Patent Description:
Various injection devices exist that employ an automated mechanism to actuate injection of a liquid medicament into a patient. Examples of such devices include jet injectors (both needle-free and needle-assisted), powered injectors and traditional, low-pressure auto-injectors (that provide, for example, automated needle insertion, and then the mechanized medicament delivery like that of a traditional, finger-powered hypodermic syringe injection). Although the precise mechanisms used to complete an injection can vary, most include a feature that stores kinetic energy that can be used to drive an injection mechanism during use. Further, many injector devices include a trigger mechanism configured to ensure that the kinetic energy remains stored until an injection is desired, whereby actuation of the trigger releases the injection mechanism, allowing the stored kinetic energy to drive the injection mechanism to cause injection.

Examples of needle-free jet injectors are described, for example, in <CIT> and <CIT>. These high force injectors are commonly button activated and administer medication as a fine, high velocity jet delivered under sufficient pressure to enable the jet to pass through the skin. The injection mechanism in such needle-free jet injectors can apply a force to a medicament storing chamber within the device such that the pressure required to inject the medicament is created within the chamber.

As noted above, a shock absorber as described herein can be used with any powered injector, and not solely needle assisted jet injectors. For example, the present invention can also be used with a powered injector that exhibit less force than a needle assisted jet injector yet greater force than an automated needle insertion powered injector (which can then deliver drug at rates that approximate a hand powered needle and syringe).

Traditional self-injectors or auto-injectors like the ones described, for example, in <CIT> and <CIT> and <CIT> inject medicament at a rate and in a manner similar to hand-operated hypodermic syringes. The described self-injectors or auto-injectors have needles that are extended at the time of activation to penetrate the user's skin to deliver medicament through movement of the drug container and related needle. Thus, the mechanism that provides the force to deliver the medicament in traditional, low-pressure self-injectors and auto-injectors can also be used to extend the needle and displace the drug container to cause the insertion of the needle through the user's skin and to apply a force to a plunger movably disposed within the drug container to cause the medicament to be expelled from the container through the needle. The auto-injectors manufactured, for example by Owen Mumford, thus use very low pressures to inject the medicament, which is typically injected through a needle in a relatively slow stream. Another self-injector includes the Simponi injector, which includes a window in the housing through which a yellow ram is visible inside a clear medicament container once the injector has been used.

Additionally, needle-assisted jet injectors have also been developed with higher injection forces that utilize a needle to initially penetrate the skin allowing a range of needle insertion depth at times less than that of a traditional hypodermic injector or low-pressure auto-injectors. Once the skin is penetrated with the needle, a jet mechanism is activated, causing the medicament containing liquid within the injector to be pressurized and expelled through the needle and into the skin. The injection mechanism in needle-assisted jet injectors can be configured to move the drug container and the needle forward to penetrate the skin and exert the necessary injection force to a plunger moveably disposed within the container. Alternatively, the needle and drug container can be positioned to penetrate the skin while keeping the needle and drug container in a stationary position, and the injection mechanism can be structured to pressurize the container. The pressure applied to the medicament within the injector can be less than that of a traditional jet injector, because the outer layers of the skin have already been penetrated by the needle. Similarly, the pressure applied to the medicament is preferably higher than that of a traditional auto-injector or the like, causing the medicament to penetrate the skin and be dispersed into the tissue or injected in the tissue below the skin to a depth that is sufficient so that the medicament remains substantially within the body. An additional benefit of the higher pressure includes a faster time of injection resulting in less psychological trauma to the patient and a decreased likelihood of the user inadvertently terminating the injection prematurely by removing the injector from the injection site.

<CIT> describes according to its abstract an injector including a trigger mechanism, an energy source, and a user-operable firing-initiation member. The trigger mechanism can include a floating trigger member having a retaining portion, a ram assembly having a ram configured to pressurize a medicament container for expelling a medicament therefrom, the ram assembly further having a floating trigger engagement member configured to engage the retaining portion of the floating trigger member when the floating trigger member is in a pre-firing condition. The energy source can be associated with the ram for powering the ram to expel the medicament, and the user-operable firing-initiation member can be operable for causing an axial rotation of the floating trigger member from the pre-firing condition to a firing condition in which the floating trigger engagement member is released from the retaining portion to allow the energy source to fire the ram.

The present invention relates to an injection device according to claim <NUM>. In one embodiment, the injection device is an auto-injector. In another embodiment, the injection device is a jet injector. In other embodiments, the injection device is a powered injector. In one embodiment, the injection device includes a shock absorbing member.

The injection device of the invention includes a shock absorbing member. In one embodiment, the shock absorbing member includes a sleeve configured to hold a medicament chamber, the sleeve having a proximal end and a distal end connected by a middle portion; wherein the sleeve includes a compressible element that is deformable such that an overall length of the sleeve is reduced by greater than <NUM>% relative to its original length when placed under a load.

In one embodiment of the invention, the load is within the range of spring forces that are used in an auto-injector. In certain embodiments, the load is <NUM>. 3N (<NUM> lbs) force. In other embodiments, the load is less than <NUM>. 8N (<NUM> lbs) force.

In one embodiment, the sleeve returns substantially to its original length once the load is removed.

In one embodiment, the compressible element is irreversibly deformed after the load is removed.

In one embodiment, the compressible element is located at the distal end of the sleeve. In another embodiment, the compressible element is located at the proximal end of the sleeve. In other embodiments, the compressible element is located at the middle portion of the sleeve.

A method is described of reducing failure rate of an injection device including providing an injection device having a shock absorbing member.

A method is described of reducing failure rate of an auto-injector including providing an auto-injector having a shock absorbing member.

These and other objects, features and advantages of the invention will be apparent from a consideration of the following non-limiting detailed description considered in conjunction with the drawing figures, in which:.

Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the present disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments and is not limited by the particular embodiments illustrated in the figures.

With reference to the accompanying figures, various embodiments of the present invention are described more fully below. Some but not all embodiments of the present invention are shown. Indeed, various embodiments of the invention may be embodied in many different forms and should not be construed as limited to the embodiments expressly described. The singular forms "a," "an," and "the" include the singular and plural unless the context clearly dictates otherwise.

<FIG> shows an exemplary injection device <NUM> according to an exemplary embodiment of the present disclosure. It is noted that, in the context of this disclosure, the terms "distal" and "proximal" are used in reference to the position of the injection device relative to a user of the injection device when held by a user. Accordingly, a point located distal to a second point would be further from the user (i.e., towards an injection end of the injection device) and vice versa. The drawings show an exemplary injection device <NUM>. Although a person having ordinary skill in the art will understand alternative embodiments employing certain features herein can be configured as needle-free jet injectors, a needle assisted jet injection devices, powered injectors, low-pressure auto-injectors or other mechanized injectors. According to certain exemplary embodiments, injection device <NUM> is a one-time disposable injector. In certain embodiments, injection device <NUM> can be modified to provide multiple and/or variable dosings upon repeated injections. According to certain exemplary embodiments, injection device <NUM> is a one-time disposable injector with a lock-out feature. For example, injection device <NUM> can facilitate an injection of medicament stored within injection device <NUM> and can include a locking feature that prevents a user from attempting to use injection device <NUM> once the medicament has been dispensed. In one embodiment, the locking feature is activated upon dispensing of the medicament and not upon use of injection device <NUM>. For example, the locking feature can be activated, thus preventing injection device <NUM> from a subsequent attempted use by a user, even in the case where the injection device was not actually used by a user for an injection, but where a firing mechanism was inadvertently activated (e.g., during transport, handling, etc. of the device) and the medicament was dispensed. Operation of injection device <NUM>, including the locking feature, is described in further detail below.

According to certain exemplary embodiments, injection device <NUM> can deliver any suitable liquid drug or medicament. Further, injection device <NUM> can allow the injection to be administered by individuals that do not have formal training (e.g., self-administered or administered by another individual family member or other caregiver who may not be a formally trained healthcare provider, such as a parent administering a drug to a child). Accordingly, injection device <NUM> can be useful in situations where self-injections/caregiver administered injections would be beneficial, including, but not limited to, inflammatory diseases, low testosterone also known as low T, hypogonadism, diabetes, infertility treatment, sexual dysfunction, cardiovascular disease, oncology, oncology supportive care, allergic reaction, multiple sclerosis, rheumatoid arthritis psoriasis, other autoimmune conditions including Crohn's disease and systemic lupus erythematosus (SLE), chronic pain, migraine, acute seizure, epileptic seizure, kidney disease, and the like. Further, injection device <NUM> can be used to inject a wide range of drugs. For example, injection device <NUM> can be used to inject drugs, water soluble medicaments, peptides, proteins, depot formulations and oil soluble medicaments. In one embodiment, the medicament includes a benzodiazepine, including midazolam. In another embodiment, the medicament is dissolved in oil instead of aqueous solutions, and can include hormone drugs used in men (e.g., testosterone, or a derivative or ester thereof) and women, In alternate embodiment the medicament includes small molecule injectable drugs such as, methotrexate (see, e.g., International Publication No. <CIT>); and, in yet another embodiment, the medicaments included are biological drugs, including those having a high viscosity. Further, and as noted above injection device <NUM> can be used to inject androgens, including testosterone formulations (e.g., testosterone cypionate and testosterone enanthate). In certain embodiments, injection device is designed to enhance the administration and performance of complex and difficult to inject viscous medicines, such as but not limited to testosterone, biologics or biosimilars. In one embodiment, the injection device is designed to cause a powerful and smooth expulsion of a medicament, which may be necessary for viscous formulations, including but not limited to biologics. In certain embodiments, the injection device is designed to administer the medicament very rapidly.

Testosterone is a steroid hormone from the androgen group. In general, androgens promote protein synthesis and growth of those tissues with androgen receptors. Testosterone is anabolic, meaning it builds up bone and muscle mass. Testosterone has the following structural formula:
<CHM>.

The original and primary use of testosterone is for the treatment of males who have too little or no natural endogenous testosterone production-males with Low T or hypogonadism. According to the Massachusetts Male Aging Study, about <NUM>% to <NUM>% men aged <NUM> to <NUM> years have symptomatic low testosterone deficiency. However, over the years, testosterone has also been given for many other conditions, e.g., reducing infertility, correcting lack of libido or erectile dysfunction, correcting osteoporosis, encouraging penile enlargement, encouraging height growth, encouraging bone marrow stimulation, reversing the effects of anemia and appetite stimulation.

In certain embodiments, injection device <NUM> can be used to inject one or more of epinephrine, atropine, dihydroergotamine, sumatriptan, antibiotics, antidepressants, anticoagulants, glucagon, diazepam, haloperidol, apomorphine, lovenox, and toradol. In other embodiments, injection device <NUM> can be used to inject biosimilar, biological and or peptide drugs, including without limitation Enbrel, Humira, Lantus, Epogen (Procrit), Neulasta, Aranesp, Avonex, PEGasys, Rebif, Neupogen, Betaseron, Avastin, Remicade, Herceptin, Erbitux, Recombinate, Cerezyme, NovoSeven, Tysabri, Synagis, Copaxone and Kogenate FS, long acting human growth hormone, hydroxyprogesterone, and donepezil.

In other embodiments, injection device <NUM> can be used to inject parathyroid hormone ("PTH") and various other medications such as exenatide and the like. Injection device <NUM> can also be used to inject medicaments listed in the Physicians' Desk Reference (PDR®), 67th Edition (<NUM>) (which is herein incorporated by reference in its entirety), and, without limitation, allergens, amebicides and trichomonacides, amino acid preparations, analeptic agents, analgesics, analgesics/antacids, anesthetics, anorexics, antacids, antihelmintics, antialcohol preparations, antiarthritics, antiasthma agents, antibacterials and antiseptics, antiviral antibiotics, anticancer preparations, anticholinergic drug inhibitors, anticoagulants, anticonvulsants, antidiabetic agents, antidiarrheals, antidiuretics, antienuresis agents, antifibrinolytic agents, antifibrotics (systemic), antiflatulents, antifungal agents, antigonadotropin, antihistamines, antihyperammonia agents, anti-inflammatory agents, antimalarials, antimetabolites, antimigraine preparations, antinauseants, antineoplastics, anti-obesity preparations, antiparasitics, antiparkinsonism drugs, antipruritics, antipyretics, antispasmodics and antichloinergics, antitoxoplasmosis agents, antitussives, antivertigo agents, antiviral agents, biologicals, biosimilars, bismuth preparations, bone metabolism regulators, bowel evacuants, bronchial dilators, calcium preparations, cardiovascular preparations, central nervous system stimulants, cerumenolytics, chelating agents, choleretics, cholesterol reducers and anti-hyperlipemics, colonic content acidifiers, cough and cold preparations, decongestants, diazepam, epinephrine expectorants and combinations, diuretics, emetics, enzymes and digestants, fertility agents, fluorine preparations, galactokinetic agents, general anesthetic, geriatrics, germicides, hematinics, hemorrhoidal preparations, histamine H receptor antagonists, hormones, hydrocholeretics, hyperglycemic agents, hypnotics, immunosuppressives, laxatives, mucolytics, muscle relaxants, narcotic antagonists, narcotic detoxification agents, ophthalmological osmotic dehydrating agents, otic preparations, oxytocics, parashypatholytics, parathyroid preparations, pediculicides, phosphorus preparations, premenstrual therapeutics, psychostimulants, quinidines, radiopharmaceuticals, respiratory stimulants, salt substitutes, scabicides, sclerosing agents, sedatives, sympatholytics, sympathomimetics, thrombolytics, thyroid preparations, tranquilizers, tuberculosis preparations, uricosuric agents, urinary acidifiers, urinary alkalinizing agents, urinary tract analgesic, urological irrigants, uterine contractants, vaginal therapeutics and vitamins and each specific compound or composition listed under each of the foregoing categories in the PDR®. Some other medicaments that can be used with injector device <NUM> include Ergocalciferol (Calciferol), diethylstilbestrol, Diprovan (propofol), estradiol valerate, fluphenazine decanoate, fulvestrant, intralipid, liposyn, nandrolone decanoate, nebido, nutralipid, paclitaxel, progesterone, prograf, testosterone cypionate, zuclopenthixol, and haloperidol dodecanoate. In certain embodiments, the medicament is dissolved in soybean oil, ethyl oleate, castor oil, sesame oil, safflower oil, arachis oil, polyoxyyethylated castor oil (Cremophor® EL), polyoxyl <NUM> hydrogenated castor oil (HCO-<NUM>), cottonseed oil, or thin oil derived from coconut oil.

In some embodiments, the medicament may be a hazardous agent. "Hazardous Agent(s)" as used herein means any one or more medications that are toxic agents, cytotoxic agents and/or other dangerous agents that may cause serious effects upon contact with a subject as well as highly potent agents, agents that have profound physiological effects at low doses. Exemplary hazardous agents include, without limitation, analgesics, immunomodulating agents, IL-<NUM> receptor antagonists, IL-<NUM> alpha receptor antagonists, anti-rejection compounds, hormonal agents, prostaglandins, sedatives, anticholinergic agents, Parkinsons disease drugs, expensive agents, neuroleptic agents, tissue necrosis factor (TNF) blockers, and other dangerous agents. Examples of hazardous agents suitable for use with injection device <NUM> in accordance with the present invention include, but are not limited to, those disclosed in <CIT>). Particular examples of cytotoxic agents include, without limitation, <NUM>-mercaptopurine, <NUM>-thioinosinic acid, azathioprine, chlorambucil, cyclophosphamide, cytophosphane, cytarabine, fluorouracil, melphalan, methotrexate, uramustine, anti-cytokine biologicals, cell receptor antagonists, cell receptor analogues, and derivatives thereof. Examples of highly potent agents include, without limitation, steroids such as dexamethasone, progesterone, somatostatin, and analogues thereof; biologically active peptides such as teriparatide; and anticholinergics such as scopolamine. Examples of agents that have profound physiological effects at low doses include, without limitation, antihypertensives and/or blood pressure down regulators. Examples of analgesics include, without limitation, fentanyl, fentanyl citrate, morphine, meperidine, and other opioids. Examples of immunomodulating agents include, without limitation, adalimumab (anti-tissue necrosis factor monoclonal antibody or anti-TNF). Examples of IL-<NUM> receptor antagonists include, without limitation, anakinra. Examples of IL-<NUM> alpha receptor antagonists include, without limitation, daclizumab and basiliximab. Examples of anti-rejection compounds include, without limitation, azathioprine, cyclosporine, and tacrolimus. Examples of hormonal agents include, without limitation, testosterone, estrogen, growth hormone, insulin, thyroid hormone, follicle stimulating hormone (FSH), epinephrine/adrenaline, progesterone, parathyroid hormone, gonadotrophin releasing hormone (GHRH), leutinizing hormone releasing hormone (LHRH), other hormones such as those where contact with the hormone by members of the opposite sex can lead to side effects, and derivatives thereof. Examples of prostaglandins include, without limitation, gamma-linolenic acid, docosahexanoic acid, arachidonic acid and eicosapentaenoic acid. Examples of sedatives include, without limitation, barbiturates such as amobarbital, pentobarbital, secobarbital, and phenobarbitol; benzodiazepines such as clonazepam, diazepam, estazolam, flunitrazepam, lorazepam, midazolam, nitrazepam, oxazepam, triazolam, temazepam, chlordiazepoxide, and alprazolam; herbal sedatives such as ashwagandha, duboisia hopwoodii, prosanthera striatiflora, kava (piper methysticum), mandrake, valerian, and marijuana; non-benzodiazepine sedatives (a. "Z-drugs") such as eszopiclone, zaleplon, zolpidem, zopiclone; antihistamines such as diphenhydramine, dimenhydrinate, doxylamine, and promethazine; and other sedatives such as chloral hydrate. Examples of anticholinergic agents include, without limitation, dicyclomine, atropine, ipratropium bromide, oxitropium bromide, and tiotropium. Examples of Parkinson's disease drugs include, without limitation, levodopa, dopamine, carbidopa, benserazide, co-ceraldopa, co-beneldopa, tolcapone, entacapone, bromocriptine, pergolide, pramipexole, ropinirole, piribedil, cabergoline, apomorphine, and lisuride. Examples of expensive agents include, without limitation, human growth hormone and erythropoietin. Examples of neuroleptic agents includes, without limitation, antipsychotics; butyrophenones such as haloperidol and droperidol; phenothiazines such as chlorpromazine, fluphenazine, perphenazine, prochlorperazine, thioridazine, trifluoperazine, mesoridazine, periciazine, promazine, triflupromazine, levomepromazine, promethazine, and pimozide; thioxanthenes such as chlorprothixene, clopenthixol, flupenthixol, thiothixene, and zuclopenthixol; atypical antipsychotics such as clozapine, olanzapine, risperidone, quetiapine, ziprasidone, amisulpride, asenapine, paliperidone, iloperidone, zotepine, and sertindole; and third generation antipsychotics such as aripiprazole and bifeprunox. Examples of TNF blockers includes, without limitation, etanercept.

In some embodiments, the hazardous agent can be selected from botulinum toxin, injectable gold, <NUM>-mercaptopurine, <NUM>-thioinosinic acid, azathioprine, chlorambucil, cyclophosphamide, cytophosphane, cytarabine, fluorouracil, melphalan, methotrexate, uramustine, anti-cytokine biologicals, cell receptor antagonists, cell receptor analogues, dexamethasone, progesterone, somatostatin, analogues of dexamethasone, analogues of progesterone, analogues of somatostatin, teriparatide, scopolamine, antihypertensives, blood pressure down regulators, fentanyl, fentanyl citrate, morphine, meperidine, other opioids, adalimumab (anti-tissue necrosis factor monoclonal antibody or anti-TNF), anakinra, daclizumab, basiliximab, azathioprine, cyclosporine, tacrolimus, testosterone, estrogen, growth hormone, insulin, thyroid hormone, follicle stimulating hormone (FSH), epinephrine/adrenaline, gamma-linolenic acid, docosahexanoic acid, arachidonic acid, eicosapentaenoic acid, amobarbital, pentobarbital, secobarbital, phenobarbitol, clonazepam, diazepam, estazolam, flunitrazepam, lorazepam, midazolam, nitrazepam, oxazepam, triazolam, temazepam, chlordiazepoxide, alprazolam, ashwagandha, duboisia hopwoodii, prosanthera striatiflora, kava (piper methysticum), mandrake, valerian, marijuana, eszopiclone, zaleplon, zolpidem, zopiclone, diphenhydramine, dimenhydrinate, doxylamine, promethazine, chloral hydrate, dicyclomine, atropine, ipratropium bromide, oxitropium bromide, tiotropium, levodopa, dopamine, carbidopa, benserazide, co-ceraldopa, co-beneldopa, tolcapone, entacapone, bromocriptine, pergolide, pramipexole, ropinirole, piribedil, cabergoline, apomorphine, lisuride, human growth hormone, erythropoietin, haloperidol, droperidol, chlorpromazine, fluphenazine, perphenazine, prochlorperazine, thioridazine, trifluoperazine, mesoridazine, periciazine, promazine, triflupromazine, levomepromazine, promethazine, pimozide, chlorprothixene, clopenthixol, flupenthixol, thiothixene, zuclopenthixol, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, amisulpride, asenapine, paliperidone, iloperidone, zotepine, sertindole, aripiprazole, bifeprunox, etanercept, derivatives of any of the foregoing, and combinations of any of the foregoing.

While injection device <NUM> can deliver an injection of up to about <NUM> per injection, other volumes can be injected in alternative embodiments. In certain embodiments, injection device <NUM> can deliver an injection of greater than <NUM> per injection. In other embodiments, injection device <NUM> can deliver an injection in range of about <NUM> to about <NUM>.

In one embodiment, injector device <NUM> can inject <NUM> of a medicament dissolved in an aqueous solution in about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , or any range determinable from the preceding times (for example, about <NUM> sec. to about <NUM> sec. or about <NUM> sec. to about <NUM> sec. In another embodiment, injector device <NUM> can inject <NUM> of a medicament dissolved in oil in about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , about <NUM> sec. , or any range determinable from the preceding times (for example, about <NUM> sec. to about <NUM> sec. or about <NUM> sec. to about <NUM> sec. In an alternate embodiment, injection device <NUM> can injection viscous materials in and about the ejection times as shown in Tables <NUM> and <NUM>. Other volumes and times are determinable from the described preceding information and Tables <NUM> and <NUM>.

Tables <NUM> and <NUM> show observed injection time for viscous oil medicament for one embodiment of injection device <NUM>.

According to certain exemplary embodiments, injection device <NUM> can be configured to inject medicament stored within a prefilled syringe. Prefilled syringes that are manufactured by a blown glass process can have significant dimensional tolerances and unevenness. Accordingly, features of injection device <NUM> can serve to accommodate the shape irregularities and to properly position and locate a prefilled syringe within injection device <NUM>. Other medicament containers such as prefilled syringes manufactured with polymers can also be accommodated. Further, in one embodiment, injection device <NUM> can be configured providing pressure during the injection of less than about <NUM>,<NUM> psi, in one embodiment, less than <NUM> psi, and in another embodiment less than about <NUM> psi. <NUM> psi equals <NUM> KPa (SI Units). In some embodiments, injection device <NUM> can be configured providing injection pressures of less than about <NUM> p. In one embodiment, injection device <NUM> can provide a peak pressure during the injection of about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM>,<NUM> psi, about <NUM>,<NUM> psi, or any range determinable from the peak pressures (for example, about <NUM> psi to about <NUM> psi or about <NUM> psi to about <NUM> psi). At an end of an injection, the pressure applied to the medicament is, in one embodiment, at least about <NUM> psi, in another embodiment, at least about <NUM> psi, and, in another embodiment, at least about <NUM> psi. In one embodiment, the pressure applied to the medicament at an end of an injection is about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, about <NUM> psi, or any range determinable from the pressures (for example, about <NUM> psi to about <NUM> psi or about <NUM> psi to about <NUM> psi). In one embodiment, the initial pressure can be around <NUM> psi, and the final pressure can be about <NUM> psi, while in another embodiment the initial pressure can be about <NUM> psi, dropping to around <NUM> psi at the end of the injection. These exemplary pressures can, for example, result in a flow rate of about <NUM>/sec to <NUM>/sec, and, in one embodiment, be about <NUM>/sec. In one embodiment, the rate is greater than <NUM>/sec. In one embodiment, the injection device <NUM> may include an energy source <NUM>, e.g., a high force spring, such as those needed for rapid ejection of difficult to eject medicaments. In one embodiment, energy source <NUM> is a high force spring of about <NUM> lbs. load capacity, about <NUM> lbs load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, about <NUM> lbs. load capacity, or any range determinable from the preceding load capacities (for example, about <NUM> lbs. load capacity to about <NUM> lbs load capacity or about <NUM> lbs. load capacity to about <NUM> lbs. load capacity). <NUM> lbf equals <NUM>. 448N (SI Units). High force springs may be desired in situations where rapid delivery of drugs is important to assure injection of the entire dose; this would be to counteract users removing the injector from the injection site prematurely. Medicaments can be difficult to eject due to either high viscosity or because of a combination of their viscosity and a therapeutic need for delivery of the medicament using fine bore needles, such as the <NUM> gauge prefilled syringe. These exemplary high spring forces for difficult to inject medicaments can result in a flow rate of about <NUM>/sec to about <NUM>/sec. In some embodiments, the injection device <NUM> in the above mentioned embodiments is a needle assisted jet injector.

In one embodiment, the needles used may be between <NUM> and <NUM> gauge. In some embodiments, the needles used are between <NUM> and <NUM> gauge, and, in other embodiments, are around <NUM> gauge, but alternatively other needle gauges can be used where the other components are cooperatively configured to produce the desired injection. In some embodiments, thin walled needles maybe used. In some embodiments, thin walled needles may be used without risk of bending when injection device <NUM> is configured to act with manual needle insertion prior to injection. In certain injection device embodiments firing aqueous medicaments, the firing mechanism, medicament container, needle, and energy source are configured to produce an average stream velocity within the needle of at least about <NUM>,<NUM>/sec, and, in certain embodiments, are at least about <NUM>,<NUM>/sec, up to about <NUM>,<NUM>/sec, and, in other embodiments, are up to about <NUM>,<NUM>/sec. In one embodiment, the average stream velocity during injection is about or reaches between about <NUM>,<NUM> and about <NUM>,<NUM>/sec or approximately about <NUM>,<NUM>/sec. In one embodiment, the average stream velocity during injection is about or reaches about <NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, about <NUM>,<NUM>/sec, or any range determinable from the average stream velocities (for example, about <NUM>,<NUM>/sec to about <NUM>,<NUM>/sec or about <NUM>,<NUM>/sec to about <NUM>,<NUM>/sec). In one embodiment, the average stream velocity during injection is greater than about <NUM>/sec. In one embodiment, the average stream velocity during injection is greater than about <NUM>/sec. In one embodiment, the average stream velocity during injection is less than about <NUM>,<NUM>/sec. In one embodiment, the average stream velocity during injection is less than about <NUM>,<NUM>/sec. In one embodiment, the average stream velocity during injection is less than about <NUM>,<NUM>/sec. The velocities used to produce a jet injection will vary for other types of medicaments, such as based on their viscosities. With some viscous medicaments, exemplary high spring forces can be used to produce stream velocity of about <NUM>/sec, up to about <NUM>/sec. In certain embodiments, the above injection devices are needle assisted jet injectors. Weaker energy sources, and/or larger bore needles, for example, can be used to obtain lower velocities and lower pressures and/or flow rates for traditional, low-pressure auto-injector embodiments. All such embodiments can benefit from the axial rotation between the trigger engagement member and the retaining portion, while moving from the pre-firing condition to the firing condition upon a proximal movement of the skin-contacting member with respect to housing. An example of which, but not limited to, is a reduction of friction between spring loaded components which can be applied to triggering designs not involving rotational motion.

In one embodiment, as shown in <FIG>, the exemplary injection device <NUM> can include an outer housing <NUM> and a housing end/end cap <NUM>. As shown in <FIG>, in one embodiment, the housing end/end cap <NUM> is coupled to a proximal end of housing <NUM>. Injection device <NUM> can further include various components and/or assemblies housed within outer housing <NUM>. As shown in <FIG>, these components can include a guard <NUM>, a container support, such as, e.g., a sleeve <NUM>, a firing mechanism <NUM>, a medicament chamber <NUM>, a needle <NUM>, and a spring <NUM>. As shown in <FIG>, outer housing <NUM> can be a single piece component, or alternatively, outer housing <NUM> multiple piece assembly that can be coupled together, for example, via a snap-fit connection, a press-fit connection, a threaded engagement, adhesives, welding, or the like.

As shown in <FIG>, in one embodiment, sleeve <NUM> is at least partially housed within outer housing <NUM> and mounted to outer housing <NUM> via, for example, a snap-fit connection, a press-fit connection, a threaded engagement, adhesives, welding, or the like. As shown in <FIG>, for example, sleeve <NUM> can include projections <NUM> configured to engage openings of housing <NUM>. Sleeve <NUM> is configured to hold a medicament chamber <NUM>, which can include a needle <NUM> at a distal end of medicament chamber <NUM>. In certain exemplary embodiments, medicament chamber <NUM> can include, for example, a separate glass ampule and a needle, or a pre-filled syringe, or sleeve <NUM> itself can include an integral medicament chamber. In one embodiment, a plunger <NUM> is provided in the medicament chamber <NUM>. Plunger <NUM> is in association with a ram <NUM> of firing mechanism <NUM>. During an injection, ram assembly <NUM> is urged by energy source <NUM> of firing mechanism <NUM> to displace plunger <NUM> distal, deeper into medicament chamber <NUM>, dispensing the medicament through needle <NUM>. In one embodiment, needle <NUM> includes an injecting tip 112a that is configured to penetrate the skin of a user and a hollow bore 112b that is in fluid communication with medicament chamber <NUM> to facilitate delivery of medicament from medicament chamber <NUM> to a user during an injection. <FIG> shows injection device <NUM> in a pre-firing state. The operation of injection device <NUM>, including its various stages and positions, are described in further detail below.

As also shown in <FIG>, injection device <NUM>, in certain embodiments, includes firing mechanism <NUM>. In one embodiment, firing mechanism <NUM> includes a ram assembly <NUM> slidably mounted within housing <NUM> and an energy source <NUM>. In an exemplary embodiment, the energy source <NUM> includes a compression spring <NUM>, however, other suitable energy source can be used, such as an elastomer or compressed-gas spring, or a gas generator, or other suitable energy storage members. In <FIG>, ram assembly <NUM> is in a pre-firing proximal-most position. During an injection, ram assembly <NUM> is urged distally by energy released by energy source <NUM>. Once an injection is completed, firing ram assembly <NUM> is disposed in a distal-most position. In this distal position, guard <NUM> is locked-out and extends over needle tip so that a user cannot attempt a subsequent injection and the needle guard <NUM> can function as sharps protection. Although shown as a single piece, ram assembly <NUM> can be a multiple piece assembly that can be coupled together, for example, via a snap-fit connection, a press-fit connection, a threaded engagement, adhesives, welding, or other suitable couplings. Ram assembly <NUM> preferable includes various features that can be configured to facilitate firing of injection device <NUM> to dispense the medicament stored in medicament chamber <NUM>. According to certain exemplary embodiments of the present disclosure, a trigger mechanism of injection device <NUM> can include ram assembly <NUM>, the floating trigger member <NUM>, which can include a retaining portion <NUM>, and ram retaining holding member <NUM>.

In one embodiment, injection device <NUM> includes a cap <NUM>, as shown in <FIG>. The cap <NUM> may be removably affixable to a distal end of outer housing <NUM>. In one embodiment, the cap <NUM> may be removably affixable to the distal end of sleeve <NUM>. For example, cap <NUM> can be removably affixed to the distal end of housing <NUM> via a threaded engagement and housing end/end cap <NUM> can include features (e.g., projections) configured to engage a portion of the proximal end of housing <NUM> (e.g., openings) to couple housing end/end cap <NUM> to housing <NUM>. When affixed to injection device <NUM>, the cap <NUM> can ensure that an injection is not triggered by an inadvertent application of a force to guard <NUM>. In one embodiment, the cap <NUM> includes two engagement features. As shown in <FIG>, the cap <NUM> can include engagement features <NUM> and <NUM>. Engagement features <NUM> and <NUM> can be threads configured to threadedly engage other features of injection device <NUM>. For example, engagement feature <NUM> can be configured to secure cap <NUM> to the distal end of housing <NUM> or be configured to threadedly engage a distal portion of sleeve <NUM>. In one embodiment, engagement feature <NUM> can be configured to threadedly engage features (e.g., threads) of guard <NUM> to prevent proximal displacement of guard <NUM>.

As shown in <FIG>, cap <NUM> has any regular or irregular shape and may be non-circular in cross-section viewed along its axis and in the initial, closed position aligns with or substantially matches the shape of the portion of the housing adjacent thereto. In one embodiment, features <NUM> and <NUM> may include a plurality of threads, having more than one thread starting point, only one of which will result in the cap lining up with the housing as in the initial closed position. Consequently, if the cap is removed and replaced, there is a chance that an incorrect starting point will be selected by the user, resulting in the cap no longer aligning with the injection device housing, and providing an indication of tampering. In one embodiment, three threads are used, so there is a two in three chance that a removed and replaced cap will become immediately obvious based on an ill-fitting cap.

As shown in <FIG>, in one embodiment, housing <NUM> includes openings configured to engage with sleeve <NUM> to couple and secure sleeve <NUM> to housing <NUM> and includes at least one window that can provide a visual indication of whether or not injection device <NUM> has been fired. For example, in a pre-firing state, the window allows a user to see medicament chamber <NUM>, along with the stored medicament, and in a fired state, the window shows one or more internal components, such as a portion of firing mechanism <NUM>, which can be a color specifically selected to alert the user that injection device <NUM> has been fired, and is, in one embodiment, sufficiently different than other colors visible to a user (in one embodiment, having ordinary eyesight) on injection device <NUM> prior to firing, so as to be conspicuously different to, or contrast from, any other colors present or significantly present. For example, in one embodiment, the color differs from all the other components of injection device <NUM> pre-firing, or visible by the user pre-firing, so as to be conspicuous (e.g., introducing an entirely new color family). In one embodiment, the new color appearing after firing, is from a non-analogous part of the color wheel, or can contrast, or can be a complementary color, with respect to the colors visible on injection device <NUM>. In one embodiment, the new color signifies caution, such as red or orange, etc. In one embodiment, the colors visible on injection device <NUM> in the pre-firing condition, and, in one embodiment, including when the cap <NUM> is on and/or off injection device <NUM>, are grays and blues, for instance. In one embodiment, when injection device <NUM> is fired, the color red is introduced. In one embodiment, this new color can be introduced after firing but prior to guard <NUM> being locked-out in the extended position.

In one embodiment, the injection device <NUM> includes a floating trigger member <NUM>, as shown in <FIG>. The floating trigger member <NUM> can have a proximal portion <NUM> and a distal portion <NUM>. In one embodiment, the floating trigger member <NUM> can include an opening <NUM>. Further, the floating trigger member <NUM> can include an opening <NUM> in the distal portion <NUM>. The opening <NUM> can include a retaining portion <NUM> configured to receive and engage trigger engagement member <NUM> of ram assembly <NUM> in facilitating firing of injection device <NUM>. The opening <NUM> is, in one embodiment, configured to engage a trigger engagement member <NUM> of ram assembly <NUM> such that they are aligned in one of two positions. For example, in first position 302a (e.g., retaining position), trigger engagement members <NUM> of ram assembly <NUM> are aligned so that they can be restrained by the retaining portion <NUM>, thereby preventing firing mechanism <NUM> from firing and dispensing the medicament. In second position 302b (e.g., firing position), the opening <NUM> can include firing portions <NUM> such that the trigger engagement members <NUM> of ram assembly <NUM> are aligned such that trigger engagement members <NUM> can splay apart, thereby permitting firing mechanism <NUM> to fire. <FIG> shows trigger engagement members <NUM> aligned in the first position (302a) and <FIG> shows trigger engagement members <NUM> aligned in the second position (302b). Further, the retaining portion <NUM> of the opening <NUM> (e.g., in the first position 302a) is, in one embodiment, curved to facilitate rotation of the floating trigger member <NUM> from the first and second positions. An exterior surface of distal portion <NUM> of the floating trigger member <NUM> can include camming surfaces <NUM>. In one embodiment, a portion of trigger engagement members <NUM> optionally engage rests <NUM>, such that when floating trigger member <NUM> rotates, trigger engagement members <NUM> disengage rests <NUM> allowing firing mechanism <NUM> to fire.

The proximal portion <NUM> of the floating trigger member can include flanges <NUM> having lips <NUM>, described further below with reference to <FIG>.

In one embodiment, as shown in <FIG>, energy source <NUM> (e.g., a spring) is decoupled from guard <NUM>. In one embodiment, the proximal end energy source <NUM> is coupled to housing <NUM>. By decoupling energy source <NUM> from guard <NUM>, the apparent friction of rotation of floating trigger member <NUM> is significantly reduced. This in turn substantially reduces the amount of force necessary to move guard <NUM> from an extended position to the firing position as described with reference to <FIG>, below. Specifically, the compression of components caused by energy source <NUM> is substantially eliminated thereby significantly reducing the amount of apparent friction and resistance to movement of guard <NUM> during use of injection device <NUM>.

As shown in <FIG>, in one embodiment, injection device <NUM> also includes housing end/end cap <NUM>. One embodiment of a housing end/end cap <NUM> is shown in <FIG>. As shown in <FIG>, in one embodiment, housing end/end cap <NUM> includes a body portion <NUM> and a ram holding member <NUM>. In one embodiment, ram holding member <NUM> is a projection, and is configured to engage a trigger engagement member of firing mechanism <NUM>. For example, as shown in <FIG>, in one embodiment, ram holding member <NUM> is a bell-shaped projection, and is engaged with a complementary shaped feature (e.g., projections) 1230a of firing mechanism <NUM>. As shown in <FIG>, in an exemplary embodiment, ram holding member <NUM> can include a groove 1042a and a bulge 1042b, and features 1230a of firing mechanism <NUM> can be configured to align with groove 1042a so as to hold bulge 1042b to prevent firing of injection device <NUM>. In one embodiment, ram holding member <NUM> and the features 1230a of firing mechanism <NUM> engaging with ram holding member <NUM> include a circular cross section to allow rotation of the features of firing mechanism <NUM> relative to ram holding member <NUM> during firing of injection device <NUM>. As shown in <FIG>, further, body portion <NUM> can include projections 1040a configured to engage openings in outer housing <NUM> to couple housing end/end cap <NUM> to housing <NUM>. <FIG> shows another embodiment of a housing end/end cap <NUM>.

In an exemplary embodiment, the housing end/end cap <NUM> optionally includes an engagement member <NUM>, as shown in <FIG>. As further detailed in <FIG>, the engagement member <NUM> engages lip <NUM> of the floating trigger member <NUM> when the floating trigger member <NUM> is rotated from the first position to the second position. In certain embodiments having engagement member <NUM> and lip <NUM>, a threshold breakaway force is needed to overcome the resistance on the floating trigger member <NUM> caused by the engagement portion <NUM> when the floating trigger member <NUM> is moved at least partially from the first position to the second position. In certain embodiments, the breakaway feature serves as a safety to prevent unintended rotation of the floating trigger member <NUM>.

As shown in <FIG>, in one embodiment, sleeve <NUM> includes a ring-like structure <NUM>, a coupling arrangement <NUM>, and a body portion <NUM>. Coupling arrangement <NUM> can be disposed at a distal portion of sleeve <NUM> and can be configured to releasably engage cap <NUM>. For example, as seen in <FIG> and <FIG>, coupling arrangement <NUM> can include threads configured to provide threaded engagement between sleeve <NUM> and cap <NUM>. Further, sleeve <NUM> can include a body portion <NUM> configured to secure medicament chamber <NUM>. Body portion <NUM> can include guides, such as grooves 1164a, configured to engage with features of guard <NUM> to align and guide axial displacement of guard <NUM>. As shown in <FIG>, a proximal end of sleeve <NUM> can include a medicament chamber support <NUM> configured to support and secure a proximal portion of medicament chamber <NUM>. For example, support <NUM> can be configured as a syringe support configured to hold a proximal end of syringe (e.g., flanges of a prefilled syringe) and can support medicament chamber <NUM> during the forces exerted on it during firing. Further, support <NUM> can include an elastomer or a rubber, and can be configured to distribute the force exerted on surfaces of the medicament chamber <NUM> during an injection and protect the medicament container from shock during transport or inadvertent damage during use. Additionally, as shown in <FIG> and <FIG>, sleeve <NUM> can include various features, such as projections <NUM>, configured to couple sleeve <NUM> to outer housing <NUM>. For example, projections <NUM> can be concentrically symmetrical and configured to engage openings 102b in outer housing <NUM> to secure sleeve <NUM> to outer housing <NUM>. In an exemplary embodiment, projections <NUM> can be disposed on legs <NUM>, which can be concentrically symmetrical and configured to engage with features of the outer housing <NUM>. Additionally, sleeve <NUM> can include locking features, such as locking projections <NUM>, disposed on legs <NUM>, which can be concentrically symmetrical, and can be configured to engage with features of guard <NUM> of firing mechanism <NUM> resulting in locking out injection device <NUM> to prevent a user from attempting to use an already-fired injection device <NUM>.

In one embodiment, ring-like structure <NUM> includes several features configured to engage sleeve <NUM> with medicament chamber <NUM> (e.g., a glass medicament chamber <NUM>), firing mechanism <NUM>, and guard <NUM>. For example, ring-like structure <NUM> can include an opening through which needle <NUM> can be received. Further, ring-like structure <NUM> can include concentrically symmetrical openings <NUM> which can be configured to receive legs of guard <NUM>. Additionally, ring-like structure <NUM> can be configured to support a distal portion of medicament chamber <NUM> and engage firing mechanism <NUM> in preventing further axial displacement of firing mechanism <NUM> during dispensing of the medicament. Operations of these components are described in further detail below.

Referring to <FIG>, in certain embodiments, at least a portion of sleeve <NUM>, which holds or receives the medicament chamber, is sufficiently deformable that it functions as a shock absorbing member to distribute the force exerted on the medicament chamber <NUM> during an injection, and /or to protect the medicament chamber <NUM> from shock during transport or from inadvertent damage during use or storage. In addition, the inclusion of such shock absorbance can be useful when there is a need to inject medicament that is quite viscous, or perform injections quickly (e.g., in less than <NUM> seconds), or perform injections at a high speed (e.g., rescue medications where quick relief is required including but not limited to muscle relaxants, anticholinergics, anti-histamines, anti-toxins, such as atropine, epinephrine, and anti-venom serums or for injections that require short needles (e.g., including but not limited to medications where the dosage is most suitable for or calibrated for intradermal delivery, or medications for subcutaneous delivery where inadvertent intramuscular administration can create adverse events, such as vaccines and/or triptans), or injections where there exists a need to minimize drug presence on the skin following injection referred to as leak back including but not limited to drugs with narrow therapeutic windows, drugs where inadvertent contact by others could be harmful, etc..

In some embodiments, in response to a force load acting upon it, at least a portion of sleeve <NUM> compresses, deforms or otherwise causes a shortening of the overall length of sleeve <NUM> upon activation of injection device <NUM>, without causing failure of the device or substantively diminishing the utility of the device (collectively referred to herein as "compression" or "compressible"). In other related embodiments, once shortened in length, the length of sleeve <NUM> does not shorten further during the injection of a medicament. After the load is removed, in certain other embodiments, sleeve <NUM> expands or lengthens such that its overall length approximates substantially the original length of sleeve <NUM>. In certain embodiments, the shortening and lengthening of sleeve <NUM> occurs quickly (e.g., in <NUM> seconds or less). Each of the above aspects is described in more detail hereafter.

<FIG> shows another exemplary embodiment of a sleeve. As shown in <FIG>, sleeve <NUM> may include one or more compressible elements <NUM>, such as posts, pillars or columns , which connect the proximal end of sleeve <NUM> to the distal end of sleeve <NUM>. In one embodiment, the sleeve <NUM> includes four compressible posts 1964a, 1964b, 1964c and 1964d spaced around and extending generally along a longitudinal axis of the sleeve <NUM>. In one embodiment, the compressible element <NUM> is radially bent as shown such that the compressible element <NUM> bends in a generally predetermined direction. In other embodiments, the compressible element <NUM> is generally parallel with the longitudinal axis. In other embodiments, the compressible elements <NUM> twists or helically wraps around the longitudinal axis.

While the compressible elements are shown as posts <NUM>, the compressible elements can be located at or be the proximal end, the distal end or a combination of proximal end, distal end and the connecting portion. While <FIG> shows the four compressible posts 1964a, 1964b, 1964c and 1964d as separated longitudinally by an empty space in sleeve <NUM>, in certain embodiments, it is contemplated that a single compressible element <NUM> can be used to connect the proximal end of sleeve <NUM> to the distal end of sleeve <NUM> (e.g., a compressible tubular member). According to the invention, the compressible element <NUM> is a single sleeve having one or more longitudinally extending cuts or openings.

In one embodiment, the compressible element <NUM> may be elastically deformable. Compressible element <NUM> may be comprised of any suitable material including elastomer, polymer, cushioning elements, metal or other solid that is deformable and capable of absorbing shock. In one embodiment, sleeve <NUM> can be comprised of one or more of the polymers listed in <FIG>. In <FIG>, posts 1964a, 1964b, 1964c, 1964d are made of the same material as the proximal and distal ends of sleeve <NUM>, but do not have supporting braces which in turn facilitates compression of posts 1964a, 1964b, 1964c, 1964d.

In response to being put under a load that is within the range of the spring forces that are anticipated for use in an injection device, e.g., an auto-injector, acting upon the compressible elements of sleeve <NUM>, the overall length of sleeve <NUM> can be shortened by greater than or equal to <NUM>% of the original length by virtue of the inclusion of a compressible element <NUM> of sleeve <NUM>. In certain embodiments, the overall length can be shortened by greater than <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>% of the original length. In certain embodiments, the overall length of sleeve <NUM> can be shortened by <NUM>% to <NUM>% of the original length of sleeve <NUM>.

For example, in response to an <NUM> lb force , in certain embodiments, sleeve <NUM>, having a starting overall length of <NUM> inches, is compressed such that its overall length becomes less than <NUM> inches. <NUM> lbf equals <NUM>. 448N and <NUM> inch equals <NUM> (SI Units). In other words, when under a load of <NUM> lb force, the overall length of sleeve <NUM> is shortened by more than <NUM> inches. In certain other embodiments, in response to an <NUM> lb force, sleeve <NUM> having a starting overall length of <NUM> inches is compressed such that its overall length is reduced to less than <NUM> inches. In certain embodiments, in response to an <NUM> lb force, the overall length of sleeve <NUM> is shortened by equal to or greater than <NUM> inches. In certain embodiments, in response to an <NUM> lb force, the overall length of sleeve <NUM> is shortened by between <NUM> and <NUM> inches, more typically <NUM> and <NUM> inches. In certain embodiments, at <NUM> lb force, sleeve <NUM> compresses such that its overall length is reduced by <NUM> inches +/- <NUM> inches. In certain embodiments, at <NUM> lb force, sleeve <NUM> compresses such that its overall length is reduced by <NUM> inches +/- <NUM> inches. In certain embodiments, at <NUM> lb force, sleeve <NUM> compresses such that its overall length is reduced by <NUM> inches +/- <NUM> inches.

In Chart <NUM>, the <NUM>-strut member does not include any compressible elements <NUM> and accordingly does not compress to the same extent as the <NUM>-strut member which contains <NUM> (four) compressible elements <NUM>. The difference in compressibility becomes apparent at relatively low force loads. For example, even at <NUM> or <NUM> lbs force, a significant difference in compressibility can be seen between the tested sleeves.

In certain embodiments, when compressed or deformed under load, the compressible element does not compress further during use of the device. In certain embodiments, once compressed or deformed under load, the compressible element <NUM> does not compress further if the force load is held constant. In one embodiment, the compressible element is permanently deformed (e.g., crumpled or crushed) when the force is removed.

In certain embodiments, one or more compressible elements <NUM> are elastically deformable when acted upon by forces within the range of the spring forces that are anticipated for use in an injection device, e.g., an auto-injector. Once use of the device is complete and the load is removed from the compressible elements <NUM> the overall length of sleeve <NUM> can return to its original length. In some embodiments, when compressed under a load of <NUM> lbs-force, upon removal of the force, the overall length of sleeve <NUM> returns to its original length +/- <NUM> inches. It should be noted that in some embodiments, sleeve <NUM>, including any compressible elements <NUM>, is configured to resist yielding/failure until a threshold force is met or exceeded. In certain embodiments, the threshold force for failure is at or about <NUM> lbs-force to <NUM> lbs-force, as shown in the following chart, Chart <NUM>:
<IMG>.

As shown in <FIG>, in one embodiment, injection device <NUM> includes a guard <NUM> slidably mounted at least partially within outer housing <NUM> and configured to engage trigger member <NUM> to actuate firing of injection device <NUM>. As shown in <FIG>, in one embodiment, guard <NUM> is slidably movable relative to outer housing <NUM> between an extended (e.g., a distal, protective) position and a retracted (e.g., proximal) position, respectively. In the extended position, guard <NUM>, in one embodiment, covers needle <NUM>, and in the retracted position, needle <NUM> is not covered by guard <NUM> and is thereby exposed. For example, <FIG> shows guard <NUM> in the extended position, and <FIG> shows guard <NUM> in the retracted position. As shown in <FIG>, in one embodiment, guard <NUM> is resiliently biased toward the extended position via a spring <NUM>, which can be disposed, for example, between a distal surface of ring-like structure <NUM> of sleeve <NUM> and an interior surface of a distal end of guard <NUM>.

In an exemplary embodiment, guard <NUM> includes a distal portion <NUM> and legs <NUM>. In an exemplary embodiment, the distal end of guard <NUM> includes a skin-contacting member. Distal portion <NUM> includes an opening through which needle <NUM> can pass and projections 1060a. In an exemplary embodiment, projections 1060a can be configured to engage engagement features <NUM> of cap <NUM> so that guard <NUM> cannot be proximally displaced when engaged with engagement features <NUM> of cap <NUM>. In an exemplary embodiment, the guard <NUM> includes a stop surface <NUM>. In an exemplary embodiment, the stop surface <NUM> can be configured to abut an inside surface of the ring like structure <NUM> of sleeve <NUM> so as to limit the proximal displacement of guard <NUM>. For example, as guard <NUM> is proximally displaced under a force applied by a user during an injection, stop surface <NUM> will come into contact with the inside surface of the ring like structure <NUM> of sleeve <NUM> so that guard <NUM> cannot be further proximally displaced.

In one embodiment, legs <NUM> of guard <NUM> are configured to be received in openings <NUM> of ring-like structure <NUM>. Further, legs <NUM> can include ridges 1062a configured to engage grooves 1164a of sleeve <NUM>, to facilitate alignment and guiding of legs <NUM> as guard <NUM> is axially displaced. As shown in the exemplary embodiment of <FIG>, legs <NUM> also include firing-initiation members, such as camming surfaces <NUM> at a proximal end of legs <NUM>. In an exemplary embodiment, legs <NUM> and camming surface <NUM> can be concentrically symmetrical. Camming surfaces <NUM> are configured to engage trigger member <NUM> in initiating a firing of injection device <NUM> and performing an injection of the medicament stored in medicament chamber <NUM>. The proximal ends of legs <NUM> can also be sloped to facilitate legs <NUM> being received within firing mechanism <NUM> when guard <NUM> is displaced from the extended position to the retracted position. As shown in <FIG>, in an exemplary embodiment, the camming surfaces <NUM> are configured to engage camming surfaces <NUM> of the floating trigger member <NUM>. In one embodiment, legs <NUM> include projections <NUM> disposed on springs <NUM> which can also include sloped surfaces 1068a. As shown in <FIG>, projections <NUM> can be configured to engage proximal surfaces of legs <NUM> of sleeve <NUM> to oppose a force exerted by spring <NUM>, which biases guard <NUM> in the extended position. Further, sloped surfaces 1068a of legs <NUM> of guard <NUM> can be configured to engage an interior surface of legs <NUM> of sleeve <NUM> so that as guard <NUM> is displaced from the extended position to the retracted position, sloped surfaces 1068a of legs <NUM> of guard <NUM> engage the interior surfaces of legs <NUM> of sleeve <NUM> so as to bias springs <NUM> of legs <NUM> of guard <NUM> towards an interior of injection device <NUM>.

<FIG> shows engagement of camming surfaces <NUM> of the guard with camming surfaces <NUM> of the floating trigger member <NUM> in a pre-firing "ready-to-use" state. <FIG> shows engagement of camming surfaces <NUM> of the guard with camming surfaces <NUM> of the floating trigger member <NUM> in a triggered or "just-fired" state. As guard <NUM> is moved in the proximal direction, the axial movement of guard <NUM> is translated into a rotational movement of the floating trigger member <NUM> via the engagement of camming surfaces <NUM> and <NUM>.

In an exemplary embodiment as shown in <FIG>, ram assembly <NUM> containing ram <NUM> can include a distal portion <NUM> and a proximal portion <NUM> separated by a feature <NUM>, such as a lip, a ledge, that can be configured to act as a seat for energy source <NUM>. As shown in <FIG>, in an exemplary embodiment, compression spring as the energy source <NUM> can be disposed between a proximal end of housing <NUM> and feature <NUM>. As shown in <FIG>, in an exemplary embodiment, housing <NUM> includes a feature 102a, such as a lip, that is configured to act as a seat for energy source <NUM>. Feature 102a can be designed or include elements that reduce friction due to compression spring rotation when energy source <NUM> is in contact with feature 102a in housing <NUM>. Ram assembly <NUM> including distal portion <NUM> can be substantially cylindrical and can be configured to concentrically receive at least a portion of sleeve <NUM> and guard <NUM>. Distal portion <NUM> can also include openings <NUM> configured to receive legs <NUM> of sleeve <NUM> and projection <NUM> of guard <NUM>.

In one embodiment, proximal portion <NUM> includes legs <NUM>, a ram <NUM>, and a trigger engagement member <NUM>. Although the trigger engagement member <NUM> is shown as projections, alternative implementations are contemplated. The trigger engagement member <NUM> can include any feature (e.g., an elongated tab, a thinned tab, a recess, a protrusion, a bulge, a thread, etc.) that can be held by ram retaining member in the pre-firing state, and released upon rotation of the floating trigger member.

As shown in <FIG>, in one embodiment, camming surface <NUM> of guard <NUM> and camming surface <NUM> of floating trigger member <NUM> are oriented at an angle with respect to the longitudinal axis of the device to achieve a selected force and throw required to depress the guard <NUM> from the extended to the retracted position to fire the device. In some embodiments, the camming surfaces are angled at between <NUM>° and <NUM>° with respect to the axis, and, in one embodiment, between about <NUM>° and <NUM>°. In one embodiment, the camming surfaces are angles at about <NUM>° with respect to the axis.

As shown in <FIG>, legs <NUM> include openings <NUM> configured to engage locking projections <NUM> of sleeve <NUM>. It is understood that openings <NUM> accommodating alternate specific delivery volumes may be configured on distal portion <NUM> to engage locking projections <NUM> of sleeve <NUM>. As shown in <FIG>, for example, locking projections <NUM> of sleeve <NUM> can engage openings <NUM> of ram assembly <NUM> after injection device <NUM> has been fired, locking-out injection device <NUM> so that a user cannot initiate subsequent retraction of guard <NUM> exposing needle <NUM>. Ram <NUM> is configured to be in association with plunger <NUM>, and distally displace plunger <NUM> under the force of energy source <NUM> to dispense the medicament contained in medicament chamber <NUM> during an injection. Additionally, trigger engagement members <NUM> can be disposed at a proximal end of proximal portion <NUM> and can be configured to engage opening <NUM> of floating trigger member <NUM> and ram holding member <NUM> of housing end/end cap <NUM>. The engagement of trigger engagement members <NUM> with opening <NUM> and ram holding member <NUM>, as well as the alignment of trigger engagement members <NUM> within opening <NUM> can control and enable firing of injection device <NUM>. For example, trigger engagement members <NUM> can include bulges 1230a configured to engage groove 1042a of ram holding member <NUM>, and shapes 1230b configured to engage bulge 1042b of ram holding member <NUM>. As noted above, trigger engagement members <NUM> and ram holding member <NUM> preferably include circular cross-sections to allow rotation of floating trigger member <NUM> during firing of injection device <NUM>. <FIG> shows a close-up view of an embodiment of the engagement of trigger engagement member <NUM> (e.g., projections) with one embodiment of ram holding member <NUM>.

In certain embodiments, as shown in <FIG>, <FIG>, the engagement of the bulges 1230a of trigger engagement members <NUM> of ram assembly <NUM> with ram holding member <NUM> of housing end/end cap <NUM> creates a latch retention angle <NUM>. In one embodiment, latch retention angle <NUM> is defined by axis <NUM> and the contact surface of a distal portion of groove 1042a of ram holding member <NUM> and bulges 1230a of ram assembly <NUM>. In certain embodiments, projections <NUM> and ram holding member <NUM> are sized and shaped to create, when engaged, a latch retention angle <NUM> of about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>° or any range determinable from the preceding angles (for example, about <NUM>° to about <NUM>° or about <NUM>° to about <NUM>°).

In certain embodiments, in a pre-fired state, trigger engagement members <NUM> are engaged with the wall of the opening of the trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM> (as discussed in more detail below)), bulges 1230a of ram assembly <NUM> and ram holding member <NUM> of housing end/end cap <NUM> are engaged, and energy source <NUM> is acting on ram assembly <NUM>. In one embodiment, the engagement of bulges 1230a and ram holding member <NUM> hold ram assembly <NUM> in place against the distally-directed force being applied to ram assembly <NUM> by energy source <NUM>. In one embodiment, in a pre-fired state, energy source <NUM> is applying axial force on ram assembly <NUM>, which causes bulges 1230a of projections <NUM> of ram assembly <NUM> to engage bulge 1042b of ram holding member <NUM>. In one embodiment, the engagement of trigger engagement members <NUM> of ram assembly <NUM> with ram holding member <NUM> causes a transfer of force from energy source <NUM> through to ram holding member <NUM>. In one embodiment, bulges 1230a are configured to bias such that exertion of force by bulges 1230a on ram holding member <NUM> causes trigger engagement members <NUM> to splay and exert a radial force on the wall of the opening of trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM>). In one embodiment, the exertion of the radial force by trigger engagement members <NUM> on the wall of the opening of the trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM>) is such that it causes any movement of the trigger member (e.g., floating trigger member <NUM> or trigger member <NUM>) to be met with a friction force. In one embodiment, the factors that affect the amount of friction force between the trigger member and trigger engagement members <NUM> include the amount of radial force being applied on the wall of the opening of the trigger member by trigger engagement members <NUM> and the interaction between the contacting surfaces of the trigger engagement members <NUM> and the wall of the opening of the trigger member. In one embodiment, generally, when holding all other variables constant, the greater the amount of radial force being applied on the wall of the opening of the trigger member by trigger engagement member <NUM>, the greater the frictional force generated by movement of the trigger member. In one embodiment, generally, when holding all other variables constant, the lower the amount of radial force being applied on the wall of the opening of the trigger member by trigger engagement member <NUM>, the lower the frictional force generated by movement of the trigger member. In one embodiment, to actuate injection device <NUM>, the user must apply a force on the distal end of guard <NUM>, which cause guard <NUM> to engage the trigger member (e.g., floating trigger member <NUM> or trigger member <NUM>) and actuate injection device <NUM>. In one embodiment, the force being applied to the distal end of guard <NUM> must be sufficient to overcome the friction force caused by the contact between the trigger member and the trigger engagement members <NUM>.

The embodiments of designs where main spring force, in its compressed pre-fired state, acts on the restraining components in such a manner where the force of the compressed main spring is more axial than radial with the result of a potentially lower triggering force. This is especially important where the compressed forces of the main spring are high spring forces as described. In one embodiment, in a pre-fired state, bulges 1230a on trigger engagement member <NUM>, when engaged with ram holding member <NUM>, distribute both an axial force and a radial force on ram holding member <NUM>. However, in one embodiment, the bulges 1230a are configured to bias the forces toward a radial force directed on ram holding member <NUM> by trigger engagement member <NUM> to cause the trigger engagement members <NUM> to splay outward and engage the wall of opening of trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM>). In one embodiment, latch retention angle <NUM> determines the amount of axial force and radial force that is translated to the ram holding member <NUM>. In one embodiment, as latch retention angle <NUM> increases, less radial force is exerted on ram holding member <NUM> by trigger engagement member <NUM> and, thus, the frictional force resulting from the splaying of ram engagement members <NUM> is decreased. In one embodiment, as the force acting to cause the splaying of trigger engagement member <NUM> is decreased, less force is exerted on the wall of the opening of trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM>) and, thereby, less force is required to actuate injection device <NUM> than in an embodiment having a larger latch retention angle <NUM>. In one embodiment, where energy source <NUM> is a high force spring of about <NUM> lbs. load capacity and latch retention angle <NUM> is <NUM>°, a user must overcome about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. about <NUM> lbs, about <NUM> lbs, about <NUM> lbs. about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. or any range determinable from the preceding pounds (for example, about <NUM> lbs. to about <NUM> lbs. or about <NUM> lbs. to about <NUM> lbs. ) of friction force to actuate injection device <NUM>. In another embodiment, where energy source <NUM> is a high force spring with <NUM> lbs. load capacity and latch retention angle <NUM> is <NUM>°, a user will need only overcome about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, about <NUM> lbs, or any range determinable from the preceding pounds (for example, about <NUM> lbs. to about <NUM> lbs. or about <NUM> lbs. to about <NUM> lbs. ) of friction force to actuate injection device <NUM>. <NUM> lbf equals <NUM>. 448N (SI Units).

Table <NUM> shows exemplary force values needed to overcome the friction force to actuate injection device <NUM> where the energy source <NUM> is a high force spring with <NUM> lbs. load capacity and the latch retention angle <NUM> is <NUM>° (Design A) and <NUM>° (Design B).

In certain embodiments, a user will need to overcome both the friction force and the force resiliently biasing guard <NUM> toward the extended position via spring <NUM> to actuate injection device <NUM>.

In certain embodiments, energy source <NUM> is configured to generate sufficient force to cause disengagement of bulges 1230a and trigger engagement member <NUM> when trigger engagement members <NUM> are no longer engaged with the wall of the opening of the trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM>). In one embodiment, the minimum axial force needed to cause disengagement of bulges 1230a and trigger engagement member <NUM> when trigger engagement members <NUM> are no longer engaged with the wall of the opening of the trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM>) is about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , about <NUM> lbs. , or any range determinable from the preceding loads (for example, about <NUM> lbs. to about <NUM> lbs. or about <NUM> lbs. to about <NUM> lbs. <NUM> lbf equals <NUM>. 448N (SI Units). In other embodiments, the minimum axial force needed to cause disengagement of bulges 1230a and trigger engagement member <NUM> when members <NUM> are no longer engaged with the wall of the opening of the trigger member (e.g., opening <NUM> of floating trigger member <NUM> or opening <NUM> of trigger member <NUM>) is about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>% or any range determinable from the preceding percentages (for example, about <NUM>% to about <NUM>% or about <NUM>% to about <NUM>%) of the force generated by energy source <NUM> acting on ram assembly <NUM>.

In one embodiment, injection device <NUM> includes an anti-rotational mechanism that prevents ram assembly <NUM> from rotating relative to housing end/end cap <NUM>. In one embodiment, the anti-rotational mechanism controls alignment of housing end/end cap <NUM> and ram assembly <NUM>. In certain embodiments, improper alignment of the housing end/end cap and ram assembly will prevent the disengagement of ram assembly <NUM> from the housing end/end cap <NUM> or cause incomplete drug delivery. In one embodiment, as shown in <FIG>, housing end/end cap <NUM> includes one or more anti-rotational ribs <NUM>. In other embodiments, ram assembly <NUM> has one or more anti-rotational ribs <NUM>. In one embodiment, in a pre-triggered, anti-rotational ribs <NUM> of the housing end/end cap <NUM> align with anti-rotational ribs <NUM> of ram assembly <NUM> within a groove <NUM> of the trigger member <NUM> such that ram assembly <NUM> is prevented from rotating relative to housing end/end cap <NUM>.

In an exemplary embodiment, the injection device <NUM> can be in a pre-firing "safeties-on" configuration. For example, in the pre-firing "safeties-on" configuration, injection device <NUM> is in a pre-firing state and cap <NUM> is affixed to injection device <NUM>. In this configuration, guard <NUM> is in the extended position under force of spring <NUM> covering needle <NUM>, ram assembly <NUM> is in its proximal position, and energy source <NUM> has not released its energy. Further, in this state, trigger engagement members <NUM> of ram assembly <NUM> are engaged with opening <NUM> of the floating trigger member <NUM> and aligned in the first position 302a (e.g., pre-firing condition) of opening <NUM>. Further, trigger engagement members <NUM> are also engaged with ram holding member <NUM> of housing end/end cap <NUM>. In this position, the trigger engagement member <NUM> with ram holding member <NUM> of housing end/end cap <NUM> oppose the force of energy source <NUM>. Further, with trigger engagement members <NUM> aligned within the first position 302a of opening <NUM>, the retaining portion <NUM> of opening <NUM> prevents trigger engagement members <NUM> from splaying open and disengaging ram holding member <NUM> under the force of energy source <NUM>.

In an exemplary embodiment, the injection device <NUM> can be in a pre-firing "ready-to-use" state. For example, in a pre-firing "ready-to-use" configuration, cap <NUM> has been removed, but the user has not otherwise initiated an injection. Accordingly, in this state, the medicament is still in medicament chamber <NUM>, guard <NUM> remains in an extended position covering needle <NUM>, energy source <NUM> has not released the energy that it has stored, and trigger engagement member <NUM> of ram assembly <NUM> remain engaged with ram holding member <NUM> and aligned in the first position (302a) of opening <NUM> of floating trigger member.

In an exemplary embodiment, the injection device <NUM> can be in a triggered or "just-fired" state. For example, in a triggered or "just-fired" state, guard <NUM> has been proximally slidably displaced (e.g., by application of a force on the distal end of guard <NUM>) from the extended position to the retracted position, thereby exposing needle <NUM>. Energy source <NUM> is just beginning to release its stored energy (e.g., the exemplary compression spring remains compressed), and ram assembly <NUM> remains in the proximal-most position. Injection device <NUM> may be in this state, for example, during an initial stage of use by a user. For example, this can be observed when the user has pressed guard <NUM> of injection device <NUM> against an injection site to perform an injection. Accordingly, the force exerted by the user in pressing guard <NUM> of injection device <NUM> against the injection site may have proximally displaced guard <NUM> against the force of spring <NUM>, thereby displacing guard <NUM> into the retracted position and exposing needle <NUM> to penetrate the user's skin at the injection site.

In on embodiment, in this triggered state, guard <NUM> has been displaced into the retracted position, camming surfaces <NUM> of guard <NUM> engage camming surfaces <NUM> of floating trigger member <NUM>, thereby camming floating trigger member <NUM>. This camming action rotates floating trigger member <NUM>, causing trigger engagement members <NUM> to become unaligned with the first position of opening <NUM> and become aligned with the second position of opening <NUM>. In this position, trigger engagement members <NUM> are no longer restrained from splaying open by retaining portion <NUM> of opening <NUM>. Accordingly, trigger engagement members <NUM> splay open under the force of, energy source <NUM>, causing bulges 1230a to disengage with ram holding member <NUM> of housing end/end cap <NUM>. The disengagement of bulges 1230a with ram holding member <NUM> allows ram assembly <NUM> to be distally slidably displaced relative to housing <NUM> under the force generated by energy source <NUM>. In one embodiment, the distal displacement of ram assembly <NUM> is restrained by ram assembly <NUM> abutting a proximal surface of ring-like structure <NUM> of sleeve <NUM>.

In an exemplary embodiment, the injection device <NUM> can be in a "just-injected" state. This state follows the disengagement of bulges 1230a with ram holding member <NUM> and the distal displacement of ram assembly <NUM> described above. In this state, energy source <NUM> (e.g., a compression spring) has released its energy, thereby distally displacing ram assembly <NUM>. Further, guard <NUM> remains compressed in the retracted position. This state may be observed during use of injection device <NUM> immediately following the trigger or "just-used" state. As described above, camming of floating trigger member <NUM> aligns projections <NUM> with the second position defined by opening <NUM>, allowing trigger engagement members <NUM> to splay open and disengage ram holding member <NUM> under the force released by energy source <NUM>. Accordingly, energy source <NUM> has released at least some, if not all, of its stored energy (e.g., compression spring is less compressed), and ram assembly <NUM>, as well as ram <NUM>, has been distally displaced into a distal position. The distal displacement of ram <NUM> urges plunger <NUM> in a distal direction, injecting the medicament into the user by dispensing the medicament in medicament chamber <NUM> through needle <NUM> and into the user. Although the injection has, in certain embodiments, been completed in this state, injection device <NUM> is still likely pressed against the injection site since guard <NUM> remains in a retracted position exposing needle <NUM>. Further, in certain embodiments, this distal displacement of ram assembly <NUM> positions ram assembly <NUM> such that it is displayed in a window of housing <NUM>. In an exemplary embodiment, after the distal displacement of ram assembly <NUM>, it is disposed between medicament container <NUM> and housing <NUM> such that it is entirely occluding the window so that only ram assembly <NUM> is visible through the window, and medicament container <NUM> is no longer visible (e.g., ram assembly is disposed between medicament container <NUM> and the window). Further, ram assembly <NUM> can have a color (as described above) that would be a clear indicator to a user that injection device <NUM> has been used, and different than the other colors visible from the outside of injection device <NUM> before firing.

In an exemplary embodiment, the injection device can be in a "locked-out" state. For example, the "locked-out" state can be observed after the user has removed injection device <NUM> from the injection site. In this state, nothing is restraining guard <NUM> in the retracted position against the force of spring <NUM>, and accordingly, guard <NUM> is distally displaced from the retracted position to the extended position under the force of spring <NUM>, thereby covering needle <NUM>. As guard <NUM> moves distally from the retracted position to the extended position under the force of spring <NUM>, projections <NUM>, which are disposed on springs <NUM> biased in an outward direction, engage the openings created between proximal surfaces of legs <NUM> of sleeve <NUM> and proximal walls of openings <NUM>. Accordingly, the association of projections <NUM> with the proximal walls of openings <NUM> prevents guard <NUM> from being displaced proximally, and the association of projections <NUM> with the proximal surfaces of legs <NUM> prevents guard <NUM> from being displaced distally. Thus, guard <NUM> is in a locked position, thereby locking-out injection device <NUM> such that needle <NUM> is covered and guard <NUM> is locked in place so that a user cannot attempt a subsequent injection. Afterwards, the user may affix cap <NUM> back onto the distal end of injection device <NUM>.

Advantageously, in one embodiment, this "locked-out" state is not dependent on displacement of guard <NUM>, but rather, is dependent on dispensing of the medicament stored in medicament chamber <NUM> and/or movement of ram assembly <NUM>. For example, injection device <NUM> becomes locked-out in situations where the medicament is inadvertently dispensed, even if guard <NUM> has not been displaced. Injection device <NUM> can become locked-out in any instance where energy source <NUM> is activated and ram assembly <NUM> is distally displaced, causing ram <NUM> to displace plunger <NUM>, thereby dispensing the medicament in medicament chamber <NUM>.

In an exemplary embodiment, many of the components of injection device <NUM> are made of a resilient plastic or polymer, or a metal. In one embodiment, projections <NUM> of ram assembly <NUM> are oriented so that ram assembly <NUM> can be molded using a single mold. For example, as shown in <FIG>, projections <NUM> (which are in certain embodiments concentrically symmetrical to each other) can be aligned at an angle relative to the alignment of the other features of ram assembly <NUM>, such as legs <NUM> (which are in certain embodiments concentrically symmetrical to each other). For example, as shown in <FIG>, a single mold can form the portion of ram assembly <NUM> designated A (including all the features, components, openings, etc. 1228A), and a single mold can form the portion of ram assembly designated B (including all the features, components, openings, etc. 1228B). Thus, in certain embodiments, each surface of projections <NUM> is accessible along a direction of separating the two molds, and the two molds can be separated linearly without a concave portion of projections <NUM> facing orthogonal to the separation direction impeding separation and removal of the molds.

Further, cap <NUM> can be configured helically so that it can be molded without a hole/opening. For example, cap <NUM> can include threads <NUM> that permit cap <NUM> to be threadedly removed from a mold. Further, outer housing <NUM> can include a translucent material to allow users to view the inner workings of injection device <NUM>, and ascertain if it is malfunctioning (e.g., as shown in <FIG>). Additionally, injection device <NUM> can include various gripping elements, such as ridges, pads, contours, or the like, to make injection device <NUM> more ergonomic, easy to use, and comfortable to the user. Further, injection device <NUM> can include markings, such as a sticker, brand markings, drug information, numerals, arrows, or the like, to indicate the steps needed to perform an injection, and areas for promotional markings such as brand and logo designations.

While illustrative embodiments of the invention are disclosed herein, it will be appreciated that numerous modifications and other embodiments may be devised by those skilled in the art. For example, the features for the various embodiments can be used in other embodiments. Other embodiments can include different mechanisms to cause the release of ram assembly <NUM> by actions on the trigger engagement member <NUM> and a triggering member. For example, in one embodiment, the injection device <NUM> includes a trigger member <NUM>, as shown in <FIG>. In one embodiment, the trigger member <NUM> has a body <NUM> and legs <NUM> extending from the body <NUM>. In one embodiment, body <NUM> includes lip <NUM>. In one embodiment, lip <NUM> is configured to engage surface <NUM> of guard <NUM> (described in more detail below and as seen in <FIG>). In certain embodiments, legs <NUM> have tabs <NUM> extending from a distal end of legs <NUM>. In one embodiment, tabs <NUM> are shaped and dimensioned to slideably engage guard <NUM>. Further, in one embodiment, trigger member <NUM> includes an opening <NUM> disposed through body <NUM>. In one embodiment, opening <NUM> is configured to engage a trigger engagement member <NUM> of firing mechanism <NUM>. In one embodiment, engagement of bulges 1230a on trigger engagement member <NUM> prevent injection device from firing. In one embodiment, trigger member <NUM> is configured such that axial movement in a proximal direction causes disengagement of opening <NUM> and projections <NUM>. Figure 14J shows another embodiment of trigger member <NUM>. In certain embodiments, trigger member <NUM> includes a groove <NUM> as part of an anti-rotational mechanism.

As shown in <FIG>, in one embodiment, injection device <NUM> includes a guard <NUM>. In one embodiment, guard <NUM> includes legs <NUM>. In another embodiment, legs <NUM> have firing-initiation members, such as surfaces <NUM> at a proximal end of legs <NUM>. In one embodiment, surfaces <NUM> are configured to engage lip <NUM> of trigger member <NUM>. In one embodiment, legs <NUM> are configured to be received in openings <NUM> of ring-like structure <NUM>. In one embodiment, legs <NUM> include ridges <NUM> configured to engage grooves 1164a of sleeve <NUM>, to facilitate alignment and guiding of legs <NUM> as guard <NUM> is axially displaced. In an exemplary embodiment, legs <NUM> and surfaces <NUM> are concentrically symmetrical. In one embodiment, surfaces <NUM> are configured to engage firing mechanism <NUM> in initiating a firing of injection device <NUM> and performing an injection of the medicament stored in medicament chamber <NUM>. In one embodiment, surfaces <NUM> are shaped to engage lip <NUM> of trigger member <NUM> when guard <NUM> is displaced from the extended position to the retracted position. In one embodiment, legs <NUM> include apertures <NUM>. In one embodiment, apertures <NUM> are sized and shaped to engage tabs <NUM> of trigger member <NUM>. In one embodiment, apertures <NUM> are sized and shaped to allow tabs <NUM> to be slideably engageable with apertures <NUM>. In one embodiment, as shown in <FIG> and <FIG>, when apertures <NUM> and tabs <NUM> are in a slideably engageable configuration, for a predetermine distance, guard <NUM> can axially translate without movement of trigger member <NUM>. In another embodiment, as shown in <FIG>, <FIG>, and <FIG>, when apertures <NUM> and tabs <NUM> are in a slideably engageable configuration, after guard <NUM> axially translates a predetermine distance without causing movement of trigger member <NUM>, axial translation of guard <NUM> beyond the predetermined distance causes axial translation of trigger member <NUM>.

In one embodiment, apertures <NUM> are sized and shaped to allow tabs <NUM> to snap-fit within the aperture <NUM>. In one embodiment, when the apertures <NUM> and tabs <NUM> are in a snap-fit configuration, axial translation of guard <NUM> causes direct axial translation of trigger member <NUM> such that guard <NUM> cannot axially translate without also translating trigger member <NUM>. In one embodiment, direct axial translation of trigger member <NUM> in a proximal direction causes disengagement of opening <NUM> of trigger member <NUM> and trigger engagement members <NUM> of firing mechanism, which causes disengagement of bulges 1230a and ram holding member <NUM>. In one embodiment, disengagement of ram holding member <NUM> housing end/end cap <NUM> and trigger engagement members <NUM> causes injections device <NUM> to fire.

Although not shown, it is also contemplated that a tab or protrusion can be located on legs <NUM> of guard <NUM> such that the tab can communicate, either slidingly or directly with an aperture located on trigger member <NUM>.

Other embodiments can include different mechanisms to cause the release of trigger engagement members <NUM> from a trigger member, such as by direct rotation of the floating trigger member <NUM> by a user, such as via a slide or other element accessible on the outside of the housing, or by a button that is pushed with a finger, or another transmission mechanism to rotate the floating trigger member. Therefore, it will be understood that the appended claims are intended to cover all such modifications and embodiments that come within the scope of the appended claims.

<FIG> is an exemplary embodiment of an injection device, e.g., an auto-injector, having a pin-like safety mechanism. In one embodiment, the pin-like safety mechanism is used to keep a high force spring compressed during assembly of the injection device.

The term "about," as used herein, should generally be understood to refer to both the corresponding number and a range of numbers. Moreover, all numerical ranges herein should be understood to include each whole integer within the range.

Claim 1:
An injection device (<NUM>) comprising:
a housing (<NUM>);
a medicament chamber (<NUM>);
a needle guard (<NUM>) moveable relative to the housing between an extended position and a retracted position; and
a shock absorbing member including a sleeve (<NUM>) configured to receive the medicament chamber, the sleeve having a proximal end and a distal end connected by a middle portion,
characterized in that the sleeve includes a compressible element (<NUM>) between the proximal end and the distal end that is deformable,
wherein the compressible element (<NUM>) is a single sleeve having one or more longitudinally extending openings.