Prime dose setting assembly for injection device

Abstract

Medication delivery devices having a dosage button which automatically returns to a prime dose setting position after dosing the device by fully depressing a dose button. An injection device having an initial dose setting suited for immediately dispensing a prime dose, wherein the injection device returns to the initial prime dose setting after the dose button is activated and released.

Description

PRIME DOSE SETTING ASSEMBLY FOR INJECTION DEVICEFIELD OF THE DISCLOSURE

[0001] The present disclosure relates to medication delivery devices and related methods of use. Specifically, the present disclosure relates to medication delivery devices having a dosage assembly for setting and dispensing a predetermined dose of medication.BACKGROUND OF THE DISCLOSURE

[0002] Patients suffering from various diseases must frequently inject themselves with medication. To allow a person to conveniently and accurately self-administer medicine, a variety of devices broadly known as pen injectors or injection pens are available. Generally, these pens are equipped with a cartridge including a piston and containing a multi-dose quantity of flowable medication, including liquids. A drive member is movable to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal cartridge end, typically through a needle. Control of the movement of the piston controls the amount of medication delivered by the medication delivery device.SUMMARY OF THE INVENTION

[0003] Exemplary embodiments of the present disclosure include medication delivery devices having a dosage button that is configured to automatically return to a prime dose setting position away from its zero position after dosing the device. In other words, the present disclosure relates to an injection device having an initial dose setting suited for immediately dispensing a prime dose, and the injection device returns to the initial prime dose setting after the dose button is activated and released.

[0004] In a first aspect of the disclosure, a medication delivery device is provided. The medication delivery device includes a housing; a plunger drive system; a dose member; and a dose button. The housing is disposed about a longitudinal axis and has an outlet. The plunger drive system is configured to selectively set a dose and selectively dispense a dose. The dose member is coupled to the plunger drive system and is rotatable about the longitudinal axis relative to the housing during dose setting. The dose button is coupled to the plunger drive system. The device is biased toward a first configuration in which the dose button is in a first position relative to the housing. The device has a second configuration inwhich the dose button is in a second position relative to the housing. The first configuration includes a predetermined set dose that is greater than zero. The second configuration includes a dose less than the predetermined set dose.

[0005] In another aspect of the disclosure, a medication delivery device is provided. The medication delivery device includes a housing; a plunger drive system; a rotatable dose member; a dose button; and a flexible member. The housing is disposed about a longitudinal axis and has an outlet. The plunger drive system is configured to selectively set a dose and selectively dispense a dose. The rotatable dose member is coupled to the plunger drive system. The rotatable dose member is rotatable about the longitudinal axis relative to the housing during dose setting. The dose button is coupled to the drive system. The flexible member is positioned between the dose button and the plunger drive system, wherein the flexible member is configured to displace upon application of force to the dose button and return to an original configuration upon removal of the force.

[0006] In yet another aspect of the disclosure, a medication delivery device is provided. The medication delivery device includes a housing; a plunger drive system; a rotatable dose member; a dose button; and a spring. The housing is disposed about a longitudinal axis and has an outlet. The plunger drive system is configured to selectively set a dose and selectively dispense a dose. The rotatable dose member is coupled to the plunger drive system. The rotatable dose member is rotatable about the longitudinal axis relative to the housing during dose setting. The dose button is coupled to the plunger drive system. The spring is positioned between at least one of the dose button and the housing and the rotatable dose member and the housing, wherein the spring is configured to bias the dose button to a first configuration associated with a preset dose. The preset dose is greater than zero.

[0007] In various aspects of the disclosure, the dose member may be inhibited from rotation in a first direction in the second configuration;

[0008] In various aspects of the disclosure, a proximal surface of the dose button may be a first distance form the housing in the first configuration and a second distance from the housing in the second configuration. The first distance may be greater than the second distance.

[0009] In various aspects of the disclosure, the dose button may be configured to move from the first position toward the second position upon application of distal force to the dose button. The dose button may return to the first position upon removal of the distal force.

[0010] In various aspects of the disclosure, movement toward the second configuration from the first configuration may be a first dispensing configuration, wherein the dose button is configured for a dose setting device after the first dispensing configuration. The dose button may be actuated for a second dispensing configuration that is greater than the first dispensing configuration.

[0011] In various aspects of the disclosure, at least a portion of the dose button may comprise a resilient material which biases the dose button toward the first position.

[0012] In various aspects of the disclosure, the medication delivery device may further include a spring axially positioned between the housing and the dose button. The spring may be configured to bias the dose button toward the first position.

[0013] In various aspects of the disclosure, the medication delivery device may further include a compliant member positioned between the dose member and a rotationally locked component of the housing. The rotationally locked component of the housing may be at least partially nested within the rotatable dose member. The compliant member may be configured to bias the member to rotate in a first direction for a first distance biasing the device toward the first configuration.

[0014] In various aspects of the disclosure, the dose button may have a rigid first portion and a flexible second portion. The flexible second portion may comprise the flexible member. The flexible second portion may be configured to form an outward bulge upon displacement of the flexible second portion. The flexible second portion may define a groove within an internal surface of the flexible second portion. The rigid first portion and the flexible second portion may define an overlap portion in which a proximal extension of the flexible second portion is positioned internally relative to a distal extension of the rigid first portion. A proximal portion of the housing may define a notch configured to receive a section of the flexible second portion.

[0015] In various aspects of the disclosure, a wall thickness of the flexible member may vary.

[0016] In various aspects of the disclosure, a first end of the spring may contact the dose button and a second end of the spring may contact the housing. The dose button and the housing may define an overlap in which a proximal portion of the housing is nested within a distal portion of the dose button. A distal edge of the dose button may be chamfered.

[0017] In various aspects of the disclosure, the dose button may be configured to move form the first configuration toward a second configuration upon application of a distal force to the dose button. The spring may be configured to move the dose button, via an axial force, from the second configuration toward the first configuration upon removal of the distal force. The first configuration may be a dose setting configuration. Movement toward the second configuration from the first configuration may be a dispensing configuration.

[0018] In various aspects of the disclosure, the spring may be positioned between the rotatable dose member and a rotationally locked component of the housing. The rotationally locked component may be at least partially nested within the rotatable dose member. The spring may be configured to bias the rotatable dose member to rotate in a first direction for a first distance biasing the device toward the first configuration. The dose button may be configured to move from the first configuration toward a second configuration upon application of a distal force to the dose button. The spring may be configured to move the dose button, via rotational force, from the second configuration toward the first configuration upon removal of the distal force. The first configuration may be a dose setting configuration. Movement toward the second configuration from the first configuration may be a dispensing configuration.

[0019] Additional features and advantages of the present invention will become apparent to those skilled in the art upon consideration of the following detailed description of the illustrative embodiment exemplifying the best mode of carrying out the invention as presently perceived.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The foregoing aspects and many additional features of the present invention and accompanying methods will become more readily appreciated and become better understood by reference to the following detailed description when taken in conjunction with the accompanying figures. The detailed description of the drawings particularly refers to the accompanying figures in which:

[0021] FIG. 1 illustrates a medication delivery device of the present disclosure in a prime dose configuration;

[0022] FIG. 2 illustrates a cross-sectional view of the medication delivery device of FIG. 1;

[0023] FIG. 3 illustrates a cross-sectional view of a proximal portion of the medication delivery device of FIG. 1;

[0024] FIG. 4 illustrates the medication delivery device of FIG. 1 in a dispensing configuration;

[0025] FIG. 5 illustrates a cross-sectional view of a proximal portion of the medication delivery device of FIG. 4;

[0026] FIG. 6 illustrates an exemplary embodiment of the medication delivery device of FIG. 5, including a notch within an internal surface of a dose button of the medication delivery device;

[0027] FIG. 7 illustrates another medication delivery device of the present disclosure in a prime dose configuration;

[0028] FIG. 8 illustrates a cross-sectional view of the medication delivery device of FIG. 7;

[0029] FIG. 9 illustrates a cross-sectional view of a proximal portion of the medication delivery device of FIG. 8;

[0030] FIG. 10 illustrates the medication delivery device of FIG. 8 in a dispensing configuration;

[0031] FIG. 11 illustrates a cross-sectional view of a proximal portion of the medication delivery device of FIG. 10;

[0032] FIG. 12 illustrates another medication delivery device of the present disclosure in a prime dose configuration;

[0033] FIG. 13A illustrates a partially transparent view of a screw element, a nut advancing plunger, and a compliant member of the medication delivery device of FIG. 12;

[0034] FIG. 13B illustrates a first view of the compliant member of FIG. 13A;

[0035] FIG. 13C illustrates a second view of the compliant member of FIG. 13A;

[0036] FIG. 13D illustrates a third view of the compliant member of FIG. 13A;

[0037] FIG. 14 illustrates the medication delivery device of FIG. 12 in a dispensing configuration;

[0038] FIG. 15A illustrates a partially transparent view of a screw element, a nut advancing plunger, and a compliant member of the medication delivery device of FIG. 14;

[0039] FIG. 15B illustrates a first view of the compliant member of FIG. 15A; and

[0040] FIG. 15C illustrates a second view of the compliant member of FIG. 15A.

[0041] Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of various features and components according to the present disclosure, the drawings are not necessarily to scale, and certain figures may be exaggerated in order to better illustrate and explain the present disclosure.DETAILED DESCRIPTION OF THE DRAWINGS

[0042] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, which are described herein. The embodiments disclosed herein are not intended to be exhaustive or to limit the invention to the precise form disclosed. Rather, the embodiments are chosen and described so that others skilled in the art may utilize their teachings.Therefore, no limitation of the scope of the claimed invention is thereby intended. The present invention includes any alterations and further modifications of the illustrated devices and described methods and further applications of principles in the invention which would normally occur to one skilled in the art to which the invention relates.

[0043] The terms “couples”, “coupled”, “coupler” and variations thereof are used to include both arrangements wherein the two or more components are in direct physical contact and arrangements wherein the two or more components are not in direct contact with each other (e.g., the components are “coupled” via at least a third component), but yet still cooperate or interact with each other.

[0044] In some instances throughout this disclosure and in the claims, numeric terminology, such as first, second, third, fourth, etc., is used in reference to various components of features. Such use is not intended to denote an ordering of the components or features. Rather, numeric terminology is used to assist the reader in identifying the components or features being referenced and should not be narrowly interpreted as providing a specific order of components or features.

[0045] Referring initially to FIGS. 1-2, an exemplary medication delivery device 100 is illustrated. Medication delivery device 100 (hereinafter “device”) includes an elongated pen-shaped body 102, or device housing, including a proximal portion 104 and a distal portion 106. In some embodiments, distal portion 106 may include a containment unit, e.g., a reservoir or a cartridge 108, configured to hold a medication to be dispensed through an outlet 110 during a dispensing operation.

[0046] The term “medication” refers to one or more therapeutic agents including, but not limited to, epinephrine, anaesthetics, analgesics, steroids, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tirzepatide or retatrutide, basal insulins, such insulin efsitora alfa, oxyntomodulin analogs, oxyntomodulin derivatives, and other treatments for diabetes and / or obesity, such as with lepodisiran (LPA siRNA), volenrelaxin, amylin agonist long acting, PNPLA3 siRNA, APOC3 siRNA, DACRA qw II, GIPR agonist long acting, glucose sensing insulin receptor agonist, nisotirostide, bimagrunab, NRG4 agonist, SCAP siRNA, mazdutide, and therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumab that can be used for treatment of diseases, such as, e.g., Crohn’s disease or ulcerative colitis, IL-17 antibody analogs or derivatives, such as ixekizumab that can be used for treatment of diseases, such as, e.g., plaque psoriasis, IL-13 antibody analogs or derivatives, such as lebrikizumab that can be used for treatment of diseases, such as, e.g., atopic dermatitis, therapeutic agents for pain-related and / or migraine treatments, such as galcanezumab or lasmiditan, for treatment of atopic dermatitis, such as with ucenprubart, for treatment of Alzheimer’s and / or dementia, such as with donanemab, remternetug, or GRN gene therapy, for treatment of Parkinson’ s disease and / or Gaucher’s disease, such as with GBA1 gene therapy, for treatment of Hidradenitis Suppurativa, such as with eltrekibart, for treatment of rheumatoid arthritis, such as with peresolimab, for treatment of cancer, and any therapeutic agent, such as CD 19 antibody for treatment of multiple sclerosis, that is capable of delivery by the devices described herein.

[0047] Devices according to the present disclosure may be operated in a manner generally as described herein by a user (for example, a healthcare professional, a caregiver, or another person) to deliver one or more medications to a patient (for example, another person or the user). Often, users will perform a prime dose using such injection devices to remove airfrom the cartridge and / or the needle prior to dosing a therapeutic amount of the medication. A prime dose is typically set by manually setting the dose to a relatively small number of units and then ejecting the set dosage so that air and / or medication is expelled from the system. If no medication is expelled, the process is repeated until medication is expelled, indicating air has been removed from the cartridge and / or needle.

[0048] The concepts of the devices disclosed herein can facilitate the elimination of the need for users to set the prime dose manually. The devices may be configured to be biased in a prime dose setting position, rather than in a zero or less than prime dose position. In other words, the devices may be configured to be automatically and / or initially set in the prime dose position, allowing the user to simply provide force to (e.g., by pressing down on) the dose button for the prime shot or ejection without manual adjustment. The devices may be configured to automatically return to the prime dose setting position from its zero position after fully dosing.

[0049] The devices disclosed herein may be configured with an automatic preset for a prime shot or ejection. In other words, the user may not be required to manually set a prime dose.

[0050] At a preset configuration, also referred to as an initial configuration, the dose button is at a first configuration described below. The device may include a dial indicator that can show an indication, such as “2” or other marking, for the prime shot or ejection. To perform the prime shot or ejection, the user may apply a distal force to the dose button overcoming biasing of a clutch spring as described further herein.

[0051] Upon application of the distal force to the dose button, a screw element rotatably coupled to and within a device body of the device rotates relative to a connector connecting the screw element with the dose button, a nut rotating element within the device body, and the dose button as described further herein. As the screw element rotates, it simultaneously moves in an axially distal direction. The user may continue to apply distal force to (e.g., by pressing on) the dose button until the dial indicator shows an indication, such as “0”, that the full prime shot or ejection has been delivered. Such configuration may be referred to as a second configuration, wherein movement of the device and its components from the first configuration toward the second configuration may be referred to as a first dispensing configuration or a prime dose dispensing configuration.

[0052] Once the prime shot is delivered, the user may remove the distal force being applied to the dose button, and the clutch spring may resultingly return the connector, the nut rotating element, the screw element, and the dose button to their initial configurations (i.e., the first configuration), via the various mechanisms described below. The dial indicator may again show an indication, such as “2”, of the prime shot or ejection.

[0053] During full dose setting, the user may apply a proximal withdrawing force to the dose button to increase the dose to be delivered, i.e., toward a full dose setting configuration. Before application of the proximal withdrawing force, the dose button may be in the first configuration as described above. During application of the proximal withdrawing force, the screw element may rotate relative to the device body while simultaneously moving in an axially proximal direction, which may include movement of the screw element out of a proximal end of the device body. Additionally, during application of the proximal withdrawing force, the dose button is being proximally moved away from the device body. In some device embodiments, the dose button is rotated to set the dose. The dose button may not rotate relative to the screw element due to it being coupled rotationally free relative to the connector connecting the screw element and the dose button.

[0054] After the dose is set, the user may apply a distal force to the dose button, overcoming the biasing of the clutch spring so that the screw element is screwed into the device body, i.e., rotating relative to the device body while simultaneously moving in an axially distal direction, and is rotated relative to the connector, the nut rotating element, and the dose button. The user may continue to apply the distal force to (e.g., by pressing on) the dose button until the dial indicator on the screw element shows an indication, such as “0”, that the full prime shot or ejection has been delivered. Such configuration may be referred to as a full dose delivery configuration, where the full dose delivery configuration and the second configuration may be similar and, in some embodiments, interchangeably used. Movement from the full dose setting configuration described above to the full dose delivery configuration may be referred to as a second dispensing configuration.

[0055] The movement of the dose button from the first configuration to the second configuration is, in some embodiments, a lesser movement or equal movement of the dose button from the full dose setting configuration to the full dose delivery configuration. In other words, the dose button may be moved a further distance relative to the device body during the second dispensing configuration relative to the first dispensing configuration so that the second dispensing configuration is greater than the first dispensing configuration.

[0056] Once the prime shot is delivered, the user may remove the distal force being applied to the dose button, and the clutch spring may resultingly return the connector, the nut rotating element, the screw element, and the dose button to their initial configurations (i.e., the first configuration), via the various mechanisms described below. The dial indicator may again show an indication, such as “2”, of the prime shot or ejection.

[0057] Outlet 110 of distal portion 106 may be equipped with an injection needle (not shown). In some embodiments, the injection needle may be removable from outlet 110 of distal portion 106. In some embodiments, the injection needle may be replaced with a new injection needle after each use. In other embodiments, body 102 and a cartridge holder containing cartridge 108 may be reusable, while cartridge 108 is configured to be replaced. In yet other embodiments, device 100 may be a single use device, so that the entire device 100 may be disposed of after use. Device 100 may also include a pen cap 112 to cover or otherwise the protect the distal portion 106 of device 100. Pen cap 112 is removable from device 100 to expose the injection needle and / or cartridge 108.

[0058] Device 100 may include a plunger drive system 114 positioned partially in proximal portion 104 of body 102 and partially in distal portion 106 of body 102. Plunger drive system 114 may include a drive member 116, which may include a screw or another suitable driving mechanism, configured to transfer force from a user to a plunger 118 located in cartridge 108 of distal portion 106 to deliver a predetermined dose of medication out of the injection needle. For example, cartridge 108 may include a generally hollow housing 120 defining an internal volume for receiving and / or holding a medication as discussed above. A plunger 118 may slidably contact an inner surface 122 of cartridge 108 in a manner that removes all or substantially all of the medication from the inner surface 122 an inner volume of cartridge 108 or a relevant portion of cartridge 108 during use. Drive member 116 may directly engage with plunger 118 via a foot portion 130 of the drive member in some embodiments to actuate plunger 118 during use. In other embodiments, a rod tip 124 may be positioned proximally of plunger 118 and include a disc and / or a collar 126 configured to receive a distal end 128, or foot 130, of drive member 116 to facilitate transfer of force from drive member 116 to plunger 118. Although plunger drive system 114 is illustrated with the embodiment of FIG. 2, any embodiment described herein may include plunger drive system 114.

[0059] Referring additionally to FIG. 3, drive member 116 may be axially moveable relative to body 102 along axis AA (FIG. 1) wherein axis AA extends longitudinally relativeto body 102. In some embodiments, drive member 116 may be rotatably locked relative to body 102. Drive member 116 may include threading 132 along the length of drive member 116. In some embodiments, threading 132 is helical in pattern, including raised portions 134 with grooves 136 therebetween.

[0060] Plunger drive system 114 may include a nut 138 having a longitudinal body 140 comprised of two spaced-apart arms 142 coupled to a foot 144 (FIG. 2) at a distal end of longitudinal body 140. A distal portion of longitudinal body 140 may include threading 145 configured to engage with threading 132 of drive member 116 to facilitate operation of device 100. Foot 144 may engage with a nut advancing plunger 146 as described further herein and / or contact a boss 148 (FIG. 2) of body 102 to prevent unwanted movement of drive member 116 during operation of device 100. A recess 150 defined by longitudinal body 140 of nut 138 may include a plurality of axial ribs 152 which are configured to cooperate with elements on nut advancing plunger 146 as further described herein to provide a clicking indicator during dose setting of device 100. Arms 142 may cooperate with an actuator assembly 154 as described further herein to facilitate operation of device 100.

[0061] Actuator assembly 154 may include a nut rotating element 156 having a longitudinal body 158 and a flange 160 extending from a central portion 162 of nut rotating element 156. Flange 160 may include a first plurality of teeth extending from a proximal face 166 of flange 160 and / or a second plurality of teeth extending from a distal face 170 of flange 160. An axial protrusion 172 may extend in a proximal direction from central portion 162 of nut rotating element 156. Nut rotating element 156 may further include two spaced-apart arms 174 that extend distally from flange 160. Arms 174 may be configured to engage with arms 142 of nut 138 to facilitate axial motion of nut 138 relative to nut rotating element 156 during dose setting, but to inhibit rotational motion of nut 138 relative to nut rotating element 156 during dose delivery; i.e., nut 138 and nut rotating element 156 are rotatably locked.

[0062] Actuator assembly 154 may further include a dose button 176 having a body portion 178 and a flange portion 180 extending radially outward in a lateral direction from a proximal end 182 of body portion 178. Body portion 178 may have a circumferential surface 184 which defines generally a diameter of body portion 178, further defining a cross- sectional area of body portion 178. Flange portion 180 may have an edge 186 which defines a diameter of flange portion 180, which further defines a cross-sectional area of the flange portion 180. The diameter of the flange portion 180 may be greater than the diameter of the body portion 178 so that the flange portion 180 forms a lip, or ridge, at the proximal end 188of dose button 176 to facilitate grip on dose button 176 and axial translation of dose button 176 as described further herein. As such, the cross-sectional area of flange portion 180 may be greater than the cross-sectional area of body portion 178. Flange portion 180 may include a push surface, or proximal surface 190, to facilitate application of a distally directed force Fi to dose button 176 to operate device 100.

[0063] A connector 192 may facilitate coupling of dose button 176 and nut rotating element 156 of actuator assembly 154. Connector 192 may include a longitudinal portion 194 and a lateral portion 196 arranged with longitudinal portion 194 to divide longitudinal portion 194 into an upper stem 198 and a lower stem 200. Upper stem 198 may be configured to be received within a stemmed opening 202 defined by dose button 176. An interior surface 204 defining stemmed opening 202 may include a ridge 206 configured to mate with a lip 208 extending laterally from upper stem 198 so that ridge 206 is received within a recess 210 defined between lip 208 and a proximal surface 212 of lateral portion 196. As such, connector 192 is axially locked with zero to minimal axial movement with dose button 176 but is capable of rotating relative to dose button 176.

[0064] Lower stem 200 may be received by the axial protrusion 172 of nut rotating element 156 to couple connector 192 with nut rotating element 156 and, thereby, dose button 176 with nut rotating element 156. Such coupling can be by, for example, adhesive, ultrasonic welding, or another mechanism known in the art. A receiving wall 214 may be positioned annularly relative to lower stem 200, extending in a distal direction from lateral portion 196 of connector 192. A gap 216 may be defined between receiving wall 214 and lower stem 200, which may be configured to receive a portion of axial protrusion 172 of nut rotating element 156.

[0065] A screw element 218 may be positioned exterior of and coaxially with nut rotating element 156 and include a main body 220 and a flange portion 222. An exterior surface 224 of main body 220 may include threading 226 configured to engage with threading 228 on an interior surface of body 102 of device 100 so that screw element 218 is rotatable relative to body 102 along threading 228 of body 102 to facilitate management of dose setting during operation of device 100. An interior surface 230 of main body 220 of screw element 218 may include threading 232 configured to engage with nut advancing plunger 146 as described further herein. Flange portion 222 and a proximal end 234 of main body 220 may be configured to be received within a hollow portion 236 of dose button 176. Flange portion 222 may be a discrete component from screw element 218 that ismechanically mated within a bore defined by screw element 218 as shown in the figures. In other embodiments, flange portion 222 may be integrally formed with screw element 218 as a single piece component.

[0066] In some embodiments, flange portion 222 of screw element 218 may be fixedly coupled to dose button 176 by, for example, adhesive, ultrasonic welding, or another mechanism known in the art. In other embodiments, flange portion 222 may not be directly coupled to dose button 176 or may be coupled to connector 192 so that screw element 218 is rotatable relative to dose button 176.

[0067] A clutch spring 350 may be disposed between connector 192, e.g., lateral portion 196 of connector 192, and flange portion 222. Clutch spring 350 may bias dose button 176, connector 192, and nut rotating element 156 distally as a unit into a first position relative to body 102, whereby connector 192 and nut rotating element 156 are rotationally locked with screw element 218 during dose setting as described further herein. A user may apply a distal force to (e.g., by pressing on) dose button 176 to overcome the biasing of clutch spring 350, dose button 176, nut rotating element 156, and connector 192, to move the components as a unit to a second position distal of the first position. Connector 192 and nut rotating element 156 may be rotationally free relative to screw element 218 during dose delivery as described further herein.

[0068] Flange portion 222 may be received within a proximal portion of main body 220 of screw element 218 in a nested configuration, and the two components may couple to each other via, for example, a tab-in-window mechanism. In other embodiments, the components may couple via another mechanism as known in the art. As illustrated, flange portion 222 and main body 220 of screw element 218 may be coupled to each other in a manner that results in tandem movement of flange portion 222 and main body 220; in other words, flange portion 222 and main body 220 may be axially and rotatably fixed to each other. An interior surface 238 of flange portion 222 may include teeth configured to cooperate with the first plurality of teeth extending from proximal face 166 of flange 160 of nut rotating element 156. Referring again to FIG. 1, an outer surface of screw element 218 may serve as a dial indicator 242 to be viewed through a window 244 defined by body 102 of device 100.

[0069] Referring again to FIGS. 1-4, nut advancing plunger 146 includes a longitudinal body 246 which may be received within hollow portion 233 of main body 220 ofscrew element 218. Longitudinal body 246 of nut advancing plunger 146 may include threading 248 configured to engage with threading 232 on interior surface 230 of main body 220 of screw element 218. A proximal portion 250 of longitudinal body 246 of nut advancing plunger 146 may include teeth , which may define at least a portion of a ring around longitudinal body 246 and may be configured to engage with the second plurality of teeth extending from distal face 170 of flange 160 of nut rotating element 156 to rotatably lock actuator assembly 154 with nut advancing plunger 146. An interior of a distal portion 254 of longitudinal body 246 of nut advancing plunger 146 may include protrusions 256 configured to be received within recess 150 of nut 138 to click over axial ribs 152 of nut 138 and prevent nut advancing plunger 146 from separating from nut 138 during operation of device 100.

[0070] It should be appreciated that while a distinct body and arrangement is shown for device 100 and dose button 176, such description as provided herein may apply across several embodiments with different shapes and arrangements as can be found, for example, as described further herein and / or in Ergo II provided by Eli Lilly and Company (Indianapolis, Indiana) and / or KwikPen™ provided by Eli Lilly and Company (Indianapolis, Indiana).

[0071] For example, further details of the design and operation of exemplary embodiments of a delivery device 100 as described above may be found in U.S. Patent No. 7,195,616, entitled “Medication Injector Apparatus with Drive Assembly that Facilitates Reset” and U.S. Patent No. 7,291,132 entitled “Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage”, the entireties of which are hereby incorporated by reference.

[0072] Many medication delivery devices as described herein include a plunger drive mechanism that includes dose setting member(s), including dose buttons, typically threadably connected in an arrangement, that rotate during dose setting to allow the drive member to be prepared to deliver a dose amount set which can vary for each use and rotate during dose dispensing to drive the drive member to move the plunger to deliver the dose amount that was set. Other medication delivery devices may include dose setting member(s), including dose buttons, which facilitate dose setting for fixed dose therapies. Such devices may include a pull-out button design, which may simplify dose setting and may facilitate extending the dose button to the fixed amount without rotation of said dose button.

[0073] Furthermore, while dose button 176 above has been described in terms of the illustrated structure, it should be understood that dose buttons having other structures may beincluded with device 100. For example, device 100 may include a dose button that is mechanically coupled to the drive member such that depression of the dose button results in ejection of the medication. The dose button may be attached to the device by being directly positioned on, received within, integral with, or otherwise connected to a component of device 100. Connections may include, for example, threading, snap fit, ultrasonic welding, splines, friction fit, adhesive, mechanical fasteners, key-in-groove, or other coupling means known in the art. Dose buttons may be cylindrical, frustoconical, or another shape. Dose buttons may include a dose member in some instances, which may be rotatable relative to the dose button or rotatably fixed relative to the dose button. In some embodiments, the dose button may include a collar. In some embodiments, the dose button may include an inner button which operates in tandem with or independently of an outer collar. In yet other embodiments, the dose button may be a tapered pull member configured to receive a stem portion of a disc for attachment to a proximal end of a device and an actuator nut for retention of said stem portion.

[0074] It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and / or in any desired combination as the disclosure is not limited to only the specific embodiments described herein. For example, while device 100 has been described in the form of a pen injector, device 100 may be any device which is used to set and deliver a predetermined dose of a medication, such as pen injectors, autoinjectors, bolus injectors, infusion, and syringes. The medication may be any one of a type that may be delivered by such a device. The device may be a reusable device capable of receiving a replaceable and disposable cartridge of medication or may be an entirely disposable device with a prefilled reservoir of medication.

[0075] Referring to FIGS. 1-5, a flexible member may be disposed between dose button 176 and body 102 as described further herein. For example, in some embodiments, dose button 176 may be formed with multiple materials. For example, dose button 176 may have a first portion, or flexible portion 258 including at least part of body portion 178 of dose button 176, and a second portion, or rigid portion 260 including flange portion 180 of dose button 176 and, in some embodiments, a part of body portion 178 of dose button 176. In such embodiments, flexible portion 258 may be comprised of the flexible member. In other words, the flexible member may be integrated with dose button 176 as flexible portion 258. In other embodiments, the flexible member may be configured similarly to flexible portion 258 asdescribed above and further herein, but be formed as a separate component from dose button 176.

[0076] Flexible portion 258 and rigid portion 260 may form dose button 176 via two- shot injection molding or another molding process. For example, in some embodiments, a rigid polymer may be injected into a first portion of a mold and partially cured. A flexible polymer, preferably including an elastomer, may then be injected into a second portion of the mold so that the flexible polymer and the rigid polymer may be full cured together, forming a single piece. In other embodiments, flexible portion 258 and rigid portion 260 may be coupled together via other means, for example, welding, adhesive, mechanical fasteners, interference fit, tab-in-groove, or other coupling means removable or permanent.

[0077] As shown, in some embodiments, flexible portion 258 and rigid portion 260 may have an overlapping portion 262 to facilitate a stronger coupling between flexible portion 258 and rigid portion 260 and / or encourage outward bulging of flexible portion 258 during depression of dose button 176 as described further herein. In some embodiments, a proximal portion 264 of flexible portion 258 may define a notch 266 to receive a distal extension 268 of rigid portion 260 to further facilitate coupling between flexible portion 258 and rigid portion 260.

[0078] A notch 270 may further be defined in a proximal portion 272 of body 102 of device 100 in some embodiments to capture a distal portion 274 of flexible portion 258. Distal portion 274 may, for example, be a tapered end 276 of flexible portion 258 so that the taper is captured by the walls defining notch 270. Tapered end 276 of flexible portion 258 may cooperate with notch 270 to form a removable coupling mechanism between dose button 176 and body 102 in some embodiments. In some embodiments, a tapered surface 278 of tapered end 276 is the external face of tapered end 276 to encourage outward bulging of flexible portion 258 during depression of dose button 176, where notch 270 can facilitate that position of tapered end 276 relative to body 102 during outward bulging. During dose setting, tapered end 276 is axially withdrawn from notch 270.

[0079] FIGS. 1-3 illustrate device 100 in a first configuration, also referred to as a primed configuration or a rest configuration. The first configuration of device 100 is the default configuration of device 100; in other words, device 100 is in the first configuration when dose button 176 is not engaged by a user, although device 100 may also be in the first configuration when dose button 176 or another part of device 100 is engaged by a user.

[0080] As shown in FIG. 1, in the first configuration, dial indicator 242 may show that device 100 is set to a small dosage which is considered the prime dosage for device 100. In other words, device 100 is preset at a prime dosage prior to manipulation by a user so that the user does not have to set a prime dose before priming device 100 for usage; instead, the user may pick up the device and engage dose button 176 to prime device 100 without first setting the prime dosage to facilitate efficiency and save time. As shown, the prime dosage may be “2” units. In other embodiments, the prime dosage may be “1”, “3”, “4”, or “5” units. Other embodiments may have another prime dosage, including full, half, third, quarter, eighth, or sixteenth units. The number of units illustrated in the first configuration is intended to only be exemplary in illustration of the operation of device 100.

[0081] Referring additionally to FIGS. 2-3, in the first configuration, flexible portion 258 of dose button 176 is in a relaxed state. In the relaxed state, an exterior surface 280 of flexible portion 258 is generally smooth and free of bulges, with dose button 176 having a first height Hi relative to body 102 of device 100.

[0082] Now referring to FIGS. 4-5, device 100 is in a second configuration, also referred to as a dosing configuration or an active configuration or zero or less than prime position. The second configuration of device 100 is the in-use configuration of device 100; in other words, device 100 is in the second configuration when dose button 176 is engaged by a user or is otherwise provided force to depress dose button 176 in relation to body 102 of device 100. Referring additionally to FIG. 6, in the second configuration, flexible portion 258 of dose button 176 is in a loaded state so that dose button 176 has a second height H2 relative to body 102 of device 100, where second height H2 is less than first height Hi and the displacement is contained in at least one bulge 282 formed by flexible portion 258 of dose button 176.

[0083] As shown in FIG. 4, dial indicator 242 may indicate that device 100 is not set to any dosage. In other words, dial indicator 242 may indicate that device 100 has fully dispensed a previously-set dosage and / or that device 100 is not prepared to immediately dispense any medication. The number of units illustrated is intended to only be exemplary in illustration of the operation of device 100; however, the number of units displayed by dial indicator 242 is generally less than the number of units displayed by dial indicator 242 in the first configuration. In other words, if dial indicator 242 is set to “2” in the first configuration, dial indicator 242 may be set to “0”, “0.5”, “1.0”, “1.5”, or any other number less than 2 inthe second configuration. Other embodiments may include full, half, third, quarter, eighth, or sixteenth units.

[0084] Comparing FIGS. 1-3 with FIGS. 4-5, in the first configuration, dose button 176 is generally in a first position, which may be a resting position. For example, in the first position, no force is applied to dose button 176 and exterior surface 280 of flexible portion 258 is in the relaxed state, i.e., generally smooth and free of bulges as described above. In the second configuration, a distal force Fi is generally applied to dose button 176, e.g., to proximal surface 190 of dose button 176, to move dose button 176 in an axial direction toward a second position, i.e., the second configuration. In the second configuration, flexible portion 258 is in the loaded state and may include at least one bulge 282. For example, flexible portion 258 is displaced by flexing circumferentially outward to form bulge 282.

[0085] In other words, in the second configuration, distal force Fi is generally being applied to proximal surface 190 of dose button 176 so that flexible portion 258 moves from the relaxed state to the loaded state as described above as dose button 176 moves from the first position towards the second position. When dose button 176 is in the second configuration and flexible portion 258 is in the loaded state, flexible portion 258 stores elastic potential energy, as flexible portion 258 is biased toward the relaxed state, i.e., toward the first position and / or the first configuration. When distal force Fi is removed from dose button 176, flexible portion 258 returns to the relaxed state and the release of elastic potential energy imparts a proximal force F2 to dose button 176, returning dose button 176 to the first position and / or the first configuration.

[0086] In use, device 100 is initially in the first configuration, which includes device 100 being set an initial prime dose as described above. A user may apply distal force Fi to the proximal surface 190 of dose button 176 or otherwise impart distal force Fi to dose button 176 to move dose button 176 from the first configuration to the second configuration, priming device 100. When the user removes distal force Fi from dose button 176, dose button 176 returns to the first configuration due to the imparted proximal force F2, which includes device 100 again being set at a prime dose.

[0087] If device 100 was not properly primed after the first application of distal force Fi (i.e., if not all air has been removed from cartridge 108 and / or the injection needle), the user may provide a second application of distal force Fi to device 100. This method may be repeated until device 100 is properly primed, i.e., until all air has been removed fromcartridge 108 and / or the injection needle or a small amount of medication has been dispensed from device 100 as described above. Once device 100 has been properly primed and dose button 176 has returned to the first position, i.e., the first configuration, a dosage for therapeutic application may be set as known in the art.

[0088] In some embodiments, flexible portion 258 may have a varying wall thickness. For example, as illustrated in FIG. 6, flexible portion 258 may define a groove 284 defined by an internal surface 286 of flexible portion 258 to encourage outward bulging of flexible portion 258 (e.g., bulge 282 of FIGS. 4-5), rather than internal bulging. Groove 284 may be an annular groove that extends partially or completely around the interior perimeter of flexible portion 258. In other embodiments, groove 284 may include a plurality of grooves spaced apart along at least a portion of the interior perimeter of flexible portion 284.

[0089] Referring again to FIG. 3, in some embodiments, flexible portion 258 may have an upper body portion 288, a central body portion 290, and a lower body portion 292. Upper body portion may be positioned between central body portion 290 and overlapping portion 262, while lower body portion 292 may be positioned between central body portion 290 and tapered end 276. In the embodiment illustrated, upper body portion 288, central body portion 290, and lower body portion 292 may have a same or similar wall thickness T. In other embodiments, upper body portion 288 and lower body portion 292 may each have a greater wall thickness than central body portion 290. In yet other embodiments, upper body portion 288 and central body portion 290 may have a greater wall thickness than lower body portion 292. Such variation in wall thickness may encourage outward bulging of flexible portion 258 (e.g. bulge 282), rather than internal bulging.

[0090] As described above, dose button 176 may be structured with preference for outward bulging rather than internal bulging of flexible portion 258 to mitigate interference between an internal bulge and the plunger drive system 114 or other internal mechanisms of device 100. In some embodiments, however, the flexible portion may bulge inward to account for displacement of material in view of the change in height of the dose button relative to the body of the device in such a manner that avoids interference with internal mechanisms of the device.

[0091] Now referring to FIGS. 7-12, an exemplary medication delivery device 1100 is disclosed. Medication delivery device 1100 (hereinafter “device”) may include characteristics and components similar to device 100 as described above, except as otherwisedescribed herein. In other embodiments, device 1100 may share only some or none of the characteristics of device 100. Components which may be similar to device 100 are similarly numbered, except such number corresponds to a “1000” counterpart (i.e., device 100 and device 1100).

[0092] Referring to FIGS. 7-8, device 1100 includes an elongated pen-shaped body 1102, including a distal portion 1106 and a proximal portion 1104. In some embodiments, distal portion 1106 may include a containment unit, e.g., a reservoir or a cartridge 1108 configured to hold a medication to be dispensed through an outlet 1110 during a dispensing operation. The term “medication” refers to one or more therapeutic agents as described above in relation to device 100. Operation of device 1100, including the process of priming the device, is similar to that of device 100 as described above.

[0093] Outlet 1110 of distal portion 1106 may be equipped with an injection needle (not shown). In some embodiments, the injection needle may be removable from outlet 1110 of distal portion 1106. In some embodiments, the injection needle may be replaced with a new injection needle after each use. In other embodiments, body 1102 and a cartridge housing 1120 containing cartridge 1108 may be reusable, while cartridge 1108 is configured to be replaced. In yet other embodiments, device 1100 may be a single use device, so that the entire device 1100 may be disposed of after use. Device 1100 may also include a pen cap 1112 to cover or otherwise protect the distal portion 1106 of device 1100. Pen cap 1112 is removable from device 1100 to expose the injection needle and / or cartridge 1108.

[0094] Device 1100 may include a plunger drive system 1114 positioned partially in proximal portion 1104 of body 1102 and partially in distal portion 1106 of body 1102 as described above in relation to device 100. For example, plunger drive system 1114 may include a drive member 1116, which may include a screw or another suitable driving mechanism, configured to transfer force from a user to a plunger 1118 located in cartridge 1108 of distal portion 1106 to deliver a predetermined dose of medication out of the injection needle.

[0095] Referring additionally to FIG. 9, plunger drive system 1114 may include a nut 1138 as described above; i.e., nut 1138 may have a longitudinal body 1140 including threading 1145 configured to engage with threading 1132 of drive member 1116 to facilitate operation of device 1100. Arms 1142 of nut 1138 may also cooperate with an actuator assembly 1154 as described above to facilitate operation of device 1100.

[0096] Actuator assembly 1154 may include a nut rotating element 1156 having two spaced-apart arms 174 configured to engage with arms 1142 of nut 1138 as described above to facilitate axial motion of nut 1138 relative to nut rotating element 1156 during dose setting , but to inhibit rotational motion of nut 1138 relative to nut rotating element 1156 during dose delivery.

[0097] Actuator assembly 1154 may further include a dose button 1176 having a body portion 1178 and a flange portion 1180 extending radially outward in a lateral direction from a proximal end 1182 of body portion 1178. Body portion 1178 may have a circumferential surface 1184 which generally defines a diameter of body portion 1178, further defining a cross-sectional area of body portion 1178. Flange portion 1180 may have an edge 1186 which defines a diameter of flange portion 1180. The diameter of flange portion 1180 may be greater than the diameter of the body portion 1178 so that the flange portion 1180 forms a lip, or ridge, at the proximal end 1188 of dose button 1176 to facilitate grip on dose button 1176 and axial translation of dose button 1176 as described further herein. As such, the cross- sectional area of flange portion 1180 may be greater than the cross-sectional area of body portion 1178. Flange portion 1180 may include a push surface, or proximal surface 1190, to facilitate application of a distally directed force Fi to dose button 1176 to operate device 1100.

[0098] A connector 1192 may facilitate coupling of dose button 1176 and nut rotating element 1156 of actuator assembly 1154. Connector 1192 may include a longitudinal portion 1194 and a lateral portion 1196 arranged with longitudinal portion 1194 to divide longitudinal portion 1194 into an upper stem 1198 and a lower stem 1200. Upper stem 1198 may be configured to be received within a stemmed opening 1202 defined by dose button 1176. An interior surface 1204 defining stemmed opening 1202 may include a ridge 1206 configured to mate with a lip 1208 extending laterally from upper stem 1198 so that ridge 1206 is received within a recess 1210 defined between lip 1208 and a proximal surface 1212 of lateral portion 1196. As such, connector 1192 may be axially locked with zero to minimal axial movement relative to dose button 1176 but is capable of rotating relative to dose button 1176. In other embodiments, connector 1192 may be axially and rotatably locked with dose button 1176.

[0099] Lower stem 1200 may be received by axial protrusion 1172 of nut rotating element 1156 to couple connector 1192 with nut rotating element 1156 and, thereby, dose button 1176 with nut rotating element 1156. A receiving wall 1214 may be positionedannularly relative to lower stem 1200, extending in a distal direction from lateral portion 1196 of connector 1192. A gap 1216 may be defined between receiving wall 1214 and lower stem 1200, which may be configured to receive a portion of axial protrusion 1172 of nut rotating element 1156.[000100] A screw element 1218 as described above may be positioned exterior of and coaxially with nut rotating element 1156 and include a main body 1220 and a flange portion 1222. Main body 1220 may be configured to engage with body 1102 of device 1100 so that screw element 1218 is rotatable relative to body 1102 while flange portion 1222 and a proximal end 1234 of main body 1220 may be configured to be received within a hollow portion 1236 of dose button 1176. In some embodiments, flange portion 1222 of screw element 1218 may be fixedly coupled to dose button 1176 by, for example, adhesive, ultrasonic welding, or another mechanism known in the art. In other embodiments, flange portion 1222 may not be directly coupled to dose button 1176 or may be coupled to connector 1192 so that screw element 1218 is rotatable relative to dose button 1176.[000101] As described above, flange portion 1222 and main body 1220 may be coupled to each other in a manner that results in tandem movement of flange portion 1222 and main body 1220; in other words, flange portion 1222 and main body 1220 may be axially and rotatably fixed to each other. Flange portion 1222 may be configured to cooperate with nut rotating element 1156 as described above. An outer surface of screw element 1218 may serve as a dial indicator 1242 to be viewed through a window 1244 defined by body 1102 of device 1100.[000102] Device 1100 may further include a nut advancing plunger 1146 as described above, including a longitudinal body 1246 which may be received within a hollow portion 1233 of main body 1220 of screw element 1218 and configured to engage with screw element 1218. Nut advancing plunger 1146 may be rotatably locked with actuator assembly 1154 and include protrusions 1256 configured to be received within recess 1150 of nut 1138 to click over axial ribs 1152 of nut 1138 and prevent nut advancing plunger 1146 from separating from nut 1138 during operation of device 1100.[000103] It should be appreciated that while a distinct body and arrangement is shown for device 1100 and dose button 1176, such description as provided herein may apply across several embodiments with different shapes and arrangements as can be found, for example, asdescribed further herein and / or in Ergo II provided by Eli Lilly and Company (Indianapolis, Indiana) and / or KwikPen™ provided by Eli Lilly and Company (Indianapolis, Indiana).[000104] For example, further details of the design and operation of exemplary embodiments of a delivery device 1100 as described above may be found in U.S. Patent No. 7,195,616, entitled “Medication Injector Apparatus with Drive Assembly that Facilitates Reset” and U.S. Patent No. 7,291,132 entitled “Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage”, the entireties of which are hereby incorporated by reference.[000105] Many medication delivery devices as described herein include a plunger drive mechanism that includes dose setting member(s), including dose buttons, typically threadably connected in an arrangement, that rotate during dose setting to allow the drive member to be prepared to deliver a dose amount set which can vary for each use and rotate during dose dispensing to drive the drive member to move the plunger to deliver the dose amount that was set. Other medication delivery devices may include dose setting member(s), including dose buttons, which facilitate dose setting for fixed dose therapies. Such devices may include a pull-out button design, which may simplify dose setting and may facilitate extending the dose button to the fixed amount without rotation of said dose button.[000106] Furthermore, while dose button 1176 above has been described in terms of the illustrated structure, it should be understood that dose buttons having other structures may be included with device 1100. For example, device 1100 may include a dose button that is mechanically coupled to the drive member such that depression of the dose button results in ejection of the medication. The dose button may be attached to the device by being directly positioned on, received within, integral with, or otherwise connected to a component of device 1100. Connections may include, for example, threading, snap fit, ultrasonic welding, splines, friction fit, adhesive, mechanical fasteners, key-in-groove, or other coupling means known in the art. Dose buttons may be cylindrical, frustoconical, or another shape. Dose buttons may include a dose member in some instances, which may be rotatable relative to the dose button or rotatably fixed relative to the dose button. In some embodiments, the dose button may include a collar. In some embodiments, the dose button may include an inner button which operates in tandem with or independently of an outer collar. In yet other embodiments, the dose button may be a tapered pull member configured to receive a stem portion of a disc for attachment to a proximal end of a device and an actuator nut for retention of said stem portion.[000107] It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and / or in any desired combination as the disclosure is not limited to only the specific embodiments described herein. For example, while device 1100 has been described in the form of a pen injector, device 1100 may be any device which is used to set and deliver a predetermined dose of a medication, such as pen injectors, autoinjectors, bolus injectors, infusion, and syringes. The medication may be any one of a type that may be delivered by such a device. The device may be a reusable device capable of receiving a replaceable and disposable cartridge of medication or may be an entirely disposable device with a prefilled reservoi r of medication.[000108] Still referring to FIGS. 7-11, and especially to FIGS. 8-9 and 11, body portion 1178 and flange portion 1180 of dose button 1176 may join at an apex 1294 of a tapered surface 1296 of flange portion 1180 which tapers from edge 1186 of flange portion 1180, i.e., the maximum diameter of flange portion 1180, to proximal end 1182 of body portion 1178. Body portion 1178 may extend from the apex 1294 for a length that results in overlap between a distal portion 1298 of body portion 1178 and proximal portion 1272 of body 1102 of device 1100. In other words, the internal diameter of body portion 1178 may be greater than an external diameter of body 1102 of device 1100 so that proximal portion 1272 of body 1102 of device 1100 is partially received within body portion 1178 of dose button 1176.[000109] A distal end 1300 of dose button 1176 may be chamfered from an outer perimeter of body portion 1178 to an inner perimeter of body portion 1178 to facilitate movement of dose button 1176 over body 1102 during operation. In some embodiments, an outer edge 1302 of a proximal end 1304 of body 1102 of device 1100 may be rounded in addition to or in lieu of chamfered end 1300 of dose button 1176 to facilitate movement of dose button 1176 over body 1102.[000110] A priming spring 1306 may be captured between an internal proximal surface 1308 of dose button 1176 and proximal end 1304 of body 1102 of device 1100. In other words, a proximal end 1310 of priming spring 1306 may be configured to contact internal proximal surface 1308 of dose button 1176 while a distal end 1312 of priming spring 1306 may be configured to contact proximal end 1304 of body 1102. The overlap of dose button 1176 and body 1102 of device 1100 facilitates entrapment of priming spring 1306 within hollow portion 1236 of dose button 1176 to mitigate inadvertent removal of priming spring 1306 from device 1100.[000111] Dose button 1176 may further include a ridge 1314 which extends into hollow portion from internal proximal surface 1308. Ridge 1314 is spaced away from an internal circumferential surface 1316 of dose button 1176 to define a gap 1318 therebetween. As illustrated, gap 1318 is shaped and sized to receive a proximal portion 1320 of priming spring 1306. In some embodiments, gap 1318 may be shaped and sized to create an interference fit between dose button 1176 and proximal portion 1320 of priming spring 1306 so that priming spring 1306 remains in the same general lateral position relative to dose button 1176, and proximal portion 1320 is axially locked with gap 1318.[000112] In some embodiments, gap 1318 may be sized and shaped to receive priming spring 1306 without forming an interference fit between priming spring 1306 and dose button 1176. In such embodiments, ridge 1314 serves as a guide for the movement of priming spring 1306 during operation so that priming spring 1306 remains in the same generally lateral position relative to dose button 1176. Additionally, in such embodiments, the biased nature of priming spring 1306 as described further herein facilitates tandem axial movement of priming spring 1306 and dose button 1176.[000113] In the illustrated embodiment, ridge 1314 is a continuous annular ridge that remains generally equidistant to internal circumferential surface 1316 of dose button 1176. In other embodiments, ridge 1314 may include one or more protrusions that extend from internal proximal surface 1308 but do not extend continuously relative to internal circumferential surface 1316. For example, in some embodiments, ridge 1316 may include a plurality of protrusions that are spaced apart from one another. Each protrusion of the plurality of protrusions may extend annularly and / or laterally some length greater than zero relative to internal circumferential surface 1316 to create corresponding gaps similar to gap 1318 for capture of priming spring 1306. In other embodiments, ridge 1316 may include one protrusion that extends annularly or laterally some length greater than zero relative to internal circumferential surface 1316 to create a gap similar to gap 1318 for capture of priming spring 1306, but such ridge may only extend a partial circumference relative to internal circumferential surface 1316.[000114] FIGS. 7-9 illustrate device 1100 in a first configuration, also referred to as a primed configuration or a rest configuration. The first configuration of device 1100 is the default configuration of device 1100; in other words, device 1100 is in the first configuration when dose button 1176 is not engaged by a user, although device 1100 may also be in thefirst configuration when dose button 1176 or another part of device 1100 is engaged by a user.[000115] As shown in FIG. 7, in the first configuration, dial indicator 1242 may show that device 1100 is set to a small dosage which is considered the prime dosage for device 1100. In other words, device 1100 is set at a prime dosage prior to manipulation by a user so that the user does not have to set a prime dose before priming device 1100 for usage; instead, the user may pick up the device and engage dose button 1176 to prime device 1100 without first setting the prime dosage to facilitate efficiency and save time. As shown, the prime dosage may be “2” units. In other embodiments, the prime dosage may be “1”, “3”, “4”, or “5” units. Other embodiments may have another prime dosage, including full, half, third, quarter, eighth, or sixteenth units. In yet other embodiments, dosage may be indicated by any number of symbols or text outside of Arabic numerals. The number of units illustrated in the first configuration is intended to only be exemplary in illustration of the operation of device 1100.[000116] Referring to FIGS. 8-9, in the first configuration, priming spring 1306 is in a relaxed state. In the relaxed state, priming spring 1306 defines a first length Li between proximal end 1310 of priming spring 1306 and distal end 1312 of priming spring 1306. In other words, coil segments 1322 of priming spring 1306 are spaced apart a first distance Di. The contact between priming spring 1306, body 1102 of device 1100, and dose button 1176 results in a first clearance Ci between internal proximal surface 1308 of dose button 1176 and proximal end 1304 of body 1102 of device 1100, where Ci may generally be about equal to Li[000117] Now referring to FIGS. 10-11, device 1100 is in the second configuration. Device 1100 may be in the second configuration when dose button 1176 is engaged by a user or is otherwise provided force to depress dose button 1176 relative to body 1102 of device 1100 as described further herein.[000118] As shown in FIG. 10, dial indicator 1242 may indicate that device 1100 is not set to any dosage. In other words, dial indicator 1242 may indicate that device 1100 has fully dispensed a previously-set dosage and / or that device 1100 is not prepared to immediately dispense any medication. The number of units illustrated is intended to only be exemplary in illustration of the operation of device 1100; however, the number of units displayed by dial indicator 1242 is generally less than the number of units displayed by dial indicator 1242 inthe first configuration. In other words, if dial indicator 1242 is set to “2” in the first configuration, dial indicator 1242 may be set to “0”, “0.5”, “1.0”, “1.5”, or any other number less than 2 in the second configuration. Other embodiments may include full, half, third, quarter, eighth, or sixteenth units. In yet other embodiments, dosage may be indicated by any number of symbols or text outside of Arabic numerals.[000119] Referring to FIG. 11, in the second configuration, priming spring 1306 is in a loaded state. In the loaded state, priming spring 1306 defines a second length L2 between proximal end 1310 of priming spring 1306 and distal end 1312 of priming spring 1306, where second length L21S less than first length Li of the first configuration. In other words, coil segments 1322 of priming spring 1306 are spaced apart a second distance D2, where second distance D2 is less than first distance Di. In the second configuration, internal proximal surface 1308 of dose button 1176 and proximal end 1304 of body 1102 of device 1100 defines a second clearance C2, whereas second clearance C2 is less than first clearance Ci.[000120] Comparing FIGS. 7-9 with FIGS. 10-11, in the first configuration (FIGS. 8- 10) dose button 1176 is generally in a first position, which may be a resting position, consistent with the relaxed state of priming spring 1306 as discussed above. For example, in the first position, no distal force Fi is applied to dose button 1176 and priming spring 1306 is in a relaxed state as discussed above. In the second configuration (FIGS. 10-11), distal force Fi is generally applied to dose button 1176, e.g., to proximal surface 1190 of dose button 1176, to move dose button 1176 in an axial direction toward a second position, i.e., the second configuration. In the second configuration, priming spring 1306 is in the loaded state.[000121] In other words, in the second configuration, distal force Fi is generally applied to proximal surface 1190 of dose button 1176 so that priming spring 1306 moves from a relaxed state to a loaded state as described above as dose button 1176 moves from the first position to the second position. When priming spring 1306 is in the loaded state, priming spring 1306 stores elastic potential energy, as priming spring 1306 is biased toward the relaxed state; i.e., toward the first position and / or the first configuration. When distal force Fi is removed from dose button 1176, priming spring 1306 returns to the relaxed state and the release of elastic potential energy imparts a proximal force F2 to dose button 1176 via the contact between priming spring 1306, body 1102 of device 1100, and dose button 1176, returning dose button 1176 to the first position and / or the first configuration.[000122] In use, device 1100 is initially in the first configuration, which includes device 1100 being preset at the initial prime dose as described above. A user may apply a distal force Fi to the proximal surface 1190 of dose button 1176 or otherwise impart distal force Fi to dose button 1176 to move dose button 1176 from the first configuration to the second configuration. When the user removes distal force Fi from dose button 1176, dose button 1176 returns to the first configuration due to the imparted proximal force F2 from priming spring 1306, which includes device 1100 again being set at a prime dosage.[000123] If device 1100 was not properly primed after the first application of distal force Fi (i.e., if not all air has been removed from cartridge 1108 and / or the injection needle), the user may provide a second application of distal force Fi to device 1100. This method may be repeated until device 1100 is properly primed, i.e., until all air has been removed from cartridge 1108 and / or the injection needle or a small amount of medication has been dispensed from device 1100 as described above. Once device 1100 has been properly primed and dose button 1176 has returned to the first position, i.e., the first configuration, a dosage for therapeutic application may be set as known in the art.[000124] Now referring to FIGS. 12-15C, an exemplary medication delivery device 2100 is disclosed. Medication delivery device 2100 (hereinafter “device”) may include characteristics and components similar to devices 100 and / or 1100 described above, except as otherwise described herein. In other embodiments, device 2100 may share only some or none of the characteristics of devices 100 and / or 1100. Components which may be similar to devices 100 and / or 1100 are similarly numbered, except such number corresponds to a “2000” counterpart (i.e., device 100, device 1100, and device 2100).[000125] Referring to FIGS. 12 and 14, device 2100 includes an elongated pen-shaped body 2102, including a distal portion 2106 and a proximal portion 2104. In some embodiments, distal portion 2106 may include a containment unit, e.g., a reservoir or a cartridge configured to hold a medication to be dispensed through an outlet during a dispensing operation as described above in relation to devices 100 and / or 1100. The term “medication” refers to one or more therapeutic agents as described above in relation to device 100. Operation of device 2100, including the process of priming the device, is similar to that of devices 100 and / or 1100 as described above.[000126] As described above in relation to devices 100 and / or 1100, the outlet of device 2100 may be equipped with an injection needle, which may be removable or replaceable in some embodiments. Furthermore, device 2100 may include a replaceable and / or reusable cartridge holder or cartridge in some embodiments. In other embodiments, device 2100 may be a single use device. Device 2100 may also include a pen cap 2112 to cover or otherwise protect the distal portion 2106 of device 2100. Pen cap 2112 is removable from device 2100 to expose the injection needle and / or the cartridge.[000127] Device 2100 may include a plunger drive system as described above in relation to devices 100 and / or 1100 configured to transfer force from a user to a plunger located in the cartridge of distal portion 2106 of device 2100 to deliver a predetermined dose of medication out of the injection needle. As with devices 100 and / or 1100 described above, the plunger drive system may include a nut configured to cooperate with a drive member and an actuator assembly to facilitate operation of device 2100. The actuator assembly may include a nut rotating element configured to engage with the nut as described above to facilitate axial motion of the nut relative to nut rotating element during dose setting, but to inhibit rotational motion of the nut relative to the nut rotating element during dose delivery.[000128] The actuator assembly may further include a dose button 2176 having a body portion 2178 and a flange portion 2180 extending radially outward in a lateral direction from a proximal end 2182 of body portion 2178. Body portion 2178 may have a circumferential surface 2184 which generally defines a diameter of body portion 2178, further defining a cross-sectional area of body portion 2178. Flange portion 2180 may have an edge 2186 which defines a diameter of flange portion 2180. The diameter of flange portion 2180 may be greater than the diameter of the body portion 2178 so that the flange portion 2180 forms a lip, or ridge, at the proximal end 2188 of dose button 2176 to facilitate grip on dose button 2176 and axial translation of dose button 2176 as described further herein. As such, the cross- sectional area of flange portion 2180 may be greater than the cross-sectional area of body portion 2178. Flange portion 2180 may include a push surface, or proximal surface 2190, to facilitate application of a distally directed force Fi to dose button 2176 to operate device 2100.[000129] As described above in relation to devices 100 and / or 1100, a connector may facilitate coupling of dose button 2176 and the nut rotating element of the actuator assembly. In some embodiments, the connector may be axially locked with zero to minimal axialmovement relative to dose button 2176 but otherwise capable of rotating relative to dose button 2176. In other embodiments the connector may be axially and rotatably locked with dose button 1176. Referring additional to FIGS. 13A-13D and 15A-15C, a screw element 2218 may be positioned exterior of and coaxially with the nut rotating element as described above in relation to devices 100 and 1100.[000130] A main body of the screw element 2218 may be configured to engage with body 2102 of device 2100 so that screw element 2218 is rotatable relative to body 2102 while a flange portion and a distal end of the main body of the screw element 2218 may be configured to be received within a hollow portion of dose button 2176. In some embodiments, screw element 2218 may be fixedly coupled to dose button 2176 by, for example, adhesive, ultrasonic welding, or another mechanism known in the art via the flange portion. In other embodiments, the flange portion may not be directly coupled to dose button 2176 or may be coupled to the connector so that screw element 2218 is rotatable relative to dose button 2176.[000131] As described above in relation to devices 100 and / or 1100, the flange portion and the main body of screw element 2218 may be coupled to each other in a manner that results in tandem movement of the flange portion and the main body; in other words, the flange portion and the main body of screw element 2218 may be axially and rotatably fixed to each other. The flange portion may be configured to cooperate with the nut rotating element. An outer surface of screw element 2218 may serve as a dial indicator 2242 to be viewed through a window 2244 defined by body 2102 of device 2100.[000132] Device 2100 may further include a nut advancing plunger 2146 as described above in relation to devices 100 and / or 1100. Nut advancing plunger 2146 may include a longitudinal body which may be received within a hollow portion of the main body of screw element 2218 so that the longitudinal body is configured to engage with screw element 2218. Nut advancing plunger 2146 may be rotatably locked with the actuator assembly.[000133] It should be appreciated that while a distinct body and arrangement is shown for device 2100 and dose button 2176, such description as provided herein may apply across several embodiments with different shapes and arrangements as can be found, for example, as described further herein and / or in Ergo II provided by Eli Lilly and Company (Indianapolis, Indiana) and / or KwikPen™ provided by Eli Lilly and Company (Indianapolis, Indiana).[000134] For example, further details of the design and operation of exemplary embodiments of a delivery device 2100 as described above may be found in U.S. Patent No. 7,195,616, entitled “Medication Injector Apparatus with Drive Assembly that Facilitates Reset” and U.S. Patent No. 7,291,132 entitled “Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage”, the entireties of which are hereby incorporated by reference.[000135] Many medication delivery devices as described herein include a plunger drive mechanism that includes dose setting member(s), including dose buttons, typically threadably connected in an arrangement, that rotate during dose setting to allow the drive member to be prepared to deliver a dose amount set which can vary for each use and rotate during dose dispensing to drive the drive member to move the plunger to deliver the dose amount that was set. Other medication delivery devices may include dose setting member(s), including dose buttons, which facilitate dose setting for fixed dose therapies. Such devices may include a pull-out button design, which may simplify dose setting and may facilitate extending the dose button to the fixed amount without rotation of said dose button.[000136] Furthermore, while dose button 2176 above has been described in terms of the illustrated structure, it should be understood that dose buttons having other structures may be included with device 2100. For example, device 2100 may include a dose button that is mechanically coupled to the drive member such that depression of the dose button results in ejection of the medication. The dose button may be attached to the device by being directly positioned on, received within, integral with, or otherwise connected to a component of device 2100. Connections may include, for example, threading, snap fit, ultrasonic welding, splines, friction fit, adhesive, mechanical fasteners, key-in-groove, or other coupling means known in the art. Dose buttons may be cylindrical frustoconical, or another shape. Dose buttons may include a dose member in some instances, which may be rotatable relative to the dose button or rotatably fixed relative to the dose button. In some embodiments, the dose button may include a collar. In some embodiments, the dose button may include an inner button which operates in tandem with or independently of an outer collar. In yet other embodiments, the dose button may be a tapered pull member configured to receive a stem portion of a disc for attachment to a proximal end of a device and an actuator nut for retention of said stem portion.[000137] It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and / or in any desired combination as the disclosure is not limited to only the specific embodiments described herein. For example, while device 2100 has been described in the form of a pen injector, device 2100 may be any device which is used to set and deliver a predetermined dose of a medication, such as pen injectors, autoinjectors, bolus injectors, infusion, and syringes. The medication may be any one of a type that may be delivered by such a device. The device may be a reusable device capable of receiving a replaceable and disposable cartridge of medication or may be an entirely disposable device with a prefilled reservoi r of medication.[000138] Referring to FIGS. 13A-13D and 15A-15C, as described above, screw element 2218 may include a main body 2220 having threading 2226 on exterior surface 2224 which is configured to engage with corresponding threading on an interior surface of body 2102 of device 2100. As shown in FIGS. 13A and 15A, threading 2226 of screw element 2218 may extend in a generally helical pattern from a proximal portion 2324 of screw element 2218 to a distal portion 2326 of screw element 2218. An end wall 2328 may be adjacent a distal end 2330 of threading 2226 at distal portion 2326 of screw element 2218 so that end wall 2328 forms an angle with a distal edge 2332 of screw element 2218.[000139] A compliant member 2334 may be positioned between screw element 2218 and nut advancing plunger 2146. As illustrated, compliant member 2334 may be a bent spring having a first portion 2336 configured to rest against or couple with screw element 2218 via end wall 2328 and a second portion 2338 configured to couple with nut advancing plunger 2146. In some embodiments, compliant member 2334 may include a V- or U-shaped portion 2340 connecting first portion 2336 and second portion 2338. Second portion 2338 may couple to nut advancing plunger 2146 by being received within a receiver 2342 defined by a ledge 2344 of nut advancing plunger 2146.[000140] Receiver 2342 may include an opening and / or a plurality of tabs positioned at proximal portion 2346 of ledge 2344 that is shaped and sized to receive a lateral extension 2339 of second portion 2338 and retain lateral extension 2339 by a mechanical snap, interference fit, or another mechanism known in the art. Ledge 2344 may extend distally from proximal portion 2346 of ledge 2344 by some distance that creates a notch 2348 within nut advancing plunger 2146 sized and shaped to receive compliant member 2334 so thatcompliant member 2334 does not extend radially or only minimally extends radially beyond an exterior surface 2350 of nut advancing plunger 2146 and / or exterior surface 2224 of screw element 2218.[000141] FIGS. 12-13D illustrate device 2100 in a first configuration, also referred to as a primed configuration or a rest configuration. The first configuration of device 2100 is the default configuration of device 2100; in other words, device 2100 is in the first configuration when dose button 2176 is not engaged by a user, although device 2100 may also be in the first configuration when dose button 2176 or another part of device 2100 is engaged by a user.[000142] As shown in FIGS. 12-13A, in the first configuration, dial indicator 2242 may show that device 2100 is set to a small dosage which is considered the prime dosage for device 2100. In other words, device 2100 is set at a prime dosage prior to manipulation by a user so that the user does not have to set a prime dose before priming device 2100 for usage; instead, the suer may pick up the device and engage dose button 2176 to prime device 2100 without first setting the prime dosage to facilitate efficiency and save time. As shown, the prime dosage may be “2” units. In other embodiments, the prime dosage may be “1”, “3”, “4”, or “5” units. Other embodiments may have another prime dosage, including full, half, third, quarter, eighth, or sixteenth units. In yet other embodiments, dosage may be indicated by any number of symbols or text outside of Arabic numerals. The number of units illustrated in the first configuration is intended to only be exemplary in illustration of the operation of device 2100.[000143] Referring to FIGS. 13A-13D, in the first configuration, compliant member 2334 is in a relaxed state. In the relaxed state, compliant member 2334 defines a first angle Ai between first portion 2336 and second portion 2338 of compliant member 2334. In other words, the contact between end wall 2328 of screw element 2218, compliant member 2334, and ledge 2344 of nut advancing plunger 2146 results in end wall 2328 of screw element 2218 and ledge 2344 of nut advancing plunger 2146 being separated by a first distance Di.[000144] Now referring to FIGS. 14-15C, device member 2100 is in a second configuration, also referred to as a dosing configuration or an active configuration. The second configuration of device 2100 is the in-use configuration of device 2100; in other words, device 2100 is in the second configuration when dose button 2176 is engaged by auser or is otherwise provided force to depress dose button 2176 relative to body 2102 of device 2100 as described further herein.[000145] As shown in FIGS. 14-15A, dial indicator 2242 may indicate that device 2100 is not set to any dosage. In other words, dial indicator 2242 may indicate that device 2100 has fully dispensed a previously-set dosage and / or that device 2100 is not prepared to immediately dispense any medication. The number of units illustrated is intended to only be exemplary in illustration of the operation of device 2100; however, the number of units displayed by dial indicator 2242 is generally less than the number of units displayed by dial indicator 2242 in the first configuration. In other words, if dial indicator 2242 is set to “2” in the first configuration, dial indicator 2242 may be set to “0”, “0.5”, “1.0”, “1.5”, or any other number less than 2 in the second configuration. Other embodiments may include full, half, third, quarter, eighth, or sixteenth units. In yet other embodiments, dosage may be indicated by any number of symbols or text outside of Arabic numerals.[000146] Referring to FIGS. 15A-15C, in the second configuration, compliant member 2334 is in a loaded state. In the loaded state, compliant member 2334 defines a second angle A2 between first portion 2336 and second portion 2338 of compliant member 2334, where second angle A2 is less than first angle Ai of the first configuration. In other words, the contact between end wall 2328 of screw element 2218, compliant member 2334, and ledge 2344 of nut advancing plunger 2146 results in end wall 2328 of screw element 2218 and ledge 2344 of nut advancing plunger 2146 being separated by a second distance D2, whereas D2 is less than first distance Di.[000147] Comparing FIGS. 12-13D with FIGS. 14-15C, in the first configuration (FIGS. 12-13D), dose button 2176 and screw element 2218 are generally in a first position, which may be a resting position, consistent with the relaxed state of compliant member 2334 above. For example, in the first position, no distal force Fi is applied to dose button 2176 and compliant member 2234 is in a relaxed state as discussed above. In the second configuration (FIGS. 14-15C), distal force Fi is generally applied to dose button 2176, e.g., to proximal surface 2190 of dose button 2176, to move dose button 2176 in an axial direction toward a second position, i.e., the second configuration. In the second configuration, compliant member 2334 is in the loaded state.[000148] In other words, in the second configuration, distal force Fi is generally applied to proximal surface 2190 of dose button 2176 so that dose button 2176 moves in a distal direction. As dose button 2176 moves in a distal direction, force is transferred to screw element 2218 which engages with body 2102 of device 2100 as described above and rotatably moves in a distal direction, further transferring force to compliant member 2334 so that compliant member 2334 moves from a relaxed state to a loaded state as described above. When compliant member 2334 is in the loaded state, compliant member 2334 stores elastic potential energy, as compliant member 2334 is biased toward the relaxed state, i.e., toward the first position and / or the first configuration. When distal force Fi is removed from dose button 2176, compliant member 2334 returns to the relaxed state and the release of elastic potential energy imparts a proximal force F2 to screw element 2218 and thereby dose button 2176, returning dose button 2176 to the first position and device 2100 to the first configuration.[000149] In use, device 2100 is initially in the first configuration, which includes device 2100 being set at an initial prime dose as described above. A user may apply a distal force Fi to proximal surface 2190 of dose button 2176 or otherwise impart distal force Fi to dose button 2176 to move dose button 2176 from the first position to the second position and device 2100 from the first configuration to the second configuration. When the user removes distal force Fi from dose button 2176, dose button 2176 returns to the first position and device 2100 returns to the first configuration due to the imparted proximal force F2 from compliant member 2334, which includes device 2100 again being set at a prime dosage.[000150] If device 2100 was not properly primed after the first application of distal force Fi (i.e., if not all air has been removed from the cartridge and / or the injection needle), the user may provide a second application of distal force Fi to device 2100. This method may be repeated until device 2100 is properly primed, i.e., until all air has been removed from the cartridge and / or the injection needle or a small amount of medication has been dispensed from device 2100 as described above. Once device 2100 has been properly primed and dose button 2176 has returned to the first position and device 2100 has returned to the first configuration, a dosage for therapeutic application may be set as known in the art.[000151] While this invention has been described as having exemplary designs, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses or adaptations of the inventionusing its general principles. Further, this application is intended to cover such departures from the present disclosure as come with known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.[000152] Various aspects are described in this disclosure, which include, but are not limited to, the following aspects:[000153] (1) A medication delivery device, including: a housing disposed about a longitudinal axis and having an outlet; a plunger drive system configured to selectively set a dose and selectively dispense a dose; a dose member coupled to the plunger drive system, the dose member rotatable about the longitudinal axis relative to the housing during dose setting; and a dose button coupled to the plunger drive system, the device being biased toward a first configuration in which the dose button is in a first position relative to the housing and the device having a second configuration in which the dose button is in a second position relative to the housing, the first configuration including a predetermined set dose greater than zero and the second configuration including a dose less than the predetermined set dose.[000154] (2) The medication delivery device of aspect (1), wherein the dose member is inhibited from rotation in a first direction in the second configuration.[000155] (3) The medication delivery device of any one of aspects (1) or (2), wherein a proximal surface of the dose button is a first distance from the housing in the first configuration and a second distance from the housing in the second configuration, the first distance being greater than the second distance.[000156] (4) The medication delivery device of any one of aspects (l)-(3), wherein the dose button is configured to move from the first position toward the second position upon application of distal force to the dose button.[000157] (5) The medication delivery device of aspect 4, wherein the dose button returns to the first position upon removal of the distal force.[000158] (6) The medication delivery device of any one of aspects ( 1 )-(5), wherein movement toward the second configuration from the first configuration is a first dispensing configuration, wherein the dose button is configured for a dose setting of the device after the first dispensing configuration, and the dose button is actuated for a second dispensing configuration that is greater than the first dispensing configuration.[000159] (7) The medication delivery device of any one of aspects (l)-(6), wherein at least a portion of the dose button comprises a resilient material which biases the dose button toward the first position.[000160] (8) The medication delivery device of any one of aspects ( l)-(6), further comprising a spring axially positioned between the housing and the dose button, the spring configured to bias the dose button toward the first position.[000161] (9) The medication delivery device of any one of aspects (l)-(6), further comprising a compliant member positioned between the dose member and a rotationally locked component of the housing, the rotationally locked component at least partially nested within the rotatable dose member, wherein the compliant member is configured to bias the member to rotate in a first direction for a first distance biasing the device toward the first configuration.[000162] (10) A medication delivery device, comprising: a housing disposed about a longitudinal axis and having an outlet; a plunger drive system configured to selectively set a dose and selectively dispense a dose; a rotatable dose member coupled to the plunger drive system, the rotatable dose member rotatable about the longitudinal axis relative to the housing during dose setting; a dose button coupled to the plunger drive system; and a flexible member positioned between the dose button and the plunger drive system, wherein the flexible member is configured to displace upon application of force to the dose button and return to an original configuration upon removal of the force.[000163] (11) The medication delivery device of aspect (10), the dose button having a rigid first portion and a flexible second portion, the flexible second portion comprising the flexible member, and wherein the flexible second portion is configured to form an outward bulge upon displacement of the flexible second portion.[000164] (12) The medication delivery device of aspect (11), wherein the flexible second portion defines a groove within an internal surface of the flexible second portion.[000165] (13) The medication delivery device of any one of aspects (11 )-(l 2), wherein the rigid first portion and the flexible second portion define an overlap portion in which a proximal extension of the flexible second portion is positioned internally relative to a distal extension of the rigid first portion.[000166] (14) The medication delivery device of any one of aspects (11)-( 13), wherein a proximal portion of the housing defines a notch configured to receive a section of the flexible second portion.[000167] (15) The medication delivery device of any one of aspects (10)-( 14), wherein a wall thickness of the flexible member varies.[000168] (16) A medication delivery device, comprising: a housing disposed about a longitudinal axis and having an outlet; a plunger drive system configured to selectively set a dose and selectively dispense a dose; a rotatable dose member coupled to the plunger drive system, the rotatable dose member rotatable about the longitudinal axis relative to the housing during dose setting; a dose button coupled to the plunger drive system; and a spring positioned between at least one of the dose button and the housing and the rotatable dose member and the housing, wherein the spring is configured to bias the dose button to a first configuration that is associated with a preset dose, the preset dose being greater than zero.[000169] (17) The medication delivery device of aspect (16), wherein a first end of the spring contacts the dose button and a second end of the spring contacts the housing, and wherein the dose button and the housing define an overlap in which a proximal portion of the housing is nested within a distal portion of the dose button.[000170] (18) The medication delivery device of aspect (17), wherein a distal edge of the dose button is chamfered.[000171] (19) The medication delivery device of any one of aspects ( 16)-(18), wherein the dose button is configured to move from the first configuration toward a second configuration upon application of a distal force to the dose button and the spring is configured to move the dose button, via an axial force, from the second configuration toward the first configuration upon removal of the distal force, the first configuration being a dose setting configuration and movement toward the second configuration from the first configuration being a dispensing configuration.[000172] (20) The medication delivery device of any one of aspects (16)-(18), wherein the spring is positioned between the rotatable dose member and a rotationally locked component of the housing, the rotationally locked component at least partially nested within the rotatable dose member; wherein the spring is configured to bias the rotatable dose member to rotate in a first direction for a first distance biasing the device toward the first configuration; wherein the dose button is configured to move from the first configurationtoward a second configuration upon application of a distal force to the dose button, and the spring is configured to move the dose button, via a rotational force, from the second configuration toward the first configuration upon removal of the distal force, the first configuration being a dose setting configuration and movement toward the second configuration from the first configuration being a dispensing configuration.

Claims

WHAT IS CLAIMED IS:

1. A medication delivery device, comprising: a housing disposed about a longitudinal axis and having an outlet; a plunger drive system configured to selectively set a dose and selectively dispense a dose; a dose member coupled to the plunger drive system, the dose member rotatable about the longitudinal axis relative to the housing during dose setting; and a dose button coupled to the plunger drive system, the device being biased toward a first configuration in which the dose button is in a first position relative to the housing and the device having a second configuration in which the dose button is in a second position relative to the housing, the first configuration including a predetermined set dose greater than zero and the second configuration including a dose less than the predetermined set dose.

2. The medication delivery device of claim 1, wherein the dose member is inhibited from rotation in a first direction in the second configuration.

3. The medication delivery device of claim 1, wherein a proximal surface of the dose button is a first distance from the housing in the first configuration and a second distance from the housing in the second configuration, the first distance being greater than the second distance.

4. The medication delivery device of claim 1, wherein the dose button is configured to move from the first position toward the second position upon application of distal force to the dose button.

5. The medication delivery device of claim 4, wherein the dose button returns to the first position upon removal of the distal force.

6. The medication delivery device of claim 1, wherein movement toward the second configuration from the first configuration is a first dispensing configuration, wherein the dose button is configured for a dose setting of the device after the first dispensing configuration, and the dose button is actuated for a second dispensing configuration that is greater than the first dispensing configuration.

7. The medication delivery device of claim 1, wherein at least a portion of the dose button comprises a resilient material which biases the dose button toward the first position.

8. The medication delivery device of claim 1, further comprising a spring axially positioned between the housing and the dose button, the spring configured to bias the dose button toward the first position.

9. The medication delivery device of claim 1, further comprising a compliant member positioned between the dose member and a rotationally locked component of the housing, the rotationally locked component at least partially nested within the rotatable dose member, wherein the compliant member is configured to bias the member to rotate in a first direction for a first distance biasing the device toward the first configuration.

10. A medication delivery device, comprising: a housing disposed about a longitudinal axis and having an outlet: a plunger drive system configured to selectively set a dose and selectively dispense a dose; a rotatable dose member coupled to the plunger drive system, the rotatable dose member rotatable about the longitudinal axis relative to the housing during dose setting; a dose button coupled to the plunger drive system; and a flexible member positioned between the dose button and the plunger drive system, wherein the flexible member is configured to displace upon application of force to the dose button and return to an original configuration upon removal of the force.

11. The medication delivery device of claim 10, the dose button having a rigid first portion and a flexible second portion, the flexible second portion comprising the flexible member, and wherein the flexible second portion is configured to form an outward bulge upon displacement of the flexible second portion.

12. The medication delivery device of claim 11, wherein the flexible second portion defines a groove within an internal surface of the flexible second portion.

13. The medication delivery device of claim 11, wherein the rigid first portion and the flexible second portion define an overlap portion in which a proximal extension of the flexible second portion is positioned internally relative to a distal extension of the rigid first portion.

14. The medication delivery device of claim 11, wherein a proximal portion of the housing defines a notch configured to receive a section of the flexible second portion.

15. The medication delivery device of claim 10, wherein a wall thickness of the flexible member varies.

16. A medication delivery device, comprising: a housing disposed about a longitudinal axis and having an outlet: a plunger drive system configured to selectively set a dose and selectively dispense a dose; a rotatable dose member coupled to the plunger drive system, the rotatable dose member rotatable about the longitudinal axis relative to the housing during dose setting; a dose button coupled to the plunger drive system; and a spring positioned between at least one of the dose button and the housing and the rotatable dose member and the housing, wherein the spring is configured to bias the dose button to a first configuration that is associated with a preset dose, the preset dose being greater than zero.

17. The medication delivery device of claim 16, wherein a first end of the spring contacts the dose button and a second end of the spring contacts the housing, and wherein the dose button and the housing define an overlap in which a proximal portion of the housing is nested within a distal portion of the dose button.

18. The medication delivery device of claim 17, wherein a distal edge of the dose button is chamfered.

19. The medication delivery device of claim 16, wherein the dose button is configured to move from the first configuration toward a second configuration upon application of a distal force to the dose button and the spring is configured to move the dose button, via an axial force, from the second configuration toward the first configuration upon removal of the distal force, the first configuration being a dose setting configuration and movement toward the second configuration from the first configuration being a dispensing configuration.

20. The medication delivery device of claim 16, wherein the spring is positioned between the rotatable dose member and a rotationally locked component of the housing, the rotationally locked component at least partially nested within the rotatable dose member; wherein the spring is configured to bias the rotatable dose member to rotate in a first direction for a first distance biasing the device toward the first configuration; and wherein the dose button is configured to move from the first configuration toward a second configuration upon application of a distal force to the dose button, and the spring isconfigured to move the dose button, via a rotational force, from the second configuration toward the first configuration upon removal of the distal force, the first configuration being a dose setting configuration and movement toward the second configuration from the first configuration being a dispensing configuration.

Images