EA041108B1 - DEVICE AND METHOD FOR PRECISION DOSE DELIVERY - Google Patents

Description

Cross-reference to related applications

This application claims priority over US Application No. 62/598212, filed December 13, 2017; application

U.S. No. 62/676047, filed May 24, 2018; and U.S. Application No. 62/722252, filed August 24, 2018, all of which are incorporated herein by reference in their entirety.

Technical field

Aspects of the invention relate to devices and methods for filling or otherwise configuring a dose delivery device, such as a syringe, to deliver a precise dose. More specifically, embodiments of this invention relate to devices and methods for loading, storing, transporting, and/or delivering precise doses of a drug, placebo drug, or other drug, including a liquid.

Introduction

Liquid drugs can be delivered to patients in a variety of ways, including by injection. In many cases, the precision and accuracy of the volume of a liquid drug is critical. For example, healthcare professionals may have an interest in ensuring that an approved or prescribed amount of a drug is consistently delivered to every patient in need of a drug. In addition, overdosing or underdosing a drug to a patient, however slight, can have an undesirable (or even negative) clinical impact on the patient. In addition, some drugs are prescribed in small volumes (for example, up to 100 μl). At low volumes, human error in preparing and delivering an accurate dose of a drug for injection can affect the efficacy of the drug in the patient and the subsequent clinical impact on the patient.

Additional aspects of liquid drug delivery can complicate the task of delivering an accurate dose by injection. For example, for the correct dose of drug to be dispensed from a device (eg, syringe), the appropriate exact volume of drug must be loaded into the device. In addition, the handling, storage, packaging and/or transport of loaded devices should not lead to inadvertent expulsion of the medicinal product from the devices. In addition, it may be necessary to prepare the device to remove air bubbles from the needle and barrel of the device before administering the drug from the device. Incorrect filling of the device can result in too much or too little drug being expelled from the device, which can also result in a reduction in the dose delivered to the patient or in the introduction of air bubbles from the device into the patient's body.

The essence of the invention

This document describes liquid delivery devices. In an aspect of the present invention, the devices may comprise a cylinder having a longitudinal axis, a proximal end region, and a distal end region. The proximal end region may comprise an opening and the cylinder may be configured to receive a drug therein. The piston rod (having a piston collar connected thereto) may be located at least partially within the cylinder and protrude from the bore. The piston rod may include a toothed rack having a plurality of teeth. The device may further comprise a gear having a plurality of teeth configured to engage with the plurality of teeth of the rack, and rotation of the gear relative to the rack may move at least a portion of the piston rod along the longitudinal axis of the cylinder.

Various aspects associated with the device may include one or more of the following design features. The device may also include a shaft attached to the gear, during rotation of which the shaft rotates the gear relative to the rack. In one embodiment of the invention, a handle may be attached to the shaft. In another embodiment of the invention, an imaging device (eg, a magnifying glass) may be located in the region of the distal end of the cylinder. In a further embodiment of the invention, the device may include a restrictor within the barrel and the restrictor may be attached to the distal end of the piston rod. In an exemplary embodiment of the invention, the device may further comprise a circular ratchet located coaxially with the gear, while the circular ratchet has a diameter less than the diameter of the gear, a spring-loaded pawl located on the inner circumference of the gear, the pawl being configured to engage with the ratchet and with the shaft attached to the ratchet, while the rotation of the shaft in one direction causes the rotation of the gear, and the rotation of the shaft in the second direction does not cause the rotation of the gear. In some embodiments of the invention, the ratchet may be located inside the gear. In some embodiments, the gear may include a plurality of teeth having a first height and a stop tooth having a second height that is greater than the first height. In additional embodiments of the invention, the second height of the locking tooth may prevent the pinion from meshing with the plurality of teeth of the rack. In still other embodiments, the second stop tooth height may be configured to contact one of the following: the piston rod and the rack to stop the rotation of the pinion. In yet other embodiments, the piston rod may comprise an inner column and an outer chamber, and a toothed rack may be located on the inner column. In some embodiments of the invention, the rotation of the gear relative to the rack may move the inner column of the piston rod independently of the outer chamber. In some embodiments, the device may also include a shaft removably attached to the gear, the shaft preventing the outer chamber of the piston rod from moving relative to the cylinder, while removing the shaft causes the outer chamber of the piston rod to move relative to the cylinder.

In some embodiments of the invention, the piston rod may further comprise a housing and a protrusion, wherein the protrusion extends partially along the longitudinal length of the housing and has a width greater than the width of the housing, and the cylinder may further comprise a piston retainer, wherein the piston retainer comprises a through hole made with the possibility of passage protrusion through the second piston retainer in a particular orientation.

In another aspect of the present invention, the drug delivery device may comprise a cylinder having a longitudinal axis, a proximal end region, a distal end region, and an interior, wherein the proximal end region comprises an opening and an interior containing a threaded region. The device may further comprise a piston rod located at least partially within the cylinder and protruding from the bore, wherein the piston rod has a threaded region configured to engage with the threaded region of the interior of the cylinder. Rotation of the piston rod about the longitudinal axis of the drug delivery device can move the piston rod along the longitudinal axis.

Various aspects associated with the device may include one or more of the following design features. The piston rod may further comprise a tongue protruding from the piston rod in a first direction and positioned proximal to the threaded region of the piston rod, and the threaded region in the interior of the cylinder may further comprise a sized slot configured to allow the tongue to pass through the threaded region in the interior. cylinder parts. In some embodiments, the slot may include a first segment parallel to the longitudinal axis of the drug delivery device and a second segment perpendicular to the longitudinal axis of the drug delivery device. In some embodiments, the groove may include a third segment parallel to the longitudinal axis of the drug delivery device, with the second segment located between the first segment and the third segment. In other embodiments of the invention, the tongue is a first tongue and the piston rod may further comprise a second tongue protruding from the piston rod in a second direction opposite to the first direction, and the threaded region in the interior of the cylinder may further comprise a second groove, matched to the size and made with the possibility of ensuring the passage of the second tongue through the threaded area in the inner part of the cylinder.

In another aspect of the present invention, the drug delivery device may comprise a cylinder having a proximal end region, a distal end region, an opening in the proximal end region, an interior, and a threaded region in the interior. The device may further comprise a sleeve located partially within the cylinder and protruding from an opening in the region of the proximal end of the cylinder, the sleeve comprising a threaded region engaging with the threaded region of the interior of the cylinder. The device may also include a piston rod located at least partially within the sleeve, and a limiter within the cylinder and located distally from the sleeve, while the limiter is connected to the distal end of the piston rod. Rotation of the sleeve in a first direction about the longitudinal axis of the drug delivery device may move the sleeve towards the distal end region of the barrel.

Various aspects associated with the device may include one or more of the following design features. Rotation of the sleeve in the first direction may move the stopper towards the distal end region of the cylinder. In some embodiments of the invention, the sleeve may contain an internal channel, and the stopper may have a diameter greater than the diameter of the internal channel. In some embodiments, the sleeve may include a tongue located on the outside of the sleeve, wherein the tongue may be positioned proximal to the threaded region of the interior of the barrel, and the tongue may stop movement of the sleeve toward the distal end region of the barrel. In other embodiments, the tongue may be configured to stop movement of the sleeve towards the distal end region of the barrel after the drug delivery device has been filled. In additional embodiments of the invention, the tab may be a first tab, while the sleeve may further comprise a second tab located on the outside of the sleeve, while the second tab can be located distal to the threaded region of the inner part of the cylinder, and the second tab can stop the movement of the sleeve in towards

- 2 041108 research institute of the proximal end of the cylinder.

In a further aspect of the present invention, the drug delivery device may comprise a cylinder having a proximal end region and a distal end region, and the proximal end region may comprise an orifice. The device may also include a piston rod having a housing and a protrusion, the protrusion extending partially along the longitudinal length of the housing and having a width greater than the width of the housing, while the piston rod is located at least partially inside the cylinder and protrudes from the hole. The device may also include a first piston retainer located on the cylinder, wherein the first piston retainer is configured to block the entry of the protrusion into the cylinder, and the second piston retainer located in the cylinder, the second piston retainer comprising a through hole configured to allow the protrusion to pass through the second piston retainer in a specific orientation.

Various aspects associated with the device may include one or more of the following design features. In some embodiments of the invention, the first piston retainer may be removable. In some embodiments, the first piston retainer may be brittle. In still other embodiments, the distance between the first plunger retainer and the second plunger retainer may be equivalent to the distance the restrictor must travel to fill the drug delivery device. In other embodiments, the piston rod may rotate about the longitudinal axis of the drug delivery device.

In a further aspect of the present invention, a method for dispensing a substance from a drug delivery device having a piston rod and a cylinder may include advancing the piston rod a predetermined distance into the cylinder until the piston rod advance is prevented by a stopper, disengaging the stopper, and actuating the action of the piston rod to deliver the substance.

Various aspects associated with the device may include one or more of the following design features. In some embodiments, advancing the piston rod may include rotating a gear relative to a rack located on the piston rod. In some embodiments, the stopper may include a shaft that is removably attached to the gear, and releasing the stopper may include removing the shaft from the gear. In still other embodiments of the invention, disabling the stopper may include rotating the piston rod. In some embodiments of the invention, the piston rod may include a protrusion, and the stopper may contain a retainer that prevents the penetration of the protrusion into the cylinder. In other embodiments of the invention, disabling the stopper may include removing the latch. In some embodiments of the invention, disabling the stopper may include destroying the latch.

Brief description of graphic materials

The accompanying drawings, which are included and form part of this specification, illustrate various exemplary embodiments of the invention, and together with the description serve to explain the principles of the described embodiments. The drawings show various aspects of the present invention and, where appropriate, reference numerals illustrating the same structures, components, materials, and/or elements in different figures are identified in the same way. It should be understood that various combinations of structures, components and/or elements in various embodiments of the invention, other than those specifically shown, are contemplated and are within the scope of this invention.

There are many embodiments of the invention described and illustrated in this document. The described devices and methods are not limited to any single aspect of the invention or its embodiment, nor any combinations and/or permutations of such aspects and/or embodiments of the invention. In addition, each of the aspects of the described inventions and/or their embodiments can be used alone or in combination with one or more other aspects of the described inventions and/or their embodiments. In this document, some permutations and combinations are not specifically described and/or illustrated for brevity.

In FIG. 1 depicts an exemplary delivery device (eg, syringe) in accordance with one embodiment of the present invention.

In FIG. 2 depicts an exemplary pawl and ratchet for a delivery device in accordance with one embodiment of the present invention.

In FIG. 3A and 3B depict an exemplary locking mechanism for a delivery device in accordance with one embodiment of the present invention.

In FIG. 3C and 3D depict an exemplary telescoping mechanism for a delivery device in accordance with one embodiment of the present invention.

In FIG. 4A and 4B depict an exemplary rotation locking mechanism for a delivery device in accordance with one embodiment of the present invention.

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In FIG. 4C-4E depict an exemplary delivery device with an exemplary rotation lock mechanism in various positions, in accordance with an embodiment of the present invention.

In FIG. 5 depicts an exemplary delivery device in accordance with one embodiment of the present invention.

In FIG. 6A-6E depict an exemplary delivery device and locking mechanism in accordance with one embodiment of the present invention.

In FIG. 7A depicts an exemplary delivery device in accordance with one embodiment of the present invention.

In FIG. 7B shows the threaded portion of the delivery device shown in FIG. 7A.

In FIG. 8 illustrates an alternative embodiment of the invention of the threaded portion shown in FIG. 7B.

In FIG. 9A depicts an exemplary delivery device in accordance with one embodiment of the present invention.

In FIG. 9B-9D show the blocking components of the delivery device shown in FIG. 9A.

In FIG. 10A-10C depict additional exemplary delivery devices in accordance with additional embodiments of the present invention.

In FIG. 11A and 11B depict further exemplary delivery devices in accordance with additional embodiments of the present invention.

In FIG. 12 depicts an exemplary delivery device in accordance with additional embodiments of the present invention.

In FIG. 13A-13C depict an exemplary filling and delivery mechanism for a delivery device, in accordance with additional embodiments of the present invention.

In FIG. 14A-14C depict another exemplary filling and delivery mechanism for a delivery device in accordance with additional embodiments of the present invention.

In FIG. 15A-15E depict another rotation locking mechanism for a delivery device in accordance with further embodiments of the present invention.

In FIG. 16A-16E depict another exemplary delivery device and locking mechanism in accordance with additional embodiments of the present invention.

In FIG. 17A-17C depict additional exemplary delivery devices and mechanisms in accordance with additional embodiments of the present invention.

In FIG. 18A-18F depict a locking and filling mechanism for a delivery device, in accordance with further embodiments of the present invention.

In FIG. 19A-19E depict another locking and filling mechanism for a delivery device, in accordance with additional embodiments of the present invention.

In FIG. 20A-20C depict another locking and filling mechanism for a delivery device in accordance with additional embodiments of the present invention.

As used herein, the terms contains, containing, includes, including, or any variation thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that contains a list of elements does not include only these elements, but may include other elements, which are not explicitly listed or not inherent in such a process, method, article or device. The term cited as an example is used in the sense of an example, not an ideal. It should be noted that the embodiment or implementation of the invention described in this document as an example or cited as an example, should not be considered as preferred or advantageous, for example, compared with other embodiments or implementations of the invention; rather, it is intended to reflect or indicate that the embodiment(s) of the invention is exemplary and not ideal. In addition, the terms first, second, etc. in this document do not denote any order, quantity, or importance, but rather are used to distinguish an element, construct, step, or process from another. In addition, the terms given in this document in the singular, do not indicate a limitation on the number, but rather indicate the presence of one or more of the specified elements.

Detailed Description of the Invention

Embodiments of this invention may be used in addition to and/or in combination with aspects of US Provisional Application No. 62/598212, which is hereby incorporated by reference in its entirety.

Embodiments of the present invention may be used with any type of liquid-containing preparations, such as liquid drugs, liquid placebo preparations, or

- 4 041108 other liquids which may be dispensed in dosage form. In some embodiments of the invention, medicinal preparations may contain one or more active ingredients, including, for example, small or large molecules or biotech drugs such as painkillers, steroids or biotech drugs. As used herein, the term biotech drug can refer to a large molecule (eg, larger than 15 kDa, larger than 30 kDa, larger than 50 kDa, larger than 75 kDa, or larger than 100 kDa) created in a living system such as a cell. Biotech products may contain proteins (eg antibodies), nucleic acids, large sugars, etc. Unlike small molecules, which can have well-defined chemical structures, biotech drugs can have very complex structures that cannot be easily quantified using laboratory methods. As used herein, the term drug product may refer to the volume of drug substance dispensed in the primary packaging component for packaging, transportation, delivery, and/or administration to a patient.

The term primary packaging component refers to a drug packaging component, such as a drug container, that is designed and manufactured to come into direct physical contact with the manufactured drug substance. (See, for example, Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologies, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research (May 1999 d.), which is incorporated herein by reference.) Examples of primary packaging components include prefilled syringes, Luer syringes, cartridges, and vials made from glass, plastic, and/or other materials.

Embodiments of the present invention may be used with formulations typically having small dose volumes, such as, for example, ophthalmic drugs. In some embodiments of the invention, devices in accordance with the present invention can be used with drugs that include an antigen-binding molecule. In some aspects of the invention, the antigen-binding molecule may be an antibody or an antigen-binding fragment. In some embodiments, the devices of the present invention may be suitable for use with medicinal products including, for example, aflibercept, alirocumab, abicipar pegol, bevacizumab, brolucizumab, conbercept, dupilumab, evolocumab, tocilizumab, certolizumab, abatacept , rituximab, infliximab, ranibizumab, sarilumab, adalimumab, anakinra, trastuzumab, pegfilgrastim, interferon beta-1a, insulin glargine (recombinant DNA origin), epoetin alfa, darbepoetin, filigrastim, golimumab, etanercept, antigen-binding fragments of any of the above, or combinations thereof binding domains such as anti-VEGF bispecific antibodies or angiopoietin-2, among others.

For some drugs, in particular, for example, ophthalmic or other drugs, dose accuracy may be particularly important. However, it is also contemplated that embodiments of the present invention may be applicable to any other liquid formulation or any other context in which precise methods of setting and administering a reliably accurate dose or delivery volume are useful.

In some embodiments of the invention, devices in accordance with the present invention may be manufactured, packaged, filled and/or otherwise prepared in accordance with processes related to drugs (eg, drugs) with which they can be used. For example, in some embodiments of the invention, devices in accordance with the present invention may be sterilized either before or after filling and/or packaging. For example, in some embodiments of the invention, devices in accordance with the present invention may be filled and packaged, for example, in a blister pack, and/or may be terminally sterilized using any suitable method in the art. For example, devices in accordance with the present invention may be terminally sterilized using a chemical sterilization method, such as a method involving ethylene oxide or hydrogen peroxide (eg, hydrogen peroxide vapor). In some embodiments of the invention, devices in accordance with the present invention may be terminally sterilized using the methods described, for example, in International Application No. PCT/US 2018/021013, filed March 6, 2018, which is hereby incorporated by reference in its entirety. .

Dose delivery devices available on the market, such as pre-filled syringes or syringes for use with vials, may not necessarily help with accurate loading of the required volume of drug, filling devices, removing excess drug from devices, and/or removing air bubbles from devices. In dose delivery devices containing, in particular, a small volume of drug (e.g., about 500 µl or less, about 300 µl or less, about 250 µl or less, about 200 µl or less, about 150 µl or less, about

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100 µl or less, about 50 µl or less, or about 25 µl or less, for example, about 25 to about 50 µl, about 50 to about 100 µl, about 25 to about 100 µl, about 50 to about 150 µl, about 100 to about 250 µl, about 100 to about 150 µl, about 150 to about 250 µl, about 200 to about 250 µl, about 200 to about 500 µl, or about 250 to about 500 µl) may also it can be difficult to confirm the presence of the correct dose of drug in the device with the naked eye. There is currently a need in the dose delivery device market, and in particular in the syringe market, for mechanisms that allow the user to accurately set the delivery of a small volume of drug in a syringe (e.g., a prefilled or refillable/refillable syringe), fill the syringe , remove air bubbles from the syringe and/or confirm or verify that the dose volume in the syringe is correct. Embodiments of the present invention can assist manufacturers, drug suppliers, healthcare professionals, and/or patients in accurately filling or otherwise preparing a dose delivery device, filling the device, removing vials from the device, confirming a dose, and/or administering a dose from the device to a patient. In addition, embodiments of the present invention can help prevent or reduce errors or changes in device manufacture or use, such as errors or changes in the placement of dosing lines on devices, changes in device geometry (e.g., changes in syringe neck geometry), and/or change or errors in setting up the dosing line for drug delivery.

In some instances, embodiments of the present invention may be of particular assistance to individuals who may have difficulty setting precise and accurate doses. For example, embodiments of the present invention may assist in setting accurate doses for the elderly, young children, or those with physical or mental disabilities.

This document describes various embodiments of the invention of devices for delivering a dose and, in particular, syringes. In some instances, the embodiments of the invention described herein can be used in conjunction with existing syringe body parts to modify off-the-shelf products, which can reduce development and manufacturing time for dose delivery devices. In other instances, the embodiments of the invention described herein may be incorporated into devices at the time they are manufactured. The syringes described herein may be pre-filled or may be refillable/refillable.

Embodiments of the present invention may include syringes having rotating parts, threaded parts, springs, gears, and the like, which can allow the user to precisely control the movement of dosing and delivery adjustment elements such as, for example, pistons and/or restrictors. In some embodiments of the invention, for example, screw and gear mechanisms can be used to transfer rotational movement (for example, on a knob or adjustment knob) to linear movement of the plunger and, thus, to set the syringe plunger rod to a predetermined position with reduced human effort and /or relatively more accurate. It is contemplated that by reducing effort and/or increasing accuracy, embodiments of the present invention may also reduce the risk of human error.

In some embodiments of the invention, imaging devices, such as magnifying glasses, may be presented, attached, or otherwise placed on the delivery devices in order to help improve the visibility of the dose measurement markers on the devices. It is contemplated that aspects of one embodiment of the invention (such as magnifying glasses, bushings, guide pins, channels, helical and gear mechanisms, rotating parts, threaded parts, grips, springs, etc.) may be combined with aspects of one or more other embodiments. implementation of the invention in order to create various combinations and permutations of design features in one device.

In some embodiments of the invention, devices in accordance with the present invention may be depicted as containing the same type of piston rod and piston, or as containing a common schematic representation of the piston rod and piston. For example, some devices in accordance with the present invention may be depicted or described as including, for example, a piston rod with a threaded end that engages threads on the inside of the piston, whereby the piston rod and piston can be screwed together. It is contemplated that multiple and/or different configurations of piston rods and pistons may be suitable for each of the embodiments of the invention described herein. For example, in some cases, the aforementioned threaded rod and piston may be used with the embodiments of the invention described herein. In some embodiments, the piston rod may not be attached to the piston and instead may be located next to, near, or against the piston such that pressure from the piston rod toward the piston may push the piston, but retraction, twisting, or other movement piston rod cannot cause the piston to also be retracted, twisted or otherwise moved. IN

- 6 041108 as another example, in some embodiments of the invention, the piston rod may be attached to the piston with adhesive or may be made in one piece with the piston (for example, may be made in one form with the piston).

In some embodiments of the invention, the devices in accordance with the present invention may contain various decorative design features related to the intended users of the devices. For example, devices in accordance with the present invention can be manufactured and sold for use by pediatric patients. In such instances, the devices of the present invention may include child-friendly coloring, cartoon images, or other decorative features to appeal to children. In some cases, devices in accordance with the present invention may contain inscriptions, markings or other design features designed to be easily recognized by intended users. For example, a label on a pediatric device or a device for use by a disabled or elderly person may have larger and more accessible markings to make it easier to recognize and read by the user(s) of the device.

In FIG. 1 shows a syringe 10 containing a volume of drug 12 and having a dosing control mechanism. The dosing control mechanism may include a rack 2 and a pinion 3. The rack 2 may be provided on the inner surface of the piston rod 1 of the syringe 10 or may be otherwise attached to the inner surface of the piston rod 1. In some embodiments of the invention, the rack 2 may be, for example engraved, machined or molded on the piston rod 1. The toothed rack 2 may comprise a plurality of teeth extending along its length.

The gear 3 may also include a plurality of teeth that are configured to mesh with the teeth of the rack 2. The gear 3 may be operatively connected to a drive (for example, a tuning knob or knob) located outside the piston rod 1 through the gear rod 4. For example, as shown in FIG. 1, rotation of the setting knob 5 can cause the gear shaft 4 to rotate and hence the gear 3 to rotate. Thus, the gear shaft 4 can extend from the inside of the syringe 10 (where it connects to the gear 3) to the outside of the syringe 10 (where it connects with setting knob 5). In the embodiment of the invention shown in FIG. 1, the pinion shaft 4 may extend partially or completely through a finger rest 7 (eg built into or attached to the syringe 10). In other embodiments of the invention, the gear rod 4 may pass through the body wall of the plunger rod 1 and/or barrel 9 of the syringe 10. The gear rod 4 may be mounted on a gasket or seal, such as an o-ring 6, where it exits the finger rest 7 (or , if necessary, the cylinder 9 of the syringe). O-ring 6 may provide physical support to pinion shaft 4 and/or pinion 3 when pinion 3 is in motion and/or at rest. Although the O-ring 6 has been described as providing structural support for the gear rod 4 and/or gear 3, it is also contemplated that the O-ring 6 may simply isolate the inside of the piston rod 1 from the outside, or both. Furthermore, other seals or gaskets, or combinations thereof, may be used in addition to or instead of the O-ring 6, and these seals or gaskets may or may not provide structural support and/or sealing. For example, such seals or spacers may simply provide a barrier to protect the interior of the syringe from the exterior, or may provide structural support and may also act as a barrier.

The teeth of the gear 3 can engage with the teeth of the rack 2, as a result of which, when the gear 3 is rotated by means of the adjustment knob 5, the rotational movement of the gear 3 can cause the translational movement of the piston rod 1. Thus, the rotation of the gear 3 may cause displacement of the piston rod 1 in the distal and/or proximal directions in the syringe barrel 9, which may also move the piston collar 8 (eg a stopper) within the syringe barrel 9. By turning the setting knob 5, the plunger collar 8 (which can also act as a stopper) inside the syringe barrel 9 can gradually move towards the end of the needle of the syringe 10, whereby air and excess drug can be forced out through the needle 13, thus filling the injection needle 13 appropriate dose of the drug 12.

Gear 3 and rack 2 may be sized and configured such that rotation of gear 3 in a predetermined direction or by a predetermined amount (for example, one turn clockwise) may cause rack 2 and pinion 3 to disengage from each other, which may stop the possibility of the setting handle 5 to advance the cuff 8 of the piston. In some embodiments of the invention, after the setting knob 5 is rotated a predetermined amount in a clockwise or counterclockwise direction, the rack 2 and/or gear 3 may stop moving. For example, an obstacle to further movement of the pinion 3 may occur as a result of reaching the proximal end of the rack 2, as a result of separation from the rack 2, as a result of separation from the pinion shaft 4, as a result of a stop against the limiter, or as a result of

- 7 041108 that the setting knob 5 can only be rotated by the set amount. Accordingly, the rotation of the adjustment knob 5 and gear 3 with a given amount and in a given direction can serve to completely fill the syringe needle.

In some embodiments, when the piston rod 1 has moved the desired amount (at which point the rotation of the tuning knob 5 and/or gear 3 may or may not be stopped), the user may pull the tuning knob 5 outward from the piston rod 1. Moving the setting handle 5 outward may disconnect the setting handle 5 from the gear shaft 4 and/or may disconnect the gear shaft 4 from the gear 3. In some embodiments, the gear shaft 4 may pass through a hole in the side wall of the piston rod 1 and pull the setting handle 5 outward. can push the pinion rod 4 out of the hole, as a result of which the pinion rod 4 will no longer interfere with the movement of the piston rod 1. In some embodiments, pulling the adjustment knob 5 may lock it in place, thereby preventing further movement of the piston rod 1 through use of the adjustment knob 5. In some embodiments, pulling the adjustment knob 5 outward may unlock the outer piston rod, allowing it to move freely. , regardless of whether the movement of the adjustment knob 5 is blocked. In some embodiments, pulling the adjustment knob 5 and/or the pinion shaft 4 outward may disengage the gear 3 from the rack 2. In some embodiments, the user may not be able to press the piston rod 1 until pinion 3 reaches its end position and/or until setting knob 5 is pulled out.

The setting knob 5 may be the only mechanism capable of moving the plunger rod 1 until the syringe 10 is filled. For example, the mating teeth of rack 2 and pinion 3 may prevent the user from depressing piston rod 1 (and/or pulling proximally on piston rod 1) until gear 3 has disengaged from rack 2. This may prevent dispensing drug 12 until syringe 10 is full and can deter underfill or overfill of syringe 10, as well as promote accurate distribution of drug 12.

As shown in the embodiment of the invention depicted in FIG. 1, the syringe 10 may further comprise a magnifying glass 11 attached to or inserted into the barrel 9 of the syringe. The magnifying glass 11 may assist in reading the measurement indicators on the syringe barrel 9, may assist in observing the presence or absence of air bubbles in the syringe barrel 9, and/or may help determine whether a full dose of drug 12 has been dispensed from the syringe 10. Magnifying glass 11 may be contained in the distal region of the syringe 10 and may be of any suitable shape or size. For example, the magnifying glass 11 may be round or rectangular, or may extend around all or part of the circumference of the syringe barrel 9. In other embodiments of the invention, the magnifying glass 11 may not be included.

The embodiment of the invention shown in FIG. 1 may work as follows. The setting knob 5 can be rotated by a given amount in a given direction until the rotation of the gear 3 stops. The user can determine if the gear 3 has stopped when the setting knob 5 can no longer be rotated and/or when the movement of the piston rod 1 stops. As discussed above, the pinion 3 may stop moving, for example, as a result of reaching the end region of the rack 2, as a result of being disconnected from the rack 2, as a result of being disengaged from the pinion shaft 4, as a result of hitting a stop, or because the adjustment knob 5 can only rotate by the specified amount. Alternatively or additionally, in some embodiments of the invention, the setting knob 5 can be pulled outward by the user to prevent further movement of the piston rod 1 through the setting knob 5.

After the movement of the piston rod 1 has been completed using the setting knob 5, the user can further confirm the dose level of the drug in the barrel 9 of the syringe and/or can, if necessary, confirm whether any air has entered the inside of the barrel 9 of the syringe. The proximal end of the piston rod 1 can then be advanced to deliver the drug dose.

In FIG. 2 illustrates an exemplary version of gear 3 shown in FIG. 1. Gear 20 in FIG. 2 may include an internal ratchet and pawl to allow gear 20 to rotate in a first direction and prevent gear 20 from rotating in a second direction opposite to the first direction. For example, only clockwise rotation may be allowed, while counterclockwise rotation may be disabled, or vice versa. In some embodiments, rotation of the gear 20 in a direction that would cause the piston rod 1 to move away from the end of the needle of the syringe 10 in the proximal direction can be prevented, while rotation in the direction that would cause the piston rod 1 to move distally towards the end of the syringe needle 10 is allowed.

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As shown in FIG. 2, the ratchet 23 may be coaxial with the gear 20, and the adjustment knob 5 (FIG. 1) may be connected to the ratchet 23, for example, through a pinion shaft (such as the shaft 4 shown in Fig. 1) through the center 25 of the ratchet 23. The ratchet 23 may include inclined teeth 24. The inner region of the gear 20 may include a spring-loaded pawl 22 operatively associated with the inner region. The pawl 22 may be angled to match the angles of the teeth of the ratchet 24 and close enough that the free end of the pawl 22 engages the teeth of the ratchet 24. Each tooth of the ratchet 24 may have a rounded surface over which the free end of each pawl 22 , can slide, and a projecting surface against which the free end of each pawl 22 can engage and stop. Rotation of the setting knob 5 shown in Fig. 1 in one direction (for example, in a direction that would cause the piston rod 1 to move away from the needle end of the syringe 10) can cause the ratchet 23 to rotate so that the teeth of the ratchet 24 do not engage with the pawl 22 and the ratchet 23 can rotate independently. away from gear 20. However, turning the setting knob 5 in the opposite direction may cause the ratchet 23 to engage with the pawl 22 and cause the gear 20 to rotate, causing the piston rod 1 and piston collar 8 to move distally towards the end of the needle of the device, providing the possibility of filling the needle 13 and expelling air.

In FIG. 3A and 3B illustrate another version of the gear 3 shown in FIG. 1. In this embodiment, the piston rod 30 may include a toothed rack 32 extending along at least a portion of its length. The rack 32 may include a plurality of teeth 34 configured to mesh with the teeth 36 on the gear 33. In addition to the teeth 36, the gear 33 may include a limiting tooth in the form of a protrusion 35. The protrusion 35 may extend radially farther from the gear 33 than the teeth 36 and may have a height greater than that of the teeth 36. The gear 33 may rotate along the rack 32 (FIG. 3A) until the projection 35 on the gear 33 contacts the rack 32 or piston rod 30 (FIG. 3B). , stopping the rotation of the gear 33. Thus, the protruding member 35 can prevent more than one rotation of the gear 33. Therefore, stopping the rotation of the gear 33 can stop the piston rod 30 and piston collar 38 from advancing beyond the predetermined point. The set point may correspond, for example, to the point at which excess air and excess drug dosage can be removed from syringe 10 (see FIG. 1), resulting in accurate filling of syringe 10. In some embodiments, when protrusion 35 contacts piston rod 30 and gear 33 is in the position shown in FIG. 3B, the protruding member 35 may not be in contact with the rack 32, and the piston rod 30 may freely slide on it. Accordingly, in the embodiment of the invention according to FIG. 3A and 3B, instead of the length of the rack that controls the amount of movement of the plunger rod 30 being retracted to fill the syringe, the circumference of the gear 33 can control this movement.

The physical cessation of further movement of the gear caused by protrusion 35 on gear 33 may also provide tactile feedback to the user to indicate that the correct dose has been set and that syringe 10 is full. Incorporating a protruding member 35 on the gear 33 into the design of the device may further prevent over or under rotation of the gear 33 in an undesired direction (for example, it would allow the piston rod to move in a proximal direction). The protruding member 35 may be useful in preventing syringe 10 from overflowing or air being drawn into syringe 10 during handling, packaging, storage, and/or transport. In other embodiments of the invention, the protruding element 35 may be located on the rack 32, and not on the gear 33, or in addition to it, to control the movement of the gear 33.

In FIG. 3C and 3D illustrate another version of the piston rod 1 shown in FIG. 1. The piston rod 40 of FIG. 3C and 3D may include a locking mechanism configured to prevent the collar of plunger 48 from being accidentally depressed, for example, when the syringe is being packed, stored, handled and/or filled. In some embodiments of the invention, the piston rod 40 may include a telescopic inner part 49 (for example, an inner tubular part or column) having a toothed rack 42. The inner part 49 of the piston rod 40 may include a piston collar 48 connected to its distal end. The inner part 49 can move relative to the fixed outer part 41 (for example, the outer chamber). Rotation of the adjustment knob 45 can push the inner part 49 in a distal direction from the outer part 41 so that the inner part 49 moves independently of the outer part 41.

The setting knob 45 may be operatively connected to the telescoping interior 49 by a gear (e.g., shaft) shaft 44 and gear 43. Rotation of the setting knob 45 may in turn rotate the gear shaft 44 and gear 43. into engagement with the teeth on the rack 42 of the inner part 49, moving the inner part 49 in a distal direction from the outer part 41. In FIG. 3C illustrates the inner portion 49 of the telescopic piston rod 40 retracted into the outer portion 41, and FIG. 3D illustrates the inside 49 of the telescopic plunger rod 40 extending from the outside 41. Thus, turning the adjustment knob 45 can move the collar of the plunger 48 distally toward the end of the syringe needle to fill the needle and remove air bubbles.

While the inner portion 49 of the piston rod 40 may be extended from the outer portion 41 during needle filling, the outer portion 41 may not move during dose preparation. In such an exemplary embodiment of the invention, the setting knob 45 and/or the gear shaft 44 may, in some cases, interfere with the outer portion 41 of the piston rod 40, as a result of which the piston rod 40 cannot move relative to the syringe barrel and cannot be lowered when the piston is pressed. protruding platform 47 of the piston rod 40 during dose preparation. For example, to connect the gear 43 to the adjustment handle 45, the gear rod 44 may pass through the opening of the telescoping outer portion 41 of the piston rod 40. Thus, when the gear rod 44 is connected to the gear 43, the passage of the gear rod 44 through the side wall of the outer portion 41 may prevent movement of the outer portion 41. Because the outer portion 41 cannot be moved, the piston rod may not be able to descend. . Removing the setting knob 45 may disengage the gear rod 44 from the gear 43, causing the gear rod 44 to no longer pass through the outer portion 41. As a result, after the tuning knob 45 is removed, the gear rod 44 can be disengaged from telescopic parts and may no longer pass through the telescopic parts, which allows the piston rod 40 to move freely inside the syringe barrel. Moving the plunger rod 40 distally while pressing the protruding platform 47 may allow the dose to be administered.

In the embodiment of the invention shown in FIG. 3C and 3D, when the tab 47 is pressed, the telescoping inner 49 of the piston rod 40 can be locked in place relative to the outer 41, whereby pressing the tab 47 and moving the piston rod 40 does not cause the telescoping inner 49 to collapse inside the outer. part 41. The outer part 41 and the inner part 49 of the piston rod 40 can, for example, be connected to each other with positive fixation of the teeth (for example, the teeth 46 of the outer part 41), which can allow the inner part 49 to pass in a distal direction from the outer part 41, but may prevent the inner portion 49 from moving back inside the outer portion 41. This may prevent the two telescoping portions from collapsing into one another when the protruding platform 47 is depressed and the piston rod 40 moves distally to push the dose out. . This may also prevent the inner portion 49 from moving proximal during filling.

During use, the setting knob 45 can be rotated to fill the syringe, as shown in FIG. 3C and 3D, and finer and/or more controlled movements of the piston rod 40 for such filling may be allowed. As described above, the inclusion of a setting knob 45 in the design of the device can prevent any volume of drug to be dispensed from flowing out before filling is complete, and, for example, the setting knob 45 is pulled out to unlock the movement of the piston rod 40. While one type of locking mechanism associated with the tuning knob 45 has been described, it is contemplated that any suitable type of locking mechanism may be incorporated and that such locking mechanism can be activated and/or deactivated by withdrawing, pushing, sliding, or manipulating the tuning knob. 45 otherwise.

For example, other embodiments of the locking mechanism are shown in cross section in FIG. 4A and 4B. The locking mechanisms shown in Fig. 4A and 4B may be used in addition to the setting knob 45 shown in FIG. 3C and 3D, or instead. In the embodiment of the invention illustrated in FIG. 4A, the entire extent of the piston rod 50 or the proximal region of the piston rod 50 (e.g., the telescoping outer portion of the piston rod) may include a physical stop (e.g., a locking lip or protrusion) to prevent pressure on the piston rod 50 during dose preparation and filling—or to allow only pressing to prepare and fill the dose. In the embodiment of the invention shown in FIG. 4A, the locking protrusion 51 (shown in cross section from top to bottom) may prevent movement of the piston rod 50 in the distal direction until the piston rod 50 and/or the portion of the piston rod 50 having the protrusion 51 is rotated relative to other parts of the syringe. , for example, a finger rest (not shown), a stop 53 located at the neck of the syringe barrel 58, and/or a syringe barrel 58. In the embodiment of the invention shown in FIG. 4B, the piston rod 50 as a whole may have a cross-sectional shape that is not radially symmetrical, whereby the shape of the piston rod 50 may prevent its distal movement until the piston rod 50 is rotated relative to other parts of the syringe, for example, stop for fingers, limiter 53 and/or barrel 58 of the syringe. In order to depress piston rod 50, piston rod 50, stopper 53 and/or barrel 58 can be rotated relative to other parts of the syringe to enable piston rod 50 to be depressed enough to fully dispense the drug.

- 10 041108

In some embodiments, the piston rod 50 may not move past, for example, a finger stop or stop 53 in the syringe barrel until the piston rod 50 is rotated a certain number of degrees (eg, 90°) relative to the finger stop or stop. . In some embodiments, the finger stop or stop 53 may be rotated (eg, 90°) relative to the piston rod 50. For example, the plunger rod 50 may have a particular cross-sectional shape (eg, typically a rectangular shape and/or a projection 51), and the syringe barrel 58 and/or stop 53 may comprise a blocking component and/or may be sized and shaped such that so that the protruding portions 51 of the piston rod 50 cannot pass until the corresponding portions are rotated sufficiently so that the complementary shapes align and the piston rod 50 can pass.

In some embodiments, opening 52 in stopper 53 and/or syringe barrel 58 (and/or finger rest, not shown) and piston rod 50 cross section may have complementary shapes, but may be offset from each other if one or the other will not be rotated until the shapes are aligned. In FIG. 4A and 4B, the protrusions 51 or the overall shape of the piston rod 50 do not align with the bore 52 until the finger rest or piston rod 50 is rotated sufficiently. Although the two projections 51 from the piston rod 50 and the corresponding shape of the bore 52 are shown in FIG. 4A, while the predetermined cross-sectional shape of the piston rod 50 is shown in FIG. 4B, it is contemplated that any suitable numbers, sizes, and profiled openings and projections and/or cross-sectional shapes may be used. In addition, although the exemplary embodiments of the invention show that the required rotation is 90°, it is contemplated that any suitable amount of rotation (less than or greater than 90°) may be required.

In FIG. 4C-4E illustrate a side view of a syringe 54 having a piston rod 50 with projections 51 in three different positions. The syringe 54 may include a stop 53 through which the projections 51 cannot align until the projections 51 and the stop 53 are rotated relative to each other so that the shape of the projections 51 matches the complementary opening in the stop 53 (see, for example, dotted lines in Fig. 4A). The piston rod 50 may be connected to a piston 56 which may be configured to fit snugly within the barrel 58 of the syringe 54. The syringe 54 may contain a volume of drug 12 suitable for dispensing from the syringe 54. FIG. 4C, syringe 54 is illustrated in a first, non-actuated position. The projections 51 are arranged around the piston rod 50 in a first orientation. In FIG. 4D syringe 54 is illustrated in a second, partially powered position. The protrusions 51 in the first orientation are blocked from passing through the stop 53, and thus further depression of the piston rod 50 is also blocked. In FIG. 4E, syringe 54 is illustrated in a fully activated position. By rotating the piston rod 50 (eg, in the order indicated by the curved arrow, or vice versa in the opposite direction), the protrusions 51 can be moved to a second orientation relative to the piston rod 50. In the second orientation, the protrusions 51 can pass through the stop 53, further pressing the piston rod 50 and the piston 56.

In some embodiments, projections 51 may be positioned on plunger rod 50 such that they do not protrude from the overall profile of syringe 54. For example, projections 51 may be positioned within, for example, barrel 58 before the syringe 54 is actuated (e.g., , in Fig. 4C). In such embodiments, the protrusions 51 may be positioned, for example, within a portion of the restrictor 53 prior to actuation of the syringe 54. In some such embodiments, the restrictor 53 may be thick enough to accommodate the projections 51, and may have a proximal cavity, which is sized to accommodate the protrusions 51 in a first orientation, and a more distal cavity configured to receive the protrusions 51 in a second orientation such that rotation of the piston rod 50 and/or the protrusions 51 can allow the piston rod 50 to move in distal direction.

In some embodiments, a second row of projections may be incorporated into the piston rod 50 either proximal or distal to projections 51. The second row of projections may have a similar geometry to projections 51, but may be radially offset relative to projections 51 in this manner. , which requires additional rotation of the piston rod 50 in order for the second row of protrusions to pass through the hole, for example, in the stopper 53 (for example, the hole 52). Alternatively, the second row of protrusions may have a geometry that cannot pass through the bore, whereby the piston rod 50 cannot move in a given direction due to its geometry. Such a second row of protrusions may be useful, for example, to limit movement of the piston rod 50 either before or after the protrusions 51 pass through the bore. In some embodiments, limiting movement in this way can be used to control the amount of movement of the piston rod 50 allowed to fill the syringe 10 before further rotation of the piston rod 50 to ensure that the dose amount is dispensed from the syringe 10. In additional embodiments of the invention limiting movement in this manner can be used to control the amount of dose that can be dispensed from syringe 50 (see, for example, FIGS. 15A-E, described below). As is the case with all embodiments of the invention illustrated and described herein, this embodiment of the invention may be combined with aspects of other embodiments of the invention described herein.

In some embodiments, the syringe may be configured to provide feedback to the user to indicate when rotation of the piston rod 50 and projections 51 and/or finger rest is complete and the piston rod 50 is aligned with the holes 52 (see FIG. .4A-4B). For example, a click sound or other audible or tactile feedback mechanism may be included in the syringe.

Referring now to FIG. 5, another exemplary syringe 60 is shown having a dosing control mechanism. In the embodiment of the invention shown in FIG. 5, the dispensing control mechanism includes two rows of angled helical threads. The first row of helical threads 62 is contained on the outer surface of the piston rod 61. The thread 62 may extend around the entire circumference of the piston rod 61 or around a portion of the circumference. The second row of helical threads 63, mate with the external helical thread 62 of the plunger rod 61, is contained on the inner circumference of the syringe barrel 69 and/or finger stop 64 through which the piston rod 61 passes. The thread 62 may extend around the entire circumference of the syringe barrel 69 and/or finger rest 64, or around a portion of the circumference. The threads 62, 63 may be cut, cast, machined, affixed, or otherwise incorporated into the surfaces of the piston rod 61 and syringe barrel 69 or finger rest 64, respectively.

Piston rod 61 can rotate to move threads 62 of piston rod 61 through threads 63, converting rotational motion of piston rod 61 into translational (or linear) movement of piston rod 61 (and hence piston collar 68) in syringe barrel 69. The linear movement of the cuff of the plunger 68 can expel air bubbles and excess drug through the needle 66 of the syringe. Thus, the needle 66 can be filled and prepared for injection by rotating the piston rod 61. Both threads 62, 63 may be sized and configured such that after thread 62 has fully passed through thread 63, air is purged from syringe barrel 69 and a predetermined volume of drug is expelled from syringe needle 66 to fill needle 66.

The threads 62, 63 can also prevent piston rod 61 from being depressed before needle 66 is filled. For example, to push piston rod 61 to dispense medication, piston rod 61 must first be rotated, i.e. needle 66 must be filled first. After thread 62 has passed through thread 63 and filling is complete, the user may depress piston rod 61 to deliver the dose.

As discussed above with reference to FIG. 1, the embodiment of the invention shown in FIG. 5 may also optionally include a magnifying glass 65. The magnifying glass 65 may assist in reading enlarged measurement indicators on the syringe barrel 69, may assist in observing the presence or absence of air bubbles in the syringe barrel 69, and/or may help determine whether a full dose has been dispensed. dose of drug from syringe 60. A magnifying glass 65 may be contained in the distal region of syringe 60 and may be of any suitable shape or size. For example, the magnifying glass 65 may be circular or rectangular, or may extend around all or part of the circumference of the syringe barrel 69. In other embodiments, the magnifying glass 65 may not be included.

To actuate the syringe 60, the user may first rotate the piston rod 61. Piston rod 61 may need to be rotated in the form of a partial turn, one full turn, or more than one full turn to pass thread 62 through thread 63 and disengage thread 62 from thread 63. At this time, the user may further confirm the dose level in syringe barrel 69. The user may use a magnifying glass 65 to perform this step if a magnifying glass 65 is provided. The user can then press the plunger rod 61 to dispense medication.

In some embodiments of the invention, the syringe 60 may provide feedback to the user to indicate when the rotation of the piston rod 61 is completed and the dose is ready for injection. For example, a click sound or other audible or tactile feedback mechanism may be included in syringe 60.

The embodiment of the invention shown in FIG. 6A-6E may operate similarly to the embodiment of the invention depicted in FIG. 5, but may further include a locking mechanism to prevent piston rod 71 from being accidentally pressed when filling of the needle is completed. For example, as in FIG. 5, the embodiment of the invention shown in FIG. 6A-12 041108

6E includes threads 72 on the piston rod 71 that must pass through the corresponding threads of the syringe barrel 75. However, the piston rod 71 may also include a stopper 74 located on the outer surface of the piston rod 71 proximal to the threads 72.

Stopper 74 may be sized and shaped to fit slot 76 that extends through thread 73. For example, stopper 74 may fit into a vertical portion of slot 76 passing through some of the internal threads 73 of syringe barrel 75 (as shown, for example, in section A-A in Fig. 6B and 6C). The groove 76 may also include a horizontal portion (eg, along section B-B shown in FIGS. 6B and 6D). After the stopper 74 is fully retracted into the vertical part of the slot 76, the user must rotate the piston rod 71 in the opposite direction to the direction of the threads 72 of the piston rod 71 to push the stopper 74 through the horizontal part of the slot 76 and advance the piston rod 71 further in the distal direction. By virtue of the need for the opposite direction of rotation, the risk of accidental further movement of the piston rod 71 can be reduced. Ultimately, the plunger may be depressed to move stopper 74 through the second vertical portion of slot 76 (eg, section C-C shown in FIGS. 6B and 6E) to expel the drug volume.

The slot 76 may be shaped to require clockwise or counterclockwise rotation, depending on the relative position of the horizontal and vertical portions. In addition, although the slot 76 is shown and described as containing a single horizontal portion requiring rotation of the stem 71, it is contemplated that multiple horizontal portions may be contained requiring rotation of the stem 71 in the same direction or in multiple directions. In addition, although the stopper 74 is depicted as having two projections on the piston rod 71, it is contemplated that one or more projections may be included as part of the stopper 74, and the slot 76 may be shaped and sized to accommodate various stopper configurations. 74.

Although the thread 73 is described as being on the inner surface of the syringe barrel 75, it is contemplated that the thread 73 and slot 76 may be located on the inner surface of the finger rest in addition to or instead of the syringe barrel 75. In addition, as is the case with all embodiments of the invention illustrated and described herein, the above-described embodiment of the invention may be combined with aspects of other embodiments of the invention described herein. For example, stem 71 may include additional projections and/or geometries such as those shown in FIG. 4A-4E and FIG. 15A-15E to immediately stop the movement of the stem 71.

In FIG. 7A and 7B illustrate another embodiment of the invention for a dosing control mechanism. Syringe 80 shown in FIG. 7A includes complementary helical threads 82 and 83. Male thread 82 in this embodiment is located on a sleeve 87 surrounding piston rod 81 rather than directly on piston rod 81. A close-up of the threaded portions of the syringe 80 is shown in FIG. 7B. Sleeve 87 may allow free distal movement of piston rod 81 (towards the end of syringe needle 80), but may block unwanted proximal movement of piston 88. end of sleeve 87) can be translated into controlled sliding movement of sleeve 87 within syringe barrel 89 by threads 82 on sleeve 87 and corresponding threads on finger rest 84 and/or syringe barrel 89. The adjustable sliding movement of the sleeve 87 can progressively push the piston rod 81 and stopper 88 towards the distal end of the needle of the device. Movement of the piston rod 81 through the threaded region can provide controlled air displacement and filling of the needle 86.

As in the previous embodiments of the invention, shown in FIG. The 7A embodiment may also optionally include a magnifying glass 90. The magnifying glass 90 may magnify measurements of the volume of drug in the syringe barrel 89, may aid in observing the presence or absence of air bubbles in the syringe barrel 89, and/or may help determine whether whether a full dose of drug has been dispensed from syringe 80. A magnifying glass 90 may be included in the distal region of syringe 80 and may be of any suitable shape or size. For example, the magnifying glass 90 may be circular or rectangular in shape, or may extend around all or part of the circumference of the syringe barrel 89. In other embodiments, the magnifying glass 90 may not be included.

Actuation of the syringe 80 may require rotation of the tuning knob stem 85 in the form of a partial turn, one full turn, or more than one full turn in order to pass the threads 82 of the sleeve 87 through the threads 83 until the threads 82 disengage. threaded 63. At this time, the user can additionally confirm the dose level in the barrel 89 of the syringe. The user may use magnifying glass 90 to perform this step if magnifying glass 90 is included. The user can then press the piston rod 81 to dispense the drug.

- 13 041108

In some embodiments of the invention, the syringe 80 may provide feedback to the user to indicate when the rotation of the piston rod 81 is completed and the dose is ready for injection. For example, a click sound or other audible or tactile feedback mechanism may be included in syringe 80. In some embodiments, the user may know that filling is complete because the tuning handle rod 85 may no longer rotate, the piston rod 81 may not move further when rotated, and/or the tuning handle stem 85 may abut against a portion of the finger stop 84 and /or cylinder 89 of the syringe, preventing further distal movement of the rod 85 of the adjustment handle.

In some embodiments, piston rod 81 may incorporate a locking mechanism similar to that described above with reference to FIG. 6A-6E. By allowing piston rod 81 to rotate (e.g., 90°, although piston rod 81 is also expected to rotate more or less than 90°) prior to insertion to allow piston rod 81 to move freely, piston rod 81 can be prevented from being pressed distally during filling. needles.

In other embodiments, bushing 87 shown in FIG. 7A and 7B, a locking or locking mechanism may be incorporated. Such a mechanism is shown in Fig. 8. By embedding stops 91 and/or 92 (for example, tongues or protrusions) on sleeve 87 (for example, at positions above and/or below threads 82 on sleeve 87 and threads 83 in the syringe barrel), excessive rotation of the sleeve in any direction ( and thus overfilling or unwanted removal of the sleeve 87) can be prevented. The stopper 91 may be located proximal to the threads 82 and may be configured to stop the movement of the sleeve 87 towards the distal end region of the syringe barrel. The stopper 92 may be located distal to the threads 82 and may be configured to stop the movement of the sleeve 87 towards the proximal end region of the syringe barrel.

Referring now to FIG. 9A-9D, another syringe 100 is shown with a further embodiment of the invention of a dosing control mechanism. This embodiment of the invention may include, for example, a key 103 that acts as a removable stop at the interface between the syringe barrel 109 and the piston rod 101. The key 103 may prevent the piston rod 101 from moving when it is in place between the syringe barrel 109 and the proximal region of the piston rod 101. The key 103 can be placed between the piston rod 101 and the syringe barrel 109, for example, during packaging, filling, or preparation of the syringe 100 The key 103 may be installed in place by a snap fit, a friction fit, a twist fit, or otherwise in any suitable manner. The user may then remove the key 103 just prior to using the syringe 101. To remove the key 103, the user may pull out the tab contained in the key 103, may tear off the tab, may break a fragile part, may turn the key 103, or may remove the key 103 in any suitable manner. Syringe 100 is depicted as having a magnifying glass 105 located at the distal end of the syringe barrel 109, which may aid in visualizing the level of drug in the barrel 109, for example.

It is contemplated that the key and/or locking mechanisms described above may be useful with refillable syringes as well as prefilled syringes that may be sterilized, packaged, stored and/or transported after filling. In pre-filled syringes, the key 103 can prevent the plunger rod 101 from being accidentally depressed prior to its intended use, thereby maintaining sterility, safety, and drug dose volume. Variations on the key 103 may include, for example, a brittle stopper that can be broken if a certain amount of force is applied to the piston rod 101.

In addition to the key 103, the embodiment illustrated in FIG. 9A may include a blocking mechanism similar to that discussed above, for example with reference to FIG. 4A-4E or FIG. 15A-E, further described herein. For example, as shown in FIG. 9D, the restrictor 104 of the syringe 100 may include a slot 107. The restrictor 104 may have an open portion 110 through which the piston rod 101 can move without being rotated to a predetermined position. The open portion 110 may allow the piston to move a suitable distance to fill the needle 106. The slot 107 may be sized and shaped to match the cross-sectional area of the piston rod 101 in a particular orientation. For example, the plunger rod 101 may include a protrusion 102 sized and shaped to pass through the slot 107 when aligned with the slot 107. The stopper 104 may be positioned in the proximal region of the syringe barrel 109 such that the plunger rod 101 must rotate into an operating position. to align projection 102 with slot 107 to pass through at least a portion of stopper 104. Although projection 102 and associated slot 107 are depicted, slot 107 and piston rod 101 may have any suitable complementary cross-sectional shape. In addition, the piston rod 101 may have several cross-sectional geometries along its length to either provide an immediate stop to the distal movement of the piston rod 101 or require additional

- 14 041108 rotation of the piston rod 101 relative to the limiter 104 to further move the piston rod 101 (see for example, Fig. 15A-15E). As is the case with all embodiments of the invention illustrated and described herein, this embodiment of the invention may be combined with aspects of other embodiments of the invention described herein.

After the key 103 is removed, the piston rod 101 can be allowed to move distally from its original position down through the open portion 110 of the stopper 104. This distal movement of the piston rod 101 can move the piston collar 108 enough to fill the needle 106 and remove air bubbles. Stopper 104 may stop further distal movement of piston rod 101 when lip 102 touches the interior of stopper 104 where slot 107 begins. may be advanced distally through the remainder of the restrictor 104 to move the collar of the plunger 108 and release the dose of drug.

In some embodiments, syringe 100 may be configured to provide feedback to the user to indicate when plunger rod 101 and lug 102 are aligned with slot 107 and/or when filling of syringe 100 is complete. For example, syringe 100 may include a clicker sound or other audible or tactile feedback mechanism.

Next, with reference to FIG. 10A-10C depict a cross section of a syringe 200 with various embodiments of the invention for an additional dosing control mechanism. The syringe 200 may include a barrel 240 and a piston rod 220. The piston rod 220 may be coupled to a first piston 222 which may be configured to fit into a bore in a lip 210 located at the proximal end of the piston rod of the cylinder 240. The lip 210 can be configured to securely fit within the cylinder 240 and can be, for example , is isolated from the interior of the cylinder 240 by an O-ring 208. The interior of the cylinder 240 may include a second piston 260 configured to fit within the interior of the cylinder 240. The first fluid 244 may be located within the cylinder 240 on the proximal side of the piston 260, and a second fluid, such as a drug 212, may be located within the cylinder 240 on the distal side of the plunger 260. A needle, cannula, tube, or other device may be attached to the distal end of the cylinder 240 through which a fluid, such as a drug, may be expelled or withdrawn. 212.

The opening of the protrusion 210 may have a cross-sectional width a which is suitable for the piston 222 to be securely fixed therein. In some embodiments, the piston 222 may be configured to form a seal on the protrusion 210, for example, using an O-ring 224. The portion of the protrusion 210 having a width a may also have a depth c. As shown in FIG. 10A, in some embodiments, depth c may correspond to the distance between the distal side of piston 222 and the distal side of lip 210. displacement in the distal direction of the first volume of liquid 244 in the opening of the protrusion 210 to a distance corresponding to the depth c. The expulsion of the first volume of fluid 244 may in turn push the piston 260 causing the second volume of drug 212 to be expelled from the syringe 200. The cylinder 240 may have a cross-sectional width b located distal to the protrusion 210, with the width b being greater than the width a. Due to differences between widths a and b (and thus due to differences in specific liquid capacity in portions of syringe 200 having widths a and b), distal movement of piston 222, for example, a distance corresponding to depth c, may cause piston 260 to distally move a smaller distance d. Thus, movement of, for example, the piston rod 220 in the distal (or proximal) direction can be converted into a proportionally smaller and thus more controlled movement of the piston 260 and, thus, a more controlled expulsion (or withdrawal) of the drug volume 212 .

The embodiments of the invention illustrated in FIG. 10B and 10C may differ to some extent from the embodiment depicted in FIG. 10A. Referring to FIG. 10B, both cross-sectional widths a and b may be the widths of the opening in the projection 210. In such embodiments, the second piston rod 262 may be positioned within the cylinder such that a portion of the piston rod 262 is located within and extends through the interior portion of the projection 210. , which has width b. The piston rod 262 may be connected to the piston 260 and may proximally extend from it. Moreover, the piston rod 262 may have a proximal side that extends through a region of the opening in the protrusion 210 having a width b, whereby distal movement of the fluid 244 may cause distal movement of the piston rod 262, which in turn may push the piston 260 into distal direction. As illustrated in FIG. 10C, the cross-sectional width b may refer to the internal cross-sectional width of the cylinder 240, as in the embodiment of the invention illustrated in FIG. 10A, and the second piston rod 262 may be located within, and may extend through, the interior of the cylinder 240. Similar to the embodiment of the invention illustrated in FIG. 10B, piston rod 262 may have a proximal side that extends through the interior of cylinder 240 having width b, whereby distal movement of fluid 244 may cause distal movement of piston rod 262, which in turn may push piston 260 in a distal direction. . As with the syringe 200 embodiment illustrated in FIG. 10A, movement of, for example, piston rod 220 in a distal direction can be translated into a proportionally smaller and thus more controlled movement of piston 260, and thus more controlled ejection (or withdrawal) of drug volume 212.

With regard to the embodiments of the invention illustrated in FIG. 10B and 10C, piston rod 262 may form a seal with adjacent parts of syringe 200 such that fluid 244 cannot pass distally through/other than piston rod 262. This may result in the need for less fluid 244 and may allow for an area of void space between fluid 244 and drug 212, which may help prevent leakage or mixing of fluid 244 with drug 212. Said void space may contain a vacuum or may contain, for example , dry or sterile air. In some embodiments, the void space may contain additional fluid 244 (or other fluid) to provide additional support to the syringe structure. In any of the embodiments of the invention illustrated in FIG. 10A-10C, liquid 244 may be any suitable liquid or gaseous liquid, such as, for example, water for injection, dry gas, sterile air, or the like.

Referring now to FIG. 11A shows a cross-sectional view of another syringe 300 with a further embodiment of the inventive dosing control mechanism. The syringe 300 may include a barrel 340, a plunger 360, and a medicament 312. The plunger rod 320 may extend into the barrel 340 and may include a plurality of ratchet teeth 321 that may engage with gears 328 that may in turn engage with ratchet teeth 326 on the inside of the cylinder 340. Each of the gears 328 may be connected to one of the rods 330, which may be connected to the piston 360. A needle, cannula, tube, or other device (not shown) may be attached to the distal end a cylinder 340 through which a liquid (eg, drug 312) can be displaced or withdrawn.

Movement of the plunger rod 320 in a proximal or distal direction may result in proportionally less movement of the plunger 360 through the gears 328 and teeth 326. Thus, controlled movement of the plunger 360 in the distal direction may, for example, expel drug 312 distally at a controlled rate. The sizes and shapes of the teeth, ratchets, and gears in the syringe 300 can be chosen to create the desired controlled speed of the piston 360.

In FIG. 11B illustrates in cross section another embodiment of the invention of a syringe 300 in which the teeth 321 of the piston 320 can be engaged with gears 328, each of which can be connected coaxially and can rotate together with relatively smaller gears 329, which in turn can engage teeth 326 on the inside of cylinder 340. Gears 328 may fit against teeth 326 such that only gears 329 engage teeth 326. Each of gears 328, 329 may be connected to one of rods 330, which may be connected to the piston 360.

Due to the relatively smaller diameter of the gears 329 compared to the gears 328, the movement of the piston 320 in the proximal or distal direction can be translated through the gears 328, gears 329 and teeth 326 into a proportionally smaller movement of the piston 360. Thus, the controlled movement of the piston 360 in the distal direction can , for example, result in relatively less movement of plunger 360 and controlled displacement of drug 312 distally. As in FIG. 11A, the sizes and shapes of the teeth, ratchets, and gears in the syringe 300 can be selected to create the desired controlled speed of the plunger 360.

Although each of the embodiments of the invention illustrated in FIG. 11A and 11B shows a symmetrical design including teeth 321 on two sides of the piston rod 321, two gears 328, two gears 329 (as with the embodiment of the invention depicted in FIG. 11B) and two rods 330, an unpaired design is also provided, for example, teeth 321 meshing with a single gear 328, which may be coupled to a single gear 329 (referring to the embodiment depicted in FIG. 11B), which may be coupled to a single shaft 330. Those skilled in the art will understand that in order to achieve controlled delivery of the contents of the syringe 300, more or fewer gears and/or rods may be included in embodiments of the present invention.

- 16 041108

Next, with reference to FIG. 12 shows a side cross-sectional view of another syringe 400 with a further embodiment of the invention for controlling the dosing. The syringe 400 may include a barrel 402, an inner sleeve 404, and a piston rod 406. The piston rod 406 may extend inside the cylinder 402 and into the opening 410 defined by the inner sleeve 404, with the opening 410 being narrower than the overall internal width of the cylinder 402. The opening 410 may receive or contain the drug 408.

In general, syringe 400 may be configured to provide a relatively narrow channel or path (eg, in bore 10) through which drug 408 may be pushed by plunger rod 406, whereby distal movement of plunger rod 406 can be made relatively gradual and controlled ejection or delivery of drug 408 through the distal end of syringe 400 (e.g., through a needle, cannula, tube, or other device connected to syringe 400) compared to a syringe having a relatively wider drug channel or path 408.

As shown, the distal portion of the piston rod 406 may be configured to pass through the bore 410 of the inner sleeve 404. The inner sleeve 404 may be integral with the cylinder 402 (e.g., may be adjacent to or integral with the cylinder 402 ) or may be a separate piece inserted into the cylinder 402. The inner sleeve 404 may extend partially or completely through the interior of the cylinder 402. In some embodiments of the invention, as shown, the inner sleeve 404 may be located in the distal portion of the interior of the cylinder 402.

The piston rod 406 can be mated, coupled, or otherwise contacted with a piston configured to contain a volume of drug 408 within the orifice 410 and/or between the piston rod 406 and the distal end of the syringe 400. The piston rod 406 and/or the piston connected to piston rod 406 may be configured to fit snugly within barrel 402 such that it contains drug 408 without leakage of drug 408 into the common interior of barrel 402 (eg, proximal to inner sleeve 404). Orifice 410 and plunger shaft 406 may be configured to have a relatively narrow width, thus creating a relatively narrow passage through which drug 408 may be expelled from syringe 400.

In some embodiments, barrel 402 may be marked with measurement indicators to visually indicate the volume of fluid remaining in and/or dispensed from syringe 400. In addition, as shown or described in relation to other embodiments of the invention, the syringe 400 may further include a magnifying glass attached to or built into the syringe barrel 402, which can assist in reading the measurement indicators on the syringe barrel 102, can assist in monitoring the presence of or the absence of air bubbles in the syringe barrel 102, and/or may help determine whether a full dose of drug 408 has been dispensed from the syringe 400. Such a magnifying glass may be included in the distal region of the syringe 10 and may be of any suitable shape or size. In other embodiments of the invention, the magnifying glass 11 may not be included.

In other embodiments, the narrow bore of the syringe 400 may be achieved in a manner that does not require an inner sleeve 400. For example, a syringe barrel (eg, barrel 402) may be made with a relatively narrow interior designed to receive the piston rod 406, resulting in so there is no need to narrow the insert located inside the cylinder. The narrow interior of the syringe barrel may be sized and configured to hold a volume of drug (eg drug 408) which will result in the required or appropriate amount of drug being dispensed from syringe 400 when it is used.

Aspects of the embodiment of the invention illustrated in FIG. 12 may be particularly suitable for combination with aspects of other embodiments of the invention discussed in this document. For example, any embodiment of the present invention may also include a relatively narrow (or tapered) interior to allow smoother and more controlled drug delivery.

Next, with reference to FIG. 13A-13C are cross-sectional side views of another syringe 420 with an additional embodiment of the invention for controlling the dosage. Syringe 420 may include a barrel 422, a piston rod 424, and a plunger 426. The interior 428 of barrel 422 may contain or receive medication 430 and insert 432.

The insert 432 may include a compressible portion, whereby the insert 432 may be compressed to a predetermined distance or volume. For example, in some embodiments of the invention, the insert 432 may be a spring, such as a wave spring, a coil spring, or any other spring known in the art. For example, in additional embodiments of the invention, the insert 432 may be made of a compressible material such as rubber, silicone, or plastic. In some embodiments of the invention, the insert 432 may be attached or otherwise held in the desired location, specific location/orientation in the cylinder 422.

The initial configuration of the filled syringe 420 is shown in FIG. 13A. In this configuration, some drug 430 is located between piston 246 and insert 432, as is an empty space (eg, air bubble) in interior 428. As illustrated in FIG. 13B, when plunger rod 424 is depressed distally, some drug 430 between plunger 426 and insert 432 may be forced distally out of syringe 420 along with an air bubble (e.g., through a needle, cannula, tube, or other device attached to the distal end). syringe 420 fixture). Upon contact with plunger 426, insert 432 may offer some resistance to further distal movement 426. This may provide, for example, tactile, auditory, and/or visual feedback to the user of syringe 420 indicating that syringe 420 has been filled and air bubbles have been removed.

The distance a that insert 432 can be compressed may be proportional to the volume of drug 430 suitable for dispensing contained within cylinder 422. For example, in some embodiments, the volume defined by insert 432 may correspond to the volume of drug 430 suitable for dispensing, which is contained within the cylinder 422. Thus, as shown in FIG. 13C, as plunger 426 moves further distally to compress insert 432 by a distance a, some drug 430 suitable for dosing can be dispensed from the distal end of syringe 420. For example, plunger 426 can move distally, resulting in whereby a volume of medicament 430 corresponding to the volume determined by insert 432 is dispensed. Insert 432 may be configured to prevent it from collapsing or moving beyond the distance a, thus ensuring that only some amount of medicament 430 suitable for dosing is dispensed. The remaining amount of the drug 430 may remain inside the cylinder 422 after dosing the dose amount. In some cases, this may provide improved dosing accuracy because piston 426 does not have to deal with any constriction in barrel 422 that may be experienced near the distal end of syringe 420.

Next, with reference to FIG. 14A-14C are side cross-sectional views of another syringe 440 with a further embodiment of the invention of a three-stage dosing control mechanism. Syringe 440 may include a barrel 442, a piston having an outer piston rod 444, and an inner piston rod 446, both of which can be actuated by a handle or a stop on the rod 448. The inner piston rod 446 can be located within and coaxial with the outer rod 444 piston. The inner piston rod may protrude proximally and/or distally from the outer piston rod 444. The piston 450 may be coupled to either or both of the inner piston rod 446 and the outer piston rod 444. In particular, the piston 450 may be movably connected to the internal piston rod 446 of the piston. A volume of drug 454 may be received or placed within barrel 442 between plunger 450 and the distal end of syringe 440. Insert 456 may be located distal to plunger 450, such as at the distal end portion of the interior of barrel 442. Insert 456 may include a channel 458 having dimensions and configuration for accommodating the inner piston rod 446 (but not the piston 450 or outer piston rod 444).

As shown in FIG. 14A, the inner piston rod 446 may protrude both proximally and distally from the outer piston rod 444. A seal (not shown) may exist between the inner piston rod 446 and the outer piston rod 444 to prevent leakage of any fluid between the piston rods. In some embodiments, the inner piston rod 446 may protrude only distally, or may protrude only proximally from the outer piston rod 444. For example, the inner piston rod 446 may be a telescoping piston rod, which may be extendable only in a distal direction from the piston rod 444. In some embodiments, inner piston rod 446 may be configured to fold and extend, slide, or otherwise move through outer piston rod 444 and piston 450 as needed. In some embodiments, for example, inner piston rod 446 may include a threaded a portion on its outer side (not shown) configured to mate with complementary threads on the inside of the outer piston rod 444 (not shown). When inner piston rod 446 and outer piston rod 444 are engaged by these threads or by any other mechanism, inner piston rod 446 and outer piston rod 444 can move proximally and distally within cylinder 442 together. When the inner piston rod 446 is rotated (for example, by turning a handle or a stop of the rod 448) relative to the outer piston rod 444, the inner piston rod 446 can be movable or can move in the proximal direction and in the distal direction independently of the outer piston rod 444 and, V

- 18 041108 in particular, can be provided with the ability to move distally through the outer rod 444 of the piston and the piston 450. In some embodiments of the invention, the piston 450 can be attached to the distal end of the outer rod 444 of the piston, as a result of which the inner rod 446 of the piston can move both through the outer both piston rod 444 and piston 450 without causing separation between outer piston rod 444 and piston 450. In other embodiments, the distal end of outer piston rod 444 may simply engage or be pressed against piston 450.

The initial configuration of syringe 440 is illustrated in FIG. 14A. As shown, inner piston rod 446, outer piston rod 444, and piston 450 are all located proximal to the drug volume 454 contained within barrel 442. As shown in FIG. 14B, when the stop of the stem or handle 448 is pressed, both the inner plunger stem 446 and the outer plunger stem 444 can move distally through the barrel 442, causing the plunger 450 to be forced through the barrel 442. This can be used to fill the syringe, remove air, and excess drug 454 from barrel 442 by expelling it through, for example, the distal end of barrel 442 (through, for example, a needle, cannula, tube, or other device at the distal end of barrel 442). Distal movement of piston rods 444, 446 and piston 450 may eventually be stopped by contact between piston 450 and insert 456. This may provide, for example, tactile, auditory and/or visual feedback to the user indicating that filling is complete.

As shown in FIG. 14C, the inner piston rod 446 can then be allowed to move distally independently of the outer piston rod 444, for example, by rotating the inner piston rod 446, causing the inner piston rod 446 to disengage from the outer piston rod 444. Such rotation may, for example, cause the threads on the outside of the inner piston rod 446 to disengage from the threads on the inside of the outer piston rod 444. In some embodiments, such rotation may allow the internal piston rod 446 to expand (eg, telescopically) distally. The inner piston rod 446 can then move distally through the channel 458, which can contain a volume of drug 454 suitable for the dose size. Thus, the inner piston rod 446 may be configured to expel a desired dose of drug 454 through the distal end of the barrel 442. a piston that may be sized and configured to move distally through channel 458 and force a volume of drug 454 appropriate for the dose amount toward and through the distal end of barrel 442.

Next, with reference to FIG. 15A-15E show views of another syringe 500 with a further embodiment of the invention for a dosing control mechanism. Syringe 500 may include a barrel 502 and a plunger rod 503 having a shaft handle or stop 504 and protrusions 506, 508 that extend in directions that are offset from each other. The piston rod 503 also includes a stopper 510. The proximal end of the cylinder 502 is capped off by a keyhole ridge 512 (a top-down view as shown in FIG. 5E). The piston 514 is located in the interior of the cylinder 502 so that it can come into contact and be pushed in the distal direction by the piston rod 503. The interior of barrel 502 may also contain a volume of medication 516 distal to piston 514.

The initial configuration of syringe 500 is illustrated in FIG. 15A. As shown, the piston rod and piston 514 are positioned proximal to the drug volume 516. The protrusions 506 that extend to the distal end portion of the piston rod 503 are positioned to pass through the keyhole shape in the protrusion 512, allowing the piston rod 503 to move into distally until the protrusion 512 touches the protrusions 508 (FIG. 15B). The amount of distal movement allowed in this configuration may be sufficient to fill syringe 500 and remove air between plunger 514 and drug 516. As shown in FIG. 15B, the piston rod 503 can be prevented from moving further by contact between the protrusion 512 and the protrusions 508, which may have a similar shape and size to the protrusions 506, but in a different configuration than the protrusions 506 (e.g., rotary offset configurations) .

In FIG. 15C illustrates syringe 500 with piston rod 503 rotated 90 degrees. In this configuration, the protrusions 508 can now pass through the protrusion 512 as shown in FIG. 15D. The piston rod 503 may then move distally until its movement is stopped by the stop 510, which may be shaped and/or sized to not pass through the protrusion 512 in any orientation. Movement of the piston rod 503 as shown in FIG. 15C-15D may dispense a volume of drug 516 equivalent to the appropriate or desired dose for the patient (eg, with a needle, cannula, tube, or other attachment to the distal end of syringe 500). Although the piston rod 503 is shown rotated 90 degrees in FIG. 15C-15D, it should be understood that the projections 506 and 508 may be rotatably offset by any suitable amount.

In some embodiments of the invention, as shown in FIG. 15D, after dispensing a desired or appropriate volume of drug 516, piston 514 may not be flush with the distal end of the interior of cylinder 502, and drug volume 516 may remain in cylinder 502. In some embodiments, this may allow for improved accuracy in volume of dose delivered from the syringe 500, since discrepancies in size or shape between the restrictor 514 and the distal end of the barrel 502 will not prevent the required or appropriate dose volume from being dispensed. Additionally, this (and other embodiments herein) can eliminate the need for a dosing line on syringe 500, which can reduce or eliminate inaccuracies that may occur when placing a dosing line on barrel 502 during manufacture and/or visual measurement. whether the volume of the drug 516 matches the dosing line on the cylinder 502.

It should be noted that while the protrusions 506, 508 are depicted as having a specific shape and size, it is intended that they and the corresponding opening in the protrusion 512 may be of any suitable shape and size to allow the protrusions 506, 508 to pass through the protrusion 512. In addition, it should be noted that although a hole is shown in the protrusion 512, any appropriately shaped hole may be included in any portion of the syringe 500 suitable for controlling the movement of the plunger rod 503 (e.g., finger rest, stopper attached to the proximal end part of the barrel 502, the proximal side of the barrel 502, or any other suitable part of the syringe 500).

Next, with reference to FIG. 16A-16E show views of another syringe 600 with a further embodiment of the invention for a dosing control mechanism. The syringe 600 may include a barrel 602 and a plunger rod 603 having a plunger stop 604 and a protrusion 606. The plunger 608 is located within the interior of the barrel 602. A removable key 610 is located at the proximal end of the barrel 602. The interior of the barrel 602 may also contain a volume of medication 612. The proximal end of the cylinder 602 may be closed or occluded in any suitable manner, having an opening configured to pass a thin portion of the piston rod 603.

In some aspects of this embodiment, protrusion 606 may be sized and configured so that it cannot extend beyond key 610. Thus, piston rod 603 can only be pushed distally until protrusion 606 contacts wrench 610. The protruding portion 606 may be attached to the piston rod 603 in any suitable manner, or it may form a single unit (for example, cast as a part) with the piston rod 603.

In some embodiments, key 610 may be a separate construction from other aspects of syringe 600. In other embodiments, key 610 may be integral with another component of syringe 600, such as, for example, a removable finger rest (not shown). ).

The initial configuration of syringe 600 is illustrated in FIG. 16A. As shown, piston rod 603 and piston 608 are positioned proximal to drug volume 612 located in the interior of cylinder 602. Projection 606 is positioned proximal to key 610. As shown in FIG. 16B, plunger rod 603 may be allowed to move distally (eg, by depressing stem stop 604) until protrusion 606 contacts key 610. The amount of distal movement allowed in this configuration may be sufficient to fill a syringe. 600 and removing air between piston 608 and drug 612. As shown in FIG. 16B, further movement of the piston rod 603 can be prevented by contact between the key 610 and the projection 606.

In FIG. 16C illustrates the syringe 600 after removal of the key 610. The height of the key 610 may be proportional to the desired or appropriate dose volume of the drug 612, so that after removal of the key 610, the piston rod 603 and the protrusion 606 can freely move further in the distal direction until protrusion 606 will not contact the proximal end of barrel 602 (FIG. 16D) and will not be obstructed by it or by another component of syringe 600 located at the distal end of barrel 602 (eg, a lip, cap, or stop). This movement of piston rod 603 allows piston 608 to also expel the desired or appropriate dose volume of drug 612 (eg, through a needle, cannula, tube, or other mechanism connected to the distal end of syringe 600).

Next, with reference to FIG. 17A-17B are two schematic views of further embodiments of the invention of delivery devices with dosing control mechanisms. In FIG. 17A illustrates a syringe 700a having a body 702, a multi-toothed piston rod 704, a piston 706, and a drug volume 708. The teeth of the piston rod 704 may be configured to mesh with complementary teeth on the idler gear 712, which in turn in turn, may be configured to mesh with the teeth on the pinion gear 714a.

Pinion gear 714a is shown with two longer teeth that are configured to engage with tongues on offset drive 710a.

Both filling and dispensing from the syringe 700a can be performed by depressing the offset actuator 710a (eg, to a first depressed position and a second depressed position). The offset drive tabs 710a can be sized and configured to engage (e.g., push) the long teeth of the drive gear 714a at desired intervals to fill the syringe 700a (the bottom tab and the first of the long teeth of the drive gear 714a) and dispense the desired amount of drug dose. 708 (the upper tongue of the drive 710a and the second of the long teeth of the drive gear 714a.) Fig. 17A shows, for example, the position of the drive gear 714a and the drive 710a after filling the syringe 700a (for example, in the first depressed position).In some embodiments of the invention pinion gear 714a, idler gear 712, or piston rod 704 may be configured to provide audible, visual, or tactile feedback when actuator 710a is moved to the first or second depressed position (e.g., by providing a click sound or resistance to movement beyond the depressed position). In some var In an embodiment of the invention, the interaction between the drive 710a and the pinion gear 714a may resemble a Maltese mechanism. In some embodiments, the rotation of the drive gear 714a can be stopped by contact between the long tooth of the drive gear 714a and the idler gear 712.

Numerous drive gear and drive configurations are possible in order to achieve the steps of filling and/or dispensing a drug by actuating the drive. For example, in FIG. 17B illustrates a second syringe 700b with a drive gear 714b having three long teeth instead of two and a drive 710b having three reeds instead of two. In such an embodiment, it is contemplated that the actuator 710b may be pressed multiple times (eg, to the first depth, the second depth, and the third depth) to achieve the desired result (eg, filling the syringe 700b). Each contact between the drive tongue 710b and the long tooth of the drive gear 714b may be accompanied by tactile, audible or visual feedback, and may correspond to partial or complete filling of the syringe 700b, removal of air bubbles from the syringe 700b, or delivery of the required dose volume from the syringe 700b. In some embodiments, the drive may have only one tongue configured to engage with the long tooth or teeth of the drive gear (see, for example, drive 710c and drive gear 714c illustrated in FIG. 17C).

In some embodiments, the actuator may be spring-loaded such that, after the actuator has been depressed to a predetermined degree (e.g., sufficient for the actuator tongue to press, contact, rotate, and/or otherwise engage with a single long pinion tooth), the actuator may be returned to its pre-pressed position, for example by means of a spring return or other return mechanism. Such an embodiment of the invention is shown schematically in FIG. 17C, where pressing actuator 710c may compress spring 716, which in turn may cause actuator 710c to return to its pre-pressed position after being released. When the actuator 710c is pressed again to a predetermined degree, the tab on the actuator 710c may push, contact, rotate and/or otherwise interact with another single long tooth of the drive gear. Each actuation of the actuator may perform a separate function (eg, prime the syringe and/or evacuate the syringe, or dispense the appropriate dose volume from the syringe).

Although in FIG. 17A-17C illustrate potential versions of embodiments of the invention, including pinion and drive, many other permutations and combinations of drive gears having longer teeth and drives having tongues are contemplated. Additional changes to these embodiments include that the actuator (eg, actuator 710c) may be spring-loaded or otherwise configured in any suitable manner to reset after, for example, completing a filling or dispensing step.

Next, with reference to FIG. 18A-18F show views of another embodiment of the invention for a dosing control mechanism. In FIG. 18A and 18B illustrate a front view and an angled view, respectively, of a sleeve 800. The sleeve 800 may be configured to wrap around and/or attach to a syringe barrel, for example, and may include a body 801, a bore 802, a projection 804, and an offset portion 806 of channel 802. Bushing 800 may be configured to be used in conjunction with piston rod 820 as shown in FIG. 18C. The piston rod 820 may include a main body 822 extending from the tip 826. The main body 822 may be configured to extend into the barrel body of the syringe. The piston rod arm 824, which may extend from the tip 826 separately from the main body 822, may be

- 21 041108 is configured to pass adjacent to the syringe barrel into which the main body 822 extends. The piston rod end 828 may be configured to contact, attach or otherwise attach to a piston (not shown).

In FIG. 18D illustrates a syringe assembly 830 comprising a sleeve 800 and a plunger rod 820 surrounding the syringe 832. As shown, the plunger shaft shoulder 824 can be sized and configured to slide through the bore 802. Because the plunger shaft 820 is depressed distally into the body of the syringe 832, the piston rod arm 824 can move distally through the channel 802. When the piston rod arm 824 reaches the displaced portion 806 of the channel 802, the shape of the channel 802 can stop the piston rod 820 from moving further in the distal direction. In FIG. 18E shows that by rotating the piston rod 820 (for example, by turning the tip 826) or by separately moving or rotating the piston rod arm 824, the piston rod arm 824 can move laterally into the offset portion 806 of the channel 802, after which it may be possible to further distal movement of the arm 824 of the piston rod pin and hence the piston rod 820.

Syringe 832 may contain a volume of drug that may be greater than or equal to the desired dose for the patient. The initial distal movement of the piston rod 820 (for example, before the piston rod shoulder 824 approaches the offset portion 806 of the channel 802) can be used to fill the syringe 832. Contact of the piston rod shoulder 824 with the reshaped channel 802 near the offset portion 806 of the channel 802 (shown, for example, in FIG. 18E) may indicate that the syringe is full and that air has been removed from the interior of the syringe 832. The length of the offset portion 806 of the channel 802 may be proportional to the required dose volume of drug within the syringe 832 after the syringe 832 has been filled. Thus, rotating the piston rod 820 to align the piston rod arm 824 with the offset portion 806 of the channel 802 and then pressing the piston rod 802 such that the piston rod arm 824 slides through the offset portion 806 can deliver the desired dose of drug. drug through the distal end of the syringe 832 (depicted, for example, in Fig. 18E and 18F, connected with a needle).

In FIG. 18F illustrates a detailed cross-sectional side view of the assembly 830. The piston rod arm 824 is shown in contact with the portion of the bore 802 where the offset portion 806 begins. Thus, the assembly 830 may be in a filled position. The interior 834 of the syringe 832 shown in FIG. 18F may correspond to the required dose volume of the drug for delivery to the patient.

Next, with reference to FIG. 19A-19E show views of another embodiment of the invention for a dosing control mechanism. The assembly 900 may include a syringe body 902, a piston rod 904a, a piston 906, a piston rod shoulder 908, and a sleeve 910a that may be connected to the sleeve protrusion 912. The syringe body 902 may contain a drug volume 914 distal to the plunger 906. The operation of this embodiment may be similar to that of the assembly 830 illustrated in FIG. 18A-18F. It should be noted that the sleeve 910a need not extend the entire length of the syringe body 902 to allow the syringe body 902 to be visible, or inside the syringe body 902 if the syringe body 902 is transparent. The length of sleeve 910a (and/or other parts of assembly 900) may be chosen to facilitate handling of assembly 900, for example.

As illustrated in FIG. 19A-D, various configurations of the sleeve and bore in the sleeve may be used in conjunction with the assembly 900 to allow the desired dose of drug to be filled and dispensed from the assembly 900. For example, the sleeve 910a illustrated in FIG. 19A includes a passage 909a that does not extend through the entire sleeve 910a. In this embodiment, the top of channel 909a can correspond to the distance that piston rod pin 908 and thus piston rod 904a can move to fill assembly 900, and the offset bottom of channel 909a can be proportional to the required dose volume of drug 914 , which can be dispensed from the distal end of the assembly 900 by rotating and distally moving the piston rod 904a until further distal movement of the piston rod arm 908 is stopped by the end of the channel 909a. The closed end of channel 909a ensures that more than the desired dosage volume is not delivered and can mitigate deviation in, for example, the desired dose volume by preventing piston 906 from moving distally into the conical portion of the distal end of the syringe body 902. Such a deviation can be caused, for example, by the possibility of changes in the geometry of the plunger 906 and the body 902 of the syringe.

In alternative embodiments of the invention, the sleeve may have different configurations, such as those illustrated in FIG. 19B-19D. On each of the FIGS. 19B-19D illustrate a cross-section of a sleeve having a change in the channel through which the piston rod arm 908 can move, thereby guiding the movement of the piston rod 904a within the syringe body 902. For example, in FIG. 19B shows a front view of the hub half 910b. The half-sleeve 910b may not wrap around the syringe body 902 to create a narrow passage through which the piston rod arm 908 may pass; instead, the piston rod arm 908 may be guided by the open wall of sleeve half 910b, and may move in a region 909b adjacent to the open wall of sleeve half 910b. Sleeve 910c illustrated in FIG. 19C provides a similar configuration to sleeve 910a, except for the open end of channel 909c as opposed to the closed end of channel 909a. Such a configuration may include, for example, lowering the piston 906 to a low point in the syringe body 902 in those embodiments of the invention in which such a low point allows the required dose of drug to be dispensed from the assembly 900. The sleeve 910d shown in FIG. 19D illustrates channel 909d having a kink in the opposite direction to that of bushings 910a, 910b, and 910c.

In FIG. 19A-19D illustrate exemplary channel configurations through which the piston rod shoulder can move. However, it is contemplated that many other embodiments of the bushings and/or channels are possible. It is also contemplated that although the bore 909a is depicted distal to the boss 912, the bore (e.g., bore 909a, 909b, 909c, or 909d) may be embedded in the bore on or near any part of the syringe body (e.g., the body 902 of the syringe) and/or may be incorporated into the syringe body itself (eg, by embossing, engraving, molding, or otherwise).

In FIG. 19E illustrates a bushing 910C and an exemplary method or mechanism by which the bushing (eg, bushing 910c) can be connected to the lug portion 912 during assembly. As shown, sleeve 910c may include one or more tabs 915 that can interact with complementary slots, holes, or recesses 913 on boss 912. the ability to connect the projection 912 and the sleeve 910c (for example, a dovetail connection, dowel connection, tongue and groove connection, or any other connection currently known or developed in the future). In alternative embodiments of the invention, the protrusion 912 may be connected to the sleeve 910c without the use of tongues, grooves, holes or recesses (for example, using glue, thermal bonding, etc.).

Attaching the protrusion and sleeve in this manner may allow one of the two components to be added first to the syringe body 902 and then the other. For example, protrusion 912 may be configured to slide, wrap, snap, or otherwise engage with syringe body 902, and a sleeve (e.g., sleeve 910a, 910b, 910c, or 910d) may subsequently slide over syringe body 902 and engage with protrusion 912. As an additional example, a sleeve may first be added to the syringe body 902 and then a lug 912. In yet another example, the sleeve and lug 912 may be connected first and then slid, looped, snapped or otherwise connected to the syringe body 902.

In additional embodiments, the sleeve (eg, sleeve 910a, 910b, 910c, or 910d) and protrusion (eg, protrusion 912) may be a single unit (eg, may be manufactured or molded together) instead of consisting of two attached pieces. In some embodiments, the sleeve and/or protrusion may be made of, or may include a material that may be sufficiently rigid to allow a bore in the sleeve to restrict and/or control movement of the piston rod arm, and may be sufficiently flexible so that the sleeve and/or protrusion is snapped or otherwise connected to the body 902 of the syringe. For example, in some embodiments of the invention, the sleeve and/or the protrusion may contain polypropylene. In some embodiments of the invention, for example, the sleeve and/or the protrusion may comprise two different injection molded materials (eg, polypropylene and a second material).

Next, with reference to FIG. 20A-20C show views of another embodiment of the invention for a dosing control mechanism. All three are discussed together in this document. As shown primarily in the cross-sectional side view of FIG. 20A and the cross section labeled A-A shown in FIG. 20B, the assembly 1000 may include a piston rod 1002, a piston 1003, a syringe body 1004, a drug volume 1005 located within the syringe body 1004, a piston rod arm 1006 configured to extend from the tip of the piston rod separate from and parallel to the piston rod 1002, bushing 1008, bushing pin 1010, spring-loaded pin casing 1012, bushing cavity 1014, piston rod shoulder cavity 1016, pin extension 1018, and bushing pin groove 1020 (illustrated in the view of bushing 1008 shown in FIG. 20C).

As in the embodiments of the invention illustrated in FIG. 19A-19E, sleeve 1008 may include a protrusion and may be configured to wrap around the circumference of syringe body 1004. Assembly 1000 differs from assembly 900, for example, in that piston rod arm 1006 does not include a pin; instead, the piston rod arm 1006 may include a cavity 1016 into which the sleeve pin 1010 may extend. The pin 1010 of the sleeve can be connected to the sleeve 1008 with the possibility of sliding so that it passes through the groove 1020 of the pin. In some embodiments, the pin shroud 1012, which may be spring loaded, may apply

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Claims (19)

exert force on the hub pin 1010 outward from the hub 1008, while the protruding pin member 1018 (shown, for example, in FIG. 20B) may prevent the hub pin 1010 from being pulled out of the pin slot 1020. In the configuration illustrated in FIG. 20A, the hub pin 1010 can be pushed distally (e.g., towards the pusher end of assembly 1000) along the length of the pin slot 1020 to move the piston rod arm 1006 distally (i.e., so that the piston rod 1002 also moves distally) , as the sleeve pin 1010 extends into the piston rod shoulder cavity 1016 (as shown, for example, in FIG. 20B). This movement of the sleeve pin 1010 and the corresponding movement of the piston rod 1002 may serve to fill the assembly 1000. When the sleeve pin 1010 is moved toward the distal end of the shaft slot 1020, the protruding element 1018 of the shaft may be aligned with the cavity 1014 of the sleeve, which can be sized and configured to accommodate the protruding element 1018 of the pin. Force applied to the bushing pin 1010 by the pin body 1012 may cause the pin extension 1018 to be drawn into the bushing cavity 1014, thereby causing the bushing pin 1010 to disengage from the piston rod shoulder cavity 1016. After the sleeve pin 1010 is released from the piston rod arm cavity 1016, the piston rod 1002 can be pushed distally independently of the sleeve pin 1010 (e.g., by a user) to dispense the desired dose of drug 1005. With respect to any embodiment of the invention in the present invention that includes a bushing and a pin that can pass through a bore or slot in the bushing, it is contemplated that the bore or slot need not be located within the bushing. For example, in embodiments where the sleeve completely or partially surrounds the syringe body or syringe, the sleeve may be replaced by, for example, a channel or groove that is imprinted, molded, or otherwise located directly on the syringe body or syringe. The design features listed above have been described in the context of specific embodiments of the invention. However, features and aspects of embodiments of the invention may be combined, added to other embodiments, subtracted from embodiments of the invention, and so on. in any way to facilitate the controlled preparation and/or delivery of a medicinal product. Aspects of the embodiments described above have been described in relation to filling doses and removing excess air bubbles from within syringes. However, aspects of these embodiments of the invention can also be used with refillable syringes and multi-dose vials. For example, the syringes of the present invention may provide a more accurate way to transfer drug from a vial to a syringe. Accuracy at this stage of syringe loading can reduce or minimize overfilling of syringes from, for example, drug vials. Prevention of overflow may, in turn, reduce wastage of drug and may increase or maximize the number of doses that can be administered from a single vial. For example, to fill the syringe 10 shown in FIG. 1, the setting knob 5 can be reversed to push the collar of the piston 8 into the barrel 9 of the syringe from the distal end of the needle to fill the syringe 10 through the needle 13. As a further example, to fill the syringe 60 shown in FIG. 5, the plunger rod 61 can be rotated in the opposite direction to that required to fill the needle 66 to push the collar of the plunger 68 into the syringe barrel 69 from the distal end of the needle to fill the syringe 60 through the needle 66. Although a number of embodiments of the invention are presented herein, numerous variations of such embodiments of the invention and combinations of elements from one or more embodiments of the invention are possible and are intended to be within the scope of this invention. In addition, those skilled in the art will appreciate that the idea behind the present invention can easily be used as a basis for developing other devices, methods, and systems to accomplish several of the objectives of the present invention. CLAIM 1. A drug delivery device (900) comprising a dosing control mechanism, wherein the drug delivery device (900) comprises a cylinder (902) containing a proximal end and a distal end; a piston rod (904a) extending inside the cylinder (902) through an opening at the proximal end of the cylinder (902), wherein the piston rod (904a) comprises a rod stop and a protrusion (908) having a distally facing surface, the protrusion (908) protrudes radially outward from the central longitudinal axis of the drug delivery device (900); And - 24 041108 protrusion (910a, 912) covering the proximal end of the cylinder (902), moreover, the protrusion (910a, 912) contains a body having a solid structure, and an opening with a circle completely enclosed by the body, and the specified body includes the first surface and the second surface , which is spaced from the first surface, while rotation of the piston rod (904a) about the central longitudinal axis moves the drug delivery device (900) from the filled configuration to the dose delivery configuration, and in the filled configuration, the distally facing surface abuts against the first surface such that the protrusion (910a, 912) blocks distal movement of the protrusion (908) to limit distal movement of the piston rod (904a), and in a dose delivery configuration, the protrusion (910a, 912) provides distal movement of the protrusion (908), allowing piston rod (904a) to move the dose delivery distance until the distally facing surface will not rest against the second surface. 2. The drug delivery device according to claim 1, characterized in that when the drug delivery device is in the initial configuration, the protrusion is separated from the first surface of the protrusion by a filling distance, and at the same time, the configuration of the drug delivery device changes from the initial the configuration to the filled configuration includes advancing the piston rod in a distal direction until the protrusion comes into contact with the first surface of the protrusion. 3. The drug delivery device of claim 1, wherein the transition of the drug delivery device configuration from a filled configuration to a dose delivery configuration includes a 90° rotation of the piston rod about a central longitudinal axis. 4. The drug delivery device of claim 3, wherein the protrusion is aligned with the first surface and offset with the second surface in a direction parallel to the central longitudinal axis, in the filled configuration. 5. The drug delivery device of claim 3, wherein the protrusion is aligned with the second surface and offset from the first surface in a direction parallel to the central longitudinal axis, in a dose delivery configuration. 6. The drug delivery device of claim 1, further comprising a piston within the barrel and in contact with the piston rod, wherein movement of the piston rod through the dose delivery distance does not bring the piston into contact with the distal end of the barrel. 7. A drug delivery device (900) comprising a dosing control mechanism, wherein the drug delivery device (900) comprises a cylinder (902) containing a proximal end and a distal end; a piston rod (904a) extending into the interior of the cylinder (902) through an opening at the proximal end of the cylinder (902) and along the central longitudinal axis of the drug delivery device (900), the piston rod (904a) comprising a rod stop and a projecting portion ( 908) having a distally facing surface, wherein the projecting portion (908) is located around the central longitudinal axis and protrudes in a direction perpendicular to the central longitudinal axis; and a protrusion (910a, 912) contacting the proximal end of the cylinder (902), the protrusion (910a, 912) including a body and an opening, the body having a first proximally facing surface that abuts against the distally facing surface when the device (900 ) for drug delivery is in a filled configuration, and a second proximally facing surface that abuts against the distally facing surface when the drug delivery device (900) is in a dose delivery configuration, said opening having a geometry configured to receive a projection ( 908) when the drug delivery device (900) is in the indicated dose delivery configuration, the body having a one-piece structure and the opening having a circumference completely enclosed by the body. 8. The drug delivery device according to claim 7, characterized in that the protrusion covers the proximal end of the cylinder. 9. The drug delivery device of claim 7, wherein the protrusion is a finger rest and includes a sleeve defining said first proximally facing surface and a second proximally facing surface. 10. The drug delivery device of claim 9, wherein the sleeve is integrated into the protrusion such that the finger rest and sleeve form a single unit. 11. The drug delivery device according to claim 7, characterized in that the piston rod rotates about a central longitudinal axis relative to the protrusion. 12. The drug delivery device of claim 7, wherein the drug delivery device is a pre-filled syringe. 13. The drug delivery device of claim 9, wherein the first proximally facing surface is positioned proximal to the second proximally facing surface. - 25 041108 14. The drug delivery device according to claim 7, characterized in that the projection geometry is symmetrical about the central longitudinal axis of the drug delivery device. 15. A method for preparing a drug delivery device (900) according to claim 7 for delivering a dose of a drug, comprising advancing the piston rod (904a) in a distal direction inside the cylinder (902) and rotating the piston rod (904a) 90° around the central longitudinal axis relative to the protrusion (910a, 912). 16. A drug delivery device (900) comprising a dosing control mechanism, wherein the drug delivery device (900) comprises a cylinder (902) containing a proximal end and a distal end; a piston rod (904a) extending into the interior of the cylinder (902) along the central longitudinal axis of the drug delivery device (900), the piston rod (904a) having a protrusion (908) that protrudes radially outward from the central longitudinal axis , while the piston rod (904a) is able to rotate about the central longitudinal axis; and a protrusion (910a, 912) comprising a housing and an opening, wherein said housing includes a first surface and a second surface that is remote from the first surface, and said opening has a geometric structure configured to receive a protruding portion (908) when the protruding part (908) aligned with the second surface, and the specified housing has a solid structure, and the specified hole has a circle, completely covered by the housing; however, in the initial configuration of the device (900) for drug delivery, the first volume of the drug is located between the piston and the distal end of the cylinder (902), and the protruding part (908) is spaced in the longitudinal direction from the first surface of the protrusion (910a, 912) and is not aligned in the longitudinal direction with the second surface, while in the filled configuration of the device (900) for drug delivery, the second volume of the drug is located between the piston and the distal end of the cylinder (902) and the protruding part (908) contacts the first surface of the protrusion (910a, 912) and is not longitudinally aligned with the second surface, in the dose delivery configuration of the drug delivery device (900) the projection (908) is longitudinally aligned with the second surface and is not longitudinally aligned with the first surface, and in the device delivery configuration ( 900) for drug delivery the third drug volume is located between the piston and the distal end of the cylinder (902) and the projection (908) is longitudinally aligned with the second surface and received within the geometric structure; wherein the first volume of the medicinal product is different from the second volume and the third volume of the medicinal product. 17. The drug delivery device of claim 16, further comprising a piston located within the barrel and in contact with the piston rod, wherein when the drug delivery device is in a delivery configuration, the piston is not flush with the distal end of the barrel. 18. The drug delivery device according to claim 16, further comprising a piston located inside the cylinder and in contact with the piston rod; a second drug volume positioned between the piston and the distal end of the barrel when the drug delivery device is in a dose delivery configuration, the second drug volume being smaller than the first drug volume; and wherein the third drug volume is less than the second drug volume and greater than zero. 19. The drug delivery device according to claim 17, wherein the transition of the drug delivery device configuration from the initial configuration to the filled configuration includes depressing the stem stop on the piston rod to advance the piston rod in a distal direction relative to the cylinder until advancement of the piston rod will not be blocked by the protrusion, the transition of the drug delivery device configuration from the filled configuration to the dose delivery configuration includes the rotation of the piston rod relative to the protrusion and the transition of the drug delivery device configuration from the dose delivery configuration to the delivery configuration includes depressing the rod stop on the piston rod to advance the piston rod in a distal direction relative to the cylinder until the piston rod advance is blocked by a ledge. -