News Column

Patent Issued for Injector for Auto-Injection of Medication and Associated Method of Use

June 4, 2014



By a News Reporter-Staff News Editor at Journal of Engineering -- TCB Medical Devices, LLC (Hilton Head, NC) has been issued patent number 8728040, according to news reporting originating out of Alexandria, Virginia, by VerticalNews editors.

The patent's inventors are Beller, Thomas C. (Hilton Head, SC); Forman, Mark (Manalapan, NJ); Morton, Matthew J. (Morrisville, NC); Bedsaul, Amanda D. (Morrisville, NC).

This patent was filed on June 23, 2011 and was published online on May 20, 2014.

From the background information supplied by the inventors, news correspondents obtained the following quote: "Certain medical conditions require immediate injection of medication. Conditions requiring such treatment may result from a variety of causes. Among the most serious of those conditions is anaphylaxis (a severe allergic reaction) that, in many cases, can become fatal within minutes if left untreated. Numerous allergens may cause anaphylaxis including insect bites, medications, latex, foods and other various chemical substances. For example, food products having even small quantities of peanuts, seafood or milk products can, in some individuals, induce severe, potentially lethal reactions. In foods, the allergen may be 'hidden', that is, the food unknowingly, may contain a minute trace of an allergenic ingredient or may have been exposed to the allergenic ingredient during its processing. When anaphylaxis occurs, often there is insufficient time for the patient to reach a hospital or other trained and equipped medical personnel.

"Individuals known to be at risk for anaphylaxis typically are advised to carry, at all times, an auto-injector apparatus adapted to deliver a dose of Epinephrine. The ability to inject the Epinephrine immediately can be a matter of life or death. Notwithstanding the severe risk involved, there is evidence that a large proportion of the population that should be carrying such an apparatus, in fact, does not. Moreover, even for those individuals that carry such an apparatus, it has been reported that a large proportion are insufficiently familiar with its use and operation.

"The most common automatic emergency Epinephrine injector apparatus is the EPIPEN.RTM. auto-injector distributed by Mylan, Inc. The EPIPEN.RTM. injector is designed to rapidly inject an adult dose of about 0.30 milligrams of Epinephrine. The injector is about six inches long and has an oval tubular shape with a diameter of approximately three inches. The injector is relatively bulky and requires training to be administered correctly since proper use of the device is not intuitive. As a patient may only use the injector infrequently, there may be some confusion in performing the required manipulative steps, particularly when the individual experiencing anaphylaxis may be in a state of panic. Furthermore, should it be necessary for someone other than the patient (e.g., a bystander) to administer the medication, that person may not know how to operate the injector. Additionally, some injectors possess complicated parts requiring multiple hands for proper use and administration. Consequently, precious time may be lost, increasing the risk to the patient. Moreover, confusion has been reported regarding which end of the device the needle protrudes from and, as such, accidental injections into the thumb or finger of the person delivering the medicine are common. Additionally, after the injector has been used to effect an injection, its hypodermic needle often remains exposed, presenting post-injection hazards. Among such hazards are those associated with accidental stabbing or puncture injuries, or the spread of blood born diseases such as HIV and hepatitis B and C.

"It would be desirable to provide a more compact, easier to use injector, which patients are more likely to carry on their person, for rapid transcutaneous administration of a predetermined dose of medication. It would also be desirable to provide an injector which can be unlocked, activated, and administered with the use of only one hand."

Supplementing the background information on this patent, VerticalNews reporters also obtained the inventors' summary information for this patent: "In certain embodiments, the injector includes a generally rectangular shaped body having an extension or stem extending from a first, forward facing surface thereof. In alternate embodiments the body is generally square, oval or other shape dimensioned to fit within a user's hand, with the extension or stem extending from a forward facing surface thereof. As such, the injector is substantially key-shaped and is configured to fit in the palm of a user's hand such that the body may be held within the user's hand with the extension extending between the index and middle fingers. A depressible safety button on each side of the extension also extend from the first surface of the body and are thus operative to be depressed (simultaneously or otherwise) by the index and middle fingers of the user. Thus, a user may hold the injector in one hand, simultaneously depressing the safety buttons with the same hand, thereby activating the injector. By depressing the injector against the user's skin at an injection site, the user engages an activation mechanism, and the injector is deployed, causing the syringe housed within the body to move towards the injection site, the point of the corresponding needle to extend beyond the body and pierce the user's skin and the liquid to be injected by virtue of a plunger. Post-deployment, when the user removes the injector from the injection site, a protective sleeve automatically extends from the extension to cover the needle point, which would otherwise extend beyond the body. Thus, in a post-deployment state, the injector automatically protects against inadvertent puncture wounds from the needle

"A first preferred embodiment of the present invention is directed to a key-shaped portable injector for delivering a dose of medication. The injector may preferably include a cap, a body having an internal cavity, a syringe or cartridge (hereinafter 'syringe') located within the internal cavity for storing the medication, a needle extending from the syringe, a protective sleeve, an activation mechanism, a power assembly that may include a spring-containing plunger arm and a crown, and a safety mechanism. In one embodiment of use, the injector is reconfigurable from a first, non-deployed configuration, to a second, deployed configuration, and a third depleted configuration. The activation mechanism, the syringe, and the plunger arm are all moveably located with respect to the body from the first, non-deployed position to a second, deployed position. The crown does move, but changes shape from a non-deformed shape when the activation mechanism is in its first position to a deformed shape when the activation mechanism is in its second position. The activation mechanism, the syringe, the plunger arm and the protective sleeve are all in their first positions when the injector is in the first, non-deployed configuration and are in their second positions when the injector is in the second, deployed configuration. The crown is in its non-deformed shape when the injector is in its first, non-deployed configuration and in its deformed shape when the injector is in its deployed configuration. The safety sleeve may be moveably located with respect to the activation mechanism. The safety sleeve is in its first position when the device is in the non-deployed configuration and in its second position when the device is in the depleted configuration. While in the deployed configuration, the activation sleeve is in a transitional position between its first and second positions. While in the non-deployed configuration, the crown of the power assembly prevents the plunger arm from moving to its second position. The safety mechanism is also moveably located with respect to the body from a first, safety position to a second, ready position. In the first position, the safety mechanism prevents the crown from deforming thus preventing the release of the plunger arm. By preventing the crown from deforming, the safety mechanism also prevents the activation member from moving to its second position.

"A second preferred embodiment of the present invention is directed to a portable injector for delivering a dose of liquid. The injector may preferably include a device body, a liquid-containing syringe, a needle, a spring-activated plunger arm, a protective sleeve, an activation mechanism and safety mechanism. The device body comprises a forward facing surface, a trailing surface, a first side surface, a second side surface, a top surface and a bottom surface wherein the forward facing surface, the trailing surface, the first side surface, the second side surface, the top surface and the bottom surface define an internal cavity. The liquid containing syringe may be preferably located within the internal cavity of the body and when activated, allows the needle to extend from the forward facing surface of the body.

"The protective sleeve is moveably located with respect to the activation mechanism. In the first position, the sleeve is located within the activation mechanism towards its distal, back end while the device is in its non-deployed configuration. This position allows for exposure of the needle when the device is in the deployed configuration, facilitating exposure of the needle. The sleeve preferably moves from a first position to a second position. From the first position, the sleeve may preferably extend proximally from the forward facing surface of the device body into its second position to encase the needle as it is removed from the injection site after deployment. More preferably, the protective sleeve may be biased so that after injection of the liquid and removal of the needle from the patient's skin, the sleeve may automatically move to its second position to protect the user from accidental needle stick. In its first position, the protective sleeve may preferably interact with or engage the activation member so that it is prevented from moving to its second position until the activation member has moved to its second position. In its second position, the protective sleeve preferably interacts with or engages the activation member in a second way so that the sleeve may be locked or secured in the second position.

"In one embodiment, the activation mechanism is moveably located with respect to the device body from a first position to a second position. The protective sleeve is contained within the activation mechanism when the device is in the non-deployed (i.e. pre-deployment) configuration.

"The safety mechanism is also moveably located with respect to the device body. The safety mechanism may move from a first position to a second position. In the first position, the safety mechanism prevents the crown from deforming, which secondarily prevents movement of the activation mechanism.

"The injector is preferably in the shape of a key. In another embodiment, the injector is preferably in the shape of a modern, battery containing, key-chain.

"The injector contains a syringe that is attached to a needle. The syringe is preferably filled with liquid, which is prevented from exiting the non-needle-containing end of the syringe by a rubber plunger. The rubber plunger may be moveably located within the syringe from a first position to a second position. In its first position, the rubber plunger is displaced from the needle-containing end of the syringe, leaving space for the liquid. In its second, deployed position the rubber plunger moves closer to the proximal, needle-containing end of the syringe, leaving less space for liquid. The rubber plunger may be threadably attached to the plunger arm. The syringe and the attached needle, are preferably in operative association with the plunger arm so that the syringe, and the attached needle are moveable with respect to the body from a first position in which the injector is in the first, non-deployed configuration, to a second position in which the injector is in the second, deployed configuration. When moving from the first position to the second position, the syringe and the attached needle is capable of moving in a proximal direction.

"The injector may also contain a power assembly that interacts with the syringe. The power assembly may comprise a crown, and a hollow plunger arm containing a spring. The plunger arm may be moveably located within the syringe. The plunger arm is preferably moveable from a first position, when the injector is in the first, non-deployed configuration, to a second position, when the injector is in the second, deployed configuration. When in its first position, the plunger arm preferably contains a compressed spring. The plunger arm extends proximally to its second position when it is separated from the crown during activation of the device. When the device is in the non-deployed configuration, the crown interacts with or engages the plunger arm, preventing the plunger arm from moving from its first position to its second position. The crown is preferably shaped like a hat with a brim on either side. Movement of the activation member into its second, deployed position, causes the crown to deform by widening and flattening, allowing it to release the plunger arm, which in turn allows expansion of a spring. Expansion of the spring preferably causes the plunger arm to force the syringe and the attached needle, proximally towards the forward facing surface of the body. Movement of the plunger arm into its second, deployed position may push the plunger proximally within the syringe, releasing the liquid in the syringe thru the needle.

"The safety mechanism may also comprise a pair of depressible buttons. More preferably, the depressible buttons may protrude proximally from the forward facing surface of the body and are located one on either side of the needle. The depressible buttons may be configured so that they must be simultaneously depressed in order for the crown to deform and for the activation mechanism to move from its first position to its second position.

"The depressible buttons of the safety mechanism contain distal ends that are preferably in contact with the peripheral portion of the crown of the power assembly. In the first, safety position, the depressible buttons prevent the crown from deforming by obstructing its peripheral edges. The peripheral edges of the crown, when immobilized by the safety buttons, prevent the activation mechanism from moving from its first position to its second position.

"The activation mechanism preferably includes a distal portion that resides in the internal cavity of the body. The distal portion of the activation mechanism interacts with the crown of the power assembly. In its first position, the activation mechanism may preferably be in close proximity to the crown or rest against the crown. In its second position the activation mechanism causes the crown to deform, releasing the plunger arm. The activation mechanism is prevented from moving to its second position when the safety mechanism is in its first, safety position, because the safety mechanism prevents the crown from deforming. After the plunger arm has been released and the syringe has moved to its second position, the activation mechanism may move back to its first, proximal position to facilitate the encasement of the needle along with the sleeve."

For the URL and additional information on this patent, see: Beller, Thomas C.; Forman, Mark; Morton, Matthew J.; Bedsaul, Amanda D.. Injector for Auto-Injection of Medication and Associated Method of Use. U.S. Patent Number 8728040, filed June 23, 2011, and published online on May 20, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=109&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5431&f=G&l=50&co1=AND&d=PTXT&s1=20140520.PD.&OS=ISD/20140520&RS=ISD/20140520

Keywords for this news article include: TCB Medical Devices LLC.

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Source: Journal of Engineering


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