SELF-CONTAINED AUTO-INJECTOR
A drug self-delivery device comprising a body portion containing a drug vial and a needle assembly, where the body portion is slidably engaged to a trigger portion. When engaged by a user pressing the trigger portion against the user's flesh, the needle assembly relative to the drug vial so as to align a needle port with an integral drug delivery port connected to the drug vial thereby allowing fluid flow of medication through the needle. Seals engaged by a penetration spring prevent loss of medication and prevent the need for direct connection between the needle assembly and the drug vial.
This application is a continuation of U.S. application Ser. No. 15/790,263, filed Oct. 23, 2017, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application Ser. No. 62/414,871 filed on Oct. 31, 2016, and U.S. Provisional Application Ser. No. 62/455,241 filed on Feb. 6, 2017, the entire disclosure of each of which is incorporated herein by reference.
TECHNICAL FIELDThe present invention relates to autoinjectors and in particular to a wearable autoinjector having a needle assembly and a drug vial arranged side by side.
BACKGROUNDIngesting, inhaling, and/or injecting certain allergens, toxins, and/or other substances can cause profound reactions for at least some and/or all people and/or animals. For example, certain people are highly allergic to certain substances, such as peanuts, shellfish, particular drugs, certain proteins, bee venom, insect bites, etc. The allergic response can lead to anaphylactic shock, which can cause a sharp drop in blood pressure, hives, and/or substantial breathing difficulties caused by severe airway constriction. As another example, inhalation of certain nerve agents can cause severe physiological trauma. Responding rapidly to such exposures can prevent injury and/or death. For example, in response to an exposure leading to anaphylactic shock, an injection of epinephrine (i.e., adrenaline) can provide substantial and/or complete relief from the reaction. As another example, injection of an antidote to a nerve agent can greatly reduce and/or eliminate the potential harm of the exposure. As yet another example, rapid injection of certain drugs, such as a beta blocker, blood thinner, nitroglycerine, antihistamines, insulin, and opioids, etc., can provide substantial relief from various dangerous medical conditions.
An autoinjector is a medical device designed to deliver one or more doses of a particular drug in a manner that facilitates self-administration of the drug via a syringe. By design, autoinjectors are easy to use and are intended to be used by patients or by untrained personnel. They typically are self-contained and designed to require only a few basic steps to operate.
SUMMARYIt is a challenge to package components into a form factor that allows a user to wear a medical device. The medical device can include a syringe, a drug dose, and a source of stored energy needed to auto-inject the dose into the user. A solution to the challenge is a wearable drug delivery device with a needle assembly and a drug vial containing a drug dose arranged side-by-side.
An exemplary wearable drug delivery device includes a handheld portion, including a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The wearable drug delivery device further includes a trigger portion in slidable engagement with the distal end of the handheld portion and a needle assembly disposed within the handheld portion and aligned with the longitudinal axis. The needle assembly being movable towards the distal end of the handheld portion to an extended position by a penetration spring when the penetration spring is activated by the trigger portion sliding towards the proximal end of the handheld portion. The wearable drug delivery device further includes a drug vial disposed within the handheld portion alongside the needle assembly. The drug vial is moveable towards the distal end of the handheld portion to a seated position by a vial spring when the vial spring is activated by the trigger portion sliding towards the proximal end of the handheld portion. The wearable drug delivery device further includes an integral drug delivery port formed at the distal end of the handheld portion and transverse to the longitudinal axis of the handheld portion. The needle assembly in the extended position and the drug vial in the seated position are in fluid communication with each other by way of the integral drug delivery port.
The handheld portion of the wearable drug delivery device can include a concave surface, the concavity of which is defined by a point offset from the longitudinal axis. The concave surface can be configured to conform to the human wrist.
The handheld portion of the wearable drug delivery device can include a slot. The wearable drug delivery device can further include a band that is received in the slot for wearing the wearable drug delivery device around a part of a user's body.
The handheld and trigger portions of the wearable drug delivery device can be made from a metal, a plastic or a combination of metal and plastic.
The trigger portion of the wearable drug delivery device can slide over the distal end of the handheld portion.
The trigger portion of the wearable drug delivery device can include a trigger arm extending from the trigger portion and through the distal end of the handheld portion. The trigger arm is configured to release energy stored in the penetration spring when the trigger portion slides toward the proximal end of the handheld portion. The trigger portion of the wearable drug delivery device can include two trigger arms.
The wearable drug delivery device can further include a rotator coupled to the drug vial. The rotator and the drug vial are urged towards the distal end of the handheld portion by the vial spring. The wearable drug delivery device can further include a yoke extending from the distal end of the handheld portion towards the proximal end. The rotator rests on the yoke thereby resisting movement toward the distal end of the handheld portion and moving the drug vial to the seated position. The trigger portion can include a trigger blade extending from the trigger portion and through the distal end of the handheld portion. The trigger blade is in slidable engagement with the rotator and is configured to lift the rotator off the yolk and allow the rotator to move towards the distal end of the handheld portion and move the drug vial to the seated position when the trigger portion slides toward the proximal end of the handheld portion.
The trigger blade of the wearable drug delivery can include an angled surface to lift and turn the rotator off the yoke. The trigger portion of the wearable drug delivery device can include three trigger blades.
The needle assembly of the wearable drug delivery device can include a J-shaped needle.
The integral drug delivery port of the wearable drug delivery device can include a vial needle, an exit, and a channel connecting the vial needle to the exit. The vial needle punctures a vial membrane of the drug vial when the drug vial is in the seated position thereby allowing a drug dose to flow through the channel and out the exit. The exit can be a septum seal that is pierced by the needle assembly when the needle assembly is in the extended position.
The wearable drug delivery device can further include a return spring interposed between an exterior surface at the distal end of the handheld portion and an opposing surface on the trigger portion. The return spring provides a force separating the handheld portion from the trigger portion. The wearable drug delivery device can further include a latch extending from the opposing surface of the trigger portion and releasable engaged with the handheld portion. The latch when engaged resists the force separating the handheld portion from the trigger portion. The latch can be a leaf spring. The return spring can be a torsion spring.
The wearable drug delivery device can further include a safety guard that covers the trigger portion and is releaseably attached to the handheld portion by any one of an interference fit and a frangible weld joint.
The wearable drug delivery device can further include a safety guard covering the trigger portion and releaseably attached to the handheld portion. The wearable drug delivery device can further include a strip disposed circumferential between the handheld portion and the safety guard. The strip is configured to be torn away from the handheld portion and the safety guard thereby allowing the safety guard to be removed from the handheld portion and expose the trigger portion.
The handheld portion of the wearable drug delivery device has an exterior surface parallel to the longitudinal axis. The wearable drug delivery device can further include a one-way barb projecting from the exterior surface of the handheld portion and a snap feature joined to the trigger portion by a virtual hinge. When the trigger portion slides toward the proximal end of the handheld portion, the snap feature slides over the exterior surface of the handheld portion and flexes about the virtual hinge, away from the exterior surface, when the snap feature slides over the one-way barb.
The foregoing and other objects, features and advantages will be apparent from the following more particular description of the examples, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the examples.
The wearable drug delivery device provides a compact drug delivery mechanism that can be worn and can efficiently and/or rapidly deliver a prescribed drug dose.
In the example shown in
The adapter 130 can include a slot 140 for receiving a band (not shown), such as an arm or wrist band, for wearing the wearable drug delivery device 100. The wrist/arm band can be elastic or include a fastener, such as hook and loop, button or snap allowing the user to readily remove the wearable drug delivery device 100 from their body when it's time to use the device.
The second compartment 160 contains a drug vial 165 surrounded in part by a rotator 170 and a piston 185. The piston 185, in turn, is surrounded by a vial spring 175. The concentric arrangement of these parts is advantageous because it allows the wearable drug delivery device 100 to be short and wearable. As will be described in greater detail below, to inject the drug dose into the user, the vial spring 175 moves the drug vial 165, the rotator 170, and the piston 185 downward within the second compartment 160, and further moves a plunger 180 downward within the drug vial 165. By way of non-limiting example, the drug vial 165 can be filled with a dose of epinephrine or insulin.
The wearable drug delivery device 100 further includes at the distal end 120, an integral drug delivery port 200 for providing a path for the drug dose to flow from the drug vial 165 to the needle assembly 150. In the close up view of
When the drug vial 165 is moved in the downward direction, the vial needle 205 encounters a vial membrane 220, which seals the drug vial 165. As the drug vial 165 continues to move downward, the vial needle 205 punctures the vial membrane 220. At this point, the drug vial 165 is in fluid communication with the integral drug delivery port 200. The drug dose flows out of the drug vial 165 through the vial needle 205 and the channel 215, and then out the exit 210.
With the needle assembly 150 in the extended position, the exit 210 of the integral drug delivery port 200 and needle port 320 are in fluid communication with each other. In some examples, the exit 210 is a septum seal that is pierced by the needle port 320 when the needle assembly 150 is in the extended position. This is beneficial because the channel 215 is sealed until the needle assembly 150 is positioned correctly. Fluid flows from the drug vial 165 through the integral drug delivery port 200 and the needle port 320, and out of the needle 310. This arrangement is advantageous because it does not require a direct connection between the needle assembly 150 and the drug vial 165. In some examples, the receiving portion 330 may be made leak resistant by a downward force applied from the penetration spring 155.
In
In
Continuing in
Turning now to a detailed discussion of the needle trigger mechanism, the mechanism operates via the trigger portion 115, which contacts the user's target injection area (e.g., thigh). The trigger portion 115 includes two trigger arms one that extend into the handheld portion 105, one of which is shown in
As more clearly seen in
The support pads 405 and ears 305 can each have an angled surface that facilitates cooperation between the needle body 300 and the trigger arms 400. As the trigger arms 400 are moved upward by the trigger portion 115, the angled surfaces cause the needle body 300 to lift and rotate away from the trigger arm support pads 405, as seen in
Turning now to a detailed discussion of the delivery trigger mechanism, like the needle trigger mechanism described above, the mechanism also operates via the trigger portion 115.
The operation of the delivery trigger mechanism is now described with reference to
Shown in
Shown in
The safety guard 700 can be removable by simple force or by using a tearaway strip 705 as shown in the figure. In the example shown, the tear-away strip 705 is disposed circumferentially between the handheld portion 105 and the safety guard 700. In use, the user pulls on the tear-away strip 705 to remove the tear-away strip 705 from the wearable drug delivery device 100. This separates the safety guard 700 from the handheld portion 105. The user action can be facilitated by one or more pre-weakened areas (not shown) in the tear-away strip 705. For example, material joining the tear-away strip 705 to the handheld portion 105 and the safety guard 700 can be thinned making it easier to remove the tear-away strip 705 away from the wearable drug delivery device 100. In another example, material joining the tear-away strip 705 to the handheld portion 105 and the safety guard 700 can be perforated, making it easier to peel the tear-away strip 705 away from the wearable drug delivery device 100.
When the user wears the wearable drug delivery device 100 around their wrist (or other body part), the pull ring 710 swings towards the wearable drug delivery device 100, and is sandwiched between the wearable drug delivery device 100 and the user's wrist (or other body part). In this position, the user cannot access or otherwise use the pull ring 710 to remove the tear-away strip 705 and thus, cannot trigger the wearable drug delivery device.
As shown in
The trigger portion 115 can also act as a needle guard/sharps protector after the wearable drug delivery device 100 is used.
During assembly of the wearable drug delivery device 100, the leaf spring 800 is bent into the configuration shown and the free end 810 engages one or more hooks 815 on the handheld portion 105. A return spring 820 sandwiched between the handheld portion 105 and trigger portion 115 supplies a force urging (separating) the handheld portion 105 and the trigger portion 115 apart. This force enhances the latching of the leaf spring 800 and inhibits the leaf spring 800 from becoming accidently disengaged from the hooks 815.
The gate 600 further includes an opening 610 through the planer member 605. The planar member 605 moves in the direction of the longitudinal axis 125 in between the upper and lower channel portions 215 a and 215 b consistent with the movement of the trigger portion 115. When the trigger portion 115 is not depressed or partly depressed, the opening 610 is not aligned with the upper and lower channel portions 215 a and 215 b, as shown in the figure, and the planer member 605 obstructs the channel With the gate 600 in this “closed” position, the drug cannot flow between the drug vial 165 and the needle assembly 150.
In
The tooth 720 is made from nonconductive material, such as plastic. (Some examples of the safety guard 700 are made from one material, in which case, the safety guard 700 is nonconductive). Consequently, positioning the tooth 720 between the electrical contact 865 and battery 870 creates a discontinuity in the electronic circuit 875 and the electronics 860 is inactive. The tooth feature is also advantageous because it reduces the loss of battery power over time, which in turn increases the shelf life of the wearable drug delivery device 100.
When the safety guard 700 is removed from the wearable drug delivery device 100 (e.g., to activate the wearable drug delivery device 100), the tooth 720 is pulled out the handheld portion 105 allowing the electrical contact 865 and the battery 870 to connect. This completes the electrical circuit 875 and activates the electronics 860. This arrangement is particularly advantageous because both the wearable drug delivery device 100 and the electronics 860 can be activated at the same time with one action. Additional, no additional electronic component like a switch is required to control the electronics 860, making the electronic circuit 875 simpler, less costly, and more reliable.
As just described, the electronics 860 can be a communication module. The communication module can provide information to the user when they activate the wearable drug delivery device (e.g., when they remove the safety guard 700). For example, speakers built into the wearable drug delivery device 100 play an audio recording of how to use the device when the user activates the device. It is understood that is beneficial to provide instructions to the user as the user is carrying them out.
In
A challenge to using an autoinjector to self-administer a drug dose is making sure that the autoinjector needle penetrates the body to a proper depth for delivering the drug. Delivering the drug dose too shallow in the body can reduce the effectiveness of the drug dose or worst yet not, the drug dose has no effect. The present invention addresses this challenge with a dose confirmation module for determining whether a needle has reached a proper depth based on impedance. Impedance changes the deeper the needle goes into conductive tissue, such as skin, fat, and muscle. This is because increased contact with the conductive material changes the overall impedance. The dose confirmation module then notifies a user or healthcare provider whether the proper depth has been reached.
In
The dose confirmation module 1000 compares the measured impedance to a threshold value and based on the comparison, confirms whether the needle 1005 or combination needle 1020 has reached a proper depth for delivering the drug dose. For example, if the measured impedance is less than or equal to 83 ohms, the dose confirmation module 1000 determines that the proper depth for the injection has been reached (i.e., OK). Impedance measurements greater than 83 ohms indicate that the proper depth for the injection has not been reached (i.e., NOT OK).
A dose confirmation can be communicated to the user using an audio cue (e.g., one beep for OK or two beeps for NOT OK) or a visual cue (e.g., a lit green light for OK or a lit red light for NOT OK). The dose confirmation can also be communicated to a healthcare provider using the communication module 900 described above with reference to
In the example shown in
The adapter 2130 can include a slot 2140 for receiving a band (not shown), such as an arm or wrist band, for wearing the wearable drug delivery device 2100. The wrist/arm band can be elastic or include a fastener, such as hook and loop, button or snap allowing the user to readily remove the wearable drug delivery device 2100 from their body when it's time to use the device.
The second compartment 2160 contains a drug vial 2165 surrounded by a rotator 2170, all of which are surrounded by a vial spring 2175. The concentric arrangement of these parts is advantageous because it allows the wearable drug delivery device 2100 to be short and wearable. As will be described in greater detail below, to inject the drug dose into the user, the vial spring 2175 moves the drug vial 2165 and the rotator 2170 downward within the second compartment 2160, and further moves a plunger 2180 downward within the drug vial 2165. By way of non-limiting example, the drug vial 2165 can be filled with a dose of epinephrine or insulin.
The wearable drug delivery device 2100 further includes at the distal end 2120, an integral drug delivery port 2200 for providing a path for the drug dose to flow from the drug vial 2165 to the needle assembly 2150. In the close up view of
When the drug vial 2165 is moved in the downward direction, the vial needle 2205 encounters a vial membrane 2220, which seals the drug vial 2165. As the drug vial 2165 continues to move downward, the vial needle 2205 punctures the vial membrane 2220. At this point, the drug vial 2165 is in fluid communication with the integral drug delivery port 2200. The drug dose flows out of the drug vial 2165 through the vial needle 2205 and the channel 2215, and then out the exit 2210. The vial needle 2205 can be located above the exit 2210 to help fluid flow out of the drug vial 2165.
With the needle assembly 2150 in the extended position, the exit 2210 of the integral drug delivery port 2200 and needle port 2320 are in fluid communication with each other. Fluid flows from the drug vial 2165 through the integral drug delivery port 2200 and the needle port 2320, and out of the needle 2310. In the examples shown, the needle assembly 2150 includes seals 2335 a and 2335 b above and below the needle port 2320. In the extended position, the seals 2335 a and 2335 b close off the upper part of the receiving portion 2330 allowing fluid entering the upper part from the exit 2210 to flow into the needle port 2320. This arrangement is advantageous because it does not require a direct connection between the needle assembly 2150 and the drug vial 2165. In some examples, the upper part may be further made leak resistant by a downward force applied from the penetration spring 2155.
In
In
In
Turning now to detailed discussion of the needle trigger mechanism, the mechanism operates via the trigger portion 2115, which contacts the user's target injection area (e.g., thigh). The trigger portion 2115 includes one or more trigger arms 2400 (e.g., two trigger arms) shown in
A support pad 2405 on the trigger arm 2400 normally supports the spring loaded needle assembly 2150. The needle body 2300 includes one or more ears 2305 each normally supported by a trigger arm support pad. The example needle body 2300 shown in
The support pad 2405 and ear 2305 can each have an angled surface that facilitates cooperation between the needle body 2300 and the trigger arm 2400. As the trigger arm 2400 is moved upward by the trigger portion 2115, the angled surfaces cause the needle body 2300 to lift and rotate away from the trigger arm support pad 2405, as seen in
In
The gate 2600 further includes an opening 2610 through the planer member 2605. The planar member 2605 moves in the direction of the longitudinal axis 2125 in between the upper and lower channel portions 2215a and 2215b consistent with the movement of the trigger portion 2115. When the trigger portion 2115 is not depressed or partly depressed, the opening 2610 is not aligned with the upper and lower channel portions 2215a and 2215b, as shown in the figure, and the planer member 2605 obstructs the channel With the gate 2600 in this “closed” position, the drug cannot flow between the drug vial 2165 and the needle assembly 2150.
In
Referring back to
When the user wears the wearable drug delivery device 2100 around their wrist (or other body part), the pull ring 2710 swings towards the wearable drug delivery device 2100, and is sandwiched between the wearable drug delivery device 2100 and the user's wrist (or other body part). In this position, the user cannot access or otherwise use the pull ring 2710 to remove the separation strip 2705 and thus, cannot trigger the wearable drug delivery device.
As shown in
As shown in
The tooth 2720 is made from nonconductive material, such as plastic. (Some examples of the trigger guard 2700 are made from one material, in which case, the entire trigger guard 2700 is nonconductive). Consequently, positioning the tooth 2720 between the electrical contact 2805 and battery 2810 creates a discontinuity in the electronic circuit 2815 and the electronics 2800 is inactive. The tooth feature is also advantageous because it reduces the loss of battery power over time, which in turn increases the shelf life of the wearable drug delivery device 2100.
When the trigger guard 2700 is removed from the wearable drug delivery device 2100 (e.g., to activate the wearable drug delivery device 2100), the tooth 2720 is pulled out the handheld portion 2105 allowing the electrical contact 2805 and the battery 2810 to connect. This completes the electrical circuit 2815 and activates the electronics 2800. This arrangement is particularly advantageous because both the wearable drug delivery device 2100 and the electronics 2800 can be activated at the same time with one action. Additional, no additional electronic component like a switch is required to control the electronics 2800, making the electronic circuit 2815 simpler, less costly, and more reliable.
As just described, the electronics 2800 can be a communication module. The communication module can provide information to the user when they activate the wearable drug delivery device (e.g., when they remove the trigger guard 2700). For example, speakers built into the wearable drug delivery device 2100 play an audio recording of how to use the device when the user activates the device. It is understood that is beneficial to provide instructions to the user as the user is carrying them out.
In
A challenge to using an autoinjector to self-administer a drug dose is making sure that the autoinjector needle penetrates the body to a proper depth for delivering the drug. Delivering the drug dose too shallow in the body can reduce the effectiveness of the drug dose or worst yet not, the drug dose has no effect. The present invention addresses this challenge with a dose confirmation module for determining whether a needle has reached a proper depth based on impedance. Impedance changes the deeper the needle goes into conductive tissue, such as skin, fat, and muscle. This is because increased contact with the conductive material changes the overall impedance. The dose confirmation module then notifies a user or healthcare provider whether the proper depth has been reached.
In
The dose confirmation module 21000 compares the measured impedance to a threshold value and based on the comparison, confirms whether the needle 21005 or combination needle 21020 has reached a proper depth for delivering the drug dose. For example, if the measured impedance is less than or equal to 83 ohms, the dose confirmation module 21000 determines that the proper depth for the injection has been reached (i.e., OK). Impedance measurements greater than 83 ohms indicate that the proper depth for the injection has not been reached (i.e., NOT OK).
A dose confirmation can be communicated to the user using an audio cue (e.g., one beep for OK or two beeps for NOT OK) or a visual cue (e.g., a lit green light for OK or a lit red light for NOT OK). The dose confirmation can also be communicated to a healthcare provider using the communication module 2900 described above with reference to
The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing examples are therefore to be considered in all respects illustrative rather than limiting of the invention described herein. Also, the words comprise, include, and/or plural forms of each are open ended and include the listed parts and can include additional parts or steps that are not listed, and the term and/or is open ended and includes one or more of the listed parts or steps and combinations of the listed parts steps.
Claims
1. A drug self-delivery device comprising:
- a handheld portion having a proximal end, a distal end and a longitudinal axis therebetween;
- a trigger portion in slidable engagement with the distal end of the handheld portion and defining an injection opening;
- a drug vial disposed within the handheld portion, the drug vial containing a fluid medication and having a first vial position wherein the drug vial is distal from the trigger portion and a second vial position wherein the drug vial is proximate to the trigger portion;
- a needle assembly comprising: a needle having an interior lumen to allow the flow of medication; a needle port for receiving medication from the drug vial; and one or more seals to reduce leakage of medication delivered from the drug vial toward the needle port;
- a drug delivery port configured to deliver medication from the drug vial to the needle assembly when the drug vial is in the second vial position.
2. The drug self-delivery device of claim 1 wherein the needle assembly has a first needle position in which the needle assembly is fully disposed within the handheld portion, and a second needle position where at least a portion of the needle extends through the injection opening.
3. The drug self-delivery device of claim 2 further comprising a penetration spring configured to transport the needle assembly from the first needle position to the second needle position when the trigger portion is slid toward the distal end of the handheld portion.
4. The drug self-delivery device of claim 2 wherein the needle port generally aligns with an exit of the drug delivery port when the needle assembly is in the second needle position.
5. The drug self-delivery device of claim 2 wherein the one or more seals comprises:
- an upper seal positioned toward the proximal end of the handheld portion relative to the needle port and;
- a lower seal positioned toward the distal end of the handheld portion relative to the needle port.
6. The drug self-delivery device of claim 5 wherein the lower seal does not move relative to the handheld portion as the needle assembly transitions between the first needle position and the second needle position.
7. The drug self-delivery device of claim 1 further comprising a separation strip configured to prevent the trigger portion from sliding toward the distal end of the handheld portion when the separation strip is disposed within a gap between the handheld portion and the trigger portion.
8. The drug self-delivery device of claim 7 further comprising a pull ring extending from a point along the separation strip wherein the pull ring is configured to remove the separation strip from the gap when pulled perpendicular to the longitudinal axis of the handheld portion.
9. The drug self-delivery device of claim 8 wherein the handheld portion and the trigger portion cooperate to form a concave outer surface shaped to fit against a user's appendage for transport such that the longitudinal axis of the handheld portion is generally perpendicular to the appendage.
10. The drug self-delivery device of claim 9:
- wherein the pull ring has a stored position in which it is sandwiched between the concave outer surface and the user's appendage and a deployed position where the pull ring swings away from the concave outer surface; and
- wherein the pull ring transitions to the deployed position when the concave outer surface is separated from the user's appendage.
11. The drug self-delivery device of claim 1 further comprising a communication module and a battery disposed within the handheld portion.
12. The drug self-delivery device of claim 11 further comprising a separation strip removably connected to an exterior surface of the handheld portion, the separation strip comprising a non-conductive member extending into the handheld portion that separates the battery from electrical connection with the communication module until the separation strip is removed from the handheld portion.
13. The drug self-delivery device of claim 11 wherein when the communication module comes into electrical contact with the battery, the communication module is configured to send a signal to one or more external communication devices, wherein the communication comprises an alert that the drug self-delivery device is in use.
14. The drug self-delivery device of claim 11 further comprising a speaker, and wherein, when the communication module comes into electrical contact with the battery, the communication module is configured to broadcast a pre-recorded instructional message via the speaker.
15. A method for administering medication stored within a drug self-delivery device comprising the steps of:
- grasping a handheld portion of the drug self-delivery device having a proximal end, a distal end and a longitudinal axis therebetween and at least partially housing: a drug vial containing a fluid medication to be administered; a needle assembly having a needle port for receiving medication from the drug vial and one or more seals to reduce leakage of medication delivered from the drug vial; a drug delivery port configured to deliver medication from the drug vial to the needle assembly;
- placing a trigger portion of the drug self-delivery device adjacent to a user's skin at a location where the medication is to be administered, the trigger portion being in slidable engagement with the distal end of the handheld portion and defining an injection opening; and
- pressing the handheld portion toward the trigger portion such that a portion of the needle extends through the injection opening.
16. The method of claim 15 wherein pressing the handheld portion toward the trigger portion causes the needle port to approximately align with the drug delivery port along a plane perpendicular to the longitudinal axis of the handheld portion.
17. The method of claim 16 wherein the one or more seals comprises an upper seal positioned toward the proximal end of the handheld portion relative to the needle port and a lower seal positioned toward the distal end of the handheld portion relative to the needle port, and wherein pressing the handheld portion toward the trigger portion causes the upper seal to move toward the lower seal such that the two seals are closely positioned on either side of the needle port along the longitudinal axis of the handheld portion.
18. The method of claim 15 further comprising the step of pulling a pull ring to remove a separation strip enabling the handheld portion to slide relative to the trigger portion along the longitudinal axis.
19. The method of claim 18 further comprising the step of activating a communication module to send an alert signal to a remote communication device identifying that the pull ring has been removed.
20. A drug self-delivery system comprising:
- a handheld component having a proximal end, a distal end and a longitudinal axis therebetween;
- a trigger component in slidable engagement with the distal end of the handheld component and defining an injection opening;
- a drug vial disposed within the handheld component, the drug vial containing a fluid medication and having a first vial position wherein the drug vial is distal from the trigger portion and a second vial position wherein the drug vial is proximate to the trigger portion;
- a needle assembly comprising a needle and a needle port, the needle assembly having a first position where the needle assembly is entirely disposed within the handheld component and an extended position where the needle is at least partially extending through the injection opening;
- a drug delivery port configured to deliver medication from the drug vial to the needle assembly when the needle assembly is in the extended position; and
- a communication module configured to send an alert to a remote communication device to indicate a state of the drug self-delivery system.
Type: Application
Filed: May 22, 2020
Publication Date: Jun 9, 2022
Inventors: Robert F. Rioux (Ashland, MA), Matthew Laplaca (Franklin, MA), Brian Grasso (Wallingford, CT), Matt Bomes (Wellesley, MA)
Application Number: 16/882,157