REUSABLE AUTO-INJECTOR DEVICE WITH REFILLABLE MEDICATION AND REPLACEABLE NEEDLE

An injection system and apparatus comprises a housing with a loading tray configured to accept a medication cartridge, a needle configured to transport medication from the medication cartridge to an injection site, a retractable sheath formed on an injection end of the housing, and a telescoping plunger comprising at least two telescoping sections, wherein the plunger is configured to impart downward force on the medication cartridge in order to release medication in the medication cartridge through the needle to an injection site.

TECHNICAL FIELD

Embodiments are generally related to the field of medicine. Embodiments are further related to the field of injections. Embodiments are also related to injection devices. Embodiments are further related to auto-injection devices. Embodiments are also related to vaccinations, inoculations, and injectable therapeutics. Embodiments are further related to devices, systems, and methods for injectable medications that can be administered via an auto-injector device.

BACKGROUND

There are numerous medications that are administered via injection in subcutaneous or intramuscular tissue. These medications may be administered by healthcare providers, emergency response teams, or may be self-administered. Some of the medications administered in this fashion include, but are not limited to, those for chronic conditions that are administered at regular intervals, such as biologic therapies, insulin, or human growth hormone; those designed for prophylactic use such as vaccines; and those that are rarely used but are required immediately in emergency situations, such as Epinephrine, Narcan, or Glucagon.

Administration for many of these indications is typically via an injector that houses the medication and quickly delivers the medicament into the subcutaneous or intramuscular space automatically. Many injector devices, particularly those used in the emergency setting, are designed for one-time use, containing one dose of medicament enclosed in the device. A common example is Epinephrine, which is used in the event of anaphylaxis; a life-threatening allergic emergency that can be triggered by a variety of substances including foods, medications, latex, and bee venom, but can also occur in the absence of a specific allergenic trigger. Due to the nature of this medical condition, Epinephrine injectors designed for emergency use, must be available at all times. The injectors must be discarded when they expire or after use, which proves very wasteful since use is rare. It is advisable to carry two doses, for those at risk of anaphylaxis, as a second dose may be required in some instances. This effectively doubles the waste of one-time use injectors in accordance with the state of the art.

There are several drawbacks associated with such injector devices. For example, medications used in the emergency setting, such as Epinephrine are expensive. In addition, most injectors can only deploy a single dose of medication, and are very often discarded unused as the medication within the injector loses efficacy and reaches expiration typically in 12 to 18 months. Furthermore, these injectors are bulky and must be treated as medical waste which requires a sharps container.

The combination of the short expiration date, the lack of use over years (particularly for chronic conditions), and the high costs of these devices, patients are deterred from refilling this medication. As a result, they risk not having the proper treatment when needed.

Likewise, public venues such as restaurants, sporting arenas, amusement parks, schools and the like are also deterred from having injectors available as part of an emergency kits, in part because they are not required to carry them, and in part because it is inconvenient to keep them. Increasing availability in such public places would lead to quicker treatment and reduce reaction severity.

Epinephrine is also required in medical or dental offices, hospital clinics, and by emergency medical service (EMS) personnel. However, many do not carry Epinephrine and if they do, it is often drawn up from a vial into a syringe rather than being dispensed from an injector, since the high price and frequent need to refill is dissuasive. Having a ready-to-use injector in these settings can decrease the time to injection of Epinephrine and other medications used in the emergency setting.

Accordingly, there is a need in the art for cost effective, reusable auto-injector systems and methods as disclosed herein.

SUMMARY

It is, therefore, one aspect of the disclosed embodiments to provide an injector device.

It is another aspect of the disclosed embodiments to provide systems and apparatuses for auto-injectors.

It is another aspect of the disclosed embodiments to provide methods and systems for reusable auto-injector devices with refillable medication cartridges and replaceable needles.

The disclosed embodiments provide auto-injectors for dispensation of emergency medications such as the epinephrine, but may have applications for other injectable medications as well. The embodiments incorporate both a replaceable needle and replaceable cartridges or vials containing medicament. Instead of having to replace the entire device every time following each use, or when the Epinephrine expires, users only have to replace the needle and cartridge containing medication, at a much lower cost to them. The lower cost may help make these types of medications more available in public venues as part of their first aid kits, and may help patients be more compliant with on-time refills. The ability to reuse the auto-injectors disclosed herein, will also impact the environment by creating significantly less medical waste, as only the expired cartridge needs to be discarded if the injector is unused.

It will be appreciated that the disclosed methods and systems can be achieved according to the embodiments herein. For example, in an embodiment, an injection system comprises a housing unit structured around loading tray configured to accept a medication cartridge, a needle situated below this loading tray to transport medication from the cartridge to the injection site, a sliding protective sheath surrounding the injection end of the housing, a plunger comprising at least two telescoping sections, built within the housing, which is capable of imparting a downward force on one end of the medication cartridge for the release of medication through the other end. In an embodiment, the needle can be further classified as a double-sided needle comprised of a first pointed end, a second pointed end, and a connective region capable of transporting medication between either end. In an embodiment, one of the first pointed end and the second pointed end of the two sided needle is configured to pierce the medication cartridge.

In an embodiment, the system further incorporates a sheath spring configured to extend and retract the protective sheath. In an embodiment, the injection further utilizes a non-electrically-actuated force generator positioned to impart a downward force on the plunger.

In an embodiment, a removable safety cap is configured to prevent the plunger from imparting any downward force on the medication cartridge.

In an embodiment the injection system further employs a needle hub configured to hold the needle component. The system further includes a needle switch operably connected to the needle hub capable of uniting the disposable needle to the sub-component

In an embodiment, the injection system further includes a cartridge insertion door connected to the overall housing unit that provides the user with access to the load tray.

In another embodiment an auto-injector comprises a medication cartridge, a housing unit with a loading tray configured to accept the medication cartridge, a double-sided needle configured to dispense medication from the medication cartridge, a sheath surrounding the injection end of the housing, built to be extended and retracted by a sheath spring, a telescoping plunger, a non-electric force generator, such as an injection spring, configured to impart a downward force on the plunger in order to transfer the force on the medication cartridge for dispensation of the medication from the opposite end of the cartridge into the needle.

In an embodiment, the needle can be further classified as a double-sided needle comprised of a first pointed end, a second pointed end, and a connective region capable of transporting medication between either end.

In an embodiment, the medication cartridge further utilizes a cap, or septum, capable of being pierced by the double-sided needle for transfer of medication into the needle body. In an embodiment, the auto-injector further comprises a removable safety cap configured to prevent the plunger from imparting any downward force on the medication cartridge.

In an embodiment, the sheath further incorporates a needle aperture. In an embodiment, the auto-injector is further constructed to restrict movement of the medication cartridge between at least two sliding positions, specifically: a first sliding stop at which medication is dispensed from the cartridge; and a second sliding stop where the cartridge can be loaded and unloaded.

In an embodiment, the injection system of further employs a needle hub configured to hold the needle component. In an embodiment the auto-injector uses a needle switch operably connected to the needle hub capable of uniting the disposable needle to the sub-component.

In another embodiment, a modular injector system comprises a dispenser assembly built from an outer housing unit, a telescoping plunger in this housing, a non-electric force generator, specifically an injection spring, configured to impart a downward force on the plunger, and a protective sheath connected to the telescoping plunger to control the initiation of the injection process; and a cartridge assembly comprising an inner housing unit built with a loading tray configured to accept a medication cartridge, a needle configured to dispense medication from a medication cartridge to the injection site.

In an embodiment, the dispenser assembly is configured to operate around the cartridge assembly and control its movement between the two sliding positions. The dispenser assembly further comprises a sheath surrounding the injection end of the housing unit, which is designed to activate injection when retracted and through which the needle of the cartridge assembly can move to inject the medication.

DETAILED DESCRIPTION

Embodiments and aspects of the disclosed technology are presented herein. The particular embodiments and configurations discussed in the following non-limiting examples can be varied, and are provided to illustrate one or more embodiments, and are not intended to limit the scope thereof.

Reference to the accompanying drawings, in which illustrative embodiments are shown are provided herein. The embodiments disclosed can 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 thorough and complete, and will fully convey the scope of the embodiments to those skilled in the art. Like numbers refer to like elements throughout.

All of the compositions and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the compositions and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit, and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims. Aspects of the embodiments disclosed herein can be readily incorporated with other embodiments, without departing from the scope of the disclosure.

The embodiments disclosed herein are generally directed to reusable auto-injector devices with refillable medication cartridges and replaceable needles. The systems and methods allow the refillable cartridge to be inserted into the auto-injector. After medication is administered, the needle can be replaced, and a new medication cartridge can be installed. The auto-injectors can be easily reset for reuse with a new needle and new medication cartridge.

FIG.1A-1EIllustrate aspects of an injection system100in accordance with the disclosed embodiments. The injection system100can be embodied as an auto-injector system100and can comprise subsystems including a cartridge loading assembly105, a retractable protective sheath110, a needle115, and a telescoping plunger120. The system100further includes a housing135for housing the subsystems. An external elevation view of the housing is provided inFIG.1C. These sub-systems work in tandem to safely deliver medication from a medication cartridge140to a patient, while advantageously reducing the number steps in the injection process and the associated waste.

The system100can make use of a generator125configured to impart downward force on the plunger120. In certain embodiments, the generator125can comprise an injection spring, but other force generating systems can also be used. For example, in certain embodiments, the generator can comprise an electrically powered linear actuator, pneumatic system, step motor, electromagnetic actuator, gas system, gear system, or the like. The plunger120can comprise telescoping sections121, configured inside the housing135and in operable communication with the generator125. The plunger120can impart a downward force on one end of the medication cartridge140for the release of medication through the needle115. In certain embodiments, a sheath spring130and associated assembly further detailed herein, is configured to extend and retract the protective sheath110.

In an exemplary embodiment, the housing135is structured around a loading tray associated with the cartridge loading assembly105, which is configured to accept a medication cartridge140. The needle115can be proximate to the loading tray. In an exemplary embodiment, the needle115is situated below the loading tray, and is configured to transport medication from the medication cartridge140to an injection site. The sliding protective sheath110surrounds the injection end of the housing135and prevents the needle115from being exposed until the injector system100is in use. This reduces the potential for accidental needle sticks.

FIG.1Aillustrates the plunger120and telescoping plunger sections121in a compressed state. In this configuration a second slide stop is illustrated in association with the cartridge140.FIG.1Billustrates the plunger120and associated plunger sections121in an uncompressed state. In this configuration the first slide stop is illustrated in association with the cartridge140. In operation, the generator125can provide a downward force on the plunger125upon activation by a user. The plunger125can include telescoping sections121which extend downward to provide force on the medication cartridge140. The downward force on the medication cartridge140pushes the medication cartridge140onto the needle115. The needle115pierces the medication cartridge140. Simultaneously, the protective sheath110slides up the housing135exposing one end of the needle115, on the delivery side of the injector system100, to dispense medication from the medication cartridge140to an injection site on the patient.

Aspects of the needle115are illustrated inFIG.1D. The needle115can comprise a double-sided needle including a first pointed end116, a second pointed end117, and a connective region118capable of transporting medication between the respective ends. In certain embodiments, the first pointed end116or the second pointed end117of the two sided needle115is configured to pierce the medication cartridge. The other end serves as the patient delivery end, for delivering the mediation to the patient at the injection site.

FIG.1Eillustrates an alternative configuration comprising a cartridge and needle assembly150. In such an embodiment, the cartridge and needle assembly150can replace the separate cartridge140and needle115. As illustrated, the cartridge and needle assembly150comprises a cartridge155connected to a needle160via a needle cone conduit165. The needle cone conduit165fluidically connects the cartridge155to the needle160. The needle cone conduit165is used to connect the top of the current main body to the bottom of the needle160, which extends to its final point at the other end. The cartridge and needle assembly150can be a single use device which can be loaded into the loading tray106of the loading assembly105.

It should be appreciated that the needle115or the needle160can comprise a 22 gauge needle. In other embodiments, other needle sizes and gauges can be used according to the specific application.

FIG.2illustrates additional aspects of the injection system100, and steps associated with a method200for use of the systems disclosed herein. It should be appreciated that certain aspects of the system100, as illustrated inFIG.2, are disproportionately sized for illustrative purposes only, and other aspects are omitted in order to show how the system works.

As illustrated at step205, a cartridge140(or other such vial containing medication) can be loaded into the loading tray106of the loading assembly105. In certain embodiments, the tray106can be released with a button on the side of the auto-injector, or by pushing open a swinging door107.

In an alternative embodiment, a removable panel can be pulled away from the housing135to expose the loading tray106for the cartridge140. In another embodiment, a spare cartridge140and/or a spare needle can be housed within the system100so as to make it convenient and compact, especially in the case of epinephrine where the recommendation is to carry two doses at all times.

The cartridge140containing medicament is loaded into the loading tray106, cap108side first. The cap108of the cartridge140can comprise a sealing material that can be penetrated by the needle115when the needle115contacts the cap108. Once the cartridge is in place, the cartridge loading assembly105can be closed. The cartridge140can include a protrusion109so that the cartridge loading assembly105will not shut if the cartridge140not loaded properly. This is a safety feature to prevent improper loading.

The cartridge loading assembly105can also be configured to be transparent so that the cartridge140is visible when the cartridge loading assembly105is closed. In certain embodiments, the housing135can include a clear window136adjacent to the cartridge140that allows the user to view the contents and information on the cartridge140, such as the name of the medication and the expiration or “use by” date.

After the cartridge140is loaded, a safety cap137, located on the front end156of the injector system100, can be removed or released. The safety cap137is used to prevent the injection spring125and plunger120from accidental activation. In order to initiate deployment of the medicament, at step210, the retractable sheath110is pushed against the skin211. The pushing force slides the sheath110along the body135and activates the plunger110as further detailed herein.

The generator120exerts a force on the plunger125pushing the medication cartridge140toward the delivery side of the housing. The cap108of cartridge140is pushed into the opening111formed in the housing135, proximate to the needle115at the delivery side of the system100. One end of the double-sided needle115penetrates the cap108of the cartridge140.

At step215, the delivery side of the needle115can be exposed as the protective sheath110slides back along the housing135. The needle115is pushed into the injection side on the patient at the injection site. The medicament141from the cartridge140can flow through the needle115into the patient. The auto-injector system100can be held in position for a few seconds to ensure that all of the medication141has been released from the cartridge140.

At step220, the injector system100can be pulled away from the injection site after the injection is complete. As the system100is pulled away, the protective sheath110slides back down the housing135, while the cartridge140and needle115are retracted back into the housing135. This deactivates the plunger120. The used cartridge140and/or needle115can then be removed from the auto-injector system100. A new cartridge140and/or needle115can then be loaded for future use.

A safety feature of the auto-injector system100is that the needle115can be replaced. The housing135and sliding sheath110prevent unwanted exposure to the needle, and protect the patient from accidental injection.

An aspect of the disclosed embodiments is that the protective sheath110slides up the housing body, while the needle and cartridge are forced to the delivery end of the system, exposing the needle for injection. In certain embodiments, the normal force applied to the sheath110by pressing it against the injections site, activates the generator125and or release the plunger120to push the cartridge140into the needle and the needle into the patient.FIG.3illustrates the process associated with these coordinated movements andFIG.4A-4DIllustrates additional aspects of the system used to accomplish the coordinated movement.

Step305ofFIG.3illustrates the deployment of the plunger120. When the protective sheath110is applied to the injection point, the normal force against the skin pushes the sheath along the housing135. Retractable sheath bars112, slide along bar tracks113formed in the walls138of the housing135. As the retractable sheath bars112reach their uppermost position, they can make contact with sliding arms405.

The sliding arms405are configured with plunger clips406configured to engage the plunger120. The plunger clips406can be biased against the plunger120with plunger clip springs407. The retractable sheath bars112press the sliding arms405inward. This inward motion compresses the plunger clip springs407and disengages the plunger clips406from the plunger120, opening the path through the housing135for the plunger to move downward. It should be appreciated that inFIG.3, the generator125, which imparts the downward force on the plunger120, is illustrated as a spring, but in other embodiments, other force generating systems can be used.

Step310ofFIG.3illustrates the retraction of the plunger120, after the injection has been delivered. As the system100is pulled away from the injection site, the sheath spring130forces the protective sheath110to slide back along the housing into an extended position. This disengages the retractable sheath bars112from the sliding arms405.

Control wire410can be connected on one end to the retractable sheath110, and can run through a channel415in the plunger110where they connect to the plunger face122at connection point411. In certain embodiments, the control wire410can comprise a cable of multiple (e.g., two or more) control wires410which are intertwined as a cable in the plunger, and then separated into separate wires as they exit the channel exit416, with each wire410connecting to a different point on the protective sheath110.

The control wires410connected to the protective sheath use the motion of the sheath to pull the plunger120back against the plunger spring125, retracting the plunger. The control wires can extend along the tracks113formed in the walls138of the housing135.

Step315illustrates the system100at reset for further use. When the retractable sheath110reaches its fully extended position, the control wires410(not shown at step315) apply less force on the front122of the plunger120. At this stage, the force exerted by the plunger spring125reaches a balance with the sheath spring130, with the front of the plunger122in a locked position. The locked position is secured by the sliding arms which are engaged with the plunger shaft123via the plunger clips406and plunger springs407.

Various details of the auto-injector system100are illustrated inFIG.4A-4D.FIG.4Aillustrates aspects of the locking assembly400in accordance with the disclosed embodiments. The locking assembly can include the sliding arms405and springs407. The sliding arms can be mounted on a rigid platform420, which can, in certain embodiments, include a series of interconnected concentric circles421. The plunger120can extend through the center most concentric circle421where it is engaged with the sliding arms405.

FIG.4Billustrates aspects of the plunger120in accordance with the disclosed embodiments. The plunger120can comprise a shaft123with a base124. The base124includes connection points411for control wires410. The channel exit416can be formed on the head430of the plunger120. The head430further includes a tapered neck431and lip432configured to engage with sliding arms405.

FIG.4Cillustrates aspects of the telescoping plunger sections121in accordance with the disclosed embodiments. In certain embodiments, the telescoping sections121can include helical guides425configured to allow each of the respective telescoping sections121to rotate into or out of a nested position with the telescoping section121above or below it. The plunger can be connected to the platform420.FIG.4Dillustrates a perspective view of the telescoping plunger120, showing the centermost concentric circle421through which the plunger120extends. The platform420can include wire track cutouts430which serve as wire guides for the control wires410. The platform also includes retractable sheath bar guides435configured to accept the retractable sheath bars112.

FIG.5illustrates a diagram of an embodiment of an auto-injector system500in accordance with the disclosed embodiments. It should be appreciated that the aspects of this and other embodiments can be used with one another. The auto-injector system500comprises a housing505configured to hold a medicament cartridge510. An insertion door515is formed in the housing and allows the cartridge510to be inserted in the housing. In this embodiment, a plunger button520, protected by a safety cap525can be used to depress a plunger530. The plunger includes a first slide stop531and a second slide stop532. When the plunger530is depressed the cartridge510is pressed against a needle535. In certain embodiments, the needle535comprises a double sided needle. The needle535is secured in a needle hub540. The needle hub is connected to a needle switch545with a connector550. The needle switch545is protected by a safety cap555.

Spring560is attached on one end to slider565and on the other end to retractable sheath570. The retractable sheath570comprises an enclosure for the needle535, with a needle opening580at the delivery end585of the injector. The sheath is covered by bottom safety cap575.

The cartridge510is replaceable through the door515, integrated in the housing505. This door515allows the user to remove the expired cartridge from and insert a new cartridge. The two sliding stops531and532prevent the medication from spilling when the cartridge510is replaced. Once the cartridge510is properly installed, the needle535can be inserted into the cartridge510. In this embodiment, the needle insertion should only be executed when the user is ready to administer the injection. To insert the needle535into the cartridge510the safety cap555on the right-side of the housing505can be lifted, and the switch545is turned upward. This process lifts the connector550upward, which in turn inserts the needle535upward into the cartridge510.

After the needle535is inserted, the safety cap555is lowered to ensure it is not flipped downward before injection. Once the needle535is inserted into the cartridge510and the safety cap555is returned to the downright position, the auto-injector system500is ready to administer an injection. First, the top safety cap525and bottom safety cap575are removed. Next the retractable sheath570can be depressed onto the injection site to expose the needle. The plunger button520can then be operated. The plunger button520is attached to a plunger530and a slider565. When the button520is pushed the slider565compresses the spring560. The spring motion and the force on the button520allows the medication to enter the double-ended needle535and move through to the end of the needle535into the injection site.

Once injection is complete, the needle535is retracted from the injection site, and the retractable sheath570extends back out to protect the needle. The safety cap525and safety cap575can be replaced for added safety.

In certain embodiments the system500can be divided into subsystems. One subsystem contains the top safety cap to the medication cartridge. The other subsystem contains the outer housing, plunger, plunger button, and bottom safety cap. The first subsystem is a replaceable unit that extends from the top safety cap to the cartridge. The second subsystem is a reusable unit that houses the plunger and plunger button. Instead of carrying two whole devices, the user can carry two of first subsystem and one of second subsystem. This decreases the bulkiness of the device and encourages patients to have their device with them at all times.

FIG.6AandFIG.6Billustrate aspects of a modular auto-injector system600. It should be understood that the modular auto-injector system600can incorporate aspects of other embodiments, without departing from the scope disclosed herein.

The modular auto-injector system600, includes a delivery assembly605and a dispenser assembly655. The delivery assembly605can be connected to the dispenser assembly655by engaging male threads606on the housing610of the delivery assembly605to female threads656on the housing660of the dispenser assembly655.FIG.6Aillustrates the delivery assembly605separate from the dispenser assembly655.FIG.6Billustrates the delivery assembly605connected to the dispenser assembly655.

The delivery assembly comprise a first slide stop615and second slide stop616configured to engage a cartridge620. A needle hub625holds a needle630. The needle extends through a needle holder635inside a retractable sheath640, covered by a safety cap645. The dispenser assembly655can comprise a plunger670, connected to a plunger button675and a safety cap680.

Once the delivery assembly605is connected to the medication assembly655, the end of the cartridge620lines up to the free end671of the plunger670. The safety cap680and safety cap645can be removed. Next the retractable sheath640can be positioned at the injection site. The force on the retractable sheath exposes the needle630which can penetrate the injection site. Once the needle630is inserted the plunger button675can be depressed. The plunger button675pushes the plunger670into the cartridge620, releasing the medication through the needle630into the injection site.

Once injection is completed the needle630is pulled out of the injection site, and the retractable sheath640extends to cover the needle630. The safety cap645and safety cap680can be replaced. After returning the safety caps are replaced the dispenser assembly655can be unscrewed from the delivery assembly605. In certain embodiments, the delivery assembly605can be discarded. The dispenser assembly650can be retained for future used and can be reset by pushing the free end671of the plunger670to its original position.

FIGS.7A-7Cillustrate a dual auto-injector700, in accordance with another embodiment that carries two doses of medicament. The dual auto-injector comprises two injector assemblies, assembly705and assembly710. Each of the injector assemblies has identical but mirrored components. The assembly705and assembly710are connected at interface715. Each of the respective assemblies comprise a housing720with an attachment clasp721configured to attach the respective assembles. The housing720includes a sheath725configured to hold a cartridge730. A plunger735is operably connected to a plunger button740with a safety cap745. A needle750is connected to the cartridge730with a needle hub755. A needle spring760surrounds the needle750, which is aligned to the needle opening765. The needle opening765is covered by a safety cap770. Each of the respective assembly705and assembly710can be designed at an angle so that the injection openings765are as centered as possible.

To assemble the system700, the needle safety cap770can be removed. The needle end slides into the open slot in the device. Once positioned, the top safety cap745can be pressed down until the attachment721clasps on the bottom of assembly705or710respectively attach to the attachment clasps on the top of the system700.

To administer an injection as illustrated inFIG.7B, one of the top safety caps745can be removed, and the bottom safety cap770can be removed. The bottom of the auto-injector assembly705can be position at the injection site. The plunger button740can be depressed which pushes the medicament735through the needle750into the injection site. The plunger button740force also activates the spring760on the needle750which moves the entire plunger system forward, resulting in the needle extending through the hole765and into the injection site. Once the injection has been completed the spring760will extend and return the needle750back into the housing720.

To remove the replaceable assembly705or710, the user can insert the L-shaped “screw-driver” tool785that can be provided with the dual auto-injector700. The point of the tool785can be inserted into the plunger button. The tool785can be pushed down into the plunger button740until the handle is slightly above the opening of the housing720. The tool785can then be used to remove the assembly705. Once removed, the needle safety cap can be replaced and the assembly705can be discarded.

FIG.8Aillustrates an embodiment comprising a single-use auto-injector system800. The system800includes a loading port805where the cartridge810is loaded and unloaded. The system further comprises a spring-loaded needle and plunger assembly815that, when activated, automatically inserts a needle820into the cartridge810and injects medicament into the patient.

The auto-injector system includes a body825with a lock assembly830, locking in place the release button835. The system also includes an injection safety cap840on the delivery side of the system800.

The interior of the auto-injector system800is held in equilibrium by two sets of springs. The first set of springs are cartridge springs845configured at either side of the cartridge810. The cartridge springs845are held in tension most of the time, as the top is locked in place by the injector body825and at the bottom by the cartridge lock826. At injection, the cartridge springs845are necessary for the auto-insertion of the needle820and release of the medicament from the cartridge810. The cartridge springs845are held in tension because they are locked in place.

The top locking assembly830is illustrated inFIG.8B. The brace855is locked in position by the injector body holding it up. The brace can be compressible, so, when pushed against the chamfers860above it, it compresses to a point where it can slip through the slot865below and the cartridge springs845compress into place. The top locking assembly includes the central rod861, and sliding lock862.

The second set of springs are needle springs865, which can be wrapped around the needle820. These needle springs865maintain the regular position of the cartridge springs845by pushing them back into their locked position after injection; however, during injection, the locked position becomes impossible to reach, so their effect is nullified.

In order to activate the auto-injector system800, the safety caps can be removed. When the cap is removed, both the release button835and a rotating knob870that is built around it for compactness. The button835includes a button spring875. The button835is inaccessible at this point as it is locked in place below the top of the knob870. This is one of the button's two conformational. Additionally, when the cap is removed, the loading port of the auto-injector system800can rotate away from the main body825to reveal a port880for the cartridge810to be inserted. The cartridge810is placed into this port880, and the port880can then be rotated into place, flat against the body825of the auto-injector system800. As the port880is rotated into place, the cartridge810is locked inside by arms that rotate out from the walls.

The knob870can then be rotated. With this knob's rotation, a sleeve extends itself from the back side of the auto-injector system800over the loading port880to prevent any unintentional motion of the cartridge-containing component. On top of rotating the sleeve, an O-ring885is lifted up and sealed against the outlet of the cartridge810, and the needle820is inserted into the cartridge810, exposing the needle820to the interior of the cartridge810.

The medication can be injected by pressing the system800against the injection site and clicking the release button835. Pressing the auto-injector system800against the injection site will raise the safety840that rests around the outside of the needle end of the auto-injector body825. The safety840slides up the outside of the housing825while the needle820extends to penetrate the injection site. The needle spring865, which wraps around the needle820, is completely compressed in between the bottom of the cartridge810and the top of the safety840, and the cartridge810is pushed back against the top of the needle820. The compressible part of the cartridge can be pinched enough to slide through the slot below. When this happens, the cartridge springs845push both the cartridge810and needle820toward the injection site.

When the safety is pushed into place, a central, thin rod861pushes the release button835out of the locked position, extending a spring875at the bottom of the release button835. The spring835holds the system800in this second conformational position. With the release button835unlocked, the button835can be pressed, pushing the thin rod861into the auto-injector body825and into the of the cartridge810. The rod861inserts itself into a button at the bottom of the cartridge810that releases a spring inside the cartridge810. The cartridges810can come pre-loaded with this spring inside in the locked position, but, when the spring is unlocked by the rod861, the spring pushes a plunger to release the medicament through the needle820to complete the injection.

Rotating the knob870back will pull the sleeve away and the cartridge loading port will extend away from the auto-injector body once again to allow unloading of the used cartridge810. The used needle can be replaced between uses. To do this, the retractable needle safety is pulled back until it clicks into place. At this point, the retractable safety840can be rotated until it tightens to a locked position and the needle820extends out the front end of the auto-injector system800. From this conformation position, the needle820only needs to be unscrewed from its housing and the new needle put in its place.

FIG.9illustrates a single use auto-injector system900, which can be configured to allow unused medication cartridges to be removed after their expiration. The system900can include a housing905with gripping grooves and a window910in the housing to view information on the cartridges915such as expiration information. To replace the cartridge, a lid920on the back end can be opened. Old cartridge(s)915can be removed and new cartridge(s)915can be inserted. The new cartridges915are positioned in the correct location by tracks930located on either side of the cartridge opening925.

The system900includes two handles955on either side of the housing905, which can be pulled down towards the safety cap935. By pulling the handles955, the cartridge915closest to the safety cap935is engaged. As the handles955are pulled down, springs940on either side shorten, bringing the cartridge915closer to the medicament dispenser945. The compressed spring940moves cartridges915via the handle955that connects the cartridges915on the track930. Once the handles955are pulled down to most extended location, the medicament dispenser945will pierce the cartridge915and provide a route for the medication to be introduced to the needle950.

After the cartridge915is engaged, the safety cap935can be pressed against the injection site for administration of the medication. The downward force against the injection site unsheathers the needle950by retracting the portion covered by the safety cap935. This retraction is possible by the needle unsheather portion960. The bottom of the device (safety lid side) can slide upwards towards the cartridge opening, occupying the space the needle unsheather960previously occupied, exposing the needle950through the needle stopper970. In certain embodiments, sensors965are configured along the walls to also react to the force produced by pressing the system900on the injection site, and further compress the spring940, aiding in the ejection of the needle.

FIG.10illustrates another embodiment of a single-use auto-injector system1000in accordance with the disclosed embodiments. The embodiment illustrated inFIG.10is intended to provide an easy to use user interface. The system1000includes a housing1005with a lid1010. The lid1010provides access to allow cartridges1015to be loaded. The lid1010opens like a door and is wide enough to accommodate at least two cartridges1015containing medicament.

The system1000includes a locking mechanism1020that rotates around the top1025cross sectional area of the system1000. The system1000includes a pusher1030. The active portion1035only occupies about 20% of the total cross-sectional area to ensure safety. The active portion1035can be the same size as the locking mechanism flap1040. Once the locking mechanism flap1040is rotated so that it aligns with the active portion1035, the locking mechanism flap1040can be pushed down to activate the system1000. The locking mechanism flap1040is kept on the inactive portion1045the device is not in use.

Before administration of medicament, the locking mechanism flap1040can be aligned with the active portion1035. Once aligned the interface1065can be pressed against the injection site so that the the needle opening1050makes contact with the skin. The interface1065can be rubbery and can be flat to allow better traction to both skin and clothes. The needle unsheather1075is formed above the interface1065. The downward pressing motion activates the needle system by providing a downward motion of springs1070and the spring contraction mechanism1055configured on the wall1060to unsheathe the needle1080, and extend it out the needle opening1050. The medicant dispenser1085provides mediation from the cartridge1015to the needle1080, into the injection site.

FIG.11illustrates a two-step auto-injector system1100in accordance with the disclosed embodiments. The system1100generally comprises a housing1105configured with a female threading1110, configured to engage with male threading1116on a medication cartridge1115. The cartridge is held in place with cartridge holder1117

The housing1105can include a clear window1106to provide visual access to information printed on the cartridge1115. A CO2 capsule1120is used to provide pressure to the medicant in the cartridge1115. The CO2 capture1120can be replaceable. A safety cap1125, prevents the retractable head1130from moving and also keeps the needle1135sterile and safe when the system1100is not in use. The top portion of the safety cap1125wraps around the housing1105above the retractable head1130, and the bottom portion covers the retractable head1130and the needle1135inside. The safety cap1125does not encapsulate the entire device so that it is easy to remove with one hand.

When the two-step auto-injector system1100is pushed against the injection site, the retractable head1130retracts, unsheathing the needle1135, while also pushing the stopper1140of the double-ended needle1135through the seal1145of the cartridge1115. The stopper1140pushes the cartridge1115towards the back of the injector. As the cartridge moves back, the end forms a seal around the mouth of the CO2 capsule1120. A needle-like piece1150on the end of the cartridge1115pushes the ball1155in the CO2 capsule1120back, releasing the CO2 into the chamber1165between the mouth of the capsule1120and the plunger1160inside of the cartridge. As the CO2 escapes the capsule1120, this chamber1165expands, pushing the plunger1160towards the injection site, and expelling the medicament through the needle into the tissue.

FIGS.12A and12Billustrate another embodiment of an auto-injector1200, that utilizes a needle1205attached to a cartridge1210. A valve1215at the base of the needle1205protects the medication from leaking, and only opens when pressure from the plunger1220pushes the medicament through the valve1215.

The system1200includes a needle cap1225comprising a piece of rubber that retracts when it is pushed against the body, exposing the needle1205. The needle1205can comprise a tear-free needle, which does not leave a hole in the cap1225once it has been extracted from it. The rubber cap1225can be reused, but can also be replaced by unscrewing the tip and placing a new one onto the injector housing1230.

Once the needle1205is positioned against the injection site, a trigger button1235is used to release a spring1240inside which pushes down the plunger1245inside of the cartridge1210.

FIG.12Bdepicts the auto-injector system1200before and during use, showing how the trigger button1235moves the latching triggers1250out of the way of the plunger1245using a set of gears1255. Once the plunger1245has been triggered, the pressure of the fluid within the cartridge1220makes the valve1215at the base of the needle1205open and release the medicament.

Once the auto-injector system1200has been used, it can be reset to its original configuration by first returning the triggers and plunger back to their locked positions. This can be accomplished by pushing the plunger1245back and locking it in place the triggers. The cartridge1210can be replaced by unscrewing the tip portion from the main housing1230, unscrewing the cartridge1210from the tip, replacing it, then replacing the tip with the cartridge1210by screwing it into the housing1230.

FIGS.13A and13Billustrate another embodiment of an auto-injector system1300that can be taken apart with a twisting mechanism in order to access the cartridge1310for replacement. The system1300includes a housing1305with a window1306which provides visual access to information printed on the cartridge1310.

The system1300comprises a retractable head1315, double sided needle1320, medicament cartridge1310, and plunger button1325, as well as a button safety cap1330dispenser safety cap1331, and sheath safety1332.

FIG.13Aillustrates the system1300before use. The first step to use the system1300is to remove the safety caps. Next, the retractable head1315can be pressed against the injection site. Pressing the retractable head1315into the injection site retracts the retractable head1315, as illustrated inFIG.13B. When the system is not in use, the retractable head1315protects against needle exposure. The retractable head1315is biased to this position with head spring1340.

During an injection, the head1315slides back towards the distal end of the housing1305, pushing the double-ended needle through the seal1335in the cartridge1310. Pushing the plunger button1325forces the plunger1345into the cartridge1310expelling the medicant through the needle1320.

The system1300is advantageous because it has a simple mechanism for exchanging cartridges1310, and the design minimizes the number of complicated, moving parts. The safety caps prevent the retractable head1315and plunger1345from moving before use, and ensure that the end of the needle1320is not exposed before use. There is a plunger spring1350under compression between the plunger button1325and the housing1305which keeps the button1325from inadvertently pushing out the medicant when the safety caps are off. The retractable head1315serves to keep the needle1320covered when the injector system1300is not in use.

The embodiments disclosed herein are directed to an auto-injector device which can be used with emergency medications such as the epinephrine. In other embodiments, the embodiments provided herein can be used with other applications for other injectable medications. The embodiments generally incorporate a replaceable needle and replaceable cartridges or vials containing medicament. The embodiments allow patients or providers to conveniently replace the needle and cartridge containing medication. The lower cost makes these types of medications more available in public venues, as part of first aid kits, and may facilitate timely medication refills. The ability to reuse the auto-injector will also impact the environment by creating significantly less medical waste, as only the expired cartridge needs to be discarded if the injector is unused.

Based on the foregoing, it can be appreciated that a number of embodiments, preferred and alternative, are disclosed herein. In an embodiment, an injection system comprises a housing with a loading tray configured to accept a medication cartridge, a needle configured to transport medication from the medication cartridge to an injection site, a sheath formed on an injection end of the housing, and a plunger comprising at least two telescoping sections wherein the plunger is configured to impart downward force on the medication cartridge in order to release medication in the medication cartridge.

In an embodiment, the needle further comprises a two sided needle comprising: a first pointed end, a second pointed end, and a body connecting the first pointed end and second pointed end. In an embodiment, one of the first pointed end and the second pointed end of the two sided needle is configured to pierce the medication cartridge.

In an embodiment, the injection system further comprises a sheath spring configured to extend and retract the sheath.

In an embodiment, the injection system further comprises a generator configured to impart a downward force on the plunger.

In an embodiment, the injection system further comprises a removable safety cap configured to prevent the plunger from imparting downward force on the medication cartridge.

In an embodiment, the injection system further comprises a needle hub configured to hold the needle. In an embodiment, the injection system further comprises a needle switch operably connected to the needle hub wherein the needle hub holds the needle in alignment with the medication cartridge.

In an embodiment, the injection system further comprises a cartridge insertion door formed in the housing that provides access to the load tray.

In an embodiment, an auto-injector comprises a medication cartridge a housing with a loading tray configured to accept the medication cartridge, a double-sided needle configured to dispense medication from the medication cartridge, a sheath form on an injection end of the housing, wherein the sheath can be extended and retracted by a sheath spring, a telescoping plunger, and a generator, configured to impart a downward force on the telescoping plunger in order to transfer the force on the medication cartridge for dispensation of the medication from the medication cartridge into the needle.

In an embodiment, the double-sided needle comprises a first pointed end, a second pointed end, and a connective region capable of transporting medication between the first end and the second end.

In an embodiment, the medication cartridge further comprises a cap capable of being pierced by the double-sided needle.

In an embodiment, the auto-injector further comprises a removable safety cap configured to prevent the plunger from imparting force on the medication cartridge.

In an embodiment, the sheath further comprises a needle aperture.

In an embodiment, the auto-injector further comprises a first sliding stop and a second sliding stop, wherein the first sliding stop and second sliding stop restrict movement of the medication cartridge between the first sliding stop and the second sliding stop.

In an embodiment, the auto-injector further comprises a needle hub configured to hold the needle component. In an embodiment, the auto-injector further comprises a needle switch operably connected to the needle hub.

In an embodiment, a modular injector system comprises a dispenser assembly comprising: an outer housing unit, a telescoping plunger in the outer housing unit, an injection spring, configured to impart a downward force on the telescoping plunger, and a protective sheath connected to the telescoping plunger to control the initiation of the injection process; and a cartridge assembly comprising: an inner housing unit with a loading tray configured to accept a medication cartridge, and a needle configured to dispense medication from the medication cartridge to an injection site.

In an embodiment, the dispenser assembly is configured to connect to the cartridge assembly. In an embodiment, the protective sheath is retracted in order to initiate an injection.