Patent Application
20060247579
1. Field of the Invention
The present invention relates to devices and methods for injecting medication, and more particularly to a disposable auto-injector featuring spring activation and concealed needle, designed for one-time self-administration of medication by an individual who is not necessarily medically trained.
2. Description of the Related Art
Many individuals suffer from chronic conditions that require them to self-administer medication, either at regular intervals or in response to certain emergency conditions. For example, some people are susceptible to life-threatening allergic reactions (anaphylaxis); upon exposure to an allergen, such individuals require immediate treatment by injection of a drug such as epinephrine. There may not be time to transport the individual to a medical facility for treatment, and there may not be a medical professional nearby to administer the treatment. Indeed, it is possible that the individual may need to self-administer the drug in the event that no capable adult is nearby who can administer it to the individual.
Accordingly, a need has arisen for devices that allow easy self-administration of emergency medication. Such devices are often disposable, and are often designed to administer a pre-measured dose, so as to make them as easy as possible to use. One example of such a device is the EpiPen® epinephrine auto-injector, available from DEY L.P. of Napa, Calif. and manufactured by Meridian Medical Technologies, Inc., a subsidiary of King Pharmaceuticals, Inc. of Bristol, Tenn. Other examples include the ConfiDose™ injector by Innoject, Inc. of Athens, Tex., and the BD™ auto-injector by BD Medical Pharmaceutical Systems of Le Pont-De-Claix, France.
All of these injectors are understood to incorporate a syringe assembly within a cylindrical pen-shaped housing. Such a design carries several disadvantages which make the devices more difficult to carry, store, and use.
For example, in some situations the pen-shaped housing may make the device more difficult to carry. Users who do not have a spare pocket that fits a large, cylindrical, pen-shaped device may find it inconvenient to carry the device and may not have it with them when the need arises.
Furthermore, the pen-shaped housing offers little space for providing instructional text, diagrams, and the like. Since the users of such devices are not usually medically trained, there is a need for large, clear, prominent instructions (and warnings) including text and drawings. Conventional devices do not usually provide sufficient surface area to provide such instructions.
In addition, the pen-shaped housing can be intimidating to some users because it resembles a needle, and/or because of acquired stigma or fear associated with such devices from past usage.
Furthermore, prior art injectors often do not provide sufficient indication as to whether the injector is in safe mode or in injection-ready mode.
What is needed, therefore, is an improved auto-injector having a housing that is more conveniently shaped for users who do not have a spare pocket to carry a pen-shaped device. For example, what is needed is an auto-injector that can be carried easily in a wallet.
What is further needed is an auto-injector that provides sufficient surface area for adequate instructions including text and/or drawings.
What is further needed is an auto-injector that does not resemble a needle and that does not intimidate users.
Conventional auto-injectors carry additional disadvantages as well. For example, they typically have a limited safety mechanism that involves a one-step disengagement operation; such a safety mechanism may be inadequate to prevent inadvertent use of the device.
What is further needed is an auto-injector that addresses the above limitations and disadvantages of the prior art and that provides an improved, easier methodology for self-administering emergency injections.
The present invention is a card-shaped disposable auto-injector. The card-shaped casing provides several advantages. It is easy to carry in a wallet-shaped case; it offers a relatively large amount of surface space for instructional text, diagrams, identifying information, warnings, and the like; and it is less intimidating to some users than a pen-shaped device.
In one aspect, the injector of the present invention is specially sized and shaped to fit in a recessed cavity of a wallet-shaped travel case.
In one aspect, the injector of the present invention includes a two-step safety mechanism to prevent inadvertent use or activation of the injection mechanism.
In one aspect, the injector of the present invention provides improved visual indication as to the current state of the injector. A lever position, which is readily discernable by the user, indicates whether the injector is in a safe mode or in injection-ready mode.
The accompanying drawings illustrate several embodiments of the invention and, together with the description, serve to explain the principles of the invention.
The present invention is now described more fully with reference to the accompanying Figures, in which several embodiments of the invention are shown. The present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather these embodiments are provided so that this disclosure will be complete and will fully convey the invention to those skilled in the art.
In the following description, the invention is set forth in the context of a single-dose disposable auto-injector. However, one skilled in the art will recognize that the invention can be implemented in other ways as well, for example in non-disposable and/or multi-use devices. It will be apparent from the description provided herein that many other variations are possible, and that the particular embodiments set forth herein are intended to be exemplary and not limiting.
Overall Architecture
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As shown in
In one embodiment, injector 200 includes casing 404, removable safety 401, lever 402, and trigger 403 (which is normally in a recessed position as shown in
In one embodiment, the lever 402 position, which is readily discernable by the user, indicates whether the injector is in a safe mode or in injection-ready mode, thus providing improved indication to the user as to whether injector 200 is in safe mode or in injection-ready mode.
In one embodiment, the protruding portion trigger 403 can be smaller, or less obtrusive, than shown in the Figures, so as to assure that the bottom of casing 404 is flush against the injection site when an injection is being performed.
The particular dimensions and proportions shown in the Figures are merely exemplary. In one embodiment, relative sizes of lever 402 and trigger 403 are such that the plastic of lever 402 acts, in safe mode, as a closed door to casing opening 1202, so as to prevent or limit debris from entering casing 404.
Referring now to
As shown in
In one embodiment, an injection take place only after safety 401 has been removed and lever 402 has been squeezed. The user can then jab injector 200 against the injection site to cause the medication to be injected.
The invention thus offers a safety feature by reducing the chance of accidental activation of the injecting mechanism. Furthermore, the user is given a sense of awareness and control by having to squeeze lever 402. In addition, casing 404 includes a lower lip that protrudes from the body of casing 404 when lever 402 is squeezed, so as to prevent the user's hand from slipping as injector 200 is jabbed.
In one embodiment, lever 402 returns to its original position if the user stops squeezing it without carrying out the injection. In another embodiment, lever 402 remains in the squeezed position unless a release mechanism (not shown) is activated. The release mechanism may be activated via a separate button, or by a brief second squeeze of lever 402.
Referring now to
One advantage of the injector of the present invention is that it can easily be carried so that it is available at all times. Referring now to
Components
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In one embodiment, casing 404 is transparent, so that the user can see if the epinephrine (or other medication) is of the expected color and consistency. In this manner, the user can check whether the medication has not expired or has any unexpected visual characteristics. In another embodiment, casing 404 includes a transparent window to allow the user to see at least a portion of its contents. In one embodiment, text on casing 404 provides guidance as to what color to expect, and how to determine if the medication has expired based on its visual characteristics.
Referring now to
In one embodiment, the plastic components of injector 200 are constructed from plastic having a grade that allows for predictable, exact molds. In one embodiment, these components are constructed from polyvinyl chloride (PVC) or polypropylene, although one skilled in the art will recognize that other materials can be used. In particular, since injector 200 is designed to be carried in wallets, back pockets, and school bags, components such as casing 404 and lever 402 are, in one embodiment, constructed from a relatively strong plastic that is difficult to break, fracture, or permanently deform. At the same time, the plastic used in lever 402 is flexible enough to allow the user to squeeze lever 402 during operation of injector 200.
In one embodiment, the plastic components are constructed from plastic that is relatively strong compared to its thickness. In one embodiment, the tensile strength of the plastic components is at least 377 pounds-force/square inch, and the density of the plastic components is at least 0.05 pounds/cubic inch, although one skilled in the art will recognize that other materials can be used. In this manner, injector 200 can be constructed to be of minimum shape while still retaining sufficient strength and structural integrity to be carried and used in real-world environments.
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In one embodiment, hook hands 1603 and arms 1602 are constructed from metal having sufficient compression and tension strength properties, while also possessing sufficient elasticity to temporarily deform as needed. In one embodiment, these components are constructed from stainless steel.
In one embodiment, torqued flippers 1405 are relatively strong and difficult to snap, so that they can effectively distribute the user's jabbing force to spring key 1501. In one embodiment, torqued flippers 1405 are constructed from metal having sufficient elasticity to temporarily deform as needed; in another embodiment, plastic can be used. In one embodiment, these components are constructed from stainless steel, or PVC, or polypropylene.
Mechanism
As described above, in one embodiment the user performs the following steps in order to use injector 200:
remove safety 401;
squeeze lever 402;
jab injector 200 into thigh or other injection site.
A mechanism for enabling the functionality of the present invention will now be described. One skilled in the art will recognize that the particular mechanism and configuration described herein is merely exemplary, and that the essential features of the invention, as set forth in the claims, can be implemented in other embodiments than that shown.
Referring now to
In
Spring key 1501 is tightly nestled on the sides by trigger assembly 1401, on the bottom by lever bridges 1304, and on the top by casing 404. Spring key 1501 restrains hook hands 1603, thus preventing spring 1703 from pushing the plunger 1604. Thus, while safety 401 is in place, none of the injector components can move.
In one embodiment, syringe 1704 is rectangular with rounded edges. In one embodiment, syringe 1704 is made of glass. However, one skilled in the art will recognize that syringe 1704 may be a different shape and/or material. For example, in one alternative embodiment, syringe 1704 may be cylindrical in shape. In one embodiment, syringe 1704 is made of glass that is no thicker than ⅛th of an inch.
In one embodiment, spring 1703 is rectangular. In one embodiment, spring 1703 is made of metal. However, one skilled in the art will recognize that spring 1703 may be a different shape and/or material. For example, in one alternative embodiment, spring 1703 may be cylindrical in shape and/or constructed from plastic.
Referring now also to
In order to perform an injection, the user first removes safety 401. Once safety 401 has been removed, the user can squeeze lever 402. Referring now to
The use of magnets 1701 and 1702 helps ensure that trigger 403 mates accurately with opening 1202, and that other components of the device mate with one another properly. In one embodiment, magnets are selected having strength that ensure that they do not attract one another until they are sufficiently proximate to one another, so as not to engage the device inadvertently. Magnets are advantageous because they can be calibrated to desired potentials with a high degree of accuracy.
In addition to ensuring an accurate mating, and in addition to providing an attraction force that waits for activation until its mating piece is in the vicinity, magnets 1701 and 1702 provide additional advantages. First, because magnets 1701 and 1702 can be embedded in the plastic of the components, they can serve their purposes without taking up any valuable space. Second, because their attraction becomes weaker as they get farther apart, when the user pushes trigger 403 against the injection site, it is more like breaking a seal than fighting a constant force. This provides appropriate tactile feedback to the user as to the current state of the device.
One skilled in the art will recognize that magnets 1701 and 1702 are not required, and that other mechanisms are available for coercing trigger 403 into proper position for injection. For example, weights, springs, and/or other mechanisms can be used instead of or in addition to magnets 1701 and 1702.
Referring now to
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In one embodiment, medication is delivered as follows. When spring 1703 pushes the plunger 1604, it does two things. First, plunger 1604 pushes syringe 1704 and needle 801 through casing 404. Simultaneously, though in one embodiment not as quickly, plunger 1604 pushes stopper 1605 through syringe 1704, causing medication to be forced into needle 801 before needle 801 breaks the user's skin. This ensures no air bubbles are part of the administered medication. A collar on plunger 1604 can be used to calibrate the device to stop after delivering a specified dosage.
In the above description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the invention. It will be apparent, however, to one skilled in the art that the invention can be practiced without these specific details. In other instances, structures and devices are shown in block diagram form in order to avoid obscuring the invention.
For example, injector 200 can be used for administering any type of medication, and is not limited to epinephrine administration. For example, injector 200 could be used for administering nerve agent antidotes; an easy-to-use and easy-to-transport injector 200 for such antidotes is an important defensive tool for front-line emergency responders and others who may be exposed to nerve agent attacks. In alternative embodiments, the present invention can be used to implement a dual cartridge injector.
Reference in the 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 of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.
As will be understood by those familiar with the art, the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. For example, the particular architectures depicted above are merely exemplary of one implementation of the present invention. The functional elements and method steps described above are provided as illustrative examples of one technique for implementing the invention; one skilled in the art will recognize that many other implementations are possible without departing from the present invention as recited in the claims. Likewise, the particular capitalization or naming of the modules, protocols, features, attributes, or any other aspect is not mandatory or significant, and the mechanisms that implement the invention or its features may have different names or formats. In addition, the present invention may be implemented as a method, process, user interface, computer program product, system, apparatus, or any combination thereof. Accordingly, the disclosure of the present invention is intended to be illustrative, but not limiting, of the scope of the invention, which is set forth in the following claims.
