RECONSTITUTION DEVICE AND METHOD OF RECONSTITUTION
20220192923 · 2022-06-23
Inventors
- Claus Geiger (Frankfurt am Main, DE)
- Sarah Helm (Frankfurt am Main, DE)
- Kerstin Traub-Hoffmann (Frankfurt am Main, DE)
- Till Bussemer (Frankfurt am Main, DE)
- Britta Furtmann (Frankfurt am Main, DE)
Cpc classification
B01F29/10
PERFORMING OPERATIONS; TRANSPORTING
B01F35/42
PERFORMING OPERATIONS; TRANSPORTING
International classification
A61J1/20
HUMAN NECESSITIES
B01F29/10
PERFORMING OPERATIONS; TRANSPORTING
Abstract
The present disclosure relates to a reconstitution device for reconstituting a medicament, the reconstitution device comprising: a base, a carrier movably arranged on the base, and a mount for a medicament container, wherein the mount is movably arranged on the carrier.
Claims
1. A reconstitution device for reconstituting a medicament, the reconstitution device comprising: a base; a carrier movably arranged on the base; a mount for a medicament container, wherein the mount is movably arranged on the carrier).
2. The reconstitution device of claim 1, wherein the carrier is rotationally mounted on the base and is rotatable relative to the base with regard to a first axis of rotation.
3. The reconstitution device of claim 1, wherein the mount is rotationally mounted on the carrier and is rotatable relative to the carrier with regard to a second axis of rotation.
4. The reconstitution device of claim 1, wherein the carrier comprises a rotational stage and wherein the mount is arrangeable at numerous positions on the carrier.
5. The reconstitution device of claim 1, wherein the mount is longitudinally displaceable on the carrier.
6. The reconstitution device according to claim 1, further comprising a first drive mechanically engaged with the carrier and configured to move the carrier relative to the base.
7. The reconstitution device according to claim 6, further comprising a second drive mechanically engaged with the mount and configured to move the mount relative to the carrier.
8. The reconstitution device according to claim 1, further comprising a support arranged on the carrier and wherein at least one of the mount and the second drive is arranged on the support.
9. The reconstitution device according to claim 8, wherein the support is longitudinally displaceable relative to the carrier and wherein the support is lockable to the carrier in numerous positional states on the carrier.
10. The reconstitution device according to claim 8, wherein the support is detachably connectable to numerous fastening positions on the carrier being spatially separated from each other.
11. The reconstitution device according to claim 8, wherein a radial distance or radial position of the support on the carrier relative to a first axis of rotation is modifiable.
12. The reconstitution device according to claim 1, further comprising a first hinge connected to the base and connected to the carrier, wherein the first hinge comprises a first hinge axis and wherein the carrier is pivotable relative to the base with regard to the first hinge axis.
13. The reconstitution device according to claim 12, further comprising a second hinge connected to the mount and connected to the carrier, wherein the second hinge comprises a second hinge axis and wherein the mount is pivotable relative to the carrier with regard to the second hinge axis.
14. The reconstitution device according to claim 12, wherein the first hinge axis extends at a non-zero angle with regard to a first axis of rotation.
15. The reconstitution device according to claim 13, wherein the second hinge axis extends at a non-zero angle with regard to a second axis of rotation.
16. The reconstitution device according to claim 1, further comprising a controller operable to control a movement of the carrier relative to the base and/or operable to control a movement of the mount relative to the carrier.
17. The reconstitution device according to claim 1, further comprising a medicament container fastened to the mount.
18. A method of reconstituting a medicament, the method comprising: fastening a medicament container to a mount of a reconstitution device according to claim 1; moving the carrier relative to the base; and moving the mount relative to the carrier.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0116] In the following, numerous examples of the container and of an injection device will be described in greater detail by making reference to the drawings, in which:
[0117]
[0118]
[0119]
[0120]
[0121]
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DETAILED DESCRIPTION
[0127] In
[0128] On the carrier 20 there is movably arranged a mount 30 for a medicament container 50. Typically, the medicament container 50 is at least partially filled with a medicament 51. The medicament 51 typically comprises a lyophilized drug or lyophilized pharmaceutical product. For reconstituting the medicament there may be provided a diluent or solvent inside the medicament container 50. The diluent or solvent may be added to the medicament 51 inside the medicament container 50 before or after the medicament container 50 is mounted, e.g. fixed or fastened to the mount 30.
[0129] As illustrated in
[0130] The mount 30 is movably arranged on the carrier 20. As it is apparent from a comparison of
[0131] The carrier 20 is rotationally supported on the base 12. As illustrated in
[0132] In either way and by activating of the drive 22 the carrier 20 can be set in a rotational movement relative to the base 12 with regard to the first axis of rotation 14. The drive 22 is mounted on the base 12. The drive 22 and the gearbox 28 may be pivot mounted on the base 12. By activating the drive 22 and by rotating the carrier 20 with regard to the first axis of rotation 14 a shaking-imitating motion of the mount 30 and of the medicament container 50 attached thereto can be realized.
[0133] The reconstitution device 10 may further comprise a housing 5. The housing 5 may be of rectangular or cubic shaped. The housing 5 as illustrated in
[0134] The housing 5 can be displaceable mounted, e.g. pivot mounted on the base 12. There may be provided a first hinge 60 by way of which the housing 5 in its entirety can be pivoted with regard to a first hinge axis 62 relative to the base 12. The base 12 typically comprises a planar-shaped base plate. There may be provided a first handle 15 attached or affixed to one end of the base 12. They may be provided a further, i.e. a second handle 15 also attached or fixed to the base 12. The two handles 15 may be located at opposite ends of the base 12. By means of the handles 15 and the base 12 the entire reconstitution device 10 can be easily carried from one place to another place.
[0135] For a secure and steadfast mounting of the reconstitution device 10, e.g. on a table, there may be provided at least one fastener 16 extending through the base 12 or through the respective base plate. By means of the fastener 16 the base 12 can be non-movably fastened to a support, e.g. to a table. The fastener 16 may comprise a fastening screw.
[0136] The housing 5 is pivot mounted on the base 12 with regard to a first hinge axis 62. The first hinge axis 62 may substantially coincide with a corner section of the back wall 9 and the bottom 6 of the housing 5. At a predefined distance from the back wall 9 and outside the housing 5 there may be provided at least one stop 18 on an upper side of the base 12. The at least one stop 18 may protrude from the base 12. The at least one stop 18 provides a well-defined stop for a pivoting motion of the housing 5 relative to the first hinge axis 62. In the configuration as illustrated in
[0137] On the opposite front wall 7 there are provided numerous control elements 96, 98. By means of the control element 98, the entire reconstitution device 10 can be switched on and off. The control elements 96 may serve to start and/or to stop a motion of at least one of the carrier 20 and the mount 30. For instance, one of the control elements 96 is operable to control a rotary motion of the carrier 20 wherein the other control element 96 is operable to control the rotary motion of the mount 30. For each one of the control elements 96 there may be provided a visual indicator 95 thus indicating whether the carrier 20 or the mount 30 is in motion or not.
[0138] There is further provided a fastener 63 by way of which a pivoting motion of the housing 5 and/or of a first hinge arm 61 of the hinge 60 can be fixed or impeded. The fastener 63 may comprise a cam lever 64 allowing to fix or to release a pivot motion of the first hinge 16. In this way also an inclined position of the housing 5 between an initial configuration as illustrated in
[0139] As it is further illustrated in
[0140] As illustrated in
[0141] On an upper side of the carrier 20 facing away from the base 12 the support 80 is displaceably mounted in radial direction with respect to the first axis of rotation 14. There may be provided a sliding mechanism 82 by way of which the support 80 is slidably displaceable on the carrier 80 at least with regard to the radial direction. In this way, the radial position of the support 80 and of the mount 30 with regard to the first axis of rotation can be modified in a way as desired by, e.g. a predefined reconstitution protocol.
[0142] The support 80 is movably connected to the carrier 20 through at least one slotted link 81. The slotted link 81 comprises at least one elongated and straight shaped groove 83. The groove 83 may be provided on top of the carrier 20. The support 80 comprises a correspondingly shaped pin slidably guided in the groove 83. With other embodiments, the support 80 is provided with an elongated groove and the carrier 20 comprises a correspondingly shaped pin slidably engaged with the groove of the support 80.
[0143] As illustrated in
[0144] There is further provided a fastener 86 on at least one of the carrier 20 and the support 80. By way of the fastener 86 the support 80 can be fixed in any available positional state of the carrier 20. By means of the slotted link 81 the support 80 can be moved continuously and/or steplessly along the groove(s) 83 on top of the carrier 20.
[0145] As further illustrated in
[0146] In addition or alternative to the sliding mechanism 82 the mount 30 can also be rotationally supported on the carrier 20 with regard to a second axis of rotation 24. The second axis of rotation 24 can be defined by the support 80 or by any other bearing structure by way of which the mount 30 is fastened or fixed to the carrier 20. In the configuration as illustrated in
[0147] The second drive 32 is typically implemented as an electrical drive. It is operable and/or controllable by the controller 90. The first drive 22 and the second drive 32 may be controllable by one and the same controller 90. With some examples, the first drive 22 may be coupled with a first controller 90. The second drive 32 may be coupled with a second controller separate from the first controller 90. Hence, they may be provided at least two independent controllers for each one of the first and second drives 22, 32, respectively. A wire 92 that may electrically connect the second drive 32 and the controller 90 extends through the hollow shaft 26. There may be provided a rotation-invariant cable bushing 94 on or through the hollow shaft 26. In addition or instead of a wire or cable connection there may also be provided sliding contacts between the controller 90 and at least one of the drives 22, 32. With a sliding contact a rotation-invariant electrical connection can be provided at least between the controller 90 and the second drive 32. The sliding contact may be provided by one or several hollow slip rings. The controller 90 may be further equipped with an interface 91, enabling data transmission to and from the controller 90. In this way, the controller 90 can be pre-programmed in accordance to a pre-defined reconstitution protocol.
[0148] With the first and the second axis of rotation 14, 24 and with first and second separate drives 22, 32 a combined rotating and circular motion of the mount 30 and hence of the medicament container 50 can be provided. By means of the second drive 32 and the respective rotational bearing of the mount 30 on the support 80 the medicament container 50 may rotate around its symmetry axis. By means of the first drive 22, a kind of a stirring motion can be implemented. The rotation directions of the mount 30 and of the carrier 20 may be equal or opposite to each other. The velocities of the carrier 20 and of the mount 30 may be identical or similar to each other. Alternatively and depending on a predefined or pre-programmed reconstitution schedule the angular velocity of the carrier 20 relative to the base 12 and with regard to the first axis of rotation 14 differs from the angular velocity of the mount 30 relative to the carrier 20 with regard to the second axis of rotation 24.
[0149] The direction of rotation and/or the angular velocities of the rotational motions of the carrier 20 and of the mount 30, as they are typically induced by the first and the second drives 22, 32 can be individually varied and controlled by the controller 90 in accordance to a predefined reconstitution schedule or reconstitution program.
[0150] With an example of a reconstitution program only one of the first and second drives 22, 32 may be active during a first time interval. Thereafter and as a second step, both drives 22, 32 may be activated and may be active during a second period of time. During or after the second period of time, at least one angular velocity of the mount 30 and the carrier 20 may be subject to a stepwise or gradual change.
[0151] As further illustrated in
[0152] The second hinge axis 72 allows and supports a pivoting or rotation of the mount 30 relative to the carrier 20. By means of the second hinge 70, the mount 30 may be rotated from an upright configuration as illustrated in
[0153] With such a tilting, and by arranging the second axis of rotation 24 non-parallel to the first axis of rotation 14 a kind of a shaking motion of the mount 30 and hence of the medicament container 50 can be imitated as the carrier 20 is subject to a continuous rotational movement relative to the base 12. For this, the second drive 32 may be inoperable and may be switched off. The second hinge 70 may provide an arbitrary stepped, discrete or a continuous and hence stepless pivoting or tilting of the mount 30 relative to the carrier 20. In any available orientation or position the second hinge 70 may be fixed, fastened or immobilized so as to maintain the tilted orientation of the mount 30 or medicament container 50 relative to the carrier 20.
[0154] Typically, the second hinge axis 72 extends parallel to a planar-shaped upper surface of the carrier 20. The second hinge axis 72 may traverse or cross the second axis of rotation 24. In particular, the second hinge axis 72 may extend perpendicular to the second axis of rotation 24.
[0155] In a further configuration as illustrated in
[0156] As it is further illustrated in
[0157] The slotted link 78 comprises a semi-circular shape with the center axis coinciding with the second hinge axis 72. The slotted link 78 typically comprises a semi-circular shaped groove 73. There is further provided a fastener 76 extending through the slotted link 78 and hence through the groove 73. As shown in
[0158] As further illustrated in
[0159] As illustrated in
[0160] In
[0161] Each one of the fastening elements 36 comprises an abutment body 37 that may protrude radially inwardly from the respective fastening element 36. The abutment body 37 may comprise or may be made of an elastic material, such as an elastomeric material, e.g. a synthetic or natural rubber material. In this way, the barrel 52 of the medicament container 50 can be mechanically fixed and locked to the mount 30 with a friction force sufficient to fasten the medicament container 50 to the mount 30.
[0162] In
[0163] In this way and when, e.g. the first hinge 60 has been pivoted by 90° as shown in
[0164] However, such an orientation of the medicament container 50 may be also obtained with the arrangement of the medicament container 50 in the mount 30 as illustrated in any of the
[0165] In
[0166] Concurrently or simultaneously the mount 30 is moved relative to the carrier 20 in step 104. With some examples of the method, the carrier and the mount will be moved by activating respective first and second drives 22, 32. The direction of movement or rotation as well as the velocity and the duration of the movement or rotation can be varied during the reconstitution process in accordance to pre-programmed reconstitution steps or reconstitution sequences. In a final step 106 and after the carrier 20 or mount 30 have been moved relative to the base 12 and/or relative to the carrier 20, respectively, for a predefined period of time, e.g. defined by a predefined reconstitution program, the method and hence the movement of the carrier 20 and/or of the mount 30 will stop in step 106.
LIST OF REFERENCE NUMBERS
[0167] 4 top [0168] 5 housing [0169] 6 bottom [0170] 7 front wall [0171] 8 side wall [0172] 9 back wall [0173] 10 reconstitution device [0174] 12 base [0175] 14 axis of rotation [0176] 15 handle [0177] 16 fastener [0178] 18 stop [0179] 20 carrier [0180] 21 frame [0181] 22 drive [0182] 23 handle [0183] 24 axis of rotation [0184] 26 shaft [0185] 28 gearbox [0186] 30 mount [0187] 31 rotary bearing [0188] 32 drive [0189] 33 bottom [0190] 34 clamping device [0191] 36 fastening element [0192] 37 abutment body [0193] 38 fastener [0194] 40 fastening screw [0195] 50 medicament container [0196] 51 medicament [0197] 52 barrel [0198] 54 bottom [0199] 60 hinge [0200] 61 hinge arm [0201] 62 hinge axis [0202] 63 fastener [0203] 64 cam lever [0204] 66 base portion [0205] 67 wing [0206] 68 wing [0207] 70 hinge [0208] 71 hinge arm [0209] 72 hinge axis [0210] 73 groove [0211] 74 scale [0212] 75 indicator [0213] 76 fastener [0214] 77 fastening screw [0215] 78 slotted link [0216] 80 support [0217] 81 slotted link [0218] 82 sliding mechanism [0219] 83 groove [0220] 84 scale [0221] 85 indicator [0222] 86 fastener [0223] 87 fastening screw [0224] 88 support element [0225] 90 controller [0226] 91 interface [0227] 92 wire [0228] 94 cable bushing [0229] 95 indicator [0230] 96 control element [0231] 98 control element