Drug delivery devices, finger grip elements and related methods

Abstract

A drug delivery device, a finger grip element for use with a syringe, and an associated method are disclosed. The drug delivery device may include a syringe and a finger grip element. The syringe may include a barrel, a barrel flange extending radially outward relative to a longitudinal axis of the barrel, and a plunger movably disposed within the barrel. The finger grip element may be coupled to the barrel flange. The finger grip element may have a first distally facing surface having a first contour configured to inhibit or prevent at least a first finger of a user from moving radially outward relative to the longitudinal axis during use of the syringe to deliver a drug, and / or to exert a first repulsive force on at least a first finger of a user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver a drug.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 64 / 208,322, filed June 8, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to features that assist a user in handling and / or operating such devices. [Background technology]

[0003] Drug delivery devices are used to administer medication to patients. Certain drug delivery devices, including syringes, can be manually operated by a user to inject medication into a patient. A syringe typically includes a barrel containing the medication and a plunger movable relative to the barrel to expel the medication through a needle or other fluid pathway member and into a patient. Manually operating a syringe typically involves a user grasping the barrel between two fingers while pressing a plunger rod with the thumb of the same hand to move the plunger through the barrel to expel the medication.

[0004] Generally, it is desirable that all or substantially all of the force applied by the user is transferred to the movement of the plunger. Any inefficiency in transferring the applied force to the plunger may result in a shortfall, which may require the user to apply extra force to expel the drug. This places a burden on the user and may be unacceptable in certain situations, for example, where the drug is viscous and therefore requires the application of significant force even under ideal conditions. In addition, the user's ability to hold the syringe steady against the patient may be reduced when applying extra force to expel the drug. Any sudden movement of the syringe needle against the patient during injection, which may occur unintentionally as a result of the user applying extra force to move the plunger, may cause pain or discomfort to the patient. Summary of the Invention [Means for solving the problem]

[0005] The present disclosure describes devices and associated methods that embody advantageous alternatives to existing drug delivery devices, syringes, ancillary or accessory components for syringes, and associated methods, and that may address one or more of the problems or needs set forth herein, as well as provide other benefits and advantages.

[0006] One aspect of the disclosure provides a drug delivery device including a syringe and a finger grip element. The syringe may include a barrel, a barrel flange, and a plunger. The barrel may include a proximal end, a distal end, and a longitudinal axis. The barrel flange may be disposed at the proximal end of the barrel and may extend radially outward relative to the longitudinal axis. The plunger may be disposed at least partially within the barrel and may be movable along the longitudinal axis. The finger grip element may be coupled to the barrel flange and may include a first distally facing surface having a first contour. The first contour may be configured to inhibit or prevent at least a first finger of a user from moving radially outward relative to the longitudinal axis during use of the syringe to deliver a drug, and / or to exert a first repulsive force on at least a first finger of a user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver a drug.

[0007] The first distally-facing surface of the finger grip element can include an outer portion and an inner portion, the inner portion being closer to the longitudinal axis than the outer portion. At least a portion of the outer portion can be distal to at least a portion of the inner portion.

[0008] The finger grip element may include a second distally-facing surface having a second contour configured to inhibit or prevent at least a second finger of a user from moving in a radially outward direction relative to the longitudinal axis during use of the syringe to deliver a medicament and / or to exert a second repulsive force on at least a second finger of a user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver a medicament.

[0009] The syringe may include a plunger rod coupled to the plunger. The finger grip element may at least partially surround the plunger rod. A threaded outer surface of the plunger rod may engage a threaded inner surface of the plunger to couple the plunger rod to the plunger. The plunger rod may include a plunger rod flange proximal to the threaded outer surface. The plunger rod flange may extend radially outward relative to the longitudinal axis. At least an inner portion of a distal-facing surface of the plunger rod flange may contact a proximal-facing outer surface of the plunger. At least an outer portion of a distal-facing surface of the plunger rod flange may be spaced apart from the proximal-facing outer surface of the plunger by a gap. A distal end of the plunger rod may be at least partially disposed within a recess formed in the plunger such that a distal-facing end face of the distal end of the plunger rod contacts a proximal-facing inner surface of the plunger. Additionally, the plunger rod may have a first axial length between a distal-facing end face of the distal end of the plunger rod and a distal-facing surface of the plunger rod flange, and the plunger may have a second axial length between a proximally-facing inner surface of the plunger and a proximally-facing outer surface of the plunger. The first axial length may be greater than the second axial length.

[0010] Another aspect of the present disclosure provides a finger grip element for use with a syringe. The finger grip element may include a proximal end and a distal end disposed at respective axial positions along a longitudinal axis. The finger grip element may further include an opening configured to receive at least a portion of the syringe. The finger grip element may additionally include a first distally facing surface having a first contour. The first contour may be configured to (a) inhibit or prevent at least a first finger of a user from moving in a radially outward direction relative to the longitudinal axis during use of the syringe to deliver a medicament, and / or (b) exert a first repulsive force on at least a first finger of a user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver a medicament.

[0011] A further aspect of the present disclosure provides a method of making a fingergrip element for a syringe. The fingergrip element may have a length LFG1 corresponding to the distance between the longitudinal axis of the barrel of the syringe and a distally facing surface of the fingergrip element for contacting a user's finger during use of the syringe to deliver a drug. The method includes determining the length LFG1 of the fingergrip element according to the following formula: M=(FFG1)(0.5)(LFG1)+((T)(cos(θ))+LB+LPR+(LF1)(Tan(θ)))(FPR)(Tan(30)) in which FFG1 may correspond to a force applied by a user's finger to a distally directed surface of the finger grip element during use of the syringe to deliver a medication, T may correspond to a distance between a user's wrist and a proximal end of the syringe's plunger rod, LB may correspond to a length of the syringe's barrel, LPR may correspond to a length of the syringe's plunger rod, LF1 may correspond to a length of the user's finger, θ may correspond to an angle between a user's finger and the user's thumb during use of the syringe to deliver a medication, FPR may correspond to a force applied by a user's thumb to the plunger rod during use of the syringe to deliver a medication, and / or M may correspond to a moment at or near the distal end of the syringe's needle.

[0012] An additional aspect of the present disclosure provides a drug delivery device including a syringe and a finger grip element. The syringe may include a barrel, a barrel flange, and a plunger. The barrel may include a proximal end, a distal end, and a longitudinal axis. The barrel flange may be disposed at the proximal end of the barrel and may extend radially outward relative to the longitudinal axis. The plunger may be disposed at least partially within the barrel and may be movable along the longitudinal axis. The finger grip element may be coupled to the barrel flange and may include a distally facing surface. During use of the syringe to deliver a drug, the finger grip element may be configured to allow at least one finger of a user to simultaneously contact the distally facing surface of the finger grip element and the barrel of the syringe.

[0013] The present disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. The omission of such elements in some of the drawings does not necessarily indicate the presence or absence of the particular elements in any of the illustrative embodiments, unless they may be explicitly depicted in the corresponding description. Also, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0014] [Figure 1] 1A-1D are perspective views of an exemplary drug delivery device according to various embodiments. [Diagram 2] FIG. 2 is a side view of the drug delivery device shown in FIG. 1. [Diagram 3] FIG. 2 is a side view of the syringe of the drug delivery device shown in FIG. 1. [Figure 4] FIG. 2 is a perspective view of a finger grip element of the drug delivery device shown in FIG. 1. [Diagram 5] FIG. 2 is another perspective view of the finger grip element of the drug delivery device shown in FIG. 1. [Figure 6] FIG. 2 is a side view of another exemplary drug delivery device according to various embodiments. [Figure 7] FIG. 7 is a perspective view of the drug delivery device shown in FIG. [Figure 8] FIG. 8 is a perspective view of a finger grip element of the drug delivery device shown in FIGS. 6 and 7. [Figure 9] FIG. 2 is a perspective view of another exemplary drug delivery device according to various embodiments. [Figure 10] FIG. 2 is a side view of another exemplary drug delivery device according to various embodiments. [Figure 11] FIG. 2 is a side view of another exemplary drug delivery device according to various embodiments. [Figure 12] FIG. 2 is a side view of another exemplary drug delivery device according to various embodiments. [Figure 13] FIG. 2 is a perspective view of another exemplary drug delivery device according to various embodiments. [Figure 14] FIG. 14 is a side view of the drug delivery device shown in FIG. 13. [Figure 15] FIG. 15 is a cross-sectional view along the longitudinal axis A of the drug delivery device shown in FIG. 14. [Figure 16] FIG. 16 is an enlarged cross-sectional view of the plunger and plunger rod of the drug delivery device shown in FIG. [Figure 17]FIG. 17 is a perspective view of a plunger rod of the drug delivery device shown in FIGS. 13 to 16. [Figure 18] FIG. 18 is an enlarged view of the distal end of the plunger rod shown in FIG. [Figure 19] 1 is a perspective view of another exemplary finger grip element according to various embodiments. [Figure 20] FIG. 20 is a side view of the finger grip element in FIG. 19. [Figure 21] 1 is a perspective view of another exemplary finger grip element according to various embodiments. [Figure 22] FIG. 22 is a side view of the finger grip element in FIG. 21. [Figure 23] 22 is a perspective view of the finger grip element of FIG. 21 being used by a user in conjunction with a syringe. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The present disclosure generally relates to drug delivery devices that can be operated by a user to administer a drug to a patient or to self-administer a drug in a scenario where the user is the patient, as well as subassemblies and components for drug delivery devices and methods of making such devices, subassemblies and components. A drug delivery device according to the present disclosure may include, for example, a syringe and a finger grip element having one or more contact surfaces against which a user presses with one or more fingers while manipulating the syringe, for example, to deliver a drug to a patient. As described below, the finger grip element can facilitate efficient translation of a force applied by the user into axial motion of a plunger of the syringe, can improve a user's ability to grip the syringe compared to a syringe lacking the finger grip elements disclosed herein, can provide mechanical leverage to the user when manipulating the syringe to expel a drug, and / or can provide other benefits and advantages. Additional features are disclosed that, when used in conjunction with or independent of the finger grip elements disclosed herein, can improve the operation of the syringe, including, for example, reducing the amount of force required to push a plunger through a barrel of a syringe. These and other advantages and benefits will become apparent to those of ordinary skill in the art upon consideration of this disclosure.

[0016] 1 and 2 show several views of an embodiment of a drug delivery device 10 for delivering a drug, which may also be referred to herein as a pharmaceutical product or drug product, for example, to a patient. The drug may be, but is not limited to, various biological agents, such as peptides, peptibodies, and / or antibodies. The drug may be in a fluid or liquid state, a gelatinous form, and / or a powder form, although the present disclosure is not limited to a particular form or state of the drug. The drug delivery device 10 shown in FIGS. 1 and 2 may be in its final assembled form and / or in a pre-delivery or stored state prior to use or manipulation by a user.

[0017] The drug delivery device 10 may include a syringe 12 and a fingergrip element 14 externally coupled (e.g., removably coupled) to the syringe 12. The fingergrip element 14 may be an accessory or add-on component that is initially separate from the syringe 12 and then coupled to the syringe 12 prior to manipulating the syringe 12 to deliver a drug. As an example, a user of the syringe 12 may be responsible for coupling the fingergrip element 14 to the syringe 12. The user of the syringe 12 may be a formally trained health care professional (e.g., a doctor, a nurse, a nurse practitioner, etc.), a caregiver, a patient, and / or any other individual and / or machine. In other embodiments, an individual and / or an entity distinct from the user may be responsible for coupling the fingergrip element 14 to the syringe 12, including, for example, a pharmacist, a manufacturer, a drug manufacturer, a medical device manufacturer, a supplier, and / or a medical device supplier. An advantage of configuring the finger grip element 14 as an accessory or add-on component is that the usability and / or ergonomics of the syringe 12 may be improved without necessarily having to modify the existing design and / or manufacturing methods of the syringe 12, which may in some cases be standardized and therefore expensive and / or impractical to modify. In alternative embodiments, the finger grip element 14 may be integrally formed with the syringe 12 such that at least a portion of the finger grip element 14 and at least a portion of the syringe 12 form a single, unitary structure and / or are permanently bonded to one another.

[0018] The syringe 12 may include a barrel 20 (shown as transparent in the figures) having a proximal end 22, a distal end 24, and a longitudinal axis A. As shown in FIGS. 1-3, the proximal end 22 and the distal end 24 of the barrel 20 may be disposed at respective axial positions along the longitudinal axis A. The barrel 20 may have a generally cylindrical wall 26 that partially or completely defines an internal bore of a reservoir 28 of the syringe 12. At least the cylindrical wall 26 of the barrel 20 may be made of a rigid or semi-rigid material including, for example, glass, plastic (e.g., polypropylene), and / or any other suitable material or combination of materials. At least a portion or the entire barrel 20 may have a cross-sectional shape (e.g., in a plane perpendicular to the longitudinal axis A) that is generally circular or of any other suitable shape.

[0019] The reservoir 28 of the syringe 12 may be partially or completely filled with a drug. In some embodiments, the syringe 12 may be pre-filled with a drug and shipped, for example by a manufacturer, to a location where the syringe 12 is mated with the finger grip element 14. In other embodiments, the reservoir 28 of the syringe 12 may be provided empty to a user, who then fills the reservoir 28 at the point of treatment, for example, by transferring a drug from a vial or other drug storage container into the syringe 12 immediately or substantially immediately prior to using the syringe 12 to perform an injection.

[0020] In some embodiments, the volume of drug stored in the reservoir 28 of the syringe 12 may be equal to or about (e.g., ±10%) 1 mL, or may be equal to or about (e.g., ±10%) 2.5 mL, or may be equal to or about (e.g., ±10%) 2.5 mL, or may be equal to or about (e.g., ±10%) 3 mL, or may be equal to or about (e.g., ±10%) 1 mL or less, or may be equal to or about (e.g., ±10%) 2 mL or less, or may be equal to or about (e.g., ±10%) 3 mL or less. L or less, or may be about (e.g., ±10%) 4 mL or less, or may be about (e.g., ±10%) less than 5 mL, or may be about (e.g., ±10%) 10 mL or less, or may be in the range of about (e.g., ±10%) 1 to 10 mL, or may be in the range of about (e.g., ±10%) 1 to 5 mL, or may be in the range of about (e.g., ±10%) 1 to 4 mL, or may be in the range of about (e.g., ±10%) 1 to 3 mL, or may be in the range of about (e.g., ±10%) 1 to 2.5 mL.

[0021] The proximal end 22 of the barrel 20 may include a proximal axial opening 22a through which the plunger rod 34 extends. The distal end 24 of the barrel 20 may include a distal axial opening 24b configured to provide fluid communication with a drug in a reservoir 28 of the syringe 12. In some embodiments, the needle 32 may be mounted or coupled to the distal end 24 of the barrel 20 and / or may be in fluid communication with the reservoir 28 via the distal axial opening 24b. The needle 32 may be secured (e.g., glued and / or mounted) to the wall 26 of the barrel 20 such that the needle 32 cannot move relative to the wall 26 of the barrel 20. The distal end 33 of the needle 32 may include a sharp tip or other pointed shape to enable the distal end 33 of the needle 32 to puncture and / or penetrate the skin, subcutaneous tissue and / or other tissue of a patient. The needle 32 may be hollow and / or may include an axial passage parallel and / or coaxial with the longitudinal axis A of the barrel 20. One or more openings may be formed in the distal end 33 of the needle 32 to allow the drug to exit the needle 32 and enter the patient during use of the syringe 12. The needle 32 may be made of metal and / or any other material having suitable rigidity. The distal end 33 of the needle 32 may be covered with a removable sterility barrier, such as a rigid needle shield (RNS) or a non-rigid needle shield (nRNS), prior to use. The removable sterility barrier may be configured to protect the needle 32 from contaminants in the external or surrounding environment prior to use of the syringe 12. A user may be required to remove the removable sterility barrier from the needle 32 prior to using the syringe 12. In alternative embodiments, the needle 32 may be omitted or may not be at least directly coupled to the wall 26 of the barrel 20. In such alternative embodiments, the distal end 24 of the barrel 20 may be coupled to and / or form a nozzle or other fluid pathway member including, for example, a Luer lock fitting.

[0022] As best seen in FIG. 3 , a barrel flange 42 may be disposed at the proximal end 22 of the barrel 20. The barrel flange 42 may be integrally formed with the wall 26 of the barrel 20 such that the barrel flange 42 and the wall 26 define a single, unitary structure, or alternatively, the barrel flange 42 and the wall 26 of the barrel 20 may be separate structures rigidly connected to one another. The barrel flange 42 may extend in a generally radially outward direction relative to the longitudinal axis A of the barrel 20. The barrel flange 42 may extend completely or partially around the barrel 20. In some embodiments, two or more separate barrel flanges may extend radially outward from corresponding portions of the wall 26 of the barrel 20. The barrel flange 42 may be included by the syringe manufacturer, for example, to prevent the syringe 12 from unintentionally rolling when placed on a flat surface. Due to its relatively small overhang or radial width, at least some users may find it difficult or impossible to use only the barrel flange 42 as a finger grip while using the syringe 12 to deliver a medication.

[0023] The syringe 12 may additionally include a plunger 38 (also referred to as a "stopper" in some contexts). The plunger 38 may be movably disposed within the barrel 20 such that it may move at least distally along the longitudinal axis A from an initial position near the proximal end 22 of the barrel 20 to at least a dose yield or end of delivery position near the distal end 24 of the barrel 20. In at least some embodiments, proximal movement of the plunger 38 along the longitudinal axis A may also be possible. The plunger 38 may be made of a resilient material, such as rubber, or any other suitable material. The plunger 38 may slidably and / or sealingly contact an inner surface of the wall 26 of the barrel 20 to, for example, prevent or inhibit the drug in the reservoir 28 from leaking past the plunger 38 as the plunger 38 moves distally. As an example, the plunger 38 may form a fluid-tight seal with the inner surface of the wall 26 of the barrel 20. As the plunger 38 moves distally, medication from the reservoir 28 of the syringe 12 may be expelled into and out of the needle 32 .

[0024] The plunger rod 34 may include a proximal end 45 and a distal end 47. The distal end 47 of the plunger rod 34 may be coupled (e.g., removably coupled) to a proximal end 49 of the plunger 38. In some embodiments, this coupling may be achieved by one or more threaded surfaces, as described in more detail below. In general, the plunger rod 34 may be configured to allow a user to manually or semi-manually move the plunger 38 distally and / or proximally along the longitudinal axis A. By way of example, the plunger rod 34 may have a longitudinal axis parallel and / or coaxial with the longitudinal axis A of the barrel 20. As a more specific example, the proximal end 45 of the plunger rod 34 may include a thumb rest 40 that may enable a user to press the user's thumb against the plunger rod 34 to push the plunger rod 34, and thus the plunger 38, distally along the longitudinal axis A to expel a drug from the reservoir 28 through the needle 32, for example, into the patient's tissue. To draw a drug from a vial or other drug storage container into the reservoir 28 of the syringe 12, the user may lift on the thumb rest 40, thereby moving the plunger 38 proximally along the longitudinal axis A. This action may create a vacuum that may, for example, allow the drug to be drawn through the needle 32 and into the reservoir 28.

[0025] The finger grip element 14 will now be described in more detail with reference to Figures 1, 2, 4 and 5. In general, the finger grip element 14 may be configured to facilitate a user's gripping of the barrel 20 of the syringe 12 during use of the syringe 12, for example, to deliver a medication to, for example, a patient. The finger grip element 14 may increase the surface area available for a user to press one or more of the user's fingers against, for example, while the user presses the user's thumb against the proximal end 45 of the plunger rod 34. As an example, a user may press the user's index finger and / or middle finger against the finger grip element 14 to apply one or more proximally directed forces to the finger grip element 14 while simultaneously pressing the user's thumb of the same hand against the thumb rest 40 to apply a distally directed force to the plunger rod 34. The finger grip element 14 may be considered to take the form of a flange extension, in the sense that it generally serves to extend the radial length of the barrel flange 42.

[0026] The finger grip element 14 may include a proximal end 54 and a distal end 56. One or more axial openings may be formed in the finger grip element 14, including, for example, a proximal axial opening 54a formed at the proximal end 54 of the finger grip element 14 and a distal axial opening 56a formed at the distal end 56 of the finger grip element 14. When the finger grip element 14 is coupled to the syringe 12, the longitudinal axis A of the barrel 20 of the syringe 12 may pass (e.g., through the middle) through the proximal axial opening 54a and / or the distal axial opening 56a. Additionally, in some embodiments, one or more side openings may be formed in the finger grip element 14, including, for example, side openings 58a formed on lateral sides 58 of the finger grip element 14. The finger grip element 14 may be generally C-shaped or U-shaped when viewed along the longitudinal axis A, due at least in part to the side openings 58a. In other embodiments, the finger grip element 14 may not have a side opening such that the finger grip element 14 completely surrounds the barrel 20 and / or plunger rod 34.

[0027] The axial passage 60 may extend through the finger grip element 14 and may be configured to receive at least a portion of the barrel 20, the barrel flange 42, and / or the plunger rod 34. The proximal axial opening 54a, the distal axial opening 56a, and / or the side opening 58a may lead to or communicate with the axial passage 60. As an example, the side opening 58a may be configured to allow the barrel 20, the barrel flange 42, and / or the plunger rod 34 to be inserted laterally into the axial passage 60 of the finger grip element 14. As a more specific example, inserting the barrel 20, the barrel flange 42, and / or the plunger rod 34 laterally into the axial passage 60 may involve moving the barrel 20, the barrel flange 42, and / or the plunger rod 34 in a direction perpendicular or orthogonal to the longitudinal axis A such that a lateral side of the barrel 20, the barrel flange 42, and / or the plunger rod 34 is initially received within the axial passage 60. As a further example, laterally inserting the barrel 20, barrel flange 42 and / or plunger rod 34 into the axial passage 60 may involve non-axially or radially inserting the barrel 20, barrel flange 42 and / or plunger rod 34 into the axial passage 60.

[0028] Coupling the finger grip element 14 to the syringe 12 may involve coupling the finger grip element 14 to, for example, the barrel flange 42 of the syringe 12. The finger grip element 14 may be configured to removably or permanently couple to the barrel flange 42. In the embodiment shown in FIGS. 1-5, the finger grip element 14 is configured to form a snap-fit ​​connection with the barrel flange 42. As an example, a recess 60 (e.g., a cavity, slot, recess, channel, interior space, etc.) may be formed in at least an inner wall of the finger grip element 14 and configured to receive the barrel flange 42 when the barrel 20 is inserted into the finger grip element 14 via the side opening 58a. The recess 60 may be in communication with the side opening 58a such that the barrel flange 20 can be inserted into the recess 60 via the side opening 58a. 4 and 5, the recess 60 may be axially bounded by a proximally facing inner surface 61 of the finger grip element 14 and a distally facing inner surface 63 of the finger grip element 14. The snap-fit ​​connection may be facilitated by a first locking tab 66 and / or a second locking tab 68. The first locking tab 66 and / or the second locking tab 68 may extend distally away from the distally facing inner surface 63 and / or may be disposed adjacent the side opening 58a. By way of example, the first locking tab 66 and / or the second locking tab 68 may be configured to allow the barrel flange 42 to be inserted into the recess 60 in a first radial direction and / or to inhibit or prevent the barrel flange 42 from being removed from the recess in a second radial direction (e.g., a radial direction opposite the first radial direction). As a more specific example, the first locking tab 66 and / or the second locking tab 68 can be configured such that the force required to insert the barrel flange 42 into the recess 60 in a first radial direction is substantially less than the force required to remove the barrel flange 42 from the recess 60 in a second radial direction.As an even more specific example, the first locking tab 66 and the second locking tab 68 may have a lead-in surface 66a and a lead-in surface 68a, respectively, which may be angled, for example, at an angle less than 90 degrees, or at an angle of about (e.g., ±10%) 75 degrees or less, or at an angle of about (e.g., ±10%) 60 degrees or less, or at an angle of about (e.g., ±10%) 45 degrees or less, or at an angle of about (e.g., ±10%) 30 degrees or less, respectively, with respect to the radial or horizontal direction. Inserting the barrel flange 42 into the recess 60 may involve sliding the barrel flange 42 along and / or against the lead-in surfaces 66a and 68a and along and / or against the proximally-facing inner surface 61 of the finger grip element 14 such that at least a portion of the proximal end 54 of the finger grip element 14 and at least a portion of the distal end 56 of the finger grip element 14 are biased (e.g., resiliently biased) away from one another. Once the barrel flange 42 overcomes the locking tabs 66 and 68, the proximal end 54 and / or distal end 56 of the finger grip element 14 may resiliently return or snap back to its original shape, thereby temporarily or permanently locking the barrel flange 42 within the recess 60 of the finger grip element 14. In some embodiments, the snap-fit ​​aspects of the finger grip element 14 and / or other aspects of the finger grip element 14 may be the same as or similar to those described in WO 2017 / 039786, the entire contents of which are incorporated herein by reference.

[0029] The finger grip element 14 may include one or more generally distally facing exterior surfaces for contacting one or more fingers of a user, for example, during use of the syringe 12 to deliver a medication to a patient. As an example, a user may apply a generally proximally directed force to the distally facing exterior surface by pressing a user's finger against the distally facing exterior surface during use of the syringe 12 to deliver a medication. In general, the distally facing exterior surfaces of the finger grip element 14 may be configured to facilitate a force mechanism applied to the finger grip element 14 by a user to efficiently translate force from the plunger rod 34 into motion of the plunger 38 (e.g., motion of the plunger 38 in a distal direction along the longitudinal axis A) to expel the medication from the syringe 12. As an example, the distally facing outer surface of the finger grip element 14 may be configured to prevent or inhibit a user's fingers from slipping radially and / or axially, thereby maintaining the fingers in a corresponding mechanically desirable position (e.g., a desired radial distance measured from the longitudinal axis A). Additionally or alternatively, the distally facing outer surface of the finger grip element 14 may be configured to apply a repulsive force to the user's fingers in a mechanically desirable direction (e.g., a direction parallel or substantially parallel to the longitudinal axis A). In facilitating efficient translation of user-applied forces into motion of the plunger 38, the finger grip element 14 may minimize force loss and / or make the syringe 12 easier and / or less cumbersome for a user to manipulate, as compared to conventional syringes.

[0030] 2 and 4, the finger grip element 14 can have a first distally-facing outer surface 62 and a second distally-facing outer surface 64. The first distally-facing outer surface 62 can have a first contour and the second distally-facing outer surface 64 can have a second contour. The first contour of the first distally-facing outer surface 62 can be the same as or similar to or different from the second contour of the second distally-facing outer surface 64. As an example, at least the first contour of the first distally-facing outer surface 62 and at least the second contour of the second distally-facing outer surface 64 can be symmetrical or substantially symmetrical to one another about the longitudinal axis A.

[0031] The first contour of the first distally-facing outer surface 62 may be configured to (a) inhibit or prevent at least a first finger (e.g., an index finger or middle finger) of a user from moving radially outward and / or radially inward relative to the longitudinal axis A of the barrel 20 during use of the syringe 12 to deliver a medication, and / or (b) exert a first repulsive force RF1 on at least a first finger of a user in a direction parallel or substantially parallel to the longitudinal axis A of the barrel 20 during use of the syringe 12 to deliver a medication. When so configured, the first contour of the first distally-facing outer surface 62 can, for example, assist in positioning and / or maintaining a user's first finger in a predetermined position relative to the barrel 20 during use of the syringe 12 to deliver a medicament (e.g., at a radial distance spaced from the longitudinal axis A of the barrel 20 that provides a desired mechanical effect) and / or can limit or eliminate undesirable mechanical moments or torques that may result from user-applied forces during use of the syringe 12 to deliver a medicament. As one example, a portion or all of the first contour of first distally-facing exterior surface 62 may have a concave curvature configured to inhibit or prevent at least a first finger of a user from moving in a radially outward and / or radially inward direction relative to the longitudinal axis A of the barrel 20 during use of the syringe 12 to deliver a medicament, and / or to exert a first repulsive force RF1 on at least a first finger of a user in a direction parallel or substantially parallel to the longitudinal axis A of the barrel 20 during use of the syringe 12 to deliver a medicament. As a more specific example, the concave curvature may be configured such that a proximal-most portion of first distally-facing exterior surface 62 has a radius of curvature that corresponds to or complements the radius of curvature of at least a portion of an index finger, middle finger, or other finger of an average adult human or other user. As an even more specific example, at least a portion of the concave curvature can have a varying radius of curvature along first distally-facing outer surface 62, including, for example, a gradually increasing radius of curvature as one moves radially away from longitudinal axis A. In addition to or instead of the concave curvature, first distally-facing outer surface 62 can have an outer portion that flares out in a distal or downward direction, as best seen in FIG.As an example, the first distally-facing outer surface 62 may have an outer portion 62a and an inner portion 62b, such that the inner portion 62b is closer to the longitudinal axis A than the outer portion 62a, and a portion or all of the outer portion 62a is located distally or below a portion or all of the inner portion 62b. As a more specific example, a radially outermost portion of the first distally-facing outer surface 62 may be distal or below a portion of the first distally-facing outer surface 62 that contacts and / or presses against a central portion of a user's first finger during use of the syringe 12 for delivery of a medicament. The distal extension of the outer portion 62a of the first distally-facing outer surface 62 may inhibit or prevent the user's first finger from unintentionally sliding or moving in a radially outward direction along the first distally-facing outer surface 62 during use of the syringe 12 for delivery of a medicament. As a result, a user's first finger can be restricted to a predetermined or desired position along first distally-facing outer surface 62 such that the force applied by the first finger has a beneficial mechanical effect.

[0032] The second contour of the second distally-facing outer surface 64 may be configured to (a) inhibit or prevent at least a second finger of a user (e.g., an index finger or middle finger) from moving radially outward and / or radially inward relative to the longitudinal axis A of the barrel 20 during use of the syringe 12 to deliver a medication, and / or (b) exert a second repulsive force RF2 on at least a second finger of a user in a direction parallel or substantially parallel to the longitudinal axis A of the barrel 20 during use of the syringe 12 to deliver a medication. When so configured, the second contour of the second distally-facing outer surface 64 can, for example, assist in positioning and / or maintaining a user's second finger in a predetermined position relative to the barrel 20 during use of the syringe 12 to deliver a medicament (e.g., at a radial distance spaced from the longitudinal axis A of the barrel 20 that provides a desired mechanical effect) and / or can limit or eliminate undesirable mechanical moments or torques that may result from user-applied forces during use of the syringe 12 to deliver a medicament. As an example, a portion or all of the second contour of second distally-facing exterior surface 64 may have a concave curvature configured to inhibit or prevent at least a second finger of a user from moving in a radially outward and / or radially inward direction relative to longitudinal axis A of barrel 20 during use of syringe 12 to deliver a medicament, and / or to exert a second repulsive force RF2 on at least a second finger of a user in a direction parallel or substantially parallel to longitudinal axis A of barrel 20 during use of syringe 12 to deliver a medicament. As a more specific example, the concave curvature may be configured such that a proximal-most portion of second distally-facing exterior surface 64 has a radius of curvature that corresponds to or complements the radius of curvature of at least a portion of an index finger, middle finger, or other finger of an average adult human or other user. As an even more specific example, at least a portion of the concave curvature can have a varying radius of curvature along the second distally-facing outer surface 64, including, for example, a gradually increasing radius of curvature as one moves radially away from the longitudinal axis A. In addition to or in lieu of a concave curvature, the second distally-facing outer surface 64 can have an outer portion that flares out in a distal or downward direction, as best seen in FIG.As an example, the second distally-facing exterior surface 64 may have an outer portion 64a and an inner portion 64b, such that the inner portion 64b is closer to the longitudinal axis A than the outer portion 64a, and a portion or all of the outer portion 64a is located distal to or below a portion or all of the inner portion 64b. As a more specific example, a radially outermost portion of the second distally-facing exterior surface 64 may be distal to or below a portion of the second distally-facing exterior surface 64 that contacts and / or presses against a central portion of a user's second finger during use of the syringe 12 for delivery of a medicament. The distal extension of the outer portion 64a of the second distally-facing exterior surface 64 may inhibit or prevent the user's second finger from unintentionally sliding or moving in a radially outward direction along the second distally-facing exterior surface 64 during use of the syringe 12 for delivery of a medicament. In this manner, a user's second finger may be restricted to a predetermined or desired position along second distally-facing outer surface 64 such that the force applied by the second finger has a beneficial mechanical effect.

[0033] In some embodiments, when a user presses a user's first finger against the first distally-facing outer surface 62, the reaction force RF1 may be the only reaction force acting on the user's first finger by the first distally-facing outer surface 62. For example, the first distally-facing outer surface 62 may exert no reaction force or only a small (e.g., infinitesimally small) reaction force radially relative to the longitudinal axis A, such that any and / or all reaction forces acting on the user's first finger by the first distally-facing outer surface 62 are parallel or substantially parallel to the longitudinal axis A. Similarly, in some embodiments, when a user presses a user's second finger against the second distally-facing outer surface 64, the reaction force RF2 may be the only reaction force acting on the user's second finger by the second distally-facing outer surface 64. For example, the second distally facing outer surface 64 may exert no or only a small (e.g., infinitesimally small) reaction force radially relative to the longitudinal axis A such that any and / or all reaction forces exerted by the second distally facing outer surface 64 on the user's second finger are parallel or substantially parallel to the longitudinal axis A. In some embodiments, the reaction force RF1 may be equal or approximately equal to the reaction force RF2.

[0034] Additional embodiments of finger grip elements will now be described with reference to Figures 6-23. Various features of the finger grip elements shown in Figures 6-23 may be similar or identical in structure, configuration and / or function to the features of the finger grip element 14 described above in connection with Figures 1-5. Such features are assigned the same reference numerals as used in Figures 1-5, except incremented by 100 or multiples of 100. The description of some of these features has been simplified or omitted for brevity.

[0035] A method of making finger grip elements, including, for example, the finger grip element embodiments shown in FIGS. 1-5, as well as other finger grip element embodiments described herein, will now be described with reference to FIG.

[0036] Similar to finger grip element 14, finger grip element 114 may have a first distally-facing outer surface 162 and a second distally-facing outer surface 164 that are pressed against by a first finger (e.g., one of the index and middle fingers) of a user and a second finger (e.g., the other of the index and middle fingers) of the user, respectively, during use of syringe 12 to deliver (e.g., eject) a medication. As an example, to eject a medication from syringe 12, a user may press the user's fingers proximally against first and second distally-facing outer surfaces 162 and 164 of finger grip element 114 while simultaneously pressing the user's thumb (e.g., of the same hand) distally against thumb rest 40 of plunger rod 34.

[0037] FIG. 6 illustrates various dimensions of the syringe 12, the finger grip element 114 and a user, various forces applied by the user during use of the syringe 12 to deliver a medication to a patient, and various moments resulting from the user applied forces.

[0038] 6, the finger grip element 114 can have a first length LFG1 corresponding to a distance (e.g., radial distance) between the longitudinal axis A of the barrel 20 of the syringe 12 and a portion (e.g., a proximal-most portion) of the first distally-facing outer surface 162 that is pressed by a first finger of a user during use of the syringe 12 to deliver a medicament. The finger grip element 114 can have a second length LFG2 corresponding to a distance (e.g., radial distance) between the longitudinal axis A of the barrel 20 of the syringe 12 and a portion (e.g., a proximal-most portion) of the second distally-facing outer surface 164 that is pressed by a second finger of a user during use of the syringe 12 to deliver a medicament.

[0039] The barrel 20 of the syringe 12 can have a length LB parallel to the longitudinal axis A. In some embodiments, the length LB of the barrel 20 can be measured between the proximal end 22 of the barrel 20 and the distal end of the barrel 20, while in other embodiments, the length of the barrel 20 can be measured between the proximal end 22 of the barrel 20 and the distal end 33 of the needle 32.

[0040] The plunger rod 34 of the syringe 12 can have a length LPR parallel to the longitudinal axis A. In some embodiments, the length LPR can correspond to the length of a portion of the plunger rod 34 that is proximal to (and therefore outside of) the proximal end 22 of the barrel 20, while in other embodiments, the length LPR can be measured between the proximal end 45 of the plunger rod 34 and the distal end 47 of the plunger rod 43.

[0041] 6 corresponds to the distance between a user's wrist (e.g., the center or central portion of the user's wrist) and the proximal end 45 of the plunger rod 34. As an example, the distance T may correspond to the distance between the center or central portion of the wrist of an average adult or other user and the thumb rest 40 of the plunger rod 34.

[0042] 6 corresponds to the length of a first finger of a user. As an example, the length LF1 may correspond to the length of the index or middle finger of a user's index finger or any other finger of a user that is used to press against the first distally-facing outer surface 162 of the finger grip element 114 to effect drug delivery via the syringe 12.

[0043] 6 corresponds to the angle between a user's first finger (e.g., the user's index finger or middle finger) and the user's thumb of the same hand during use of the syringe 12 to deliver a drug. As an example, the angle θ may correspond to the angle between a user's first finger when pressed against the first distally-facing outer surface 162 of the finger grip element 114 and the user's thumb when pressed against the thumb rest 40 of the plunger rod at the start of drug delivery or at any time during drug delivery.

[0044] The force FFG1 in FIG. 6 corresponds to a force applied by a first finger of a user to a first distally directed surface 162 of the finger grip element 114. As an example, the force FFG1 may be applied in a proximal direction to the first distally directed surface 162. As a more specific example, the force FFG1 may be parallel or substantially parallel to the longitudinal axis A. The force FFG2 in FIG. 6 corresponds to a force applied by a second finger of a user to a second distally directed surface 164 of the finger grip element 114. As an example, the force FFG2 may be applied in a proximal direction to the second distally directed surface 164. As a more specific example, the force FFG2 may be parallel or substantially parallel to the longitudinal axis A. As an even more specific example, the force FFG2 may be parallel or substantially parallel to the force FFG1.

[0045] 6 corresponds to a force applied by a user's thumb or other portion of the hand to the proximal end 45 of the plunger rod 34. As an example, the force FPR may be applied distally to the thumb rest 40 of the plunger rod 34. As a more specific example, the force FPR may be parallel or substantially parallel to the longitudinal axis A. As a more specific example, the force FPR may be perpendicular or substantially perpendicular to the forces FFG1 and / or FFG2. According to some embodiments, the FPR may be related to FFG1 and / or FFG2, respectively, to satisfy the following Equations I and II: FPR = (0.5)(FFG1) + (0.5)(FFG2) FFG1=(2)(FPR-(0.5)(FFG2))

[0046] 6 corresponds to a moment at or near a user's wrist and / or hand during use of the syringe 12 to deliver a medication. As an example, moment M1 may be formed, at least in part, by a user's first finger applying a force FFG1 to the finger grip element 114 and / or a user's thumb applying a force FPR to the plunger rod 34. According to some embodiments, moment M1 may be related to FFG1, LFG1, FPR, and / or T to satisfy Equation III below. M1=(FFG1)(0.5)(LFG1)+(FPR)(Tan(30))(T)(cos(θ))

[0047] 6 corresponds to a moment formed at or near the distal end 33 of the needle 32 and / or tissue adjacent to the distal end 33 of the needle 32 during use of the syringe 12 to deliver a drug. As an example, moment M1 may be formed, at least in part, by a user's first finger applying a force FFG1 to the finger grip element 114 and / or a user's thumb applying a force FPR to the plunger rod 34. According to some embodiments, moment M1 may be related to FFG1, LFG1, T, LB, LF1, and FPR to satisfy the following mathematical equation IV: M2=(FFG1)(0.5)(LFG1)+((T)(cos(θ))+LB+LPR+(LF1)(Tan(θ)))(FPR)(Tan(30))

[0048] Equation IV is useful in selecting at least a length LFG1 for the fingergrip element 114 when constructing (e.g., designing, building, manufacturing, etc.) the fingergrip element 114. For example, it may be desirable for moment M2 in Equation IV to be equal to or approximately equal to zero. In at least some embodiments, having M2 equal to or approximately equal to zero may ensure that the syringe 12 is prevented or at least inhibited from rotating about the distal end 33 of the needle 32 in the delivery device. In at least some embodiments, such stability of the syringe 12 and / or needle 32 may provide a relatively comfortable injection for the patient. Thus, according to some embodiments, a method of constructing the fingergrip element 114 may involve selecting a length LFG1 of the fingergrip element 114 that results in M2 in Equation IV being equal to or approximately equal to zero. In scenarios where there is the ability to select the dimensions of the syringe 12, the methods described above may additionally or alternatively involve selecting the length LB of the barrel 20 of the syringe 12 and / or the length LPR of the plunger rod 34 of the syringe 12.

[0049] 7 is another view of the drug delivery device 110 shown in FIG. 6. In this view, it can be seen that the finger grip element 114 completely surrounds the barrel 20 of the syringe 12. At least during use of the syringe 12 to deliver a drug, a proximally facing inner surface 170 (FIG. 8) of the finger grip element 114 may contact the barrel flange 42, e.g., to prevent or inhibit the barrel 20 from moving in a proximal direction relative to the finger grip element 114. Additionally, in some embodiments, a radially inwardly facing surface 172 (FIG. 8) of the finger grip element 114 may contact the barrel flange 42 to form a snap-fit ​​connection, a press-fit connection, an interference fit connection, a friction fit connection, or a similar connection with the barrel flange 42, e.g., to prevent or inhibit the barrel 20 from moving in a distal direction relative to the finger grip element 114.

[0050] FIG. 9 illustrates an alternative embodiment of the finger grip element 114 illustrated in FIGS. 6-8. The finger grip element 214 is shown assembled in combination with the syringe 12 to define the drug delivery device 210. The finger grip element 214 illustrated in FIG. 9 may be structurally and / or functionally similar to the finger grip element 114 illustrated in FIGS. 6-8, for example, except that the finger grip element 214 does not completely surround the barrel 20 of the syringe 12. Rather, (similar to the finger grip element 14 illustrated in FIGS. 1-5), the finger grip element 214 has a side opening 258a formed in a lateral side 258 of the finger grip element 214 such that the finger grip element 214 only partially surrounds the barrel 20 of the syringe 12. As discussed above with respect to the side opening 58a of the finger grip element 14, the side opening 258a of the finger grip element 214 may facilitate lateral insertion of the barrel 20 into the finger grip element 214.

[0051] FIG. 10 illustrates another embodiment of a finger grip element, designated by reference numeral 314. The finger grip element 314 is shown assembled in combination with the syringe 12 to define a drug delivery device 310. The finger grip element 314 in FIG. 10 may be structurally and / or functionally similar to the finger grip 114 illustrated in FIGS. 6-8, except for, for example, the axial location of the first and second distally facing outer surfaces 362 and 364 of the finger grip element 314. More specifically, the first and second distally facing outer surfaces 362 and 364 of the finger grip element 314 may be closer to the distal end 356 of the finger grip element 314 compared to their counterparts in the finger grip element 114. As an example, the first and second distally-facing outer surfaces 362 and 364 can be completely distal from the proximally-facing inner surface 370 (shown in hidden lines in FIG. 10 ) of the finger grip element 314 and / or the barrel flange 42 of the syringe 12. The axial distance that the first and second distally-facing outer surfaces 362 and 364 are distally offset from the proximally-facing inner surface 370 of the finger grip element 314 and / or the barrel flange 42 of the syringe 12 can be selected based on a predetermined or desired pivot position that exists while a user is using the syringe 12 to expel a medication.

[0052] FIG. 11 illustrates another embodiment of a finger grip element, designated by reference numeral 414. The finger grip element 414 is shown assembled in combination with the syringe 12 to define a drug delivery device 410. The finger grip element 414 of FIG. 11 may be structurally and / or functionally similar to the finger grip element 114 of FIGS. 6-8, for example, except for the first contour of the first distally-facing outer surface 462 and the second contour of the second distally-facing outer surface 464. More specifically, the first contour of the first distally-facing outer surface 462 may include two or more separate finger grip locations (instead of a single finger grip location) and the second contour of the first distally-facing outer surface 464 may include two or more separate finger grip locations (instead of a single finger grip location). 11, a first contour of the first distally-facing outer surface 462 may include two valleys or depressions disposed radially adjacent one another, and a second contour of the second distally-facing outer surface 464 may include two valleys or depressions disposed radially adjacent one another. In alternative embodiments, the first and second distally-facing outer surfaces 462 and 464 may be located distal to the location shown in FIG. 11, for example, similar to the location of the distal-facing outer surfaces of the finger grip elements shown in FIG.

[0053] FIG. 12 illustrates another embodiment of a finger grip element, designated by reference numeral 514. The finger grip element 514 is shown assembled in combination with the syringe 12 to define a drug delivery device 510. The finger grip element 514 of FIG. 12 may be structurally and / or functionally similar to the finger grip element 114 of FIGS. 6-8, except that it includes, for example, a stabilizer 574. As an example, the stabilizer 574 may be configured to contact a patient (e.g., the patient's skin) during use of the syringe 12 to deliver a drug to a patient at an injection site to assist in maintaining the longitudinal axis A of the barrel 20 and / or the longitudinal axis of the needle 32 at a predetermined injection angle α relative to the patient (e.g., the patient's skin adjacent the injection site). As a more specific example, the stabilizer 574 may be disposed radially outward of the first distally-facing exterior surface 562 and may include an outer surface 574a that contacts and / or rests on the patient's skin when the syringe 12 is positioned at the predetermined injection angle α relative to the patient. As an even more specific example, the outer surface 574a of the stabilizer 574 may be configured such that when the finger grip element 514 is coupled to the barrel 20 of the syringe 12, the outer surface 574a faces the predetermined injection angle α relative to the longitudinal axis A of the barrel 20 and / or the longitudinal axis of the needle 32.

[0054] 13-18, another embodiment of a drug delivery device 610 according to the principles of the present disclosure is shown. Drug delivery device 610 may include a syringe 12 and a finger grip element 614. For example, aspects of the syringe 12, including aspects of the plunger rod 34 and / or plunger 38 described below in connection with drug delivery device 610, may be applied to any and all of the other embodiments described herein, including, for example, drug delivery devices 10, 110, 210, 310, 410 and / or 510.

[0055] The finger grip element 614 may be structurally and / or functionally similar to the finger grip element 14 described above, except for, for example, the configuration of the first distally facing outer surface 662 and / or the second distally facing outer surface 664. More specifically, the first distally facing outer surface 662 may have a first contour that is partially or completely flat. As an example, the first contour of the first distally facing outer surface 662 may be partially or completely perpendicular or substantially perpendicular to the longitudinal axis A. As a more specific example, a radially outer portion of the first distally facing outer surface 662 may be axially flush or substantially flush with a radially inner portion of the first distally facing outer surface 662. Alternatively, at least a portion of the radially outer portion of the first distally facing outer surface 662 may be distal to at least a portion of the radially inner portion of the first distally facing outer surface 662.

[0056] Similar to the first distally-facing outer surface 662, the second distally-facing outer surface 664 can have a second contour that is partially or completely flat. As an example, the second contour of the second distally-facing outer surface 664 can be partially or completely perpendicular or substantially perpendicular to the longitudinal axis A. As a more specific example, a radially outer portion of the second distally-facing outer surface 664 can be axially flush or substantially flush with a radially inner portion of the second distally-facing outer surface 664. Alternatively, at least a portion of the radially outer portion of the first distally-facing outer surface 664 can be distal to at least a portion of the radially inner portion of the first distally-facing outer surface 664.

[0057] The distal end 47 of the plunger rod 34 may be coupled (e.g., removably coupled) to at least the proximal end 49 of the plunger 38. In some embodiments, coupling the plunger rod 34 to the plunger 38 may cause a portion or all of the plunger 38 to deform (e.g., elastically deform). As an example, coupling the plunger rod 34 to the plunger 38 may cause deformation of an outer wall and / or other portions of the plunger 38, which may reduce friction (e.g., sliding friction) between an outer surface of the outer wall of the plunger 38 and an inner surface of the wall 26 of the barrel 20 during axial movement (e.g., distal and / or proximal movement) of the plunger 38 relative to the barrel 20, as compared to when the plunger 38 is not deformed by the plunger rod 34. Such deformation of the plunger 38 may be achieved by configuring the plunger rod 34 and / or the plunger 38 as described below.

[0058] The distal end 47 of the plunger rod 34 may include a threaded outer surface 80, a plunger rod flange 82, and a distally facing end surface 47a. The plunger rod flange 82 may be proximal to a portion or all of the threaded outer surface 80. The plunger rod flange 82 may extend generally radially outward relative to the longitudinal axis A of the barrel 20 and / or the longitudinal axis of the plunger rod 34. The plunger rod flange 82 may have a distally facing surface 82a. The plunger rod 34 may have an axial length L1 corresponding to the distance between the distally facing end surface 47a of the distal end 47 of the plunger rod 34 and the distally facing surface 82a of the plunger rod flange 82 of the plunger rod 34. As an example, the axial length L1 may be greater than the axial length of the threaded outer surface 80.

[0059] The plunger 38 may include a recess 84 (e.g., a cavity, slot, recess, channel, interior space, etc.) and an axial opening 86. By way of example, the axial opening 86 may be formed in a proximally-facing outer surface 38a of the plunger 38 and / or may be in communication with (e.g., open to) the recess 84. A distal end of the recess 84 may be closed by a proximally-facing inner surface 38b of the plunger 38. The plunger 38 may have an axial length L2 corresponding to the distance between the proximally-facing outer surface 38a of the plunger 38 and the proximally-facing inner surface 38b of the plunger 38. Additionally, the plunger 38 may include a threaded inner surface 88.

[0060] Coupling the plunger rod 34 to the plunger 38 may include engaging (e.g., threadingly engaging) the threaded outer surface 80 of the plunger rod 34 with the threaded inner surface 88 of the plunger 38. As an example, the distal end 47 of the plunger rod 34 may be threaded into the plunger 38. As a more specific example, the distal end 47 of the plunger rod 34 may be axially inserted through the axial opening 86 in the proximal end 49 of the plunger 38 while rotating the plunger rod 34 relative to the plunger 38 to threadingly engage the threaded outer surface 80 of the plunger rod 34 with the threaded inner surface 88 of the plunger 38. As a more specific example, the distal end 47 of the plunger rod 34 may be threadably advanced axially into the recess 84 of the plunger 38 at least until the distal-facing end surface 47a of the plunger rod 34 contacts the proximal-facing inner surface 38b of the plunger 38.

[0061] In some embodiments, the axial length L1 of the plunger rod 34 may be greater than the axial length L2 of the plunger 38, at least prior to coupling the plunger rod 34 to the plunger 38. In such embodiments, threading the plunger rod 34 into the plunger 38 may involve continuing to thread the plunger rod 34 into the plunger 38 after the distal-facing end face 47a of the plunger rod 34 contacts the proximal-facing inner face 38b of the plunger 38. This additional threading may be continued until the distal-facing surface 82a of the plunger rod flange 82 contacts and / or presses against the proximal-facing outer surface 38a of the proximal end 49 of the plunger 38. As a result of this additional threading, the plunger 38 may deform axially and / or radially (e.g., elastically deform) to accommodate the distal end 47 of the plunger rod 34 within the recess 84. The plunger rod 34 and / or plunger 38 can be configured (e.g., dimensioned) such that this deformation has a beneficial effect on the performance of the plunger 38 during use of the syringe 12. For example, the deformation of the plunger 38 caused by coupling the plunger 38 to the plunger rod 34 may reduce friction (e.g., sliding friction) between an outer surface of the outer wall of the plunger 38 and an inner surface of the wall 26 of the barrel 20 during axial movement (e.g., distal and / or proximal movement) of the plunger 38 relative to the barrel 20 compared to if the outer wall of the plunger 38 was not deformed by the plunger rod 34.

[0062] In some embodiments, a limited portion of the distally facing surface 82a of the plunger rod flange 82 may contact and / or press against the proximally facing outer surface 38a of the plunger 38. For example, the distally facing surface 82a of the plunger rod flange 82 may include a radially inner portion 90 and a radially outer portion 92, the radially inner portion 90 being closer to the longitudinal axis A than the radially outer portion 92. As can be seen in FIGS. 15 and 16 , when the plunger rod 34 is threaded into or coupled to the plunger 38, only the radially inner portion 90 of the distally facing surface 82a of the plunger rod flange 82 may contact and / or press against the proximally facing outer surface 38a of the plunger 38. A radially outer portion 92 of the distally facing surface 82a of the plunger rod flange 82 may be spaced apart from the proximally facing outer surface 38a of the plunger 38 by a gap G. When the plunger rod flange 82 contacts and / or presses against the radially inner portion but not the radially outer portion of the proximally facing outer surface 38a of the plunger 38, the plunger rod flange 82 may deform (e.g., elastically deform) the plunger 38 in a mechanically advantageous manner, including, for example, a manner that reduces friction (e.g., sliding friction) between the outer surface of the outer wall of the plunger 38 and the inner surface of the wall 26 of the barrel 20 during axial movement (e.g., distal and / or proximal movement) of the plunger 38 relative to the barrel 20. This, in turn, may reduce the amount of force a user needs to apply to the finger grip element 614 and / or the plunger rod 34 to expel a drug from the syringe 12, for example, during drug delivery.

[0063] 19 and 20, there is shown another embodiment of a fingergrip element 714 in accordance with the principles of the present disclosure. As with the other fingergrip element embodiments described herein, the fingergrip element 714 may be used in conjunction with the syringe 12. The fingergrip element 714 may be structurally and / or functionally similar to the fingergrip element 14 described above, except, for example, that the axial length of the collar of the fingergrip element 714 is less than the corresponding portion of the fingergrip element 14.

[0064] More specifically, as shown in Figures 19 and 20, the distal end 756 of the finger grip element 714 may include a collar 773. The collar 773 may partially surround the barrel 20 of the syringe 12 as shown in Figures 19 and 20, or in alternative embodiments may completely surround the barrel 20 of the syringe 12. At least a portion of the collar 773 may be disposed axially distal to at least a portion of the first distally-facing exterior surface 762 and / or at least a portion of the second distally-facing exterior surface 764. As an example, a distal-most portion of the collar 773 may be disposed axially distal to a proximal-most portion of the first distally-facing exterior surface 762 and / or a proximal-most portion of the second distally-facing exterior surface 764. As a more specific example, a distal-most portion of collar 773 can be disposed axially distal to a distal-most portion of first distal-facing exterior surface 762 and / or a distal-most portion of second distal-facing exterior surface 764. As an even more specific example, a distal-most portion of collar 773 can be disposed axially distal to outer portion 762a of first distal-facing exterior surface 762 and / or outer portion 764a of second distal-facing exterior surface 764.

[0065] The collar 773 can have an inner portion 773a configured to contact the barrel 20 of the syringe 12 and an outer portion 773b. As an example, the inner portion 773a of the collar 773 can be closer to the longitudinal axis A than the outer portion 773b of the collar 773. As a more specific example, the outer portion 773b of the collar 773 can be at least partially defined by the inner portion 762a of the first distally-facing outer surface 762 and / or the inner portion 764a of the second distally-facing outer surface 764.

[0066] 20, the collar 773 may have a length LC measured in a direction parallel to the longitudinal axis A. As an example, the length LC of the collar 773 may be measured between the lead-in surface 774 for the barrel flange 42 and the distal-most surface 756a of the distal end 756 of the finger grip element 714. The length LC may be selected to be less than: (a) the diameter and / or width of the index finger of an average adult or other user, and / or (b) the diameter and / or width of the middle finger of an average adult or other user. As a result of the length LC and / or the reduced wall thickness of the collar 773, a user may be able to position the user's (a) index finger in contact with both the finger grip element 714 and the barrel 20 of the syringe 12 in parallel (e.g., simultaneously or substantially simultaneously), and / or (b) middle finger in contact with both the finger grip element 714 and the barrel 20 of the syringe 12 simultaneously during use of the syringe 12 to deliver a medication. As an example, the index finger may simultaneously contact both the first distally facing surface 762 of the finger grip element 714 and a first lateral side of the barrel 20 of the syringe 12, and the middle finger may simultaneously contact both the second distally facing surface 764 of the finger grip element 714 and a second lateral side of the barrel 20 of the syringe 12. By allowing one or both of the index and middle fingers to contact the barrel 20 of the syringe 12, the width of the "V"-like gap separating the index and middle fingers during use of the syringe 12 by a user to deliver a medication may be reduced. In at least some circumstances, this may result in less twisting or other undesirable torquing of the user's hand and / or the syringe 12, and / or may be more comfortable and / or ergonomic for the user.

[0067] 21-23, another embodiment of a fingergrip element 814 in accordance with the principles of the present disclosure is shown. As can be seen in FIG. 23, the fingergrip element 814 can be used in conjunction with a syringe 12 to define a drug delivery device 810. The fingergrip element 814 can be structurally and / or functionally similar to the fingergrip element 714 described above, except, for example, that the fingergrip element 814 omits any elements similar to the collar 773.

[0068] 22 , due to the absence of a collar element, an inner portion 862b of a first distally-facing outer surface 862 of the finger grip element 814 may define a proximal-most portion of the first distally-facing outer surface 862, and / or an inner portion 864b of a second distally-facing outer surface 864 of the finger grip element 814 may define a proximal-most portion of the second distally-facing outer surface 864. Further, as shown in FIG. 22 , an outer portion 862a of the first distally-facing outer surface 862 may be disposed axially distal to at least a portion or the entirety of an inner portion 862b of the first distally-facing outer surface 862, and / or an outer portion 864a of the second distally-facing outer surface 864 may be disposed axially distal to at least a portion or the entirety of an inner portion 864b of the second distally-facing outer surface 864.

[0069] 23 illustrates the finger grip element 814 being held by a person's hand, as would be the case during use of the syringe 10 to deliver a medication. As shown in FIG. 23, the configuration of the finger grip element 814 allows the user's index finger 3 and middle finger 5 to contact the exterior surface of the barrel 20 of the syringe 12. Thus, the width of the "V"-like gap separating the index finger 3 and middle finger 5 is reduced (compared to when the user's index finger 3 and / or middle finger 5 are separated from the exterior surface of the barrel 20 by a portion of the finger grip element). In at least some circumstances, this results in less twisting or other undesirable torquing of the user's hand and / or the syringe 12 during use of the syringe 12 to deliver a medication, and / or may be more comfortable and / or ergonomic for the user. Further, as can be seen in FIG. 23 , a user while using the syringe 12 to deliver a medication may be able to position the user's (a) index finger 3 in parallel (e.g., simultaneously or substantially simultaneously) contacting both the second distal-facing outer surface 864 of the finger grip element 814 and the outer surface of the second lateral side of the barrel 20 of the syringe 12, and / or (b) middle finger 3 in parallel contacting both the first distal-facing outer surface 862 of the finger grip element 814 and the outer surface of the first lateral side of the barrel 20 of the syringe 12. Further, as can be seen in FIG. 23 , at least a first portion of the outer surface of the first lateral side of the barrel 20 of the syringe 12 may be axially disposed proximal to the outer portion 862a of the first distal-facing outer surface 862 of the finger grip element 814 and distal to the inner portion 862b of the first distal-facing outer surface 862 of the finger grip element 814, and / or at least a second portion of the outer surface of the second lateral side of the barrel 20 of the syringe may be axially disposed proximal to the outer portion 864a of the second distal-facing outer surface 864 of the finger grip element 814 and distal to the inner portion 864b of the second distal-facing outer surface 864 of the finger grip element 814.Further, as can be seen in FIG. 23 , at least a first portion of the outer surface of a first lateral side of the barrel 20 of the syringe 12 may not contact and / or be covered by the finger grip element 814, and / or at least a second portion of the outer surface of a second lateral side of the barrel 20 of the syringe 12 may not contact and / or be covered by the finger grip element 814.

[0070] All features described in this specification, including the specification, claims, abstract and drawings, and all steps in any method or process described in this specification may be combined in any combination except combinations in which one or more of the features and / or steps are mutually exclusive.

[0071] As will be appreciated, the devices and methods according to the present disclosure may have one or more advantages over the prior art, any one or more of which may be present in a particular embodiment and in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically recited herein may be appreciated as well.

[0072] The above description describes various devices, assemblies, components, subsystems, and methods for use in connection with drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0073] The drug is contained within a reservoir. In some cases, the reservoir is a primary container into which the drug is either filled or prefilled for treatment. The primary container may be a vial, cartridge, or prefilled syringe.

[0074] In some embodiments, the reservoir of the drug delivery device can be loaded with or the device can be used with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez) or FULPHILA (pegfilgrastim-bmez).

[0075] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoietin. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin stimulating proteins include erythropoietin and its variants, analogs or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), Epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin and molecules or variants or analogs thereof.

[0076] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; and in particular, binding to the receptor for IL-4 and / or IL-13. Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., particularly a dimer of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, which inhibits activity mediated by human CD22-specific antibodies, including, but not limited to, humanized and fully human monoclonal antibodies, particularly including, but not limited to, human CD22-specific IgG antibodies, such as the human CD22-specific fully humanized antibody of epratuzumab (CAS Registry No. 501423-23-0); IGF-1 receptor-specific antibodies, including, but not limited to, anti-IGF-1R antibodies, peptibodies and related proteins; B7RP-specific fully human monoclonal IgG2 including, but not limited to, antibodies, including, but not limited to, fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; B-7 related protein 1 specific antibodies, peptibodies, related proteins, and the like (also referred to as "B7RP-1" and B7H2, ICOSL, B7h, and CD275); IL-15 specific antibodies, peptibodies, related proteins, and the like, particularly humanized monoclonal antibodies, including, but not limited to, HuMax IL-15 antibodies and related proteins, such as 145c7;IFN gamma specific antibodies, including but not limited to, human IFN gamma specific antibodies, including but not limited to, fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., as well as other TALL specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, etc.; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as monoclonal antibodies; TRAIL-R2 specific antibodies, peptibodies, related proteins, and the like; activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; and proteins that bind to c-Kit and / or other stem cell factor receptors, including, but not limited to, including, but not limited to, c-Kit specific antibodies, peptibodies, related proteins, etc.; OX40L specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, stimulating de novo erythropoiesis Protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered ® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alpha); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb);Tarceva® (erlotinib);Roferon-A®-(interferon alpha-2a);Simulect® (basiliximab);Prexige® (lumiracoxib);Synagis® (palivizumab);145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507);Tysabri® (natalizumab, anti-α4 integrin mAb);Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb);ABthrax®;Xolair® (omalizumab);ETI211 (anti-MRSA mAb);IL-1 trap (Fc portion of human IgG1 and extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, an anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388; anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;Anti-GDF-8 human mAb (MYO-029);Anti-GM-CSF receptor mAb (CAM-3001);Anti-HepC mAb (HuMax HepC);Anti-IFNα mAb (MEDI-545, MDX-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;Anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0077] In some embodiments, the drug delivery device may contain or be used in conjunction with sclerostin antibodies, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib niphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to, OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with an endogenous tissue inhibitor of metalloproteinases (TIMP), such as but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine. Antagonistic antibodies to the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell engager (BiTE®) molecules, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used with an APJ large molecule agonist, such as, but not limited to, apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device can contain or be used with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), a new bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtib mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the contractile machinery of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS. G12C Small molecule inhibitors or KRAS G12CThe drug delivery device may contain or be used with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a), or a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product that contains a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160 or another product that contains a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133 or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171 or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176 or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 199 or a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may house or be used in conjunction with another product containing AMG 427 or a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct.In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multispecific FAPx4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with efavalukin alpha (previously AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug. The delivery device may contain or be used with another product containing AMG 596 or CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecules. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 673 or a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 701 or a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may house or be used in conjunction with AMG 910 or another product containing the half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0078] The drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, but are not limited thereto. The detailed description should be interpreted merely as an example, and does not describe all possible embodiments of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments still fall within the scope of the claims that define the invention disclosed herein.

[0079] Those skilled in the art will understand that various modifications, alterations and combinations may be made to the above-described embodiments without departing from the spirit and scope of the present invention disclosed herein, and that such modifications, alterations and combinations are to be construed as falling within the scope of the concept of the present invention.

Claims

1. 1. A drug delivery device comprising: A syringe, a barrel including a proximal end, a distal end and a longitudinal axis; a barrel flange disposed at the proximal end of the barrel and extending radially outward relative to the longitudinal axis; a plunger disposed at least partially within the barrel and movable along the longitudinal axis; A syringe comprising: a finger grip element coupled to the barrel flange and including a first distally facing surface, the first distally facing surface comprising: (a) inhibiting or preventing at least a first finger of a user from moving radially outwardly relative to the longitudinal axis during use of the syringe to deliver a medicament; and / or (b) exerting a first repulsive force on at least the first finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the medication. a finger grip element having a first contour configured to 13. A drug delivery device comprising:

2. The first contour of the first distally-facing surface comprises: (a) inhibiting or preventing at least the first finger of the user from moving in the radial outward direction relative to the longitudinal axis during use of the syringe to deliver the medication; and (b) exerting the first repulsive force on at least the first finger of the user in the direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver a medicament. The drug delivery device of claim 1 , configured to:

3. 3. The drug delivery device of claim 1 or 2, wherein the first distally facing surface includes an outer portion and an inner portion, the inner portion being closer to the longitudinal axis than the outer portion, and at least a portion of the outer portion being distal to at least a portion of the inner portion.

4. 4. The drug delivery device of claim 3, wherein the outer portion of the first distally facing surface of the finger grip element is configured to inhibit or prevent at least the first finger of the user from moving in the radially outward direction relative to the longitudinal axis during use of the syringe to deliver the drug.

5. The drug delivery device of claim 1 or 2, comprising a plunger rod connected to the plunger, the finger grip element at least partially surrounding the plunger rod.

6. 6. The drug delivery device of claim 5, wherein a threaded outer surface of the plunger rod engages a threaded inner surface of the plunger to connect the plunger rod to the plunger.

7. 7. The drug delivery device of claim 6, wherein the plunger rod includes a plunger rod flange proximal to the threaded outer surface and extending radially outward relative to the longitudinal axis, at least an inner portion of a distal-facing surface of the plunger rod flange contacting a proximal-facing outer surface of the plunger.

8. 8. The drug delivery device of claim 7, wherein an outer portion of the distal-facing surface of the plunger rod flange is spaced from the proximal-facing outer surface of the plunger by a gap.

9. 8. The drug delivery device of claim 7, wherein the distal end of the plunger rod is at least partially positioned within a recess formed in the plunger such that a distal-facing end surface of the distal end of the plunger rod contacts a proximally-facing inner surface of the plunger.

10. 10. The drug delivery device of claim 9, wherein the plunger rod has a first axial length between the distally facing end face of the distal end of the plunger rod and the distally facing surface of the plunger rod flange, the plunger has a second axial length between the proximally facing inner surface of the plunger and the proximally facing outer surface of the plunger, and the first axial length is greater than the second axial length.

11. The drug delivery device of claim 6 , wherein the finger grip element has an opening that allows the plunger rod to be inserted laterally into the finger grip element.

12. The drug delivery device of claim 1 or 2, wherein the finger grip element is connected to the barrel flange via a snap-fit ​​connection.

13. 13. The drug delivery device of claim 12, wherein the finger grip element includes a locking tab configured to allow the barrel flange to be inserted into the opening in the finger grip element and to inhibit or prevent the barrel flange from being removed from the finger grip element through the opening.

14. The drug delivery device of claim 13 , wherein the locking tab extends distally from a distally-facing inner surface of the finger grip element.

15. The drug delivery device of claim 1 or 2, wherein at least a portion of the first contour of the first distally facing surface has a concave curvature.

16. The drug delivery device of claim 1 or 2, wherein at least a portion of the finger grip element is C-shaped or U-shaped when viewed in a direction along the longitudinal axis.

17. The drug delivery device of claim 1 or 2, wherein the finger grip element includes a proximal end and a distal end, the proximal end of the finger grip element being coupled to the barrel flange.

18. 18. The drug delivery device of claim 17, wherein at least a portion of the first distally-facing surface of the finger grip element is distal to at least a portion of the barrel flange.

19. 18. The drug delivery device of claim 17, wherein at least a portion of the first distally facing surface of the finger grip element is proximal to or axially flush with at least a portion of the barrel flange.

20. 3. The drug delivery device of claim 1 or 2, wherein the finger grip element includes a stabilizer configured to contact a patient and assist in maintaining the longitudinal axis at a predetermined angle relative to the patient during use of the syringe to deliver the drug.

21. 21. The drug delivery device of claim 20, wherein at least a portion of the first distally facing surface is closer to the longitudinal axis than at least a portion of the stabilizer.

22. 3. The drug delivery device of claim 1 or 2, wherein the finger grip element includes a second distally facing surface having a second contour configured to (a) inhibit or prevent at least a second finger of a user from moving in a radially outward direction relative to the longitudinal axis during use of the syringe to deliver the drug, and / or (b) exert a second repulsive force on at least the second finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the drug.

23. 23. The drug delivery device of claim 22, wherein the first distally facing surface and the second distally facing surface are disposed on opposite sides of the longitudinal axis.

24. 3. The drug delivery device of claim 1 or 2, wherein the first contour of the first distally facing surface of the finger grip element is configured to inhibit or prevent at least the first finger of the user from moving radially inward relative to the longitudinal axis during use of the syringe to deliver the drug.

25. The drug delivery device of claim 1 or 2, wherein the syringe is a pre-filled syringe.

26. The drug delivery device of claim 1 or 2, wherein the syringe includes a needle coupled to the distal end of the barrel.

27. The drug delivery device of claim 1 or 2, wherein the finger grip element is removably coupled to the barrel flange.

28. 1. A finger grip element for use with a syringe, comprising: a proximal end and a distal end disposed at respective axial positions along a longitudinal axis; an opening configured to receive at least a portion of the syringe; a first distal-facing surface, (a) inhibiting or preventing at least a first finger of a user from moving radially outwardly relative to the longitudinal axis during use of the syringe to deliver a medicament; and / or (b) exerting a first repulsive force on at least the first finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the medication. a first distally-facing surface including a first contour configured to A finger grip element including:

29. 30. The finger grip element of claim 28, wherein the first distally facing surface includes an outer portion and an inner portion, the inner portion being closer to the longitudinal axis than the outer portion, and at least a portion of the outer portion being distal to at least a portion of the inner portion.

30. 30. The finger grip element of claim 29, wherein the outer portion of the first distally facing surface of the finger grip element is configured to inhibit or prevent at least the first finger of the user from moving in the radially outward direction relative to the longitudinal axis during use of the syringe to deliver the medication.

31. (a) inhibiting or preventing at least a second finger of a user from moving radially outwardly relative to the longitudinal axis during use of the syringe to deliver the medication; and / or (b) exerting a second repulsive force on at least the second finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the medication. The fingergrip element of any one of claims 28 to 30, comprising a second distally-facing surface having a second contour configured to:

32. 32. The fingergrip element of claim 31, wherein the first distally facing surface and the second distally facing surface are disposed on opposite sides of the longitudinal axis.

33. 32. The fingergrip element of claim 31, wherein the first contour and the second contour are symmetrical to one another across the longitudinal axis.

34. 1. A method of making a fingergrip element for a syringe, the fingergrip element having a length LFG1 corresponding to a distance between a longitudinal axis of a barrel of the syringe and a distally facing surface of the fingergrip element for contacting a user's finger during use of the syringe to deliver a medicament, the method comprising: The length LFG1 for the finger grip element is calculated according to the following formula: M=(FFG1)(0.5)(LFG1)+((T)(cos(θ))+LB+LPR+(LF1)(Tan(θ)))(FPR)(Tan(30)) In the above, M is selected to be equal to or approximately equal to zero. wherein FFG1 corresponds to a force applied by the finger of the user to the distally directed surface of the finger grip element during use of the syringe to deliver the medication; T corresponds to the distance between the user's wrist and the proximal end of the syringe's plunger rod; LB corresponds to the length of the barrel of the syringe; LPR corresponds to the length of the plunger rod of the syringe; LF1 corresponds to the length of the user's finger, θ corresponds to the angle between the user's finger and the user's thumb during use of the syringe to deliver the medication; and A method, wherein FPR corresponds to the force applied to the plunger rod by the user's thumb during use of the syringe to deliver the medication.

35. 35. The method of claim 34, wherein M corresponds to a moment at or near the distal end of the syringe needle.

36. 36. The method of claim 34 or 35, wherein the finger of the user corresponds to an index finger of the user.

37. 36. The method of claim 34 or 35, wherein the force FPR is applied to the plunger rod in a direction parallel and / or coaxial with the longitudinal axis of the barrel.

38. The distally facing surface of the finger grip element comprises: (a) inhibiting or preventing at least the fingers of a user from moving radially outwardly relative to the longitudinal axis during use of the syringe to deliver the medication; and / or (b) exerting a repulsive force on at least the finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the medication.

36. The method of claim 34 or 35, comprising a profile configured to:

39. 40. The method of claim 38, wherein at least a portion of the contour of the distally facing surface of the finger grip element has a concave curvature.

40. 36. The method of claim 34 or 35, wherein the distally facing surface of the finger grip element includes an outer portion and an inner portion, the inner portion being closer to the longitudinal axis than the outer portion, and at least a portion of the outer portion being distal to at least a portion of the inner portion.

41. 41. The method of claim 40, wherein the outer portion of the distally facing surface of the finger grip element is configured to inhibit or prevent at least the fingers of the user from moving in a radially outward direction relative to the longitudinal axis during use of the syringe to deliver the medication.

42. 36. The method of claim 34 or 35, wherein the finger grip element is configured to form a snap-fit ​​connection with the barrel of the syringe.

43. 1. A drug delivery device comprising: A syringe, a barrel including a proximal end, a distal end and a longitudinal axis; a barrel flange disposed at the proximal end of the barrel and extending radially outward relative to the longitudinal axis; a plunger disposed at least partially within the barrel and movable along the longitudinal axis; A syringe including: a finger grip element coupled to the barrel flange and including a distally facing surface; wherein during use of the syringe to deliver a medication, the finger grip element is configured to allow at least one finger of a user to simultaneously contact the distally facing surface of the finger grip element and the barrel of the syringe.

44. 44. The drug delivery device of claim 43, wherein the distally facing surface of the finger grip element includes an inner portion and an outer portion, the inner portion being closer to the longitudinal axis of the barrel than the outer portion.

45. 45. The drug delivery device of claim 44, wherein at least a portion of the outer portion of the distally facing surface of the finger grip element is distal to at least a portion of the inner portion of the distally facing surface of the finger grip element.

46. 46. ​​The drug delivery device of claim 44 or 45, wherein the outer portion of the distally facing surface of the fingergrip element defines a distal-most portion of the fingergrip element.

47. 46. ​​The drug delivery device of claim 44 or 45, wherein the outer portion of the distally facing surface of the finger grip element is configured to inhibit or prevent the at least one finger of the user from moving radially outward relative to the longitudinal axis during use of the syringe to deliver the drug.

48. 46. ​​The drug delivery device of claim 44 or 45, wherein at least a portion of the outer surface of the barrel is proximal to the outer portion of the distal-facing surface of the finger grip element and distal to the inner portion of the distal-facing surface of the finger grip element.

49. 49. The drug delivery device of claim 48, wherein the at least a portion of the outer surface of the barrel is free of contact with and / or covered by the finger grip element.

50. 46. ​​The drug delivery device of any one of claims 43 to 45, wherein the distally facing surface comprises a first contour configured to: (a) inhibit or prevent the at least one finger of the user from moving in a radially outward direction relative to the longitudinal axis during use of the syringe to deliver the drug; and / or (b) exert a first repulsive force on the at least one finger of the user in a direction parallel or substantially parallel to the longitudinal axis during use of the syringe to deliver the drug.

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