Drug injection device and method

Abstract

A drug delivery device includes a housing and a first drive member including at least one arm having teeth. The nut includes at least one tooth, and the at least one tooth of the nut includes a first face and a second face. The teeth of the first drive member are engageable with the first face during dose dispensing to allow rotation of the first drive member relative to the housing, and are engageable with the second face during dose setting to prevent rotation of the first drive member relative to the housing. Systems and methods of use are disclosed.

Description

Technical Field

[0001] The present disclosure relates generally to injection devices for dispensing medicaments to patients, and more particularly to injection devices including components for setting and delivering one or more selected doses from a drug cartridge. Background Art

[0002] Injectable drugs and biologics are used to treat a variety of diseases, disorders, injuries, and / or conditions. For example, in patients with diabetic conditions, injectable drugs and biologics are used in an attempt to treat and prevent complications associated with diabetes, such as high blood pressure, kidney disease, nerve damage, heart disease, and / or blindness. These injectable drugs and biologics can be administered to patients with the assistance of a caregiver or through self-administration using a drug delivery device.

[0003] Drug delivery devices can provide single doses or set doses of drugs, biological products and / or reagents from a cartridge containing a certain amount of drugs, biological products and / or reagents for preparing a therapeutic dose. Drug delivery devices can be configured differently, including disposable pre-filled syringe devices, which can be user-activated, gear-driven, spring-activated, electronic and / or automatic. In some cases, drug delivery devices include disposable and / or reusable pen devices that allow diabetics to inject continuously measured doses of insulin solutions. These types of pen devices can be configured to administer one or more set doses and enable the patient or caregiver to set the measured dose, correct the amount of the dose if necessary, and inject the dose. These pen devices can also provide feedback to the user during dose setting, correction and / or dose dispensing. The present disclosure describes improvements to these prior arts. Summary of the Invention

[0004] In one example, a drug delivery device is provided. The drug delivery device includes a housing and a first drive member, the first drive member including at least one arm having teeth. A nut includes at least one tooth, and the at least one tooth of the nut includes a first face and a second face. The tooth of the first drive member is engageable with the first face during dose dispensing to allow the first drive member to rotate relative to the housing, and is engageable with the second face during dose setting to prevent the first drive member from rotating relative to the housing. Systems and methods of use are also disclosed.

[0005] In one example, a drug delivery device comprises a housing and a first single-arm ratchet having teeth comprising arcuate surfaces. A dose member comprises internal teeth engageable with the teeth to provide audible and / or tactile feedback during dose setting.

[0006] In one example, a drug delivery device includes a housing and a first single-arm ratchet having teeth including arcuate surfaces. A first drive member includes internal teeth engageable with at least one tooth to provide audible and / or tactile feedback during dose correction.

[0007] In one example, a drug delivery device includes a housing and a dose button. A double ratchet includes an upper ring comprising a first single-arm ratchet having teeth with arcuate surfaces, and a lower ring comprising a second single-arm ratchet having teeth with arcuate surfaces. The first single-arm ratchet has teeth with arcuate surfaces, and the second single-arm ratchet has teeth with arcuate surfaces. The dose sleeve includes internal teeth that can engage with teeth on the upper ring to provide audible and / or tactile feedback during dose setting. The drive sleeve includes internal teeth that can engage with teeth on the lower ring to provide audible and / or tactile feedback during dose correction. A non-return drive sleeve is keyed to the drive sleeve and includes at least one arm having teeth. The nut includes at least one tooth having a first face and a second face defining an arc. In some non-limiting embodiments, the arc can have a uniform radius. The teeth of the non-return drive sleeve can engage with the first face during dose dispensing to allow the drive sleeve to rotate relative to the housing, and can engage with the second face during dose setting to prevent the drive sleeve from rotating relative to the housing. The drug delivery device includes a leadscrew and a drug cartridge including a piston.

[0008] In one example, a drug delivery device includes a housing, a non-return drive sleeve including at least one arm having teeth, and a nut including at least one tooth. The at least one tooth of the nut includes a first face and a second face. During dose dispensing, the tooth of a first drive member can engage with the first face to define a linearly decreasing torque gradient, thereby allowing the first drive member to rotate relative to the housing. During dose setting, the tooth of the first drive member can engage with the second face to prevent the first drive member from rotating relative to the housing and prevent backdriving of one or more components of the drug delivery device.

[0009] In one example, a drug delivery device includes a housing defining a longitudinal axis. A non-return drive sleeve includes a first circumferential arm having teeth, a second circumferential arm having teeth, and a third circumferential arm having teeth. The arms are spaced approximately equidistantly around the non-return drive sleeve. A nut includes at least one tooth. The arms are configured to be disposed with the nut such that the non-return drive sleeve is coaxially aligned with the housing. During dose dispensing, the teeth of the non-return drive sleeve can engage with at least one tooth of the nut, thereby allowing a first drive member to rotate relative to the housing. During dose setting, the teeth of the non-return drive sleeve can engage with at least one tooth of the nut to prevent the first drive member from rotating relative to the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The present disclosure will become more apparent from the detailed description accompanying the following drawings, in which:

[0011] Figure 1 is a perspective view of components of one example of a drug delivery device according to the principles of the present disclosure;

[0012] Figure 2 is Figure 1 is a cross-sectional view of the components shown;

[0013] Figure 3 is Figure 1 is a cross-sectional view of the components shown;

[0014] Figure 4 is Figure 1 is a perspective view of components of the device shown, with parts broken away;

[0015] Figure 5 is Figure 3 is a cutaway view of the components shown;

[0016] Figure 6 is Figure 3 is a cutaway view of the components shown;

[0017] Figure 7 is Figure 1 is a perspective view of components of the device shown;

[0018] Figure 8 is Figure 3 is a cutaway view of the components shown;

[0019] Figure 9 is Figure 1 is a perspective view of components of the device shown;

[0020] Figure 10 is Figure 1 is a perspective view of components of the device shown;

[0021] Figure 11 is Figure 1 is a cutaway view of components of the device shown;

[0022] Figure 12 is Figure 11 is a close-up view of Detail A shown;

[0023] Figure 13 is Figure 1 is a close-up cutaway view of components of the device shown;

[0024] Figure 14 is Figure 1 is a perspective view of components of the device shown;

[0025] Figure 15 is Figure 1 is a perspective view of components of the device shown;

[0026] Figure 16 is Figure 1a perspective view of the components of the device shown;

[0027] Figure 17 yes Figure 1 an enlarged cutaway view of components of the illustrated apparatus;

[0028] Figure 18 yes Figure 1 an enlarged cutaway view of components of the illustrated apparatus;

[0029] Figure 19 yes Figure 1 an enlarged cutaway view of components of the illustrated apparatus;

[0030] Figure 20 yes Figure 1 a graphical representation of performance characteristics of components of the illustrated drug delivery device;

[0031] Figure 21 is an enlarged cutaway view of components of one example of a drug delivery device according to the principles of the present disclosure;

[0032] Figure 22 is an enlarged cutaway view of components of one example of a drug delivery device according to the principles of the present disclosure;

[0033] Figure 23 is an enlarged cutaway view of components of one example of a drug delivery device according to the principles of the present disclosure;

[0034] Figure 24 yes Figure 21 a graphical representation of performance characteristics of components of the illustrated drug delivery device;

[0035] Figure 25 yes Figure 22 a graphical representation of performance characteristics of components of the illustrated drug delivery device;

[0036] Figure 26 yes Figure 23 a graphical representation of performance characteristics of components of the illustrated drug delivery device;

[0037] Figure 27 is a plan view of components of one example of a drug delivery device according to the principles of the present disclosure;

[0038] Figure 28 is a plan view of components of one example of a drug delivery device according to the principles of the present disclosure;

[0039] Figure 29 yes Figure 27 and Figure 28 a graphical representation of performance characteristics of components of the illustrated drug delivery device;

[0040] Figure 30 yes Figure 28 a graphical representation of performance characteristics of components of the illustrated drug delivery device;

[0041] Figure 31 yes Figure 29 a graphical representation of performance characteristics of components of the illustrated drug delivery device;

[0042] Figure 32 yes Figure 1 a perspective view of components of the illustrated drug delivery device;

[0043] Figure 33 yes Figure 1 a perspective view of components of the illustrated drug delivery device;

[0044] Figure 34 yes Figure 1 a perspective view of components of the illustrated drug delivery device;

[0045] Figure 35 yes Figure 1 a cross-sectional view of components of the illustrated drug delivery device;

[0046] Figure 36 yes Figure 1 a cross-sectional view of components of the illustrated drug delivery device;

[0047] Figure 37 yes Figure 1 a schematic cross-sectional view of components of the illustrated drug delivery device;

[0048] Figure 38 yes Figure 1 a schematic cross-sectional view of components of the illustrated drug delivery device;

[0049] Figure 39 yes Figure 1 a schematic cross-sectional view of components of the illustrated drug delivery device;

[0050] Figure 40 yes Figure 1 a schematic cross-sectional view of components of the illustrated drug delivery device;

[0051] Figure 41 yes Figure 1 a schematic view of components of the illustrated drug delivery device; and

[0052] Figure 42 yes Figure 1 Schematic view of components of a drug delivery device is shown. DETAILED DESCRIPTION

[0053] Examples of disclosed delivery systems for dispensing a biologically active substance to a patient and related methods of use are discussed in accordance with a drug delivery pen for dispensing a biologically active substance to a patient, and more particularly in accordance with an injection device including components for setting and delivering one or more selected doses from a drug cartridge. In some examples, the present delivery systems and methods are for administering one or more drugs, e.g., insulin. In some examples, the present delivery systems include a drug delivery pen having components configured to provide audible and / or tactile feedback associated with dose setting, dose correction, and / or dose delivery. In some examples, the drug delivery pen has components configured to provide audible and / or tactile feedback, including a click, e.g., produced by at least one component having one or more teeth. In some examples, the drug delivery pen includes one or more ratchet components that produce a torque for driving movement that corresponds to a force directly associated with the audible and / or tactile feedback. In some examples, the ratchet components include one or more arm configurations that provide uniform audible and / or tactile feedback. In some examples, one or more components of the present delivery systems can be reusable or disposable.

[0054] In some examples, the present delivery systems include a drug delivery pen having a first ratchet, a second ratchet, and a drive ratchet, e.g., a non-return ratchet. In some examples, the non-return ratchet is disposed between a drive component and a nut component. In some examples, the first ratchet defines a smaller circumference relative to the second ratchet. In some examples, one or more of the ratchets have one or more arms on a component having a first ratchet segment and a second ratchet segment, e.g., a stepped ratchet and / or a double ratchet. In some examples, the first ratchet interacts with a drive component, e.g., a threaded sleeve, and the second ratchet interacts with a dose setting and / or dialing component, e.g., a dose sleeve. In some examples, the second ratchet provides tactile feedback while increasing a selected dose setting. In some examples, the first ratchet provides tactile feedback while decreasing a selected dose setting.

[0055] In some examples, the present delivery systems include a drug delivery pen having a non-return ratchet that prevents one or more components from being driven in reverse due to reverse pressure from a drug cartridge and / or prevents a user from winding a piston rod, e.g., a lead screw, back into a housing of the drug delivery pen to avoid moving the lead screw and / or bearings connected to the lead screw away from a plunger and / or a cartridge stop. In some examples, the non-return ratchet controls incremental rotational step movements of the lead screw when the lead screw is rotated to control rotational accuracy of the drug delivery pen. In some examples, the non-return ratchet resists torque applied from a first ratchet when a user decreases a dose setting to avoid pressurizing a cartridge when the user attempts to decrease a selected dose.

[0056] In some examples, the present delivery system includes a drug delivery pen having one or more ratchets, as described herein, wherein the one or more ratchets include a ratchet profile that provides a selected torque curve. In some examples, the ratchet profile includes a selected tooth profile. In some examples, the ratchet includes a tooth profile that has an initial position and / or start of the ratchet. In some examples, the ratchet includes a tooth profile that provides torque to initiate rotation of the ratchet and resistance to reverse drive. In some examples, the ratchet includes a tooth profile with a continuous curve that provides a sharp torque at the beginning of movement and a decreasing rate of torque increase as the ratchet movement increases. In some examples, the ratchet includes a tooth profile with a torque gradient that decreases linearly with movement of the ratchet. In some examples, the ratchet includes a tooth profile with a continuous radius that prevents abrupt changes in torque. In some examples, the ratchet includes a tooth profile that includes tooth points and / or plateaus with flat or planar surfaces. In some examples, the tooth tops are located adjacent to the middle of the tooth profile. In some examples, the tooth profile transitions from the tooth tops to the adjacent tooth profiles along a descending portion. In some examples, the tooth profile includes a continuous curve that matches the selected torque when ratcheting motion is initiated such that the rate of torque increase decreases as ratcheting movement increases. In some examples, the tooth profile includes a gradient that decreases linearly through ratcheting movement.

[0057] In some examples, the delivery system includes a drug delivery pen having one or more ratchets with a one-arm arrangement. In some examples, the one-arm arrangement provides audible feedback, such as a click, without excessive force being applied. In some examples, the one-arm arrangement includes bearing surfaces on opposite sides of the tooth profile to maintain the ratchet position and / or orientation, such as centering. In some examples, the drug delivery pen has one or more ratchets with a two-arm arrangement. In some examples, the two-arm arrangement provides increased rigidity and / or stiffness for drug delivery pen operation. In some examples, the drug delivery pen has one or more ratchets with a three-arm arrangement, including an even number of positions and an odd number of arms / teeth, the odd number of arms / teeth being self-positioning.

[0058] In some examples, the delivery system includes a drug delivery pen having a driver including a single-tooth ratchet. In some examples, the driver includes a three-tooth ratchet that provides uniform audible and / or tactile feedback and / or balance to the drug delivery pen operation to counteract and / or prevent, for example, asynchronous audible and / or tactile feedback.

[0059] In some examples, the delivery system includes a drug delivery pen having a driver, the driver including a non-return drive sleeve, the non-return drive sleeve including a single-arm or single-leg toothed ratchet. In some examples, the driver includes a non-return drive sleeve having a three-arm or three-leg toothed ratchet. In some examples, the driver includes a dual ratchet having a first side with a single toothed arm or leg and a second side with a single toothed arm or leg. In some examples, the arms or legs are arranged in a circumferential configuration. In some examples, the first arm or leg has a larger circumference than the second arm or leg. In some examples, the dual ratchet includes a bearing surface configured to react to a force applied to the dual ratchet (e.g., a force on opposing surfaces of a tooth profile). In some examples, the ratchet includes a first ratchet arm tooth that resists upward dial rotation, which would cause the second ratchet arm tooth to click against the ratchet feature, such that downward dial rotation does not cause the non-return drive sleeve to rotate. In some examples, the ratchet includes large diameter ratchet teeth that prevent rotation of the dual ratchet during dial down, which would cause the small diameter ratchet arms to click / deflect over the ratchet features when the dose sleeve is rotated to select a lower dose.

[0060] In some examples, the present delivery system includes a drug delivery pen having one or more drive components with a low-torque configuration. In some examples, the present delivery system includes a drug delivery pen having a lead screw and a non-backdrive sleeve that provide a range of approximately 80% to 90% of the total torque used to move the lead screw. In some examples, the present delivery system includes a drug delivery pen having a nut and a non-backdrive sleeve that include a tooth form and a nut profile that maintain ratchet resistance to movement and reduce peak torque to approximately 90% of the total torque used to move the lead screw. In some examples, the nut and non-backdrive sleeve include a smooth transition between different torques.

[0061] In some examples, the present delivery system includes a drug delivery pen having a dose setting component, the dose setting component including a housing thread form and a dose sleeve thread form having an axial clearance in the range of about 0.10 millimeters (mm) to 0.50 mm. In some examples, the present delivery system includes a drug delivery pen having a dose setting component, the dose setting component including a housing thread form and a dose sleeve thread form having a radial clearance in the range of about 0.05 mm to 0.25 mm. In some examples, the present delivery system includes a drug delivery pen having a dose setting component, the dose setting component including a housing thread form and a dose sleeve thread form having an axial clearance of about 0.30 mm and / or a radial clearance of 0.15 mm. In some examples, the dose setting component includes a housing thread form and a dose sleeve thread form having an axial clearance of 0.2 mm.

[0062] In some examples, the present delivery system includes a drug delivery pen with a zero dose stop having an overstroke tolerance of about + / - 7 degrees in the zero dose stop position.

[0063] In some examples, the present delivery system includes a drug delivery pen with a cap providing one or more of the following features: a UV blocker, a pocket clip, a needle protector for storage, a cartridge protector that absorbs impact during a drop, attachment to a cartridge holder in any orientation, cap rotation limit or stop until torque limit, providing visual indicia of the drug container and / or cartridge contents, providing visual indicia of the plunger, attachment and detachment of the pen needle, access to the needle cannula and / or cartridge septum, drive and / or housing support, axial force transfer of the piston rod to the cartridge plunger, torque transfer limit of the cartridge plunger, point load distribution from the piston rod to the cartridge plunger surface, an assist assembly, providing visual indicia of the selected dose, zero dose stop, and / or non-locking thread engagement with the housing.

[0064] In some examples, the present delivery system includes a drug delivery pen with a piston rod providing one or more of the following features: large diameter ratchet teeth prevent rotation of the double ratchet during dial down causing the small diameter ratchet arm to click over the ratchet and / or visual indicia of correct use. In some examples, the present delivery system includes a drug delivery pen with a housing providing one or more of the following features: visual indicia of the label and dial component, non-locking thread engagement with the dial component, axial restraint of the nut, thread engagement with the piston rod, and / or ratchet engagement with the driver (e.g., a non-return drive sleeve).

[0065] In some examples, the present delivery system includes a drug delivery pen with a driver, e.g., a threaded sleeve, providing one or more of the following features: placement of the last dose nut in the correct orientation during assembly, thread engagement with the last dose nut, axial ratchet feature that allows rotation relative to the dial component (e.g., the dose sleeve during dialing and dose delivery), and / or small diameter ratchet teeth that cause the upper ratchet arm to click over the large diameter ratchet in the dose sleeve against dial up rotation.

[0066] In some examples, the present delivery system includes a drug delivery pen with a last dose nut providing one or more of the following features: prevention of dialing a dose greater than the amount of insulin deliverable from the cartridge, rotational keying to the dial component (e.g., the dose sleeve) and axial freedom of movement along the pen axis, and / or facilitation of assembly.

[0067] In some examples, the present delivery system includes a drug delivery pen having a dual ratchet that provides one or more of the following features: small diameter ratchet arm teeth that resist upward dial rotation causing the upper ratchet arm to click over the ratchet feature, large diameter ratchet teeth that prevent the dual ratchet from rotating during downward dialing causing the small diameter ratchet arms to click / deflect over the ratchet feature while a dialing component (e.g., a dose sleeve is rotated to select a lower dose) allows a small axial movement of the driver (e.g., a threaded sleeve) during dialing, transferring axial force from the dose button to the dose sleeve, and / or limiting axial travel of the threaded sleeve.

[0068] In some examples, the delivery system includes a drug delivery pen for use with a method for dispensing a medicament to a patient, the method comprising the steps of dialing and / or canceling a dose. In some examples, the step of dialing and / or canceling a dose comprises rotating a dose sleeve clockwise so that the dose sleeve extends out of a housing. In some examples, the step of dialing and / or canceling a dose comprises generating a dose increment click using a topmost pawl of a double ratchet clicker that clicks over teeth in the dose sleeve. In some examples, the step of dialing and / or canceling a dose prevents the lead screw and the non-return drive sleeve from rotating, which is prevented by a ratchet between the non-return drive sleeve and a threaded nut. In some examples, the step of dialing and / or canceling a dose comprises selecting a maximum dose indicated by the maximum extension of the non-return drive sleeve from the threaded sleeve. In some examples, the step of dialing and / or canceling a dose comprises rotating the dose sleeve counterclockwise and canceling the selected dose. In some examples, the step of dialing and / or canceling a dose includes rotating a double ratchet clicker together with the dose sleeve so that a lower pawl clicks against teeth of the threaded sleeve. In some examples, the step of dialing and / or canceling a dose includes preventing rotation of the leadscrew because a pawl at one end of a non-return drive sleeve is more rigid and / or harder than a pawl on the double ratchet clicker, thereby allowing relative rotation of the ratchets between the double ratchet clicker and the threaded sleeve. In some examples, the step of dialing and / or canceling a dose includes advancing a last dose nut of the threaded sleeve upward and downward when dialing and / or canceling a dose.

[0069] In some examples, the delivery system includes a drug delivery pen for use with a method for dispensing a medicament to a patient, the method comprising the step of delivering a dose. In some examples, the step of delivering a dose includes engaging teeth of a dose sleeve with teeth of a threaded sleeve to lock the sleeves together. In some examples, the step of delivering a dose includes driving the dose sleeve into the body, causing the dose sleeve to rotate to rotate the threaded sleeve, the non-return drive sleeve, and the lead screw. In some examples, the step of delivering a dose includes rotating the non-return drive sleeve without linear movement relative to the pen housing. In some examples, the step of delivering a dose includes advancing the lead screw via the threads of a threaded nut by an amount equal to the rotation angle multiplied by the pitch of the lead screw threads. In some examples, the step of delivering a dose includes: before completing the injection (e.g., midway through the injection), interrupting the application of force to the dose button so that the dose sleeve can rotate to zero and the dose is canceled and / or continuing to apply force to the dose button to continue the injection. In some examples, the step of delivering a dose includes repositioning the last dose nut, e.g., moving the threaded sleeve upward during dose dialing. In some examples, when the last dose nut advances to the top of the threaded sleeve, the last dose nut abuts and / or engages the threaded sleeve in a fixed orientation and prevents further clockwise movement of the dose selector, which limits the size of the final dose that can be dialed.

[0070] In some examples, the present delivery system includes a drug delivery pen for use with a method for dispensing a drug to a patient, the method comprising the steps of: resisting and / or preventing a pawl or ratchet arm at one end of a non-return drive sleeve from resisting torque transmitted from a dose sleeve to overcome a smaller pawl or ratchet arm of a dual ratchet and to drive a threaded sleeve by engaging axial teeth of the dose sleeve. In some examples, the present drug delivery system includes a drug delivery pen for use with a method for dispensing a drug to a patient, the method comprising: axial ratcheting engagement between the threaded sleeve and the dual ratchet such that during dose setting or dose correction, the axial teeth of the threaded sleeve and the dual ratchet move relative to each other, and during dose delivery, the threaded sleeve and the axial teeth of the dual ratchet are axially engaged by a user, causing the dose sleeve and the threaded sleeve to rotate, causing the non-return drive sleeve to rotate and drive the leadscrew to deliver the dose.

[0071] In some examples, the present delivery system includes a drug delivery pen for use with a method for dispensing a medication to a patient, the method comprising the steps of: preventing rotation of a double ratchet during dose calibration by large ratchet teeth that cause a small-diameter ratchet arm to click / deflect over the ratchet feature when the dose sleeve is rotated to select a lower dose. In some examples, the drug delivery pen allows for small axial movement of the threaded sleeve during dose dialing. In some examples, the present delivery system includes a drug delivery pen for use with a method for dispensing a medication to a patient, the method comprising the steps of preventing backward rotation of a non-return drive sleeve. In some examples, the present delivery system includes a drug delivery pen for use with a method for dispensing a medication to a patient, the method comprising the steps of preventing dialing a dose greater than the amount of insulin that can be delivered from the cartridge, for example, via a last-dose nut. In some examples, the last-dose nut is rotationally keyed to the dose sleeve and is free to move axially along the device axis.

[0072] The present disclosure may be more readily understood by reference to the following detailed description of the examples in conjunction with the accompanying drawings, which form a part of this disclosure. It should be understood that the present application is not limited to the specific apparatus, methods, conditions, or parameters described and / or illustrated herein, and that the terms used herein are intended to describe specific examples by way of example only and are not intended to be limiting. In some examples, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" include the plural, and references to a particular value include at least that particular value unless the context clearly indicates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value. When such a range is expressed, another example includes from one particular value and / or to another particular value. Similarly, when a value is expressed as an approximation by using the antecedent "about," it will be understood that the particular value forms another example. It should also be understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left, and right, are used for illustrative purposes only and may vary within the scope of this disclosure. For example, the references "upper" and "lower" are relative and are used only in the context of being relative to one another and not necessarily "superior" and "inferior."

[0073] As used in the specification and including the appended claims, "treatment" of a disease or condition can include administering one or more drugs to a patient (human or other mammal). Relief can occur before the signs or symptoms of the disease or condition appear as well as after their appearance. Thus, treatment includes preventing a disease or an undesirable condition (e.g., preventing the disease from occurring in a patient who may be susceptible to the disease but has not yet been diagnosed as having the disease). In addition, treatment does not require complete relief of signs or symptoms, does not require a cure, and particularly includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., preventing its development, or alleviating the disease, e.g., causing the disease to regress. For example, treatment includes, but is not limited to, alleviating acute or chronic inflammation, inducing antiplatelet effects, reducing hypertension, and reducing cholesterol.

[0074] In some examples, a drug dose includes each individual release of a substance into body tissue. In some examples, a bioactive substance includes any one or more substances, including medicaments, drugs, or medicines, including active therapeutic substances, metabolites, hormones, steroids, vitamins, fatty acids, amino acids, sugars, carbohydrates, polypeptides, or minerals. In some examples, a bioactive substance includes any substance used to treat, prevent, diagnose, cure, or alleviate a disease or condition. In some examples, a bioactive substance includes any substance that affects anatomical structure or physiological function. In some examples, a bioactive substance includes any substance or its metabolites that alters the effect of an external influence on an animal.

[0075] In some examples, the bioactive substance includes a flowable drug containing a drug that is released into body tissue in a controlled manner, for example, such as a liquid, solution, gel, or fine suspension. In some examples, the drug includes one or more pharmaceuticals, for example, peptides, proteins (such as insulin, insulin analogs, and C-peptide), hormones, biologically derived or active agents, hormone- and gene-based agents, and / or nutritional formulas. In some examples, the bioactive substances as described herein can be used to treat and / or prevent diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders (such as deep vein or pulmonary thromboembolism), acute coronary syndrome, angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0076] The following discussion includes a description of a dispensing system including a drug injection device, related components, and methods employing the dispensing system. Alternative examples are also disclosed. Detailed reference is made to examples of the present disclosure illustrated in the accompanying drawings. Figures 1 to 4 , showing components of a dispensing system including a medication injection pen 10 .

[0077] The components of the medication injection pen 10, individually or collectively, can be made of materials suitable for the storage and dispensing of medications. In some examples, such materials include metals, ceramics, synthetic polymers such as thermoplastics, semi-rigid and rigid materials, elastomers, fabrics, and / or composites thereof. The various components of the medication injection pen 10 have material composites that include the above-mentioned materials to achieve various desired properties, such as strength, stiffness, elasticity, compliance, and durability. The components of the medication injection pen 10, individually or collectively, can also be made of heterogeneous materials, such as a combination of two or more of the above-mentioned materials. The components of the medication injection pen 10 can be integrally formed, integrally connected, or include fastening elements and / or devices, as described herein.

[0078] The drug injection pen 10 includes a housing 12 defining a longitudinal axis A and supporting dose setting and drive components, as described herein. The housing 12 is connected to a cartridge housing 14 that supports a drug cartridge 16. The drug injection pen 10 includes a pen cap 18 to selectively cover the drug cartridge 16 and the cartridge housing 14. In some examples, such as Figures 5 to 9 As shown, the cartridge housing 14 is attached to the housing 12 via one or more protrusions 20, and / or the cap 18 is removably attached to the cartridge housing 14 via a flange 22. In some examples, the cartridge housing 14 and the nut 24 are arranged in an interfering orientation, as described herein.

[0079] In some examples, the cap 18 blocks UV light and provides a pocket clip. In some examples, the cap 18 protects the pen needle during storage. In some examples, the cap 18 protects the medication cartridge 16 and can absorb shock during drops. In some examples, the cap 18 remains on the medication cartridge 16 in any orientation, for example, an orientation that prevents the cap 18 from rotating on the cartridge housing 14 up to a torque limit, an orientation that supports the weight of the medication cartridge 16, an orientation that provides a visual indication of the medication cartridge 16, an orientation that provides a visual indication of the contents of the medication cartridge 16, an orientation that provides a visual indication of the plunger, and / or an orientation that provides a visual indication of the medication cartridge 16 graduations to inform the user of the approximate remaining contents. In some examples, the cap 18 allows for needle removal, needle attachment, and needle insertion into the needle cannula of the cartridge septum. In some examples, the rotation of the cap 18 is restricted when installed in a specific orientation.

[0080] The dose member (e.g., dose sleeve 26) has a dose setting knob 28 that is rotatable to set a desired dose. The dose setting knob 28 is provided with a proximal end of the dose sleeve 26. The dose sleeve 26 includes a plurality of numbers corresponding to dosage units visible through a window 31 provided on the housing 12. The dose setting knob 28 is rotatable to set a desired dose, and the dose is visible through the window 31. The housing 12 includes an indicator 32 that provides a tactile and / or visual indication of the set dose. In some examples, the dose setting knob 28 includes a gripping surface. In some examples, such as Figures 10 to 12 As shown, the dose sleeve 26 comprises a stop 34 and the housing 12 comprises a stop 36 which are engageable to define a zero dose stop angular position during dose setting, the zero dose stop angular position corresponding to the end of the dose position.

[0081] The outer surface of the dose sleeve 26 is threadedly engaged with the inner surface of the housing 12. The dose sleeve 26 includes a wall having an outer helical track that can engage with a helical rib along the wall of the housing 12. In some examples, such as Figure 13 As shown, the thread form of the dose sleeve 26 and / or housing 12 includes an axial play of approximately 0.2 to 0.3 mm and a radial play of 0.15 mm.

[0082] A drive member (e.g., drive sleeve 38) has an enlarged proximal end 30 and a wall defining a longitudinal slot 47. The drive sleeve 38 fits into the dose sleeve 26 and over the drive member (e.g., non-return drive sleeve 42). In some examples, the drive sleeve 38 and the dose sleeve 26 have a toothed dog clutch engagement, as described herein. The drive sleeve 38 is keyed to the non-return drive sleeve 42, and as described herein, the nut 24 is secured to the housing 12. The sleeve 42 has a wall including splines 45 that slide within the slot 47, such that the sleeves 38 and 42 are fixed in rotation and can translate axially relative to each other.

[0083] The nut 24 has an internal thread and is fixed to the housing 12. The nut 24 includes an outer surface having one or more locking elements 46 that cooperatively engage one or more locking elements on the inner surface of the housing 12 to lock the nut 24 from rotating relative to the housing 12. Figure 14 The piston rod 48 has an external thread that can engage with and rotate through the internal thread of the nut 24. The piston rod 48 has a distal end connected to a pressure foot and providing a bearing 50 for the pressure foot. The pressure foot can rotate relative to the piston rod 48 and can engage the plunger of the drug cartridge 16.

[0084] The non-return drive sleeve 42 is supported by the nut 24 to prevent the non-return drive sleeve 42 from relative axial movement and to allow the non-return drive sleeve 42 to rotate unidirectionally relative to the nut 24 via the non-return ratchet 52. Figure 15 A non-return ratchet 52 acts between the non-return drive sleeve 42 and the nut 24. In some examples, the non-return ratchet 52 prevents the drug injection pen 10 from being driven back due to back pressure from the drug cartridge 16, and prevents the user from winding the piston rod 48 back into the housing 12, which would move the piston rod 48 away from the plunger of the drug cartridge 16. In some examples, the non-return ratchet 52 controls the incremental rotational steps of the piston rod 48 as the piston rod 48 rotates.

[0085] The non-return ratchet 52 includes one or more ratchet arms, as described herein, that engage a ratchet profile of the nut 24, as described herein, to prevent the non-return drive sleeve 42 from rotating in one direction (e.g., a dose setting direction), for example, and to allow the non-return drive sleeve 42 to rotate in an opposite direction (e.g., a dose dispensing direction). Figure 15 and Figure 17 As shown, the non-return drive sleeve 42 includes a ratchet arm 80 having teeth 84, and the nut 24 includes internal teeth 82. The teeth 82 each include a face 83 and a reverse drive face 85. The reverse drive face 85 increases reverse drive resistance during engagement with the teeth 84, for example, during dose setting, to prevent the drive sleeve 38 and / or the non-return drive sleeve 42 from rotating relative to the housing 12 during dose setting. In some examples, the nut 24 includes a circumferential wall 25, such that the face 83 extends from the wall 25 to define a radius R. In some examples, the face 83 defines an arc, which in some examples can have a uniform radius. In some examples, the face 83 can define alternative configurations, such as a variable radius, linear, arcuate, flat, wavy, offset, increasing or decreasing inclination, tapered, or spiral. In some examples, the teeth 82 each include a tooth crest, such as a snap-over radius 87, as described herein, disposed between the face 83 and the face 85 adjacent the mid-portion of the tooth profile of the tooth 82. In some examples, the tooth profile of the teeth 82 transitions from the tooth top along a descending portion to the adjacent tooth profile. In some examples, the tooth profile of the teeth 82 transitions from the tooth top along a steep or sharp angle descending portion to define a greater backdrive resistance to prevent the drive sleeve 38 and / or the non-return drive sleeve 42 from rotating relative to the housing 12 during dose setting.

[0086] During dose dispensing, teeth 84 can engage with surfaces 83 to allow rotation of the drive sleeve 38 and / or the non-return drive sleeve 42 relative to the housing 12. The ratchet arm 80 of the non-return drive sleeve 42 tracks the internal teeth 82, such that the ratchet profile including teeth 84 engages the internal teeth 82, causing the flat surfaces of the rotating teeth 84 and teeth 82 to contact each other, with the surfaces sliding against each other. During dose setting, teeth 84 can engage with counter-drive surfaces 85 to prevent rotation of the drive sleeve 38 and / or the non-return drive sleeve 42 relative to the housing 12. The engagement of teeth 84 and teeth 82, due to their respective configurations as described herein, prevents rotation of the non-return drive sleeve 42 and the drive sleeve 38 in the dose setting direction and allows rotation of the non-return drive sleeve 42 in the dose dispensing direction through their keyed connection with the non-return drive sleeve 42.

[0087] In some examples, such as Figure 16 As shown, housing 12 includes a spacer 113 that includes a continuous circular configuration that supports, guides, and / or aligns components of the non-return ratchet 52 as described herein with housing 12. In some examples, the engagement of teeth 84 and teeth 82 defines a torque gradient that decreases linearly as the respective faces slide against each other due to their respective configurations as described herein. In some examples, as used herein, "linearly decreasing torque gradient" is understood to mean that the rate of change of torque decreases gradually in a continuous manner (as opposed to a step-like manner) and is in no way limited to a strictly linear relationship in a mathematical sense. In some examples, tooth 82 includes a snap radius 87 disposed between face 83 and face 85 that guides and / or regulates the movement of tooth 84 as tooth 84 slides from face 83 to face 85.

[0088] In some examples, the non-return ratchet 52 has one or more ratchet arms of the non-return drive sleeve 42, each ratchet arm including a ratchet profile having teeth 184 that follow the internal teeth 182 of the nut 24, as shown in FIG. Figures 17 to 19 In some examples, the teeth 184 have a uniform and / or continuous radius such that the non-reset ratchet 52 provides a plurality of Figure 20 The performance characteristics of the torque curve depicted in the graphical representation shown in . In some examples, the non-return ratchet 52 maintains resistance to movement when rotation is initiated while reducing the peak torque required. In some examples, the non-return ratchet 52 includes a ratchet profile having a tooth form, the tooth form including a tooth form having a uniform and / or continuous radius, the uniform and / or continuous radius preventing abrupt changes in torque. In some examples, such as Figures 21 to 23 As shown, the size of the ratchet profile of the non-return ratchet 52 is selectively changed to provide Figures 24 to 26The performance characteristics depicted in the graphical representation shown. In some examples, the engagement of teeth 84 with face 83 produces a peak torque in the range of approximately 2.00 to 3.00 Nmm. In some examples, the engagement of teeth 84 with face 85 produces a maximum backdrive resistance torque in the range of approximately 3.00 to 6.00 Nmm.

[0089] In some examples, the non-return ratchet 52 has a 2-arm configuration of the non-return drive sleeve 42, with each arm 242 including a ratchet profile having teeth 252 that follow the internal teeth 290 of the nut 24, as shown. Figure 27 In some examples, the engagement of teeth 252 with teeth 290 during dose dispensing produces a peak torque in the range of approximately 1.00 to 2.00 Newton millimeters (Nmm). In some examples, as Figure 28 As shown and similar to what is described herein, the non-return ratchet 52 has a 3-arm configuration of the non-return drive sleeve 42, the 3-arm configuration including a first circumferential arm 334 having teeth 352, a second circumferential arm 334 having teeth 352, and a third circumferential arm 334 having teeth 352, with the arms 334 being generally equally spaced about the non-return drive sleeve 42. In some examples, as used herein with respect to the arms, "generally equally spaced" means that the arms are as close to equally spaced as possible given the number of teeth and geometry of the nut. For example, in Figure 28 In the non-limiting example shown, because the total number of teeth 52 of the nut 24 is not divisible by three, the circumferential arms 334 are considered to be "approximately equidistant" even though one of the spaces between the teeth 352 is slightly smaller than the other two (in this non-limiting example, the shorter nut 24 has one less tooth 52). Each arm 334 has a ratchet profile that includes teeth 352 that follow the internal teeth 390 of the nut 24. The arms 334 are configured for being arranged with the nut 24 such that the non-backward drive sleeve 42 is coaxially aligned with the axis A of the housing 12. In some examples, the arms 334 are provided with the nut 24 such that the non-backward drive sleeve 42 is configured for self-centering and / or self-positioning with the nut 24 for coaxial orientation with the axis A. In some examples, engagement of the teeth 352 with the teeth 390 produces a peak torque in the range of approximately 2.00 to 3.00 Nmm. Figures 29 to 31 A comparison of performance characteristics of a 2-arm configuration and a 3-arm configuration of a non-returning ratchet 52, including torque curves, is depicted in the graphical representation shown in In some examples, the non-return ratchet 52 includes a 3-arm configuration with an even number of positions and an odd number of arms and teeth, such that the teeth 352 and the teeth 390 are configured to provide audible and tactile feedback, including a single click per tooth.

[0090] The click member, for example, the double ratchet 84 has a ratchet wheel (for example, a small ratchet wheel 90) and a ratchet wheel (for example, a large ratchet wheel 92), as shown in FIG. Figures 32 to 36As shown. The dual ratchet 84 is attached to the dose button 54 via a snap ring or the like and is positioned on the top surface of the drive sleeve 38. The small ratchet 90 has a single-arm configuration and includes an arm 94. Arm 94 includes a bearing 96 and teeth 98. The bearing 96 and teeth 98 form a ratchet profile with the internal teeth 100 of the drive sleeve 38, such that the teeth 98 follow the internal teeth 100. The teeth 98 engage the internal teeth 100 to rotate the corresponding faces of the teeth 98 and teeth 100 through flat surface contact, and the two surfaces slide against each other. The engagement of the teeth 98 and teeth 100, due to their respective configurations as described herein, allows relative rotation between the dual ratchet 84 and the drive sleeve 38 in a first direction, providing, for example, tactile and / or audible indication / feedback, and prevents relative rotation between the dual ratchet 84 and the drive sleeve 38 in a second, opposite direction. The large ratchet 92 has a single-arm configuration and includes an arm 102. The arm 102 includes a bearing 104 and teeth 106 that form a ratchet profile with internal teeth 108 of the dose sleeve 26, such that the teeth 98 follow the internal teeth 108. The teeth 106 engage the internal teeth 108 to rotate the corresponding faces of the teeth 106 and 108 through flat surface contact, and the two surfaces slide against each other. The engagement of the teeth 106 and 108, due to their respective configurations as described herein, allows relative rotation between the dual ratchet 84 and the drive sleeve 26 in a first direction to provide, for example, tactile and / or audible indicia / feedback, and prevents relative rotation between the dual ratchet 84 and the dose sleeve 26 in a second, opposite direction.

[0091] The small ratchet 90 interacts with the drive sleeve 38, and the large ratchet 92 interacts with the dose sleeve 26. In some examples, when a user decreases a dose, the non-return ratchet 52 resists torque from the small ratchet 90 to prevent back-pressurization of the cartridge 16. In some examples, when setting a dose with the dose sleeve 26, the teeth 98 of the small ratchet 90 resist rotation, causing the large ratchet 92 to deflect and click over the teeth 108 of the dose sleeve 26, and the teeth 108 of the large ratchet 92 prevent rotation of the dual ratchet 84 during the decrease in the set dose, which causes the teeth 98 of the small ratchet 90 to deflect and click over the teeth 100 of the drive sleeve 38 when the dose sleeve 26 is rotated to select a lower dose. In some examples, the pawl of the ratchet arm of the non-return drive sleeve 42 can resist torque transmitted from the dose sleeve 26 to overcome the small ratchet 90 and resist torque to lift the drive sleeve 38 out of axial tooth engagement with the dose sleeve 26.

[0092] The large ratchet 92 provides tactile feedback during dose setting. The small ratchet 90 provides tactile feedback during dose reduction. In some examples, the small ratchet 90 has greater flexibility and / or less rigidity than the non-return ratchet 52 to prevent back-pressurization of the cartridge 16 when the user reduces the dose. In some examples, the non-return ratchet 52 comprises a single-arm ratchet with opposing bearing surfaces to maintain the dual ratchet 84 centered relative to the housing 12. In some examples, the large ratchet 92 includes a bearing surface and a circular and / or arcuate tooth form to create a continuous running surface. In some examples, the small ratchet 90 includes a circular and / or arcuate tooth form to create a continuous running surface. In some examples, the teeth 98 of the small ratchet 90 move and / or slide over the teeth 100 of the drive sleeve 38 during upward or downward dialing of a selected dose using the dose sleeve 26. In some examples, during dose delivery of a selected dose using user actuation pressure applied to the dose button 54, the teeth 98 of the small ratchet 90 translate axially and engage the teeth 100 of the drive sleeve 38, rotationally fixing the dose sleeve 26 and the drive sleeve 38, thereby causing the non-return drive sleeve 42 to rotate, rotationally fixed with the drive sleeve 38, causing the piston rod 48 to rotate and translate axially to deliver the set dose. In some examples, the teeth 106 of the large ratchet 92 engage the teeth 108 of the dose sleeve 26 and prevent rotation of the dual ratchet 84 during dialing down, causing the teeth 98 of the small ratchet 90 to deflect over the teeth 100 of the drive sleeve 38 and click when the dose sleeve 26 is rotated to select a lower dose. In some examples, the drive sleeve 38 includes axial movement and / or play during dose setting.

[0093] The dose sleeve 26 is threadedly coupled to the housing 12, and the drive sleeve 38 is supported by and fixed to the dose sleeve 26. The drive sleeve 38 is keyed to a non-return drive sleeve 42, which is engaged and rotationally fixed to a piston rod 48, as described herein. The piston rod 48 extends through the non-return drive sleeve 42. The non-return drive sleeve 42 includes an inner surface with a non-circular cross-section that is engageable with the outer surface of the piston rod 48. The outer surface of the piston rod 48 also has a non-circular cross-section. Rotation of the non-return drive sleeve 42 is transmitted to the piston rod 48, thereby preventing rotation of the piston rod 48 relative to the non-return drive sleeve 42. The piston rod 48 is threadedly coupled to the internal threads of the nut 24, allowing the piston rod 48 to translate distally through the nut 24. The relative rotational movement between the two translates the rotational movement of the piston rod 48 into linear movement. The piston rod 48 engages a plunger bearing 50, which transmits axial force to the plunger. In this manner, the piston rod 48 is permitted to move axially in a distal direction relative to the non-return drive sleeve 42 as the external threads of the piston rod 48 engage the internal threads of the nut 24 such that the piston rod 48 is rotated through the nut 24 to dispense a selected dose of the drug.

[0094] To set a drug dose using the drug injection pen 10, Figure 37 As shown, the user rotates the dose sleeve 26 having the dose setting knob 38. In some examples, the dose sleeve 26 can be rotated for dialing, reducing, and canceling a set dose. Figure 38 As shown, to set the selected drug dose, the dose setting knob 28 is rotated to rotate the dose sleeve 26 in a clockwise direction when viewed from the dose button 54 end of the drug injection pen 10, which causes the dose sleeve 26 to translate in a proximal direction and move out of the housing 12. The dose increment click is provided by the teeth 106 of the large ratchet 92 of the double ratchet 84 clicking over the teeth 108 of the dose sleeve 26, as described herein. The piston rod 48 and the non-return drive sleeve 42 do not rotate because they are prevented by the non-return ratchet 52 and the components of the non-return drive sleeve 42 and the nut 24, as described herein.

[0095] The maximum selectable dose is determined by the maximum extension of the non-return drive sleeve 42 outwardly and in the proximal direction from the threaded sleeve 38, as limited by the last dose nut 110, as shown. Figure 39 and Figure 40 As shown. When the amount of medicament remaining in the medicament cartridge 16 is reached, the last dose nut 110 prevents the dose sleeve 26 from rotating, thereby preventing the selection of a dose greater than the maximum dose and / or the amount of medicament remaining in the medicament cartridge 16. The drive sleeve 38 is threadedly engaged with the last dose nut 110. The last dose nut 110 is keyed to the dose sleeve 26 via a spline and slot configuration and is rotatably fixed thereto, and is rotatable relative to the drive sleeve 38 when the last dose nut 110 is able to rotate with the threads of the drive sleeve 38. In some examples, this configuration causes the large ratchet 92 to deflect over the teeth 108 of the dose sleeve 26 and produce a clicking sound.

[0096] The last dose nut 110 is keyed to the dose sleeve 26, and the drive sleeve 38 has an outer surface comprising a thread, so that the last dose nut 110 follows the threaded path of the drive sleeve 38. The last dose nut 110 rotates relative to the drive sleeve 38 and translates axially along the drive sleeve 38 by an amount corresponding to the rotation during dose dialing. When the last dose nut 110 reaches the top of the drive sleeve 38, as shown Figure 40 and Figure 41 As shown, the last dose nut 110 is fixed to the drive sleeve 38 and prevents further clockwise movement of the dose sleeve 26. This configuration of the last dose nut 110 limits the size of the final dose that can be dialed. In some examples, the distal end of the dose sleeve 26 engages the nut 38 to prevent the dose from being set below the selected zero amount of drug in the drug cartridge 16.

[0097] To decrease or cancel a set dose, the dose sleeve 26 with the dose setting knob 28 is rotated, for example, in a counterclockwise direction. The double ratchet 84 rotates with the dose sleeve 26, and the teeth 98 of the small ratchet 90 of the double ratchet 84 click over the teeth 100 of the drive sleeve 38. The piston rod 48 and the non-return drive sleeve 42 do not rotate because the teeth 84 of the non-return drive sleeve 42 are harder and / or more rigid than the teeth 98 of the drive sleeve 38. When dialing, decreasing, or canceling one or more doses, the last dose nut 110 translates in the proximal or distal direction to advance the drive sleeve 38 up or down.

[0098] To deliver the dose, e.g. Figure 42 As shown, the dose button 54 is actuated by the user, driving the teeth 112 of the drive sleeve 38 into engagement with the teeth 114 of the dose sleeve 26 to rotationally secure them therebetween. This engagement causes the dose sleeve 26 to rotate, for example, in a counterclockwise direction and translate distally into the housing 12. As the dose sleeve 26 rotates, the drive sleeve 38, the non-return drive sleeve 42, and the piston rod 48 rotate in a counterclockwise direction due to their component connections, as described herein. The non-return drive sleeve 42 rotates relative to the housing 12 but does not translate axially. In some examples, the piston rod 48 translates axially distally via the internal threads of the nut 38 by an amount equal to the rotation angle multiplied by the pitch of the piston rod 48, causing the bearing 50 to engage the plunger of the cartridge 16 to dispense the set dose of medication.

[0099] In some examples, if the user stops pressing the dose button 54 during an injection, the user can rotate the dose sleeve 26 to the zero position and cancel the set dose, or continue the injection by pressing the dose button 54. When a dose is delivered, the last dose nut 110 does not change its position on the drive sleeve 38.

[0100] In some examples, the bearing 50 transfers the axial force of the piston rod 48 to the cartridge 16, causing the plunger to limit torque transfer and spread point loads from the piston rod 48 to the plunger surface. In some examples, the dose sleeve 26 supports the double ratchet 48 and displays the selected dose.

[0101] In some examples, the medication injection pen 10 includes child-resistant features while being easy for adults to use. For example, the medication injection pen 10 includes components that can be moved between a child-resistant, locked, and / or medication-inaccessible configuration and an unlocked and / or medication-accessible configuration. In some examples, instructional indicia is located with the housing 12.

[0102] It should be understood that various modifications may be made to the examples disclosed herein. Therefore, the above description should not be interpreted as limiting, but only as an example. Those skilled in the art will envision other modifications within the scope and spirit of the appended claims.

Claims

1. A drug delivery device comprising: case; a first drive member comprising at least one arm having teeth; as well as a nut comprising at least one tooth, said at least one tooth of said nut comprising a first face and a second face, The teeth of the first drive member are engageable with the first face to allow the first drive member to rotate relative to the housing during dose dispensing, and engageable with the second face to prevent the first drive member from rotating relative to the housing during dose setting.

2. The drug delivery device according to claim 1, wherein Engagement of the teeth of the first drive member with the first face defines a linearly decreasing torque gradient.

3. The drug delivery device according to claim 1, wherein: The at least one tooth of the nut further includes a snap radius disposed between the first face and the second face.

4. The drug delivery device according to claim 1, wherein: The at least one arm includes two circumferential arms.

5. The drug delivery device according to claim 4, wherein: Engagement of the teeth of the first drive member with the first face generates a peak torque in the range of approximately 1.00 to 2.00 Nmm.

6. The drug delivery device according to claim 1, wherein: The at least one arm includes three circumferential arms.

7. The drug delivery device according to claim 6, wherein: Engagement of the teeth of the first drive member with the first face generates a peak torque in the range of approximately 2.00 to 3.00 Nmm.

8. The drug delivery device according to claim 1, wherein: The second face is configured to generate a maximum backdrive resistance torque in the range of approximately 3.00 to 6.00 Nmm during engagement with the teeth of the first drive member.

9. The drug delivery device according to claim 1, wherein: The at least one tooth of the nut includes a plurality of teeth, and the nut includes a circumferential wall containing the plurality of teeth, each tooth of the plurality of teeth extending from the wall to define an arc.

10. The drug delivery device according to claim 9, wherein: The arc has a uniform radius.

11. The drug delivery device of claim 1 , further comprising a second drive member disposed in keyed engagement with the first drive member such that the first and second drive members are rotationally fixed and relatively axially translatable.

12. A drug delivery device comprising: case; a first single-arm ratchet having teeth including arcuate surfaces; as well as A dose member comprising internal teeth engageable with the teeth to provide audible and / or tactile feedback during dose setting. 13 . The drug delivery device of claim 11 , further comprising a click member comprising the first single-arm ratchet and further comprising a second single-arm ratchet having teeth.

14. The drug delivery device of claim 12, wherein: The teeth of the second single-arm ratchet are engageable with internal teeth of the drive member to provide audible and / or tactile feedback during dose correction.

15. The drug delivery device of claim 13, wherein: The drive member includes a first drive member disposed in keyed engagement with a second drive member such that the first and second drive members are rotationally fixed and relatively axially translatable.

16. The drug delivery device of claim 11, further comprising: a drive member comprising at least one arm having teeth; as well as a nut, said nut comprising at least one tooth, The at least one tooth of the nut includes a first face and a second face, the first face defining a radius, The teeth of the drive member are engageable with the first face to allow the drive member to rotate relative to the housing during dose dispensing, and engageable with the second face to prevent the drive member from rotating relative to the housing during dose setting.

17. A drug delivery device comprising: case; a first single-arm ratchet having teeth including arcuate surfaces; and A first drive member comprising internal teeth engageable with at least one of the teeth to provide audible and / or tactile feedback during dose correction.

18. The drug delivery device of claim 16, further comprising a click member comprising the first single-arm ratchet and further comprising a second single-arm ratchet having teeth.

19. The drug delivery device of claim 17, wherein: The teeth of the second single-arm ratchet are engageable with internal teeth of the dose member to provide audible and / or tactile feedback during dose setting.

20. The drug delivery device of claim 16, wherein: The first drive member is arranged in keyed engagement with the second drive member such that the first and second drive members are rotationally fixed and relatively axially translatable.

21. The drug delivery device of claim 16, further comprising: a second drive member provided together with the first drive member and comprising at least one arm having teeth; as well as a nut, said nut comprising at least one tooth, The at least one tooth of the nut includes a first face and a second face, the first face defining a radius, The teeth of the second drive member are engageable with the first face to allow the second drive member to rotate relative to the housing during dose dispensing, and engageable with the second face to prevent the second drive member from rotating relative to the housing during dose setting.

22. A drug delivery device comprising: case; Dosage button; a double ratchet having an upper ring including a first single-arm ratchet having teeth including an arcuate surface and a lower ring including a second single-arm ratchet having teeth including an arcuate surface; a dose sleeve comprising internal teeth, said internal teeth of said dose sleeve being engageable with the teeth of said upper ring to provide audible and / or tactile feedback during dose setting; a drive sleeve comprising internal teeth, the internal teeth of the drive sleeve being engageable with the teeth of the lower ring to provide audible and / or tactile feedback during dose correction; a non-return drive sleeve keyed to the drive sleeve and comprising at least one arm having teeth; a nut comprising at least one tooth having a first face and a second face, the first face defining an arc, the tooth of the non-return drive sleeve being engageable with the first face during dose dispensing to allow rotation of the drive sleeve relative to the housing and engageable with the second face during dose setting to prevent rotation of the drive sleeve relative to the housing; Lead screw; as well as A medicament cartridge comprising a piston.

23. The drug delivery device of claim 22, wherein: The at least one tooth of the nut defines an arc having a uniform radius.

24. The drug delivery device of claim 22, further comprising a septum provided with the housing and configured to guide the non-return drive sleeve and / or align the non-return drive sleeve with the housing.

25. A drug delivery device comprising: case; a non-return drive sleeve comprising at least one arm having teeth; as well as a nut, said nut comprising at least one tooth, said at least one tooth of said nut comprising a first face and a second face, During dose dispensing, the teeth of the first drive member are engageable with the first face to define a linearly decreasing torque gradient such that the first drive member is allowed to rotate relative to the housing, and During dose setting, the teeth of the first drive member are engageable with the second face to prevent rotation of the first drive member relative to the housing and prevent backdriving of one or more components of the drug delivery device.

26. A drug delivery device comprising: a housing defining a longitudinal axis; a non-return drive sleeve comprising a first circumferential arm having teeth, a second circumferential arm having teeth, and a third circumferential arm having teeth, the arms being generally equally spaced about the non-return drive sleeve; as well as a nut, said nut comprising at least one tooth, The arms are configured for positioning with the nut so that the non-return drive sleeve is coaxially aligned with the housing. During dose dispensing, the teeth of the non-return drive sleeve are engageable with the at least one tooth of the nut such that a rotation of the first drive member relative to the housing is allowed, and During dose setting, the teeth of the non-return drive sleeve are engageable with the at least one tooth of the nut to prevent the first drive member from rotating relative to the housing.

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