Non-circular reservoir injection pen with telescopic screw

Abstract

The delivery pen includes a reservoir including a non-circular shape, a plunger disposed within the reservoir, and a threaded mechanism at least partially inserted within the reservoir, the threaded mechanism including a drive shaft including one or more projections at a proximal end and an elongated member extending longitudinally from the proximal end, an internal thread concentrically engaging the elongated member, an outer housing including a circular section rotatably engaging the one or more projections and a non-circular section sized to fit within the reservoir, and a pusher disposed between the internal thread and the outer housing for linearly translating the plunger to dispense medicament from the reservoir.

Description

[Technical Field]

[0001] The present disclosure relates to a non-circular drug reservoir and associated screw mechanism in a delivery pen for delivering a therapeutic compound. [Background technology]

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 479,772, filed January 13, 2023, and U.S. Provisional Patent Application No. 63 / 507,657, filed June 12, 2023, the contents of which are incorporated herein by reference in their entireties.

[0003] In the treatment of several diseases and conditions, it is often desirable to inject a drug directly into a patient's tissue. For example, pen injection or pump devices are used to inject medication into tissue areas. Currently, pen injection or pump devices are quite bulky, options for achieving intra-tissue drug administration are limited, and their use is often complicated or uncomfortable. Therefore, there is a need for an easy-to-use, ergonomic drug delivery system that can accommodate different lifestyles. Summary of the Invention [Problem to be solved by the invention]

[0004] These and other problems are overcome by embodiments of the present disclosure. [Means for solving the problem]

[0005] The present disclosure relates to a delivery pen including a reservoir including a non-circular shape, a plunger disposed within the reservoir, a screw mechanism at least partially inserted within the reservoir, the drive shaft including one or more protrusions at a proximal end and an elongated member extending longitudinally from the proximal end, an internal thread concentrically engaging the elongated member, an outer housing including a circular section rotatably engaging the one or more protrusions and a non-circular section sized to fit within the reservoir, and a pusher disposed between the internal thread and the outer housing for linearly translating the plunger to dispense medicament from the reservoir.

[0006] The present disclosure relates to a delivery pen including a reservoir including a non-circular shape, a plunger disposed within the reservoir, and a screw mechanism at least partially inserted within the reservoir, the screw mechanism including: a drive shaft including one or more protrusions at a proximal end and an elongated member extending longitudinally from the proximal end; an inner thread concentrically engaging the elongated member, the inner thread including a wide section and a narrow section extending longitudinally from the wide section; an outer thread concentrically engaging the wide section, the outer thread including a circular section rotatably engaging the one or more protrusions and a non-circular section sized to fit within the reservoir; and a pusher disposed between the narrow section and the outer thread for linearly translating the plunger to dispense medicament from the reservoir.

[0007] The present disclosure provides a torque coupling component comprising: a body, a cap engaged to the body; a torque coupling component including an internal axial slot, wherein the torque coupling component is received with the body; a screw mechanism including a drive shaft including a proximal end and an elongated member extending distally from the proximal end, wherein the proximal end of the drive shaft includes one or more protrusions configured to mate with the internal axial slot of the torque coupling component; an internal thread concentrically engaging the elongated member and including a first external thread; an outer housing including a circular section and a non-circular section, wherein the proximal end of the circular section includes a recess configured to engage with the one or more protrusions such that the drive shaft can rotate about the recess but cannot extend longitudinally from the recess; and a pusher, wherein an inner surface of the pusher includes an internal thread configured to mate with the first external thread of the internal thread. a pusher; a reservoir contained within the cap, the reservoir including a non-circular shape, an exit port at a distal end, and a plunger movable along a longitudinal axis of the reservoir, the plunger configured to engage with the distal end of the pusher and provide a seal against an inner wall of the reservoir to prevent fluid provided in a fluid chamber defined on a first side of the plunger from leaking into a portion of the reservoir defined by a second side of the plunger; and a dose knob engaged with the torque-coupling component, the dose knob rotatable relative to the body to adjust the volume of fluid delivery such that rotation of the dose knob in the first direction facilitates axial movement of the drive shaft from the proximal end of the drive shaft, and rotation of the dose knob in the second direction facilitates axial movement of the drive shaft towards the proximal end of the body.

[0008] The present disclosure relates to a delivery pen including a non-circular reservoir and a screw mechanism at least partially inserted within the non-circular reservoir, the screw mechanism including: a drive shaft, wherein a proximal end of the drive shaft includes one or more protrusions; an internal thread including a wide section and a narrow section, wherein an inner surface of the internal thread transmits torque applied to the drive shaft to the internal thread, the wide section including a first external thread and the narrow section including a second external thread; an external thread including a circular section and a non-circular section, wherein the circular section includes an internal thread configured to engage with the first external thread, the proximal end of the circular section including a recess configured to engage with the one or more protrusions such that the drive shaft can rotate about the recess but cannot extend longitudinally from the recess; and a pusher configured to engage a plunger, wherein an inner surface of the pusher includes an internal thread configured to mate with the second external thread of the internal thread.

[0009] Exemplary embodiments of the present disclosure prevent plunger rotation in circular fluid delivery devices while retaining the characteristics of reliable and proven systems such as medication pens and pen needles, syringes, or pump systems that employ more expensive and non-portable lead screw drive mechanisms. [Brief explanation of the drawings]

[0010] The features of the present disclosure are set forth with particularity in the appended claims. The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Patent and Trademark Office upon request and payment of the necessary fee. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description of illustrative embodiments, utilizing the principles of the invention, and the accompanying drawings.

[0011] [Figure 1A]FIG. 1A shows a perspective view of a delivery pen with a cap, according to an embodiment of the present disclosure. [Figure 1B] FIG. 1B shows a perspective view of a delivery pen without a cap and with a needle attached, according to an embodiment of the present disclosure. [Figure 1C] FIG. 1C shows a perspective view of a capless and needleless delivery pen according to an embodiment of the present disclosure. [Figure 1D] FIG. 1D shows a perspective cross-sectional view of a delivery pen taken along the longitudinal axis of the delivery pen, according to an embodiment of the present disclosure. [Figure 2A] FIG. 2A shows a cross-sectional view of a screw mechanism in a mated position and an extended position, according to some embodiments of the present disclosure. [Figure 2B] FIG. 2B shows a cross-sectional view of a screw mechanism in a mated position and an extended position, according to some embodiments of the present disclosure. [Figure 2C] FIG. 2C shows an isometric view of the screw mechanism in a mated position, according to some embodiments of the present disclosure. [Figure 2D] FIG. 2D shows an isometric view of the screw mechanism in a mated position, according to some embodiments of the present disclosure. [Figure 3] FIG. 3 shows an isometric cross-sectional view of a screw mechanism in a partially extended position, according to some embodiments of the present disclosure. [Figure 4] FIG. 4 illustrates a drive shaft and inner screw stop feature according to some embodiments of the present disclosure. [Figure 5] FIG. 5 shows an internal screw and plunger stop feature according to some embodiments of the present disclosure. [Figure 6] FIG. 6 is a cross-sectional view showing a screw mechanism in a partially extended position according to some embodiments of the present disclosure. [Figure 7] FIG. 7 is a cross-sectional view showing a screw mechanism in a partially extended position according to some embodiments of the present disclosure. [Figure 8] FIG. 8 is a cross-sectional view illustrating an alternative stop feature of the drive shaft and inner screw according to some embodiments of the present disclosure. [Figure 9A]FIG. 9A shows a transparent cross-sectional view in a mated position and an extended position according to some embodiments of the present disclosure. [Figure 9B] FIG. 9B shows a transparent cross-sectional view in a mated position and an extended position according to some embodiments of the present disclosure. [Figure 10] FIG. 10 shows a perspective view of a screw mechanism in a partially extended position, according to some embodiments of the present disclosure. [Figure 11] FIG. 11 shows a front view of a delivery pen according to some embodiments of the present disclosure. [Figure 12A] FIG. 12A shows a perspective view of a single component of a torque coupling according to some embodiments of the present disclosure. [Figure 12B] FIG. 12B shows a perspective view of an assembled torque coupling and screw mechanism according to some embodiments of the present disclosure. [Figure 13] FIG. 13 shows a perspective view of a delivery pen having an arrow-shaped storage compartment according to some embodiments of the present disclosure. [Figure 14] FIG. 14 shows a perspective view of a delivery pen having a storage compartment in an expanded configuration, according to some embodiments of the present disclosure.

[0012] While the above-identified drawings depict presently disclosed embodiments, other embodiments are contemplated, as noted in the description. The present disclosure presents exemplary embodiments by way of representation, not limitation. Many other modifications and embodiments can be devised by those skilled in the art that fall within the scope and spirit of the principles of the disclosed embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0013] The following description provides a screw mechanism for enabling a fluid or medication delivery device, such as a delivery pen, to interface with a reservoir having a non-circular cross-section within the fluid delivery device. In some embodiments, implementing a non-circular cross-section reservoir can make the delivery pen shorter, more ergonomic, and provide more storage space. Because many pen injection devices have multiple components and limited medication capacity, a medication delivery system is needed in which the main equipment used to determine the dose administered to the patient is modularized from the pen injection or pump device while reducing size and shape. A pump with a reduced size of the basic mechanism realizes the possibility of using a larger reservoir while minimizing size. This is a potential benefit for patients, as a single pen can be used for more days. An extension screw mechanism can be used to advance a plunger within a fluid reservoir for controlled delivery of fluid. In some examples, for example, in medical fluid delivery devices with circular reservoirs, an anti-rotation feature is required to allow movement of such an extension screw mechanism between a nested and an extended configuration, which would otherwise prevent the plunger from advancing through the reservoir. However, non-circular reservoirs can circumvent this problem by preventing the screw mechanism from rotating when administered, thus allowing the screw mechanism to extend through the reservoir without additional anti-rotation features. The assemblies described herein overcome this challenge and provide anti-rotation capabilities to telescoping screw mechanisms for non-circular reservoirs.

[0014] Exemplary embodiments of the present disclosure generally relate to telescoping screw mechanisms for use in fluid delivery devices, such as delivery pens. Exemplary embodiments generally relate to nesting a telescoping screw with a non-circular section for controllably extending or retracting a plunger within a non-circular reservoir of a syringe, which does not affect the reservoir's volume to ensure biocompatibility, is fully retractable outside the reservoir, and engages the reservoir for anti-rotation control. Telescoping screw drive mechanisms, designed for pens used to administer medication, rely on limiting rotation with one screw to generate extension; otherwise, the system simply rotates without advancing. This is necessary because the opposite end of the telescoping screw is fixed to the device body to provide a reference for rotation and advancement of the screw. In certain embodiments, the non-circular shape of the reservoir can be used to create anti-rotation, thereby allowing the plunger to extend from a nested position. The present disclosure relates to anti-rotation mechanisms with a substantially shortened length.

[0015] Implementing a non-circular reservoir for anti-rotation can eliminate or reduce the need for additional anti-rotation mechanisms within the fluid delivery device. In some embodiments, reducing or eliminating these additional anti-rotation mechanisms allows for more space within the fluid delivery device for other components, such as a dose measurement encoder. In some embodiments, reducing or eliminating the additional anti-rotation mechanisms can use the increased space within the fluid delivery device to accommodate a larger fluid or medication reservoir within the fluid delivery device. That is, the overall size of the fluid delivery device may remain unchanged, but a larger fluid reservoir can be included in the fluid delivery device, thereby increasing the flow rate of the fluid delivery device. Compared to conventional delivery pens, the delivery pens disclosed herein can hold at least 10% more drug than conventional delivery pens, at least 20% more drug than conventional delivery pens, at least 25% more drug than conventional delivery pens, at least 50% more drug than conventional delivery pens, at least 60% more drug than conventional delivery pens, at least 70% more drug than conventional delivery pens, at least 80% more drug than conventional delivery pens, at least 90% more drug than conventional delivery pens, at least 100% more drug than conventional delivery pens, at least 110% more drug than conventional delivery pens, at least 120% more drug than conventional delivery pens, at least 130% more drug than conventional delivery pens, at least 140% more drug than conventional delivery pens, at least 150% more drug than conventional delivery pens, at least 160% more drug than conventional delivery pens, at least 170% more drug than conventional delivery pens, at least 180% more drug than conventional delivery pens, at least 190% more drug than conventional delivery pens, or at least 200% more drug than conventional delivery pens.

[0016] In some embodiments, delivery pens disclosed herein that are standard length but have increased reservoir sizes can hold 3.3 mL or more of a drug, 3.6 mL or more of a drug, 3.75 mL or more of a drug, 4.5 mL or more of a drug, 4.8 mL or more of a drug, 5.1 mL or more of a drug, 5.4 mL or more of a drug, 5.7 mL or more of a drug, 6.0 mL or more of a drug, 6.3 mL or more of a drug, 6.6 mL or more of a drug, 6.9 mL or more of a drug, 7.2 mL or more of a drug, 7.5 mL or more of a drug, 7.8 mL or more of a drug, 8.1 mL or more of a drug, 8.4 mL or more of a drug, 8.7 mL or more of a drug, or 9.0 mL or more of a drug.

[0017] In some embodiments, the overall footprint of a fluid delivery device can be reduced by reducing or eliminating additional anti-rotation features through the implementation of a non-circular reservoir. That is, in some embodiments, rather than filling the increased interior space of the fluid delivery device with additional components or a larger reservoir, the exterior of the fluid delivery device can be reduced to eliminate the increased interior space. In such embodiments, the flow rate of the fluid delivery device may remain unchanged, but the overall size or length of the fluid delivery device can be reduced to improve ergonomics and transportability. Compared to conventional delivery pens, the length of the delivery pens disclosed herein can be 90% or less of the length of conventional delivery pens, 80% or less of the length of conventional delivery pens, 70% or less of the length of conventional delivery pens, 60% or less of the length of conventional delivery pens, 50% or less of the length of conventional delivery pens, 40% or less of the length of conventional delivery pens, 35% or less of the length of conventional delivery pens, 30% or less of the length of conventional delivery pens, or 25% or less of the length of conventional delivery pens.

[0018] In some embodiments, delivery pens disclosed herein having standard reservoir volumes but reduced pen lengths can be 10.0 cm or less in length, 9.5 cm or less in length, 9.0 cm or less in length, 8.5 cm or less in length, 8.0 cm or less in length, 7.5 cm or less in length, 7.0 cm or less in length, 6.5 cm or less in length, 6.0 cm or less in length, 5.5 cm or less in length, or 5.0 cm or less in length.

[0019] In some embodiments, the cross-sectional shape of the non-circular reservoir can be selected as desired to achieve a constant reservoir volume (if an increased flow rate is desired) or a constant delivery pen length (if a reduced pen length is desired). Generally, however, the cross-sectional shape of the non-circular reservoir is selected to maintain a desired range of delivery pen width and a desired range of force required to advance the plunger through the reservoir.

[0020] 1A-1D show perspective views of a delivery pen 10 according to an embodiment of the present disclosure. FIG. 1A shows a perspective view of the delivery pen 10 with a body 100, a cap 101, and a dose knob 102, which can be used to set and administer a dose of a desired volume, as described in further detail below. In some embodiments, the body 100 includes a circular body 1001 on the proximal side and a non-circular body 1002 on the distal side, and the shape of the body 100 transitions between the circular body 1001 and the non-circular body 1002. The non-circular body 1002 can house a non-circular reservoir 104. In some embodiments, the cross-sectional shape of the non-circular body 1002 or the non-circular reservoir 104 is oval, square, rectangular, triangular, or other non-circular shape. FIG. 1B shows a perspective view of the delivery pen 10 with the cap 101 removed, revealing a needle 103 attached to the distal end of the reservoir 104. 1C shows a perspective view without needle 103, revealing exit port 105 at the distal end of reservoir 104. FIG. 1D shows a perspective cross-sectional view of delivery pen 10, revealing screw mechanism (SM) 200 or 300, torque coupling component (TCC) 500, and plunger 400 inside body 100. In some embodiments, the shape of plunger 400 matches the shape of non-circular body 1002 to have the desired seal compression.

[0021] 2A-2B show cross-sectional views of SM 200 in the nested and extended positions, respectively. SM 200 includes three main components: drive shaft 210, inner screw 220, and pusher 230, collectively referred to as a telescoping screw member. In some embodiments, each of the three main components includes the same longitudinal centerline (e.g., axis X). In some embodiments, drive shaft 210 is disposed laterally within inner screw 220, which is disposed laterally within pusher 230. For example, as can be seen in FIG. 2B , these components are interconnected such that movement of drive shaft 210 longitudinally translates inner screw 220 and pusher 230. In some embodiments, rotation of drive shaft 210 can translate inner screw 220 and pusher 230. The pusher 230 can include a body 235 and a distal non-circular end 234 extending from the body 235, where the non-circular end 234 contacts a proximal face of a plunger 400 within the reservoir 104. In some embodiments, the non-circular end 234 and the plunger 400 are coupled together. In some embodiments, the non-circular end 234 and the plunger 400 can be coupled together after they contact. In some embodiments, the plunger 400 floats freely within the reservoir 104. The non-circular end 234 of the pusher 230 contacts the plunger 400, advancing the plunger 400 through the reservoir 104 and subsequently dispensing liquid from the reservoir 104. FIGS. 2C-2D are isometric views of the SM 200 in a nested position. In some embodiments, the SM 200 can include an outer housing 240. In the nested position, the SM 200 can be housed within the outer housing 240. Specifically, in the nested position, the inner screw 220 can be disposed within the outer housing 240 and the body 235 of the pusher 230 can be disposed within the outer housing 240 .

[0022] As shown in FIG. 2B , in some embodiments, drive shaft 210 can include a first portion 212 extending distally from second portion 214. First portion 212 includes a mechanism for engaging internal threads 220 to allow internal threads 220 to move longitudinally along axis X. In some embodiments, an outer surface of first portion 212 includes a protrusion 218 that engages with an inner surface 222 of internal threads 220 such that rotation of drive shaft 210 due to applied torque facilitates longitudinal advancement of internal threads 220 along axis X at a first speed. In some embodiments, protrusion 218 includes at least a portion of a first thread. In some embodiments, inner surface 222 of internal threads 220 includes corresponding threads for engaging with protrusion 218 of drive shaft 210. Second portion 214 is provided at a proximal end of drive shaft 210 to allow engagement between drive shaft 210 and outer housing 240. In some embodiments, the second portion 214 of the drive shaft 210 includes one or more members 211 that engage with the TCC 500 (also shown in FIG. 12B ) so that torque applied to the dose knob 102 is transmitted to the drive shaft 210. In some embodiments, the outer housing 240 includes a proximal section 242 and a distal section 244. In some embodiments, the proximal section 242 has a circular diameter to allow the inner threads 220 and the pusher 230 to nest within the proximal section 242. In some embodiments, the distal section 244 has a non-circular diameter that fits within the reservoir 104 when the reservoir 104 includes a non-circular shape. In some embodiments, approximately half of the distal section 244 of the outer housing 240 is disposed within the reservoir 104. That is, the proximal end of the reservoir 104 is disposed between the distal end of the distal section 244 and the proximal end of the distal section 244 of the outer housing 240. 2B, outer housing 240 includes an annular circumferential protrusion 246 at the proximal end of proximal section 242, which engages member 216 of drive shaft 210. In some embodiments, member 216 includes a snap feature for a more secure engagement.Member 216 may extend laterally from second portion 214 and curve over circumferential projection 246 to create a snap-fit ​​joint between member 216 and a distal side of circumferential projection 246. Such a snap-fit ​​joint may allow drive shaft 210 to rotate about outer housing 240 but not extend longitudinally from outer housing 240 due to engagement with circumferential projection 246.

[0023] In some embodiments, the distal end of the inner screw 220 comprises a mechanism for engaging with the pusher 230 to allow the pusher 230 to advance longitudinally along the axis X away from the proximal end of the inner screw 220. In some embodiments, the mechanism for engagement comprises a protrusion 224 on an outer surface of the inner screw 220, the protrusion 224 engaging an inner surface 232 of the pusher 230 such that rotation of the inner screw 220 due to an applied torque advances the pusher 230 longitudinally along the axis X at a second speed. In some embodiments, the protrusion 224 comprises at least a portion of a second thread. In some embodiments, the inner surface 232 of the pusher 230 comprises an internal thread corresponding to the second thread such that movement of the inner screw 220 is applied to the pusher 230. In some embodiments, the inner surface 232 of the body 235 of the pusher 230 comprises an internal thread corresponding to the second thread such that movement of the inner screw 220 is applied to the pusher 230. In some embodiments, the corresponding threads are such that rotation of the inner screw 220 can longitudinally advance the pusher 230. As can be seen in Figures 2A-2B, the pusher 230 includes an inner surface 236 of the non-circular end 234 such that the inner surface 236 engages the distal end of the inner screw 220 while in the nested position, and the inner surface 236 advances longitudinally from the distal end of the inner screw 220 when rotation is applied to the inner screw 220.

[0024] 3 shows an isometric cross-sectional view of the SM 200 in a partially extended position, illustrating an example use scenario when torque is input at the proximal end of the drive shaft 210. In some embodiments, the first thread of the protrusion 218 on the drive shaft 210 is of the same thread direction and pitch as the first thread of the protrusion 224 on the internal thread 220, and the corresponding second thread of the internal surface 222 of the internal thread 220 is of the same thread direction and pitch as the corresponding second thread of the internal surface 232 of the pusher 230. In such a configuration, only one of the pusher 230 and the internal thread 220 can advance longitudinally at a given time. Such a configuration allows for the opportunity for either the internal thread 220 or the pusher 230 to advance relative to the other at a given time. That is, depending on the drive torque of the drive shaft 210 / internal screw 220 relative to the internal screw 220 / pusher 230 (e.g., the torque required to rotate the drive shaft 210 relative to the internal screw 220) (e.g., the torque required to rotate the internal screw 220 relative to the pusher 230), either the drive shaft 210 rotates relative to the internal screw 220, or the internal screw 220 rotates relative to the pusher 230 at a given time, and therefore either the internal screw 220 advances longitudinally at a given time (due to the relative rotation of the drive shaft 210 relative to the internal screw 220) or the pusher 230 advances longitudinally at a given time (due to the relative rotation of the internal screw 220 relative to the pusher 230). In such a configuration, the drive torque of the drive shaft 220 / internal screw 220 or the drive torque of the internal screw 220 / pusher 230 can change over time. Thus, due to changes in the relative drive torque, there can be a shift back and forth between whether the inner screw 220 or the pusher 230 is longitudinally advancing at a given time. In some embodiments, rotation of the drive shaft 210 longitudinally advances the inner screw 220 (e.g., when the drive torque is such that the drive shaft 210 rotates relative to the inner screw 220). In some embodiments, rotation of the drive shaft 210 rotates the inner screw 220 with the drive shaft 210, which can longitudinally advance the pusher 230 relative to the inner screw 220.The inner screw 220 and the pusher 230 can advance longitudinally in the same direction toward the reservoir. The drive torque between two members (e.g., the drive shaft 210 and the inner screw 220) can be affected by the shape of the two members or the tightness of the fit between the two members. For example, a tighter fit between the drive shaft 210 and the inner screw 220 will require a greater drive torque to rotate the drive shaft 210 relative to the inner screw 220. Thus, until this greater drive torque is achieved, the drive shaft 210 and the inner screw 220 can rotate together, which can cause longitudinal advancement of the pusher 230 (if the relative drive torque of the inner screw 220 / pusher 230 is lower than that of the drive shaft 210 / inner screw 220).

[0025] In some embodiments, a configuration in which the first thread of the protrusion 218 on the drive shaft 210 is of the same thread direction and pitch as the first thread of the protrusion 224 on the internal thread 220, and the corresponding second thread on the inner surface 222 of the internal thread 220 is of the same thread direction and pitch as the corresponding second thread on the inner surface 232 of the pusher 230, may allow the pusher 230 to advance longitudinally at half the displacement per rotation as the internal thread 220, or vice versa. By maintaining equivalent thread pitch between the internal thread 220 and the pusher 230, the SM may advance longitudinally with twice the resolution per rotation of the dose knob 102 relative to a configuration in which the first and second threads are of opposite thread directions. The torque ratio between the internal thread 220 and the pusher 230 may be related to the diameter of each part, with minimum drive torque being associated with a smaller diameter of the internal thread 220. In some embodiments, the inner screw 220 may be driven longitudinally forward first rather than the pusher 230 based on the relative torque between the parts. Generally, the inner screw 220 has a smaller thread radius and therefore a lower torque requirement to be driven, and may advance longitudinally before the pusher 230. In some embodiments, the pusher 230 may advance longitudinally before the inner screw 220. In some embodiments, the outer housing 240 is fixed with the body of the pen 10, allowing (a) rotation of the drive shaft 210 to longitudinally advance the inner screw 220 in one direction relative to the drive shaft 210 toward the distal end of the reservoir 104, and (b) relative rotation of the protrusions 224 of the inner screw 220 to longitudinally advance the pusher 230 toward the distal end of the reservoir 104. In this arrangement, the torque is constant and does not change.

[0026] 2A, 2B, and 4-5 illustrate stop mechanisms that can ensure that none of the components of the SM 200 are completely unthreaded before the next component is advanced, as described in more detail below. FIG. 4 illustrates a perspective view of the drive shaft 210 and inner screw 220, allowing visibility of the inner surface 222 of the inner screw 220. In some embodiments, the inner screw 220 includes an interruption in the inner surface 222 to accept the stop mechanism. The stop mechanism functions regardless of which component is longitudinally advanced first, for example, the inner screw 220 or the pusher 230. In some embodiments, the interruption includes an insertion plug 228 configured to interrupt the inner surface 222, specifically the threads of the inner surface 222. In some embodiments, the protrusion 218 of the drive shaft 210 terminates in a vertical wall 219. Rotation of the drive shaft 210 can drive the inner screw 220 longitudinally forward relative to the drive shaft 210. As the inner screw 220 advances longitudinally along the drive shaft 210, the distance between the projection 218 and the plug 228 decreases until the vertical wall 219 contacts the plug 228, thereby preventing further longitudinal advancement of the inner screw 220. The plug 228 may be inserted after the inner screw 220 and drive shaft 210 are fully threaded during assembly.

[0027] FIG. 5 shows a perspective view of the inner screw 220 and pusher 230, allowing visibility of the inner surface 232 of the pusher 230. Similar to FIG. 4, the pusher 230 can include an interruption in the inner surface 232 to accept a stop mechanism. The stop mechanism operates regardless of which component longitudinally advances first, for example, the inner screw 220 or the pusher 230. In some embodiments, the interruption includes an insertion plug 238 configured to interrupt the inner surface 232, specifically the threads of the inner surface 232. In some embodiments, the protrusion 224 of the inner screw 220 terminates in a vertical surface 226. Rotation of the drive shaft 210 can rotate the inner screw 220. Rotation of the inner screw 220 can drive the pusher 230 longitudinally forward relative to the inner screw 220. As the pusher 230 advances longitudinally along the inner threads 220, the distance between the projection 224 and the plug 238 is reduced until the vertical surface 226 contacts the plug 238, thereby preventing further longitudinal advancement of the pusher 230. The plug 238 may be inserted after the pusher 230 and inner threads 220 are fully threaded during assembly.

[0028] Generally, the expected behavior based on the nominal geometry is that the smaller diameter part will extend first due to the lower torque requirement. Figure 6 illustrates a scenario in which the inner screw 220 advances first, rather than the pusher 230. For example, due to relative drive torque, the drive shaft 210 can rotate relative to the inner screw 220, which does not rotate relative to the pusher 230, advancing the inner screw 220 longitudinally (and carrying the pusher 230 with it). Here, the distal end of the inner screw 220 remains in contact with the inner surface 236 of the end 234 of the pusher 230 as the two parts advance translationally or longitudinally relative to the drive shaft 210, as shown in Figure 6. Separation between the inner thread 220 and the pusher 230 occurs when the vertical wall 219 of the protrusion 218 of the drive shaft 210 collides with the side wall of the plug 228 within the inner surface 222 of the inner thread 220, initiating longitudinal advancement of the pusher 230 along the second thread of the pusher 230. In some embodiments, as the drive shaft 210 rotates, the inner thread 220 advances longitudinally relative to the drive shaft 210 until the vertical wall 219 of the protrusion 218 of the drive shaft 210 collides with the side wall of the plug 228 within the inner surface 222 of the inner thread 220. In some embodiments, after the vertical wall 219 of the protrusion 218 of the drive shaft 210 collides with the side wall of the plug 228 within the inner surface 222 of the inner thread 220, rotation of the drive shaft 210 can cause rotation of the inner thread 220, thereby initiating longitudinal advancement of the pusher 230 relative to the inner thread 220. Specifically, in some embodiments, contact between the plug 228 within the inner surface 222 of the inner thread 220 and the vertical wall 219 of the protrusion 218 of the drive shaft 210 increases the drive torque of the inner thread 220 / drive shaft 210. As an example, contact between the protrusion 218 and the plug 228 can tighten the fit between the inner thread 220 and the drive shaft 210. Such tightening can make the drive torque of the inner thread 220 / drive shaft 210 greater than the drive torque of the pusher 230 / inner thread 220.Thus, continued rotation of the drive shaft 210 can cause the drive shaft 210 and the inner thread 220 to rotate together, and relative rotation of the inner thread 220 with respect to the pusher 230 can cause the pusher 230 to advance longitudinally relative to the inner thread 220. Longitudinal advancement of the pusher 230 along the second thread continues until the plunger 400 has displaced all of the agent within the reservoir 104. In some embodiments, longitudinal advancement of the pusher 230 along the second thread continues until the distal end of the plunger 400 reaches the distal end of the reservoir. In some embodiments, longitudinal advancement of the pusher 230 along the second thread continues until the vertical surface 226 of the protrusion 224 of the inner thread 220 abuts the sidewall of the plug 238 within the inner surface 232 of the pusher 230. FIG. 2B shows an example of a pusher 230 that advances longitudinally relative to an inner screw 220 that advances longitudinally relative to a drive shaft 210 .

[0029] In some embodiments, as shown in FIG. 7 , the pusher 230 may be first longitudinally advanced before the inner screw 220. For example, due to relative drive torque, the inner screw 220 can rotate relative to the pusher 230 while the drive shaft 210 does not rotate relative to the inner screw 220, advancing the pusher 230 longitudinally. In some embodiments, the pusher 230 includes an interruption in the inner surface 232. As shown in FIGS. 6 and 7 , the pusher 230 includes an insertion plug 238 configured to interrupt the inner surface 232, particularly the threads of the inner surface 232. The plug 228 can be inserted after the pusher 230 and inner screw 220 are fully threaded during assembly. As mentioned above, the protrusion 224 of the inner screw 220 terminates in a vertical surface 226. In this configuration, the pusher 230 can advance longitudinally relative to the inner thread 220 until the sidewall of the plug 238 abuts the vertical surface 226 of the protrusion 224 of the inner thread 220, initiating advancement along the second thread of the inner thread 220. In some embodiments, after the vertical surface 226 of the protrusion 224 of the inner thread 220 abuts the sidewall of the plug 238 within the inner surface 232 of the pusher 230, the drive shaft 210 can rotate relative to the inner thread 220, thereby initiating longitudinal advancement of the inner thread 220 relative to the drive shaft 210. Specifically, in some embodiments, contact between the plug 238 within the inner surface 232 of the pusher 230 and the vertical wall 226 of the protrusion 224 of the inner thread 220 increases the drive torque of the pusher 230 / inner thread 220. As an example, contact between the protrusion 224 and the plug 238 can tighten the engagement between the inner thread 220 and the pusher 230. Such tightening can cause the drive torque of the pusher 230 / internal thread 220 to be greater than the drive torque of the internal thread 220 / drive shaft 210. Thus, as rotation of the drive shaft 210 continues, the drive shaft 210 can rotate relative to the internal thread 220, and the relative rotation of the drive shaft 210 relative to the internal thread 220 can longitudinally advance the internal thread 220 relative to the drive shaft 210. The longitudinal advancement of the pusher 230 along the second thread continues until the plunger 400 has displaced all of the agent within the reservoir 104.In some embodiments, longitudinal advancement of pusher 230 along the second thread continues until the distal end of plunger 400 reaches the distal end of the reservoir. In some embodiments, longitudinal advancement of inner thread 220 along the second thread continues until vertical wall 219 of protrusion 218 of drive shaft 210 collides with a side wall of plug 228 within inner surface 222 of inner thread 220. FIG. 2B shows an example of pusher 230 advancing longitudinally relative to inner thread 220, which in turn advances longitudinally relative to drive shaft 210.

[0030] FIG. 8 illustrates a second embodiment of a stop mechanism between the drive shaft 210 and the inner screw 250, where the inner screw 250 is an alternative embodiment to the inner screw 220. The proximal end of the inner screw 250 may include a cantilever 254, the distal surface of which includes a vertical surface 258. The inner surface 252 of the inner screw 250 may include a single continuous thread interrupted only by a slot 251 and a ramp 259, as a replacement for the plug 228 to interrupt the inner surface 252. During assembly, the drive shaft 210 is threaded onto the inner screw 250, and the protrusion 218 is configured to engage and deform the cantilever 254 until the vertical wall 219 of the protrusion 218 of the drive shaft 210 clears the vertical surface 258 of the inner screw 250. The drive shaft 210 and inner screw 250 can now be assembled into a collapsed position similar to the configuration shown in FIG. 2A. Once the device is assembled and torque is applied to the drive shaft 210, the inner screw 220 can advance longitudinally along the drive shaft 210 until the vertical wall 219 of the drive shaft 210 impacts the vertical face 258 of the cantilever beam 254. As described in the previous embodiment, after contact between the vertical wall 219 of the drive shaft 210 and the stop mechanism of the inner screw 250, in this case the vertical face 258 of the cantilever beam 254, rotation of the drive shaft 210 can cause rotation of the inner screw 250. The pusher 230 can then begin to advance longitudinally until the reservoir 104 is emptied of medication. Alternative designs for the stop mechanism for the drive shaft 210 and inner screw 250 can be a swage, heat crimp, or clip after the parts are threaded together.

[0031] According to an exemplary embodiment, the length of SM 200 is dimensioned so that the inner threads 220 and body 235 of pusher 230 are all contained within housing 240 when all of the telescoping threads are telescopic or collapsed. In some embodiments, each of the telescoping threads is a desired length. The desired length corresponds to the potential extension length of pusher 230 relative to outer housing 240.

[0032] 9A-9B show transparent cross-sectional views of SM 300 in respective mated and extended positions according to some aspects of the present disclosure. In the nested position, as shown in FIG. 9A, SM 300 includes four main components aligned about longitudinal axis X: drive shaft 310, inner thread 320, outer thread 330, and pusher 340, collectively referred to as a telescoping screw member. Outer thread 330 can be a housing that at least partially houses drive shaft 310, inner thread 320, and pusher 340. In some embodiments, each of the three main components includes the same longitudinal centerline (e.g., axis X). In some embodiments, drive shaft 310 is disposed laterally within inner thread 320, which is disposed at least partially laterally within pusher 340, which is disposed laterally within outer thread 330. The extended position, shown in FIG. 9B, more clearly illustrates how each component is connected. Specifically, drive shaft 310 is shown having a first portion 311 extending longitudinally from second portion 312. While in the nested position, first portion 311 is internal to internal threads 320, and the internal surface of internal threads 320 engages with first portion 311 such that rotation of drive shaft 310 induces rotation of internal threads 320. In some embodiments, the internal surface of internal threads 320 includes an internal keying feature that corresponds to the external keying feature on the external surface of first portion 311 to facilitate this engagement. The engagement between drive shaft 310 and internal threads 320 can be such that rotation of the drive shaft induces rotation of internal threads 320 (e.g., internal threads 320 do not rotate relative to drive shaft 310), but internal threads 320 are longitudinally advanceable relative to drive shaft 310. For example, in some embodiments, the external keying feature of the first portion 311 of the drive shaft 310 can slide longitudinally within the internal keying feature of the internal threads 320, but cannot rotate out of engagement with the internal keying feature of the internal threads 320.

[0033] The second portion 312 is provided at the proximal end of the drive shaft 310, and the second portion 312 externally engages the outer threads 330. In some embodiments, the outer threads 330 include a proximal section 331 and a distal section 332. In some embodiments, the proximal section 331 has a circular diameter. In some embodiments, the distal section 332 has a non-circular diameter. In some embodiments, approximately half of the distal portion 332 of the outer threads 330 is disposed within the reservoir 104. That is, the proximal end of the reservoir 104 is disposed between the distal and proximal ends of the distal section 332 of the outer threads 330. As shown in FIG. 9B , the outer threads 330 include an annular recess 333 at the proximal end of the proximal section 331, and the recess 333 is configured to engage with one or more members 313 extending from the second portion 312 of the drive shaft 310. In some embodiments, the one or more members 313 include a snap feature. One or more members 313 extend laterally from second portion 312 and curve over the distal end of outer threads 330 to seat within recess 333, creating a snap-fit ​​engagement between member 313 and the distal side of a circumferential protrusion formed by recess 333. Such snap-fit ​​engagement can allow drive shaft 310 to rotate about outer threads 330 but not extend longitudinally from outer threads 330 due to engagement with recess 333.

[0034] The outer threads 330 further comprise an inner surface 334 configured to engage with the inner threads 320. As shown in FIG. 9B , the inner threads 320 include a wide section 321 and a narrow section 322, where the outer diameter of the wide section 321 is greater than the outer diameter of the narrow section 322. In some embodiments, the wide section 321 includes a wide outer surface 323 configured to engage with the inner surface 334 of the outer threads 330, such that rotation of the inner threads 320 due to an applied torque facilitates longitudinal advancement of the inner threads 320 along the axis X at a first rate. In some embodiments, the wide outer surface 323 of the inner threads 320 includes a first thread and the inner surface 334 of the outer threads 330 includes a corresponding second thread. In some embodiments, the corresponding threads enable longitudinal advancement of the inner threads 320 along the outer threads by rotation of the inner threads 320.

[0035] 10 , in some embodiments, narrow section 322 of inner thread 320 includes narrow outer surface 324, which is configured to engage inner pusher surface 341 of pusher 340. In some embodiments, narrow outer surface 324 of inner thread 320 is configured to engage inner pusher surface 341 of pusher 340 such that rotation of inner thread 320 due to applied torque advances pusher 340 longitudinally along axis X. In some embodiments, narrow outer surface 324 of inner thread 320 includes a first thread, and inner pusher surface 341 of pusher 340 includes a corresponding second thread. In some embodiments, the corresponding threads enable longitudinal advancement of pusher 340 along inner thread 320 by rotation of inner thread 320. In some embodiments, the first thread on the narrow outer surface 324 of the inner thread 320 is counter-threaded relative to and has the same pitch as the first thread on the wide outer surface 323 of the inner thread 320, and the corresponding second thread on the inner pusher surface 341 of the pusher 340 is counter-threaded relative to and has the same pitch as the corresponding second thread on the inner surface 334 of the outer thread 330. In such a configuration, the pusher 340 advances longitudinally relative to the inner thread 320 at the same time that the inner thread 320 advances longitudinally relative to the drive shaft 310 and outer thread 330. In such a configuration, the inner thread 320 can rotate relative to the outer thread 330 and the pusher 340 at the same time that the inner thread 320 advances longitudinally relative to the drive shaft 310 and outer thread 330. With this configuration, the inner thread 320 advances longitudinally along the outer thread 330 the same amount at the same time that the pusher 340 advances longitudinally along the inner thread 320. The inner screw 320 and the pusher 340 advance in the same direction towards the reservoir. In some embodiments, the outer screw 330 is fixed with the body of the pen.9A-10 can allow for (a) simultaneous advancement of inner thread 320 toward the reservoir relative to outer thread 330 (by relative rotation of wide section 321 of inner thread 320 relative to outer thread 330) upon rotation of drive shaft 310, and (b) simultaneous advancement of pusher 340 toward the reservoir by relative rotation of narrow section 322 of inner thread 320 relative to pusher 340. In this arrangement, the torque is constant and does not change.

[0036] According to an exemplary embodiment, the length of the SM 300 is dimensioned so that when the telescoping screw members (e.g., drive shaft 310, inner screw 320, and pusher 340) are all telescoping or collapsed, the inner screw 320 and the body 345 of the pusher 340 are contained within the outer screw 330. In some embodiments, each of the telescoping screw members is a desired length. The desired length corresponds to the potential longitudinal extension length of the pusher 340 relative to the outer screw 330. Because the pusher 340 and inner screw 320 advance longitudinally simultaneously, the non-circular end 342 of the pusher 340 can reach the distal end of the reservoir 104 without the proximal end of the pusher 340 reaching the distal end of the inner screw 320, thereby preventing the pusher 340 and inner screw 320 from unthreading.

[0037] 1D , at a distal end of the body 345 that engages the plunger 400. In some embodiments, the non-circular end 342 comprises a shape that corresponds to the shape of the interior of the reservoir 104. The shape of the non-circular end 342, which corresponds to the shape of the non-circular body 1002 as shown in FIG. 11 , constrains the pusher 340 within the reservoir 104 to prevent rotation such that torque applied to the inner threads 320 cannot be transmitted to the pusher 340, but rather facilitates the pusher 340 extending longitudinally along the axis X from the narrow section 322 of the inner threads 320 at the second speed. In some embodiments, the first advancement rate of the inner thread 320 and the second longitudinal advancement rate of the pusher 340 can be modified by changing the pitch of at least one of (a) the corresponding thread between the wide section 321 of the inner thread 320 and the outer thread 330, or (b) the corresponding thread between the inner thread 320 and the narrow section 322 of the pusher 340.

[0038] FIG. 11 shows a front view of a delivery pen according to some aspects of the present disclosure. In some embodiments, the pusher 230 includes a non-circular end 234 (shown in FIG. 7 ), which corresponds to the shape of the non-circular body 1002 and can engage the plunger 400. In some embodiments, the non-circular end 234 has a shape that corresponds to the shape of the interior of the reservoir 104. The shape of the non-circular end 234 constrains the pusher 230 within the reservoir 104 and prevents its rotation such that torque applied to the inner screw 220 cannot be transmitted to the pusher 230, but rather facilitates the pusher 230 extending longitudinally along the axis X at the second speed. In some embodiments, the first advancement speed of the inner screw 220 and the second advancement speed of the pusher 230 can be modified by changing the pitch of corresponding threads between at least one of (a) the drive shaft 210 and the inner screw 220, or (b) the inner screw 220 and the pusher 230.

[0039] 12A-12B show perspective views of the TCC 500 alone and assembled with an SM 200, respectively, in accordance with some aspects of the present disclosure. The engagement between the TCC 500 and the SM 200 is specifically described below, but it should be understood that the same description applies equally to the engagement between the TCC 500 and the SM 300. In some embodiments, the TCC 500 is driven by another rotating component, such as the dose knob 102 of the delivery pen 10, when a button (not shown) at the proximal end of the delivery pen 10 or other delivery method is pressed. In some embodiments, the TCC 500 includes one or more axial slots 501 configured to mate with one or more of the members 211 of the drive shaft 210 (or, in the case of the SM 300, the members 313 of the drive shaft 310) such that torque applied to the TCC 500 is transmitted to the SM 200. Rotation of the drive shaft 210 facilitates axial slidable advancement through one or more axial slots 501 until member 211 of the drive shaft 210 contacts the bottom of the slot 501 of the TCC 500, preventing disassembly of the drive shaft 210 and TCC 500. In some embodiments, one or more ratchet arms 502 are disposed on the inner surface of the TCC 500. During dose setting, the TCC 500 is pulled back or pushed forward along the drive shaft 210 by rotation of the dose knob 102 to set the desired dose size. In some embodiments, the TCC 500 includes a plurality of teeth 503 on its proximal end. The teeth 503 interact with corresponding ratchet arms of a double clicker component (not shown) sandwiched between the TCC 500 and the dose knob 102. In some embodiments, the teeth 503 produce an audible and tactile "click" noise when the user dials, corrects, or dispenses the dose. The double clicker component facilitates load transmission during button press at the proximal end of the dose knob 102 to move the TCC 500.

[0040] Because the size and form factor of the SMs 200, 300 and reservoir 104 have been reduced, the delivery pen 10 can be designed for additional features incorporating further functionality. In some embodiments, with reference to FIG. 13 , the delivery pen 10 further comprises one or more storage compartments 106. In some embodiments, the one or more storage compartments 106 may have an arrow shape. The storage compartments 106 can be designed to maintain manageable dimensions for the delivery pen 10. In some embodiments, the storage compartment 106 is configured to fit one or more additional pen needle assemblies 107, each of the one or more pen needle assemblies further comprising a needle shield 108. In some embodiments, the storage compartment 106 further comprises one or more of a press-in cap or hinge (not shown) for covering the one or more additional pen needle assemblies 107. In some embodiments, the storage compartment 106 is configured to fit an additional medication (not shown) for delivery. In some embodiments, the storage compartment 106 is formed as part of the cap 101 so as to extend the longitudinal length of the cap 101 at the distal end of the delivery pen 10, as shown in Figure 14. In some embodiments, the storage compartment 106 extends longitudinally at the proximal end of the delivery pen (not shown).

[0041] In some embodiments, an additional feature that may be incorporated as a result of the reduced size is an electronic component or module. In some embodiments, one or more electronic components or modules may be coupled to the delivery pen 10. In some embodiments, one or more electronic components may be mounted to the delivery pen 10 in an electronics storage compartment (not shown). In some embodiments, one or more electronic components may be electrically and communicatively coupled to each other within the electronics storage compartment. In some embodiments, the electronic component may include a dose capture device including a microcontroller electrically coupled to other electronic components. In some embodiments, the one or more electronic components may include a battery, a gyroscope, a force sensor, a controller, network interface hardware, and / or other electronic modules. In some embodiments, the battery may be a coin cell battery. In some embodiments, the battery is designed to provide power to run the systems of the dose capture device for a determined lifetime of the dose capture device. In some embodiments, the battery is a rechargeable battery connected to a charging port (not shown).

[0042] In some embodiments, the delivery pen 10 may be disposable. In some embodiments, the reservoir 104 may contain a drug supply to be administered to a patient. In some embodiments, the reservoir 104 may have a capacity of up to 6 mL. In some embodiments, as shown in FIG. 3 , the pusher 230 optionally includes one or more openings 233. In some embodiments, one or more of the openings 233 allow air to flow around the perimeter to fill voids after the plunger 400 moves. In some embodiments, the pusher 230 includes one or more openings 233 in the non-circular end 234. The opening feature can facilitate higher delivery rates by providing a more open flow path. One or more of the openings 233 serve as an assembly aid to allow the outer housing 240 to be pressed onto the body 100 of the delivery pen 10, which can help reduce pressing and possible bending forces on the pusher 230 that could cause damage or failure. In some embodiments, as shown in FIG. 10, pusher 340 optionally includes one or more openings 343 similar to openings 233 of pusher 230.

[0043] In some embodiments, the body 100 may provide a gripping surface for a user to grasp when administering a medication to a patient. In some embodiments, the delivery pen includes a dose knob 102 disposed at a proximal end of the body 100. The dose knob 102 may be rotatable relative to the body 100 of the delivery pen 10. In some embodiments, a user may rotate the dose knob 102 to selectively set a desired amount of medication to be injected into a patient. In some embodiments, rotation of the dose knob 102 in a first direction may adjust and decrease the amount of rotation achievable by the drive shaft 210, thereby decreasing the volume of the dose of medication administered with the delivery pen 10. In some embodiments, rotation of the dose knob 102 in a second direction may adjust and increase the amount of rotation achievable by the drive shaft 210, thereby increasing the volume of the dose of medication administered with the delivery pen 10. In some embodiments, a button 109 may be coupled to the proximal end of the dose knob 102. A user can apply an axial force to the button 109 to depress the button 109 and dose knob 102 axially toward the proximal end of the body 100, thereby actuating the SM 200, 300 to dispense a dose from the delivery pen 10. In some embodiments, a delivery method using at least one of a motor and a mechanical automation system may be coupled to the proximal end of the dose knob 102 such that the delivery method depresses the dose knob 102 axially toward the body 100 to actuate the SM 200 to dispense a dose of medication from the delivery pen 10.

[0044] It should be appreciated that the dose knob 102 can control the telescoping screw to incrementally move the telescoping screw from a fully retracted position to the fully extended position shown, moving the plunger 400 and delivering a respective specified dose of fluid from the reservoir 104. The TCC 500 rotates the drive shaft 210, 310 on the SM 200, 300. The TCC 500 can have different configurations. For example, the TCC 500 can also be in the form of a ratchet indexing mechanism or other indexing mechanism that precisely rotates the drive shaft 210, 310 a mechanically controlled amount. The TCC 500 and drive shaft 210 of the SM 200 (or drive shaft 310 of the SM 300) can be attached to one another.

[0045] The configuration of the SM200, 300 components relative to the reservoir 104 and plunger 400 realizes several advantages. For example, having the SM200, 300 attached to the proximal end of the reservoir 104 and having a nested configuration that does not extend into the reservoir 104 until the drive shaft 210, 310 rotates optimizes the use of the reservoir 104 for fluid delivery, eliminating the need to accommodate pen components prior to delivery. Additionally, the overall length of the reservoir 104 can be substantially the same as the length of the cap 101 and body 100 by adding a small amount of headspace to accommodate the connection of the TCC 500 to the drive shaft 210, 310. Thus, the overall footprint of the SM200, 300 is minimized, as is the longitudinal axis dimension of the overall delivery pen 10. Use of the plunger 400 and SM200, 300 design also minimizes contact of the SM200, 300 with the fluid being delivered, ensuring biocompatibility between the fluid and the body 100. The exemplary embodiment described herein uses a telescoping screw of appropriate size and thread configuration to achieve controlled movement of the non-circular reservoir plunger 400. The screw technology is well-defined and understood, allowing for repeatable, powerful movement. When driven by the TCC 500 with appropriate resolution and controlled movement, the telescoping screw member can provide precise movement under virtually all environmental conditions. Furthermore, the drive mechanism (e.g., SM 200, 300) does not affect the base volume of the reservoir 104 where the drug resides, thus eliminating compatibility issues.

[0046] The reservoir 104 can be configured to be durable, i.e., not removable, but rather pre-installed within the body 100. The reservoir 22 can be of a material similar to a syringe and associated stopper. The reservoir 104 can be pre-filled, with the SMs 200, 300 initially in a retracted position. The fill port can be configured for a user to fill with a syringe or for use with a fill station that fluidly couples to the fill port.

[0047] The drive and delivery mechanisms of the delivery pen 10 should be understood by those skilled in the art and therefore will not be described in detail herein. However, in general, distal depression of the button and dose knob 102 injects the administered medication via the SMs 200, 300 and plunger 400 through the reservoir 104 contained within the delivery pen 10. Distal movement of the plunger 400 within the reservoir 104 forces the medication into the needle 103. The reservoir 104 may be sealed by a septum (not shown) that may be punctured by the needle. In some embodiments, the pen needle may be threaded into the reservoir 104, although other attachment means may be used. It should be understood that the foregoing description is merely one representative example of a delivery pen 10, and that other designs of the delivery pen 10 are contemplated herein. In some embodiments, the dose knob 102 is coupled to an electronic or “smart” dose capture device. In some embodiments, the “smart” dose capture device includes wireless functionality that allows for transfer of dose information to an external wireless device.

[0048] The technical solution of the example embodiment is based on a basic screw drive mechanism in which lifting torque is a function of applied axial load (force or pressure), thread pitch, friction parameters, and diameter. In some cases, the equations can be further expanded to incorporate thread profile details such as flank and lead angles, as well as many other specialized parameters. Industry-standard ACME thread sizes can generally be used to balance lifting torque, required power, efficiency, and other functional parameters such as smoothness of operation and cost. Other thread profiles, such as buttress threads, can also be used to precisely control load transfer and minimize dosing errors. Each screw design can affect torque, so modifications must be made to accommodate the capabilities of the motor and gearbox or index drive subsystem.

[0049] No delivery pens use this type of mechanism. This design offers significant space savings while trading off some mechanical losses. This space savings significantly opens up the design space for new drug delivery pumps with the promise of high delivery accuracy. The design of the exemplary embodiments of the present disclosure can be complemented with a ratcheting or indexing drive transmission to further improve motion resolution and provide precise drug delivery.

[0050] Non-limiting embodiments of the present disclosure are described in the following clauses.

[0051] Clause 1. A delivery pen comprising: a reservoir having a non-circular shape; a plunger disposed within the reservoir; a screw mechanism at least partially inserted within the reservoir, the screw mechanism comprising: a drive shaft having one or more protrusions at a proximal end and an elongated member extending longitudinally from the proximal end; an internal thread concentrically engaging the elongated member; an outer housing having a circular section rotatably engaging the one or more protrusions and a non-circular section sized to fit within the reservoir; and a pusher disposed between the internal thread and the outer housing for linearly translating the plunger to dispense medicament from the reservoir.

[0052] Clause 2. The delivery pen of Clause 1, further comprising a first protrusion toward the distal end of the outer surface of the elongated member and a first interruption toward the proximal end of the inner surface of the inner screw, the first protrusion configured to engage with the first interruption as the inner screw advances longitudinally along the drive shaft.

[0053] Clause 3. A delivery pen as described in clause 1 or 2, wherein the first protrusion and the first interruption are positioned so that they are maximally separated when the drive shaft is fully nested within the inner thread.

[0054] Clause 4. The delivery pen of any of clauses 1-3, wherein the first protrusion includes a screw thread and the first interruption includes an inserted plug.

[0055] Clause 5. A delivery pen described in any of clauses 1 to 4, further comprising a second protrusion toward the distal end of the outer surface of the inner screw and a second interruption toward the proximal end of the inner surface of the front pusher, the second protrusion configured to engage with the second interruption as the pusher advances longitudinally along the inner screw.

[0056] Clause 6. A delivery pen described in any of clauses 1 to 5, wherein the second protrusion portion and the second interruption portion are positioned so that they are most separated when the inner screw is fully nested within the pusher.

[0057] Clause 7. The delivery pen of any of clauses 1-6, wherein the second protrusion comprises a screw thread and the second interruption comprises an inserted plug.

[0058] Clause 8. A delivery pen described in any of clauses 1 to 7, wherein the drive shaft includes a first thread at the distal end of the outer surface of the elongated member, the internal screw includes a second thread on the inner surface of the internal screw, the first thread and the second thread being engaged so that the internal screw can advance longitudinally by rotation of the drive shaft, the internal screw includes a third thread at the distal end of the outer surface of the internal screw, and the pusher includes a fourth thread on the inner surface of the pusher, the third thread and the fourth thread being engaged so that the pusher can advance longitudinally by rotation of the internal screw.

[0059] Clause 9. A delivery pen described in any of clauses 1 to 8, wherein the first thread and the third thread are threads in the same direction as each other, and the second thread and the fourth thread are threads in the same direction as each other.

[0060] Clause 10. A delivery pen described in any of clauses 1 to 9, wherein the inner thread includes a wide section and a narrow section extending longitudinally from the wide section, the outer housing is an outer thread concentrically engaged with at least a portion of the wide section, and the pusher is positioned between the narrow section of the inner thread and the outer thread.

[0061] Clause 11. A delivery pen as described in any of clauses 1 to 10, wherein the diameter of the narrow section is smaller than the diameter of the wide section such that rotation of the inner screw causes the pusher to extend from the inner screw at a first speed and the inner screw to extend from the outer screw at a second speed, the first speed being greater than the second speed.

[0062] Clause 12. A delivery pen described in any of clauses 1 to 11, further comprising a torque-coupling component configured to at least partially receive the screw mechanism, and a dose knob configured to rotate the torque-coupling component when the dose knob is depressed.

[0063] Clause 13. A delivery pen as described in any of clauses 1 to 12, further comprising a dose capture device configured to measure a dose size to be dispensed from the delivery pen, the dose capture device being removably coupled to the torque coupling component.

[0064] Clause 14. A delivery pen according to any of clauses 1 to 13, wherein the non-circular shape corresponds to the shape of the plunger so as to allow unhindered movement.

[0065] Clause 15. A delivery pen described in any of clauses 1 to 14, wherein the pusher is positioned between the plunger and the distal end of the inner screw, the pusher abutting the proximal side of the plunger and configured to move along the longitudinal axis of the reservoir in response to rotation of the inner screw.

[0066] Clause 16. A delivery pen described in any of clauses 1 to 15, wherein the length of the screw mechanism is dimensioned so that the inner screw and the body of the pusher are contained within the outer housing when the inner screw and the pusher are nested or folded.

[0067] Clause 17. A delivery pen described in any of clauses 1 to 16, further comprising a torque coupling component configured to at least partially receive the screw mechanism, the torque coupling component having one or more internal axial slots at a proximal end thereof, the torque coupling component preventing the drive shaft from disengaging from the torque coupling component when the one or more protrusions translate through the one or more internal axial slots.

[0068] Clause 18. A delivery pen described in any of clauses 1 to 17, wherein the pusher includes a non-circular distal end configured to engage with the plunger, the non-circular distal end corresponding to the non-circular shape of the reservoir to prevent rotation of the pusher within the reservoir.

[0069] Clause 19. A delivery pen comprising: a reservoir having a non-circular shape; a plunger disposed within the reservoir; and a screw mechanism at least partially inserted within the reservoir, the screw mechanism comprising: a drive shaft having one or more projections at a proximal end and an elongated member extending longitudinally from the proximal end; an inner thread concentrically engaging the elongated member, the inner thread having a wide section and a narrow section extending longitudinally from the wide section; an outer thread concentrically engaging the wide section, the outer thread having a circular section rotatably engaging the one or more projections and a non-circular section sized to fit within the reservoir; and a pusher disposed between the narrow section and the outer thread for linearly translating a plunger to dispense medicament from the reservoir.

[0070] Clause 20. The delivery pen of clause 19, wherein the diameter of the narrow section is smaller than the diameter of the wide section such that rotation of the inner screw causes the pusher to extend from the inner screw at a first speed and the inner screw to extend from the outer screw at a second speed, the first speed being greater than the second speed.

[0071] Clause 21. A delivery pen as described in clause 19 or 20, further comprising a torque coupling part configured to at least partially receive the screw mechanism, and a dose knob configured to rotate the torque coupling part when the dose knob is depressed.

[0072] Clause 22. A delivery pen as described in any of clauses 19 to 21, further comprising a dose capture device configured to measure a dose size to be dispensed from the delivery pen, the dose capture device being removably coupled to the torque coupling component.

[0073] Clause 23. A delivery pen according to any of clauses 19 to 22, wherein the non-circular shape corresponds to the shape of the plunger so as to allow unhindered movement.

[0074] Clause 24. A delivery pen described in any of clauses 19 to 23, wherein the pusher is positioned between the plunger and the distal end of the inner screw, the pusher abutting the proximal side of the plunger and configured to move along the longitudinal axis of the reservoir in response to rotation of the inner screw.

[0075] Clause 25. A delivery pen described in any of clauses 19 to 24, wherein the length of the screw mechanism is dimensioned so that the inner screw and the body of the pusher are contained within the outer screw when the inner screw and the pusher are nested or folded.

[0076] Clause 26. A delivery pen described in any of clauses 19 to 25, further comprising a torque coupling component having an internal axial slot shaped to mate with one or more protrusions of the drive shaft, the torque coupling component having one or more slots at its proximal end to prevent the drive shaft from disengaging from the torque coupling component when the one or more protrusions translate through the internal axial slot.

[0077] Clause 27. A delivery pen described in any of clauses 19 to 26, wherein the pusher includes a non-circular distal end configured to engage with the plunger, the non-circular distal end corresponding to the non-circular shape of the reservoir to prevent rotation of the pusher within the reservoir.

[0078] Clause 28. A delivery pen described in any of clauses 19 to 27, wherein the wider section of the inner screw includes a first thread on an outer surface of the wider section, the outer screw includes a second thread on an inner surface of the outer screw, the first thread and the second thread engaged so as to allow longitudinal advancement along the outer screw by rotation of the inner screw, the narrower section of the inner screw includes a third thread on an outer surface of the narrower section of the inner screw, and the pusher includes a fourth thread on an inner surface of the pusher, the third thread and the fourth thread engaged so as to allow longitudinal advancement of the pusher by rotation of the inner screw.

[0079] Clause 29. A delivery pen described in any of clauses 19 to 28, wherein the first thread and the third thread are threads in opposite directions to each other, and the second thread and the fourth thread are threads in opposite directions to each other.

[0080] Clause 30. A delivery pen, comprising: a body; a cap engaged to the body; a torque coupling component housed with the body, the torque coupling component having an internal axial slot; a screw mechanism, the drive shaft having a proximal end and an elongated member extending distally from the proximal end, the proximal end of the drive shaft comprising one or more protrusions configured to mate with the internal axial slot of the torque coupling component; an internal screw concentrically engaging the elongated member and comprising a first external screw thread; an outer housing having a circular section and a non-circular section, the proximal end of the circular section comprising a recess configured to engage with the one or more protrusions such that the drive shaft can rotate about the recess but cannot extend longitudinally from the recess; and a pusher, the inner surface of the pusher configured to mate with the first external screw thread of the internal screw. a screw mechanism comprising a pusher having an internal screw thread; a reservoir contained within the cap, the reservoir including a non-circular shape, an outlet port at a distal end, and a plunger movable along a longitudinal axis of the reservoir, the plunger configured to engage the distal end of the pusher and provide a seal against an inner wall of the reservoir to prevent fluid provided in a fluid chamber defined in a first side of the plunger from leaking into a portion of the reservoir defined by a second side of the plunger; and a dose knob engaged with the torque coupling element, the dose knob rotatable relative to the body to adjust a volume of fluid delivery such that rotation of the dose knob in a first direction facilitates axial movement of the drive shaft away from the proximal end of the body, and rotation of the dose knob in a second direction facilitates axial movement of the drive shaft towards the proximal end of the body.

[0081] Clause 31. A delivery pen as described in Clause 30, wherein the inner screw includes a wide section, a narrow section, and an inner surface, the inner surface of the inner screw keyed to engage with the distal end of the drive shaft so that torque applied to the torque coupling component is transmitted to the inner screw, the narrow section including the first outer thread, and the wide section including a second outer thread.

[0082] Clause 32. A delivery pen as described in clause 30 or 31, wherein the outer housing is externally threaded and the circular section of the outer thread comprises an internal thread configured to engage with the second external thread of the internal thread.

[0083] Clause 33. A delivery pen as described in any of clauses 30 to 32, wherein the diameter of the narrow section is smaller than the diameter of the wide section such that rotation of the inner screw causes the pusher to extend from the inner screw at a first speed and the inner screw to extend from the outer screw at a second speed, the first speed being greater than the second speed.

[0084] Clause 34. A delivery pen described in any of clauses 30 to 33, wherein the first external thread and the second external thread are threads of opposite directions, and the internal thread of the pusher and the internal thread of the external screw are threads of opposite directions.

[0085] A delivery pen as described in any of clauses 30 to 34, further comprising a dose capture device configured to measure a dose size to be dispensed from the delivery pen, the dose capture device being removably coupled to the torque coupling component.

[0086] Clause 36. A delivery pen according to any of clauses 30 to 35, wherein the non-circular shape corresponds to the shape of the plunger so as to allow unhindered movement.

[0087] Clause 37. A delivery pen described in any of clauses 30 to 36, wherein the pusher is positioned between the plunger and the distal end of the inner screw, the pusher abutting the proximal side of the plunger and configured to move along the longitudinal axis of the reservoir in response to rotation of the inner screw.

[0088] Clause 38. A delivery pen described in any of clauses 30 to 37, wherein the length of the screw mechanism is dimensioned so that the inner screw and the body of the pusher are contained within the outer housing when the inner screw and the pusher are nested or folded.

[0089] Clause 39. A delivery pen described in any of clauses 30 to 38, wherein the torque coupling component includes one or more slots at a proximal end thereof to prevent the drive shaft from disengaging from the torque coupling component when the one or more protrusions translate through the inner axial slots.

[0090] Clause 40. A delivery pen described in any of clauses 30 to 39, wherein the distal end of the pusher is non-circular, and the non-circular distal end of the pusher corresponds to the non-circular shape of the reservoir to prevent rotation of the pusher within the reservoir.

[0091] Clause 41. A delivery pen described in any of clauses 30 to 40, wherein the drive shaft has a second thread on the outer surface of the elongated member, the internal screw includes a third thread on the inner surface of the internal screw, the second thread and the third thread are engaged so that the internal screw can be advanced longitudinally by rotation of the drive shaft, and the first external thread of the internal screw and the internal thread of the pusher are engaged so that the pusher can be advanced longitudinally by rotation of the internal screw.

[0092] Clause 42. A delivery pen described in any of clauses 30 to 41, wherein the first external thread and the second thread are threads of the same direction as each other, and the third thread and the internal thread of the pusher are threads of the same direction as each other.

[0093] Clause 43. A delivery pen, comprising: a non-circular reservoir; and a threaded mechanism at least partially inserted into said non-circular reservoir, said drive shaft, said proximal end of said drive shaft comprising one or more protrusions; an inner thread including a wide section and a narrow section, an inner surface of said inner thread keyed to engage a distal end of said drive shaft such that torque applied to said drive shaft is transmitted to said inner thread, said wide section including a first external thread and said narrow section including a second external thread; a screw mechanism comprising: an outer screw having a circular section including an inner thread configured to engage the first outer thread, the circular section including an inner thread configured to engage the first outer thread, and a proximal end of the circular section including a recess configured to engage the one or more protrusions such that the drive shaft can rotate about the recess but cannot extend longitudinally from the recess; and a pusher distally configured to engage a plunger, an inner surface of the pusher including an inner thread configured to mate with the second outer thread of the inner screw.

[0094] As used herein, the terms "comprise" and "comprising" are intended to be interpreted as inclusive rather than exclusive. As used herein, the terms "exemplary," "example," and "illustrative" are intended to mean "serving as an example, instance, or illustration" and should not be construed as indicating or not indicating a preferred or advantageous configuration over other configurations. As used herein, the terms "about," "generally," and "approximately" are intended to cover variations that may exist at the upper and lower limits of a range of subjective or objective values, such as variations in properties, parameters, sizes, and dimensions. In one non-limiting example, the terms "about," "generally," and "about" mean variations up or down within 10 percent. In one non-limiting example, the terms "about," "generally," and "approximately" mean close enough to be considered included by one of ordinary skill in the relevant art. As used herein, the term "substantially" refers to the complete or nearly complete extension or extent of an action, characteristic, property, state, structure, item, or result, as understood by one of ordinary skill in the art. For example, an object that is "substantially" circular means that the object is a perfect circle to mathematically determinable limits, or is nearly a circle as recognized or understood by one of ordinary skill in the art. The exact acceptable degree of deviation from absolute perfection may, in some instances, depend on the particular circumstances. However, in general, the proximity of completion will be such that the same overall result would be achieved as if absolute and complete completion had been achieved or had been achieved. The use of "substantially" is equally applicable when used in the negative sense to refer to the complete or nearly complete lack of an action, characteristic, property, state, structure, item, or result, as understood by one of ordinary skill in the art.Use of the term X "or" Y herein should be construed to mean either "X" or "Y" individually, or both "X and Y" together.

[0095] Numerous modifications and alternative embodiments of the present disclosure will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only, and is for the purpose of teaching those skilled in the art the best mode of carrying out the present disclosure. Details of construction may be varied substantially without departing from the spirit of the present disclosure, and the exclusive use of all modifications that come within the scope of the appended claims is reserved. While embodiments have been described herein in a manner that permits a clear and concise specification to be written, it is intended and understood that the embodiments may be combined or separated in various ways without departing from the present disclosure. It is intended that the present disclosure be limited only to the extent required by the appended claims and the rules of applicable law.

[0096] It is also to be understood that the following claims are intended to cover all general and specific features of the disclosure described herein, and all statements of the scope of the disclosure that may be said to fall therebetween, as a matter of language.

Claims

1. 1. A delivery pen comprising: a reservoir having a non-circular shape; a plunger disposed within the reservoir; a threaded mechanism at least partially inserted into the reservoir, a drive shaft having one or more projections at a proximal end and an elongated member extending longitudinally from said proximal end; an internal thread concentrically engaging the elongated member; an outer housing comprising a circular section that rotatably engages the one or more projections and a non-circular section sized to fit within the reservoir; a pusher disposed between the inner screw and the outer housing for linearly translating the plunger to dispense medicament from the reservoir; a screw mechanism comprising: A delivery pen comprising:

2. a first projection on an outer surface of the elongate member toward a distal end thereof; a first interruption toward the proximal end of the inner surface of the internal thread; Furthermore, The delivery pen of claim 1 , wherein the first protrusion is configured to engage the first interruption as the inner screw advances longitudinally along the drive shaft.

3. The delivery pen of claim 2 , wherein the first protrusion and the first interruption are positioned such that they are maximally separated when the drive shaft is fully nested within the internal threads.

4. The delivery pen of claim 2 , wherein the first protrusion comprises a thread and the first interruption comprises an inserted plug.

5. a second projection toward the distal end of the outer surface of the internal screw; a second interruption toward the proximal end of the inner surface of the front pusher; Furthermore, The delivery pen of claim 2 , wherein the second protrusion is configured to engage the second interruption as the pusher advances longitudinally along the internal threads.

6. The delivery pen of claim 5 , wherein the second protrusion and the second interruption are positioned such that they are maximally separated when the inner screw is fully nested within the pusher.

7. The delivery pen of claim 5 , wherein the second protrusion comprises a thread and the second interruption comprises an inserted plug.

8. the drive shaft includes a first thread on a distal end of an outer surface of the elongate member; the internal screw includes a second thread on an interior surface of the internal screw, the first thread and the second thread being engaged such that the internal screw can be advanced longitudinally by rotation of the drive shaft; the internal screw includes a third thread at a distal end of an outer surface of the internal screw; 2. The delivery pen of claim 1, wherein the pusher includes a fourth thread on an inner surface of the pusher, the third thread and the fourth thread being engaged such that the pusher can be advanced longitudinally by rotation of the inner screw.

9. the first thread and the third thread are threads in the same direction as each other, The delivery pen of claim 8 , wherein the second thread and the fourth thread are co-threaded.

10. 2. The delivery pen of claim 1, wherein the inner threads include a wide section and a narrow section extending longitudinally from the wide section, the outer housing is an outer thread that concentrically engages at least a portion of the wide section, and the pusher is disposed between the narrow section of the inner thread and the outer thread.

11. 11. The delivery pen of claim 10, wherein a diameter of the narrow section is smaller than a diameter of the wide section such that rotation of the inner screw causes the pusher to extend from the inner screw at a first speed and the inner screw to extend from the outer screw at a second speed, the first speed being greater than the second speed.

12. a torque coupling component configured to at least partially receive the screw mechanism; a dose knob configured to rotate the torque coupling component upon depression of the dose knob; The delivery pen of claim 1 further comprising:

13. a dose capture device configured to measure a dose size dispensed from the delivery pen; The delivery pen of claim 12 , wherein the dose capture device is removably coupled to the torque coupling component.

14. The delivery pen of claim 1 , wherein the non-circular shape corresponds to the shape of a plunger to allow unimpeded movement.

15. 2. The delivery pen of claim 1, wherein the pusher is disposed between the plunger and a distal end of the internal screw, the pusher abutting a proximal side of the plunger and configured to move along a longitudinal axis of the reservoir in response to rotation of the internal screw.

16. 10. The delivery pen of claim 1, wherein the length of the screw mechanism is dimensioned such that when the inner screw and the pusher are nested or collapsed, the inner screw and the body of the pusher are contained within the outer housing.

17. a torque coupling component configured to at least partially receive the screw mechanism; 2. The delivery pen of claim 1, wherein the torque coupling component comprises one or more internal axial slots at a proximal end thereof to prevent the drive shaft from disengaging from the torque coupling component when the one or more projections translate through the one or more internal axial slots.

18. 10. The delivery pen of claim 1, wherein the pusher includes a non-circular distal end configured to engage the plunger, the non-circular distal end corresponding to the non-circular shape of the reservoir to prevent rotation of the pusher within the reservoir.

19. 1. A delivery pen comprising: a reservoir having a non-circular shape; a plunger disposed within the reservoir; a threaded mechanism at least partially inserted into the reservoir, a drive shaft having one or more projections at a proximal end and an elongated member extending longitudinally from said proximal end; an internal thread concentrically engaging the elongated member, the internal thread including a wide section and a narrow section extending longitudinally from the wide section; an outer thread concentrically engaging the wide section, the outer thread including a circular section that rotatably engages the one or more projections and a non-circular section sized to fit within the reservoir; a pusher disposed between the narrow section and the outer threads for linearly translating the plunger to dispense medicament from the reservoir; a screw mechanism comprising: A delivery pen comprising:

20. 20. The delivery pen of claim 19, wherein a diameter of the narrow section is smaller than a diameter of the wide section such that rotation of the inner screw causes the pusher to extend from the inner screw at a first speed and the inner screw to extend from the outer screw at a second speed, the first speed being greater than the second speed.

21. a torque coupling component configured to at least partially receive the screw mechanism; a dose knob configured to rotate the torque coupling component upon depression of the dose knob; 20. The delivery pen of claim 19, further comprising:

22. a dose capture device configured to measure a dose size dispensed from the delivery pen; 22. The delivery pen of claim 21, wherein the dose capture device is removably coupled to the torque coupling component.

23. 20. The delivery pen of claim 19, wherein the non-circular shape corresponds to the shape of a plunger to allow for unimpeded movement.

24. 20. The delivery pen of claim 19, wherein the pusher is disposed between the plunger and a distal end of the internal screw, the pusher abutting a proximal side of the plunger and configured to move along a longitudinal axis of the reservoir in response to rotation of the internal screw.

25. 20. The delivery pen of claim 19, wherein the length of the screw mechanism is dimensioned such that the inner screw and the body of the pusher are contained within the outer screw when the inner screw and the pusher are nested or collapsed.

26. a torque coupling component having an internal axial slot shaped to mate with one or more projections on the drive shaft; 20. The delivery pen of claim 19, wherein the torque coupling component includes one or more slots at a proximal end thereof to prevent the drive shaft from disengaging from the torque coupling component when the one or more projections translate through the internal axial slots.

27. 20. The delivery pen of claim 19, wherein the pusher includes a non-circular distal end configured to engage the plunger, the non-circular distal end corresponding to the non-circular shape of the reservoir to prevent rotation of the pusher within the reservoir.

28. the wide section of the internal thread includes a first thread on an outer surface of the wide section; the outer thread includes a second thread on an interior surface of the outer thread, the first thread and the second thread engaged such that rotation of the inner thread allows longitudinal advancement along the outer thread; the narrow section of the internal threads includes a third thread on an outer surface of the narrow section of the internal threads; 20. The delivery pen of claim 19, wherein the pusher includes a fourth thread on an inner surface of the pusher, the third thread and the fourth thread being engaged such that the pusher can be advanced longitudinally by rotation of the inner screw.

29. the first thread and the third thread are threads in opposite directions; 29. The delivery pen of claim 28, wherein the second thread and the fourth thread are counter-threads.

30. 1. A delivery pen comprising: The main body and a cap engaged with the body; a torque-coupling element having an internal axial slot, said torque-coupling element being accommodated with said body; A screw mechanism comprising: a drive shaft comprising a proximal end and an elongated member extending distally from the proximal end, the proximal end of the drive shaft comprising one or more protrusions configured to mate with the internal axial slot of the torque coupling component; an internal screw concentrically engaging the elongated member and having a first external thread; an outer housing comprising a circular section and a non-circular section, a proximal end of the circular section comprising a recess configured to engage the one or more protrusions such that the drive shaft can rotate about the recess but cannot extend longitudinally from the recess; a pusher, the inner surface of the pusher comprising an internal thread configured to mate with the first external thread of the internal screw; a screw mechanism comprising: a reservoir contained within the cap, the reservoir including a non-circular shape, an exit port at a distal end, and a plunger movable along a longitudinal axis of the reservoir, the plunger configured to engage a distal end of the pusher and provide a seal against an interior wall of the reservoir to prevent fluid disposed within a fluid chamber defined by a first side of the plunger from leaking into a portion of the reservoir defined by a second side of the plunger; a dose knob engaged with the torque coupling component, the dose knob rotatable relative to the body to adjust a volume of fluid delivery such that rotation of the dose knob in a first direction facilitates axial movement of the drive shaft away from the proximal end of the body and rotation of the dose knob in a second direction facilitates axial movement of the drive shaft towards the proximal end of the body; A delivery pen comprising:

31. the internal threads include a wide section, a narrow section, and an internal surface; the inner surface of the internal thread is keyed to engage a distal end of the drive shaft such that torque applied to the torque coupling component is transmitted to the internal thread; the narrow section includes the first external thread; 31. The delivery pen of claim 30, wherein the wider section comprises a second external thread.

32. the outer housing is externally threaded; 32. The delivery pen of claim 31, wherein the circular section of the outer threads comprises inner threads configured to engage the second outer thread of the inner threads.

33. 33. The delivery pen of claim 32, wherein a diameter of the narrow section is smaller than a diameter of the wide section such that rotation of the inner screw causes the pusher to extend from the inner screw at a first speed and the inner screw to extend from the outer screw at a second speed, the first speed being greater than the second speed.

34. the first external thread and the second external thread are opposite threads; 33. The delivery pen of claim 32, wherein the internal threads of the pusher and the internal threads of the external screw are counter-threads.

35. a dose capture device configured to measure a dose size dispensed from the delivery pen; 31. The delivery pen of claim 30, wherein the dose capture device is removably coupled to the torque coupling component.

36. 31. The delivery pen of claim 30, wherein the non-circular shape corresponds to the shape of a plunger to allow unimpeded movement.

37. 31. The delivery pen of claim 30, wherein the pusher is disposed between the plunger and a distal end of the internal screw, the pusher abutting a proximal side of the plunger and configured to move along a longitudinal axis of the reservoir in response to rotation of the internal screw.

38. 31. The delivery pen of claim 30, wherein the length of the screw mechanism is dimensioned such that when the inner screw and the pusher are nested or collapsed, the inner screw and the body of the pusher are contained within the outer housing.

39. 31. The delivery pen of claim 30, wherein the torque coupling component includes one or more slots at a proximal end thereof to prevent the drive shaft from disengaging from the torque coupling component when the one or more projections translate through the internal axial slots.

40. 31. The delivery pen of claim 30, wherein the distal end of the pusher is non-circular, and the non-circular distal end of the pusher corresponds to the non-circular shape of the reservoir to prevent rotation of the pusher within the reservoir.

41. the drive shaft includes a second thread on an outer surface of the elongated member; the internal screw includes a third thread on an interior surface of the internal screw, the second thread and the third thread being engaged such that the internal screw can be advanced longitudinally by rotation of the drive shaft; 31. The delivery pen of claim 30, wherein the first external thread of the internal screw and the internal thread of the pusher are engaged such that rotation of the internal screw can longitudinally advance the pusher.

42. the first external thread and the second external thread are threads of the same direction; 42. The delivery pen of claim 41, wherein the third thread and the internal thread of the pusher are co-threaded.

43. 1. A delivery pen comprising: a non-circular reservoir; a threaded mechanism at least partially inserted into the reservoir, a drive shaft, the proximal end of the drive shaft comprising one or more prongs; an internal thread including a wide section and a narrow section, an interior surface of the internal thread keyed to engage a distal end of the drive shaft such that torque applied to the drive shaft is transmitted to the internal thread, the wide section including a first external thread and the narrow section including a second external thread; an outer screw comprising a circular section and a non-circular section, the circular section including inner threads configured to engage the first outer thread, a proximal end of the circular section comprising a recess configured to engage the one or more protrusions such that the drive shaft can rotate about the recess but cannot extend longitudinally from the recess; a pusher configured distally to engage the plunger, the inner surface of the pusher comprising an internal thread configured to mate with the second external thread of the internal screw; a screw mechanism comprising: A delivery pen comprising:

Images