WO2016075193A1

WO2016075193A1 - A device for supplying inspiratory gas pressure to a patient

Info

Publication number: WO2016075193A1
Application number: PCT/EP2015/076333
Authority: WO
Inventors: Mikael Tiedje; Carl VAN LOEY; Jesus Gonzales; Nicke Svanvik
Original assignee: Breas Medical Ab
Priority date: 2014-11-11
Filing date: 2015-11-11
Publication date: 2016-05-19

Abstract

A handheld device (100) for supplying at least inspiratory gas pressure to a patient (101), comprising a gas flow generator (110) adapted to generate a gas flow to the patient (101) via a patient gas outlet portion (120) of the handheld device (100) such that a predetermined inspiratory gas pressure at an end (121) of the patient gas outlet portion (120) is obtained. The handheld device enables a user to easily carry and use the handheld device to receive inspiratory gas in an easy manner.

Description

A DEVICE FOR SUPPLYING INSPIRATORY GAS PRESSURE TO A PATIENT

TECHNICAL FIELD Embodiments herein relate to supplying inspiratory aid to a patient. In particular, embodiments herein relate to a handheld device and a use of the handheld device for supplying at least inspiratory gas pressure to a patient.

BACKGROUND

Patients suffering from different forms of breathing disorders can be subject to several types of treatments depending on the illness or disorder present.

One example of a breathing disorder is ventilatory failure, which includes all forms of insufficient ventilation with respect to metabolic need and may occur during wake or periods of sleep. Ventilatory failure is a potentially life threatening condition. The general comorbidity in patients with failing ventilation is considerable. The condition is highly disabling in terms of reduced physical capacity, cognitive dysfunction in severe cases and poor quality of life. Patients with ventilatory failure therefore experience significant daytime and nighttime symptoms. Daytime complications may, for example, include sleepiness and cognitive dysfunction. Another example of a breathing disorder is hypoventilation and periodic breathing, which in its most frequently occurring form also may be referred to as Cheyne-Stokes ventilation, may occur periodically or constantly during wake or sleep. A non-invasive technique for treatment of such breathing disorders is the use of mechanical ventilators. Examples of mechanical ventilators includes continuous positive airway pressure (CPAP) ventilators, which maintain an elevated airway pressure throughout the breathing phase of a patient, or bi-level CPAP ventilators, which administers different pressure levels during inhalation and exhalation.

However, patients that are dependent on such mechanical ventilators, but still spontaneously breathing, must usually carry the unwieldy ventilator with them at all time. Bringing the ventilator along when e.g. taking care of personal hygiene, going for shorter walks to front door, etc., may be considered both cumbersome and may require a lot from an already weak patient. To alleviate this need for at least short periods of time for this group of patients would mean increasing their quality of life significantly.

SUMMARY

It is an object of embodiments herein to improve the quality of life for patients in need of inspiratory aid.

According to a first aspect of embodiments herein, the object is achieved by a handheld device for supplying at least inspiratory air pressure to a patient. The handheld device comprises an gas flow generator adapted to generate a gas flow to the patient via a patient gas outlet portion of the handheld device such that a predetermined inspiratory air pressure at an end of the patient gas outlet portion is obtained. According to a second aspect of embodiments herein, the object is achieved by a handheld device for supplying at least inspiratory gas pressure to a patient. The handheld device comprises an gas flow generator adapted to generate an gas flow to the patient via a patient gas outlet portion of the handheld device such that a predetermined inspiratory gas pressure at an end of the patient gas outlet portion is obtained, and a one-way valve restricting gas flow to a one directional flow path in the patient gas outlet portion.

According to a third aspect of embodiments herein, the object is achieved by a use of a handheld device for supplying at least inspiratory gas pressure to a patient. The handheld device comprises an gas flow generator adapted to generate an gas flow to the patient via a patient gas outlet portion of the handheld device such that a predetermined inspiratory gas pressure at an end of the patient gas outlet portion is obtained, and a one-way valve restricting gas flow to a one directional flow path in the patient gas outlet portion.

According to a fourth aspect of embodiments herein, the object is achieved by a handheld device for supplying at least inspiratory gas pressure to a patient. The handheld device comprises a gas flow generator adapted to generate a gas flow to the patient via a patient gas outlet portion of the handheld device such that a predetermined inspiratory gas pressure at an end of the patient gas outlet portion is obtained, and a container comprising oxygen and being connected via a gas fluid connector such that the oxygen is mixed with the generated gas flow of the flow generator. The gas flow generator can be a gas flow generator generating the gas flow by mechanically influencing the ambient air, e.g. by a fan arrangement. Optionally or additionally the gas flow generator may generate the gas flow by releasing gas from a pressurised container.

The temperature of the gas flow may be adjusted e.g. cooled or heated before exiting the handheld device, via a temperature adjustment element, such as a heating element and/or cooling element. The incoming air flow can advantageously be heated via a heating element before exiting the handheld device for example. An advantage of heating the gas flow before it leaves the handheld device e.g. by heating an incoming air flow, is that it can reduce the discomfort of inhaling cold gas from a pressurized container, or simply cold air when being outdoors for example. This feature may be applicable on any breathing apparatus including the handheld device disclosed herein.

The gas flow generated to the patient can be a gas flow of a single gas and/or a mixture of different gases. The gas flow generated to the patient can be a mixture of one or more single gases, air, or a mixture of one or more single gases and air. A single gas and a mixture of gases may be oxygen which is mixed with air for example to get an oxygen enriched gas flow.

The single gas can be a gas selected from the list of; oxygen (02), nitric oxide (NO), or nitrogen (N2). The mixture of different gases can be one or more of the following gases; air or anaesthetics.

By providing a handheld device or a use of the handheld device for supplying at least inspiratory gas pressure to a patient as described above, patients who normally are required to carry their ventilator with them at all time may instead utilize the more conveniently carried handheld device to provide sufficient inspiratory support for shorter periods of time. This will increase these patients mobility when performing shorter task, such as, going to the bathroom or taking short walks, by being able to get away from their normal more or less stationary ventilatory equipment during this time. Thus, the quality of life for patients in need of inspiratory support is increased. BRIEF DESCRIPTION OF THE DRAWINGS In the following the invention will be described in a non-limiting way and in more detail with reference to exemplary embodiments illustrated in the enclosed drawings, in which:

Figs. 1 -3 illustrates embodiments of a handheld device,

Fig. 4 illustrates a use of embodiments of a handheld device.

DETAILED DESCRIPTION The figures are schematic and simplified for clarity, and they merely show details which are essential to the understanding of the embodiments presented herein, while other details have been left out. Throughout, the same reference numerals are used for identical or corresponding parts. Figure 1 -3 depicts embodiments of a handheld device 100 for supplying at least inspiratory gas pressure to a patient. The handheld device 100 may comprise an gas inlet 181 allowing gas to flow into the handheld device 100 and a patient gas outlet portion 120 allowing gas to flow out of the handheld device 100 and into the mouth of a patient. Also, the handheld device 100 may comprise an gas flow generator 1 10 adapted to generate an gas flow to the patient via the patient gas outlet portion 120. The gas flow generator 1 10 may comprise an electric motor 160 adapted to drive a fan wheel 170 located within a fan housing 180 in the handheld device 100. The fan housing 180 may be arranged to be in fluid communication with the gas inlet 181 and the patient gas outlet portion 120. Further, the gas flow generator 1 10 may also be connected to an actuating means 130, a rechargeable battery 140 and one or more indicators 150 for indicating the remaining energy level of the rechargeable battery 140 to the patient.

The gas flow generator 1 10 may be adapted to generate a gas flow to the patient via a patient gas outlet portion 120 of the handheld device 100. This is performed such that a predetermined inspiratory gas pressure at an end 121 of the patient gas outlet portion 120 is obtained. This advantageously allows a patient to be free of his/hers normal ventilator equipment for an extended period of time. This extended period of time may of course vary based on the patient's need for ventilation. However, the time away may, for example, be extended to up to 30-60 minutes which gives the patient enough time to perform various indoor or outdoor activities without the constraint of a ventilator carry bag or trolley.

It should also be noted that the predetermined inspiratory gas pressure is preferably 5 higher than the atmospheric gas pressure of the ambient gas surrounding the handheld device 100. Normal atmospheric gas pressure is around 1 bar. In some embodiments, the predetermined inspiratory gas pressure is comprised within the range of 5-20 mbar. This advantageously provides a suitable inspiratory gas pressure for a patient that may suffer from various breathing disorders and is in the need of inspiratory aid. The predetermined 10 inspiratory gas pressure may also be said to provide a predetermined Positive Airway Pressure, PAP, to the patient.

In some embodiments, the gas flow generator 1 10 may be adapted automatically stop generating the gas flow with the predetermined inspiratory gas pressure after a

15 predetermined period of time. This advantageously allows the handheld device 100 to automatically stop in order to prevent the accidental energy loss in the rechargeable battery, e.g. in case of accidental activation of the gas flow generator 1 10.

The electric motor 160 may be adapted to drive the fan wheel 170 within the fan housing 20 180. The fan housing 180 may also be adapted to be in fluid communication with the gas inlet 181 and the patient gas outlet portion 120 such that the gas flow generated by the fan wheel 170 causes the predetermined inspiratory gas pressure at an end 121 of the patient gas outlet portion 120 of the handheld device 100. For example, the electric motor 160 may comprise a Brushless Direct Current, BLDC, motor. The BLDC motor may be 25 controlled by an electronic control circuit, such as, e.g. a Hall-sensor less motor, adapted to control and measure the phase back Electric Motoric Force, EMF, to determine the phase position and control the phase currents. A BLDC motor is generally a type of motor that is controlled by turning the three phases on or off in certain pattern to get the motor to rotate, therefore the electronic control circuit need to determine the rotor position in any 30 given moment to be able to control the motor rotation. In this example, the BLDC motor may be adapted to drive the fan wheel 170 within the fan housing 180. The electronic control circuit controls the speed of the BLDC motor, which generates the required gas flow with the predetermined inspiratory gas pressure to the patient. The actuating means 130 may be adapted to control the gas flow generator 1 10 to generate the gas flow with the predetermined inspiratory gas pressure when activated. The actuating means 130 may be arranged on the handheld device 100 such that an easy one-handed use of the handheld device 100 is achieved. Since the gas flow with the predetermined inspiratory gas pressure is generated as long as the actuating means is activated, it advantageously provides the patient with the opportunity to autonomously select the inspiration time and control his or hers breathing pattern.

In some embodiments, the actuating means 130 may comprise a button or switch operable to cause the gas flow generator 1 10 to start generating the gas flow with the predetermined inspiratory gas pressure when pressed, and to cause the gas flow generator 1 10 to stop generating the gas flow with the predetermined inspiratory gas pressure when released. This advantageously further allows an easy one-handed use of the handheld device 100.

In some embodiments, e.g. as shown in Fig. 3, the handheld device 100 may comprise, or be configured to be connected to, a container 200 comprising oxygen, e.g. an oxygen canister. The container 200 may form part of, or be connectable to, an attaching device 201 , e.g. a snap-on holder. The attaching device 201 may be configured to keep the container 200 attached to the handheld device 100 and connect the container 200 to a gas fluid connector 202. The gas fluid connector 202 may be configured in the handheld device 100. The gas fluid connector 202 may, when being actuated, be configured to allow a flow of oxygen from the container 200 and into the fan housing 180 to be mixed with the gas flow generated by the gas flow generator 1 10 (e.g. as shown by the dash- dotted line in Fig. 3). In this case, the actuating means 130 may, e.g. when causing the gas flow generator 1 10 to start generating the gas flow, further be configured to also actuate the gas fluid connector 202 and allow oxygen to flow from the container 200 and into the fan housing 180. This means that the generated gas flow and the flow of oxygen will mix in the fan housing 180, and leave through the patient gas outlet portion 120.

Thus, in view of the above, the gas flow generator 1 10 shall not be limited to creating an air flow, but can also add oxygen to the air flow. This may, for example, be obtained by the container 200 comprising oxygen being internally mounted in the handheld device 100 (not shown) or attached to the handheld device 100, e.g. as shown in Fig. 3. In some embodiments, this may also be obtained by an external feed line or external feeding tube (not shown) being connected to the gas fluid connector 202 in the handheld device 100 and configured to feed oxygen from an external container comprising oxygen.

Hence, the handheld device 100 may comprise a gas fluid connector 202 adapted to 5 provide oxygen to the generated gas flow of the gas flow generator 1 10 from a container 200 comprising the oxygen. In some embodiments, the container 200 may be internally mounted inside the handheld device 100. In some embodiments, the container 200 may be attached to the handheld device 100 by an attaching device 201 such that the container 200 is connected to the gas fluid connector 202. In this case, the attaching 10 device may be a snap-on holder 201. In some embodiments, the container 200 may be external to the handheld device 100 and wherein an external feeding line is connected to the gas fluid connector 202 of the handheld device 100.

In some embodiments, the patient gas outlet portion 120 may also comprise a one-way 15 valve 122 restricting gas flow to a one directional flow path in the patient gas outlet portion 120. The one-way valve 122 may be adapted to be in a closed position when the gas flow generator 1 10 is not generating gas flow such that gas is prevented from entering in through the patient gas outlet portion 120 and towards the gas flow generator 1 10. This advantageously prevents any contamination agents from entering the handheld device 20 1 10 and helps to keep the inside of the handheld device 100 clean and sterile.

Furthermore, the one-way valve 122 may be adapted to be in an open position when the gas flow generator 1 10 is generating gas flow such that gas is able to exit out through the patient gas outlet portion 120. The patient gas outlet portion 120 may also be adapted to comfortable connect with a patient's mouth.

25

In some embodiments, the rechargeable battery may also be connected to a connector 141 for connecting an external power source capable of charging the rechargeable battery while simultaneously supplying enough energy to the gas flow generator 1 10 to drive/energize the gas flow generator 1 10. The connector 141 may also be arranged to 30 connect an external power supply, such as, e.g. an external battery, in order to further extend the operating time of the handheld device 100. The rechargeable battery may be adapted to provide suitable battery duration, e.g. about 30-60 minutes.

It should be noted that the term handheld means that the device 100 is adapted to be held 35 and used with one hand by a patient. To further provide an easy use, the handheld device 100 may comprise a one-handed grip 190 facilitating a single handed use of the handheld device 100 by a patient. It should be noted that the entire device, i.e. each component of the device, can be handheld, e.g. by the patient. Figure 4 depicts a use of embodiments of the handheld device 100. A patient 101 may operate the handheld device 100 by holding it with one hand, placing his or her mouth close to the end of the patient gas outlet portion 120, and activating the handheld device 100 by use of the actuating means 130. This will cause gas to flow into the patient's mouth at a predetermined inspiratory gas pressure and down into the patient's lungs, thus facilitating an easier and more relaxed breathing.

It should further be noted that while an objective of the embodiments herein is to enhance the quality of life for a patient by increasing the patient's mobility by giving the patient the opportunity to supply short bursts of pressurized gas into the patient's airways during shorter times away from the normally required ventilator or in between ventilator use, the embodiments herein may also be used in e.g. emergency rooms to substitute, to some extent, resuscitation bags as an emergency ventilator.

The embodiments herein may advantageously be used by spontaneous breathing patients who suffer from various diseases that affect their breathing, such as, e.g.

Chronical Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Amyotrophic Lateral Sclerosis (ALS), etc., which still have a need for moving around and exercise. Further, the embodiments herein may also advantageously be used by personnel working in emergency rooms and ambulances for acute response on lung injuries and other acute disease, such as, e.g. pneumonia, Acute Respiratory Failure (ARF), emphysema, congestive heart failure acute treatment of breath shortness, etc.

The terminology used in the detailed description of the particular exemplary embodiments illustrated in the accompanying drawings is not intended to be limiting of the described handheld device 100 or use of the handheld device 100. As used herein, the term "and/or" comprises any and all combinations of one or more of the associated listed items.

Further, as used herein, the common abbreviation "e.g.", which derives from the Latin phrase "exempli gratia," may be used to introduce or specify a general example or examples of a previously mentioned item, and is not intended to be limiting of such item. If used herein, the common abbreviation "i.e.", which derives from the Latin phrase "id est," may be used to specify a particular item from a more general recitation. The common abbreviation "etc.", which derives from the Latin expression "et cetera" meaning "and other things" or "and so on" may have been used herein to indicate that further features, similar to the ones that have just been enumerated, exist.

As used herein, the singular forms "a", "an" and "the" are intended to comprise also the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms "includes," "comprises," "including" and/or "comprising," when used in this specification, specify the presence of stated features, actions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, actions, integers, steps, operations, elements, components, and/or groups thereof. Unless otherwise defined, all terms comprising technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the described embodiments belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The embodiments herein are not limited to the above described preferred embodiments. Various alternatives, modifications and equivalents may be used. Therefore, the above embodiments should not be construed as limiting.

Claims

A handheld device (100) for supplying at least inspiratory gas pressure to a patient (101 ), comprising

a gas flow generator (1 10) adapted to generate a gas flow to the patient (101 ) via a patient gas outlet portion (120) of the handheld device (100) such that a predetermined inspiratory gas pressure at an end (121 ) of the patient gas outlet portion (120) is obtained.

The handheld device (100) according to claim 1 , wherein the predetermined inspiratory gas pressure is higher than the atmospheric gas pressure of the ambient gas surrounding the handheld device (100).

The handheld device (100) according to claim 1 or 2, wherein the predetermined inspiratory gas pressure is comprised within the range of 5-20 mBar.

The handheld device (100) according to any of claims 1 -3, further comprising an actuating means (130) adapted to control the gas flow generator (1 10) to generate the gas flow with the predetermined inspiratory gas pressure when activated.

The handheld device (100) according to claim 4, wherein the actuating means (130) comprises a button or switch operable to cause the gas flow generator (1 10) to start generating the gas flow with the predetermined inspiratory gas pressure when pressed, and to cause the gas flow generator (1 10) to stop generating the gas flow with the predetermined inspiratory gas pressure when released.

The handheld device (100) according to any of claims 1 -5, wherein the gas flow generator (1 10) is further adapted automatically stop generating the gas flow with the predetermined inspiratory gas pressure after a predetermined period of time.

The handheld device (100) according to any of claims 1 -6, further comprising a rechargeable battery (140), and

a connector (141 ) for connecting an external power source capable of charging the rechargeable battery while simultaneously supplying enough energy to the gas flow generator (1 10) to drive/energize the gas flow generator (1 10), and one or more indicators (150) indicating the remaining energy level of the rechargeable battery to the patient (101 ).

The handheld device (100) according to any one of the preceding claims, wherein the gas flow generator (1 10) comprises an electric motor (160) for generating said gas flow.

9. The handheld device (100) according to claim 8, wherein said electric motor is adapted to drive a fan wheel (170) within a fan housing (180), wherein the fan housing (180) is located inside the handheld device (100) and is in fluid communication with an gas inlet (181 ) and the patient gas outlet portion (120) such that the gas flow generated by the fan wheel (170) causes the

predetermined inspiratory gas pressure at an end of a patient gas outlet portion (120) of the handheld device (100).

10. The handheld device (100) according to any of one of the preceding claims, further comprising a one-handed grip (190) facilitating a single handed use of the device (100) by the patient (101 ).

1 1 . The handheld device (100) according to any one of the preceding claims, wherein said gas flow generated to said patient is a gas flow of a single gas and/or a mixture of different gases.

12. The handheld device (100) according to claim 1 1 , wherein said gas flow

generated to said patient is a mixture of one or more single gases, air, or a mixture of one or more single gases and air.

13. The handheld device (100) according to claim 1 1 or 12, wherein said single gas is a gas selected from the list of; oxygen (0₂), nitric oxide (NO), or nitrogen (N₂).

14. The handheld device (100) according to claim 1 1 or 12, wherein said mixture of different gases is one or more of the following gases; air or anesthetics.

15. The handheld device (100) according to any one of the preceding claims, wherein said handheld device further comprises a one-way valve (122) restricting gas flow to a one directional flow path in the patient gas outlet portion (120). 16. The handheld device (100) according to claim 15, wherein the one-way valve (122) is adapted to be in a closed position when the gas flow generator (1 10) is not generating gas flow such that gas is prevented from entering in through the patient gas outlet portion (120) and towards the gas flow generator (1 10).

17. The handheld device (100) according to claim 15 or 16, wherein the one-way valve (122) is adapted to be in an open position when the gas flow generator (1 10) is generating gas flow such that gas is able to exit out through the patient gas outlet portion (120). 18. The handheld device (100) according to any one of the preceding claims, wherein said handheld device (100) further comprises a gas fluid connector (202) adapted to provide oxygen to the generated gas flow of the gas flow generator (1 10) from a container (200) comprising the oxygen.

19. The handheld device (100) according to claim 18, wherein the container (200) internally mounted inside the handheld device (100).

20. The handheld device (100) according to claim 19, wherein the container (200) is attached to the handheld device (100) by an attaching device (201 ) such that the container (200) is connected to the gas fluid connector (202).

21 . The handheld device (100) according to claim 20, wherein the attaching device is a snap-on holder (201 ).

22. The handheld device (100) according to claim 21 , wherein the container (200) is an external to the handheld device (100), and wherein an external feeding line is connected to the gas fluid connector (202) of the handheld device (100).

23. Use of a handheld device (100) for supplying at least inspiratory gas pressure to a patient (100), wherein the handheld device (100) comprises an gas flow generator (1 10) adapted to generate an gas flow to the patient (101 ) via a patient gas outlet portion (120) of the handheld device (100) such that a predetermined inspiratory gas pressure at an end (121 ) of the patient gas outlet portion (120) is obtained.