Description:[0001] The present invention relates to the field of respiratory therapy and mechanical ventilation systems, particularly to integrated devices used in closed respiratory circuits. The invention is especially relevant in critical care units, emergency medicine, and MRI-compatible environments, where seamless switching between humidification (HME) and nebulization (NEB) without breaking the respiratory circuit is vital for infection control, patient safety, and treatment efficiency.

BACKGROUND OF THE INVENTION
[0002] Current Heat and Moisture Exchangers (HMEs) and nebulization devices used in mechanical ventilation systems generally serve mutually exclusive functions. In traditional setups, switching between humidification and nebulization often necessitates disconnection of the breathing circuit, introducing serious clinical risks. These risks include the development of ventilator-associated pneumonia (VAP) due to circuit contamination, loss of positive airway pressure leading to ventilation compromise, increased exposure time, and greater chances of manual handling errors during therapy.
[0003] Existing devices on the market attempt to offer combined functionality by providing bypass mechanisms or auxiliary ports for nebulization. However, many such devices present notable limitations. Some designs are optimized only for humidification and do not facilitate real-time nebulization effectively within a closed ventilatory circuit. Others may offer monitoring clarity but lack true dual-mode switching capabilities. Additionally, some systems require manual disengagement or circuit disconnection, which compromises sterility and increases infection risks.
[0004] Furthermore, many of these devices incorporate inefficient internal flow structures, resulting in increased dead space that adversely impacts therapeutic efficacy. The internal configurations often create stagnant airflow zones, reducing effective humidification and decreasing the dose delivery efficiency during nebulization therapy. Some designs also contain metallic components, rendering them unsuitable for environments where MRI compatibility is essential.
[0005] Thus, there remains a significant unmet need for a dual-mode respiratory support device that enables seamless switching between humidification and nebulization modes without requiring any disconnection of the ventilator circuit. Such a device should minimize dead space, ensure maximum infection control, provide more filtration space in HME mode for enhanced efficiency, and maintain ease of use with modular, sterilizable, lightweight, and fully plastic construction.

OBJECTS OF THE INVENTION
[0006] An object of the present invention is to provide a combined Heat and Moisture Exchanger and Nebulizer (HMENEB) system that operates without disconnecting the patient’s ventilator circuit.
[0007] Another object of the present invention is to reduce dead space and optimize medicine delivery during nebulization.
[0008] Yet another object of the present invention is to ensure total infection control through closed-loop operation.
[0009] Another object of the present invention is to offer a lightweight, metal-free, and MRI-compatible device.
[0010] Another object of the present invention is to enable simple mechanical switching via a plastic rotary knob mechanism.
[0011] Another object of the present invention is to design all components as modular and plastic-based, ensuring reusability and sterilizability.
[0012] Another object of the present invention is to provide more space for filtration in HME mode compared to existing devices.

SUMMARY OF THE INVENTION
[0013] The present invention provides a dual-function plastic respiratory support device capable of switching between humidification (HME) and nebulization (NEB) functions without interrupting the breathing circuit. The invention features:
A top cover integrated with a rotatable knob that mechanically redirects airflow between NEB and HME channels. A modular base with an integrated plastic filter chamber. A lever mechanism activated by the knob, redirecting airflow inside the device without obstruction.
[0014] All parts are molded from medical-grade plastics, ensuring no interference in magnetic fields (MRI-safe). The device’s internal flow geometry is designed to maximize airflow efficiency and minimize dead space to under 1%. This solution is applicable to intensive care, emergency setups, MRI-compatible ventilator systems, and portable ventilatory devices, offering a safe, cost-effective, and durable tool for clinicians.
[0015] In this respect, before explaining at least one object of the invention in detail, it is to be understood that the invention is not limited in its application to the details of set of rules and to the arrangements of the various models set forth in the following description or illustrated in the drawings. The invention is capable of other objects and of being practiced and carried out in various ways, according to the need of that industry. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
[0016] These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there are illustrated preferred embodiments of the invention.

BRIEF DESCRIPTION OF DRAWINGS
[0017] The advantages and features of the present invention will be understood better with reference to the following detailed description and claims taken in conjunction with the accompanying drawings, wherein like elements are identified with like symbols, and in which:
[0018] Figure 1 illustrates the dual-mode heat and moisture exchange (HME) and nebulization device in accordance with the present invention.
[0019] Figure 2 illustrates the different views of the device in accordance with the present invention.
[0020] Figure 3 illustrates the modular base assembly and its different views in accordance with the present invention.
[0021] Figure 4 illustrates the top cover assembly and its different views in accordance with the present invention.
[0022] Figure 5 illustrates the lever attached with rotatable knob and its views in accordance with the present invention.
[0023] Figure 6 illustrates the modular base assembly with airflow redirecting lever arrangement in accordance with the present invention.
[0024] Figure 7 illustrates the top cover with filter assembly in accordance with the present invention.
[0025] Figure 8 illustrates the exploded view of the device in accordance with the present invention.

Reference Numerals
Part Name Referral Numeral
A Dual-Mode Heat and Moisture Exchange (HME) and Nebulization Device 100
Top Cover Assembly 101
Modular Base Assembly 102
Rotatable Knob 10
Lower O2 Port 20
Upper O2 Port 30
Slot (Low-Resistance Profile) 40
Airflow Redirecting Lever 50
Switching Mechanism 60
Upper Base Section 70
Filter 80
Lower Base Section 90

DETAILED DESCRIPTION OF THE INVENTION
[0026] An embodiment of this invention, illustrating its features, will now be described in detail. The words "comprising," "having," "containing," and "including," and other forms thereof are intended to be equivalent in meaning and be open-ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items or meant to be limited to only the listed item or items.
[0027] The terms “first,” “second,” and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another, and the terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item.
[0028] The present invention titled "A Dual-Mode Heat and Moisture Exchange (HME) and Nebulization Device with Integrated Switching Mechanism" offers an advanced solution in the field of respiratory therapy. This device combines the functionalities of both Heat and Moisture Exchanger (HME) and Nebulization (NEB) in a single system, allowing for efficient switching between the two modes without disconnecting the patient's ventilatory circuit. The integrated switching mechanism provides a seamless transition, enhancing patient safety by reducing the risk of infection, preserving positive airway pressure, and improving treatment efficiency. Designed with a fully plastic, non-metallic structure, the device ensures MRI compatibility, ease of cleaning, and reusability. Its low dead space design optimizes airflow and medication delivery, making it an ideal solution for critical care units, emergency medical settings, and MRI-compatible environments. This invention addresses the need for a reliable, easy-to-use, and infection-controlled respiratory device that enhances both patient care and clinical workflow.
[0029] Referring to the figure 1 to 4, exploded view provided, the device comprises the following key components, all constructed from medical-grade plastics to ensure biocompatibility, MRI compatibility, and ease of sterilization:
[0030] 1. Top Cover Assembly: The uppermost component, labeled "TOP," is a single molded plastic part designed to interface with the ventilator circuit and house the integrated switching mechanism. It features:
a. Ventilator Connection Port: A standardized connector (not explicitly shown but implied by its position) designed for secure and leak-proof attachment to the inspiratory limb of a ventilator circuit.
b. Integrated Knob Housing: A recessed area structured to accommodate the "Knob," allowing for its rotational movement and secure placement.
c. Dual Airflow Channels (Internal): Internally, the top cover houses two distinct airflow pathways: one dedicated to the HME function and another to the nebulization function. These channels are designed to minimize airflow resistance and dead space. The geometry of these channels is crucial for efficient delivery of humidified gas or aerosolized medication.
d. Lever Engagement Interface: A feature slot on the underside of the top cover that interacts with the "Lever" to redirect airflow based on the knob's position.
[0031] 2. Rotatable Knob: The component labeled "Knob" is a manually operable plastic part that allows the user to select either the HME or NEB mode. Its features include:
a. Ergonomic Design: Shaped for easy gripping and rotation, even with gloved hands.
b. Lever Actuation Feature: A protrusion or shaped element on its underside that directly engages with the "Lever," causing it to pivot or move as the knob is rotated.
[0032] 3. Airflow Redirecting Lever: The component labeled "Lever" is a pivotal or sliding plastic mechanism situated between the top cover and the base. Its function is to physically block or open the respective airflow channels within the device based on the position of the "Knob." Key features include:
a. Dual Sealing Surfaces: The lever likely incorporates sealing element as flexible plastic that create a tight seal against the internal walls of the airflow channels in the top cover and base, ensuring that airflow is directed exclusively through the selected pathway (HME or NEB).
b. Pivot or Slide Point: A central pivot or sliding interface that allows the lever to move in response to the rotation of the knob.
c. Low-Resistance Profile: The lever is designed to minimize obstruction to airflow in either the open or closed position, thereby contributing to the overall low dead space of the device.
[0033] 4. Modular Base Assembly: The base of the device consists of two interconnected plastic components that house the filter and provide the lower connection to the patient's airway.
a. Upper Base Section: This section directly interfaces with the "Lever" and the "Filter." It contains internal channels that align with the airflow channels in the top cover, allowing airflow to be directed either through the filter (for HME) or bypass it (for NEB).
b. Integrated Filter Chamber: A specifically designed cavity within the upper base section that securely houses the "Filter." The chamber ensures proper contact between the airflow and the hygroscopic material of the filter during HME operation.
c. Lower Base Section: This section connects to the patient's airway (e.g., via an endotracheal tube or tracheostomy tube connector, not explicitly shown). It features a smooth internal bore to minimize airflow turbulence and resistance.
d. Nebulizer Port (Implied): A port or connection point (not explicitly labeled but implied by the device's dual functionality) located on either the upper or lower base section, designed to interface with a nebulizer (e.g., a vibrating mesh nebulizer or a jet nebulizer adapter). This port allows aerosolized medication to be introduced into the airflow when the device is in NEB mode. The internal channel connecting this port to the main airflow path is designed for efficient aerosol delivery with minimal impaction.
[0034] 5. Filter Element: The component labeled "Filter" is a cylindrical or similarly shaped element composed of a hygroscopic material (e.g., pleated paper, foam coated with a hygroscopic salt) designed to retain heat and moisture from the patient's exhaled breath and release it during inhalation. Its key characteristics include:
a. High Hygroscopic Capacity: Efficiently captures and releases moisture to provide optimal humidification.
b. Low Flow Resistance: Designed to minimize pressure drop across the device during both HME and NEB operation.
c. Biocompatible Material: Constructed from materials safe for patient contact and compatible with respiratory gases.
Mode of Operation:
[0035] HME Mode: When the "Knob" is rotated to the HME setting, the "Lever" is positioned to direct the patient's exhaled breath through the "Filter" element within the "Base." As the warm, moist exhaled gas passes through the filter, the hygroscopic material captures heat and humidity. During the subsequent inhalation, the dry, cool inspiratory gas from the ventilator passes through the same filter, where it is warmed and humidified by the previously captured heat and moisture before being delivered to the patient. The nebulizer port is sealed off in this mode.
[0036] NEB Mode: When the "Knob" is rotated to the NEB setting, the "Lever" is repositioned to bypass the "Filter" element. The inspiratory gas from the ventilator now flows directly to the patient without passing through the hygroscopic filter. Simultaneously, the nebulizer (connected to the implied nebulizer port) introduces aerosolized medication into this airflow. The geometry of the internal channels in this mode is optimized for efficient mixing and delivery of the aerosolized medication to the patient. The airflow path through the filter is sealed off in this mode, preventing any loss of medication or reduction in nebulization efficiency.
Key Advantages Enabled by the Design:
[0037] Zero-Disconnection Switching: The integrated "Knob" and "Lever" mechanism allows for instantaneous switching between HME and NEB modes without the need to disconnect any part of the ventilator circuit, significantly reducing the risk of VAP and maintaining a closed system.
[0038] Minimized Dead Space: The internal design, including the streamlined airflow channels and the low-profile "Lever," is optimized to keep the dead space of the device to a minimum, improving ventilation efficiency and CO2 clearance.
[0039] MRI Compatibility: The use of medical-grade plastics for all components ensures that the device is entirely metal-free and safe for use in MRI environments.
[0040] Simple Operation: The single "Knob" provides an intuitive and easy-to-use interface for switching between modes.
[0041] Modular Design and Sterilizability: The modular nature of the components allows for easy assembly and disassembly for cleaning and sterilization, promoting reusability and cost-effectiveness.
[0042] Optimized Drug Delivery: The dedicated nebulization pathway ensures efficient delivery of aerosolized medication with minimal loss or deposition within the device.
[0043] This detailed description elucidates the structure and function of the dual-mode HME and nebulization device, highlighting its innovative integrated switching mechanism and the benefits it offers in respiratory therapy. The use of medical-grade plastics, the focus on minimizing dead space, and the seamless switching capability represent significant advancements in the field.
[0044] The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described to best explain the principles of the present invention, and its practical application to thereby enable others skilled in the art to best utilize the present invention and various embodiments with various modifications as are suited to the particular use contemplated. It is understood that various omission and substitutions of equivalents are contemplated as circumstance may suggest or render expedient, but such are intended to cover the application or implementation without departing from the spirit or scope of the claims of the present invention.
, Claims:1. A dual-mode heat and moisture exchange (HME) and nebulization device (100), comprising:
a top cover assembly (101) with a ventilator connection port, an integrated knob housing, dual airflow channels, and a lever engagement interface;
a rotatable knob (10) for selecting between HME and nebulization modes, said knob (10) being configured to engage and actuate an airflow redirecting lever (50) for switching airflow between a filter chamber and a nebulizer port;
the airflow redirecting lever (50) that is pivotally and slidingly mounted within the device (100), said lever (50) having dual sealing surfaces to direct airflow exclusively through either the filter chamber in HME mode or the nebulizer port in nebulization mode;
a modular base assembly (102), comprising an upper base section (70) with an integrated filter chamber, and a lower base section (90) configured to connect to a patient's airway;
a filter element (80) housed within the filter chamber of the upper base section (70), wherein the filter (80) captures and releases moisture to humidify the inspiratory gas during HME mode;
a nebulizer port located within the base assembly (102) for connecting to a nebulizer in nebulization mode, allowing aerosolized medication to be introduced into the airflow.

2. The device (100) as claimed in claim 1, wherein the top cover assembly (101) is constructed from medical-grade plastics to ensure MRI compatibility, ease of cleaning, and biocompatibility.
3. The device (100) as claimed in claim 1, wherein the rotatable knob (10) is ergonomically designed for gripping and operation, even when wearing gloves.

4. The device (100) as claimed in claim 1, wherein the lever engagement interface allows the lever (50) to pivot and slide based on the position of the knob (10), thereby controlling the airflow path through the filter or nebulizer port.

5. The device (100) as claimed in claim 1, wherein the filter element (80) is made from a hygroscopic material that efficiently captures and releases moisture to humidify the inspiratory gas.

6. The device (100) as claimed in claim 1, wherein the airflow redirecting lever (50) includes dual sealing surfaces made of flexible plastic to create a tight seal against internal walls of the airflow channels.

7. The device (100) as claimed in claim 1, wherein the nebulizer port is configured to connect to a vibrating mesh nebulizer or jet nebulizer, allowing efficient delivery of aerosolized medication during nebulization mode.

8. The device (100) as claimed in claim 1, wherein the base assembly includes an integrated chamber for securely housing the filter (80), ensuring optimal contact between the airflow and the hygroscopic material of the filter during HME operation.

9. The device (100) as claimed in claim 1, wherein the device operates in two distinct modes as HME mode, where the airflow passes through the filter to humidify the inspiratory gas, and nebulization mode, where the airflow bypasses the filter and the nebulizer port introduces aerosolized medication.

10. The device (100) as claimed in claim 1, wherein the device is constructed with a low dead space design to minimize airflow resistance and optimize both the delivery of humidified gas and aerosolized medication.