Passive lung simulator

Abstract

A passive lung simulator device is provided. It includes a casing or box that includes a first lung simulator balloon; an air collector coupled to one end of the first balloon; a first set of servo valves, arranged in series, connected to the air collector via air flow conduits; and a connection element for a mechanical ventilator. The servo valves are configured to independently recirculate the air flow passing through them to the air collector, expanding the balloon. It also includes a first set of cams to be actuated by a servomotor to modify the compliance or capacity of the balloon simulator through the rotation of the first set of cams; and a communications module connected to the first set of servo valves and the first set of cams, with wireless connection to a remote computing device to receive instructions to simulate different pulmonary pathologies.

Description

[0001] PASSIVE LUNG SIMULATOR

[0002] Technical field

[0003] The present invention relates to a passive lung simulator device. The simulator can be remotely controlled, for example, for training and validation in the use of mechanical ventilators, enabling the simulation of various pulmonary pathologies.

[0004] Background of the Invention

[0005] Currently, the training of healthcare personnel in mechanical ventilators relies on simple lung simulators, such as passive devices, balloons, or "lung testers," as well as highly complex and sophisticated electronic simulators that are expensive and challenging to use outside a laboratory environment. Passive devices are easily transportable but do not allow quick adjustments to simulate different operating conditions and / or pathologies. Furthermore, they do not facilitate easy modification of compliance or air flow resistance. Changes often have to be made in front of the trainee, reducing the realism, continuity, and quality of the simulation.

[0006] Additionally, programming ventilators is a complex process that varies depending on the pathology and its progression, requiring medical expertise based on observing case studies of various pulmonary diseases.

[0007] Several patents / patent applications related to lung simulators are known, indicating ongoing interest in improving training tools for mechanical ventilators.

[0008] For example, EP79795-B describes a pneumatic lung for ventilator testing. The lung includes an expandable pulmonary simulator chamber and an expandable spontaneous breathing chamber housed within a framework.

[0009] US4996980-A describes a ventilation training apparatus with fault simulation, featuring a fault activation unit that can be connected to or exchanged with standard system components.

[0010] US4996980-A describes a ventilation training apparatus with fault simulation, featuring a fault activation unit that can be connected to or exchanged with standard system components.

[0011] US6874501-B1 discloses a lung simulator used as an educational tool. This lung simulator includes valves coupled to simulated lung lobes and configured to simulate varying degrees of fluid flow resistance. DE102010027436-B3 also describes a lung simulator for training and testing ventilators in simulating a patient’s lung. The simulator comprises a controller whose input is connected to the electrical outputs of pressure sensors and a volumetric flow sensor.

[0012] Finally, CN202682596-U describes a portable instrument for testing positive-pressure air, where the main instrument body includes a main structural box, a servomotor, a micropressure sensor, and a piston connected to the servomotor through a rigid outer casing.

[0013] Despite these known solutions, new lung simulators that allow the real-time simulation of various pulmonary pathologies remotely without requiring the physical presence of healthcare or training personnel are needed.

[0014] Disclosure of the invention

[0015] The objective of the present invention is to provide a passive lung simulator device (or artificial lung) capable of simulating various pulmonary pathologies controlled through a mobile application.

[0016] Specifically, the proposed device is intended for training physicians and nurses who routinely use mechanical ventilation in critical care, anesthesiology, and pulmonology services through advanced simulation courses. Additionally, it can be used to validate certain mechanical ventilation devices.

[0017] To this end, the present invention provides a passive lung simulator device, which comprises a casing or box that includes a first lung simulator balloon, an air manifold connected to one end of the first lung simulator balloon, a first set of servo valves (for example, solenoid valves) arranged in series and connected to the air manifold through air flow conduits and a connection element for a mechanical ventilator. The connection element is coupled to one of the servo valves in the first set to allow air to flow into and out of the housing. The servo valves are configured to independently recirculate the air flow passing through them back to the air manifold, causing the lung simulator balloon to expand.

[0018] The simulator also includes a first set of cams, consisting of at least two cams arranged parallel to the central zone of the first lung simulator balloon, which are configured to be actuated by a servomotor to continuously adjust the compliance or capacity of the expanded lung simulator balloon through the rotation of the cams. Additionally, the simulator comprises a communication module operatively connected to the first set of servo valves and the first set of cams. This module is configured for wireless connection, for example, via Bluetooth or Wi- Fi, to a remote computing device, such as a mobile phone or tablet, to receive instructions for simulating different pulmonary pathologies.

[0019] In some embodiments, the lung simulator includes one or more leakage servo valves to channel air flow out of the housing. Alternatively, in some configurations, one of the servo valves in the first set acts as a leakage valve. In some embodiments, one, several, or all air flow conduits include cylinders with at least one concentric hole to restrict the air flow passing through them. If multiple air flow conduits or a single conduit include several holes, these can have different diameters to enable varying degrees of air flow obstruction.

[0020] In some embodiments, the connection element is a nozzle.

[0021] In certain embodiments, the simulator comprises a second lung simulator balloon connected in parallel to the first lung simulator balloon and coupled to the air manifold at one of its ends. In this case, the simulator also includes a second set of servo valves arranged in series and connected to the air manifold through air flow conduits, as well as a second set of cams with at least two cams arranged parallel to the central zone of the second lung simulator balloon and configured to be actuated by the servomotor. The communication module is also connected to the second set of servo valves and the second set of cams.

[0022] In some embodiments, the casing or box is made of rigid, portable material.

[0023] In some embodiments, the casing or box can be made of transparent or opaque material.

[0024] In some embodiments, the simulator incorporates one or more pressure and / or volume sensors to measure the pressure and / or volume parameters of the first and / or second lung simulator balloons.

[0025] The proposed lung simulator thus allows the simulation of a wide range of pulmonary pathologies and enables rapid adjustments to a patient's conditions. This is an ideal scenario for training, as it exposes the physician to potential critical events for the patient, requiring precise actions from the physician controlling the mechanical ventilator. Furthermore, remote control enhances the realism of the simulation by eliminating the need for the instructor's physical presence during the scenario.

[0026] Brief description of the drawings The foregoing and other features and advantages will be more fully understood from the following detailed description of some exemplary embodiments, which are merely illustrative and not limiting, with reference to the accompanying drawings, in which:

[0027] Fig. 1 schematically illustrates a passive lung simulator device, according to an embodiment of the present invention.

[0028] Fig. 2 schematically illustrates another embodiment of the proposed passive lung simulator device.

[0029] Detailed description of the invention and of an embodiment

[0030] The proposed simulator device, as illustrated in Fig. 1 , consists of a portable casing or box 1 , preferably rigid and transparent, although it may also be opaque.

[0031] Inside, the casing 1 houses the key components of the device, specifically: a lung simulator balloon 10, an air manifold 14 connected to the lung simulator balloon 10, a set of servo valves 12 arranged in series and connected to the air manifold 14 through air flow conduits 15, a set of cams 16 comprising two cams, a servomotor or similar mechanism (not illustrated) to operate the cams 16, a connection element 11 , such as a nozzle, for a mechanical ventilator, and a communication module (not illustrated).

[0032] The device enables control of the cams and servo valves through the communication module. The communication module, in turn, is controlled, for example, via Bluetooth or Wi-Fi, through a mobile application installed on a computing device, such as a mobile phone. This control allows the definition of various restriction and compliance conditions, simulating pulmonary pathologies in real-time and without physical contact.

[0033] In this embodiment, the connection element 11 is linked to one of the servo valves 12 to facilitate air flow into or out of the casing 1. The servo valves 12 are designed to independently recirculate air flow back to the air manifold 14, thereby expanding the lung simulator balloon 10.

[0034] The two cams 16, although not limited to this number — since in non-illustrated embodiments the device could include more — are actuated by the servomotor. This action, thanks to its continuous rotation, allows the compliance or capacity of the lung simulator balloon to be adjusted as it expands. This setup makes it possible to simulate conditions such as pulmonary fibrosis and acute respiratory distress syndrome caused by COVID. In this embodiment, the device incorporates a leakage servo valve 13 designed to direct air flow outside the casing 1 , enabling the simulation of an intubation leakage. Additionally, one of the air flow conduits 15 includes a concentric hole 150 that facilitates the gradual restriction of air flow, thereby allowing the simulation of pulmonary diseases such as obstructive pulmonary disease.

[0035] It is important to note that in other alternative embodiments not illustrated, air flow restriction through the hole could be achieved using more than one air flow conduit 15, which increases the device’s versatility and adaptability to various simulation needs. Furthermore, the different holes may have varying diameters, enabling different degrees of air flow obstruction. However, in some less versatile embodiments, none of the air flow conduits may possess this restriction capability.

[0036] Referring now to Fig. 2, another embodiment of the proposed device is illustrated. In this case, the device comprises two lung simulator balloons 10, 10B connected in parallel and sharing the aforementioned air manifold 14. The device also includes an additional set of servo valves 12B and two sets of cams 16, 16B for each lung simulator balloon 10, 10B. This setup is nonlimiting, as other examples could include a single set with at least two cams. All servo valves 12, 12B, 13 and cams 16, 16B are operated by the communication module based on instructions received from the computing device.

[0037] The device, in any of the described embodiments, could be equipped with one or more pressure and / or volume sensors. This would enable the measurement of pressure and / or volume parameters of the lung simulator balloon(s) 10. This additional capability allows for more precise and detailed monitoring of the simulated conditions, enhancing the device's versatility and utility in various applications.

[0038] The following section details examples of the device's operation in two different scenarios: A) Simulating the lung of a neonate under normal conditions. B) Simulating the lung of a neonate under conditions of restricted air flow and compliance limitation.

[0039] A) Simulation of Normal Condition: Healthy Lung

[0040] I. The device is connected to a mechanical ventilator, which induces air flow through the connection element 11 .

[0041] II. The air flow enters the set of servo valves 12, which remain open — representing a healthy lung condition — to recirculate the air flow through the different conduits 15. One or more of these conduits 15 include flow restrictors 150. All conduits converge and connect at the inlet of the air manifold 14.

[0042] III. The leakage servo valve 13 remains closed by default. If opened, it allows air to escape from the system, simulating improper patient intubation.

[0043] IV. The air flow enters the manifold 14 and flows into the lung simulator balloon 10, which can fully expand because the cams 16 located in parallel in the central part do not interact with it.

[0044] V. Next, the reverse path occurs: the lung simulator balloon 10 exhales an air flow, which is divided across the different conduits 15 until reaching the servo valves 12, which remain open, except for the leakage servo valve 13.

[0045] VI. Finally, the air flow exits the connection element 11 towards the mechanical ventilator.

[0046] B) Simulation of Pulmonary Pathology: Restriction and Compliance Impairment.

[0047] I. The device is connected to a mechanical ventilator that induces air flow through the connection element 11 .

[0048] II. The air flow enters the set of servo valves 12, where half or more are closed, simulating acute pulmonary obstruction. Some of the conduits 15 have flow restrictors 150. Therefore, half or more of the conduits leading to the air inlet of the lung simulator balloon 10 do not allow air flow circulation.

[0049] III. The leakage servo valve 13 remains closed by default. If opened, it would release air from the device, simulating improper intubation of the patient.

[0050] IV. The air flow enters the manifold 14 and is introduced into the lung simulator balloon 10, which cannot fully expand because the cams 16 are creating resistance to its expansion. The higher the resistance defined by the rotation of the cams, the lower the compliance of the balloon 10.

[0051] V. The reverse path occurs: the lung simulator balloon 10 exhales air flow, which is divided across the available conduits 15 with open servo valves 12.

[0052] VI. Finally, the air flow exits the connection element 11 towards the mechanical ventilator.

[0053] The scope of the present invention is defined in the attached claims.

Claims

CLAIMS1. A passive lung simulator device, comprising a casing or box (1) that includes: a first lung simulator balloon (10); an air collector (14) coupled to one end of the first lung simulator balloon (10); a first set of servo valves (12), arranged in series, connected to the air collector (14) via air flow conduits (15); a connection element (11) for a mechanical ventilator, the connection element being coupled to one of the servo valves (12) of the first set of servo valves (12) to allow the input / output of air flow into / from the casing or box (1), and the servo valves (12) being configured to independently recirculate the air flow passing through them to the air collector (14), in order to expand the lung simulator balloon (10); a first set of cams (16), including at least two cams (16) arranged in parallel with the first lung simulator balloon (10) in its central area, and configured to be driven by a servomotor to continuously modify the compliance or capacity of the expanded lung simulator balloon (10) through rotation of the first set of cams (16); and a communications module operatively connected to the first set of servo valves (12) and to the first set of cams (16) and configured for wireless connection with a remote computing device to receive instructions for simulating different pulmonary pathologies.

2. The device of claim 1 , further comprising at least one leakage servo valve (13) configured to channel the air flow out of the casing or box (1).

3. The device of claim 1 , wherein one of the servo valves (12) of the first set of servo valves (12) is a leakage valve configured to channel the air flow out of the casing or box (1).

4. The device of any one of the previous claims, wherein at least part of the air flow conduits (15) comprise cylinders with at least one concentric hole (150) to restrict the air flow passing through them.

5. The device of any one of the previous claims, wherein the connection element (11) comprises a nozzle.

6. The device of any one of the previous claims, further comprising: at least one second lung simulator balloon (10B), connected in parallel with the first lung simulator balloon (10) and coupled to the air collector (14) at one of its ends; a second set of servo valves (12B), arranged in series, connected to the air collector (14) through air flow conduits (15B); anda second set of cams (16B), including at least two cams arranged in parallel with the second lung simulator balloon (10B) at its central area, and configured to be operated by the servomotor; wherein the communications module is also operatively connected to the second set of servo valves (12B) and to the second set of cams (16B).

7. The device of any one of the previous claims, wherein the casing or box (1) is made of rigid material.

8. The device of any one of the previous claims, wherein the casing or box (1) is made of transparent or opaque material.

9. The device of any one of the previous claims, further comprising one or more pressure and / or volume sensors to measure pressure and / or volume parameters of the first and / or second lung simulator balloon(s) (10, 10B).

10. The device of any one of the previous claims, wherein the servo valves (12, 12B) comprise solenoid servo valves.

11. The device of any one of the previous claims, wherein the casing or box (1 ) has dimensions that allow the portability of the lung simulator device.

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