WO2020221952A1

WO2020221952A1 - Insufflator device for artificial ventilation

Info

Publication number: WO2020221952A1
Application number: PCT/ES2020/070498
Authority: WO
Inventors: José Javier Aroca Ochoa
Original assignee: Aroca Ochoa Jose Javier
Priority date: 2019-04-16
Filing date: 2020-07-31
Publication date: 2020-11-05
Also published as: ES1229950Y; WO2020221952A4; ES1229950U

Abstract

The invention relates to a portable, lightweight insufflator device for improving artificial ventilation in patient resuscitation, allowing resuscitation specialists to free their hands in a health emergency and also to increase the quality of the ventilations, where said device comprises a fan (1) coupled with a motor (10) intended for moving the fan (1) in order to insufflate air to the patient, an electronic speed controller (3) connected to the motor and configured to control motor power (10) and consequently to regulate the insufflation flow, a microcontroller (4) comprising a connection module and operationally connected to the motor (10) in order to control time intervals between insufflations transmitted by the fan (1), defining a plurality of different operating programmes and a frame (5) which comprises a lower portion (53) that has an oxygen inlet (54) for enriching the air insufflated by the fan (1) to the patient.

Description

INSUFFLATION DEVICE FOR ARTIFICIAL VENTILATION

DESCRIPTION

OBJECT OF THE INVENTION

The present invention provides an insufflator device for artificial ventilation of a patient. More in particular, the present invention discloses a portable and lightweight device to improve artificial ventilation in the resuscitation of patients that allows simultaneously freeing the hands of rescuers in a health emergency and also increasing the quality of ventilations

BACKGROUND OF THE INVENTION

Some insufflating devices for artificial ventilation of a patient are widely known in the state of the art. These known devices can be categorized into two groups: manual and mechanical.

For example, resuscitation masks are masks with a small filter and a mouthpiece where the rescuer breathes directly from his mouth. This type of device is not part of the healthcare provision of a healthcare unit or hospital. It is indicated for any lay rescuer or off-duty professional personnel who do not have the optimal equipment.

The resuscitation balloon, commonly known as Ambú® (Airway Mask Bag Unit), is the most used device when it comes to ventilating a patient in the first moments of care or indefinitely if there are no advanced devices. It can be used with the mask directly to the patient's mouth-nose or connected to an intubation device (laryngeal mask or endotracheal tube). It is usually in any health provision both at the hospital and out-of-hospital level.

As for mechanical devices, such as mechanical fans or also known as artificial respirators, there is a wide range of devices, from the simplest to the most complex and advanced. Advanced devices are common in health emergencies, both at the hospital and out-of-hospital levels, with a high level of complexity, volume, weight and cost. There are turbine and piston, the latter are the most used and work with the pressure provided by the connection to a compressed oxygen bullet. It is used in patients intubated with endotracheal tubes or any similar device, although it also allows air to be supplied to the patient through masks (BI-PAP, CPAP).

With the current devices we go from the extreme simplicity of the resuscitation balloon to the complexity of the mechanical respirator. Although there are simpler and lighter respirators, they have not finished entering the market as they are still bulky and do not facilitate patient mobilization.

The resuscitation balloon was invented in 1956 and has hardly evolved at all to this day. We could find some drawbacks in its use, such as the volume control that we breathe into the patient. These devices use a 1500 ml reservoir that, by pressing it with our hand, we would be insufflating about 700 ml to the patient (which would be an optimal volume) but this volume depends on how we squeeze it and how big or small our hand is. We also need to use both hands, one to adjust the mask and the other to compress the balloon, it is even recommended that a rescuer adjusts the mask with both hands and a second rescuer compresses the balloon, so its use requires a lot of dedication. It is also difficult to maintain the rate of inflations, for example, every 6 seconds, since the rescuer is usually aware of more things and it is very common for the patient to take long pauses or hyperventilate the patient.

The most commercialized mechanical ventilators that we see both in medical ambulances and in hospitals are sophisticated devices with a multitude of parameters and it is the doctor who is in charge of configuring and adapting them to the patient. These devices come with a specific tube for each device and most of them depend on being connected to an oxygen bullet. Among the most common parameters we can find control of volume, inspiratory time, respiratory rate, oxygen concentration, PEER (Positive pressure at the end of expiration), trigger sensitivity (Trigger), ventilation modes, etc.

It is evident that these devices are ideal when it comes to maintaining a patient with assisted respiration, either in hospitalization or in a transfer by ambulance or any means, for example, air. But reality makes the use of these devices complicated, especially in the first moments of assistance, since many ambulances do not have them and are only used by medical personnel. In other countries they are used by paramedical personnel. The high weight and volume also make it difficult to move or evacuate the patient with these devices.

DESCRIPTION OF THE INVENTION

The present invention aims to solve some of the problems mentioned in the state of the art.

More in particular, the present invention discloses a portable insufflator device for artificial ventilation intended to be operatively attached to the mouth of a patient comprising:

- a ventilator coupled to a motor designed to move the ventilator to blow air into the patient,

- a battery configured to transmit power to the engine and store energy,

- an electronic speed controller designed to control motor power to regulate air insufflation flow to the patient,

- a microcontroller comprising a connection module and is configured to control a plurality of operating modes of the device designed to control time intervals between insufflations,

- a chassis comprising a compartment to house the battery, a compartment to house the electronic speed controller and a tubular portion that comprises an upper tubular portion to house the fan and a lower tubular portion that includes an oxygen intake to enrich the air inflated by the ventilator to the patient.

Preferably, the microcontroller is compatible with Arduino, where the Arduino is arranged on a breadboard and in turn connected by cables to two other breadboards where pushbuttons and ieds lights are located. More preferably, for a more compact design the breadboards can be replaced by printed circuit boards (PCB).

The battery can be connected to the electronic speed controller (ESC) through a main switch. The ESC can have three derivations that go directly to the motor and a connector with three cables, one powers the Arduino, another is connected to a pin (D9) and the last to ground (GND). Furthermore, the device may comprise an accelerometer configured to detect movements of the patient during a cardiopulmonary arrest. The accelerometer can be housed under the Arduino breadboard, also connected with cables.

In a preferred embodiment, the device has three programs and, in turn, two modes. The modalities can be Adult and Pediatric. By default, the device is configured in Adult mode, being destined to trigger an insufflation of 700 ml in approximately 0.6 seconds.

If we want to change to pediatric mode, we would have to press a button, called by way of example button 4. When pressed, a green LED can remain lit and the ESC reduces the motor power to reduce the volume of air, this being equivalent to a balloon pediatric resuscitator, as a consequence, allowing an insufflation of 450 ml in 0.6 seconds, which we will call the pediatric mode of the device.

It is also possible to add more modalities to the device, such as neonatal, decreasing the flow and increasing the frequency.

Preferably, the three programs are executed by means of three additional buttons. The first button can be configured to, when pressed, execute a single insufflation to the patient. During the insufflation time, for example, a yellow LED lights up and then goes off.

The second button can be configured to activate an insufflation every 6 seconds indefinitely when it is pressed. In this program, for example, a blue led turns on and until we press it again, the program is not disconnected. This mode is used to ventilate a person indefinitely with either a mask or an endotracheal tube.

The third pushbutton can be configured to activate two separate insufflations in an interval of one second indefinitely while the accelerometer detects no movement during a cardiorespiratory arrest, while it detects some movement it does not activate insufflations to the patient. This is CPR (Cardiopulmonary Resuscitation) mode. It works like the previous one, when you press it, the program remains open (with a red led) and until we press it again it does not stop. In this case what it does is inflate 2 ventilations spaced one second apart, When detecting movement, the device does not actuate and when detecting inaction, it performs two inflations. The purpose of this program is to use it in any cardiorespiratory arrest as it helps to carry out an effective intervention. Before a patient in CRP and after opening the airway and placing an oropharyngeal device, we placed the mechanical insufflator anchored by means of harnesses in the patient's mouth-nose. At the moment it is activated, it performs the two inflations and the assistant would begin to perform chest compressions with a frequency of 30: 2 for adults. That is, the patient's chest is compressed and when compression 30 stops, the device detects inaction and performs two inflations, then an auxiliary begins the compressions again the cycle of 30. The device is sensitive and detects that slight movement performed by the patient when we compress the chest.

If the device were in pediatric mode and a sequence is performed in the CPR program of 15: 2, the device works the same, at the moment compression 15 is reached, the auxiliary stops and the device will insufflate. Whenever compression stops, it inflates.

Preferably, a battery with an estimated autonomy of at least 40 minutes in ventilatory mode (every 6 seconds) and easily connectable and rechargeable.

Preferably, the chassis is manufactured by 3D printing. Additionally, it can be designed with the Cinema 4D program.

The lower tubular portion of the chassis can be approximately 22mm in diameter. With this measure, any filter, mask or tube can be connected. As a consequence any standard mask can be connected since the connection can be universal.

Alternatively, as the bactericidal filter is usually bulky, the lower tube can be connected to a mask that already has a bactericidal filter incorporated, for example, a mouth insufflation mask.

The device can also connect with an endotracheal tube, for example, when a person is ventilating indefinitely every 8 seconds with the program executed by button 2. Preferably, the battery is housed in a chassis compartment located substantially on the vertical axis of the center of the device, more preferably near the vertical axis of the device's center of gravity. This arrangement of the battery provides the device with a good balance because when placed on the patient, the patient encounters hyperextension of the neck to open the airway and the battery, which is the heaviest, remains in the middle axis of the assembly.

Anchorage of the device to the patient can be through a harness connected to the housing or chassis. Alternatively, there are masks with the possibility of connecting an anchor.

The device is very easy to use and has very good performance, allowing it to perfectly replace the resuscitation balloon in any phase of healthcare, improving the quality of inflations and freeing the rescuer to focus on other aspects of the intervention.

With this device we are able to have a small, compact and light device, of approximately 220 grams, having enough force to ventilate a patient. With the ability to attach it to the patient using a harness, the healthcare worker can focus on other aspects of healthcare. When it comes to ventilation, great precision is achieved, since for example with the resuscitation balloon it will depend on how and how much we compress the balloon.

A single rescuer could perform a quality CPR as they could focus on chest compressions with the airway covered with this device.

In hostile environments such as armed conflicts, accidents involving multiple victims or catastrophes, this device allows the patient's airway to be controlled quickly and safely, allowing the assistant or doctor to focus on other victims or perform complex evacuations. The simplicity and safety of the device enables its use by personnel without experience or specialization in the use of highly complex insufflating devices.

In addition, it is also very useful and convenient in any out-of-hospital health care unit, hospital, armed forces, security and / or rescue bodies. DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of a practical embodiment thereof, a set of drawings is attached as an integral part of said description. where, for illustrative and non-limiting purposes, the following has been represented:

Figure 1.- Shows an exploded view of the device in a preferred embodiment where the fan, the battery, the electronic speed controller and the microcontroller are clearly shown.

Figure 2.- Shows a perspective view of a preferred embodiment of the chassis of the device where the tubular portion to house the fan and the compartment to house the battery is shown.

Figure 3.-; It shows a circuit diagram of a preferred embodiment where the four buttons are shown to activate 3 operating programs and two modes, 4 led lights to illustrate the type of operation of the device, the accelerometer, the Arduino compatible microcontroller and the motor to operate the fan.

PREFERRED EMBODIMENT OF THE INVENTION

Figure 1 shows an exploded view of a preferred embodiment of the insufflator device for artificial respiration of a patient. More particularly, according to said preferred embodiment, it is shown that the device comprises a 6-blade fan (1) intended to be coupled to a brushless motor (10) with a maximum continuous power of approximately 120 W and 19.5 g of total weight.

Figure 1 further shows a battery (2) configured to store energy and transmit power to the motor (10) and store energy. According to the preferred embodiment described, the battery is easily rechargeable and has a storage capacity of 1500 mAh and 95 g of total weight, in this way it has an autonomy of at least 40 minutes in continuous operation, that is, in the second operating mode. which is explained later. Likewise, an electronic speed controller (3) is shown to control the electrical power of the motor (10) that is transformed into mechanical power, consequently, it allows regulating the flow rate of insufflation of air to the patient, Said electronic speed controller (3 ) according to the preferred embodiment described is 30A and weighs approximately 25 g.

Figure 1 also shows a microcontroller (4) compatible with Arduino, according to the preferred embodiment it presents an Elegoo Nano CH340 / ATmega328P board. Said microcontroller (4) is configured to control a plurality of operating modes of the device intended to control time intervals between insufflations, and is programmed by Arduino-compatible software to execute said plurality of operating modes.

Finally, figure 1 also shows a switch (12) that supports 12V and 20A configured to allow the ESC (3) to detect the motor (10) and the Arduino to connect, leaving the device ready for operation.

Figure 2 shows a chassis (5) of the device according to a preferred embodiment, comprising a first compartment (50) to house the battery, a second compartment (not shown) to house the electronic speed controller and a tubular portion (51) comprising an upper tubular portion (52) to house the ventilator (1) and a lower tubular portion (53) presenting an oxygen intake (54) to enrich the air blown by the ventilator (2) to the patient.

According to the preferred embodiment described, the chassis is manufactured by 3D printing and is designed with the Cinema 4D program. Furthermore, the lower tubular portion (53) of the chassis (5) will be approximately 22mm in diameter. With this measure any filter, mask or endotracheal tube can be connected. As a consequence any standard mask can be connected since the connection is universal.

Figure 3 shows a circuit plan of a preferred embodiment where four buttons (6, 7, 8, 9) are shown to activate 3 operating programs and two modes. Also, four LEDs are displayed to illustrate the type of operation the device is in when it is operating. Figure 3 also shows an accelerometer (11), the Arduino-compatible microcontroller (4) and the motor (10) configured to drive the fan (1). According to the preferred embodiment described, the microcontroller (4) is arranged on a breadboard (20) and in turn connected by cables to two other breadboards (21) where the buttons (6, 7, 8,9) and some LEDs are located.

In a preferred embodiment, the device has three programs and, in turn, two modes. The modalities can be called Adult type and Pediatric type. By default, the device is configured in Adult mode, being destined to trigger an insufflation of 700 ml in approximately 0.6 seconds.

If we want to change to pediatric mode, we would have to press button four (9). When pressed, a green IED can remain on and the ESC (3) reduces the power of the motor (10) to reduce the volume of air, this being equivalent to a pediatric resuscitation balloon, as a consequence, allowing an insufflation of 450 ml at 0 , 6 seconds which we will call the pediatric mode of the device.

Preferably, the three programs are executed by means of the other three buttons (6,7,8). The first button (6) can be configured to, when pressed, execute a single insufflation to the patient. During the insufflation time, a yellow Ied lights up and then goes off.

The second button (7) can be configured to actuate an insufflation every 6 seconds indefinitely. In this program, a blue Ied lights up and until we press it again, the program is not disconnected. This mode is used to ventilate a person indefinitely with either a mask or an endotracheai tube.

The third pushbutton (8) can be configured to activate two separate insufflations in an interval of one second indefinitely while the accelerometer (11) does not detect movement during a cardiorespiratory arrest, while it detects some movement it does not activate insufflations to the patient . This is the CPR (Cardiopuimonary Resuscitation) mode. It works as the previous one, when pressing the third button (8) the program remains open (with a red Ied) and until we press it again it does not stop. In this case, what it does is to inflate 2 ventilations swords for a second, when detecting movement the device is not activated and when detecting inaction it performs the two inflations.

The purpose of this program is to use it in any cardiorespiratory arrest as it helps to carry out an effective intervention. Before a patient on CRP and after opening the airway and placing an oropharyngeal device, we placed the mechanical insuffi- lator using harnesses in the patient's mouth-nose. At the moment it is activated, it performs the two inflations and the assistant would begin to perform chest compressions with a frequency of 30: 2 for adults. That is, the patient's chest is compressed and when compression 30 is stopped, the device detects inaction and performs two inflations, then an auxiliary begins the compressions again the cycle of 30. The device is sensitive and detects that slight movement that performed by the patient when we compress the chest using the accelerometer (11).

The device can be anchored to the patient by means of a harness connected to the chassis (5). Alternatively, there are masks with the possibility of connecting an anchor.

The device is very easy to use and has very good performance, allowing it to perfectly replace the resuscitator balloon in any phase of healthcare, improving the quality of inflations and freeing the rescuer to focus on other aspects of the intervention.

Claims

1.- A portable insufflation device for artificial ventilation intended to be operatively coupled to the mouth of a patient, characterized in that it comprises:

- a ventilator (1) coupled to a motor (10) designed to move the ventilator (1) to blow air into the patient,

- a battery (2) connected to the motor (10) and intended to store energy and transmit electrical power to the motor (10),

- an electronic speed controller (3) connected to the motor and configured to control motor power (10) and consequently regulate air insufflation flow to the patient by the ventilator (1),

- a microcontroller (4) comprising a connection module and is operatively connected to the motor (10) to control time intervals between inflations transmitted by the fan (1) defining a plurality of different operating programs

- a chassis (5) comprising a first compartment (50) to house the battery (2), a second compartment to house the electronic speed controller and an upper portion (52) to house the fan and a lower portion (53) It has an oxygen intake (54) to enrich the air inflated by the ventilator (1) to the patient.

2.-. Insuffing device for artificial ventilation of a patient according to claim 1, characterized in that the microcontroller (4) is compatible with Arduino.

3.- Insuffing device for artificial ventilation of a patient according to claim 1, characterized in that the connection module is a printed circuit board (PCB).

4 Insuffing device for artificial ventilation of a patient according to claim 1, characterized in that the connection module comprises at least one protoboard (21).

5.- Insufflator device for artificial ventilation of a patient according to claim 1, characterized in that it also comprises an accelerometer (11) connected to the microcontroller (4) and intended to detect movements of the patient during a cardiorespiratory arrest. ø.- Insufflator device for artificial ventilation of a patient according to claim 1, characterized in that it comprises a first button

(6) connected to the microcontroller (4) and configured to, when pressed, execute a single insufflation to the patient.

7.- Insufflator device for artificial ventilation of a patient according to claim 1, characterized in that it comprises a second button (7) connected to the microcontroller (4) and configured to, when pressed, actuate an insufflation every 6 seconds indefinitely .

8.- Insufflator device for artificial ventilation of a patient according to claim 5, characterized in that it comprises a third button (8) connected to the microcontroller (4) and configured, when pressed, to activate two separate insufflations in an interval of one second indefinitely, as long as the accelerometer does not detect movement during a cardiorespiratory arrest, if it detects any movement, insufflations are not triggered.

9.- Insufflator device for artificial ventilation of a patient according to claim 1, characterized in that it comprises a fourth button (9) connected to the microcontroller (4) intended to switch between a first mode of use for adults and a second mode of use pediatric.

10.- Insuffing device for artificial ventilation of a patient according to claim 9, characterized in that in the first mode the ventilator (1) generates a volume of 700ml of air in 0.6 seconds by means of the motor power regulated by the electronic speed controller.

1 1.- Insufflator device for artificial ventilation of a patient according to claim 10, because in the second mode the ventilator generates (1) a volume of 450ml of air in 0.6 seconds by means of the motor power regulated by the electronic speed controller.

12.- Insuffing device for artificial ventilation of a patient according to claim 1, characterized in that the lower portion (53) is tubular and has a diameter of substantially 22 mm.

13.- Insufflator device for artificial ventilation of a patient according to claim 1, characterized in that it comprises a bactericidal filter connected in the lower portion (53).

14. Insuffing device for artificial ventilation of a patient according to claim 1, characterized in that the battery (2) is housed in a compartment of the chassis (5) located substantially on the vertical axis of the center of gravity of the device.