Delivery device for drug pellets
11622914 · 2023-04-11
Assignee
Inventors
- John Hayman (Gothenburg, SE)
- Anders Jimgren (Kungsbacka, SE)
- Magnus Karemyr (Vastra Frolunda, SE)
- Simon Pettersson (Gothenburg, SE)
Cpc classification
B65D83/0409
PERFORMING OPERATIONS; TRANSPORTING
International classification
A61J7/00
HUMAN NECESSITIES
Abstract
There is provided an apparatus for dispensing one or more drugs in pellet form. The apparatus includes a cartridge assembly configured to store drugs in pellet form, and dispense the drugs upon actuation of one or more dispensing mechanisms located within the cartridge assembly. The apparatus further includes a control unit configured to actuate the one or more dispensing mechanisms located within the cartridge assembly, as well as a cover including a collection region configured to receive and store drugs dispensed from the one or more dispensing mechanisms. The cover is movable between a first position in which the collection region of the cover forms an enclosed cavity, and a second position in which the collection region is exposed such that a user can access drugs contained therein.
Claims
1. An apparatus for dispensing one or more drugs in pellet form, comprising: a cartridge assembly configured to store drugs in pellet form, and dispense the drugs upon actuation of one or more dispensing mechanisms located within the cartridge assembly; a control unit configured to actuate the one or more dispensing mechanisms located within the cartridge assembly; and a cover comprising a collection region configured to receive and store drugs dispensed from the one or more dispensing mechanisms; wherein the cover is movable between a first position in which the collection region of the cover forms an enclosed cavity, and a second position in which the collection region is exposed such that a user can access drugs contained therein; and wherein the collection region of the cover takes the form of an open, generally U-shaped trough, and comprises one or more pouring lips in an upper rim thereof configured to pour the drugs in pellet form from the collection region when the cover occupies its second position.
2. The apparatus as claimed in claim 1, wherein the apparatus forms a handheld device for dispensing one or more drugs in pellet form, and the drugs in pellet form have a diameter between about 150 μm and about 1200 μm.
3. The apparatus as claimed in claim 1, wherein the enclosed cavity is formed by the cover and portions of the cartridge assembly and the control unit.
4. The apparatus as claimed in claim 1, wherein the whole collection region translates as the cover moves between the first and second positions.
5. The apparatus as claimed in claim 1, wherein the cover is detachable from the rest of the apparatus, so that the cover is detached in the second position.
6. The apparatus as claimed in claim 1, wherein the one or more dispensing mechanisms each comprise one or more rotatable elements, and rotation of the one or more rotatable elements causes drugs to move from a respective one of the storage cavities within the cartridge assembly to the collection region of the cover, wherein the one or more rotatable elements comprise a screw pump.
7. A method of using an apparatus as claimed in claim 1, comprising: actuating at least one of the dispensing mechanisms to dispense a dose of one or more drugs into the collection region, wherein the one or more drugs are received and stored in the collection region when the cover occupies its first position; and then moving the cover from its first position to its second position so as to expose the collection region and the dose of the one or more drugs contained therein.
8. An apparatus for dispensing one or more drugs in pellet form, comprising: a cartridge assembly configured to store drugs in pellet form, and dispense the drugs upon actuation of one or more dispensing mechanisms located within the cartridge assembly; a control unit comprising one or more actuators configured to actuate the one or more dispensing mechanisms located within the cartridge assembly, wherein the one or more dispensing mechanisms each comprise one or more rotatable elements, and rotation of the one or more rotatable elements causes drugs to move from a respective one of the storage cavities within the cartridge assembly to a collection region; and wherein the cartridge assembly comprises one or more locking members movable between first and second positions, wherein the locking members are each configured to prevent actuation of a respective dispensing mechanism in the first position and permit actuation of the dispensing mechanisms in the second position.
9. The apparatus as claimed in claim 8, wherein the cartridge assembly is configured to dock and undock with the control unit, and the apparatus is configured such that each of the locking members move from their first, locking position to their second, unlocked position upon the cartridge assembly docking with the control unit.
10. The apparatus as claimed in claim 9, wherein the locking members each comprise one or more pins configured to contact one or more static portions of the control unit, wherein the contact between the pins and the static portion(s) causes the locking members to move from their first, locking position to their second, unlocked position upon the cartridge assembly docking with the control unit.
11. The apparatus as claimed in claim 8, wherein the rotatable elements comprise one or more radially extending surfaces and the locking members comprise one or more teeth configured to engage with the radially extending surfaces when the locking members occupy their first, locking position, and disengage with the radially extending surfaces when the locking members occupy their second, unlocked position.
12. The apparatus as claimed in claim 11, wherein the locking members are restricted against rotational movement so as to prevent rotation of the rotatable elements when the locking members occupy their first, locking position and the teeth are engaged with the radially extending surfaces, and permit rotation of the rotatable elements when the locking members occupy their second, unlocked position and the teeth are disengaged with the radially extending surfaces.
13. The apparatus as claimed in claim 12, wherein the locking members are biased towards their first, locking position by one or more respective resilient members, such that the teeth are biased into engagement with the radially extending surfaces by the resilient members.
14. The apparatus as claimed in claim 8, wherein the cartridge assembly comprises one or more rotatable connection elements, each connected to a respective one of the rotatable elements and configured to cooperate with a rotatable connection element on the control unit, such that rotation of the connection element on the control unit causes rotation of the connection element on the cartridge assembly to rotate the rotatable elements of the dispensing mechanisms on the cartridge assembly.
15. The apparatus as claimed in claim 14, wherein one of the connection elements on the cartridge assembly and the control unit comprises a male connector and the other of the connection elements on the cartridge assembly and the control unit comprises a mating female connector.
16. The method of using an apparatus as claimed in claim 8, comprising moving the one or more locking members from their first position to their second position to permit actuation of the one or more dispensing mechanisms located within the cartridge assembly.
17. An apparatus for dispensing one or more drugs in pellet form, comprising: a cartridge assembly configured to store drugs in pellet form, and dispense the drugs upon actuation of one or more dispensing mechanisms located within the cartridge assembly; a control unit configured to actuate the one or more dispensing mechanisms located within the cartridge assembly; a cover comprising a collection region configured to receive and store drugs dispensed from the one or more dispensing mechanisms; and a funnel configured to receive drugs dispensed from the one or more dispensing mechanisms, the funnel having an outlet end configured to direct the drugs to the collection region, wherein the outlet end is positioned at least partially within the collection region and/or the outlet end is offset or otherwise positioned so that pellets are directed into a specific portion of the collection region; wherein the cover is movable between a first position in which the collection region of the cover forms an enclosed cavity, and a second position in which the collection region is exposed such that a user can access drugs contained therein.
18. An apparatus for dispensing one or more drugs in pellet form, comprising: a cartridge assembly configured to store drugs in pellet form, and dispense the drugs upon actuation of one or more dispensing mechanisms located within the cartridge assembly; a control unit configured to actuate the one or more dispensing mechanisms located within the cartridge assembly; and a cover comprising a collection region configured to receive and store drugs dispensed from the one or more dispensing mechanisms; wherein the cover is movable between a first position in which the collection region of the cover forms an enclosed cavity, and a second position in which the collection region is exposed such that a user can access drugs contained therein; and wherein the cartridge assembly comprises one or more locking members movable between first and second positions, wherein the locking members are each configured to prevent actuation of a respective dispensing mechanism in the first position and permit actuation of the dispensing mechanisms in the second position.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Various embodiments will now be described, by way of example only, and with reference to the accompanying drawings in which:
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DETAILED DESCRIPTION
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(31) In various embodiments the apparatus 10 can deliver doses meeting regulatory standards such as within +/−10% of a desired dose, or even within +/−5% of a desired dose.
(32)
(33) In the illustrated embodiment the apparatus 10 is a generally oblong shape having a generally flat upper surface 12 and a curved lower surface 14 opposite the upper surface 12. Although such a shape is visually appealing, the apparatus 10 is not limited to this particular arrangement, and other suitable shapes may be provided whilst achieving the functionality set out herein. The apparatus extends from a first end 22 a second, opposite end 22.
(34) The control unit 100 shown in
(35) The apparatus 10 is configured as a handheld unit, and sized appropriately. For example, the apparatus 10 may easily rest in the palm of a user's hand whilst the user interface 102 may be operated by a user's thumb in a similar manner to a remote control device. The size of the apparatus 10 may be no more than about 200 mm, 150 mm or 100 mm in length and/or width, for example the apparatus 10 may have a largest dimension of between about 50 mm to about 200 mm, for example about 100 mm to about 200 mm, or about 100 mm to about 150 mm.
(36) The apparatus 10 may also be light enough that it can be easily carried and operated by a user with one hand. In various embodiments, the apparatus 10 (including the control unit 100 and cartridge assembly 200) may have a weight of about 200 g to 500 g, for example 300 g to 400 g. The weight of the apparatus 10 may be no more than 400 g.
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(38) The control unit 100 extends from the first end 20 to the second end 22 of the apparatus 10 (when it is assembled), so that the first end 20 and the second end 22 are also opposite ends of the control unit 100.
(39) The control unit 100 is split into a first portion 110 located towards the first end 20, and a second portion 120 located towards the second end 22. The first portion 110 is configured to receive and hold the cartridge assembly 200, while the second portion 120 is configured to contain the various control electronics and actuator(s) that operate to control the dispensing of one or more drugs from the cartridge assembly 200. The apparatus 10 may comprise a battery, and the battery may be held within the first portion 110. This can help to distribute the weight of the apparatus 10 evenly and make it more comfortable to hold and/or easier to operate.
(40) The control unit 100 may comprise an interface 130 at the junction between the first portion 110 and the second portion 120, which interface 130 is configured to mate and cooperate with various mechanical and electrical features located on the cartridge assembly 200 (which will be described in more detail below).
(41) The first portion 110 and the second portion 120 of the control unit 100 may occupy roughly equal halves of the control unit 100, wherein the junction between the first portion 110 and the second portion 120 may extend across a lateral centerline of the control unit 100.
(42) The first portion 110 comprises a substantially planar section 112 that extends from the junction between the first portion 110 and the second portion 120 to the first end 20 of the control unit 100.
(43) The first portion 110 further comprises two opposing walls 114 that extend at least partially along either side of the control unit 100. The walls 114 may extend from the junction between the first portion 110 and the second portion 120 towards the first end 20 of the control unit 100, but may terminate prior to reaching the first end 20. The outer surface of the walls 114 may form the outer surface of the apparatus 10. As shown in more detail in
(44) The second portion 120 of the control unit 100 comprises various electronics and other components for operating/controlling the cartridge assembly 200 and user interface. The outer surface of the second portion 120 may form the outer surface of the apparatus 10 when assembled, for example the lower surface 14 thereof. The second portion 120 may comprise an input port 122 located towards the second end 22 of the control unit 100, which input port 122 may receive power and electronic control inputs via a suitable input device, such as a computer.
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(46) The cartridge assembly 200 comprises a cartridge 202 and a cover 204 that is slidable relative to the cartridge 202. The cartridge assembly 200, including the cartridge 202 and cover 204, is configured to slide onto the first portion 110 of the control unit 100 so as to engage with the control unit 100. When the cartridge assembly 200 is engaged with the control unit 100, the cartridge 202 may be substantially fixed in position, whilst the cover 204 may slide relative to the cartridge.
(47) The cartridge 202 and/or cover 204 may be made from a material selected from the group of vectran, liquid crystal polymer, polybutylene terephthalate (“PBT”), acrylonitrile butadiene styrene (“ABS”), polypropylene (“PP”), polycarbonate (“PC”). In various embodiments the cartridge 202 and/or cover 204 may be made from stainless steel or aluminum. In embodiments in which the cover 204 is transparent, the cover 204 may be made from an amorphous and/or semi-crystalline polymer such as polycarbonate (“PC”), polypropylene (“PP”), styrene acrylonitrile resin (“SAN”), polyethylene terephthalate (“PET”).
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(49) Various suitable mechanisms in this regard are described in International (PCT) Patent Publication Number WO 2019/115832, which is incorporated by reference herein in its entirety. For example, the one or more dispensing mechanisms may comprise a screw pump 306 (see, e.g.,
(50) The cartridge 202 comprises one or more first guide cavities 242 that are formed in the housing 240 and configured to receive cooperating rails 216 (described below) on the cover 204 to aid in guiding the cover 204 onto the cartridge 202 so as to form the cartridge assembly 200. In the illustrated embodiment two sets of three first guide cavities 244 are provided, with each set being located on either side of the cartridge 200 (to cooperate with the rails 216 on the cover 204). However, according to various embodiments any suitable number of first guide cavities 242 and cooperating rails 216 may be provided.
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(52) The outlet ends 302 of the dispensing mechanism 300 are located at (or adjacent to) a first, dispensing end 250 of the cartridge 202. The cartridge 202 further comprises one or more features at a second, mating end 252 thereof (see, e.g.,
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(54) The cover 204 comprises an inner, generally concave surface 210 and an outer, generally convex surface 214, wherein the outer surface 214 may correspond to the curved lower surface 14 of the apparatus 10 in its assembled state. The inner surface 210 comprises a plurality of protrusions or rails 216 that are configured to cooperate with (e.g., fit into) the one or more first guide cavities 242 (see, e.g.,
(55) Referring to both
(56) In order to fit the cover 204 onto the cartridge 202 initially (to form the cartridge assembly 200), the cover 204 will need to be deformed so that the rails 216 can move over the walls 243 and into their respective guide cavities 242. Once the rails 216 are positioned within their respective guide cavities 242 they cannot move out unless the cover 204 is again plastically deformed. The cover 204 is, however, able to slide relative to the cartridge 202 a limited amount depending on the length(s) of the guide cavities 242 and the rails 216.
(57) Referring now to
(58) The cartridge assembly 200 is configured such that the pellets that are dispensed from the cartridge 202 are collected within a portion of the cover 204 located adjacent to the first end 220 thereof, so that they are not lost and can be easily accessed by a user. The cover 204 comprises a plate or baffle 218 located a distance X from the first end 220 and extending laterally (with respect to the longitudinal axis of the cover 204). The distance X may be between about 10 mm and 20 mm, for example 11 mm and 14 mm.
(59) In the illustrated embodiment, the cartridge 202 comprises two dispensing mechanisms 300, each of which is separately configured to dispense a drug in pellet form and comprises an outlet end 302 that rests on a portion of the baffle 218. In accordance with various aspects, the apparatus 10 is configured so that one or more drugs dispensed from the dispensing mechanism(s) 300 will fall into a collection region 230 of the cover 204. This means, for example, that a user can control the dispensing and subsequent handling of one or more drug with greater ease. In various embodiments, more than two dispensing mechanisms 300 may be provided, or a single dispensing mechanism 300 may be provided.
(60) A further function of the cover 204 is to contain the pellets as they are expelled from the dispensing mechanisms 300 of the cartridge 202. For example, upon exiting the dispensing mechanisms 300 the pellets may have a large amount of energy (e.g., the method of dispensing may input a large amount of kinetic energy to the pellets) and so the pellets may be liable to, e.g., bounce off opposing surfaces if the cover 204 were not present.
(61) The collection region 230 of the cover 204 forms an enclosed cavity when the apparatus 10 is in its assembled state (e.g., as shown in
(62) In order to access the one or more drugs contained within the cartridge 202, a user may move the cover 204 from its first position as shown in
(63) Referring back to
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(65) In the assembled state of the apparatus 10 (as shown, e.g., in
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(67) In the illustrated embodiment the aperture 227 is teardrop shaped, which directs pellets easily from the collection region 230. However, other shapes are possible, for example circular, square, etc. This embodiment may allow for enhanced tamper resistance, since it would restrict users from accessing the collection tray 230, and specifically the output ends of the cartridge cylinders.
(68) As described above, therefore, various embodiments of an apparatus 10 are described that includes a cover 204 that is configured to collect and dispense pellets during a dosing operation. Once a dosing operation is complete (for example, once the cartridge 202 has dispensed one or more doses of one or more drugs), the user can slide the cover 204 outwards to reveal the collection region 230. This allows one or more drugs, in particular drugs in pellet form, to be poured from the apparatus 10 onto e.g. a suitable receptacle or compatible foodstuff in a controlled manner.
(69) When the cover 204 is in its first, closed or engaged position (as shown in
(70) The one or more drugs may be dispensed by a user upon operation of the control unit 100, such that the drugs in pellet form are dispensed from the cartridge 202 into the collection region 230. The pellets are then held in this collection region and are prevented from leaving at least in part by the baffle 218, which baffle 218 is configured to follow the contour of the cartridge housing 240 and/or dispensing mechanisms 300 and assist in providing the enclosed cavity of the collection region 230 when the cover 204 is in its first position.
(71) As described above, in one embodiment (see, e.g.,
(72) In another embodiment, as described with above with reference to
(73) In various embodiments the cover 204 may be replaced by other features that achieve a similar function.
(74) For example, in various embodiments as shown in
(75) Although not shown at present in
(76) In various embodiments as shown in
(77) Similar to the rotating barrel 404 embodiment of
(78) Referring now to
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(80) In order to lock the cartridge 202 into position with the control unit 100, a locking tab 260 is provided on the cartridge that is configured to engage (and disengage) with features of the control unit 100. The locking tab 260 is provided on an outer surface 270 of the cartridge housing 240, which outer surface 270 opposes the inner surface 110 of the cover 204. As shown in
(81) On the rear of the cover 204, there may be provided one or more tactile features (in
(82) In various embodiments, the cover 204 may be made from a substantially rigid, durable material to assist in protecting the cartridge 202 from physical damage and also increasing tamper resistance. Additionally, or alternatively (and as discussed below) the cover 204 may be made from a translucent and/or transparent material to allow a user to view the one or more drugs (e.g., pellets) deposited in the collection region 230 prior to moving the cover 204 to its second, dispensing position.
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(84) The control unit 100 comprises an outer wall 140, the exterior surface of which forms the lower surface 14 of the control unit 100. In the region of the interface 130, the outer wall 140 comprises a recess or cavity 142 that is configured to mate with a flange or lip 262 of the locking tab 260. The flange or lip 262 may comprise a triangular shape so that as the cartridge 202 is moved into engagement with the control unit 100, the flange or lip 262 comprises a ramped surface 265 that contacts an end surface 144 of the outer wall 140, such that the ramped surface 265 rides along the end surface 144 and forces the locking tab 260 downwards so that it passes the end surface 144 of the outer wall 140. The locking tab 260 is resilient, such that upon reaching the recess or cavity 142, the flange or lip 262 will spring back into the recess or cavity 142. In this position (as shown in
(85) The locking tab 260 may comprise a tactile feature 264 (in the illustrated embodiment an eject symbol) that is configured to prompt the user to depress the locking tab 260 when it is desired to disengage the cartridge 202 and cartridge assembly 200 from the control unit 100. In doing so, the flange or lip 262 moves downwards and out of the recess or cavity 142 so that the cartridge 202 and cartridge assembly 200 can slide away from the control unit 100.
(86) The cover 204 also comprises a tactile feature 228 on the outer surface 214 thereof (in the illustrated embodiment three parallel lines or depressions) and adjacent to the locking tab 260 when the cartridge assembly 200 is engaged with the control unit 100. The tactile feature 228 on the outer surface 214 of the cover 204 is configured to prompt the user to use this portion of the cover 204 to slide the cover 204 into its second, dispensing position so that a user can access one or more drugs contained within the collection region 230 thereof. Sliding the cover 204 into its second position in this manner also reveals the tactile feature 264 located on the locking tab 260 of the cartridge 202. In other words, the tactile feature 264 that prompts the user to depress the locking tab 260 to disengage the cartridge 202 is hidden behind the cover 204 prior to dispensing of any drugs from the cover 204. This reduces the chance that the cartridge 202 will be ejected accidentally during dispensing.
(87) In various embodiments, the cover 204 may be made of a transparent or translucent material so that a user may see the drugs (e.g., pellets) deposited in the collection region 230 when the cover 204 is in its first position, i.e., prior to moving the cover 204 to its second, dispensing position. This can reduce the chance that a user will open the cover 204 unintentionally, and, e.g., accidentally spill part or all of a dosage. Additionally, or alternatively the cover 204 may be colored or marked differently to the other portions of the apparatus 10, for example the cartridge 202 and/or control unit 100, so that a user can easily distinguish and/or determine the function of the cover 204 from the other parts of the apparatus 10.
(88) Generally, as discussed above the cartridge assembly 200 and control unit 100 are configured to engage one another to allow the control unit 100 to operate the cartridge mechanism so as to dispense drugs contained within the cartridge 202. This engagement is initiated by inserting the cartridge assembly 200 into the first portion 110 of the control unit 100 (see
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(91) The cartridge 202 comprises one or more male connection elements 280 that each form part of a respective dispensing mechanism 300 located within the cartridge 202 as described above. The male connection elements 280 are located at the mating end 250 of the cartridge 202 and are held within circular cavities 282 formed in the external surface of the mating end 250 (although the cavities 282 need not be circular). Rotation of the male connection elements 280 may cause actuation of a respective dispensing mechanism 300, such that, upon rotation of the male connection element 280 one or more drugs, e.g., in pellet form, are dispensed from the cartridge 202. In the illustrated embodiment, the male connection elements 280 are presented as star elements, although any suitable rotatable, connection element may be used.
(92) The cartridge 202 further comprises one or more movable pins 284 that form part of respective locking members or plates 290 (see
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(94) As seen in
(95) Although the interface 130 is described as comprising female connection elements, and the cartridge 202 as comprising male connection elements, in various embodiments these may be switched so that the interface 130 comprises male connection elements, and the cartridge 202 comprises female connection elements. It will be appreciated that the function of the connection elements on the interface 130 may remain the same, that is, to drive the connection elements on the cartridge, and in turn the dispensing mechanisms 300 within the cartridge 202. The use of male connection elements on the cartridge, as shown, can lead to improved tamper resistance since it is generally more difficult to actuate a male connection element without the corresponding female connection element than it would be vice versa.
(96) The interface 130 further comprises one or more static pins 184 that are configured to abut the movable pins 284 of the cartridge 202 upon engagement of the cartridge 202 with the control unit 100. The one or more static pins 184 are configured to push the movable pins 284 in a direction away from the interface 130 when the cartridge 202 is moved into engagement with the control unit 100.
(97) According to various aspects, the dispensing mechanism(s) 300 within the cartridge 202 may only be actuated upon engagement of the cartridge 202 with the control unit 100. In order to achieve this, the movable pins 284 form part of respective locking plates 290 (as mentioned above) that are configured to prevent actuation of the dispensing mechanism(s) 300 in a first, locking position and permit actuation of the dispensing mechanisms 300 in a second, unlocked position.
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(99) With reference to
(100) The locking element 290 is disposed generally concentrically around the male connection element 280, and is biased by a resilient member 294 (e.g., a spring) in a direction towards the interface 130 of the control unit 100 when the cartridge 202 is approaching an engaged position therewith. The locking plate 290 is movable in a direction along a longitudinal axis Y of the connection element 280 (and optionally the shaft 304), wherein the connection element 280 is configured to rotate about the longitudinal axis Y to actuate the dispensing mechanism 300 as described above.
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(102) In its unlocked position the first locking plate 290A exposes one or more radial extensions 286 of the male connection element 280A that define circumferential cavities 287 therebetween. The radial extensions 286 may comprise radially and axially extending surfaces with respect to a rotational axis of the respective shaft 304. The locking plates 290A, 290B comprise one or more teeth 292 that are configured to enter respective ones of the cavities 287 in the locking position, and move out of their respective cavity 287 in the unlocking position. The teeth 292 may extend circumferentially with respect to the rotational axis of the respective shaft 304.
(103) The locking plates 290A, 290B are both restricted from rotational movement, which means that in the locking position (as exhibited by the second locking plate 290B) the male connection element 280B cannot rotate due to the engagement of the teeth 292 within their respective cavities 287. In contrast, in the unlocked position (as exhibited by the first locking plate 290A) the male connection element 280A is free to rotate due to the disengagement of the circumferential teeth 292 from their respective cavities 287. That is, in the locking position the teeth 292 of the locking plates 290 may occupy the same circumferential plane as the radial extensions 286, with respect to the rotational axis of the respective shaft 304, preventing rotation of the respective shaft 304, and then as the locking plates 290 move to their unlocked position the teeth 292 move out of the same circumferential plane to permit rotation of the respective shaft 304.
(104) In order to operate the assembly 10, a user may slide the cartridge assembly 200 into the control unit 100, during which they will receive minimal resistance, until the interface of the cartridge assembly 200 contacts the cooperating interface of the control unit 100. At this point the pins 284 on the cartridge assembly 200 contact the cooperating pins 184 on the control unit 100, which begins to move the locking plates 290 from their first, locking positions to their second, unlocked positions. Prior to any interaction between the interfaces of the cartridge assembly 200 and the control unit 100, as discussed above the locking plates 290 prevent rotation of the shaft 304 and actuation of the dispensing mechanisms 300. Once the interfaces of the cartridge assembly 200 and the control unit 100 are connected, and the cartridge assembly 200 is fully docked with the control unit 100, the locking plates 290 move into their second, unlocked position, which permits rotation of the shaft 304 and actuation of the dispensing mechanism 300.
(105) The apparatus 10 may comprise one or more features configured to latch the cartridge assembly 200 to the control unit 100 when it is fully docked therewith, and prevent relative movement between the cartridge assembly 200 and the control unit 100. For example, the locking tab 260 (
(106) A user may eject the cartridge assembly 200 by drawing back the cover 204 to expose the locking tab 260, e.g., an eject button thereon. The user may then push down on the locking tab 260, flexing it downwards and allowing the cartridge assembly 200 to slide relative to the control unit 100. In embodiments involving the use of resilient members 294, these may push back against the control unit 100, and assist in sliding the cartridge assembly 200 away from the control unit 100.
(107) The control unit 100 may comprise a computing device, for example including a processor and memory, wherein the computing device may be configured to receive instructions or signals from the user interface 102 and process these to output one or more commands or control signals. For example, a control signal may be sent from the computing device to one or more motors contained within the control unit 100 that are configured to actuate the one or more dispensing mechanisms 300 within the cartridge assembly 200 as described above.
(108) In various embodiments, the control unit 100 (e.g. the computing device thereof) may be configured to detect the cartridge assembly 200 being fully docked with the control unit 100. The control unit 100 may be configured to actuate the one or more dispensing mechanisms 300 within the cartridge assembly 200 only when the cartridge assembly 200 is fully docked therewith. For example, the computing device may only send a control signal to operate one or more motors contained within the control unit 100 once the cartridge assembly 200 is fully docked.
(109) In various embodiments, the cartridge assembly 200 may contain a memory chip that, when docked, the control unit 100 (e.g., the computing device thereof) can detect and read. The memory chip on the cartridge assembly 200 may contain information regarding the cartridge assembly 200, such as the type and amount of drugs contained within the cartridge assembly 200. Additionally, or alternatively the memory chip may contain a specific identifier for that particular cartridge assembly 200. The control unit 100 may detect that a specific cartridge assembly 200 has been docked therewith, and from that point onward pair with that cartridge assembly 200 such that the control unit 100 does not work with other cartridge assemblies. This can prevent cartridge assemblies being swapped between control units, effectively forming a digital security seal.
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(111) The apparatus 10 comprises a control unit 100 that may comprise any of the features referred to above in respect of the previous embodiments, including for example the display 104 and input device or user interface 102. The apparatus 10 further comprises a cartridge assembly 200 configured to mate with the control unit 100 in the same manner as the previous embodiments, that is comprising the various actuation and dispensing mechanisms 300 that are described above. Instead of having a sliding cover 204 that forms the outer surface of the apparatus 10, in this embodiment the cartridge 202 itself is configured to mate with the control unit 100 such that the outer surface of the cartridge sits flush with the outer surface of the control unit 100 as shown in
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(113) The cap 600 is removable and/or detachable (e.g., completely, as shown in
(114) The cap 600 may be configured to connect to remainder of the apparatus 10 (e.g., the cartridge 202 and/or control unit 100) by any suitable manner, for example an interference fit, magnetic latch, clip fastener or screw connection. The cap 600 could be connected to the remainder of the apparatus 10, e.g., the cartridge 202 and/or control unit 100 by a snap fit, which provides a convenient method of detaching and re-attaching the cap or cover.
(115) The cap 600 may comprise a base portion 602 and one or more side portions 604 extending from the base portion 602. The one or more side portions 604 may be configured to connect to the cartridge 202 and/or control unit 100 so as to provide a seal (e.g., a hermetic seal) between the cap 600 and the remainder of the apparatus 10 (e.g., cartridge 202 and/or control unit 100). In this manner, the cap 600 may form a cup configured to hold pellets dispensed from the cartridge 202 (e.g., the dispensing mechanisms 300 thereof).
(116) The apparatus 10 may comprise a funnel 550, which may be similar to the funnel 500 described above in respect of
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(118) The cap 600 may be configured to connect to the cartridge 202 at the dispensing end 250 thereof so as to cover the dispensing end 250 and create a collection region 630 configured to receive and store drugs dispensed from the one or more dispensing mechanisms 300 of the cartridge 202. The cap 600 is movable between a first position in which the collection region 630 forms an enclosed cavity, and a second position (i.e., detached) in which the collection region 630 is exposed such that a user can access drugs contained therein.
(119) In various embodiments, and similar to the cover 200, at least part of the cover or cap 600 in various embodiments may be made of a transparent or translucent material so that a user may see the drugs (e.g., pellets) deposited in the collection region 630 of the cover or cap 600. For example, at least the portion of the cap 600 corresponding to the upper and/or lower surface of the apparatus 10 may be transparent or translucent.
(120) The funnel 550 may comprise an inlet end 552 configured to be placed over the outlet end and/or dispensing mechanism(s) 300 of the cartridge 202, so as to receive pellets that are dispensed therefrom. The funnel 550 may further comprise an outlet end 554 that is positioned at least partially within the collection region 630. In this manner, the funnel 550 may be configured to direct pellets from the cartridge 202 and into the collection region 630.
(121) The funnel 550 tapers from the inlet end 552 to the outlet end 554, wherein the outlet end 554 may be offset or otherwise positioned so that pellets are directed into a specific portion of the collection region 630. For example, the outlet end 554 of the funnel 550 may be positioned adjacent and/or overlying the specific portion of the collection region 630.
(122) The outlet end 554 of the funnel 550 may be biased towards a surface 632 of the collection region 630, which surface 632 may be positioned on the side of the cap 600 corresponding to the lower surface 14 of the apparatus 10, and/or may correspond to a side portion 604 of the cap 600 that itself forms part of the lower surface 14 of the apparatus 10. The specific portion may be a corner of the cap 600, a central region of the cap 600 or any other suitable portion as will be described in more detail below.
(123) The funnel 550 may be configured so that pellets are directed into a bottom corner of the cap 600 (wherein the bottom corner comprises the surface 632 described above), which corner is positioned on the same side as the lower surface 14 of the apparatus 10. That is, the outlet end 554 of the funnel 550 may be positioned adjacent and/or overlying this corner or surface 632 of the cap 600.
(124) The funnel 550 may be configured to allow a directed removal of the cap 600, such that a user is directed to remove the cap 600 in a certain direction. For example, and as shown in
(125) Accordingly, a relatively small gap G1 will be present between the outlet end 554 of the funnel 550 and the respective side portion 604 of the cap 600 on one side (in this case the lower surface 14 of the apparatus 10), and a relatively large gap G2 will be present between the outlet end 554 of the funnel 550 and the respective side portion 604 of the cap 600 on the other, opposing side (in this case the upper surface 12 of the apparatus 10).
(126) As a result of this, a user will be directed to remove the cap 600 in a direction as shown in
(127) The above features can combine to lower the chance that pellets dispensed into the collection region 630 are lost (e.g., spilled) as the cap 600 is removed. In the embodiment of
(128) The cap 600 may be further optimized to facilitate the pouring of pellets therefrom, and in various embodiments may have certain features that assist in this action as described below.
(129)
(130) The cap 600 may comprise corner portions 604b located on the side portions 604 of the cap 600 corresponding to the upper surface 12 of the apparatus 10. These corner portions 604b may provide separate (but identical) pouring lips 606b of the cap 600 that are opposite the pouring lip 606a formed by the lower surface 604a. Since the pouring lips 606b involve the sharp corners of the cap 600, they may be used for more targeted pouring of pellets than the wider pouring lip 606a, as indicated by arrows 2.
(131) Other arrangements are envisaged wherein one or more pouring lips are provided on the cap 600 by manipulating the one or more side portions 604 thereof. Any suitable shape of the side portions 604 may be used as will be appreciated by a person of skill in the art.
(132) The curved nature of the cap 600 as shown in
(133)
(134) The specific portion 640 may correspond to a region or portion of the cap 600 in which pellets are configured to pool or gather as they fall into the cap 600 (e.g., when it is upright). One or more surfaces (e.g., a tapered surface(s) 622) of the inserts or solid portions 620 may lead to the specific portion 640.
(135) Various suitable geometries could be used in connection with the one or more inserts or solid portions 620, which could depend on pellet size and the required pouring characteristics (e.g., for different users). The one or more inserts 620 may be provided in modular form, so that a user or manufacturer could select a plurality of different inserts that provide the most practical pouring technique for all users. In various embodiments the steepness of one or more surfaces of the one or more inserts or solid portions 620 could be varied or tailored for specific requirements. In addition, or a location of the specific portion 640, curvature of the one or more surfaces (e.g., the tapered surface(s) 622), height or thickness of the insert or solid portion 620 could be varied.
(136) In various embodiments the one or more inserts or solid portions 620 may comprise one or more of contours, protrusions, bump, ridges, cavities, embossments, etc., which may be configured to direct or channel pellets towards the specific portion 640.
(137) In the embodiment of
(138) In the embodiment of
(139) Of course, many other arrangements of insert are envisaged that could be configured to direct pellets into a specific portion similar to the embodiments described in respect of
(140) It is further envisaged that an insert or solid portion may be used to create a funneling effect during pouring of the pellets from the cap 600. For example, an insert or solid portion of the cap 600 could be shaped so as to direct pellets contained within the collection region 630 to one or more of the pouring lips, for example a pouring lip 606a, 606b as described above. The skilled person could envisage how an insert or solid portion may be configured in this manner, for example an insert or solid portion could provide a channel or valley for pellets that leads from the collection region to one or more of the pouring lips.
(141)
(142) In this embodiment the cap 600 further comprises a cavity 650 located within the insert 620 and tapered surface 622c, such that it forms a depression in the tapered surface 622c towards the base 602 of the cap 600. The cavity 650 is shaped so as to form a collection region 630 at a base 654 thereof, wherein the tapered surface 622b is configured to direct pellets into the cavity 650 as they are dispensed into the cap 600. The cavity 650 itself increases in size as one moves from the top (e.g., the rim 608) of the cap 600 to the base 602 of the cap 600, and itself comprises a sloping surface 652 configured to direct pellets to the base 654 of the cavity 650 once they enter the cavity 650, e.g. from the tapered surface 622b.
(143) The features of this embodiment mean that the cap 600 can be inverted, as shown in
(144) The insert or solid portion (e.g., the insert 620 shown in
(145)
(146)
(147) The predominant direction of removal of the cap 600, as described above in respect of
(148) A rolling pivot may be provided between the cap 600 and the funnel 550. For example, the funnel 550 may comprise a curved surface 559 and the cap 600 may be configured to roll over the curved surface 559 as it is removed (e.g., in the predominant direction of removal described above). In the illustrated embodiment, the upper surface 558 of the funnel 550 comprises a curved portion 559 adjacent an opposing inside surface 609 of the cap 600. As the cap 600 is removed the inside surface 609 thereof is configured to roll over and/or across the curved portion 559 of the funnel 550, which can create a ramp to gently rotate the cap 600 to an open position. The use of a rolling pivot or curved surface lowers the chances of a jerky opening, which can leads to pellets being lost through spillage.
(149) It should also be noted that the funnel 550 can aid in the replacement of the cap 600, by ensuring that the cap 600 aligns properly with the remainder of the apparatus 10 as it is being connected thereto.
(150)
(151) The tactile area 660 may be used to improve a user's grip as they manipulate the cap 600, for example as shown and described above, such as in respect of
(152) As shown in the illustrated embodiment, the tactile area 660 may be applied only to the side portion 604 of the cap 600 that forms part of the upper surface 12 of the apparatus 10. This can help to indicate to a user that they should push on this region of the cap 600 in order to remove the cap 600 as described above, e.g., in respect of
(153)
(154) These embodiments may be combined with those in which the cap 600 (or at least the side portion 604 that forms part of the upper surface 12 of the apparatus 10) is provided as transparent or translucent, in which case positioning the tactile area 660 on this portion of the cap 600 would mean that a user is able to easily view drugs (e.g., pellets) that are dispensed into the collection region 630 of the cap 600. This is indicated by the arrow 664 in
(155)
(156) In addition, when combined with embodiments in which the cap 600 (or at least the side portion 604 that forms part of the upper surface 12 of the apparatus 10) is transparent or translucent, positioning the tactile area 660 on this portion of the cap 600 would mean that a user is able to very easily view drugs (e.g., pellets) that are dispensed into the collection region 630 of the cap 600. This is indicated by the arrows 666 in in
(157) Alternatively, or additionally to the texture shown in
(158)
(159) The funnels 550 described herein may be modified in order to provide a controlled fallout of pellets from the cartridge 202 into the collection region 630. For example, one or more screens may extend across the outlet end 554 (or 554′) of the funnel 550, wherein the one or more screens may be configured to catch pellets dispensed from the cartridge 202 and temporarily arrest them before they are dispensed into the collection region 630.
(160)
(161) The bars 572 may be teardrop shaped, as shown in
(162) Providing a screen as described above, and in particular a grill 570 as shown in
(163) The one or more screens may be configured such that pellets are more inclined to fall through the screen in a first, dispensing direction (see arrow 574 in
(164) The one or more screens may be provided in any suitable form, as shown in
(165)
(166)
(167)
(168)
(169) As discussed above the cartridge assembly 200 and control unit 100 are configured to engage one another to allow the control unit 100 to operate the cartridge mechanism so as to dispense drugs contained within the cartridge 202. This engagement may be initiated by inserting the cartridge assembly 200 into the first portion 110 of the control unit 100 (see
(170) In the embodiment of
(171)
(172)
(173) That is, a locking member may be made up of a first ring 720, a second ring 722 and one or more connecting elements 724. The locking member, including the first ring 720, second ring 722 and connecting elements 724, is fixed against rotation, for example using a tab 726 that engages a non-rotating portion of the apparatus 10.
(174) The locking member may surround each receiving element 712 and may be configured to lock the spline teeth 714 of the receiving elements 712 against rotation when the cartridge 202 is not engaged with the control unit 100. Upon engagement of the cartridge 202 with the control unit 100, part of each locking member is configured to move (as discussed in more detail below) so as to permit rotation of the receiving elements 712 and allow actuation of the respective dispensing mechanism 300.
(175)
(176) The receiving element 712 is shown as forming an end part of a shaft 304 of a dispensing mechanism 300 as described above. As such, rotation of the receiving element 712 causes rotation of the shaft 304 and, in turn, actuation of the dispensing mechanism 300 associated with the shaft 304. The first ring 720 of the locking member initially surrounds the receiving element 712, and specifically radially extending surfaces of the receiving element, wherein the first ring 720 comprises teeth 721 configured to selectively engage with the radially extending surfaces of the receiving element 712.
(177) In this embodiment the radially extending surfaces are conveniently the radially extending surfaces of the spline teeth 714 of the receiving element 712. This has been found to simplify the number of parts required to provide the locking feature of the rotating elements (i.e., shafts 304) of the dispensing mechanisms 300 of the cartridge 202.
(178) A second ring 722 of the locking member is connected to the first ring 720, and the first ring 720 is connected to the second ring 722 via one or more resilient connecting elements 724, which are configured to deform in the directed of arrow 3 upon application of a pressure be applied to the first ring 720 in the same direction.
(179) The first ring 720 is slidably received on the outer surface of the shaft 304, such that the first ring 720 can slide between a first position as shown in
(180) In the first position the teeth 721 of the first ring 720 engage with the spline teeth 714 of the receiving element 712, so as to prevent rotation of the shaft 304. In the second position the first ring 720 has moved along the axis of the shaft 304 in the direction of arrow 3, so that the teeth 721 of the first ring 720 are now disengaged from the spline teeth 714 of the receiving element 712, so as to permit rotation of the shaft 304.
(181) The resilient connecting elements 724 permit the sliding movement of the first ring 720. The sliding movement itself may be caused by engagement of the first ring 720 with one or more elements 132 of the interface 130 on the control unit 100. These elements 132 could take the form of pins, for example similar to the pins 184 shown in
(182)
(183) The combined locking member 800 is for simultaneous locking of the two receiving elements 712 shown in
(184) The locking member 800 (and specifically the rings 820 thereof) may surround each receiving element 712 and may be configured to lock the spline teeth 714 of the receiving elements 712 against rotation when the cartridge 202 is not engaged with the control unit 100. Upon engagement of the cartridge 202 with the control unit 100, part of the locking member is configured to move (as discussed in more detail below) so as to permit rotation of the receiving elements 712 and allow actuation of the respective dispensing mechanism 300.
(185) The rings 820 of the locking member initially surround a respective receiving element 712, and specifically radially extending surfaces (e.g., of the spline teeth 714) of the receiving elements, wherein each ring 820 comprises teeth 821 configured to selectively engage with the radially extending surfaces of the receiving elements 712.
(186) The locking member 800 comprises a single resilient member (e.g., spring) 824 of the locking member, which is connected to both rings 820 and configured to deform upon application of a pressure applied to the first ring 820. The resilient member 824 may be configured to become biased against a portion of the control unit 100 as the locking member 800 moves between its first and second position.
(187) The rings 820 are slidably received on the outer surface of the shafts 304, such that the rings 820 can slide between a first position and a second position, in a similar manner to the rings 720 of
(188) In the first position the teeth 821 of the rings 820 engage with the spline teeth 714 of the receiving elements 712, so as to prevent rotation of the shafts 304. In the second position the rings 820 have moved along the axes of the shafts 304 (e.g., in the direction of arrow 3), so that the teeth 821 of the rings 820 are now disengaged from the spline teeth 714 of the receiving elements 712, so as to permit rotation of the shafts 304.
(189) The resilient member 724 permits the sliding movement of the rings 820. The sliding movement itself may be caused by engagement of the rings 820 with one or more elements 132 of the interface 130 on the control unit 100. These elements 132 could take the form of pins, for example similar to the pins 184 shown in
(190) As such, the combined locking member 820 comprises lock rings 820 that beneficially have a common resilient member. The rings 820 may be pushed back by the control unit 100 during docking of a cartridge 200 to the control unit 100, in a similar manner to the rings 720 of the previous embodiment. When undocking the cartridge 200 from the control unit 100, the combined locking member 820 may spring back and reengages the lock to prevent actuation of the dispensing mechanism(s).
(191) As with the locking members 720 described earlier, the locking member 800, including the rings 820 are fixed against rotation, for example using one or more tabs 826 that engage a non-rotating portion of the apparatus 10.
(192) Generally, the devices disclosed herein may be aimed at providing an accurate dose of medication by weight, and also providing a simple mechanism by which to adjust a dosage and/or titrate a medication during use. Various mechanical features are provided for ease of dispensing a dosage, including swallowing a dose and providing general convenience when doing this. Various embodiments are aimed at monitoring compliance as well.
(193) The handheld apparatus 10 may combine medical knowledge with digital capabilities. The control unit 100 may be reusable, and may be combined with various different cartridge assemblies 200 that are prefilled with a prescribed medication. For ADHD, for example, a cartridge assembly 200 could be prefilled with the relevant medication for use over a one-month period. The cartridges 202 could be filled with pellets or granules (i.e., the oral dosage form) of less than 1000 nm in size (each). The granules could be taken with liquid or soft foods supporting swallowing of the medicine. The digitization of the control unit 100 can enable accurate dose setting and titration. Although the apparatus have a particular use with ADHD, the technology disclosed herein is applicable to many other treatments and especially for pediatric use or for use in psychiatry, neurology, cardio-metabolic disorders or oral cancer treatments.
(194) Example treatments that may be associated with the apparatus described herein are Attention Deficit Hyperactivity Disorder (“ADHD”—wherein the medication used in the apparatus could include amphetamines and/or methylphenidate), general pain (wherein the medication could include one or more of fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocodone, oxycodone, hydromorphone, naltrexone, buprenorphine and methadone), immunosuppression post organ transplant (wherein the medication could include one or more of tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate and azathioprine), diabetes (wherein the medication could include one or more of sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, Dapagliflozin, empagliflozin and semaglutide), heart failure (wherein the medication could include one or more of carvedilol, metoprolol, bisoprolol and diurethics), Parkinson's disease (“PD”—wherein the medication could include levodopa and/or carbidopa), epilepsy (wherein the medication could include one or more of sodium valproate, carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethosuximide and topiramate), depression (wherein the medication could include one or more of Citalopram, bupropion, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine and reboxetine), schizophrenia (wherein the medication could include one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone and olanzapine), cancer, animal health. For example, the apparatus 10 may be combined with medication (e.g., in pellet form) that is aimed or associated with the aforementioned treatments, for example any or all of those described above.
(195) Various embodiments disclosed herein are aimed at improving how a user is prompted to dispense the medication from the apparatus 10 to either a receptacle, liquid or soft foods or into their mouth. For example, as described above in relation to
(196) The apparatus 10 disclosed herein may provide simpler dose setting and accurate dose titration, especially for children. Use of a medication formulated as small pellets or granules can support accurate dose adjustment and help pediatrics with swallowing issues. Developments for pediatric medicines have generally included different formulations or devices which go toward solving one or two of the challenges faced with this patient population. By combining the medication with a digital capability with the handheld apparatus 10 disclosed herein, leads to improvements in dose setting, titration, ease of use, swallow-ability and compliance. The technology can be tailored to different treatment regimens for pediatric populations including combination therapy. Other areas for treatment using the apparatus 10 disclosed herein could be epilepsy and general pain alleviation. The dispensing technology could also be developed for infectious diseases, for example in children, for example the medication used with the apparatus (e.g., in pellet form) could include amoxicillin and/or penicillin.
(197) The control unit 100 (in any of the aspects or embodiments described herein) may include an input device or user interface 102, which may include one or more buttons for operating the apparatus 10, for example the dispensing mechanisms 300 therein. The control unit 100 may incorporate means to ensure that only the correct or a specific user, or type of user can handle and/or operate the device. For example, the control unit 100 may incorporate a fingerprint sensor configured to detect a fingerprint of a user, or a pin code technology.
(198) The control unit 100 may comprise a control system configured to operate the various electrical and mechanical parts of the apparatus 10, for example the user interface 102, display 104 and dispensing mechanisms 300.
(199) The control system may be configured to improve the approach to dosing oral medicines, enabled by the various features of the apparatus 10 described herein. The digitalization of medication using techniques described herein may have several advantages compared to providing, e.g., conventional pills in a bottle. A prefilled cartridge 202 (e.g., for ADHD, with a one-month prescription) may have an integrated circuit board trip that communicates relevant information to the control unit. The control unit 100, and specifically the control system thereof, may set the dosage, prevent taking more than a maximum dosage, allow titration, and ensure notification of tampering. The control system may record dispensing of medication, for example over a defined period (e.g., the one month prescription).
(200) The control system could be configured to provide dosage reminders, and also a log of the previous dose taken, for example on the display 104 of the control unit 100. It is envisaged that further personalization could be achieved through provision of a wireless connection to external devices, such as a smart phone, smart watch or other smart device, sensors or wearables. The wireless connection could be using Bluetooth or any other suitable wireless platform. The control system could combine with an application on a smart phone, smart watch or other smart device, or could be implemented at least partially on such devices.
(201) The control system could be configured to receive symptom reports from a user and log these in connection with the medication being provided. For example, with ADHD the symptoms could include concentration, hyperactivity, behavior, work productivity, etc., which could support a treatment program and other outcomes.
(202) The control system may be combined with, or at least partially implemented on an application for a caregiver. For example, the control system may be configured to send reports to such an application, e.g., wirelessly and/or through the Internet. The report could include compliance data, e.g., has the user been taking dosages in line with a treatment program. The report could include data or information regarding the dose taken, and the time that the dose was dispensed, as well as the symptoms described above.
(203) The methods, method steps, or functional features disclosed herein, for example in connection with the control system of the control unit 100 described above, may be implemented at least partially using software, e.g., computer programs. These may be located on a data processor on the control unit 100 itself. It will thus be seen that when viewed from further aspects the present invention provides computer software specifically adapted to carry out the methods, method steps, or functional features herein described when installed on data processing means, a computer program element comprising computer software code portions for performing the methods, method steps, or functional features herein described when the program element is run on data processing means, and a computer program comprising code means adapted to perform all the steps of a methods, method steps, or functional features herein described when the program is run on a data processing system. The data processor may be a microprocessor system, a programmable FPGA (field programmable gate array), etc.
(204) This could e.g. be a fingerprint sensor or a code pattern on the display that is needed to activate the device (e.g. up, up, down, right, up, left on the D-pad) so that parents and caregivers can use the device without the need for the specific fingerprint (also lower cost without the fingerprint sensor).
(205) Although the present invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the scope of the invention as set forth in the accompanying claims.