WO2016082009A1

WO2016082009A1 - Radioactive aerosol nebulization equipment

Info

Publication number: WO2016082009A1
Application number: PCT/BR2015/000007
Authority: WO
Inventors: Paulo Roberto Walter FERREIRA; Rafael Ribeiro MADKE; Patricia Coelho Lamachia MADKE; Salus Cardoso VIDAL; Edison Martins da SILVA JUNIOR; Ricardo Galileo ANELE FILHO; Rodrigo Santos KALIKOSKI; Alice Fialho Viana; Patrícia Machado NABINGER; Marcelo SPERB; Fausto KAUER; Osvaldo Estrela ANSELMI; Frederico Paulo LAMACHIA FILHO; Ivan MIRANDA; Marcelo Saraiva DOS SANTOS
Original assignee: Serviço Nacional De Aprendizagem Industrial - Senai; Bhio Supply Indústria E Comércio De Equipamentos Médicos Ltda; Mjm Produtos Farmaceuticos E De Radioproteção Ltda; Wirklich Indústria De Plásticos Ltda
Priority date: 2014-11-24
Filing date: 2015-01-23
Publication date: 2016-06-02
Also published as: BR102014029318A2; BR102014029318B1

Abstract

A description is given of radioactive aerosol nebulization equipment provided with a cabinet (100) clad with interchangeable lead plates (110) for adaptation to SPECT scans (single-photon emission computerized tomography) or PET scans (positron emission tomography), with means for the engagement of a detachable respiratory circuit (200) in the form of a polymeric matrix provided with niches formed to guarantee the positioning of each component of the inspiratory circuit and of the expiratory circuit that make up said respiratory circuit, the operator having no need to assemble components prior to the use thereof, and including means in the cabinet (100) for preventing the reuse of the respiratory circuit (200).

Description

Aerosol Fogging Equipment

RADIOACTIVE

FIELD OF INVENTION

[01] The present invention describes an equipment for radioactive aerosol nebulization. More specifically, it comprises radio-aerosol production apparatus provided with an enclosure covered with interchangeable lead plates for adaptation to SPECT (single photon emission tomography) or PET (positron emission tomography) examinations, with means for engaging a disposable breathing circuit in the form of a polymeric matrix provided with shaped niches to ensure the positioning of each component of the inspiratory circuit and the expiratory circuit as part of said breathing circuit, requiring the handler to assemble components prior to use, and including means in the enclosure to prevent reuse of the breathing circuit.

BACKGROUND OF THE INVENTION

[02] The non-invasive functional state of organs can be analyzed by marking molecules participating in physiological processes with radioactive markers, which mark their location with the emission of gamma rays detected with an appropriate camera that allows imaging or movies.

[03] Pulmonary nebulizers are used to assess pulmonary ventilation by introducing aerosol inhaled radioactive tracers. With this noninvasive practice, the radiopharmaceutical reaches the alveolar airspace, allowing the evaluation of the pulmonary deposition pattern through scintigraphic examination. The alveolar / vascular interface allows the radiopharmaceutical to travel toward the vascular compartment, so that it is metabolized and excreted in the body. This procedure has a medical indication, mainly for patients with clinical suspicion of pulmonary thromboembolism (PTE), alveolitis and chronic obstructive pulmonary disease (COPD), among other pulmonary / thoracic pathologies.

[04] Radioaerosols employed in the assessment of pulmonary ventilation status must meet certain criteria: particle size should be about 1 m (<2pm) to allow penetration of the bronchoalveolar space. Most particles larger than 3.5 μιτι never leave the nebulizer, thus returning to the fluid to be atomized again. Particles of approximate size between 1, 5 and 3.5 μιπ can be deposited on the nebulization system tube walls and often impregnate the lips, mouth and bronchi without even reaching the alveoli. Particles larger than 2μπι are susceptible to deposition in the proximal trunk of the bronchi, whose excessive deposits make it difficult and even impossible, in some cases, to produce a diagnostic image and, consequently, to evaluate pulmonary ventilation. Aerosol particles smaller than 0.5 μ ^η τι have a high air stability and can be exhaled together with the air without being deposited. Another criterion lies in the fact that nebulized radioactive particles must provide stable radioactivity of a region of the lung for the time required for image acquisition. This stability is essential to ensure that the scintigraphic image of a region retains the same appearance during image projection acquisition. [05] State-of-the-art radioactive aerosol nebulizers feature a lead-coated cabinet to allow attenuation of radioactive gamma rays from radioactive particles. In the inner region of the cabinet is a breathing circuit that includes an administration route for introducing radioactive material, which is aerosolized within the nebulizer upon receipt of compressed air or oxygen. Thus, the patient inhales the radioactive material through the mouthpiece disposed at the end of the inspiratory circuit tube and exhales into the expiratory circuit where a filter is provided which retains the radioactive material and microorganisms.

[06] Several prior art documents describe radioactive aerosol nebulizers, such as US4819629 which describes an apparatus for aerosol delivery to the airways and / or lungs that has an inspiratory line and an expiratory line with a generator. of aerosol attached to the inspiration line. A breath monitor generates signals corresponding to the patient's breathing cycle, which is used to control the aerosol generator. Aerosol is generated during the exhalation phase and is deposited at the inspiration line.

[07] US4598704 describes a disposable aerosol inhalation device wherein a nozzle is connected to a Y-connector, containing a valve system for radioactive aerosol inhalation and exhalation for a filter, said device housed in a lead enclosure. reduce radiation exposure.

[08] US4907581 describes an apparatus for use in diagnostic and respiratory therapy procedures that generates radioactive particles for evaluation of lung ventilation, utilizing a nebulizer and a combination of baffles is a settling chamber, which works to remove larger radioactive particles from the mist generated by the nebulizer through impaction, turbulence and sedimentation.

[09] Thus, state-of-the-art hebulizers feature lead-coated cabinets to prevent patient and practitioner exposure to radiation, with an inspiratory and expiratory circuit in the inner region for delivery of radioaerosol to the patient. However, the misting circuit, that is, the inspiratory circuit and the expiratory circuit, are assembled by the operator who then positions said misting circuit in the inner region of the shielded housing and, after use, the misting circuit is removed by the operator for proper asepsis. In other words, the nebulization circuit is not only for single use, but also needs pre-assembly before use and subsequent disassembly after use, exposing the operator to radiation.

[010] In order to avoid exposure of the operator to any contact with radioactive material, as well as to provide a single-use breathing circuit with expiratory and inspiratory circuit mounted and sealed in a polymeric matrix, it is an object of the present invention to provide nebulization equipment. radioactive aerosol which additionally features an enclosure with interchangeable lead plates, which allow for adaptation to SPECT or PET examinations, and with mechanical or electronic means to prevent reuse of the nebulization circuit.

SUMMARY

[011] It is a feature of the invention that a radioactive aerosol nebulization apparatus having a cabinet coated with Interchangeable lead for adaptation to SPECT (Single Photon Emission Tomography) or PET (Positron Emission Tomography) examinations, with the removal and placement of lead plates simplified without incurring assembly errors.

[012] It is a feature of the invention that radioactive aerosol nebulization equipment is provided with a single use breathing circuit in the form of a polymeric material plate having shaped niches to ensure the positioning of each component of the inspiratory and expiratory circuit, said cassette is preferably of electrostatic and bactericidal polymeric material.

[013] It is a feature of the invention that a radioactive aerosol nebulization apparatus having a breathing circuit has a settling reservoir that permits the conversion of wet aerosol to dry aerosol at the exit of the inspiratory pathway by deposition and moisture in said reservoir. particle size less than 1.5 hangs inhalation for the patient.

[014] It is a feature of the invention that radioactive aerosol nebulization equipment is provided with an identification system which interfaces mechanically, electromechanically or electronically between the polymeric matrix of the respiratory circuit and the shielded enclosure to prevent the reuse of the said circuit.

[015] A feature of the invention is a radioactive aerosol nebulization apparatus having a respiratory circuit arranged in an electrostatic polymeric matrix and / or covered with an elastomeric layer which favors the retention of particulates larger than 1.5pm in the settling chamber. said matrix may incorporate particles of silver or other bactericidal material to cause disruption of the bacterial wall by atomic action of the silver particle.

[016] It is a feature of the invention a radioactive aerosol nebulization device for pulmonary ventilation assessment which has a universal breathing circuit that allows the use of different breathing circuit arrangements and designs made available by the manufacturer, depending on the plastic components employed internally in the circuits. inspiratory and expiratory. This peculiarity of the breathing circuit allows the device to be optimized to meet the user's needs, considering the possibility of increasing or decreasing the inhalation time and increasing or decreasing the volume of radiopharmaceutical loaded. The breathing circuit may therefore have different configurations for the inspiratory and expiratory circuits based on the same external breathing circuit.

[017] It is a feature of the invention radioactive aerosol nebulization equipment provided with a shielded enclosure with mechanical or electronic means to prevent reuse of the respiratory circuit.

BRIEF DESCRIPTION OF THE FIGURES

[018] Figure 1 shows the perspective view of the armored cabinet.

[019] Figure 2 shows the internal view of the shielded cabinet, showing the guides for the fitting of the lead plates and the ventilation circuit in the form of a polymeric matrix and Figure 2A shows the lead plates fitted in the internal region of the shielded enclosure. cabinet. [020] Figure 3 presents the exploded view showing the cabinet and the nebulized breathing circuit arranged in a polymeric matrix.

[021] Figure 4 shows the nebulized breathing circuit attached to the inside of the enclosure.

[022] Figure 5 shows details of the nebulization breathing circuit elements.

[023] Figure 6 shows the flowchart of the electro-mechanical interface where a resistive electrical circuit is activated upon opening the enclosure lid to press and weld the nebulizer circuit radiopharmaceutical administration route, preventing its reuse. .

[024] Figure 7 shows the electronic interface flowchart where a radio frequency traceability system is foreseen using an RFID (Radio Frequency Identification) chip that performs electronic surveillance of the polymeric matrix of the respiratory circuit, avoiding the its reuse.

DETAILED DESCRIPTION OF THE INVENTION

The equipment of radioactive aerosol nebulization, object of the present invention, comprises an enclosure (100) having a hinged base (10) and a lid (11) and having internal region provided with inserts (101) for positioning of interchangeable lead plates (110) to ensure radiation retention in said internal region of the enclosure (100) with a single-use nebulizer breathing circuit (200) positioned and fitted to a polymeric material plate where shaped niches are provided to ensure the positioning of each inspiratory and expiratory circuit component. [026] The inner region of the cabinet (100) has fittings disposed on the base (10) and the lid (11) where tabs (111) protrude from the edge of the lead plate (110) as shown in figures 2 and 2A, ensuring shielding of said cabinet (100) and suitability for SPECT (single photon emission tomography) or PET (positron emission tomography) examinations.

[027] As will be detailed below with respect to the nebulized breathing circuit elements (200), the cabinet (100) has side indentations (12) for fitting the inspiratory trachea (23) and expiratory trachea (25), to maintain the nozzle (26) in the outer portion of the cabinet (100), an inlet for connection to the compressed air or oxygen source (13) to supply the nebuliser and an inlet for the radioactive material inlet (14), said side indentations (12) and inlets (13, 14) as a guide for the correct positioning of the polymeric matrix that houses the nebulization breathing circuit (200) in the inner region of the cabinet (100).

[028] The nebulization breathing circuit (200) is mounted on a polymeric matrix provided with shaped niches to ensure the positioning of each component of the inspiratory and expiratory circuit, featuring a nebulizer (20) with an inlet for coupling to the power source. compressed air or oxygen (13) from the cabinet (100), said nebulizer (20) interconnected with an inspiratory relief valve (21) and the radiopharmaceutical delivery pathway (211) connected to the inlet (14) disposed in the cabinet (100) .

[029] The radioactive aerosol generated in the nebulizer (20) goes to a settling chamber (22) where the moisture is decanted, and the dry radioactive aerosol with particulate smaller than 1.5 m is released. for the inspiratory pathway including a free-end inspiratory trachea (23) provided with an inspiratory valve (24) followed by a T-piece (241) containing a mouthpiece (26) for inhalation of the radioactive material by the user, followed by Exhalation is directed to the expiratory valve (242) coupled to the expiratory trachea (25) which features an activated carbon filter (251) that ensures retention of radioactive particulate matter and microorganisms to avoid environmental contamination.

[030] The inspiratory valve (24) connects the inspiratory pathway and the expiratory valve (242) connects the expiratory pathway, thereby isolating the inspiratory and expiratory flows.

Preferably, the polymeric nebulizer breathing circuit matrix (200) has an elastomeric layer which favors the retention of particulates in the settling reservoir (22).

Preferably, the polymeric matrix of the nebulized breathing circuit (200) has electrostatic properties.

Preferably, the polymeric nebulized breathing circuit matrix 200 has silver particles or other bactericidal material to cause the bacterial wall to rupture by atomic action of the silver particle.

[034] The electrostatic charge generated by the polymer and optionally by the inclusion of silver nanoparticles or an elastomeric strap disposed within the settling reservoir favors particulate retention, preventing particles larger than 1, 5 μιη from being aspirated by the user. .

[035] Including nebulized breathing circuit components (200) in a polymer matrix prevents the operator from Directly handle material with risk of contamination, both for the assembly of inspiratory and expiratory circuits, conventional procedures in state-of-the-art radioaerosol nebulizers, as well as for the operation of withdrawal of the nebulized respiratory circuit (200) after use. It also simplifies the preparation steps of the misting equipment, minimizing errors.

[036] In manual operating mode, the operator opens the enclosure lid (11) and positions the nebulizer breathing circuit polymer matrix (200) in the internal region, using the compressed air source coupling openings (13) as a guide. ) of the cabinet (100) and the inspiratory (23) and expiratory (25) tracheas. Once the polymer matrix (200) is positioned, the cover (11) of the cabinet (100) is closed and locked by means of a lock. The compressed air tube is then connected to the opening (13) provided in the cabinet (100) and thereafter the radiopharmaceutical is injected into the opening (14) of the cabinet (100) which directs said radiopharmaceutical to the administration route (211). towards the nebulizer (20) of the nebulization breathing circuit (200).

Basically, in cabinet 100, a breathing circuit based on the production of radioactive aerosol based on the Venturi Principle is provided, namely: formation of small particles through a source of long air or oxygen. To this end, it has a closed breathing circuit that conducts the radioaerosol flow from the generator to the patient (inspiratory route) and back from the patient to the retention filter of radioactive particulate matter (expiratory route). [038] The assessment of alveolar-capillary permeability is performed using radiopharmaceuticals labeled with the technetium-99-metastable radioisotope. Consciously, Tc-99m-DTPA has been employed for lung ventilation studies. As an alternative for radioactive aerosol production, Tc-99m-FITATO and Tc-99m-PIROPHOSPHATE have also been employed, considering the differential deposition and pulmonary clearance of these radiopharmaceuticals.

[039] The shielded enclosure (100) has a mechanical, electro-mechanical or electronic interface with the polymeric matrix (200) that supports the nebulization breathing circuit to prevent total or partial reuse of said polymeric matrix.

[040] At the mechanical interface, the shielded cabinet (100) has a means that modifies the shape of the polymeric matrix (200) positioned in the inner region of said cabinet (100) when the lid (11) of the cabinet (100) is opened, to prevent reuse because the array cannot be re-fitted.

Preferably, there is provided a blade actuated by closing the lid (11) of the cabinet (100) which provides for cutting off one end of the polymeric die (200), preventing reuse because it cannot be repositioned in the cabinet ( 100).

[042] At the electro-mechanical interface, as shown in Figure 4, the shielded cabinet (100) has a resistive electrical circuit driven upon opening of the cover (11) of the cabinet (100), said resistive electrical circuit that causes the press and welding of the radiopharmaceutical administration route (211), preventing reuse of the nebulized respiratory circuit (200). Welding takes place through an electrical resistance with a heating element. a This circuit provides power to the electromagnet that pulls and holds the shielded cabinet cover (11) until the ventilation process is complete. When the venting process is completed, the operator presses the lid open button (11), then the press and weld process of the radiopharmaceutical delivery pathway (211) of the nebulized breathing circuit (200) is initiated.

[043] In the electro-electronic interface, a bimetallic tape (thermostat) can optionally be used to switch off the electromagnet. These tapes have two materials with different physical and mechanical properties that are combined in their length. Thus, when the tape heats up due to the temperature rise inside the shielded enclosure (100), it begins to warp until a push switch is cut that cuts off the electromagnet.

Optionally, a circuit may be provided with a solenoid valve (not shown) connected to the compressed air or oxygen inlet (13) of the cabinet (100) so that the circuit breaks when a second lid opening is identified. (11) of the cabinet (100), preventing the ingress of compressed air or oxygen and, consequently, the generation of radioactive aerosol.

[045] The electronic interface provides for a radio frequency traceability system using an RFID (Radio Frequencyldentification) chip that performs electronic surveillance of the polymer matrix (200), preventing its reuse.

[046] In this embodiment, the polymeric matrix (200) has an RFID tag and the cabinet (100) has an RFID tag reader. The reader (or antenna) outputs radio signals to activate the matrix RFID tag (200), which can be active or passive. When the RFID tag passes through the electromagnetic field zone of the reader, is detected. If the label is active, an internal battery must be provided for power and the polymer matrix (200) can be traced.

[047] If the polymer matrix has already been used, the bit is set to high logic level (or 1), and the display (102) of the cabinet (100) displays an alert informing that the nebulization breathing circuit (200) is already was used and should be discarded as well as preventing the supply of compressed air or oxygen to the nebulizer (20). If the nebulizer circuit (200) has not been used, the bit remains at low logic level (or 0) and the chassis processor (100) allows the nebulizer circuit (200) to be used.

[048] In this electronic interface, the nebulizer equipment features an integrated circuit that allows programming and control of oxygen or compressed air flow, nebulization time, traceability of the nebulization circuit through identification on the RFID chip. In this embodiment, the display (102) of the shielded cabinet (100) displays information related to the operation of the equipment, such as correct positioning of the polymeric matrix of the respiratory circuit (200) verified by sensors, nebulization time, storage of clinical data of the device. patient and interface for docking the equipment in a report printer or a communication module for remote transfer of diagnostic exam data.

Claims

CLAIMS:

positioning tabs (111) protruding from interchangeable lead plates (110), and side indentations (12) for fitting the inspiratory trachea (23) and expiratory trachea (25), an inlet for connection to the compressed air source or oxygen (13) and an inlet for ingress of radioactive material (14);

bj a motorized breathing circuit (¾Q) is a polymeric matrix positioned in the internal region of the gabineite (100), said polymeric matrix with niches.

2/4

RADIOACTIVE according to Claim 1, characterized in that the polymeric matrix of the nebulized breathing circuit (200) preferably has an elastomeric layer.

RADIOACTIVE AEROSOL SNAPPING EQUIPMENT according to claim 1, characterized in that preferably the polymeric nebulizer breathing circuit matrix (200) has silver particles or other particulate retention material larger than 1,5μιη in the settling chamber (22).

RADIOACTIVE Aerosol NEBULIZATION EQUIPMENT according to claim 1, characterized in that the shielded enclosure (100) has a means for modifying the shape of the polymeric matrix (200) positioned in the inner region of said enclosure (100) when the enclosure is provided. cover (11) of the cabinet (100) opens.

RADIQATIVE AEROSOL SNAPPING EQUIPMENT according to claim 4, characterized in that preferably a blade actuated by closing the lid (11) of the enclosure (100) which provides for cutting off one end of the polymeric matrix ( 200).

RADIOACTIVE AEROSOL NEBULATION EQUIPMENT according to claim 1, characterized in 3/4 because the shielded enclosure (100) has a resistive electrically operated circuit when opening the lid (11) of the enclosure (100), said resistive electric circuit that causes the pressing and welding of the radiopharmaceutical administration pathway (211) , preventing reuse of the nebulized breathing circuit (200), where welding occurs through an electrical resistor with a heating element, having a circuit that provides power to the electromagnet that attracts and holds the shielded cover (11) (100) ) until the nebulization process ends.

RADIOACTIVE Aerosol NEBULATION EQUIPMENT according to claim 6, characterized in that a bimetallic tape (thermostat) is optionally used to switch off the electromagnet.

RADIOACTIVE AEROSOL SNAPPING EQUIPMENT according to claim 6, characterized in that a circuit is optionally provided with a solenoid valve (not shown) connected to the compressed air or oxygen inlet (13) of the enclosure (100); such that the circuit breaks when identifying a second opening of the cover (11) of the cabinet (100).

RADIOACTIVE AEROSOL SNAPPING EQUIPMENT according to claim 1, characterized in that the polymeric matrix (200) has an RFID tag and the cabinet (100) has an RFID tag reader, so that the reader emits signals of to activate the matrix RFID tag (200), which identifies whether the polymer matrix has already been used, by setting the bit to a high logical level (or 1) and preventing compressed air or oxygen from 4/4 enclosure (100) to the nebulizer circuit (20) nebulizer (200), or identifying that the polymeric matrix was not used by setting the bit to low logic level (or 0) and the enclosure processor (100) allowing the use of the nebulization circuit (200).