WO2019186095A1

WO2019186095A1 - Injection device

Info

Publication number: WO2019186095A1
Application number: PCT/GB2019/050171
Authority: WO
Inventors: Lincoln BARRETT; John ESHELBY
Original assignee: Humboldt Uk Ltd
Priority date: 2018-03-29
Filing date: 2019-01-22
Publication date: 2019-10-03
Also published as: GB201805204D0

Abstract

An injection device (1) comprising a housing (13), a first chamber (11A) for holding a first quantity of medicament, a first retractable needle (11B) for communication with the first chamber (11A) to inject a patient with medicament, a second chamber (12A) for holding a second quantity of medicament, and a second retractable needle (12B) for communication with the second chamber (12A) to inject a patient with medicament, wherein the first chamber (11A) and second chamber (12A) hold, or are configured to hold, the same quantity, e.g. dosage and/or volume, of medicament; the first needle (11B) and second needle (12B) may each have a diameter of between 27 gauge and 19 gauge.

Description

INJECTION DEVICE

This invention relates generally to an injection device. More specifically, although not exclusively, this invention relates to an injection device suitable for rapid injection of adrenaline (epinephrine).

Anaphylaxis, or anaphylactic shock, is a severe and potentially life-threatening reaction to a trigger such as an allergy. Allergies that are known to cause anaphylaxis include insect bites and stings (e.g. bee and wasp stings) as well as food allergies including those relating to nuts, shellfish, and dairy products. The onset of anaphylaxis is rapid; symptoms are observed over minutes to hours, and include feeling faint, breathing difficulties, wheezing, fast heartbeat, clammy skin, confusion and anxiety, and the collapse or loss of consciousness.

Anaphylaxis is a medical emergency. The NHS (National Health Service in the UK), for example, recommends that an ambulance is called immediately, that the trigger is removed, and that the person is administered a dose of adrenaline using an auto-injector. It is further recommended that a second dose of adrenaline be administered using a second auto injector, five to fifteen minutes after the first dose, if the symptoms do not improve and if a second auto-injector is available.

Adrenaline auto-injectors are pre-loaded, disposable, single use devices that provide a rapid dose of adrenaline to the patient, for example when in anaphylactic shock. Adrenaline auto-injectors currently on the market in the UK include Epi Pen (RTM) distributed by Mylan UK, Jext (RTM) distributed by Alk-Abello and Emerade (RTM) distributed by Bausch & Lomb UK. Adrenaline auto-injectors are available in several sizes; 150 micrograms, 300 micrograms, and 500 micrograms, and the appropriate dosage depends upon the weight of the patient. In general, the dose of adrenaline is delivered intra-muscularly in the outer thigh.

It is recommended by the MHRA (Medicines and Healthcare products Regulatory Agency in the UK) that people with allergies should carry two adrenaline autoinjectors at all times. However, patient compliance with this advice may be affected by a number of factors. For example, the second adrenaline auto-injector may become lost or mis-placed in the patient’s belongings over time, especially when the patient has not had cause to use and therefore replace an auto-injector for a long period of time. It may also be difficult to locate a second auto-injector in the panic caused by the rapid onset of anaphylaxis symptoms. This may delay administration of the second dose of adrenaline, which could have dire and some-times fatal consequences. It is a first non-exclusive object of the invention to mitigate problems associated with the prior art.

Accordingly, a first aspect of the invention provides an injection device comprising a housing, a first chamber for holding a first quantity of medicament, a first extendable needle for communication with the first chamber to inject a patient with medicament, a second chamber for holding a second quantity of medicament, and a second extendable needle for communication with the second chamber to inject a patient with medicament, wherein the first and second chambers are configured to hold the same quantity of medicament, e.g. the same dosage and/or the same volume of medicament. Preferably, the first and second chamber have the same volume. Preferably the first and second needles have the same diameter.

Advantageously, providing two doses of a medicament within a single housing enables the patient to have immediate access to a second dose of a medicament for a medical emergency, once a first dose of the medicament has been administered, or if administration of the first dose fails.

The first chamber and the second chamber may be configured to hold an identical volume and/or dosage of medicament. In embodiments, the first chamber and the second chamber may be of identical volume. The first chamber and the second chamber may each independently have a volume of between 1.0 cm³ and 4.0 cm³, for example, 1.0 cm³, 1.5 cm³, 2.0 cm³, 2.5 cm³, 3.0 cm³, 3.5 cm³, or 4.0 cm³. For example, 1.6 cm³, 1.7 cm³, 1.8 cm³, 1.9 cm³, 2.0 cm³, 2.1 cm³, 2.2 cm³, 2.3 cm³, or 2.4 cm³. Advantageously, this is beneficial if it is required or desired to administer two identical doses.

This is particularly useful if the medicament is e.g. adrenaline. The volume of the first chamber and/or the second chamber may be selected depending upon the medicament contained within the first and/or second chamber, and depending upon the patient. For example, children will require smaller doses of the medicament in comparison to adults, so the volume of the first chamber and second chamber may be scaled down or up accordingly.

Preferably, the diameter of each needle is between size-X and size-Y.

Size-X may be between 27 gauge (G) (nominal outer diameter of 0.413 mm) and 22 gauge (nominal outer diameter of 0.718 mm). For example, size-X may be 27 gauge (nominal outer diameter of 0.413 mm), 26 gauge (nominal outer diameter of 0.464 mm), 25 gauge (nominal outer diameter of 0.515 mm), 24 gauge (nominal outer diameter of 0.566 mm), 23 gauge (nominal outer diameter of 0.642 mm) or 22 gauge (nominal outer diameter of 0.718 mm).

Size-Y may be between 22 gauge (nominal outer diameter of 0.718 mm) and 19 gauge (nominal outer diameter of 1.067). For example, size-Y may be 22 gauge (nominal outer diameter of 0.718 mm), 21 gauge (nominal outer diameter of 0.819 mm), 20 gauge (nominal outer diameter of 0.908 mm), or 19 gauge (nominal outer diameter of 1.067).

In this specification the gauge (G) is measured in accordance with the standard Birmingham gauge.

The needle length of each of the first needle and/or the second needle may be between 10 mm and 30 mm, for example, between 15 mm and 25 mm, for example, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29, 30 mm.

The medicaments may be the same type of medicament. The medicament in the first chamber may be different to the medicament in the second chamber. In embodiments, the medicament in the first chamber and/or the second chamber is adrenaline (epinephrine). For example, the injector device may be a pre-loaded and/or disposable/single use device that provides a first rapid dose of adrenaline, followed by, on demand, a second rapid dose of adrenaline, to the patient in anaphylactic shock. Other medicaments can be provided in the chambers. In particular, medicaments for emergency or palliative care, medicaments administered for chronic or acute conditions, repeat prescriptions or the like. Preferably, the medicament is epinephrine.

The quantity, e.g. dosage, of medicament to be delivered may depend upon the type of medicament. For example, the first dosage of medicament contained within the first chamber may be between 150 micrograms and 500 micrograms, for example, 150 micrograms, 300 micrograms, or 500 micrograms. The second dosage of medicament contained within the second chamber may be identical to the first dosage, e.g. the second dosage of medicament may be between 150 micrograms and 500 micrograms, for example, 150 micrograms, 300 micrograms, or 500 micrograms. Alternatively, the second dosage of medicament may be different from the first dosage of medicament. The medicament may be dissolved in a solvent, for example, water.

The first and second needles may be extendable from a first condition to a second condition. In the first condition one or both of the first and second needles may both housed within the housing. The first and/or second needles may be caused to extend to the respective second condition by manual or automatic actuation, for example, actuation of a biaser or biasing means, preferably respective first and second biasers or biasing means. Alternatively, actuation may be caused by a chemical reaction, for example, respective first and second chemical reactions. In the second condition medicament may be delivered from the needle.

The first needle and/or the second needle may be retractable, i.e. the first needle and/or the second needle are able to be drawn back into the housing of the device after delivery of the medicament. The first and or second needle may move relative to a shroud, for example a respective first and second shroud, after actuation thereof, whereby the first and/or second needle is covered.

The second needle may only be capable of effecting an injection once the first needle has been retracted.

Advantageously, this means that undesired engagement with an actuated needle is avoided.

The device may further comprise first and second actuator portions, whereby a person can actuate a desired needle to effect an injection of medicament. The injector device may comprise a locking mechanism, preferably respective first and second locking mechanisms. The, or each, locking mechanism may comprise a cap over a respective actuator portions. In a preferred embodiment, the second locking mechanism is secured or unlockable until the first needle has been actuated.

The housing may be provided by any suitable means. For example, the housing may comprise a plastic case. The housing may further comprise a belt carry case, for example, with clips for attachment to a bag or an item of clothing. The housing may be UV resistant to protect the medicament within the first chamber and the second chamber from degradation by UV light. The housing may further comprise one or more viewing windows to view the medicaments within the first chamber and/or the second chamber, to check for signs of degradation and/or to check the quantity of the medicaments over time, and/or before use.

A further aspect of the invention provides a package comprising an injection device as detailed above housed within a container bearing indicia. The container may be a box, for example a box made from paper, paperboard or cardboard. The indicia may include information (for example dose information, use instructions, trademark information)

A third aspect of the invention provides a method of providing an injection device, the method comprising locating in a first chamber in a housing a first quantity of a medicament and locating in a second chamber in the housing a second quantity of a medicament, the device comprising a first needle operable to communicate with the medicament in the first chamber and a second needle operable to communicate with the medicament in the second chamber, wherein the first quantity and the second are the same.

In this specification, where the quantity of medicament is said to be the same, it is to be considered that the quantity/dose is equivalent, for example the quantity/dose is sufficient to have the desired/required physiological effect and need not mean volumetrically identical.

It should be noted that the injector device of the present invention is for use in situations in which administration of a rapid dose of medicament is required, for example in an emergency setting, i.e. the dose is delivered to the patient within seconds. This is in contrast to the use of injector devices for slow delivery of a medicament, i.e. administration of a medicament over a relatively longer period of time, for example, over tens of seconds or minutes, or in situations in which administration of the medicament is not an emergency, e.g. administration of vaccines or local anaesthetic.

Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings in which:

Figure 1 is an injector device in its initial state, according to a first embodiment of the invention; and

Figure 2 is the injector device of Figure 1 in its partially used state after the first injection has been administered;

Figure 3 is the injector device of Figure 1 and 2 in its completely used state after the second injection has been administered; and

Figure 4 is an injector device according to a second embodiment of the invention.

Referring now to Figure 1 , there is shown an injector device 1 in its initial (unused) state, according to a first embodiment of the invention. The injector device 1 comprises a first injector 11 , a second injector 12, and a housing 13.

The first injector 11 comprises a first chamber 11 A, a first retractable needle 11 B, and a first injection mechanism 11C. The first chamber 11A comprises a first quantity of medicament 14. The first retractable needle 11 B comprises a tip T1. The second injector 12 comprises a second chamber 12A, a second retractable needle 12B, and a second injection mechanism 12C. The second chamber 12A comprises a second quantity of medicament 15. The second retractable needle 12B comprises a tip T2.

The housing 13 has a first end 13A, a second end 13B, and further comprises a first needle shield 16A, and a second needle shield 16B.

In this embodiment, each of the first retractable needle 11 B and the second retractable needle 12B is a 22 gauge needle. In this embodiment, the first injection mechanism 11C and the second injection mechanism 12C is a spring-operated mechanism. However, it is understood by the skilled person that other injection mechanisms may be used in combination with the injection device 1.

Referring now to Figure 2, there is shown the injector device 1 of Figure 1 , in a partially used state 2 after the first injection has been administered. In use, the user removes the first needle shield 16A, the user then places the housing 13 onto the patient’s body, e.g. on the outer thigh, and applies pressure to the first end 13A so that the first injection mechanism 11 C is activated. In this embodiment, the first injector mechanism 11 C comprises a spring, which is activated via compression. The tip T1 of the first retractable needle 11 B is released from the housing 13 of the injector device 1 , and is able to penetrate the flesh of the patient. Simultaneously, activation of the first injection mechanism 11 C causes the opposite end of the first retractable needle 11 B to penetrate the first chamber 1 1A and release the medicament 14, which is then rapidly injected into the patient.

Referring now to Figure 3, there is shown the injector device 1 of Figure 1 , in a completely used state 3 after the second injection has been administered. In use, after the first injection has been administered, the user removes the second needle shield 16B. The user then places the housing 13 onto the patient’s body, e.g. on the outer thigh, and applies pressure to the second end 13B so that the second injection mechanism 12C is activated. In this embodiment, the second injector mechanism 12C comprises a spring, which is activated via compression. The tip T2 of the second retractable needle 12B is released from the housing 13 of the injector device 1 , and is able to penetrate the flesh of the patient. Simultaneously, activation of the second injection mechanism 12C causes the opposite end of the second retractable needle 12B to penetrate the second chamber 12A and release the medicament 15, which is then rapidly injected into the patient.

Referring now to Figure 4, there is shown an injector device 4, according to a second embodiment of the invention wherein like references are designated with a prime Q and refer to like components which will not be described further. The injector device 4 is shown in a partially-used state, wherein the medicament 14’ in the first injector 1 T has been administered, but the second injector 12’ is yet to be used.

The injector device 4 has a housing 13’ in which are provided a first injector 1 T and a second injector 12’. The housing 13’ is a unitary body, preferably formed from plastics by injection moulding orthe like, which has a first and second compartment 131 A’, 131 B’ which may be subdivided from each other by an optional internal wall 131C’. The first injector 1 T is located in the first compartment 131A’ and the second injector 12’ is located in the second compartment 131 B’.

The first injector 1 T of the injector device 4 further comprises a first safety cap 17A, a first button 19A, a first injection mechanism 11 C’, a first chamber 1 1 A’ holding a medicament 14’, a first plunger mechanism 16, a first spring 18A and a first needle 1 1 B’. The second injector 12’ of the injector device 4 further comprises a second safety cap 17B, a second button 19B, a second injection mechanism 1 1 C’, a second chamber 11 B’ holding a medicament 15’, a second plunger mechanism 16B’, a second spring 18B and a second needle 12B’.

In this embodiment, the first 1 1 B’ and second 12B’ needles each have a tip T1 , T2 respectively and are retractable. The tip T1 of the first retractable needle 1 1 B’ and the tip T2 of the second retractable needle 12B’ both eject from the second end 13B’ of the injector device 4 to deliver the medicament 14’, 15’ to the patient.

The first button 19A and the second button 19B are both located at the first end 13A’ of the injector device 4.

The first safety cap 17A is located at the first end 13A’, and prior to use, covers the first button 19A. The second safety cap 17B is also located at the first end 13A’, and prior to use, covers the second button 19B. The first and second safety caps 17A, 17B, act to protect the first and second buttons 19A, 19B, to prevent accidental activation of the first and/or second injector 1 1’, 12’.

In this embodiment, the first injection mechanism 11C’ and the second injection mechanism 12C’ each operate using a combustible material, wherein gas is generated in a chemical reaction, which upon activation, cause the needle 11 B’, 12B’ to eject from the housing 13’ into the target area of the patient (not shown) to deliver the medicament 14’, 15’. This mechanism is known and understood by the skilled person.

In use, the user removes the first safety cap 17A of the first injector 1 T, the user then places the second end 13B’ of the injector device 4 onto the patient’s body, e.g. on the outer thigh, and applies pressure to the first button 19A so that the first injection mechanism 11 C’ is activated. This causes the tip TT of the first retractable needle 11 B’ to be ejected from the housing 13’ of the injector device 4, and is able to penetrate the flesh of the patient. The plunger mechanism 16A’ is actuated to cause the medicament 14 to flow through the needle and be forced into the patient’s body. Upon actuation medicament 14’ is released and is rapidly injected into the patient. After the injection process is complete, the first spring 18A enables the first retractable needle 11 B’ to retract into the housing 13’ in the direction of arrow A. This prevents injury to the user that may be caused by the exposed tip T 1.

This process is repeated, but instead, using the second injector 12’ in a likewise manner to deliver the second medicament 15’ to the patient.

It will be appreciated by those skilled in the art that several variations to the aforementioned embodiments are envisaged without departing from the scope of the invention. For example, any suitable injection mechanism may be used to release the medicament from the injector device and to deliver this to the patient rapidly. The medicament is not limited to adrenaline, and may be any other appropriate medicament that is able to be delivered rapidly to the patient.

It will also be appreciated by those skilled in the art that any number of combinations of the aforementioned features and/or those shown in the appended drawings provide clear advantages over the prior art and are therefore within the scope of the invention described herein.

Claims

1. An injection device comprising a housing, a first chamber for holding a first quantity of medicament, a first retractable needle for communication with the first chamber to inject a patient with medicament, a second chamber for holding a second quantity of medicament, and a second retractable needle for communication with the second chamber to inject a patient with medicament, wherein the first and second chambers hold or are configured to hold the same quantity, e.g. dosage and/or volume, of medicament; the first and second needles may each have a diameter of between 27 gauge and 19 gauge.

2. An injection device according to Claim 1 , wherein the first and/or second needle has a gauge size of from 27 gauge (nominal outer diameter of 0.413 mm) to and 19 gauge (nominal outer diameter of 1.067), e.g. is 27, 26, 25, 24, 23, 22, 21 , 20, or 19 gauge.

3. An injection device according to Claim 1 or 2, wherein the needle length of each of the first needle and/or the second needle is between 10 mm and 30 mm, for example, between 15 mm and 25 mm.

4. An injection device according to any preceding Claim, wherein the first chamber and the second chamber each have a volume of between 1.0 cm³ and 4.0 cm³, for example, 1.0 cm³, 1.5 cm³, 2.0 cm³, 2.5 cm³, 3.0 cm³, 3.5 cm³, or 4.0 cm³. For example, 1.6 cm³, 1.7 cm³, 1.8 cm³, 1.9 cm³, 2.0 cm³, 2.1 cm³, 2.2 cm³, 2.3 cm³, or 2.4 cm³.

5. An injection device according to any preceding Claim, wherein the medicament is adrenaline.

6. An injection device according to any preceding Claim, wherein the first quantity of medicament and/or the second quantity of medicament is between 150 micrograms and 500 micrograms, for example, 150 micrograms, 300 micrograms, or 500 micrograms.

7. An injection device according to any preceding Claim, wherein the first needle and/or the second needle is extendable from a first condition to a second condition.

8. An injection device according to Claim 7, wherein in the first condition one or both of the first needle and/or the second needle is housed within the housing.

9. An injection device according to Claim 7 or 8, wherein the first needle and/or second needle is caused to extend to the respective second condition by manual or automatic actuation.

10. An injection device according to Claim 9, wherein the first needle and/or second needle is caused to extend to the respective second condition, by the action of one or more of:

a. actuation of a biaser or biasing means,

b. expansion of a compressed fluid;

c. a chemical reaction.

1 1. An injection device according to any preceding Claim, wherein the first needle and/or the second needle is retractable.

12. An injection device according to any preceding Claim, wherein the first needle and or second needle is movable relative to a shroud.

13. An injection device according to any preceding Claim, further comprising a locking mechanism, preferably respective first and second locking mechanisms.

14. An injection device according to Claim 13, wherein the, or each, locking mechanism comprises a cap to obstruct access to an actuator portion.

15. A package comprising an injection device according to any preceding Claim housed within a container bearing indicia.

16. A method of providing an injection device, the method comprising locating in a first chamber in a housing a first quantity of a medicament and locating in a second chamber in the housing a second quantity of a medicament, the device comprising a first needle operable to communicate with the medicament in the first chamber and a second needle operable to communicate with the medicament in the second chamber, wherein the first quantity and the second are the same.