WO2017001923A1

WO2017001923A1 - Dosing assembly for a dispensing device

Info

Publication number: WO2017001923A1
Application number: PCT/IB2016/001042
Authority: WO
Inventors: Marc Andrew Koska
Original assignee: Marc Andrew Koska
Priority date: 2015-07-02
Filing date: 2016-07-01
Publication date: 2017-01-05

Abstract

The invention is a dosing assembly (10) configured for use with a syringe (100), or other dispensing or delivery device, for the controlled dispensing of multiple doses of a fluid agent (108) therefrom without requiring specialized skill or resources for ensuring accurate dispensing of the fluid agent (108) into delivery devices for subsequent administration to patients. The dosing assembly (10) is configured to allow a metered dose (20, 50) of fluid agent (108) to be dispensed from the syringe (100) and into a delivery device in a consistent and controlled manner.

Description

DOSING ASSEMBLY FOR A DISPENSING DEVICE

Cross Reference to Related Applications

This application claims the benefit of and priority to U.S. Provisional Application No. 62/188,103, filed July 2, 2015, the content of which is hereby incorporated by reference herein in its entirety.

Field of the Invention

The present invention generally relates to dispensing devices for dispensing fluids, and, more particularly, to a dosing assembly for use with a multi-dose syringe or other dispensing device, wherein the dosing assembly is configured to control the amount of fluid agent to be dispensed from the syringe.

Background

Every year, millions of people become infected and die from a variety of diseases, some of which are treatable or entirely preventable. For example, many diseases may be prevented via immunization programs which include the administration of vaccines. Although vaccination has led to a dramatic decline in the number of cases of several infectious diseases, some of these diseases remain quite common. In many instances, large populations of the world, particularly in developing countries, suffer from the spread of vaccine-preventable diseases due to ineffective immunization programs, either because of poor implementation, lack of affordable vaccines, or inadequate devices for administering vaccines, or combinations thereof.

As part of an ongoing effort to address inadequacies of immunization programs globally, there has been increasing focus on the manner in which vaccines are packaged and provided. For example, in many parts of the world, vaccinations may be supplied in multi-dose containers or vials. A multi-dose vial is a vial of liquid that contains more than one dose of medication and may be used for providing multiple doses for a single individual or for providing a single dose for multiple individuals in a group. In contrast, single-dose format generally includes single- dose vials or pre-filled single dose delivery devices.

The multi-dose format may be a more attractive option for various reasons. For example, a multi-dose format may be more cost-effective, as the filling and packaging costs for multi-dose vials are generally cheaper than single-dose vials, and multi-dose vials generally have less cold chain capacity requirements (e.g., less packed volume per dose) when compared to single-dose vials. Furthermore, the distribution of a vaccine within a given population may be improved with the use of multi-dose format, as the multi-dose format has less cold chain requirements and a larger volume of vaccine (e.g. more doses) can be available at a single instance. The multi- dose format is particularly attractive given that a single source of vaccine (e.g., 10-dose, 20-dose, 50-dose, etc. vial) may be used in the vaccination of a large population within a short timeframe (e.g., administer vaccine to a large group of people), thereby providing a better coverage rate than would be available with the single-dose format.

Although the multi-dose format may provide numerous advantages over a single-dose format, the multi-dose format has drawbacks. For example, multi-dose vials or delivery devices must be handled with care so as to protect against cross-contamination, particularly if a multi- dose vial is to be used for more than one patient. If care is not taken by the medical professional administering the vaccine, inadvertent contamination of a multi-dose vial may occur through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. For example, a vaccine may be administered via injection with a syringe having a needle. Accordingly, a new, sterile needle and sterile syringe should always be used to access the vaccine in a multi-dose vial. Reuse of needles or syringes to access a vaccine can result in contamination of the vaccine that can be spread to others when the medicine is used again. In many situations, particularly in developing countries, the

administration of vaccines occurs outside of a hospital and may be provided by a nonprofessional. Such non-professionals may not have formal training, or the resources, for the proper handling of a multi-dose vial or delivery device, and contamination may occur, thereby increasing the risk of infection and spread of blood-borne diseases.

Summary

The present invention provides a dosing assembly configured for use with a syringe, or other dispensing device, wherein the dosing assembly overcomes the drawbacks of current multi- dose devices and methods. In particular, the dosing assembly of the present invention is configured for use with a standard syringe (e.g., barrel, plunger, and hub with luer-type fitting or connection). The syringe may be used for the storage of multiple doses of a fluid agent (e.g., medication, vaccine, therapeutic, etc.) is configured to be coupled to delivery devices (e.g., single use delivery devices) and dispense an amount (e.g., dose) of fluid agent into such delivery devices for subsequent administration of the dose of fluid agent to a patient. The dosing assembly of the present invention is configured to control the amount of fluid agent to be dispensed from the syringe. In particular, the dosing assembly is configured to allow a metered dose of fluid agent to be dispensed from the syringe and into a delivery device in a controlled manner.

In one aspect, the dosing assembly generally includes two discrete elements configured to form a ratchet-type engagement with one another. For example, the dosing assembly includes a rack member configured to be coupled to the plunger of the syringe and a locking member configured to be coupled to the barrel of the syringe. The rack member generally includes an elongate body having a plurality of teeth along a surface thereof. The locking member includes a locking head portion having a channel configured to receive a portion of the elongate body of the rack member, wherein the channel includes at least one pawl within and configured to engage one or more of the teeth on the elongate body of the rack member as the rack member moves through the channel. For example, upon compression of the plunger (e.g., movement towards the barrel), the rack member is configured to correspondingly move towards the barrel and locking member coupled thereto. The pawl and teeth are arranged in a manner so as to allow movement of the rack member in a direction towards the barrel (e.g. pawl deflects to allow teeth of elongate member to pass through channel towards barrel) while preventing movement of the rack member in a direction away from the barrel (e.g., pawl engages teeth of elongate member preventing movement away from barrel). Accordingly, the rack member and locking member allow compression of the plunger and subsequent dispensing of fluid agent from the barrel into a connected delivery device while preventing expansion movement of the plunger away from the barrel, thereby prevent potential contamination of the fluid agent stored within the syringe barrel.

The dosing assembly is configured to control the amount of compression (e.g., movement in direction of barrel) of the plunger and thus the amount of fluid agent dispensed from the syringe based on the specific arrangement of the teeth of the elongate body of the rack member. For example, the dosing assembly may be configured to provide haptic or audible feedback as the plunger is compressed so as to indicate the distance that the plunger has moved based on the number of teeth having moved relative to the pawl of the locking member. For example, as each tooth moves past the pawl, the pawl deflects to allow a tooth to pass therethrough and subsequently returns to a normal position to engage the next adjacent tooth. This process may result in haptic feedback (e.g., person can feel pawl and tooth engagement) and/or audible feedback (e.g., pawl make a sound upon engagement with the tooth). The spacing or distance between the teeth may generally correspond to a specific volume of fluid agent to be dispensed from the syringe. Thus, a dose of fluid agent may correspond to one or more distances between two or more adjacent teeth. For example, in one embodiment, the spacing between two adjacent teeth may correspond to a single dose of fluid agent. Accordingly, a person need only compress the plunger sufficient enough so as to move one tooth past the pawl and bring an adjacent tooth into subsequent engagement with the pawl, in which the person may hear a single audible click and/or sense the engagement.

Accordingly, the dosing assembly, when coupled to standard syringe containing multiple doses of a fluid agent, is configured to allow a relatively straightforward and simple means of dispensing accurate doses of fluid agent to delivery devices for subsequent delivery to a patient. The dosing assembly of the present invention is suitable for use in situations in which a nonprofessional, who may lack adequate training or resources, is able to quickly and accurately dispense doses of a fluid agent with little or no risk of contamination of the fluid agent remaining within the syringe. In particular, the dosing assembly is designed such that a person dispensing the fluid agent need only compress the plunger of the syringe until they feel and/or hear indications that the plunger has moved a particular distance which corresponds to the desired amount of fluid agent to be dispensed (e.g., single dose of fluid agent). Accordingly, the dosing assembly in conjunction with a standard syringe does not require a trained, skilled healthcare profession for the dispending of doses of vaccines or drugs. As such, the dosing assembly may be particularly useful in situations in which vaccines or drugs are being administered in non- healthcare related facilities (e.g., outside of clinics or hospitals) and given to large numbers of individuals over a short period of time by a non-professional. Furthermore, the simplicity of the design of the dosing assembly further provides a more cost-effective means of ensuring accurate dispensing of doses of a vaccine or drug.

Brief Description of the Drawings FIG. 1 is a perspective exploded view of a dosing assembly consistent with the present disclosure.

FIG. 2 is a side view, partly in section, of the rack and locking members of the dosing assembly of FIG. 1 separated from one another.

FIG. 3 is a perspective view of a dosing assembly consistent with the present disclosure coupled to a dispensing device embodied as a standard syringe.

FIGS. 4A and 4B are side views, partly in section, of the rack and locking members illustrating movement of the rack member within the locking member and the arrangement between the teeth and the pawl upon compression of the plunger of the syringe.

FIG. 4C is an enlarged side view of the syringe illustrating dispensing of a fluid agent in an amount controlled by the dosing assembly upon compression of the plunger within the barrel of the syringe.

FIG. 5 is a side view, partly in section, of the rack and locking members illustrating a safety feature provided by the dosing assembly, specifically the prevention of withdrawal of the rack member from within the locking member upon attempted expansion of the plunger from barrel of the syringe.

FIGS. 6A and 6B are side views, partly in section, of the rack and locking members illustrating an override feature on the locking member configured to disengage the pawl from the teeth to thereby allow withdrawal of the rack member from the locking member upon expansion of the plunger from the barrel of the syringe.

FIG. 7 illustrates an exemplary single use delivery device configured to be coupled to the syringe and receive a metered dose of fluid agent as controlled by a dosing assembly consistent with the present disclosure.

Detailed Description

By way of overview, the dosing assembly generally includes two discrete elements configured to form a ratchet-type engagement with one another. For example, the dosing assembly includes a rack member configured to be coupled to the plunger of the syringe and a locking member configured to be coupled to the barrel of the syringe. The rack member generally includes an elongate body having a plurality of teeth along a surface thereof. The locking member includes a locking head portion having a channel configured to receive a portion of the elongate body of the rack member, wherein the channel includes at least one pawl within and configured to engage one or more of the teeth on the elongate body of the rack member as the rack member moves through the channel. For example, upon compression of the plunger (e.g., movement towards the barrel), the rack member is configured to correspondingly move towards the barrel and locking member coupled thereto. The pawl and teeth are arranged in a manner so as to allow movement of the rack member in a direction towards the barrel (e.g. pawl deflects to allow teeth of elongate member to pass through channel towards barrel) while preventing movement of the rack member in a direction away from the barrel (e.g., pawl engages teeth of elongate member preventing movement away from barrel). Accordingly, the rack member and locking member allow compression of the plunger and subsequent dispensing of fluid agent from the barrel into a connected delivery device while preventing expansion movement of the plunger away from the barrel, thereby prevent potential contamination of the fluid agent stored within the syringe barrel.

FIG. 1 is a perspective exploded view of a dosing assembly 10 consistent with the present disclosure. FIG. 2 is a side view, partly in section, of components of the dosing assembly 10. FIG. 3 is a perspective view of a dosing assembly 10 coupled to a dispensing device embodied as a standard syringe 100. As shown most clearly in FIG. 1, the dosing assembly 10 generally includes two separate components, a rack member 12 and a locking member 14. The dosing assembly 10 is configured for use with a dispensing device, such as, for example, a standard syringe 100 (as shown in FIG. 3) and configured to control the amount of fluid agent to be dispensed from the syringe 100. A standard syringe 100 generally includes a barrel 102 having a distal hub 104 including an outlet for dispensing a fluid agent from the barrel 102. The syringe 100 further includes a plunger 106 to be received within the barrel 102 and further provide compression against a volume of a fluid agent within the barrel 102 to cause dispensing of the fluid agent from the distal hub 104.

The dosing assembly 10 is configured to control the amount of fluid dispensed from the syringe 100 by limiting compression of the plunger 106 (e.g., movement towards the barrel 102) to distinct increments so as to provide a user with improved control and accuracy when dispensing a dose of fluid agent from the syringe 100. More specifically, engagement between the rack and locking members 12, 14 allows a metered dose of fluid agent to be dispensed from the syringe 100.

As shown, the rack member 12 includes an elongate body 16 having a proximal end 18 and a distal end 20. The proximal end 18 is generally shaped and/or sized to be directly coupled to the plunger 106 of the syringe 100. For example, as shown, the proximal end 18 may generally resemble a cup- shaped annular body including a throughhole 19. The throughhole 19 is sized to accommodate the plunger rod therethrough while the cup- shaped body is configured to receive the disc-shaped end of the plunger 106 by way of press-fit or other type of secure engagement. The elongate body 116 generally extends from the proximal end 18 and has a plurality of teeth 22 along a surface thereof configured to engage and interact with a portion of the locking member 14 to permit metered dosing of the fluid agent, as will be described in greater detail herein.

The locking member 14 includes a body 24 configured to be directly mounted or affixed to a portion of the barrel 102 of the syringe 100. For example, as shown, the body 24 may generally be in the form of two pliable prong members having a shape corresponding to the exterior contour of the barrel 102, such that the body 24 is configured to be snap-fit mounted to an exterior portion of the barrel 102 by way of the prong members. It should be noted that the locking member body 24 may be coupled to the barrel 102 via other known means (e.g., adhesive, ultrasonic welding, etc.) and may not be limited to a press or snap-fit approach. The locking member 14 should be sufficiently coupled to the barrel 102 so as to prevent movement of the locking member 14 upon engagement with the rack member 12.

The locking member 14 further includes a locking head 26 including a channel 28 configured to receive at least a portion of the elongate body 16 of the rack member 12. As shown in FIG. 2, the channel 28 includes at least one pawl 30 disposed within and configured to engage one or more of the plurality of teeth 22 of the rack member 12 upon movement of the elongate body 16 in a direction towards the locking member 14, as indicated by arrow 32.

Accordingly, the teeth 22 of the elongate body 16 and the pawl 30 of the locking member 30 generally form a ratchet-type engagement with one another upon linear movement of the elongate body 16 of the rack member 12 relative to the locking member 14. For example, the pawl 30 and teeth 22 are arranged in such as manner so as to only allow incremental movement of the elongate body 16 through the channel 28 in a direction towards the locking member 14. For example, the teeth 22 are each arranged to have a leading edge having such a taper or angle so as to cause the pawl 30 to deflect and allow the tooth to pass upon contact between the leading edge and pawl 30. However, each of the teeth 22 includes a back edge that is substantially vertical or at such an extreme angle so as to cause the pawl 30 to securely engage with the back edge, in which the pawl 30 does not sufficient deflect and prevents linear movement of the elongate body 16 in a direction away from the locking member 14. The locking head 26 further includes an extension member 34 coupled to the pawl 30 and configured to allow manual disengagement of the pawl from the teeth 22, so as to allow withdrawal of the rack member 12 from the locking member 14.

Each of the teeth 22 are spaced a distance D apart from one another, as generally measured between tips (or gullets) of adjacent teeth 22. The spacing or distance D between the teeth 22 may generally correspond to a specific volume of fluid agent to be dispensed from the syringe 100. For example, a specific volume of fluid (e.g., 1 ml, 2 ml, 3 ml, 4 ml, etc.) may correspond to one or more distances D between two or more adjacent teeth 22. In one embodiment, a single distance D between two immediately adjacent teeth 22 corresponds to a specific volume. Thus, a person need only compress the plunger 106 sufficient enough to move the rack member 12 a distance D (engagement of pawl 30 from one tooth to the next tooth) to dispense the corresponding volume from the syringe 100. In other embodiments, multiple distances D between multiple teeth 22 may correspond to a specific volume. For example, a person may need to compress the plunger 106 to cause the rack member 12 to move two distances D (e.g., move two teeth 22 past the pawl 30). Accordingly, the plurality of teeth 22 may be designed (e.g., spaced) a specific distance apart based on at least one of the size of the syringe 100 (e.g., 1 ml, 2 ml, 5 ml, 20 ml, 50 ml, etc.) to which the dosing assembly 10 is to be coupled to and used with and/or the desired volume of fluid to be dispensed from the syringe 100.

The rack and locking members 12, 14 are composed of a medical grade material. In some embodiments, the rack member 12, the locking member 14, or both, may be composed of a thermoplastic polymer, including, but not limited to, polypropylene, polyethylene,

polybenzimidazole, acrylonitrile butadiene styrene (ABS) polystyrene, polyvinyl chloride, PVC, or the like. It should be noted that the dosing assembly 10 may be sold as a separate add-on component for use with standard syringes (ISO syringes) and thus may be interchangeable and reusable. In some embodiments, the dosing assembly 10 may be preassembled with a pre-filled syringe.

As shown in FIG. 3, the rack member 12 is coupled to the plunger 106 of the syringe 100 and the locking member 14 is coupled to the barrel 102. Accordingly, upon compression of the plunger 106, as indicated by arrow 34, the rack member 12 is configured to correspondingly move in a direction towards the locking member 14, as indicated by arrow 36. FIGS. 4A and 4B illustrate movement of the rack member 12 within the locking member 14 and the arrangement between the teeth 22 and the pawl 30 upon compression of the plunger of the syringe 100. As shown, upon linear movement of the rack member 12 relative to the locking member 14, the pawl 30 is configured to engage at least one of the plurality of teeth 22. As previously described, the pawl 30 may generally engage the leading edge of a tooth as the rack member 12 moves through the channel 28 of the locking head 26. The pawl 30 may be flexible so as to bend or otherwise deflect upon engagement with the leading edge of the tooth, as indicated by arrow 38, and upon a sufficient amount force applied thereto. For example, in order for a tooth to move past the pawl 30, a certain amount of force may be required to overcome the resistance of the pawl 30 upon the leading edge of a tooth.

Upon applying sufficient force, an individual tooth moves past the pawl 30, thereby allowing movement of rack member 12 a certain distance D until the pawl 30 engages a subsequent tooth 22, as indicated by arrow 40 in FIG. 4B. The pawl 30 may be configured to provide haptic or audible feedback to user as the user compresses the plunger 106 so as to indicate the distance that the plunger 106 has moved relative to the barrel 102 and thus the amount of fluid dispensed. For example, as each tooth moves past the pawl 30, the pawl 30 deflects to allow a tooth to pass therethrough and subsequently returns to a normal position to engage the next adjacent tooth, as shown in FIG. 4B. This process may result in haptic feedback (e.g., user can feel pawl 30 and tooth engagement with one another) and/or audible feedback (e.g., pawl 30 may make a clicking sound upon engagement with the tooth).

FIG. 4C is an enlarged side view of the syringe 100 illustrating dispensing of a fluid agent 108 in an amount controlled by the dosing assembly 10 upon compression of the plunger 106. As previously described, the spacing or distance D between the teeth 22 generally corresponds to a specific volume of fluid agent dispensed from the syringe 100. Accordingly, in some embodiments, a dose of fluid agent 108 may correspond to one or more distances D between two or more adjacent teeth. For example, in one embodiment, the spacing between two adjacent teeth may correspond to a single dose of fluid agent. Accordingly, a user need only compress the plunger 106 sufficient enough so as to move one tooth past the pawl 30 and bring an adjacent tooth into subsequent engagement with the pawl 30, in which the user may hear a single audible click and/or sense the engagement.

Accordingly, the dosing assembly, when coupled to standard syringe containing multiple doses of a fluid agent, is configured to allow a relatively straightforward and simple means of dispensing accurate doses of fluid agent to delivery devices for subsequent delivery to a patient. The dosing assembly of the present invention is suitable for use in situations in which a nonprofessional, who may lack adequate training or resources, is able to quickly and accurately dispense doses of a fluid agent with little or no risk of contamination of the fluid agent remaining within the syringe. In particular, the dosing assembly is designed such that a person dispensing the fluid agent need only compress the plunger of the syringe until they feel and/or hear indications that the plunger has moved a particular distance which corresponds to the desired amount of fluid agent to be dispensed (e.g., single dose of fluid agent). Accordingly, the dosing assembly in conjunction with a standard syringe does not require a trained, skilled healthcare profession for the dispending of doses of vaccines or drugs. As such, the dosing assembly may be particularly useful in situations in which vaccines or drugs are being administered in non- healthcare related facilities (e.g., outside of clinics or hospitals) and given to large numbers of individuals over a short period of time by a non-professional.

As previously described, the teeth 22 and pawl 30 are specifically arranged so as to provide a safety feature, specifically the prevention of withdrawal of the rack member 12 from within the locking member 14 upon attempted expansion of the plunger 106 from barrel 102 of the syringe 100. By limiting movement of the plunger 106 in a direction towards the barrel 102, the dosing assembly 10 helps to reduce the opportunity for contamination. In other words, the plunger 106 is prevented from being withdrawn to any extent, thus a potential contaminant is unable to be drawn back into the syringe 100. Furthermore, the limited movement ensures a consistent dispensing of fluid volumes, thereby providing accurate control over dispensing of doses to be delivered to patients.

As shown in FIG. 5, upon attempted movement of the rack member 12 in a direction away from the locking member 14, as indicated by arrow 42, the pawl 30 is configured to engage the back edge of a tooth, as indicated by arrow 44. The pawl 30 securely engages the back edge and maintains its shape (e.g., does not sufficiently deflect) and thus prevents the tooth from moving past. However, in some embodiments, the locking member 14 may include an override feature for overcoming the secure engagement between the pawl 30 and tooth. For example, as shown in FIGS. 6A and 6B, a user need only apply sufficient pressure against the extension member 34 coupled to the pawl 30, as indicated by arrow 46. The extension member 34 is of sufficient length such that, upon pressure applied thereto, the extension member 34 is configured to pivot the pawl 30 out of engagement with the back edge of the tooth, as indicated by arrow 48. At this point, the pawl 30 is deflected a sufficient amount so as to allow a tooth to pass by in either direction, as indicated by arrow 50, thereby allowing the rack member 12 to be withdrawn from the channel 28.

FIG. 7 illustrates an exemplary single use delivery device 200 configured to be coupled to the syringe 100 and receive a metered dose of fluid agent 108 as controlled by a dosing assembly 10 consistent with the present disclosure. As previously described, the syringe 100 may be used as a multi-dose dispensing device, essentially acting as a means of storing and dispensing aliquots of the fluid agent 108 to a plurality of delivery devices. The syringe 100 may be compatible with a variety of delivery devices. In one embodiment, the syringe 100 may be configured to dispense doses of a fluid agent to a plurality of single use delivery devices, similar to the delivery devices as described in co-pending U.S. Non-Provisional Application No.

14/575,635, filed December 18, 2014, the contents of which are incorporated by reference herein in their entirety. For example, the hub 104 may be configured to be releasably coupled to an inlet port of the device 200 by way of a Luer-type connection. Accordingly, once coupled to the delivery device 200, a user need only compress the plunger 106 sufficient enough until the appropriate number of clicks are heard or felt, indicating to the user that a dose of fluid agent was dispensed from the syringe 100 to the delivery device 200.

Upon the syringe 100 being fully depleted of fluid agent, a user need only utilize the override feature 34 to allow the rack member 12 to be fully withdrawn from the locking member 14 and thus allow the plunger 106 to be fully removed from the barrel 102. At which point, the dosing assembly 10 can be separated from the used syringe 100 and then coupled to another sterile syringe for subsequent use. In other embodiments, the dosing assembly 10 may be intended as a one-time use, and thus may be discarded.

While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or

configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.

Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure. All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

The indefinite articles "a" and "an," as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean "at least one."

The phrase "and/or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

Incorporation by Reference

References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.

Equivalents

Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.

Claims

Claims What is claimed is:

1. A dosing assembly for use with a syringe, said dosing assembly comprising:

a rack member having a proximal end couplable to a plunger of a syringe and an elongate body extending from said proximal end and having a plurality of teeth along a surface thereof; and

a locking member comprising a body mountable to a barrel of said syringe and a locking head comprising a channel configured to receive at least a portion of said elongate body of said rack member therethrough, said channel having at least one pawl disposed within and configured to engage one or more of said plurality of teeth upon linear movement of said elongate body through said channel of said locking head;

wherein said plurality of teeth are spaced apart from one another by a distance associated with a volume of a fluid agent to be dispensed from a syringe to which the dosing assembly is couplable.

2. The dosing assembly of claim 1, wherein, upon linear movement of said rack member relative to said locking member, said pawl is configured to engage at least one of the plurality of teeth on the elongate body of the rack member.

3. The dosing assembly of claim 2, wherein, upon sufficient force applied to said rack member in a direction towards said locking member, said pawl is configured to engage a leading edge of a tooth and move from a resting state to deflected state and allow said tooth to move past said pawl and advance through said channel.

4. The dosing assembly of claim 3, wherein said pawl is configured to return to said resting state upon passage of said tooth and to engage an immediately adjacent tooth.

5. The dosing assembly of claim 4, wherein said pawl is configured to provide at least one of haptic feedback and audible feedback upon returning to said resting state, wherein said feedback is indicative of movement of said rack member a distance between two adjacent teeth.

6. The dosing assembly of claim 2, wherein, upon attempted movement of said rack member in a direction away from said locking member, said pawl is configured to securely engage a back edge of a tooth and prevent said tooth from moving past said pawl, thereby preventing substantial movement of said rack member in a direction away from said locking member.

7. The dosing assembly of claim 6, wherein said locking head further comprises an extension member being of sufficient length to allow engagement of a distal end of said extension member to pivot said pawl from a resting state to a deflected state and out of engagement with said back edge of said tooth to allow said tooth to move past said pawl and allow movement of said rack member in a direction away from said locking member.

8. The dosing assembly of claim 1, wherein said distance between adjacent teeth corresponds to a dose of said fluid agent to be dispensed from a syringe to which the dosing assembly is couplable to.

9. A dispensing system comprising:

a syringe comprising:

a body forming a barrel for containing a fluid agent within;

a distal hub having a port for dispensing said fluid agent from said barrel; and a plunger configured to be received within said barrel and to be compressed to cause a volume of fluid agent to be dispensed from said port; and

a dosing assembly coupled to said syringe and configured to control movement of said plunger to allow a metered dose of fluid agent to be dispensed from said syringe, said dosing assembly comprising:

a rack member having a proximal end coupled to said plunger and an elongate body extending from said proximal end and having a plurality of teeth along a surface thereof; and a locking member comprising a body mounted to said barrel and a locking head comprising a channel configured to receive at least a portion of said elongate body of said rack member therethrough, said channel having at least one pawl disposed within and configured to engage one or more of said plurality of teeth upon movement of said elongate body through said channel of said locking head;

wherein said plurality of teeth are spaced apart from one another by a distance associated with a volume of a fluid agent to be dispensed from said syringe.

10. The dispensing system of claim 9, wherein, upon compression of said plunger, said rack member is configured to correspondingly move in a direction towards said locking member.

11. The dispensing system of claim 10, wherein, upon sufficient compression force applied to said plunger, said pawl is configured to engage a leading edge of a tooth and move from a resting state to deflected state and allow said tooth to move past said pawl and advance through said channel, thereby allowing said plunger to advance towards said barrel and allow dispensing of a volume of said fluid agent from said port.

12. The dispensing system of claim 11, wherein said pawl is configured to return to said resting state upon passage of said tooth and to engage an immediately adjacent tooth.

13. The dispensing system of claim 12, wherein said pawl is configured to provide at least one of haptic feedback and audible feedback upon returning to said resting state, wherein said feedback is indicative of movement of said rack member a distance between two adjacent teeth.

14. The dispensing system of claim 9, wherein, upon attempted expansion of said plunger from said barrel, said pawl is configured to securely engage a back edge of a tooth and prevent said tooth from moving past said pawl, thereby preventing substantial movement of said plunger in a direction away from said barrel.

15. The dispensing system of claim 14, said locking head of said locking member further comprises an extension member being of sufficient length to allow engagement of a distal end of said extension member to pivot said pawl from a resting state to a deflected state and out of engagement with said back edge of said tooth to allow said tooth to move past said pawl and allow movement of said plunger in a direction away from said barrel.

16. The dispensing system of claim 9, wherein said distance between adjacent teeth corresponds to a dose of said fluid agent to be dispensed from said syringe.

17. The dispensing system of claim 16, wherein said dose of said fluid agent is in the range of 0.05 ml to 1.0 ml.

18. The dispensing system of claim 9, wherein said barrel of said syringe has a sufficient volume to contain multiple doses of said fluid agent within.

19. The dispensing system of claim 18, wherein said syringe is couplable a plurality of single use delivery devices and configured to dispense metered doses of fluid agent to said plurality of single use delivery devices.