Patent Application
20150150665
The present invention relates generally to apparatuses and methods for dispensing therapeutic agents to animals, and particularly applicators and methods for transdermally administering therapeutic agents to domestic animals.
Drug delivery devices and applicators for dispensing known quantities of therapeutic agents to animals are well known in the art. While there are numerous ways to deliver these therapeutic agents to the coats and skins of the animals, many of these methods are either ineffective and/or present safety risks to the animal or user during or after the dispensing activity. More particularly, because a physical connection must be achieved between the applicator tip and the drug delivery device during the dispensing activity, there is inherently a risk that the connection will be inadequate, thereby permitting some of the therapeutic agent to leak out of the device and into physical contact with the user. Not only is this leakage wasteful and messy, it also places the user at a heightened risk of suffering from a skin irritation or other such health concern, particularly if the user comes into direct contact with the agent. These health and safety risks can be of particular concern when a controlled substance is used as the dispensing agent.
In addition to leakage concerns, many conventional drug delivery devices also have a tendency to leave some residual therapeutic agent inside the body of the device after dispensing is completed. This is not only wasteful both in terms of product and cost, but also presents an increased safety risk to any individual who may contact the device after it has been used. More particularly, if the device still contains a poisonous or skin irritating ingredient, a person may suffer a serious health risk (or even death) if they handle the component after it has been discarded. Further, a residual amount of a controlled substance remaining in the dispenser after dispensing may create an issue of unauthorized use of a controlled substance.
The present invention overcomes or ameliorates at least one of the prior art disadvantages or provides a useful alternative thereto by providing an apparatus and associated methods for dispensing therapeutic agents, and particularly applicators and methods for transdermally administering therapeutic agents to domestic animals.
In accordance with one aspect of the present invention, an applicator for dispensing a therapeutic agent to an animal is provided. The applicator comprises a housing including first and second sections coupled together, the first and second sections defining a channel therebetween that includes at least one outlet; a hub integral with the first section and extending therefrom, the hub defining a conduit; and a bent path connecting the conduit to the channel. In accordance with this embodiment, the conduit, the bent path and the channel are fluidly connected.
In accordance with yet another aspect of the present invention, a method of manufacturing an applicator for transdermally dispensing a therapeutic agent to an animal is provided. The method comprises providing a first housing section including a hub portion attachable to a syringe and a pair of spaced ribs with a groove formed therebetween, the hub portion further defining a conduit; providing a second housing section including a ledge, the ledge being formed by a pair of spaced grooves; mating the pair of spaced ribs with the pair of spaced grooves to form a channel for dispensing the therapeutic agent, the channel being fluidly connected to the conduit by way of a bent path; and coupling the first housing section to the second housing section to form an applicator body, the applicator body defining at least one outlet for dispensing the therapeutic agent.
In accordance with still another aspect of the present invention, a method is provided for dispensing a therapeutic agent from an applicator of the type having a housing including first and second sections coupled together to form a channel and a hub extending from the housing, the hub being attachable to a syringe. The method comprises attaching the hub to a syringe containing a therapeutic agent; placing an outlet of the applicator on or near the animal; causing the therapeutic agent to be released from the syringe into the applicator; passing the therapeutic agent through the hub, through a bent path and then into the channel; and dispensing the therapeutic agent from the applicator through the outlet.
The above-mentioned aspects of the present teachings and the manner of obtaining them will become more apparent and the teachings will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:
The embodiments of the present teachings described below are not intended to be exhaustive or to limit the teachings to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present teachings.
The present invention is generally directed to drug delivery devices for dispensing liquid based formulations to animals, particularly domesticated or companion animals such as, but not limited to, dogs, cats, horses and the like. While certainly not intended to be required herein, the present invention is particularly useful for transdermally delivering doses of controlled veterinary substances (e.g., Fentanyl) to the coat and skin of an animal, which may include a human. As such, it should be understood and appreciated herein that the drug delivery devices, systems and methods of the present invention can also be used with other types of fluids, liquids or gels without straying from the teachings of the present invention. Some non-limiting examples of other such substances envisioned to be useful in accordance with the present teachings include, but are not limited to, therapeutic agents, pesticides, parasiticides, glues, solvents, lubricants, medicaments and the like. For simplicity purposes, the present disclosure will primarily focus on therapeutic agents as the illustrative and non-limiting dispensing substance; however, as is clearly explained above, the teachings of the present invention are not intended to be limited to these therapeutic applications alone.
In certain exemplary embodiments of the present invention, the drug delivery device includes an applicator device or tip that is compatible with a standard luer lock syringe and consists of a housing that allows the formulation to be spread over a large surface area of the animal's skin or coat. To accomplish this, the applicator body includes one or more outlets that are in the form of legs or tines configured to penetrate the fur of the animal and thereby deliver the drug directly to the animal's skin or coat. In certain aspects of the present invention, the outlet(s) further includes a pair of spaced prongs or feet that extend from its distal end, thereby allowing the therapeutic agent to be freely dispensed onto the surface of the animal. More particularly, because the spaced feet extend outwardly from the distal end of applicator, they are the only structural portion of the assembled applicator that directly contact and seal against the surface of the animal. Moreover, since the outlet opening is positioned between the spaced apart prongs and in such a manner that it does not directly contact or seal against the surface of the animal during a dispensing operation, the therapeutic agent is able to be freely dispensed and spread onto the animal without being physically impeded or interrupted.
A non-limiting illustration of an assembled applicator coupled to a fluid delivery device in accordance with the present teachings is shown in
As will be explained in detail below, the applicator devices 106 of the present invention generally consist of at least two parts or halves (i.e., sections 114 and 214) that are coupled or assembled together to form the applicator structure. Unlike many other traditional applicator devices that consist of either one applicator part or two structurally complementary parts, the devices of the present invention include two sections 114, 214 that are somewhat complementary in terms of structure, yet specifically shaped in such a manner that once assembled, the therapeutic agent can be dispensed therefrom without experiencing much associated leakage or residual buildup. More particularly, the sections 114, 214 are structurally shaped such that when they are coupled together, the therapeutic agent is discouraged from leaking out of the applicator body. In addition, the structural orientation of the dispensing passageway that is created between the first and second sections is shaped in such a manner that substantially all of the therapeutic agent is encouraged from being dispensed from the applicator device during a dispensing operation. As such, it should be understood and appreciated herein that at least some of the unexpected advantages of the present invention are influenced by the resultant shape and configuration of the dispensing passageway that is formed by the assembled applicator sections. Additional details of these advantageous characteristics of the present invention are discussed below.
Moving now to
In terms of assembly, the applicator 106 comprises first and second sections or faces (114, 214) that are coupled or assembled together to form the housing 108. As shown in
In certain aspects of the present invention, the groove 127 is sunken or depressed below the top surface 117 of the first section, thereby creating a channel for delivering the therapeutic agent to the outlet ends 123, 125 and ultimately onto the animal. To achieve the sunken channel formation, the groove 127 is provided as a depression below the surface 117 and has a substantially semi-circular shape. A more detailed and non-limiting exemplary illustration of this semi-circular geometry can be seen with reference to
As explained above, it should be understood and appreciated herein that the first preassembled section 114 is configured to be coupled to and molded with the second preassembled section 214 to form a fully assembled applicator device 106. In addition, the channel or groove 127 that is formed between the ribs 124 and 126 is positioned and shaped in such a manner that a fluid passageway or conduit for dispensing the therapeutic agent is formed between the fluid delivery device 104 and the dispensing end of the outlet 112 once section 114 is coupled to and molded with section 214.
Moving now to
During assembly of the applicator 106, the pair of spaced ribs 124, 126 of the first preassembled section 114 are configured to substantially align with (and mate) the spaced grooves 226, 228 of the second section 214, thereby forming the passageway or channel 127 for dispensing the therapeutic agent. In accordance with certain exemplary embodiments of the present invention, the passageway 127 is asymmetric relative to a seamless joint 113 that attaches the first and second sections 114, 214 together. A fully assembled view of the first and second sections 114, 214 aligned and mated together can be seen in
As can be seen particularly in
In accordance with the teachings of the present invention, the first and second preassembled sections 114, 214 can be coupled together to form an assembled applicator 106 by various known plastic molding and manufacturing methods. However, in certain aspects of the present invention, the applicator 106 is formed by ultrasonically welding the first and second preassembled sections 114, 214 together. In accordance with this exemplary and non-limiting embodiment, the first and second preassembled sections 114, 214 are mated and aligned together as explained above, and an ultrasonic weld, for instance along the ledge 224, is initiated to thereby cause the sections to seamlessly meld or join together. As is readily known and appreciated by those of skill in the plastics manufacturing and welding arts, the process of ultrasonically welding two plastic parts together along an energy director that has been formed into one of the preassembled parts allows a bond to be formed that is tensile and resists the tendency of forces to tear the bond apart. Specifically, the ultrasonic energy melts the point contact between the parts, thereby creating a seamless joint. Moreover, these types of welds can typically be strengthened by either increasing the weld depth, or increasing the size of the energy director to provide a larger weld area. Accordingly, it should be understood and appreciated herein that the precise shapes and sizes of the preassembled components described herein are not essential to the present invention, particularly as a skilled artisan would understand how to maximize the size and shapes of the components to achieve the best welded result for the specific dispensing applicator device to be assembled.
There are, however, advantages to the embodiment of the applicator 106 illustrated in
Another advantage with the illustrated embodiment of the applicator 106 is the shape of the grooves 226, 228 and the ledge 224 in the second section 214. Each groove is substantially V-shaped and the ledge 224 is substantially flat, as shown in
This is not, however, the case with differently shaped grooves and/or ledge in the second section. In
In
A more detailed description of the various parts of the applicator 106 will now be provided. As is particularly shown in
The inlet hub 110 has a pair of winged ears 111 adapted to lock to the fluid delivery device (not shown). More particularly, the fluid delivery device (e.g., device 104 in
As can be appreciated from the discussion above, the flow path 128 undergoes a significant reduction in diameter along the direction of fluid flow (i.e., from the inlet hub 110 to the distal end 112a of the outlet 112). This is necessary to adapt the applicator for connection to larger fluid delivery devices at the end of hub 110 on the one hand, and on the other hand to the very small channel 127 through which the fluid is moved before being dispensed from the outlet(s) 112. This reduction in diameter causes significant pressure within path 128, which in turn can cause leakage if there are any weak or vulnerable points such as weld seams along path 128. To address these structural issues, path 128 is bent or shaped such that it is circuitous in nature—i.e., is not a direct route between the first and second openings 130, 132 and changes direction one or more times. In this manner, path 128 is formed entirely within a single section, section 114, of the applicator, which avoids weld seams being present for any of the structure that defines path 128. With reference to
The structure defining path 128 can be appreciated with reference to
In certain aspects of the present invention one or more tubes or other such enclosed tubular structures can be internally incorporated into the structural design of the present applicators. For instance, to avoid any associated leakage that may occur around the connection between the fluid delivery device and the applicator or along the joint 113 that is formed between the first and second molded sections 114, 214, one or more chambers can be internally added into the inlet hub 110 portion and/or within the formed channel 127 of the applicator body. While such additional structure can be incorporated into any of the embodiments of the present invention without straying from the present teachings, it should be understood and appreciated herein that such structures are not required. More particularly, the present inventors have found that utilizing the bent path orientation and complementary structural design of the applicator sections makes it possible to achieve a tubeless design that is not only free of manifolds, but is also capable of operating without resultant leakage.
In certain exemplary embodiments in accordance with the present invention, the chamber 134 contains ridges, ledges, or other such similar structures to cause a bending configuration and stepped down diameter of the path 128. In still other aspects of the present invention, the path 128 is positioned below the seamless joint 113 that is formed between the first and second sections 114, 214 and underneath the channel 127 formed therebetween.
In accordance with certain aspects of the present invention, the second opening 132 directs the therapeutic agent into the channel in a direction that is substantially orthogonal to the lengthwise direction of the channel 127. Such exemplary embodiment can be seen, for instance, with reference to
In accordance with yet another illustrative aspect of the present invention, the bent path 128 comprises a substantially semi-circular portion that is connected to the conduit for receiving the therapeutic agent from the fluid delivery device 104 and the channel 127. In accordance with this illustrative aspect, the bent path 128 terminates at the second opening 132, which in turn, is positioned substantially orthogonally relative to the substantially semi-circular portion of the bent path 128.
Once the therapeutic agent completely travels and circumnavigates the channel 127 and reaches the distal end 112a of the one or more outlets 112, it is now ready to be dispensed onto the surface or coat of the animal. As explained above, to spread the formulation evenly over a large surface area of the animal, the outlet 112 must be able to penetrate the animal's fur and thereby reach the animal's skin. To accomplish this, the outlet 112 may include one or more prongs 129 for assisting with the dispensing of the therapeutic agent onto the surface of the animal. In accordance with certain exemplary embodiments, the prongs 129 comprise spaced feet or tines that are configured to penetrate the fur of the animal 102 so that the applicator 106 can substantially reach or touch the surface of the animal's body during the dispensing of the therapeutic agent. This penetration allows a more efficient topical and transdermal release of the agent. In addition, those of skill in the drug delivery and fluid dispensing arts will understand and appreciate that the addition of prongs or other such structural projections from the outlet 112 will discourage capillary action or attraction (i.e., will stop the therapeutic agent from moving upwardly along the outside of the outlet) from happening during the dispensing action. The minimization and/or elimination of such capillary action effects are particularly beneficial when dealing with therapeutic agents that can be considered harmful and/or dangerous.
While various illustrative embodiments incorporating the principles of the present teachings have been disclosed hereinabove, the present teachings are not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present teachings and use its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which these teachings pertain and which fall within the limits of the appended claims.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12581658 | Oct 2009 | US |
| Child | 14618993 | US |
