Abstract
A device for administering an active substance comprises a multi-chamber carpule having a bypass in one wall and at least one first chamber with a solid active substance and a second chamber with a solvent for the active substance, the second chamber being delimited by a first plug arranged distally in the multi-chamber carpule and a second plug arranged proximally therein; a mixing element is rotatably mounted about a rotational axis in relation to the housing and can be rotated about the rotational axis in a rotational direction in order to mix the active substance and the solvent; and a first detent device is provided on the device such that, after the mixing operation, an axial displacement of the distal end of the second plug in relation to the wall of the multi-chamber carpule is blocked in the proximal direction by means of the distal end of the bypass.
Claims
1. A device for administering an active substance, comprising a multi-chamber carpule comprising a bypass in a wall of the multi-chamber carpule, at least one first chamber with a solid active substance and a second chamber with a solvent for the active substance, wherein the second chamber is delimited by a first plug arranged distally in the multi-chamber carpule and a second plug arranged proximally in the multi-chamber carpule; a housing, wherein the multi-chamber carpule is accommodated at least partially by the housing; and a mixing device for mixing the active substance and the solvent in a mixing operation, the mixing device comprising a mixing element, a sliding element and a bendable piston rod; wherein the mixing element is rotatably mounted about a rotational axis in relation to the housing and for rotation about the rotational axis in a rotational direction in order to mix the active substance and the solvent in the mixing operation, wherein, after the mixing operation, the sliding element is movable axially back and forth in relation to the housing, and wherein the sliding element is coupled to the second plug via the piston rod in such a manner that, during the axial back and forth movement of the sliding element in relation to the housing, the second plug is movable back and forth in relation to the wall of the multi-chamber carpule, wherein the device further comprises a detent device configured such that, after the mixing operation, an axial displacement of a distal end of the second plug in relation to the wall of the multi-chamber carpule is blocked in the proximal direction by means of a distal end of the bypass.
2. The device according to claim 1, wherein the detent device forms a first detent position between the housing and the mixing element or the sliding element or the piston rod.
3. The device according to claim 1, further comprising a second detent device, the second detent device configured such that during the mixing of the active substance and the solvent in the mixing operation, an axial displacement of the second plug in relation to the wall of the multi-chamber carpule in the proximal direction is prevented.
4. The device according to claim 3, wherein the second detent device forms a second detent position between the housing and the mixing element or the sliding element or the piston rod.
5. The device according to claim 1, wherein the bendable piston rod is configured to be resilient.
6. The device according to claim 1, wherein the sliding element is mounted axially displaceably in relation to the multi-chamber carpule.
7. The device according to claim 1, wherein the sliding element is in a longitudinal guide with the housing.
8. The device according to claim 1, wherein the mixing element further comprises a thread and the sliding element comprises a counter-thread, wherein the thread and the counter-thread are in a threaded engagement.
9. The device according to claim 1, wherein the sliding element comprises a gear configured to interact with a toothed surface arranged on a surface of the housing.
10. The device according to claim 1, wherein, during mixing of the active substance and the solvent in the mixing operation, the sliding element is accommodated by the housing.
11. A method for operating a device according to claim 1, comprising: relative rotation of the mixing element towards the housing of the device about the rotational axis; mixing of the solid active substance with the solvent for the active substance in the multi-chamber carpule; axial movement of the sliding element after the mixing operation in relation to the housing; and blocking of the axial displacement of the distal end of the second plug in relation to the wall of the multi-chamber carpule by means of the distal end of the bypass in the proximal direction after the mixing operation.
12. The method of claim 11, wherein a gear of the sliding element rolls off a toothing of the housing.
13. The method of claim 11, wherein after the completion of the mixing operation, at least a portion of the sliding element protrudes from the housing.
14. The method of claim 11, wherein, during the mixing operation, a holding element of the mixing element covers a sliding portion of the sliding element.
15. The method of claim 11, wherein the mixing element rotates about the rotational axis in only one rotational direction in relation to the housing.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] FIG. 1 shows a perspective view of a first embodiment of an administration device.
[0031] FIG. 2 shows a perspective view of the first embodiment of an administration device, wherein the administration device can be seen in an exploded view.
[0032] FIG. 3a shows a longitudinal sectional view of the first embodiment of the administration device in a start position.
[0033] FIG. 3b shows a longitudinal sectional view of the first embodiment of the administration device in a mixing position.
[0034] FIG. 3c shows a longitudinal sectional view of the first embodiment of the administration device in a priming position.
[0035] FIG. 3d shows a longitudinal sectional view of the first embodiment of the administration device in an aspiration stop position.
[0036] FIG. 3e shows a longitudinal sectional view of the first embodiment of the administration device in an end position.
[0037] FIG. 4 shows a perspective view of a second embodiment of the administration device.
[0038] FIG. 5 shows a perspective view of a third embodiment of the administration device.
[0039] FIG. 6 shows a perspective view of a fourth embodiment of the administration device.
[0040] FIG. 7a shows a perspective view of a fifth embodiment of the administration device.
[0041] FIG. 7b shows a longitudinal sectional view of the fifth embodiment of the administration device according to FIG. 7a.
DETAILED DESCRIPTION
[0042] In FIG. 1, a perspective view of a first embodiment of the administration device according to the invention is represented. In FIG. 2, the first embodiment of the administration device according to the invention is represented in an exploded view. The administration device comprises a multi-chamber carpule (4) having a bypass (7) in a wall (8) of the multi-chamber carpule (4). The multi-chamber carpule (4) comprises at least one first chamber (FIG. 3a, 9) with a solid active substance and a second chamber (FIG. 3a, 10) with a solvent for the active substance, wherein the second chamber (FIG. 3a, 10) is delimited by a first plug (FIG. 3a, 5) arranged distally in the multi-chamber carpule (4) and a second plug (FIG. 3a, 6) arranged proximally in the multi-chamber carpule (4). Through the bypass (7), the solvent can be redirected from the second chamber (FIG. 3a, 10) into the first chamber (FIG. 3a, 9). The multi-chamber carpule (4) is accommodated at least partially by a housing (11) of the administration device. The housing (11) is arranged in an axially and rotationally fixed manner in relation to the multi-chamber carpule (4). The administration device moreover comprises a mixing device for mixing the active substance and the solvent. The mixing device comprises a mixing element (1), a sliding element (2), and a bendable piston rod (3). The mixing element (1) comprises a drive element (1a) with an outer thread (1b) and with an outer toothing (1c). The outer thread (1b) of the drive element (1a) extends from a distal end of the drive element (1a) in the proximal direction, wherein the outer thread (1b) is provided on only a portion of the drive element (1a). The outer thread (1b) of the drive element (1a) extends up to an aspiration stop position. The outer toothing (1c) of the drive element (1a) is in engagement with an inner toothing (1e) of a holding device (1d) of the mixing element (1). The holding device (1d) can comprise longitudinal and/or transverse webs for improved gripability by the patient. The mixing element (1) is rotatably mounted about a rotational axis in relation to the housing (11), and, for mixing the active substance and the solvent, it is rotatable about a rotational axis in a rotational direction, wherein, in particular, the rotational axis is parallel to the longitudinal axis of the device. For this purpose, the patient rotates the holding device (1d) of the mixing element (1) about the rotational axis in the rotational direction. The sliding element (2) comprises a gliding element (2a) and a gear (2d). The gliding element (2a) comprises an inner thread (2b), which is in threaded engagement with the outer thread (1b) of the mixing element (1). Furthermore, the gliding element (2a) comprises a longitudinal guide (2c), which is in engagement with a longitudinal guide provided in the interior of the housing (11). After the mixing operation, the sliding element (2), in particular the gear (2d), protrudes from a recess (11c) provided on the housing (11). The sliding element (2), in particular the gear (2d), is accessible to the patient after the mixing operation. After the mixing operation, the sliding element (2) can be moved axially back and forth in relation to the housing (11), wherein the sliding element (2) is coupled via the piston rod (3) to the second plug (6) in such a manner that, during the axial back and forth movement of the sliding element (2) in relation to the housing (11), the second plug (FIG. 3a, 6) can be moved back and forth in relation to the wall (8) of the multi-chamber carpule (4). For this purpose, a first end of the piston rod (3a) is connected in an axially fixed manner and preferably in a rotationally fixed manner to the gliding element (2a) via a fastening element (2e), for example, in the form of a slot. Alternatively, the first end of the piston rod (3a) can be connected directly or indirectly to the gliding element (2a). A second end of the piston rod (3b) is connected in an axially fixed manner and preferably in a rotationally fixed manner via a connection element (12) to the second plug (6). For this purpose, the connection element (12) comprises, on the one hand, an outer thread (12a), which is in threaded engagement with an inner thread (FIG. 3a, 6a) of the second plug (FIG. 3a, 6), and, on the other hand, a holding element (12b), for example, in the form of a slot, which is in engagement with the second end of the piston rod (3b). Alternatively, the second end of the piston rod (3) can be connected directly or indirectly to the second plug (FIG. 3a, 6). The bendable piston rod (3) can preferably be of resilient design. Particularly preferably, the bendable piston rod (3) is a resilient band, in particular a metal band made of a spring steel, for example. The housing (11) can comprise a guide slot, which can guide the bendable piston rod (3), in particular, a two-walled saddle guide which deflects the piston rod (3), in particular a band made of a spring material, by traction and pressure by approximately 180. Alternatively or additionally, the holding device (1d) can comprise a guide slot for guiding the piston rod (3). The housing (11) moreover comprises a toothing (FIG. 3a, 11 a), which is in engagement with the gear (2d) of the sliding element (2). The gear (2d) can roll off on the toothing (FIG. 3a, 11a) of the housing (11), wherein its rotational axis is rotatably guided longitudinally in the sliding element (2) through the housing (11). The distal end of the administration device is formed in such a manner that an infusion set or a her device with a cannula can be attached so that, for example, a fluid connection can be established with a patient. On the administration device, a first detent device can be provided in such a manner that, after the completion of the mixing operation, an axial displacement of a distal end of the second plug (FIG. 3a, 6) in relation to the wall (8) of the multi-chamber carpule (4) is blocked by means of a distal end of the bypass (7) in the proximal direction. For this purpose, the sliding element (2) can comprise a detent arm (not visible), which can reach a detent groove (not visible) of the housing (11). The detent groove of the housing (11) can comprise a distal abutment (not visible) and a proximal abutment (not visible), wherein the detent arm of the sliding element (2) can be moved axially back and forth between the distal and the proximal abutment of the detent groove of the housing (11). The detent arm can be pretensioned radially outward in such a manner that it slides along the surface of the housing (11) and engages in the detent groove of the housing (11). The abutment contact between the detent arm of the sliding element (2) and the distal abutment of the detent groove defines an aspiration stop position, and the abutment contact between the detent arm of the sliding element (2) and the proximal abutment of the detent groove defines a dispensing position. The two abutment contacts can be formed as axial abutment contacts. The detent groove of the housing can be used as a longitudinal guide for the axial guiding of the sliding element (2) towards the housing (11).
[0043] The housing (11) of the administration device can moreover comprise a detent arm (11b), which is in engagement with an inner toothing (10 of the holding device (1d) for the detent arm (11b). This engagement can generate a clicking noise. The inner toothing (10 of the holding device (1d) for the detent arm (11b) of the housing (11) can be identical to the inner toothing (1e) of the holding device (1d) for the outer toothing (1c) of the drive element (1a).
[0044] Preferably, an engagement between the detent arm (11b) of the housing (11) and the inner toothing (1f) of the holding device (1d) for the detent arm (11b) can form a second detent and/or indicator device for the detent mechanism and/or the indicator of the individual preparation steps of the administration device. The detent mechanism can be formed as a reverse motion lock. The detent mechanism can preferably generate an acoustic signal, which can indicate the reaching of a corresponding position. The detent arm (11b) is designed in such a manner that, due to its pretensioning, it blocks the holding device (1d) from being rotated out again or from being rotated back in relation to the housing (11) by an abutment on the inner toothing (1f) of the holding device. From the start position, it is therefore only possible to rotate the holding element (1d) further in one rotational direction. Alternatively or additionally to the acoustic signal, a visual and/or tactile and/or other acoustic signal can be provided on the administration device.
[0045] In FIG. 3a, a longitudinal sectional view of the first embodiment of the administration device is represented in a start position of the mixing element (1). In the second chamber (10) of the multi-chamber carpule (4), the solvent is accommodated, and in the first chamber (9) of the multi-chamber carpule (4), the solid active substance is accommodated. The first plug (5) is arranged proximally offset in relation to the bypass (7). The second chamber (10) is delimited on the distal side by the first plug (5) and on the proximal side by the second plug (6). The sliding element (2) is arranged in a distal position in relation to the housing (11), wherein the sliding element (2) is accommodated by the housing (11). The sliding element (2) is not accessible to the patient. The gliding element (2a) is in threaded engagement via the inner thread (2b) with the outer thread (1b) of the drive element (1a) of the mixing element (1).
[0046] In FIG. 3b, a longitudinal sectional view of the first embodiment of the administration device of a mixing position is represented. On the distal end of the administration device, an infusion set or another device with a cannula can be placed. The holding device (1d) of the mixing element (1) is rotated about a rotational axis in a rotational direction in relation to the housing (11). Due to the toothing engagement between the inner toothing (1e) of the holding device (1d) and of the outer thread (1c) of the drive element (1a), the rotation movement of the holding device (1d) is transmitted via the threaded engagement between the outer thread (1b) of the drive element (1a) and the inner thread (2b) of the gliding element (2a) of the sliding element (2), and via the longitudinal guide (2c) of the gliding element (2a) and the housing (11) in an axial movement of the sliding element (2). The sliding element (2) moves over the toothing (11a) of the housing (11) in the proximal direction. The bendable piston rod (3) coupled to the sliding element (2) can be moved, with deflection in the radial direction, by the guide slot of the housing (11) and/or of the holding device (1d). The second piston (6) that is connected in an axially fixed manner to the piston rod (3) is also moved in the distal direction. The drive force is thereby transmitted first through the solvent in the second chamber (10) to the first plug (5), so that the two plugs (5, 6) are driven distally. As soon as the first plug (5) comes in contact in the area of the bypass (7), the first plug (5) remains at rest in relation to the wall (8) of the multi-chamber carpule (4). The second plug (6) is driven further, so that the solvent arrives from the first chamber (10) via the bypass (7) in the first chamber (5) and can dissolve the active substance located therein. The second plug (6) is driven until it strikes the first plug (5). Thereby, the mixing position of the administration device is reached. The sliding element (2), in particular the gear (2d) of the sliding element (2), can now protrude from the recess (11c) of the housing (11) and it is consequently accessible to the patient.
[0047] In FIG. 3c, a longitudinal representation of the first embodiment of the administration device of a priming position is represented. The gear (2d) of the sliding element is moved via the toothing (11a) of the housing (11) axially in the proximal direction in relation to the housing (11). The piston rod (3) is moved further in the distal direction. Here, the first plug (5) and the second plug (6) are moved in the distal direction. By means of the infusion set or the other device with a cannula, excessive air can thus escape from the first chamber (9).
[0048] Alternatively, the gear (2d) of the sliding element (2) can protrude from the recess (11c) of the housing (11) only once it is in the priming position. To reach this priming position, the holding device (1d) of the mixing element (1) therefore has to be moved further in the rotational direction.
[0049] FIG. 3d is a longitudinal sectional view of the first embodiment of the administration device in an aspiration stop position. The gliding element (2a) of the sliding element (2) is disengaged from threaded engagement with the drive element (1a) of the mixing element (1). The administration device comprises a first detent device, which is designed so that, after the completion of the mixing operation, an axial displacement of a distal end of the second plug (6) in relation to the wall (8) of the multi-chamber carpule (4) over a distal end of the bypass (7) in the proximal direction is blocked. For this purpose, a detent arm (not visible) can be provided on the sliding element (2) and reach a detent groove (not visible) of the housing (11) with a distal abutment (not visible) and a proximal abutment (not visible) of the housing (11), in order to limit a relative axial movement between the sliding element (2) and the housing (11). The abutment contact between the distal abutment of the detent groove of the housing (11) and the detent arm can define the aspiration stop position, and the abutment contact between the proximal abutment of the detent groove of the housing (11) and the detent arm can define the dispensing position. The engagement between the detent arm of the sliding element (2) and the detent groove of the housing (11) can be used for the axial guiding of the sliding element (2) towards the housing (11). The sliding element (2), in particular the gear (2d) of the sliding element (2), can be moved back and forth between the aspiration stop position and preferably before reaching the dispensing position in relation to the housing (11). The gear (2d) of the sliding element (2) is in engagement with the toothing (11a) of the housing (11). The relative back and forth movement between the sliding element (2), in particular the relative back and forth movement of the gear (2d) of the sliding element and the housing (11), should be designed in such a manner that the patient can control whether the infusion set or the other device with a cannula for the administration of the dissolved active substance has been stuck into the vein. After this control or after several such controls, or after this relative back and forth movement or several such relative back and forth movements, the patient moves the sliding element (2), preferably the gear (2d) of the sliding element (2), further in the proximal direction until the dispensing position, as can be seen in FIG. 3e, has been reached. The movement of the sliding element (2) is transmitted via the piston rod (3) and the guide slot to the first plug (5) and to the second plug (6), so that the mixed active substance is dispensed from the first chamber (9) or bodily fluid is aspired.
[0050] In FIG. 4, an exploded view of a second embodiment of an administration device according to the invention is represented. The administration device differs from the administration device of the first embodiment substantially only with regard to the design of the sliding element (2) and of the housing (11) and with regard to the interaction of the two parts during the mixing operation. The drive element (2) comprises two gears (2d), which collaborate with corresponding toothings (11a) of the housing (11). Furthermore, the housing (11) is designed in such a manner that the two gears (2d) are accessible to the patient during the entire mixing operation. Alternatively, the housing (11) can be formed in such a manner that the two gears (2d) are accessible to the patient only after the mixing operation or only after the priming operation.
[0051] In FIG. 5, a perspective view of a third embodiment of an administration device according to the invention is represented. The administration device differs from the administration device of the first embodiment substantially only with regard to the design of the sliding element (2) and of the housing (11) and with regard to the interaction of the two parts during the mixing operation. Instead of the gear, the sliding element (2) comprises a sliding portion (2f), which is connected to a gliding element (not visible) of the sliding element (2). The sliding portion (2f) is in a longitudinal guide with the housing (11), wherein the housing (11) comprises no toothing. Furthermore, the housing (11) is designed in such a manner that the sliding portion (2f) is accessible to the patient during the entire mixing operation. Alternatively, the housing (11) can be designed in such a manner that the sliding portion (2f) is accessible to the patient only after the mixing operation or only after the priming operation.
[0052] In FIG. 6, a perspective view of a fourth embodiment of an administration device according to the invention is represented. The administration device differs from the administration device of the second embodiment substantially only with regard to the arrangement of the mixing element (1). The mixing element (1), in particular the holding element (1d) of the mixing element, is arranged on the distal side of the administration device.
[0053] In FIG. 7a, a perspective view of a fifth embodiment of an administration device according to the invention, and, in FIG. 7b, the fifth embodiment of the administration device according to the invention are represented in a longitudinal representation. The administration device differs from the administration device of the fourth embodiment substantially only with regard to the design of the mixing element (1), in particular of the holding device (1d) of the mixing element (1) and with regard to the interaction of the mixing element (1) with the sliding element, in particular the sliding portion (2f). During the mixing operation, the holding device (1d) covers the sliding portion (2f). After the mixing operation or alternatively after the priming operation, the sliding portion (2f) is accessible to the patient.
