An autoinjector is a medical device used to deliver pre-measured doses of medication to a patient. They are designed to make the delivery of medication easier and more convenient. Autoinjectors can be used for a variety of medications, including insulin for the treatment of diabetes, adrenaline for the treatment of anaphylaxis, and methotrexate for the treatment of arthritis. They are particularly useful for patients who have difficulty self-administering medication, such as those with physical disabilities or impaired vision, or for patients who have a needle-phobia.
One type of autoinjector includes a pre-filled syringe, a spring-loaded mechanism, and a needle. The spring-loaded mechanism is designed to push the plunger of the syringe to deliver the medication into the patient's body. There are also needle-free autoinjectors, also known as jet injectors, that operate by using high-pressure streams of medication to penetrate the skin without the use of a traditional needle. Needle-free autoinjectors use a spring-loaded mechanism to create a high-pressure stream of medication that is forced through a small orifice and into the skin. The high velocity of the stream creates a fine mist that penetrates the skin, delivering the medication into the tissue beneath. Needle-free autoinjectors can be easier to use than traditional injection methods, eliminate the risk of needle-stick injuries, and reduce pain and discomfort associated with injections.
Gripping an autoinjector is an important part of using the device properly to ensure safe and effective medication delivery. An autoinjector may have a handle or grip that the patient can hold onto to keep the device steady during injection. In one example, the autoinjector utilizes a “hammer” grip in which the patient wraps their hand in a fist around the syringe body of the autoinjector so that the needle or jet (for needle-free) points downwardly from the bottom of the patient's fist. While mostly effective, for some patients such a grip can make it challenging to properly orient the autoinjector relative to the patient's skin or to firmly grip the autoinjector without slipping during use.
An autoinjector according to an example of the present disclosure includes a pump that has a reservoir for holding a medication, an outlet associated with the reservoir for discharging the medication, a working side at which the medication is deliverable from the pump, and a non-working side opposite the working side. A housing holds the pump and has at least one finger grip proximally located to the working side.
In a further embodiment of the foregoing embodiment, the pump includes a button portion operable to mechanically activate an evacuated driver, and the button portion protrudes from the housing on the working side.
In a further embodiment of any of the foregoing embodiments, the evacuated driver is configured to be activated by pressing the at least one finger grip to move the button portion against an injection surface to exert a force on the button portion that causes retraction of the button portion at least partially into the housing, thereby triggering release of the evacuated driver to pressurize the medication to discharge through the outlet.
A further embodiment of any of the foregoing embodiments includes an electronic control powered by an air-activated battery that is exposed to air upon release of the evacuated driver.
In a further embodiment of any of the foregoing embodiments, the at least one finger grip includes a pocket.
In a further embodiment of any of the foregoing embodiments, the at least one finger grip includes a ring.
In a further embodiment of any of the foregoing embodiments, the at least one finger grip includes first and second finger grip that straddle the pump.
In a further embodiment of any of the foregoing embodiments, the pump includes a stopper disposed in the reservoir, a plunger coupled with the stopper, and an evacuated driver is operable to move the plunger and stopper upon activation of the evacuated driver.
In a further embodiment of any of the foregoing embodiments, the evacuated driver defines a pressure differential that stresses a spring device to store a potential energy and, upon release of the pressure differential the spring device releases and moves the plunger and the stopper to discharge the medication through the outlet.
In a further embodiment of any of the foregoing embodiments, the plunger includes a tip portion and retraction of the button portion at least partially into the housing moves the tip portion to pierce the evacuated driver and thereby release the pressure differential.
In a further embodiment of any of the foregoing embodiments, a direction of the pressing is approximately orthogonal to a direction of movement of the plunger.
A further embodiment of any of the foregoing embodiments includes a lock that has an engaged state in which the lock prevents release of the spring device.
In a further embodiment of any of the foregoing embodiments, the stopper includes a first cross-sectional area and the evacuated driver includes a second cross-sectional area that is larger than the first cross-sectional area by a factor of at least 1.5.
In a further embodiment of any of the foregoing embodiments, the outlet includes a needle.
A further embodiment of any of the foregoing embodiments includes a collapsible needle cover on the working side and a needle cover driver coupled with the collapsible needle cover, the needle cover driver operable to move the needle cover from collapsed position to a deployed position shielding the needle.
In a further embodiment of any of the foregoing embodiments, the outlet includes a nozzle.
In a further embodiment of any of the foregoing embodiments, the housing includes at least one leveling bumper on the working side.
In a further embodiment of any of the foregoing embodiments, the finger grip is adjustable in size.
In a further embodiment of any of the foregoing embodiments, the outlet includes a needle, the pump includes a first evacuated driver configured to move the needle from a stored position in which the needle is inside the housing to a deployed position in which the needle protrudes from the working side, and a second evacuated driver configured to pressurize the medication to discharge through the outlet.
A method for using an autoinjector according to an example of the present disclosure includes providing an autoinjector as in any of the foregoing embodiments, inserting at least one finger into the at least one finger grip with a nail-side of the at least one finger facing the non-working side, using the at least one finger to exert a force on the at least one finger grip and thereby depress the working side against the skin of a patient, and activating the pump to discharge the medication from the reservoir and through the outlet into the patient.
A method for using an autoinjector according to an example of the present disclosure includes providing an autoinjector as in any of the foregoing examples. At least the stopper, the reservoir, and the medication are part of a cartridge that is removeable from the housing, wherein the autoinjector has been used to discharge the medication such that the cartridge is spent. The spent cartridge is removed, and a fresh cartridge is inserted into the housing. The fresh cartridge contains additional medication. The evacuated driver is reset such that the autoinjector is operable for a re-use to discharge the additional medication in the fresh cartridge.
In a further example of any of the foregoing embodiments, the autoinjector is re-useable. A method for re-using the autoinjector includes resetting the vacuum of the evacuated driver such that the spring device is stressed, and at least partially filling the reservoir with fresh medication. The autoinjector may be washed and/or otherwise sterilized as part of the method of re-use, such as prior to the resetting of the vacuum. The autoinjector may include a vacuum port connected to the driver and which is used to connect to a vacuum device to reset the vacuum. Alternatively, the outlet of the autoinjector serves as a vacuum port that is connectable to a vacuum device and through which the vacuum is reset.
In a further example of any of the foregoing embodiments, the reservoir is incorporated into a cartridge that is insertable and removeable from the autoinjector. A method for re-using the autoinjector includes removing a spent cartridge from the autoinjector and then inserting a new cartridge into the autoinjector. The new cartridge includes a reservoir that contains additional medication.
The present disclosure may include any one or more of the individual features disclosed above and/or below alone or in any combination thereof.
The various features and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description. The drawings that accompany the detailed description can be briefly described as follows.
In this disclosure, like reference numerals designate like elements where appropriate and reference numerals with the addition of one-hundred or multiples thereof designate modified elements that are understood to incorporate the same features and benefits of the corresponding elements.
The autoinjector 20 includes a pump 22 that has a reservoir 24 that is pre-filled with a medication 26 in a desired dosage. The medication is a fluid, such as but not limited to, a liquid, a gas, a semi-solid, a gel, a suspension, a flowable powder, a flowable solid (e.g., solid that transitions to liquid form at elevated pressure), or combinations of these. The pump 22 has an outlet 28 associated with the reservoir 24, through which the medication can be dispensed. In this example, the outlet 28 includes a needle 28a, although needle-free configurations are also contemplated. The pump 22 in this example is of a manual syringe type and includes a plunger 30 that has a stopper 32 at one end that is disposed in the reservoir 24 and a handle 34 at its other end protruding from the reservoir 24.
In general, the autoinjector 20 is configured such that it has a working side 20a at which the medication is dispensable from the pump 22 and a non-working side 20b opposite the working side 20a. For example, the working side 20a is the side of the autoinjector 20 that is held against the skin of a patient for injection, and the non-working side 20b is the side of the autoinjector that faces away from the patient's skin. In these regards, the working side 20a may be associated with the bottom-most plane of the autoinjector 20 when in the vertical position, and the non-working side 20b may be associated with the top-most plane of the autoinjector 20 when in the vertical position.
The pump 22 is held in a housing 36. The housing 36 includes at least one finger grip 38 (two shown in this example) proximately located to the working side 20a. The term “proximately located” means that the finger grip 38 is located closer to the working side 20a than to the non-working side 20b. The location of the finger grip 38 is taken with respect to the working surface of the finger grip 38, i.e., the location where pressure is to be applied for use of the autoinjector 20 (for example location L1). In one example, the location is in the first 30% span length of the distance from the working side 20a to the non-working side 20b. In a further example, the location is in the first 15% span length.
In the illustrated example, the finger grips 38 are rings 38a that form pockets 38b for receiving a finger when operating the autoinjector 20, such as the index finger and the middle finger, respectively. The pockets 38b may be smooth, textured, or include a traction material that increases friction to facilitate anti-slipping.
To operate the autoinjector 20, the user inserts a finger into each finger grip 38, as shown in
The finger grips 38 not only enable the autoinjector 20 to be held against the skin, but the finger grips 38 being proximately located to the working side 20a also provides stability. For instance, by being proximately located to the working side 20a, the finger grips 38 are below the center of gravity 40 (
The vacuum in the casing 44 holds the spring device 46 in its stressed, elevated potential energy state (relative to the spring device 46 at rest) until the pressure differential is released. The pressure differential is released by opening the casing 44 to the surrounding ambient environment of the pump 120. Once opened, air enters into the casing 44, thereby equalizing the initial vacuum in the casing 44 with the ambient surroundings. Once equalized, without the vacuum holding the casing 44 in its collapsed state, the potential energy of the spring device 46 is converted to kinetic energy and the spring device 46 expands. Under the force of expansion of the spring device 46, the casing 44 expands to move the plunger 30. The force of release of the spring device 46 may in some configurations be designed to rip or tear the casing 44, rendering it non-reusable, a desirable outcome in some contexts to, for example, eliminate needle sharing among illicit drug users.
To open the casing 44 and release the spring device 46, the pump 120 includes a button portion 48 that initially protrudes from the housing 36 on the working side 20a. The button portion 48 is attached with the reservoir 24 via hinged couplings 50 such that the reservoir 24, the plunger 30, and the stopper 32 are moveable in unison in the retraction direction. Thus, moving the button portion 48 against the injection surface (skin) exerts a force that causes retraction of the button portion 48 at least partially into the housing 36 and pushes the plunger 30 toward the evacuated driver 42. The plunger 30 includes a breaker tip 30a that is situated near the evacuated driver 42. When the button portion 48 retracts, the plunger 30 moves such that the breaker tip 30a pierces the pierceable seal 49 of casing 44 of the evacuated driver 42, thereby triggering release of the evacuated driver 42. A vent passage 31 fluidly connected with the breaker tip 30a that enables air to move freely within the plunger 30 and into the driver 42. The expansion of the spring device 46 then moves the plunger 30, the stopper 32, and the reservoir 24 in the opposite direction toward the working side 20a. The hinged couplings 50 release to decouple the button portion 48 from the plunger 30, stopper 32, and reservoir 24 such that the plunger 30, stopper 32, and reservoir 24 move toward the working side 20a and deploy the needle 28a from the button portion 48 into the skin of the patient. This also causes the plunger 30 to pressurize the medication to discharge through the outlet 28 and needle 28a. Thus, the single evacuated driver 42 deploys the needle 28a and injects the medication.
In further examples, the outlet 28, nozzle 28b, reservoir 24, stopper 32, and stem 30 and may in part or in whole form a replaceable, pre-fillable cartridge or prefilled vial 53 which slides into the main body 36. The controller 51 may include an air-activated battery (e.g., an air-activated zinc-air battery) and electrical circuitry. Upon release of the evacuated drive 42, air entering the drive 42 activates the battery to power the electrical circuitry. The controller 51 may be used for communication to a remote device, such as a cellular phone, to transmit data indicative of use of the autoinjector 220. In this way, drug delivery can be verified, in one example, or, in another example, measure and communicate biometrics of the patient while maintaining battery life during transport. The vacuum across the driver 42 can also be reset, allowing the autoinjector 220 to be re-used. By resetting the evacuated drive 42 and inserting a fresh cartridge, the device can be reusable for delivering multiple pre-filled injections. As will be described in a further embodiment later on below, the resetting of the evacuated drive 42 may be accomplished by an external, vacuum generating device 55 that connects to the nozzle 28 or other port 57 that is in communication with the evacuated drive 42.
Similar to the autoinjector 20, the user inserts a finger into each finger grip 38, as shown in
In this example, the autoinjector 320 also includes a needle cover 152 and needle cover driver 154. The needle cover driver 154 is an evacuated driver similar to the afore-mentioned evacuated drivers. There is a breaker 155 near the needle 28a such that, upon deployment of the needle 28a, the breaker 155 pierces the needle cover driver 154. Upon initial release, however, the needle cover driver 154 is substantially prevented from expanding because it is pressed against the skin of the patient. As shown in
Although a combination of features is shown in the illustrated examples, not all of them need to be combined to realize the benefits of various embodiments of this disclosure. In other words, a system designed according to an embodiment of this disclosure will not necessarily include all of the features shown in any one of the Figures or all of the portions schematically shown in the Figures. Moreover, selected features of one example embodiment may be combined with selected features of other example embodiments.
The preceding description is exemplary rather than limiting in nature. Variations and modifications to the disclosed examples may become apparent to those skilled in the art that do not necessarily depart from this disclosure. The scope of legal protection given to this disclosure can only be determined by studying the following claims.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/018122 | 4/11/2023 | WO |
| Number | Date | Country | |
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| 63329627 | Apr 2022 | US | |
| 63342653 | May 2022 | US | |
| 63345930 | May 2022 | US | |
| 63358334 | Jul 2022 | US | |
| 63358337 | Jul 2022 | US | |
| 63359262 | Jul 2022 | US | |
| 63388405 | Jul 2022 | US | |
| 63389205 | Jul 2022 | US | |
| 63389496 | Jul 2022 | US | |
| 63405173 | Sep 2022 | US | |
| 63416647 | Oct 2022 | US | |
| 63482116 | Jan 2023 | US |