires an initial activation of the activation means and the gas is continued to be produced after releasing the activation means, or that the gas production is deactivated as soon as the activation means is no longer operated by the patient.

For further treatment compatibility, the device is preferably configured to identify the vessel mechanically and/or electrically, wherein the activation means is operable dependent on the identified vessel. This has the advantage that incompatible vessels may not be activated and hence ensures that a medical gas exiting the patient interface corresponds to a prescribed treatment. Preferably, the activation means and/or connecting means is/are preferably dimensioned to engage matching geometries of said vessel and/or provide a snap-fit arrangement with said vessel to identify said vessel. This has the advantage that the patient is not only informed about the presence of a suitable vessel upon an activation attempt, but is already provided with feedback upon insertion or coupling of the vessel to the device. Furthermore, this ensures that the vessel is inserted in the appropriate way and hence does not require further considerations or interpretations of the patient.

Alternatively, or in addition, the device preferably comprises a sensor in communication with the activation means and which is configured to detect an electrically conducting element on said vessel to identify said vessel. For example, the sensor may detect a magnetic strip on the vessel, which is indicative of the gas releasing compound or molecules comprised in the vessel.

To identify said vessel, the sensor may also be configured as an optical sensor, which may identify optical information on the vessel, e.g. a barcode or QR code, to identify the gas releasing compound or molecules comprised in the vessel.

Furthermore, such optical information or electrically conducting element may provide information relating to a brand, batch number, calibration, production and/or expiry date, the dose or content amount, and/or whether the vessel has previously been activated. Furthermore, this information may be implemented in an RFID, wherein the vessel may comprise said RFID and wherein the device is configured to read said RFID by a corresponding sensor configured as an RFID reader comprised in the device. The RFID reader may automatically detect the RFID comprised in or on the vessel, such that no further action is required to identify the vessel and retrieve the required information. The activation means may hence be configured to only be operable, when a vessel suitable for the prescribed treatment and/or device is identified.

To ensure that the medical gas is applied to the patient according to a prescribed treatment, the device is preferably configured to provide a predefined dosage of the medical gas to the patient based on a characteristic of the vessel, preferably a membrane characteristic, pore size, and/or size of said vessel, the type of activation means, and/or an activation duration of the activation means. For example, the vessel may comprise a semi-permeable membrane composed in a way that only allows gaseous molecules such as e.g. carbon monoxide or nitric oxide, to pass. Furthermore, the size of the vessel may correspond to the total amount of gas produced and hence the amount or dose of medical gas to be applied to the patient. In addition, the dosage may be dependent on the type of activation. For example, when the activation means comprises a light source, the produced gas and dosage may be dependent on the intensity and the spectral range provided by the light source. By the same token, the activation means may be configured to induce a chemical reaction in the vessel to produce the required gas, which may produce gas at a different rate when compared with e.g. an electromagnetic reaction. Furthermore, the production of gas may depend on the activation duration such that the medical gas dosage that is applied corresponds to the activation or operation time of the activation means.

The predefined dosage is preferably predefined for the treatment of a respiratory disorder and/or complications thereof. For example, the dosage may be suitable for the treatment of patients suffering from chronic respiratory disorders who are faced with reoccurring acute respiration difficulties. The vessel may e.g. be configured to provide a dose of nitric oxide or carbon monoxide which immediately facilitates the breathing of a patient upon inhalation of the medical gas, e.g. by causing a vasodilatory effect of the blood vessels surrounding the alveoli, reducing mucus, and/or by providing a bactericidal effect. At the same time, the predefined dosage is set not to exceed a maximum dose for the patient. For example, the applied dosage should not exceed in vivo tolerance levels, i.e. should not induce detrimental side effects or potentially toxic concentrations, such that e.g. the amount of methemoglobin or hemoglobin-bound carbon monoxide in the blood does not pose a health risk to the patient.

Preferably, the device comprises a controller that is in communication with the activation means and is configured to obtain and/or process dosage and/or activation data of the device, wherein the controller is configured to control the activation of the activation means based on said data. The data may comprise data relating to a duration, frequency, time, and/or absolute number of the activation of the activation means, wherein the controller is preferably configured to block the activation of the activation means and/or emits a warning signal, when a predefined threshold of the data is exceeded.

For example, the controller may, e.g. by using a timer, detect the number of activations per amount of time, e.g. per 24 hours, and may be configured to only allow the activation of the activation means if a predefined number of activations is not exceeded. Furthermore, the controller may require a certain amount of time between each of the activations to ensure that the application of the medical gas to the patient does not exceed predefined thresholds and reduce the health risk of the patient. By the same token, the controller may prevent the activation of the vessel by blocking the activation means, when a limit relating to the number of activations is not exceeded, but a total activation duration, which may correspond to the activation of the vessel and hence the total dosage or medical gas applied to the patient, reaches an upper limit. Preferably, the controller is configured to simultaneously provide a warning signal when the activation means is actively blocked.

In addition, the controller may be configured to automatically indicate a servicing requirement after a predefined time and/or predefined absolute number of activations of the activation means, wherein the activation means is preferably simultaneously blocked. The provision of the controller hence has the advantage that the patient may not inadvertently apply an overdose or exceed predefined limits relating to the activation of the activation means.

The controller may furthermore be configured to obtain and/or process patient specific data, wherein the patient specific data preferably comprises data relating to an identity, a prescribed therapy, and/or a treatment of the patient and wherein the controller is configured to control the activation of the activation means based on said patient specific data. Preferably, the patient specific data is provided by a configuration and/or corresponding registration number of the device, and/or the device comprises an identifying means, wherein the patient specific data is provided by identifying a patient identifier by the identifying means.

Such patient specific data hence allows that the vessel coupled to the device may only be activated and the medical gas may only be provided to the patient, when the application of the medical gas is required and/or prescribed for the respective patient. In other words, the controller automatically prevents the activation of the vessel and the production of the medical gas, should the application of the medical gas not be suitable for a specific patient or specific disorder. For example, the patient identity may be provided by a corresponding configuration of the device, e.g. a corresponding registration or batch number of the device, which is suitable for a specific treatment of the patient and linked to a medical record of the patient. Also, a variety of devices for use with different vessels corresponding to different therapies or treatments may be provided, wherein the safety of the patient is ensured by the respective controller and by the obtained or processed patient identity.

The patient-specific data is preferably provided by identifying a patient identifier. Accordingly, the identifying means may comprise a barcode scanner, a fingerprint reader and/or scanner, an RFID reader, and/or a wireless coupling device, preferably a Bluetooth or Zigbee device, configured to identify the patient identifier. Alternatively, or in addition, the identifying means is in communication with a database in a computer system providing patient specific data. The patient identifier may be any entity that is compatible with and is suitable to be read by the identifying means. For example, the patient identifier may be a barcode or QR-code indicative of patient-specific data such as a patient number, a prescribed therapy, and/or a corresponding dosage requirement, which may be scanned by a barcode scanner and accordingly controls the activation of the activation means by means of the controller. Preferably, the patient identifier is a wearable entity, e.g. a smart watch, a smart phone, or an RFID chip, which is configured to automatically detect or detects the presence of a patient identifier of the device on request, and transmits a corresponding response signal to identify the patient and establish a wireless connection to transmit the patient-specific data stored in the wearable entity, e.g. by Bluetooth, Zigbee, or Near Field Communication. The patient identifier may also be configured as a fingerprint reader, such that the patient is only required to press the fingerprint reader to provide the patient identity, wherein the controller compares the identified patient with patient-specific data stored in the device or provided to the device by e.g. a database to accordingly control the activation of the activation means.

Accordingly, the patient identifier and the patient identifying means have the advantage that the device may only be operated by a suitable patient and may only be activated, i.e. provide the medical gas to the patient, according to a prescribed therapy.

In order to provide a larger flexibility of the dosage of the applied medical gas, the device preferably comprises a control valve that is in fluid communication with the gas outlet and is arranged upstream of the patient interface, wherein the controller is in communication with the control valve and is configured to adjust the control valve to provide a predefined dosage, preferably according to dosage and/or activation data and/or patient specific data. Accordingly, the control valve may be set according to a predefined dosage that is provided by patient specific data and relates to a prescribed therapy. The control valve may e.g. be opened and closed according to a predefined frequency to ensure that the applied medical gas is inhaled during multiple inhalations and/or the control valve may be set to ensure that the amount of medical gas applied per amount of time is controlled. Preferably, the device comprises a flow sensor in fluid communication with the gas outlet and in communication with the controller. Accordingly, the controller may be provided with feedback from the flow sensor relating to e.g. a volume flow and may accordingly adjust the control valve, if required, thereby further increasing the safety of the treated patient.

The provision of the control valve hence has the advantage that the dosage of the applied medical gas may be varied and may be adapted to a large variety of therapies.

The device may furthermore comprise and/or be in communication with a measurement device for obtaining at least one physiological parameter of the patient, wherein the controller is configured to control the activation of the activation means based on the obtained at least one physiologic parameter of the patient. This not only allows the monitoring of the patient during treatment with the medical gas from the device, e.g. to ensure that physiological tolerance levels are not exceeded, but also monitors the requirement of the treatment with the medical gas, e.g. when physiological parameters indicate the necessity of the application of the medical gas, for example, when the patient’s oxygen levels are reduced and/or the breathing pattern or heart rate of the patient indicate a change or anomalies.

Preferably, the device comprises and/or is in communication with a pulse oximeter to obtain the physiologic parameter of the patient. Accordingly, blood values and oxygen saturation levels may be monitored and the activation of the vessel and hence the application of the medical gas by the device may be accordingly adjusted. Furthermore, the pulse oximeter may monitor the occurrence of potentially toxic hemoglobin levels such as methemoglobin or hemoglobin-bound carbon monoxide, such that the controller may enable the controller to e.g. block the activation means and the application of the gas to allow a normalization of the patient physiological and blood parameters.

The device furthermore preferably comprises a wireless communication means configured to communicate data relating to dosage and/or activation data of the device to an external monitoring device. This has the advantage that treatment data may be transmitted to e.g. a health care professional and thus enables telemedical monitoring of the patient. For example, a health care professional may be provided with information relating to a total dosage of the medical gas applied per 24 hours and/or may be alerted, when the activation of the activation means exceeds a predefined number or is attempted yet blocked by the controller. Such alert may e.g. indicate the occurrence of an emergency situation or a request by the patient to modify predefined settings in the device or controller. The health care professional may then choose to override the blocking of the activation means, notify medical personnel, and/or may contact the patient prior to further action. Furthermore, the health care professional may monitor the consistency and efficacy of the prescribed therapy and may be informed about the patient’s adherence to the prescribed dosage.

Preferably, the wireless communication means is configured to update patient specific data, preferably in a database of a computer system, by communicating the data relating to dosage and/or activation data of the device. The patient data may hence be stored and updated in a medical record, wherein a medical professional may retrieve the patient history and previous therapy from said data. When the device also comprises or is in communication with a measurement device for obtaining at least one physiological parameter of the patient and/or comprises a flow sensor, the wireless communication means may also be configured to transmit data relating to the at least one physiological parameter of the patient and/or the flow or breathing characteristics of the patient, respectively. Prior to transmitting the data to the database, the data may be transiently stored in the device or on a secured external device, e.g. on a storage medium, wherein the data may furthermore be transmitted continuously or periodically depending on the necessary update frequency.

Accordingly, the substantially autonomous and safe to use device may be used in a remote location or home care setting while at the same time a monitoring and telemedical function, e.g. by providing various patient and therapy related information and/or adjusting the configuration of the device, is provided by means of the wireless communication means.

To further increase the safety of the device and the vessel, the device is preferably configured to modify the vessel after a predefined activation duration, preferably by means of a deformation of said vessel and/or by means of a modification of an electrically conductive element on said vessel. For example, the device may modify the vessel after an activation duration that is estimated to correspond to a time after which the occurrence of gas production or gas passing through the membrane of the vessel is considered minimal or may be essentially excluded. For example, the device may modify the vessel by opening or closing a predefined gap or aperture, e.g. an opening or hole.

The gap or aperture may be either provided or pre-formed on the vessel or may be established by the connecting means or activation means upon previous activation. For example, the vessel may already comprise an aperture to release the gas upon activation, wherein the device closes said aperture e.g. after the application of the gas to a patient or after a predefined time. Alternatively, the activation means may establish a gap in the vessel upon activation, e.g. by pinching a predefined seal of the vessel, wherein the device closes said gap, e.g. when the gas is no longerto be applied.

By the same token, the activation means may open or break a vial, wherein the device is configured to seal said vial after sufficient gas has been produced and applied to the patient.

Previously established or exposed by the connecting means or activation means upon activation. The modification may also comprise a conformation change that prevents any subsequent positive locking of the vessel to the connecting means, such that any re-coupling of the vessel to the device is prevented. Such modifications may be performed by the connecting means and/or the activation means.

Preferably, the modification comprises the modification of a magnetic element on said vessel. For example, the modification may comprise changing an indicator, e.g. a magneticstrip, which may be recognized by a sensor in an attempt to re-couple the vessel to the device.

Accordingly, by modification of the vessel, a safe disposal of said vessel is provided and any future inadvertent attempts to couple the used vessel to the device will be immediately recognized by the patient. In addition, the device may be configured to eject orde-couple the vessel after the modification, such that the patient is immediately notified when the vessel is inactive and the medical gas is no longer applied.

The connecting means is preferably configured to releasably engage the vessel dependent on the activation of the activation means and the modification of said vessel. This has the advantage that an inadvertent ejection orde-coupling of the vessel may be prevented and it is ensured that the produced gas is not accidentally released in the surrounding environment or atmosphere.

According to a further aspect of the invention, a vessel for the production of a medical gas, preferably carbon monoxide or nitric oxide, is suggested, wherein the vessel comprises a semipermeable membrane composed to be gas permeable only and a gas releasing molecule activatable by an activation means and wherein the vessel is configured to be used in a device as described in the above.

Preferably, the gas releasing molecules or the gas releasing compound are selected to be compatible with the activation means, such that only the required medical gas component is produced upon activation, thereby preventing the application of gaseous by-products via the patient interface.

The vessel is preferably configured for the treatment of a respiratory disorder and/or complications thereof. For example, the vessel may be configured to provide a dose that is adapted to provide a patient with a necessary amount of nitric oxide and/or carbon monoxide to induce a vasodilatory effect and increase the breathing volume and/or oxygen uptake in the alveoli of the patient. Preferably, the vessel may be configured to provide a dose adapted for the treatment of persistent pulmonary hypertension of newborns (PPHN), pulmonary hypertension of other etiologies, inflammation in asthma, sepsis, lung injury, oxidative lung damages, idiopathic fibrosis, cardiovascular diseases, prevention of transplant rejections, cancer, postoperative ileus as well as antimicrobial treatment of airways and lungs caused by bacteria and viruses.

The vessel may, for example, be configured to be activated by a mechanical and/or structural modification or by light, preferably UV-light. For example, the device may induce a structural modification in the vessel, e.g. a puncture or rupture of an inner membrane, e.g. by a mechanical element or by pressure, which causes two compartments in the interior of the vessel to be brought in fluid communication and allows the mixing of the components comprised in each of the compartments. Upon mixing, the gas required for the medical gas is produced. Alternatively, the production of the gas may be induced by incident light emitted by a light source in the device, which does not require any structural modifications. The produced gas is then released through the semipermeable membrane to the patient interface via the gas outlet, whereas any irrelevant or even toxic by-products are retained in the vessel.

Accordingly, the specific configuration of the vessel and the activation means has the advantage that the activation of the vessel only occurs upon activation by the activation means and any premature and inadvertent activation of the vessel is prevented. For example, the vessel may require a mechanical interaction, e.g. a puncture of the surface or an outer membrane of the vessel, in order to activate the vessel, wherein the required puncture may only be provided by the activation means, preferably due to a specific geometry or configuration of the activation means. By the same token, the vessel may be configured to only be activated by a specific spectral range, which is not present or not present in the required intensity of ambient light and may hence only be provided by a specific configuration of the activation means, e.g. by the provision of a filter and/or lens structure to provide the required spectral range. Alternatively, light sources such as e.g. LEDs providing the required wavelengths may be used. In addition, the vessel may be safely disposed of after activation, as described in the above. The vessel is hence safe for the patient or user to use while at the same time allowing a safe transportation, shipping, and handling of the vessel.

The vessel may be transported in standard shipping and packaging means, such as e.g. blister packaging, strips, cartridges, cartons, and/or (padded) envelopes. Preferably, the vessel is formed and sized to be packaged as a plurality of vessels, e.g. in a blister packaging or cartridge. The vessels may then be distributed as prescribed drugs via standard pharmaceutical networks.

Furthermore, the vessel is preferably sized to provide a single required dosage, however, may also be sized such that multiple doses may be applied, e.g. when the device comprises a control valve and/or activation means that permit the application of a single dose at in subsequent steps.

Together, the vessel and the device form a system for treating a patient with a medical gas, which may be operable by the patient, is safe to use and dispose of, is suitable for treatment of the patient at remote locations such as home care, and does not require pressurized gas cylinders of any kind.

Brief description of the drawings

The present disclosure will be more readily appreciated by reference to the following detailed description when being considered in connection with the accompanying drawings in which:

Figure 1A is a schematic view of a device forthe application of a medical gas to a patient;

Figure 1B is a schematic view of the device according to Figure 1A, wherein the connecting means is configured comprising a container;

Figure 2 is a schematic view of a further embodiment of the device according to Figure 1A or 1B;

Figure 3 is a schematic view of a further embodiment of the device according to any of the Figures, wherein the device furthermore comprises a controller;

Figure 4 is a schematic view of a further embodiment of the device according to any of the Figures in communication with further entities;

Figure 5A is a schematic view of a vessel for use in the device; and

Figure 5B is a schematic view of a further embodiment of a vessel for use in the device.

Detailed description of preferred embodiments

In the following, the invention will be explained in more detail with reference to the accompanying figures. In the Figures, like elements are denoted by identical reference numerals and repeated description thereof may be omitted in order to avoid redundancies.

In Figure 1A a device 1 for the application of a medical gas to a patient 50 is schematically shown, comprising a connecting means 3 for connecting a vessel 2 to the device 1. The connecting means 3 is configured to provide a sealed connection with the vessel 2 upon insertion 22 of the vessel 2 into the device 1. The connecting means 3 may engage the vessel 2 in order to fix the vessel 2 to the device 1 or otherwise support or hold the vessel 2 in place to prevent any de-coupling or movement of the vessel 2 when connected to the device 1. The connecting means 3, although only schematically depicted in Figure 1 A, may e.g. comprise a bayonet connection to both connect and seal the vessel 2 to the connecting means 3. In addition, the device 1 is formed to provide a platform or support for the vessel 2 to provide an initial support or further structural support for the vessel 2.

Furthermore, the connecting means 3 is in fluid communication with a gas outlet 4 comprised in the device 1 to provide a fluid connection between a patient interface 5, arranged on the device 1 at a downstream end of the gas outlet 4, and the vessel 2, when the vessel is coupled to the connecting means 3. The gas outlet 4 is schematically depicted as a conduit or tube, however, other dimensions and geometries may be provided, such that the gas outlet 4 may also be formed, for example, as an opening or through hole. The connecting means 3 preferably comprises an opening or through hole, which connects the gas outlet 4 of the device 1 with an area or corresponding opening of the vessel 2, preferably with an area of the vessel 2 comprising a semi-permeable membrane (not shown). Accordingly, the connecting means 3 permits a fluid flow between the vessel 2 and the patient interface 5. Alternatively, however, the connecting means 3 may be configured to merely connect the vessel 2 to the device 1; in such configuration the gas outlet 4, for example, may be configured to be in direct fluid communication with the vessel 2 upon coupling of the vessel 2 to the device 1.

Although other configurations may be provided, the device 1 depicted in Figure 1A is configured as an inhaler. Accordingly, a patient 50 may use the device 1 on-demand, e.g. when experiencing breathing difficulties or according to a prescribed dosage and treatment regimen. The patient interface 5, schematically depicted in a triangular shape, is hence configured as a face mask, nasal mask, nasal cannula, or mouth piece to accommodate to the anatomy of the face or mouth of the patient 50. The patient interface 5 is arranged downstream of the gas outlet 4 and is connected to the device 1 and gas outlet 4 by a press-fit arrangement, e.g. a luer lock arrangement, such that the patient interface 1 protrudes into and engages an inner shaft of the gas outlet 4 at the downstream end of the gas outlet 4. The patient interface 5 is configured as a disposable, so that the device 1 is compatible to be used for multiple patients 50, e.g. by providing various dimensions, geometries, and/or sizes. Furthermore, this facilitates the compliance with hygienic standards. However, other connections may be provided, e.g. a screwing arrangement, or the patient interface 5 may be integrally formed with the device 1. In such cases, the patient interface 5 is preferably made of a material that is easy to clean and sterilize.

The vessel 2 is configured to produce the medical gas upon activation. Accordingly, the device 1 comprises an activation means 6, which is configured to activate the vessel 2 for providing the medical gas to the patient interface 5 via the gas outlet 4. The activation means 6 may cause a structural or mechanical modification of the vessel 2, e.g. in the interior of the vessel 2, such that the vessel 2 is activated upon operation of the activation means 6. However, the activation means may also emit light upon activation, wherein the incident light on the vessel 2 causes the activation of the vessel 2. The activation means 6 may be triggered in various ways.

For example, an inhalation of the patient 50 through the patient interface 5 may cause an under pressure in the device 1, i.e. in the patient interface 5, the gas outlet 4 and the connecting means 3, which causes the activation means 6 to be activated. This has the advantage that the handling of the device 1 is facilitated and the patient 50 is not required to take further actions in order to be provided with the medical gas. Alternatively, or in addition, the activation means 6 may be configured to be operable by the patient 50, wherein the activation means 6 is activated by means of depression of a button or turning of a knob (not shown). Such operation may then cause either a mechanical or electrochemical interaction with the vessel 2 to produce the medical gas in the vessel 2.

Upon activation of the vessel 2 by the activation means 6, the medical gas is produced and flows through the connecting means 3 and the gas outlet 4 to the patient interface 5. Upon inhalation, or by passive incubation, the medical gas is then applied 52 to the airways of the patient 50. Accordingly, the specific configuration of the device 1 with the activation means 6 and the corresponding vessel 2, the patient 50 is provided with an on-demand and self-administrating device 1 for the treatment of respiratory disorders and/or to alleviate breathing difficulties and circumstances with low blood oxygen levels. Accordingly, the medical gas provided to the patient 50 preferably comprises nitric oxide and/or carbon monoxide.

In Figure 1B a schematic view of the device 1 according to Figure 1A is shown, wherein the connecting means 3 is configured comprising a container 30. The container 30 comprises a cavity 32 and a sealable opening 34, which are dimensioned to receive the vessel 2. Accordingly, the vessel 2 may be inserted in the container 30 and sealed prior to activation of the activation means 6. The sealing of the opening may e.g. occur by a lid, which pivots around an axis at one end of the opening, e.g. about a hinge, and is biased into a closing position by means of a spring, such that, after opening of the lid, the sealing of the opening occurs automatically. The provision of the container 30 has the advantage that the vessel 2 may comprise different dimensions and may generally be sized smaller. Accordingly, the production and/or shipping of the vessel 2 may be more cost efficient and it is furthermore easier for the patient 50 to carry the vessel 2.

Furthermore, the vessel 2 may be configured and activated by means as previously described in the above, such that the activation of the vessel 2 not only occurs on-demand, but also only upon activation by the activation means 6. The vessel 2 is hence safe for the patient 50 to use since any premature and inadvertent activation of the vessel 2 is prevented, thereby allowing a safe transportation, shipping, and handling of the vessel 2. By the same token, the vessel 2 may be safely disposed of after activation, as described in the above. The vessel 2 may hence be transported in standard shipping and packaging means such as e.g. blister packaging, strips, cartridges, cartons, and/or (padded) envelopes.

A further embodiment of the device 1 according to Figure 1A or 1B is schematically depicted in Figure 2. The connecting means 3 is adapted to receive and engage the vessel 2 to provide a snapfit arrangement. Such snap-fit arrangement is provided by the snap-fit element 36, which is arranged at an open end of the device 1 and is configured to engage a corresponding geometry of the vessel 2. The snap-fit element 36 may be a resilient element or may be pivotably coupled to the device 1 or connecting means 3 to facilitate the insertion 22 and coupling of the vessel 2. The snapfit element 36 may furthermore be dimensioned to only engage a specific type of vessel 2 to ensure a compatibility of the vessel 2 for the device 1 and/or patient 50. For example, the snap-fit element 36 may correspond to a geometry of the vessel 2 that relates to a type of gas and/or a specific dose of the gas to be produced.

To further facilitate the use of a compatible vessel 2, the device 1 may furthermore comprise a sensor 10 to detect or identify an electrically conducting element such as, as depicted in Figure 2, a magnetic strip 24. The magnetic strip 24 may be indicative of various characteristics of the vessel 2, for example, the gas to be produced, the type of the required activation means 6, the dose to be produced, a gas production rate, an expiry date, an activity record, etc. Accordingly, the sensor 10 is capable of identifying the vessel 2 and retrieves and processes the relevant information. The sensor 10 is in communication with the activation means 6, such that the sensor 10 may, depending on the identified vessel 2, either enable or block the activation means 6.

The activation means 6 furthermore comprises a mechanical element or light source 60, which are dimensioned to be compatible with a specific vessel 2, e.g. by matching a corresponding geometry of the vessel 2. The mechanical element or light source 60 may hence be formed to be brought into proximity with a surface or component of the vessel 2 to be activated. Should the vessel 2 not comprise such a matching surface, the activation means 6 may not be activated, e.g. not be able to be depressed in order to activate the vessel 2. The matching geometries between the mechanical element or light source 60 of the activation means 6 hence provide that the vessel 2 and compatibility thereof may be identified and the activation of the vessel 2 may be more specifically directed.

To ensure that the medical gas is applied to the patient 50 and to prevent any gas or fluid to enter the device via the patient interface 5 and the gas outlet 4, e.g. during an exhalation of the patient 50, the patient interface 5 furthermore comprises a demand valve 54. The demand valve is configured to only allow a fluid or gas to flow in a single direction, i.e. the direction of application 52. Accordingly, the risk of contaminating the interior of the device 1 is minimized and any potential impairment or undesirable reaction with the vessel 2 is essentially prevented. The demand valve 54 may furthermore be configured to comprise a checkvalve, which allows the adaptation or setting of the fluid flow downstream of the demand valve 54 and hence facilitates the optimization of the application 52 of the medical according to the respective patient 50.

In Figure 3 a schematic view of a further embodiment of the device 1 according to any of the Figures 1A, 1B, and 2 is shown, wherein the device 1 furthermore comprises a controller?. For redundancy reasons, only the features corresponding to Figure 1A are shown, however, any of the features and embodiments shown in Figures 1B or 2 may be comprised in the embodiment of Figure 3. The controller 7 is in communication with the activation means 6 and is configured to obtain and/or process dosage and/or activation data of the device 1. The data may comprise data relating to a duration, frequency, time, and/or absolute number of the activation of the activation means 6. For example, the controller 7 may calculate the time between each of two activations and may simultaneously calculate the duration of each of two activations. This data is then compared with maximum thresholds or tolerance levels relating to prescribed data for the patient 50 and the controller 7 is configured to control the activation of the activation means based on said data. Should, for example, the total duration of a single activation correspond to a maximum dose for a predefined amount of time, the controller 7 may block the activation of the activation means 6, when a second activation of the activation means 6 is attempted within said predefined amount of time. Alternatively, or in addition, the controller 7 may emit a warning signal to the patient, e.g. by a visual indicator, e.g. a warning LED, or by emitting an acoustic warning signal.

Figure 4 shows a further embodiment of the device 1 according to any of the Figures in communication with further entities. Again and for redundancy reasons, only the features corresponding to Figure 1A are shown, however, any of the features and embodiments shown in Figures 1B, 2, or 3 may be comprised in the embodiment of Figure 4. The controller 7 essentially comprises the same functions of the embodiment according to Figure 3. In addition, the controller 7 according to Figure 4 comprises an identifying means 70. However, such identifying means 70 may also be provided independently of and separated from the controller 7 yet remaining in communication with the controller 7. The identifying means 70 is configured to automatically identify a patient identifier 72.

Such patient identifier 72 is depicted in Figure 4 as a wearable patient entity, e.g. a smart watch or smart phone, however, may also be configured as an RFID chip or be part of another medical device carried by or in proximity of the patient 50.

The patient identifier 72 comprises patient specific data and is configured to automatically process an authorization request from the identifying means 70 to retrieve the required patient specific data. For example, the identifying means 72 may send such request upon detection of the presence of the patient identifier 72, e.g. by means of Near Field Communication. Accordingly, the identifying means 70 is preferably configured as a wireless identifying means 70, such that further connectivity may be provided, e.g. Bluetooth, Zigbee, and/or RFID via wireless communication. By the same token, the identifying means 70 may read a patient identifier 72 by insertion of or via cable connection of said patient identifier 72. When receiving the authorization request, the patient identifier 72 may be operated by the patient 50 to accept or decline the establishment of a wireless connection and accordingly send the patient specific data required by the device 1, e.g. data relating to an identity, a prescribed therapy, and/or a treatment of the patient. Should the identified patient 50 be compatible with the device 1, the controller 7 or the identifying means 70 may automatically enable the activation means 6. By the same token, the controller 7 or the identifying means 70 may automatically block the activation means 6, when the identified patient 50 is found to be incompatible with the device 1.

The device 1 is furthermore in communication with a measurement device 74 for obtaining at least one physiological parameter of the patient 50, wherein the controller 7 is configured to control the activation of the activation means 6 based on the obtained at least one physiologic parameter of the patient 50. According to Figure 4, the communication between the measurement device 74 and the device 1 is provided by the controller 7. The measurement device 74 may be any medical instrument that is connected with the patient 50 and is capable to derive a patient parameter. For example, the measurement device 74 may be a heart monitor or ECG apparatus or a pulse oximeter to obtain cardiovascular parameters and monitor the blood values of the patient 50.

To be provided with or retrieve patient specific data, the device 1 may furthermore be in communication with a database 9. Such communication is preferably provided by a wireless communication device 8. The wireless communication device 8 is configured to not only receive patient specific data from the database 8, e.g. for comparison with the patient identification, but is also configured to update the patient specific data in the database 9 by communicating the data relating to dosage and/or activation data of the device 1 and/or the patient parameters derived from the measurement device 74. The wireless communication device 8 is provided independently of the wireless communication feature of the controller 7 or identifying means 74, however, depending on the complexity and authorization requirements, it may also be provided that all communication with external devices and entities occurs centrally and is processed in the wireless communication device 8.

A vessel 2 for the production of a medical gas is schematically depicted in Figures 5A and 5B. The vessel 2 comprises a semi-permeable membrane 25 on a partial surface of the vessel 2. The semipermeable membrane 25 is configured to be gas permeable only, such that only a particular gaseous molecule or a range of gaseous molecules is permitted to pass the membrane and byproducts and/or liquids are retained within the vessel 2. To produce the medical gas, the vessel comprises an amount of gas releasing molecules ora compound 26, which are activatable by an activation means, as described in relation to the device according to Figures 1A to 4. The vessel 2 is configured to be used in the above described device, preferably for the treatment of a respiratory disorder and/or complications thereof. Accordingly, the vessel 2 preferably produces carbon monoxide and/or nitric oxide, preferably as the only gaseous molecule.

The vessel 2 according to Figure 5B furthermore comprises an activation element 28. Such element may e.g. comprise a chemical reagent, which reacts with the gas releasing molecule or compound 5 26 upon mixture. The mixture may occur by the activation means of the device, which may break a seal of the activation element 28 and causes the chemical reagent to be mixed with the gas releasing molecule or compound 26. Alternatively, the activation element 28 may comprise a lens and/or band-pass filter, which focusses the light emitted by a light source comprised in the activation means and provides a specific spectral light of the emitted and incident light to activate 10 the gas releasing molecule or compound 26. By the same token, the activation element 28 may comprise an electrically inducible element, e.g. a Hall or magnetic element, which causes an electrical charge to be applied to the gas releasing molecule or compound 26 for activation.

The produced gas may then pass the semi-permeable membrane 25 and is forwarded in the corresponding device to on-demand provide the required medical gas to the patient.

It will be obvious for a person skilled in the art that these embodiments and items only depict examples of a plurality of possibilities. Hence, the embodiments shown here should not be understood to form a limitation of these features and configurations. Any possible combination and configuration of the described features can be chosen according to the scope of the invention.

List of reference numerals

Device for the application of a medical gas

Sensor

Vessel

Insertion

Magnetic strip

Semi-permeable membrane

Gas releasing molecule or compound

Activation element

Connecting means

Container

Cavity

Sealable opening

Snap-fit element

Gas outlet

Patient interface

Patient

Application

Demand valve

Activation means

Mechanical element or light source

Controller

Identifying means

Patient identifier

Measurement device

Wireless communication device

Database

Claims

1. Device (1) forthe application of a medical gas to a patient (50), the device (1) comprising:

a connecting means (3) for receiving an activatable vessel (2), said vessel (2) being configured to produce the medical gas, preferably comprising nitric oxide or carbon monoxide, when activated;

a gas outlet (4), which is in fluid communication with the connecting means (3); and a patient interface (5), which is in fluid communication with the gas outlet (4) and is arranged downstream of the gas outlet (4);

characterized in that the device (1) further comprises an activation means (6), which is configured to activate the vessel (2) for providing the medical gas to the patient interface (5) via the gas outlet (4).

2. Device (1) according to claim 1, characterized in that the device (1) is a portable device, preferably configured as an inhaler, wherein the patient interface (5) preferably comprises a mouthpiece, face mask, nasal mask, or nasal cannula and/or a demand valve (54), wherein the connecting means (3) preferably comprises a container (30) having a cavity (32) with a sealable opening (34) and in fluid communication with the gas outlet (4), the cavity (32) and opening being dimensioned to receive the vessel (2), and/or wherein the device (1) preferably comprises a positive airway pressure device.

3. Device (1) according to claim 1 or 2, characterized in that the activation means (6) comprises a mechanical element (60), which is configured to engage the vessel (2) when the activation means (6) is operated and which is configured to mechanically and/or structurally modify the vessel (2) to activate the vessel (2); or a light source (60), preferably at least one light emitting diode, which is configured to activate the vessel (2) when the activation means (6) is operated, wherein an intensity and/or spectral range of the light source (60) is preferably adaptable to a predefined production of the medical gas.

4. Device (1) according to any of the preceding claims, characterized in that the device (1) is configured to identify the vessel (2) mechanically, optically and/or electrically, wherein the activation means (6) is operable dependent on the identified vessel (2), wherein the activation means (6) and/or connecting means (3) is/are preferably dimensioned to engage matching geometries of said vessel (2) and/or provide a snap-fit arrangement with said vessel (2) to identify said vessel (2), and/or the device (1) preferably comprises a sensor (10) in communication with the activation means (6) and configured to detect an information or electrically conducting element on said vessel (2) to identify said vessel (2).

5. Device (1) according to any of the preceding claims, characterized in that the device (1) is configured to provide a predefined dosage of the medical gas to the patient (50) based on a characteristic of the vessel (2), preferably a membrane characteristic and/or size of said vessel (2), the type of activation means (6), and/or an activation duration of the activation means (6), wherein said dosage is preferably predefined for the treatment of a respiratory disorder and/or complications thereof.

6. Device (1) according to any of the preceding claims, characterized in that the device (1) comprises a controller (7) that is in communication with the activation means (6) and is configured to obtain and/or process dosage and/or activation data of the device (1), wherein the controller (7) is configured to control the activation of the activation means (6) based on said data.

7. Device (1) according to claim 6, characterized in that the data comprises data relating to a duration, frequency, time, and/or absolute number of the activation of the activation means (6), wherein the controller (7) is preferably configured to block the activation of the activation means (6) and/or emits a warning signal, when a predefined threshold of the data is exceeded.

8. Device (1) according to claim 6 or 7, characterized in that the controller (7) is configured to obtain and/or process patient specific data, the patient specific data preferably comprising data relating to an identity, a prescribed therapy, and/or a treatment of the patient, wherein the controller (7) is configured to control the activation of the activation means (6) based on said patient specific data.

9. Device (1) according to claim 8, characterized in that the patient specific data is provided by a configuration and/or corresponding registration number of the device (1), and/or wherein the device (1) comprises an identifying means (70) and the patient specific data is provided by identifying a patient identifier (72) by the identifying means (70).

10. Device according to claim 9, characterized in that the identifying means (70) comprises a barcode scanner, a fingerprint reader and/or scanner, an RFID reader, and/or a wireless coupling device, preferably a Bluetooth or Zigbee device, configured to identify the patient identifier (72), and/or wherein the identifying means (70) is in communication with a database (9) in a computer system providing patient specific data.

11. Device (1) according to any of the claims 6 to 10, characterized in that the device (1) comprises a control valve that is in fluid communication with the gas outlet (4) and arranged upstream of the patient interface (5), the controller (7) being in communication with the control valve and configured to adjust the control valve to provide a predefined dosage, preferably according to dosage and/or activation data and/or patient specific data, wherein the device (1) preferably comprises a flow sensor in fluid communication with the gas outlet (4) and in communication with the controller (7).

12. Device (1) according to any of the claims 6 to 11, characterized in that the device (1) comprises and/or is in communication with a measurement device (74) for obtaining at least one physiological parameter of the patient (50) and wherein the controller (7) is configured to control the activation of the activation means (6) based on the obtained at least one physiologic parameter of the patient (50), wherein the device (1) preferably comprises and/or is in communication with a pulse oximeterto obtain the physiologic parameter of the patient (50).

13. Device (1) according to any of the preceding claims, characterized in that the device (1) further comprises a wireless communication means (8) configured to communicate data relating to dosage and/or activation data of the device (1) to an external monitoring device, wherein the wireless communication means (8) is preferably configured to update patient specific data, preferably in a database (9) of a computer system, by communicating the data relating to dosage and/or activation data of the device (1).

14. Device (1) according to any of the preceding claims, characterized in that the device (1) is configured to modify the vessel (2) after a predefined activation duration, preferably by means of a deformation of said vessel (2) and/or by means of a modification of an electrically conductive element, preferably a magnetic element, on said vessel (2), wherein the connecting means (3) is preferably configured to releasably engage the vessel (2) dependent on the activation of the activation means (6) and the modification of said vessel (2).

15. Vessel (2) for the production of a medical gas, preferably carbon monoxide or nitric oxide, the vessel (2) comprising a semi-permeable membrane (25) configured to be gas permeable only and a gas releasing molecule (26) activatable by an activation means (6), characterized in that the vessel (2) is configured to be used in a device (1) according to any of the preceding claims,

5 preferably for the treatment of a respiratory disorder and/or complications thereof.

Intellectual Property Office