# US 10,500,355 B2 · System composed of inhaler and capsule > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,355 B2 - Document ID: US10500355B2 - Status: Granted - Kind: B2 - Application number: 14/402,507 - Filed: 2013-05-17 - Published: 2015-05-21 - Granted: 2019-12-10 - Earliest claimed: 2012-05-21 - Assignees: Boehringer Ingelheim International GmbH - Applicants: Boehringer Ingelheim International GmbH - Inventors: Holger Holakovsky; Jessica Frentzel-Beyme; Stephen Terence Dunne; Jens Besseler; Claudius Weiler - Web page: https://patentgrep.com/patent/US10500355B2 ## CPC - A61M 15/0035: {Piercing means} - A61M 15/0025: {with caps} - A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up} - A61M 15/0043: {Non-destructive separation of the package, e.g. peeling} - A61M 15/0086: {Inhalation chambers} - B65D 47/283: {between tubular parts} - A61J 3/071: {into the form of telescopically engaged two-piece capsules} - A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles} - A61M 15/0071: {having a display or indicator} - A61M 15/0081: {Locking means} - A61M 2202/064: Powder - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The invention relates to a system composed of an inhaler and a capsule, preferably intended for single use. The capsule contains a preferably powdered pharmaceutical preparation which, for inhalation, is expelled from the capsule through at least one hole. The capsule comprises as capsule elements a capsule cap and a capsule body, at least one of which comprises at least one prefabricated hole. The prefabricated hole in the capsule is sealed off in the transporting state of the system and is open in the usage state. The hole is exposed by actuation of a pulling mechanism. Prior to this the hole is closed off by a capsule receptacle or a film. In one embodiment the capsule may be present in two different states, for example in different insertion positions of the capsule elements. In the first state the prefabricated hole is closed off and in the second it is exposed. Also shown is an inhaler suitable as a disposable product, which is manufactured from thermoformed parts or from blister film. ## Claims ### Claim 1 System comprising an inhaler and a capsule for use as a reservoir for a pharmaceuticals wherein the capsule comprises two capsule elements open at one end, the two capsule elements including a capsule body (2) and a capsule cap (1), which are fitted into one another telescopically through their respective openings so as to form a cavity, the inhaler comprises a capsule chamber (74), the capsule body (2) and/or the capsule cap (1) each comprise, in addition to the respective opening at one end, at least one prefabricated hole (7, 6), before the inhaler is used, the capsule (71) is stored in a capsule receptacle (173a), the capsule receptacle (173a) sealing off at least one hole (72a, 72b) which leads into the cavity of the capsule (71), the capsule receptacle (173a) is at least partly arranged in the capsule chamber (74), and the capsule receptacle (173a) is removed from the capsule chamber (74) by means of a pulling mechanism, such that when the capsule receptacle (173a) is removed, the capsule (71) remains in the capsule chamber (74), the inhaler comprises a mouthpiece (78) with a mouth tube (78d) that connects the capsule chamber (74) to an air outlet, a component that forms or encompasses the capsule receptacle (173a) extends through the mouth tube (78d) in the inhaler, the inhaler comprises a tongue, pin or bar (75) that delimits the capsule chamber (74) and extends through the capsule receptacle (173a), and the capsule receptacle (173a) comprises a recess through which the tongue, pin or bar (75) slides during relative movement between the component and the capsule chamber (74). ### Claim 2 (depends on 1) The system according to claim 1, wherein the capsule receptacle (173a) is part of, or is formed by, a pulling element (173). ### Claim 3 (depends on 1) The system according to claim 1, wherein each of the capsule body (2) and the capsule cap (1) are of cup-shaped configuration, comprise a capsule casing which forms a cylindrically or elliptically encircling wall, and the at least one prefabricated hole (7, 6) in the capsule body (2) and/or the capsule cap (1) are arranged in an encircling wall region of the capsule casing. ### Claim 4 (depends on 3) The system according to claim 3, wherein the capsule casing of the capsule body (2) and the capsule cap (1) comprise, on sides that abut on one another in an inserted state, a structuring that enables the two capsule elements to be fitted into one another only in a defined alignment. ### Claim 5 (depends on 3) The system according to claim 3, wherein the at least one prefabricated hole (7, 6) of the capsule body (2) and the capsule cap (1) comprise two holes (7a, 7b, 6a, 6b) in upper and lower regions of the capsule casing, so that in the second insertion position the capsule (71) comprises two holes in the capsule casing. ### Claim 6 (depends on 5) The system according to claim 5, wherein each of the two holes in the capsule casing is close to a capsule end. ### Claim 7 (depends on 1) The system according to claim 1, wherein: both the capsule cap (1) and the capsule body (2) each comprise the at least one prefabricated hole (6, 7) in addition to the opening at one end, and there is an insertion position with respect to the telescopic fitting together of the capsule body (2) and capsule cap (1) in which the at least one prefabricated hole (7, 6) in the capsule body (2) and the capsule cap (1) are in registry with one another, such that the otherwise closed capsule comprises at least one hole at corresponding locations. ### Claim 8 (depends on 7) The system according to claim 7, wherein the closed capsule comprises two holes at the corresponding locations. ### Claim 9 (depends on 1) The system according to claim 1, wherein: both the capsule cap (1) and the capsule body (2) each comprise the at least one prefabricated hole (6, 7) in addition to the opening at one end, the capsule comprises, with respect to the telescopic fitting, together of the capsule body (2) and the capsule cap (1), two insertion positions, in a first insertion position, the capsule body (2) and the capsule cap (1) are fitted into one another such that the at least one prefabricated hole (7, 6) in the capsule body (2) and the capsule cap (1) are covered, and thus the cavity in the capsule (71) is closed off, and in a second insertion position, the capsule body (2) and the capsule cap (1) are fitted into one another such that the at least one prefabricated hole (7, 6) in the capsule body (2) and the capsule cap (1) overlap one another, such that the entire capsule (71) comprises a hole at a corresponding location. ### Claim 10 (depends on 9) The system according to claim 9, wherein the capsule body (2) and the capsule cap (1) comprise latching elements interacting with one another which have the effect that the two capsule elements after being fitted into one another up to the first insertion position can no longer be separated from one another non-destructively and/or in that the relative position of the two capsule elements relative to one another is fixed. ### Claim 11 (depends on 9) The system according to claim 9, wherein the capsule body (2) and the capsule cap (1) each comprise the at least one prefabricated hole (7, 6), which can be brought into registry by fitting the two capsule elements into one another, and one of the at least one prefabricated hole (7) in an outer capsule element, is larger than the other of the at least one prefabricated hole (6), and/or is embodied as an oblong hole or an elliptical hole. ### Claim 12 (depends on 1) The system according to claim 1, wherein the capsule elements are made from polyethylene, polycarbonate, polyester, polypropylene or polyethylene terephthalate, in an injection moulding process and the at least one prefabricated hole (6, 7) are formed in the same injection moulding process. ### Claim 13 (depends on 1) The system according to claim 1, wherein the air outlet representing an opening in the center of the end of the mouthpiece (78) that is next to the mouth during use. ### Claim 14 (depends on 1) The system according to claim 1 wherein: the inhaler comprises the mouthpiece (78) with one end that is closest to a mouth of a user during use and forms an opening that is connected to the capsule chamber (74) in a middle of a mouth end, and a component that forms the capsule receptacle (173a) is embodied as a cap which, in a transporting state of the system, closes off the opening at the mouth end. ### Claim 15 (depends on 14) The system according to claim 14, wherein the cap closes off the opening at the mouth end in such a way that the areas to which a user places his lips when using the inhaler are covered. ### Claim 16 (depends on 1) The system according to claim 1, wherein a component that forms the capsule receptacle (173a) comprises elements which prevent the capsule receptacle (173a) from being non-destructively reinserted in the capsule chamber (74) after being fully removed from the capsule chamber (74). ### Claim 17 (depends on 16) The system according to claim 16, wherein the elements include spring arms which prevent the capsule receptacle (173a) from being non-destructively reinserted in the capsule chamber (74) after being fully removed from the capsule chamber (74). ### Claim 18 (depends on 1) The system according to claim 1, wherein the capsule receptacle (173a) is formed by a thermoformed film or blister film. ### Claim 19 (depends on 1) The system according to claim 1, wherein the inhaler comprises a body (100) forming the capsule chamber (74), which is formed by two parts, preferably in the form of halves, which are joined together by a joint formed by welding, lamination, gluing or sealing. ### Claim 20 (depends on 1) The system according to claim 1 wherein the inhaler comprises a body (100) forming the capsule chamber (74) which consists essentially of a thermoformed film or blister film. ### Claim 21 (depends on 1) The system according to claim 1, wherein: the capsule is located in the inhaler in a transporting state of the system, the capsule (71) comprises at least one prefabricated hole (72, 72a, 72b), the capsule receptacle (173a) comprises or is formed by, an extensible and/or flexible film, which film at least partially surrounding the capsule such that in the transporting state of the system the film closes off the at least one prefabricated hole (72, 72a, 72b) and/or all the holes in the capsule (71), part of the film protrudes beyond the capsule (71) at one end of the capsule (71) and/or the film is connected to a pull strip, and the inhaler comprises an opening or an opening can be exposed on the inhaler, and the film can be pulled out of the inhaler by its protruding part and/or by its pull strip through the opening, whereupon the at least one prefabricated hole (72, 72a, 72b) and/or all the holes on the capsule (11, 74) are exposed. ### Claim 22 (depends on 1) The system comprising the inhaler and capsule according to claim 1, wherein two capsules (71) belong to the system and the inhaler comprises two capsule chambers (74) and two capsule receptacles (173a). ### Claim 23 (depends on 22) The system comprising the inhaler and two capsules according to claim 22, wherein the two capsules are filled with different formulations and/or different amounts of formulation. ### Claim 24 (depends on 1) A method for using a system comprising an inhaler and capsule according to claim 1, wherein the capsule receptacle (173a) which is part of a pulling element (173) or is formed by a pulling element (173) with a powder-filled, pre-perforated capsule (71) contained therein, is assembled with the other components of the inhaler, the part of the capsule receptacle (173a) that holds the capsule (71) being arranged in the capsule chamber (74) of the inhaler, after the assembly of the components of the inhaler, the system is in a state that is suitable for transportation or storage, in which the holes of the capsule (71) formed by the capsule body (2) and capsule cap (1) are closed off, and comprising the step of converting the system into a state ready for use by pulling the pulling element (173), such that the pulling exposes the holes of the capsule. ### Claim 25 (depends on 24) The method according to claim 24, wherein the inhaler comprises a body (100) forming the capsule chamber (74), which is formed by two parts preferably in the form of halves, the capsule receptacle (173a) with the capsule (71) initially being placed in the first part of the body (100) in place of the capsule chamber (74), then the capsule chamber (74) being completed by the placement of the second part of the body (100) and the two parts of the body (100) being joined together by welding, laminating, gluing or sealing. ### Claim 26 (depends on 25) The method according to claim 25, wherein before the capsule receptacle (173a) is assembled with other components of the inhaler, firstly the capsule body (2) being open at one end is inserted in the capsule receptacle (173a), the capsule body (2) is filled with a measured amount of preferably powdered pharmaceutical preparation, and secondly the capsule body is then closed off with a capsule cap (1). ### Claim 27 (depends on 1) The system of claim 1, wherein the reservoir contains the pharmaceutical in the form of a powdered pharmaceutical preparation, which is nebulised by the Bernoulli effect when the inhaler is used. ### Claim 28 (depends on 1) The system according to claim 1, wherein the pharmaceutical is a powdered preparation.