• 专利附录
  • 专利说明
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    • 专利摘要:
    DRY POWDER INHALATION DEVICE This document presents a drug inhalation device in the form of disposable dry powder breathed with a powdered drug storage chamber with complete toroidal geometry and air path flow to incorporate and break up powder aggregates before delivery to the patient. The toroidal chamber is connected fluidly by one or more air inlets directed in a non-tangential manner to the powder to smoothly create an irregular rotational flow pattern. Also, in fluid connection the toroidal chamber is air outlet centrally or almost centrally and the outlet of the powder consisting of one or more orifices forming a grid in fluid connection with a channel providing a powder flow passage for the patient.
    公开号:BR112014004921B1
    申请号:R112014004921-1
    申请日:2012-09-07
    公开日:2020-12-08
    发明作者:Richardson Eric Carl
    申请人:Concentrx Pharmaceuticals, Inc.；
    IPC主号:
    专利说明:

    This application claims priority for US Provisional Application 61 / 573,496 filed on September 7, 2011 and is included in this document entirely 5 by reference. COPYRIGHT NOTICE
    A portion of the disclosure of this patent contains material that is subject to copyright protection. The copyright owner has no objection to anyone reproducing a patent document or patent disclosure, as it appears in the files and registrations of Patents and Trademarks at the Patent Office, but otherwise reserves all rights. copyright whatever. BACKGROUND OF THE INVENTION Application field
    The present invention relates to a dry powder inhalation device for inhaling pharmaceutical or nutraceutical compounds including excipients in the form of dry powder. More particularly, it relates to a dry powder inhalation device having a toroidal chamber for uniform delivery of partial size to a patient. Related Matter Description
    Pressurized metered dose inhalation devices (Pressurized metered dose inhalation devices - pMDI) are well known for delivering dose to patients via their lungs. PMDI's are made up of a pressurized propellant container with a measuring valve housed in a molded actuator body with an integral nozzle. This type of inhalation device presents the challenge of delivering drugs to patients, requiring significant strength to trigger with inhalation and coordination of time to effectively receive the drug. PMDI's containing suspended drug formulations must also be properly shaken by the patient prior to triggering to receive an effective dose of the drug. These relatively complicated devices also require conditioning, due to the low drug content in initial doses and may require cleaning by the patient. In some devices, an additional spacer device is prescribed together with the pMDI to compensate for the issue of time coordination although the disadvantage for the patient has to pay to clean, store the bulky spacer device. While many patients are experienced with the operation of pMDI's or pMDI's with spacers, new patients have to go through the relatively significant learning curve to operate these devices correctly.
    Dry powder inhalation (DPI) devices are also well known for delivering powdered drugs to the lungs. DPI technologies are active involving external energy to break up and disperse particles, or passive use of the patient's inspiratory energy to drag and deliver the powder to the lungs. Some DPI technologies integrate electronics while others are completely mechanical. The powder drug storage formats are usually reservoirs, individually pre-measured doses or capsule-based systems. The drug delivery formulations by these devices involve in some devices innovative drug particle engineering but in many devices deliver a conventionally sized blend of active pharmaceutical ingredient (API) plus sized lactose monohydrate used as a thickening agent to aid in the process of filling the powder and the carrier particle to assist in the delivery of the active pharmaceutical ingredient (s) to the patient. These API - milactose monohydrate mixture, among others, require a means to break up aggregates formed by attractive forces held together.
    Nebulizers are well known for delivering drugs in solution to the lung. While these drug delivery systems are effective for patients lacking inhalation capability or coordination to operate some manual assist inhalation devices, they are large equipment requiring an electrical power source, cleaning and maintenance. Nebulizer drug administration involves significant time and effort; transport, electrically establish, charge an individual nebulizer, assemble the patient's mouthpiece interface and deliver doses to the patient.
    Current inhalation therapies that are administered in an institutional setting are multidose pMDI, multidose DPI or nebulizer all of which require substantial attention from the caregiver provided to administer. All current options require substantial effort by the nurse or respiratory therapist to administer, doses in a row and maintain the necessary measure for the patient. Options currently available in the institutional environment require the home pharmacy to dispense multidose devices which in most devices contain an inappropriate number of doses in relation to the patient's stay and elimination of unused doses when patients are released. Additionally, multidose inhalation devices requiring repeated handling over multiple days in this set increase the chance of viral and bacterial transmission from the person to the device within the environment. Thus, the complexity associated with currently available inhalation devices results in a considerable impact on the cost to the health care system.
    Unit dose inhalation devices taught in the art typically involve relatively complicated delivery systems that are relatively heavy, bulky and expensive to manufacture. In addition, most passive dry powder inhalation devices suffer from problems depending on the reason that drug delivery can vary from low to high flow rates. Some devices require substantially low pressure to be generated by the patient in order to operate properly and receive the drug effectively.
    In addition, most passive dry powder inhalation devices suffer from flow dependency problems where drug delivery can vary from low to high flow rates. Some devices require substantially low pressure to be generated by the patient in order to operate properly and receive the drug effectively
    Generating significant low pressure can be difficult to achieve especially for young and elderly patients. In many cases, the inhalation device technologically taught in the field does not provide adequate feedback to inform the patient or health care providers provided. 1) inhalation device is activated and ready for use, 2) sprayed drug is available for inhalation, 3) sprayed drug has been delivered, or 4), and inhaled device has been used and is ready to be discarded.
    US 2012/0132204 (Lucking, et al.) Describes an inhalation device with a simple flow through the sprayed drug storage chamber. In this device, range of air flows present after the activation strip is removed from the back of the inhalation device. Air flow in a non-specific flow pattern 10 for entry of the powdered powder drug and delivery of it directly through the inhalation device and to the patient. The amount of air and resistance of the airflow entry into the drug storage chamber is susceptible to reducing and leveling irregularities in the model or formed components and compressive forces applied by the patient's hands while operating the inhalation device. The sprayed drug is not removed from the powder storage chamber with a controlled flow pattern leaving the possibility of 20 dead zones, dust trapping and variability in drug delivery performance especially within a low to high flow rate range, 30 1 / min to 90 1 / min for example. There are no means specifically designed for the disintegration of pulverized groga beyond the flow transition from the powder storage chamber to the fluidly connected channel.
    A second embodiment is described with a circulation of the separate spherical powder dispersion chamber and the underside of the powder storage chamber.
    This embodiment involves further complication with the action of drops moving as a mechanical means to break, and break up the aggregate powder as part of the dispersion process.
    The separate chambers and fluidly connected channel create relatively large surface area for sprayed drug including the breathable fine particles to bind and drop to emit the inhalation device. The circulation droplets are driven by the air flow generated by the patient which can vary dramatically having an effect on the performance that such mechanisms lead to inhalation. In addition, these types of mechanisms require substantially low pressure to be generated by the patient to act.
    US 6,286,507 (Jahnsson, et al.) Describes an inhalation device with a simple powder storage chamber separate from the breakdown of the powder meaning that it is located in the fluidly connected channel. Having these two design elements separated creates a significant contact surface area of the drug device and the potential for substantial drug storage due to thinner respiratory particles with less mass and bonded time to the contact surfaces. In addition, the activation band is removed from the back of the device, providing no mouthpiece obstruction and obvious indication to the patient that the device needs to be activated. BRIEF SUMMARY OF THE INVENTION
    There is a need to have a safer, more efficient, and more cost-effective option for delivering inhalation therapies that are currently available. The present invention completely fulfills this need by providing a dry powder inhalation device for inhaling a pre-amount of the pharmaceutical or nutraceutical form of dry powder, including mixtures of single and multiple active ingredients and excipients designed to meet, but not limited to , the aforementioned unmet needs while providing consistently safe and effective delivery of pulmonary drugs. Examples of applications for use are, but are not limited to, meeting the needs of infrequent users, vaccine delivery, drug delivery in institutional settings and drug delivery by bio defense or any other applications where delivery of a dry powder form is needed or desired.
    Some of the advantages of using the inhalation device described over alternatives are; drug stability for use of a protective wrapper for each individual dose, ease of bar code or pre bar code, intuitive, ease of administration and use, minimum size and weight, efficient dose delivery, low airflow resistance, simple construction, low manufacturing cost, disposable, minimized human contamination such as viral or bacterial, consisting of minimal materials reducing the impact of the environment, reliable operation without movement of parts and mechanisms, visual dose delivery indicator, inhalation device with easy visual indication, no coordination requirement, no cleaning requirement, no maintenance requirement, no dose advance is required, no source of electricity is required, no propellant is required, no handling of capsules is required dose counter is required, multidose prevention is not required, nozzle cap is not required, is modular and can be packaged as multiple inhalation devices, can be packaged as multiple inhalers each with different drug formulations, an inhalation device can contain two toroidal chambers with two different drug formulations.
    Accordingly, in one embodiment the present invention is a dose-measuring inhalation device for inhaling a dry powder form by a patient comprising: a body having an exterior and an interior; a toroidal breakdown chamber inside the body having a lower portion characterized by: the dry powder form being sealed within at least a portion of the toroidal chamber by a removable partition characterized by: when the partition is removed the dry powder form be released into the toroidal chamber; at least one air intake passage in fluid communication with the exterior of the body and the interior of the toroidal chamber which directs air inlet through the bottom of the toroidal chamber at a non-tangential angle when the partition is removed; and an outlet passage in fluid communication with the outside of the body and the interior of the toroidal chamber when the partition is removed such that after inhalation to the patient in the outlet passage, air is drawn from the air inlet passage to the toroidal chamber to the outlet such that the dry powder form is conveyed to the outlet passage for the patient.
    According to another embodiment of the present invention, there is a metered dose inhalation arrangement for inhaling a dry powder form by a patient comprising a toroidal breakdown chamber BRIEF DESCRIPTION OF THE DRAWINGS
    Figure 1 is a view of the invention representing its main elements such as body, channel, air inlet passages, airflow passages, drug flow and toroidal chamber.
    Figure 2 presents a detailed view of the air inlet passages, internal air and drug flow and the function of the toroidal chamber. 1 Figure 3 shows the assembly of the channel component for the body of the inhalation device with the hinge active in the open state.
    Figure 4 shows the inhalation device with the hinge active in the open position and filling the drug in the toroidal chamber.
    Figure 5 shows the inhalation device with the hinge active in the open position and filling the drug inside the toroidal chamber and the activation strip positioned in the sealed or connected area around the toroidal chamber.
    Figure 6 shows the body of the inhalation device being closed and the activated activation strip being folded with the drug contained within the toroidal chamber.
    Figure 7 shows the drug inhalation device contained within the toroidal chamber, sealed and folded activation strip and perimeter of the body of the sealed device 25 or connected.
    Figure 8 shows a different perspective view than Figure 7.
    Figure 9 shows a different perspective view than Figure 7.
    Figure 10 is an illustration of the use of the inhalation device including a protective shell.
    Figure 11 shows an example of a multidose embodiment with multiple doses of the same drug available for inhalation.
    Figure 12 shows an example of a multidose embodiment with different drugs available for inhalation.
    Figure 13 shows orthogonal views.
    Figure 14 shows a detailed cross section of the toroidal chamber illustrating key features.
    Figure 15 is a side cross-sectional view illustrating a serpentine inlet, drug spillage, air inlet flow and bypass and outlet air flow.
    Figure 16 is a cross-sectional side view illustrating an air inlet, air inlet flow and bypass flow and air outlet.
    Figure 17 illustrates drug flow from the toroidal chamber, through the outlet grid - toroidal chamber interface and through the outlet channel to the patient.
    Figure 18 shows drug filling sprayed into the inhalation device for use with a common 'drum' filling system.
    Figure 19 shows a front view of the inhalation device with a rigid and compatible body member, forced and attached during assembly to reduce the air gap between the members of two bodies.
    Figure 20 shows an alternate embodiment of a complete toroidal chamber.
    Figure 21 shows orthogonal and sectional views of an alternative embodiment of a complete toroidal chamber. DETAILED DESCRIPTION OF THE INVENTION
    While this invention is susceptible to embodiment in many different forms, they are shown in the drawings, and specific embodiments will be described in detail in this document, with the understanding that the present description of such embodiments is to be considered as an example of the main and not understood to limit the invention to the specific embodiments shown and described. In the description below, numeral references are used to describe the same, similar or corresponding parts in various views of the drawings. This description defines the meaning of the terms used in this document and specifically describes embodiments so that those skilled in the art practice the invention. DEFINITIONS
    The terms "about" and "essentially" mean ± 10 percent.
    The terms "one" or "one", as used in this document, are defined as one or more than one. The term "plurality", as used in this document, is defined as two or more than two, the term "other", as used in this document, is defined as at least one second or more. The terms "including" and / or "having", as used in this document, are defined as comprising (i.e., open language). The term "connected", as used in this document, is defined as connected, although not necessarily directly, and not necessarily mechanically. The term "comprising" is not understood to limit inventions, but only to clarify the present invention with such understood language. Any invention using the term comprising can be separated into one or more claims using "consisting" or "consisting of" the claim language and is so intended.
    Reference throughout this document to "an embodiment", "certain embodiments", and "an embodiment" or similar terms means that a particular feature, structure, or feature described in connection with the embodiment is included in at least one embodiment of the given invention. Thus, the appearance of such phrases or in various places across this specification are not necessarily all referenced to the same embodiment. In addition, the particular feature, structure, or characteristics can be combined in any suitable manner into one or more embodiments without limitation. The term "or" as used in this document is to be interpreted as an inclusive or means any or any combination. Therefore, "A, B or C" means any of the following: "A; B; C; A and B; A and C; Be C; A, B and C". An exception to this definition will only occur when a combination of elements, functions, steps or actions is somehow inherently mutually exclusive.
    The drawings shown in the figures are for the purpose of illustrating certain convenient embodiments of the present invention, and are not to be considered as limitations thereon. The term "means" that precedes a present participle of an operation indicates a desired function for which there is one or more embodiments, that is, one or more methods, devices, or apparatus to achieve the desired function and that an expert in the field may select from these or their equivalents in view of the descriptions in this document and the use of the term "means" is not intended to be limiting.
    As used herein, the terms "device", 5 "device of the present invention," "present inhalation device", "inhaler" or "inhalation device" are synonymous.
    As used hereinafter, the terms "body", l "lining" and "housing" are synonymous and refer to 10 for the inhalation device as a whole. The body has an outer and an inner portion.
    As used herein, the term "inhalation device" refers to a device where a patient inhales into the device to extract the dry powder form for the patient. This is typically done to extract a drug into the patient's lung. In one embodiment, the device is built for simple use.
    For the purpose of this description, the term 20 'disintegration' is synonymous with de-agglomeration and disintegration which describes the dissolution of similar particles or not to form one or more uniform suspensions of the powder in an air stream.
    As used in this document, a "25-breakout toroidal chamber" refers to a chamber having a toroidal shape. In general, in an embodiment that is a torus shape but any general toroidal shape such as square taper or the like will be worked out in the present invention. The camera is positioned inside the body of the device. Sealed inside the chamber, in only one partition of the chamber, it is in the form of dry powder. The powder is sealed in place by a removable partition. The partition separates the rest of the chamber from the dry powder form such that when the partition is removed the dry powder form is exposed into the toroidal chamber.
    As used in this document, the "removable partition" or "activation strip" is a device that stores the dry powder form within a portion of the device such that when the partition is removed the dry powder form can move into the entire interior of the device. toroidal chamber. In one embodiment, the partition has a tab which can be pulled from the outside of the body to remove the partition. The removable partition or activation strip can be made of the following materials: Aluminum foil film structure, foil structure, laminated polymer or polymer film, cellulose, cellulose lamination, wax coating, biodegradable or compostable materials.
    As used in this document, the "air inlet passage" refers to an air inlet in fluid communication to the air outside the device into the unbundling toroidal chamber. Air inlet at the air inlet passage is delivered to the toroidal chamber. In one embodiment, the air intake is aided at a non-tangential angle, for example at an angle to the bottom of the toroidal chamber. In the present invention there is at least one and in another embodiment there are two. In yet another embodiment, there are two opposite air intake passages, yet another embodiment is that the passages are on the same side of the body.
    As used in this document, an "exit path" is a passage in fluid communication with the outside of the body and the interior of the toroidal chamber such that during inhalation by the patient at the exit passage, air is extracted from the air inlet passage to the toroidal chamber for the exit such that the dry powder form is led to the exit passage for the patient. In one embodiment, the outlet passage increases as it exits the device body. In another embodiment, it increases sufficiently for a patient to place his nose at the powder inhalation outlet inside the toroidal chamber. In another embodiment, the outlet passage has an air flow channel. For the purpose of this description, the term 'drugs' includes both pharmaceutical and nutraceutical components including any formulations including excipients. All mentions of 'drug' refer to powdered drug. For the purpose of this description, the term 'powder' is synonymous with powdered drug and includes both pharmaceutical and nutraceutical components including any formulations including excipients.
    PMDI is a pressurized metered dose inhaler designed to deliver the drug by metered doses from a reservoir filled with propellant and aerosol doses to release propellant energy.
    DPI is a form of dry powder inhaler designed to passively spray drugs into the lung using the patient's inspiration effort alone or actively using an external energy source along with the patient's inspiration effort to disperse and break down the sprayed drug.
    The disposable respirator driver of the dry powder inhalation device has an integral powdered drug storage chamber for a toroidal chamber and airflow path for entry and incorporation and separation of aggregated powder before inhalation of the powder by the patient. The toroidal chamber is fluidly connected to one or more air inlets directed non-tangentially towards the powder to soften and configure an irregular rotational flow pattern. Also in the connection of the fluid to the toroidal chamber is a centrally located air and outlet of powder consisting of one or more holes forming a grid or hole in the connection of the fluid with a channel providing an air passage for the flow of the drug to the patient. During the actuation of the inhalation device by the patient's induced low pressure breathing, the air inlet enters the toroidal chamber causing aggregation of the powder with greater mass and centrifugal force to circulate through the outlet walls for a longer time duration than the small particles. The first stage of the impact force is applied to dust aggregates when they collide with each other and the walls of the toroidal chamber. In addition, a second stage of forces is applied to dust aggregates when they flow through the irregular rotational intersection and non-tangent entry of air currents subordinating particles to air cutting forces, speed and directional changes. The resulting powder is partially disaggregated and these small particles with less mass and centrifugal force flow to the exit of the chamber where the additional forces of the third impact are applied due to collisions with the exit grid or orifice structure and particle driven between the chamber. toroidal - exit grid or hole interface ("interface"). In one embodiment, the exit chamber is centrally located. The degraded powdered drug then flows from the outlet orifice through the fluid connection channel to the patient.
    Now referring to Figures 1 and 2 present a perspective view of an embodiment of the present invention with the Figure showing a more detailed perspective view. This embodiment in Figure 11 is an inhaler with a removable partition removed (115). This is the device in use since, with the partition in place; the device is designed to store until use. The inhaler (115) consists of a body which, in this embodiment, consists of an upper inhaler body (80) and a lower inhaler body (65). This inhaler has an exterior with the mechanics arranged inside the device. In use, a patient will place his nose over the area where the air exits the inhaler (115). This is indicated by the deviation of the airflow channels (20) and spray drug and airflow channel (25) both of which deliver to the patient when the patient inhales. During inhalation, air enters through the air inlet passage (5) and moves downwards at an angle in a non-tangential way (10) and into the toroidal chamber (60) which is shown in this figure as a circle. in 3D will be seen in other figures. This embodiment has two air inlet ports (5) which are positioned at the top (80) of the inhaler (115). The swirls of air in the toroidal chamber (60) and swirls of dry powder (not shown in this view) break any agglomerate of powder up to the air and the powder exiting through the outlet grid (75) to create fluid drug and flow communication air with outlet passage formed by component (40). The aerosolized powder enters the outlet passage area at (40) characterized by: there are multiple passageways. The open air flow regulator (15) allows the reduction of air flow resistance by dimensioning the openings to regulate the amount of air that passes through the channels (20) and main channel (25) delivering the powder that leaves the main channel (25). Dimensioning the powder outlet (75) the orifices provide for regulating the flow (15) which determines the resistance of the air flow level and therefore, the inspiratory effort necessary to activate the inhaler of the inhaler (115). The preferred embodiment includes a stop mechanism integrated into the body of the inhalation device providing a stopping point for insertion into the patient's mouth, thus providing an indication to the patient that the proper docking depth has been reached to safely and effectively operate the inhalation device by the breath of the trigger.
    Figure 2 shows this air flow / drug flow in a closed perspective view of the inhaler (115). Because larger aggregate particles tend to flow around the outlet circumference (200) of the toroidal chamber (60), they are subject to impact force and break before they flow into the outlet grid (75). As shown in Figure 2, the toroidal chamber (60) is designed to use the centrifugal force of rotationally irregular that flow aggregates of powder with relatively large mass to partially break down by impact with one another the walls of the toroidal chamber yielding finer particles with reduced mass and centrifugal force. In addition, a second stage of forces are applied to dust aggregates when they flow (20) 0 through the irregular rotational intersection and non-tangent entry of air currents (10) subjecting the particles to forces of air cutting, speed change, change of direction, and particle to particle collisions. Smaller aggregate drugs or particles with reduced mass and centrifugal force can then flow into the grid of the outlet toroidal chamber or orifice interface (75). As the particles start to get smaller due to the forces inside the toroidal chamber (60) that move closer and closer to the outlet grid (75), near the center of the toroidal chamber (60) until it leaves the grid (75) and between the airflow path (25) in the component outlet passage 40.
    Figures 3 to 9 represent a perspective view of the construction of an inhaler with the activation strip (95). Figure 3 represents the body of the inhaler molded from a single piece of material on the outside of the upper body (80) and the lower external part (65) are shown in this view. The toroidal shape of the toroidal chamber (60) can easily be seen. The outlet passage component (40) is mounted on the outside of the upper side (80) creating a deflection of the channels (30) and the drug / air channel (35). The air bypass holes (45) are shown in this view. The upper part (80) and lower part (65) of the body are connected by an active hinge (70), a molded strip, just as the upper part (80) and lower part (65) of the body are shaped like a piece.
    Figure 4 shows the inner surface of the upper body (80) and lower body (65). Clearly in this view is the inner surface of the toroidal chamber (60) showing the powder (85) in the chamber (60). Because the removable partition is not added, the dust merely remains at the bottom of the chamber (60). An attachment area (90) for the partition is shown, which can include an adhesive material to adhere to a partition.
    In Figure 5 a partition (95) is on the inner surface of the body portions (80) and (5) covering the interior of the powder delivery toroidal chamber (60) to the flow path of the inhaler. Figure 6 shows the fold (100) of the upper body (80) meeting the lower body 9650 by folding the removable partition. In Figure 7 an embodiment of the present invention the inhaler is completely constructed and noted as an inhaler (110) in the following Figures.
    Figure 8 represents a perspective view of the same inhaler (110) as shown in Figure 7 although, from a different view that allows a view of the inhaler outlet passage (110). Figure 9 shows a bottom perspective view of the inhaler (110).
    Figure 10 is a series of open perspective view, removable from the partition and use of the inhaler (110) in a single use embodiment. An embodiment of the present inhalation device (110) as shown in Figure 10 is protected from contamination, ultraviolet light, oxygen, if required, and ingress of water vapor by a protective wrapper (105) such as, but not limited to, laminated aluminum foil joined to contain the inhalation device as individually packaged or attached to a strip, sheet, or roll form with individually removable inhalation device for shearing or separation when access to inhalation devices from a package of multiple dose. In addition, the aforementioned packaging protective wrapper configurations providing color code and barcode printing area for scanning in electronic graphics systems and providing general information to patients and administrators.
    As shown in Figure 10, the preferred embodiment requires, but is not limited to, a minimum number of steps, as described below to administer or self-administer the dry powder drug. open protective wrapper (105) packaged pull the activation strip (95) at the end and remove this the patient inhale the sprayed drug (125) eliminate the inhalation device (135) and protective wrapper
    This embodiment of the inhalation device can be eliminated after use to facilitate clean environments for use or administration by reducing the possibility of transmitting hazardous materials such as viruses and bacteria from person to device to person.
    As shown in Figure 10, patient feedback of the status of the inhalation device indicator includes obstruction of the mouthpiece by the activation strip because its length in the mounted state (110), providing indication to the patient that the activation strip (95) is removable is required before inhalation (125) of the sprayed drug. Indicators also include the use of transparent materials for a body of the inhalation device or powder storage chamber providing visibility of the drug before and after use to confirm delivery of the drug by visual inspection (130). In Figure 10, (105) represents the protective wrap, (110) shows the removable device in the protective wrap, (115) represents the inhalation device with the activation strip (95) removed and the drug for inhalation reading, (125) arrow illustrates breathing of the trigger by the patient (125) and (135) represents disposition for use of the inhalation device.
    A further embodiment is a multidose strip as shown in Figure 11 comprising the inhalation devices integrated and packaged as one with each toroidal chamber containing the same powdered drug formulation (140) drug "A".
    A further embodiment is a multidose strip as shown in Figure 12 comprising the inhalation devices integrated and packaged as one. One side of the inhalation device can contain sprayed drug "B" (145) and the other sprayed "C" (150) as well as additional drugs.
    A further embodiment includes multiple toroidal inhalation chambers fluidly joined for a powder outlet passage and patient interface nozzle. Each toroidal chamber can contain different sprayed drugs.
    Figure 13 represents a series of orthogonal views of the inhaler (110).
    Figure 14 represents a series of views of embodiments including an activation strip 95 designed to retain and protect the drug sprayed in the toroidal chamber by closing a region of the chamber (and in some embodiments the entrance to the chamber). The removal of the activation strip (95) "activated" the inhalation device exposed and fluidly connected to the sprayed drug (85) residing in the toroidal chamber (60) for one or more airway entrances (55) and exit grid or orifice (75). This prepares the inhalation device (115) for delivering the dose to the patient when low pressure for breathing (inhalation) occurs. The activation strip (95) can be removed from the inhalation device and disposed of separately. The aforementioned design is useful due to its simplicity and being intuitive for the user. An alternative embodiment can include a displaceable activation strip. In this embodiment, the activation strip moving or moving from one position to another activates the inhalation device (115) while remaining inside the inhalation device (115). The activation strip can be mounted or connected, but not limited, by the following methods; heat sealing, mechanical capture, adhesive, detachable adhesive, friction form, adjustment press, fitting form, laser welded, radio frequency or ultrasonic welding. It can be mounted or attached to the inhalation device with or without folds. Folding (100) the activation strip (95) together with the inhaler body during assembly as shown in Figure 6 results in a detachable attachment to facilitate sliding activation of the displaceable link area (90) to Figure 5 between the activation and inhalation body device. The activation strip (95) can provide a printing area for color coding and barcode for scanning in electronic graphic systems and provide general information to patients and administrators.
    As shown in Figure 14, the embodiment includes an integrated powdered toroidal drug store and disintegration chamber (60) designed to retain and protect dust (85) during storage and provide the means for disintegrating powder during the triggering breath event. . The toroidal chamber (60) designed is an improvement over the state of the art due to its reduced contact surface area between the powder and the inhalation device, (losses) in the device, controlled and in air and efficient drug path and simplified construction . Integration of the powder storage chamber and disintegration chamber into a simplified inhalation device design and reduced area for the powder contact surface and inhalation device resulting in reduced powder loss and thus improving drug delivery performance. The toroidal chamber consists of an outer wall (265), inner wall (260), outlet grid or hole (75) interface region which is an air gap between (75) and (155), lower and upper surfaces.
    In Figure 14 the geometry of the toroidal chamber includes an elevated region located on the central axis (270) that guides the flow of drug particles from the outlet chamber to the grid or orifice (75) eliminating a dead zone of air flow at the bottom of the chamber where the powder (85) would normally be collected and no longer delivered to the patient, the flow pattern within the toroidal chamber (60) is irregular and not a truly circular path due to the non-tangential intersection of the air flow inlet (10) interrupting the circular flow and modifying the flow path in an irregular rotational path.
    The following is applicable for both toroidal and complete torus chambers; for the purpose of illustration in this disclosure, the toroidal chamber including interior (example 260, Figure 14) and internal surfaces (example (265),
    Figure 14) is shown as various toroidal circular geometries although the embodiments are not limited to circular. Additional geometries can be used such as polygonal, polygonal with radial, oval, elliptical or irregular curves or any combination of these applied to the inner and outer surfaces of the toroidal chamber.
    Air inlet (10) can be guided through channel (s) (55), (120) as shown in Figure 15 with redirection path (s) creating a storage area (s) (120) for dust at the event, after activation of the inhalation device, it is tilted as the drug powder (85) spills into any of the air intakes before the inhalation device fires breath. The redirection of the path (s) as shown in Figure 15 prevents loss of dust when the inhalation device is tilted and retains dust in the storage area (s) (120) by entrainment and flow to the patient during trigger breath.
    In Figure 16 after inhalation, air inlet (10) flows into the toroidal chamber (60) and the sprayed drug (85) flows. The non-tangential entry of airflow paths (10) intersects the fluid connection of the toroidal chamber (60) creates regions of relatively high airflow velocity, redirecting the sprayed drug circulation (85) in the irregular rotational flow pattern. This intersection of the airflow path provides air-cutting force, speed changes and direction for the flow of particles, also breaking down the sprayed drug (85). The air inlet can be guided through the channels (55) with a geometry designed to direct the flow non-tangentially towards the powder or elsewhere to improve the desired dose delivery performance.
    Figure 17 shows that the powder is subjected to the impact forces of the additional third stage as the drug aggregates the impact (205) of the rigid surfaces in the air gap region and pushes between the interface surfaces.
    In Figure 17 the embodiment includes an outlet grid or orifice (75) fluidly intersecting the toroidal chamber (60) close to its central axes providing an opening or openings for sprayed drug flow (205), (165) to exit the toroidal chamber (60) and flow through the fluidly connected channel (35) to the patient. The outlet grid (75) can consist of round holes or any of the following polygonal, rounded polygonal, oval, elliptical, ribbed, with steps, convex, concave, tapered holes, openings, staggered arrangement, linear arrangement, radial arrangement, openings radial, a mesh, a screen, irregular and any reasonable combination or variants of these. The outlet grid (75) can be replaced by a simple orifice (75) sized and located to facilitate the outflow of drug powder with flow properties, particle size and cohesion to optimize drug delivery performance. The simple exit orifice (75) can be round, polygonal, rounded polygonal, ribbed, in steps, convex, concave, oval, elliptical, conical, irregular and any reasonable variant thereof. The outflow area is the choke point of the powder flow from the drug flow passage in the inhalation device. A characteristic of the project is the adjustment of the flow exit area that determines the air volume, air flow speed, impact forces of the drug powder and duration of the air flow through the toroidal chamber (60). The flow outlet area is equal to the sum of the areas of all the holes in the grid or the area of the single hole. As shown in Figure 17, the outlet grid structure (75) includes solid partitions or ribs between and around the open outlet grid, transmitting the impact forces on the sprayed drug when rotationally aggregates of powder (205), (165 ) are forced through the stationary grid.
    In addition, a single outlet port (75) transmits the transition of the impact forces on the powdered drug as an aggregate of the rotational flow of the drug (205) impacts the upper surface of the chamber before exiting to the fluidly connected channel.
    As shown in Figure 17, one embodiment includes an outlet grille or orifice - toroidal chamber interface and air gap region formed between surfaces (75), (155) and consisting of an outlet grille or orifice (75) and an enlarged section of the toroidal chamber (270) with the internal surface (155). The air gap formed by this interface defines a region where the sprayed drug is forced into the flow through the passage (165) during the triggering breath event due to the low differential pressure generated by the patient. The drug particles flowing (165) trying to escape are particles of various sizes with varying degrees of aggregation. The smaller particles are able to redirect the flow through the outlet opening (s) (75) while the particles with greater mass and momentum impact the solid grid structure of (75) and the surface around the opening. This impact transmits forces on the aggregated drug particles to break them down into smaller, more breathable drug particles. The impacted particles are free to bounce back and forth (path 165) in this region of air gap between the outlet grille or orifice (75) and raised section of the toroidal chamber (155). The particle bounce effect (path 165) applies additional impact to the aggregated particles before exiting to the fluidly connected channel (35) and flows to the patient. The geometry of the outlet grid or orifice - interface of the toroidal chamber (75), (155) can consist of many variables. The embodiments are not limited to specific interface geometries but only examples include: point, dome, hemispherical, flat, cone, convex, concave, cylindrical, irregular, conical, steps and irregular shapes, including any combination of these.
    In Figure 18, the active hinge (70) located in front of or behind the surfaces of the inhalation device creates a strict profile while in the open state to efficiently fill the sprayed drug in multiples of the inhalation device at the same time. Each rotation (190) of a drum powder filling system (175) with multiple dosing holes (170) can fill a large number of inhalation devices (185) per cycle when compared to inhalation devices with an active hinge on the side surface. Due to the active hinge characteristic (70), additional manufacturing efficiencies can be achieved, such as reduction; tool management, handling, automation equipment and supply chain. Figure 18, (180) represents filling of drug powder in an empty inhalation device in the flat state (185) and (195) represents linear indexing of inhalation devices (185) between cycles of
    fill. An alternative embodiment can be constructed without the active hinge (70) as described above. The inhalation device can be composed of components produced and assembled as individual body components; the separate upper part of the body component (80) and separate lower part of the body component (65).
    As shown in Figure 19, this embodiment includes means for ensuring closure of the air gap or minimization between the halves of the inhalation device by producing a convex side (240) and the opposite side (245) flat or a convex radius or different concave. During assembly, the two body halves are forced together and joined (250) along the perimeter of the area (255) to form the two body halves (65) and (80) towards each other to reduce the gap (s) of air between them due to irregularities in dimension of the components such as reducing and deforming. The built-in force polarizes the two halves of the body of the inhalation device (65) and (800 each other in the mounted state also acts to retain the activation strip (95) and closes the activation interval strip after activation of this way preventing air leakage and dust loss in the interval.
    As shown in Figures 20 and 21, an alternative embodiment (160) may include a fully integrated torus chamber for storing the sprayed and disintegrating drug (215) designed to retain and protect the dust (85) during storage and provide a means for disintegrating the powder before delivery to the patient. Integration of the powder in the powder storage chamber and breakdown chamber in the design of an inhalation device design simplifies and reduces powder for inhaling drugs from the contact surface area of the device, resulting in less loss of drug powder and therefore , improve the performance of drug delivery and thereby improve the performance of drug delivery. The complete toroidal chamber consists of a toroidal shape complete with outer wall, inner wall, outlet grid or hole (225) interface region, bottom surface, top surface and intersecting channel. The complete toroidal chamber (215) is designed to use the centrifugal force of irregular rotational flow of powder aggregates (2000 with relatively large mass to partially break by impact from one another and the walls of the complete toroidal chamber yielding fine particles (205 ) with reduced mass and centrifugal force.In addition, a second stage of forces are applied to powder aggregates 200 when they flow in a rotational path and impact the protruding channel (210) subjecting the particles to the impact forces, speed change and small powder aggregates with reduced mass (205) and centrifugal force can then flow into the outlet grid of the toroidal chamber or orifice interface (225) where they are subjected to third stage impact forces when the aggregates impact the rigid surfaces at this interface (225) region and shoulder between the interface surfaces In addition, the full torus geometry chamber (2150 incl ui raised central axis or central axis located near regions that guide the particle flows to the outlet grid or chamber hole (225) eliminating the dead zone of air flow on the upper and lower surface of the chamber where the drug powder (85 ) would normally be collected and taken to be delivered to the patient, the flow pattern within the full torus chamber (215) is irregular and not a circular path due to interruption of the circular intersecting flow channel and modification of the flow path in the path irregular. One or more air outlets (55) can be used fluidly connected and intersected with the complete toroidal chamber (215) tangentially or non-tangentially. In Figures 20 and 21, (220) and (230) are components of the inhalation device body and (235) is the fluid connection outlet channel through channel component (210) to the outlet or grid (225) ).
    The inhalation device can be made from the following materials for example including injection molded polymers, anti-static polymers, thermoformed polymers or pressure formed, cellulose (paper) or laminated partial cellulose material, coated laminated wax, compostable, elastomers, silicone, sheets biodegradable aluminum sheets including hot or cold metal sheets, glass, ceramic and composite materials or any combination of these
    The components of the inhalation device can be produced by the following manufacturing methods: injection molding, thermoforming, pressure forming, blow molding, cold forming, die cutting, stamping, extrusion, machining, drawing, casting, lamination, blowing of glass.
    The components of the inhalation device can be connected by the following methods: heat sealing, heat staking, ultrasonic welding, radio frequency welding, fitting fits, friction fitting, fitting press, adhesive, heat activated adhesive and laser welding or any combination of these.
    The exit grid or orifice region can be made with the following materials: polymers, antistatic polymers, metal, mesh or metal tile, elastomers, silicone, cellulose, glass, coated with wax, ceramic sheets, aluminum, including foil and leaf laminations, biodegradable and compostable or any combination thereof.
    The embodiments reside well alone or in sub-combinations of the objects, aspects, elements, characteristics, advantages, indicators, methods and steps presented and described.
    It is an objective of all embodiments to provide a better disposable dry powder inhalation device for pulmonary inhalation of dry pharmaceutical or nutraceutical powder form including excipients.
    The embodiment or embodiments include any sub-combinations of the objects, aspects, elements, characteristics, advantages, indicators, methods and steps and can be used on any type of patient in any therapy set in any orientation.
    The embodiment or embodiments including any subsets of objects, aspects, elements, characteristics, advantages, indicators, methods and steps can be used in a multiple dose inhalation device with a separate drug indexed strip or replaceable drug cartridge or blister or capsule .
    The embodiment or embodiments include any subcombination of the objects, aspects, elements, characteristics, advantages, indicators, methods and steps and can be used in a nasal drug delivery device.
    The embodiments including any subcombination of the objects, aspects, elements, characteristics, advantages, methods described of the inhalation device and method for pulmonary inhalation of pharmaceutical or nutraceutical dry powder form including excipients.
    The embodiments are not limited to the specifics mentioned as many other objects, aspects, elements, characteristics, advantages, methods and steps and combinations can be used. The embodiments are only limited by the claims only. Additional information describing the embodiments is presented in other sections of this disclosure.
    It should be understood that the embodiments also reside in the subsets of objects, aspects, components, characteristics, indicators, methods, materials and steps described.
    Those skilled in the field to which the present invention belongs can make modifications that result in other embodiments using the principles of the present invention, without departing from its spirit or characteristics, particularly when considering the preceding teachings. Therefore, the described embodiments are to be considered in all respects only as illustrative and not restrictive, and the scope of the present invention is, therefore, indicated by the appended claims than by the preceding description or drawings. Therefore, although the present invention has been described with reference to particular embodiments, changes in structure, sequence, materials and the like evident to those skilled in the art are still within the scope of the invention, as claimed by the applicant.
    权利要求:
    Claims (11)
    [0001]
    1. Inhalation device (115) for inhaling a pre-measured dry powder medicine (85) by a patient characterized by comprising: a body (65, 80) having an exterior and an interior; a toroidal disintegration chamber (60) inside the body having a lower portion in which the dry powder is sealed within at least a portion of the toroidal chamber by a removable partition (95) in which when the partition is removed the dry powder can be exposed to the entire toroidal chamber and where the removable partition (95) obstructs a nozzle before being removed; at least one air inlet passage (55) in fluid communication with the exterior of the body and the interior of the toroidal chamber that directs the incoming air towards the bottom of the toroidal chamber (60) at a non-tangential angle when the partition is removed; and an outlet passage (40) in fluid communication with the outside of the body and the interior of the toroidal chamber (60) when the partition is removed so that, after inhalation by the patient in the outlet passage (40), the air is attracted from the air inlet passage (55) to the toroidal chamber (60) to the outlet, so that the dry powder (85) is carried out through the outlet passage (40) for the patient.
    [0002]
    2. Inhalation device according to claim 1, characterized by the fact that there are two opposite air intake passages.
    [0003]
    3. Inhalation device according to claim 1, characterized by the fact that all air inlet passages are on the same side of the body.
    [0004]
    4. Inhalation device according to claim 1, characterized by the fact that the outlet passage widens as it leaves the body.
    [0005]
    5. Inhalation device according to claim 1, characterized by the fact that the partition is removed by a pull tab on the outside of the body.
    [0006]
    6. Inhalation device according to claim 1, characterized by the fact that the outlet passage has airflow channels that lead to the outside of the body.
    [0007]
    7. Inhalation device according to claim 1, characterized in that there are air bypass holes to adjust the air flow through the inhaler.
    [0008]
    8. Inhalation device, according to claim 1, characterized by the fact that there is an outlet grid in the toroidal chamber to create fluid communication between the toroidal chamber and the outlet passage.
    [0009]
    Inhalation device according to claim 1, characterized in that the device further comprises a protective housing.
    [0010]
    10. Inhalation device according to claim 1, characterized by the fact that at least a part of the body is transparent.
    [0011]
    11. Inhalation device according to claim 1, characterized by the fact that the air inlet passage is serpentine, so that it can retain a spilled powder.
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    同族专利:
    公开号 | 公开日
    US10376660B2|2019-08-13|
    US9446209B2|2016-09-20|
    CN106730186B|2020-06-09|
    WO2013036881A3|2013-05-02|
    BR112014004921A2|2017-04-11|
    CN106730186A|2017-05-31|
    CA2846899A1|2013-03-14|
    EP2747815B1|2017-11-29|
    EP2747815A4|2015-05-20|
    US20190358414A1|2019-11-28|
    CA2846899C|2019-12-03|
    US20140230817A1|2014-08-21|
    WO2013036881A2|2013-03-14|
    US20170000960A1|2017-01-05|
    CN104080502A|2014-10-01|
    EP2747815A2|2014-07-02|
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    法律状态:
    2018-01-30| B25G| Requested change of headquarter approved|Owner name: SYPHASE, LLC (US-US) (US) |
    2018-03-20| B25C| Requirement related to requested transfer of rights|Owner name: SYPHASE, LLC (US-US) (US) Free format text: A FIM DE ATENDER A TRANSFERENCIA, REQUERIDA ATRAVES DA PETICAO NO 20160001273 DE 26/02/2016, E NECESSARIO APRESENTAR A TRADUCAO JURAMENTADA DO DOCUMENTO DE CESSAO, ALEM DA GUIA DE CUMPRIMENTO DE EXIGENCIA. Owner name: SYPHASE, LLC (US-US) (US) |
    2018-06-26| B25A| Requested transfer of rights approved|Owner name: CONCENTRX PHARMACEUTICALS, INC. (US) |
    2018-08-14| B15V| Prolongation of time limit allowed|
    2018-09-04| B15G| Others concerning applications: unknown petition|Free format text: REFERENTE A PETICAO NO 870180042524 DE 21/05/2018 EM VIRTUDE DO PLEITO DO REQUERENTE, ATRAVES DA PETICAO NO 870180042508 DE 21/05/2018 JA TER SIDO ATENDIDO, CONFORME PUBLICADO NA RPI 2484 DE 14.08.2018 |
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-09-08| B09A| Decision: intention to grant|
    2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/09/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161573496P| true| 2011-09-07|2011-09-07|
    US61/573,496|2011-09-07|
    PCT/US2012/054325|WO2013036881A2|2011-09-07|2012-09-07|Dry powder inhalation device|
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