Drug group delivery device

Abstract

A device (100) for dispensing a medicament or medicament in the form of pellets is described. The apparatus comprises a cartridge (200) comprising a chamber (220) for containing a plurality of pellets and a screw pump, where the screw pump is configured to receive pellets from the chamber (220) and to transmit the pellets from the chamber (220) upon rotation of the screw pump to dispense the pellets from the apparatus (100) by the screw pump. The apparatus further includes a rotating member (250) extending through the cartridge (200) and configured to rotate the screw pump to dispense pellets therefrom. The cartridge (200) further comprises a tapered portion (207) configured to direct pellets contained within the chamber (220) into the screw pump for dispensing from the device (100) by the screw pump as described above. The screw pump is positioned outside the tapered portion (207) of the cartridge (200).

Description

[0001] The present invention is a divisional application of the patent with application number 202080052226X, application date June 19, 2020, and invention name “Drug Granule Delivery Device”. Technical Field

[0002] The present disclosure relates generally to drug pellet (eg, drug or medicament in pellet form) delivery devices and various aspects of such devices, such as relating to dispensing of pellets from the devices and the operation and mechanics of such devices. Background Art

[0003] Solid oral dosage form ("ODF") medications can be prepared, for example, in tablet or granule form. Tablets or granules can contain different substances, the main ingredient of which is the active pharmaceutical ingredient ("API"). Drug granules can be administered to patients in the form of pre-filled capsules, or compressed with other materials in tablets. Dispensing mechanisms for various types of ODFs are known, and can range from blister pack type devices, in which individual tablets can be retained in recesses and retained therein through the use of foil, to dispensing bottles. Various more complex mechanisms are also known, particularly for other types of drug formulations, such as those in granule form, which can typically be less than 10% of a specific dose per unit.

[0004] The advantage of dispensing drugs in the form of granules is that the same dispensing device can be used to change the dosage. Another advantage is that granules are relatively easy to ingest, while tablets are sometimes crushed so that patients can ingest or swallow the tablets. Patients often use crushed or split tablets to obtain, for example, half doses of prescribed drugs, which is a process that is not recommended. Using granules can allow for more precise adjustment of dosages than can be achieved using larger dosage forms such as tablets or capsules. In addition, for modified release formulations, granules are generally more robust than larger dosage forms such as tablets in terms of food interactions.

[0005] It is desirable to improve the mechanisms for dispensing drugs in pellet form. It is recognized that such improvements would benefit many areas, such as: pediatric drugs and prescriptions; easier swallowing of antibiotics, especially in geriatric medicine; easier swallowing of chronic drugs; in the case of certain controlled substances, such as stimulants for ADHD or pain medications such as opioids; for improved control of dispensed doses or to limit the risk of overdose; for drugs that require titration or flexible adjustment at the beginning due to disease variability or because the results have been achieved, such as in the case of immunosuppression after organ transplantation; for psychiatric diseases, such as depression; for neurological disorders, such as epilepsy.

[0006] Methods for dispensing granular-type medicaments have been considered, but it has been found that the mechanics of such devices can be difficult to optimize due to the properties of the granules and their interaction with the moving parts of such devices. For example, it has been found that the granules shear, bunch or agitate within the device, leading to problems such as clogging or grinding when dispensing the granules.

[0007] It would therefore be desirable to improve the mechanics of devices used to dispense oral dosage forms of this type in order to avoid these and similar problems. Summary of the invention

[0008] Various aspects and embodiments of dispensing devices that may be used in the present invention will be described herein and relate to any aspects and embodiments of the present invention described herein insofar as they are suitable herewith.

[0009] According to the present invention, a device for distributing at least one solid oral dosage form (e.g., medicine or medicament) in the form of a granule is provided. As described below, the maximum dimension (e.g., width or diameter) of the solid oral dosage form (e.g., granule) can be between about 150 μm and about 1200 μm (or even about 1500 μm), optionally between about 200 μm and about 300 μm, between about 300 μm and about 500 μm, between about 500 μm and about 700 μm. In various embodiments, the maximum dimension (e.g., width or diameter) of the solid oral dosage form (e.g., granule) can be between about 700 μm and about 900 μm or between about 800 μm and about 1100 μm.

[0010] The device comprises:

[0011] a cartridge comprising a chamber configured to store a plurality of units of the solid oral dosage form;

[0012] a screw pump, such as an Archimedean screw, configured to receive a plurality of units of the solid oral dosage form from the chamber and, upon rotation of the screw pump, to transport the units of the solid oral dosage form from the chamber for dispensing from the device (and / or, e.g., the cartridge and / or chamber) through the screw pump (e.g., an outlet thereof);

[0013] A rotating member extends through the barrel and is configured to rotate the screw pump to dispense a plurality of units of the solid oral dosage form therefrom.

[0014] The cartridge may further include a tapered portion configured to direct the pellets contained within the chamber into the screw pump for dispensing from the device via the screw pump as described above. Although the tapered portion is essential to the first and second aspects of the invention discussed below, it may not be essential in other aspects (e.g., aspects involving threads having variable pitches).

[0015] In a first aspect of the invention, the screw pump is positioned outside the tapered portion of the barrel (e.g., offset from the tapered portion of the barrel). The tapered portion can then provide a convenient funnel or feeder for the pellets entering the screw pump, while the offset avoids undesirable interactions between the screw pump and the funnel, including any rough interfaces of the pellets. This makes it easier and more efficient to feed the pellets into the screw pump. If the screw pump is not offset from the tapered portion, a rough interface can be formed in other ways by the interaction of the screw pump with the tapered portion. The offset can be in the direction of the outlet of the screw pump.

[0016] The screw pump may not have a portion located at, within or near the conical portion, particularly any edge formed by the inner surface of the barrel at the conical portion. Offsetting the screw pump from such an edge avoids shearing of the pellets at this location, which may otherwise occur.

[0017] The barrel may include an outlet tube extending from the tapered portion of the barrel. The outlet tube may accommodate the screw pump, wherein the screw pump may be offset from a junction of the tapered portion and the outlet tube.

[0018] The conical portion may extend a distance (d) in a first direction, wherein the screw pump may be offset in the first direction from the junction of the conical portion and the outlet pipe by at least 50% of the distance. The first direction may correspond to the axial direction of the rotating member. This provides a large gap between the conical portion and the screw pump, thereby further reducing the chance of pellet damage (e.g., shearing).

[0019] The inner wall of the barrel may form at least the tapered portion and may gradually decrease from a first diameter (D1) to a second diameter (D2), wherein the first diameter (D1) is greater than the second diameter (D2). The inner wall may have a first diameter (D1) in a portion of the barrel above the tapered portion, and when the inner wall extends through the tapered portion, the inner wall may gradually decrease from the first diameter (D1) to the second diameter (D2).

[0020] The rotating member may gradually decrease from a first diameter (d1) to a second diameter (d2) as the rotating member extends through the tapered portion of the barrel, wherein the first diameter (d1) is greater than the second diameter (d2). The rotating member may have a first diameter (d1) in a portion of the barrel above the tapered portion, and may gradually decrease from the first diameter (d1) to the second diameter (d2) as the rotating member extends through the tapered portion of the barrel.

[0021] In a second aspect of the invention, the screw pump may be positioned within the conical portion of the barrel and taper with the conical portion. This means that the screw pump follows the geometry of the barrel through the conical portion, making it easier and more efficient to feed pellets from the chamber into the screw pump in use.

[0022] The inner wall of the barrel may form at least the tapered portion, and may form a funnel configured to guide the pellets contained in the chamber into the screw pump.

[0023] The barrel may include an outlet tube including the tapered portion of the barrel, and the outlet tube may accommodate the progressive cavity pump.

[0024] The tapered portion may extend a distance (d) in a first direction, the distance (d) being between about 30% and 100% of a length (L) of the outlet pipe in the first direction. The first direction may correspond to an axial direction of the rotating member. The distance (d) may be between about 40% and 60% of a length (L) of the outlet pipe (212) in the first direction.

[0025] The outer diameter of the screw pump may remain substantially flush with the inner surface of the barrel within its tapered portion.

[0026] The first and second aspects of the invention contribute to solving essentially the same problem, namely the effect of a rough interface between the screw pump and the inner surface of the chamber. This is solved in each case as discussed above and involves the same effect of easier and more efficient feeding of pellets into the screw pump. It should be noted that the invention is not limited to the first and second aspects.

[0027] In any of the aspects and embodiments described above and herein, the largest dimension of the pellets may be between about 150 μm and 1200 μm. The pellets may have other dimensions, including any specific dimensions specified elsewhere herein.

[0028] The device may further include a plurality of pellets providing an oral dosage form contained within the chamber.

[0029] The rotating member may include one or more fins positioned at the inlet of the screw pump and configured to collect pellets and guide the pellets into the screw pump. Each of the one or more fins may be aligned with and / or associated with a corresponding screw head of the screw pump. Such fins may beneficially help break up the pellets and avoid pellet clogging when the pellets enter the screw pump.

[0030] The rotating member may include one or more baffles configured to rotate with the rotating member and help move the pellets through the chamber and into the conical portion. Such baffles may beneficially help break up the pellets and avoid pellet clogging as the pellets move toward the screw pump.

[0031] In one aspect of the invention there is provided a method of using an apparatus as described above, the method comprising rotating the screw pump, for example using the rotating member, to dispense pellets from the apparatus.

[0032] The method may further comprise:

[0033] filling the chamber with granules providing an oral dosage form;

[0034] determining an amount of rotation of the screw pump that will cause a predetermined (and / or approximate) amount of the pellets to be dispensed from the device; and

[0035] The screw pump is rotated a predetermined (and / or approximate) amount to dispense the predetermined amount of pellets from the device.

[0036] In any of the aspects and embodiments described above and herein, the chamber may extend from a first end of the device to a second dispensing end of the device. The barrel may extend from a first end to a second dispensing end, and a screw pump may be positioned at the second dispensing end of the barrel.

[0037] The progressive cavity pump may be positioned at the second dispensing end of the device.

[0038] The progressive cavity pump may be gravity fed. In other words, when the device is in the dispensing orientation (eg, with the dispensing end pointing downwards), pellets contained within the chamber may be moved towards the second dispensing end at least in part by gravity.

[0039] The device may be a handheld and / or portable device. In other words, the device may be held and transported with one hand and / or may be operated with one hand.

[0040] For example, the length of the device (e.g., the entire device or cartridge) (corresponding to its longest dimension) can be no more than about 250 mm (e.g., less than about 200 mm, about 150 mm, or about 100 mm), and the width or height of the device (i.e., transverse to its length) is no more than about 50 mm, and optionally no more than about 40 mm (and in some embodiments, less than 30 mm or even less than 20 mm).

[0041] To optimize its hand-held properties, the length of the device can be between about 150 mm and about 220 mm (e.g., between about 160 mm and about 180 mm, and optionally about 165 mm), the width of the device (transverse to its length) is between about 35 mm and about 45 mm (optionally about 40 mm), and the height of the device (transverse to its width) is between about 22 mm and about 32 mm (optionally about 28 mm).

[0042] The weight of the device (or cartridge) may not exceed about 500 g, about 400 g, about 300 g, about 200 g, or even about 100 g. This can ensure that the device is light enough to carry in one hand.

[0043] The length of the barrel (or barrel assembly) (corresponding to its longest dimension) can be between about 90 mm and about 120 mm (optionally about 105 mm), the width of the barrel (transverse to its length) is between about 33 mm and about 43 mm (optionally about 40 mm), and the height of the barrel (transverse to its width) is between about 15 mm and about 32 mm, for example, between about 23 mm and about 32 mm (optionally about 28 mm). In combination with any of the above-mentioned barrel (or barrel assembly) length values, the width can alternatively be between about 33 mm and about 43 mm, and the height can alternatively be between about 15 mm and about 25 mm.

[0044] The screw pump may be or include a part of the rotating member. For example, the screw pump may include one or more threads formed around the rotating member, so that the screw pump forms a part of the rotating member. Due to the possibility that the screw pump may include one or more screw heads, the term "one or more" is used in this document, each screw head forming a separate thread. Although plural terms are used in the following text for the sake of brevity, it should be understood that the one or more threads mentioned in this document cover the singular thread or multiple threads.

[0045] The screw pump may include one or more threads with variable pitch. It has been found that this helps to transport the pellets through the screw pump, for example by packing or compressing the pellets toward its outlet. The pitch can vary along the axial length of the screw pump. For at least some (or all) of the axial length of the screw pump, the pitch can gradually (e.g., continuously) increase in the axial direction away from the outlet. In other words, for at least some (or all) of the axial length of the screw pump, the pitch can gradually (e.g., continuously) reduce in the axial direction toward the outlet.

[0046] This feature is seen as advantageous in itself and therefore, from one aspect of the invention, there is provided a cartridge, a screw pump and a rotating member as described above, wherein the screw pump comprises one or more threads having a variable pitch as described above.

[0047] In any of the aspects and embodiments described above and herein, the length of the screw segment (e.g., along the longitudinal axis of the barrel) can be defined by the length of the thread, which can be between about 10 mm and about 30 mm, such as between about 10 mm and 20 mm.

[0048] The apparatus may be configured such that when the rotating member and screw pump rotate in use, pellets travel along the threads of the screw pump from the portion of the threads extending into the chamber to the opposite end of the threads for dispensing from the screw pump.

[0049] The threads may cooperate with the inner cylindrical surface of the barrel to form a screw pump, so that when the rotating member rotates in use, the threads rotate within the inner cylindrical surface, thereby causing the pellets contained in the chamber to enter the threads and move down along the threads to be dispensed from the screw pump. It should be noted that the barrel itself may not be generally cylindrical. Rather, in order to form a screw pump, the barrel may include an inner cylindrical surface, although this should not be interpreted as necessarily meaning that the barrel itself is cylindrical in whole or in part.

[0050] The barrel and / or chamber can be any suitable shape, such as cylindrical or cuboid. The barrel and / or its chamber can be cylindrical at least in part, and the cylindrical portion of the barrel and / or chamber can include the inner cylindrical surface of the screw pump and at least a portion of the chamber for accommodating the pellets. In this embodiment, the barrel can be open at the second distribution end of the device, and the rotating member can include a screw section (forming a part of the screw pump) with an outer diameter that substantially matches the inner diameter of the barrel and / or a chamber at the second distribution end of the device.

[0051] Alternatively, the barrel can include an outlet or outlet pipe (e.g., as described above) extending from the chamber. The width or diameter of the outlet pipe can be less than the inner diameter of the chamber. The rotating member can extend into the outlet pipe so that the inner cylindrical surface of the outlet pipe forms the inner cylindrical surface of the screw pump. In these embodiments, the barrel and / or chamber can include a truncated cone or a tapered portion (e.g., as described above) at the second distribution end of the barrel and / or chamber, which guides the pellets contained in the chamber into the outlet pipe.

[0052] In various embodiments, the majority of the length of the rotating member (e.g., within the barrel) may be free of threads forming a screw pump. For example, at least about 70%, 80%, 90%, or even 95% of the length of the rotating member (e.g., within the barrel) may be free of threads forming a screw pump. This means that the threads only act on and collect pellets toward the second dispensing end of the chamber, which is advantageous for pellets positioned toward the first end because the threads do not act on or otherwise interfere with most of the pellets.

[0053] Gravity (and / or a plunger arrangement as described below) may be used to move the pellets to the dispensing end of the chamber, at which point they may be collected by the threads and drawn into a progressive cavity pump.

[0054] The device may further include a device (e.g., a plunger) configured to force the pellets contained in the chamber toward the screw pump. This device may work in addition to gravity, so that the combination of gravity and the force provided by the device causes the pellets contained in the chamber to move toward the screw pump. For example, the device may be or include a plunger in the form of a weight, the plunger being configured to rest on top of the pellets contained in the chamber when the device is in an orientation that allows the pellets to be dispensed.

[0055] The device may include a plunger configured to move along the rotating member automatically or due to the rotation of the rotating member. For example, a portion of the rotating member in the chamber may include a thread (e.g., a plunger thread, which may be different from any thread of the screw pump), and the plunger may form a nut around the rotating member, which is configured to travel along the thread of the rotating member in use, so that when the rotating member rotates, the plunger moves toward the screw pump, thereby forcing the pellets contained in the chamber toward the screw pump. The plunger may be configured to abut and / or contact the inner surface of the barrel and / or chamber, and there may be a friction fit between the plunger and the inner surface of the barrel and / or chamber to help prevent the plunger from rotating with the rotating member.

[0056] The friction fit may be particularly useful in embodiments where the plunger rotates within a cylinder (e.g., a cylindrical barrel). The friction fit described (i.e., preventing the plunger from rotating when a cylindrical barrel (and / or a cylindrical inner surface along which the plunger moves) is used) may be particularly important. For non-cylindrical barrels (or non-cylindrical surfaces), the plunger may be prevented from rotating due to the abutment of the perimeter of the plunger with the inner surface of the barrel. For example, if the barrel is square or cuboid, the plunger cannot rotate.

[0057] In various embodiments, the device may include certain features of providing a driving force to the plunger toward the pellet positioned in the chamber, such as in addition to or in addition to relying on the weight of the plunger as described above. For example, a ratchet mechanism may be used to ensure that the plunger can only move in a single direction, i.e., toward the pellet positioned in the chamber. Alternatively or additionally, an elastic member (e.g., a spring) may be provided (e.g., biased between the surface of the plunger and a portion of the barrel) to force the plunger toward the pellet positioned in the chamber. Alternatively or additionally, a pneumatic air source may be provided that may pressurize the plunger toward the pellet positioned in the chamber.

[0058] The device may include a deformable material press-fitted between a rotating member and a barrel, wherein the plunger is configured to push the deformable material along a longitudinal axis of the rotating member, and the deformable material is configured to move the pellets when it is pushed by the plunger (e.g., scraping one or more (or all) inner walls of the barrel forming the chamber) to help move the pellets toward the screw pump.

[0059] The plunger may include one or more teeth or tines extending from the body of the plunger in an axial direction (relative to the longitudinal axis of the rotating member). The teeth may include a track at a distal end (away from the body) and configured to engage a thread on the rotating member such that rotation of the rotating member causes the track to travel along the thread and move the plunger along the axis. The teeth may be configured to flex in a radial direction so that the track may disengage from the thread.

[0060] The plunger may include one or more teeth or tines extending from the body of the plunger in an axial direction (relative to the longitudinal axis of the rotating member) and biased toward the rotating member to stabilize the plunger as it travels along the axis in use.

[0061] The plunger may include a resilient device including a plurality of projections (eg, teeth or tines as described above) and a resilient member configured to bias the projections radially inwardly. The resilient member may be a resilient band extending concentrically around the rotating member.

[0062] The plunger can be gradually reduced from a first thickness adjacent to the rotating member to a second thickness at the periphery of the plunger (in a radial direction), wherein the second thickness is less than the first thickness. The periphery can be adjacent to the inner wall of the barrel forming a part of the chamber. The plunger can be gradually reduced to a sharp edge at the periphery of the plunger. The plunger can be configured to bend at the periphery in an elastic manner. This reduces friction between the plunger and the barrel and also helps to move the pellets toward the screw pump.

[0063] The device may further include a valve connected to the outlet of the screw pump and configured to prevent pellets from being dispensed from the screw pump, for example when the screw pump is not rotating or outside a dispensing operation before use, and may allow pellets to be dispensed from the screw pump during a dispensing operation, for example when the screw pump is rotating in use.

[0064] The valve may include a resilient portion, such as a rubber membrane, configured to flex open to allow dispensing of pellets when the screw pump is rotating in use, and then flex back when the screw pump is not rotating to stop the pellets from falling out of the screw pump and help seal the cartridge.

[0065] The elastic membrane can be moved between a first position and a second position, wherein in the first position the membrane blocks the end of the screw pump to prevent the pellet from being dispensed, and in the second position the membrane moves to unlock the end of the screw pump and allow the pellet to be dispensed. In various embodiments, the membrane can be configured to move due to rotation of the pellet via the screw pump and forces applied to the membrane as the screw pump rotates.

[0066] The valve may comprise an umbrella valve.

[0067] The valve may include a truncated conical portion extending from a first end of the valve connected to the outlet of the screw pump to a second end of the valve. The second end of the valve may include an outlet portion including an outlet for dispensing pellets therefrom. The valve may be configured so that when the rotating member rotates, the pellets need to be pushed out of the valve through the outlet of the valve. For example, the size of the outlet may be suitable for the size of the pellets to be dispensed, so that the minimum dimension (e.g., width) may be substantially equal to the width or diameter of the pellets, and / or may be less than about 1.5, 1.4, 1.3, 1.2 or 1.1 times the width or diameter of the pellets.

[0068] The device may include one or more actuators configured to rotate the rotating member. The actuator may be a mechanical or electromechanical actuator. The actuator may be located at the first end of the device. The actuator may be configured to rotate the rotating member. This may cause (in a related embodiment) a plunger to move downward along the screw portion of the rotating member, and / or cause the screw segment to rotate, thereby dispensing the pellets through the screw pump.

[0069] The actuator may be an electromechanical actuator (e.g., one or more motors) or include an electromechanical actuation mechanism that enables the device to repeatedly dispense precise amounts of pellets. The motor and control system may be powered by an integrated battery (which may be replaced by the user) that may be housed within the housing of the actuator.

[0070] The device may include a control system (e.g., as part of the actuator) that may be configured to dispense a dose within a predetermined time (e.g., less than 2, 3, or 5 seconds) after receiving an actuation signal from an input device or mechanism. The actuation signal may be initiated, for example, by a user pressing a suitable button or other input mechanism on the device or optionally by a different control such as a wireless or wired external control.

[0071] The actuator may include one or more motors (e.g., stepper motors) that may be configured to rotate the rotating member any suitable number of turns (e.g., steps) based on current circumstances, such as the type of medicament in the cartridge or the user. A control system may be provided in the form of a microcontroller, such as on a printed circuit board ("PCB"), which may be located within the housing of the device within the actuator.

[0072] In one aspect of the invention, there is provided a method of using the apparatus of any of the aspects and embodiments described above.

[0073] The method may include:

[0074] For example, a rotating member is used to rotate a screw pump a predetermined amount of rotation to dispense a predetermined amount of pellets from the device. The device may be a disposable or relatively inexpensive device intended to make dispensing of short-term prescriptions including but not limited to antibiotics simpler and more convenient than, for example, existing blister-packed drugs and liquid preparations.

[0075] The method may further include: filling the chamber with pellets providing an oral dosage form; determining an amount of rotation of the screw pump that will cause a predetermined amount of the pellets to be dispensed from the device; and rotating the screw pump a predetermined amount to cause the predetermined amount of pellets to be dispensed from the device.

[0076] The method may include storing pellets providing an oral dosage form within a cartridge (e.g., a chamber thereof), wherein the pellets may include a drug or compound for treating one or more of: attention deficit hyperactivity disorder ("ADHD" - wherein the drug or compound may include amphetamine and / or methylphenidate), general pain (wherein the drug or compound may include one or more of: fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocodone, oxycodone, hydromorphone, naltrexone, buprenorphine, and methadone), post-organ transplant immunosuppression (wherein the drug or compound may include one or more of: tacrolimus ), sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate and azathioprine), diabetes (wherein the drug or compound may include one or more of the following: sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, dapagliflozin, empagliflozin and semaglutide), heart failure (wherein the drug or compound may include one or more of carvedilol, metoprolol, bisoprolol and diuretics), Parkinson's disease disease) (“PD” – wherein the drug or compound may include levodopa and / or carbidopa), epilepsy (wherein the drug or compound may include one or more of: sodium valproatevalproate, carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethosuximide and topiramate), depression (wherein the drug or compound may include one or more of the following: Citalopram, bupropion, paroxetine, milnacipran, fluoxetine e), duloxetine, fluvoxamine and reboxetine), schizophrenia (wherein the drug or compound may comprise one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone and olanzapine), cancer, animal health.

[0077] The method may comprise using the device to treat one or more of: attention deficit hyperactivity disorder ("ADHD"), general pain, immunosuppression after organ transplantation, diabetes, heart failure, Parkinson's disease ("PD"), epilepsy, depression, schizophrenia, cancer, and animal health. The oral dosage form within the cartridge (e.g., its chamber), when used for a specific treatment, may comprise one or more of the drugs or compounds described above for the specific treatment.

[0078] Device can relate to more solid and long-term distributor, wherein the first part of device (for example, actuator 300 described below, 300 'and optionally rotating member 250, 250 ', 250A, 250B) comprises relatively complicated or expensive part of distribution mechanism, and one or more second parts of device (for example, one or more barrels 200 described below, 200 ', 200AB) comprises relatively simple or cheap part of distribution mechanism and medicine or oral dosage form.One or more second parts can be replaceable barrels (or replaceable integrated barrels, such as barrel 200AB described below) that can be inserted into the first part, so that the first part can be used with different barrels and different types of medicaments, medicines and dosages (for example, oral dosage forms).In certain embodiments, the first part can include the housing (see, for example, housing 400 described below) configured to keep one or more barrels, and the second part can include one or more barrels that can be inserted into the housing.

[0079] The present invention relates to the integration of tube and dispensing mechanism.Use, for example, a screw pump in the form of "Archimedes" screw mechanism to distribute pellets, which has been found to be advantageous due to its accuracy, simplicity and ease of use.In certain embodiments, the device may include a device for applying pressure to the pellets in the chamber containing the pellets, for example, using a plunger 230 as described below.Exerting pressure on the pellets in this way to make them well packaged may mean that the dosage is consistent throughout the life cycle of the tube, thereby ensuring that the first dose is similar to the volume or weight of the last dose.In addition, such operation may mean that the device can be operated in any orientation.

[0080] In some embodiments, the device further incorporates the use of a plunger mechanism that separates the pellet from the actuation mechanism of the device.

[0081] Further technical effects will become apparent from the description provided below.

[0082] definition

[0083] Granule - a single granule of a solid oral dosage form (e.g., a medicament, drug, medicine, etc.), optionally having a size (e.g., maximum dimension, width or diameter) between about 150 μm and about 1200 μm (or even about 1500 μm), optionally between about 200 μm and about 300 μm, between about 300 μm and about 900 μm, or between about 500 μm and about 700 μm. "Diameter" means that although the granule can be irregularly shaped, it is assumed to be roughly spherical. If it is not considered to be spherical, the diameter may correspond to the maximum width of the granule. The granule may or may not have a surface coating. Where a surface coating is provided, the sizes provided herein correspond to the granule with any surface coating.

[0084] In various embodiments, the size of the pellets (e.g., maximum dimension, width, or diameter) may be within one or more of the following ranges: 150-300 μm; 150-400 μm; 200-400 μm; 200-500 μm; 300-500 μm; 400-600 μm; 300-700 μm; 500-700 μm; 200-800 μm; 600-800 μm; 700-900 μm; 700-1200 μm; 800-1000 μm; 800-1100 μm; 900-1100 μm; 900-1200 μm; and 1000-1200 μm.

[0085] Dose - a single measurement (eg, volume or weight) of a pellet, for example totaling between about 0.05 ml to about 0.8 ml (eg, about 0.1 ml to about 0.6 ml) by volume, for example about 0.3 ml by volume (although sometimes such pellets are measured by weight).

[0086] Dispensing mechanism – a system, such as an electromechanical system, which converts a user's action into dose dispensing.

[0087] Cartridge - an assembly, such as a replaceable assembly for storing and dispensing pellets, optionally containing features of a device such as a rotating member in the form of, for example, a central threaded rod, a movable plunger, and the pellets.

[0088] Plunger - a plate (although other types of plungers are contemplated) which can ensure that the pellets remain packed together towards the dispensing end of the cartridge. The plate may be substantially rigid, but portions of the plate may be flexible, such as those that interact with other portions of the cartridge.

[0089] Dispensing Orifice - the open end of the cartridge that allows the pellets to be dispensed for consumption.

[0090] Cap – A container or tray covering the delivery orifice that collects a dose and protects the stored pellets from moisture.

[0091] Press – the action performed on the device when the user wishes to dispense their prescribed dose, which can be either a rotational or linear movement.

[0092] It will be understood that "a" drug or agent referred to herein may be considered as "one or more" drugs or agents. For example, a granule may include several drugs or agents in granule form. This may be achieved by mixing granules that each include a different drug or agent and / or mixing drugs or agents within each granule. BRIEF DESCRIPTION OF THE DRAWINGS

[0093] Various embodiments will now be described, by way of example only, and with reference to the accompanying drawings, in which:

[0094] Figure 1 A perspective view of a device capable of dispensing a drug or medicament (e.g., an oral dosage form) in pellet form is shown;

[0095] Figure 2 and 2A Shows Figure 1 A cross-sectional view of the device shown in;

[0096] Figure 3 The threads located at the transition point or junction of the tapered surface and the outlet pipe are schematically indicated;

[0097] Figure 4 An embodiment of the present invention is shown. Figure 1 a second dispensing end of a device similar to the device, but wherein the screw pump is offset from the confluence of the conical surface and the outlet tube;

[0098] Figure 5 An embodiment of the present invention is shown. Figure 1 A second dispensing end of a similar device to that of the device, but wherein the screw pump is positioned within the tapered portion of the barrel and tapers with the tapered portion;

[0099] Fig. 6A and 6B Shows Figure 5 A variation of the embodiment (although it may also be applied to Figure 4 ), wherein the rotating member comprises one or more fins configured to collect the pellets and direct the pellets into a screw pump;

[0100] Fig. 7A and 7B One or more baffles are shown Figure 5 Further modifications of the embodiment (which may also be applied to Figure 4 ), the one or more baffles are configured to rotate with the rotating member and deflect or help move the pellets through the barrel;

[0101] Figure 8 The profile of the thread of a screw pump and the various dimensions that may be associated therewith are schematically shown;

[0102] Fig. 9 and 10 An embodiment of a thread having a variable pitch is shown;

[0103] Fig.11 and 12 An embodiment is shown that includes two cartridges positioned side by side within the housing;

[0104] Fig.13 , 14A and 14B show an embodiment incorporating a first valve positioned above the outlet tube of the cartridge;

[0105] Fig.15 and 16A -16G shows an embodiment incorporating a second valve positioned above the outlet tube of the cartridge in the form of a plug;

[0106] Fig.17 , 18A and 18B show an embodiment incorporating an improved outlet tube;

[0107] Fig.19A and 19B An embodiment is shown that includes a movable assembly that can be positioned above the outlet end of the outlet tube;

[0108] Figures 20A-20C A modified embodiment is shown, in which Fig.16A and 16B The valve shown in the embodiment of is replaced by a different valve extending from the end of the rotating member in a similar manner;

[0109] Fig.21A An improved rotating member having threads communicating with an internal passage is shown;

[0110] Fig. 21B Shows the Fig.21A a modification of an embodiment wherein a resilient cap is placed over the end of the rotating member to prevent dispensing of pellets when the device is not in operation;

[0111] Fig. 22 , 23 , 24A and 24B show a device including a cap configured to be connected to the cartridge at the second dispensing end of the cartridge so as to cover the outlet tube;

[0112] Figures 25 to 26 Shows something like Fig.11 and 12An embodiment of a cartridge of the double cartridge embodiment, except that the two cartridges are combined in a single unit;

[0113] Fig. 27 , 28A and 28B show an embodiment of a barrel in which the screw segments of the rotating members are replaced by screw segments in the form of a "twisted plate" arrangement;

[0114] Fig.29A , 29B and 29C show an embodiment of the device in which the plunger is accompanied by a deformable material positioned on a radially extending surface of the plunger;

[0115] Fig. 30A , 30B and 30C show an embodiment in which the plunger of the device is provided with a plurality of axially extending teeth or projections;

[0116] Fig.31A , 31B and 31C show an embodiment in which the plunger of the device comprises a resilient device having a Fig. 30A , 30B Function similar to the teeth of the embodiment 30C; and

[0117] Fig.32A , 32B and 32C illustrate an embodiment of a device having an improved plunger that includes a shape configured to reduce friction between the plunger and the wall of the barrel. DETAILED DESCRIPTION

[0118] Figure 1 A perspective view of a device 100 is shown, which is a delivery device capable of dispensing a drug or medicament (e.g., an oral dosage form) in pellet form. The purpose of the device 100 is to make the dispensing of pellet-type doses more efficient, wherein various embodiments are directed to improving the mechanics of the device to prevent the pellets from clogging and / or grinding as they pass through the device.

[0119] The device 100 includes a first end 102 for connection to an actuator or other drive mechanism (e.g., a motor) and a second end 104 (opposite the first end 102) comprising a dispensing end of the device 100. In use, as a result of operation of the drive mechanism (e.g., a motor), the drug in the form of pellets will be dispensed from the second end 104.

[0120] The device 100 includes one or more cartridges 200 configured to be attached to an actuator or drive mechanism (e.g., a motor) at a first end 102 of the device 100. The cartridge 200 includes one or more chambers 220 configured to store or hold a plurality of units of an oral dosage form (in this case, pellets).

[0121] The device 100 includes a rotating member 250 extending through the barrel 200. As described in more detail below, at the first end 102 of the device 100, the rotating member 250 is connected to an actuator or drive mechanism (e.g., a motor) that rotates the rotating member 250 to dispense pellets from the second end 104 of the device 100.

[0122] The device 100 includes an outlet at its second end 104 (e.g., Figure 2 An outlet tube 212 is provided in the embodiment of the present invention, through which particles (drugs, pharmaceutical agents, etc.) are distributed.

[0123] Figure 2 and 2A Shows Figure 1 , which shows in more detail some features of the interior of the cartridge 200 and the rotating member 250. The cartridge 200 is hollow and, as described above, includes a chamber 220 for containing pellets, and the rotating member 250 extends through the chamber from the first end 102 of the device 100 to the second end 104 of the device 100.

[0124] The chamber 220 and / or the cartridge 200 can be substantially airtight (e.g., except for the passage through which the pellets are dispensed). For example, at the first end 102, the connection between the rotating member 250 and the cartridge 200 can include a seal, such as an elastomeric gasket or a valve (not shown). Similarly, at the second dispensing end 104 of the device 100, a suitable seal (not shown) can be provided between the rotating member 250 and the outlet tube 212. For example, a packaging seal can be provided that covers and seals an outlet of the device (e.g., the outlet tube 212), which can be removed (e.g., peeled off) by the user when he or she wishes to begin use. Additionally or alternatively, a valve can be used to at least partially seal the second dispensing end of the device 100 (an example "umbrella valve" in Figure 4 ). These features can help prevent air and / or moisture from entering chamber 220 and undesirably interacting with the units of the solid oral dosage form.

[0125] The rotating member 250 extends into the outlet tube 212 at the second end 104 of the device 100 and includes a screw segment 240. The outlet tube 212 and the screw segment 240 together form a screw pump that is configured to dispense pellets from the second end 104 of the device 100. That is, the pellets will enter the threads 242 of the screw segment 240 and, as the rotating member 250 rotates, will be forced out of the outlet tube 212 by the threads 242 and dispensed from the device 100.

[0126] The rotating member 250 and the barrel 200 may have a common longitudinal axis, which is also the axis of rotation of the rotating member 250. This can effectively load the pellets symmetrically into the screw section 240. However, in various embodiments, the longitudinal axis of the barrel 200 may deviate from the longitudinal axis of the rotating member 250 and / or the axis of rotation of the rotating member 250 and still achieve the technical effects described elsewhere herein.

[0127] Figures 1 to 2A The cartridge 200 is shown as having an oval shape, but this is not required and the cartridge 200 may have any suitable shape, such as a cylindrical shape.

[0128] The device 100 may further include a plunger 230 (e.g. Figures 1 to 2A As shown), the plunger is configured to move along the rotating member automatically or as a result of the rotation of the rotating member.

[0129] As described above, each cartridge 200 contains pellets within its chamber 220. In embodiments involving a plunger 230, the volume of chamber 220 varies during operation of device 100 and throughout its life through the action of plunger 230, as will be described in more detail below.

[0130] At one end, the chamber 220 is at least partially closed by the plunger 230, and more specifically, by a radially extending surface 232 of the plunger 230 facing the chamber 220. The other end of the chamber 220 is at least partially closed by the surface 210 of the barrel 200. The rotating member 250 extends through the chamber 220 along the longitudinal axis A of the barrel 200.

[0131] Figure 2 There is shown a cross-sectional view of the cartridge 200 including the plunger 230. The plunger 230 rests on top of pellets (not shown) positioned within the chamber 220 as the rotating member 250 rotates in use.

[0132] This plunger may act by gravity to move the pellets contained in the chamber towards the screw pump. For example, the plunger may be a weight configured to rest on top of the pellets contained in the chamber when the device is in an orientation that allows the pellets to be dispensed. There may be a no-back device (e.g., a ratchet) to prevent the plunger from moving in a direction away from the dispensing end during use.

[0133] The plunger can be configured to move along the rotating member automatically or due to the rotation of the rotating member. For example, a portion of the rotating member in the chamber may include a thread (e.g., a plunger thread, which may be different from any thread of the screw pump), and the plunger may form a nut around the rotating member, which is configured to travel along the thread of the rotating member in use, so that when the rotating member rotates, the plunger moves toward the screw pump, thereby forcing the pellets contained in the chamber toward the screw pump. The plunger can be configured to abut and / or contact the inner surface of the barrel and / or chamber, and there may be a friction fit between the plunger and the inner surface of the barrel and / or chamber to help prevent the plunger from rotating with the rotating member.

[0134] The device 100 may include certain features that provide a driving force to the plunger 230, e.g., independent of the weight of the plunger 230 as described above, that acts in a direction toward the pellet located within the chamber 220. For example, a ratchet mechanism may be used to ensure that the plunger 230 can only move in a single direction, i.e., toward the pellet located within the chamber 220. A resilient member (e.g., a spring) may be provided to force the plunger 230 toward the pellet located within the chamber 220. A pneumatic air source may be provided that can pressurize the plunger 230 toward the pellet located within the chamber 220.

[0135] In use, the radially extending surface 232 of the plunger 230 presses on the pellets and forces them towards the second dispensing end 104 of the device 100 , which helps to tightly pack the pellets within the chamber 220 .

[0136] Despite Figure 2 200 as extending perpendicular to the axis A, but the radially extending surface 232 of the plunger 230 can alternatively be shaped to precisely mate with the opposing surface 210 of the barrel 200, which can enhance the capture of pellets within the chamber 220 so that the pellets can be dispensed therefrom. For example, the surface 232 can be angled in a manner similar to and cooperative with the opposing surface 210 of the barrel 200.

[0137] In various embodiments, the plunger 230 is operably connected to the rotating member 250 such that rotation of the rotating member 250 causes the plunger 230 to move axially along the rotating member 250 (i.e., along the longitudinal axis A of the rotating member 250 and the cartridge 200). For example, the plunger 230 can be a nut that translates along the rotating member from the first end 102 of the cartridge 200 (i.e., the end to be inserted into the actuator, as described below) toward the second dispensing end 104 of the cartridge 200 as the rotating member 250 rotates.

[0138] In this manner, the volume of chamber 220 is gradually reduced as plunger 230 translates along rotating member 250. Furthermore, throughout operation and life of device 100, pellets contained within chamber 220 will be forced toward second end 104 of barrel 200 by plunger 230.

[0139] To achieve direct movement of the plunger 230, the rotating member 250 may include threads 252 configured to cooperate with corresponding threads 233 on the plunger 230 to move it along the longitudinal axis A, as described above. At the second dispensing end 104 of the cartridge 200, the rotating member 250 includes a screw section 240 that is axially separated from the threads 252 that cooperate with the plunger 230.

[0140] In various embodiments, the plunger 230 (or at least its threads 233) can be made of a thermoplastic elastomer ("TPE") or polybutylene terephthalate ("PBT") and / or the hardness of the plunger can be less than about 100, 80, 70, 60 or even 50 Shore. The Shore hardness test can be performed at Shore 00 or Shore A. In these embodiments, when the plunger 230 moves along the axis A, the threads 233 can be disengaged from the threads 252 when the plunger 230 encounters sufficient resistance (e.g., preventing the end of the pellet or the barrel 200 from encountering the pellet). Once the plunger 230 contacts the pellet, this allows the rotating member 250 to rotate and limits the force applied to the pellet by the plunger 230. For example, once the pellet is reduced in volume during dispensing, the resistance will be reduced, for example, and the threads 233 will be engaged with the threads 252 again at a certain point to continue to move the plunger 230 along the axis A.

[0141] In various embodiments, the threads 233 can be removed, and a tight friction fit can be used to move the plunger along the threads 252 when the rotating member 250 rotates. For example, the plunger 230 can have two friction surfaces, the first friction surface on the outer periphery of the inner surface facing the barrel 200, and the second friction surface on the inner periphery facing the rotating member 250. The friction between the first friction surfaces prevents the plunger 230 from rotating, but allows the plunger 230 to move axially (i.e., along the axis A). The hole in the center of the plunger 230 (through which the rotating member 250 extends) can be made slightly smaller than the outer diameter of the threads 252. This means that even if the rotating member 250 itself does not include a mating thread, the plunger 230 will move axially along the threads 252 as the rotating member rotates. The plunger can be made of rubber to facilitate this embodiment. The second friction surface can be configured so that when the pellet is fully compressed, that is, if the plunger 230 has pressed the pellet down as far as possible, the plunger 230 will slide.

[0142] Figure 2A The second dispensing end 104 of the cartridge 200 is shown in greater detail, with the outlet tube 212 being located at the end, with the screw section 240 of the rotating member 250 extending through the outlet tube 212, as described above.

[0143] The radially outer surface 241 of the screw segment 240 may substantially contact (and / or abut) the radially inner surface 214 of the outlet tube 212. That is, the outer surface 241 of the screw segment 240 and the radially inner surface 214 of the outlet tube 212 may substantially contact or abut each other (e.g., continuously or intermittently). This may not be to the extent that the outer surface and the radially inner surface have an interference fit or friction fit with each other to ensure that they can move smoothly relative to each other and ensure reliable dispensing in use. That is, as the radially outer surface 241 of the screw segment 240 rotates past the radially inner surface of the outlet tube 212. It is foreseeable that any tolerance between the outer surface 241 of the screw segment 240 and the inner surface 214 of the outlet tube 212 is as tight as possible while still allowing the screw segment 240 to rotate within the outlet tube 212.

[0144] For example, there may be a small tolerance or gap between the outer surface 241 of the screw segment 240 and the inner surface 214 of the outlet tube 212, such as due to manufacturing tolerances. If the surfaces are configured to contact each other (e.g., continuously or intermittently), the surfaces can be made of a low friction material (e.g., a non-stick coating or additive such as Teflon is applied to one or both opposing surfaces), which may result in a tight (e.g., contact fit) without friction or interference fit. In various embodiments (e.g., those embodiments that include a barrel in which pellets are contained), there may be a tolerance or gap between the outer surface 241 of the screw segment 240 and the inner surface 214 of the outlet tube 212, and it may be large enough to allow free rotation of the shaft 250, but small enough to prevent any pellets (and / or pellet debris) from sliding between the gaps (which may increase friction and inhibit free rotation).

[0145] The screw section 240 includes a thread 242 configured to receive pellets contained within the chamber 220 and, when the rotating member 250 rotates, transport them along the thread 242 for dispensing from the outlet tube 212. The thread 242 is composed of one or more thread starts, each of which forms a continuous spiral, and during operation of the device 100, for example (at least in part) due to the action of the plunger 230 pressing on the pellets in the chamber 220, these pellets fill the continuous spiral, forcing them into the thread 242.

[0146] The screw segment 240 and its threads 242 are in contact with the inner radial surface of the outlet tube 212, thereby forming a screw pump (e.g., an "Archimedes" screw) with the outlet tube 212 of the barrel 200. That is, as the rotating member 250 rotates, the screw segment 240 and its threads 242 will also rotate, causing the pellets contained in the chamber 220 to enter the gaps in the threads 242, travel under the threads 242 and leave the barrel 200. The screw pump may include an outlet 243 through which the pellets are dispensed.

[0147] The actuator or drive mechanism (e.g., a motor) can be configured to rotate the rotating member 250 and can be connected to the rotating member 250 at the first end 102 of the device as described above. The actuator can be configured to provide a rotational force to the rotating member 250 and, in turn, to the threads 242, 252 of the rotating member 250. The actuator can be mechanical (e.g., manually operated) or electromechanical (e.g., electrically operated, such as a motor). The actuator (or a control unit including the actuator) can be detachable from the cartridge 200 so that different cartridges can be connected to the same actuator or control unit.

[0148] To dispense pellets from the cartridge 200, the actuator 300 may rotate the rotating member 250. This causes (in a related embodiment) the plunger 230 to move downward along the threads 252 of the rotating member 250 and rotate the screw segment 240, thereby dispensing the pellets through the screw pump formed between the screw segment 240 and the outlet tube 212.

[0149] The device 100 may include a control system (e.g., as part of an actuator or control unit) that may be configured to dispense a dose of pellets contained in the chamber 220, for example, upon receiving an actuation signal from an input device or mechanism. The actuation signal may be initiated, for example, by a user pressing a suitable button or other input mechanism located on the control unit or optionally by a different control such as a wireless or wired external control.

[0150] By using an electromechanical actuation mechanism, the device 100 may be able to repeatedly dispense precise amounts of pellets.The motor and control system may be powered by an integrated battery (which may be replaced by the user) that may be housed within the housing of the actuator.

[0151] The actuator may include one or more motors. The actuator (e.g., its motor) may be configured to rotate the rotating member 250 by an amount corresponding to the prescribed dose or a portion of the dose. For example, the actuator may be configured to pulse the rotating member 250, for example, by operating a certain period of time (e.g., 0.5 seconds). The dose may consist of a plurality of pulses, so different doses may be dispensed according to the number of pulses of the motor. For example, a dose of 0.3 ml may correspond to approximately 3 seconds of motor rotation, so the actuator may pulse the motor 6 times, i.e., 6 pulses, each 0.5 seconds.

[0152] The motor may be a stepper motor, which may be configured to rotate the rotating member 250 by any suitable number of steps depending on the current situation, for example, depending on the type of medicament in the cartridge 200 or the user. The control system may be in the form of a computer, a processor, a processing device or a microcontroller, for example, provided on a PCB, which may be located in the housing of the device 100 or in the actuator or control unit.

[0153] The tube 200 can be made of rigid material, such as polycarbonate or polyamide, but any suitable material can be used. The part of the tube 200, such as those parts contacted with the rotating member 250 and / or the plunger 230, can have the friction surface that reduces (such as, reduce with respect to other parts of the tube), to help the relative motion between them. The internal diameter of the tube 200 (that is, forming the chamber 220) can be between about 5mm and about 200mm, optionally between about 10mm and about 20mm. The length of the tube 200 (corresponding to its longest dimension) can be between about 90mm and about 120mm, the width of the tube (transverse to its length) is between about 33mm and about 43mm, and the height of the tube (transverse to its width) is between about 15mm and about 25mm.

[0154] The inner diameter of the outlet tube 212 can be substantially equal to the diameter of the rotating member 250, in particular the screw section 240 thereof. This inner diameter can be less than 10 mm, for example less than about 6 mm. The length of the outlet tube 212 along the longitudinal axis A of the device 100 can be less than about 20 mm (e.g., about 15 mm or about 10 mm).

[0155] The volume of the chamber 220 (ie, before operation or maximum volume) can be less than about 50 mL, such as less than 20 mL or approximately equal to 11 mL.

[0156] The plunger 230 may be configured to fill a gap between the rotating member 250 and the wall of the container 200 such that pellets contained in the chamber 220 are unable to move past the plunger 230 as they move downwardly along the rotating member 250 in use.

[0157] In various embodiments, the size (and, for example, circumference) of the plunger 230 can be such that there is a small gap between the plunger 230 and the wall of the barrel 200 to avoid substantial friction between the plunger 230 and the barrel 200. This may mean that pellets may pass through the gap between the plunger 230 and the wall of the barrel 200. To avoid this, the size (e.g., width) of the gap can be configured so that it is smaller than the size (e.g., average size or diameter) of the pellets. Additionally or alternatively, a material that is deformable and / or less frictional than the plunger 230 can be provided near the plunger 230, the material being configured to contact the wall of the barrel 200 when the plunger 230 moves in use.

[0158] The barrel 200 can include a tapered portion at the second end 104 of the device 100, which can be configured to guide or direct the pellets contained within the chamber 220 into the threads 242 of the screw section 240. In other words, the surface 210 can taper or angle so that it is not perpendicular to the longitudinal axis A, but rather is oriented at an angle relative to the longitudinal axis, such as an angle greater than about 30°, greater than about 60°, or greater. In other embodiments, the surface 210 can be perpendicular to the longitudinal axis A. The tapered portion can be frustoconical or flared.

[0159] The cartridge 200 may include a Figure 2A ) is connected to one or more side portions 202 of a conical portion 204 extending from said axial position toward an outlet tube 212. Thus, when the barrel 200 is in its normal orientation, the pellets will be caused to travel down the conical portion 204 (along the now angled surface 210) and into the flights 242 of the screw portion 240.

[0160] As described above, although not shown, the lower surface 232 of the plunger 230 can have a matching geometry so that when the plunger reaches the end of its stroke along the rotating member 250, the lower surface 232 of the plunger 230 contacts the tapered surface over its entire area. This will help to distribute as many pellets as possible, which minimizes waste. Since the threads 252 eventually give way to the threads 242, it may be necessary to provide threads on the plunger 230 away from its lower surface 232, so that the portion of the plunger 230 containing the lower surface 232 extends below the threads (if present) of the plunger 230, which allows the surface 232 to contact, abut or at least move closer to the opposite surface 210 of the barrel when the plunger 230 is at its lowest point (i.e., at the end of the threads 252).

[0161] The outer surface 241 of the screw segment 240 can be made of a low friction material, such as nylon, polyethylene ("PE"), polyethylene terephthalate ("PET"), optionally containing a friction reducing additive. The barrel 200 and its portions adjacent to, opposing or contacting the screw segment 240, plunger 230 or other moving parts of the device 100 can also be made of a low friction material, such as nylon, polyethylene ("PE"), polyethylene terephthalate ("PET"), optionally containing a friction reducing additive.

[0162] exist Figures 1 to 2A In the embodiment of the present invention, the screw segment 240 is configured so that the height of the flight 242 extends at least one full revolution above the outlet tube 212 (toward the chamber 220). If the flight is located at or near the transition point or confluence of the opposing surface 210 and the outlet tube 212, it has been found that a certain degree of shearing may occur. Figure 3denoted at point P1 , corresponds to a region around edge 211 which may form a transition point or junction between surface 210 and outlet pipe 212 .

[0163] According to the present invention, the screw pump is offset from the transition point or junction of the surface 210 and the outlet pipe 212 so that any shearing of the pellets at this location can be avoided. In various embodiments, the screw pump (e.g., screw section 240) is offset toward the outlet 243 of the screw pump. In an optimized embodiment, the barrel 200 may include a tapered portion 207, as described above, and an offset of the transition point or junction of the surface 210 (which will be a tapered surface) and the outlet pipe 212. This provides further optimization of pellet transport through this component of the device 100, because the pellets can be effectively fed from the chamber 220 to the inlet region of the outlet pipe 212 using the tapered portion 207, and then subsequently (rather than simultaneously) enter the screw pump.

[0164] Figure 4 An embodiment is shown showing a second dispensing end 104 (e.g., the second dispensing end of the device 100 as described above), which includes a tapered portion 207 that facilitates the transfer of pellets from the chamber 220 to the screw pump formed by the screw segment 240, thereby optimizing the transport of the pellets as described above.

[0165] In this embodiment, the side portion 202 of the cartridge 200 follows a substantially straight (or cylindrical) profile until a first junction 206 between the side portion 202 of the cartridge 200 and the tapered portion 207, at which point the wall of the cartridge 200 formed by the tapered portion 207 forms a funnel having a surface 210. The funnel and / or surface 210 are configured to guide pellets contained within the chamber 220 from an inlet 301 of the funnel to an inlet 311 of an outlet tube 212 (which also corresponds to an outlet of the funnel).

[0166] If you can Figure 4 As seen in FIG. 2 , the screw pump is offset from the junction of the surface 210 and the outlet tube 212 (e.g., its inlet, edge or rim 311) by a distance D (measured in the direction along the axis A of the rotating member 250). In other words, the inlet of the screw pump is offset from the junction toward the outlet of the outlet tube 212. It has been found that this reduces the shearing of the pellets at the interface between the tapered portion 207 and the outlet tube 212, which reduces the chance of crushing or otherwise damaging the pellets and provides improved filling of the screw pump. In addition, it has been found that offsetting the screw pump in this manner can reduce the torque requirements for the rotating member 250. Without wishing to be bound by theory, this may be due to the removal of the interaction between the screw pump and the rim 311, and the screw pump having a lower surface area in contact with the wall of the barrel 200.

[0167] The tapered portion 207 may extend a distance d in the axial direction, wherein the offset distance D of the screw pump may be at least 50% of the axial distance d of the tapered portion 207. In a further refinement, the offset distance D of the screw pump may be at least 60%, 70%, 80% or 90% of the axial distance d of the tapered portion 207. In a particular arrangement, the offset distance D of the screw pump may be between about 50% and about 90% of the axial distance d of the tapered portion 207, for example between about 60% and about 80%.

[0168] The barrel 200 may also be tapered such that its inner wall (e.g., forming the chamber 220, the tapered portion 207, and the outlet tube 212) tapers from a first diameter D1 to a second diameter D2, wherein the inner wall has the first diameter D1 in a portion of the barrel 200 above the first transition 206 (e.g., above the tapered portion 207). As the inner wall extends through the tapered portion 207, the inner wall may taper from the first diameter D1 to the second diameter D2, such that once the inner wall reaches the outlet tube 212, it has the second diameter D2.

[0169] In various embodiments, the screw shaft 250 may also taper from a first diameter d1 to a second diameter d2, wherein the screw shaft 250 has the first diameter d1 in a portion of the barrel 200 above the first transition 206 (e.g., above the tapered portion 207). As the screw shaft 250 extends through the tapered portion 207 of the barrel 200, the screw shaft may taper from the first diameter d1 to the second diameter d2, such that the screw shaft 250 has the second diameter d2 once it reaches the outlet tube 212. This further optimizes and facilitates the transport of pellets through this section of the device.

[0170] Figure 4 Embodiments of also include an optional valve positioned above the outlet tube 212 of the barrel 200 (and, for example, the outlet 243 of the screw pump). The valve can be configured to prevent pellets from accidentally falling out of the screw pump (eg, when the rotating member 250 is stationary).

[0171] In the illustrated embodiment, this is provided in the form of a plug 500. The plug 500 can be configured to contact the end of the outlet tube 212 facing away from the chamber 220. In various embodiments, the plug 500 is configured to be inserted into the cavity 254 formed at the second dispensing end 104 of the rotating member 250 (i.e., including the screw portion 240). The plug 500 includes a base portion 502 and an elongated portion 504 extending from the center of the base portion 502 into the cavity 254 of the rotating member 250. The base portion 502 can be configured to rest (e.g., provide a seal) against the outlet tube 212 (and, for example, the outlet 243 of the screw pump), for example to seal (e.g., hermetically seal) the pellets 200 in the cartridge, for example before or during use.

[0172] The valve may be an "umbrella valve" as embodied by the plug 500. That is, at least the base portion 502 of the plug 500 is resilient, such as a rubber membrane, wherein the outer edge 506 of the base portion 502 is configured to flex open when the pellet is pushed out of the screw pump in use, and then rebound when the screw pump is not rotating to prevent the pellet from falling out and optionally also seal the cartridge 200. The elongated portion 504 of the plug 500 may not substantially move from its position within the cavity 254 of the rotating member 250.

[0173] Figure 5 Another embodiment is shown showing a second dispensing end 104 (eg, of a device 100 as depicted above). Figure 4 The embodiment includes a pronounced tapered portion 207 and an outlet tube 212, while Figure 5 In the embodiment of the present invention, the outlet pipe 212 includes a conical trumpet portion 207 to facilitate the transfer of the pellets from the chamber 220 to the screw pump formed by the screw segment 240 to optimize the transfer of the pellets. Figure 5 It is shown as a trumpet shape, but the tapered portion can be a frustoconical shape.

[0174] In this embodiment, the side portion 202 of the barrel 200 follows a substantially straight (or cylindrical) profile until a junction 206 between the side portion 202 of the barrel 200 and the tapered portion 207 of the outlet tube 212, at which point the wall of the barrel 200 forms a funnel having a surface 210. The surface 210 is configured to guide pellets contained within the chamber 220 from the inlet 311 of the outlet tube 212 through a portion of the screw pump for ultimate dispensing from the outlet 243 thereof.

[0175] The tapered portion 207 of the outlet tube 212 extends in the axial direction (i.e., corresponding to the axis A) by a distance d, which may be approximately 50% of the length L of the outlet tube 212. In various embodiments, the distance d may be at least 30%, 40%, 50%, 60%, 70%, 80%, 90% of the length L of the outlet tube 212. The distance D may even be 100% of the length L of the outlet tube 212, such that the entire outlet tube 212 is tapered or flared.

[0176] The screw pump in this embodiment is at least partially within the tapered portion 207 of the outlet pipe 212. For example, the starting point of the screw pump can be offset from the inlet 311 of the outlet pipe 212 by a distance l, which can be less than 50%, 40%, 30%, or even 10% of the axial extent (i.e., distance d) of the tapered portion 207. In various alternative embodiments, the screw pump may not be offset from the inlet 311 of the outlet pipe 212 at all.

[0177] The screw pump includes a thread 242 that gradually decreases along the conical portion 207 of the outlet pipe 212, so that the screw pump gradually decreases from a first diameter D1' at its starting point (for example, adjacent to the inlet 311 of the outlet pipe 212) to a second diameter D2 adjacent to the outlet of the outlet pipe 212 (and the outlet 243 of the screw pump), wherein the first diameter D1' is greater than the second diameter D2.

[0178] The first diameter D1' of the screw pump can be greater than the diameter d1 of the rotating member 250, so that the screw pump's threads 242 extend outward from the diameter d1 of the rotating member 250. Therefore, the pellets will rest on the top of the threads 242 without having to move substantially radially inward before entering the screw pump. This further optimizes the pellet transfer into the screw pump.

[0179] In various embodiments, the screw pump threads 242 remain flush (or substantially flush) with the inner surface of the outlet tube 212, including the surface 210 of the tapered portion thereof. Thus, the pellets contained within the chamber 220 do not encounter, for example, Figure 3 Rough interface shown (see point P1). This creates a larger and easier inlet for the pellets to enter the screw pump and reduces the risk of pellets clogging or crushing.

[0180] and Figure 4 As with the embodiments of the present invention, a valve (e.g., umbrella valve 500) may be included as shown (although this is optional). The features of this valve may be the same as those described above with reference to Figure 4 Same as described.

[0181] Some further modifications to the second allocation of apparatus 100 and 104 will now be described. These will be combined with Figure 5 The embodiments are shown, but it should be understood that the features described are applicable to any device incorporating a progressive cavity pump.

[0182] Fig. 6A and 6B An embodiment is shown in which the rotating member 250 includes one or more fins 290 configured to collect pellets and direct them into the screw pump (e.g., the threads 242 thereof). Fig. 6A and 6BOnly one fin 290 is shown, but it should be understood that more (e.g., 2, 3, or even 4) may be provided, for example, based on whether multiple screw heads are provided in the screw pump. For example, the screw pump may include multiple screw heads as described elsewhere herein, and each of the multiple fins 290 may be aligned with and associated with one of the screw heads. One or more fins 290 may each be configured to guide into a corresponding screw head (e.g., its threads 242) of the screw pump. If multiple fins 290 are provided, the multiple fins may be spaced substantially equidistantly around the circumference of the rotating member 250.

[0183] One or more fins 290 may be angled, such as Fig. 6A and 6B In some embodiments, fin 290 can extend from thread 242 (e.g., the screw head thereof) and can have a steeper angle than the corresponding thread (e.g., larger / steeper than the thread angle of thread 242). The angle of fin 290 (e.g., taken along its longitudinal axis) relative to axis A (e.g., opposite from axis A) can vary from about 10 degrees (e.g., at one end of fin 290) to about 80 degrees (e.g., at the other end of fin 290).

[0184] In various embodiments, the width of each fin 290 can taper, such as from a first relatively large width at the point where it meets the screw pump to a second relatively small width at its opposite end (relative to axis A). The first width can correspond to the width of the threads 242, while the second width can be zero.

[0185] The fins 290 may be wrapped around the screw shaft 250 , and in various embodiments, may extend between about 10 degrees and about 180 degrees around the screw shaft 250 .

[0186] The fins 290 may be positioned at the start of the threads 242 and may be shaped to direct pellets from within the chamber 220 into the screw pump (e.g., its threads 242). The fins 290 may also help loosen pellets that have accumulated within the chamber 220, making it easier for the pellets to pass through the threads 242. The use of the fins 290 may also help ensure improved packaging and / or transfer of pellets through the screw pump, for example by helping to remove voids in its threads 242. This helps improve accuracy.

[0187] In various embodiments, one or more fins 290 may be positioned between the progressive cavity pump (eg, the threads 242 thereof) and the threads 252 of the rotating member 250 along which the plunger 230 moves.

[0188] One or more fins 290 may extend away from the body of rotating member 250 in a radial direction (e.g., relative to axis A) and may extend at least as far as the radial extent of threads 242. In some embodiments, fins 290 may extend further in the radial direction than threads 242 to further facilitate scooping pellets into threads 242.

[0189] One or more fins 290 may be positioned within the tapered portion 207 of the cartridge 200 (eg, as described above), whether or not this forms a separate element from the outlet tube 212 (eg, Figure 4 ), or forms part of the outlet tube 212 itself (such as Figure 5 ). The fin 290 can be positioned at or adjacent to the inlet 301, 311 of the tapered portion 207. In various embodiments, the fin 290 can be positioned above the tapered portion 207 of the cartridge 200 and can extend into the tapered portion 207.

[0190] The fin 290 can extend over the screw pump (e.g., its threads 242) a distance approximately equal to the pitch of the screw pump (e.g., its threads 242). The pitch can be the maximum pitch (if this varies). For example, the fin 290 can extend over the screw pump (e.g., its threads 242) a distance between about 0.5 times and about 1.5 times the pitch of the screw pump (e.g., its threads 242). In various embodiments, the fin 290 can extend over the screw pump (e.g., its threads 242) a distance between about 1 mm and about 10 mm.

[0191] Fig. 7A and 7B A further modification is shown in the form of one or more baffles 390 which are configured to rotate with the rotating member 250 and are intended to assist in the movement of the pellets, e.g., to agitate the pellets and break up clusters of pellets so that the pellets are in optimal condition for transport by a screw pump.

[0192] exist Fig. 7A and 7B Only one baffle 390 is shown in the figure, but it should be understood that more (e.g., 2, 3, or even 4) may be provided. If multiple baffles 390 are provided, the multiple fins may be substantially equally spaced around the circumference of the rotating member 250. Alternatively or additionally, the baffles 390 may be located at the same or different axial positions along the axis A of the rotating member 250.

[0193] The baffle 390 may extend a distance between about 0.5 mm and about 3 mm from the screw shaft 250 (eg, transverse to the axis A). Any or all of the width and / or length and / or thickness of the baffle may be between about 0.5 and about 3 mm.

[0194] although Fig. 7A and 7B The baffle 390 is shown extending from the threads 252 of the screw shaft 250, but this may not be the case and the baffle 390 can be positioned outside the threads 252, such as between the threads 252 and the screw pump (e.g., its threads 242) and / or between the threads 252 and the fins 290 (e.g., its upper extent along axis A).

[0195] In addition to the fins 290 , one or more baffles 390 may be provided, although in various embodiments, baffles 390 may be provided without the fins 290 .

[0196] One or more baffles 390 may be similar to the fins 290 described above, but may be axially offset from the screw pump (e.g., its threads). In embodiments involving threads 252 on a rotating member 250 for moving the plunger 230, the baffles 390 may be positioned on the rotating member 250 at its threads 252.

[0197] The baffle 390 may extend away from the body of the rotating member 250 in a radial direction (e.g., perpendicular to the axis A) and may extend at least as far as the radial extent of the threads 242. In some embodiments, the baffle 390 may extend further in the radial direction than the threads 242 to facilitate breaking up of pellets as they move past the baffle 390 in use.

[0198] One or more baffles 390 may be slightly angled, such as Fig. 7A and 7B In some embodiments, the baffle 390 may have a steeper angle than the threads (e.g., greater / steeper than the thread angle of threads 242), but may have a shallower angle than one or more fins 290 (if provided). The baffle 390 may be positioned at a distance X from the screw pump (e.g., its threads 242), and / or at a distance Y from the inlet 301, 311 or tapered portion 207 of the barrel 200, whether or not this forms a separation element from the outlet tube 212 (e.g., Figure 4 ), or forming part of the outlet tube 212 itself (such as Figure 5 shown).

[0199] The one or more baffles 390 have a function similar to the fins 290. It has been found that positioning the baffles 390 axially offset from the screw pump provides additional functionality and capability because (although not wishing to be bound by theory) the baffles 390 will agitate the pellets prior to the screw pump so that the pellets can more easily pass into the screw pump further assisted by the one or more fins 290 (if provided) as described above.

[0200] The length X can be at least 1, 2 or even 3 times the pitch of the screw pump (e.g., its thread 242). The pitch can be the maximum pitch (if this changes). For example, if the pitch (e.g., maximum pitch) of the thread 242 is about 4mm, then X can be about 4mm, 8mm or 12mm. In various embodiments, X can be about 3 times the pitch (e.g., maximum pitch) of the screw pump (e.g., its thread 242). In various embodiments, the length X can be in the range of about 6mm to about 20mm.

[0201] The baffle 390 can be positioned about 5 mm above the screw pump (eg, its threads 242 ), and in various embodiments, can be positioned at a distance between about 1 mm and about 15 mm around the screw pump (eg, its threads 242 ).

[0202] Typically, the length of the screw segment 240 may be defined by the length of the flights 242, which may be between about 10 mm and about 30 mm, such as between about 10 mm and 20 mm.

[0203] The length of the outlet tube 212 can be between about 5 mm and about 20 mm (optionally between about 10 mm and about 15 mm), wherein the length of the thread 242 in the direction along the longitudinal axis A of the barrel 200 can be at least 0.5 times the length of the outlet tube 212 in the same direction, for example between about 0.5 and about 2 times the length of the outlet tube 212 or about 0.5 to about 1 times the length of the outlet tube 212.

[0204] It has been found that the pitch has an effect on the precision of the dose dispensed, especially in terms of pellet penetration (even if the rotating member is not rotating, the pellet passes through the screw section). In some cases, this may cause the device to "leak" pellets. High pitch appears to increase the risk of pellets passing through the screw section outside the dispensing operation. Therefore, it has been found that low pitch (e.g., less than about 15-30 times the pellet diameter, as described below) increases the precision of the pellet dose dispensed, for example, because it is easier to control the output rate of the pellet. Low pitch can increase the load and increase the torque requirement for driving the rotating member, and this is a compromise that leads to this pitch range being considered important.

[0205] Thus, the threads 242 can have a pitch that is at least 15-30 times smaller than the diameter of the pellet (as described above). In various embodiments, the pitch can be between about 1 mm and about 20 mm, and optionally between about 4 mm and about 8 mm. If the pitch varies, as described below, this can correspond to the maximum pitch.

[0206] Figure 8 The profile of the flight 242 and various dimensions that may be associated therewith are schematically shown. "D" represents the outer diameter of the screw, "CD" represents the depth of the feed channel, "CW" represents the width of the feed channel, and "P" represents the pitch of the screw 242, which can be defined as the distance between adjacent flights. Figure 8 The features of can be applied to any aspect and embodiment described herein that includes a thread for transferring pellets from a chamber to be dispensed from a barrel. The dimension values ​​given can represent the dimensions of the entire length of the thread 242 and / or the screw segment 240.

[0207] refer to Figure 8 , the following table provides some exemplary dimensions of thread (in mm), and the dimensions shown therein and described above. In the embodiment of the table, the pellet diameter is about 200-300 μm, although the same size can be used for pellets with a larger diameter, such as up to about 900 μm. The typical size (e.g., width or diameter) of the pellet can be between about 150 μm and about 1200 μm (or even 1500 μm), optionally between about 200 μm and about 300 μm, between about 300 μm and about 500 μm, between about 300 μm and about 700 μm, between about 500 μm and about 700 μm, between about 700 μm and about 900 μm, or between about 800 μm and about 1100 μm. Values ​​can be provided according to multiples of the diameter of the pellet, and these values ​​should be considered as general values ​​and are not limited to any specific size (or size range) of the pellet.

[0208]

[0209]

[0210] The number of screw heads has been found to have an effect on the dispensing speed of the pellets, with a higher number of screw heads naturally resulting in a higher output per revolution. So far, it has proven to be beneficial to have a relatively low output ratio to maximize the accuracy of the dispensed pellets, and using one or two screw heads is considered to be advantageous over using, for example, three or more.

[0211] Observe the relationship between the groove depth / width and the pellet size, it can be selected so that there is space for multiple pellets between the screw and the thread surface. It may be important to allow the pellets to flow freely without negative interference with each other, for example, causing clogging or blocking during the distribution operation. Therefore, in some embodiments, the size is selected so that there is enough space for at least 2-3 pellets to pass each other in the groove. It may be important to make the dosing sequence without clogging or blocking in the flow to achieve high precision and repeatability between dosages. Therefore, in various embodiments, the groove depth and / or width can be at least 2,3 or 4 times the pellet diameter.

[0212] For example, for pellet diameters between about 200 and 300 μm, the channel depth ("CD") and / or channel width ("CW") may be between about 1 and 2 mm. For pellet diameters between 700 μm and about 900 μm, the channel depth and / or channel width may be between about 1.4 mm and about 3.6 mm, and for pellet diameters between about 800 μm and about 1100 μm, the channel depth and / or channel width may be between about 1.6 mm and about 4.4 mm.

[0213] As described above, it has been found that the pitch ("P") has a significant effect on the precision (e.g., dosing accuracy) of the device. A high pitch appears to increase the risk of pellets passing through the screw when the device is idle, although there is a tradeoff because reducing the pitch increases the torque required to rotate the rotating member. In various embodiments, the pitch can be limited to less than about 15-30 times the diameter of the pellet, and in some cases, less than about 10 times the diameter of the pellet. For example, for pellet diameters between about 200 and 300 μm, the pitch can be about 6 mm, sometimes less than about 3, 4, or 5 mm.

[0214] The pitch may be variable, for example the pitch of the thread may be variable along the axial length of the screw pump. This variable pitch may be applied to the embodiments described above, for example comprising a tapered portion, or any embodiment described herein (for example, even without providing a tapered portion). This feature itself is considered advantageous, and therefore, from one aspect of the invention, a barrel, a screw pump and a rotating member as described above (or below) are provided, wherein the screw pump comprises one or more threads having a variable pitch.

[0215] Fig. 9An embodiment of a thread 242 having a variable pitch is shown, and a thread 242 having a variable pitch is shown, wherein the pitch gradually (e.g., continuously) increases in an axial direction away from the outlet 243. It has been found that this improves the manner in which the pellets are forced through the screw pump because the pellets can be additionally packed / compressed by the screw pump itself. For example, the first pitch A of the thread 242 near the inlet of the screw pump can be relatively high or at a maximum value, and the second pitch B of the thread 242 near the outlet 243 of the screw pump can be relatively low or at a minimum value. The first pitch A can be between about 1.2 and 2 times the second pitch B, and optionally the first pitch A can be about 1.4-1.6 times the second pitch B.

[0216] like Fig.10 As shown, the force applied to the particle can be regarded as a rotational force (F r ) and axial (F a ) forces. For the reasons above, variable pitch may be desirable. However, although not necessarily necessary, it may be beneficial to limit the pitch variation across the axial length of the screw pump. For example, a first pitch A greater than 3 times the second pitch B may reduce the flow of pellets into the screw pump because the rotational force F r Begins to dominate the axial force F a . Too high a pitch may also increase the risk of uncontrolled movement of particles through the screw. This may negatively affect the uniformity of the dose and the feeding and movement of the pellets through the screw pump. Therefore, in various embodiments, the change in pitch can be limited so that its change (e.g., increase or decrease) along the axial length of the screw pump does not exceed about 3 times the initial value (e.g., maximum or minimum value). For example, the first pitch A may not exceed 3 times the second pitch B.

[0217] Return to reference Figure 8 The "flight width" ("FW") is the thickness of the flight and is the result of the selection of the pitch and the channel width. More specifically, the flight width is equal to the pitch minus the channel width. It has been found that the flight width is an important factor in preventing the screw from sticking. At a smaller flight width, the contact area between the outer surface of the screw and the surface of the flight is reduced, which reduces the risk of dust generated by small pellets and / or crushed pellets getting stuck and causing the screw to stick.

[0218] Therefore, in various embodiments, the screw flight width can be limited to less than about 3, 5, or 10 times the pellet diameter. In particular, for pellets with a diameter between about 200 and 300 μm, the screw flight width can be less than about 1, 2, or 3 mm. For pellets not exceeding about 900 μm, or between about 700 μm and about 900 μm, or between about 800 μm and about 1100 μm, the screw flight width can be limited to less than about 1, 2, or 3 mm, for example, about 1 mm.

[0219] It has been found that a low flight width (e.g., less than about 1 mm) is advantageous for pellets up to about 900 μm because it provides a more consistent dose. For smaller pellets (i.e., about 200-300 μm), it has been found that dust may be generated as they pass through the screw segment 240, which may get stuck between the exterior of the screw segment 240 and the outlet tube 212. It has been found that limiting the flight width to less than about 1, 2, or 3 mm, especially about 1 mm, minimizes this effect for these smaller pellets, in addition to the effect of having a more consistent dose for larger pellets as described above.

[0220] In various embodiments, the rotating member 250 (e.g., at the screw section 240) will have an outer diameter of 6 mm, and two screw heads, each having a height or screw channel width of about 2 mm, a screw channel depth of about 1 mm, and a pitch of about 6 mm. In these embodiments, the pellet diameter may be between 200-900 μm, such as about 200-300 μm.

[0221] Each of the parameters of the thread will have some effect on the mass output rate and the required drive torque. The pitch may be a set value and may not change as the diameter of the screw increases; however, the effective angle of the thread relative to the pellet does change. If the pitch remains the same value, and the diameter increases, the pellet threads strike the pellet at a reduced angle. This may affect the dispensing speed and the required torque. As described above, the pitch may vary along the axial length of the screw pump.

[0222] The screw parameters may be adjusted or configured based on the size of the pellets to be dispensed. The flights 242 may be at least 1-3 times the diameter of the largest pellet.

[0223] The depth of the threads 242 may be between about 1 mm and about 3 mm. Alternatively, the depth of the threads 242 may be adapted to the diameter of the pellet, such that the depth of the threads 242 is at least the diameter of the pellet. Similarly, the height of the threads 242 may be in the range of about 1 mm to about 10 mm, such as about 1 mm to about 4 mm. The threads 242 may include at least 2 screw heads.

[0224] The screw section 240 of the rotating member 250 may include a diameter that allows at least 1, 2, 3 or more screw heads to be incorporated into a screw pump. The pitch of each thread 242 may increase accordingly and / or may vary within each thread.

[0225] The rotating member 250 may include a high stiffness and / or rigid material, such as polycarbonate or polyamide. The diameter of the rotating member 250 may vary between about 3 mm and about 10 mm, such as about 3 mm to about 6 mm. The diameter of the rotating member 250 may be equal to the diameter of the outer surface 241 of the screw segment 240, for example, along its entire length (along the longitudinal axis A).

[0226] The threads 252 that cooperate with the plunger 230 may extend along at least about 80%, about 90%, or more, of the length of the rotating member 250 within the cartridge 200. The pitch of the threads 252 may be selected so that the plunger 230 continuously applies pressure to the pellets stored therein.

[0227] The actuator 300 , if provided with an electromechanical motor, may be configured to rotate the rotating member 250 at a rate between about 0 rpm and about 1000 rpm, optionally between about 50 rpm and about 500 rpm, optionally between about 90 rpm and about 150 rpm.

[0228] The device 100 may include a cap (e.g., as described below) that fits over one end of the cartridge 200 at the second end 104 of the device 100. The cap may include an interference fit with the outer surface of the cartridge 200. Means may be provided for preventing pellets from accidentally falling out of the outlet tube 212 (or cartridge 200). The cap may include a marking configured to align with a cooperating groove positioned on the cartridge 200, such that the marking is aligned with a first end of the groove before the cap is twisted, moves along the groove during the twisting, and then reaches the end of the groove once the desired or predetermined dose has been dispensed.

[0229] In various embodiments, actuator 300 can be configured to rotate rotating member 250 in the opposite direction after completing dosage. This may be useful in drawing pellets back into chamber 220, which can reduce pellet losses (this may be partly due to the passage of pellets). This change in direction of rotation may also be useful for moving the stopper into contact with outlet pipe 212 or disengaging contact with sealing tube 200. This can be used to provide sealing (e.g., airtight seal as described elsewhere herein), and also avoid pellet losses. In various embodiments, the change in rotation can also be used to destroy the drive mechanism at the end of the life of tube 200, to prevent, for example, refilling and reusing tube 200 by a user or a third party. Various embodiments may include latches, and if its direction of rotation is opposite to the direction required for driving pellets, the latches permanently lock the rotation of rotating member 250.

[0230] Various embodiments of the present invention will now be described, and the features described below may be combined with any embodiment described above, as long as the features are compatible therewith. Similar features are indicated with similar reference numerals.

[0231] In the figures associated with the following, the threads of the screw pump may not be depicted as described above, for example offset from the tapered portion or tapered together with the tapered portion, or have a variable pitch. However, the described features can still be combined with the aspects and embodiments described above. In other words, the embodiments described below can be adapted so that the threads of the screw pump correspond to the threads as described above and according to the present invention. For example, offset from the tapered portion or tapered together with the tapered portion, or have a variable pitch. Similarly, the drawings may not show the tapered portion, but it should be understood that the tapered portion can be provided where appropriate.

[0232] Fig.11 and 12 An embodiment is shown that includes two cartridges 200 positioned side by side within a housing 400. The two cartridges 200 are adjacent and can be operated by a common actuator 300'. The actuator 300' may include a dual connection portion 303', wherein each connection portion 303' is configured to drive a corresponding connection portion 280 of each corresponding rotating member 250 of each cartridge 200, and is driven in a manner similar to that described above with respect to the single-cartridge actuator 300.

[0233] Fig.13 , 14A 14B show an embodiment incorporating a first valve positioned above the outlet tube 212 of the cartridge 200 .

[0234] The first valve 500 includes a first surface 252 configured to contact the outer surface 216 of the outlet tube 212 in an interference fit or friction fit type manner. The first valve 500 further includes a funnel portion including a frustoconical second surface 251 to gradually decrease from the first surface 252 to an outlet portion 255. The funnel portion is configured to receive pellets from the screw segment 240, and in particular from its threads 242. The outlet portion 255 includes an outlet 257 configured to receive pellets from the frustoconical portion and distribute the pellets to a user. The outlet portion 255 and / or the outlet 257 may be elongated, such as Fig.13 As shown, and the width of the outlet 257 (i.e., its smaller width, such as Fig. 14B The width of the pellets can be adapted to the size of the pellets to be dispensed. For example, this width can be less than 1.5 times the width or diameter of the pellets.

[0235] Fig.15 , 16A16B shows an embodiment incorporating a second valve 550 positioned above the outlet tube 212 of the cartridge 200 in the form of a plug 550. The plug 550 can be configured to contact one end of the outlet tube 212 that faces away from the chamber 220. In various embodiments, the plug 550 is configured to be inserted into a cavity 254 formed at the second dispensing end 104 (i.e., including the screw portion 240) of the rotating member 250. The plug 550 includes a base portion 552 and an elongated portion 554 extending from the center of the base portion 552 into the cavity 254 of the rotating member 250. The base portion 552 can be configured to rest against the outlet tube 212 (e.g., provide a seal against the outlet tube), for example, to hermetically seal the pellets within the cartridge 200 before or during use (in some embodiments).

[0236] The plug 550 may be in the form of an "umbrella valve". That is, at least the base portion 552 of the plug 550 may be resilient, such as a rubber membrane, wherein the outer edge of the base portion 552 is configured to flex open when the pellet is pushed out of the screw pump in use, and then rebound when the screw pump is not rotating to prevent the pellet from falling out and help seal the cartridge 200. The elongated portion 554 of the plug 550 may not substantially move from its position within the cavity 254 of the rotating member 250.

[0237] Fig. 16C -E shows the available Fig.16A and 16B 1. The embodiment of the present invention is a modification of the umbrella valve concept of the illustrated embodiment. In this embodiment, the device 100 includes a sliding member 560 that is concentrically positioned about the outlet tube 212 and is configured to slide axially relative to the outlet tube (i.e., along the axis A). The base portion 552 of the plug 550 extends in a radial direction (relative to the axis A) through the radial extent of the outlet tube 212 and at least partially into the line of travel of the sliding member 560. This Fig. 16C Shown in.

[0238] As the rotating member 250 (i.e., including the screw portion 240 and the threads 242) rotates, the pellets 10 will be forced downward through the threads 242, and at least some of the pellets 10' will be trapped between the base portion 552 of the elastic plug 550 and the end of the outlet tube 212 or the end of the sliding member 560, as shown in FIG. Fig.16D Indicated schematically.

[0239] To dispense pellets from the device 100, the user may slide the sliding member 560 along the axis A, which causes the base portion 552 of the resilient plug 550 to flex, causing the pellets 10' captured between the base portions 552 of the plug 550 to be released and dispensed from the device 100. Fig.16E Indicated schematically in FIG.

[0240] Once the pellets are dispensed from the device 100, the user can slide the slide member 560 back into position, at which point the valve has returned to its original position (eg, Fig. 16C 550), which prevents pellets from being inadvertently dispensed from the outlet tube 212. In various embodiments, the sliding member 560 can be biased toward this home position by the elasticity of the base portion 552 of the plug 550. For example, a suitable elastic member can bias the sliding member 560 to this position, or an electromechanical device such as a solenoid, relay or other actuator.

[0241] It will be appreciated that during the rotation of the rotating member 250, pellets will be continuously dispensed from the outlet tube 212 through the base portion 552 of the resilient plug 550. The purpose of the sliding member 560 is to remove any pellets remaining between the resilient plug 550 and the base portion 552 of the plug 550 or the end of the sliding member 560 after this dispensing operation, as described above. In this way, the sliding member 560 is configured to end the dispensing operation and prevent stray pellets from falling out of the device 100 outside of any dispensing operation.

[0242] Fig.16F and 16G Another embodiment is shown in which a valve in the form of a deformable material or membrane 545 is placed above the dispensing end of the outlet tube 212. The deformable material 545 can be substantially elastic and can include an orifice 546 through which a pin 253 extends, which extends from one end of the rotating member 250. In the non-operating or stationary position, such as Fig.16F As shown, the outer surface of the pin 253 contacts the inner surface of the orifice 546 to close the end of the outlet tube 212 and prevent the pellets from being dispensed.

[0243] In various embodiments, the length of the pin 253 can be about 1.5 mm (i.e., along the longitudinal axis of the rotating member 250) and the diameter of the pin is about 2.5 mm, and the thickness of the deformable material 545 can be about 1 mm, wherein the width or diameter of the orifice is about 2 or 2.5 mm. The length of the deformable material 545 (in the direction of the longitudinal axis of the rotating member 250) can be less than the length of the pin 253, and can be less than about 80% of the length of the pin 253. The deformable material 545 can include a thermoplastic elastomer ("TPE") or polybutylene terephthalate ("PBT") and / or the hardness of the deformable material can be less than about 100, 80, 70, 60 or even 50 Shore. The Shore hardness test can be performed at Shore 00 or Shore A. Optionally, the hardness can be between about 30 Shore and about 50 Shore, performed at Shore 00 or Shore A. The pin 253 can be substantially rigid. The deformable material 545 may be attached to the outlet tube 212 in any suitable manner, such as by an adhesive.

[0244] As the rotating member 250 rotates, the pellets will be pushed toward the end of the outlet tube 212 for dispensing from the device 100 and upon encountering the deformable material 545 in its stationary position (eg, Fig.16F As shown), the pellets will be forced against the deformable material 545 and deform it, as shown in FIG. Figure 16G As shown, a gap G is created between the deformable material 545 and the pin 253, through which the pellets can be dispensed. At the end of the dispensing operation, once the rotating member 250 stops rotating, the pellets will no longer be pushed against the deformable material 545, and the deformable material 545 will rebound to its resting position, as shown in FIG. Fig.16F As shown, the end of the outlet pipe 212 is closed.

[0245] Fig.17 , 18A 18B shows an embodiment incorporating a modified outlet tube 212', the features of which may be incorporated into any other embodiment described herein involving an outlet tube. In this embodiment, the outlet tube 212' is modified to cooperate with a movable assembly configured to move between a first position in which the movable assembly prevents pellets from being dispensed or removed from the screw pump and a second position in which pellets are allowed to be dispensed from the screw pump.

[0246] More specifically, in the illustrated embodiment, the movable assembly is in the form of a nut 270 configured to travel along the threads 242 of the screw segment 240. The outlet tube 212 includes a generally cylindrical portion 215 and a flange 217 extending from the cylindrical portion 215 in the direction of the longitudinal axis A of the rotating member 250. The flange 217 includes a track 218 along which the nut 270 travels in use. The flange 217 further includes opposing shoulder portions 219A, 219B located at either end of the track 218 and configured to provide a stop for the nut 270.

[0247] The nut 270 is configured to move along the longitudinal axis A of the rotating member 250 (also the axis of the threads 242) when the rotating member (and the screw segment 240) rotates. The nut 270, due to its association with the threads 242, is configured to block the threads and prevent the pellets from moving downward along the threads 242 past a position thereon. In addition, when the nut 270 meets the first portion 219A of the shoulder portion, the nut 270 forms a seal against the cylindrical portion 215 of the outlet tube 212, which means that no portion of the threads 242 is exposed. In this way, the pellets cannot leave the threads 242 and cannot be dispensed from the device.

[0248] When the rotating member 250 rotates in the first rotational direction, the nut 270 is configured to move along the track 218 away from the first shoulder portion 219A, exposing the threads 242 so that the pellets can move down the threads 242 and be dispensed from the cartridge 200. After the rotating member 250 rotates a certain amount, the nut 270 will contact the second shoulder portion 219B, which prevents the nut 270 from moving further (and conveniently also prevents further rotation of the rotating member 250). In this position (which is shown in FIG. 2 ), the nut 270 is moved away from the first shoulder portion 219A, exposing the threads 242, so that the pellets can move down the threads 242 and be dispensed from the cartridge 200. Fig.18B ), the screw pump formed by the threads 242 and the outlet tube 212' will dispense a certain volume (eg, a predetermined or predefined amount) of pellets.

[0249] When the rotating member 250 rotates in a second rotational direction (opposite to the first rotational direction), the nut 270 is configured to move along the track 218 away from the second shoulder portion 219B and eventually contact the first shoulder portion 219A, thereby sealing the cylindrical portion 215 of the outlet tube 212 and preventing pellets from being dispensed from the device.

[0250] Nut 270 may move linearly (axially) along longitudinal axis A of threads 242. Nut 270 may be rotationally constrained (ie, prevented from rotating with rotating member 250) by a friction fit between nut 270 and flange 217 extending downwardly from cylindrical portion 215 of outlet tube 212'.

[0251] When the desired dose is delivered (which may not correspond to the nut 270 traveling all the way along the track 218), the rotating member 250 can be rotated in the opposite direction as described above, thereby pulling the pellets retained in the threads 242 back into the chamber 220, while vertically pulling the nut 270 until it returns to its resting position, contacting the first shoulder portion 219A of the outlet tube 212'. As described above, this contact causes the cylindrical portion 215 of the outlet tube 212' to seal, thereby preventing the pellets from falling out.

[0252] Fig.19A and 19B 2 shows an embodiment including a movable assembly 570 that can be positioned above the outlet end of the outlet tube 212. The movable assembly 570 can be included in Fig.16A and 16B In the illustrated embodiment, and may be provided in addition to, or in place of, the valve 550 (and optional sliding member 560) disclosed in conjunction with this embodiment.

[0253] In this embodiment, the movable assembly 570 may include a spring loaded plate 572 configured to close the outlet end of the outlet tube 212. A suitable resilient member (not shown) may be configured to bias the movable assembly 570 to its position. Fig.19A212. This can help increase moisture protection and prevent pellets from accidentally falling out of the outlet tube 212. In some embodiments, the plate 572 can be configured to rest against the outlet tube 212 in an airtight seal (e.g., an airtight seal). The plate 572 itself can be made of an elastic material, for example, the plate 572 can be made of an elastomer, or include an elastomeric coating. This will further help seal the outlet tube 212 and prevent pellets from falling out of it.

[0254] In one particular embodiment, the movable component 570 is combined with an electronic relay 580 including an electromagnet, which is schematically shown and configured to move the movable component 570 from Fig.19A Its resting position shown is moved to Fig.19B 572 is shown in its open position. In the rest position, the electromagnet can be turned off, thereby biasing the plate 572 toward the end of the outlet tube 212 to seal it and prevent the pellets from falling out. In the open position, the electromagnet can be turned on so that the plate 572 is pulled toward the electronic relay 580, which allows the pellets to be dispensed from the outlet tube 212 during the dispensing operation. In this embodiment, the movable assembly 570 will need to include a magnetic assembly so that the electromagnet of the electronic relay 580 can properly move it from its rest position.

[0255] In various other embodiments, the movable assembly 570 may simply be spring loaded against the action of the user. For example, the electronic relay 580 may not be provided, and the movable assembly 570 may be moved by the user from its rest position to its open position. Other types of electromechanical devices may be used, such as solenoids or other actuators.

[0256] Fig. 20A and 20B An embodiment is shown, which can be regarded as Fig.16A and 16B 243, wherein the valve 550 is replaced by a valve 590 extending from the end of the rotating member 250 in a similar manner. The valve 590 of this embodiment includes a disk 591 having a notch 592 configured to align with the outlet 243 of the thread 242, wherein when the notch 592 and the outlet 243 are aligned, the pellets are configured to be dispensed from the device 100. The disk 591 can be in a first position (e.g., when the notch 592 is aligned with the outlet 243) in which the notch 592 is aligned with the outlet 243. Fig. 20A 592 is rotated between a second position in which the notch 592 is moved and not aligned with the outlet 243.

[0257] In various embodiments, Fig. 20BAs shown, valve 590 may include a resilient member 594 configured to bias disc 591 toward its second position. Disc 591 may be configured to rotate with rotating member 250 due to the friction fit between the two components. When rotating member 250 begins to rotate to begin a dispensing operation, disc 591 may rotate with it and move to its first position to align notch 592 with outlet 243 and allow pellets to be dispensed. Once rotating member 250 completes rotation to end the dispensing operation, resilient member 594 may bias disc 591 and move it back to its second stationary position.

[0258] A slight modification of this type of valve is Fig. 20C , which shows a valve 590' in the form of an elastic member (e.g., a rubber member). The elastic member 590' includes a recess 592' having a shape similar to that of the Fig. 20A and 20B The same function as described, namely, the recess 592' is configured to align with the outlet 243 of the thread 242 to allow the pellets to be dispensed during the dispensing operation. In this embodiment, the resilient member 590' is a single piece and includes a disc portion 591', which has a protrusion 596' extending from the disc portion 591' toward the rotating member 250 in use. In this embodiment, the rotating member 250 includes an orifice 254' formed at its end, wherein the protrusion 596' of the resilient member 590' is inserted into the orifice 254'. The protrusion 596' of the resilient member 590' (e.g., its crown 597') has a friction fit with the inner surface of the orifice 254'. The disc portion 591' can be assembled in the outlet pipe 212 and frictionally fit with the outlet pipe (in this embodiment, the outlet pipe 212 can extend over the resilient member 590').

[0259] During the dispensing operation, the rotating member 250 may rotate, and this will cause the rotating member 250 to rotate relative to the disk portion 591' of the resilient member 590', thereby aligning the notch 592' of the disk portion 591' with the outlet 243 of the thread 242. During this operation, the protrusion 596' of the resilient member 590' will flex relative to the disk portion 591' until the notch 592' is aligned, and then the entire resilient member 590' will rotate with the rotating member 250 with the notch 592', maintaining alignment with the outlet 243. When the dispensing operation is completed and the rotation stops, the resilience of the resilient member 590' will cause the disk portion 591' to rotate relative to the rotating member 250 (and the protrusion 596'), so that the notch 592' moves out of alignment with the outlet 243.

[0260] The first valve 500 and the second valve 550 (as well as the modified outlet tube 212' and valves 590, 590') can be configured to help prevent pellets positioned within the threads 242 from falling out during use. The device 100 can be configured so that in order to dispense pellets through the first valve 500 or the second valve 550, the user must rotate the rotating member 250 to force the pellets along the threads 242 and provide a force to the first valve 500 or the second valve 550 so that the pellets can be dispensed through either valve. In some cases, a valve may not be necessary (but may still be included), for example, the pellets themselves may be held in the threads 242 by friction, or a cap or cover may be provided over the outlet of the cartridge (e.g., outlet tube).

[0261] In various embodiments, Fig.21A As shown, the rotating member 250 can be modified so that the threads 242 communicate with an internal passage 245, which is configured to receive pellets from the threads 242, which then travel through the passage to be dispensed from an outlet 243' positioned in the bottom surface of the rotating member 250. Fig. 21B As shown in , a resilient (e.g., rubber) cap 540 can be placed over the end of the rotating member 250, the cap being configured to prevent pellets from being dispensed when the device 100 is not in operation. The cap 540 may include a resilient opening 542 aligned with the outlet 243', but biased to a substantially closed position that prevents pellets from passing through. As the rotating member 250 rotates, the pellets will be forced out of the outlet 243' and toward the opening 542, which is configured to open in a resilient manner, resulting in the pellets being dispensed.

[0262] Fig. 22 , 23 , 24A and 24B show a device 100 including a cap 600, which is configured to be connected to the barrel 200 at the second dispensing end 104 of the barrel so as to cover the outlet tube 212. The cap 600 can be configured to be connected to the barrel 200 by any suitable means (e.g., interference fit, magnetic latch, clip fastener or screw connection). The cap 600 includes a base portion 602 and one or more side portions 604 extending from either end of the base portion 602. Each side portion 604 is connected to the barrel 200 to optionally provide a seal (e.g., an airtight seal) between the cap 600 and the chamber 200. A chamber 606 can be formed between the barrel 200 and the cap 600.

[0263] Cap 600 can be used to provide a collection cup for pellets (eg, can hold a dispensed dose in chamber 606) and / or provide a seal (eg, an airtight seal) prior to and during use. Cap 600 can be combined with first valve 500 or second valve 550 described above.

[0264] Figures 25 to 26 Shows something like Fig.11 and 12 An alternative to the double cartridge embodiment is an embodiment of cartridge 200AB, except that two cartridges 200 are combined in a single unit.

[0265] The single barrel 200AB includes a first set of components, which includes a first rotating member 250A extending through the first chamber 220A, the first rotating member 250A including a first thread 252A and a first screw portion 240A extending into the first outlet tube 212A, and a first plunger 230A, which moves downward along the first thread 252A in a manner similar to that described above for the single barrel 200 during use.

[0266] The first screw portion 240A of the first set of components includes threads 242A extending from the chamber 220A into the outlet member 212A so that when the first rotating member 250A rotates, the pellets are dispensed out of the first outlet tube 212A through the threads 242A in a manner similar to that described above with respect to the single barrel 200.

[0267] A single barrel 200AB includes a second set of components, which includes a second rotating member 250B extending through the second chamber 220B, the second rotating member 250B including threads 252B and a second screw portion 240B extending into the second outlet tube 212B, and a second plunger 230B, which moves downward along the second threads 252B in a manner similar to that described above with respect to barrel 200 during use.

[0268] The second screw portion 240B of the second set of components includes threads 242B extending from the chamber 220B into the outlet member 212B such that upon rotation of the second rotating member 250B, pellets are dispensed from the second outlet tube 212B via the threads 242B in a manner similar to that described above with respect to the single cartridge 200 .

[0269] The first and second groups of components can be configured differently, such that, for example, the various threads 242A, 252A, 242B, 252B can be configured so that the first group of components is configured to dispense pellets at a faster rate than the second group of components. Similarly, different chambers 220A and 220B can be configured to be used with pellets of different sizes. For example, the actuator 300' can be configured so that each individual rotating member 250A, 250B is driven by a different motor or mechanical control, wherein the different motors or mechanical controls are configured to run at different speeds.

[0270] like Fig.26As shown, the first rotating member 250A is configured to rotate about a first axis AA, and the second rotating member 250B is configured to rotate about a second axis AB. In various embodiments, the first axis AA and the second axis AB may be parallel to each other.

[0271] The two rotating members 250A and 250B may be operated by a common actuator 300'. The actuator 300' may be similar to that described above with respect to Fig.11 and 12 An actuator is described that includes a dual connection portion 303 ′, wherein each connection portion 303 ′ is configured to drive a respective rotating member 250A, 250B, and in a manner similar to that described above with respect to the monocylinder actuator 300 .

[0272] Fig. 27 , 28A 28B show an embodiment of a barrel 200 in which the screw segment 240 of the rotating member 250 is replaced by a screw segment 240" in the form of a "twisted plate" arrangement, which maximizes the volume of its flight 242" and minimizes the frictional effects of the screw segment on the pellets. The screw segment 240" of this embodiment is formed from a plate that has been twisted multiple times to produce directly opposed screw heads that extend along the entire length of the flight 242". This is in contrast to embodiments in which the flight is cut away from the circumferential surface of the rotating member, as shown in the previously described embodiments.

[0273] The screw segment 240" can be directly connected to the thread 252 of the rotating member 250 and extend from a position within the chamber 220 into the outlet pipe 212 in a manner similar to the screw segment 240 of the aforementioned embodiment. The width of the screw segment 240" defined by its outer spiral surface 241" can be substantially equal to the width of the inner cylindrical surface 214 of the outlet pipe 212. That is, the surface of the screw segment 240" and the inner cylindrical surface 214 of the outlet pipe 212 can be substantially in contact or abut each other (e.g., continuously or intermittently), but not to the extent that they have an interference fit or friction fit relative to each other to ensure that they can move smoothly relative to each other and ensure reliable dispensing.

[0274] Fig.29A , 29B29C show an embodiment of the device 100 in which the plunger 230 is accompanied by a deformable material 234, which is positioned on the radially extending surface 232 of the plunger 230. In various embodiments, the deformable material 234 can be a foam or sponge. The function of the deformable material 234 is to help press the pellets toward the dispensing end of the device 100 (i.e., into the screw section 240). In particular, the deformable material 234 can provide an effective method in which the small pellets contained in the chamber 220 are ensured to move toward the dispensing end, especially from the inner wall of the chamber 220.

[0275] In various embodiments, the plunger 230 may extend radially (relative to the axis A) a distance that is slightly less than the radial distance to the inner wall of the chamber 220 to avoid friction between the plunger 230 and the wall of the barrel 200. However, in these embodiments, the deformable material 234 may extend radially to a distance equal to the radial distance to the inner wall of the chamber 220, so that the deformable material 234, rather than the plunger 230, ensures that the pellets move from the inner wall of the chamber 220 toward the dispensing end and cannot pass between the plunger 230 and the wall of the barrel 200. The deformable material 234 may be sized so that it partially deforms when placed in place, such as Fig.29A -C, this means that the deformable material will, in use, be pressed against the wall of the cartridge 200 to maximise this effect.

[0276] The deformable material 234 may be press-fitted between the rotating member 250 and the barrel 200 and not attached to the plunger 230 (e.g., by an adhesive). In use, the plunger will move along the axis A as described herein, contacting the deformable material 234 and causing it to also move along the axis A. Alternatively, the deformable material 234 may be secured to the plunger 230 by any suitable means, such as an adhesive.

[0277] The deformable material 234 may be included in any aspect or embodiment of the combined plunger 230 included herein and is not limited to Fig.29A -C (which is provided only to illustrate this feature). For example, the deformable material 234 can be provided in embodiments where the plunger 230 moves along the threads 252, and in these embodiments, the axial thickness of the deformable material 234 can be at least twice the pitch of the threads 252 to ensure that few or no pellets can move through the deformable material 234.

[0278] Fig. 30A , 30B30C shows an embodiment in which the plunger 230 of the device 100 is provided with a plurality of axially extending teeth or protrusions 236. At least some (or all) of the teeth 236 include tracks 237 configured to travel along the threads 252 of the rotating member 250. In addition, the teeth 236 are configured to be radially bent so that the tracks 237 on the teeth 236 can move in and out of the threads 252. When the rotating member 250 rotates in use, the plunger 230 will move along the axis A due to the engagement of the tracks 237 with the threads 252. Once the plunger 230 contacts the pellets contained in the chamber 220 (or reaches the bottom of the chamber 220), further axial movement of the plunger 230 can be limited. At this time, the teeth 236 are configured to bend radially outwardly so that the tracks 237 are disengaged from the threads 252, and the rotating member 250 continues to rotate without the plunger 230 moving along the axis A. As shown in the illustrated embodiment, the track 237 is positioned at the axial end of the teeth 236 farthest from the body of the plunger 230 to maximize the ability of the teeth 236 to flex radially outward as described above.

[0279] Some teeth 236 may be configured as stabilizers, i.e., do not have tracks 237 that engage with the threads 252, and these teeth may be used to stabilize the plunger 230 as it moves along the axis A and as other teeth 236 that do include tracks 237 bend. The teeth 236 used to stabilize the plunger 230 may be biased radially inwardly so that they abut the rotating member 250 as the plunger 230 moves along the axis A.

[0280] Any suitable number of teeth 236 may be provided, such as between 2 and 10, and in some embodiments, a single tooth 236 may be provided. In the illustrated embodiment, the plunger 230 includes six teeth 236, three of which have tracks 237 and the other three serve as stabilizers (i.e., have no teeth 236).

[0281] In any aspect or embodiment provided herein, the plunger 230 may include Fig. 30A -C. The teeth 236 may include a track 237, or alternatively may be provided as a stabilizer as described above. In such embodiments, the plunger 230 will typically not include its own threads. In other words, the plunger 230 moves along the axis A only through the engagement of the track 237 with the threads 252 of the rotating member 250.

[0282] Fig.31A , 31B31C show an embodiment in which the plunger 230 of the device 100 includes a resilient device 260 having a function similar to the teeth 236 described above. The resilient device 260 includes a plurality of protrusions 262 (two are shown in the illustrated embodiment) and a resilient member 264 configured to bias the protrusions 262 radially inwardly. The protrusions 262 extend from the body of the plunger 230 and may be integrally formed with the body or provided as a separate piece and fixed thereto by any suitable method. Each protrusion 262 includes a track 266 configured to engage the threads 252 on the rotating member 250. As shown in the illustrated embodiment, the track 266 is positioned at the axial end of the protrusion 262 farthest from the body of the plunger 230 to maximize the ability of the protrusion 262 to bend radially outwardly, as described below. The resilient member 264 may be, for example, an elastic band.

[0283] When the rotating member 250 rotates in use, the plunger 230 will move along the axis A due to the engagement of the track 266 with the thread 252. The elastic member 264 ensures that the track 266 engages with the thread 252 during this rotation. Once the plunger 230 contacts the pellets contained in the chamber 220 (or reaches the bottom of the chamber 220), further axial movement of the plunger 230 can be restricted. At this time, the protrusion 262 is configured to bend radially outward against the action of the elastic member 264, so that the track 266 is disengaged from the thread 252, and the rotating member 250 continues to rotate without the plunger 230 moving along the axis A.

[0284] In any aspect or embodiment provided herein, the plunger 230 may include Fig.31A -C shows and describes the elastic device 260. In such an embodiment, the plunger 230 will generally not include its own thread. In other words, the plunger 230 moves along the axis A only through the engagement of the track 266 with the thread 252 of the rotating member 250.

[0285] Fig.32A , 32B 32C shows an embodiment with an improved plunger 230'. In this embodiment, the plunger 230' includes a unique shape that is configured to reduce friction between the plunger and the wall of the barrel 200. In particular, the plunger 230' gradually decreases from a first thickness adjacent to the threads 252 of the rotating member 252 to a second thickness at its periphery and adjacent to the wall of the barrel 200, wherein the second thickness is less than the first thickness.

[0286] More specifically, if Fig.32CAs shown, the plunger 230' can include a substantially flat lower surface 232', which includes the perimeter of the plunger 230', which is configured to contact the wall of the barrel 200. A tapered surface 233' can be provided, which extends from the perimeter and radially inward to an upper edge 231', which is located away from the wall of the barrel 200 and adjacent to the rotating member 250. By providing a reduced thickness portion close to the wall of the barrel 200, the friction between the plunger 230' and the barrel 200 can be reduced. In addition, as shown in the illustrated embodiment, the use of the tapered surface 233' means that as the plunger 230' moves axially, the perimeter of the plunger 230' can bend. In such embodiments, the plunger 230' can be made of an elastomeric material such as rubber to enhance the ability of the plunger 230' to bend in this manner.

[0287] In various embodiments of the plunger 230', it can taper to a sharp edge at the periphery of the plunger 230'. The thickness of the plunger 230' at the periphery can be less than, for example, about 2 mm or even about 1 mm. The plunger 230' can be made of a thermoplastic elastomer ("TPE") or polybutylene terephthalate ("PBT"). The hardness of the plunger 230' can be less than about 100, 80, 70, 60 or even 50 Shore. The Shore hardness test can be performed at Shore 00 or Shore A. It has been found that this provides a plunger 230' that is able to bend sufficiently during movement along the axis A when in use. The plunger 230' can be slightly oversized because the width of the plunger 230' (e.g., in an isolated manner) is slightly larger than the size of the barrel 200 in which it is installed. The plunger 230' can also be configured with threads that are configured to cooperate with the threads 252 of the rotating member 250.

[0288] In general, the devices and apparatus disclosed herein can be intended to provide an accurate dose of a drug by weight and also provide a simple mechanism by which a dose can be administered and / or titrated. Various mechanical features are provided to facilitate dispensing of a dose, including swallowing a dose and providing general convenience in doing so. Various embodiments are also intended to ensure efficient movement of pellets through the apparatus or device.

[0289] Handheld device 10 can combine medical knowledge with digital capabilities. Control unit can be reusable and can be combined with various barrels 200 prefilled with prescription drugs. For example, for ADHD, barrel 200 can be prefilled with relevant drugs to use within a month. Barrel 200 can be filled with granules or particles (i.e., oral dosage form). The granules can be taken together with liquid or soft food that supports drug swallowing. Although the device has specific uses for ADHD, the technology disclosed herein is applicable to many other therapeutic methods, and is particularly applicable to pediatric use or for psychiatry, neurology, cardiometabolic disorders or oral cancer treatment.

[0290] Example treatments that may be associated with the devices described herein are attention deficit hyperactivity disorder (“ADHD” – wherein the medication used in the device may include amphetamines and / or methylphenidate), general pain (wherein the medication may include one or more of the following: fentanyl, methadone, pethidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocodone, oxycodone, hydromorphone, naltrexone, buprenorphine, and methadone), post-organ transplant immunosuppression (wherein the medication may include one or more of the following: tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate mofetil, and azathioprine), diabetes (wherein the medication may include one or more of the following: sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, dapagliflozin, empagliflozin, and semaglutide), heart failure (wherein the medication may include carvifloxacin, , metoprolol, bisoprolol, and diuretics), Parkinson's disease ("PD" - wherein the drug can include levodopa and / or carbidopa, epilepsy (wherein the drug can include one or more of: sodium valproate, carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethosuximide, and topiramate), depression (wherein the drug can include one or more of: citalopram, bupropion, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine, and reboxetine), schizophrenia (wherein the drug can include one or more of: aripiprazole, asenapine, buproprazole, cariprazine, clozapine, iloperidone, lurasidone, and olanzapine), cancer, animal health. For example, the device 10 can be combined with drugs (e.g., in pellet form) for or related to the above-mentioned treatments, such as any or all of the treatments described above.

[0291] The use of medications formulated as small pellets or granules can support accurate dosage adjustments and help pediatric patients with swallowing problems. The development of pediatric medications often includes different formulations or devices that address one or both of the challenges faced by this patient population. By combining digitally enabled medications with the handheld device 10 disclosed herein, improvements in dose setting, titration, ease of use, swallowability, and compliance are achieved. The technology can be tailored to different treatment regimens for the pediatric population, including combination therapies. Other areas of treatment using the device 10 disclosed herein can be epilepsy and general pain relief. Distribution technology for infectious diseases such as children can also be developed, for example, where the medication used with the device (e.g., in the form of pellets) can include amoxicillin and / or penicillin.

[0292] The control unit (in any aspect or embodiment described herein) may include an input device or user interface, which may include one or more buttons for operating the device 10, such as the dispensing mechanism 300 therein.

[0293] The control unit may include a control system configured to operate the various electrical and mechanical components of the device 10 , such as the user interface, display, and dispensing mechanism 300 .

[0294] The pre-filled cartridge 200 (e.g., for ADHD, with a one-month prescription) may have an integrated circuit board program that transmits relevant information to the control unit. The control unit, and in particular its control system, may set the dose, prevent taking more than the maximum dose, allow titration, and ensure tampering notification. The control system may record the dispensing of the medication, for example within a defined time period (e.g., a one-month prescription).

[0295] For example, at least in combination with the control system of the control unit described above, the methods, method steps or functional features disclosed herein can be implemented at least in part using software such as a computer program. These can be located on a data processor on the control unit itself. It is therefore understood that from another aspect, the present invention provides computer software specifically adapted to perform the methods, method steps or functional features described herein when installed on a data processing device; a computer program element comprising a computer software code portion, which is used to perform the methods, method steps or functional features described herein when the program element is run on a data processing device; and a computer program comprising code means adapted to perform all steps of the methods, method steps or functional features described herein when the program is run on a data processing system. The data processor can be a microprocessor system, a programmable FPGA (field programmable gate array), etc.

[0296] 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 details may be made without departing from the scope of the present invention as set forth in the following claims.

Claims

1. A device (100) for dispensing a drug or medicament in the form of pellets, the device comprising: a cartridge (200) comprising a chamber (220) for containing a plurality of pellets and a screw pump, wherein the screw pump is configured to receive the pellets from the chamber (220) and to transfer the pellets from the chamber (220) upon rotation of the screw pump to dispense the pellets from the device (100) through the screw pump; as well as a rotating member (250) extending through the barrel (200) and configured to rotate the screw pump to dispense pellets therefrom, wherein the cartridge (200) further comprises a tapered portion (207) configured to direct the pellets contained in the chamber (220) into the screw pump for dispensing from the device (100) via the screw pump as described above, wherein the screw pump is positioned outside the conical portion (207) of the barrel (200), and The screw pump comprises a thread, and the thread cooperates with the inner cylindrical surface of the barrel to form the screw pump, so that when the rotating member rotates in use, the thread rotates within the inner cylindrical surface, thereby causing the pellets contained in the chamber to enter the thread and move downward along the thread to be dispensed from the screw pump.

2. An apparatus according to claim 1, wherein the barrel (200) includes an outlet pipe (212), which extends from the conical portion (207) of the barrel (200), and the outlet pipe (212) accommodates the screw pump, wherein the screw pump is offset from the confluence of the conical portion (207) and the outlet pipe (212), wherein the inner cylindrical surface of the outlet pipe (212) forms the inner cylindrical surface of the barrel (200), and the inner cylindrical surface of the barrel (200) cooperates with the screw pump.

3. An apparatus according to claim 1 or 2, wherein the conical portion (207) extends a certain distance (d) in a first direction, and wherein the screw pump is offset from the confluence of the conical portion (207) and the outlet pipe (212) in the first direction by at least 50% of the distance (d).

4. A device (100) for dispensing a drug or medicament in the form of pellets, the device comprising: a cartridge (200) comprising a chamber (220) for containing a plurality of pellets and a screw pump, wherein the screw pump is configured to receive the pellets from the chamber (220) and to transfer the pellets from the chamber (220) upon rotation of the screw pump to dispense the pellets from the device (100) through the screw pump; as well as a rotating member (250) extending through the barrel (200) and configured to rotate the screw pump to dispense pellets therefrom, wherein the cartridge (200) further comprises a tapered portion (207) configured to direct the pellets contained in the chamber (220) into the screw pump for dispensing from the device (100) via the screw pump as described above, The screw pump is positioned within the conical portion (207) of the barrel (200) and gradually decreases along the conical portion (207).

5. The device according to claim 4, wherein the inner wall of the barrel (200) forming at least the conical portion (207) forms a funnel, and the funnel is configured to guide the pellets contained in the chamber (220) into the screw pump.

6. An apparatus according to claim 4 or 5, wherein the barrel (200) comprises an outlet pipe (212), the outlet pipe comprising the tapered portion (207) of the barrel (200), and the outlet pipe (212) accommodates a screw pump, wherein the tapered portion (207) extends a certain distance (d) in a first direction, and the distance (d) is between about 30% and 100% of the length (L) of the outlet pipe (212) in the first direction.

7. The device of claim 6, wherein the distance (d) is between about 40% and 60% of the length (L) of the outlet tube (212) in the first direction.

8. Apparatus according to any one of claims 4 to 7, wherein the outer diameter of the screw pump remains substantially flush with the inner surface of the barrel (200) within its tapered portion (207).

9. The device of any preceding claim, wherein the maximum dimension of the pellets is between about 150 μm and 1200 μm.

10. The device according to any one of the preceding claims, wherein the cartridge (200) extends from a first end to a second dispensing end, and the screw pump is positioned at the second dispensing end of the cartridge (200).

11. The device according to any of the preceding claims, wherein the device (100) is a handheld device (100).

12. The device according to any of the preceding claims, further comprising a plurality of pellets providing an oral dosage form contained within the chamber (220).

13. Apparatus according to any preceding claim, wherein the screw pump comprises one or more threads having a variable pitch.

14. An apparatus according to any preceding claim, wherein the screw pump comprises one or more threads formed around the rotating member such that the screw pump forms part of the rotating member.

15. A method of using the apparatus according to any one of the preceding claims, the method comprising: For example, the screw pump is rotated using the rotating member (250) to dispense the pellets from the device (100); filling the chamber (220) with pellets providing an oral dosage form; determining an amount of rotation of the screw pump that will cause a predetermined amount of the pellets to be dispensed from the device (100); as well as The screw pump is rotated a predetermined amount to dispense the predetermined amount of pellets from the device (100).

16. A device (100) for dispensing a drug or medicament in the form of pellets, the device comprising: a cartridge (200) comprising a chamber (220) for containing a plurality of pellets and a screw pump, wherein the screw pump is configured to receive the pellets from the chamber (220) and to transfer the pellets from the chamber (220) upon rotation of the screw pump to dispense the pellets from the device (100) through the screw pump; as well as a rotating member (250) extending through the barrel (200) and configured to rotate the screw pump to dispense pellets therefrom, wherein the cartridge (200) further comprises a tapered portion (207) configured to direct the pellets contained in the chamber (220) into the screw pump for dispensing from the device (100) via the screw pump as described above, The screw pump comprises one or more threads with variable pitch.

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