Delivery device for drug pellet

Abstract

To provide a device for dispensing a drug or medicament in pellet form.SOLUTION: The device 100 for dispensing a pellet 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 and transport the pellets from the chamber to be dispensed from the device via the screw pump. The device further comprises a rotating member 250 extending through the cartridge and configured to rotate the screw pump so as to dispense pellets therefrom. The cartridge further comprises a tapered portion configured to guide pellets contained within the chamber into the screw pump for dispensing from the device via the screw pump as aforesaid.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to delivery devices for drug pellets (e.g., drugs or pharmaceuticals in pellet form) and to various aspects of such devices, for example, relating to the ejection of pellets from the devices and the operation and mechanics of such devices. [Background technology]

[0002] Solid oral dosage forms ("ODF") drugs can be manufactured in tablet or pellet form, for example. The tablets or pellets can contain various substances, the main component of which is the active pharmaceutical ingredient ("API"). The drug pellets can be administered to patients as pre-filled capsules or compressed into tablets with other materials. Discharge mechanisms for various types of ODFs are known and can range from transparent packaging-type devices in which individual tablets can be held in pockets, and can be held in pockets by the use of foil, to discharge bottles. Various more complex mechanisms are also known, especially for other types of drug formulations, such as those in pellet form, which can usually be less than 10% of the specific dosage per unit.

[0003] An advantage of delivering drugs in pellet form may be the ability to vary the dosage using the same delivery device. Another advantage is that pellets are relatively easy to ingest, whereas tablets may be crushed for ingestion or swallowing by the patient. Crushing or splitting tablets is often used by patients to obtain half the dose from a prescribed medication, but this process is not recommended. The use of pellets allows for more precise dosage adjustment than can be achieved using larger dosage forms such as tablets or capsules. Furthermore, in modified-release formulations, pellets are often more robust to food interactions than larger dosage forms such as tablets.

[0004] It is desirable to improve the mechanism by which drugs in pellet form are expelled. It has been recognized that such improvements would be beneficial in many areas, including, for example, easier-to-swallow antibiotics in pediatric and prescription medicines, especially in geriatric medicine, easier-to-swallow chronic medications, certain controlled substances such as stimulants for ADHD or painkillers such as synthetic anesthetics, improved control over the excreted dose or limiting the risk of overexcretion, for example in the case of immunosuppression after organ transplantation, medications that require initial titration or flexible adjustment as a result of disease variability or the outcome achieved, psychiatric disorders such as depression, and neurological disorders such as epilepsy.

[0005] Although methods have been devised for ejecting pellet-type medications, it has been found that the mechanics of such devices can be difficult to optimize due to the nature of the pellets and their interaction with the moving parts of such devices. For example, pellets have been found to shear, clump, or move violently within the device, causing problems such as clogging or shattering of the pellets as they are ejected.

[0006] Therefore, it would be desirable to improve the mechanism of the device for expelling this type of oral dosage form to avoid these and similar problems. Summary of the Invention

[0007] Various aspects and embodiments of evacuation devices will now be described that may be used in the present invention and relate to any of the inventive aspects and embodiments described herein.

[0008] According to the present invention, a device is provided for discharging at least one solid oral dosage form (e.g., a drug or pharmaceutical product) in pellet form. As described below, the maximum dimension (e.g., width or diameter) of the solid oral dosage form (e.g., pellet) can be about 150 μm to about 1200 μm (or even about 1500 μm), optionally about 200 μm to about 300 μm, about 300 μm to about 500 μm, or about 500 μm to about 700 μm. In various embodiments, the maximum dimension (e.g., width or diameter) of the solid oral dosage form (e.g., pellet) can be about 700 μm to about 900 μm, or about 800 μm to about 1100 μm.

[0009] This device is a cartridge comprising a chamber configured to store a solid oral dosage form; a screw pump, e.g., an Archimedes screw, configured to receive a plurality of units of the solid oral dosage form from a chamber and, upon rotation of the screw pump, transport the units of the solid oral dosage form from the chamber through the screw pump (e.g., an outlet of the screw pump) for ejection from the device (and / or, e.g., cartridge and / or chamber); a rotating member extending through the cartridge and configured to rotate the screw pump to dispense a plurality of units of the solid oral dosage form from the cartridge.

[0010] The cartridge may further comprise a tapered portion configured to guide pellets contained within the chamber into the screw pump for expulsion from the device via the screw pump as described above. The tapered portion is essential for the first and second aspects of the invention discussed below, but may not be essential in other aspects (e.g., aspects requiring a screw thread with a variable pitch).

[0011] In a first aspect of the present invention, the screw pump is located outside of (e.g., displaced from) the tapered portion of the cartridge. The tapered portion can then provide a convenient funnel or feed path for pellets entering the screw pump, while the displacement avoids undesirable interactions between the screw pump and the funnel, including an interface that may be difficult for the pellets to pass through. This provides for easier and more efficient feeding of pellets into the screw pump. If the screw pump were not displaced from the tapered portion, the screw pump's interaction with the tapered portion could potentially create an interface that is difficult for the pellets to pass through. This displacement can be in the direction of the screw pump's outlet.

[0012] The tapered section must be free of edges formed by parts of the screw pump located inside or adjacent to it, particularly the inner surface of the cartridge at the tapered section, and by displacing the screw pump from such edges, shearing of the pellets at this location, which might otherwise occur, is avoided.

[0013] The cartridge can include an outlet conduit extending from the tapered portion of the cartridge. The outlet conduit can house a screw pump, which can be displaced from the junction of the tapered portion and the outlet conduit.

[0014] The tapered portion can extend a distance (d) in a first direction, and the screw pump can be displaced in the first direction from a junction of the tapered portion and the outlet pipe by at least 50% of the distance (d). The first direction can correspond to an axial direction of the rotating member. This creates a large clearance between the tapered portion and the screw pump, which further reduces the possibility of damage (e.g., shearing) to the pellets.

[0015] The inner wall of the cartridge can define at least a tapered portion and can taper from a first diameter (D1) to a second diameter (D2), where the first diameter (D1) is greater than the second diameter (D2). The inner wall can have the first diameter (D1) in a portion of the cartridge above the tapered portion, and can taper from the first diameter (D1) to the second diameter (D2) as it extends through the tapered portion.

[0016] The rotating member may taper from a first diameter (d1) to a second diameter (d2) as it extends through the tapered portion of the cartridge, the first diameter (d1) being larger than the second diameter (d2). The rotating member may have the first diameter (d1) in a portion of the cartridge above the tapered portion, and the rotating member may taper from the first diameter (d1) to the second diameter (d2) as it extends through the tapered portion of the cartridge.

[0017] In a second aspect of the invention, the screw pump is located inside the tapered section of the cartridge and can be tapered with the tapered section, meaning that the screw pump follows the geometry of the cartridge through the tapered section, so that pellets are more easily and efficiently fed from the chamber into the screw pump during use.

[0018] The inner wall of the cartridge may define at least a tapered portion and may define a funnel configured to guide pellets contained within the chamber into the screw pump.

[0019] The cartridge may include an outlet tube that includes a tapered portion of the cartridge, and the outlet tube may house a screw pump.

[0020] The tapered portion can extend a distance (d) in a first direction, the distance (d) being approximately 30% to 100% of the length (L) of the outlet tube in the first direction. The first direction can correspond to the axial direction of the rotating member. The distance (d) can be approximately 40% to 60% of the length (L) of the outlet tube (212) in the first direction.

[0021] The outer diameter of the screw pump remains substantially flush with the inner surface of the cartridge within the tapered portion of the cartridge.

[0022] The first and second aspects of the present invention contribute to solving essentially the same problem, namely the effect of a difficult interface between the screw pump and the inner surface of the chamber. This is solved in each case as described above, with the same effect: easier and more efficient feeding of pellets into the screw pump. It should be noted that the present invention is not limited to the first and second aspects.

[0023] In any of the aspects and embodiments described above and herein, the maximum dimension of the pellets may be from about 150 μm to 1200 μm. The pellets may have other dimensions, including any of the specific dimensions specified elsewhere herein.

[0024] The device may further comprise a plurality of pellets providing the oral dosage form contained within the chamber.

[0025] The rotating member can include one or more fins located at an inlet to the screw pump and configured to concentrate and direct pellets within the screw pump. Each of the one or more fins can be aligned with and / or associated with the start of a respective screw of the screw pump. Such fins can effectively help break up and avoid clogging of pellets as they enter the screw pump.

[0026] The rotating member can include one or more baffles configured to rotate with the rotating member and assist in moving the pellets through the chamber and into the tapered portion, which can effectively help break up and avoid clogging of the pellets as they move toward the screw pump.

[0027] In one aspect of the invention, there is provided a method of using a device as described above, the method comprising, for example, rotating a screw pump to cause pellets to be expelled from the device using a rotating member.

[0028] This method is filling the chamber with pellets to provide an oral dosage form; determining the amount of rotation of the screw pump that will cause a predetermined (and / or approximate) amount of pellets to be expelled from the device; The method may further include rotating the screw pump a predetermined amount to expel a predetermined (and / or approximate) amount of pellets from the device.

[0029] In any of the aspects and embodiments described above and herein, the chamber can extend from a first end of the device to a second discharge end of the device. The cartridge can extend from the first end to the second discharge end, and the screw pump can be located at the second discharge end of the cartridge.

[0030] A screw pump may be located at the second discharge end of the device.

[0031] The screw pump may be gravity fed, i.e., the pellets held in the chamber may move at least partially by gravity toward the second discharge end when the device is in a discharge orientation (e.g., with the discharge end facing downward).

[0032] The device may be a handheld and / or portable device, in other words, the device may be capable of being held and transported with one hand and / or operable using one hand.

[0033] For example, the length (corresponding to its largest dimension) of the device (e.g., the entire device or cartridge) can be about 250 mm or less (such as less than about 200 mm, about 150 mm, or about 100 mm), and the width or height (i.e., transverse to its length) can be about 50 mm or less, optionally about 40 mm or less (and, in some embodiments, less than 30 mm, or even less than 20 mm).

[0034] To optimize the handheld nature of the device, the length of the device can be about 150 mm to about 220 mm (e.g., about 160 mm to about 180 mm, optionally about 165 mm), the width (transverse to the length of the device) can be about 35 mm to about 45 mm (optionally about 40 mm), and the height (transverse to the width of the device) can be about 22 mm to about 32 mm (optionally about 28 mm).

[0035] The weight of the device (or cartridge) may be no more than about 500 g, about 400 g, about 300 g, about 200 g, or even about 100 g, which can ensure that the device is light enough to be carried in one hand.

[0036] The length of the cartridge (or cartridge assembly) (corresponding to its largest dimension) can be about 90 mm to about 120 mm (optionally about 105 mm), the width (transverse to its length) can be about 33 mm to about 43 mm (optionally about 40 mm), and the height (transverse to its width) can be about 15 mm to about 32 mm, e.g., about 23 mm to about 32 mm (optionally about 28 mm). In combination with any of the above values ​​for the length of the cartridge (or cartridge assembly), its width can instead be about 33 mm to about 43 mm, and its height can instead be about 15 mm to about 25 mm.

[0037] A screw pump may be part of or comprise a part of a rotating element. For example, a screw pump may comprise one or more threads formed around a rotating element, such that the screw pump forms part of the rotating element. The term "one or more" is used herein due to the possibility that a screw pump may comprise one or more thread starts, each forming a separate thread. Hereinafter, for the sake of brevity, plural terms will be used, but it will be understood that references to a singular or plural threads described herein encompass the singular or plural threads.

[0038] The screw pump may include one or more screw threads having a variable pitch. This has been found to aid in the transport of pellets through the screw pump, for example, by packing or compressing the pellets toward the outlet of the screw pump. The pitch may be variable along the axial length of the screw pump. The pitch may increase gradually (e.g., continuously) in the axial direction away from the outlet for at least a portion (or all) of the axial length of the screw pump. Stated differently, the pitch may decrease gradually (e.g., continuously) in the axial direction toward the outlet for at least a portion (or all) of the axial length of the screw pump.

[0039] This feature is considered advantageous in itself and therefore an aspect of the present invention provides a cartridge, a screw pump and a rotating member as described above, wherein the screw pump includes one or more screw threads having a variable pitch as described above.

[0040] In the aspects and embodiments described above and herein, the length of the threaded portion (e.g., along the longitudinal axis of the cartridge) can be defined by the length of the threads, which can be from about 10 mm to about 30 mm, e.g., from about 10 mm to 20 mm.

[0041] The device may be configured such that when the rotating member and screw pump rotate in use, the pellets move along the threads of the screw pump from a portion of the thread extending into the chamber to the opposite end of the thread for discharge from the screw pump.

[0042] The screw threads may cooperate with the inner cylindrical surface of the cartridge to form a screw pump, such that when the rotating member rotates in use, the screw threads rotate within the inner cylindrical surface, forcing pellets contained in the chamber to enter the screw threads and move down the screw threads for ejection from the screw pump. Note that the cartridge itself need not be generally cylindrical. Rather, to form a screw pump, the cartridge may include an inner cylindrical surface, although this should not be construed to necessarily mean that the cartridge itself is wholly or partially cylindrical.

[0043] The cartridge and / or chamber may be any suitable shape, for example, cylindrical or rectangular. The cartridge and / or its chamber may be at least partially cylindrical, and the cylindrical portion of the cartridge and / or chamber may comprise the inner cylindrical surface of the screw pump and at least a portion of the chamber for holding pellets. In this embodiment, the cartridge may be open at the second discharge end of the device, and the rotating member may comprise a threaded portion (forming part of the screw pump) having an outer diameter that substantially matches the inner diameter of the cartridge and / or chamber at the second discharge end of the device.

[0044] Alternatively, the cartridge can include an outlet or outlet tube (e.g., as described above) extending from the chamber. The outlet tube can have a width or diameter that is less than the inner diameter of the chamber. The rotating member can extend into the outlet tube, such that the inner cylindrical surface of the outlet tube forms the inner cylindrical surface of the screw pump. In these embodiments, the cartridge and / or chamber can include a frustoconical or tapered portion (e.g., as described above) at a second discharge end of the cartridge and / or chamber that directs pellets contained in the chamber into the outlet tube.

[0045] In various embodiments, the majority of the length of the rotating element (e.g., within the cartridge) does not have threads that form a screw pump. For example, at least about 70%, 80%, 90%, or even 95% of the length of the rotating element (e.g., within the cartridge) does not have threads that form a screw pump. This means that the threads only interact with and collect pellets that face the second discharge end of the chamber, which can be beneficial for pellets located toward the first end in that the threads do not interact with or interfere with the majority of the pellets.

[0046] Gravity (and / or a plunger device as described below) can be used to move the pellets to the discharge end of the chamber, at which point they can be collected by the screw threads and drawn into the screw pump.

[0047] The device can further include a device (e.g., a plunger) configured to urge the pellets contained in the chamber toward the screw pump. This device can act in addition to gravity, such that the combination of gravity and the force provided by the device moves the pellets contained in the chamber toward the screw pump. For example, the device can be or include a plunger in the form of a weight configured to rest on the pellets contained in the chamber when the device is in an orientation that allows for the pellets to be ejected.

[0048] The device may include a plunger configured to move along the rotating member, either automatically or as a result of rotation of the rotating member. For example, a portion of the rotating member within the chamber may include threads (e.g., plunger threads that may be different from any threads of the screw pump), and the plunger may form a nut around the rotating member that is configured to move along the threads of the rotating member during use, such that when the rotating member rotates, the plunger moves toward the screw pump and forces pellets contained in the chamber toward the screw pump. The plunger may be configured to abut and / or contact the inner surface of the cartridge and / or chamber, and a friction fit may exist between the plunger and the inner surface of the cartridge and / or chamber, which can help prevent the plunger from rotating with the rotating member.

[0049] This friction fit can be particularly useful in embodiments where the plunger rotates within a cylinder (e.g., a cylindrical cartridge). The described friction fit (i.e., to prevent the plunger from rotating) can be particularly important when using a cylindrical cartridge (and / or a cylindrical inner surface along which the plunger moves). In the case of a non-cylindrical cartridge (or non-cylindrical surface), the plunger may be prevented from rotating due to the outer periphery of the plunger abutting the inner surface of the cartridge. For example, if the cartridge is square or rectangular, the plunger cannot rotate.

[0050] In various embodiments, the device can include specific features that provide a driving force to the plunger toward a pellet located in the chamber, in addition to or in addition to relying on the weight of the plunger, for example, as described above. For example, a ratchet mechanism can be used to ensure that the plunger can move in only one direction, i.e., toward a pellet located in the chamber. Alternatively, or additionally, a resilient member (e.g., a spring) can be provided (e.g., biased between a surface of the plunger and a portion of the cartridge) to urge the plunger toward a pellet located in the chamber. Alternatively, or additionally, a source of compressed air can be provided to pressurize the plunger toward a pellet located in the chamber.

[0051] The device can include a deformable material pressure-fitted between the rotating member and the cartridge, wherein the plunger is configured to push the deformable material along the longitudinal axis of the rotating member, and the deformable material is configured to displace the pellets (e.g., rub against one or more (or all) interior walls of the cartridge that form a chamber) when pushed by the plunger, thereby assisting in displacing the pellets toward the screw pump.

[0052] The plunger can include one or more tines or prongs extending axially (relative to the longitudinal axis of the rotating member) from the body of the plunger. The tines can include a rail at a distal end (away from the body) and configured to engage with threads on the rotating member, such that rotation of the rotating member causes the rail to move along the threads and move the plunger along the axis. The tines can be configured to curve radially so that the rail can disengage from the threads.

[0053] The plunger may include one or more teeth or prongs extending axially (relative to the longitudinal axis of the rotating member) from the body of the plunger and biased towards the rotating member, thereby stabilizing the plunger as it moves along the axis in use.

[0054] The plunger can include a resilient device including a plurality of protrusions (e.g., tines or tines as described above) and a resilient member configured to bias the protrusions radially inward, which can be an elastic band extending concentrically around the rotating member.

[0055] The plunger can taper from a first thickness adjacent the rotating member to a second thickness at the outer periphery (radial direction) of the plunger, the second thickness being smaller than the first thickness. The outer periphery can be adjacent to an inner wall of the cartridge that forms a portion of the chamber. The plunger can taper toward a leading edge at the periphery of the plunger. The plunger can be configured to bend at the outer periphery in a resilient manner, which reduces friction between the plunger and the cartridge and also aids in moving pellets toward the screw pump.

[0056] The device may further comprise a valve connected to the outlet of the screw pump and configured to prevent pellets from being discharged from the screw pump other than during a discharge operation, for example when the screw pump is not rotating or prior to use, and may allow pellets to be discharged from the screw pump during a discharge operation, for example when the screw pump is rotating in use.

[0057] The valve may include a resilient portion, for example a rubber sheet, that is configured to flex and open when the screw pump rotates in use to allow pellets to be expelled, and then return to its original position when the screw pump is not rotating, thereby stopping pellets from falling out of the screw pump and helping to seal the cartridge.

[0058] The resilient sheet can be movable between a first position and a second position, where in the first position the sheet closes the end of the screw pump to prevent the pellets from being discharged and in the second position the sheet releases the end of the screw pump to allow the pellets to be discharged. In various embodiments, the sheet can be configured to move due to forces exerted on the sheet by the pellets through and based on rotation of the screw pump.

[0059] The valve may comprise an umbrella valve.

[0060] The valve can include a frusto-conical portion extending from a first end of the valve, which connects to the outlet of the screw pump, to a second end of the valve. The second end of the valve can include an outlet portion having an outlet for discharging pellets therethrough. The valve can be configured such that, upon rotation of the rotating member, the pellets must be forced out of the valve through the outlet of the valve. For example, the size of the outlet can be adapted to the size of the pellets to be discharged, such that the minimum dimension (e.g., width) can be substantially equal to the width or diameter of the pellets and / or less than about 1.5, 1.4, 1.3, 1.2, or 1.1 times the width or diameter of the pellets.

[0061] The device can include one or more actuators configured to rotate the rotating member. The actuators can be mechanical or electromechanical. The actuators can be located at a first end of the device. The actuators can be configured to rotate the rotating member, which (in related embodiments) can move a plunger down a threaded portion of the rotating member and / or rotate the threaded portion, causing pellets to be expelled through the screw pump.

[0062] The actuator may be an electromechanical actuator (e.g., one or more motors) or may comprise an electromechanical operating mechanism, such that the device may be capable of repeatedly dispensing precise amounts of pellets. The motor and control system may be powered by an integral battery (which may be user-replaceable), which may be held within the housing of the actuator.

[0063] The device can include a control system (e.g., as part of the actuator) that can be configured to expel the 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 can be initiated, for example, by a user pressing a suitable button or other input mechanism located on the device, or optionally via a different control device, such as a wireless or wired external control device.

[0064] The actuator may include one or more electric (e.g., stepper) motors, which may be configured to rotate the rotatable member any suitable number of rotations (e.g., number of steps) based on the situation at hand, e.g., the type of medication in the cartridge, or the user. The control system may be provided, for example, in the form of a microcontroller on a printed circuit board ("PCB"), which may be located within the device housing within the actuator.

[0065] In accordance with an aspect of the present invention, there is provided a method of using a device in any of the above aspects and embodiments.

[0066] The method comprises: The method includes, for example, using a rotating member to rotate a screw pump a predetermined amount of rotation to expel a predetermined amount of pellets from the device. The device may be a disposable or relatively inexpensive device intended for short-term prescription drug expulsion, including, but not limited to, antibiotics, that is simpler and more convenient than existing clear-packaged medications and liquid formulations.

[0067] The method may further include filling the chamber with pellets that provide the oral dosage form, determining an amount of rotation of the screw pump that will cause a predetermined amount of pellets to be expelled from the device, and rotating the screw pump a predetermined amount to expel the predetermined amount of pellets from the device.

[0068] The method may include storing pellets providing an oral dosage form within a cartridge (e.g., a chamber of the cartridge), and the pellets may include a drug or compound for the treatment of one or more of the following: attention deficit hyperactivity disorder ("ADHD" - drugs or compounds may include amphetamine and / or methylphenidate), general pain (drugs or compounds may include fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrochloride, hydroxybenzoates, benzocaine, benzodiazepine, benzocaine, benzoyl peroxide ... and methadone), immunosuppression after organ transplantation (drugs or compounds may include one or more of tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate, and azathioprine), diabetes (drugs or compounds may include sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, dapa ... and semaglutide), heart failure (drugs or compounds may include one or more of carvedilol, metoprolol, bisoprolol, and diuretics), Parkinson's disease ("PD" - drugs or compounds may include levodopa and / or carbidopa), epilepsy (drugs or compounds may include sodium valproate, carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethosuximide, and and topiramate), depression (drugs or compounds may include one or more of citalopram, amfebutamone, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine, and reboxetine), schizophrenia (drugs or compounds may include one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, and olanzapine), cancer, and animal health.

[0069] The method may include using the device in the treatment of 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 in the cartridge (e.g., the chamber of the cartridge), when used in a particular treatment, may include one or more of the drugs or compounds mentioned above with respect to that particular treatment.

[0070] This device may be for a more robust, long-lasting dispenser, where a first portion of the device (e.g., actuator 300, 300′, described below, and optionally rotating members 250, 250′, 250A, 250B) comprises a relatively complex or expensive portion of the ejection mechanism, and one or more second portions of the device (e.g., cartridge or cartridges 200, 200′, 200AB, described below) comprise a relatively simple or inexpensive portion of the ejection mechanism and a drug or oral dosage form. One or more second portions may be replaceable cartridges (or replaceable integrated cartridges, such as cartridge 200AB, described below) that can be inserted into the first portion, such that the first portion can be used with different cartridges and various types of pharmaceuticals, drugs, and dosages (e.g., oral dosage forms). In some embodiments, the first portion can include a housing (e.g., see housing 400, described below) configured to hold a cartridge or cartridges, and the second portion can include a cartridge or cartridges that can be inserted into the housing.

[0071] The present invention relates to the integration of a cartridge and an ejection mechanism. Pellets are ejected using a screw pump, for example, in the form of an "Archimedes" screw mechanism, which has been found to be advantageous due to its precision, simplicity, and ease of use. In some embodiments, the device can include means for applying pressure to the pellets within the chamber in which they are held, for example, using a plunger 230, as described below. Applying pressure to the pellets in this manner to properly pack them can mean that the dosage is consistent over the life of the cartridge, with the first dose being a similar dose to the last, either in volume or weight. Furthermore, such operation can mean that the device can be operated in any orientation.

[0072] In some embodiments, the device also incorporates the use of a plunger mechanism, which separates the pellet from the operating mechanism of the device.

[0073] Further technical advantages will become apparent from the description provided below.

[0074] definition Pellets - single granules of an oral dosage form (e.g., a pharmaceutical, drug, medication, etc.), optionally having a dimension (e.g., largest dimension, width, or diameter) of about 150 μm to about 1200 μm (or even about 1500 μm, optionally about 200 μm to about 300 μm, about 300 μm to about 900 μm, or about 500 μm to about 700 μm). By "diameter," it is meant that the pellets are assumed to be roughly spherical, even if they are irregularly shaped. The diameter may correspond to the largest width of the pellet if the pellet is not assumed to be spherical. Pellets may or may not have a surface coating. If a surface coating is provided, the dimensions provided herein correspond to the pellets with any surface coating.

[0075] In various embodiments, the pellets may have dimensions (e.g., largest dimension, width, or diameter) 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.

[0076] Dose - a single measurement (e.g., volume or weight) of pellets, for example, a total volume of about 0.05 mL to about 0.8 mL (such as about 0.1 mL to about 0.6 mL), for example, a volume of about 0.3 mL (although in some cases such pellets are measured by weight).

[0077] Discharge mechanism - a system, for example an electromechanical system that converts user action into dose discharge.

[0078] Cartridge - a component, e.g., a replaceable component used to store and eject pellets, optionally containing device features such as a rotating member in the form of a central threaded bar, a moving plunger, and pellets.

[0079] Plunger - a plate that can ensure that the pellets remain compressed together towards the discharge end of the cartridge (although other types of plungers are envisioned). The plate may be substantially rigid, although portions of the plate, for example, those portions that interact with other parts of the cartridge, may be flexible.

[0080] Ejection Aperture - The open end of the cartridge through which the pellets can be ejected for consumption.

[0081] Cap - A container or tray that covers the delivery aperture for collecting the dose and protecting the stored pellets from moisture.

[0082] Press - the action that the user performs on the device when he wants to expel the specified dosage, which can be a rotary or linear movement.

[0083] It should be understood that, as referred to herein, reference to "one" drug or pharmaceutical may be considered "one or more" drugs or pharmaceuticals. For example, a pellet may contain several drugs or pharmaceuticals in pellet form. This can be achieved by mixing pellets, each with a different drug or pharmaceutical, and / or by mixing drugs or pharmaceuticals within each pellet. [Brief explanation of the drawings]

[0084] Various embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0085] [Figure 1] 1 shows a perspective view of a device capable of dispensing a drug or pharmaceutical product in pellet form (eg, an oral dosage form). [Figure 2] 2 shows a cross-sectional view of the device shown in FIG. 1. [Figure 2A] 2 shows a cross-sectional view of the device shown in FIG. 1. [Figure 3] 10 shows a schematic representation of the threads located at the transition or junction of the tapered surface and the outlet pipe. [Figure 4] 1 illustrates an embodiment of the present invention showing a second discharge end of a device similar to that of FIG. 1, but with the screw pump displaced from the junction of the tapered surface and the outlet tube. [Figure 5] 1 illustrates an embodiment of the invention showing a second discharge end of a device similar to that of FIG. 1, but with a screw pump located inside and tapered with the tapered portion of the cartridge. [Figure 6A]A variation of the embodiment of Figure 5 (although also applicable to the embodiment of Figure 4) is shown in which the rotating member includes one or more fins configured to concentrate and direct pellets within the screw pump. [Figure 6B] A variation of the embodiment of Figure 5 (although also applicable to the embodiment of Figure 4) is shown in which the rotating member includes one or more fins configured to concentrate and direct pellets within the screw pump. [Figure 7A] A further improvement to the embodiment of Figure 5 (which is also applicable to the embodiment of Figure 4) is shown in the form of one or more baffles that rotate with the rotating member and are configured to displace or assist in moving pellets through the cartridge. [Figure 7B] A further improvement to the embodiment of Figure 5 (which is also applicable to the embodiment of Figure 4) is shown in the form of one or more baffles that rotate with the rotating member and are configured to displace or assist in moving pellets through the cartridge. [Figure 8] 1 shows a schematic representation of the thread profile of a screw pump and various dimensions that may be associated with the thread. [Figure 9] 1 illustrates an embodiment of a thread having a variable pitch. [Figure 10] 1 illustrates an embodiment of a thread having a variable pitch. [Figure 11] 1 shows an embodiment with two cartridges positioned side by side within a housing. [Figure 12] 1 shows an embodiment with two cartridges positioned side by side within a housing. [Figure 13] 10 shows an embodiment incorporating a first valve positioned over the outlet tube of the cartridge. [Figure 14A] 10 shows an embodiment incorporating a first valve positioned over the outlet tube of the cartridge. [Figure 14B] 10 shows an embodiment incorporating a first valve positioned over the outlet tube of the cartridge. [Figure 15]10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 16A] 10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 16B] 10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 16C] 10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 16D] 10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 16E] 10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 16F] 10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 16G] 10 shows an embodiment incorporating a second valve in the form of a plug positioned over the outlet tube of the cartridge. [Figure 17] 10 shows an embodiment incorporating a modified outlet tube. [Figure 18A] 10 shows an embodiment incorporating a modified outlet tube. [Figure 18B] 10 shows an embodiment incorporating a modified outlet tube. [Figure 19A] 10 illustrates an embodiment including a movable component that can be positioned over the outlet end of the outlet tube. [Figure 19B] 10 illustrates an embodiment including a movable component that can be positioned over the outlet end of the outlet tube. [Figure 20A] An alternative embodiment is shown in which the valve shown in the embodiment of Figures 16A and 16B is replaced by a different valve that extends in a similar manner from the end of the rotating member. [Figure 20B]An alternative embodiment is shown in which the valve shown in the embodiment of Figures 16A and 16B is replaced by a different valve that extends in a similar manner from the end of the rotating member. [Figure 20C] An alternative embodiment is shown in which the valve shown in the embodiment of Figures 16A and 16B is replaced by a different valve that extends in a similar manner from the end of the rotating member. [Figure 21A] 1 shows a modified rotating member having threads communicating with an internal passageway. [Figure 21B] 21B shows a variation of the embodiment of FIG. 21A, in which a resilient cap is placed over the end of the rotating member to prevent the pellet from being ejected when the device is not operating. [Figure 22] 10 shows a device comprising a cap configured to connect to the cartridge at a second discharge end of the cartridge so as to cover the outlet tube. [Figure 23] 10 shows a device comprising a cap configured to connect to the cartridge at a second discharge end of the cartridge so as to cover the outlet tube. [Figure 24A] 10 shows a device comprising a cap configured to connect to the cartridge at a second discharge end of the cartridge so as to cover the outlet tube. [Figure 24B] 10 shows a device comprising a cap configured to connect to the cartridge at a second discharge end of the cartridge so as to cover the outlet tube. [Figure 25] 13 shows a cartridge embodiment similar to the dual cartridge embodiment of FIGS. 11 and 12, except that the two cartridges are combined into a single unit. [Figure 26] 13 shows a cartridge embodiment similar to the dual cartridge embodiment of FIGS. 11 and 12, except that the two cartridges are combined into a single unit. [Figure 27]1 shows an embodiment of a cartridge in which the screw portion of the rotating member is replaced by a screw portion in a "twist plate" configuration. [Figure 28A] 1 shows an embodiment of a cartridge in which the screw portion of the rotating member is replaced by a screw portion in a "twist plate" configuration. [Figure 28B] 1 shows an embodiment of a cartridge in which the screw portion of the rotating member is replaced by a screw portion in a "twist plate" configuration. [Figure 29A] 1 illustrates an embodiment of the device in which the plunger is accompanied by a deformable material positioned on a radially extending surface of the plunger. [Figure 29B] 1 illustrates an embodiment of the device in which the plunger is accompanied by a deformable material positioned on a radially extending surface of the plunger. [Figure 29C] 1 illustrates an embodiment of the device in which the plunger is accompanied by a deformable material positioned on a radially extending surface of the plunger. [Figure 30A] 10 shows an embodiment in which the plunger of the device is provided with a plurality of axially extending teeth or protrusions. [Figure 30B] 10 shows an embodiment in which the plunger of the device is provided with a plurality of axially extending teeth or protrusions. [Figure 30C] 10 shows an embodiment in which the plunger of the device is provided with a plurality of axially extending teeth or protrusions. [Figure 31A] 30A, 30B, and 30C. An embodiment is shown in which the plunger of the device comprises a resilient device that functions similarly to the teeth of the embodiment of FIGS. 30A, 30B, and 30C. [Figure 31B] 30A, 30B, and 30C. An embodiment is shown in which the plunger of the device comprises a resilient device that functions similarly to the teeth of the embodiment of FIGS. 30A, 30B, and 30C. [Figure 31C] 30A, 30B, and 30C. An embodiment is shown in which the plunger of the device comprises a resilient device that functions similarly to the teeth of the embodiment of FIGS. 30A, 30B, and 30C. [Figure 32A] 1 illustrates one embodiment of a device having a modified plunger with a shape configured to reduce friction between the plunger and the wall of the cartridge. [Figure 32B] 1 illustrates one embodiment of a device having a modified plunger with a shape configured to reduce friction between the plunger and the wall of the cartridge. [Figure 32C] 1 illustrates one embodiment of a device having a modified plunger with a shape configured to reduce friction between the plunger and the wall of the cartridge. DETAILED DESCRIPTION OF THE INVENTION

[0086] 1 shows a perspective view of device 100, which is a delivery device capable of ejecting a drug or pharmaceutical agent in pellet form (e.g., an oral dosage form). Device 100 is intended to more efficiently eject pellet-type doses, and various embodiments are directed to improving the mechanics of the device to prevent clogging and / or crushing of the pellets as they travel through the device.

[0087] The device 100 comprises 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) that comprises the discharge end of the device 100. During use, the medicament in pellet form will be discharged out the second end 104 as a result of operation of the drive mechanism (e.g., a motor).

[0088] The device 100 comprises one or more cartridges 200 configured to attach to an actuator or drive mechanism (e.g., a motor) at a first end 102 of the device 100. The cartridges 200 comprise one or more chambers 220 configured to store or hold multiple units of an oral dosage form (in this case, pellets).

[0089] The device 100 includes a rotating member 250 that extends through the cartridge 200. At a first end 102 of the device 100, the rotating member 250 connects to an actuator or drive mechanism (e.g., a motor) that is configured to rotate the rotating member 250 and eject pellets from a second end 104 of the device 100, as described in further detail below.

[0090] The device 100 includes an outlet (eg, outlet tube 212 in FIG. 2) at its second end 104 through which the pellets (drug, pharmaceutical, etc.) are expelled.

[0091] 2 and 2A show cross-sectional views of the device 100 shown in FIG. 1 , detailing the interior of the cartridge 200 and some features of the rotating member 250. The cartridge 200 is hollow and, as described above, includes a chamber 220 for holding a pellet, through which the rotating member 250 extends from the first end 102 of the device 100 to the second end 104 of the device 100.

[0092] The chamber 220 and / or cartridge 200 may be substantially hermetically sealed (e.g., except for the flow path through which the pellets are discharged). For example, at the first end 102, the connection between the rotating member 250 and the cartridge 200 may include a seal, such as an elastomeric packing or a valve (not shown). Similarly, at the second discharge end 104 of the device 100, a suitable seal (not shown) may be provided between the rotating member 250 and the outlet tube 212. For example, a packaging seal may be provided that covers and seals the outlet (e.g., outlet tube 212) of the device, and the user can remove (e.g., peel) the seal when they wish to begin using the device. Additionally or alternatively, a valve may be used to at least partially seal the second discharge end of the device 100 (an exemplary "umbrella valve" is shown and described in connection with FIG. 4). These features may help prevent air and / or moisture from entering the chamber 220 and undesirably interfering with the solid oral dosage unit.

[0093] Rotating member 250 extends into outlet tube 212 at second end 104 of device 100 and includes threaded portion 240. Together, outlet tube 212 and threaded portion 240 form a type of screw pump configured to eject pellets from second end 104 of device 100. That is, pellets will enter threads 242 of screw portion 240 and, upon rotation of rotating member 250, will be forced out of outlet tube 212 via threads 242 and ejected from device 100.

[0094] The rotating member 250 and the cartridge 200 may have a common longitudinal axis, which may also be the axis of rotation of the rotating member 250. This may effectively provide for symmetrical loading of pellets into the screw portion 240. However, in various embodiments, the longitudinal axis of the cartridge 200 may be offset from the longitudinal axis of the rotating member 250 and / or the axis of rotation of the rotating member 250 while still achieving the technical effects described elsewhere herein.

[0095] Although Figures 1-2A show cartridge 200 having an oval shape, this is not required and cartridge 200 can have any suitable shape, for example, cylindrical.

[0096] Device 100 may further include a plunger 230 (shown in FIGS. 1-2A) configured to move along the rotatable member automatically or as a result of rotation of the rotatable member.

[0097] As described above, each cartridge 200 holds pellets within its chamber 220. In embodiments using a plunger 230, the volume of the chamber 220 varies during operation of the device 100 and throughout its useful life by manipulation of the plunger 230, as described in more detail below.

[0098] At one end, chamber 220 is at least partially sealed by plunger 230, more specifically, by a radially extending surface 232 of plunger 230 that faces chamber 220. At the other end, chamber 220 is at least partially sealed by surface 210 of cartridge 200. Rotating member 250 extends through chamber 220 along longitudinal axis A of cartridge 200.

[0099] 2 shows a cross-sectional view of cartridge 200 with plunger 230. When rotating member 250 rotates during use, plunger 230 rests on top of a pellet (not shown) located within chamber 220.

[0100] The plunger can be gravity-activated to move pellets contained within the chamber toward the screw pump. For example, the plunger can be a weight configured to rest on top of pellets contained within the chamber when the device is in an orientation that allows for pellet ejection. An anti-retraction device (e.g., a ratchet) can be provided to prevent the plunger from moving away from the ejection end during use.

[0101] The plunger can be configured to move automatically along the rotating member or as a result of rotation of the rotating member. For example, a portion of the rotating member within the chamber can include a thread (e.g., a plunger thread that can be different from any thread of the screw pump), and the plunger can form a nut around the rotating member that is configured to move along the thread of the rotating member during use, such that when the rotating member rotates, the plunger moves toward the screw pump and forces pellets contained in the chamber toward the screw pump. The plunger can be configured to abut and / or contact the inner surface of the cartridge and / or chamber, and a friction fit can exist between the plunger and the inner surface of the cartridge and / or chamber, which can help prevent the plunger from rotating with the rotating member.

[0102] Device 100 may include certain features that provide a driving force to plunger 230 that acts in a direction toward a pellet located within chamber 220, other than relying on the weight of plunger 230, for example, as described above. For example, a ratchet mechanism may be used to ensure that plunger 230 can move in only a single direction, i.e., toward a pellet located within chamber 220. A resilient member (e.g., a spring) may be provided to urge plunger 230 toward a pellet located within chamber 220. A source of compressed air may be provided to pressurize plunger 230 toward a pellet located within chamber 220.

[0103] In use, the radially extending surface 232 of the plunger 230 presses against the pellets, forcing them towards the second discharge end 104 of the device 100 and helping to tightly compress the pellets within the chamber 220 .

[0104] 2 as extending perpendicular to axis A, the radially extending surface 232 of plunger 230 may instead be shaped to precisely match the opposing surface 210 of cartridge 200, thereby enhancing the capture of the pellet within chamber 220 so that it can be ejected from the chamber. For example, surface 232 may be angled in a similar and complementary manner to the opposing surface 210 of cartridge 200.

[0105] In various embodiments, the plunger 230 is operably connected to the rotating member 250 such that rotation of the rotating member 250 moves the plunger 230 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 may be a nut that, upon rotation, translates along the rotating member 250 from the first end 102 of the cartridge 200 (i.e., the end that is inserted into an actuator, described below) to the second, ejection end 104 of the cartridge 200.

[0106] In this manner, the volume of chamber 220 gradually decreases as plunger 230 translates along rotating member 250. Furthermore, pellets contained within chamber 220 will be forced by plunger 230 toward second end 104 of cartridge 200 throughout the operation and service life of device 100.

[0107] To achieve direct movement of the plunger 230, the rotating member 250 can include threads 252 configured to cooperate with corresponding threads 233 on the plunger 230, thereby moving the plunger along the longitudinal axis A, as previously described. At the second discharge end 104 of the cartridge 200, the rotating member 250 includes a threaded portion 240 that is axially separated from the threads 252 that cooperate with the plunger 230.

[0108] In various embodiments, plunger 230 (or at least threads 233) can be made from a thermoplastic elastomer (“TPE”) or polybutylene terephthalate (“PBT”) and can have a hardness of less than about 100, 80, 70, 60, or even 50 Shore. Shore hardness testing can be performed at Shore 00 or Shore A. In these embodiments, as plunger 230 moves along axis A, if plunger 230 meets sufficient resistance, for example, from encountering a pellet or the end of cartridge 200, threads 233 can disengage from threads 252. This allows rotation of rotating member 250 when plunger 230 contacts a pellet, limiting the force exerted by plunger 230 on the pellet. For example, if the volume of the pellet decreases during ejection, the resistance force will decrease, and threads 233 will at some point re-engage with threads 252 to continue moving plunger 230 along axis A.

[0109] In various embodiments, the threads 233 can be removed, and a secure friction fit can be used to move the plunger along the threads 252 as the rotating member 250 rotates. For example, the plunger 230 can have two friction surfaces: a first surface on its outer periphery that faces the inner surface of the cartridge 200, and a second surface on its inner periphery that faces the rotating member 250. Friction between the first friction surfaces can prevent the plunger 230 from rotating but allow it to move axially (i.e., along axis A). The central hole in the plunger 230 (through which the rotating member 250 extends) can be manufactured slightly smaller than the outer diameter of the threads 252. This means that the plunger 230 will move axially along the threads 252 as the rotating member 250 rotates, even though the plunger does not include cooperating threads itself. The plunger can be made of rubber to facilitate this embodiment. The second friction surface can be configured to allow the plunger 230 to slide when the pellet is fully compressed, ie, when the plunger 230 has pressed the pellet as far down as possible.

[0110] FIG. 2A shows the second discharge end 104 of the cartridge 200 in more detail, with the outlet tube 212 located at the end of the cartridge and, as described above, the threaded portion 240 of the rotating member 250 extending through the outlet tube 212.

[0111] The radially outer surface 241 of the threaded portion 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 threaded portion 240 and the radially inner surface 214 of the outlet tube 212 may substantially contact or abut one another (e.g., continuously or intermittently). This does not require them to have an interference or friction fit with one another, to ensure they can move smoothly past one another and to ensure reliable ejection during use. That is, when the radially outer surface 241 of the threaded portion 240 rotates past the radially inner surface of the outlet tube 212. It is contemplated that any tolerance between the outer surface 241 of the threaded portion 240 and the inner surface 214 of the outlet tube 212 will be as tight as possible while still allowing the threaded portion 240 to rotate within the outlet tube 212.

[0112] For example, a slight dimensional error or gap may exist between the outer surface 241 of the threaded portion 240 and the inner surface 214 of the outlet tube 212, e.g., due to manufacturing tolerances. When surfaces are configured to contact one another (e.g., continuously or intermittently), the surfaces may be manufactured with low-friction materials (e.g., Teflon, with, e.g., a non-stick coating or additive applied to one or both of the opposing surfaces), which may provide a fit without a friction or interference fit (e.g., a contact fit). In various embodiments (e.g., those including a cartridge containing pellets therein), a dimensional tolerance or gap may exist between the outer surface 241 of the threaded portion 240 and the inner surface 214 of the outlet tube 212, which may be wide enough to allow free rotation of the shaft 250, but narrow enough to prevent any pellets (and / or pellet debris) from moving smoothly through the gap (which may increase friction and inhibit free rotation).

[0113] Threaded portion 240 includes threads 242 configured to receive pellets contained within chamber 220 and, upon rotation of rotating member 250, transport those pellets along threads 242 for ejection out of outlet tube 212. Threads 242 are comprised of one or more starts, each of which presses onto a pellet in chamber 220, forming a continuous spiral that the pellets fill during operation of device 100, due (at least in part) to the action of plunger 230 pressing the pellet against threads 242, for example.

[0114] The screw portion 240 and its threads 242 contact the inner radial surface of the outlet tube 212 of the cartridge 200 to form a screw pump (e.g., an "Archimedes" screw) with the outlet tube 212. That is, when the rotating member 250 rotates, the screw portion 240 and its threads 242 also rotate, causing pellets contained within the chamber 220 to enter the voids of the threads 242, move down the threads 242, and out of the cartridge 200. The screw pump can include an outlet 243 through which the pellets are discharged.

[0115] An actuator or drive mechanism (e.g., a motor) may be configured to rotate the rotating member 250 and may be connected to the rotating member 250 at the first end 102 of the device, as described above. The actuator may 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 may be either mechanical (e.g., manually operated) or electromechanical (e.g., electrically operated, e.g., an electric motor). The actuator (or a control unit comprising the actuator) may be detachable from the cartridge 200 such that another cartridge can be connected to the same actuator or control unit.

[0116] To eject pellets from cartridge 200, actuator 300 can rotate rotating member 250, which (in a related embodiment) causes plunger 230 to move down threads 252 of rotating member 250, rotating screw portion 240 and ejecting pellets through a screw pump formed between screw portion 240 and outlet tube 212.

[0117] Device 100 can include a control system (e.g., as part of an actuator or control unit) that can be configured to expel a dose of pellets contained within chamber 220, for example, after receiving an actuation signal from an input device or mechanism. The actuation signal can optionally be initiated, for example, by a user pressing a suitable button or other input mechanism located on the control unit, or via another control, such as a wireless or wired external control.

[0118] By using an electromechanical actuation mechanism, device 100 may be able to repeatedly dispense precise pellet amounts. The motor and control system may be powered by an integral battery (which may be user-replaceable), which may be held within the actuator housing.

[0119] The actuator can include one or more motors. The actuator (e.g., the actuator's motor) can be configured to rotate the rotating member 250 an amount corresponding to a predetermined dose or a portion of a dose. For example, the actuator can be configured to rotate the rotating member 250 in pulses, e.g., by operating for a specific period of time, e.g., 0.5 seconds. A dose can consist of multiple pulses, such that different doses can be dispensed depending on the number of motor pulses. For example, a 0.3 mL dose can correspond to approximately 3 seconds of motor rotation, so the actuator pulses the motor six times, which is six pulses every 0.5 seconds.

[0120] The motor may be a stepper motor, which may be configured to rotate the rotatable member 250 any suitable number of steps based on the situation at hand, for example, based on the type of medication in cartridge 200 or the user. The control system may be provided, for example, in the form of a computer, processor, processing device, or microcontroller on a PCB, which may be located within the housing of device 100 or within an actuator or control unit.

[0121] Cartridge 200 can be made of a rigid material, such as polycarbonate or polyamide, although any suitable material can be used. Portions of cartridge 200, such as those in contact with rotating member 250 and / or plunger 230, can have reduced-friction surfaces (e.g., reduced relative to other portions of the cartridge) to facilitate relative movement therebetween. The inner diameter of cartridge 200 (i.e., forming chamber 220) can be about 5 mm to about 200 mm, optionally about 10 mm to about 20 mm. Cartridge 200 can have a length (corresponding to its longest dimension) of about 90 mm to about 120 mm, a width (transverse to its length) of about 33 mm to about 43 mm, and a height (transverse to its width) of about 15 mm to about 25 mm.

[0122] The outlet tube 212 can have an inner diameter that is substantially equal to the diameter of the rotating member 250, specifically the threaded portion 240 of the rotating member. This inner diameter may 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 may be less than about 20 mm (such as about 15 mm or about 10 mm).

[0123] The volume of the chamber 220 (ie, prior to the operating or maximum volume) can be less than about 50 mL, for example, less than 20 mL, or approximately equal to 11 mL.

[0124] The plunger 230 can be configured to fill the gap between the rotating member 250 and the wall of the container 200, so that pellets contained within the chamber 220 cannot move past the plunger 230 as the pellets move down the rotating member 250 during use.

[0125] In various embodiments, the size (and, e.g., circumference) of plunger 230 can be such that a small gap exists between plunger 230 and the wall of cartridge 200, avoiding substantial friction between plunger 230 and cartridge 200. This can mean that pellets can pass through the gap between plunger 230 and the wall of cartridge 200. To avoid this, the size (e.g., width) of the gap can be configured to be less than the size (e.g., average size or diameter) of the pellets. Additionally or alternatively, a material that is deformable and / or has less friction than plunger 230 can be provided adjacent plunger 230 that is configured to contact the wall of cartridge 200 as plunger 230 moves during use.

[0126] Cartridge 200 can include a tapered portion at second end 104 of device 100, which can be configured to guide or direct pellets contained within chamber 220 into threads 242 of screw portion 240. In other words, surface 210 can be tapered or angled such that the surface is not perpendicular to longitudinal axis A, but is oriented at an angle relative to longitudinal axis A, for example, an angle greater than about 30°, greater than about 60°, or even greater. In other embodiments, surface 210 can be perpendicular to longitudinal axis A. The tapered portion can be frusto-conical or trumpet-shaped.

[0127] Cartridge 200 can include one or more side portions 202 that connect to tapered portion 204 at axial location 206 (FIG. 2A), with tapered portion 204 extending from that location toward outlet tube 212. Thus, when cartridge 200 is in its normal orientation, the pellet will travel down tapered portion 204 (along the now angled surface 210) and into threads 242 of screw portion 240.

[0128] As explained above, although not shown, the lower surface 232 of the plunger 230 can have a matching geometry so that when the lower surface reaches the end of its travel along the rotating member 250, the lower surface 232 of the plunger 230 contacts the tapered surface over substantially its entire area. This helps eject as many pellets as possible, minimizing waste. Because the threads 252 eventually replace the threads 242, it may be necessary to provide the threads on the plunger 230 away from its lower surface so that a portion of the plunger 230, including the lower surface 232, extends below the threads of the plunger 230 (if any) to allow the surface 232 to contact, abut, or at least move near the cartridge opposite surface 210 when the plunger 230 is at its lowest point (i.e., at the end of the threads 252).

[0129] The outer surface 241 of the threaded portion 240 may be made of a low-friction material, such as nylon, polyethylene ("PE"), polyethylene terephthalate ("PET"), optionally containing friction-reducing additives. The cartridge 200 and portions of the cartridge that abut, oppose, or contact the threaded portion 240, plunger 230, or other moving parts of the device 100 may also be made of a low-friction material, such as nylon, polyethylene ("PE"), polyethylene terephthalate ("PET"), optionally containing friction-reducing additives.

[0130] 1-2A, the screw portion 240 is configured such that the height of the threads 242 extends above the outlet conduit 212 (toward the chamber 220) for at least one full revolution. It has been found that some shear can occur if the threads are located at or near the transition or junction between the opposing surface 210 and the outlet conduit 212. This is shown at point P1 in FIG. 3, which corresponds to the area surrounding the outer periphery 211 that may form the transition or junction between the surface 210 and the outlet conduit 212.

[0131] According to the present invention, the screw pump is displaced from the transition or confluence of the surface 210 and the outlet tube 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 displaced toward the screw pump outlet 243. In an optimized embodiment, the cartridge 200 can include the tapered section 207, as described above, as well as a displacement of the transition or confluence of the surface 210 (which can be a tapered surface) and the outlet tube 212. This provides further optimization of the transport of pellets through this portion of the device 100, because the pellets can be efficiently fed from the chamber 220 to the inlet region of the outlet tube 212, using the tapered section 207, subsequently (rather than simultaneously) to the screw pump.

[0132] FIG. 4 illustrates an embodiment showing the second discharge end 104 (e.g., of the device 100 as described above) which includes a tapered portion 207 that can facilitate transport from the chamber 220 to the screw pump formed by the screw portion 240 to optimize transport of the pellets, as described above.

[0133] In this embodiment, side portion 202 of cartridge 200 follows a substantially linear (or cylindrical) profile until a first junction 206 between side portion 202 of cartridge 200 and tapered portion 207, at which point the wall of cartridge 200 formed by tapered portion 207 forms a funnel having surface 210. Funnel and / or surface 210 are configured to guide pellets contained within chamber 220 from an inlet 301 of the funnel to an inlet 311 of outlet tube 212 (which also corresponds to the outlet of the funnel).

[0134] As can be seen in FIG. 4 , the screw pump is displaced a distance D (measured in a direction along the axis A of the rotating element 250) from the confluence of the surface 210 and the outlet tube 212 (e.g., its inlet, edge, or periphery 311). In other words, the inlet of the screw pump is displaced from the confluence toward the outlet of the outlet tube 212. This has been found to reduce shearing of the pellets at the interface between the tapered portion 207 and the outlet tube 212, thereby reducing the likelihood of crushing or damaging the pellets and improving filling of the screw pump. Furthermore, it has been found that displacing the screw pump in this manner can reduce the torque requirements of the rotating element 250. Without wishing to be bound by theory, this may be due to the elimination of interaction between the screw pump and the periphery 311, as well as the screw pump's smaller contact area with the wall of the cartridge 200.

[0135] The tapered portion 207 may extend axially a distance d, in which case the displacement 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 displacement 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 one particular configuration, the displacement distance D of the screw pump may be between about 50% and about 90%, e.g., between about 60% and about 80%, of the axial distance d of the tapered portion 207.

[0136] Cartridge 200 can also be tapered such that the inner walls of the cartridge (e.g., forming chamber 220, tapered portion 207, and exit tube 212) taper from a first diameter D1 to a second diameter D2, the inner walls having the first diameter D1 in a portion of cartridge 200 above first transition 206 (e.g., above tapered portion 207). The inner walls can taper from the first diameter D1 to the second diameter D2 as they extend through tapered portion 207, such that the inner walls have the second diameter D2 upon reaching exit tube 212.

[0137] In various embodiments, the screw shaft 250 may also taper from a first diameter d1 to a second diameter d2, where the screw shaft 250 has the first diameter d1 in a portion of the cartridge 200 above the first transition 206 (e.g., above the tapered portion 207). The screw shaft 250 may taper from the first diameter d1 to the second diameter d2 as it extends through the tapered portion 207 of the cartridge 200, such that the screw shaft 250 has the second diameter d2 upon reaching the exit tube 212. This further optimizes and assists the transport of pellets through this portion of the device.

[0138] The embodiment of Figure 4 also includes a removable valve positioned over the outlet tube 212 of the cartridge 200 (and, e.g., the outlet 243 of the screw pump). This valve can be configured to prevent pellets from unintentionally falling out of the screw pump (e.g., when the rotating member 250 is stationary).

[0139] 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 that faces away from the chamber 220. In various embodiments, the plug 500 is configured to be inserted into a cavity 254 formed in the second discharge end 104 of the rotating member 250 (i.e., comprising the threaded portion 240). The plug 500 comprises a base portion 502 and an elongated portion 504 that extends 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, e.g., the outlet 243 of the screw pump), e.g., before or during use, to seal (e.g., hermetically seal) the pellets within the cartridge 200.

[0140] The valve may be an "umbrella valve" as embodied by plug 500. That is, at least a base portion 502 of plug 500 is resilient, e.g., a rubber membrane, and an outer periphery 506 of base portion 502 is configured to flex open when pellets are forced out of the screw pump during use, and then spring back when the screw pump is not rotating, thereby stopping the pellets from falling out and optionally sealing cartridge 200. Elongated portion 504 of plug 500 may not move substantially from its position within cavity 254 of rotating member 250.

[0141] Figure 5 shows another embodiment showing second discharge end 104 (e.g., of device 100 as described above). While the embodiment of Figure 4 includes a separate tapered section 207 and outlet tube 212, the embodiment of Figure 5 includes outlet tube 212 with a tapered trumpet-shaped section 207 to facilitate transport of pellets from chamber 220 to the screw pump formed by screw section 240 to optimize pellet transport, as described above. While shown as trumpet-shaped in Figure 5, the tapered section may also be frusto-conical.

[0142] In this embodiment, the side portion 202 of the cartridge 200 follows a substantially straight (or cylindrical) profile until a junction 206 between the side portion 202 of the cartridge 200 and a tapered portion 207 of the outlet tube 212, at which point the walls of the cartridge 200 form a funnel having a surface 210. The surface 210 is configured to direct pellets contained within the chamber 220 from an inlet 311 of the outlet tube 212, through a portion of the screw pump, and ultimately out an outlet 243 thereof.

[0143] The tapered portion 207 of the outlet tube 212 extends axially (i.e., corresponding to axis A) 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%, or 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 trumpet-shaped.

[0144] The screw pump in this embodiment is located at least partially inside the tapered portion 207 of the outlet tube 212. For example, the start of the screw pump may be displaced a distance I from the inlet 311 of the outlet tube 212, which distance I may 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 displaced all the way from the inlet 311 of the outlet tube 212.

[0145] The screw pump has threads 242 that taper with the tapered portion 207 of the outlet tube 212, such that the screw pump tapers from a first diameter D1' at its starting point (e.g., adjacent the inlet 311 of the outlet tube 212) to a second diameter D2 adjacent the outlet of the outlet tube 212 (and the outlet 243 of the screw pump), the first diameter D1' being larger than the second diameter D2.

[0146] The screw pump first diameter D1' may be larger than the diameter d1 of the rotating member 250, such that the screw pump threads 242 extend outward from the diameter d1 of the rotating member 250. Thus, the pellets rest on top of the threads 242 without having to be moved substantially radially inward before entering the screw pump. This further optimizes the transport of the pellets into the screw pump.

[0147] In various embodiments, the screw pump's threads 242 remain flush (or substantially flush) with the inner surface of the outlet tube 212, including the surface 210 of its tapered portion. Thus, pellets contained within the chamber 220 do not encounter a difficult interface, as shown, for example, in FIG. 3 (see point P1). This creates a larger and easier entrance for the pellets into the screw pump, reducing the risk of pellet clogging or pellet shattering.

[0148] As with the embodiment of Figure 4, a valve (e.g., umbrella valve 500) may be included as shown (although this may be optional). The features of this valve may be the same as those described above with reference to Figure 4.

[0149] Several further improvements to the second discharge end 104 of the device 100 are described below. These will be illustrated in relation to the embodiment of Figure 5, although it will be understood that the features described are applicable to any device incorporating a screw pump.

[0150] 6A and 6B illustrate an embodiment in which the rotating member 250 includes one or more fins 290 configured to concentrate and direct pellets into the screw pump (e.g., its threads 242). While only one fin 290 is shown in FIGS. 6A and 6B, it will be understood that more fins (e.g., two, three, or even four) may be provided, depending, for example, on whether multiple screw starts are provided in the screw pump. For example, the screw pump may include multiple screw starts, as described elsewhere herein, and each of the multiple fins 290 may be aligned with and associated with one of the screw starts. The one or more fins 290 may each be configured to guide pellets into the start of a respective screw of the screw pump (e.g., its threads 242). When multiple fins 290 are provided, they may be positioned substantially equally spaced around the circumference of the rotating member 250.

[0151] 6A and 6B, one or more fins 290 can be angled. In some embodiments, fin 290 can extend from thread 242 (e.g., from the screw start of the thread) and have a steeper angle than the respective thread (e.g., greater / steeper than the thread angle of thread 242). The angle of fin 290 (e.g., taken along its longitudinal axis) relative to (e.g., angled 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).

[0152] In various embodiments, the width of each fin 290 may taper, for example, from a first, relatively larger width where the fin meets the screw pump to a second, relatively smaller width (relative to axis A) at the opposite end of the fin. The first width may correspond to the width of the thread 242, while the second width may be zero.

[0153] The fins 290 can wrap around the screw shaft 250 and, in various embodiments, can extend between about 10 degrees and about 180 degrees around the screw shaft 250 .

[0154] The fins 290 may be positioned at the beginning of the threads 242 and may be curved to guide the pellets from inside the chamber 220 into the screw pump (e.g., its threads 242). The fins 290 may also help break up any pellets that have clumped together within the chamber 220, so that they move more easily through the threads 242. The use of the fins 290 may also help ensure improved compression and / or transport of the pellets through the screw pump, for example, by helping to eliminate voids within the screw pump's threads 242, which may help improve accuracy.

[0155] In various embodiments, one or more fins 290 can be located between the screw pump (eg, its threads 242) and the threads 252 of the rotating member 250 along which the plunger 230 moves.

[0156] The one or more fins 290 may extend radially outward (e.g., relative to axis A) from the body of the rotating member 250 and may extend to at least the radial extent of the threads 242. In some embodiments, the fins 290 may extend radially further than the threads 242 to further facilitate scooping pellets into the threads 242.

[0157] One or more fins 290 can be located within the tapered portion 207 of the cartridge 200 (e.g., as described above), whether the fins form a separate element in the outlet tube 212 (e.g., as shown in FIG. 4) or form part of the outlet tube 212 itself (e.g., as shown in FIG. 5). The fins 290 can be located at or adjacent to the inlets 301, 311 of the tapered portion 207. In various embodiments, the fins 290 can be located above the tapered portion 207 of the cartridge 200 and can extend into the tapered portion 207.

[0158] The fins 290 can extend a distance above the screw pump (e.g., its threads 242) that is approximately equal to the pitch of the screw pump (e.g., its threads 242). This pitch can be the maximum pitch (if the pitch varies). For example, the fins 290 can extend a distance above the screw pump (e.g., its threads 242) that is about 0.5 to about 1.5 times the pitch of the screw pump (e.g., its threads 242). In various embodiments, the fins 290 can extend a distance above the screw pump (e.g., its threads 242) that is about 1 mm to about 10 mm.

[0159] 7A and 7B show further refinements in the form of one or more baffles 390 configured to rotate with rotating member 250 and intended to aid in the movement of the pellets, e.g., agitating the pellets and breaking up pellet clumps, so that they are in an optimized state for transport through a screw pump.

[0160] 7A and 7B show only one baffle 390, it will be understood that more (e.g., two, three, or even four) baffles may be provided. When multiple baffles 390 are provided, they may be positioned substantially equally spaced around the circumference of the rotating member 250. Alternatively, or in addition, the baffles 390 may be positioned at the same or different axial positions along the axis A of the rotating member 250.

[0161] The baffle 390 can extend a distance of about 0.5 mm to about 3 mm from the screw shaft 250 (e.g., across the axis A). Any or all of the width and / or length and / or thickness of the baffle may be about 0.5 mm to about 3 mm.

[0162] 7A and 7B show the baffle 390 extending from the thread 252 of the screw shaft 250, this may not be the case, and the baffle 390 may be positioned outside the thread 252, for example, between the thread 252 and the screw pump (e.g., its thread 242) and / or between the thread 252 and the fin 290 (e.g., its upper extent along axis A).

[0163] One or more baffles 390 may be provided in addition to fins 290, although in various embodiments, baffles 390 may be provided without fins 290.

[0164] The one or more baffles 390 may be similar to the fins 290 described above, but may be axially displaced from the screw pump (e.g., its threads). In embodiments requiring threads 252 on the rotating member 250 to move the plunger 230, the baffles 390 may be located on the rotating member 250 at the screw pump's threads 252.

[0165] Baffle 390 may extend radially outward (e.g., perpendicular to axis A) from the body of rotating member 250 and may extend to at least the radial extent of threads 242. In some embodiments, baffle 390 may extend radially further than threads 242, thereby facilitating breaking up of pellets as they move past baffle 390 during use.

[0166] As shown in Figures 7A and 7B, the one or more baffles 390 can be slightly angled. In some embodiments, the baffle 390 can have a steeper angle than the threads (e.g., greater / steeper than the thread angle of the threads 242), but a shallower angle than the one or more fins 290 (if provided). The baffle 390 can be positioned a distance X from the screw pump (e.g., its threads 242) and / or a distance Y from the inlet 301, 311 to the tapered portion 207 of the cartridge 200, whether the baffle forms a separate element in the outlet tube 212 (e.g., as shown in Figure 4) or forms part of the outlet tube 212 itself (e.g., as shown in Figure 5).

[0167] The one or more baffles 390 have a similar function as the fins 290. It has been found (without wishing to be bound by theory) that positioning the baffles 390 axially displaced from the screw pump provides additional functionality and capability in that the baffles 390 will agitate the pellets ahead of the screw pump, thereby allowing the pellets to pass more easily through the screw pump with the further assistance of the one or more fins 290 (if provided), as described above.

[0168] Length X can be at least 1, 2, or even 3 times the pitch of the screw pump (e.g., its threads 242). This pitch can be the maximum pitch (if this pitch varies). For example, if threads 242 have a pitch (e.g., maximum pitch) of about 4 mm, X can be about 4 mm, 8 mm, or 12 mm. In various embodiments, X can be about 3 times the pitch (e.g., maximum pitch) of the screw pump (e.g., its threads 242). In various embodiments, length X can be in the range of about 6 mm to about 20 mm.

[0169] The baffle 390 can be positioned approximately 5 mm above the screw pump (e.g., its threads 242), and in various embodiments, can be positioned at a distance of approximately 1 mm to approximately 15 mm around the screw pump (e.g., its threads 242).

[0170] Generally, the length of the screw portion 240 may be defined by the length of the threads 242, and may be about 10 mm to about 30 mm, for example, about 10 mm to 20 mm.

[0171] The outlet tube 212 may have a length of about 5 mm to about 20 mm (optionally, about 10 mm to about 15 mm), in which case the length of the thread 242 in a direction along the longitudinal axis A of the cartridge 200 may be at least 0.5 times the length of the outlet tube 212 in the same direction, for example, about 0.5 to about 2 times the length of the outlet tube 212, or about 0.5 to about 1 time the length of the outlet tube 212.

[0172] Pitch has been found to have a significant effect on the accuracy of the discharged dose, particularly with respect to pellet run-through (pellets flowing through the screw section even when the rotating element is not rotating). This can cause the device to "leak" pellets in certain circumstances. A high pitch appears to increase the risk of pellets progressing through the screw section outside of the discharge action. Therefore, a low pitch (e.g., less than about 15-30 times the pellet diameter, as explained below) has been found to increase the accuracy of the discharged pellet dose, for example, because it is easier to control the pellet output rate. A small pitch can increase the load and torque requirements to drive the rotating element, which is a trade-off, and this pitch range has become considered important.

[0173] Thus, the threads 242 may have a pitch that is at least 15-30 times less than the diameter of the pellet (as described above). In various embodiments, the pitch may be from about 1 mm to about 20 mm, and optionally from about 4 mm to about 8 mm. If the pitch varies, as described below, this may correspond to the maximum pitch.

[0174] FIG. 8 schematically illustrates the profile of the thread 242 and various dimensions that may be associated with the thread. "D" represents the thread profile, "CD" represents the feed channel depth, "CW" represents the feed channel width, and "P" represents the pitch of the thread 242, which may be defined as the distance between adjacent threads. The features of FIG. 8 may be applied to any of the aspects and embodiments described herein that include threads for transporting pellets from a chamber for ejection from the cartridge. The values ​​given for the dimensions may represent the overall length of the thread 242 and / or the screw portion 240.

[0175] The following table provides some exemplary dimensions (in mm) of threads with reference to the dimensions shown in FIG. 8 and herein and described above. In the embodiments in the table, the pellet diameter was about 200-300 μm, but the same dimensions could be used for pellets having larger diameters, e.g., up to about 900 μm. Typical dimensions (e.g., width or diameter) of pellets may be about 150 μm to about 1200 μm (or even 1500 μm), optionally about 200 μm to about 300 μm, about 300 μm to about 500 μm, about 300 μm to about 700 μm, about 500 μm to about 700 μm, about 700 μm to about 900 μm, or about 800 μm to about 1100 μm. Values ​​may be provided in multiples of the pellet diameter; these values ​​are considered general values ​​and should not be limited to any particular size (or size range) of pellets. [Table 1]

[0176] The number of screw starts has been found to affect the rate at which pellets are ejected; the more screw starts there are, the higher the power per revolution will naturally be. Up until this point, it has been found that to maximize the precision of the ejected pellets, it is beneficial to have a relatively low power ratio, and that using either one or two screw starts, so to speak, is more beneficial than using three or more starts.

[0177] Looking at the relationship between channel depth / width and pellet size, this can be selected so that there is room for multiple pellets between the screw and thread surfaces. It can be important that the pellets can flow freely without adversely affecting each other, for example, without causing clogging or blockages in the flow during ejection. Thus, in some embodiments, dimensions are selected so that there is enough room for at least two to three pellets to pass each other within the channel. Having ejection continuity without causing clogging or blockages in the flow can be important in achieving high accuracy and reproducibility between doses. Thus, in various embodiments, the channel depth and / or width can be at least two, three, or four times the diameter of the pellets.

[0178] For example, if the pellet diameter is about 200-300 μm, the channel depth ("CD") and / or channel width ("CW") can be about 1-2 mm. If the pellet diameter is 700 μm to about 900 μm, the channel depth and / or channel width can be about 1.4 mm to about 3.6 mm, and if the pellet diameter is about 800 μm to about 1100 μm, the channel depth and / or channel width can be about 1.6 mm to about 4.4 mm.

[0179] As noted above, pitch ("P") has been found to have a significant impact on device accuracy (i.e., ejection precision). While a high pitch appears to increase the risk of a pellet progressing through the threads when the device is idle, a trade-off exists because a reduced pitch increases the torque required to rotate the rotating element. In various embodiments, the pitch may be limited to less than about 15-30 times the pellet diameter, and in some cases, less than about 10 times the pellet diameter. For example, if the pellet diameter is about 200-300 μm, the pitch may be about 6 mm, and in some cases, less than about 3, 4, or 5 mm.

[0180] The pitch can be variable, for example, the pitch of the screw thread can be variable along the axial length of the screw pump. This variable pitch can be applied, for example, to the embodiments described above that include a tapered portion, or to any of the embodiments described herein (e.g., even if a tapered portion is not provided). This feature is considered advantageous in its own right, and therefore, aspects of the present invention provide a cartridge, a screw pump, and a rotating member as described above (or below), where the screw pump comprises one or more screw threads with a variable pitch.

[0181] FIG. 9 shows an embodiment of a thread 242 having a variable pitch, illustrating a thread 242 having a variable pitch, where the pitch increases progressively (e.g., continuously) axially away from the outlet 243. This has been found to improve the way pellets are forced through the screw pump because the pellets can be further packed / compressed by the screw pump itself. For example, a first pitch A of the thread 242 closer to the inlet of the screw pump can be relatively large or at a maximum value, and a second pitch B of the thread 242 closer to the outlet 243 of the screw pump can be relatively small or at a minimum value. The first pitch A can be approximately 1.2 to 2 times the second pitch B; optionally, the first pitch A can be approximately 1.4 to 1.6 times the second pitch B.

[0182] As shown in Figure 10, the force applied to the granules is the rotational force (F r ) and axial force (F a ) can be understood as a combination of. For the reasons discussed above, a variable pitch may be desirable. However, although not necessarily required, it may be beneficial to limit the variation in pitch over the axial length of the screw pump. For example, having a first pitch A that is more than three times the second pitch B may reduce the flow of pellets into the screw pump because of the rotational force F. r is the axial force F a, and begin to dominate. Too large a pitch can also increase the risk of uncontrolled granule flow through the screw. This can adversely affect dosage uniformity and pellet feed and run-through through the screw pump. Therefore, in various embodiments, the pitch change can be limited so that the pitch does not change (e.g., increase or decrease) along the axial length of the screw pump to more than about three times its initial value (e.g., maximum or minimum value). For example, the first pitch A cannot be more than three times the second pitch B.

[0183] Referring back to FIG. 8, "flight width" ("FW") is the thickness of the thread and is the result of selecting the pitch and channel width. More specifically, flight width is equal to the pitch minus the channel width. Flight width has been found to be an important factor in preventing thread jamming. A smaller flight width reduces the contact area between the outer surface of the thread and the surface of the thread, which reduces the risk of dust from small and / or broken pellets, jamming, and thread sticking.

[0184] Thus, in various embodiments, the flight width can be limited to less than about 3, 5, or 10 times the pellet diameter. In particular, for pellet diameters of about 200 to 300 μm, the flight width can be less than about 1, 2, or 3 mm. For pellets up to about 900 μm, or about 700 μm to about 900 μm, or about 800 μm to about 1100 μm, the flight width can be limited to less than about 1, 2, or 3 mm, e.g., about 1 mm.

[0185] It has been found that a small flight width (e.g., less than about 1 mm) is beneficial even for pellets up to about 900 μm in size because it provides a more stable dose. It has been found that for smaller pellets (i.e., about 200-300 μm), dust can be created as the pellet travels through thread 240, and the dust can become lodged between the outside of thread 240 and outlet tube 212. Limiting flight width to less than about 1, 2, or 3 mm, and particularly less than about 1 mm, has been found to minimize this effect for these smaller pellets, in addition to providing a more stable dose for larger pellets, as discussed above.

[0186] In various embodiments, the rotating member 250 (e.g., at the threaded portion 240) will have an outer diameter of 6 mm and two thread starts, each with a height or channel width of about 2 mm, a channel depth of about 1 mm, and a pitch of about 6 mm. The pellet diameter in these embodiments can be 200-900 μm, e.g., about 200-300 μm.

[0187] Each of the thread parameters affects the mass output rate and the required drive torque. The pitch may be a set value and may not change as the screw diameter increases, but the effective angle of the thread relative to the pellet changes. If the pitch remains the same and the diameter increases, the pellet threads will encounter the pellet at a reduced angle. This can affect the discharge rate and the required torque. As mentioned above, the pitch can vary along the axial length of the screw pump.

[0188] The thread parameters can be adjusted or configured based on the size of the pellets being ejected. The thread 242 can be at least 1-3 times the maximum pellet diameter.

[0189] The depth of the thread 242 can be from about 1 mm to about 3 mm. Alternatively, the depth of the thread 242 can be matched to the diameter of the pellet, such that the depth of the thread 242 is at least the diameter of the pellet. Similarly, the height of the thread 242 can be in the range of from about 1 mm to about 10 mm, for example, in the range of from about 1 mm to about 4 mm. The thread 242 can include at least two thread starts.

[0190] The screw portion 240 of the rotating member 250 can have a diameter that allows at least one, two, three, or more screw starts to be incorporated into the screw pump. The pitch of each thread 242 can be increased and / or varied within each thread accordingly.

[0191] Rotating member 250 may comprise a high stiffness and / or rigid material, such as polycarbonate or polyamide. The diameter of rotating member 250 may vary from about 3 mm to about 10 mm, e.g., from about 3 mm to about 6 mm. The diameter of rotating member 250 may, for example, be equal to the diameter of outer surface 241 of threaded portion 240 along the entire length of the rotating member (along longitudinal axis A).

[0192] The threads 252 that cooperate with the plunger 230 can travel 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 can be selected to ensure that the plunger 230 consistently applies pressure to pellets stored within the cartridge.

[0193] Actuator 300, if provided with an electromechanical motor, can be configured to rotate rotating member 250 at a speed 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.

[0194] The device 100 may include a cap (e.g., as described below) at the second end 104 of the device 100 that fits over the end of the cartridge 200. The cap may include an interference fit with the outer surface of the cartridge 200. A means may be provided to prevent pellets from unintentionally falling out of the outlet tube 212 (or cartridge 200). The cap may include a marker configured to align with a cooperating groove located on the cartridge 200, such that the marker aligns with a first end of the groove before twisting the cap, moves along the groove during twisting, and then reaches the end of the groove when the required or predetermined dose has been expelled.

[0195] In various embodiments, the actuator 300 can be configured to rotate the rotating member 250 in the opposite direction after ejection is complete. This can be useful in drawing pellets back into the chamber 220, thereby reducing pellet loss (which may be due in part to pellet run-through). Such a change in rotational direction can also be useful in moving a plug in and out of contact with the outlet tube 212 to seal the cartridge 200. This can be used to provide a seal (e.g., an airtight seal as described elsewhere herein) and also to prevent pellet loss. In various embodiments, the change in rotation can also be used to destroy the drive mechanism at the end of the cartridge 200's life, preventing refilling and reuse of the cartridge 200, for example, by a user or third party. Various embodiments can include a latch that permanently locks the rotation of the rotating member 250 when the rotation of the rotating member is reversed from the direction required to drive the pellets.

[0196] Hereinafter, various embodiments of the present invention will be described, and the features described below can be combined with any of the above-described embodiments to the extent that they are compatible with the embodiment, with like features being indicated with like reference numerals.

[0197] In the figures associated below, the screw pump threads may not be shown as described above, for example, they may be displaced from a tapered portion, or tapered with a tapered portion, or have a variable pitch. However, the described features may still be combinable with the above-described aspects and embodiments. In other words, the embodiments described below may be adapted so that the screw pump threads correspond to those described above and of the present invention, for example, displaced from a tapered portion, or tapered with a tapered portion, or have a variable pitch. Similarly, the figures may not show a tapered portion, but it should be understood that this may be provided as appropriate.

[0198] 11 and 12 show an embodiment including two cartridges 200 positioned side-by-side within a housing 400. The two cartridges 200 abut and can be operated by a common actuator 300'. The actuator 300' can include a dual connecting portion 303', each connecting portion 303' configured to drive a respective connecting portion 280 of each respective rotating member 250 of each cartridge 200, in a manner similar to that described above with respect to the single cartridge actuator 300.

[0199] 13, 14A, and 14B show an embodiment incorporating a first valve positioned over the outlet tube 212 of the cartridge 200. FIG.

[0200] The first valve 500 comprises 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 comprises a funnel portion comprising a second surface 251 that is frusto-conical and tapers from the first surface 252 to an outlet portion 255. The funnel portion is configured to receive pellets from the threaded portion 240, specifically from its threads 242. The outlet portion 255 is configured to receive pellets from the frusto-conical portion and comprises an outlet 257 through which the pellets are discharged to the user. The outlet portion 255 and / or the outlet 257 can be elongated, as shown in FIG. 13, and the width of the outlet 257 (i.e., its smaller width, as shown in FIG. 14B) can be adapted to the size of the pellets to be discharged. For example, the width can be less than 1.5 times the width or diameter of the pellets.

[0201] 15, 16A, and 16B illustrate embodiments incorporating a second valve 550 in the form of a plug 550 positioned over the outlet tube 212 of the cartridge 200. The plug 550 can be configured to contact the end of the outlet tube 212 facing away from the chamber 220. In various embodiments, the plug 550 is configured to insert into a cavity 254 formed in the second discharge end 104 of the rotating member 250 (i.e., including the threaded portion 240). 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 (e.g., provide a seal) against the outlet tube 212 to maintain and, e.g., hermetically seal, the pellets within the cartridge 200, e.g., before use or (in some embodiments) during use.

[0202] 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, e.g., a rubber sheet, with the outer edge of the base portion 552 configured to bend open when pellets are forced out of the screw pump during use, and then spring back when the screw pump is not rotating, thereby stopping the pellets from falling out and helping to seal the cartridge 200. The elongated portion 554 of the plug 550 may not move substantially from its position within the cavity 254 of the rotating member 250.

[0203] 16C-E show a refinement of the umbrella valve concept that can be applied to the embodiment shown in FIGS. 16A and 16B. In this embodiment, device 100 includes a slide member 560 that is concentrically positioned around outlet tube 212 and configured to slide axially (i.e., along axis A) relative to the outlet tube. A base portion 552 of plug 550 extends radially (relative to axis A) and passes through the radial extent of outlet tube 212, at least partially within the line of travel of slide member 560. This is shown in FIG. 16C.

[0204] As shown schematically in FIG. 16D, when the rotating member 250 (i.e., having the threaded portion 240 and the threads 242) rotates, the pellets 10 are forced downward through the threads 242, and at least some of the pellets 10′ become trapped between the base portion 552 of the elastic plug 550 and the end of the outlet tube 212 or the end of the slide member 560.

[0205] To eject a pellet from device 100, a user can slide slide member 560 along axis A, which causes base portion 552 of resilient plug 550 to bend, causing pellet 10′ captured between base portion 552 of plug 550 to be released and ejected from device 100. This is shown schematically in FIG. 16E.

[0206] Once the pellets have been expelled from device 100, the user can slide slide member 560 back into place, at which point the valve will return to its original position (as shown in FIG. 16C ), thereby preventing pellets from being unintentionally expelled from outlet tube 212. In various embodiments, slide member 560 may be biased toward this original position by the resilience of base portion 552 of plug 550. For example, a suitable resilient member may bias slide member 560 toward this position, or it may be an electromechanical device such as a solenoid, relay, or other actuator.

[0207] It will be appreciated that during rotation of the rotating member 250, pellets are continuously ejected past the base portion 552 of the resilient plug 550 and out the outlet tube 212. The purpose of the sliding member 560 is to remove any pellets remaining between the resilient plug 550 and either the base portion 552 of the plug 550 or the end of the sliding member 560 after this ejection operation, as described above. In this manner, the sliding member 560 is configured to terminate the ejection operation and prevent floating pellets from falling out of the device 100 outside of any ejection operation.

[0208] 16F and 16G illustrate a further embodiment in which a valve in the form of a deformable material or sheet 545 is positioned to cover the discharge end of the outlet tube 212. The deformable material 545 may be substantially elastic and may include an aperture 546 through which a pin 253 extends, the pin 253 extending from the end of the rotating member 250. As shown in FIG. 16F, in the non-operating or rest position, the outer surface of the pin 253 contacts the inner surface of the aperture 546 to close the end of the outlet tube 212 and prevent pellets from being discharged.

[0209] In various embodiments, the length of pin 253 may be about 1.5 mm (i.e., along the longitudinal axis of rotating member 250), its diameter may be about 2.5 mm, the thickness of deformable material 545 may be about 1 mm, and the width or diameter of the aperture may be about 2 or 2.5 mm. The length of deformable material 545 (in the direction of the longitudinal axis of rotating member 250) may be less than the length of pin 253 and may be less than about 80% of the length of pin 253. Deformable material 545 may comprise a thermoplastic elastomer (“TPE”) or polybutylene terephthalate (“PBT”) and / or may have a hardness of less than about 100, 80, 70, 60, or even 50 Shore. The Shore hardness test may be performed at Shore 00 or Shore A. Optionally, the hardness may be about 30 Shore to about 50 Shore, performed at Shore 00 or Shore A. The pin 253 may be substantially rigid. The deformable material 545 may be attached to the outlet tube 212 in any suitable manner, for example with an adhesive.

[0210] As the rotating member 250 rotates, the pellet will be propelled towards the end of the outlet tube 212 for ejection from the device 100, and when it encounters the deformable material 545 in its rest position (as shown in FIG. 16F), the pellet will be pressed against the deformable material 545, deforming the deformable material and creating a gap G between the deformable material 545 and the pin 253 through which the pellet can be ejected, as shown in FIG. 16G. At the end of the ejection operation, when the rotating member 250 stops rotating, the pellet will no longer be propelled against the deformable material 545, and the deformable material 545 will spring back to its rest position, as shown in FIG. 16F, closing off the end of the outlet tube 212.

[0211] 17, 18A, and 18B illustrate an embodiment incorporating a modified outlet tube 212', features of which may be incorporated into any of the other embodiments described herein that use an outlet tube. In this embodiment, the outlet tube 212' is modified to cooperate with a movable component configured to move between a first position that prevents pellets from being discharged or moving out of the screw pump, and a second position that allows pellets to be discharged from the screw pump.

[0212] More specifically, the movable component in the illustrated embodiment is in the form of a nut 270 that is configured to move along the threads 242 of the threaded portion 240. The outlet tube 212 comprises a substantially cylindrical portion 215 and a flange 217 that extends from the cylindrical portion 215 in the direction of the longitudinal axis A of the rotating member 250. The flange 217 comprises a track 218 along which the nut 270 moves in use. The flange 217 further comprises opposed shoulder portions 219A, 219B located at either end of the track 218 and configured to provide a stop for the nut 270.

[0213] Nut 270 is configured to move along longitudinal axis A of rotating member 250 (which is also the axis of threads 242) when rotating member (and threaded portion 240) rotates. Nut 270 is configured, by its association with threads 242, to block the threads and prevent pellets from moving past its position down threads 242. Furthermore, when nut 270 meets first shoulder portion 219A, nut 270 forms a seal against cylindrical portion 215 of outlet tube 212, meaning that no portion of threads 242 is exposed. Therefore, pellets cannot leave threads 242 and be expelled from the device.

[0214] As the rotating member 250 rotates in a 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 pellets can move down the threads 242 and be expelled from the cartridge 200. After the rotating member 250 has rotated a certain amount, the nut 270 will come into contact with the second shoulder portion 219B, which prevents the nut 270 from moving any further (and advantageously prevents further rotation of the rotating member 250). In this position (shown in FIG. 18B ), the screw pump formed by the threads 242 and the outlet tube 212′ will have expelled a certain volume (e.g., a predetermined or predefined amount) of pellets.

[0215] As the rotating member 250 rotates in a second rotational direction (opposite 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 against the cylindrical portion 215 of the outlet tube 212 and preventing pellets from being ejected from the device.

[0216] The nut 270 can move linearly (and axially) along the longitudinal axis A of the threads 242. The nut 270 can be rotationally constrained (i.e., so that it does not rotate with the rotating member 250) through a friction fit between the nut 270 and a flange 217 that extends downwardly from the cylindrical portion 215 of the outlet tube 212′.

[0217] Once the required dose (which may not accommodate the nut 270 moving all the way along the track 218) has been delivered, the rotating member 250 can be rotated in the opposite direction, as described above, thereby drawing any pellets remaining in the threads 242 back into the chamber 220 and simultaneously withdrawing the nut 270 vertically until it returns to its rest position and contacts the first shoulder portion 219A of the outlet tube 212'. As described above, this contact seals against the cylindrical portion 215 of the outlet tube 212', preventing the pellets from falling out.

[0218] 19A and 19B show an embodiment including a movable component 570 that can be positioned to cover the outlet end of outlet tube 212. Movable component 570 can be included in the embodiment shown in Figures 16A and 16B and can be provided in addition to or as a replacement for valve 550 (and optional slide member 560) disclosed in connection with that embodiment.

[0219] In this embodiment, the movable component 570 can include a spring-loaded plate 572 configured to seal the outlet end of the outlet tube 212. A suitable resilient member (not shown) can be configured to bias the movable component 570 to the position shown in FIG. 19A . This can help provide moisture protection and prevent pellets from unintentionally falling out of the outlet tube 212. In some embodiments, the plate 572 can be configured to rest against (e.g., hermetically seal) the outlet tube 212. The plate 572 can itself be made of a resilient material; for example, the plate 572 can be made of an elastomer and can include an elastomeric coating. This further helps seal the outlet tube 212 and prevent pellets from falling out of the outlet tube.

[0220] In one particular embodiment, the movable component 570 is combined with an electronic relay 580 comprising an electromagnet, which is shown schematically and configured to move the movable component 570 from its rest position shown in FIG. 19A to its open position shown in FIG. 19B. In the rest position, when the electromagnet is switched off, the plate 572 can be biased against the end of the outlet tube 212 to seal the end and prevent pellets from falling out. In the open position, when the electromagnet is switched on, the plate 572 is pulled toward the electronic relay 580, thereby allowing pellets to be ejected from the outlet tube 212 during the ejection operation. In this embodiment, the movable component 570 may need to include a magnetic component so that the electromagnet of the electronic relay 580 can move away from its rest position to properly move the movable component.

[0221] In various other embodiments, movable component 570 may simply be spring-loaded for user manipulation. For example, electronic relay 580 may not be provided, and movable component 570 may be moved from its rest position to its open position by the user. Other types of electromechanical devices, such as solenoids or other actuators, may also be used.

[0222] 20A and 20B show an embodiment that may be considered an improvement over FIGS. 16A and 16B, in which valve 550 is replaced by valve 590 extending in a similar manner from the end of rotatable member 250. Valve 590 in this embodiment includes a disk 591 having a notch 592 configured to align with outlet 243 of thread 242, such that pellets are ejected from device 100 when notch 592 and outlet 243 are aligned. Disk 591 is rotatable between a first position (as shown in FIG. 20A ) in which notch 592 is aligned with outlet 243, and a second position in which notch 592 is moved out of alignment with outlet 243.

[0223] In various embodiments, as shown in FIG. 20B , the valve 590 can include a resilient member 594 configured to bias the disk 591 toward its second position. The disk 591 can be configured to rotate with the rotatable member 250 due to a friction fit between these two components. When the rotatable member 250 begins to rotate to initiate an ejection operation, the disk 591 can rotate with the rotatable member and move to its first position to align the notch 592 with the outlet 243 and allow for the ejection of pellets. When the rotatable member 250 stops rotating to end the ejection operation, the resilient member 594 can be biased and move the disk 591 back to the second, resting position.

[0224] A slight modification of this type of valve is shown in FIG. 20C, which shows a valve 590' in the form of a resilient member (e.g., a rubber member). The resilient member 590' includes a notch 592' having the same function as described with respect to FIGS. 20A and 20B, i.e., the notch 592' is configured to align with the outlet 243 of the screw thread 242 to allow the ejection of pellets during the ejection operation. In this embodiment, the resilient member 590' is a single piece and includes a disk portion 591' having a protrusion 596' that extends from the disk portion 591' toward the rotating member 250 in use. In this embodiment, the rotating member 250 includes an aperture 254' formed in the end of the rotating member, and the protrusion 596' of the resilient member 590' is inserted into the aperture 254'. The protrusion 596' of the resilient member 590' (e.g., its crown 597') has a friction fit with the inner surface of the aperture 254'. The disc portion 591' may fit within and have a friction fit with the outlet tube 212 (in this embodiment, the outlet tube 212 may extend through the resilient member 590').

[0225] During the ejection operation, the rotating member 250 may be rotated, causing the rotating member 250 to rotate relative to the disk portion 591' of the resilient member 590', thereby aligning the notch 592' in 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' remaining aligned with the outlet 243. When the ejection operation is completed and rotation stops, the resiliency of the resilient member 590' will cause the disk portion 591' to rotate relative to the rotating member 250 (and the protrusion 596'), causing the notch 592' to move out of alignment with the outlet 243.

[0226] The first valve 500 and the second valve 550 (as well as the improved outlet tube 212′ and valves 590, 590′) can be configured to help prevent pellets located within the threads 242 from falling out during use. The device 100 can be configured such that, to eject a pellet through the first valve 500 or the second valve 550, the user must rotate the rotating member 250 to urge the pellet along the threads 242 and provide a force against the first valve 500 or the second valve 550, so that the pellet can be ejected through either valve. In some situations, a valve may not be necessary (but may still be included); for example, the pellets may themselves be retained within the threads 242 by friction, or a cap or cover may be provided to cover the cartridge outlet (e.g., the outlet tube).

[0227] In various embodiments, as shown in FIG. 21A , the rotating member 250 can be modified such that the threads 242 are in fluid communication with an internal channel 245 configured to receive pellets from the threads 242, which then travel through the channel for discharge out an outlet 243′ located in the bottom surface of the rotating member 250. As shown in FIG. 21B , in a modification, a resilient (e.g., rubber) cap 540 can be positioned to cover the end of the rotating member 250, the end configured to prevent pellets from being discharged when the device 100 is not in operation. The cap 540 can include a resilient opening 542 that is aligned with the outlet 243′ but is biased to a substantially closed position that prevents pellets from passing through. As the rotating member 250 rotates, the pellets are forced out of the outlet 243′ and toward the opening 542, which is configured to resiliently open and allow for the discharge of the pellets.

[0228] 22, 23, 24A, and 24B show device 100 including a cap 600 configured to connect to cartridge 200 at second discharge end 104 of the device to cover outlet tube 212. Cap 600 can be configured to connect to cartridge 200 in any suitable manner, for example, by an interference fit, a magnetic latch, a clip fastener, or a threaded connection. Cap 600 includes a base portion 602 and one or more side portions 604 extending from either end of base portion 602. Each of side portions 604 connects to cartridge 200 to optionally provide a seal (e.g., an airtight seal) between cap 600 and chamber 200. A chamber 606 may be formed between cartridge 200 and cap 600.

[0229] Cap 600 can be used to provide a collection cap for the pellets (e.g., so that the expelled dose can be retained within chamber 606) and / or to provide a seal (e.g., an airtight seal) before and during use. Cap 600 may be combined with either first valve 500 or second valve 550 described above.

[0230] 25-26 show an alternative cartridge 200AB embodiment that is similar to the dual cartridge embodiment of FIGS. 11 and 12, except that two cartridges 200 are combined into a single unit.

[0231] The single cartridge 200AB comprises a first set of components including a first rotating member 250A extending through the first chamber 220A and having a first thread 252A and a first threaded portion 240A extending into the first outlet tube 212A, and a first plunger 230A that moves down the first thread 252A in use in a similar manner as described above with respect to the single cartridge 200.

[0232] The first threaded portion 240A of the first set of components has threads 242A extending from the chamber 220A into the outlet member 212A, so that as the first rotating member 250A rotates, pellets are expelled through the threads 242A and out the first outlet tube 212A in a similar manner as described above with respect to the single cartridge 200.

[0233] The single cartridge 200AB comprises a second set of components including a second rotating member 250B extending through the second chamber 220B and having a thread 252B and a second threaded portion 240B extending into the second outlet tube 212B, and a second plunger 230B that moves down the second thread 252B in use in a similar manner as described above with respect to the single cartridge 200.

[0234] The second threaded portion 240B of the second set of components has threads 242B extending from the chamber 220B into the outlet member 212B, so that as the second rotating member 250B rotates, pellets are expelled out the second outlet tube 212B via the threads 242B in a similar manner as described above with respect to the single cartridge 200.

[0235] The first and second sets of components can be configured differently, such that, for example, the various threads 242A, 252A, 242B, 252B are configured so that the first set of components eject pellets at a faster rate than the second set of components. Also, the different chambers 220A and 220B can be configured for use with different sized pellets. For example, the actuator 300' can be configured so that each separate rotating member 250A, 250B is driven by a different motor or mechanical controller configured to operate at different rotational speeds.

[0236] 26, first rotating member 250A is configured to rotate about a first axis AA, and second rotating member 250B is configured to rotate about a second axis AB. In various embodiments, first axis AA and second axis AB may be parallel to one another.

[0237] 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 Figures 11 and 12 and includes a dual connecting portion 303' with each connecting portion 303' configured to drive a respective rotating member 250A, 250B in a manner similar to that described above with respect to the single cartridge actuator 300.

[0238] 27, 28A, and 28B show an embodiment of cartridge 200 in which screw section 240 of rotating member 250 is replaced by screw section 240'' in a "twist plate" configuration, which maximizes screw section threads 242'' and minimizes the significant impact of screw section friction on the pellet. Threads 240'' in this embodiment are formed by multiple twisted plates, creating directly opposed thread starts that extend along the entire length of threads 242''. This is in contrast to embodiments in which threads are cut from the circumferential surface of the rotating member, as shown, for example, in previously described embodiments.

[0239] The threaded portion 240'' may connect directly to the threads 252 of the rotating member 250 and extend from a position within the chamber 220 into the outlet conduit 212 in a manner similar to the threaded portion 240 of the previously described embodiments. The width of the threaded portion 240'' defined by its outer helical surface 241'' may be substantially equal to the width of the inner cylindrical surface 214 of the outlet conduit 212. That is, the surfaces of the threaded portion 240'' and the inner cylindrical surface 214 of the outlet conduit 212 may substantially contact or abut one another (e.g., continuously or intermittently), but not to the extent that they have an interference or friction fit relative to one another, ensuring that they can move smoothly past one another and ensuring reliable discharge.

[0240] 29A, 29B, and 29C show an embodiment of device 100 in which plunger 230 is accompanied by a deformable material 234 positioned on radially extending surface 232 of plunger 230. In various embodiments, deformable material 234 may be foam or sponge. The function of deformable material 234 is to assist in pushing pellets toward the discharge end of device 100 (i.e., toward threaded portion 240). In particular, deformable material 234 can provide an efficient way to ensure that small pellets contained within chamber 220 move toward the discharge end, particularly away from the interior walls of chamber 220.

[0241] In various embodiments, plunger 230 can extend radially (relative to axis A) a distance slightly less than the radial distance to the inner wall of chamber 220 to avoid friction between plunger 230 and the wall of cartridge 200. However, in these embodiments, deformable material 234 can extend radially a distance equal to the radial distance to the inner wall of chamber 220, such that deformable material 234, rather than plunger 230, can ensure that pellets are displaced from the inner wall of chamber 220 toward the discharge end and cannot pass between plunger 230 and the wall of cartridge 200. Deformable material 234 can be sized to partially deform when in place, as shown in FIGS. 29A-29C, meaning that the deformable material will push against the wall of cartridge 200 in use to maximize this effect.

[0242] The deformable material 234 may be press-fit between the rotating member 250 and the cartridge 200 and may not be attached to the plunger 230 (e.g., by an adhesive). In use, the plunger, as described herein, moves along axis A, contacting the deformable material 234 and similarly moving the deformable material along axis A. Alternatively, the deformable material 234 may be secured to the plunger 230 by any suitable means, for example, by an adhesive.

[0243] The deformable material 234 may be included in any of the aspects or embodiments contained herein that incorporate the plunger 230, including but not limited to the embodiments shown in Figures 29A-29C (which are provided solely to illustrate this feature). For example, the deformable material 234 may be provided in embodiments in which the plunger 230 moves along the threads 252; in these embodiments, the axial thickness of the deformable material 234 may be at least twice the pitch of the threads 252, thereby ensuring that some or all of the pellets cannot move past the deformable material 234.

[0244] 30A, 30B, and 30C illustrate an embodiment in which plunger 230 of device 100 is provided with a plurality of axially extending teeth or protrusions 236. At least some (or all) of teeth 236 include rails 237 configured to ride along threads 252 of rotating member 250. Additionally, teeth 236 are configured to be radially curved such that rails 237 on teeth 236 can move in and out of threads 252. When rotating member 250 is rotated in use, plunger 230 will move along axis A as a result of rails 237 engaging threads 252. When plunger 230 contacts a pellet contained within chamber 220 (or reaches the bottom of chamber 220), plunger 230 may be restricted from further axial movement. At this point, teeth 236 are configured to curve radially outward, such that rails 237 disengage from threads 252 and rotating member 250 continues to rotate without plunger 230 moving along axis A. As shown in the illustrated embodiment, rails 237 are located at the axial ends of teeth 236 farthest from the body of plunger 230, maximizing the ability of teeth 236 to curve radially outward, as described above.

[0245] Some teeth 236 may be provided as stabilizers, i.e., without rails 237 that engage threads 252, and these may function to stabilize plunger 230 as it moves along axis A and deflect other teeth 236 that include rails 237. Teeth 236 that function to stabilize plunger 230 may be biased radially inward so that they fit tightly against rotating member 250 as plunger 230 moves along axis A.

[0246] Any suitable number of teeth 236 may be provided, for example, 2 to 10 teeth, 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 rails 237 and the other three of which act as stabilizers (i.e., no teeth 236).

[0247] The plunger 230 in any of the aspects and embodiments provided herein can include teeth 236, as shown and described with respect to Figures 30A-30C. The teeth 236 can include rails 237 or alternatively can serve as a stabilizing device, as described above. In such embodiments, the plunger 230 typically does not include its own threads. In other words, the plunger 230 is moved along the axis A solely by the engagement of the rails 237 with the threads 252 of the rotating member 250.

[0248] 31A, 31B, and 31C illustrate 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 inward. The protrusions 262 extend from the body of the plunger 230 and may be integrally formed with the body or provided as separate components and secured to the plunger by any suitable method. The protrusions 262 each include a rail 266 configured to engage with the threads 252 on the rotation member 250. As shown in the illustrated embodiment, the rail 266 is located at the axial end of the protrusion 262 farthest from the body of the plunger 230, maximizing the ability of the protrusions 262 to bend radially outward, as described below. The resilient member 264 may be, for example, an elastic band.

[0249] As the rotating member 250 rotates during use, the plunger 230 will move along axis A as a result of the rails 266 engaging the threads 252. The resilient member 264 ensures that the rails 266 engage the threads 252 during this rotation. When the plunger 230 contacts a pellet contained within the chamber 220 (or reaches the bottom of the chamber 220), the plunger 230 may be restricted from further axial movement. At this point, the protrusions 262 are configured to bend radially outward against the action of the resilient member 264, such that the rails 266 disengage from the threads 252 and the rotating member 250 continues to rotate without the plunger 230 moving along axis A.

[0250] Plunger 230 in any of the aspects or embodiments provided herein can include resilient device 260, as shown and described with respect to Figures 31A-31C. In such embodiments, plunger 230 typically does not include its own threads. In other words, plunger 230 is moved along axis A solely by engagement of rail 266 with threads 252 of rotating member 250.

[0251] 32A, 32B, and 32C illustrate one embodiment comprising an improved plunger 230'. In this embodiment, the plunger 230' comprises a unique shape configured to reduce friction between the plunger and the wall of the cartridge 200. In particular, the plunger 230' tapers from a first thickness adjacent the threads 252 of the rotating member 252 to a second thickness at the outer periphery of the plunger adjacent the wall of the cartridge 200, the second thickness being smaller than the first thickness.

[0252] More specifically, as shown in FIG. 32C , the plunger 230′ can include a substantially flat lower surface 232′, with the outer periphery of the plunger 230′ configured to contact the wall of the cartridge 200. A tapered surface 233′ can be provided extending radially inward from the outer periphery to an upper edge 231′ that is spaced apart from the wall of the cartridge 200 and adjacent the rotation member 250. By providing a thinner portion closer to the wall of the cartridge 200, friction between the plunger 230′ and the cartridge 200 can be reduced. Furthermore, as shown in the illustrated embodiment, the use of a tapered surface 233′ means that the outer periphery of the plunger 230′ can bend as the plunger 230′ moves axially. In such an embodiment, the plunger 230′ can be made of an elastomeric material, such as rubber, which can enhance the ability of the plunger 230′ to bend in this manner.

[0253] In various embodiments, the plunger 230' can be tapered to a point edge at the periphery of the plunger 230'. The thickness of the plunger 230' at its periphery can be, for example, less than about 2 mm, or even less than about 1 mm. The plunger 230' can be made from a thermoplastic elastomer ("TPE") or polybutylene terephthalate ("PBT"). The plunger 230' can have a hardness of less than about 100, 80, 70, 60, or even 50 Shore. Shore hardness testing can be performed at Shore 00 or Shore A. This has been found to provide a plunger 230' that can adequately flex during movement along axis A during use. The plunger 230' can be sized slightly oversized in that the width of the plunger 230' (e.g., in isolation) is slightly larger than the dimensions of the cartridge 200 within which it fits. The plunger 230 ′ may also be configured with threads configured to cooperate with the threads 252 of the rotating member 250 .

[0254] Generally, the apparatus and devices disclosed herein may be intended to provide accurate dosage of medication by weight and also to provide a simple mechanism for administering the dose and / or titrating the medication. Various mechanical features are provided to facilitate expulsion of the dose, including providing swallowing of the dose and general convenience in doing so. Additionally, various embodiments are intended to ensure efficient movement of pellets through the device or instrument.

[0255] The handheld device 10 can combine medical knowledge with digital functionality. The control unit can be reusable and can be paired with a variety of different cartridges 200 pre-filled with prescribed medications. For example, in the case of ADHD, the cartridges 200 can be pre-filled with the relevant medication for use over a one-month period. The cartridges 200 can be filled with pellets or granules (i.e., oral dosage forms). The pellets can be ingested with liquids or soft food to aid in swallowing the medication. While the device is particularly useful for ADHD, the technology disclosed herein is applicable to many other treatments, and particularly for use in pediatrics, psychiatry, neurology, cardiometabolic disease, or oral cancer treatment.

[0256] Exemplary treatments that may be associated with the devices described herein include attention deficit hyperactivity disorder ("ADHD" - medications used in the device may include amphetamine and / or methylphenidate), general pain (medications may include one or more of fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocodone, oxycodone, hydromorphone, naltrexone, buprenorphine, and methadone), immunosuppression after organ transplant (medications may include one or more of tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate, and azathioprine), diabetes (medications may include one or more of sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, dapagliflozin, empagliflozin, and semaglutide), and therapies for treating rheumatoid arthritis (including rheumatoid arthritis). or more), heart failure (medications may include one or more of carvedilol, metoprolol, bisoprolol, and diuretics), Parkinson's disease ("PD" - medications may include levodopa and / or carbidopa), epilepsy (medications may include one or more of sodium valproate-carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethosuximide, and topiramate), depression (medications may include one or more of citalopram, amfebutamone, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine, and reboxetine), schizophrenia (medications may include one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, and olanzapine), cancer, and animal health. For example, the device 10 can be combined with medications (eg, in pellet form) directed to or associated with the aforementioned treatments, eg, any or all of those described above.

[0257] The use of medications formulated as small pellets or granules can support accurate dosing and benefit pediatric patients with swallowing disorders. Pediatric drug development typically includes various formulations or devices that help address one or more of the challenges faced by this patient population. Combining the handheld device 10 disclosed herein with medications equipped with digital capabilities offers improvements in dose setting, titration, ease of use, swallowing ability, and compliance. This technology can be tailored to various treatments for pediatric populations, including combination therapies. Other areas of treatment using the device 10 disclosed herein could be epilepsy and general pain relief. Ejection technology could also be developed, for example, for infections in children; for example, medications (e.g., in pellet form) used with the device could include amoxicillin and / or penicillin.

[0258] The control unit (in any of the aspects or embodiments described herein) can include an input device or user interface, which can include one or more buttons for operating the instrument 10, for example, the ejection mechanism 300 therein.

[0259] The control unit may include a control system configured to operate various electrical and mechanical components of the instrument 10 , such as the user interface, the display, and the ejection mechanism 300 .

[0260] A pre-filled cartridge 200 (e.g., with a one-month prescription for ADHD) may have integrated circuit board trips that communicate relevant information to a control unit. The control unit, and in particular its control system, may set dosages, prevent ingestion above maximum doses, allow titration, and ensure tamper notification. The control system may, for example, record drug discharge over a defined period (e.g., a one-month prescription).

[0261] The methods, method steps, or functional features disclosed herein may be implemented, at least in part, using software, e.g., computer programs, in connection with, for example, the control system of the control unit described above. These may be located on a data processor on the control unit itself. Viewed from a further aspect, therefore, it will be seen that the present invention provides computer software specifically adapted to perform the methods, method steps, or functional features described herein when implemented on a data processing means; computer program elements comprising computer software code portions for performing the methods, method steps, or functional features described herein when the program elements are executed on a data processing means; and computer programs comprising code means adapted to perform all steps of the methods, method steps, or functional features described herein when the program is executed on a data processing system. The data processor may be a microprocessor system, a programmable FPGA (Field Programmable Gate Array), or the like.

[0262] Although the present invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the scope of the invention as set forth in the appended claims.

Claims

1. A device (100) for discharging a drug or pharmaceutical product in pellet form, comprising: a cartridge (200) comprising a chamber (220) for containing a plurality of pellets, and a screw pump configured to receive pellets from the chamber (220) and transport the pellets from the chamber (220) upon rotation of the screw pump so that the pellets are discharged from the device (100) via the screw pump; a rotating member (250) extending through the cartridge (200) and configured to rotate the screw pump to expel pellets from the cartridge; the cartridge (200) further comprises a tapered portion (207) configured to guide pellets contained in the chamber (220) into the screw pump for ejection from the device (100) via the screw pump as described above; The device, wherein the screw pump is located outside the tapered portion (207) of the cartridge (200).

2. 2. The device of claim 1, wherein the cartridge (200) comprises an outlet pipe (212) extending from the tapered portion (207) of the cartridge (200), the outlet pipe (212) housing the screw pump, the screw pump being displaced from the confluence of the tapered portion (207) and the outlet pipe (212).

3. 3. The device of claim 1, wherein the tapered portion (207) extends a distance (d) in a first direction, and the screw pump is displaced in the first direction from the confluence of the tapered portion (207) and the outlet pipe (212) by at least 50% of the distance (d).

4. 4. The device of claim 1, 2, or 3, wherein an inner wall of the cartridge (200) forming at least the tapered portion (207) tapers from a first diameter (D1) to a second diameter (D2), the first diameter (D1) being greater than the second diameter (D2), the inner wall having the first diameter (D1) in a portion of the cartridge (200) above the tapered portion (207), and the inner wall tapering from the first diameter (D1) to the second diameter (D2) as it extends through the tapered portion (207).

5. 10. The device of claim 9, wherein the rotating member (250) tapers from a first diameter (d1) to a second diameter (d2) as it extends through the tapered portion (207) of the cartridge (200), the first diameter (d1) being greater than the second diameter (d2), the rotating member (250) having the first diameter (d1) in a portion of the cartridge (200) above the tapered portion (207), and the rotating member (250) tapers from the first diameter (d1) to the second diameter (d2) as it extends through the tapered portion (207) of the cartridge (200).

6. A device (100) for discharging a drug or pharmaceutical product in pellet form, comprising: a cartridge (200) comprising a chamber (220) for containing a plurality of pellets, and a screw pump configured to receive pellets from the chamber (220) and transport the pellets from the chamber (220) upon rotation of the screw pump so that the pellets are discharged from the device (100) via the screw pump; a rotating member (250) extending through the cartridge (200) and configured to rotate the screw pump to expel pellets from the cartridge; the cartridge (200) further comprises a tapered portion (207) configured to guide pellets contained in the chamber (220) into the screw pump for discharge from the device (100) via the screw pump as described above; A device wherein the screw pump is located inside the tapered portion (207) of the cartridge (200) and tapers together with the tapered portion (207).

7. 7. The device of claim 6, wherein an inner wall of the cartridge (200) forming at least the tapered portion (207) forms a funnel configured to guide pellets contained in the chamber (220) into the screw pump.

8. 8. The device of claim 6 or 7, wherein the cartridge (200) comprises an outlet tube (212) comprising the tapered portion (207) of the cartridge (200), the outlet tube (212) housing the screw pump, the tapered portion (207) extending a distance (d) in a first direction, the distance (d) being approximately 30% to 100% of the length (L) of the outlet tube (212) in the first direction.

9. The device of claim 8, wherein the distance (d) is about 40% to 60% of the length (L) of the outlet tube (212) in the first direction.

10. A device according to any one of claims 6 to 9, wherein the outer diameter of the screw pump remains substantially flush with the inner surface of the cartridge (200) within the tapered portion (207) of the cartridge (200).

11. 10. A device according to any one of the preceding claims, wherein the pellet has a maximum dimension of between about 150 μm and 1200 μm.

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

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

14. 10. The device of any one of the preceding claims, further comprising a plurality of pellets providing an oral dosage form contained within said chamber (220).

15. 10. The device of any one of the preceding claims, wherein the rotating member (250) comprises one or more fins (290) located at an inlet to the screw pump and configured to concentrate and direct pellets within the screw pump.

16. 16. The device of claim 15, wherein each of the one or more fins (290) is aligned with and associated with a respective screw start of the screw pump.

17. 10. The device of any one of the preceding claims, wherein the rotating member (250) comprises one or more baffles (390) configured to rotate with the rotating member (250) and to assist in moving pellets through the chamber (220) and into the tapered portion (207).

18. 10. A device according to any one of the preceding claims, wherein the screw pump comprises one or more screw threads with a variable pitch.

19. 10. A device according to any one of the preceding claims, wherein the screw pump comprises one or more screw threads formed around the rotating member such that the screw pump forms part of the rotating member.

20. 10. A method of using a device according to any one of the preceding claims, comprising: rotating the screw pump, for example using the rotating member (250), to eject pellets from the device (100).

21. filling said chamber (220) with pellets providing an oral dosage form; determining the amount of rotation of the screw pump that will cause a predetermined amount of the pellets to be discharged from the device (100); 21. The method of claim 20, further comprising rotating the screw pump a predetermined amount to expel the predetermined amount of pellets from the device (100).

22. A device (100) for discharging a drug or pharmaceutical product in pellet form, comprising: a cartridge (200) comprising a chamber (220) for containing a plurality of pellets, and a screw pump configured to receive pellets from the chamber (220) and transport the pellets from the chamber (220) upon rotation of the screw pump so that the pellets are discharged from the device (100) via the screw pump; a rotating member (250) extending through the cartridge (200) and configured to rotate the screw pump to expel pellets from the cartridge; the cartridge (200) further comprises a tapered portion (207) configured to guide pellets contained in the chamber (220) into the screw pump for ejection from the device (100) via the screw pump as described above; A device wherein the screw pump comprises one or more screw threads having a variable pitch.

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