TWI551315B - Injection device - Google Patents

Description

Injection device

The present invention relates to an injection device for supplying a dose of liquid medicine in accordance with the first item of the scope of the patent application.

Supplying an injection is a process that presents some risks and challenges to the user and both the mental and physical health care professions.

Injection devices (i.e., devices capable of delivering medicament from a drug container) generally fall into two categories: manual devices and autoinjectors.

In a manual device, the user must provide mechanical energy to drive the fluid via the needle. This is typically done during the injection by some form of button/plunger that must be continuously pressed by the user. From this approach, there are still many disadvantages for the user. If the user stops pressing the button/plunger, the injection will also stop. This means that if the device is not properly used (ie, the plunger is not fully pressed to its end position), the user will deliver an insufficient amount of medicament. For the user, the injection force may be too high, especially if the patient is elderly or has a flexible problem.

The extension of the button/plunger may be too large. Therefore, it may be inconvenient for the user to reach a fully extended button. The combination of injection force and button extension causes the uncomfortable hand to tremble/shake as the inserted needle moves.

The autoinjector device is intended to make self-supply of injection therapy easier for the patient. Current therapies delivered using self-administered injections include diabetes (both insulin and newer GLP-1 grade drugs), Medicines for migraine, hormone therapy, anticoagulants, etc.

Autoinjectors are devices that completely or locally replace activities involving the delivery of non-oral medications from standard syringes. These activities may include removal of a protective syringe cover, insertion of a needle into the skin of a patient, injection of a medicament, removal of a needle, shielding of the needle, and avoidance of reuse of the device. This overcomes the shortcomings of many manual devices. The possibility of injecting force/button extension, hand shaking and delivering an incomplete dose is reduced. Triggering can be performed by a number of means, such as a trigger button or the action of a needle that reaches its depth of injection. In some devices, the energy delivered to the fluid is provided by a spring.

US 2002/0095120 A1 discloses an automatic injection device that automatically injects a predetermined amount of fluid medication when a tension spring is released. The tension spring moves an ampoule and needle portion from a storage position to a deployed position as it is released. The contents of the ampoules are then discharged by forcing a piston to extend forward within the ampoules. After the fluid drug has been injected, the torque stored in the tension spring is released and the needle portion is automatically returned to its original storage position.

It is an object of the present invention to provide an improved injection device.

This object is achieved by an autoinjector according to item 1 of the patent application.

Preferred embodiments of the invention are provided in the dependent items.

In the context of this specification, the term "proximal" is used to mean The direction of the patient is pointed during an injection, and the term "distal" is used to mean pointing in the opposite direction away from the patient. The term "inwardly" means the radial direction of the longitudinal axis of an autoinjector, and the term "outwardly" means that the radial direction is directed in the opposite direction away from the longitudinal axis.

An injection device for supplying a dose of liquid medicine to a patient, comprising

- a syringe containing the drug in this dose

a hollow injection needle adapted to pierce the skin of the patient, an occluder that is translatably disposed within the syringe, a plunger connected to the occluder and translatable toward at least one proximal end, The occluder is removed in a proximal direction, and a releasable acoustic element is capable of producing an audible and/or tactile feedback to a user upon release. Proximal displacement of the occluder causes this dose of drug to be expelled via the hollow needle. The acoustic element is released when the plunger connected to the occluder reaches a position associated with the syringe, wherein the occluder is located adjacent the proximal end of a syringe. The released acoustic element strikes at least one component of the injection device to produce an audible and/or tactile feedback indicative of the end of the injection.

Injections must be performed frequently by health care professionals or patients with chronic conditions like diabetes. It is often difficult to properly estimate the time required to completely expel the dose of the drug contained in the syringe of the injection device because, among other things, it depends on the particular layout of the injection device and the viscosity of the drug. Moreover, today's injection devices often block the direct line of sight of a syringe contained therein to alleviate the patient's possible fear of the needle. fear. However, this also makes it possible to visually confirm the position of the occluder in the syringe cylinder. The injection device according to the present invention produces an audible and/or tactile feedback to the user just before the drug is completely expelled and the occluder is lowered to the bottom of the syringe. For the user, this makes it easier to get used to an unfamiliar injection device, or even when injecting drugs of different viscosities, this ensures that the injection is properly performed and that the dose of the drug is completely disposed on the patient's skin. under. In particular, audible and/or tactile feedback helps to avoid underdosing or wasting of the drug.

The acoustic element interacts with a frame of the injection device, a container, a trigger button, a carrier, a plunger and/or at least a portion of a sleeve actuator for producing an audible and/or tactile feedback. The audible and/or tactile feedback is generated by combining functional elements of the injection device, which, among other things, primarily provides a housing, provides a release member to an injection mechanism, provides an insertion mechanism to the injection needle or completes the injection. A retraction mechanism is then provided to provide needle safety.

According to a possible embodiment of the invention, the injection device is arranged as an autoinjector operated by some key mechanical actions:

The container is advanced relative to the frame that compresses a control spring, which gives the user the impression of pressing the skin interlocking sleeve. During the advancement of the container, all other components remain in the same position, thereby causing the trigger button to appear from the end of the container.

- The user pushes the trigger button that can now be operated. Pressing the button directly moves the carrier (and thus the driver element) in a proximal direction by a set distance until the control spring receives the needle via a first collar and inserts the needle into Until the injection site.

- When the carrier continues to translate in the proximal direction, the trigger button stops at the end of the container. The relative movement of the carrier relative to the trigger button is just prior to reaching the full insertion depth to release the drive spring, for example by pulling the peg on a trigger button away from the carrier to allow the plunger to move. The drive spring drives the plunger down and the syringe cylinder discharges the drug.

- Shortly before the occluder descends to the bottom of the syringe, an audible mechanism is released when the plunger is near the end of the stroke to indicate to the end of the injection.

- the needle remains fully inserted until the user returns the container to a set distance, at which point the second collar is separated from the container and coupled to the carrier, and the first collar is separated from the carrier and coupled to the frame Thereby allowing the control spring to retract the carrier (and thus the needle).

According to another possible embodiment, at least one of the components of the injection device relating to the production of tactile and/or audible feedback has a physical shape or design suitable for amplifying and/or transmitting a sound. In particular, the element may be arranged to have a tubular carrier or to act as a trigger button similar to a drum to amplify the sound. The acoustic element can strike the element directly to produce sound, or the element can be operatively coupled to a second element having a shape suitable for amplifying the sound.

During an injection, the element adapted to provide a tactile feedback is preferably a portion of one of the external components of the injection device that is particularly gripped and actuated by the user, such as, for example, a trigger sleeve, a container or a trigger button. The external component is in contact with a body part of one of the users performing the injection to facilitate contact Awareness of feedback.

In accordance with yet another possible embodiment of the present invention, the plunger is proximally actuated by the action of a slack drive spring to translate the occluder proximally and to dispense the dose of medicament to the patient Under the skin. The injection device may be designed as an auto-injector that automatically expels the dose of medication when the trigger sleeve or trigger button is activated. Alternatively, the injection device may be designed as a manual injection device in which the plunger must be manually pushed to supply the dose of medication to the patient.

According to yet another possible embodiment of the present invention, the acoustic element is biased by an acoustic spring and, upon release, is accelerated by an acoustic spring and driven toward at least one component of the injection device to produce Audible and/or tactile feedback to the user. The acoustic spring ensures that the feedback produced is strong enough to be easily perceived by the user.

In accordance with yet another embodiment of the present invention, the syringe can be translatably disposed in relation to the container of the injection device. An acoustic release mechanism couples the acoustic element to a translational movement of the syringe until the acoustic element is released. This in particular allows to provide an injection device that is always safe for the needle, i.e., the needle is covered before and after the injection with an audible and/or tactile feedback indicating the end of the injection. During the needle insertion phase of the injection, the syringe is operated proximally to expose and insert the needle portion. During this phase, the acoustic element is coupled to the movement of the syringe and operates in a proximal direction with the syringe. Upon completion of the injection, the acoustic element is released to produce an audible and/or tactile feedback.

In particular, the syringe may be mounted to a carrier that is configurable in translation with respect to the container of the injection device. An acoustic release mechanism is disposed between the carrier and the acoustic element to couple the acoustic element to the translational movement of the syringe.

According to yet another possible embodiment, the acoustic spring biasing the acoustic element is grounded to the container and compressed and filled by proximal movement of the syringe associated with the container. This allows the acoustic spring to be configured in an unstressed state and stored within the injection device. The acoustic spring is loaded when the injection device is used. This helps to avoid material fatigue and ensures that the injection device does work reliably even after long periods of storage.

In particular, the audible release mechanism can include a second spring arm that is deflectable in a radially outward direction to release the acoustic element. The plunger includes a distal plunger sleeve that abuts the second spring arm in a radially outward direction to avoid release of the acoustic element. The distal plunger sleeve moves with the plunger, which translates the occluder to expel the dose of medicament via the hollow needle. The distal plunger sleeve avoids deflection of the second spring arm until the occluder drops almost to the bottom within the syringe and is located near the proximal end of the syringe.

According to the same embodiment, the acoustic element comprises an extension having an outward eleventh slope, and the outward eleventh slope is engaged by the inwardly protruding portion of the slope of the second elastic arm for coupling the acoustic element Connect to the syringe carrier. The outward deflection of the second spring arm causes the outward eleventh slope to separate from the inwardly protruding portion, thereby releasing the acoustic element to produce an audible and/or tactile feedback to the user.

The injection device or autoinjector is preferably for subcutaneous or intramuscular injection, especially for delivering an analgesic, an anticoagulant, insulin, An insulin derivative, heparin, Lovenox, a vaccine, a growth hormone, a peptide hormone, a protein, an antibody, and a complex carbohydrate.

As used herein, the term "agent" means a pharmaceutical formulation comprising at least one pharmaceutically active compound, wherein in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and/or is a peptide a protein, a polysaccharide, a vaccine, a DNA, an RNA, an antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above pharmaceutically active compounds, wherein in a further In embodiments, the pharmaceutically active compound is associated with diabetes-related diabetes or complications (eg, diabetic retinopathy), thromboembolic disorders (eg, deep vein or pulmonary thromboembolism), acute coronary syndrome (ACS), angina pectoris, myocardial infarction, The treatment and/or prevention of cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis is useful, wherein in a still further embodiment, the pharmaceutically active compound comprises at least one peptide For the treatment and/or prevention of diabetes-related diabetes or complications (such as diabetic retinopathy), one of which is more In one embodiment, the pharmaceutically active compound comprises at least one human insulin or a human insulin analog or derivative, glucagon-like peptide (GLP-1) or one of its analogs or derivatives, or exedin-3 or Exedin-4 or one of exedin-3 or exedin-4 analogues or derivative.

Insulin analogs such as Gly (A21), Arg (B31), Arg (B32) human insulin; Lys (B3), Glu (B29) human insulin; Lys (B28), Pro (B29) human insulin; Asp (B28) Human insulin; human insulin, wherein the proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala, and wherein Lys may be replaced by Pro in position B29; Ala (B26) human insulin; Des ( B28-B30) human insulin; Des (B27) human insulin and Des (B30) human insulin.

Insulin derivatives such as B29-N-myristoyl-des (B30) human insulin; B29-N-palmitoyl-des (B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N -myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)- Des(B30)human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( Omega-carboxyhepta-decanoyl) human insulin.

Exendin-4譬 means Exendin-4(1-39), a peptide sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met- Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser- NH2.

The Exendin-4 derivative is, for example, selected from the list of compounds: H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2, H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,des Pro36[Asp28]Exendin-4(1-39),des Pro36[IsoAsp28]Exendin-4(1-39),des Pro36[Met(O)14,Asp28 Exendin-4 (1-39), des Pro36[Met(O)14, IsoAsp28]Exendin-4(1-39), des Pro36[Trp(O2)25, Asp28]Exendin-4(1-39), Des Pro36[Trp(O2)25, IsoAsp28]Exendin-4(1-39), des Pro36[Met(O)14 Trp(O2)25, Asp28]Exendin-4(1-39),des Pro36[Met( O)14 Trp(O2)25, IsoAsp28]Exendin-4(1-39); or des Pro36[Asp28]Exendin-4(1-39), des Pro36[IsoAsp28]Exendin-4(1-39),des Pro36[Met(O)14, Asp28] Exendin-4(1-39), des Pro36[Met(O)14, IsoAsp28]Exendin-4(1-39), des Pro36[Trp(O2)25, Asp28] Exendin-4 (1-39), des Pro36[Trp(O2)25, IsoAsp28]Exendin-4(1-39), des Pro36[Met(O)14 Trp(O2)25, Asp28]Exendin-4(1 -39), des Pro36[Met(O)14 Trp(O2)25, IsoAsp28]Exendin-4(1-39), wherein the group-Lys6-NH2 may be bound to Exendin-4 derived C-terminus; or a sequence of Exendin-4 derivatives

H-(Lys)6-des Pro36[Asp28]Exendin-4(1-39)-Lys6-NH2,des Asp28 Pro36,Pro37,Pro38Exendin-4(1-39)-NH2,H-(Lys)6-des Pro36,Pro38[Asp28]Exendin-4(1-39)-NH2,H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-NH2,des Pro36,Pro37,Pro38 [Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2 , H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36[Trp(O2)25 , Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38[Trp(O2)25]Exendin-4(1-39)-NH2,H-(Lys)6- Des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,des Pro36,Pro37,Pro38[Trp(O2)25,Asp28] Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys) 6-NH2,H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6 -des Pro36[Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, desMet(O)14 Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,H-(Lys 6-desPro36, Pro37, Pro38[Met(O)14, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Met(O)14, Asp28]Exendin-4(1-39)-NH2,des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6 -des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-Asn-(Glu)5 des Pro36,Pro37,Pro38[Met(O 14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Lys6-des Pro36[Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39) -Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25]Exendin-4(1-39)-NH2,H-(Lys)6-des Pro36,Pro37, Pro38[Met(O)14,Asp28] Exendin-4(1-39)-NH2,H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)- NH2, des Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36,Pro37 ,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(S1-39)-(Lys)6-NH2,H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met (O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any of the above Exedin-4 derivatives .

Hormones such as pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, as listed in Rote Liste, 2008 edition, Chapter 50, such as gonadotropins (recombinant follicle stimulating hormone (Follitropin), promote Lutropin, Choriongonadotropin, Menotropin, Somatropin, Desmopressin, Terlipressin, Gonadotropin Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

A polysaccharide such as glucosaminoglycane, hyaluronic acid, heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulfuric acid (such as the above polysaccharide) One of the types of polysulfate), and / Or a pharmaceutically acceptable salt thereof. One example of a pharmaceutically acceptable salt of a polysulfate low molecular weight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. The acid addition salt is, for example, a HCl or HBr salt. The basic salt is, for example, a salt having a cation selected from a base or a basic such as Na+, or K+, or Ca2+, or a monoammonium N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other means: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or a Any alternative C6-C10-heteroaryl group. A further example of a pharmaceutically acceptable salt is described in "Remington's Pharmaceutical Sciences" by Mark Publishing Company, Easton, Pa., 1985, 17th edition, Alfonso R. Gennaro (Ed .), and in the Encyclopedia of Pharmaceutical Technology.

A pharmaceutically acceptable solvate is, for example, a hydrate.

The drive spring and the control spring may be compression springs. However, they are equally likely to be any type of stored energy mechanism, such as torsion springs, gas springs, and the like.

Further scope of the applicability of the present invention will become more apparent from the detailed description provided herein. However, it will be understood by those skilled in the art that the present invention will be able to ) is only provided as an example.

The invention will be more fully understood from the following detailed description and appended claims appended claims

Corresponding parts are denoted by the same reference symbols throughout the figures.

A ramped engagement in the specialized terminology of the specification is a connection between two elements, at least one of which has a slope for utilizing one of the elements to rest against the elements The other element is engaged in such a way that it is bent axially to each other (if this element is not bent to the side).

Figures 1A and 1B show two longitudinal sections of the autoinjector 1 in different cross-sections, the different sections being rotated almost 90° to each other, wherein the autoinjector 1 is in an initial state prior to the start of an injection. The autoinjector 1 includes a frame 2. In the following, the frame 2 is generally considered to be fixed in position, so the action of the other components is illustrated relative to the frame 2. A syringe 3 (e.g., a Hypak syringe) having a hollow needle portion 4 is disposed in a proximal portion of the autoinjector 1. When the autoinjector 1 or the syringe 3 is combined, a protective needle shield 5 is attached to the needle portion 4. An occluder 6 is configured to distally seal the syringe 3 and to remove a liquid medication M via the hollow needle 4. The syringe 3 is held in a tubular carrier 7 and supported therein at its proximal end. The carrier 7 is slidably disposed in the frame 2.

A drive spring 8 present in the shape of a compression spring is disposed in a distal end portion of the carrier 7. a plunger 9 for driving the drive spring 8 The force is delivered to the occluder 6.

The drive spring 8 is mounted between a distal carrier end face 10 of the carrier 7 and a thrust face 11 disposed distally on the plunger 9.

The carrier 7 is an important component for housing the syringe 3, the drive spring 8 and the plunger 9 (which is an element that must discharge the drug M from the syringe 3). These elements can therefore be referred to as a driver sub-element.

The frame 2 and the carrier 7 are disposed within a tubular case 12. A trigger button 13 is disposed at the end of a container 12. In a plunger release mechanism 27, a peg 14 projects from the end face of a trigger button 13 in a proximal direction P between two spring arms 15 originating from the distal end face 10 of the distal end, Thereby they are prevented from bending toward each other in the initial state A shown in Fig. 15A. In Fig. 15A, only one of the elastic arms 15 is shown to illustrate this principle. On the surface, the elastic arms 15 are hooked into respective first recesses 16 in a distal plunger sleeve 17, which is distally mounted to the thrust surface 11 and disposed in the drive spring 8 internal. The engagement of the spring arms 15 in the first recess 16 avoids axial translation of the plunger 9 relative to the carrier 7. The elastic arm 15 is under the load of the drive spring 8 (which is blocked by the pile 14 in the initial state A), and they are bent inwardly according to the relative movement between the plunger 9 and the carrier 7. The way has risen sharply.

The carrier 7 is latched to the frame 2 by a pawl mechanism 18 shown in more detail in Figures 11A through 11D to avoid relative translation.

The trigger button 13 is first engaged to the container 12 by a button release mechanism 26 and cannot be depressed. The button release mechanism 26 is shown in detail in Figs. 16A to 16C. Referring now to Figure 16A, the button release mechanism 26 includes Including a resilient proximal beam 13.1 on the trigger button 13, the proximal beam 13.1 has an outward first ramp 13.2 and an inward second ramp 13.3. In the initial state A shown in Fig. 16A, the outward first ramp 13.2 is engaged with a ramp first container pawl 12.1 to avoid the trigger button 13 moving away from the end D. The trigger button 13 abuts both the container 12 and the carrier 7 proximally, thereby preventing the trigger button 13 from being depressed in the proximal direction P.

Referring again to Figures 1A and 1B, a control spring 19, which is present in the shape of another compression spring, is disposed about the carrier 7 and acts between a proximal first collar 20 and a distal second collar 21. The control spring 19 is used to move the carrier 7 (and thus the driver element) in the proximal direction P for insertion of the needle or to move in the distal direction D for retraction of the needle.

In the state of being conveyed as shown in Figs. 1A and 1B, a cover 22 is attached to the proximal end of the container 12, and the protective needle shield 5 is still positioned on the needle portion 4 and the needle hub. position. An inner sleeve 22.1 of a cover 22 is disposed inside the frame 2 and above the protective needle shield 5. In the inner sleeve 22.1, a barb 23 is mounted. The barbs 23 are coupled to the protective needle shield 5 for joint axial translation.

The sequence of operation of the autoinjector 1 is as follows: A user pulls the cover 22 from the proximal end of the container 12. The barbs 23 engage the protective needle shield 5 to the cover 22. Therefore, the protective needle shield 5 is also removed when the cover 22 is removed. 2A and 2B show the autoinjector 1 with the cover 22 and the needle shield 5 removed. The carrier 7 and the syringe 3 are avoided by the pawl mechanism 18 in the state A as in Fig. 11A. Move in the proximal direction P. Referring now to Figure 11A, the pawl mechanism 18 includes a resilient beam 2.1 on the frame 2 and having a first beam head 2.2 extending inwardly. The first beam head 2.2 has a proximal third ramp 2.3. The pawl mechanism 18 further includes a ramp member 7.1 on the carrier 7 and having a rhomboid shape with a proximal fourth ramp 7.2 and a distal fifth ramp 7.3. In the state A, the rounded distal end side of a first beam head 2.2 abuts the ramp member 7.1 in the distal direction D, thereby resisting the movement of the carrier 7 relative to the frame 2 in the proximal direction P. The ribs on a container 12 are provided to avoid outward deflection of the resilient beam 2.1, thereby also avoiding movement of the carrier 7 relative to the frame 2.

Referring again to Figures 2A and 2B, the user grasps the container 12 and places the frame 2 extending from the container 12 at a proximal end against an injection site (e.g., the skin of a patient). When the autoinjector 1 is pressed against the injection site, the container 12 is translated relative to the frame 2 in a proximal direction P into a propelled position, as shown in Figures 3A and 3B. The second collar 21 is latched to the container 12 and is moved together with respect to the frame 2 and with respect to almost all other elements of the autoinjector 1 to slightly compress the control spring 19 against the first collar 20 By the frame 2, the first collar 20 is prevented from moving in the proximal direction P by a needle insertion control mechanism 24 in a state A shown in detail in Fig. 12A. Referring now to Figure 12A, an elastic member, in the shape of an arrow 20.1, is disposed proximally on the first collar 20. The first collar 20 having the arrow 20.1 is advanced in the proximal direction P under the load of the compressed control spring 19. An outward sixth slope 20.2 on an arrow 20.1 and a second distal seventh slope on a frame 2 2.4 The interaction is such that the arrow 20.1 is caused to rise in the inward direction I, while the arrow 20.1 is prevented from adjoining the carrier 7 to the inside. Therefore, the first collar 20 cannot translate in the proximal direction P.

Referring again to Figures 3A and 3B, the second collar 21 is latched to the container as a result of a syringe retraction control mechanism 25 shown in detail in Figure A of Figure 13A. Referring now to Figure 13A, the syringe retraction control mechanism 25 includes a resilient proximal end beam 21.1 on the second collar 21, the proximal end beam 21.1 having a second beam head portion 21.2 having an inwardly projecting portion 21.3 and a distal end. The end is outward to the eighth slope 21.4. The distal end outwardly eighth ramp 21.4 is engaged in a manner that causes the second beam head 21.1 to rise in the inward direction I and rises under the load of the control spring 19 to cause the second collar 21 to rise in the distal direction D. A sloped second container jaw 12.2 can be avoided by abutting the inwardly projecting portion 21.3 of the carrier 7 internally.

Referring again to Figures 3A and 3B, if the user is about to move the container 12 away from the injection site, the control spring 19 is expanded to return the autoinjector 1 to the initial state after removal of the cover 22 as shown in Figures 2A and 2B.

In the state of Figures 3A and 3B, the pawl mechanism 18 continues to avoid movement of the carrier 7 in the proximal direction P, however with respect to the container 12 in its advanced position, since the ribs on the container 12 have also been moved and not The outward deflection of the elastic beam 2.1 is then prevented, so that the pawl mechanism 18 is not locked. Movement of the container 12 relative to the carrier 7 (which is latched to the frame 2 by the jaw mechanism 18) causes the button release mechanism 26 to switch to the state B shown in Figure 16B. The trigger button 13 cannot be brought together with the container 12 when it abuts against the carrier 7 The proximal direction P is translated. The slope on the first container jaw 12.1 interacts with the outward first slope 13.2 on the proximal beam 13.1 on the trigger button 13 whereby the proximal beam 13.1 is deflected towards the inner direction I such that the proximal beam 13.1 The inward second ramp 13.3 engages in a carrier pawl 7.4 disposed in the ramp in the carrier 7. When the container 12 is further translated in the proximal direction P, it supports the proximal beam 13.1 outwardly, thereby locking the trigger button 13 to the carrier 7. The trigger button 13 now protrudes from the end D of the frame 2 and is ready to be pressed.

In the state of FIGS. 3A and 3B, the user presses the trigger button 13 toward the proximal direction P. When the trigger button 13 abuts against the carrier 7, the carrier 7 is propelled against the frame 2 in the proximal direction P, and the carrier 7 interacts with the frame 2 using the pawl mechanism 18. The force applied by the user pressing the trigger button 13 is disassembled via the frame 2 onto the injection site, rather than between the trigger button 13 and the container 12. When the user pushes the trigger button 13, the pawl mechanism 18 provides a resistance. Once the user applies a force that exceeds a predetermined value, the pawl mechanism 18 is released, thereby initiating the injection cycle. Referring now to Figure 11B showing the pawl mechanism 18 in a state B, the resilient beam 2.1 on the frame 2 begins to bend under the load from the rhomboid ramp member 7.1 on the carrier 7 to store the elastic energy. Regardless of the proximal fourth slope 7.2 on the ramp member 7.1, the friction between the contact surface of the first beam head 2.2 and the proximal fourth ramp 7.2 prevents the first beam head 2.2 from moving outwardly in the direction O until elastic The straightening force in the deformed beam 2.1 is large enough to overcome it. At this point, the elastic beam 2.1 is oriented outwards. The deflection is thereby moved away from the carrier 7 to allow the carrier 7 to translate in the proximal direction P. When the carrier 7 is moved far enough in the proximal direction P, the rhomboid ramp member 7.1 on the carrier 7 passes under the first beam head 2.2, allowing it to relax and return to the far side in the inward direction I. 11C shows the state of the rhombic slope member 7.1 behind the state C, while forcing the carrier 7 to translate relative to the frame 2 in the distal direction D.

Once the carrier 7 slides far enough toward the proximal direction P relative to the first collar 20, the needle insertion control mechanism 24 is switched to a state B as shown in Figure 12B. In Fig. 12B, the carrier 7 has been translated in the proximal direction P in such a manner that the arrow 20.1 on the first collar 20 is no longer supported internally. This may be achieved by a second recess 7.5 in a carrier 7. The arrow 20.1 is now deflected into the second recess 7.5 in the inward direction I under the load of the control spring 19, thereby reaching a state C as shown in Fig. 12C. The first collar 20 is now separated from the frame 2. Instead, arrow 20.1 couples first collar 20 to carrier 7 by an inward ninth ramp 20.3 (which engages a distal tenth ramp 7.6 on a carrier 7 at the proximal end of second recess 7.5). Thus, the control spring 19 continues to move the carrier 7 from this point towards the proximal direction P. When the user advances the needle 4 for a ratio of its stroke, the control spring 19 is inserted into the needle before the needle 4 projects from the proximal end P. Therefore, the user experience is to press a button instead of manually inserting a needle.

The pawl mechanism 18 exerts a force rather than a displacement by the user. Once the applied force exceeds the force that must be switched, the user will The trigger button 13 is fully pushed to ensure that the first collar 20 will always switch. If the user is unable to pass the pawl, the trigger button 13 returns to its unused state ready for use, as shown in Figures 3A and 3B. This feature prevents the autoinjector 1 from reaching an undefined state.

4A and 4B show that the trigger button 13 of the autoinjector 1 is depressed enough to couple the control spring 19 to the carrier 7 and continue to move the carrier 7 in the forward direction without abutting the container 12.

The carrier 7 coupled to the first collar 20 is translated toward the proximal direction P driven by the control spring 19. When the syringe 3 is configured for axial translation in conjunction with the carrier 7, the syringe 3 and the needle 4 are also translated, thereby causing the needle 4 to extend out of the proximal end P and be inserted into the injection site. The trigger button 13 returns to its original position relative to the container 12 and is latched back from the carrier 7 to the container 12, as in state A of Figure 16A. The carrier 7 is further translated in the proximal direction P to avoid the inward deflection of the proximal beam 13.1, so that the outward first ramp 13.2 cannot be disengaged from the first container jaw 12.1.

Immediately before the needle portion 4 reaches the full insertion depth (as shown in Figures 5A and 5B), the pile 14 on the trigger button 13 is completely pulled out from between the elastic arms 15 on the carrier 7. Therefore, the plunger release mechanism 27 reaches the state B shown in Fig. 15B, in which the elastic arm 15 is no longer supported by the pile 14 to the inside. Due to the sharp rise of the spring arms 15 in the first recess 16, they are deflected in the inward direction I under the load of the drive spring 8 to reach the state B shown in Figure 15C. Therefore, the plunger 9 is released from the carrier 7 and is driven in the proximal direction P by the drive spring 8, ready Inject the drug M. The force pulling the pile 14 from between the spring arms 15 is provided by the control spring 19, and the force that must deflect the spring arm 15 away from the plunger 9 is provided by the drive spring 8.

When the plunger 9 moves and closes the gap to the occluder 6, the movement of the carrier 7 in the proximal direction P is accomplished by pushing the control spring 19 of the first collar 20. When the carrier 7 is moved relative to the chassis 2 during insertion of the needle, the needle insertion mechanism 24 reaches the state D shown in Fig. 12D. The arrow 20.1 has been moved with the carrier 7 and still remains deflected internally by the frame 2, thereby preventing the first collar 20 from coming off the carrier 7. The arrow 20.1 must be able to deflect towards the outer direction O to allow retraction, which will be discussed below. To allow for outward deflection, the arrow 20.1 runs proximally beyond one of the frames 2 shown in Figures 12A through 12F adjacent the aperture 2.5 in a frame 2. However, as long as the container 12 remains pressed against the injection site and is not allowed to return in the distal direction D by more than a predetermined distance under the load of the control spring 19, the arrow 20.1 will be in the lower half of the movement of the needle insertion. During the second half, it is maintained from being deflected outwardly by O through a first rib 12.3 on a container 12 (not shown in Figures 12A-F, see Figures 5A-8A).

The needle 4 is now fully inserted into the injection site as shown in Figures 6A and 6B. The time between the pressed trigger button 13 and the fully inserted needle 4 is very short, however several mechanical operations occur at this time. The insertion depth of the needle is defined by the carrier 7 relative to the frame 2 rather than to the container 12, so if the user retracts or cannot hold the autoinjector 1 tightly against the skin, then when the depth of injection remains fixed, only container 12 will move in the distal direction D.

Once the plunger 9 closes the gap of the occluder 6 under the force of the drive spring 8, the occluder 6 is pushed within the syringe 3 in the proximal direction P, whereby the drug M is removed via the needle 4 into the injection site. .

An acoustic element 28 is released directly before the end of the injection (where the occluder 6 has almost reached the bottom of the syringe 3, as shown in Figures 7A and 7B). Most obviously due to the stacking of the tolerances of the syringe 3, it is necessary to always release the sound before the end of the injection. Otherwise, with some combination of parts, the sound will not be released. The acoustic element 28 includes an extension portion 28.1 disposed within the distal plunger sleeve 17 and an end plate 28.2 disposed between the carrier end face 10 and a distal end face of a trigger button 13. The two second spring arms 30 extend from the distal carrier end face 10 and extend in the proximal direction P. An acoustic spring 29 is configured to bias the acoustic element 28 relative to the carrier 7 by applying a proximal pressure to the rib on a second resilient arm 30 and distally applying pressure to the acoustic element 28 (not shown). The distal direction is biased by D.

Note that for the sake of clarity, the acoustic element 28 is not shown in Figures 16A, 16B and 16C because it does not affect the function of the button release mechanism 26. An acoustic release mechanism 31 for releasing the acoustic element 28 is schematically shown in Figures 14A, 14B and 14C. Referring now to Figure 14A, the acoustic release mechanism 31 includes a second spring arm 30. A sloped inwardly projecting portion 30.1 is disposed on each of the second spring arms 30 in a manner that the second spring arm 30 is deflected toward the outer direction O under the load of the acoustic spring 29 to Each of the outward eleventh ramps 28.3 on the extension 28.1 of the acoustic element 28. In the initial state A of the sound release mechanism 31, The second spring arm 30 is prevented from being deflected outwardly due to the outward support of the distal plunger sleeve 17, thereby avoiding translation of the acoustic element 28 relative to the carrier 7. The audible release mechanism 31 is maintained in state A until immediately before the end of the injection (where the occluder 6 has almost reached the bottom of the syringe 3, as shown in Figures 7A and 7B). At this point, the plunger 9 has been translated relative to the carrier 7 in the proximal direction P to the extent that the second spring arm 30 is no longer supported by the distal plunger sleeve 17. Therefore, the sound release mechanism 31 has reached the state B shown in Fig. 14B. Due to the sharp rise between the inwardly projecting portion 30.1 of the ramp and the outward eleventh ramp 28.3, the second spring arm 30 is deflected outwardly under the load of the acoustic spring 29, thereby disengaging the acoustic element 28 from the carrier 7. And in the state C shown in Fig. 14C, the acoustic element 28 is allowed to move in the distal direction D driven by the acoustic spring 29. Thus, the acoustic element 28 is accelerated in the distal direction D, and the end plate 28.2 strikes the interior of the trigger button 13, thereby producing an audible and tactile feedback to the user who completed the injection.

8A and 8B show the autoinjector 1 in which the occluder 6 has completely reached the bottom of the syringe 3.

As described above, the user can cause the container 12 to move a few centimeters in the distal direction D under the force of the control spring 19 without affecting the position of the needle portion 4 as long as that motion is below a predetermined distance. If the user wishes to end the injection at any time, they must allow the container 12 to move more than that distance in the distal direction D. 9A and 9B show the autoinjector 1 lifted from the injection site, wherein the container 12 is always moved in the distal direction D, which allows the frame 2 to protrude from the proximal end of the container 12. When the container When the 12 is moved, the first collar 20 releases the carrier 7, and then the second collar 21 is released from the container 12 and pulls the carrier 7 in the distal direction D. This sequential arrangement of switches is important because if both of the collars 20, 21 are simultaneously attached to the carrier 7, the retraction will fail. This is overcome by spacing the collars 20, 21 apart by a significant displacement of the container 12.

The switching of the first collar 20 is shown in Figures 12E and 12F. In Figure 12E, the container 12 has been allowed to move in the distal direction D under the load of the control spring 19 during removal of the autoinjector 1 from the injection site. The first rib 12.3 (not shown, see Fig. 9A) is moved outwardly away from the rear of the arrow 20.1. The first collar 20 is still urged by the control spring 19 in the proximal direction P. Due to the inward ninth ramp 20.3 on arrow 20.1 and the distal tenth ramp 7.6 on the carrier 7, the arrow 20.1 is deflected towards the outer direction O into the aperture 2.5 of the frame 2 (shown in Figures 12A to 12F), the needle The portion insertion control mechanism 24 reaches a state E as shown in FIG. 12E, separating the first collar 20 from the carrier 7 and latching it to the frame 2.

When the container 12 moves further in the distal direction D as it moves away from the injection site, the syringe retraction control mechanism 25 switches from its state A (refer to FIG. 13A) to the state B shown in FIG. 13B. The container 12 and the second collar 21 latched to the container 12 are moved together in the distal direction D, and the carrier 7 is held by the pawl mechanism 18 (see Fig. 11C) in its state C as described above. In a certain position. Due to this movement, the inwardly projecting portion 21.3 on the second beam head 21.2 of the proximal beam 21.1 on the second collar 21 no longer abuts the carrier 7 towards the inside. Instead, under the load of the control spring 19, due to the sharp rise of the second beam head 21.1 To the second container jaw 12.2 of the ramp, the inwardly projecting portion 21.3 is deflected inwardly into the third recess 7.7 in a carrier 7. The syringe retracts the control mechanism 25 to thereby reach a state C as shown in Figure 13C, wherein the second collar 21 is separated from the container 12 and coupled to the carrier 7. Before the syringe retraction control mechanism 25 is switched to the state C, since there is a small sliding force applied by the second collar 21, the pawl mechanism 18 applies a small delay to the movement of the carrier 7, thereby inserting the needle When the control mechanism 24 has been switched to the state E, the container 12 is translated in the distal direction D by the container 12 to pull the carrier 7 in the distal direction D. If the carrier 7 is moved too far in the distal direction D before the second collar 21 is switched, the container 12 runs out of stroke before the inwardly projecting portion 21.3 can deflect into the third recess 7.7 to avoid retraction.

Starting from position C of the pawl mechanism 18 (see Fig. 11C), the carrier 7 (and thus the rhomboid ramp member 7.1) is translated in the distal direction D under the load of the control spring 19. Thus, the distal fifth ramp 7.3 of the rhomboid ramp member 7.1 engages the proximal third ramp 2.3 on the first beam head 2.2 of the resilient beam 2.1 in a manner that deflects the resilient beam 2.1 inwardly. This applies a small delay to the movement of the carrier 7 required to ensure that the second collar 21 is switched to the carrier 7. The elastic beam 2.1 and the rhomboid ramp member 7.1 are laterally offset to allow the elastic beam 2.1 to pass without the first beam head 2.2 being oriented toward the interior from the slope member 7.1 in the state D shown in Figure 11D. The rhomboid slope member 7.1 is contacted.

The control spring 19 is determined by the first collar 20 of the frame 2 Based on the proximal end of its container. The end of the control spring 19 moves the second collar 21 with it in the distal direction D, and the carrier 7 (and thus the syringe 3 with the needle 4) together overcomes the pawl mechanism 18, as shown in Figure 11D. Note that once the user allows the container 12 to translate sufficiently far away from the opposing autoinjector with the needle shield (which requires the user to move the autoinjector away from the injection site), the needle 4 is retracted from the skin by the autoinjector 1 Have them pull the needle out of the skin to allow the needle to move forward.

When the movement of the acoustic element 28 is allowed to be restricted relative to the carrier 7, it is no longer in contact with the trigger button 13, which has moved in the distal direction D with the container 12 when moved away from the injection site. When the retraction begins, the acoustic spring 29 does not provide any delaying force. Once the acoustic element 28 hits the trigger button 13 again when the carrier 7 is retracted, the acoustic spring 29 must be recompressed to reduce the force of the last portion of the drive retraction. In order to ensure reliable retraction, regardless of this reduction force, the control spring 19 must have an appropriate size.

As in Figures 10A and 10B, when the distal collar 21 hits a first back stop 12.4 on a container 12, the retraction ends. The arrow 20.1 on the first collar 20 is supported internally by the carrier 7 in the state F shown in Fig. 12F, thereby preventing it from deflecting inwardly. The outward sixth slope 20.2 of the arrow 20.1 is engaged behind the first rib 12.3 on the container 12 to prevent the container 12 from being pushed again in the proximal direction P. A gap may be provided between the arrow 20.1 and the first rib 12.3 to allow for tolerances.

The pawl mechanism 18 reverts to the state A as in FIG. 11A, whereby the carrier 7 is locked in a position relative to the frame 2 as it was originally, but when the container 12 cannot move relative to the frame 2, it cannot Immediately locked.

Through the indicator window 32 in a container 12, a projection 20.4 on the first collar 20 is now visible to indicate that the autoinjector 1 has been used.

Figure 17 is an isometric view of an alternative embodiment of the plunger release mechanism 27. The plunger release mechanism 27 prevents the plunger 9 from moving relative to the carrier 7 in the proximal direction P until the carrier 7 is moved in the proximal direction P for insertion of the needle portion. With respect to the plunger release mechanism 27 of FIG. 15 (where the relative movement of the carrier 7 and the trigger button 13 is used to trigger the release of the plunger 9), the alternative embodiment of FIG. 17 is by the carrier 7 relative to the second collar 21 It moves to release the plunger 9. Figure 17 shows the plunger release mechanism 27 prior to release of the plunger. The second collar 21 is shown to be transparent to improve clarity. The plunger 9 is urged in the proximal direction P by the drive spring 8. In order to advance the plunger 9, it must rotate about a twelfth ramp 7.8 on a carrier 7. A ramp member 9.1 on a plunger 9 is configured to engage this twelfth ramp 7.8. The rotation of the ramp member 9.1 is blocked by an inward longitudinal rib 21.5 that is keyed to a second collar 21 of one of the longitudinal apertures 7.9 in the carrier 7. The container 12 is maintained in the same position as the second collar 21, that is, coupled to each other for joint axial translation. On the recess of the trigger button 13, the carrier 7 and the plunger 9 belonging to one of the driving sub-elements are first pressed by the user by the trigger button 13, and then, by the A collar 20 takes over the control spring 19 and is moved in the proximal direction P. Once the carrier 7 has moved far enough in the proximal direction P relative to the second collar 21, the ramp member 9.1 on the collar 9 is removed from the longitudinal rib 21.5 on the second collar 21 and can be driven in the spring 8 Under the load, it rotates past the proximal end of the longitudinal rib 21.5 as it rises to the twelfth ramp 7.8. Therefore, the drive spring 8 advances the plunger 9 in the proximal direction P for injecting the drug M.

Figure 18 is a longitudinal section of an alternative embodiment of the button release mechanism 26. In addition to the button release mechanism 26 of FIG. 16 (which provides the appearance of the exposed trigger button 13 on a skin contact by switching the basis of the trigger button 13 between the carrier 7 and the container 12), the button of FIG. 18 is released. The mechanism 26 begins with the trigger button 13 being latched but extending from the end of the container 12. Once the carrier 7 has been moved in the distal direction D when the skin of the frame 2 is in contact, it is possible to depress the trigger button 13 and activate the autoinjector 1. This ensures a sequential operation.

In the present embodiment of Fig. 18, the trigger button 13 has two proximal beams 13.1, each of which has a ramped outwardly projecting portion 13.4. In the initial state shown in FIG. 18, the outwardly projecting portions 13.4 of the ramps are engaged with respective fourth recesses 12.5 in the container 12. Disengaging the outwardly projecting portion 13.4 of the ramp from the fourth recess 12.5 in a manner that prevents the proximal beam 13.1 from deflecting inwardly is avoided by supporting the carrier 7 of the proximal beam 13.1 internally. The inwardly convex portion 13.5 on the proximal end beam 13.1 abuts against the second rib on the carrier 7 in a manner that prevents the carrier 7 from moving further in the proximal direction P in the initial state. 7.10. Once the carrier 7 has moved in the distal direction D when the skin of the frame 2 is in contact, the first window 7.11 in a carrier 7 is moved behind the inward projection 13.5, which allows the proximal beam 13.1 to be triggered by them. The sharp rise in the fourth recess 12.5 on the recess of the button 13 is deflected to the inside. The proximal beam 13.1 is now supported outwardly by the container 12 and remains attached to the carrier 7 even when the needle 4 is retracted. Therefore, the trigger button 13 does not return to its original position, thereby indicating that the autoinjector 1 has been used.

19A and 19B show two longitudinal sections of an alternative embodiment of the pawl mechanism 18. The pawl mechanism 18 of Figures 11A through 11D has multiple functions of controlling the movement of the carrier 7 relative to the frame 2, which may be referred to as a first beam head 2.2 running around the rhomboided ramp member 7.1. "race track" agency. The alternative pawl mechanism 18 of Figures 19A and 19B uses three clips 7.12, 7.13, 2.6 to produce the same effect.

The first clip 7.12 is configured as an outwardly biased resilient beam on the carrier 7 that extends from the carrier 7 in a proximal direction P. The first clip 7.12 is configured to prevent the carrier 7 from being moved in the proximal direction P before the frame 2 is depressed, more precisely before the container 12 is translated upon skin contact. The first clip 7.12 consists of two parallel sections. A first section 7.14 prevents movement of the carrier 7 in the proximal direction P by abutting the frame 2 in a recess. A second section 7.15 is configured as an outwardly extending clip head that is configured to be inwardly raised by a ramp feature 12.6 on a frame 2 for releasing the first clip 7.12, The carrier 7 is unlocked from the frame 2 when the container 12 is translated in the proximal direction P while the skin 12 is in contact with the skin. Once the lock has been released, the longitudinal slot 2.7 in a frame 2 is configured to allow the second section 7.15 to slide in the proximal direction P. The slight friction between the first clip 7.12 and the frame 2 provides the delay required to ensure retraction.

The second clip 7.13 is configured as an elastic beam on a carrier 7 that extends in the distal direction D and has a third beam head 7.16 that projects outwardly with a proximal slope. The third beam head 7.16 acts as a backing against one of the third ribs 2.9 on a frame 2 to avoid movement of the carrier 7 from its initial position in the distal direction D. The carrier 7 and the frame 2 and the second clamp 7.13 are assembled in this position prior to insertion of the syringe 3 into the carrier 7, which is assisted by the proximal slope on the third beam head 7.16. The syringe 3 locks the clip in place by avoiding inward deflection to establish a fixed stop.

The third clip 2.6 is an elastic beam extending on the frame 2 in a distal direction D. The fourth beam head 2.8 of one of the slopes on the third clip 2.6 is configured to be internally engaged in a fifth recess 7.17 in a carrier 7. Once the first clip 7.12 is not latched, the user can load the third clip 2.6 by pressing the carrier 7 in the proximal direction P on the recess of the trigger button 13. The third clip 2.6 is loaded with compression, i.e., it will flex outwardly and suddenly release due to its sharp rise to the carrier 7, thereby providing a pawl functionality similar to that shown in Figure 11B.

Figure 20 is a longitudinal section of a third embodiment of the pawl mechanism 18, which is a variation of the embodiment of Figures 19A and 19B. Yu Shishi In the embodiment, the pawl function of the third clip 2.6 has been added to the first clip 7.12. The latch between the container 12 and the carrier 7 is likewise released, but the pawl is provided by deflecting the first clip 7.12 inwardly by a second level, by not having a second section 7.15. This is achieved with the rack 2 of slot 2.7. Instead, once the second section 7.15 is lifted inward by the ramp feature 12.6 on the container 12, it must be further inside the frame 2 depending on the axial load between the frame 2 and the carrier 7. The drama rose and suddenly released their connections.

Figure 21 is a longitudinal section of an alternative embodiment of the acoustic release mechanism 31. With respect to the acoustic release mechanism 31 of Fig. 14 (wherein the acoustic spring 29 acts between the carrier 7 and the acoustic element 28), in the embodiment shown in Fig. 21, the acoustic spring 29 acts on the container 12 and the acoustic element 28. between. During insertion of the needle, the acoustic spring 29 is compressed as the acoustic element 28 moves with the carrier 7 relative to the container 12. When the acoustic element 28 is quickly released by the plunger 9 before the end of the dose, the acoustic element 28 moves in the distal direction D and strikes the trigger button 13. Unlike FIG. 14, the acoustic spring 29 is no longer compressed during retraction of the needle because it is based on the base 12 in the container 12 rather than in the carrier 7.

22A and 22B show a longitudinal section of an alternative embodiment of the needle insertion control mechanism 24 that is also configured to perform the pawl function of the pawl mechanism 18 when the needle is retracted and the needle is inserted. Figure 23 shows a corresponding isometric view. A fourth clip 20.5 on a first collar 20 is configured as an elastic beam having a beam head having an inwardly proximal thirteenth ramp 20.6 for engaging a carrier 7. The fourth rib 7.18 is supported outwardly by the container 12 to maintain the first collar 20 engaged to the carrier 7 during needle insertion and during injection and prior to use. When the user lifts the container 12 away from the injection site at the end of the injection, a sixth groove 12.7 in the container 12 is moved outwardly behind the fourth clip 20.5, whereby the carrier 7 is moved by the second collar 21 The fourth clip 20.5 is allowed to release when the distal direction D is pulled down. Because the fourth clip 20.5 must be lifted outward, a small force is required to release the fourth clip 20.5, thereby providing a retracting pawl.

Prior to use, the fifth clip 2.10 on a frame 2 abuts a block 20.7 on a first collar 20 to avoid the first collar 20 (and thus the carrier 7 that is coupled to the first collar 20) ) moves toward the proximal direction P. For release, the fifth clip 2.10 must be deflected outwardly and past the obstruction 20.7. The outward deflection of the fifth clip 2.10 is first blocked by the container 12. Once the container 12 has been moved over the skin contact, the second window 12.8 in a container 12 emerges outwardly from the fifth clip 2.10, thereby allowing outward deflection. Since the fourth clip 20.5 does not allow the carrier 7 to translate relative to the first collar 20 in the proximal direction P rather than reversed, when the carrier 7 is pushed toward the proximal direction P when the button is depressed, the fifth clip 2.10 is then deflected by a fourteenth ramp 7.19 on a carrier 7. The pawl for insertion of the needle is provided by having to deflect the fifth clip 2.10 (when it is loaded by the control spring 19).

24A and 24B show a longitudinal section of a third embodiment of a needle insertion control mechanism 24 that is also configured to perform the function of the pawl mechanism 18. Figure 25 is an isometric view of the needle insertion control mechanism 24 of Figure 24. this Embodiments are similar to those shown in Figures 22A, 22B, and 23. The difference is that the fifth clip 2.10 is disposed on the first collar 20 and the obstructions 20.7 are disposed on the frame 2, that is, their positions have been switched, so there are two on the first collar 20 Clips 2.10 and 20.5.

The fourth clip 20.5 is the same as that in Fig. 22B. It maintains the first collar 20 attached to the carrier 7 until the needle retraction is triggered, ensuring that the full injection depth is reached and maintained until the retraction cycle begins by moving the autoinjector 1 away from the skin.

The fifth clip 2.10 provides a pawl for insertion of the needle and releases the first collar 20 from the frame 2 to initiate needle insertion. Prior to use, the fifth clamp 2.10 prevents the first collar 20 (and thus the carrier 7 that is coupled to the first collar 20) from moving in the proximal direction P by abutting the obstruction 20.7 on the frame 2. For release, the fifth clip 2.10 must be deflected outwardly and past the obstruction 20.7. The outward deflection of the fifth clip 2.10 is first blocked by the container 12. Once the container 12 has been moved over the skin contact, the second window 12.8 in the container 12 will appear outwardly from the fifth clip 2.10, thereby allowing outward deflection. Since the fourth clip 20.5 does not allow the carrier 7 to translate relative to the first collar 20 in the proximal direction P rather than reversed, when the carrier 7 is pushed toward the proximal direction P when the button is depressed, the fifth clip 2.10 is then deflected by the fourteenth ramp 7.19 on the carrier 7. The pawl for insertion of the needle is provided by having to deflect the fifth clip 2.10 (when it is loaded by the control spring 19).

26A and 26B show a longitudinal section of a third embodiment of one of the acoustic release mechanisms 31. This embodiment does not require a dedicated acoustic spring. Work under. The plunger 9 includes a proximal ramp rib 9.2 that is configured to directly enlarge the two seventh clips 7.21 on the carrier 7 before the end of the dose. When the proximal ramp ribs 9.2 have been run past the seventh clip 7.21, they suddenly bounce back and strike the plunger 9, thereby producing a sound. The tubular shape of the carrier 7 helps to transmit sound. Fig. 26A shows the sound release mechanism 31 before release. Fig. 26B shows the sound release mechanism 31 after the release. The proximal end face of the seventh clip 7.21 on the carrier 7 is axially offset for facilitating assembly by lifting the seventh clip 7.21 over the distal side of the proximal ramp rib 9.2 one by one.

27A and 27B show longitudinal sections of another embodiment of the autoinjector 1 in different cross sections, the different sections being rotated almost 90° to each other, wherein the autoinjector 1 is in an initial state prior to the start of an injection. The autoinjector 1 is essentially the same as the autoinjector illustrated in Figures 1-16. However, in addition to the autoinjectors of Figures 1 through 16, the autoinjector 1 of the present embodiment has a wrap-over sleeve actuator instead of a trigger button.

The wrap-around sleeve actuator 12 is the same component as the container 12 and has a closed end face 12.10 in addition to one of Figures 1-16. An internal trigger button 13 is disposed at the end of the interior of the sleeve actuator 12. Unlike FIGS. 1 to 16, the trigger button 13 is neither visible nor extended from the container 12 in any state. In the initial state, a gap 33 is provided between the end face 12.10 of the sleeve actuator 12 and the internal trigger button 13 to allow some operation of the sleeve actuator 12 without obstructing the trigger button 13.

Some of the operation of the actuator 12.

Since the autoinjector 1 is otherwise different from the autoinjectors of Figures 1 to 16, it operates essentially the same, with the exception of the following: since the frame 2 is placed against the injection site, In a one-stage sleeve stroke, the sleeve actuator 12 translates into the advanced position relative to the frame 2 in a proximal direction P, thereby removing the gap between the end face 12.10 of the sleeve actuator 12 and the internal trigger button 13. 33. As in the embodiment of Figures 1 to 16, this movement does not lock the pawl mechanism 18 and the trigger button 13. When the user continues to depress the sleeve actuator 12 during the second stage of the sleeve stroke to further advance it in the proximal direction P, the end face 12.10 hits the internal trigger button 13 to thereby press it until the first The collar 20 is released from the frame 2 and the control spring force is coupled to the carrier 7. Then, the carrier 7 is advanced until the inner trigger button 13 stops at the other rib in the container 12 and the plunger release mechanism 27 is released (note that the pile 14 is shorter in this embodiment).

From the perspective of the user, the pawl mechanism 18 is configured to provide a resistance when the user reaches the second stage of the sleeve stroke. Internally, there is no difference in the embodiments of Figures 1 to 16 at this point.

The needle insertion is triggered by the user, and the user fully advances the sleeve actuator 12 in the second face of the sleeve stroke to fully depress the internal trigger button 13 and overcome the pawl mechanism, as shown in Figures 1 through 16. Shown in the examples.

When the control spring 19 takes over the carrier 7 when the button is depressed, When the needle is inserted, the internal trigger button 13 is lowered to the bottom of the inner fifth rib 12.11 of the sleeve actuator 12, and the internal trigger button 13 is returned to be locked to the sleeve actuator 12, as shown in Fig. 16C. Shown.

The embodiment of Figures 27A and 27B can also be combined with the alternative features shown in Figures 17-26.

As a matter of course, in the dramatic connection between the two components described in the above embodiments, there may be exactly one slope on one or the other component, or there may be multiple slopes on the two components, without The effect of the land is sharply connected.

1‧‧‧Autoinjector

2‧‧‧Rack

2.1‧‧‧Flexible beams

2.2‧‧‧First beam head

2.3‧‧‧ proximal third slope

2.4‧‧‧ distal seventh slope

2.5‧‧‧ pores

2.6‧‧‧ third clip

2.7‧‧‧ slots

2.8‧‧‧Four beam head

2.9‧‧‧ Third rib

2.10‧‧‧ fifth clip

2.11‧‧‧ sixth clip

3‧‧‧Syringe

4‧‧‧ hollow needle

5‧‧‧c

6‧‧‧Blocker

7‧‧‧ Carrier

7.1‧‧‧Ramp components

7.2‧‧‧ Near fourth slope

7.3‧‧‧ distal fifth slope

7.4‧‧‧ Carrier claws

7.5‧‧‧second groove

7.6‧‧‧ distal tenth slope

7.7‧‧‧ third groove

7.8‧‧‧ twelfth slope

7.9‧‧‧Longitudinal pores

7.10‧‧‧second rib

7.11‧‧‧ first window

7.12‧‧‧ first clip

7.13‧‧‧second clip

7.14‧‧‧First section

7.15‧‧‧Second section

7.16‧‧‧ Third beam head

7.17‧‧‧ fifth groove

7.18‧‧‧4th rib

7.19‧‧‧fourteenth slope

7.20‧‧‧15th slope

7.21‧‧‧ seventh clip

8‧‧‧Drive spring

9‧‧‧Plunger

9.1‧‧‧Ramp components

9.2‧‧‧ proximal slope ribs

10‧‧‧ Carrier end face

11‧‧‧

12‧‧‧ Container

12.1‧‧‧First container claw

12.2‧‧‧Second container claw

12.3‧‧‧First rib

12.4‧‧‧First back obstruction

12.5‧‧‧fourth groove

12.6‧‧‧Ramp features

12.7‧‧‧ sixth groove

12.8‧‧‧ second window

12.9‧‧‧ Third Window

12.10‧‧‧End face

12.11‧‧‧ fifth rib

13‧‧‧ trigger button

13.1‧‧‧ proximal beam

13.2‧‧‧Outward first slope

13.3‧‧‧Inward second slope

13.4‧‧‧ outward projection of the slope

13.5‧‧‧Inward convex

13.6‧‧‧Second behind obstruction

14‧‧ ‧ pile

15‧‧‧Bounce arm

16‧‧‧First groove

17‧‧‧ distal plunger sleeve

18‧‧‧ claw mechanism

19‧‧‧Control spring

20‧‧‧First collar

20.1‧‧‧ arrow

20.2‧‧‧Outward sixth slope

20.3‧‧‧Inward ninth slope

20.4‧‧‧Protruding

20.5‧‧‧Four clip

20.6‧‧‧Inward proximal thirteen slopes

20.7‧‧‧ Obstructions

20.8‧‧‧ fifth clip

21‧‧‧Second collar

21.1‧‧‧ proximal beam

21.2‧‧‧Second beam head

21.3‧‧‧Inwardly protruding parts

21.4‧‧‧ distal to the eighth slope

21.5‧‧‧ longitudinal ribs

22‧‧‧ Cover

22.1‧‧‧Internal sleeve

23‧‧‧ Barb

24‧‧‧needle insertion control mechanism

25‧‧‧Symbolic retraction control mechanism

26‧‧‧ button release mechanism

27‧‧‧Plunger release mechanism

28‧‧‧Sound components

28.1‧‧‧Extension

28.2‧‧‧End Plate

28.3‧‧‧Outward eleventh slope

29‧‧‧Sound spring

30‧‧‧Second arm

30.1‧‧‧ Inwardly protruding part of the slope

31‧‧‧Sound release mechanism

32‧‧‧ indicator window

33‧‧‧ gap

D‧‧‧end, distal direction

I‧‧‧Inward direction

M‧‧‧ drugs

O‧‧‧ outward direction

P‧‧‧ proximal and proximal directions

Figure 1 shows two longitudinal sections of an autoinjector in different sections in a state prior to use.

Figure 2 shows two longitudinal sections of the autoinjector after removal of a cover and a protective needle guard.

Figure 3 shows two longitudinal sections of an autoinjector pressed against a proximal injection site.

Figure 4 shows two longitudinal sections of an autoinjector with a trigger button depressed.

Figure 5 shows two longitudinal sections of the autoinjector during insertion of the needle into the injection site.

Figure 6 shows two longitudinal sections of the autoinjector with the needle fully inserted.

Figure 7 shows the autoinjector during the injection near the end of the dose Two longitudinal sections.

Figure 8 shows two longitudinal sections of the autoinjector at the end of the dose.

Figure 9 shows two longitudinal sections of the autoinjector moving away from the injection site.

Figure 10 shows two longitudinal sections of the autoinjector with the needle retracted into a secure position of the needle.

Figure 11 shows an overview of one of the jaw mechanisms for controlling the movement of a carrier relative to an autoinjector in four different states.

Figure 12 shows a schematic view of one of the needle insertion control mechanisms for controlling the movement of a first collar in six different states.

Figure 13 shows a schematic view of one of the syringe retraction control mechanisms in three different states.

Figure 14 shows a schematic view of one of the sound release mechanisms for audibly indicating the end of an injection in three different states.

Figure 15 shows a schematic view of one of the plunger release mechanisms in three different states.

Figure 16 shows a schematic view of one of the button release mechanisms in three different states.

Figure 17 is an isometric view of an alternative embodiment of a plunger release mechanism.

Figure 18 is a longitudinal section of an alternative embodiment of the button release mechanism.

Figure 19 shows a longitudinal section of an alternative embodiment of the pawl mechanism.

Figure 20 is a longitudinal section of a third embodiment of a pawl mechanism.

Figure 21 is a longitudinal section of an alternative embodiment of an acoustic release mechanism.

Figure 22 shows a longitudinal section of an alternative embodiment of a needle insertion control mechanism that is further configured to perform the function of the pawl mechanism with respect to needle retraction and needle insertion.

Figure 23 is an isometric view of the needle insertion control mechanism of Figure 22.

Figure 24 shows a longitudinal section of a third embodiment of a needle insertion control mechanism that is again configured to perform the function of a pawl mechanism.

Figure 25 is an isometric view of the needle insertion control mechanism of Figure 24.

Figure 26 shows a longitudinal section of a third embodiment of the acoustic release mechanism.

Figure 27 is another embodiment of an autoinjector having a wrap-over sleeve trigger in place of a trigger button.

1‧‧‧Autoinjector

2‧‧‧Rack

3‧‧‧Syringe

4‧‧‧ hollow needle

5‧‧‧Protection needle shield

6‧‧‧Blocker

7‧‧‧ Carrier

7.5‧‧‧second groove

8‧‧‧Drive spring

9‧‧‧Plunger

10‧‧‧ Carrier end face

11‧‧‧

12‧‧‧ Container

12.3‧‧‧First rib

12.4‧‧‧First back obstruction

13‧‧‧ trigger button

14‧‧ ‧ pile

15‧‧‧Bounce arm

17‧‧‧ distal plunger sleeve

18‧‧‧ claw mechanism

19‧‧‧Control spring

20‧‧‧First collar

21‧‧‧Second collar

22‧‧‧ Cover

22.1‧‧‧Internal sleeve

23‧‧‧ Barb

24‧‧‧needle insertion control mechanism

27‧‧‧Plunger release mechanism

28‧‧‧Sound components

29‧‧‧Sound spring

D‧‧‧end, distal direction

P‧‧‧ proximal and proximal directions

Claims (10)

An injection device (1) for supplying a dose of a liquid drug (M), comprising a syringe (3) containing the dose of the drug (M), a hollow injection needle portion (4) suitable for piercing The skin of the patient, a stopper (6), translatably disposed within the syringe (3), a plunger (9) connectable to the occluder (6) and at least near An end direction (P) translation for removing the occluder (6) toward the proximal direction (P) and a releasable acoustic element (28) capable of producing an audible and/or tactile sensation upon release Feedback, wherein the proximal displacement of the occluder (6) causes the dose of the drug (M) to be expelled via the hollow needle portion (4), and the acoustic element (28) is attached to the plunger (9) Releasing with respect to the syringe (3) reaching a position in which the occluder (6) is located near the proximal end of one of the syringes (3), and wherein the released acoustic element (28) strikes the injection device ( 1) at least one component to produce the audible and/or tactile feedback indicative of the end of the injection, and wherein the component of the injection device (1) impinged by the released acoustic element (28) comprises a touch Button (13) at least a part of. The injection device (1) of claim 1, wherein the component of the injection device (1) that the released acoustic component (28) strikes further comprises a frame (2) and a container (12). a carrier (7), at least a portion of the plunger (9) and/or a sleeve actuator (12). An injection device (1) according to claim 1 or 2, wherein at least one of the components of the injection device (1) has a physical shape suitable for amplifying and/or transmitting a sound or design. The injection device (1) of claim 1, wherein the plunger (9) is driven proximally by the action of a slack drive spring (8) to cause the occluder ( 6) Pan in the proximal direction (P). An injection device (1) according to claim 1, wherein the acoustic element (28) is biased by an acoustic spring (29) and, when released, by the acoustic spring (29) And accelerated and driven towards the at least one component of the injection device (1). The injection device (1) according to claim 1, wherein the syringe (3) is translatably disposed with respect to the container (12) of the injection device (1), and an acoustic release mechanism (31) coupling the acoustic element (28) to one of the injectors (3) for translational movement until the acoustic element (28) is released. An injection device (1) according to claim 6, wherein: the syringe (3) is mountable to the carrier (7), which is configurable in translation with respect to the container (12), and An acoustic release mechanism (31) is disposed between the carrier (7) and the acoustic element (28) to couple the acoustic element (28) to the translational movement of the injector (3). The injection device (1) of claim 6, wherein the acoustic spring (29) biased by the acoustic element (28) is grounded to the container (12) by The proximal movement of one of the syringes (3) associated with the container (12) is compressed and filled. The injection device (1) according to any one of the preceding claims, wherein the sound release mechanism (31) comprises a second elastic arm (30) which is movable in a radially outward direction (O) Deflecting to release the acoustic element (28), wherein one of the distal end plunger sleeves (17) of the plunger (9) abuts the second spring arm (30) in the radially outward direction (O), To avoid release of the acoustic element (28) until the occluder (6) connectable to the plunger (9) is located near the proximal end of the syringe (3). The injection device (1) of claim 9, wherein the sound element (28) comprises an extension (28.1) having an outward eleventh slope (28.3), the outward eleventh slope (28.3) is engaged by the inwardly protruding portion (30.1) of the slope of the second elastic arm (30), and the outward deflection of the second elastic arm (30) results in the outward eleventh slope (28.3 ) is separated from the inwardly protruding portion (30.1).