Improved manual artificial resuscitation bag
The improved BAVU design with a double pressure discharge valve and additional unidirectional valves addresses the challenge of inconsistent gas tank filling, ensuring efficient and consistent patient ventilation during cardiac resuscitation.
Patent Information
- Application Number
- FR2023000067
- Authority / Receiving Office
- FR · FR
- Patent Type
- Utility models
- Current Assignee / Owner
- Filing Date
- 2023-03-22
- Publication Date
- 2025-04-11
- Estimated Expiration
- 2033-03-22
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
Title of the invention: Improved manual artificial resuscitation balloon
[0001] The invention relates to an artificial or assisted respiration device, namely a manual artificial resuscitation bag, commonly called a Self-Filling Bag with a One-Way Valve or BAVU, usable for resuscitating a person, namely a patient, in cardiac arrest, and an installation for resuscitating a person in cardiac arrest comprising such an artificial resuscitation bag.
[0002] During cardiac resuscitation of a person in cardiac arrest, it is usual to perform cardiac massage on this person by implementing chest compressions alternating with chest decompressions, which generates gas exchanges with the person's lungs.
[0003] These gas exchanges result in the entry and exit of small volumes of gas from the person's lungs, and in the maintenance of a positive gas pressure in the lungs which keeps the alveoli of the lungs open, thereby improving gas exchange.
[0004] Positive pressure also makes it possible to create resistance to the expulsion, that is to say the exit, of gas from the lungs during the phases of thoracic compressions.
[0005] To administer the gas, and therefore the required gas pressure, it is known to use a manual artificial resuscitation bag, also called a BAVU, as described by EP-A-3645094. If this BAVU makes it possible to carry out gas insufflations in complete safety while allowing chest compressions to be carried out under positive gas pressure, during cardiac massage of a person in cardiac arrest, that is to say subjected to cardiopulmonary resuscitation (CPR) by one or more rescuers, such as doctors or other healthcare personnel, it also suffers from a major limitation linked to the filling speed of the gas reservoir which supplies the flexible bag to refill it, when the rescuer has released the flexible bag. Indeed, the time required for the gas reservoir to refill with fresh gas depends closely on the oxygen flow rate within the oxygen supply line supplying the BAVU.However, this impacts the time required for the flexible balloon of the BAVU to return to its resting state, i.e. its fully filled state, therefore the time separating 2 successive gas insufflations, and introduces variability in the patient's ventilation procedure which can cause negative effects on the effectiveness of the patient's ventilation.
[0006] The aim of the invention is therefore to improve the BAVU described by EP-A-3645094 so as to avoid these problems and / or drawbacks.
[0007] The solution of the invention then concerns a manual artificial resuscitation balloon or BAVU comprising: - a deformable balloon comprising a gas inlet and a gas outlet, - a gas tank comprising an outlet orifice, - a first conduit element fluidically connected to the outlet orifice of the gas tank and to the gas inlet of the deformable balloon, - a first one-way inlet valve arranged in the first conduit element and fluidly communicating with the ambient atmosphere to allow ambient air to enter the first conduit element, - a second one-way valve arranged in the first conduit element to allow gas to move only from the first conduit element to the deformable balloon, - a gas conduit arranged in fluid communication with the gas outlet of the deformable balloon, and - a connection port for an oxygen supply line, arranged in the first conduit element.
[0008] In addition, the BAVU according to the invention comprises: - a double pressure relief valve arranged in fluid communication with the first conduit element, and furthermore with the gas tank, via a junction line, - the junction line comprising an upstream end fluidly connected to the double pressure relief valve and a downstream end fluidly connected to a portion of upstream conduit connecting the gas tank to the first conduit element, and - the portion of conduit comprising an additional one-way valve allowing only the passage of gas from the gas tank towards the first conduit element.
[0009] Depending on the embodiment considered, the BAVU of the invention may comprise one or more of the following characteristics: - a pressure relief valve is arranged in the gas conduit downstream of the deformable balloon. - a third one-way valve is arranged in the gas duct downstream of the pressure relief valve. - a pneumatic control valve is arranged in the gas duct downstream of the third one-way valve. - a bypass conduit comprises a first end fluidly connected to the gas conduit and a second end fluidly connected to the pneumatic control valve. - a gas supply conduit is in fluid communication with the gas conduit to convey at least a portion of the gas flowing in the gas conduit to a patient interface, such as a breathing mask. - the pneumatic control valve comprises an inner compartment, the second end of the bypass conduit being fluidically connected to said inner compartment of the pneumatic control valve. - a bypass conduit has a first end fluidly connected to the gas conduit between the gas outlet of the deformable balloon and the pressure relief valve. - the second one-way valve is arranged in the first conduit element between the first one-way inlet valve and the gas inlet of the deformable balloon. - the oxygen supply line connection port is arranged in the first conduit element between the additional one-way valve and the second one-way valve. - the double pressure relief valve is described below in relation to the attached Figures.
[0010] The invention also relates to an installation for artificially ventilating a person in cardiac arrest comprising a BAVU according to the invention and an oxygen source fluidically connected to the oxygen supply line connection port of the BAVU, i.e. an oxygen inlet, via an oxygen supply line, such as a flexible pipe. The oxygen source may be a pressurized oxygen cylinder.
[0011] The invention will now be better understood thanks to the following detailed description, given for illustrative but non-limiting purposes, with reference to the appended figures among which:
[0012] [Fig.l] illustrates an embodiment of a BAVU according to the invention,
[0013] [Fig.2] is a pressure / time curve showing the time required to fill the gas tank of the BAVU of EP-A-3645094,
[0014] [Fig.3] to [Fig.10] schematize an embodiment of the double pressure relief valve of the BAVU of [Fig.l], and
[0015] [Fig. 11] compares the pressure / time curves obtained with a BAVU according to EP-A-3645094 as in [Fig.2] and a BAVU according to the present invention.
[0016] [Fig.l] is an embodiment of a Self-Filling Balloon with One-Way Valve 5 or BAVU according to the invention, constituting a manual insufflator making it possible to administer gas, i.e. gas pressure, to a person, i.e. a patient, in cardiac arrest, in particular when carrying out cardiac massage on this person with alternating chest compressions and chest decompressions.
[0017] The architecture and operation of this BAVU 5 are generally identical to what is taught in document EP-A-3645094, to which reference may be made for further details; moreover, the same references have been used below to designate the same components as those of the BAVU of EP-A-3645094.
[0018] Schematically, the BAVU 5 of the invention comprises a flexible bag or deformable balloon 54 comprising a gas inlet 54a and a gas outlet 54b, a gas reservoir 59 comprising an outlet orifice 59a, a first conduit element 56 fluidly connected to the outlet orifice 59a of the gas reservoir 59 and to the gas inlet 54a of the deformable balloon 54, i.e. flexible and / or supple.
[0019] A first one-way inlet valve or valve 57 is arranged in the first conduit member 56, which fluidly communicates with the ambient atmosphere to allow ambient air to enter the first conduit member 56.
[0020] A second valve or one-way valve 55 is arranged in the first conduit member 56 between the first one-way inlet valve 57 and the gas inlet 54a of the deformable balloon 54 to allow gas to move only from the first conduit member 56 to the deformable balloon 54.
[0021] A gas conduit 47 is arranged in fluid communication with the gas outlet 54b of the deformable balloon 54. A pressure relief valve 48 and a third one-way valve 53 are arranged in the gas conduit 47, said third one-way valve 53 being arranged downstream of the pressure relief valve 48 so as to prevent gas from rising, thus only allowing the circulation of gas through the third one-way valve 53 towards the respiratory interface 6 supplying the respiratory gas to the patient 1.
[0022] Furthermore, a gas supply conduit 51 in fluid communication with the gas conduit 47 makes it possible to convey at least a portion of the gas circulating in the gas conduit 47 to the patient interface 6, such as a breathing mask or the like.
[0023] The BAVU 5 further comprises a pneumatic control valve 50 arranged in the gas conduit 47 downstream of the third one-way valve 48 and a bypass conduit 49 having a first end 49a fluidly connected to the gas conduit 47 between the gas outlet 54b of the deformable balloon 54 and the pressure relief valve 48.
[0024] The bypass conduit 49 further comprises a second end 49b fluidically connected to an interior compartment 50f of the valve or pneumatic control valve 50. This makes it possible to apply a gas pressure supplied by the bypass conduit 49 to a membrane arranged in the pneumatic control valve. 50 to keep it closed, in the absence of gas overpressure downstream of the balloon 54.
[0025] More specifically, the pneumatic control valve 50 comprises, as described by EP-A-3645094, a spring arranged in a housing which applies a constant thrust force on the membrane to normally close it, as already described. In the event of gas overpressure beyond a defined opening threshold, the membrane moves to open an overpressure discharge port 52 of the valve 50 serving to discharge the gas overpressure to the atmosphere, via an outlet port 50c of said valve 50.
[0026] The assembly forms a resuscitation installation for a person in a state of cardiac arrest comprising the BAVU 5 and a source of O2 2, such as a bottle 20 of pressurized oxygen, fluidically connected to the BAVU 5 via an oxygen supply line 21 supplying gaseous oxygen to the first conduit element 56, via a connection port 21a of the oxygen supply line 21.
[0027] To send gas to the patient 1, a rescuer presses on the flexible balloon 54 which then deforms, expelling the gas towards the patient, via the gas conduit 47 and the gas supply conduit 51. When the rescuer releases the flexible balloon 54, it fills again with gas, in particular oxygen coming from the O2 source 2 via the oxygen supply line 21, until it returns to a resting state, in which the flexible balloon 54 is fully inflated. This is repeated each time the rescuer presses and then releases the flexible balloon 54.
[0028] This architecture and this operation are therefore, up to now, identical to what EP-A-3645094 teaches.
[0029] However, in order to overcome a problem of the BAVU 5 described by EP-A-3645094, certain elements of this BAVU 5 have been modified and / or replaced by others, as described below, so as to obtain the improved BAVU 5 of the invention.
[0030] More precisely, the problem posed by the known BAVU 5 is linked to the filling speed of the gas tank 59 which supplies the flexible balloon 54 to refill it, when the rescuer has released the flexible balloon 54.
[0031] Indeed, the time required for the gas tank 59 to refill with fresh gas coming from the O2 source 2 via the connection port 21a of the oxygen supply line 21 and the first conduit element 56, depends closely on the oxygen flow rate within the oxygen supply line 21.
[0032] Thus, it is easy to understand that an oxygen flow rate of 30 L / min allows the gas tank to be filled 59.6 times faster than an oxygen flow rate of 6 L / min, for example in 1 second at 30 L / min versus 6 seconds at 5 L / min. This phenomenon is illustrated in [Fig.2],
[0033] This also impacts the time required for the flexible balloon 54 to return to its resting state, i.e. its fully filled state, therefore the time separating 2 insuff gas inflations to the patient. This duration, which is flow-dependent, introduces variability into the patient's ventilation procedure which can have negative effects on the effectiveness of patient ventilation 1.
[0034] In an attempt to remedy this, according to the invention, the BAVU 5 of EP-A-3645094 has been improved so that the speed of filling of the flexible balloon 54 and its return to its rest state, i.e. completely full of gas, do not depend on the flow rate of oxygen coming from the oxygen supply line 21.
[0035] To do this, the first conduit element 56 of the BAVU 5 also comprises a double pressure relief valve 90 arranged in a bypass conduit 56b connected to and in fluid communication with the first conduit element 56.
[0036] The dual pressure relief valve 90 is in fluid communication with the gas reservoir 59, via a junction line 91, such as a junction tube. The junction line 91 comprises an upstream end 91b fluidly connecting to the dual pressure relief valve 90 and a downstream end 91a fluidly connecting to an upstream conduit portion 94 connecting the gas reservoir 59 to the first conduit element 56 of the BAVU 5. The dual pressure relief valve 90 also comprises an outlet port 92 connected to the atmosphere for discharging a gas flow to the atmosphere.
[0037] Furthermore, the conduit portion 94 comprises an additional one-way valve 93 allowing only the passage of gas coming from the gas reservoir 59 towards the first conduit element 56, then the flexible balloon 54.
[0038] [Fig.3] to [Fig. 10] schematize an embodiment of the discharge valve of double pressure 90.
[0039] In [Fig.3] and [Fig.4], a cover 901 forming the upper part of the valve 90 is seen, which comprises a frame or upper wall 9011 comprising a threaded portion 9012 and a cylindrical conduit 9013 projecting towards the valve body 902, i.e. under the cover 901, and comprising an orifice 9014. The conduit 9013 widens into a wider conduit 9016 comprising a Tauric seal 9017 on its external perimeter. An annular shoulder 9015 is located at the junction of the conduit 9013 and the wider conduit 9016.
[0040] In [Fig.5] and [Fig.6], it can be seen that the cover 901 is screwed onto the valve body 902 which forms the lower part or base of the valve 90. The valve body 902 comprises a frame or peripheral wall 9021 delimiting a lower chamber 9024 and an upper chamber 9028, and comprising a tubular inlet passage 9023 comprising an end 9023a forming a valve seat cooperating with a PEP membrane 9027 used to control a PEP, i.e. a positive expiratory pressure, by preventing any fluid communication between the tubular inlet passage 9023 and the internal chamber 9024 of the valve body 902.
[0041] The lower chamber 9024 includes an outlet port 9025 which is in fluid communication with the terminal end 9026b of a conduit 9026. The PEP membrane 9027b is attached to a spring 9027 which is itself attached to an exhaust membrane 9027a. The spring 9027 is inserted into the upper chamber 9028 which includes the outlet port 92. The upper chamber 9028 surmounts the lower chamber 9024 within the valve body 902.
[0042] The valve body 902 comprises a thread 9012 carried by the frame or peripheral wall 9021.
[0043] [Fig.6], the cover 901 is connected by screwing to the valve body 902 via the thread 9012 and thread 9012 which are complementary to each other. The joining of the cover 901 and the valve body 902 creates an additional chamber 9026d in fluid communication with the conduit 9026 via its terminal end 9026.
[0044] The additional chamber 9026d in fluid communication with the lumen or internal passage 9014a of the conduit 9013 via an orifice 9014 passing through the wall of the conduit 9013. The annular shoulder 9015 of the cover 901 forms a circular rim acting as a seat for the PEP membrane 9027b.
[0045] The spring 9027 of the chamber 9028 is compressed and exerts upward and downward forces acting on the evacuation membrane 9027a and the PEP membrane 9027b to push them towards their seats 9015, 9023a.
[0046] The seal between the conduit 9016 and the inner wall 9026c of the conduit 9026 is ensured by the O-ring 9017. Thus, the gas present in the space 9026e cannot circulate in the chamber 9028 due to the seal created by the O-ring 9017.
[0047] When a gaseous force exists, for example in the inlet passage 9023, and it is greater than the elastic force of the spring 9027, then the PEP membrane 9027b is displaced and detached from the seat 9023a thereby creating a fluid communication between the inlet passage 9023 and the chamber 9024, as illustrated in [Fig. 7]. The force existing in the inlet passage 9023 is equal to the product of the pressure therein times the surface area on which this pressure is applied, typically the surface area 9027b 1 of the PEP membrane 9027b.
[0048] Given that the cover 901 can be more or less screwed onto the valve body 902, the rim 9015 can take different positions along the vertical axis, which then also impacts the position of the evacuation membrane 9027a, thus making it possible to vary the compression of the spring 9027.
[0049] For example, in [Fig.8], we see that the cover 901 is completely screwed onto the valve body 902 and compresses the spring 9027 to the maximum, whereas, in [Fig.7], the screwing is only partial.
[0050] In this way, the opening pressure of the PEP 9027b membrane can be adjusted between 1 and 20 cmH20, for example, to 5 cmH20.
[0051] The spring 9027 exerts the same force on the PEP membrane 9027b and the exhaust membrane 9027a.
[0052] There is therefore an opening pressure of the evacuation membrane 9027a which is then lower than that of the opening of the PEP membrane 9027b given that the surface 9027al of the evacuation membrane 9027a, facing the chamber 9014a, is greater than the surface 9027b 1 of the PEP membrane 9027b, facing the inlet passage 9023, for example the pressure difference can be of the order of 1 mbar.
[0053] During a gas insufflation phase, when a rescuer presses on the flexible balloon 54, the gas flows normally to the interface 6, therefore to the patient, since the valve 50 is closed. The second one-way valve 55 prevents gas from rising towards the reservoir 59.
[0054] During a release phase, when a rescuer stops pressing on the flexible balloon 54 and releases it, a negative pressure is produced which opens the second one-way valve 55. The flow of oxygen supplied by the connection port 21a of the oxygen supply line 21 enters the flexible balloon 54 to fill it and the gas contained in the reservoir 59 also passes through the additional one-way valve 93 and participates in filling the flexible balloon 54. The first one-way admission valve 57 also opens to admit ambient air into the conduit 56 which can also fill the flexible balloon 54.
[0055] At the same time, the negative pressure causes the third one-way valve 53 and the third one-way valve 48 to close, and a pressure drop in the bypass conduit 49 and in the chamber 50f of the pneumatic control valve 50, which allows this valve 50 to be opened to release the excess pressure existing in the patient's lungs, i.e. the volume of exhaled gas. It remains open until the pressure in the conduits 47, 51 downstream of the flexible balloon 54, equilibrates.
[0056] In [Fig.9] and [Fig. 10], it is understood that the inlet 9023 of the double pressure relief valve 90 is in fluid communication with the bypass conduit 56b.
[0057] As soon as the balloon 54 is again in its natural state (i.e. atmospheric pressure) after being refilled, the oxygen arriving via the line 21 will gradually increase the pressure in the first conduit element 56 which will then close the inlet valve 57 and the additional one-way valve 93 but open the second one-way valve 55, which allows the gas flow to enter the balloon 54 and then continue its path towards the patient, via the interface 6, by closing the valve 50 via the bypass conduit 49.
[0058] The pressure then also passes through the bypass conduit 56b which communicates with the inlet 9023 of the double pressure relief valve 90.
[0059] The dual pressure relief valve 90 has an opening pressure of its PEEP membrane 9027b set at, for example, 5 cmH20. Therefore, when the pressure across the inlet 9023, the conduit 56b and the conduit 56 reaches this level of 5 cmH20, the PEEP membrane 9027b recoils and allows communication between the inlet 9023 and the chamber 9024.
[0060] The gas flow will then be able to reach the chamber 9024 and exit via the port 9025 which is connected (at 91b) to the junction line 91 and therefore to the upstream conduit portion 94 connecting the gas reservoir 59 to the first conduit element 56, which will make it possible to fill the reservoir 59 with gas brought by the junction line 91.
[0061] The PEEP pressure is restored in the patient's lungs before the reservoir 59 begins to fill. If the latter were completely empty, the entry of gas into this reservoir 59 increases the pressure therein. Since there is a fluid communication between the outlet port 9025 and the conduit 9026 via the terminal end 9026a, the excess pressure from the reservoir 59 is transferred to the conduit 9026 via the outlet port 9025 and the junction tube 91, then to the chambers 9026d and 9014a via the orifice 9014, and is applied against the outlet membrane 9027a.
[0062] As soon as the pressure level reaches that of the opening pressure of the outlet membrane 9027a, namely here 4mb, the latter will be pushed back, therefore detached from the edge forming the seat 9015, thus creating a passage 9015a, therefore a fluid communication between the chambers 9014a and 9028 so as to evacuate the gas flow to the atmosphere via the chamber 9028 and the outlet port 92.
[0063] Such an arrangement according to the invention makes it possible to control the filling of the reservoir 59 and to limit the pressure in the reservoir 59 below any excessive pressure, as illustrated in [Fig.11], where: - Cl represents the pressure curve of [Fig. 1] obtained with the balloon of the prior art, - C2 represents the pressure curve with the balloon 1 according to the invention.
[0064] [Fig. 11] therefore allows the pressure / time curves obtained with a BAVU according to EP-A-3645094 (curve C1) and with a BAVU according to the present invention (curve C2) to be compared.
[0065] It is clearly seen that, thanks to the invention, the PEEP pressure is first restored in the patient's lungs, then the reservoir 59 is filled by limiting the pressure there to a level slightly below the PEEP level.
[0066] This allows a return to a state of equilibrium independently of the flow rate or flux of oxygen supplied by the oxygen supply line 21.
Claims
1. Claims Manual artificial resuscitation balloon (5) comprising: - a deformable balloon (54) comprising a gas inlet (54a) and a gas outlet (54b), - a gas reservoir (59) comprising an outlet orifice (59a), - a first conduit element (56) fluidically connected to the outlet orifice (59a) of the gas tank (59) and the gas inlet (54a) of the deformable balloon (54), - a first one-way inlet valve (57) arranged in the first conduit member (56) and fluidly communicating with the ambient atmosphere to allow ambient air to enter the first conduit member (56), - a second one-way valve (55) arranged in the first conduit element (56) to allow gas to move only from the first conduit element (56) to the deformable balloon (54), - a gas conduit (47) arranged in fluid communication with the gas outlet (54b) of the deformable balloon (54), and - a connection port (21a) of an oxygen supply line (21), arranged in the first conduit element (56), characterized in that it further comprises: - a double pressure relief valve (90) arranged in fluid communication with the first conduit element (56), and furthermore with the gas reservoir 59, via a junction line (91), - the junction line (91) comprising an upstream end (91b) fluidly connecting to the double pressure relief valve (90) and a downstream end (91a) fluidly connecting to a portion of upstream conduit (94) connecting the gas tank (59) to the first conduit element (56), and - the portion of conduit (94) comprising a one-way valve- additional connection (93) allowing only the passage of gas from the gas tank (59) towards the first conduit element (56).
2. Balloon according to claim 1, characterized in that the double pressure relief valve (90) is arranged in a bypass conduit (56b) fluidically connected to the first conduit element (56).
3. Balloon according to claim 1, characterized in that the double pressure relief valve (9) further comprises an outlet port (92) connected to the atmosphere.
4. Installation (1) for artificially ventilating a person in cardiac arrest comprising a manual artificial resuscitation bag (5) according to one of the preceding claims, and an oxygen source (2) fluidically connected to the oxygen supply line connection port (21a), via an oxygen supply line (21).