WO2019070191A1

WO2019070191A1 - An unfoldable and foldable auto-injector

Info

Publication number: WO2019070191A1
Application number: PCT/SE2018/051029
Authority: WO
Inventors: Andreas Luis RUIZ; Gustav Nicolas FELDREICH
Original assignee: Feldreich Caro Ruiz AB
Priority date: 2017-10-06
Filing date: 2018-10-06
Publication date: 2019-04-11

Abstract

The present invention relates to a flat auto-injector to be unfolded into its injection position, comprising one or more pre-filled syringes where the needle (10) has the length and gauge thickness appropriate for intramuscular injection of the pre-filled substance (3). A trigger (9) releases a compressed spring (12) with own housing (4) which pushes the needle (10) to penetrate a potential thin layer of plastic (8) on the skin of the user to reach an intramuscular depth. The case (7) secures the components so that no unintentional injections occur. A handle (6) opens the case and unfolds the auto-injector. Hinge-like mechanisms (2) are connected to the case (7) in a way that makes the syringe attached, but still movable in a perpendicular motion. A hooking mechanism (5) upholds the elevated stand. A patch (1 ) may attach the casing to the body. After injection the needle (10) is removed either by lifting the syringe out from the skin and/or complete removal of the device.

Description

AN UNFOLDABLE AN D FOLDABLE AUTO-I NJECTOR TECHN ICAL FIELD

The present invention relates to unfoldable and foldable and portable auto-injectors used as quick and automatic drug administration tools with liquid based medications, in combination with adhesives.

BACKGROUN D ART

The ability to deliver drugs to a patient is a key procedure in medicine. There are a range of medical needs where it is of great advantage if the drug delivery can be automized to a greater extent. One way to automize drug delivery is by

auto-injection which can be handled by the human in need themselves, or by a third party helping a human or an animal. It is advantageous is the drug-delivery system is safe, reliable and simple to understand. One example of a life-threatening clinical condition is anaphylaxis which is a severe allergic reaction.

Auto injectors are devices that automatically administers medication to patients without the presence of medical personnel e.g. the injectable device shown and described in EP 09765236.6 with references ¹.

The amount of medication is the amount that will give an intended medical effect, such as the abrogation of a severe allergic reaction such as a anaphylactic reaction (an allergic reaction that effects two organ system, most often is one of the respiratory system i.e. an asthmatic reaction). The amount of epinephrine used to abrogate an anaphylactic reaction may start with 0.3 mg s.c.

An appropriate diameter of needle or cannula commonly used to reach the subcutaneous or the hypodermic tissue is 30G and the length of the needle A syringe is a simple reciprocating pump consisting of a "plunger" or a piston that fits tightly within a cylindrical tube called a barrel. The plunger can be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and expel liquid or gas through a discharge orifice at the front (open) end of the tube. The open end of the syringe may be fitted with a hypodermic needle, a nozzle or a tubing to help direct the flow into and out of the barrel.

Syringes are frequently used in clinical medicine to administer injections, infuse intravenous therapy into the bloodstream, apply compounds such as glue or lubricant.

To push or pull the piston or plunger in the syringe one or several springs are attached. The place of injection is where suitable for hypodermic injections, commonly the front of area of the quadriceps femoris, the belly between the symphysis and the navel or on side of the shoulder, e.g. m. deltoids.

The depth of the administration is commonly hypodermic, i.e. subcutaneous or intramuscular.

The product may be in a single package, although there are examples of auto injectors that come to the consumer in double packages.

A common length of the durability of an auto injector is most commonly limited by the durability of the medication and is dependent on the temperature and the environment where the device and the medication is stored.

The durability when kept in an emergency pack at maximum 25 Celsius may be 12 months for epinephrine.

A common and efficient drug delivery device when it comes to anaphylaxis, is an auto-injector e.g. "Epipen™" ^2,SA. This type of auto-injector is a preassembled syringe containing 300 micrograms of adrenaline for intramuscular injection carried by patients at risk of anaphylaxis for self or third-party injection⁵. The Epipen™ is an advantageous device⁶, but it has it's flaws, especially with needle-stick accidents and somewhat challenging administration methods, since the activation isn't

standardized⁷. Patients new to the Epipen™ will not know exactly how to

administrate it until suffering a anaphylactic shock (although instructions is included, but still not easy to interpret). There is no "test-mode" and the price for each pen is approximated to at least 100 USD⁸. The device is bulky and somewhat hard to carry around. Time is also an important factor where mere seconds can be the difference between open and closed airways. Emphasis on hospital care is important as well, but the availability isn't always present, especially outside of big cities. Today the Epipen™ is mostly subscribed to "at-risk" patients, suffering from moderate to severe allergies⁹. This device can be a life saver in critical situations¹⁰.

I n allergy, the body reacts to a certain stimuli or protein as if it was a threat. This could be basically anything, including food. When an allergic reaction occurs, histamine (a granule constituent) is released and starts an inflammatory cascade. In allergic reactions, mast cells remain inactive until an allergen binds to IgE, already coated upon the cell. Other membrane activation events can either prime mast cells for subsequent degranulation or act in synergy with FcERI signal transduction¹¹. IgE is therefor known as the primary immunological molecule in allergy¹². The mast cell is a white blood cell (leukocyte) that play an important part in the human immune system, protecting us against pathogens, create new blood vessels (angiogenesis), wound healing and more. Mast cells are a type of leukocyte called granulocyte, meaning basically that the cell contains small molecules, that can be released when the immune system feels that there is a threat. Mast cells store a number of different chemical mediators— including histamine, interleukins, proteoglycans (e.g., heparin), and various enzymes— in coarse granules found throughout the cytoplasm of the cell¹³. Antihistamines and cortisone (anti-inflammatory drugs) has long been the therapy of choice when treating allergy. Antihistamines is used to inhibit histamine receptors and cortisone to degrade the infla mmatory reaction. I n acute anaphylactic situations, epinephrine is used as a complement, because of its bronchodilating features, but studies has showed that epinephrine does not only help the patient by clearing airways and raise blood sugar, but to inhibit the mast cell itself¹⁴'¹⁵. By inhibiting the mast cells granulation, histamine can't be released (or at least not in the same amount) and because of the fast metabolic nature of epinephrine (together with the way of administration), the patient gets a faster and safer recovery.

Epinephrine was discovered in the dawn of the past century, a highly active molecule was concomitantly and independently discovered by John Abel, who extracted it from adrenal glands in 1897, and by Jokichi Takamine, who also purified a new chemical from adrenal glands, in 1901. Hailing from the Greek words "on top of the kidney", epinephrine later took the name more commonly known as "Adrenaline"¹⁶.

Adrenaline is a natural occurring hormone produced in medulla of the adrenal grands (and certain neurons) in the body. It included in an organic compound called catecholamine's and is derived from the amino acid "Tyrosine"¹⁷. Adrenaline's main function is to trigger the sympathetic portion of the autonomous nervous system. Pupil dilation, increased heart rate/blood pressure, vasoconstriction and more. As a hormone, epinephrine acts on nearly all body tissues. Its actions vary by tissue type and tissue expression of adrenergic receptors. For example, high levels of

epinephrine causes smooth muscle relaxation in the airways but causes contraction of the smooth muscle that lines most arterioles¹⁸. I n the term "Fight or Flight", adrenaline is a main component stimulating both alpha (1 and 2) and beta receptors (1, 2 and 3) and converting glycogen into glucose, increasing blood glucose levels [Bender 2014]. Epinephrine has various medical uses, because of the many effects the substance has in the human body.

I n conditions constricting the airways, such as acute asthma and croup, epinephrine is used as a bronchodilator and the agent also has the ability to relax smooth muscle, which is present in the airways as well. This mechanism is very advantageous since contraction of smooth muscles in the airways is prime cause of these conditions and therefore be easily treated with epinephrine¹⁹, either by injecting or aerosol.

As mentioned earlier, epinephrine has a vasoconstriction effect, which causes increase in blood pressure. This can be used to create a spontaneous return of circulation (together with CPR)²⁰, when a patient is in cardiac arrest. It can also be used to enhance the effect of local anesthesia (LA). When mixing epinephrine and a LA substance, such as lidocaine, the duration is prolonged because of the

vasoconstriction ability. This also decreases bleeding, making epinephrine modified LA a prime agent for dental and surgical therapies.

Epinephrine is a premium substance for various acute conditions, for example, anaphylaxis (food allergies, poisonous snakebites e.g.), where it's the drug of choice²¹. These situations are often sudden, allergens could be hidden in food, insect bites can occur on a family outdoor trip etc. A common problem is traces of allergens in food, for example, traces of nuts in cakes. The cake could be "nut-free", but baked on a table that has traces of nuts from previous baking's.

There are numerous injectable substances to date e.g. Insulin.²² Safety measures and simplified solutions has made auto-injectors a common administration tool, since they're pre-loaded and doesn't require any management besides injecting. OBJECTS OF THE INVENTION

The primary object of the invention is to hold and administrate liquid based substances by intramuscular and/or subcutaneous injections, through a folding syringe and a patch, making the device applicable on various parts of the body. Additional objects of the invention will become evident from the following description and the claims.

SUMMARY OF THE I NVENTION

The invention is an unfoldable-foldable auto-injector with one or more syringes, able to hold bolus medications. The device comprises a protective housing attachable to a medical plaster, making the device possible to wear direct onto the skin. The auto-injector is unfoldable-foldable in order to be lean when carrying and manageable and stable during injection. A shield prevents the needle from accidental trauma. The unfolding-folding mechanism, along with the housing around the auto-injector, works as security too. When the auto-injector is in its unfolded angled position, the medication may be expelled by pressing a trigger that releases a spring that moves the syringe, needle and piston to administer the medication into the hypodermal tissue. Instructions can be placed on the housing, both in text and/or pictures. The device can use a three step system, where fixation-unfolding and injection is done separately. The purpose of the device is to offer a small, easy to carry solution to people in need of an auto-injector. The integrated patch makes the auto-injector possible to carry on the body if needed and the foldable design saves space when not activated.

DESCRIPTION OF THE DRAWINGS

The provided figures are only to describe the invention and does not limit the scope of the invention in anyway. The first prototype was made by Ruiz A. and Feldreich N. the 15/2-2017 in Stockholm, Kista.

DESCRIPTION OF THE DRAWINGS I n the accompanying drawings:

FIG 1A Illustrates the device on a horizontal stand, with the syringe also in a horizontal position

FIG IB Showing the device from a horizontal view, with the syringe in its vertical, ready state, before injection

FIG 1C A view from above the device without the lid, showing the containable parts, inside the housing FIG 2A and 2B Illustrates above the device, without a lid, with two wheels on each side of the syringe, able to help get the syringe in its vertical state

FIG 3A Showing the device in its unfolded state from a horizontal view, when the syringe is in its angled activated state, with the needle penetrating the hole in the bottom of the housing

FIG 3B A picture from underneath the housing, showing the paper covering the sticky part of the patch.

FIG 3C The device is unfolded at its predetermined angle and activated in this picture, like FIG 3A, but from another perspective, showing the top of the syringe

FIG 4A Showing the short side of the housing, from a horizontal view

FIG 4B A picture of the housing from above and with a diagonal angle, showing 3 out of 6 sides of the whole housing

FIG 5 As in FIG 4B, the housing is presented with the device in its unfolded state, from a diagonal and elevated view, but with the device in a predetermined 90 degree angle towards the underlying target

FIG 6 Presents the device with two syringes in their folded state, viewed from above without the housing lid and at a horizontal view, in an unfolded state at a 24 degree angle between underlying surface and the unfolded angled syringe and needle

A medical patch 1 with a sticky surface that's able to attach on the skin and/or clothing, without the need of shaving or any kind of adhesive treatment. The other side of the patch, that is not sticky can be part of the case holding the rest of the device or attached to the case in a way that secures the usage of the device. The patch should have some kind of protective paper 14, easily removed when applying the patch. The paper should be in a material that makes is easy to remove, but still protective enough not to fall of the sticky surface of the patch. Some transparency 8 in the patch is needed where the needle can break through the patch and then the skin. The material can be any that is suited for a medical patch and the part the needle is intended to break through have to be in a material where a thin needle injected with a small force, can be penetrated.

The inject-able device 3 is a pre-filled syringe carrier assembly with enough volume to carry the desired amount, but small enough in length and width to fit the case. The carrier containing medication can preferably be transparent and made by either plastic, glass or other similar materials. A piston 13 responsible for helping the medication to be pushed out of the syringe could be attached inside the carrier. The needle 10 has the gauge (G) thickness appropriate for the selected substance. The needle 10 also has to be at a length appropriate for intramuscular injection. The syringe 3 can be placed in a horizontal line, much like a credit card laying on a flat surface. This can save space but also make the device safer, since an accidental injection would be horizontal and most likely miss the body of the person wearing the device. An integrated cover can be build inside the wall of the case right next to the tip of the syringe which prohibits the needle to penetrate that surface if the fail-safe measures of the device is somehow compromised. The wall should be thin enough not to increase the size of the product to much and should also be in a material strong enough to withstand the needle and it's force.

A case or housing 7 carrying the various components stated in this description that also combines with the medical patch mentioned earlier. The case 7 should be manufactured in a way that secures the components so that no unintentional injections occur and the case doesn't lose its form or composure, when carrying in a pocket or other pressured areas. This includes plastic fabrics, light metallic structures and other material with the desired features. Some substances that could be used with this device are sensitive to ultraviolet (UV) lighting and/or other external exposure, which creates the need of certain coating and/or treatment of the housing, in order to maintain proper quality. The housing 7 works not just as protection for the device, but is also a surface where written and/or figurative information can be present. I nside the case, numerous walls and other structures capable of creating stability, without adding to much weight can be present. Since the auto-injector penetrates the skin, the inside casing needs to be sterile to ensure that the risk of getting infections caused by the needle is at its minimum.

On top of case, a lid can be used to fold the syringe in to its activation stage. The lid would then be a movable part of the case and also act as additional protection, along with a handle 6, as used in figures 1A-C and 3. As seen in figure 2, the lid doesn't need to be present for the apparatus to work, as long as enough safety measures can be upheld without it. If the lid is used, as in the case in whole, the liquids need to be protected from UV lighting e.g.

The folding mechanism 2 can be a part connected to the syringe, or an appendage, creating movement in 0 to 90 degrees, much like a hinge. This hinge-like mechanism 2 should be connected to the case in way that makes the syringe attached, but still movable in a perpendicular motion. Depending on fabric use, the folding mechanism 2 can either be molded into the casing and/or be screwed 11. I n order to keep the device in a vertical position a hooking 5 mechanism can be used to uphold the vertica l stand. This option should prefera bly made in some kind of stiff, yet elastic material, such as plastic or thin metal. There is no restrictions regarding material in this part as long as the syringe 3 can maintain its upright position. This position may leave some of the transparent part of the syringe visible, which could help determine whether or not the substance is usable or not. Changes in coloration and/or spots in the liquid could potentially affect the therapeutic effect of the substance. If a lid is not present and/or a transparent part is located where the syringe can be seen, changes in color could also be detected through there and by that increase further safety in the device.

To trigger an injection a compressed spring 12 is used to fixate the needle 10 into the skin and preferably inject the substance at the same time, by the release of a locking mechanism, where the force of the spring causes the needle 10 to penetrate a potential thin layer of plastic in the patch 1 and the skin of the user. The force from the spring needs to be strong enough for the needle 10 to reach desired depth through the skin, meaning that the spring is able to move the syringe 3 forward. The depth of the injection is also factored by the length of the needle 10 and the force of the loaded spring 12. When the spring 12 is released, the difference in length between a contracted and relaxed spring is the same as the desired length the syringe needs to be moved forward. The spring can have its own housing inside the case 4 (where the locking mechanism can be found), but can also be placed behind the syringe 3 if it doesn't compromise the functionality of the device and/or makes the device too long horizontally. Activation is initiated by a button 9 or other mechanisms able to release the spring 12 from its compressed state. The length from which the spring 12 increases from its compressed state, when released it equivalent to the amount of medication that needs to exit the syringe 3 and/or the depth that the needle 10 needs to reach work the mechanism to work as

accordingly.

The device can also use more than one spring in order to first fixate the needle 10 (as step two, where step one is the folding) and then inject by activating the other spring/s (step three). In this case, spring 4 is used for fixating the needle 10 and position the syringe 3 without injecting any fluids. Another spring/s can then be used to inject the medication, where in that case the device require one more step in activating the secondary spring/s. After injection the needle 10 is removed either by lifting the syringe out from the skin and/or complete removal of the device.

I n its unfolded state the needle is protected from the target tissue by a shield 15 parallel, semicircular or circular around the needle, longitudinal to the length of the needle and where said shield follows parallel with the needle when the device is unfolded, but stays in a retracted position when the device is moved forward and injects the predetermined medication.

Dimensions can vary, but should not exceed four inches in horizontal length, two inches in width and one inch in height (when unfolded). The syringe 3 holding the medication could be in different volumes depending on dosage. Substances have different therapeutic dosage, where epinephrine e.g. usually have 0,3 ml initially. It is also in the case of epinephrine, preferable to have a greater volume that the actual dosage, since the stability of the drug is improved when stored in larger volumes. It is advantageous if the device is as small as possible, without risking the functionality.

Safety mechanisms can be one or several steps, where one is the need of placing the syringe in a vertical position to be able to inject. A security pin can be attached that needs to be pulled in order to enable injecting. This pin could be a part of the lid and also be used as a tool to bring the syringe from a horizontal, laying position, into a vertical, standing position, where injection ca be triggered. Strips can be used on top of the syringe, either on the lid and/or covering a safety pin. Strips can then be peeled of in order to reach desired part.

DETAI LED DESCRI PTION OF THE I NVENTION

The following detailed description, and the examples contained therein, are provided for the purpose of describing and illustrating certain embodiment of the invention only and are not intended to limit the scope of the invention in any way.

The invention is based on the insight that there is an advantage of providing auto-injecting devices that are smaller and easier to carry, with the ability to wear the injector on the body for quick injecting (if needed).

The invention is based on the insight that there is an advantage of providing an auto-injecting device that is adhesive to the body. Further, it is an advantage if such adhesive can be exchanged so that the auto-injector can be returned to the storage place when it is not needed to be carried on the body. On the following occasion a new adhesive can attached to the skin, and the auto-injector can be attached to the adhesive. On such adhesive can be a plaster, and one way to attach the auto-injector to the adhesive can be with Velcro. For example rock climbers , mountain bikers or runners or construction workers may experience an advantage to have the auto injector attached to the body.

The invention is further based on the insight that it may be an advantage to inject the liquid into the hypoderm tissue in a certain angle. This increases the areas where the auto-injector may be placed and the ares of use. For example, intramuscular injections need to be deeper than subcutaneous and need to be made in a steeper angle > 45 degrees against the underlying tissue. Subcutaneous injections, such as insulin made on the stomach between the navel and the symphysis for example, are suitable to be made in less angle, 10-30 degrees. The invention is also based on the insight that a combined treatment of several different drugs may have therapeutic advantages compared to injection of a single drug. One preferable combination is a corticosteroid e.g betapred in one syringe and adrenaline in the other. Or adrenaline and one anti-histamine.

The invention is further based on the insight that an auto injector with two or more syringes gives the advantage of a more reliable administration of the drug, as two or more syringes gives at least two depositions of drugs at least two injections, in addition it gives to opportunity to deliver two or more separate drugs, and in the case of two or more syringes with the same drugs but separate mechanisms it gives a higher reliability i.e. if one mechanism fails, the other may carry out the intended drug administration. Instructions and safety symbols can be printed or added to the case in order to simplify the usage of the device. This information can be put on any part of the invention as long as it doesn't interfere with the function and/or safety of the product.

Several medical conditions may need drugs provided by an auto-injector that are easily at hand and easily carried and administered by a person without previous medical training. The medication injected can be one to treat and emergency situation e.g. anti-convulsives or anxiolytics e.g. diazepam. Anti-toxins against venoms or anti-dotes e.g. atropine, naloxone or flumazenil, or an antibiotic. It may be intended for single or multiple dose of anxiolytics e.g. hydroxyzine, pain-relief such as morphine or against nausea and vomiting such as metoclopramide or anti-psychotics e.g. haloperidol. It may be cardiotonic medications or anti-arrhytmics (e.g. betablockers, amiodarone or lidocaine). Anti-migraine medication e.g.

sumatriptane or ergonovine. It may be compounds used to provide relief for endogenous deficits such as growth hormones or insulin. It may be drugs used to treat neuromuscular disorders or neuropathies e.g. interferons or neostigmine. It may be anticoagulants e.g. heparinesulphate or low-molecule-weight heparines. Other possible injectable medications will be apparent to those familiar with medications and the indications for their use.

It should be added that above mentioned features can be used in various combinations along with different injectable substances. The auto-injector able to fold, the auto-injector being connected to a medical patch, with the ability to be worn by the patient or applied when needed. An auto-injector with a protected needle. The case having a rectangular shape with less height than length and width, in a somewhat flatter forming. A two or three step method for safe and functional injecting, together with the rest of above mentioned features in this description.

It is an advantage if the invention may be reloaded with new syringes, preferably prefilled with the medication needed. An advantageous aspect of the invention is a calibration of the power-source and the springs that moves the syringe and the needle and expels the medication slightly retracts the device after the medication has been expelled when the spring or springs are in a relaxed state so that the needle is resting above the skin out of the tissue after the medication has been fully expelled within the intended tissue compartment.

Another advantageous aspect of the invention is the calibration of the device so that it is easily retractable from the tissue after the autoinjection i.e. the medication or medications has been expelled. It is an advantage if parts of the invention is made of leight weight durable materials e.g. carbon fibre.

The invention is related to a device described by, but not limited by the following:

1. A device for automatic injection of medication comprising: One or several syringes containing a preloaded bolus volume of medication, each syringe including a piston which expels a predetermined volume of medication through a flow path into and through a needle dimensioned to allow rapid administration of the medication when the syringe and the needle with its power source has been unfolded into an injection position which is at an predetermined angle compared to the rest of the housing and the folded position and the trigger for injection has been released, and the syringe and the communicating needle being longitudinally rapidly moveable when standing in its angled unfolded position where the housing in said unfolded position works as a stative stabilizing its the movable parts, and said syringe with the attached needle is moveable from a retracted position when the said trigger releases the syringe and needle into the injection position where the needle at the predetermined angle reaches through a hole in the housing into the hypodermal tissue and the power source compresses the piston to expel a predetermined volume through the flow-path and the needle into the said tissue. 2. A device as defined by claim 1 with one syringe, one flow-path and one-needle.

3. A device as defined by claim 1-2 wherein the volume defined within each syringe is greater than the predetermined volume of the bolus to be injected.

4. A device as defined by the claims 1-3 that may be unfolded and auto-injected by a person without previous medical training into the hypodermal tissue when standing in its fold.

5. A device as defined by the claims 1-4 wherein the extended length of the needle is intramuscular injection.

6. A device as defined by the claims 1-4 wherein the extended length of the needle is subcutaneous injection. 7. A device as defined by the claims 1-6 further comprising a self-contained power-source in the housing for effecting movement of the syringe forward ly to the extended position.

8. A device as defined by the claim 7 wherein the power source comprises a spring.

9. A device as defined by the claim 8 wherein the spring is substantially compressed when the syringe is in its retracted position. 10. A device as defined by the claim 1-9 wherein the needle in its unfolded state is protected from the target tissue by a shield parallel with the length of the needle and where said shield follows parallel with the needle when the device is unfolded, but stays in a retracted position when the device is moved forward and injects the predetermined medication.

11. A device as defined by the claim 10 wherein said shield the needle in its unfolded state is protected from the target tissue by a shield parallel and circular or semicircular longitudinally around the length of the needle with an opening at the point of the needle. 12. A device as defined by the claim 10-11 wherein said shield is connected to the non-moveable parts of the housing or to the non-movable parts of the power source.

13. A device as defined by the claim in 1-12 where the housing in the unfolded state measures less than 2 cm height, 3 cm width and 15 cm length. 14. A device as defined by the claim in 1-13 housing in the unfolded state measures less than 1 cm height, 2 cm width and 10 cm length.

15. A device as defined by the claim in 1-14 comprising more than one ampulla or syringe with separate needles.

16. A device as defined by the claim in 1-15 comprising separate triggers for each syringe.

17. A device as defined by the claim in 1-16 comprising at least one syringe with epinephrine in the doses 0.1-1 mL of 1 mg/mL.

18. A device as defined by the claim in 1-17 comprising at least one syringe filled with epinephrine in the doses of 0.1-0.5 mL of 1 mg/mL. 19. A device as defined by the claim in 1-18 where the standing position comprises an elevation of 5-175 degrees in the unfolded state.

20. A device as defined by the claim in 1-19 where the standing unfolded position comprises an elevation of 45-135 degrees in the unfolded state

21. A device as defined by the claim in 1-20 where the standing unfolded position has an elevation of 90 degrees against the area targeted for hypodermal injection.

22. A device as defined by the claim in 1-21 where the housing has a handle to easily elevate said device into the unfolded position. 23. A device as defined by the claim in 1-22 where the housing can be attached to the user by an adhesive plaster.

24. A device as defined by the claim in 1-23 where the housing including said device can be removed and replaced onto and off the adhesive plaster.

25. A device as defined by the claim in 1-24 where there is a velcro between the housing and the adhesive plaster.

TABLE 1. ABBREVATIONS AND TERMINOLOGY

REFERENCES

1. EP 09765236.6

2. Chipps BE. Update in pediatric anaphylaxis: a systematic review. Clin Pediatr (Phila), 52 (5) (2013), pp. 451-461

3. Frost DW, Chalin. CG The effect of income on anaphylaxis preparation and management plans in Toronto primary schools. Can J Public Health, 96 (4) (2005), pp. 250-253 4. Mclntyre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. Pediatrics, 116 (5) (2005), pp. 1134-1140

5."EpiPen." In A Dictionary of Dentistry, edited by Ireland, Robert. : Oxford University Press, 2010. http://www.oxfordreference.com.proxy.kib.ki.se/view/10.1093/acref/9780199533015.001.0001/acre f-9780199533015-e-1463.

6.Arya VB, Shrivastava A. Prescribing epinephrine injection (EPIPEN) for anaphylaxis in primary care - a survey.Archives of Disease in Childhood April 2011, Vol.96(Suppl 1), p.A50. BMJ Publishing Group Ltd and Royal College of Pediatrics and Child Health 7. Cohen MR. Medication errors.(EpiPen hazard). Nursing, April, 2011, Vol.41(4), p.17(1)

8. Reuters Health News: "Another look at the surge in EpiPen costs" [Internet]. Mon Mar 27, 2017. 3:37pm EDT. Cited date 2017-06-16 13:48. Available at:

9. Wolf MS, Prenner BM.A Survey of Treatment and Referral of Food Allergy Cases by Primary Care Physicians in San Diego County. The Journal of Allergy and Clinical Immunology, 2006, Vol.117(2), pp.S48-S48

10. Abramowicz M, Zuccotti G, Pflomm JM. Epinephrine Auto-Injectors for Anaphylaxis. JAMA, 17 January 2017, Vol.317(3), pp.313-313

11. Pulendran B, Ono SJ. A shot in the arm for mast cells. Nat Med. 2008 May;14(5):489-90. doi: 10.1038/nm0508-489.

12. Handlogten MW, Serezani AP, Sinn AL, Pollok KE, Kaplan MH, Bilgicer B.A heterobivalent ligand inhibits mast cell degranulation via selective inhibition of allergen-lgE interactions in vivo. Journal of immunology (Baltimore, Md. : 1950), 1 March 2014, Vol.192(5), pp.2035-41

13. Mast cell 2016. Britannica Academic. Retrieved 15 October 2016, from

14.Graevskaya E, Akhalaya M, Goncharenko E. Effects of Cold Stress and Epinephrine on

Degranulation of Peritoneal Mast Cells in Rats. Bulletin of Experimental Biology and Medicine, 2001, Vol.131(4), pp.333-335 15. Aim PA, Bloom GD. Catecholamine inhibition of rat mast cell histamine secretion— A process independent of cyclic AMP levels and counteracted by glucose. Life Sciences, 1983, Vol.32(4), pp.307-314

16.Cervellin G, Sanchis-Gomar F, Lippi G. Adrenaline in anaphylaxis treatment. Balancing benefits and harms. Expert opinion on drug safety, June 2016, Vol.15(6), pp.741-6

17. Bender DA. A Dictionary of Food and Nutrition. Oxford University Press 4 ed. 2014. 18.Vedung T. Blood Flow in Human Skeletal Muscle : The Effect of Adrenaline and the Influence of a Small Muscle Injury. Inst for fysiologi och farmakologi / Dept of Physiology and Pharmacology 2010-11-10T13:44:25Z

19. Middleton E. Asthma Deaths: Are They Preventable? Allergy and Asthma Proceedings, 7, 5, 462-466(5)

20. Callaway CW. Questioning the Use of Epinephrine to Treat Cardiac Arrest. JAMA, 21 March 2012, Vol.307(ll), pp.1198-1200

21. Alvarez-Perea A, Tomas-Perez M, Ameiro B, Martinez-Lezcano P, Zambrano G, Baeza M L. When Is Epinephrine Used in Anaphylaxis? The Journal of Allergy and Clinical Immunology, February 2016, Vol.137(2), pp.AB51-AB51

22. Gray A, Wright J, Goodey V, Bruce L. Injectable Drugs Guide. First Edition. London, Great Britain, Published by Medicational Press, 2011.

Claims

CLAI MS

1. A device for automatic injection of medication comprising:

One or several syringes containing a preloaded bolus volume of medication, each syringe including a piston which expels a predetermined volume of medication through a flow path into and through a needle dimensioned to allow rapid administration of the medication when the syringe and the needle with its power source has been unfolded into an injection position which is at an predetermined angle compared to the rest of the housing and the folded position and the trigger for injection has been released, and the syringe and the communicating needle being longitudinally rapidly moveable when standing in its angled unfolded position where the housing in said unfolded position works as a stative stabilizing its the movable parts, and said syringe with the attached needle is moveable from a retracted position when the said trigger releases the syringe and needle into the injection position where the needle at the predetermined angle reaches through a hole in the housing into the hypodermal tissue and the power source compresses the piston to expel a predetermined volume through the flow-path and the needle into the said tissue.

2. A device as defined by claim 1 with one syringe, one flow-path and one-needle.

6. A device as defined by the claims 1-4 wherein the extended length of the needle is subcutaneous injection.

7. A device as defined by the claims 1-6 further comprising a self-contained power-source in the housing for effecting movement of the syringe forward ly to the extended position.

9. A device as defined by the claim 8 wherein the spring is substantially compressed when the syringe is in its retracted position.

10. A device as defined by the claim 1-9 wherein the needle in its unfolded state is protected from the target tissue by a shield parallel with the length of the needle and where said shield follows parallel with the needle when the device is unfolded, but stays in a retracted position when the device is moved forward and injects the predetermined medication.

11. A device as defined by the claim 10 wherein said shield the needle in its unfolded state is protected from the target tissue by a shield parallel and circular or semicircular longitudinally around the length of the needle with an opening at the point of the needle.

12. A device as defined by the claim 10-11 wherein said shield is connected to the non-moveable parts of the housing or to the non-movable parts of the power source.

13. A device as defined by the claim in 1-12 where the housing in the unfolded state measures less than 2 cm height, 3 cm width and 15 cm length.

14. A device as defined by the claim in 1-13 housing in the unfolded state measures less than 1 cm height, 2 cm width and 10 cm length.

18. A device as defined by the claim in 1-17 comprising at least one syringe filled with epinephrine in the doses of 0.1-0.5 mL of 1 mg/mL.

19. A device as defined by the claim in 1-18 where the standing position comprises an elevation of 5-175 degrees in the unfolded state.

22. A device as defined by the claim in 1-21 where the housing has a handle to easily elevate said device into the unfolded position.

23. A device as defined by the claim in 1-22 where the housing can be attached to the user by an adhesive plaster.