Resuscitation assembly

Abstract

A resuscitation assembly (5) with a patient mask (13), a resuscitator bag (11), an intermediate part (15) between the patient mask and the resuscitator bag, and an expiration outlet (17) A microphone (27) is arranged in acoustic connection to an airflow inside of or out of the resuscitation assembly. A processing unit (53) is arranged in connection with the microphone (27). The processing unit (53) provides an output based on the sound signals recorded by the microphone (27).

Description

RESUSCITATION ASSEMBLYTechnical Field

[0001] The present invention relates to a resuscitation assembly, and in particular to the object of ensuring correct utilization of a resuscitation assembly.Background Art

[0002] Common resuscitation assemblies comprise a ventilation bag to provide the pressure necessary to inflate air into a non-breathing patient. Moreover, they have a patient mask that seals around the nose and mouth of the patient. During use, the operator needs to apply the mask correctly over the face of the patient, while simultaneously compress the bag to provide the inflation.

[0003] It is not always easy to detect if ventilation is correctly performed or not. In some situations, the operator may perform several intended inflations without the mask being properly applied or without discovering that the airway of the patient is blocked.

[0004] Publication DE202006006312U1 presents the idea of providing a breathing bag for emergency resuscitation with a whistle in the expiration valve. The whistle gives an audible signal when the patient is exhaling, hence indicating correct use of the breathing bag. Absence of the whistle sound hence indicates erroneous utilization of the breathing bag.

[0005] US2002117173A1 discloses a resuscitation system where, in one of the embodiments, a microphone is connected in association with the airflow through the exhalation port. The microphone connects to a signal processor with wires, and an earphone connects to the signal processor through wires.Summary of invention

[0006] According to a first aspect of the present invention, there is provided a resuscitation assembly comprising a patient mask, a resuscitator bag, an intermediate part between the patient mask and the resuscitator bag, and an expiration outlet. The resuscitation assembly further comprises a microphone inacoustic connection to an airflow inside of or out of the resuscitation assembly and a processing unit in connection with the microphone. The processing unit is configured to provide an output based on the sound signals recorded by the microphone.

[0007] Herein, the term “intermediate part” refers to the portion of the resuscitation assembly that is arranged between the patient mask and the resuscitator bag. The intermediate part distributes airflows depending on their direction.

[0008] When stating that the processing unit is configured to provide the said output, it will typically be programmed to provide the output. Such output may be in various forms, for instance as sound played on a speaker or a graphic representation of the recorded sound. The processing unit will typically be in form of a CPU (central processing unit) or a microcontroller.

[0009] In some embodiments, the resuscitation assembly can further comprise an acoustic waveguide that constitutes at least a part of the acoustic connection between the microphone and the airflow.

[0010] Advantageously, the acoustic waveguide can be a flexible waveguide, such as a flexible tube.

[0011] Advantageously, the acoustic waveguide connects between the intermediate part and the microphone. This enables locating the microphone remotely from the patient, while still using it for picking up the sounds of airstreams inside or out of the intermediate part. It also contributes in preventing contamination of the microphone, such that it does not require disinfection I cleaning after every use.

[0012] In some alternative embodiments, the microphone and the processing unit can be attached directly to the intermediate part.

[0013] With the term “attached directly to” is meant that there is no flexible, intermediate connection between the microphone and the processing unit, and the intermediate part. In other words, a movement of the intermediate part would result in a movement of the microphone and processing unit.

[0014] Advantageously, the microphone and the processing unit can be embedded in one common device. Typically, with such embodiments the said device can also comprise a wireless communication unit for transmission of recorded sounds, such as to an external processing unit, as a tablet or computer.

[0015] The intermediate part can comprise a valve assembly and an adapter, wherein the adapter is arranged between the valve assembly and the patient mask. The adapter comprises a mask interface configured to attach against the patient mask and an opposite interface configured to attach against the valve assembly. The adapter further comprises an acoustic pickup mouth in acoustic connection with the microphone.

[0016] The adapter can have a main body with a through channel, through which an inflation airstream and an expiration airstream can flow.

[0017] The acoustic pickup mouth can advantageously be located in the reciprocating airstreams resulting from inflation and expiration of the patient during operation of the resuscitation assembly.

[0018] Preferably, the mask interface and the opposite interface are interfaces in accordance with the ISO 5356 standard for patient ventilator equipment.

[0019] The adapter may further comprise a disturbance arrangement configured to provide different sounds depending on the flow direction through the adapter.

[0020] The disturbance arrangement can be of various designs, for instance baffles mounted on the inner wall of the main body I through channel, or as part of the acoustic pickup mouth. By designing the disturbance arrangement such that the two airstreams are affected differently because of their different directions, different sounds will be produced depending on flow direction. This enables the processing unit to distinguish between the sounds of the expiration airstream and the inflation airstream.

[0021] The resuscitation assembly may comprise a microphone assembly, wherein the microphone assembly comprises the microphone and a sound-insulating encapsulation. The sound-insulating encapsulation comprises a sound-insulating material.

[0022] With the term sound-insulating material is meant a material for the purpose of reducing the amount of external sound that reaches the microphone. Such material can typically metals or plastics, preferably in combination with soft materials like batting, cotton, or wadding to isolate from both high and low sound frequencies from the surroundings.

[0023] The resuscitation assembly can in some embodiments comprise an expiration outlet that comprises one or more outlet ports and a connection interface, and wherein the connection interface constitutes an acoustic connection with the microphone.

[0024] In embodiments including the said acoustic waveguide, such as a flexible tube, the acoustic waveguide can connect to the connection interface. In other embodiments, the microphone assembly can connect onto the connection interface.

[0025] In embodiments where the microphone assembly is connected directly to the intermediate part, the resuscitation assembly can comprise a sound-transmitting membrane to prevent contamination of the microphone assembly. The membrane can be arranged between the microphone assembly and the airstreams.

[0026] According to a second aspect of the present invention, there is provided an adapter for mounting with a resuscitation assembly. The adapter comprises a mask interface and an opposite interface in accordance with the ISO 5356 standard for patient ventilator equipment. It further comprises a main body with a through channel, a pickup mouth, a pickup channel extending from the pickup mouth to an acoustic interface, wherein the acoustic interface is configured for connection to an acoustic waveguide and / or to a microphone assembly.

[0027] The pickup mouth is advantageously arranged in the through channel, or at least in fluid communication with the airstreams flowing through the through channel.

[0028] The adapter may further comprise a disturbance arrangement configured to provide different sounds depending on the flow direction of an airstream flowing through the main body.

[0029] By picking up the sounds with a microphone and provide an output based on the sensed sound with a processing unit, one enables signal processing of the information in the sound. By doing this, one can for instance adapt the sound played back to the operator using the resuscitation assembly, record the sound for later use I study, use signal processing such as artificial intelligence and computer learning to interpret the sounds.

[0030] The recording of the different ventilation sound can be used in debriefsituations where the operator is trained to distinguish between the different sounds toimprove their ventilation technique accordingly. Recordings can also be used for machine-learning, with the purpose of making a computer able to analyze the ventilations in real-time and give the operator feedback and advice on how to adjust the ventilation technique to improve the aeration of the lungs of the patient.Detailed description of the invention

[0031] While various aspects of the invention have been discussed in general terms above, a more detailed example of embodiments will be presented in the following with reference to the drawings, in whichFig. 1 depicts a possible situation wherein a resuscitation assembly according to the present invention is utilized by an operator on a patient;Fig. 2 is a schematic, cross-section sideview of a resuscitation assembly according to the invention;Fig. 3 is an enlarged perspective view of a portion of a resuscitation assembly;Fig. 4 is a schematic perspective view of a microphone assembly;Fig. 5 is another schematic, cross-section view of a resuscitation assembly according to the invention, which includes an adapter;Fig. 6 is a stand-alone, schematic view of the adapter shown in Fig. 5;Fig. 7 depicts another embodiment including the adapter;Fig. 8 illustrates another embodiment without the adapter;Fig. 9 to Fig. 11 depict graphic illustrations of recorded sound signals representing different ventilation scenarios; andFig. 12 is a schematic illustration of the interfaces between a microphone, a processing unit, a speaker, and a display unit.

[0032] Fig. 1 depicts a resuscitation situation with a patient 1 (a new-born infant in the present example) and an operator 3 that utilizes a resuscitation assembly 5 according to the invention. The resuscitation assembly 5 is shown with a schematic cross-section view in Fig. 2.

[0033] The resuscitation assembly 5 comprises a resuscitator bag 11, a patient mask 13, and an intermediate part 15. In the shown embodiment, the intermediate part 15 is arranged between and connects to the resuscitator bag 11 and to the patient mask 13.

[0034] The intermediate part 15 has a valve assembly 16. The valve assembly 16 has valves that distribute airflow. Such valve assemblies 16 are known to the skilled person and will not be discussed in further detail herein.

[0035] The intermediate part 15 has an expiration outlet 17 for the expiration airstream.

[0036] The expiration outlet 17 comprises one or more outlet ports 17a, through which expiration air exits the resuscitation assembly 5.

[0037] As shown in Fig. 2, the expiration outlet 17 can also comprise a PEEP valve 18 (PEEP - positive end expiratory pressure).

[0038] The resuscitation assembly 5 further comprises, in the present embodiment, an acoustic waveguide 19. The acoustic waveguide 19 can be in the form of a hollow, flexible tube.

[0039] The acoustic waveguide 19 is attached to the expiration outlet 17, in such manner that sound waves produced by the exiting expiration air enters the acoustic waveguide 19. As shown in Fig. 1, the acoustic waveguide 19 connects at an opposite end to a microphone assembly 21. The microphone assembly 21 comprises a microphone arranged in association with the end of the acoustic waveguide 19, such that acoustic waves (i.e. sound) travelling through the acoustic waveguide 19 can be recorded.

[0040] In some embodiments, the recorded acoustic waves (sound) can comprise acoustic waves produced by the PEEP valve 18.

[0041] Fig. 3 is a perspective view of a part of the resuscitation assembly 5, depicting in better detail how the acoustic waveguide 19 is connected to the expiration outlet 17. The connection is made with a connector 23 that connects to an opposite connection interface 25 of the expiration outlet 17. The connector 23 can for instance comprise threads (not shown) for connection to the connection interface 25 or may have a snap-on or quick-connection arrangement.

[0042] As the skilled person will appreciate, there will be substantially no flow of gas through the acoustic waveguide 19. Instead, it will merely transmit the sound produced by the flow exiting the expiration outlet 17 towards the microphone assembly 21. Consequently, the acoustic waveguide 19 provides a partition between the microphone assembly 21 and parts being in contact with the patient 1 and operator 3. One will thus not need to wash or disinfect the microphone assembly 21 between use for different patients 1.

[0043] Fig. 4 depicts an embodiment of the microphone assembly 21. It is connected to the acoustic waveguide 19, which extends between the microphone assembly 21 and the expiration outlet 17. In this embodiment, the microphone assembly 21 comprises a microphone 27 which is enclosed by a sound-insulating encapsulation 29. The sound-insulating encapsulation 29 removes most of or a substantial part of the background sound. This enables the microphone 27 to be more sensitive and to better provide a usable signal for determining correct utilization of the resuscitation assembly 5.

[0044] A microphone wire 31 that connects to the microphone 27 extends out of the encapsulation 29 for transmission of recorded sound signals.

[0045] Fig. 5 depicts another embodiment, where the resuscitation assembly 5 comprises an adapter 33. The adapter 33 is interposed between the patient mask 13 and the intermediate part 15. The adapter 33 is shown in better detail with the enlarged cross section side view of Fig. 6.

[0046] The adapter 33 has a main body 35, which in the depicted embodiment is shaped as a pipe. At one end the main body 35 has a mask interface 37, configured to connect to the patient mask 13. At the opposite end the main body 35 has an opposite interface 39, configured to connect to the intermediate part 15. Fig. 5 shows how the adapter 33 connects to the patient mask 13 and the intermediate part 15.

[0047] Advantageously, the mask interface 37 and the opposite interface 39 meets the ISO 5356 standard for patient ventilator equipment.

[0048] The main body 35 has a through channel 36, through which an inflation airstream and an expiration airstream can flow. The flow is schematically indicated with the two arrows in Fig. 6.

[0049] The adapter 33 further comprises an acoustic pickup mouth 41. The acoustic pickup mouth 41 is arranged at the end of a pickup tube 43 that extends through the wall of the main body 35. The bore of the pickup tube 43 comprises a pickup channel 44 that guides acoustic waves from the acoustic pickup mouth 41 to an acoustic interface 46. The acoustic pickup mouth 41 is located in the airstream that will flow through the main body 35 when operating the resuscitation assembly 5.

[0050] As shown in Fig. 5 and Fig. 6, the acoustic pickup interface 46 connects to an acoustic waveguide 19, such as the one previously discussed. In other embodiments, the acoustic pickup interface 46 can connect directly to a microphone assembly 21 (such as shown in Fig. 7).

[0051] As inspiratory and expiratory air is ventilated through the adapter 33, the microphone 27 (not depicted in Fig. 5 and Fig. 6) will record the sounds of said flows.

[0052] To increase difference of sounds produced by the inspiratory and expiratory airstreams, there is arranged a stream-distinguishing disturbance arrangement 45 in the flow-path. In the present embodiment, the disturbance arrangement 45 is provided with an inclined shape of the acoustic pickup mouth 41. In particular, the acoustic pickup mouth 41 faces towards the expiratory airstream (hence facing in the direction of the inspiratory airstream). This produced different sounds, such that the expiratory airstream sounds different from the inspiratory airstream.

[0053] In other embodiments, one could use a dedicated disturbance arrangement 45, for instance baffles attached to the inner surface of the wall of the main body 35.

[0054] Thus, contrary to the embodiment shown in Fig. 2 and Fig. 3, with the embodiment discussed with reference to Fig. 5 and Fig. 6 enables the microphone 27 to record the sounds both from inspiratory and from expiratory airstreams. An advantage of this is that the system can be universally used for all types of ventilation devices, not only those that concentrate expiratory air through one expiration channel only.

[0055] Fig. 7 depicts an alternative embodiment of the adapter 33. In this embodiment, instead of transmitting the picked-up sound to a remote microphone 27 at the end of the acoustic waveguide 19, the adapter 33 itself comprises a microphone assembly 21. In Fig. 7, this is schematically depicted with a microphoneassembly 21 attached to the main body 35, in contact with the external end of the pickup tube 43.

[0056] Advantageously, the microphone assembly 21 may be part of an arrangement comprising, or may itself comprise, a battery, amplifier, and a wireless communication unit, such as a Bluetooth unit. In this manner, the recorded sound can be transmitted to an external device configured to analyze the recorded sound. Instead of a wireless communication unit, it could instead be wired, such as shown in Fig. 4.

[0057] A similar solution is shown with the embodiment of Fig. 8. This embodiment is without the adapter 33 discussed above. The resuscitation assembly 5 shown in Fig. 8 has a microphone assembly 21 attached to the expiration outlet 17, for recording of the sound of the expiration flow. Like the microphone assembly 21 discussed above with reference to Fig. 7, the microphone assembly 21 shown in Fig.8 can have a wireless communication unit for distribution of the recorded sound.

[0058] Advantageously, the embodiment shown in Fig. 8 may further comprise a PEEP valve 18. In such embodiments, the PEEP valve 18 can be configured to produce acoustic waves (sound) that can be picked up (i.e. recorded) by the microphone assembly 21 .

[0059] Fig. 9, Fig. 10, and Fig. 11 depict visualizations of recorded sounds of ventilations on a newborn simulator, simulating common situations of normal, effective ventilations on open airways, ventilation attempts on an obstructed (blocked) airway, and ventilations with a poor mask seal (i.e. large air leakage between ventilation mask and the face of the patient). The positions indicated at A is at the periods of inflation, while the positions B indicate the periods of air expiration.

[0060] The curves at positions B show the amount of expired air. In particular, both the duration of the expiration and the flow rate is indicated with the curves.

[0061] For the first situation, shown in Fig. 9, Although some differences are visible between the two graphical expressions of the expiration, a clear recognizable shape is present. The representation of recorded expiration airstream sound depicted in Fig.9 is an example of a correct use of the resuscitation assembly, wherein a significant amount of exhaled air is detected, and the succeeding shapes are comparable.

[0062] Fig. 10 depicts sound recordings in a situation where ventilation attempts are disturbed by an obstructed airway. As clearly visible at positions B, sounds produced by expiration airstream are barely recorded.

[0063] The corresponding representation shown in Fig. 11 visualizes the recorded expiration airstream when the resuscitation assembly 5 is erroneously utilized. Typically, this representation is a result of an air leak between the patient mask 13 and the patient 1 , such that instead of inflating air into the patient 1 , air is merely inflated into the patient mask 13 and leaks out through a gap between the patient 1 and the patient mask 13.

[0064] It may be difficult for an operator 3 of the resuscitation assembly 5 to detect such errors, and the result can be occurrence of several inflation cycles without actually inflating air into the patient 1.

[0065] With a resuscitation assembly 5 according to the present invention, however, the recorded sounds or a modified version thereof, may be produced for the operator 3 to hear during use of the resuscitation assembly 5. The risk of repeated erroneous inflation attempts will thus be reduced.

[0066] To give the operator 3 of the resuscitation assembly 5 further assistance, instead of or in addition to relying on her / his ability to give a correct interpretation of the ventilation sounds, digital signal processing and real time sound-analysis can be used to automatically assess the ventilation quality. This assessment, for instance performed with an artificial intelligence I machine learning component, can then give the operator 3 visual or audible advice on how to improve the ventilation technique to give effective lung aeration. Visual feedback may be given on a screen showing text or preferably graphical illustrations I animations showing what to improve.

[0067] Audible feedback can be advice like “Remember to tilt the patient’s head backwards to open the airways", or “Make sure that the mask is covering the patients mouth and nose, and check for possible leaks between the mask and the patient’s face".

[0068] Fig. 12 depicts a schematic diagram of a microphone 27, a display unit 49, a speaker 51 , as well as a processing unit 53. The processing unit 53 is configured to receive and process sound signals as picked up by the microphone 27. Thisprocessing may include merely playing the signals on the speaker 51. It may, however, also include editing the signals such that the sound played on the speaker 51 is easier to recognize and interpret for the operator 3.

[0069] In some embodiments, the processing unit 53 may also include the functionality discussed above.

[0070] Also schematically shown in Fig. 12 is the display unit 49, through which the processing unit 53 may communicate to the operator 3.

[0071] The arrows shown in Fig. 12, which illustrate communication between the processing unit 53 and the various components, may be wired or wireless, such as with a Bluetooth communication arrangement.

[0072] Reference is again made to Fig. 1. The microphone assembly 21 can advantageously be part of a tablet 47. The tablet 47 can further comprise a display unit 49 and / or a speaker 51.

[0073] The above-mentioned processing of the recorded sounds can be performed with a processing unit of the tablet 47, or it may be performed at a remote processing unit that is in communication with the tablet 47.

[0074] With embodiments where recorded sound is played through the speaker 51 , it may be advantageous to use a microphone assembly 21 comprising an encapsulation 29, such that sound feedback is reduced or avoided. A microphone assembly 21 comprising the encapsulation 29 can also be part of the tablet 47, such as shown in Fig. 1.

Claims

Claims1. A resuscitation assembly (5) comprising a patient mask (13), a resuscitator bag (11), an intermediate part (15) between the patient mask and the resuscitator bag, and an expiration outlet (17), wherein the resuscitation assembly (5) further comprises- a microphone (27) in acoustic connection to an airflow inside of or out of the resuscitation assembly (5);- a processing unit (53) in connection with the microphone (27); wherein the processing unit (53) is configured to provide an output based on the sound signals recorded by the microphone (27).

2. A resuscitation assembly (5) according to claim 1 , further comprising an acoustic waveguide (19) constituting at least a part of the acoustic connection between the microphone (27) and the airflow.

3. A resuscitation assembly (5) according to claim 1 , wherein the microphone (27) and the processing unit (53) are attached directly to the intermediate part(15).

4. A resuscitation assembly (5) according to any one of the preceding claims, wherein the intermediate part (15) comprises a valve assembly (16) and an adapter (33), wherein the adapter (33) is arranged between the valve assembly(16) and the patient mask (13), and wherein the adapter (33) comprises- a mask interface (37) configured to attach against the patient mask (13);- an opposite interface (39) configured to attach against the valve assembly (16);- an acoustic pickup mouth (41) in acoustic connection with the microphone (27).

5. A resuscitation assembly (5) according to claim 4, wherein the adapter (33) further comprises a disturbance arrangement (45) configured to provide different sounds depending on the flow direction through the adapter (33).

6. A resuscitation assembly (5) according to any one of the preceding claims, comprising a microphone assembly (21), wherein the microphone assembly comprises the microphone (27) and a sound-insulating encapsulation (29), the sound-insulating encapsulation (29) comprising a sound-insulating material.

7. A resuscitation assembly (5) according to any one of the preceding claims, wherein it comprises an expiration outlet (17) that comprises one or more outlet ports (17a) and a connection interface (25), wherein the connection interface (25) constitutes an acoustic connection with the microphone (27).

8. A resuscitation assembly (5) according to any one of the preceding claims, wherein the expiration outlet (17) comprises a positive end expiratory pressure (PEEP) valve (18) configured to produce acoustic waves that are detectable with said microphone (27).

9. An adapter (33) for mounting with a resuscitation assembly (5), the adapter (33) comprising- a mask interface (37) and an opposite interface (39) in accordance with the ISO 5356 standard for patient ventilator equipment;- a main body (35) with a through channel (36);- a pickup mouth (41);- a pickup channel (44) extending from the pickup mouth (41) to an acoustic interface (46), wherein the acoustic interface is configured for connection to an acoustic waveguide (19) and / or to a microphone assembly (21).

10. An adapter (33) according to claim 9, wherein it further comprises a disturbance arrangement (45) configured to provide different sounds depending on the flow direction of an airstream flowing through the main body (35).

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