Auto-Injection Device
20190240421 ยท 2019-08-08
Inventors
Cpc classification
A61M5/326
HUMAN NECESSITIES
A61M5/2033
HUMAN NECESSITIES
A61M2005/3247
HUMAN NECESSITIES
A61M2005/2013
HUMAN NECESSITIES
A61M2005/3258
HUMAN NECESSITIES
A61M2005/312
HUMAN NECESSITIES
A61M5/3245
HUMAN NECESSITIES
International classification
A61M5/32
HUMAN NECESSITIES
Abstract
An auto-injection device including a housing, cartridge, needle, and needle cover. The housing includes longitudinally extending flexible arms. The cartridge moves relative to the housing and contains fluid medicament. The needle is at a proximal end of the device. The needle cover has openings along the longitudinal direction and moves between a first position, a second position, and a third position, wherein the needle is unexposed in the first and third positions and in the second position the needle is exposed. The needle cover is biased towards the third position. An abutment on the at least one longitudinally extending arm of the housing is receivable within the at least one opening along the longitudinal direction of the needle cover when the needle cover is biased into the third position.
Claims
1. An auto-injection device defining a longitudinal direction, the auto-injection device comprising: a housing comprising at least one longitudinally extending arm, the at least one longitudinally extending arm being flexible between a first position and a second position; a cartridge movable along the longitudinal direction relative to the housing, the cartridge comprising a fluid medicament contained between a stopper and a proximal end of the cartridge; a needle located at a proximal end of the auto-injection device; and a needle cover movable along the longitudinal direction relative to the housing between the proximal end of the auto-injection device and a distal end of the auto-injection device, the needle cover comprising at least one opening along the longitudinal direction, wherein the needle cover is movable along the longitudinal direction relative to the housing from a first covering position to a second uncovering position and from the second uncovering position to a third covering position, the needle cover being biased towards the third covering position, wherein the needle is unexposed along the longitudinal direction when the needle cover is in the first covering position, the needle is exposable along the longitudinal direction when the needle cover is in the second uncovering position, and the needle is unexposed when the needle cover is in the third covering position, wherein an abutment on the at least one longitudinally extending arm of the housing is receivable within the at least one opening along the longitudinal direction of the needle cover when the needle cover is biased into the third covering position, wherein the at least one longitudinally extending arm of the housing extends inwardly from the housing when the at least one longitudinally extending arm is in the second position, the at least one longitudinally extending arm being in the second position when the needle cover is in the third covering position, and wherein a proximal end of the housing includes an opening, the needle cover extending through the opening of the housing.
2. The auto-injection device of claim 1, further comprising an opening located along the proximal end of the needle cover, wherein the proximal end of the needle is movable through the opening when the needle cover is moved to the second uncovering position.
3. The auto-injection device of claim 2, further comprising a needle sheath disposed between the proximal end of the needle cover and the proximal end of the cartridge, the needle being at least partially disposed within the needle sheath, wherein the needle sheath is pierced by the needle when the needle cover is moved from the first covering position to the second uncovering position.
4. The auto-injection device of claim 1, wherein the at least one longitudinally extending arm of the housing is flexible between the first position and the second position, such that in the first position, the at least one longitudinally extending arm extends inwardly from the housing at a first angle and in the second position, the at least one longitudinally extending arm extends inwardly from the housing at a second angle.
5. The auto-injection device of claim 4, wherein the first angle is from about 0 degrees to about 5 degrees, and wherein the second angle is from about 5 degrees to about 15 degrees.
6. The auto-injection device of claim 1, wherein the needle is fixed to the cartridge.
7. The auto-injection device of claim 1, further comprising at least one outwardly extending abutment on an exterior urface of the cartridge and at least one projection extending along an interior surface of the needle cover, wherein the at least one outwardly extending abutment is configured to abut the at least one projection extending along an interior surface of the needle cover.
8. The auto-injection device of claim 1, further comprising a removable safety, wherein the removable safety prevents movement of the needle cover from the first covering position to the second uncovering position, prevents movement of the cartridge from a first cartridge position to a second cartridge position, or both when in place on the auto-injection device.
9. The auto-injection device of claim 8, further comprising: a plunger, a proximal end of the plunger being attached to the stopper; an end stop; and a retainer, wherein the safety is configured to be removably inserted into a distal end of the plunger, such that when the safety is removed from the plunger, the retainer is movable towards the distal end of the auto-injection device such that the end stop is engageable around the distal end of the plunger and the plunger is then removable from the retainer.
10. The auto-injection device of claim 9, wherein the retainer is movable towards the distal end of the auto-injection device by the distal end of the needle cover, the distal end of the needle cover abutting against the retainer when the needle cover moves from the first covering position to the second uncovering position.
11. The auto-injection device of claim 9, further comprising: a first biasing element, wherein a proximal end of the first biasing element exerts a force on a circumferential flange of the plunger and a distal end of the first biasing element exerts a force on the retainer; and a second biasing element, wherein a proximal end of the second biasing element exerts a force on a circumferential flange on an exterior surface of the needle cover and a distal end of the second biasing element exerts a force on a flange on an interior surface of the housing.
12. A method for delivering a dose of fluid medicament via an auto-injection device, wherein the auto-injection device defines a longitudinal direction and comprises a housing comprising an opening at a proximal end of the housing and at least one longitudinally extending arm, the at least one longitudinally extending arm being flexible between a first position and a second position; a cartridge movable along the longitudinal direction relative to the housing, the cartridge containing a fluid medicament contained between a stopper and a proximal end of the cartridge, wherein the stopper includes a recess located at a distal end of the stopper; a needle located at a proximal end of the auto-injection device; a needle cover movable along the longitudinal direction relative to the housing between the proximal end of the auto-injection device and a distal end of the auto-injection device, the needle cover extending through the opening of the housing and comprising at least one opening along the longitudinal direction; and a plunger, a proximal end of the plunger being engaged in the recess at the distal end of the stopper; the method comprising: pressing the proximal end of the auto-injection device against a surface of skin, wherein the longitudinal direction of the auto-injection device is generally perpendicular to the surface of skin, and wherein the at least one longitudinally extending arm is in the first position, such that the needle cover moves from a first covering position to a second uncovering position and the cartridge moves from a first cartridge position to a second cartridge position; piercing the surface of skin and underlying tissue with a proximal end of the needle by continuing to press the proximal end of the auto-injection device against the surface of the skin such that the cartridge moves from the second cartridge position to a third cartridge position; delivering the fluid medicament by continuing to press the proximal end of the auto-injection device against the surface of skin until a circumferential flange of the plunger abuts a circumferential flange on an interior surface of the cartridge; and removing the proximal end of the auto-injection device from the surface of skin after the fluid medicament is delivered such that the needle cover is biased from the second uncovering position into a third covering position and the at least one longitudinally extending arm of the housing is received within the at least one opening along the longitudinal direction of the needle cover, such that the needle is unexposed and at least one longitudinally extending arm of the housing is moved to the second position, the at least one longitudinally extending arm of the housing extending inwardly from the housing when the at least one longitudinally extending arm is in the second position.
13. The method of claim 12, wherein the at least one longitudinally extending arm extends inwardly from the housing at an angle of from about 0 degrees to about 5 degrees in the first position, and wherein the at least one longitudinally extending arm extends inwardly from the housing at an angle of from about 5 degrees to about 15 degrees in the second position.
14. The method of claim 12, wherein the proximal end of the cartridge includes an opening, wherein a distal end of the needle is contained within the opening.
15. The method of claim 12, wherein the auto-injection device further comprises a needle sheath disposed between the proximal end of the needle cover and the proximal end of the cartridge, the needle being at least partially disposed within the needle sheath such that when the needle cover moves from the first covering position to the second uncovering position, the needle sheath is pierced by the needle.
16. The method of claim 12, wherein the auto-injection device further comprises an end stop; a retainer; and a safety, the safety being insertable into a distal end of the plunger such that the safety prevents the needle cover from sliding against the housing, prevents the cartridge from sliding against the needle cover, or both when in place on the auto-injection device; the method further comprising removing the safety prior to positioning the proximal end of the auto-injection device against the surface of skin such that when the needle cover moves from the first covering position to the second uncovering position, the distal end of the needle cover moves the retainer towards the distal end of the auto-injection device, the end stop engages around the distal end of the plunger, and the plunger is removable from the retainer.
17. The method of claim 16, wherein a proximal end of a first biasing element exerts a force on the circumferential flange of the plunger and a distal end of the first biasing element exerts a force on the retainer to move the cartridge towards the third cartridge position and to facilitate delivery of the fluid medicament when the cartridge is in the third cartridge position, and wherein a proximal end of a second biasing element exerts a force on a circumferential flange on an exterior surface of the needle cover and a distal end of the second biasing element exerts a force on a circumferential flange on an interior surface of the housing to bias the needle cover towards a third covering position.
18. (canceled)
19. The method of claim 12, wherein the fluid medicament contains epinephrine or naloxone.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] A full and enabling disclosure of the present disclosure, including the best mode thereof to one skilled in the art, is set forth more particularly in the remainder of the specification, including reference to the accompanying figures, in which:
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[0034] Repeat use of reference characters in the present specification and drawings is intended to represent the same or analogous features or elements of the present disclosure.
DETAILED DESCRIPTION OF REPRESENTATIVE EMBODIMENTS
[0035] Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present disclosure covers such modifications and variations as come within the scope of the appended claims and their equivalents.
[0036] Generally speaking, the present disclosure is directed to an auto-injection device for the delivery of a fluid medicament and a method for delivering fluid medicament (e.g., intramuscularly, subcutaneously, etc.) using an auto-injection device. The auto-injection device can deliver the fluid medicament by piercing a surface of skin and delivering the fluid medicament.
[0037] The fluid medicament contained within the auto-injection device can be any fluid medicament that can be delivered intramuscularly or subcutaneously. In one particular embodiment, such as when the auto-injection device is used to treat anaphylaxis, the fluid medicament can be epinephrine. Epinephrine, also known as 4-[(1R)-1-Hydroxy-2-(methylamino)ethyI]-1,2-benzenediol, is the active principle of the adrenal medulla and an endogenous catecholamine which acts directly on both alpha and beta adrenergic receptors. When used in pharmaceutical compositions, epinephrine can act as a non-selective alpha and beta adrenergic agonist and can work rapidly to improve breathing, stimulate the heart, raise dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat. Uses for epinephrine include emergency treatment of allergic reactions (Type 1), including anaphylaxis, induction and maintenance of mydriasis during intraocular surgery, treatment of bronchospasm, sensitivity reactions, cardiac arrhythmias, GI and renal hemorrhage, superficial bleeding, premature labor, hypoglycemia, and cardiogenic, hemorrhagic, and traumatic shock. Epinephrine can also be used to increase blood flow in ACLS during CPR, as an adjunct to local anesthesia, and for radiographic uses. Although the use of the auto-injection device of the present disclosure to deliver epinephrine is described herein, it is to be understood that the auto-injection device and its method of use can be utilized in conjunction with any fluid medicament that can be delivered intramuscularly or subcutaneously. For example, naloxone is another fluid medicament that can be delivered using an auto-injection device as described herein, for emergency treatment of an opioid overdose. When used in pharmaceutical compositions, naloxone binds to opioid receptors and can reverse and block the effects of other opioids on the central nervous system and respiratory system to improve breathing, stimulate the heart, raise blood pressure, and alleviate itchiness.
[0038] Referring to
[0039] As shown in
[0040] In addition, the auto-injection device 100 can include a removable safety 160 that, when installed, can lock the needle cover 104 such that it is not movable with respect to the housing 102, and can lock the cartridge 106 such that it is not movable with respect to housing 102 such that the needle 114 does not unintentionally pass through the opening 146. The auto-injection device 100 can also include one or more longitudinally extending arms 162 of housing 102, hereinafter referred to as arms 162, located along the longitudinal direction L, and openings 164 of needle cover 104, located along the longitudinal direction L. The arms 162 are biased such that they extend inwardly and are flexible between a first position P1 and a second position P2, such that in the first position P1 the arms 162 extend inwardly from the exterior surface 132 of the housing 102 at a first angle A1, and in the second position P2 the arms 162 extend inwardly from the exterior surface 132 of the housing 102 at a second angle A2. The first angle A1 may be from about 0 degrees to about 5 degrees and the second angle A2 may be from about 5 degrees to about 15 degrees. It can be appreciated throughout the specification that about is intended to mean within 10% of the range end values. As such, it may be appreciated that the arms 162 only slightly extend outwardly from the exterior surface 132 of the housing 102, or not at all, such that a user will not feel the arms 162 underneath a decorative wrapping during use of the auto-injection device 100.
[0041] Further, the auto-injection device 100 can also include an end stop 176 that is positioned at a distal end 178 of the auto-injection device 100, a retainer 180, and a plunger 182. The plunger 182 includes a proximal end 184 and a distal end 186. The proximal end 184 of the plunger 182 is received within the stopper 110 and the distal end 186 of the plunger 182 is configured to receive the removable safety 160. When the safety 160 is removed from the plunger 182, the retainer 180 is movable towards the distal end 178 of the of the auto-injection device 100 by the distal end 138 of the needle cover 104 when the needle cover 104 moves from the first position L1 to the second position L2, such that the end stop 176 engages around the distal end 186 of the plunger 182. As such, it may be appreciated that the needle cover 104 is movable to be in direct contact with the retainer 180.
[0042] Additionally, a first biasing element 188 (e.g., compression spring, a compressed gas, etc.) can be included within the auto-injection device 100 and positioned between the retainer 180 and a circumferential flange 190 on the plunger 182, where the first biasing element 188 can be in a compressed state when the needle cover 104 is in the initial or first position L1 and remains compressed when the needle cover is moved from the first position L1 towards the second position L2. Further, a second biasing element 194 (e.g., a compression spring, a compressed gas, etc.) can be included within the auto-injection device 100 and positioned between a circumferential flange 196 on the exterior surface 140 of the needle cover 104 and a circumferential flange 198 on the interior surface 134 of the housing 102, where the second biasing element 194 can be in a compressed state when the needle cover 104 is in the first position L1 and is further compressed when the needle cover 104 is moved from the first position L1 towards the second position L2.
[0043] In its unused state, the auto-injection device 100 is assembled such that the first position L1 of the needle cover 104 is between the second position L2 and the third position L3, with the needle cover 104 being biased towards the third position L3 by the second biasing element 194. From
[0044] Additionally, the housing 102, needle cover 104, and cartridge 106 can be formed from any suitable plastic (e.g., polycarbonate, a polyolefin such as a cyclic olefin polymer or a cyclic olefin copolymer, a polyethylene or polypropylene, a polystyrene, etc.). Further, because the cartridge 106 can be formed from a plastic as opposed to glass, the present disclosure contemplates an auto-injection device that does not require the cartridge 106 to be contained within a protective casing (e.g., the auto-injection device 100 is free of a casing or container) such that the cartridge 106 can come into direct contact with the needle cover 104 and/or the housing 102. In other words, the housing 102 and/or the needle cover 104 can instead serve as a protective casing to hold the cartridge 106 as opposed to a separate, distinct casing surrounding the cartridge 106. It can be appreciated that such a cartridge may reduce the manufacturing cost of such an auto injection device to improve patient non-compliance due to costs.
[0045] In
[0046] Next,
[0047] It can be additionally appreciated, as shown in
[0048] Turning now to
[0049] It can again be appreciated from
[0050] As described above, the present disclosure contemplates an auto-injection device having a housing with arms that engage a needle cover after use to prevent accidental reuse and wherein the needle cover directly contacts a retainer. Such an auto-injection device improves the safety of the auto-injection device after use and significantly reduces the number of parts required for such a device which reduces the corresponding costs of manufacture and ultimately the cost for the user. In other words, by locking the needle cover in place with arms of the housing after use and by having a needle cover in direct contact with a retainer, the auto-injection device of the present disclosure enables delivery of the fluid medicament in a safe and cost-effective manner.
[0051] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.