WO2022139596A1

WO2022139596A1 - An emergency drug delivery device and method of using same

Info

Publication number: WO2022139596A1
Application number: PCT/NZ2021/050228
Authority: WO
Inventors: Timothy Marinus ANDREWS; Benjamin MURTON
Original assignee: Andrews Timothy Marinus
Priority date: 2020-12-24
Filing date: 2021-12-22
Publication date: 2022-06-30

Abstract

The invention is a device for delivering an emergency dose of an opioid antagonist to a person who may have become incapacitated through the effects of an overdose of a self-administered opioid. The operation of the device is entirely mechanical, using a spring-operated timing mechanism which acts upon a delivery mechanism to administer the opioid antagonist to the wearer of the device after a period of time has elapsed without the timing mechanism being reset or deactivated. No physiological sensors are required. The wearer's conscious response to resetting the device is used as a measure of physiological wellbeing. This removes the need for potentially expensive electronic components making the invention more economically viable for consumers.

Description

AN EMERGENCY DRUG DELIVERY DEVICE AND METHOD OF USING SAME

Field of Invention

The invention relates to an emergency drug delivery device and a method of using same. The invention has particular application to the automatic delivery of an opioid antagonist to a person who has become incapacitated due to overdosing on opioid drugs.

Background to the Invention

Despite being an illegal or a controlled substance, opioids (in the following discussion, this term should be understood to include opiates, and derivatives of opioids or opiates) such as opium, heroin, morphine, and oxycodone are commonly used as a recreational drug or prescribed by medical professionals for pain relief. However, there is a substantial risk associated with using opioids, as it can be easy to overdose on them. Care also needs to be taken when opioids are taken in combination with other drugs or alcohol, as their effects can be attenuated or have unexpected and adverse outcomes.

In humans, opioids affect the nervous system and, consequentially, the rate of respiration. In the case of an overdose, opioids can suppress a person's rate of respiration which leads to death. When attenuated by other drugs or alcohol, a change in respiration can be so rapid that the person afflicted can suddenly become unresponsive and are unable to help themselves or seek assistance.

There is considerable stigma associated with opioid use. When opioids are taken recreationally, the person often does so in isolation or with other people also taking the opioid. This means that there is a significant risk that users may fatally overdose as there is no person nearby able or capable to stage an intervention.

Even a person experienced with usage of opioids may become incapacitated if their drug of choice is at a higher potency than expected or has been contaminated or supplemented with other chemicals which interact with the opioid in an unexpected way. For example, a person taking a prescribed amount of an opioid for pain relief may concurrently consume excess alcohol which could enhance the effects of the opioid or, in an impaired state, take an incorrect amount of the opioid.

The effects of opioids can be counteracted by the timely delivery of an opioid antagonist. An example of an opioid antagonist is Naloxone, examples of which are marketed in various jurisdictions as NARCAN™, EVZIO™, and NYXOID™. Naloxone acts to block the opioid receptors in the human body and is unusual in respect of its extremely quick mode of action; it can begin to negate the effects of the opioid on respiration within a few minutes of delivery. Therefore, when a person has overdosed on an opioid, prompt intervention through the use of an opioid antagonist can be lifesaving.

Addiction to opioids and/or overdosing on same is a major problem in many countries and has a significant economic and societal cost. Because of the behavioural aspects of addiction, many users of opioids end up having limited or no financial means.

It then falls upon government or charitable organisations to provide means of assisting addicted users to minimise the risk of overdosing from opioids. However, the illegality of the use of opioids for recreational purposes, and the number of opioid addicts in countries such as the United States, mean that measures to counter and reduce the risk of overdosing on opioids may face considerable public scrutiny.

A number of devices or arrangements have been developed for use by persons consuming opioids to alert them of potential overdoses or prevent them entirely through self-administration of a suitable opioid antagonist. However, these have their problems which mean that they are not practical or suitable for uptake on a widespread basis.

For example, one such device is disclosed in United States Patent No. 10,661,010, which describes a surgically implanted medical device designed to monitor the human body for symptoms associated with an overdose of opioids. This device uses electronic sensors to monitor the respiratory activity of the person with which it is to be used and, upon detection of a low respiratory rate, releases an antagonist. As will be appreciated, this requires medical assistance in order to be implanted in the wearer and is highly invasive. Furthermore, the device requires complex, and therefore expensive, respiratory sensors. As a consequence, the practicality of the device of '010 is limited and uneconomic.

Some alternatives that do not require implantation are the devices disclosed in United States Published Patent Application Nos. 2017/0172522 and 2020/0121852. These both disclose the use of an electronic band, worn on the arm of a person, with a processor receiving signals from a respiration monitor, oxygen saturation, and/or blood pressure sensors. Upon detecting appropriate signs of respiratory distress, the devices will automatically deliver, via an injector mechanism in the form of a needle, a dose of NARCAN™ and send a geolocatable signal to emergency services. While helpful in that it requires no intervention from the user and is much less invasive than the arrangement of '010, the devices of '522 and '852 still carries with them considerable economic disadvantage due to the inherent cost of using electronic components.

Furthermore, the complexity of these devices presents a range of problems. For the devices to work, they need to be capable of monitoring the physiological characteristics of the wearer; for example, rate of respiration, blood pressure and oxygen levels. If certain criteria are met, for example, the respiratory rate becomes depressed below a specified level, then the device delivers the required emergency dosage of antagonist. If not met, then a potential consequence is the failure of the device to automatically dispense the antagonist.

As previously noted, the devices of '522 and '852 use physiological sensors that measure parameters such as oxygen saturation and blood pressure. These require contact with the body of the wearer. If the sensors do not contact the body, or have poor contact, then the devices have no data to assess whether delivery of the antagonist is needed. If the sensors do appropriately contact the body, the data collected may still be misinterpreted by the onboard processor. While one possibility in this scenario is delivery of the antagonist (when not required), another is non-delivery of the antagonist. The latter scenario could be fatal for the wearer. A source of power, i.e. a battery, is required for the devices of '522 and '852. If these are flat or somehow become ineffective, then the devices are unable to deliver the antagonist. Similarly, if there is a failure in the software/hardware or the injector mechanism then there may be no delivery of the antagonist. In these scenarios, there is a possibility that this could be fatal for the wearer. Some examples of failure modes that may be associated with these electronic based devices can be summarised in Table 1 as follows.

Table l:Failure analysis of components of prior art devices As can be seen, there are a number of scenarios that may arise where the dose of antagonist is not delivered by the devices in the prior art. Thus, as well as being inaccessible to many users due to cost considerations, the prior art devices may have a greater potential for failure due to their overall complexity.

In light of the preceding discussion, a solution to these problems is desired and needed.

Object of the Invention

It is an object of the invention to provide a drug delivery device for the automatic dispensing of an opioid antagonist to a person who has become incapacitated due to overdosing on opioids.

Alternatively, it is an object to provide a cost-effective drug delivery device for the automatic dispensing of an opioid antagonist to a person who has become incapacitated due to overdosing on opioids.

Alternatively, it is an object of the invention to provide an easy-to-use drug delivery device for the automatic dispensing of an opioid antagonist to a person who has become incapacitated due to overdosing on opioids.

Alternatively, it is an object of the invention to provide a reliable drug delivery device for the automatic dispensing of an opioid antagonist to a person who has become incapacitated due to overdosing on opioids.

At the very least, it is an object of the invention to at least provide the public with a useful choice.

Summary of the Invention

According to a first aspect of the invention, there is provided an emergency drug delivery device, the device including: a band configured to be secured to a person's body; a body attached to the band, wherein the body includes: a mechanical timing mechanism; a delivery mechanism for an opioid antagonist to be delivered to the person, characterised in that the mechanical timing mechanism includes: an operator which is movable relative to a portion of the body; and an arming mechanism for the operator, and wherein the mechanical timing mechanism is operative upon the delivery mechanism after a specified period of time has elapsed.

The invention is a device for delivering an emergency dose of an opioid antagonist to a person who may have become incapacitated through the effects of an overdose of a self-administered opioid (this term should be understood to also cover opiates, and derivatives of opioids or opiates). Examples of an opioid include opium, heroin, morphine or oxycodone. The user of the invention may be recreational users of opioids or persons who have been prescribed opioids for medical reasons and who are of greater risk of accidental overdoses due to pre-existing health conditions or adverse reactions when taken with other drugs, such as alcohol.

The operation of the device is entirely mechanical, using a spring-operated timing mechanism which acts upon a delivery mechanism to administer the opioid antagonist to the wearer of the device after a period of time has elapsed without the timing mechanism being reset or deactivated. No physiological sensors are required. The wearer's conscious response to resetting the device is used as a measure of physiological wellbeing. This removes the need for potentially expensive electronic components making the invention more economically viable for consumers.

The drug to be delivered with the invention is an opioid antagonist, such as Naloxone. Alternative names for Naloxone include, but are not limited to, NARCAN™, EVZIO™, and NYXOID™. Reference will be made throughout the remainder of the specification to the drug to be delivered with the present invention as being an antagonist.

The device will be understood to be worn by a person on their body, in contact with their skin. Preferably, the device is worn about one of the person's limbs, i.e. the arm or leg. In exemplary embodiments, the device is worn about the arm, preferably the upper arm in the bicep/tricep area. This means that when the device is actuated in an emergency, the antagonist is likely to be delivered subcutaneously or intramuscularly. However, it should be appreciated that the device may alternatively be worn about the wrist, in a manner similar to a wristwatch, or alternatively around the thigh or abdomen.

The device includes a band or strap. In use, the band encompasses the portion of the limb of the wearer about which the device is to be worn. The band may be formed from two or more lengths connected together. Alternatively, the band may be formed as a loop.

In exemplary embodiments, the band includes a fastening means to secure it to the body of the wearer. Preferably, the fastening means is hook and loop material such as VELCRO™. This is preferred for accessibility, ease of manufacture, and cost.

However, in alternative embodiments, the fastening means may be co-operating studs and buttons, latch or the like positioned at or proximate the respective ends of the bands. In these embodiments, the fastening means may be arranged at regular intervals around the band for sizing purposes. In other embodiments, the band may be formed or partially formed of elastic material that holds the device in place on the body through tension.

The device includes a body. This should be understood to include a housing containing or bearing the necessary components of the invention. The body may take a variety of forms including, without limitation, a disc-like structure, similar to the body of a watch, or a box-like structure. The body includes an upper side and a lower side. When the device is being worn, the lower side is in contact with the body of the wearer. In some embodiments, the lower side may include a contoured surface to better complement the area of the body with which it is to be in contact.

The body is mounted to or otherwise integrated with the band. In one embodiment as noted above, the band is in at least two portions, each portion connected or mounted to an opposing side of the body. In this embodiment, each portion may be of similar lengths such that the body is central to the invention. However, this is not meant to be limiting and the body may favour one of the portions of the band. In other embodiments, where the band is a loop, the body is mounted to the band via an appropriate fastening mechanism. In further embodiments, the body and/or band may be moulded or over-moulded in plastics material such as silicone or rubber

Within the body is provided the mechanical timing mechanism and the delivery mechanism. After a period of time has elapsed, the delivery mechanism is actuated by the mechanical timing mechanism. The delivery mechanism delivers a dose of antagonist to counteract the adverse symptoms of an opioid overdose.

The mechanical timing mechanism should be understood to mean a clockwork mechanism which uses an arrangement of a main spring in combination with gears to measure time intervals. Such clockwork mechanisms are used in devices such as egg timers or boardgame timers. Persons skilled in the art will readily appreciate how these clockwork mechanisms may be packaged and integrated into the present invention.

In exemplary embodiments, the mechanical timing mechanism counts down time from a specified starting time. However, in some embodiments, the mechanical timing mechanism measures elapsed time from zero. Reference shall now be made to the mechanical timing mechanism being a timer. The timer should be understood to include an operator which is movable relative to a portion of the body. The operator is articulated by the user of the device to impart a tensioning force onto the main spring of the timer.

In exemplary embodiments, the operator is a ring rotatably mounted about the circumference of the body. In this embodiment, the operator shall be referred to as a timer ring. To articulate the timer ring, the wearer grips it and twists it relative to the body of the device to place the main spring of the timer under tension. This is a relatively straightforward and intuitive action for a person to perform.

In exemplary embodiments the timer ring includes markings or indicia at regular intervals. These indicate time intervals and conditions. To provide a reference point, the central portion of the body, about which the timer ring rotates is provided with a complementary marker. Movement of the markings of the timer ring relative to the reference point provide an indication of passage of time and/or status to the wearer or nearby persons.

In alternative embodiments, the operator may be a rotatable knob which works in a manner similar to the ring previously described. In this embodiment, the knob may include a reference marker that is used in conjunction with markings or indicia arranged at regular intervals on the portion of the body surrounding the knob. In other embodiments, the operator may be a knob or the like slidably movable along a track provided to the upper side of the body. To articulate the operator, the wearer pushes against the knob to advance it along the track. This action biases the main spring. As with the previous embodiment described, the knob and upper side of the body may be provided with markings or indicia to provide the wearer and/or nearby persons with information on the passage of time and/or status of the device.

In some embodiments, the markings/indicia are provided as a separate component that is fixed to the timer ring with adhesive or a snap-lock or similar arrangement. This allows the wearer and/or the provider to change the time intervals depending on the opioid of choice or other factors that may affect the speed at which the respiratory rate suppression that is symptomatic of an opioid overdose begin to manifest itself in the wearer.

The timer should be understood to include an arming mechanism; this is articulated by the user to release the stored energy in the main spring and begin counting down time. As it does so, the timer ring progressively advances around the circumference of the body, providing a visual indication of passage of time and the status of the device.

In exemplary embodiments, the arming mechanism is a button, lever or catch provided to the side of the body of the device. To operate the arming mechanism, the user depresses the button. This in turn releases the operating mechanism of the timer. In other embodiments, the arming mechanism may be provided to the upper side of the device.

The timer may be reset and deactivated within a specified period of time to reset the device and avoid the antagonist from being delivered and alleviating the effects of the opioid.

The specified period of time may depend on the type of opioid and the quantity being self-administered.

In exemplary embodiments, the specified period of time is between five and ten minutes. Any longer than this increases the risk that the effects of the overdose may be fatal, and unable to counteracted by the antagonist. Conversely, a specified period of time less than five minutes may require frequent resetting and be thought of as a nuisance and inhibit use of the invention.

The wearer may visually monitor the progress of the timer ring about the body of the device. If they conclude the risk of overdose has passed they may deactivate the timer ring entirely by holding the arming mechanism and rotating the timer ring back to a safe position, locking out the tension in the timing mechanism and thereby avoiding delivery of the antagonist.

Alternatively, the wearer may rotate the timer ring back to increase the available time although the timing mechanism continues to be operative. For example, they may still not feel any adverse effects from the opioid, but as a precaution still wish to retain the option of the emergency dose of antagonist being ready if their condition deteriorates rapidly.

If the wearer does become incapacitated or impaired through the effects of the opioid or a related health issue, the timer ring will still progress to the next step, which may be an alarm mode and/or an injection mode.

In exemplary embodiments, the device includes an alarm mechanism. This serves as a signal to the wearer that there is a limited amount of time before the device will deliver the emergency dose of antagonist to offset the effects of the opioid. If they do not feel any particularly adverse effects by the time of the activation of the alarm, then the timer ring can be deactivated or reset by rotating it back to the appropriate position. The use of an alarm mechanism may be helpful in avoiding the need to visually monitor the progress of the timer ring.

The alarm mechanism may be in the form of a tensioned spring or the like which when released, acts against a metal surface within the body. This makes an audible noise, alerting the wearer that if delivery of the antagonist is not desired, the timer ring needs to be reset. In some embodiments, the alarm mechanism may include an additional or alternative alarm mechanism in the form of a vibration means, such as an unbalanced mass or the like within the device.

In exemplary embodiments, the alarm mechanism is powered by the main spring of the clockwork mechanism of the mechanical timing device. This means that fewer components are required for the invention than if a separate alarm mechanism was provided.

The delivery mechanism provides a means by which the antagonist is delivered to the wearer of the device. If the device has not be reset within the specified time, and after a period of alarming if such functionality is present, it is assumed that the wearer of the device has been incapacitated through the effects of an opioid overdose or related health event and, due to reduction in respiration, may be in danger of death. The delivery mechanism includes a biased piston. Preferably, the delivery mechanism is a spring-loaded piston. This is placed under tension through the user rotating the timer ring to the desired time period for triggering delivery of the antagonist. When this time period has elapsed, the spring-loaded piston is released. If the spring-loaded piston is not released, due to the timer ring being reset either to the safe mode or to add extra time after some time has already elapsed after the device has been set running, it remains in a charged state; it does not need to be re-tensioned.

In alternative embodiments of the invention, the biased piston may be an electric motor or part of an electric motor, powered by a power source in the form of a small battery. In some instances, the power source may be one or more photo-voltaic cells. The use of this form of biased piston may be helpful for packaging of the invention as it reduces the size of the delivery mechanism and provides a degree of miniaturisation.

In exemplary embodiments of the invention, the spring-loaded piston is operative on a jet injector that contains a dose of the antagonist.

A jet injector should be understood to be a type of syringe that delivers a stream of liquid, in which the drug to be administered is entrained, through the skin and into the underlying tissue and/or muscle. In this embodiment, the liquid is the antagonist (and carrier if present). The use of a jet injector is preferred since it does away with the sharps risk presented by the use of needles. It is also more hygienic, with only the dose piercing the skin. Persons skilled in the art will readily identify jet injectors suitable for use or that may be miniaturised for use with the present invention.

However, it should be noted that the use of a jet injector is not meant to be limiting and in some embodiments, the spring-loaded piston may alternatively act upon a plunger and displace a needle from within the body through an opening in the lower side of the body of the device into the tissue of the body of the wearer in order to deliver the antagonist. In other embodiments, the biased piston may act upon a gas canister or similar which supplies pressure to displace a plunger and/or needle from the within the body into the tissue of the body of the wearer. Other arrangements will be readily envisaged by a skilled addressee.

In embodiments using a needle, the delivery mechanism may include means to withdraw the needle following the delivery of the antagonist. This may be through the use of a biasing mechanism, which urges the needle backwards. In this example, it will be appreciated that the force applied by the spring- loaded piston to advance the needle would need to be greater than that applied by the biasing mechanism.

The jet injector includes a nozzle and a housing for the dose of antagonist. In exemplary embodiments, the jet injector is dimensioned such that it contains a single dose of the antagonist. In this embodiment, the device is intended to be single use; once the antagonist has been delivered, the device can be discarded. This may be a more economic proposition compared to prior art devices given the relative cost-effectiveness of manufacture and absence of electronic components in the present invention. There is no need for cleaning and/or recycling the device, which would otherwise present a contamination risk if the wearer suffers an infectious disease or illness.

However, it should be appreciated that in some embodiments, the device may be configured for reuse if desired.

In one embodiment, the jet injector may be dimensioned to contain multiple doses of the antagonist. In other embodiments which use a needle and plunger, the movement of the plunger may be staggered in order to deliver discrete doses of the antagonist. This will facilitate reuse of the device.

In other embodiments, the delivery mechanism or portions of the delivery mechanism, such as the nozzle and housing for the dose may be arranged as a module fitted within the body of the device. The module may be suitably configured such that once the antagonist has been discharged, it may be easily removed from the device and replaced with a fresh module without requiring adjustment or removal of any other components, such as the timer ring. This reduces the risk of contamination since the most obvious component to be exposed is the nozzle of the delivery mechanism.

In some embodiments, the delivery mechanism may be operative via an override mechanism such that the user receives the antagonist without having to wait for the specified period of time to elapse. This may be useful for emergency responders or the like who come across the user in an unresponsive state while the delivery mechanism has yet to be activated. Alternatively, the user may decide to activate the override mechanism themselves if they have concerns for their safety after having taken an opioid. In these embodiments, it is preferable that the override mechanism be relatively large and easy to identify ad may be in the form of a large button or the like which is directly operative on the biased piston.

In some embodiments, the invention may include a separate module or modules with geolocatable and physiological monitoring functionality using battery powered electronic componentry. This may be responsive to the actuation of the delivery mechanism and send a signal to emergency services with location and physiological information. However, this should be understood to be a separate, electronic mode of action that does not affect or rely on the mechanical action of the invention. It will be appreciated that implementing such an embodiment will also add extra expense to the cost of manufacture of the invention, which may be undesirable.

Further aspects of the invention, which should be considered in all its novel aspects, will become apparent to those skilled in the art upon reading of the following description which provides at least one example of a practical application of the invention.

Brief Description of the Drawings

One or more embodiments of the invention will be described below by way of example only, and without intending to be limiting, with reference to the following drawings, in which: is a perspective view of an emergency drug delivery device according to one aspect of the present invention; Figure 2 is a top plan view of the emergency drug delivery device of Figure 1;

Figure 3 is a side view of the emergency drug delivery device of Figures 1 and 2;

Figure 4 is a bottom plan view of the emergency drug delivery device of Figures 1 to 3;

Figure 5 is a schematic of the operation of an emergency drug delivery device according to one aspect of the present invention;

Figure 6 is a perspective view of an alternative embodiment of the emergency drug delivery device; and

Figure 7 is a perspective view of a further alternative embodiment of the emergency drug delivery device.

Detailed Description of Preferred Embodiments of the Invention

An exemplary embodiment of the invention (generally indicated by 100) is shown in Figures 1 to 4. As can be seen, the invention consists of a body 102 orientated centrally upon a band 104, in a manner similar to a watch. It should be noted that the body is not necessarily dimensioned to approximate the size of a watch; it is likely to be larger, due to size of the internal components (not visible).

For sake of understanding the functioning of the invention 100, reference will be made to the invention being worn about the upper arm of the wearer (not shown), proximate the bicep/tricep. However, this is not meant to be limiting and the invention may be worn elsewhere on the body, for example, about the wrist, abdomen or the leg of the wearer.

The free ends 104a, 104b of the band 104 are provided with complementary interlocking features (not visible) to secure the invention about the wrist of the wearer (not shown).

In the illustrated embodiment, the interlocking features are hook and loop material such as VELCRO™. This type of material is easily sourced and is cost effective to be added to the band during manufacture of the device through the use of techniques such as stitching or bonding with adhesive. However, it should be appreciated that other options for securing the invention 100 to the arm or leg are envisaged; for example, button studs or the like may be used. The band 104 may include elements of elastic material to apply tension and to prevent or minimise inadvertent movement of the invention while being worn.

The body 102 has an upper side or face 102a and a lower side or face 102b, the lower side contacting the skin of the wearer (not shown) when the device is being worn. The tension of the band 104 helps ensure the lower side remains in contact with the upper arm.

About the circumference of the upper side 102a of the body 102 is a timer ring 106. This is rotatable relative to an inner portion 108 of the upper side of the body. It will be seen that the timer ring bears markings; these indicate the passage of time relative to a marker arrow 110 located on the inner portion, as well as specific conditions: Safe 112a, Alarm 112b, and Injection 112c.

The timing markings is in minutes, beginning at six minutes and decreasing in 60 second intervals (this time is given by way of example, the time period indicated may be greater or lesser than shown here). There is also a directional arrow 114 indicate the direction for the wearer to reset the device 100. The movement of the ring 106, and thus the markings relative to the marker arrow 110, indicate the time and/or status of the device.

In the illustrated embodiment 100, after six minutes has elapsed, an alarm is triggered and after a further two minutes, an emergency dose of antagonist is delivered. This time period is preferred by the inventors due to the relatively fast acting impact on humans following an overdose of opioids. Having a longer time period increases the risk that the overdose is fatal.

An important aspect of the invention is the use of a mechanical, clockwork-based, timing mechanism within the interior of the body 102 of the device 100. It will be understood that such a mechanism is powered by a main spring (not visible) that is tensioned by a wind-up arrangement. Mechanisms suitable for this purpose are used in apparatus such as egg timers and other simple timing devices and will be readily adapted for use in the present invention by persons skilled in the art.

The wearer (not shown) of the device 100 places the main spring (not visible) under tension by resetting the timer ring 106; i.e. by rotating the ring so that the marker arrow 110 is in alignment with the ring marking indicating six minutes (although it could just as easily be five or four minutes if preferred).

To set the timing mechanism running, the wearer (not shown) depresses the arming mechanism 116 on the side of the body 102. This releases the timer ring 106 which, urged by the tensioned spring (not visible), progressively moves about the body, counting down elapsed time.

If desired, the wearer (not shown) can rotate the timer ring 106 back; for example, after five minutes has elapsed without noticeable ill-effect following self-administration of the opioid, the wearer may choose to keep the timing mechanism running by rotating the timer ring back to add an additional three minutes. Alternatively, they may rotate the timer ring all the way back into the safe position 112a, concurrently with depressing the arming mechanism.

After a period of time has elapsed, six minutes in the illustrated example, without the wearer (not shown) adding extra time or resetting the device 100 altogether, the timer ring 106 reaches the alarm position 112b, at which time an alarm (not visible) is triggered. This provides an audible warning to the wearer that unless the timer ring is reset and/or brought into a safe condition, an antagonist to counteract the opioid will be delivered.

This will prompt the wearer (not shown), assuming they still have control of their faculties following the self-administration of the opioid, to reset the timer ring 106.

The alarm condition 112b runs for two minutes in the illustrated example 100. If, after this time, the wearer (not shown) has still not reset or made safe the timer ring 106, then it is possible that they may have become incapacitated and their rate of respiration decreased to the point where they are at risk of death; the antagonist to counteract the opioid is then delivered. It is also possible to advance the timer ring 106 to immediately place the device 100 into the injection mode 112c to deliver the antagonist. If the wearer (not shown) begins to experience the symptoms of an opioid overdose, then they, or nearby persons, can bring about the immediate delivery of the antagonist by rotating the timer ring to the injection mode. Within the interior of the body 102 is a delivery mechanism for the antagonist. This consists of a spring-loaded piston (not visible in Figures 1 to 4) interacting with a jet injector, the nozzle 118 of which is visible in Figure 3 on the lower side of the body 102. In use, the nozzle will be covered by a thin membrane of waxed paper 120 or plastics material for hygienic reasons.

The jet injector holds a gas which, when pressurised through the movement of the spring-loaded piston (not visible), delivers, via the nozzle 116 a narrow stream of liquid under extremely high pressures subcutaneously through the skin of the wearer (not shown) into the underlying tissue. A suitably miniaturised piston and gas jet injector as used in the art will be readily implemented for the purposes of the invention by a person skilled in the art.

The spring-loaded piston (not visible) is tensioned through the action of the timer ring 106 when it is reset to tension the mainspring (not visible). The piston is then released by the timer ring reaching the injection position 112c. This delivers the dosage of antagonist, which may be NARCAN™ or the like, through the skin of the wearer (not shown). In the illustrated example 100, the injection position is reached after two minutes of the alarm condition 112b being reached, as indicated by the markings on the timer ring. Of course, to potentially increase survival rate, the alarm condition could be for a shorter period although this may lead to scenarios where the antagonist is delivered if it was not required because the wearer was simply too slow to reset the device in the available time.

Turning now to Figure 5, the operation of the invention 100 is briefly described in the form of a schematic. When the wearer (not shown) decides to administer the opioid, they operate the mechanical timer 500 to provide the necessary bias to the main spring (if this has not already been done) and to charge the spring-loaded piston of the delivery mechanism 502. They then trigger the arming mechanism to set the timer running. This is a simple action, requiring little effort or thought.

After a period of time has elapsed, for example six minutes, this triggers an alarm 504; this may be audible and/or in the form of a vibration means. This triggers a period of time during which the wearer (not shown) must reset the device 100. Failure to do so by the end of the allotted period of time, for example two minutes, will result in the release of the spring-loaded piston 502. This in turns causes delivery of an opioid antagonist to the wearer via the jet injection nozzle 506 that bears against their body when the device is being worn.

It should be appreciated that a key aspect of the invention 100 is the use of a mechanical-based timing 500 and delivery system 502 for delivering the antagonist. Compared to prior art devices requiring electronic components, such as sensors, batteries and the like, the present invention has fewer instances where non-delivery is a result of failure of the device.

The failure modes for the invention 100, and the effects of these failure modes are summarised in Table 2 below:

Table 2: Failure analysis of components of invention

If the timing mechanism 500 counts down too fast and instantly triggers, the wearer still receives the antagonist. Similarly, if the alarm mechanism 502 does not trigger at all, the antagonist is still delivered. If the alarm mechanism is triggered early, the wearer can still reset the device 100 if they have the capacity and ability to do so. However, if the reset mechanism fails, the antagonist is still delivered.

In these scenarios, while the delivery of the antagonist may not have been desired by the wearer, this is superior to the alternative, which is failure to deliver the antagonist when it is required; the consequence of this could be the death of the wearer. It should be appreciated that the delivery of naloxone, the antagonist most commonly used for opioids, when it is not required has no side effects, other than the side effects caused by the withdrawal from opioids.

If the timing mechanism 500 is not reset, as required in order to avoid the delivery of the antagonist, then this is potentially indicative that the wearer of the device has become incapacitated. In this scenario, the antagonist is clearly desirable and may be required to mitigate the risk of respiratory depression and possible death.

A failure in the injection mechanism 506 where it activated early and without input from the timing mechanism 500 may be undesirable from the perspective of the wearer wanting to obtain the "high" of the opioid consumed, but is still preferable to the alternative in which the wearer has become incapacitated.

Thus, the potential for failure to deliver the antagonist in the present invention 100 is limited to two possible scenarios; one which the timer mechanism 500 stops counting altogether or the injection mechanism 506 fails to deliver the antagonist. This compares favourably to the greater number of failure scenarios that are possible with more complex devices used for emergency delivery of antagonist drugs, as discussed above in relation to Table 1.

While the embodiment of the invention depicted in Figures 1 to 4 is configured to have an appearance of a watch, albeit oversized, the body may take a more basic form. An example 600 of this is shown in Figure 6; in this instance, the body 602 is a substantially rectangular shape. This may be more suitable for wearing around flatter areas of the body, for example the abdomen. Straps (not shown) are attached to the sides 604 to hold it in place on the body of the person using the device. Provided to the upper face 604 of the body is the operator 606 of the timing mechanism, the workings of which is contained within the body. The operator is in the form of a twist knob 606 which is articulated to align with the appropriate indicia 608 provided to the body to determine its running time, and then activated by the button 612, which is the arming mechanism in this embodiment.

Although not visible in this view, the needle may be orientated in the same plane as the length dimension of the body 602; a wedge or similar structure (not shown) may be provided to bend the needle as it is displaced, angling it through an outlet (not visible) provided to the underside of the body.

An alternative embodiment 700 is shown in Figure 7. The body 702 in this example assumes a rounded triangular shape with a contoured lower side 704 that is more suitable for being held in place about the leg or upper arm of the person wearing the device. It also allows for the use of a larger, sloping delivery mechanism, the rear portion of which is identified as 706.

The delivery mechanism 706 may be a separate structure that is inserted into the body 702 and engages with the timing mechanism (not visible), the operator 708 of which is provided to the upper side 710 of the body. As with the previous embodiment provided, the body is provided with indicia 712 around the operator to serve as a reference point when arming this embodiment 700 of the invention.

The operator 708 has two modes of action; it can be rotated, in order to tension the timing mechanism, and it can be depressed, in order to release the tension and set the timing mechanism running. Once the timing mechanism has been set running, the timer may be deactivated or placed in a snooze mode by actuating button 714. Alternatively, the operator could be rotated in the appropriate direction to increase or restore the desired period of elapsed time.

A second button 716 is provided as an emergency override; this is operative directly on the delivery mechanism 706. This may be useful in the scenario the user becomes unconscious and rather than wait for the specified period of time to elapse before the antagonist is delivered, an emergency responder may activate the device 700 themselves.

The relative size of the delivery mechanism 706 of this embodiment 700 of the invention is conducive to the use of multiple dosages. The advancement of the plunger (not visible) of the delivery mechanism may be staggered in order to deliver individual discrete dosages of the antagonist. After each dosage, the needle (not visible) of the delivery mechanism is withdrawn via a biasing mechanism or cessation of the applied force to the plunger.

The invention confers advantages of simplicity, cost, and ease of use to the invention. Significantly, relying solely on a wind-up mechanism, means no electrical components are required. Hence, it is more fail-safe compared to prior art devices that use electronic components that may be a potential source of failure, for example through a flat battery or malfunctioning electronic sensors.

Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like, are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense, that is to say, in the sense of "including, but not limited to".

The entire disclosures of all applications, patents and publications cited above and below, if any, are herein incorporated by reference.

Reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that that prior art forms part of the common general knowledge in the field of endeavour in any country in the world. The invention may also be said broadly to consist in the parts, elements, characteristics and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements, characteristics or features.

Aspects of the present invention have been described by way of example only and it should be appreciated that modifications and additions may be made thereto without departing from the scope thereof as defined herein.

Where in the foregoing description reference has been made to integers or components having known equivalents thereof, those integers are herein incorporated as if individually set forth.

It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the appended claims and without diminishing the attendant advantages of the invention claimed therein. It is therefore intended that such changes and modifications be included within the present invention.

Claims

1. An emergency drug delivery device, the device including: a band configured to be secured to a person's body; a body attached to the band, wherein the body includes: a mechanical timing mechanism; a delivery mechanism for an opioid antagonist to be delivered to the person, characterised in that the mechanical timing mechanism includes: an operator which is movable relative to a portion of the body; and an arming mechanism for the operator, and wherein the mechanical timing mechanism is operative upon the delivery mechanism after a specified period of time has elapsed.

2. The emergency drug delivery device of claim 1, wherein the band is configured to encompass a portion of the person's body.

3. The emergency drug delivery device of claim 2, wherein the portion of the person's body is one of: an arm, a wrist, a leg, an ankle, or the trunk.

4. The emergency drug delivery device of any one of the preceding claims, wherein the band includes a fastening means to secure it to the person's body.

5. The emergency drug delivery device of any one of the preceding claims, wherein the mechanical timing mechanism is a clockwork mechanism include a main spring and gears.

6. The emergency drug delivery device of any preceding claim, wherein the operator is configured to place the mechanical timing mechanism under tension.

24 The emergency drug delivery device of any one of the preceding claims, wherein the body includes an upper side and a lower side. The emergency drug delivery device of claim 7, wherein the lower side contacts the person's skin when the device is worn. The emergency drug delivery device of either claim 7 or claim 8, wherein the operator is provided to the upper side. The emergency drug delivery device of any one of claims 7 to 9, wherein the operator is a ring rotatably mounted to the body. The emergency drug delivery device of claim 10, wherein the ring incudes markings/indicia at regular intervals to indicate time intervals and/or conditions. The emergency drug delivery device of either claim 10 or claim 11, wherein the body includes a reference marker. The emergency drug delivery device of any one of claims 7 to 9, wherein the operator is a twist knob. The emergency drug delivery device of claim 13, wherein the body incudes markings/indicia at regular intervals about the body to indicate time intervals and/or conditions. The emergency drug delivery device of either claim 13 or claim 14, wherein the operator includes a reference marker. The emergency drug delivery device of any preceding claim, wherein the arming mechanism is a button lever or catch that releases the mechanical timing mechanism. The emergency drug delivery device of any preceding claim, wherein the delivery mechanism is a spring-loaded piston. The emergency drug delivery device of claim 17, wherein the spring-loaded piston is operative on a jet injector containing the opioid antagonist. The emergency drug delivery device of claim 17, wherein the spring-loaded piston is operative on an needle and plunger containing the opioid antagonist. The emergency drug delivery device of any preceding claim, wherein the device includes an alarm mechanism. The emergency drug delivery device of claim 20, wherein the alarm mechanism becomes operative after a portion of the specified period of time has elapsed. A method of using the emergency drug delivery device claimed in any one of claims 1 to 21, wherein, the method includes the steps of: securing the band about a portion of a person's body; articulating the operator of the mechanical timing mechanism to specify a period of time to elapse before the delivery mechanism delivers the opioid antagonist; and setting the mechanical timing mechanism running by articulating the arming mechanism. The method as claimed in claim 22, wherein the opioid antagonist is Naxolone.