Dipneo

Dipneo is developing a portable and autonomous external ventilation device to improve the accessibility and effectiveness of ventilation maneuvers in healthcare emergencies.

The achievement of this objective is contingent upon the attainment of a series of specific technical and business objectives, which are crucial for both the uniqueness of the device and the success of the company’s commercialization efforts:

Technical Objectives (OT):

1. Portability and Usability Anywhere: Develop an autonomous RCP ventilation device with a design that facilitates portability, ensuring accessibility and availability in any environment, whether medical or non-medical.
2. Autonomy: Optimize the ergonomics and efficiency of the device for automation. This eliminates the need for manual operation by the operator, allowing them to focus on other tasks and removing limitations based on the operator’s physical capabilities (strength, endurance, hand size). While the device will allow manual use as a redundancy and safety measure, it will primarily be intended for automatic and autonomous operation.
3. Non-Professional Use: The device will not require any pre-configuration to determine ventilation parameters, thus relieving the user of decision-making responsibilities, facilitating its use, and reducing stress during high-pressure situations like out-of-hospital cardiac arrests. Additionally, integration with a support and monitoring platform will assist the operator during device use, guiding them to execute proper CPR maneuvers. This platform will also ensure traceability, tracking, and effective monitoring of the device’s status. Initially, this assistance will be provided through video conferencing with a medical professional and will progress towards the inclusion of Augmented Reality (AR) technologies for operator guidance.

In addition to these technical objectives, the following business objectives (OE) are crucial:

Business Objectives (OE):

1. Ensure Regulatory Compliance: Ensure compliance with various standards to enable the commercialization of the device in diverse markets. This includes conducting clinical trials and necessary tests to obtain the CE mark and obtaining the medical device manufacturer’s license.
2. Execute an Effective Market Approach Strategy: Start by targeting segments considered more receptive and gradually expand into a wider range of usage environments and customer types, ensuring a comprehensive market penetration strategy.

The Dipneo device is a hands-free autonomous resuscitator intended for both professional and non-professional use. It consists of a sealed chamber containing an air bag, which is activated by a small compressed air tank that also supplies air to the patient. Equipment control is carried out through a limited mobile phone, which handles both internal device management and communication with emergency services for user assistance.

To facilitate understanding of the entire solution, a diagram of the different blocks that compose it is included below

Figure 1. Components of Dipneo

Breaking down, the system consists of:

1- Medical air or O2 bottle: This component not only provides compressed air or oxygen to the patient but also drives the contraction of the bag to inflate air through the mask. This avoids the need for additional power sources or connecting the equipment to the grid.

2- Sensor and valve hardware: These components regulate the entry of air into the capsule and its administration to the patient by controlling a valve regulated by a PLC.

Additionally, the system allows for pressure monitoring through the air inlet and outlet circuit, as well as chamber pressure, providing key information about lung capacity, coordination of cardiac resuscitation maneuvers, and potential airway obstructions.

The hardware receives parameters from the mobile device’s data controller, such as ventilation frequency (breaths per minute), which is crucial for opening and closing times.

Figure 2. Hardware Diagram

Based on the needs of the situation, the type of ventilation generated can be chosen:

• Continuous: Providing constant ventilation. This ventilation mode is set as the default mode as it provides greater oxygenation for a patient in cardiac arrest. CPR: 
• In CPR mode, the device audibly indicates 30 compressions/100-120 seconds and two breaths, acting in a situation of cardiac arrest with chest compressions. This alternative ventilation mode requires active selection and is recommended in more specific situations that require optimization of air or O2 consumption. 

3- Capsule: This rigid element contains an AMBU-type bag inside, as well as a tubular membrane with two non-return valves that allow airflow in one direction. The capsule chamber has a topology of strategically placed protrusions with differentiated thicknesses to overcome resistance to bag compression uniformly, achieving total tricuspid collapse.

Figure 3. Device Diagram: A) Sealed chamber. B) Control panel. C) Innovative valve. D) Tricuspid valve collapse sequence.

Additionally, the capsule has a fine-tuning unidirectional regulator and two additional quick-release valves to facilitate pressure release and recovery of the membrane’s original shape.

4- Mobile control device (smartphone) limited for device use and attached to it, serves several key functions:

• Acts as a controller for sensor and valve hardware 
• Assists the operator in the resuscitation process and device use. This includes not only auditory and visual alerts for chest compressions but also an automated call to emergency services (112), via phone call/video call, to support the person conducting resuscitation. 
• Sends data to the medical platform about the patient’s condition until the emergency services (ambulance) arrive. 

To fulfill these functions, the controller device has Wi-Fi, 4G/5G connectivity, as well as a highly limited and user-friendly interface, to be used in a critical situation without any training.

5- Server for data storage and processing, including maintenance alerts, dates and times of use, important data during use (configured and monitored parameters), and communication with the control device (APP updates, permission changes in the APP, device location and movement, dates and times of use).

The collected data includes device usage frequency, geolocation, maintenance (for repair or replacement of parts), and patient parameters.

Based on this technology, DIPNEO has been able to carry out initial tests with a Laerdal mannequin simulator, demonstrating the effectiveness of the prototype and ensuring proper air delivery to the patient, monitoring parameters such as intrapulmonary pressure, delivered volume, and other vital signs important in the patient during CPR.

Therefore, the project is in a TRL-4 state, initiating the design and development of a second version of the prototype. This prototype will serve as a commercial prototype with which tests and trials will be conducted to obtain the CE certification required for subsequent sale in the European Union.

Figure 4. Dipneo Prototype Rendering

Technological Challenge and Innovation

Identification of the Technical Challenge:

Despite significant advancements from its early prototypes, the device is still considered to be in the development stage. To achieve a commercial device, Dipneo must address a series of technical challenges across its three key characteristics: portability, autonomy, and non-professional use.

• Portability: Material Engineering and Geometries for the Device:

The current prototype features a rigid capsule housing the AMBU, ensuring a consistent operating environment for automated bag opening and closing. However, to enhance the current device, several aspects need addressing:

To improve chamber efficiency, studies will explore engineering the bag’s geometry by adjusting its length and constituent materials. This aims to improve collapsibility, durability, and resistance, especially in areas under greater compression.

Furthermore, considering that Air2Life is an emergency device, DIPNEO considers it important for it to have redundancy measures in its use. This is materialized in the redesign of the compression chamber, so that in the event of electronic failure or input pressure issues, the chamber housing can be removed to manually ventilate directly with the bag.

Incorporating extraction mechanisms to maintain chamber airtightness during automatic use poses a significant engineering challenge.

Additionally, ongoing prototype development will focus on reducing device weight through careful evaluation of suitable lightweight materials, directly contributing to portability and ease of use.

• Autonomy: Precision of Automatic Control Systems:

Sensor systems and valve control are pivotal for device functionality, necessitating solutions for the following challenges:

Ensuring precise air delivery tailored to each patient’s specific needs. This entails developing pressure control to monitor lung capacity, compatibility, chest compression frequency, airway obstruction, and gastroesophageal reflux. Advanced control algorithms continuously monitor patient conditions for precise adjustments, regulating electrovalve operation accordingly.

Given the device’s emergency context, optimizing energy consumption is essential. This involves implementing technologies and strategies to minimize power usage, ensuring optimal efficiency and prolonging the lifespan of both electrical and gas pressure energy sources.

• Non-Professional Use: Assistance for Non-Professional Operators:

While the current prototype provides operator guidance through visual and auditory alerts, further improvements are expected in the following areas:

• Level 1: Auditory and visual alerts (already achieved).
• Level 2: Calling/video calling emergency personnel, to be included in the 2024 prototype.
• Level 3: AR glasses with integrated calling for «in-situ» operator guidance, expected development by 2026.

The latter requires advanced AR algorithms for virtual information overlaying on the patient’s physical environment. Integrating these technologies effectively poses a challenge, ensuring usability and accuracy in a dynamic clinical setting.

Additionally, to ensure that the operator can receive quick assistance from emergency teams, it is necessary to ensure robust communication between the device and qualified professionals. This involves developing robust connectivity between the mobile device and the medical device. Furthermore, a protocol for connection and queue determination must be established to prioritize Dipneo calls over others, thus ensuring a quick and effective response in critical situations.

The difficulty lies, on one hand, in the need to implement robust wireless technologies, develop secure communication protocols, and establish communication methods that allow for both assistance and continuous transmission of the patient’s vital signs during the operation of Air2Life.

Advantages and Technological Innovations:

Thanks to the results obtained in the initial prototypes testing and especially after solving the technological challenges outlined in the previous section, DIPNEO will achieve that the device possesses multiple technological advantages.

For easier understanding, the following innovations have been established:

Innovation 1 – Portable and versatile device for use in any environment: Current manual ventilation systems require a qualified medical operator, while mechanical ventilation systems also require electrical connection and mechanized environments. Thanks to its simple, lightweight, and low-cost design, it is perfect for assisting people in both professional and non-professional environments, serving as a perfect complement to an AED.

Innovation 2 – Effective and precise ventilation in emergency situations: Existing solutions in the market for emergency use have limitations due to manual handling, limiting the precision and effectiveness of ventilation to the operator’s physical characteristics and knowledge. Additionally, there is no real control over the supplied volume, nor is it possible to know the patient’s lung capacity, which can lead to medical problems such as gastroesophageal reflux. In contrast, Dipneo, through the use of air pressure sensors at various points, allows for the identification of possible respiratory obstructions, as well as adjusting the amount of air supplied according to the patient’s lung capacity.

Innovation 3 – Automatic usage to free the operator’s hands: In an emergency situation, freeing the hands and attention of the operator from something as important as ventilation is invaluable. This innovation becomes even more important considering that the operator is often a person close to the patient, who, in a moment of maximum tension, can be reassured that their loved one is receiving the optimal amount of air. This situation is not addressed by any device on the market, as both manual and automatic ventilators are focused on hospital environments and emergency equipment (ambulances, firefighters).

Innovation 4 – Device safety and robustness: To increase the safety and robustness of the product and the person handling it, as well as the patient, the device does not have gears to lubricate, bearings, follower rollers, shafts, spindles, or moving parts to protect, nor electric motors that heat up and warm the surrounding environment or produce interference in adjacent electronic equipment. Its design, carried out by medical professionals, aims to be safe and useful in any environment, incorporating additional redundancy and security measures such as the extraction of the capsule in case of electrical failure.

Innovation 6 – Early alert to emergency services: During emergency situations, people attending to patients must also alert emergency services (112). The device automates this alert to 112, establishing a priority communication channel that not only alerts the need for an ambulance but also enables medical services to monitor the patient’s vital signs.

Innovation 7 – Professional assistance during the resuscitation process: The high level of training required to effectively perform CPR limits the correct application of devices by untrained individuals, increasing the risks associated with a cardiac arrest in non-hospital environments. 

In response to this issue, the device guides the operator during the resuscitation process, both through the incorporation of auditory and visual signals and through direct contact with a medical professional who is aware of the patient’s situation. 

These assistance methods will be complemented in the near future by the incorporation of AR glasses that allow for instructions on how to place the device and how to correctly perform chest compressions, so that anyone can perform them optimally while maintaining contact with the emergency medical professional.