AEROSOL TRANSITION ADAPTER

专利摘要:
AEROSOL FAN DELIVERY SYSTEM. A transition adapter component (100) of a ventilator aerosol delivery system for delivering an aerosol to a patient, which includes a housing (110) having a proximal end (120) and a distal end (130) , wherein the proximal end (120) has an aerosol passage (140) for receiving an aerosol (234) produced by a heated capillary (232) and a gas connection port (150) for receiving carrier gas (316) at from a fan (300), which is in communication with a plurality of gas inlet ports (154) contained in the transition adapter (100). An internal cavity (170) of the transition adapter (100) receives aerosol (234) from heated capillary (232) and carrier gas streams (316) from a plurality of gas outlet ports (156) contained in the transition adapter (100) and directs the carrier gas streams (316) to surround at least partially and in parallel with the aerosol (234). An outlet port (160) at the distal end (130) of the transition adapter housing (110) delivers a contained aerosol to an aerosol delivery connector.
公开号:BR112015003599B1
申请号:R112015003599-0
申请日:2013-08-21
公开日:2021-07-13
发明作者:James Leamon；Timothy Gregory；Jan Mazela；Christopher Henderson
申请人:Philip Morris Products S.A.；
IPC主号:

专利说明:

BACKGROUND OF THE INVENTION
[0001] The present disclosure relates to a transition adapter for delivering aerosol from an aerosol generator, and a ventilator aerosol delivery system, which uses a portion of a pressurized inspiratory gas flow from the ventilator to deliver aerosol from the aerosol generator to a patient.
[0002] Patients, both adults and children, with respiratory failure or those with respiratory dysfunction are often mechanically ventilated in order to provide adequate rescue and prophylactic therapy. A ventilatory circuit for administering positive pressure ventilation includes a positive pressure generator connected by tubing to a patient interface, such as a mask, nasal parts, or an endotracheal tube, and an exhalation path, such as tubing, that enables the discharge of the expired gases, for example, to the ventilator.
[0003] Ventilation gas tube, expiratory flow tube and contained aerosol tube can be connected to the patient interface by means of an aerosol delivery connector, for example, as disclosed in document in WO 2009/117422A2. SUMMARY
[0004] In accordance with an exemplary embodiment, an aerosol transition adapter for delivering an aerosolized active agent to a patient comprises: a housing having a proximal end and a distal end, the proximal end having a passageway. aerosol for receiving an aerosol produced by an aerosol source comprising an aerosolized active agent and the distal end having an outlet port, the housing having a length between the distal end and the proximal end; a carrier gas connection port for receiving a carrier gas from a gas source, which is in communication with a plurality of carrier gas outlet ports, the carrier gas outlet ports being disposed adjacent to the passing aerosol in a pattern that partially surrounds the aerosol flow; an internal cavity, which is adapted to receive aerosol from the aerosol passage and carrier gas from the plurality of carrier gas outlet ports and to direct carrier gas streams to at least partially surround and flow into parallel to a main direction of an aerosol flow along the length of the housing towards the exit port; and the exit port, at the distal end of the housing, for delivering the aerosol to a patient in need of aerosolized active agent.
[0005] In accordance with an exemplary embodiment, an aerosol delivery system, comprises: an aerosol generator for producing an aerosol; a positive pressure generator for producing a pressurized vent gas; in one example, a splitter for splitting the pressurized ventilation gas into a carrier gas and a ventilation gas and a conduit from the positive pressure generator to the splitter; an aerosol transition adapter arranged to combine the aerosol produced by the aerosol generator with the carrier gas from the splitter, and wherein the transition adapter divides the carrier gas into a plurality of carrier gas streams, which are directed to surround at least partially and flow in parallel with the aerosol entering the transition adapter, and forming a contained aerosol; an aerosol delivery connector having a port for receiving the contained aerosol, a port for admitting the vent gas, a patient-aerosol interface port for delivering the contained aerosol from the aerosol transition adapter and the vent gas from the divider to a patient and a port for exhausting exhalation gas from the patient; and a patient interface for receiving the contained aerosol and vent gas from the aerosol delivery connector.
[0006] In accordance with an exemplary embodiment, a method for producing a contained aerosol comprises: generating an aerosol; providing a source of carrier gas from a fan; and combining the aerosol and carrier gas by dividing the carrier gas into a plurality of carrier gas streams, which at least partially surround and parallel with the aerosol to form a contained aerosol. BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The description is explained below with reference to the exemplary embodiments shown in the drawings. In the drawings:
[0008] Figure 1 is a perspective view of a transition adapter in accordance with an exemplary embodiment.
[0009] Figure 2 is a side view of the transition adapter as shown in Figure 1 in accordance with an exemplary embodiment.
[00010] Figure 3 is a cross-sectional view of the transition adapter as shown in Figure 1 along line A-A of Figure 2.
[00011] Figure 4 is an end view of the transition adapter as shown in Figure 1 in accordance with an exemplary embodiment.
[00012] Figure 5A is a side view of the transition adapter as shown in Figure 1.
[00013] Figure 5B is a cross-sectional view of the transition adapter as shown in Figure 5A along line B-B.
[00014] Figure 5C is a cross-sectional view of the transition adapter as shown in Figure 5A along line C-C.
[00015] Figure 5D is a cross-sectional view of the transition adapter as shown in Figure 5A along line A-A.
[00016] Figure 6A is an end view of the transition adapter as shown in Figure 1 in accordance with an exemplary embodiment.
[00017] Figure 6B is an end view of the transition adapter as shown in Figure 1 in accordance with an exemplary embodiment.
[00018] Figure 6C is an end view of the transition adapter as shown in Figure 1 in accordance with an exemplary embodiment.
[00019] Figure 7A is a block diagram of a ventilator aerosol delivery system for a continuous positive airway pressure ("CPAP") system in accordance with an exemplary modality.
[00020] Figure 7B is a block diagram of a ventilator aerosol delivery system for a bubble CPAP in accordance with an exemplary modality.
[00021] Figure 7C is a block diagram of a ventilator aerosol delivery system for a bubble CPAP in accordance with an exemplary modality, in which two independent ventilation sources are used.
[00022] Figure 8 is a schematic view of a ventilator aerosol delivery system after aerosol delivery has been completed and the patient has received only one ventilation gas.
[00023] Figure 9A is a side view of a transition adapter in accordance with an exemplary embodiment.
[00024] Figure 9B is an end view of the transition adapter as shown in Figure 9A in accordance with an exemplary embodiment.
[00025] Figure 9C is a cross-sectional view of the transition adapter as shown in Figure 9A along line B-B.
[00026] Figure 9D is a cross-sectional view of the transition adapter as shown in Figure 9A along line C-C.
[00027] Figure 9E is a cross-sectional view of the transition adapter as shown in Figure 9A along line A-A.
[00028] Figure 10A is a perspective view of a transition adapter in accordance with an exemplary embodiment.
[00029] Figure 10B is another perspective view of the transition adapter as shown in Figure 10A in accordance with an exemplary embodiment.
[00030] Figure 10C is a partial cutaway view of the transition adapter as shown in Figures 10A and 10B in accordance with an exemplary embodiment.
[00031] Figure 11A is a perspective view of a transition adapter in accordance with an additional exemplary embodiment.
[00032] Figure 11B is an end view of the transition adapter as shown in Figure 11A in accordance with an exemplary embodiment.
[00033] Figure 11C is a cross-sectional view of the transition adapter as shown in Figure 11A in accordance with an exemplary embodiment.
[00034] Figure 11D is a side view of the transition adapter as shown in Figure 11A in accordance with an exemplary embodiment.
[00035] Figure 12A is a perspective view of a transition adapter in accordance with an exemplary embodiment.
[00036] Figure 12B is an end view of the transition adapter as shown in Figure 12A in accordance with an exemplary embodiment.
[00037] Figure 12C is a side view of the transition adapter as shown in Figure 12A in accordance with an exemplary embodiment.
[00038] Figure 12D is a cross-sectional view of the transition adapter as shown in Figure 12C along line A-A.
[00039] Figure 12E is a cross-sectional view of the transition adapter as shown in Figure 12C along line B-B. DETAILED DESCRIPTION
[00040] Aerosols are useful in drug delivery. For example, it is often desirable to treat respiratory ailments with, or deliver drugs by means of, fine particle aerosol sprays dispersed in liquid and/or solid, e.g., dust, drugs, etc., which are inhaled and delivered to the lungs of a patient. Aerosols can be generated by a heated capillary aerosol generator (CAG) by feeding a liquid formulation into a heated capillary tube or passageway (herein referred to as "heated capillary") while heating the capillary sufficiently so that the liquid formulation is at least partially volatilized so that, upon discharge from the heated capillary, the liquid formulation is in the form of an aerosol. Capillary length may depend on heating requirements dictated, among other factors, by the composition of the aerosol that must be generated.
[00041] As used herein, the term "aerosol" refers to liquid or solid particles that are suspended in a gas. The "aerosol" or "aerosolized agent" recited herein contains one or more of the active agents as recited above.
[00042] The term "ventilation" or "respiratory ventilation" as used herein refers to the mechanical or artificial support of a patient's breathing. The overall goals of mechanical ventilation are to optimize gas exchange, patient breathing work, and patient comfort while minimizing ventilator-induced lung injury. Mechanical ventilation can be delivered via positive pressure breaths or negative pressure breaths. Additionally, positive pressure breaths can be delivered non-invasively or invasively. Non-invasive mechanical ventilation (NIMV) generally refers to the use of a mask or nasal pieces to provide ventilatory support through a patient's nose and/or mouth. The most commonly used interfaces for non-invasive positive pressure ventilation are nasal pieces, nasopharyngeal tubes, masks, or nasal masks. NIMV can be distinguished from invasive mechanical ventilation techniques that bypass the patient's upper airway with an artificial airway (endotracheal tube, laryngeal mask airway, or tracheostomy tube). NIMV can be provided either by bilevel pressure support (called "BI-PAP") or continuous positive airway pressure (CPAP).
[00043] The use of mechanical ventilation, both invasive and non-invasive, involves the use of various respiratory gases, as would be noted by the person skilled in the technique. Respiratory gases are sometimes referred to in this document as "CPAP gas", "ventilation gas", "ventilation air", "inspiratory flow", "expiratory flow", or simply "air". As used herein, the terms "vent gas", "air", "oxygen", "medical gas" and "gas" are used interchangeably to refer to a vent gas or air/oxygen powered by flow and include any type of gas normally used for respiratory therapy. The term "fan" referred to herein may also be described as an oxygen/air mixing flow driver as pressurized oxygen and air are mixed and provide the source of vent gas. A carrier gas is used to carry aerosolized drugs in the administration of respiratory therapy. The term "carrier gas" may be used herein interchangeably with the term "containment gas" and includes any type of gas commonly used for respiratory therapy as disclosed above.
[00044] A ventilation circuit for delivering positive pressure ventilation includes a positive pressure generator or an end-expiratory positive pressure source (PEEP valve or water column) connected by tubing to a patient interface such as a mask, nasal parts , or an endotracheal tube, and an exhalation path such as tubing that allows the discharge of expired gases, for example, to the ventilator as a constant-flow CPAP or to an underwater receptacle as for "bubble" CPAP. The inspiratory and expiratory tubes can be connected to the patient interface via a "Y" connector or an aerosol delivery connector, for example, as disclosed in WO document 2009/117422A2, which contains a port to attach each. the inspiratory and expiratory tubes, as well as an aerosol port for the patient interface and a port for attaching a pressure sensor.
[00045] The aerosol generated by the capillary or other medium is known to be mixed with a carrier gas or sheath gas for transporting to the patient. Mixing by adding the aerosol and heated sheath gas in a transition adapter is disclosed, for example, in US Patent Publication No. 2008/0110458, which is incorporated herein by reference in its entirety, wherein the Sheath gas is heated to about 125 °C to 145 °C and is introduced into the transition adapter through a cavity that is perpendicular to the main direction of aerosol flow entering the transition adapter (as shown in Figure 16 of the Publication Patent No. 2008/0110458). The gas and aerosol mixed by addition impact the spherical surface of the transition adapter before the aerosol is retained in the aerosol tube. Due to this aerosol impaction, lost drug is directed to a fluid retainer while large aerosol particles are removed from the aerosol stream. The present disclosure enables the introduction of the carrier gas at a lower temperature and parallel to the main direction of the aerosol flow so that as the carrier gas surrounds and is combined with the aerosol in a much less turbulent pattern it minimizes drug loss. The geometry of the internal cavity of the transition adapter resembles the geometry of the aerosol cloud exiting the heated capillary and includes a cone and a cylinder, in which, at a distal end of the internal cavity, the diameter of the cone is greater than the diameter. diameter of the widest portion of the aerosol cloud so that aerosol impaction is minimized.
[00046] In accordance with an exemplary embodiment, the less turbulent pattern of the carrier gas flow transition adapter results from the splitting of the carrier gas into a plurality of carrier gas streams entering the transition adapter cone in parallel and co-directionally with the main direction of the aerosol flow entering the transition adapter after being generated by the aerosol generator. In accordance with an exemplary embodiment, the carrier gas source can be any gas source suitable for the delivery of pulmonary therapy and pulmonary therapy drugs.
[00047] In an exemplary modality, the source of the carrier gas is a ventilator, which is used to provide ventilatory support to the patient receiving aerosolized drug. For example, in an exemplary modality, the ventilator's inspiratory gas flow is divided into a plurality of subflows that use a splitter, so that at least one subflow continues to be used for ventilation purposes, such as providing pressure positive end-expiratory (PEEP) in CPAP ventilation and at least one subflow is used as a carrier gas to deliver aerosol to the patient.
[00048] The transition adapter will now be revealed in more detail with references to Figures 1 to 6C and 9A to 12E, which represent exemplary embodiments of the transition adapter.
[00049] Figure 1 is a perspective view of an aerosol transition adapter 100 in accordance with an exemplary embodiment. As shown in Figure 1, transition adapter 100 includes a housing 110 having a proximal end 120 and a distal end 130. The proximal end 120 has an aerosol passage 140 for receiving an aerosol 234 produced by a heated capillary 232 (see Figures 7A to 7B) of a 230 aerosol generator (see Figures 7A to 7B). The aerosol passage 140 preferably includes a coupling port 142, which contains a connection to a distal end (see Figures 7A to 7B) of the heated capillary 232. The aerosol 234 enters an internal cavity 170 (see Figure 3) contained therein in the transition adapter 100 through the aerosol passage 140 where the aerosol 234 is at least partially surrounded and carried forward by parallel streams of carrier gas 316, which originate from a gas source or fan 300 and introduced into the adapter. transition through at least one gas inlet port 154, or alternatively, a plurality of gas inlet ports 154 (see Figures 3 and 6) to form a contained aerosol 240 (see Figures 7A to 7B) that is a combination of aerosol 234 and carrier gas 316. In accordance with an exemplary embodiment, the gas source 300 (see Figures 7A to 7B) is a continuous positive pressure in-way fan (CPAP), which produces inspiratory flow 302 and receives filtered expiratory flow 362 (see Figures 7A to 7B).
[00050] As shown in Figure 1, the aerosol passage 140 has a coupling port 142 that receives the distal end of the heated capillary 232 of the aerosol generator 230, which is positioned in an oval cavity 144 in the proximal end 120 of the housing 110 In accordance with an exemplary embodiment, cavity 144 (which may be any shape, e.g. oval, round, rectangular or square; only the oval shape is shown in Figure 1) preferably has an end wall 146 and side walls 148 , which are configured to provide a secure method for coupling the distal end of the aerosol generator 230 to the coupling port 142 of the aerosol passage 140. The aerosol passage 140 is in communication with the internal cavity 170 (see Figure 3) of the transition adapter 100.
[00051] Housing 110 preferably includes a generally cylindrical proximal portion 112, a cylindrical distal portion 114, and a carrier gas connection port 150 (see Figure 3) extending perpendicular to the proximal end 120 and configured to receive a line carrier gas stream 314 (see Figures 7A through 7B), which carries a stream of carrier gas 316 (see Figures 7A through 7B) from fan 300 to transition adapter 100.
[00052] Figure 2 is a side view of the transition adapter 100 as shown in Figure 1 in accordance with an exemplary embodiment. As shown in Figure 2, the housing 110 of the transition adapter 100 has a cylindrical proximal portion 112 and a cylindrical distal portion 114, which extend from the proximal end 120 to the distal end 130 of the housing 110. In accordance with an exemplary embodiment , an outer diameter of the cylindrical proximal portion 112 is smaller than an outer diameter of the cylindrical distal portion 114.
[00053] Figure 3 is a cross-sectional view of the transition adapter 100 as shown in Figure 1 along line AA of Figure 2. As shown in Figure 3, the housing 110 of the transition adapter 100 includes a cylindrical body 116 , which includes a carrier gas connection port 150 for receiving carrier gas 316 via a carrier gas line 314 from a blower 300 (Figures 7A to 7B). Carrier gas connection port 150 has a cylindrical cross-section 152, which is in communication with a plurality of gas inlet ports 154 and a plurality of corresponding gas outlet ports 156 via a passageway 158. gas outlet ports 156 deliver a carrier gas stream 316 to internal cavity 170 of transition adapter 100.
[00054] In accordance with another exemplary embodiment as shown in Figures 12A to 12E, the gas source 300 can be introduced into the internal cavity 170 by means of a single gas inlet port 154 and a single gas passage 158 In accordance with an exemplary embodiment, instead of multiple or a plurality of passages or conduits 158 for introducing flow gas 300 into cavity 170, separation of gas streams 300 in internal cavity 170 can be carried out through a plurality of openings. or output ports 156 along tapered section 180.
[00055] As shown in Figure 3, the aerosol passage 140 is in communication with the internal cavity 170 that receives the aerosol 234 from the heated capillary 232 and the carrier gas streams 316 from the plurality of gas outlet ports 156 and directs the carrier gas streams 316 to flow parallel to the main direction of the aerosol flow 234. The carrier gas streams 316 at least partially surround the aerosol flow path in the internal cavity and drive the aerosol 234 towards the distal end 130 so that the contained aerosol 240 is created within the internal cavity. The contained aerosol exits the transition adapter 100 through an outlet port 160 at the distal end 130 and flows into an aerosol tube 318 (see Figures 7A through 7B).
[00056] As shown in Figure 3, the internal cavity 170 has a proximal portion 172 that has a conical section 180, which expands outward from the aerosol passage 140 towards the distal end 130 of the housing 110. In accordance with an embodiment For example, the walls of conical section 180 of proximal portion 172 of internal cavity 170 form an angle of approximately 45 degrees to approximately 75 degrees (e.g., an approximately 60 degree cone). In accordance with an exemplary embodiment, the distal portion 174 of the inner cavity 170 may have a slightly tapered inner diameter. In accordance with an exemplary embodiment, the plurality of corresponding gas outlet ports 156 are positioned in the proximal portion 172 of the internal cavity 170 along the conical section 180.
[00057] In accordance with an exemplary embodiment, the plurality of gas inlet ports 154 for receiving carrier gas 316 from fan 300 has at least two inlet ports 154 (Figure 6C), and preferably at least three inlet ports 154 (Figure 6A) or more (see for example Figure 6B) and, which thereby divides the carrier gas into a plurality of carrier gas streams. From each of the inlet ports 154, a carrier gas stream is further directed to a corresponding number of gas outlet ports 156, which are located in the conical section 180 of the internal cavity 170. In accordance with an exemplary embodiment, each of the gas outlet ports 156 delivers a plurality of carrier gas streams so that they at least partially surround and flow parallel to the main aerosol stream 234 delivered from the aerosol passage 140. As the aerosol can have a cloud with sprays angled from the main direction toward the outlet of the transition adapter, the term "aerosol main stream" is used to indicate the direction along which the 316 carrier gas will be flowing. In accordance with an exemplary embodiment, the plurality of gas outlet ports 156 are located at a distance from the aerosol passage 140 in a pattern that enables the plurality of carrier gas streams to at least partially surround the aerosol flow 234 after the aerosol has entered the conical section 180 and has passed through the gas outlet ports 156. For example, for a plurality of outlet ports 156, which is three in number, each of the three outlet ports 156 is separate approximately 120 degrees from one another around the aerosol passage 140.
[00058] In accordance with an exemplary embodiment, each of the plurality of outlet ports 156 is approximately 1 to 10 millimeters in diameter and is situated within a radius of approximately 3 to 20 millimeters from a central aerosol passageway that runs off. extends axially 143 where aerosol 234 enters housing 110 of transition adapter 100. Outlet port 160 at distal end 174 of transition adapter 100 forms a flow channel having an internal diameter 176, for example, of approximately 22 mm to 50 mm.
[00059] Figure 4 is an end view of the proximal end 120 of the transition adapter 100 as shown in Figure 1 in accordance with an exemplary embodiment. As shown in Figure 4, the proximal end 120 of the transition adapter 100 includes an aerosol passage 140, which is housed in a cavity 144 that has a round, oval, or other suitable shape for receiving a distal end of the heated capillary 232 housed in it. in a 230 aerosol generator.
[00060] Figure 5A is a side view of the transition adapter 100 as shown in Figure 1 showing the gas connection port 150 in accordance with an exemplary embodiment. As shown in Figure 5A, the carrier gas connection port 150 is configured to receive a carrier gas line 314 from a fan 300. The carrier gas connection port 150 has a cylindrical cross-section 152 and a plurality of ports. inlet ports 154, each of which is in communication with corresponding outlet ports 156. Each of the outlet ports 156 delivers a stream of carrier gas to the internal cavity 170 of the transition adapter 100. For example, as shown in Fig. In 5A, the plurality of gas inlet ports 154 may have three (3) ports in number which may be situated in a vertical or straight line with respect to each other in the carrier gas connection port 150.
[00061] Figure 5B is a cross-sectional view of the transition adapter 100 as shown in Figure 5A along line BB. As shown in Figure 5B, each of the plurality of gas inlet ports 154 is in communication with a corresponding outlet port 156 via a passage 158. The passages 158 extend from the gas inlet port 154a a corresponding gas outlet port 156. In accordance with an exemplary embodiment, passages 158 are cylindrical and extend into carrier gas connection port 150. In accordance with an exemplary embodiment, two of the three outlet ports 156 are slightly offset from a distal end of the corresponding passages 158 (for example, approximately 0.15 cm (0.06 in.)). The displacement of two among the three outlet ports 156 enables the outlet ports 156 to be evenly spaced around the aerosol passage 140 while the aerosol passage 140 enters the inner cavity 170 of the transition adapter 100. In addition, the plurality of gas outlet ports 156 may be positioned in the proximal portion of the internal cavity 170 at an equidistance from the aerosol passage 140.
[00062] Figure 5C is a cross-sectional view of the transition adapter 100 as shown in Figure 5A along line CC. As shown in Figure 5C, each of the passages 158 may extend into the carrier gas connection port 150 towards the aerosol passage 140 and then each of the passages 158 transition towards the internal cavity 170. passages 158 have a proximal portion extending from the inlet port 154 to the transition, and a distal portion extending from the transition to the outlet port 156. The transition of passage 158 from the proximal portion to the portion distal can be at a right angle to each other, or alternatively, the transition can be rounded or have a curvature in it.
[00063] As shown in Figure 5C, the inner cavity 170 has a proximal portion 172 that has a conical section, which expands outwardly from the aerosol passage 140 towards the distal end 130 of the housing 110. For example, the distal portion 174 of the inner cavity 170 has a slightly tapered inner diameter. In accordance with an exemplary embodiment, the plurality of corresponding gas outlet ports 156 are positioned in the proximal portion 172 of the internal cavity 170.
[00064] Figure 5D is a cross-sectional view of the transition adapter as shown in Figure 5A along line A-A. As shown in Figure 5D, passages 158 may extend into carrier gas connection port 150 toward aerosol passage 140 and then transition toward internal cavity 170.
[00065] Figures 6A, 6B and 6C are end views of the distal end 130 of the transition adapter 100 as shown in Figure 1. As shown in Figure 6A, the distal end 130 of the transition adapter 100 has a uniform inner diameter 176 (See also Figure 3). In accordance with an exemplary embodiment, the plurality of outlet ports 156 are positioned in the proximal portion 172 of the internal cavity 170 along the tapered portion 180. In accordance with an exemplary embodiment, the plurality of gas inlet ports 154 for receiving the carrier gas stream 316 from fan 300 has at least three inlet ports 154, each of the at least three inlet ports 154 directing a gas stream 316 to a corresponding gas outlet port 156, which is located in the conical portion 180 of the inner cavity 170. In accordance with an exemplary embodiment, the plurality of gas outlet ports 156 are positioned in the proximal portion of the inner cavity 170 at an equidistance from the aerosol passage.
[00066] Figure 6B shows another embodiment of the transition adapter 100 with more than two gas outlet ports 156. As shown in Figure 6B, the plurality of gas outlet ports 156 may include a plurality of ports outlet ports 156, which form an outer ring around aerosol passage 140. Figure 6C shows an exemplary embodiment in which the plurality of outlet ports 156 include two outlet ports 156, which form an outer ring that has two or more sections in it. Each of the two or more sections forms a portion of the outer ring, which surrounds the aerosol passage 140.
[00067] In accordance with an exemplary embodiment, in the aerosol delivery system 200 (Figures 7A to 7B), this example shows that there can be a critical balance of the vent gas flow 317 and the carrier gas flow 316 after they are split . From splitter 312, vent gas 317 flows through vent gas tube 315 to aerosol delivery connector 330 at vent port 332 and aerosol 342 exits aerosol delivery connector 330 at patient port 336 and enters patient interface 340 directly or through optional tubing or conduit 344. Carrier gas 316 flows from splitter 312 through carrier gas tube 314 into transition adapter 100. Carrier gas 100, the gas carrier 316 is divided as it passes through outlet ports 156 into internal cavity 170 in the form of parallel trajectories or streams (eg in the range from 3 to 50 in number) and conveys the aerosol along the length of the carrier adapter. transition 100, thereby forming the contained aerosol 240. The contained aerosol exits the transition adapter 100 and enters the contained aerosol tube 318 before entering the aerosol delivery connector 330 at the aerosol port 334. Ordinance with an exemplary modality, the flow resistance of the carrier gas 316 can be created in the transition adapter 100 by dividing into smaller streams and selecting the sizes of the parallel streams (triggered by the size of the output ports 156) contained in the transition adapter 100. For example, selecting a larger diameter of parallel streams or larger numbers of streams can provide less resistance compared to a single stream or multiple streams with smaller diameters. In an exemplary modality, an important feature is that the geometry of the exit ports does not significantly contribute to the increase in resistance in the carrier gas flow, and ensures optimal aerosol containment. The inspiratory flow of ventilator 304 is operated over a pressure range, for example, between approximately 5 and 50 cm of H2O. An increase in the resistance flow of carrier gas 316 contained in the transition adapter 100 can influence the gas pressure of the inspiratory flow 304, and thus interfere with patient ventilation.
[00068] In accordance with an exemplary embodiment, the ventilator aerosol delivery system 200 is disclosed, in which the inspiratory flow 304 is divided into separate substreams, so that one substream is used as a carrier gas 316 for the aerosol and is directed to the transition adapter 100, and another subflow is used as a vent gas 317. For example, currently, a common fan aerosol delivery system is a closed vent system in which the volume of gas produced by the ventilator transitions to a patient who is receiving mechanical ventilation and returns to the ventilator. Introducing gas from a separate source into this closed ventilation system (such as a carrier gas to deliver pulmonary medication) may not be desirable as the inspiratory flow increases, and thus creates an imbalance of flows in the closed ventilation system . Consequently, it would be desirable to split the inspiratory flow 304 originating from the ventilator 300 and which uses a portion of the inspiratory flow 304 as a carrier gas 316. The ventilator aerosol delivery system 200 as disclosed herein may also be used in open ventilation circuits such as bubble CPAP (see Figure 7B).
[00069] Figure 7A is a block diagram of an aerosol delivery system 200 in accordance with an exemplary embodiment. Aerosol delivery system 200 includes an aerosol generator 230, a source of liquid material or liquid formulation 212 that flows through aerosol generator 230, a transition adapter 100, a blower 300, an aerosol delivery connector 330 , and a patient interface 340. In accordance with an exemplary embodiment, the aerosol delivery system 200 as shown in Figure 7A delivers inspiratory flow 304 via inspiratory branch 302 from ventilator 300. In addition, to account for heat of the aerosol produced by the aerosol generator 230, the system 200 can limit the temperature of the contained aerosol 240 by optimizing the length of a contained aerosol tube 318, which delivers the contained aerosol 240 from the transition adapter 100 to the delivery connector of aerosol 330.
[00070] According to the present disclosure, the delivery of the inspiratory flow 304 through the inspiratory branch 302 of the fan circuit enables the fan 300 to control the levels of inspiratory flow. For example, in accordance with an exemplary modality, a flow of approximately 3 liters per minute (LPM) of ventilation gas 317 can be divided from the inspiratory flow 304 of approximately 6 liters per minute (LPM) from the ventilator 300 that uses a divider 312 in a shape, for example, of a T-fitting or a Y-fitting ("Ipsilon"). The gas volumes divided by divider 312 can be in equal or unequal portions to the initial volume of gas produced by ventilator 300. By diverting the inspiratory flow portion 304 and its use to deliver the contained aerosol 240 to the patient, the flow rate of contained aerosol 240 is reduced from approximately 6 liters per minute to approximately 3 liters per minute, providing a less turbulent flow pattern.
[00071] In an exemplary embodiment, the splitter 312 is not used and the required volume of vent gas 317 and carrier gas 316 are provided by separate sources as shown in Figure 7C. In other words, the original flow of approximately 6 liters per minute of oxygen and air is divided into two separate air and oxygen supply lines that are supplied by two separate fans. A flow of approximately 3 liters per minute (LPM) of vent gas 317 is generated separately by a fan 300 and a second fan 300 generates inspiratory flow 304 of approximately 3 liters per minute (LPM). In accordance with an exemplary embodiment, aerosol losses are minimized since impaction is lessened with the less turbulent flow pattern in the transition adapter 100. For example, a more concentrated contained aerosol 240 that flows at a flow rate of approximately 3 liters per minute at the patient interface is close to the expected peak inspiratory flow produced by the patient, and thus more drug is delivered to the patient. In accordance with an exemplary modality, in accordance with the current standard of care, aerosol is added to the inspiratory flow of approximately 6 liters per minute which exceeds the expected peak inspiratory flow. Thus, the amount of aerosolized drug per unit volume directed to the patient is less than that described in this disclosure. Carrier gas 316 is combined with the aerosol in transition adapter 100 and the resulting contained aerosol 240 is directed to patient interface 340 via aerosol port 336 of aerosol delivery connector 330. The other inspiratory flow 304 approaches - approximately 3 liters per minute (LPM) is the vent gas flow 317. In an exemplary embodiment, the vent gas flow enters the aerosol delivery connector at a vent port 332, for a total flow of approximately 6 liters per minute (LPM), initially produced by the 300 ventilator, which is available for patient inspiration. In addition, considering the total emission of the inspiratory flow from ventilator 300, system 200 avoids activating an alarm, which can be audible due to the unconsidered and/or excessive gas flow returned to ventilator 300 upon exhalation. It should be understood that the values for inspiratory flow, carrier gas flow, vent gas flow and contained aerosol flow are given herein as examples and may be modified and broken down as necessary to adapt to a particular patient or system.
[00072] In accordance with an exemplary embodiment as shown in Figure 7A, the aerosol 234 is produced from a drug delivery container 210, which includes a liquid formulation 212, such as, for example, a Surfaxin® pulmonary surfactant ( lucinactant) marketed by Discovery Laboratories, Inc. For example, the liquid 212 formulation may include a lung surfactant or any other drug preparation adapted for delivery as an aerosol to a child's lung or a medication to treat Respiratory Distress Syndrome ( ARDS) in infants or any other illness in children and adults. The liquid formulation 212 may be contained in a dose container, such as a syringe, which may be pre-filled.
[00073] In accordance with an exemplary embodiment, the liquid formulation 212 is prepared by initially heating the dose container on a hot plate/stirrer to liquefy the formulation to a desired viscosity for delivery to the aerosol generator 230. aerosol delivery system 200 is configured to supply the liquid formulation 212 from the dose container at a constant and continuous rate to the heated capillary 232 of the aerosol generator 230, wherein the liquid formulation 212 is at least partially volatilized. Alternatively, liquid formulation 212 is prepared by reconstituting a solid formulation (e.g., lyophilized pharmaceutical formulation) with a suitable pharmaceutically acceptable vehicle such as, e.g., water, saline or buffering and optionally heated. Alternatively, multiple liquid formulations 212 that contain different drugs or reservoirs that contain auxiliary substances other than drugs, e.g., pharmaceutically acceptable vehicles together with multiple feed lines, can be provided as needed.
[00074] The liquid formulation 212 is delivered via a flow line 220 in the form of a high pressure filter and tubing arrangement 222 to an inlet of the heated capillary 232 of the aerosol generator 230. Alternatively, the feed line 220 in the form of a high pressure filter and tubing arrangement 222 can be eliminated, and the liquid formulation 212 can be directly connected with the aerosol generator 230.
[00075] The aerosol generator 230 may include a pair of electrical conductors (not shown), which transfer power from a power source to a heater, which transfer heat to the heated capillary 232 of the aerosol generator 230 and heat the capillary heated 232 to a temperature sufficient to at least partially volatilize the liquid formulation 212 which is introduced to the heated capillary 232. For example, the at least partially volatilized liquid formulation 212 may be driven through a restrictor to atomize the material or formulation of liquid 212. Liquid material is preferably introduced into heated capillary 232 through a heated capillary inlet 232 connected to a source of liquid material. The material at least partially volatilized, the aerosol 234 is conducted out of the heated capillary 232 through the outlet of the heated capillary, e.g., back pressure of liquid from liquid formulation source 212 causes liquid to be ejected from of the exit. Alternatively, system 200 may include a heater block in thermal contact with heated capillary 232. The heater block may include an upper assembly and a lower assembly that encompasses heated capillary 232 to produce an aerosol 234, e.g. disclosed in US Patent Publication No. 2008/0110458, which is incorporated herein by reference in its entirety.
[00076] In accordance with an exemplary embodiment, the heated capillary is an inclined capillary as disclosed in U.S. Patent 7,500,479, the contents of which are incorporated herein by reference in their entirety. For example, as disclosed in U.S. Patent 7,500,479, the heated capillary may include a constriction in the form of a domed (restricted) capillary end or tip formed at the outlet or distal end of the flow passage. Aerosol generator 230 may be a gentle mist generator as disclosed in U.S. Patents 5,743,251 and 7,040,314. Alternatively, aerosol generator 230 may be an ultrasonic nebulizer or vibrating membrane nebulizer or vibrating mesh nebulizer. In one embodiment, aerosol generator 230 is an Aeroneb® Professional Nebulizer (Aerogen Inc., Mountain View, Calif., U.S.A.). Alternatively, the aerosol generator 230 may be a metered dose inhaler, a liquid dose instillation device, or a dry powder inhaler as disclosed in Patent Publication No. US 2012/0003318, which is incorporated herein. for reference in its entirety. Also, one or more aerosol generators 230 can be used.
[00077] As shown in Figure 7A, the aerosol 234 exits the heated capillary 232 to the transition adapter 100. In addition to receiving the aerosol 234, the transition adapter 100 also receives carrier gas 316, which is introduced as a plurality of streams separate carrier gas 316 flowing in parallel with the main stream of aerosol 234. The plurality of separate carrier gas streams 316 drive aerosol 234 contained in transition adapter 100 and out of transition adapter 100 in a form of an aerosol contained 240.
[00078] As disclosed above, the transition adapter 100 includes a housing 110 and a plurality of inlet ports 154 for receiving a plurality of carrier gas streams 316 exiting through a corresponding outlet port 156 parallel to the main direction of the generated aerosol 234 to produce a contained aerosol 240. Due at least to the configuration of the transition adapter 100 which includes (i) the geometry of the transition adapter 100 and (ii) the arrangement of ports 254, 256 for the aerosol 234 and the plurality of carrier gas streams contained in transition adapter 100, two or more carrier gas streams 316 flowing parallel to the main direction of aerosol flow 234 at least partially surround the aerosol flow 234 and convey the thus-formed contained aerosol 240 through and out of the transition adapter 100 into a contained aerosol tube 318. Such a configuration of the transition adapter 100 minimizes the amount of aero impaction. sol 234 on the sidewalls of the transition adapter 100 and on the connecting aerosol delivery components or contained aerosol tubing 318.
[00079] In accordance with a modality, the ventilator 300 is a constant flow CPAP/ventilator circuit used for breath support, which consists of an inspiratory line 302, an expiratory line 360, a patient interface 340, and a source positive end-expiratory pressure (PEEP valve or water column). As an example, ventilator 300 delivers an inspiratory gas stream 304 through a supply line or inspiratory branch 302 to a splitter 312. Splitter 312 splits the flow of the vent inspiratory gas stream 302 into two lines 314 and 315, which include a carrier gas 316 and a vent gas 317, respectively. In accordance with an exemplary modality, the divider 312 is a "Y" (Ipsilon) or "T" fitting, which divides the inspiratory branch of the ventilator 302 into two lines 314 and 315. In another exemplary modality, both a flow of approximately 3 liters per minute (LPM) of 317 vent gas and a flow of approximately 3 liters per minute (LPM) of 316 carrier gas can be generated separately by two fans. Carrier gas 316 is delivered via a carrier gas line 314 to the transition adapter 100, and the vent gas 317 is delivered via a vent gas line 315 to the aerosol delivery connector 330. The carrier gas 316 passes through transition adapter 100 as it cools and enters aerosol 234 in a laminar flow pattern. The contained aerosol 240 is effectively routed to the aerosol delivery connector 330 reducing the amount of aerosol that could potentially be lost due to impaction as turbulence is minimized. Carrier gas 316 reduces the amount of aerosol 234, which could potentially be lost due to condensation, since the relative temperature of the aerosol generated in this mode is approximately from 40 °C to 80 °C, preferably from 40 °C at 60 °C, at which point the aerosol 234 exiting the heated capillary 232 meets the carrier gas 316 (approximately heated to 40 °C +/- 5 °C) in the transition adapter 100. The aerosol tube contained 318 in the The output of the transition adapter 100 has an initial temperature of 20 °C to 25 °C. It should be understood that the temperature of aerosol 234 can be greater than 60°C and that the temperature of carrier gas 316 can be adjusted upward to maintain the ideal concentration of aerosol 234.
[00080] In an exemplary embodiment, the vent gas 317 is humidified to approximately 38 °C before entering the aerosol delivery connector 330. The temperatures of contained aerosol 240 entering the aerosol delivery connector 330 and exiting the 330 aerosol delivery connector are kept within the range of approximately 35 °C to 40 °C. In an exemplary embodiment, the inspiratory flow of ventilator 304 is humidified. In an exemplary embodiment, a non-humidified vent gas can be used.
[00081] For example, for a neonatal application, an inspiratory gas flow rate of a total of approximately 6 liters per minute (LPM) is divided into approximately 3 liters per minute (LPM) for 316 carrier gas and approximately 3 liters per minute (LPM) for vent gas 317. As shown, one branch of the Y or T fitting 312 is connected via the carrier gas tube 314 to the transition adapter 100. The other branch or vent gas 317 from the Y fitting 312 it is humidified and transits through the vent gas tube 315 to a vent port 332 of the aerosol delivery connector 330. For adult application, the Y fitting 312 would split the flow rate from approximately 10 to 120 liters per minute (LPM) in two branches from approximately 5 to 100 LPM and approximately 115 to 20 LPM.
[00082] In accordance with an exemplary embodiment, the carrier gas line 314 is connected to the transition adapter 100 and has a diameter of approximately 3 millimeters to 12 millimeters. Vent gas tube 315, for example, has a diameter of approximately 10 or 12 millimeters, corrugated tubing with a tapered end connector of approximately 15 millimeters.
[00083] The contained aerosol 240 is directed from the outlet port 170 of the transition adapter 100 into an aerosol tubing 318, which provides unobstructed flow through a fluid retainer 320, and which maintains a laminar flow pattern and reduces the impact of the contained aerosol 240. For example, the contained aerosol tubing 318 that connects the fluid retainer 320 to the aerosol delivery connector 330 may be approximately 10 mm to 15 mm in diameter and preferably be corrugated. In accordance with an exemplary embodiment, the length of the contained aerosol tubing 318 is approximately 40 cm to approximately 100 cm. For example, fluid retainer 320 may have a capacity of at least 60 milliliters with an airway through fluid retainer 320 of approximately 15 to 22 millimeters in diameter.
[00084] As shown in Figure 7A, the fluid retainer 320 is situated between the transition adapter 100 and the aerosol delivery connector 330, and is configured to retain condensed liquid or liquid from the contained aerosol 240. In accordance with In an exemplary embodiment, the contained aerosol 240 entering the aerosol delivery connector 330 and the patient interface 340 from the contained aerosol tube 318 has a temperature of approximately 35°C to 39°C. The airway of the fluid retainer 320 is minimally obstructed and the contained aerosol tube 318 connected to the outlet of the fluid retainer 320 provides an unobstructed path to the aerosol delivery connector 330 to maintain laminar flow and reduce impaction.
[00085] For example, in accordance with an exemplary embodiment, the length of the contained aerosol tube 318 is selected to cool the warm aerosol 234 to a desired or preferred patient aerosol interface temperature. Furthermore, the humidified air flowing within the vent gas line 315, which enters the aerosol delivery connector 330, is also preferably controlled at approximately 35°C to 40°C by a humidifier device 350. In accordance with In an exemplary embodiment, humidifier device 350 may be located between connector 312 (e.g., epsilon fitting) and aerosol delivery connector 330.
[00086] In accordance with an exemplary embodiment, the transition adapter 100 provides a smooth transition from aerosol 240 driven by carrier gas 316 to contained aerosol tubing 318 through fluid retainer 320, which minimizes generated aerosol impaction 234 on the walls of the transition adapter 100 and relevant tubing. In addition, fewer large particles in the aerosol stream 234 impact the tubing walls and inner surface of the transition adapter 100, which can result in an average particle size of the contained aerosol 240 of approximately 1.5 µm to 3.5 µm from diameter for the aerosolized drug.
[00087] In accordance with an exemplary modality, the division of the 304 inspiratory flow can be varied from approximately 3 liters per minute (LPM) for the 316 carrier gas and approximately 3 liters per minute (LPM) for the 317 vented gas for a source flow rate of approximately 6 liters per minute (LPM) (eg a 3/3 split) to a 4/2 split with a flow of approximately 4 liters per minute (LPM) passing through carrier gas tube 314 to the transition adapter 100 and approximately 2 liters per minute passing through vent gas tube 315 and humidifier 350. Also, depending on aerosol concentration and particle/droplet density, this split ratio may be changed to a ratio of 4/2 or 5/1. For example, a 3/3 range for a 5/1 ratio can be used, where between approximately 3 to 5 liters per minute (LPM) of inspiratory gas (or "oxygen/air") passes through the carrier gas tube. 314 to the transition adapter 100. For higher levels of carrier gas passing through the transition adapter 100, the number of gas outlet ports 156 contained in the transition adapter 100 can be increased and/or the diameter of the inlet ports. gas 154 and/or the gas outlet ports 156 may be increased to accommodate a higher flow rate. For example, when inspiratory flow 304 from ventilator 300 is increased for adult therapeutic applications, higher carrier gas flow rates 316 may provide a more laminar flow of contained aerosol 240.
[00088] Aerosol delivery connector 330 is configured to deliver contained aerosol 240, with ventilation gas 317 providing positive end expiratory pressure (PEEP), as an aerosolized active agent to a patient interface 340 with positive pressure ventilation concomitant. For example, connector 330 may be as disclosed in U.S. Patent Publication 2011/0011395, which is incorporated herein in its entirety. As shown in Figure 7A, the vent gas 317 transits through the vent gas tube 315 through the humidifier 350 to a vent port 332 of the aerosol delivery connector 330. In addition, the contained aerosol 240 transits through the vent tube. contained aerosol 318 to aerosol port 334 of aerosol delivery connector 330. Flows 317 and 240 can be mixed with each other when the patient's inspiratory flow exceeds the contained aerosol flow 240 and delivered to the patient through patient port 336 through patient interface 340. If the patient's inspiratory flow is equal to or less than the contained aerosol flow 240, the vent flow 317 is not mixed with the contained aerosol 240 and flows through the aerosol delivery connector 330 to the purpose of providing positive end-expiratory pressure (PEEP).
[00089] In accordance with an exemplary embodiment, the aerosol delivery connector 330 also includes an expiratory port 338, which is connected to an expiratory tube 360, which delivers an expiratory flow 362 back to the ventilator 300 after the expiratory flow. 362 pass through a filter (not shown). For example, for a 304 inspiratory flow of approximately 6 liters per minute (LPM), the expiratory flow 362 might be approximately 6 liters per minute (LPM).
[00090] In another modality, as shown in Figures 7B and 7C, in a bubble CPAP, the expiratory flow 362 is not returned to the ventilator 300, but is directed to a source of back pressure, such as a reservoir or bath of water 370.
[00091] When aerosolized drug therapy is completed, aerosol generator 230 can be paused or turned off, and ventilation gas therapy can continue through aerosol delivery connector 330 using either or both lines , the contained aerosol line 318 (filled with carrier gas only) and/or the vent gas line 315. In accordance with an exemplary embodiment, as shown in Figure 8, the divider is capped with a closure 372 and the connector The aerosol delivery tube is capped with a closure 374, which removes the contained aerosol tube and carrier gas tube from the circuit, and the vent gas line 315 is used to deliver the complete inspiratory gas volume to a patient. . Although in Figure 8, bubble CPAP is shown, it is understood that a closed-circuit CPAP where the exhaled gas is returned to the ventilator or any other ventilation circuit can be used. In another exemplary example with two fans 300 (for example, as shown in Figure 7C), the aerosol flow in the tube can be paused simply by removing the aerosol tube from the aerosol delivery connector 330 and capping it the aerosol delivery connector.
[00092] The 340 patient interface is selected to suit the type of ventilatory support that is to be delivered. For example, invasive applications such as controlled, assisted, or intermittent mandatory ventilation will use an endotracheal or tracheostomy tube such as the 340 patient interface. Non-invasive applications such as CPAP or BI-PAP may use nasal parts or nasopharyngeal tubes, or a mask that covers the nose or both the nose and mouth as the patient interface 340. In accordance with one embodiment, the patient interface 340 is directly connected to the connector 330. In other embodiments, a length of tubing or conduit 344 may be introduced between a patient port 336 of connector 330 and patient interface 340.
[00093] Figure 9A is a side view of the transition adapter 100 as shown in Figure 1 showing the gas connection port 150 in accordance with an exemplary embodiment in which the outlet ports 156 are positioned at a distal end of the passages corresponding 158. As shown in Figure 9A, the carrier gas connection port 150 is configured to receive a carrier gas line 314 from a fan 300. The carrier gas connection port 150 has a cylindrical cross section 152 and a a plurality of gas inlet ports 154, each of which is in communication with a corresponding outlet port 156. Each of the outlet ports 156 delivers a stream of carrier gas to the internal cavity 170 of the transition adapter 100. For example, as shown in Figure 9A, the plurality of gas inlet ports 154 may have three (3) ports that can be positioned together in a vertical or straight line.
[00094] Figure 9B is an end view of the transition adapter 100 as shown in Figure 9A in accordance with an exemplary embodiment. As shown in Figure 9B, the distal end 130 of the transition adapter 100 may have a uniform internal diameter 176. In accordance with an exemplary embodiment, the plurality of outlet ports 156 may be positioned in the proximal portion 172 of the internal cavity 170 along of the conical portion 180. The plurality of gas inlet ports 154 for receiving the carrier gas stream 316 from the fan 300 may include at least three inlet ports 154, each of the at least three inlet ports 154 directing a gas stream 316 to a corresponding gas outlet port 156 located in conical portion 180 of internal cavity 170. Gas outlet ports 156 are positioned at the distal end of passages 158 extending from the gas inlet ports 154 located on the carrier gas connection port 140. In accordance with an exemplary embodiment, if the positioning of the gas outlet ports 156 at the distal end. as long as one of the passages 158 is without a displacement, the three gas outlet ports 156 can vary from approximately 100 degrees to 140 degrees to each other around the aerosol passage 140 to accommodate the fabrication of the same. For example, as shown in Figure 9B, two of the three output ports 156 are approximately 138 degrees apart.
[00095] Figure 9C is a cross-sectional view of the transition adapter 100 as shown in Figure 9A along line BB. As shown in Figure 9C, each port of the plurality of gas inlet ports 154 is in communication with a corresponding outlet port 156 via a plurality of passages 158. The passages 158 extend from an inlet port of gas 154 to a corresponding gas outlet port 156. In accordance with an exemplary embodiment, passages 158 are cylindrical. In accordance with this embodiment, each of the three exit ports 156 is situated or positioned at a distal end of the corresponding passage 158.
[00096] Figure 9D is a cross-sectional view of the transition adapter 100 as shown in Figure 9D along line CC. As shown in Figure 9D, each of the passages 158 may extend into the carrier gas connection port 150 towards the aerosol passage 140, and then transits towards the internal cavity 170. Each of the passages 158 has a proximal portion extending from the inlet port 154 to a transition, and a distal portion extending from the transition to the outlet port 156. The transition of passage 158 from the proximal portion to the distal portion may be at a right angle to each other, or alternatively, the transition can be rounded or have a curvature in it.
[00097] As shown in Figure 9D, the internal cavity 170 has a proximal portion 172 that has a tapered section that expands outward from the aerosol passage 140 toward the distal end 130 of the housing 110. In accordance with an exemplary embodiment , the distal portion 174 of the inner cavity 170 may have a slightly tapered inner diameter. In accordance with an exemplary embodiment, the plurality of corresponding gas outlet ports 156 are positioned in the proximal portion 172 of the internal cavity 170.
[00098] Figure 9E is a cross-sectional view of the transition adapter as shown in Figure 9A along line A-A. As shown in Figure 9E, passages 158 may extend into carrier gas connection port 150 toward aerosol passage 140, and then transition toward internal cavity 170.
[00099] Figure 10A is a perspective view of a transition adapter 400 in accordance with another exemplary embodiment. As shown in Figure 10A, transition adapter 400 includes a housing 410 having a proximal end 420 and a distal end 430. The proximal end 420 has an aerosol passage 440 for receiving an aerosol 234 produced by a heated capillary 232 (Figures). 7A to 7B) of an aerosol generator 230 (Figures 7A to 7B). Aerosol passage 440 preferably includes a coupling port 442, which contains a connection to a distal end (Figures 7A to 7B) of heated capillary 232. Aerosol 234 enters an internal cavity 470 (Figures 10B and 10C) contained in the adapter transition 400 through the aerosol passage 440 where the aerosol 234 is at least partially surrounded and carried forward by parallel streams of carrier gas 316, which originate from a gas source or blower 300 and introduced into the adapter. transition through the plurality of gas inlet ports 454 (Figure 10C) to form a contained aerosol 240 (Figures 7A to 7B) that is a combination of aerosol 234 and carrier gas 316. In accordance with an exemplary embodiment, the source of 300 gas (see Figures 7A through 7B) is a continuous positive airway pressure (CPAP) ventilator that produces 302 inspiratory flow and receives 362 filtered expiratory flow (Figures 7A through 7B).
[000100] As shown in Figure 10A, the aerosol passage 440 has a coupling port 442, which receives the distal end of the heated capillary 232 of the aerosol generator 230, which is positioned within a cavity 444 at the proximal end 420 of the housing 410. In accordance with an exemplary embodiment, cavity 444 may include an aerosol coupling end wall 446 and a pair of end side walls 447. In accordance with an exemplary embodiment, the aerosol coupling end wall aerosol 446 is recessed compared to the pair of end sidewalls 447, which enables a compression ring or O-ring seal (not shown) to be positioned in a recessed portion of cavity 444. O-ring directs aerosols 234 generated by aerosol generated 230 into aerosol passage 440. In accordance with an exemplary embodiment, the end wall Aerosol Case 446 is generally rectangular that has a height greater than its width. The height of aerosol end wall 446 is slightly greater than a height of each of the side end walls 447, producing a second cavity 445 within cavity 444. Second cavity 445 is generally rectangular in shape with sufficient depth to receive the compression ring or O-ring seal.
[000101] In accordance with an exemplary embodiment, each of the side end walls 447 may include one or more openings or holes 449, which secure the distal end of the aerosol generator 230 to the transition adapter 400. Cavity 444 also includes a a plurality of side walls 448, which extend outwardly from an outer edge of the aerosol coupling end wall 446 and the side end walls 448 to form a generally elongated rectangular cavity 444. In accordance with an exemplary embodiment, the Cavity 444 is configured to provide a secure method for coupling the distal end of aerosol generator 230 to coupling port 442 of aerosol passage 440. Aerosol passage 440 is in communication with internal cavity 470 (Figures 10B and 10C) of the 400 transition adapter.
[000102] In accordance with an exemplary embodiment, the proximal end 420 of the housing 410 includes a flange 412. The flange 412 may include one or more openings or holes 414, which may be configured to be attachable to a distal portion of the aerosol generator 230. Housing 410 also includes a carrier gas connection port 450, which extends perpendicular to one face of flange 412 and is configured to receive a carrier gas line 314 (Figures 7A to 7B). Gas line 314 carries a stream of carrier gas 316 (Figures 7A to 7B) from blower 300 to transition adapter 400.
[000103] Figure 10B is another perspective view of the transition adapter as shown in Figure 10A in accordance with an exemplary embodiment. As shown in Figure 10B, housing 410 of transition adapter 400 includes a cylindrical body 416 that includes a carrier gas connection port 450 for receiving carrier gas 316 via a carrier gas line 314 from a fan 300 (Figures 7A to 7B). Carrier gas connection port 450 has a cylindrical cross-section 452, which is in communication with a plurality of gas inlet ports 454 and a plurality of corresponding gas outlet ports 456 via passages 458 (Figure 10C). Each of the gas outlet ports 456 delivers a carrier gas stream 316 to the inner cavity 470 of the transition adapter 400.
[000104] Figure 10C is a partial cutaway view of the transition adapter as shown in Figures 10A and 10B in accordance with an exemplary embodiment. As shown in Figure 10C, aerosol passage 440 is in communication with internal cavity 470 which receives aerosol 234 from heated capillary 232 and carrier gas streams 316 from the plurality of gas outlet ports 456 and directs the carrier gas streams 316 to flow parallel to the main direction of the aerosol flow 234. The carrier gas streams 316 at least partially surround the aerosol flow path in the internal cavity and drive the aerosol 234 towards the end distal 430 so that the contained aerosol 240 is created within an internal cavity 470. The contained aerosol 240 exits the transition adapter 400 through an outlet port 460 at the distal end 430 and flows into an aerosol tube 318 (Figures 7A to 7B).
[000105] As shown in Figure 10C, the inner cavity 470 has a proximal portion 472 that has a tapered section 480, which expands outward from the aerosol passage 440 towards the distal end 430 of the housing 410. In accordance with a In an exemplary embodiment, the walls of tapered section 480 of proximal portion 472 of inner cavity 470 form an angle of approximately 45 degrees to approximately 75 degrees (e.g., an approximately 60 degrees cone). The distal portion 474 of the inner cavity 470 may also have a slightly tapered inner diameter. In accordance with an exemplary embodiment, the plurality of corresponding gas outlet ports 456 are positioned in the proximal portion 472 of the internal cavity 470 along the conical section 480.
[000106] In accordance with an exemplary embodiment, the plurality of gas inlet ports 454 for receiving carrier gas 316 from fan 300 has at least two inlet ports 454, and preferably at least three inlet ports 454 or more, and which thereby splits the carrier gas into a plurality of carrier gas streams. From each of the inlet ports 454, a carrier gas stream 316 is further directed to a corresponding number of gas outlet ports 456, which are located in the conical section 480 of the internal cavity 470. In accordance with an exemplary embodiment , the gas outlet ports 456 deliver a plurality of carrier gas streams 316 so that the carrier gas streams 316 surround at least partially and flow parallel to the main stream of aerosol 234 delivered from the aerosol passageway 440. whereas the aerosol 234 may have a cloud with sprays angled from the main direction towards the exit of the transition adapter 400, the term "aerosol main stream" is used to indicate the direction along which the carrier gas 316 will be in flux. In accordance with an exemplary embodiment, the plurality of gas outlet ports 456 are located at a distance from the aerosol passage 440 in a pattern that enables the plurality of carrier gas streams 316 to at least partially surround the aerosol flow. 234 after the aerosol has entered the conical section 480 and has passed through the gas outlet ports 456.
[000107] In accordance with an exemplary embodiment, each of the plurality of outlet ports 456 is approximately 1 to 10 millimeters in diameter and is situated within a radius of approximately 3 to 20 millimeters from a central aerosol passageway that runs off. extends axially 443 where aerosol 234 enters housing 410 of transition adapter 400. Outlet port 460 at distal end 474 of transition adapter 400 forms a flow channel having an inside diameter 476, for example, of approximately 22 mm to 50 mm.
[000108] Figure 11A is a perspective view of a transition adapter 500 in accordance with another exemplary embodiment. As shown in Figure 11A, transition adapter 500 includes a housing 510 that has a proximal end 520 and a distal end 530 (Figures 11B through 11D). Proximal end 520 has an aerosol passage 540 for receiving an aerosol 234 produced by a heated capillary 232 (Figures 7A to 7B) of an aerosol generator 230 (Figures 7A to 7B). The aerosol passage 540 preferably includes a coupling port 542, which contains a connection to a distal end (Figures 7A to 7B) of the heated capillary 232. The aerosol 234 enters an internal cavity 570 contained in the transition adapter 500 through the passage. of aerosol 540 where the aerosol 234 is at least partially surrounded and carried forward by parallel streams of carrier gas 316, which originate from a gas source or vent 300 and introduced into the transition adapter through the plurality of inlet ports. of gas 554 (Figure 11C) to form a contained aerosol 240 (Figures 7A to 7B) which is a combination of the aerosol 234 and the carrier gas 316.
[000109] Figure 11B is an end view of the transition adapter as shown in Figure 11A in accordance with an exemplary embodiment. As shown in Figure 11B, housing 510 of transition adapter 500 includes a carrier gas connection port 550 for receiving carrier gas 316 via a carrier gas line 314 from a blower 300 (Figures 7A to 7B) . Carrier gas connection port 550 has a cylindrical cross-section 552 which is in communication with a plurality of gas inlet ports 554 and a plurality of corresponding gas outlet ports 556 via at least one passageway 558 (Figure 11C). Each of the gas outlet ports 556 delivers a carrier gas stream 316 to the inner cavity 570 of the transition adapter 500.
[000110] Figure 11C is a cross-sectional view of the transition adapter as shown in Figures 11A and 11B in accordance with an exemplary embodiment. As shown in Figure 11C, aerosol passage 540 has a coupling port 542, which receives the distal end of heated capillary 232 of aerosol generator 230, and which is positioned on a flange or aerosol housing 512 at the proximal end 520 of the transition adapter 500. The flange or aerosol housing 512 has an internal portion or cavity 514 that is configured to receive the aerosol generator 230. In accordance with an exemplary embodiment, the internal portion or cavity 514 of the flange or housing aerosol dispenser 512, for example, can have any suitable geometric shape, preferably the shape with a rectangular, a cylindrical, or a triangular cross-section. In accordance with an exemplary embodiment, the inner portion 514 of the flange or aerosol housing 512 is configured to enable an O-ring seal or compression ring (not shown) to be positioned in a recessed portion of the flange or housing 512. Compression ring or O-ring seal directs the aerosols 234 generated by the aerosol generator 230 into the aerosol passage 540. The inner portion or cavity 514 is configured to provide a secure method for coupling the distal end of the aerosol generator 230 to the coupling port 542 of aerosol passage 540. Aerosol passage 540 is in communication with internal cavity 570 (Figure 11C) of transition adapter 500.
[000111] As shown in Figure 11C, the aerosol passage 540 is in communication with the internal cavity 570 that receives the aerosol 234 from the heated capillary 232 and the carrier gas streams 316 from the plurality of gas outlet ports 556 and directs the carrier gas streams 316 to flow parallel to the main direction of the aerosol flow 234. The carrier gas streams 316 at least partially surround the aerosol flow path within the internal cavity and drive the aerosol 234 into towards the distal end 530 so that the contained aerosol 240 is created within the internal cavity 570. The contained aerosol 240 exits the transition adapter 500 through an outlet port 560 at the distal end 530 and flows into an aerosol tube 318 (Figures 7A to 7B).
[000112] Inner cavity 570 has a proximal portion 572 that has a tapered section 580 that expands outward from aerosol passage 540 toward distal end 530 of housing 510. In accordance with an exemplary embodiment, the walls of the section taper 580 of the proximal portion 572 of the internal cavity 570 form an angle of approximately 45 degrees to approximately 75 degrees (for example, a cone of approximately 60 degrees). Distal portion 574 of inner cavity 570 may also have a slightly tapered inner diameter. In accordance with an exemplary embodiment, the plurality of corresponding gas outlet ports 556 are positioned in proximal portion 572 of internal cavity 570 along conical section 580.
[000113] In accordance with an exemplary embodiment, the gas outlet ports 556 deliver a plurality of carrier gas streams 316 so that they at least partially surround and flow parallel to the main stream of aerosol 234 delivered from the aerosol passage. 540. Since the aerosol may have a cloud with sprays angled from the main direction toward the outlet of the transition adapter, the term "aerosol main stream" is used to indicate the direction along which the gas is transported. pain 316 will be in flux. In accordance with an exemplary embodiment, the plurality of gas outlet ports 556 are located at a distance from the aerosol passage 540 in a pattern that enables the plurality of carrier gas streams to at least partially surround the aerosol flow 234 after the aerosol has entered conical section 580 and has passed through gas outlet ports 556.
[000114] As shown in Figure 11D, the plurality of gas inlet ports 554 for receiving carrier gas 316 from fan 300 has at least two inlet ports 554, and preferably at least three inlet ports 554 or more and which thereby splits the carrier gas 316 into a plurality of carrier gas streams. From the inlet ports 554, a carrier gas stream is further routed to a corresponding number of gas outlet ports 556, which are located in the conical section 580 of the internal cavity 570.
[000115] In accordance with an exemplary embodiment, each of the plurality of outlet ports 556 is approximately 1 to 10 millimeters in diameter and is situated within a radius of approximately 3 to 20 millimeters from a central aerosol passageway that runs off. extends axially 543 where aerosol 234 enters housing 510 of transition adapter 500. Outlet port 560 at distal end 574 of transition adapter 500 forms a flow channel having an inside diameter 576, for example, of approximately 22 mm to 50 mm.
[000116] Figure 12A is a perspective view of a transition adapter 600 in accordance with another exemplary embodiment. As shown in Figure 12A, transition adapter 600 includes a housing 610 that has a proximal end 620 and a distal end 630. The proximal end 620 has an aerosol passage 640 (Figure 12D) for receiving an aerosol 234 produced by a capillary heated 232 (Figures 7A to 7B) of an aerosol generator 230 (Figures 7A to 7B). The aerosol passageway 640 preferably includes a coupling port 642, which contains a connection to a distal end (Figures 7A to 7B) of the heated capillary 232. The aerosol 234 enters an internal cavity 670 contained in the transition adapter 600 through the passageway. of aerosol 640 where the aerosol 234 is at least partially surrounded and carried forward by parallel streams of carrier gas 316, which originate from a gas source or vent 300 and introduced into the transition adapter through a plurality of ports. gas outlet 656 (Figure 12B) to form a contained aerosol 240 (Figures 7A to 7B) which is a combination of aerosol 234 and carrier gas 316.
[000117] Figure 12B is an end view of the transition adapter 600 as shown in Figure 12A in accordance with an exemplary embodiment. As shown in Figure 12B, the distal end 630 of the transition adapter 600 has an inner cavity 670. The inner cavity 670 has a proximal portion 672 that has a tapered section 680 that expands outwardly from the aerosol passage 640 toward the distal end 630 of housing 610. Gas source, or blower 300, is introduced into internal cavity 670 through a plurality of gas outlet ports 656 that surround aerosol port 640 to form contained aerosol 240.
[000118] Figure 12C is a side view of the transition adapter 600 in accordance with an exemplary embodiment. As shown in Figure 12C, housing 610 of transition adapter 600 includes a carrier gas connection port 650 for receiving carrier gas 316 via a carrier gas line 314 from a blower 300 (Figures 7A to 7B) .
[000119] Figure 12D is a cross-sectional view of the transition adapter as shown in Figure 12C along line A-A. As shown in Figure 12D, aerosol passage 640 has a coupling port 642, which receives the distal end of heated capillary 232 of aerosol generator 230, and is positioned within an aerosol housing 612 at proximal end 620 of the adapter. of transition 600. Aerosol housing 612 has an internal portion or cavity 614 that is configured to receive aerosol generator 230. In accordance with an exemplary embodiment, internal portion or cavity 614 of aerosol housing 612, for example, may have any suitable geometric shape, preferably the shape with a rectangular, a cylindrical, or a triangular cross-section. In accordance with an exemplary embodiment, the inner portion 614 of the flange or aerosol housing 612 is configured to enable an O-ring seal or compression ring (not shown) to be positioned in a recessed portion of the flange or housing 612. Compression ring or O-ring seal directs aerosols generated by aerosol generated in aerosol passage 640. Inner portion or cavity 614 is configured to provide a secure method for coupling the distal end of aerosol generator 230 to coupling port 642 of the aerosol passageway 640. The aerosol passageway 640 is in communication with the internal cavity 670 of the transition adapter 600.
[000120] As shown in Figure 12D, the carrier gas connection port 650 has a cylindrical cross section 652 that is in communication with a gas source 300, which can be introduced into the internal cavity 670 through a single inlet port of gas 654. The single gas inlet port 654 is in communication with a single gas passageway 658, which is in communication with a plurality of outlet openings or ports 656 along the tapered section 680 of the internal cavity 670. with an exemplary embodiment, the walls of tapered section 680 of proximal portion 672 of inner cavity 670 form an angle of approximately 45 degrees to approximately 75 degrees (e.g., a cone of approximately 60 degrees). The distal portion 674 of the inner cavity 670 may also have a slightly tapered inner diameter. In accordance with an exemplary embodiment, the plurality of corresponding gas outlet ports 656 are positioned in proximal portion 672 of internal cavity 670 along conical section 680.
[000121] Figure 12E is a cross-sectional view of the transition adapter 600 as shown in Figure 12C along line B-B. As shown in Figure 12E, the carrier gas connection port 650 has a cylindrical cross-section 652, which is in communication with a gas source 300 that can be introduced into the internal cavity 670 via a single gas inlet port 654 The single gas inlet port 654 is in communication with a single gas passage 658, which is in communication with a plurality of openings or outlet ports 656 along the conical section 680.
[000122] In accordance with an exemplary embodiment, the length of each of the carrier gas passages 158, 458, 558, 658 contained in the transition adapter 100, 400, 500, 600 is selected to be approximately the same to ensure uniformity of carrier gas velocity and volume.
[000123] Although several modalities have been revealed, it should be understood that variations and modifications can be reordered as will be evident to those skilled in the art. In particular, the external shape of the transition adapter can be modified without affecting the internal structure. Such variations and modifications are to be considered within the scope and scope of the claims attached to this document.

权利要求:
Claims (7)
[0001]
1. Aerosol transition adapter (100, 400, 500, 600) for delivering an aerosolized active agent to a patient, the aerosol transition adapter comprising: a housing (110, 410, 510, 610) having a proximal end and a distal end, the proximal end (120, 420, 520, 620) having an aerosol passage (140, 143, 440, 540, 640) for receiving an aerosol produced by an aerosol source comprising an active agent aerosolized, and the distal end (130, 430, 530, 630) having an outlet port (160, 460, 560), the housing having a length between the distal end and the proximal end; characterized in that the adapter further comprises: a carrier gas connection port (150, 450, 550, 650) for receiving a carrier gas from a gas source, which is in communication with a plurality of output ports carrier gas (156, 456, 556, 656), with the plurality of carrier gas outlet ports being disposed adjacent to the aerosol passage (140, 143, 440, 540, 640) in a pattern that partially circulates the flow of aerosol; and an internal cavity (170, 470, 57, 670) which is adapted to receive aerosol from the aerosol passage (140, 143, 440, 540, 640) and carrier gas from the plurality of outlet ports of carrier gas (156, 456, 556, 656) and to direct carrier gas streams to at least partially circulate and flow in parallel with a main direction of an aerosol flow along the length of the housing (110, 410, 510, 610) toward the exit port (160, 460, 560), the inner cavity (170, 470, 570, 670) having an outwardly expanding conical inner wall (180, 480, 580, 680) to an inner wall of a distal portion of the inner cavity (170, 470, 570, 670), the plurality of carrier gas outlet ports (156, 456, 556, 656) being located on said conical inner wall, and the port outlet (160, 460, 560) at the distal end (130, 430, 530, 630) of the housing (110, 410, 510, 610) being for delivering the aerosol.
[0002]
2. Adapter (110, 400, 500, 600), according to claim 1, characterized in that a distal portion (174, 474, 574, 674) of the internal cavity (170, 470, 570, 670) has a tapered inner diameter.
[0003]
3. Adapter (110, 400, 500, 600), according to claim 2, characterized in that the plurality of carrier gas outlet ports (156, 456, 556, 656) is positioned within the proximal portion ( 172, 472, 572,672) of the internal cavity (170, 470, 570, 670) at an equidistance from the aerosol passage.
[0004]
4. Adapter (110, 400, 500, 600) according to claim 1, characterized in that the housing (110, 410, 510, 610) includes a cylindrical proximal member and a cylindrical distal member, and wherein the cylindrical proximal member has a coupling for receiving a carrier gas from the gas source.
[0005]
5. Adapter (110, 400, 500, 600), according to claim 4, characterized in that an outer diameter of the cylindrical proximal member is smaller than an outer diameter of the cylindrical distal member.
[0006]
6. Adapter (110, 400, 500, 600) according to claim 1, characterized in that the gas connection port (150, 450, 550, 650) for receiving the carrier gas from the source of gas includes at least one gas inlet port (154, 454, 554, 654) for receiving carrier gas, the at least one gas inlet port directing a stream of carrier gas to one or more carrier gas outlet ports. gas (156, 456, 556, 656).
[0007]
7. Adapter (110, 400, 500, 600) according to claim 6, characterized in that the at least one gas inlet port comprises at least three gas inlet ports (154, 545) and one corresponding gas outlet port for each of the at least three gas inlet ports (156).

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US20180064889A1|2018-03-08|

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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-11-26| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-05-11| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-07-13| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/08/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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US201261691678P| true| 2012-08-21|2012-08-21|

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US61/691,678|2012-08-21|

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US201261732082P| true| 2012-11-30|2012-11-30|

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US61/732,082|2012-11-30|

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US13/843,172|2013-03-15|

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US13/843,172|US9713687B2|2012-08-21|2013-03-15|Ventilator aerosol delivery system with transition adapter for introducing carrier gas|

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PCT/EP2013/067421|WO2014029827A1|2012-08-21|2013-08-21|Ventilator aerosol delivery system|

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