Device for a breathing apparatus

Abstract

The present invention relates to a device for a breathing apparatus. The device comprises a conduit having a first opening and a second opening, the first opening being connectable to an air / gas source, such as a resuscitation bag, and the second opening being connectable to a face mask, such that a fluid path is established along the longitudinal direction of the conduit from the first opening to the second opening. The device further comprises a flow constriction disposed in the conduit, the flow constriction causing a pressure difference across the flow constriction when fluid flows through the conduit, the flow constriction at least partially comprising a laminar flow section, wherein the device further comprises at least one pressure connection port arranged in pressurized communication with the fluid between the flow constriction and the first opening, and wherein the pressure connection port is arranged in the longitudinal direction of the conduit.

Description

Technical Field

[0001] The inventive concept relates to a device for a breathing apparatus which is generally used for providing respiratory support to a patient, preferably an infant. The inventive concept also relates to a breathing apparatus comprising a patient interface such as a face mask, an air / gas source and the device. Background Art

[0002] At birth, an infant may require immediate support to initiate breathing or to maintain breathing. This may be due to apnea, airway obstruction, respiratory distress syndrome or because their respiratory system is immature when the infant is born prematurely. Sometimes, immediate respiratory support is required as soon as the infant is born, which is typically performed by manually pumping air into the infant's lungs. Respiratory support or manual ventilation may also be performed in other situations, and may be performed on any patient regardless of their age.

[0003] A breathing device or breathing apparatus generally comprises: a patient interface such as a face mask fitted over the patient's mouth and nose, an endotracheal tube, a laryngeal mask or a nasal cannula; an air source (or other gas source such as oxygen); and an air path which supplies air from the air source to the face mask. The air source may be, for example, a resuscitation bag / bellows. In many cases, it is necessary to monitor the patient's breathing or to measure the patient's non-respiratory ventilation. Therefore, it is necessary to know the amount of air supplied to the patient. This monitoring is typically performed by a monitoring device arranged along the air path and a display which discloses respiratory information, the monitoring device comprising a flow sensor which determines the flow of air using, for example, a pressure sensor such as a differential pressure sensor. An example of such a resuscitation device is disclosed in WO 2015 / 167388 A1.

[0004] Flow sensors are generally based on the Venturi principle, which means that the pressure drop associated with a flow constriction in the air path is measured. The algorithm for converting the differential pressure to flow is typically performed with the aid of a processor or CPU and a memory. In order to achieve a high degree of accuracy in flow measurement, the flow sensor needs to be carefully designed with respect to, for example, the geometry of the flow constriction.

[0005] Due to the risk of cross-contamination between patients, single-use units are preferred for those parts which are contaminated by the patient. Therefore, there is an incentive to keep the cost of the components as low as possible. However, since the accuracy of flow measurement is very important, there is usually a conflict between cost and accuracy. Therefore, there is a need in the industry for breathing apparatuses and related parts which better balance cost and measurement accuracy. Summary of the Invention

[0006] The object of the present inventive concept is to overcome the above problems and to provide a device which is at least to some extent less complex compared to prior art solutions while still achieving sufficient measurement accuracy. This object and other objects which will become apparent hereinafter are accomplished by a device for a breathing apparatus and a breathing apparatus including such a device as defined in the appended claims.

[0007] The present inventive concept is based on the insight that more accurate flow measurements can be performed when fluid flows from an air / gas source to a patient interface (e.g., a face mask, an endotracheal tube, a laryngeal mask, or a nasal cannula) or when fluid flows in the opposite direction from the patient interface to the air / gas source by controlling the fluid flowing towards a flow constriction in an air path and / or by controlling the fluid flow in the flow constriction in the air path. For example, the fluid can be controlled by guiding the flow towards the flow constriction by a flow guiding element and / or by providing a laminar flow section for the flow constriction.

[0008] According to at least a first aspect of the present inventive concept, there is provided a device for a breathing apparatus. The device comprises:

[0009] - a conduit having a first opening and a second opening, the first opening being connectable to an air / gas source, such as a resuscitation bag, and the second opening being connectable to a patient interface, such that a fluid path along a longitudinal direction of the conduit is established from the first opening to the second opening;

[0010] - a flow constriction arranged in the conduit, the flow constriction causing a pressure difference across the flow constriction when fluid flows through the conduit, wherein the device further comprises at least one flow guiding element arranged in the conduit between the first opening and the flow constriction, and the at least one flow guiding element is configured to guide the fluid flow towards the flow constriction.

[0011] Thus, any accuracy problems originating from flow measurement with respect to an asymmetric flow constriction, such as a flow constriction not centered in the conduit or a flow constriction causing an undesired flow turbulence, can be avoided or at least reduced. Thus, the flow guiding element is able to achieve an accurate measurement independent of the orientation of the incoming fluid flow when the flow guiding element guides the fluid flow towards the flow constriction. In addition, since the flow guiding element occupies space inside the conduit, the flow guiding element helps to reduce unwanted dead zones inside the device, thereby improving the breathing process.

[0012] It should be noted that the device can be, for example, an adapter, such as an airway adapter, which is arranged in a detachable manner on a patient interface (such as a face mask) of a breathing device. As an alternative, the device can form part of an integrated patient interface or include part of an integrated patient interface, the integrated patient interface being, for example, in the form of a face mask, endotracheal tube, laryngeal mask or nasal cannula attached to a catheter at an end portion including a second opening. The device can also be referred to as a breathing device, a catheter device or an air transport device. For an embodiment where the patient interface is a face mask, the face mask can be, for example, a soft mask, and the device forms part of a hard mask or adapter capable of being connected to the soft mask.

[0013] Hereinafter, the patient interface is mainly referred to as a face mask, but it should be understood that the patient interface can also be other patient interfaces, such as an endotracheal tube, a laryngeal mask or a nasal cannula. Thus, when it is stated that the second opening can be connected to a face mask, the second opening may also be capable of being connected to other patient interfaces, such as an endotracheal tube, a laryngeal mask or a nasal cannula. The face mask, endotracheal tube, laryngeal mask and nasal cannula can be referred to as patient interfaces because they serve as an interface between the second opening of the catheter of the device and the patient.

[0014] It should be understood that the conduit provides an air / gas path in two directions, namely from the air / gas source via the first opening, the conduit, and the second opening in that order to the face mask, and from the face mask via the second opening, the conduit, and the first opening in that order to the air / gas source. In the former case, the first opening serves as the conduit inlet, and the second opening serves as the conduit outlet, and the flow constriction is arranged downstream of the inlet. In the other case, when the fluid flows from the face mask to the air / gas source, typically during patient exhalation, the second opening serves as the conduit inlet, and the first opening serves as the conduit outlet. Then, the exhaled air / gas is typically discharged from the breathing device. Thus, the flow guiding element is arranged and configured to direct or guide the fluid flow towards the flow constriction when the fluid flow is from the first opening to the second opening. When the fluid flows in the opposite direction, i.e., from the second opening to the first opening, the fluid is transported through the flow guiding element in the reverse direction, i.e., from the flow constriction towards the first opening. Thus, the flow guiding element can be arranged and configured to transport the flow through the flow guiding element. In other words, the flow guiding element can include a channel or fluid passageway that enables the fluid to flow between the first opening and the flow constriction and between the flow constriction and the first opening. According to at least one example embodiment, the conduit includes a conduit wall surrounding the air / gas path. That is, the conduit wall is formed by a separate element (or separate part) compared to the flow guiding element, or in other words, the conduit wall and the flow guiding element are separate elements (or separate parts). For example, the conduit and its conduit wall can be physically separated from the flow guiding element before the flow guiding element is inserted into the conduit. Thus, the conduit and its conduit wall can be manufactured separately from the flow guiding element. After the flow guiding element is inserted into the conduit, the flow guiding element is typically in contact with the conduit wall, for example, by a press fit or by some type of welding or other contact means with the conduit wall. Since the conduit and its conduit wall form separate elements (or parts) compared to the flow guiding element, the flow guiding element can be arranged in the conduit in a detachable manner.

[0015] In addition, the flow constriction is designed such that regardless of the direction of the fluid flow (from the air / gas source to the face mask, or from the face mask to the air / gas source), a pressure difference can be used for, for example, flow rate measurement, and the flow constriction is arranged in the conduit to cause a pressure difference across the flow constriction when the fluid flows through the conduit. That is, the flow rate of the air / gas provided from the air / gas source to the face mask, as well as the flow rate of the air / gas from the face mask towards the air / gas source caused by patient exhalation, can be measured. By measuring the flow rates in both directions, the amount of leakage in the system can be determined.

[0016] According to at least one example embodiment, the flow guiding element is arranged on the conduit in a detachable manner. Thus, the flow guiding element can be removed from the conduit via the first opening, for example, for maintenance or adaptation reasons, and then subsequently refitted into the conduit. The flow guiding element being arranged on the conduit in a detachable manner can alternatively or additionally mean that the flow guiding element can be removed from the conduit after use and, for example, recycled or otherwise reused. Thus, the flow guiding element is generally attached to the conduit, for example, by press-fitting into the conduit and / or welding or otherwise connecting to the conduit wall, but the flow guiding element can be detached from the conduit by simply pulling the flow guiding element out of the conduit after removing any welds or other connectors (if present) between the flow guiding element and the conduit wall.

[0017] According to at least one example embodiment, the air / gas source is a resuscitation bag or a T-piece resuscitator. Alternatively, the air / gas source can be an air source or other gas source, such as an oxygen source. Thus, the conduit of the device is preferably at an end portion including the first opening, and the first opening is arranged and configured to connect to an air / gas source, such as a resuscitation bag.

[0018] According to at least one example embodiment, the device includes at least one pressure connection port arranged in pressurized communication with the fluid between the flow constriction and the first opening, and the pressure connection port is connectable to a pressure sensor for measuring the fluid pressure.

[0019] According to at least one example embodiment, the device includes at least one pressure connection port arranged in pressurized communication with the fluid between the flow constriction and the first opening, the pressure connection port is connectable to a pressure sensor for measuring the fluid pressure, and wherein the pressure connection port is arranged in the longitudinal direction of the conduit.

[0020] Thus, the at least one pressure connection port and the flow constriction have fluid paths arranged in the same direction (the longitudinal direction of the conduit), which facilitates the manufacture of the device (e.g., by injection molding). In addition, with the at least one pressure connection port oriented in this way, a filter, such as a bacteria filter, can be easily inserted into the device via the first opening and further into the pressure connection port.

[0021] It should be understood that when indicating the longitudinal direction of the conduit in which at least one pressure connection port is arranged, the cross-section of the inlet of the at least one pressure connection port is arranged perpendicular to the longitudinal direction. Or in other words, the at least one pressure connection port includes an inlet facing a geometric plane perpendicular to the longitudinal direction. However, it should be noted that the inlet of the at least one pressure connection port is not arranged to receive any fluid flow in the conduit, but serves as a port for achieving fluid communication, thereby enabling the measurement of the pressure of the fluid between the flow constriction and the first opening (i.e., upstream of the flow constriction when the fluid flows from the first opening to the second opening). In other words, the at least one pressure connection port includes an elongate fluid chamber having a longitudinal axis parallel to the longitudinal direction of the conduit.

[0022] According to at least one example embodiment, the flow guiding element is configured to guide the fluid flow away from the pressure connection port. For example, the flow guiding element may include a flow passage that guides the flow away from the pressure connection port towards the flow constriction.

[0023] According to at least one example embodiment, the at least one pressure connection port may simply be referred to as a pressure port.

[0024] According to at least one example embodiment, the at least one pressure connection port is at least partially arranged parallel to the flow constriction. Thus, the device can be made more compact.

[0025] According to at least one example embodiment, the flow constriction at least partially includes a laminar flow section having a plurality of elongate channels arranged in the longitudinal direction of the conduit such that the at least one pressure connection port and the plurality of elongate channels are arranged at least partially parallel.

[0026] Therefore, due to the common direction of the elongate channels and the fluid channels of the at least one pressure connection port, the manufacture of the device is facilitated. Furthermore, by arranging the at least one pressure connection port and the plurality of elongate channels at least partially parallel, the device can be made more compact because the cross-section of the conduit perpendicular to the longitudinal direction includes the at least one pressure connection port and the elongate channels at the flow constriction. In other words, at least a part of the pressure connection port shares the same conduit space as the flow constriction. With this configuration, the flow constriction is typically asymmetrically arranged in the conduit, and the flow guiding element can achieve its purpose by guiding the fluid flow towards the flow constriction. In the absence of such a flow guiding element, the fluid would be able to flow into the pressure connection port and thereby reduce the measurement accuracy.

[0027] It should be understood that each of the plurality of elongated channels has a main direction in the longitudinal direction. The elongated channels may be referred to as elongated holes or elongated tubes. The number and length of the channels are typically adjusted based on the expected fluid flow through the flow constriction to achieve laminar flow rather than turbulent flow, as this improves measurement accuracy. How to design the laminar section to achieve laminar flow is known to those skilled in the art. It should also be noted that since the laminar conditions depend at least in part on the fluid flow, where high fluid flow rates increase the risk of turbulence occurring, the fluid flow in at least some of the elongated channels may still sometimes be turbulent. According to at least one example embodiment, the laminar section may simply be referred to as the flow section.

[0028] Typically, the laminar section forms at least a part of the flow constriction and thus completely houses the channels in the flow constriction at least partially along the longitudinal direction of the conduit. According to at least one example embodiment, the laminar section is the flow constriction of the device.

[0029] According to at least one example embodiment, the laminar section includes a mesh portion having a plurality of holes instead of elongated channels. Thus, such a mesh portion serves the same purpose as the elongated channels, namely to provide laminar flow.

[0030] It should be understood that the purpose of the laminar section is to provide a relatively large contact surface between the inner wall of the elongated channel and the fluid, which results in a more linear relationship between the fluid flow rate and the pressure drop, thereby improving measurement accuracy.

[0031] According to at least a second aspect of the inventive concept, there is provided another device for a breathing apparatus. The device includes:

[0032] - a conduit having a first opening and a second opening, the first opening being connectable to an air / gas source such as a resuscitation bag, and the second opening being connectable to a patient interface such that a fluid path is established along the longitudinal direction of the conduit from the first opening to the second opening;

[0033] - a flow constriction disposed in the conduit, the flow constriction causing a pressure difference across the flow constriction when fluid flows through the conduit,

[0034] wherein the flow constriction at least partially includes a laminar section,

[0035] wherein the device further includes at least one pressure connection port arranged in pressurized communication with the fluid between the flow constriction and the first opening, the pressure connection port being connectable to a pressure sensor for measuring the fluid pressure, and wherein the pressure connection port is arranged in the longitudinal direction of the conduit.

[0036] Accordingly, a second aspect of the inventive concept is very similar to the first aspect of the inventive concept, but (in the broadest concept of the present invention) instead of providing a flow guiding element for guiding the flow towards the flow constriction, the flow inside the flow constriction is controlled by a laminar section and a connection port. Thus, the effects and features related to the pressure connection port and the laminar section of the second aspect of the inventive concept are largely similar to the effects and features described above in connection with the first aspect of the inventive concept.

[0037] According to at least one example embodiment, the device of the second aspect of the inventive concept includes at least one flow guiding element as described above.

[0038] Thereafter, embodiments related to both the first and second aspects of the inventive concept are described in detail. It should be understood that each embodiment may be related to the first aspect and the second aspect of the inventive concept respectively.

[0039] According to at least one example embodiment, the flow guiding element includes:

[0040] - a shielding portion that is arranged in the conduit to cover the inlet of the pressure connection port,

[0041] - a fluid passage that enables fluid to flow between the first opening and the flow constriction, and,

[0042] - at least one pressure conduit that is arranged to provide a fluid channel between the fluid passage and the pressure connection port.

[0043] Thus, the fluid flow into or through the pressure connection port can be avoided by the shielding portion while still providing a fluid passage that is guided towards the flow constriction (generally towards the laminar section). Thus, the pressure connection port can be in fluid communication with the fluid present between the first opening and the flow constriction via at least one pressure conduit (i.e., under upstream conditions of the flow constriction when the fluid flows through the device from the first opening to the second opening) without receiving any fluid flow. Thus, the pressure of the fluid can be measured by a pressure sensor connected to the pressure connection port.

[0044] According to at least one example embodiment, the fluid passage is shaped to achieve a minimum flow resistance, for example, by having a crescent cross-section perpendicular to the longitudinal direction of the conduit. Thereby, the respiratory support for the patient is improved. Thus, most of the cross-section of the flow guiding element can be used for the fluid passage instead of the shielding portion.

[0045] According to at least one example embodiment, at least one pressure conduit is arranged to be close to an end portion of the fluid passageway to minimize the effect of potential fluid turbulence. According to at least one example embodiment, the flow guiding element includes at least two pressure conduits to reduce measurement errors.

[0046] According to at least one example embodiment, the pressure connection port is a first pressure connection port, and the device further includes a second pressure connection port arranged to be in pressurized communication with the fluid between the flow constriction and the second opening, such that a differential pressure sensor can be connected to the first pressure connection port and the second pressure connection port to measure the differential pressure across the flow constriction.

[0047] Thus, the flow rate through the flow constriction can be measured by a flow rate sensor based on, for example, the Venturi principle or the Bernoulli equation, which means measuring the pressure drop associated with the flow constriction in the air path. The algorithm for converting the differential pressure into a flow rate can be executed by means of a processor or a CPU and a memory.

[0048] According to at least one example embodiment, the second pressure connection port is arranged in the longitudinal direction of the conduit. Accordingly, the cross-section of the inlet of the second pressure connection port is arranged perpendicular to the longitudinal direction. In other words, the second pressure connection port includes an elongated fluid chamber having a longitudinal axis parallel to the longitudinal direction of the conduit.

[0049] According to at least one example embodiment, the device includes a pressure sensor connection portion arranged between the first opening and the second opening, generally close to the flow constriction. The pressure sensor connection portion is capable of being connected to a pressure sensor unit. Generally, the pressure sensor connection portion includes a tubular portion extending from the conduit perpendicular to the longitudinal direction. Further, according to at least one example embodiment, the first pressure connection port and the second pressure connection port are arranged in the device to have corresponding openings (the corresponding openings may be referred to as the outlets of the pressure connection ports) in the pressure sensor connection portion, each of the openings having a cross-section parallel to the longitudinal direction. Thus, these openings are arranged at the opposite ends of the openings of the corresponding pressure connection ports, and the openings of the corresponding pressure connection ports (i.e., the openings referred to as the inlets of the pressure connection ports) have cross-sections perpendicular to the longitudinal direction of the conduit. That is, each of the first pressure connection port and the second pressure connection port can have an L-shaped channel.

[0050] According to at least one example embodiment, the fluid flow rate in the pressure connection port is minimized, at least the fluid flow rate through the corresponding pressure connection port is minimized. Thereby, any contaminants that may enter the device will not spread to the connected pressure sensor.

[0051] According to at least one example embodiment, the flow guiding element is a first flow guiding element, and the device further includes a second flow guiding element, which is arranged in the conduit between the flow constriction and the second opening, and the second flow guiding element is configured to guide the fluid flow away from the second pressure connection port.

[0052] Thus, when the fluid flow is from the second opening of the conduit to the first opening (i.e., when the patient exhales and the fluid flows in the direction from the patient interface towards the air / gas source), the fluid is guided towards the flow constriction in a manner similar to that described above for the first flow guiding element. Therefore, the second flow guiding element is arranged and configured to direct or guide the fluid flow towards the flow constriction when the fluid flow is from the second opening to the first opening. When the fluid flows in the opposite direction, i.e., from the first opening to the second opening, the fluid is transported through the second flow guiding element in the reverse direction, i.e., from the flow constriction towards the second opening. Thus, any accuracy issues originating from the flow measurement regarding an asymmetric flow constriction, such as a flow constriction not centered in the conduit or a flow constriction causing undesired flow turbulence, can be avoided or at least reduced. Therefore, the second flow guiding element can achieve accurate measurement independent of the orientation of the incoming fluid flow when the second flow guiding element guides the fluid flow towards the flow constriction and away from the second pressure connection port. Additionally, since the second flow guiding element occupies space inside the conduit, the second flow guiding element helps to reduce undesired dead zones inside the device, thereby improving the breathing process. This is particularly important for embodiments having a laminar flow section because the large contact area between the inner wall of the laminar flow section and the fluid flow typically results in an increase in dead zones. Therefore, the reduction in dead zones caused by the flow guiding element offsets the increased dead zones caused by the laminar flow section.

[0053] According to at least one example embodiment, the second flow guiding element acts as a protector that prevents any liquid (saliva, vomit) coughed up by the patient from further entering the conduit, thereby preventing the further spread of contaminants into the device. This is particularly important for embodiments having a laminar flow section because the narrow channels may otherwise be blocked.

[0054] According to at least one example embodiment, the second flow guiding element includes:

[0055] - a shielding portion that is arranged in the conduit to cover the inlet of the second pressure connection port, - a fluid passage that enables fluid to flow between the second opening and the flow constriction, and,

[0056] - at least one pressure conduit that is arranged to provide a fluid channel between the fluid passage and the second pressure connection port, and

[0057] - A protection part, which is arranged in the catheter to prevent any liquid coughed up by the patient from further entering the catheter.

[0058] Thus, the second flow guiding element also serves to protect the device from contaminants from the patient. That is, the protection part of the second flow guiding element prevents liquid from the patient, such as saliva or vomit, from passing over the second flow guiding element and entering the device. Since the channel is narrow, this is particularly important for embodiments having a laminar flow section.

[0059] Corresponding to the first flow guiding element, the second flow guiding element is constructed and arranged to prevent fluid flow from entering or passing through the second pressure connection port through a shielding part, while still providing a fluid channel that is directed towards the flow constriction (usually towards the laminar flow section). Thus, the second pressure connection port can be in fluid communication with the fluid present between the second opening and the flow constriction via at least one pressure catheter without receiving any fluid flow. Therefore, the pressure of the fluid can be measured by a pressure sensor connected to the second pressure connection port.

[0060] According to at least one example embodiment, the fluid channel is arranged between the inner wall of the catheter and the protection part. Preferably, the fluid channel of the second flow guiding element is arranged close to the inner wall of the catheter. Correspondingly, the protection part is preferably arranged closer to the center of the catheter compared to the fluid channel to effectively impede any liquid coughed up by the patient.

[0061] According to at least one example embodiment, the device further includes a patient interface, such as a face mask, connected to the catheter at an end portion including the second opening.

[0062] That is, the catheter can include a first end portion arranged at the first opening and a second end portion arranged at the second opening. Thus, the patient interface can be connected to, for example, detachably connected to, the second end portion of the catheter, or integrated with the second end portion of the catheter such that the second opening leads to a void in the patient interface, such as a void in the face mask.

[0063] As already stated above, another patient interface, such as an endotracheal tube, a laryngeal mask, or a nasal cannula, can be selected instead of a face mask.

[0064] According to at least one example embodiment, the device is a single-use component and will be discarded after use. Thus, contamination between patients can be minimized.

[0065] According to at least one example embodiment, the device is injection molded. This provides a suitable and inexpensive way to produce the device.

[0066] That is, the device is manufactured by an injection molding process. This is particularly advantageous for the production of the specific geometries required for the laminar section, such as a plurality of channels. Specifically, the pressure connection ports, the orientation of at least the respective portions arranged to face the first opening and the second opening of the conduit, and the direction of the plurality of channels in the laminar section are aligned in the longitudinal direction of the conduit during the injection molding process.

[0067] According to at least one example embodiment, the device further includes a pressure sensor unit, which is arranged on the conduit in a detachable manner to measure the pressure upstream and / or downstream of the flow constriction.

[0068] Thus, the pressure sensor unit can measure the pressure difference across the flow constriction, i.e., the pressure difference at the position between the first opening and the flow constriction and at the position between the flow constriction and the second opening. Thus, the pressure sensor unit generally includes channels that enable connection to the first pressure connection port and the second pressure connection port to transport the fluid pressure inside the pressure sensor unit to the pressure sensor.

[0069] Advantageously, the pressure sensor unit is arranged on the conduit in a detachable manner via a pressure sensor connection part.

[0070] According to at least one example embodiment, the pressure sensor unit is not part of the device and is thus considered a separate component of the device. For example, the device (without the pressure sensor unit) can be a single-use component (i.e., a disposable item), while the pressure sensor unit can be reused.

[0071] According to at least one example embodiment, the pressure sensor unit can, for example, include a differential pressure sensor, which is used to measure the pressure difference across the flow constriction by being in pressurized communication with the first pressure port and the second pressure port. The pressure sensor unit can alternatively or additionally include a gauge pressure sensor to evaluate the (positive) pressure used during ventilation. According to at least one example embodiment, the gauge pressure sensor is implemented using an absolute pressure sensor, which compares the (ambient) pressure measured before ventilation with the pressure during ventilation and then calculates the gauge pressure by subtracting these values. This allows the use of only one (inexpensive but accurate) barometric pressure sensor to evaluate both the ambient pressure and the gauge pressure. According to at least one example embodiment, the pressure sensor unit includes a pressure sensor that prevents fluid flow through the pressure sensor, for example, by means of a membrane. Thus, the pressure sensor can be a membrane-based pressure sensor.

[0072] In addition, the pressure sensor unit can include a battery, a CPU or processor, a memory, a wireless communication device, such as a Bluetooth module. The pressure sensor unit can also include a housing that holds all of the aforementioned components of the pressure sensor unit.

[0073] As described above, the device is constructed and arranged such that there will be no fluid flow through the respective first and second pressure connection ports. Thus, when the pressure sensor unit is attached to the conduit of the device, there will be no fluid flow in the pressure sensor unit. Generally, this would result in poor zero-level stability of the pressure measurement. However, the above-described laminar section according to an embodiment of the present invention counteracts this drawback, thereby resulting in satisfactory accuracy of the flow measurement.

[0074] According to at least one example embodiment, the device includes one or more filters disposed in one or both of the first and second pressure connection ports. Thus, further entry of contaminants into the pressure sensor unit is prevented.

[0075] According to at least a third aspect of the inventive concept, there is provided a breathing device for providing respiratory support to a patient, preferably an infant. The breathing device includes:

[0076] - a patient interface, such as a face mask, which is adapted to fit over the mouth and nose of the patient,

[0077] - an air / gas source that supplies air or gas to the patient interface, and

[0078] - a device according to the first or second aspect of the inventive concept.

[0079] The effects and features related to the third aspect of the inventive concept are largely similar to those described above in connection with the first and second aspects of the inventive concept. For example, the air / gas source may be, for example, a resuscitation bag, and the patient interface may be an endotracheal tube, a laryngeal mask, or a nasal cannula instead of a face mask.

[0080] According to at least one example embodiment, the patient interface is a face mask that is connected to, such as detachably connected to, or integrated with the second end portion of the conduit such that the second opening results in a void in the face mask.

[0081] Other features of the inventive concept and advantages of utilizing the inventive concept will become apparent when studying the appended claims and the following description. Those skilled in the art will recognize that different features of the inventive concept can be combined without departing from the scope of the inventive concept to produce embodiments other than those described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0082] These and other aspects of the inventive concept will now be described in more detail with reference to the drawings, which show example embodiments of the inventive concept, in which:

[0083] Figure 1 Schematically illustrates a breathing device for providing respiratory support to a patient, such as an infant, according to at least one exemplary embodiment of the inventive concept.

[0084] Figure 2 Illustrates in cross-section a device for a breathing device according to at least one exemplary embodiment of the inventive concept;

[0085] Figure 3 Illustrates in cross-section another device for a breathing device according to at least one exemplary embodiment of the inventive concept;

[0086] Figure 4 Illustrates in cross-section yet another device for a breathing device according to at least one exemplary embodiment of the inventive concept; and

[0087] Figure 5A and Figure 5B Illustrates a perspective view of a first flow guiding element and a second flow guiding element. Detailed Description

[0088] In this detailed description, various embodiments of the inventive concept are mainly described with reference to a device for a breathing device and a breathing device for providing respiratory support to a patient, preferably an infant.

[0089] Figure 1 Is a schematic view illustrating a breathing device 1 for providing respiratory support to a patient 3, such as an infant 3. The breathing device 1 includes: a face mask 5 adapted to fit over the mouth and nose of the patient 3; an air / gas source 7 that supplies air or gas to the face mask 5; and a device 9 that provides an air / gas path from the air / gas source 7 to the face mask 5. Note that in Figure 1 the device 9 is implemented as an airway adapter detachably connected to the face mask 5, but according to at least one exemplary embodiment, the face mask 5 is integrated with the airway adapter and thus forms part of the device 9. The device 9 may, for example, have corresponding tubular portions disposed at both ends of the device 9. That is, the end portion facing the face mask 5 may be tubular in a manner corresponding to the end portion facing the air / gas source and thus does not include Figure 1The different parts presented. The face mask 5 can be a separate / existing face mask or a soft mask, and / or the device 9 can form part of a hard mask that can be connected to the soft mask to form an integrated device / face mask. The breathing device 1 can also include a pressure sensor unit 11 arranged on the device 9 in a detachable manner. According to at least one exemplary embodiment of the inventive concept, the pressure sensor unit 11 forms part of the device 9. The pressure sensor unit 11 is generally used to measure the pressure generated by the fluid flowing through the device, which can be used to calculate the fluid flow rate from the air / gas source 7 through the device to the face mask 5 and thus the amount of air / gas supplied to the patient 3, and / or to calculate the fluid flow rate from the face mask 5 towards the air / gas source 7, i.e., the air / gas exhaled by the patient and transported in the other direction along the device 9. The pressure sensor unit 11 can, for example, include a differential pressure sensor to measure the pressure drop across the flow constriction in the device (refer to Figure 4 for a more detailed description). The breathing device 1 can also include a display 13 or other information presenting device for communicating with the pressure sensor unit 11. The display 13 is generally adapted to present the fluid flow rate through the device 9 and thus the amount of air / gas supplied to the patient 3 and / or the amount of air / gas exhaled by the patient 3.

[0090] Figures 2 to 4 illustrates Figure 1 various embodiments of the device 9. In Figure 2 , the device 19 is illustrated in cross-section along the longitudinal direction L of the device 19. The device 19 includes a conduit 21 having a first opening 23 that can be connected to a resuscitation bag or other gas source (shown in Figure 1 ) and a second opening 25 that can be connected to a face mask (also shown in Figure 1 ). Thus, a fluid path is established along the longitudinal direction L of the conduit 21 from the first opening 23 to the second opening 25, and naturally a fluid path from the second opening 25 to the first opening 23 is established.

[0091] As seen in Figure 2 , the device 19 includes a flow constriction 27 or a flow restriction 27 in the conduit 21 that causes a pressure difference across the flow constriction 27 when the fluid flows through the conduit 21. Figure 2 The device 19 in Figure 5Ais described in more detail. Accordingly, any accuracy issues stemming from flow measurement regarding the asymmetric geometry of the flow constriction portion 27 are alleviated, since for example, a flow constriction portion not centered in the conduit 21, or a device including other fluid ports (such as pressure connection ports) risks fluid bypass or other disturbances (such as turbulent eddies). Thus, the flow guiding element 29 is able to achieve accurate measurement independent of the direction of the incoming fluid flow to the device 19.

[0092] Figure 3 illustrates a device 39 similar to the device shown in Figure 2 except that the flow guiding element is absent in the device 39 and the flow constriction portion is designed in a different manner. Thus, the device 39 includes a conduit 41 having a first opening 43 connectable to a resuscitation bag or other gas source (shown in Figure 1 and a second opening 45 connectable to a face mask (also shown in Figure 1 ), thereby establishing a fluid path along the longitudinal direction L of the conduit 41. In a similar manner to Figure 2 the flow constriction portion 47 in the conduit 41 of Figure 3 is arranged to cause a pressure difference across the flow constriction portion 47 as fluid flows through the conduit. In Figure 3 the flow constriction portion 47 includes a laminar flow section 49 having a plurality of elongated channels 49a arranged along the longitudinal direction L of the conduit 41 (only one of the channels is indicated in Figure 3 ).

[0093] Figure 3 The device 39 of

[0094] also includes a pressure connection port 51 arranged in pressurized communication with the fluid between the flow constriction portion 47 and the first opening 43 (i.e., upstream of the flow constriction portion 47 when fluid flows from the first opening 43 to the second opening 45). The pressure connection port 51 is arranged in the longitudinal direction L of the conduit 41. That is, the inlet 51A of the pressure connection port 51 extends in a geometric plane perpendicular to the longitudinal direction L of the conduit 41. Thus, the main direction of the pressure connection port 51 is the same as the main direction of the plurality of elongated channels 49A. Thereby, the manufacture of the device 39, for example by injection molding, is facilitated. Further, by orienting the pressure connection port 51 having the inlet 51A towards the first opening 43 of the conduit, a filter, such as a bacterial filter, can be easily inserted into the device 39. However, it should be noted that according to at least one alternative embodiment of the inventive concept, the inlet 51A of the pressure connection port 51 extends in a geometric plane parallel to the longitudinal direction L of the conduit 41. Figure 4As shown therein. Thus, the pressure between the flow constriction portion 47 and the first opening 43 can be measured, and this pressure can be used to determine the fluid flow rate through the conduit 41.

[0095] Figure 4 The figure shows a device 119 similar to the device Figure 2 and Figure 3 shown in. Thus, the device 119 includes a conduit 121 having a first opening 123 that can be connected to a resuscitation bag or other gas source (shown in Figure 1 ), and a second opening 125 that can be connected to a face mask (also shown in Figure 1 ). Thus, a fluid path is established along the longitudinal direction L of the conduit 121. Figure 4 The flow constriction portion 127 in the conduit 121 of Figure 2 is arranged in a similar manner to that in Figure 4 to cause a pressure difference across the flow constriction portion 127 when fluid flows through the conduit 121. In Figure 4 , the flow constriction portion 127 includes a laminar flow section 128 having a plurality of elongated channels 128A arranged along the longitudinal direction L of the conduit 121 in a similar manner to that in Figure 3 (only one of the channels in the channel is indicated in Figure 4 ).

[0096] As seen in Figure 4 , the device 119 includes a first pressure connection port 151 and a second pressure connection port 153. The first pressure connection port 151 is arranged to be in pressurized communication with the fluid between the flow constriction portion 127 and the first opening 43, and the second pressure connection port 153 is arranged to be in pressurized communication with the fluid between the flow constriction portion 127 and the second opening 125 (i.e., downstream of the flow constriction portion 127 when fluid flows from the first opening 123 to the second opening 127). The first pressure connection port 151 is similar to the pressure connection port 51 described with reference to Figure 2 . Thus, the first pressure connection port 151 is arranged in the longitudinal direction L. That is, the inlet 151A of the first pressure connection port 151 extends in a geometric plane perpendicular to the longitudinal direction L of the conduit 121, and the main direction of the first pressure connection port 151 is the same as the main direction of the plurality of elongated channels 128A. In a corresponding manner, the second pressure connection port 153 is arranged in the longitudinal direction L, but wherein the inlet 153A faces in a direction opposite to the inlet 151A of the first pressure connection port 151. Thus, the inlet 153A of the second pressure connection port 153 faces the second opening 125 of the conduit 121. Thus, the inlet 153A of the second pressure connection port 153 also extends in a geometric plane perpendicular to the longitudinal direction L of the conduit 121.

[0097] Accordingly, the first pressure connection port 151 and the second pressure connection port 153 are arranged in the device 119 to provide ports for the upstream pressure and the downstream pressure relative to the flow constriction 127. As seen in Figure 4 it is shown that the pressure sensor unit 111 is arranged on the conduit 121 in a detachable manner. More specifically, the conduit 121 includes a pressure sensor connection portion 122 arranged and configured to be connected to the pressure sensor unit 111. In Figure 4 it, the pressure sensor connection portion 122 is tubular and extends from the conduit 121 perpendicular to the longitudinal direction L. Further, the first pressure connection port 151 and the second pressure connection port 153 are arranged in the device 119 such that the respective outlets 151B, 153B of the first pressure connection port 151 and the second pressure connection port 153 are in the pressure sensor connection portion 122, wherein the respective outlets 151B, 153B face a direction perpendicular to the respective inlets 151A, 153A of the first pressure connection port 151 and the second pressure connection port 153. That is, the respective outlets 153A, 153B of the first pressure connection port 151 and the second pressure connection port 153 have a cross-section parallel to the longitudinal direction l. However, it should be noted that the inlets 151A of the first pressure connection port and the inlets 153A of the second pressure connection port are not arranged in the conduit to receive any fluid flow, but serve as ports for achieving fluid communication, thereby enabling the measurement of the fluid pressures upstream and downstream of the flow constriction. Accordingly, the outlets 151B of the first pressure connection port 151 and the outlets 153B of the second pressure connection port 153 are not arranged in the conduit 121 to discharge any fluid flow, but serve as ports for achieving fluid communication with the pressure sensor in the pressure sensor unit 111.

[0098] By providing the first pressure connection port 151 and the second pressure connection port 153 - the first pressure connection port 151 and the second pressure connection port 153 are arranged in the device 119 to provide ports for the upstream pressure and the downstream pressure relative to the flow constriction 127, as shown in Figure 4 it can be measured the pressure difference across the flow constriction 127 by a differential pressure sensor included in the pressure sensor unit 111. The pressure sensor unit may include, for example, a battery, a CPU or a processor, a memory, a wireless communication device such as a Bluetooth module, and a battery. The pressure sensor unit 111 and the flow constriction 127 may be referred to as a monitoring arrangement, and the pressure sensor unit 111 and the flow constriction 127 are arranged together with an information presentation device (such as Figure 1 shown as the display 13 in it) to calculate and present the amount of air / gas flowing to the patient or the amount of air / gas flowing out of the patient.

[0099] Figure 4The device 119 therein includes a first flow guiding element 129 which is arranged in the conduit 121 between the flow constriction 127 and the first opening 123, and the first flow guiding element 129 is configured to direct the fluid flow from the first opening 123 towards the flow constriction 127 when the fluid flows from the first opening 123 towards the second opening 125, and the device 119 includes a second flow guiding element 131 which is arranged in the conduit 121 between the flow constriction 127 and the second opening 125, and the second flow guiding element 131 is configured to direct the fluid flow from the second opening 125 towards the flow constriction 127 when the fluid flows from the second opening 125 towards the first opening 123. The first flow guiding element 129 largely corresponds to Figure 2 the flow guiding element 29 of the device 19. Thus, the first flow guiding element 129 is arranged and configured to direct the fluid flow to the flow constriction 127 so as to alleviate any accuracy issues arising from the flow measurement with respect to either the asymmetrical geometry of the flow constriction 127 or the unwanted fluid flow into the first pressure connection port 151 here. Therefore, the first flow guiding element 129 enables accurate measurement independent of the direction of the incoming fluid flow via the first opening 123 into the device 119.

[0100] The second flow guiding element 131 is configured to direct the fluid flow to the flow constriction 127 so as to alleviate any accuracy issues arising from the flow measurement with respect to either the asymmetrical geometry of the flow constriction 127 or the unwanted fluid flow into the second pressure connection port 153 here. Therefore, the second flow guiding element 131 enables accurate measurement independent of the direction of the incoming fluid flow via the second opening 125 into the device 119.

[0101] Figure 5A and Figure 5B respectively illustrate detailed views of the first flow guiding element 129 and the second flow guiding element 131.

[0102] The first flow guiding element 129 includes a first surface 129A which faces the first opening 123 when the first flow guiding element 129 is arranged in the conduit 121 of the device 119, wherein the first surface 129A includes a shielding portion 160. The first flow guiding element 129 is arranged and configured in the conduit 121 such that the shielding portion 160 covers the first pressure connection port 151, or at least the inlet 151A of the first pressure connection port 151. Thus, the fluid flow into the first pressure connection port 151 can be avoided by the shielding portion 160.

[0103] The first flow guiding element 129 further includes a fluid passage 162 which enables a fluid flow between the first opening 123 and the flow constriction 127 when the first flow guiding element 129 is disposed in the conduit 121 of the device 119. The first flow guiding element 129 is disposed in the conduit 121 and configured such that the fluid passage 162 covers the flow constriction 127, or at least guides the fluid flow towards the flow constriction 127 when the fluid flows from the first opening 123 through the device 119 to the second opening 125. In Figure 5A , the fluid passage 162 is shaped to achieve a minimum flow resistance by having a crescent cross-section (the cross-section is perpendicular to the longitudinal direction L of the conduit 121).

[0104] In addition, in Figure 5A 's embodiment, the first flow guiding element 129 includes two pressure conduits 164 which are arranged close to the end portions of the fluid passage 162 to provide a fluid passage between the fluid passage 162 and the first pressure connection port 151. The pressure conduits 164 can place the first pressure connection port 151 in fluid communication with the fluid existing between the first opening 123 and the flow constriction 127 without receiving any fluid flow. Therefore, the pressure of the fluid can be measured by a pressure sensor connected to the first pressure connection port 151.

[0105] As can be seen in Figure 5B , the second flow guiding element 131 includes a first surface 131A which faces the second opening 125 when the second flow guiding element 131 is disposed in the conduit 121 of the device 119, wherein the first surface 131A includes a shielding portion 161. The second flow guiding element 131 is disposed in the conduit 121 and configured such that the shielding portion 161 covers the second pressure connection port 153, or at least covers the inlet 153A of the second pressure connection port 153. Thereby, the fluid flow into the second pressure connection port 153 can be avoided by the shielding portion 161.

[0106] The second flow guiding element 131 further includes a fluid passage 163 which enables a fluid flow between the second opening 125 and the flow constriction 127 when the second flow guiding element 131 is disposed in the conduit 121 of the device 119. The second flow guiding element 131 is disposed in the conduit 121 and configured such that the fluid passage 163 covers at least a part of the flow constriction 127, or the fluid passage 163 at least guides the fluid flow towards the flow constriction 127 when the fluid flows from the second opening 125 through the device 119 to the first opening 123.

[0107] The second flow guiding element 131 further includes a protection portion 165 which is disposed in the conduit 121 and configured to cover at least a part of the flow constriction portion 127, and thereby prevent liquids from the patient, such as saliva or vomit, from passing over the second flow guiding element 131 and into the device 119.

[0108] In Figure 5B it, the fluid passage 163 is disposed between the inner wall of the conduit 121 and the protection portion 165. In Figure 5B the embodiment in, the fluid passage 163 of the second flow guiding element 131 is disposed close to the inner wall of the conduit 121, and the protection portion 165 is disposed closer to the center of the conduit 121. Thus, the protection portion 165 can effectively obstruct any liquid coughed up by the patient.

[0109] In addition, in Figure 5B the embodiment of, the second flow guiding element 131 includes two pressure conduits 167 which are arranged to provide a fluid passage between the fluid present between the second opening 125 and the flow constriction portion 127 and the second pressure connection port 153. The pressure conduits 167 can put the second pressure connection port 153 in fluid communication with the fluid present between the second opening 125 and the flow constriction portion 127 without receiving any fluid flow. Therefore, the pressure of the fluid can be measured by a pressure sensor connected to the second pressure connection port 153.

[0110] It should be noted that the air / gas source 7 can be, for example, an air source 7 or other types of gas sources providing, for example, oxygen. In one exemplary embodiment, the air / gas source 7 is a resuscitation bag / bellows 7 or a T-piece resuscitator.

[0111] Even though the inventive concept has been described with reference to specific exemplary embodiments thereof, many different variations, modifications, etc. will become apparent to those skilled in the art. Also, it should be noted that parts of the pressure sensor units 11, 111 can be omitted, interchanged or arranged in various ways, and the devices 9, 119 can still perform the functions of the inventive concept. In addition, the patient interface can be an endotracheal tube, a laryngeal mask or a nasal cannula instead of a face mask.

[0112] Additionally, upon study of the drawings, the disclosure and the appended claims, those skilled in the art can understand and implement variations of the disclosed embodiments when practicing the claimed inventive concept. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

Claims

1. An apparatus for a breathing device, the apparatus comprising: - a conduit having a first opening and a second opening, the first opening being connectable to an air / gas source and the second opening being connectable to a patient interface such that a fluid path is established along a longitudinal direction of the conduit from the first opening to the second opening; - a flow constriction disposed in the conduit, the flow constriction causing a pressure difference across the flow constriction when fluid flows through the conduit, wherein the apparatus further comprises at least one flow guiding element, at least one of the at least one flow guiding element being disposed in the conduit between the first opening and the flow constriction and being configured to guide a fluid flow to the flow constriction, wherein the apparatus further comprises at least one pressure connection port arranged in pressurized communication with the fluid between the flow constriction and the first opening, the pressure connection port being connectable to a pressure sensor for measuring fluid pressure, and wherein the pressure connection port is arranged in the longitudinal direction of the conduit, wherein the flow guiding element comprises: - a shielding portion disposed in the conduit to cover an inlet of the pressure connection port, - a fluid passage enabling fluid to flow between the first opening and the flow constriction, and - at least one pressure conduit arranged to provide a fluid passage between the fluid passage and the pressure connection port.

2. The apparatus according to claim 1, wherein the flow constriction at least partially comprises a laminar flow section including a plurality of elongated channels arranged in the longitudinal direction of the conduit such that the pressure connection port and the plurality of elongated channels are arranged at least partially parallel.

3. The apparatus according to claim 1 or 2, wherein the pressure connection port is a first pressure connection port and the apparatus further comprises a second pressure connection port arranged in pressurized communication with the fluid between the flow constriction and the second opening such that a differential pressure sensor can be connected to the first pressure connection port and the second pressure connection port to measure the differential pressure across the flow constriction.

4. The apparatus according to claim 3, wherein the flow guiding element is a first flow guiding element and the apparatus further comprises a second flow guiding element disposed in the conduit between the flow constriction and the second opening and configured to guide the fluid flow away from the second pressure connection port.

5. The apparatus according to claim 4, wherein the second flow guiding element comprises: - a shielding portion disposed in the conduit to cover an inlet of the second pressure connection port, - a fluid passage enabling fluid to flow between the second opening and the flow constriction, and - At least one pressure conduit arranged to provide a fluid passage between the fluid passageway and the second pressure connection port, and - A protection part arranged in the conduit to prevent any liquid coughed up by the patient from further entering the conduit.

6. The device according to any one of claims 1 to 2, 4 to 5, further comprising a patient interface in the form of a face mask, the face mask being connected to the conduit at an end portion including the second opening.

7. The device according to any one of claims 1 to 2, 4 to 5, wherein, the device is injection molded.

8. The device according to any one of claims 1 to 2, 4 to 5, further comprising a pressure sensor detachably arranged on the conduit to measure the pressure upstream and / or downstream of the flow constriction.

9. The device according to claim 1, wherein, the air / gas source is a resuscitation bag.

10. A respiratory device for providing respiratory support to a patient, the respiratory device comprising: - A patient interface adapted to fit over the mouth and nose of the patient, - An air / gas source for providing gas to the patient interface, and - The device according to any one of claims 1 to 9.

11. The respiratory device according to claim 10, wherein, the respiratory device is for providing respiratory support to an infant.

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