Pill delivery device

Through the combination of screw pump and plunger mechanism, the accurate and convenient distribution of pellet drugs is achieved, and the problem of inaccurate distribution of pellet drugs in the prior art is solved. It is suitable for a variety of medical scenarios, especially pediatrics, geriatrics and drug treatment after organ transplantation.

CN120482544APending Publication Date: 2025-08-15ONDOSIS AB
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Patent Information

Application Number
CN202510670987.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2017-12-15
Filing Date
2018-12-17
Publication Date
2025-08-15

AI Technical Summary

Technical Problem

The prior art is difficult to accurately and conveniently distribute drugs in the form of pills, especially in the case of pediatric drugs, geriatric medicine, ADHD drugs and immunosuppressive drugs after organ transplantation, and there are problems of dysphagia and inaccurate dose control.

Method used

The screw pump device is adopted, including a cylinder, a screw pump and a rotating member, and the precise distribution of the pellets is achieved through the rotation of the screw pump. Combined with gravity and plunger mechanism, the device is designed to be portable and hand-held, supporting flexible dose adjustment.

Benefits of technology

It achieves accurate and convenient distribution of pellets, suitable for different patient groups, especially those with dysphagia, supports flexible dosage adjustment and precise control, avoids the unrecommended practice of tablet crushing, and improves the safety and effectiveness of drug use.

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Abstract

There is provided a device (100) for dispensing a medicament in the form of one or more pellets, comprising a cartridge (200) comprising a chamber (220) for containing a plurality of medicaments in the form of pellets; a screw pump configured to receive pellets from the chamber (220) and to convey the pellets from the chamber for dispensing from the device via the screw pump when the screw pump rotates; and a rotating member (250) extending through the barrel and configured to rotate the screw pump to dispense pellets therefrom.
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Description

[0001] This patent application is a divisional application of application number 201880079675.6 (PCT / EP2018 / 085320) filed on December 17, 2018, entitled “Pill delivery device”. Technical Field

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

[0003] Solid oral dosage form ("ODF") medications can be formulated as tablets or pellets. Tablets or pellets can contain a variety of substances, with the primary ingredient being the active pharmaceutical ingredient ("API"). Pills can be administered to patients in prefilled capsules or compressed into tablets with supplemental filler materials. Dispensing mechanisms for various ODF medications are known and can range from blister pack-type devices, in which individual tablets are retained in recesses and held in place by the use of foil, to dispensing bottles. More complex mechanisms are also known, particularly for other types of pharmaceutical formulations, such as those in pellet form, which typically contain less than 10% of a specific dose per unit. Dispensing medications in pellet form has the advantage of allowing the same dispensing device to be used to vary the dosage. Another advantage is that pellets are easier to swallow for patients with dysphagia, who currently crush their tablets to facilitate swallowing. Currently, patients also resort to crushing or splitting tablets to obtain, for example, half a dose of a prescription medication, a procedure that is not recommended and could be avoided if a device could dispense pellets in varying, flexible amounts. The variable dosing of pellets allows for more precise adjustment of dosages than can be achieved using larger dosage forms such as tablets or capsules. In addition, for modified release formulations, pellets are generally more robust to food interactions than larger dosage forms such as tablets.

[0004] It would be desirable to improve the dispensing mechanism of drugs in pellet form, for example in the case of pediatric drugs; to ease swallowing of antibiotics in the case of geriatric medicine; to ease swallowing of chronic medications in the case of certain controlled substances such as stimulants for ADHD or analgesics (e.g., opioids); to improve control over the dispensed dose or to limit the risk of overdose for psychiatric diseases such as depression or neurological disorders such as epilepsy or for drugs that require titration or flexible adjustment at the beginning due to disease variability or after the desired outcome has been achieved, such as in the case of immunosuppression after organ transplantation. Summary of the Invention

[0005] Various aspects and embodiments of dispensing devices that may be used in the present invention will be described herein and relate to any aspects and embodiments of the present invention described herein insofar as they are suitable herewith. It will be understood that all devices operate on similar principles.

[0006] In one aspect of the present invention, a device is provided for dispensing pellets (e.g., a drug or medication in pellet form). As described below, the maximum dimension (e.g., width or diameter) of the pellets can be between about 150 μm and about 1200 μm (or even about 1500 μm), alternatively between about 200 μm and about 300 μm, between about 300 μm and about 500 μm, or between about 500 μm and about 700 μm. In various embodiments, the maximum dimension (e.g., width or diameter) of the pellets can be between about 700 μm and about 900 μm or between about 800 μm and about 1100 μm.

[0007] The device comprises: a cartridge comprising a chamber for containing or housing a plurality of pellets; a progressive cavity pump, such as an Archimedean screw, configured to receive pellets from the chamber and, upon rotation of the progressive cavity pump, convey the pellets from the chamber for dispensing from the device (and, e.g., the barrel and / or chamber) through the progressive cavity pump; A rotating member extends through the barrel and is configured to rotate the progressive cavity pump to dispense pellets therefrom.

[0008] The above-described device solves the problem of how to accurately and easily administer pellets, which can provide oral dosage forms (particularly, but not limited to, those with a size between about 150 μm and about 1200 μm or even about 1500 μm), because the use of a screw pump allows precise dosages to be administered from the device in a simple manner. Previously (and as discussed above), pellet-type medications have been administered to patients as pre-filled capsules or compressed in tablets. The pellets can provide oral dosage forms, and the oral dosage forms can be unit doses and / or solid oral dosage forms. It is envisioned that in some cases, the pellets may include a hard, solid (or semi-solid, such as gelatin or cellulose) shell and a softer core, such as a gel or even a liquid core.

[0009] The chamber may extend from a first end of the device to a second dispensing end of the device.The barrel may extend from the first end to the second dispensing end, and the screw pump may be located at the second dispensing end of the barrel.

[0010] A progressive cavity pump may be located at the second dispensing end of the device.

[0011] The progressive cavity pump may be gravity fed. In other words, when the device is in the dispensing orientation (eg, with the dispensing end pointing downward), the pellets contained within the chamber may be moved toward the second dispensing end at least in part by gravity.

[0012] The device can be handheld and / or portable. In other words, the device can be held and transported with one hand and / or can be operated with one hand. For example, the length (corresponding to its longest dimension) of the device (e.g., the entire device or the cartridge) can be no greater than approximately 250 mm (e.g., less than approximately 200 mm, approximately 150 mm, or approximately 100 mm), and the width or height (i.e., transversely to its length) can be no greater than approximately 50 mm, and optionally no greater than approximately 40 mm (and in some embodiments, less than 30 mm or even less than 20 mm). To optimize its handheld nature, the length of the device can be between approximately 180 mm and approximately 220 mm, the width (transversely to its length) can be between approximately 35 mm and approximately 45 mm, and the height (transversely to its width) can be between approximately 22 mm and approximately 32 mm. The weight of the device (or cartridge) can be no more than approximately 500 g, approximately 400 g, approximately 300 g, approximately 200 g, or even approximately 100 g. This ensures that the device is light enough to be carried in one hand.

[0013] The barrel (or barrels) may have a length (corresponding to its longest dimension) between about 90 mm and about 120 mm, a width (transverse to its length) between about 33 mm and about 43 mm, and a height (transverse to its width) between about 15 mm and about 25 mm.

[0014] A progressive cavity pump can be or include a portion of a rotating component. For example, a progressive cavity pump can include one or more threads formed around the rotating component. The term "one or more" is used herein because a progressive cavity pump can include one or more screw heads, each forming a separate thread. Although plural terms are used below for simplicity, it should be understood that references to a thread include the singular thread.

[0015] The threads may extend at least partially into the chamber to receive the pellets from the chamber during use. The threads may be about 1 or about 2 times, for example about 1.5 times, the inner diameter of the chamber or barrel or the width of the chamber or barrel (e.g., the minimum or maximum width extending through and transverse to the longitudinal axis of the barrel). This has been found to prevent certain undesirable effects, such as "bulging" of the pellets within the chamber.

[0016] The length of the threaded portion (eg, along the longitudinal axis of the barrel) may be defined by the length of the threads, which may be between about 10 mm and about 30 mm, such as between about 10 mm and 20 mm.

[0017] The apparatus may be configured such that when the rotating member and the screw pump are rotated in use, the pellets travel along the screw pump's threads from the portion of the threads extending into the chamber to the opposite end of the threads for dispensing from the screw pump.

[0018] The threads may cooperate with the inner cylindrical surface of the barrel to form a progressive cavity pump, such that when the rotating member is rotated in use, the threads rotate within the inner cylindrical surface, causing the pellets contained in the chamber to enter the threads and travel down the threads to be dispensed from the progressive cavity pump. It should be noted that the barrel itself may not be generally cylindrical. Rather, in order to form a progressive cavity pump, the barrel may include an inner cylindrical surface, although this should not be interpreted as necessarily meaning that the barrel itself is cylindrical in whole or in part.

[0019] The barrel and / or chamber may be of any suitable shape, such as cylindrical or cuboid. The barrel and / or its chamber may be at least partially cylindrical, and the cylindrical portion of the barrel and / or chamber may include the inner cylindrical surface of the screw pump and at least a portion of the chamber for receiving the pellets. In this embodiment, the barrel may be open at the second dispensing end of the device, and the rotating member may include a screw portion (forming part of the screw pump) having an outer diameter that substantially matches the inner diameter of the barrel and / or the chamber at the second dispensing end of the device.

[0020] Alternatively, the barrel may include an outlet or outlet pipe extending from the chamber. The width or diameter of the outlet pipe may be less than the inner diameter of the chamber. The rotating member may extend into the outlet pipe such that the inner cylindrical surface of the outlet pipe forms the inner cylindrical surface of the screw pump. In these embodiments, the barrel and / or chamber may include a frustoconical or tapered portion at the second dispensing end of the barrel and / or chamber that directs the pellets contained in the chamber into the outlet pipe.

[0021] The threads may extend the entire length of the outlet pipe. The threads may extend partially into the chamber, extending a distance between approximately 1 and 2 times the diameter of the rotating member within the outlet pipe, which has been found to prevent certain undesirable effects, such as "bumping" of the pellet. The threads may then be stopped at this distance so that the remainder of the rotating member is not missing threads forming part of the screw pump.

[0022] In various embodiments, the majority of the length of the rotating member (e.g., within the barrel) may be free of threads forming a progressive cavity pump. For example, at least approximately 70%, 80%, 90%, or even 95% of the length of the rotating member (e.g., within the barrel) may be free of threads forming a progressive cavity pump. This means that the threads only act upon and collect pellets directed toward the second dispensing end of the chamber, which is advantageous for pellets directed toward the first end because the threads do not act upon or otherwise interfere with the majority of the pellets.

[0023] Gravity (and / or a plunger arrangement as described below) may be used to move the pellets to the dispensing end of the chamber where they may be collected by the screw thread and fed into a progressive cavity pump.

[0024] The device may further include a device (e.g., a plunger) configured to force the pellets contained in the chamber toward the progressive cavity pump. The device may act in addition to gravity, such that a combination of gravity and the force provided by the device causes the pellets contained in the chamber to move toward the progressive cavity pump. For example, the device may be or include a plunger in the form of a weight, the plunger being configured to rest on the pellets contained in the chamber when the device is in an orientation that allows the pellets to be dispensed.

[0025] The device may include a plunger configured to move along the rotating member automatically or as a result of the rotation of the rotating member. For example, a portion of the rotating member within the chamber may include threads (e.g., plunger threads, which may be different from any threads of the progressive cavity pump), and the plunger may form a nut around the rotating member that is configured to travel along the threads of the rotating member during use, such that when the rotating member rotates, the plunger moves toward the progressive cavity pump, thereby forcing the pellets contained in the chamber toward the progressive cavity pump. The plunger may be configured to abut and / or contact an inner surface of the barrel and / or chamber, and there may be a friction fit between the plunger and the inner surface of the barrel and / or chamber to help prevent the plunger from rotating with the rotating member.

[0026] The threads associated with the plunger can extend along the length of the rotating member until the threads of the progressive cavity pump are formed. In some embodiments, the threads forming the progressive cavity pump can extend along the rotating member and form the threads associated with the plunger.

[0027] In various embodiments, the device can include certain features that, for example, provide a driving force to the plunger toward the pellet located in the chamber in addition to or instead of relying on the weight of the plunger as described above. For example, a ratchet mechanism can be used to ensure that the plunger can only move in a single direction, i.e., toward the 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 barrel) to urge the plunger toward the pellet located in the chamber. Alternatively or additionally, a pneumatic air source can be provided that can pressurize the plunger toward the pellet located in the chamber.

[0028] The apparatus may include a deformable material press mounted between a rotating member and a barrel, wherein a plunger is configured to push the deformable material along a longitudinal axis of the rotating member, and the deformable material is configured to move the pellet (e.g., scrape one or more (or all) inner walls of the barrel forming the chamber) when pushed by the plunger to help move the pellet toward the progressive cavity pump.

[0029] The plunger may include one or more teeth or tines extending axially (relative to the longitudinal axis of the rotating member) from the body of the plunger. The teeth may include a track at a distal end (away from the body) and configured to engage threads on the rotating member such that rotation of the rotating member causes the track to travel along the threads and move the plunger along the axis. The teeth may be configured to flex in a radial direction such that the track can disengage from the threads.

[0030] The plunger may comprise one or more teeth or tines extending axially (relative to the longitudinal axis of the rotating member) from the body of the plunger and biased towards the rotating member to stabilise the plunger as it travels along the axis in use.

[0031] The plunger may comprise a resilient arrangement comprising a plurality of protrusions (eg teeth or tines as described above) and a resilient member configured to bias the protrusions radially inwardly. The resilient member may be a resilient band extending concentrically around the rotating member.

[0032] The plunger can taper from a first thickness adjacent to the rotating member to a second thickness at the periphery (radially) of the plunger, wherein the second thickness is less than the first thickness. The periphery can be adjacent to an inner wall of a barrel forming part of the chamber. The plunger can taper to a sharp edge at the periphery of the plunger. The plunger can be configured to flex resiliently at the periphery. This reduces friction between the plunger and the barrel and also helps move the pellet toward the screw pump.

[0033] The device may further include a valve connected to the outlet of the screw pump and configured to prevent pellets from being dispensed from the screw pump, for example when the screw pump is not rotating or outside of a dispensing operation prior to use, and to allow pellets to be dispensed from the screw pump during a dispensing operation, for example when the screw pump is rotating in use.

[0034] The valve may include a resilient portion, such as a rubber membrane, configured to flex open to allow pellets to be dispensed as the screw pump rotates in use, and then flex back when the screw pump is not rotating, thereby stopping pellets from falling out of the screw pump and helping to seal the cartridge.

[0035] The elastic membrane can be moved between a first position, wherein the membrane blocks the end of the screw pump to prevent the pellet from being dispensed, and a second position, wherein the membrane moves to unlock the end of the screw pump and allow the pellet to be dispensed. In various embodiments, the membrane can be configured to move due to rotation of the pellet via the screw pump and the force applied to the membrane as the screw pump rotates.

[0036] The valve may comprise an umbrella valve.

[0037] The valve may include a frustoconical portion extending from a first end of the valve connected to the outlet of the screw pump to a second end of the valve. The second end of the valve may include an outlet portion including an outlet for dispensing pellets therefrom. The valve may be configured such that, upon rotation of the rotating member, pellets are ejected from the valve through the outlet of the valve. For example, the size of the outlet may be adapted to the size of the pellets to be dispensed, such that the minimum dimension (e.g., width) may be substantially equal to the width or diameter of the pellets, and / or may be less than approximately 1.5, 1.4, 1.3, 1.2, or 1.1 times the width or diameter of the pellets.

[0038] The use of a progressive cavity pump to dispense medicine or medicament in pellet form is inherently advantageous. Accordingly, in one aspect of the present invention (for which the applicant reserves the right to independently claim), there is provided a device for dispensing medicine or medicament in pellet form, the device comprising a progressive cavity pump including threads, wherein, when the progressive cavity pump is rotated in use, the pellets are received into the threads, travel down the threads, and are dispensed from the threads and the device. In this regard, the threads are configured such that a predetermined rotation of the progressive cavity pump causes a predetermined amount of pellets to be dispensed from the device.

[0039] The device may include one or more actuators configured to rotate a rotating member. The actuators may be mechanical or electromechanical. The actuators may be located at a first end of the device. The actuators may be configured to rotate the rotating member. This may cause (in related embodiments) a plunger to move downward along a screw portion of the rotating member and / or cause the screw portion to rotate, thereby dispensing pellets through a screw pump formed between the screw portion and an outlet tube (or, in related embodiments, between the screw portion and the barrel).

[0040] The actuator may be an electromechanical actuator (e.g., one or more electric motors), or include an electromechanical actuation mechanism, such that the device may be capable of repeatedly dispensing a precise amount of pellets. The electric motor and control system may be powered by an integrated battery (which may be replaced by the user) that may be housed within the housing of the actuator.

[0041] The device may include a control system (e.g., as part of the actuator) that can be configured to dispense a dose within a predetermined time (e.g., less than 2, 3, or 5 seconds) after receiving an actuation signal from an input device or mechanism. The actuation signal can be initiated, for example, by a user pressing a suitable button or other input mechanism on the device, or alternatively via a different control, such as a wireless or wired external control.

[0042] The actuator may include one or more electric (e.g., stepper) motors that may be configured to rotate the rotating member any suitable number of revolutions (e.g., steps) depending on the current circumstances, such as the type of medication in the cartridge or the user. A control system may be provided in the form of a microcontroller, such as on a printed circuit board ("PCB"), which may be located within the housing of the device within the actuator.

[0043] In one aspect of the present invention, there is provided a method of using the apparatus as described above, comprising: For example, a rotary member is used to rotate a screw pump a predetermined amount of rotation to dispense a predetermined amount of pellets from the device. The device may be a disposable or relatively inexpensive device designed to make dispensing short-term prescriptions, including but not limited to antibiotics, simpler and more convenient than, for example, existing blister-packed medications and liquid preparations.

[0044] The method may further include filling the chamber with pellets providing the oral dosage form, determining an amount of rotation of the screw pump that will result in a predetermined amount of pellets being dispensed from the device, and rotating the screw pump the predetermined amount such that the predetermined amount of pellets is dispensed from the device (100).

[0045] The device can be a more robust and long-lasting dispenser, wherein a first portion of the device (e.g., actuator 300, 300' and optional rotating members 250, 250', 250A, 250B described below) comprises the relatively complex or expensive portion of the dispensing mechanism, and one or more second portions of the device (e.g., one or more cartridges 200, 200', 200AB described below) comprise the relatively simple or inexpensive portion of the dispensing mechanism and the medication or oral dosage form. The one or more second portions can be replaceable cartridges (or replaceable integrated cartridges, such as cartridge 200AB described below) that can be inserted into the first portion, allowing the first portion to be used with different cartridges and different types of medications, medications, and dosages (e.g., oral dosage forms). In some embodiments, the first portion can include a housing configured to hold one or more cartridges (e.g., see housing 400 described below), and the second portion can include one or more cartridges that can be inserted into the housing.

[0046] The present invention relates to the integration of a cartridge and a dispensing mechanism. Dispensing the pellets using a screw pump, for example in the form of an "Archimedes" screw mechanism, has been found to be advantageous due to its accuracy, simplicity, and ease of use. In some embodiments, the device may include a means for applying pressure to the pellets within the chamber containing the pellets, for example using a plunger 230 as described below. Applying pressure to the pellets in this way to ensure they are well packed can mean that the dosage is consistent throughout the life of the cartridge, ensuring that the first and last doses are of similar volume or weight. Furthermore, such operation can mean that the device can be operated in any orientation.

[0047] In some embodiments, the device also incorporates the use of a plunger mechanism that separates the pellet from the actuation mechanism of the device.

[0048] Further technical effects will become apparent from the description provided below.

[0049] definition Pellet – A single particle of an oral dosage form (e.g., a drug, medicine, medicament, etc.), optionally having a size (e.g., diameter) between about 150 μm and about 1200 μm (or even about 1500 μm), optionally between about 200 μm and about 300 μm, between about 300 μm and about 900 μm, or between about 500 μm and about 700 μm. "Diameter" means that the pellet is assumed to be roughly spherical, although it may be irregularly shaped. If it is not considered spherical, the diameter may correspond to the maximum width of the pellet. The pellet may or may not have a surface coating.

[0050] In various embodiments, the size (e.g., largest dimension, width, or diameter) of the pellets may be within one or more of the following ranges: 150-300 μm; 150-400 μm; 200-400 μm; 200-500 μm; 300-500 μm; 400-600 μm; 300-700 μm; 500-700 μm; 200-800 μm; 600-800 μm; 700-900 μm; 700-1200 μm; 800-1000 μm; 800-1100 μm; 900-1100 μm; 900-1200 μm; and 1000-1200 μm.

[0051] Dose – a single measurement (eg, volume or weight) of a pellet, eg, totaling about 0.05 ml to about 0.8 ml by volume (eg, about 0.1 ml to about 0.6 ml), eg, about 0.3 ml by volume (although such pellets are sometimes measured by weight).

[0052] Dispensing Mechanism – A system, such as an electromechanical system, that converts a user's action into the dispensing of a dose.

[0053] Cartridge - A component, such as a replaceable component for storing and dispensing pellets, optionally containing features of a device, such as a rotating member in the form of a central threaded rod, a movable plunger, and the pellets.

[0054] Plunger – A plate (although other types of plungers are contemplated) that ensures the pellets remain packed together toward the dispensing end of the cartridge. The plate may be substantially rigid, but portions of the plate may be flexible, such as those that interact with other portions of the cartridge.

[0055] Dispensing Orifice – The open end of the cartridge that allows the pellets to be dispensed for consumption.

[0056] Cap – A container or tray covering a delivery hole to collect a dose and protect the stored pellets from moisture.

[0057] Press – The action a user performs on a device when they wish to dispense their prescribed dose, which can be either a rotary or linear motion.

[0058] It will be understood that references herein to "a" drug or medication may be considered to be "one or more" drugs or medications. For example, a pellet may contain several drugs or medications in pellet form. This may be achieved by mixing pellets that each contain a different drug or medication and / or mixing drugs or medications within each pellet. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Various embodiments will now be described, by way of example only, and with reference to the accompanying drawings, in which: Figure 1-3 A first embodiment of a dispensing device according to various aspects of the present invention is shown; Figure 4-6 A second embodiment of a dispensing device according to various aspects of the present invention is shown; Figure 7 and 8A -8B shows Figure 1-3 An embodiment of the device shown includes a gravity-driven plunger; Figure 9 and 10A -10C shows Figure 1-3 The embodiment of the device shown includes a screw-driven plunger; Figure 11 、 12 and 13A-13B show Figure 9-1 0 embodiment, which includes an actuator or drive mechanism; Figure 14 and 15 An embodiment comprising two cartridges within a housing is shown; Figure 16 and 17A -17B shows Figure 9-1 0 embodiment, which includes a valve; Figure 18 and 19A -19G shows Figure 9-10 embodiment, which includes various embodiments of the valve; Figure 20-22B Shown Figure 9-1 0 embodiment, which includes a cover; Figure 23-25 An embodiment of a cartridge including two dispensing mechanisms is shown; Figure 26-28B Shown Figure 9-1 0 embodiment, which includes a tapered portion at the dispensing end of the device; and Figure 29 and 30A -30B shows Figure 9-1 0 embodiment, which has an improved screw portion; Figure 31 and 32A -32B shows Figure 9-1 0 embodiment, which has an improved outlet pipe; Figure 33A and 33B Shown Figure 9-1 0 embodiment, wherein the movable member is located above the outlet tube of the cartridge; Figure 34A -C shows Figure 9-1 0 embodiment, wherein various embodiments of the disc valve are located at the outlet of the outlet tube of the cartridge; Figure 35A and 35B Shown Figure 9-1 0 embodiment having a slightly modified thread which places the pellets in communication with an internal passage of the rotating member which leads to an outlet at the bottom of the rotating member; Figure 36 Various sizes of threads are shown for use in any of the aspects and embodiments described herein; Figure 37A -C shows Figure 7 An embodiment of the device shown in , wherein the plunger is accompanied by a deformable material; Figure 38A -C shows an embodiment in which Figure 9 The plunger of the device shown is provided with a plurality of axially extending teeth or projections; Figure 39A -C shows an embodiment, in which Figure 9 The plunger of the device shown includes resilient means; and Figure 40A -C shows something like Figure 9 but with an improved plunger. DETAILED DESCRIPTION

[0060] Figure 1A perspective view of a device 100, according to various aspects and embodiments of the present invention, is shown. It is a delivery device capable of dispensing medication or drugs (e.g., oral dosage forms) in pellet form. Device 100 is intended to make dispensing repeat prescriptions simpler and more convenient than, for example, existing blister-packed medications, and to enable a straightforward way to change the administered dose if desired for a particular treatment (e.g., for medications that would benefit from instillation or flexible adjustments). Device 100 is also designed to deliver reliable doses of medication in pellet form. In various embodiments, the device can deliver doses that meet regulatory standards, such as within + / - 10% of the desired dose, or even within + / - 5% of the desired dose.

[0061] Figure 1 The device 100 is shown in a partially assembled state, including a first end 102 for connection to an actuator or other drive mechanism (described later) configured to convert a user's action into the delivery of a dose of a drug.

[0062] The device 100 comprises a second end 104 opposite the first end 102 and comprising the dispensing end of the device 100. In use, the drug will be dispensed from the second end 104 in the form of pellets as a result of the action of a user operating the actuation mechanism.

[0063] The central portion 106 of the device 100 may form the body of the device 100 and include a cartridge 200. The cartridge 200 is attached at the first end 102 of the device 100 to an actuator or drive mechanism (described later).

[0064] The device 100 includes a rotating member 250 extending through the barrel 200. As described in more detail below, at the first end 102 of the device 100, the rotating member 250 is connected to a drive device that rotates the rotating member 250 to dispense pellets from the second end 104 of the device 100.

[0065] exist Figure 1 In the embodiment of the present invention, there is an outlet tube 212 at the second end 104 of the device 100, through which the drug (medication, etc.) is dispensed in pellet form as described herein.

[0066] Figure 2 Shown Figure 1 A cross-sectional view of the device 100 is shown, which shows in more detail the interior of the cartridge 200 and some features of the rotating member 250. The cartridge 200 is hollow and includes a chamber 220 for containing the medication in the form of pellets, and the rotating member 250 extends through the chamber from the first end 102 of the device 100 to the second end 104 of the device 100.

[0067] The chamber 220 and / or the cartridge 200 can be substantially hermetically sealed (e.g., except for the passageway through which the pellets are dispensed). For example, at the first end 102, the connection between the rotating member 250 and the cartridge 200 can include a seal, such as an elastomeric gasket or a valve (not shown). Similarly, at the second dispensing end of the device 100, a suitable seal (not shown) can be provided between the rotating member 250 and the outlet tube 212. For example, a packaging seal can be provided that covers and seals an outlet of the device (e.g., the outlet tube 212), which can be removed (e.g., peeled off) by the user when they wish to begin use. Additionally or alternatively, a valve can be used to at least partially seal the second dispensing end of the device 100 (examples will be discussed later with respect to Figures 16 to 19B and Figure 31-32B These features can help prevent air and / or moisture from entering chamber 220 and interacting undesirably with the pellets.

[0068] The rotating member 250 extends into the outlet tube 212 at the second end 104 of the device 100 and includes a screw portion 240. The outlet tube 212 and the screw portion 240 together form a screw pump that is configured to dispense pellets from the second end 104 of the device 100. That is, the pellets will enter the threads of the screw portion 240 and, as the rotating member 250 rotates, will be forced out of the outlet tube 212 and dispensed from the device 100.

[0069] Figure 3 Shown Figure 1 and Figure 2 FIG2 is an exploded view of the device 100 in a partially assembled state. In this embodiment, the rotational member 250 and the cartridge 200 share a common longitudinal axis, which also serves as the axis of rotation for the rotational member 250. However, in various embodiments, the longitudinal axis of the cartridge 200 may be offset from the longitudinal axis of the rotational member 250 and / or the axis of rotation for the rotational member 250.

[0070] Figures 1 to 3 The cartridge 200 is shown as having an oblong shape, although this is not required and the cartridge 200 may have any suitable shape.

[0071] Figure 4 and 5 Shows something like Figure 1-3 An alternative device 100' is shown which is an alternative device 100 of the type shown in FIG. 1 but comprises a cylindrical cartridge 200'. The device 100' comprises a first end 102' for connection to a drive device (not shown) and a second end 104' comprising the dispensing end of the device 100'.

[0072] Additionally, the device 100' does not include an outlet tube 212 (similar to Figures 1 to 3Instead, the barrel 200′ is open at the second end 104′ of the device 100′, and the rotating member 250′ includes a screw portion 240′ at the second end 104′ having an outer diameter that substantially matches the inner diameter of the barrel 200′. That is, the surfaces of the screw portion 240′ and the barrel 200′ may substantially contact or abut each other (e.g., continuously or intermittently), but not to the extent that they have an interference fit or friction fit relative to each other, thereby ensuring that they can move smoothly relative to each other and ensure reliable dispensing.

[0073] The barrel 200′, together with the screw portion 240′ at the second end 104′, forms a screw pump configured to dispense pellets from the second end 104′ of the device 100′. That is, the pellets will enter the threads of the screw portion 240′ and, upon rotation of the rotating member 250′, will be forced out of the second end 104′ and dispensed from the device 100′.

[0074] Figure 6 Shown Figure 4 and 5 FIG2 is an exploded view of the device 100′ in a partially assembled state. In this embodiment, the rotational member 250′ and the cartridge 200′ share a common longitudinal axis, which also serves as the rotational axis of the rotational member 250′. However, in various embodiments, the longitudinal axis of the cartridge 200′ may be offset from the longitudinal axis of the rotational member 250′ and / or the rotational axis of the rotational member 250′.

[0075] It should be understood that Figure 1-3 The principles described for cartridge 200 also apply to Figure 4-6 The barrel 200' can be used as described above, as long as they are compatible with each other. The main difference between the embodiments is that the screw pump of the second embodiment does not use the outlet pipe 212 of the previous embodiment, but instead uses a larger diameter screw portion 240', which mates with the inner radial surface 124' of the barrel 200' at its second end 104'. In this embodiment, the inner diameter of the barrel 200' can remain substantially unchanged along its length.

[0076] The screw portion 240' of the rotary member 250' of this embodiment has a radially extending upper surface 246' ( Figure 5) and a radially extending lower surface 247' from which the pellets are dispensed. A chamber 220', which holds a quantity of pellets, is at least partially enclosed by an upper surface 246' of the screw portion 240', such that, in use, the pellets held within the chamber 220' rest on the upper surface 246'. The screw portion 240' includes threads 242' extending around the periphery of the screw portion 240', forming a helical path from the upper surface 246' to the lower surface 247'. Thus, in use (as the rotating member 250' rotates), the pellets enter the upper surface 246' from the chamber 220', travel downward along the threads 242', and exit the device 100' as they exit the threads 242' at the lower surface 247'.

[0077] Return Reference Figures 1 to 3 embodiment (although the principles also apply to Figures 4 to 6 ), Figure 7 The barrel 200 is shown containing a plunger 230 therein.

[0078] As described above, each cartridge 200 holds a pellet within its chamber 220. In embodiments involving a plunger 230, the volume of the chamber 220 varies during operation of the device 100 and throughout its life by the action of the plunger 230, as will be described in greater detail below.

[0079] At one end, the chamber 220 is at least partially enclosed by the plunger 230, and more specifically, by a radially extending surface 232 of the plunger 230 that faces the chamber 220. The other end of the chamber 220 is at least partially enclosed by the planar surface 210 of the barrel 200. A rotating member 250 extends through the chamber 220 along the longitudinal axis A of the barrel 200.

[0080] Figure 8A A cross-sectional view of the cartridge 200 is shown including the plunger 230. As the rotating member 250 rotates in use, the plunger 230 rests on top of the pellets (not shown) located within the chamber 220, thereby loading the chamber 220 with the pellets by their weight as the rotating member 250 rotates and the pellets are dispensed from the device 100.

[0081] The device 100 may include certain features that provide a driving force to the plunger 230, e.g., independent of the weight of the plunger 230 as described above, that acts in a direction toward the pellet located within the chamber 220. For example, a ratchet mechanism may be used to ensure that the plunger 230 can only move in a single direction, i.e., toward the pellet located within the chamber 220. A resilient member (e.g., a spring) may be provided to urge the plunger 230 toward the pellet located within the chamber 220. A pneumatic air source may be provided that can pressurize the plunger 230 toward the pellet located within the chamber 220.

[0082] Figure 8B The plunger 230 within the cartridge 200 is shown in greater detail, and also the pellet is shown positioned within the chamber 220. As can be seen, the radially extending surface 232 of the plunger 230 presses against the pellet and pushes it toward the second dispensing end 104 of the device 100 to tightly pack the pellet within the chamber 220.

[0083] The radially extending surface 232 of the plunger 230 can be shaped to enhance capture of the pellets within the chamber 220 so that they can be dispensed therefrom. For example, the surface 232 can be the bottom or lower surface of the plunger and can precisely mate with the opposing surface 210 of the barrel 200. In embodiments where the opposing surface 210 is angled, the surface 232 of the plunger 230 can be angled in a similar and mating manner.

[0084] Additionally or alternatively, a plate (e.g., a baffle) may be coupled to the plunger 230 that is configured to sweep or move the pellets inwardly toward the central axis A of the rotating member 250 for ultimate pickup by the screw portion 240 and dispensing from the barrel 200. The plate may extend downwardly from the body of the plunger and be configured to rotate with the plunger 230 and / or the rotating member 250. This feature would be particularly useful in embodiments involving a cylindrical barrel 200, where the plate may sweep around the interior surface of the barrel 200.

[0085] Figure 9 Shown Figure 1-3 Similarly, the principle can be equally applied to Figure 4-6 In this embodiment, the plunger 230 is operably connected to the rotating member 250 such that rotation of the rotating member 250 directly causes the plunger 230 to move axially along the rotating member 250 (i.e., along the longitudinal axis A of the rotating member 250 and the cartridge 200). In other words, the plunger 230 can be considered a nut that translates along the rotating member 250 from the first end 102 of the cartridge 200 (i.e., the end to be inserted into the actuator, as described below) toward the second dispensing end 104 of the cartridge 200 as the rotating member 250 rotates.

[0086] In this way, and with Figure 7-8B As with the embodiment of the present invention, as the plunger 230 translates along the rotating member 250, the volume of the chamber 220 gradually decreases. In addition, throughout the operation and life of the device 100, the pellets contained in the chamber 220 will be pushed toward the second end 104 of the barrel 200 by the plunger 230. This is from Figure 10A As shown in the side cross-sectional view.

[0087] To achieve direct movement of the plunger 230, the rotating member 250 includes threads 252 that are configured to mate with corresponding threads 233 on the plunger 230 (see FIG. Figure 10B) to move it along the longitudinal axis A, as described above. At the second dispensing end 104 of the cartridge 200 , the rotating member 250 comprises a screw portion 240 axially separated from a thread 252 cooperating with the plunger 230 .

[0088] In various embodiments, the plunger 230 (or at least its threads 233) can be made of a thermoplastic elastomer ("TPE") or polybutylene terephthalate ("PBT") and / or can have a hardness of less than about 50 shores. In such embodiments, when the plunger 230 encounters sufficient resistance (e.g., a pellet or the end of the cartridge 200) as it moves along the axis A, the threads 233 can disengage from the threads 252. This allows the rotating member 250 to rotate once the plunger 230 contacts the pellet and limits the force applied to the pellet by the plunger 230. For example, once the pellet decreases in volume during dispensing, the resistance will decrease, and the threads 233 will at some point reengage with the threads 252 to continue moving the plunger 230 along the axis A.

[0089] In various embodiments, threads 233 can be removed, and a tight friction fit can be used to move the plunger along threads 252 as rotating member 250 rotates. For example, plunger 230 can have two friction surfaces: a first friction surface on its outer circumference facing the inner surface of barrel 200, and a second friction surface on its inner circumference facing rotating member 250. The friction between the first friction surfaces prevents plunger 230 from rotating but allows it to move axially (i.e., along axis A). The hole in the center of plunger 230 (through which rotating member 250 extends) can be made slightly smaller than the outer diameter of threads 252. This means that even if rotating member 250 itself does not include mating threads, plunger 230 will move axially along threads 252 as rotating member 250 rotates. The plunger can be made of rubber to facilitate this embodiment. The second friction surface can be configured so that when the pellet is fully compressed, that is, when plunger 230 has pressed the pellet down as far as possible, plunger 230 will slide.

[0090] Figure 10C Shown in greater detail is the second dispensing end 104 of the cartridge 200, at which is located the outlet tube 212 through which, as described above, the screw portion 240 of the rotating member 250 extends.

[0091] The radially outer surface 241 of the screw portion 240 can substantially contact (and / or abut) the radially inner surface 214 of the outlet tube 212. That is, the outer surface 241 of the screw portion 240 and the radially inner surface 214 of the outlet tube 212 can substantially contact or abut each other (e.g., continuously or intermittently), but not to the extent that they have an interference fit or friction fit relative to each other, thereby ensuring that they can move smoothly relative to each other and ensure reliable dispensing. It is contemplated that any tolerances between the outer surface 241 of the screw portion 240 and the inner surface 214 of the outlet tube 212 are as close as possible while still allowing the screw portion 240 to rotate within the outlet tube 212.

[0092] For example, due to manufacturing tolerances, a small tolerance or gap may exist between the outer surface 241 of the screw portion 240 and the inner surface 214 of the outlet tube 212. If the surfaces are configured to contact each other (e.g., continuously or intermittently), the surfaces can be made of a frictionless material (e.g., by applying a non-stick coating or additive, such as Teflon, to one or both opposing surfaces), which can result in a tight (e.g., contact fit) without friction or interference fit. In various embodiments (e.g., those including a barrel containing pellets), a tolerance or gap may exist between the outer surface 241 of the screw portion 240 and the inner surface 214 of the outlet tube 212, and the gap may be large enough to allow free rotation of the shaft 250, but small enough to prevent any pellets (and / or pellet debris) from sliding between the gaps, increasing friction, and inhibiting free rotation.

[0093] The screw portion 240 includes a thread 242 configured to receive the pellets contained within the chamber 220 and, when the rotating member 250 rotates, transport them along the thread 242 for dispensing from the outlet tube 212. The thread 242 is composed of one or more thread starts, each of which forms a continuous spiral, and during operation of the device 100, the pellets are formed into the continuous spiral, for example, due to the action of the plunger 230 pressing on the pellets within the chamber 220, forcing them into the thread 242.

[0094] The screw portion 240 and its threads 242 are in contact with the inner radial surface of the outlet tube 212, thereby forming a screw pump (e.g., an "Archimedes" screw) with the outlet tube 212 of the barrel 200. That is, as the rotating member 250 rotates, the threaded portion 240 and its threads 242 will also rotate, causing the pellets contained in the chamber 220 to enter the gaps in the threads 242, travel under the threads 242, and exit the barrel 200.

[0095] Figure 11The device 100 is shown, which includes an actuator or drive mechanism 300 configured to rotate the rotating member 250. The actuator 300 is connected to the rotating member 250 at the first end 102 of the device 100. The actuator 300 is 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 300 can be mechanical (i.e., manually operated) or electrically operated (i.e., operated by an electric motor, for example). The actuator 300 can be removed from the cartridge 200 so that different cartridges can be connected to the same actuator.

[0096] To manually operate the first device 100, a user can rotate the actuator 300 (or a portion thereof), thereby rotating the rotational member 250, for example, via a suitable gear arrangement, such that after a partial rotation of the actuator 300, the rotational member 250 makes multiple (full) rotations to move the screw portion 240 to dispense the pellets. In some embodiments, the actuator 300 can be configured so that the user presses a button (or the like), which causes a corresponding rotation of the rotational member 250. The device 100 can be configured so that a partial rotation (e.g., half a rotation) of the actuator 300 causes multiple (e.g., at least two or three) rotations of the rotational member 250 and the screw portion 240, thereby ensuring efficient delivery of the pellets contained in the chamber 220.

[0097] The cartridge 200 can be tamper-resistant, for example, such that a user may not be able to access the chamber 220 without substantially destroying components of the device 100 or damaging the pellets. For example, a chemical can be contained within a pouch or other container within the chamber 220, the chemical being configured to be released if the cartridge 200 is ruptured or portions of the device 100 are separated from one another. Such a chemical can be a bitter and / or other foul-smelling chemical, in which case it would be spilled onto the pellets, rendering them inedible.

[0098] In further alternative embodiments, the actuator 300 may be configured to prevent unintended use, for example, the actuator 300 may include a mechanical or digital lock that prevents the rotating member 250 from rotating (and operating the device 100), for example, if a user attempts to remove the actuator 300 or modify it so that it can dispense more pellets than the prescribed dose.

[0099] Figure 12 、 13A13B show the actuator 300 in more detail. The rotating member 250 includes a male connecting member 280 that interfaces with the female connecting portion 303 of the actuator 300. This allows the rotating member 250 to be connected to the actuator 300 and its drive mechanism, allowing rotational force to be transmitted from the drive mechanism of the actuator 300 to the rotating member 250. The connection between the rotating member 250 and the actuator 300 can be made in any suitable manner, including, for example, a key arrangement (e.g., a hex key), a Torx key, or other standard screwdriver interface, as well as by a friction fit, an interference fit, another other type of friction arrangement (e.g., a friction clutch), or an adhesive.

[0100] It should be understood that to dispense pellets from either cartridge 200, the actuator 300 can rotate the rotating member 250. This causes (in the relevant embodiment) the plunger 230 to move downward along the threads 252 of the rotating member 250 and / or the screw portion 240 to rotate, thereby dispensing the pellets through the screw pump formed between the screw portion 240 and the outlet tube 212 (or the screw portion 240' and the cartridge 200').

[0101] By using an electromechanical actuation mechanism, the device 100 may be able to repeatedly dispense precise amounts of pellets. The motor and control system may be powered by an integrated battery (which may be replaced by the user) that may be housed within the housing of the actuator 300.

[0102] The device 100 may include a control system (e.g., as part of the actuator 300) that can be configured to dispense a dose within a predetermined time (e.g., less than 2, 3, or 5 seconds) after receiving an activation signal from an input device. The activation signal can be initiated, for example, by a user pressing a suitable button or other input mechanism located on the device 100.

[0103] The actuator 300 may include one or more motors. The actuator 300 (e.g., its motor) may be configured to rotate the rotating member 250 by an amount corresponding to the prescribed dose or a portion of the dose. For example, the actuator may be configured to pulse the rotating member 250, for example, by operating for a certain period of time (e.g., 0.5 seconds). A dose may consist of multiple pulses, so different doses can be dispensed based on the number of pulses of the motor. For example, a 0.3 ml dose may correspond to approximately 3 seconds of motor rotation. Therefore, the actuator may pulse the motor six times, i.e., six pulses of 0.5 seconds each.

[0104] The motor may be a stepper motor that can be configured to rotate the rotating member 250 by any suitable number of steps depending on the current situation, such as the type of drug in the cartridge 200 or the user. The control system may be provided in the form of a microcontroller, for example on a PCB, which may be located within the housing of the device 100 within the actuator 300.

[0105] To the extent applicable, the following general features may apply to any aspect or embodiment of the invention described herein. For simplicity, the reference numerals used are Figure 9 and 10A -10C, but this should not be interpreted as meaning that these features apply only to this device.

[0106] The device 100 may include an output device, such as a speaker, configured to provide audio feedback when a dose is selected and dispensed. For example, once a dose has been dispensed, the output device may provide a suitable output.

[0107] The device can be handheld. For example, the device 100 (e.g., the entire device 100 or cartridge 200) can have a length (corresponding to its longest dimension) of no more than approximately 250 mm (e.g., less than approximately 200 mm, approximately 150 mm, or approximately 100 mm), and a width or height (i.e., transverse to its length) of no more than approximately 50 mm, and optionally no more than approximately 40 mm (and in some embodiments, less than 30 mm or even less than 20 mm). To optimize its handheld nature, the device can have a length between approximately 180 mm and approximately 220 mm, a width (transverse to its length) between approximately 35 mm and approximately 45 mm, and a height (transverse to its width) between approximately 22 mm and approximately 32 mm. The device 100 (or cartridge 200) can weigh no more than approximately 300 g (e.g., approximately 200 g), and optionally less than approximately 100 g. This ensures that the device is lightweight enough to be carried in one hand.

[0108] The barrel 200 can be made of a rigid material, such as polycarbonate or polyamide, although any suitable material can be used. Portions of the barrel 200, such as those in contact with the rotating member 250 and / or the plunger 230, can have a reduced friction surface (e.g., reduced relative to other portions of the barrel) to facilitate relative movement therebetween. The inner diameter of the barrel 200 (i.e., forming the chamber 220) can be between about 5 mm and about 200 mm, optionally between about 10 mm and about 20 mm. The barrel 200 can have a length (corresponding to its maximum dimension) between about 90 mm and about 120 mm, a width (transverse to its length) between about 33 mm and about 43 mm, and a height (transverse to its width) between about 15 mm and about 25 mm.

[0109] The inner diameter of the outlet tube 212 can be substantially equal to the diameter of the rotating member 250, particularly the screw portion 240 thereof. The inner diameter can be less than 10 mm, for example, less than about 6 mm. The length of the outlet tube 212 along the longitudinal axis of the device 100 can be less than about 20 mm (e.g., about 15 mm or about 10 mm).

[0110] The volume of the chamber 220 (ie, before operation or maximum volume) can be less than about 50 mL, such as less than 20 mL or about 11 mL.

[0111] The plunger 230 can be made of a low-friction, rigid material such as nylon, although other suitable materials can be used. Resilient materials (e.g., rubber and thermoplastic elastomers) can also be used for the plunger, and are of particular interest for the concept of a thread-driven plunger. A friction fit around the threads 252 (e.g., the aforementioned second friction surface) or a matching thread on the surface 233 that contacts the threads 252 will provide sufficient traction to move the plunger axially along the barrel, thereby compacting the pellet. The surface of the plunger 230 opposite the threads 252 can deform, allowing the shaft to continue rotating while holding the plunger in place.

[0112] The plunger 230 can be configured to fill the gap between the rotating member 250 and the wall of the container 200 so that the pellets contained in the chamber 220 cannot move past the plunger 230 as they move down the rotating member 250 during use. In embodiments where the container 200 is cylindrical, the plunger 230 will also be cylindrical, and it should be ensured that the friction between the plunger 230 and the wall of the container 200 is sufficiently high to prevent the plunger 230 from rotating with the rotating member 250 during use. Alternatively, the plunger 230 can include a notch that cooperates with a guide (e.g., one or more rails parallel to the longitudinal axis of the barrel 200) located on the inner surface of the barrel 200, such that in use, the notch travels along the guide as the plunger 230 moves, wherein the cooperation of the notch and the guide restricts rotation of the plunger during such movement.

[0113] In various embodiments, the size (and, for example, circumference) of the plunger 230 can be such that there is a small gap between the plunger 230 and the wall of the barrel 200 to avoid substantial friction between the plunger 230 and the barrel 200. This may mean that pellets may pass between the plunger 230 and the wall of the barrel 200 through the gap. To avoid this, the size (e.g., width) of the gap can be configured to be smaller 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 the plunger 230 can be provided near the plunger 230, the material being configured to contact the wall of the barrel 200 when the plunger 230 moves in use (e.g., deformable material 234, as described below with respect to Figure 37A -C).

[0114] The cartridge 200 may include a tapered portion at the second end 104 of the device (examples are described below). Figure 26-28B), the tapered portion can be configured to guide or direct the pellets contained within the chamber 220 to the threads 242 of the screw portion 240. In other words, the surface 210 can be angled such that it is not perpendicular to the longitudinal axis A, but rather oriented at an angle relative to the longitudinal axis A, such as approximately 30°, 60°, or greater. In such an embodiment, the lower surface 232 of the plunger 230 can have a matching geometry so that when the plunger 230 reaches the end of its travel along the rotating member 250, the lower surface 232 of the plunger 230 contacts the tapered surface over its entire area. This will help dispense as many pellets as possible, which minimizes waste. Because threads 252 eventually give way to threads 242, it may be necessary to provide threads on plunger 230 that are spaced apart from lower surface 232 thereof so that the portion of plunger 230 including lower surface 232 extends below the threads of plunger 230 (if present, but as described herein, plunger threads are not required), which allows surface 232 to contact, abut, or at least be closer to the opposing surface 210 of the barrel when plunger 230 is at its lowest point (i.e., at the end of threads 252). An example of such a tapered portion will be described later with reference to Figure 26-28B Provide a description.

[0115] The outer surface 241 of the threaded portion 240 can be made of a low-friction material, such as nylon, polyethylene ("PE"), polyethylene terephthalate ("PET"), optionally containing a friction-reducing additive. The barrel 200 and portions thereof that abut, oppose, or contact the screw portion 240, the plunger 230, or other moving parts of the device 100 can also be made of a low-friction material, such as nylon, polyethylene ("PE"), polyethylene terephthalate ("PET"), optionally containing a friction-reducing additive.

[0116] The screw portion 240 can be configured such that the height of the flights 242 is such that the flights extend at least one full revolution above the outlet tube 212 (toward the chamber 220). In various embodiments, the distance that the flights 242 extend into the chamber 220 is approximately 1 or 2 times the inner diameter of the barrel 200 or the diameter of the rotating member 250, for example, approximately 1, 1.5, or 2 times the inner diameter of the barrel 200 or the diameter of the rotating member 250 (this applies to all aspects and embodiments disclosed herein). This has been found to prevent certain undesirable effects, such as pellet "bulging" within the chamber 220. The length of the screw portion 240 can be defined by the length of the flights 242, which can be between approximately 10 mm and approximately 30 mm, for example, between approximately 10 mm and 20 mm.

[0117] The outlet tube 212 can have a length between about 5 mm and about 20 mm (optionally between about 10 mm and about 15 mm), wherein the length of the thread 242 in a direction along the longitudinal axis A of the barrel 200 can be at least the length of the outlet tube 212 in the same direction, for example, between about 1 times and about 10 times the length of the outlet tube 212, or between about 1 times and about 5 times the length of the outlet tube 212, for example, about 1.2, 1.3, 1.4, 1.5 or 2 times the length of the outlet tube 212 (this applies to all aspects and embodiments that include the outlet tube 212).

[0118] The pitch of the threads 242 can be between about 1 mm and about 20 mm, and optionally between about 4 mm and about 8 mm. It has been found that the pitch affects the accuracy of the dispensed dose, particularly with respect to pellet passage (the pellets pass through the screw portion even when the rotating member is not rotating). In some cases, this can cause the device to "leak" pellets. A high pitch appears to increase the risk of pellets passing through the screw portion outside of the dispensing operation. Thus, a low pitch (e.g., less than about 15-30 times the pellet diameter, as described below) has been found to increase the accuracy of the dispensed pellet dose, for example, because the pellet output rate is more easily controlled. A low pitch does increase the load and torque required to drive the rotating member, and this is a trade-off that leads to this pitch range being considered important.

[0119] Figure 36 The profile of the threads 242 and the various dimensions that can be associated therewith are schematically shown. "D" represents the outer diameter of the screw, "CD" represents the depth of the feed channel, "CW" represents the width of the feed channel, and "P" represents the pitch of the screw 242, which can be defined as the distance between adjacent threads. Figure 36 The features of can be applied to any aspects and embodiments described herein that include threads 242. Additionally, the dimension values given can represent the dimensions of the entire length of the threads 242 and / or the screw portion 240.

[0120] The following table provides some example thread sizes (in mm) for reference Figure 36and the sizes shown therein and described above. In the examples of this table, the pellet diameter is about 200-300 μm, although the same dimensions can be used for pellets having larger diameters, such as up to about 900 μm. Typical dimensions (e.g., width or diameter) of the pellets can be between about 150 μm and about 1200 μm (or even 1500 μm), optionally between about 200 μm and about 300 μm, between about 300 μm and about 500 μm, between about 300 μm and about 700 μm, between about 500 μm and about 700 μm, between about 700 μm and about 900 μm, or between about 800 μm and about 1100 μm. Values may be provided in multiples of the pellet diameter and should be considered general and not limited to any particular size (or size range) of the pellets; screw Number of screw heads Diameter [D] Screw channel depth [CD] Screw channel width [CW] Pitch [P] A 1 6 1 2 3 B 1 7 2.4 3 4 C 1 7 1.6 4 5 D 2 6-14 1.5-5.5 2 6

[0121] The number of screw heads has been found to have an effect on the dispensing speed of the pellets, with a higher number of screw heads naturally resulting in a higher output per revolution. To date, it has been shown to be beneficial to have a relatively low output ratio to maximize the accuracy of the dispensed pellets, and the use of one or two screw heads is considered advantageous over, for example, three or more.

[0122] Observe the relationship between the groove depth / width and the pellet size, it can be selected so that there is space for a plurality of pellets between the screw and the thread surface. It may be important to allow the pellets to flow freely without negative interference with each other, for example, causing clogging or obstruction during the distribution operation. Therefore, in some embodiments, the size is selected so that there is enough space for at least 2-3 pellets to pass each other in the groove. It may be important to make the dosing sequence without clogging or obstruction in the flow to achieve high precision and repeatability between doses. Therefore, in various embodiments, the groove depth and / or width can be at least 2, 3 or 4 times the pellet diameter.

[0123] For example, for a pellet diameter of about 200-300 μm, the groove depth and / or groove width may be between about 1-2 mm. For a pellet diameter between 700 μm and about 900 μm, the groove depth and / or groove width may be between about 1.4 mm and about 3.6 mm, and for a pellet diameter between about 800 μm and about 1100 μm, the groove depth and / or groove width may be between about 1.6 mm and about 4.4 mm.

[0124] As mentioned above, the screw pitch has been found to have a significant impact on the accuracy of the device. A high screw pitch appears to increase the risk of a pellet passing through the screw when the device is idle, although there is a trade-off, as reducing the screw pitch increases the torque required to rotate the rotating member. In various embodiments, the screw pitch can be limited to less than approximately 15-30 times the pellet diameter, and in some cases, less than 10 times the pellet diameter. For example, for a pellet diameter of approximately 200-300 μm, the screw pitch can be approximately 6 mm, and sometimes less than approximately 3, 4, or 5 mm.

[0125] "Flight width" is the thickness of the screw threads and is the result of the selection of pitch and channel width. More specifically, flight width is equal to the pitch minus the channel width. It has been found that flight width is an important factor in preventing screw jams. With smaller flight widths, the contact area between the outer surface of the screw and the surface of the flight is reduced, which reduces the risk of dust from small pellets and / or crushed pellets becoming lodged and causing the screw to stick.

[0126] 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 pellets having a diameter between about 200-300 μm, the flight width can be less than about 1, 2, or 3 mm. For pellets not exceeding about 900 μm, or between about 700 μm and about 900 μm, or between about 800 μm and about 1100 μm, the flight width can be limited to less than about 1, 2, or 3 mm, for example, about 1 mm.

[0127] It has been found that a low flight width (i.e., less than about 1 mm) is advantageous for pellets up to about 900 μm because it provides a more consistent dose. For smaller pellets (i.e., approximately 200-300 μm), it has been found that dust may be generated as they pass through the screw portion 240, which may become lodged between the exterior of the screw portion 240 and the outlet tube 212. It has been found that limiting the flight width to less than about 1, 2, or 3 mm, and particularly about 1 mm, minimizes this effect for these smaller pellets, in addition to providing a more consistent dose for larger pellets as described above.

[0128] In various embodiments, the rotating member 250 (e.g., at the screw portion 240) will have an outer diameter of 6 mm, and two screw heads, each having a height or screw channel width of approximately 2 mm, a screw channel depth of approximately 1 mm, and a pitch of approximately 6 mm. In these embodiments, the pellet diameter can be between 200-900 μm, for example, approximately 200-300 μm.

[0129] Each of these parameters affects the mass output rate and required drive torque. Screw pitch is a set value that does not change with increasing screw diameter; however, the effective angle of the threads relative to the pellet does change. If the pitch remains the same and the diameter increases, the pill threads strike the pellet at a reduced angle. This can affect dispensing speed and required torque.

[0130] The screw parameters can be adjusted or configured based on the size of the pellets to be dispensed. The flights 242 can be at least 1-3 times the diameter of the largest pellet.

[0131] The depth of the threads 242 can be between about 1 mm and about 3 mm. Alternatively, the depth of the threads 242 can be adapted to the diameter of the pellet, such that the depth of the threads 242 is at least the diameter of the pellet. Similarly, the height of the threads 242 can be in the range of about 1 mm to about 10 mm, for example, about 1 mm to about 4 mm. The threads 242 can include at least two screw heads.

[0132] The screw portion 240 of the rotating member 250 may include a diameter that allows at least 1, 2, 3, or more screw heads to be incorporated into the threads 242. The pitch of each thread 242 may increase accordingly.

[0133] Rotating member 250 may comprise a highly rigid and / or stiff material, such as polycarbonate or polyamide. The diameter of rotating member 250 may vary from about 3 mm to about 10 mm, for example, 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 screw portion 240 along its entire length (along longitudinal axis A).

[0134] The threads 252 that cooperate with the plunger 230 can extend along at least about 80%, about 90%, or more, of the length of the rotating member 250 within the barrel 200. The pitch of the threads 252 can be selected so that the plunger 230 continuously applies pressure to the pellets stored therein.

[0135] The actuator 300 , if provided with an electromechanical motor, may be configured to rotate the rotating member 250 at a rate between about 0 rpm and about 1000 rpm, optionally between about 50 rpm and about 500 rpm, optionally between about 90 rpm and about 150 rpm.

[0136] The device 100 may include a cover (described below) Figure 20-22B), the cap fits over one end of the cartridge 200 at the second end 104 of the device 100. The cap may include an interference fit with the outer surface of the cartridge 200. Means may be provided to prevent the pills from accidentally falling out of the outlet tube 212 (or cartridge 200). The cap may include a marking configured to align with a cooperating groove located on the cartridge 200, such that the marking 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 once the desired or predetermined dose has been dispensed.

[0137] In various embodiments, the actuator 300 can be configured to rotate the rotating member 250 in the reverse direction after a dose is completed. This can be useful in drawing the pellet back into the chamber 220, which can reduce pellet loss (which may be due in part to the passage of the pellet). This change in direction of rotation is useful for resetting the stopper (e.g., see the apparatus described below). Figure 18-19B It may also be useful to move the rotary member 250 (e.g., a stopper) into or out of contact with the outlet tube 212 to seal the cartridge 200. As described elsewhere herein, this can be used to provide an airtight seal and also prevent pellet loss. In various embodiments, the change in rotation can also be used to destroy the drive mechanism at the end of the life of the cartridge 200 to prevent, for example, refilling and reuse of the cartridge 200 by a user or a third party. Various embodiments can include a latch that permanently locks the rotation of the rotating member 250 if its direction of rotation is opposite to the direction required to drive the pellets.

[0138] Some more specific embodiments of the invention will now be described, but features may be combined with any of the embodiments described above insofar as they are compatible therewith.

[0139] Figure 14 and 15 An embodiment is shown that includes two cartridges 200 placed side by side within a housing 400. The two cartridges 200 are adjacent and can be operated by a common actuator 300'. The actuator 300' can include a dual connection portion 303', wherein each connection portion 303' is configured to drive a corresponding connection portion 280 of each corresponding rotating member 250 of each cartridge 200, and is driven in a manner similar to that described above with respect to the single-cylinder actuator 300.

[0140] Figure 16 、 17A 17B shows an embodiment incorporating a first valve located above the outlet tube 212 of the cartridge 200. This embodiment is also applicable to Figures 4 to 6 An embodiment in which the valve would be positioned on the outer cylindrical surface of the barrel 200.

[0141] The first valve 500 includes a first surface 252 configured to contact the outer surface 216 of the outlet tube 212 in an interference fit or friction fit type manner. The first valve 500 also includes a funnel portion that includes a frustoconical second surface 251 so as to taper from the first surface 252 to the outlet portion 255. The funnel portion is configured to receive pellets from the screw portion 240, in particular from its threads 242. The outlet portion 255 includes an outlet 257 that is configured to receive pellets from the frustoconical portion and distribute the pellets to the user. The outlet portion 255 and / or the outlet 257 can be elongated, such as Figure 16 As shown, and the width of the outlet 257 (ie, its smaller width, as shown Figure 17B The width of the pellets (as shown) can be adapted to the size of the pellets to be dispensed. For example, the width can be less than 1.5 times the width or diameter of the pellets.

[0142] Figure 18 、 19A 19B illustrate an embodiment incorporating a second valve 550 in the form of a plug 550 positioned above 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 be inserted into the cavity 254 formed at the second dispensing end 104 (i.e., including the screw portion 240) of the rotating member 250. The plug 550 includes a base 552 and an elongated portion 554 extending from the center of the base 552 into the cavity 254 of the rotating member 250. The base 552 can be configured to provide a seal against the outlet tube 212 to hermetically seal the pellets within the cartridge 200, for example, before or during use (in some embodiments).

[0143] The plug 550 may be in the form of an "umbrella valve." That is, at least the base 552 of the plug 550 may be resilient, such as a rubber membrane, wherein the outer edge of the base 552 is configured to flex open when a pellet is pushed out of the screw pump during use, and then to spring back when the screw pump is not rotating, thereby preventing the pellet from falling out and helping to seal the cartridge 200. The elongated portion 554 of the plug 550 may not substantially move from its position within the cavity 254 of the rotating member 250.

[0144] Figure 19C -E shows a modification of the umbrella valve concept, which can be applied to Figure 19A and 19BIn this embodiment, the device 100 includes a sliding member 560 that is concentrically positioned about the outlet tube 212 and configured to slide axially relative to the outlet tube 212 (i.e., along the axis A). The base 552 of the plug 550 extends in a radial direction (relative to the axis A) through the radial extent of the outlet tube 212 and at least partially into the line of travel of the sliding member 560. This Figure 19C Shown in.

[0145] As the rotating member 250 (i.e., including the screw portion 240 and the threads 242) rotates, the pellets 10 will be forced downward through the threads 242, and at least some of the pellets 10' will be captured between the base 552 of the resilient plug 550 and the end of the outlet tube 212 or the end of the sliding member 560, as shown. Figure 19D It is shown schematically in FIG.

[0146] To dispense a pellet from the device 100, the user may slide the sliding member 560 along the axis A, which causes the bases 552 of the resilient plugs 550 to flex, causing the pellet 10' captured between the bases 552 of the plugs 550 to be released and dispensed from the device 100. Figure 19E Indicated schematically.

[0147] Once the pellets have been dispensed from the device 100, the user can slide the slide member 560 back into place, at which point the valve has returned to its original position (e.g., Figure 19C ), which prevents pellets from being inadvertently dispensed from the outlet tube 212. In various embodiments, the sliding member 560 can be biased toward the home position by the resiliency of the base 552 of the plug 550. For example, a suitable resilient member can bias the sliding member 560 to this position, or an electromechanical device such as a solenoid, relay, or other actuator.

[0148] It will be appreciated that during the rotation of the rotating member 250, pellets will be continuously dispensed from the outlet tube 212 through the base 552 of the resilient plug 550. The purpose of the sliding member 560 is to remove any pellets remaining between the resilient plug 550 and the base 552 of the plug 550 or the end of the sliding member 560 after the dispensing operation, as described above. In this manner, the sliding member 560 is configured to end the dispensing operation and prevent stray pellets from falling out of the device 100 outside of any dispensing operation.

[0149] Figure 19F and 19GAnother embodiment is shown in which a valve in the form of a deformable material or membrane 545 is placed over the dispensing end of the outlet tube 212. The deformable material 545 may be substantially elastic and may include a hole 546 through which extends a pin 253 extending from one end of the rotating member 250. In the non-operating or stationary position, as shown Figure 19F As shown, the outer surface of the pin 253 contacts the inner surface of the hole 546 to close the end of the outlet tube 212 and prevent the dispensing of the pellets.

[0150] In various embodiments, the pin 253 can be approximately 1.5 mm long (i.e., along the longitudinal axis of the rotating member 250) and have a diameter of approximately 2.5 mm. The deformable material 545 can be approximately 1 mm thick, with the hole width or diameter being approximately 2 or 2.5 mm. The length of the deformable material 545 (along the longitudinal axis of the rotating member 250) can be less than the length of the pin 253 and can be less than approximately 80% of the length of the pin 253. The deformable material 545 can comprise a thermoplastic elastomer ("TPE") or polybutylene terephthalate ("PBT") and / or can have a hardness of less than approximately 50 psi, and optionally between approximately 30 psi and 50 psi. The pin 253 can be substantially rigid. The deformable material 545 can be attached to the outlet tube 212 in any suitable manner, such as by an adhesive.

[0151] As the rotating member 250 rotates, the pellets are pushed toward the end of the outlet tube 212 for dispensing from the device 100 and when they encounter the deformable material 545 in their stationary position (e.g., Figure 19F ), the pellets will be forced onto the deformable material 545 and deform it, as shown Figure 19G As shown, a gap G is formed between the deformable material 545 and the pin 253, through which the pellets can be dispensed. At the end of the dispensing operation, once the rotating member 250 has stopped rotating, the pellets are no longer pushed against the deformable material 545, and the deformable material 545 will rebound to its rest position, as shown. Figure 19F As shown, the end of the outlet pipe 212 is closed.

[0152] Figure 31 、 32A 32B illustrate an embodiment incorporating a modified outlet tube 212', the features of which may be incorporated into any other embodiment described herein relating to an outlet tube. In this embodiment, the outlet tube 212' is modified to cooperate with a movable member configured to move between a first position, in which the movable member prevents pellets from being dispensed or removed from the progressive cavity pump, and a second position, in which the pellets are permitted to be dispensed from the progressive cavity pump.

[0153] More specifically, in the embodiment shown, the movable member is in the form of a nut 270 that is configured to ride along the threads 242 of the screw portion 240. The outlet tube 212 includes a generally 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 portion 250. The flange 217 includes a track 218 along which the nut 270 rides during use. The flange 217 also includes opposing shoulders 219A, 219B located at either end of the track 218 and configured to provide a stop for the nut 270.

[0154] Nut 270 is configured to move along the longitudinal axis A of rotating member 250 (also the axis of threads 242) as the rotating member (and screw portion 240) rotates. Due to its association with threads 242, nut 270 is configured to block the threads and prevent pellets from moving downward along threads 242 past a point on it. Furthermore, when nut 270 meets first portion 219A of shoulder, nut 270 forms a seal against cylindrical portion 215 of outlet tube 212, meaning no portion of threads 242 is exposed. Thus, pellets cannot escape threads 242 and be dispensed from the device.

[0155] When the rotating member 250 is rotated in a first rotational direction, the nut 270 is configured to move along the track 218 away from the first shoulder 219A, exposing the threads 242 so that the pellets can move down the threads 242 and be dispensed from the cartridge 200. After the rotating member 250 has rotated a certain amount, the nut 270 will contact the second shoulder 219B, which prevents the nut 270 from moving further (and conveniently also prevents further rotation of the rotating member 250). In this position (as shown in FIG. Figure 32B ), the screw pump formed by the threads 242 and the outlet tube 212' will have dispensed a certain volume (eg, a predetermined amount or a predefined amount) of pellets.

[0156] When the rotating member 250 is rotated in a second rotational direction (opposite to the first rotational direction), the nut 270 is configured to move along the track 218 away from the second shoulder 219B and ultimately contact the first shoulder 219A, thereby sealing the cylindrical portion 215 of the outlet tube 212 and preventing the dispensing of pellets from the device.

[0157] Nut 270 is linearly (axially) movable along longitudinal axis A of threads 242. Nut 270 is rotationally constrained (ie, prevented from rotating with rotating member 250) by a friction fit between nut 270 and flange 217 extending downwardly from cylindrical portion 215 of outlet tube 212'.

[0158] When the desired dose is delivered (which may not correspond to the nut 270 traveling straight along the track 218), the rotating member 250 can be rotated in the opposite direction to that described above, thereby pulling the pellets retained in the threads 242 back into the chamber 220, while simultaneously pulling the nut 270 vertically until it returns to its resting position, contacting the first shoulder 219A of the outlet tube 212'. As described above, this contact seals the cylindrical portion 215 of the outlet tube 212', thereby preventing the pellets from falling out.

[0159] Figure 33A and 33B An embodiment is shown that includes a movable member 570 that can be positioned above the outlet end of the outlet tube 212. The movable member 570 can be included in Figure 19A and Figure 19B 5. In the embodiment shown, and may be provided in addition to or in place of the valve 550 (and optional sliding member 560) disclosed with respect to this embodiment.

[0160] In this embodiment, the movable member 570 may include a spring loaded plate 572 configured to close the outlet end of the outlet tube 212. A suitable resilient member (not shown) may be configured to bias the movable member 570 to its Figure 33A 212. This can help increase moisture protection and prevent pellets from accidentally falling out of the outlet tube 212. In some embodiments, the plate 572 can be configured to form an airtight seal relative to the outlet tube 212. The plate 572 itself can be made of a resilient material, for example, the plate 572 can be made of an elastomer or include an elastomer coating. This will further help seal the outlet tube 212 and prevent pellets from falling out therefrom.

[0161] In one particular embodiment, the movable member 570 is combined with an electronic relay 580 comprising an electromagnet, which is shown schematically and is configured to move the movable member 570 from Figure 33A The rest position shown is moved to Figure 33B 572 is shown in the open position. In the rest position, the electromagnet can be turned off, causing the plate 572 to bias toward the end of the outlet tube 212 to seal it and prevent the pellets from falling out. In the open position, the electromagnet can be turned on, causing the plate 572 to be pulled toward the electronic relay 580, which allows the pellets to be dispensed from the outlet tube 212 during the dispensing operation. In this embodiment, the movable part 570 will need to include a magnetic component so that the electromagnet of the electronic relay 580 can properly move it from its rest position.

[0162] In various other embodiments, the movable member 570 may simply be spring-loaded against the action of the user. For example, the electronic relay 580 may not be provided, and the movable member 570 may be moved from its rest position to its open position by the user. Other types of electromechanical devices may be used, such as solenoids or other actuators.

[0163] Figure 34A and 34B An embodiment is shown. Figure 19A and 19B A modification of the embodiment of the present invention is shown in which valve 550 is replaced by valve 590, which extends in a similar manner from the end of rotating member 250. Valve 590 of this embodiment includes a disk 591 having a notch 592 configured to align with outlet 243 of thread 242, wherein when notch 592 and outlet 243 are aligned, pellets are configured to be dispensed from device 100. Disk 591 can be in a first position (e.g., when notch 592 is aligned with outlet 243) in which case notch 592 is aligned with outlet 243. Figure 34A 592 and the outlet 243 are rotated between the second position.

[0164] In various embodiments, such as Figure 34B As shown, valve 590 may include a resilient member 594 configured to bias disk 591 toward its second position. Disk 591 may be configured to rotate with rotating member 250 due to the friction fit between the two components. When rotating member 250 begins to rotate to initiate a dispensing operation, disk 591 may rotate therewith and move to its first position to align notch 592 with outlet 243 and allow dispensing of a pellet. Once rotating member 250 completes rotation to end the dispensing operation, resilient member 594 may bias disk 591 and move it back to its second, resting position.

[0165] exist Figure 34C A slight modification of this type of valve is shown in FIG, which shows a valve 590' in the form of a resilient member (eg, a rubber member). The resilient member 590' includes a recess 592' having a similar shape to that described with respect to FIG. Figure 34A and 34BThe resilient member 590' performs the same function as described above, namely, the recess 592' is configured to align with the outlet 243 of the thread 242 to allow for dispensing of pellets during a dispensing operation. In this embodiment, the resilient member 590' is a single piece and includes a disc portion 591' having a protrusion 596' that extends from the disc portion 591' toward the rotating member 250 during use. In this embodiment, the rotating member 250 includes a hole 254' formed at its end, into which the protrusion 596' of the resilient member 590' is inserted. The protrusion 596' of the resilient member 590' (e.g., its crown portion 597') has a friction fit with the inner surface of the hole 254'. The disc portion 591' fits within the outlet tube 212 and frictionally engages with the outlet tube 212 (in this embodiment, the outlet tube 212 may extend beyond the resilient member 590').

[0166] During a dispensing operation, the rotating member 250 can rotate, causing the rotating member 250 to rotate relative to the disk portion 591' of the resilient member 590', thereby aligning the notch 592' of the disk portion 591' with the outlet 243 of the thread 242. During this operation, the protrusion 596' of the resilient member 590' will flex relative to the disk portion 591' until the notch 592' is aligned, and then the entire resilient member 590' will rotate along with the rotating member 250 with the notch 592', maintaining alignment with the outlet 243. When the dispensing operation is completed and rotation stops, the resilience of the resilient member 590' will cause the disk portion 591' to rotate relative to the rotating member 250 (and the protrusion 596'), causing the notch 592' to move out of alignment with the outlet 243.

[0167] The first and second valves 500, 550 (as well as the modified 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 in order to dispense a pellet through either the first or second valve 500, 550, the user must rotate the rotary member 250 to push the pellet along the threads 242 and apply force to either the first or second valve 500, 550, thereby dispensing the pellet through either valve. In some cases, valves may not be necessary (but may still be included); for example, the pellet itself may be retained in the threads 242 by friction, or a cap or cover may be provided over the outlet of the cartridge (e.g., the outlet tube).

[0168] In various embodiments, such as Figure 35A As shown, the rotating member 250 can be modified so that the threads 242 communicate with an internal passage 245 that is configured to receive pellets from the threads 242 and then travel through the passage to be dispensed from an outlet 243′ located in the bottom surface of the rotating member 250. In one refinement, as shown Figure 35BAs shown, a resilient (e.g., rubber) cover 540 can be placed on the end of the rotating member 250, which is configured to prevent the dispensing of pellets when the device 100 is not in operation. The cover 540 can include a resilient opening 542 aligned with the outlet 243', but biased to a substantially closed position that prevents the passage of pellets. As the rotating member 250 rotates, the pellets will be forced out of the outlet 243' and toward the opening 542, which is configured to open in a resilient manner, thereby allowing the pellets to be dispensed.

[0169] Figure 20 、 21 , 22A and 22B show a device 100 comprising a lid 600, which is configured to be connected to the barrel 200 at the second dispensing end 104 of the barrel 200, so as to cover the outlet pipe 212. The lid 600 can be configured to be connected to the barrel 200 by any suitable means (e.g., interference fit, magnetic latch, clip fastener or screw connection). The lid 600 comprises a base 602 and one or more side portions 604 extending from either end of the base 602. Each side portion 604 is connected to the barrel 200, to alternatively provide an airtight seal between the lid 600 and the chamber 200. A chamber 606 can be formed between the barrel 200 and the lid 600.

[0170] The lid 600 can be used to provide a collection cup for the pellets (eg, to hold the dispensed dose in the chamber 606) and / or to provide an airtight seal before and during use. The lid 600 can be combined with the first valve 500 or the second valve 550 described above.

[0171] Figures 23 to 25 Shows something like Figure 14 and Figure 15 An alternative to the double cartridge embodiment is an embodiment of cartridge 200AB, except that the two cartridges 200 are combined in a single unit.

[0172] The single barrel 200AB includes a first set of components, which includes a first rotating member 250A extending through the first chamber 220A, the first rotating member 250A including a first thread 252A and a first screw portion 240A extending into the first outlet tube 212A, and a first plunger 230A, which moves downwardly along the first thread 252A in a manner similar to that described above for the single barrel 200 during use.

[0173] The first screw portion 240A of the first set of components includes threads 242A extending from the chamber 220A into the outlet member 212A such that upon rotation of the first rotating member 250A, pellets are dispensed from the first outlet tube 212A via the threads 242A in a manner similar to that described above with respect to the single barrel 200.

[0174] The single barrel 200AB includes a second set of components, which includes a second rotating member 250B extending through the second chamber 220B, the second rotating member 250B including threads 252B and a second screw portion 240B extending into the second outlet tube 212B, and a second plunger 230B, which, in use, moves downwardly along the second threads 252B in a manner similar to that described above with respect to barrel 200.

[0175] The second screw portion 240B of the second set of components includes threads 242B extending from the chamber 220B into the outlet member 212B such that upon rotation of the second rotating member 250B, pellets are dispensed from the second outlet tube 212B via the threads 242B in a manner similar to that described above with respect to the single barrel 200.

[0176] The first and second sets of components can be configured differently, such that, for example, the various threads 242A, 252A, 242B, 252B can be configured so that the first set of components is configured to dispense pellets at a faster rate than the second set of components. Similarly, the different chambers 220A and 220B can be configured for use with pellets of different sizes. For example, the actuator 300' can be configured so that each individual rotating member 250A, 250B is driven by a different motor or mechanical control device, where the different motors or mechanical control devices are configured to operate at different speeds.

[0177] like Figure 25 As shown, the first rotating member 250A is configured to rotate about a first axis AA, and the second rotating member 250B is configured to rotate about a second axis AB. In various embodiments, the first axis AA and the second axis AB can be parallel to each other.

[0178] 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 Figure 16 17 , which includes dual connection portions 303 ′, each connection portion 303 ′ being configured to drive a respective rotating member 250A, 250B in a manner similar to that described above with respect to the monocylinder actuator 300 .

[0179] Figure 26 、 27 , 28A and 28B show Figure 9-10A An embodiment of the cartridge 200 in which a surface 210 of the cartridge 200 opposite the radially extending surface 232 of the plunger 230 includes a frustoconical or tapered portion 204 at the second dispensing end 104 of the cartridge 200 to facilitate delivery of the pellets from the chamber 220 into the outlet tube 212.

[0180] like Figure 28BAs shown, barrel 200 includes one or more side portions 202 connected at axial location 206 to a tapered portion 204 extending from the side portion toward an outlet tube 212. Thus, when barrel 200 is in its normal orientation, the pellets will be caused to travel along the frustoconical or tapered portion 204 (along the now angled surface 210) and into the flights 242 of the screw portion 240.

[0181] Although not shown, as described above, the radially extending surface 232 of the plunger 230 can have a corresponding profile or shape that matches the surface 210 of the tapered portion 204. This can help ensure that the pellets are dispensed from the tapered portion 204.

[0182] Figure 29 、 30A and 30B shows Figure 9-10A An embodiment of the barrel 200 is shown in which the screw portion 240 of the rotating member 250 is replaced by a screw portion 240" in the form of a "twisted plate" arrangement, which maximizes the volume of its flights 242" and minimizes the frictional impact of the screw portion on the pellets. The screw portion 240" of this embodiment is formed from a plate that has been twisted multiple times to produce directly opposing screw heads that extend along the entire length of the flights 242". This is in contrast to embodiments in which the flights are cut away from the circumferential surface of the rotating member, as shown in the previously described embodiments.

[0183] The screw portion 240" can be directly connected to the threads 252 of the rotating member 250 and extend from a position within the chamber 220 into the outlet tube 212 in a manner similar to the screw portion 240 of the previous embodiment. The width of the screw portion 240" defined by its outer helical surface 241" can be substantially equal to the width of the inner cylindrical surface 214 of the outlet tube 212. That is, the surface of the screw portion 240" and the inner cylindrical surface 214 of the outlet tube 212 can substantially contact or abut each other (e.g., continuously or intermittently), but not to the extent that they have an interference fit or friction fit relative to each other, to ensure that they can move smoothly relative to each other and ensure reliable dispensing.

[0184] Figure 37A 、 Figure 37B and Figure 37C Shown Figure 7The embodiment of the device 100 is shown in which the plunger 230 is accompanied by a deformable material 234, which is located on a radially extending surface 232 of the plunger 230. In various embodiments, the deformable material 234 can be a foam or sponge. The function of the deformable material 234 is to help press the pellets toward the dispensing end of the device 100 (i.e., into the screw portion 240). In particular, the deformable material 234 can provide an effective method for ensuring that the small pellets contained within the chamber 220 are moved toward the dispensing end, particularly from the inner wall of the chamber 220.

[0185] In various embodiments, the plunger 230 can extend radially (relative to the axis A) a distance that is slightly less than the radial distance to the inner wall of the chamber 220 to avoid friction between the plunger 230 and the wall of the barrel 200. However, in these embodiments, the deformable material 234 can extend radially to a distance equal to the radial distance to the inner wall of the chamber 220, such that the deformable material 234, rather than the plunger 230, ensures that the pellet moves from the inner wall of the chamber 220 toward the dispensing end and cannot pass between the plunger 230 and the wall of the barrel 200. The deformable material 234 can be sized such that it is Figure 37A -C is shown partially deformed when placed in position, which means that it will press against the wall of the cartridge 200 in use to maximise this effect.

[0186] The deformable material 234 can be press-fitted between the rotating member 250 and the barrel 200 and not attached to the plunger 230 (e.g., by an adhesive). In use, the plunger will move along the axis A as described herein, contacting the deformable material 234 and causing it to also move along the axis A. Alternatively, the deformable material 234 can be secured to the plunger 230 by any suitable means, such as an adhesive.

[0187] The deformable material 234 may be included in any aspect or embodiment included herein in conjunction with the plunger 230 and is not limited to Figure 37A -C (which is provided only to illustrate this feature). For example, the deformable material 234 can be provided in an embodiment in which the plunger 230 moves along the threads 252, such as Figure 9 As shown, and in these embodiments, the axial thickness of the deformable material 234 may be at least twice the pitch of the threads 252 to ensure that little or no pellet can migrate through the deformable material 234 .

[0188] Figure 38A 、 38B and 38C show an embodiment in which Figure 9The plunger 230 of the illustrated device 100 is provided with a plurality of axially extending teeth or protrusions 236. At least some (or all) of the teeth 236 include tracks 237 configured to travel along threads 252 of a rotating member 250. Furthermore, the teeth 236 are configured to flex radially, allowing the tracks 237 on the teeth 236 to move into and out of the threads 252. As the rotating member 250 rotates during use, the engagement of the tracks 237 with the threads 252 causes the plunger 230 to move along the axis A. Once the plunger 230 contacts a pellet contained within the chamber 220 (or reaches the bottom of the chamber 220), further axial movement of the plunger 230 is limited. At this point, the teeth 236 are configured to flex radially outward, disengaging the tracks 237 from the threads 252. The rotating member 250 continues to rotate without the plunger 230 moving along the axis A. As shown in the illustrated embodiment, the track 237 is located at the axial end of the teeth 236 farthest from the body of the plunger 230 to maximize the ability of the teeth 236 to flex radially outward as described above.

[0189] Some of the teeth 236 may be configured as stabilizers, i.e., do not have tracks 237 that engage the threads 252, and these teeth may serve to stabilize the plunger 230 as it moves along the axis A and as other teeth 236 that do include tracks 237 flex. The teeth 236 that serve to stabilize the plunger 230 may be biased radially inwardly so that they abut the rotating member 250 as the plunger 230 moves along the axis A.

[0190] Any suitable number of teeth 236 may be provided, for example, between 2 and 10, and in some embodiments, a single tooth 236 may be provided. In the illustrated embodiment, the plunger 230 includes six teeth 236, three of which have tracks 237 and the other three serve as stabilizers (i.e., have no teeth 236).

[0191] In any aspects and embodiments provided herein, the plunger 230 may include, for example, Figure 38A -C shown and described teeth 236. The teeth 236 may include tracks 237, or alternatively may be provided as stabilizers as described above. In such an embodiment, the plunger 230 will typically not include such Figure 10B In other words, the plunger 230 moves along the axis A solely through the engagement of the track 237 with the threads 252 of the rotating member 250 .

[0192] Figure 39A 、 39B and 39C show an embodiment in which Figure 9The plunger 230 of the illustrated device 100 includes a resilient device 260 having a similar function 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 therewith or provided as a separate component and secured thereto by any suitable method. Each protrusion 262 includes a track 266 configured to engage the threads 252 on the rotating member 250. As shown in the illustrated embodiment, the track 266 is located at the axial end of the protrusion 262 furthest from the body of the plunger 230 to maximize the ability of the protrusion 262 to flex radially outward, as described below. The resilient member 264 may be, for example, an elastic band.

[0193] When the rotating member 250 rotates during use, the plunger 230 will move along the axis A due to the engagement of the track 266 with the thread 252. The elastic member 264 ensures that the track 266 engages the thread 252 during this rotation. Once the plunger 230 contacts the pellet contained within the chamber 220 (or reaches the bottom of the chamber 220), further axial movement of the plunger 230 is restricted. At this point, the protrusion 262 is configured to flex radially outward against the action of the elastic member 264, causing the track 266 to disengage from the thread 252, and the rotating member 250 continues to rotate without the plunger 230 moving along the axis A.

[0194] In any aspects and embodiments provided herein, the plunger 230 may include, for example, Figure 39A -C shown and described elastic means 260. In such an embodiment, the plunger 230 will generally not include such Figure 10B In other words, the plunger 230 moves only along the axis A through the engagement of the track 266 with the threads 252 of the rotating member 250 .

[0195] Figure 40A 、 40B and 40C shows a similar Figure 9 2 , but with an improved plunger 230 ′. In this embodiment, the plunger 230 ′ includes a unique shape that is configured to reduce friction between the plunger and the wall of the barrel 200. Specifically, the plunger 230 ′ gradually decreases from a first thickness adjacent to the threads 252 of the rotating member 252 to a second thickness at its periphery and adjacent to the wall of the barrel 200, wherein the second thickness is less than the first thickness.

[0196] More specifically, if Figure 40CAs shown, the plunger 230' can include a substantially flat lower surface 232' that includes the periphery of the plunger 230' that is configured to contact the wall of the barrel 200. A tapered surface 233' can be provided that extends radially inward from the periphery to an upper edge 231' that is positioned away from the wall of the barrel 200 and adjacent to the rotating member 250. By providing a reduced thickness portion near the wall of the barrel 200, friction between the plunger 230' and the barrel 200 can be reduced. Additionally, as shown in the illustrated embodiment, the use of the tapered surface 233' means that as the plunger 230' moves axially, the periphery of the plunger 230' can flex. In such an embodiment, the plunger 230' can be made of an elastomeric material such as rubber to enhance the ability of the plunger 230' to flex in this manner.

[0197] In various embodiments of the plunger 230', it can taper to a pointed edge at the periphery of the plunger 230'. The thickness of the plunger 230' at the periphery can be less than, for example, about 2 mm or even about 1 mm. The plunger 230' can be made of a thermoplastic elastomer ('TPE') or of polybutylene terephthalate ('PBT'). The plunger 230' can have a durometer of less than about 50 shore, which has been found to provide the plunger 230' with sufficient flexibility during movement along the axis A in use. The plunger 230' can be slightly oversized in that the width of the plunger 230' is slightly larger (e.g., in isolation) than the size of the barrel 200 in which it is mounted. The plunger 230' can also be configured with threads that are configured to mate with the threads 252 of the rotating member 250.

[0198] Although the present invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made without departing from the scope of the present invention as set forth in the following claims.

Claims

1. A device (100) for dispensing a medicine or drug in pellet form, comprising: a cartridge (200) comprising a chamber (220) for receiving a plurality of pellets; a progressive cavity pump configured to receive pellets from the chamber (220) and, upon rotation of the progressive cavity pump, convey the pellets from the chamber (220) for dispensing from the device (100) via the progressive cavity pump; A rotating member (250) extends through the barrel (200) and is configured to rotate the screw pump to dispense pellets therefrom.

2. The device of claim 1 , wherein the maximum dimension of the pellets is between about 150 μm and 1200 μm.

3. The device of claim 1 or 2, wherein the cartridge (200) extends from a first end to a second dispensing end, and the screw pump is located at the second dispensing end of the cartridge (200).

4. The device of claim 1 , 2 or 3 wherein the progressive cavity pump is gravity fed such that pellets contained within the chamber are moved towards the second dispensing end at least in part by gravity when the device is in the dispensing orientation.

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

6. An apparatus according to any preceding claim, wherein the screw pump comprises a portion of a rotating member (250), and the screw pump comprises threads (242) formed around the rotating member (250), and the threads (242) extend at least partially into the chamber (220) to receive pellets from the chamber in use, and The threads (242) cooperate with the inner cylindrical surface (124', 214) of the barrel (200) to form the screw pump, so that when the rotating member (250) rotates in use, the threads (242) rotate within the inner cylindrical surface (124', 214), causing the pellets contained in the chamber (220) to enter the threads (242) and travel downward along the threads (242) to be dispensed from the screw pump.

7. The device according to claim 6, wherein When the rotating member (250) and the screw pump rotate in use, pellets from the portion of the threads (242) extending into the chamber (220) travel along the screw pump threads (242) to the opposite end of the threads (242) for dispensing from the screw pump.

8. The device of claim 7, wherein the barrel (200) is at least partially cylindrical, and the cylindrical portion of the barrel (200) includes the inner cylindrical surface (124') of the screw pump and at least a portion of the chamber (220) for receiving the pellets.

9. The apparatus of claim 7, wherein the cartridge (200) comprises an outlet tube (212) extending from the chamber (220), and the outlet tube (212) comprises an inner cylindrical surface (214) of the progressive cavity pump.

10. The device of claim 9, wherein the thread (242) extends over the entire length of the outlet tube (212) and also partially into the chamber (220) for a certain distance.

11. The apparatus of claim 10, wherein the distance is between about 1-2 times the diameter of the rotating member (250) within the outlet tube (212).

12. The device according to any one of claims 6 to 11, wherein the majority of the length of the rotating member (250) is free of threads (242) forming the screw pump.

13. The device according to any of the preceding claims, further comprising means (230) configured to force pellets contained in the chamber (220) towards the progressive cavity pump.

14. The apparatus of claim 13, wherein the device (230) includes a weight configured to rest on top of the pellets contained within the chamber (220) when the apparatus (100) is in an orientation that allows for dispensing of pellets.

15. An apparatus according to claim 13, wherein the portion of the rotating member (250) within the chamber (220) includes threads (252), and the apparatus (230) is configured as a plunger that travels along the threads (252) of the rotating member (250) such that when the rotating member (250) rotates in use, the plunger (230) moves towards the progressive cavity pump, thereby forcing the pellets contained in the chamber (220) towards the progressive cavity pump.

16. The device according to any of the preceding claims, further comprising means (500, 550, 590, 590') connected to the outlet of the screw pump and configured to prevent pellets from being dispensed from the screw pump when the screw pump is not rotating or prior to use, and to allow pellets to be dispensed from the screw pump when the screw pump is rotated in use.

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

18. A device (100) for dispensing a drug or medicine in pellet form, comprising a screw pump including a thread (242), wherein: When the screw pump rotates in use, pellets are received into the threads (242), travel down the threads (242), and are dispensed from the threads (242) and the device (100); wherein the thread (242) is configured such that a predetermined rotation of the screw pump causes a predetermined amount of pellets to be dispensed from the device (100).

19. A method of using the apparatus according to any preceding claim, comprising: For example, the screw pump is rotated by a predetermined amount using the rotating member (250) to dispense a predetermined amount of pellets from the device (100).

20. The method according to claim 19, further comprising: filling the chamber with pellets providing an oral dosage form (220); determining an amount of rotation of the screw pump that will result in dispensing a predetermined amount of pellets from the device (100); and The screw pump is rotated the predetermined amount to dispense the predetermined amount of pellets from the device (100).