Claims for Patent: 5,840,279

Summary for Patent: 5,840,279

Title:	Pharmaceutical powder cartridge with integrated metering device and inhaler for powdered medicaments
Abstract:	Pharmaceutical powder cartridge for powder inhalers for receiving a medicament depot for a large number of pharmaceutical powder doses, having an integrated metering device which comprises at least one metering cavity for receiving a predetermined quantity of a pharmaceutical powder, the integrated metering device being capable of being moved at least out of a filling position into an emptying position approximately transversely with respect to the flow direction of the pharmaceutical powder, and an inhaler for powdered medicaments, in which inhaler the medicament can be received by a patient by means of an air stream and which has a receptacle for such a pharmaceutical powder cartridge.
Inventor(s):	Narodylo; Andre (Linsengericht, DE), Gottenauer; Wolfgang (Bruchkobel, DE), Goede; Joachim (Hanau, DE), Lerk; Coenraad (Peize, NL), De Boer; Anne H. (Drachten, NL)
Assignee:	ASTA Medica Aktiengesellschaft (Dresden, DE)
Application Number:	08/667,414
Patent Claims:	1. A replaceable pharmaceutical powder cartridge for powder inhalers for holding a supply of medicament for a large number of doses of pharmaceutical powder, said replaceable cartridge including an integrated metering device which comprises at least one metering cavity for holding a predetermined quantity of a pharmaceutical powder, said integrated metering device comprising a metering slide which is movable from a filling position wherein medicament is transferred from said supply into said metering cavity into an emptying position wherein said medicament in said metering cavity is available to a user of the inhaler by substantially transverse movement of said metering slide with respect to the flow direction of pharmaceutical powder into said metering cavity. 2. The pharmaceutical powder cartridge as claimed in claim 1, wherein the metering slide can also be moved into a transportation position. 3. The pharmaceutical powder cartridge as claimed in claim 2, wherein the metering slide is fixed in the transportation position by spring-elastic means. 4. The pharmaceutical powder cartridge as claimed in claim 1, which comprises a lid which can be inserted into an upper edge and has the purpose of closing a reservoir space for a large number of doses of pharmaceutical powder, a side wall of the reservoir space tapering in the lower region of the pharmaceutical powder cartridge in a funnel shape to an outlet opening in the lower region of the pharmaceutical powder cartridge, a device for holding the metering device at the lower end of the pharmaceutical powder cartridge, and a means for feeding in purging air, which means is arranged laterally on the outside of the reservoir space and has the purpose of promoting a complete emptying of the metering cavity of the metering device in its emptying position. 5. The pharmaceutical powder cartridge as claimed in claim 4, wherein the device for holding the metering device is a metering slide duct which is arranged under the lower end of the reservoir space and in which the metering slide is displaceably arranged as a metering device so that in the filling position of the metering slide the metering cavity is located in the region of the outlet opening and in the emptying position of the metering slide the metering cavity is located in the region of the means for feeding in purging air in order to promote complete emptying of the metering cavity, and in the region of a discharge opening which corresponds to the means for feeding in purging air. 6. The pharmaceutical powder cartridge as claimed in claim 5, wherein the metering slide duct is laterally open over a substantial part of its length transversely with respect to the direction of movement of the metering slide so that an activation device can laterally take hold of the metering slide and displace it. 7. The pharmaceutical powder cartridge as claimed in claim 4, wherein, in the transportation position of the metering slide, the metering cavity of the metering slide is located outside the regions of the outlet opening and of the means for feeding in purging air. 8. The pharmaceutical powder cartridge as claimed in claim 1, wherein the metering slide has a U-shaped cross section and there are recesses on the outside of the legs for activation means to engage through the recesses in the side walls of the metering slide duct, and the metering slide has at the end facing away from the metering cavity a protruding element with a downwardly directed stop for engaging in a corresponding slit which extends in the longitudinal direction of the base of the cartridge, as well as a keyway for a lug which faces the metering slide duct to engage in the upper wall of the metering slide duct. 9. The pharmaceutical powder cartridge as claimed in claim 1, wherein the outer edge is constructed to be higher than the upper edge of the pharmaceutical powder cartridge, and the pharmaceutical powder cartridge has a lid with a connector element which, after the insertion of the lid, is held by form fit of the edge of the pharmaceutical powder cartridge, and wherein the outer edge of the lid which extends outward from the connector element extends via the upper edge and the annular gap into a shoulder on the inside of the outer edge and is arranged countersunk within the outer edge of the cartridge. 10. The pharmaceutical powder cartridge as claimed in claim 1, wherein the cartridge lid, the metering slide and the pharmaceutical cartridge are manufactured with the integrated metering device from thermoplastic as separate parts without the metering slide. 11. The pharmaceutical powder cartridge as claimed in claim 1, wherein the pharmaceutical cartridge has on its underside a viewing window by means of which the position of the metering slide can be checked. 12. The pharmaceutical powder cartridge as claimed in claim 1, characterized by a display device for the quantity of medicament doses which have been removed or which remain in the pharmaceutical powder cartridge, the display device for the quantity of medicament doses which have been removed or which remain being integrated into the upper edge region of the pharmaceutical powder cartridge. 13. The pharmaceutical powder cartridge as claimed in claim 12, wherein the display device is formed by a film strip or ring which can be moved along the circumference of the upper edge region of the pharmaceutical powder cartridge. 14. The pharmaceutical powder cartridge as claimed in claim 13, wherein the film strip or ring is provided with a toothing by means of which the film strip or ring can be moved along the circumference of the upper edge region of the pharmaceutical powder cartridge. 15. The pharmaceutical powder cartridge as claimed in claim 13, wherein the pharmaceutical powder cartridge has in its upper edge region an annular gap for receiving the film strip or ring. 16. The pharmaceutical powder cartridge as claimed in claim 15, wherein an outer edge which radially bounds the annular gap on the outside has at at least one point on its circumference a recess in the form of a viewing window so that the film strip or the ring can be seen from the outside. 17. The pharmaceutical powder cartridge as claimed in claim 15, wherein the annular gap is downwardly open at at least one point on its circumference so that a drive wheel for the film strip or ring can project into the annular gap from underneath. 18. The pharmaceutical powder cartridge as claimed in claim 12, wherein the display device is provided with a scale for the quantity of medicament doses which have been removed or remain in the pharmaceutical powder cartridge. 19. An inhaler for powdered medicaments, in which the medicament can be received by a patient by means of an air stream, which inhaler comprises a receptacle for a replaceable pharmaceutical powder cartridge as claimed in claim 1. 20. The inhaler for powdered medicaments as claimed in claim 19, which comprises a device for activating the metering slide of the integrated metering device of a pharmaceutical powder cartridge moving it at least from a filling position into an emptying position and a securing device for preventing the metering slide from returning into the filling position before the medicament dose is removed from the inhaler. 21. The inhaler for powdered medicaments as claimed in claim 20, wherein the inhaler also comprises a safety device which largely prevents the formation of an air stream for the removal of the medicament if the metering slide has not yet completely reached the emptying position. 22. The inhaler as claimed in claim 19, characterized by a device for reading, from outside the inhaler, the display device of a pharmaceutical powder cartridge, which has been inserted into the inhaler. 23. The inhaler as claimed in claim 19, wherein the visual display devices and the device for reading the display device of a pharmaceutical powder cartridge, which has been inserted into the inhaler are arranged on that side of the inhaler on which a mouthpiece for inhaling the air stream with the medicament is also located. 24. The inhaler as claimed in claim 19, wherein the visual display devices and the device for reading the display device of a pharmaceutical powder cartridge, which has been inserted into the inhaler are arranged on the inhaler in such a way that they are located in the field of vision of a patient when the said patient holds the inhaler in its position of use for inhaling. 25. The inhaler for powdered medicaments as claimed in claim 19, with flow paths in the inhaler for one or more air streams, a dispersing device for dispersing the powdered medicament and a mouthpiece for inhaling the air stream with the medicament, wherein the flow paths, the dispersing device and the mouthpiece are arranged in such a way that during inhalation out of the inhaler an air stream is formed in which a core air stream containing the dispersed, powdered medicament is surrounded by a surrounding air stream without the addition of medicament. 26. The inhaler as claimed in claim 25, wherein the flow paths comprise a powder duct in which a depression for collecting the pharmaceutical powder metered into the flow paths is formed. 27. The inhaler as claimed in claim 19, having a housing and a mouthpiece, which can be removed from the housing, for inhaling, a receptacle, which can be closed by a lid, for the insertion of a pharmaceutical powder cartridge with metering device integrated therein, and a metering button on the upper side of the housing. 28. The inhaler as claimed in claim 27, in which within the housing and the mouthpiece there are arranged: a functional carrier with horizontal and a plurality of vertical elements for receiving means which act on a pharmaceutical powder cartridge after its insertion into the powder inhaler and its metering device and a horizontal receiving surface of the functional carrier for the insertable pharmaceutical powder cartridge, the receiving surface having a passage opening which is aligned with the discharge opening of the metering device which is integrated into the pharmaceutical powder cartridge. 29. The inhaler as claimed in claim 27 which also comprises a dispersing device, arranged in the mouthpiece, for dispersing powdered medicament doses, in the air stream which is sucked in through a central opening in the mouthpiece during inhalation, the dispersing device being connected by a powder duct to the passage opening in the supporting surface of the functional carrier and the dispersing device having means in order to branch off from the dispersing air stream fed to the dispersing device a powder-free partial air stream which surrounds, as a surrounding air stream, the air stream which leaves the dispersing device and is charged with powder. 30. The inhaler as claimed in claim 27, which also comprises an impulse transmitter which is coupled to first vertical elements of the functional carrier which are arranged parallel to one another at a distance, for the purpose of supplying a mechanical impulse to an inserted pharmaceutical powder cartridge. 31. The inhaler as claimed in claim 27, which also comprises a metering lever which is coupled to a second vertical element with two side walls of the functional carrier which are arranged parallel to one another at a distance, for the purpose of activating the metering device, integrated into the pharmaceutical powder cartridge, for pharmaceutical powder, parts of the metering button which extend through the housing and whose front ends are coupled to other points of the side walls, arranged parallel to one another at a distance, of the second vertical element of the functional carrier, and there are means which engage on the parts on the metering lever in order to pivot the metering lever about its pivotal center, and there are means for activating the impulse transmitter. 32. The inhaler as claimed in claim 27, which also comprises further elements of the functional carrier which form at the rear end of its horizontal part a valve chamber, with an opening to the rear part of the housing interior, which opening can be closed by a valve flap which is coupled to functional carrier elements, and the valve chamber is connected to the dispersing device via an air duct, and a partial air duct branches off from the air duct to the metering device of the pharmaceutical powder cartridge in order to lead a partial air stream through the metering device to the powder duct, in order to convey a medicament dose out of the metering device into the dispersing device. 33. The inhaler as claimed in claim 32, wherein the valve flap has at its upper edge a shaft with outwardly directed bearing journals which engage in bearing bushes on functional carrier elements which form the valve chamber walls, and in the shaft there is a recess with a blocking edge, and an arm extends upward from the shaft next to the recess, at the end of which arm a hook with a blocking edge is constructed. 34. The inhaler as claimed in claim 32, wherein the second vertical element of the functional carrier is a shaft with two side walls whose inner cross section is matched to the outer contour of the pharmaceutical powder cartridge to be inserted, and, between the side walls of the shaft and the side walls of the pharmaceutical powder cartridge, there is still space for the metering lever and the parts of the metering button. 35. The inhaler as claimed in claim 32, wherein the dispersing device has a chamber which is formed by a baffle plate as front wall, a plate as rear wall and an outer wall of the chamber arranged between them, the outer wall diameter of said chamber being smaller than the inner diameter of the mouthpiece surrounding the dispersing device, so that an annular space surrounding the chamber is constructed within the mouthpiece and the outer wall of the chamber is divided into webs by a plurality of slits which extend tangentially into the chamber interior, the outer diameter of the baffle plate is larger than the outer diameter of the chamber so that its edge fits tight against the inside of the mouthpiece, the baffle plate has in the center an outlet opening from which an outlet duct extends through a truncated cone-shaped connector element which is attached on the front side of the baffle plate, and in the edge region of the baffle plate there are a plurality of passage openings which are distributed symmetrically over the circumference and through which powder-free air can pass out of the annular space into the space in front of the baffle plate, the front end of the powder duct which starts at the rear of the baffle plate is connected to one of the slits in the outer and of the chamber and the rear end of the powder duct which extends to below the supporting surface is constructed so as to be fixable in a vertical element of the functional carrier, which vertical element extends downward as far as the inner wall of the housing. 36. The inhaler as claimed in claim 35, wherein the surface, which faces the interior of the chamber, of each of the webs which form the outer wall of the chamber is constructed as a continuous extension of the slit wall so that the chamber has a polygonal cross section. 37. The inhaler as claimed in claim 32, wherein the first vertical elements of the functional carrier are arms which extend upward from the horizontal part of the functional carrier behind the supporting surface, having bearing bushes at their upper ends, and the impulse transmitter has a lever with a hammer element, extending in the direction of the longitudinal axis of the powder inhaler, at the lower end with a shaft at the upper end, the outwardly directed journals of which shaft engage in the bearing bushes in the arms, and in the lower part of the lever there is a laterally offset, upwardly extending transverse spring element which cannot be deflected in the direction of movement of the impulse transmitter but rather transversely thereto, and a drive spring which extends upward from the lower part is molded onto the impulse transmitter. 38. The inhaler as claimed in claim 37, wherein there is a projection with an oblique surface on the transverse spring element of the impulse transmitter on the side facing away from the lever. 39. The inhaler as claimed in claim 37, wherein a drive device is arranged between the housing wall and a side wall of the shaft, having means for activating the display device which is integrated into the upper edge of the pharmaceutical powder cartridge for medicament doses removed from the pharmaceutical powder cartridge. 40. The powder inhaler as claimed in claim 39, wherein the means for activating the display device are a toothed wheel which engages in the display device and which is mounted on a journal which protrudes from the upper edge of the housing, which toothed wheel is driven by a toothed pinion, connected to a toothed transportation wheel, with a smaller number of teeth, the toothed pinion being mounted through an oval opening in the lateral surface of the metering lever in a bearing hole in a lateral surface of the shaft of the functional carrier. 41. The inhaler as claimed in claim 32, wherein the parts of the metering button are two parallel rockers, the distance between which is slightly larger than the width of the pharmaceutical powder cartridge so that during insertion the pharmaceutical powder cartridge can be pushed through the space between the rockers and the front ends of the rockers are connected to one another by means of a bridge, from which bearing journals extend on both sides in bearing bushes in the third vertical elements, and the bridge on the front side has a step bearing for receiving a restoring spring whose other end is supported in a bearing on the rear of the vertical plate of the functional carrier. 42. The inhaler as claimed in claim 32, wherein the means on the rockers of the metering button are driver journals on the outside of both rockers for engaging on the metering lever and a projection which extends upward from the other rocker, the projection projecting beyond the rocker also on the inside in order to activate the impulse transmitter, and the distance between the driver journals and the pivotal center of the metering button being smaller than the distance from the projection so that the engagement of the projection on the transverse spring element of the impulse transmitter takes place with a smaller degree of pressing in of the metering button than the engagement of the driver journal on the metering lever and the further movement of the metering lever up until the engagement of the driver journal releases the engagement of the projection on the transverse spring element of the impulse transmitter. 43. The inhaler as claimed in claim 33, wherein the metering lever has two lateral surfaces at a distance from one another, the ends of which lateral surfaces are connected to one another by bridges forming a ring which engages around the pharmaceutical powder cartridge at a distance, and bearing journals extend outward from the lateral surfaces in their upper regions in bearing bushes in the side walls of the shaft so that the metering lever is pivotably mounted in the longitudinal direction of the powder inhaler, and a lateral surface has an obliquely downwardly running stop edge for the driver journal of the metering button and the metering lever has means for engaging in the metering device integrated into the lower part of the powder cartridge, and there are means for locking the blocking edge of the recess in the shaft of the valve flap and for locking the blocking edge of the hook on the arm which extends upward from the shaft next to the recess, in order to make it possible to lock the metering lever in a center position, differing from its initial position, and in a limit position. 44. The inhaler as claimed in claim 43, wherein the metering lever has on one of its lateral surfaces a lug for hooking in a restoring spring, and the other end of the restoring spring is fixed to a hook which is arranged on a horizontal element of the functional carrier, which element forms the top of the valve chamber, and the force of the restoring spring is not sufficient to release the locking of the metering lever in the center position and limit position but is sufficient to pull back the metering lever into the initial position after the limit locking is released. 45. The inhaler as claimed in claim 43, wherein the means on the metering lever for engaging in the metering device are fingers which extend from arms which are offset laterally into the ring against the lateral surface and extend downward, directed toward one another, through recesses in the side shafts of the metering slide duct into recesses in the side edges of a metering slide which is arranged so as to be capable of moving forward and backward in the metering slide duct of the metering device.