Plunger rod releasably attached to plunger head in pump device

Abstract

A disposable reservoir includes a plunger head that includes a PEM and is bidirectionally movable in unison with the PEM between a proximal end of the disposable reservoir and a distal end of the disposable reservoir. The PEM is configured to engage a plunger rod of a reusable portion of the drug delivery device. The disposable reservoir also includes a PRM configured to release the plunger rod from the PEM when the PEM is retracted into a stowed position in the PRM. The plunger rod may be locked by and released from the PEM by using a snap-fit feature. Alternatively, the plunger rod may be locked by the PEM using a snap fit feature and may be released from the PEM using a socket connection tool. Alternatively, by using a socket connection tool, the plunger rod can be both locked by the PEM and released from the PEM.

Description

Field of the Invention

[0001] The present invention generally relates to systems and methods for coupling a disposable portion ("DP") (e.g., a liquid drug reservoir) of a drug delivery device (e.g., a pump device) to a reusable portion ("RP") of the pump device. More specifically, the present invention relates to a plunger rod and plunger head design that enables the plunger rod to releasably engage with the plunger head.

[0002] background

[0003] Some liquid drug delivery systems are two-part systems, including a reusable part and a disposable part, the reusable part generally includes an electric motor and a gear system driven by an electric motor, etc., and the disposable part generally includes a liquid drug reservoir and a gear-driven plunger tool or an independent plunger tool for discharging medicine from the reservoir. In conventional drug delivery devices, the plunger tool includes a plunger rod (sometimes referred to as "lead screw (leadscrew)" or spindle) and a plunger head, and the plunger rod is the inseparable part of the plunger head. In addition, this plunger tool is usually inseparable from the reservoir itself, and therefore, this plunger tool is used to have disadvantages. For example, a disposable reservoir is discarded with a plunger rod and a plunger nut (a kind of tool, its rotational movement is converted into the linear movement of the plunger rod) or other / additional drive elements after use, which is wasteful and uneconomical. In addition, because the plunger rod (lead screw) is conventionally resident in the disposable reservoir, the connection between the disposable reservoir and the reusable part often causes the accuracy of the delivered medicament to be reduced, and this is due to the accurate positioning of the lead screw in the reservoir or some uncertainties of the position. In addition, the assembly process of the disposable reservoir including the plunger rod is relatively complicated. In addition, the inseparable attachment of the plunger rod to the disposable reservoir prevents such disposable reservoirs from being stored or distributed as "pre-filled" disposables. Therefore, conventional disposable reservoirs are usually filled from vials only a short time before they are used. SUMMARY OF THE INVENTION

[0005] The pump device for delivering medicament comprises a disposable reservoir and a reusable part that can be detachably connected to the disposable reservoir.The disposable reservoir comprises a plunger head, etc., which can move bidirectionally between the proximal end of the disposable reservoir and the distal end of the disposable reservoir in the disposable reservoir.The reusable part comprises a plunger rod, etc.The plunger head and the plunger rod are designed so that when the disposable reservoir and the reusable part are connected to each other, as the plunger rod moves linearly and optionally bidirectionally (front and back) in the disposable reservoir in unison with the plunger head, the plunger rod can be releasably locked in the plunger head.The "distal end" of the disposable reservoir is the end of the reservoir, which includes an injection opening, through which a liquid medicament can be, for example, moved from a vial to the reservoir, so as to fill the reservoir, and can be moved to the outside of the disposable reservoir when the medicament is discharged from the reservoir to reach the patient.The "proximal end" of the disposable reservoir is the end of the reservoir opposite to the distal end of the disposable reservoir. Thus, to fill the disposable reservoir with medicament, the plunger head will move longitudinally (axially) within the disposable reservoir from the distal end of the reservoir to the proximal end of the reservoir, and in the opposite direction to deliver the medicament from the reservoir to the patient.

[0006] The plunger head includes a concentric plunger engagement member (PEM) that can move bidirectionally between the proximal end of the disposable reservoir and the distal end of the disposable reservoir in unison with the plunger head, and the disposable reservoir also includes a perforated plunger release member (PRM) concentrically and fixedly mounted to the proximal end of the disposable reservoir. The plunger rod includes a distal end and can move bidirectionally through the perforated PRM. When the disposable reservoir and the reusable part are connected to each other, the distal end of the plunger rod can be locked in the PEM and can be released from the PEM by the PRM. By using both an ejection tool and a retraction tool, the PRM ejects the plunger rod from the PEM when the plunger rod pulls the PEM into the retracted position in the PRM. By using a snap-fit ​​connection means or a bayonet connection means or a combination of a snap-fit ​​connection means and a bayonet connection means, the plunger rod can be locked in the PEM and can be released from the PEM. The snap-fit ​​connection means may include an annular snap-fit ​​feature or a cantilevered snap-fit ​​connection feature, or a combination of an annular snap-fit ​​feature and a cantilevered snap-fit ​​connection feature.

[0007] Configuration #1: Locking and releasing via "snap fit"

[0008] In some embodiments, the plunger rod is lockable in and releasable from the PEM by using a snap-fit ​​connection tool. The snap-fit ​​connection tool may include the distal end of the plunger rod, the PEM, and the PRM. The snap-fit ​​connection is an irreversible snap-fit ​​connection, which means that once the plunger rod is locked in / by the PEM by snap-fitting the plunger rod to the PEM, the plunger rod can only be released from the PEM by using a "third party" (i.e., the PRM).

[0009] The distal end of the plunger rod includes an entry tip (plunger interface) and an annular locking groove formed circumferentially in the distal end between the entry tip and the remainder of the plunger rod. The PEM includes an annular base and elongated flexible arms extending circumferentially from the annular base and bending inwardly toward the central axis of the PEM to form a flexible cap-like structure with a central opening. The flexible cap-like structure is designed to be a snap-fit ​​table into the annular locking groove of the plunger rod.

[0010] The PRM comprises an outer (external) cylindrical body and a concentric inner (inner) hollow cylindrical body through which the plunger rod can be bidirectionally moved, for example, by an electric motor included in the reusable part. The outer cylindrical body and the concentric inner hollow cylindrical body define an open annular channel therebetween to accommodate the PEM, and the inner hollow cylindrical body of the PRM is configured to deflect the elongated flexible arms of the PEM radially outward to release the plunger rod from the PEM ("snap-out") when the PEM is retracted by the plunger rod to a rest (stowed) position in the open annular channel in the PRM. The entry end of the plunger rod can be selected from a group consisting of a hemispherical end, a conical end, and a truncated trapezoid.

[0011] Each elongated flexible arm of the PEM may include a proximal section extending from the annular base at an acute angle α relative to the plane of the annular base (where 0°<α<90°, e.g., α=80°). Each elongated flexible arm of the PEM may additionally include a distal section extending continuously (and seamlessly) from the corresponding proximal section at an acute angle β relative to the annular base (where 0°<β<α, e.g., β=60°). The distal section of the elongated flexible arm is configured to snap fit (lock) into the annular locking groove of the plunger rod when the entry end of the plunger rod is linearly pushed against the elongated flexible arm of the PEM.

[0012] The annular locking groove of the plunger rod includes an annular pulling platform for pulling the PEM in the backward (refilling) direction in unison with the plunger rod by pulling the distal section of the elongated flexible arm when the plunger rod is retracted in the disposable reservoir. The annular locking groove may also include a conical surface so that the plunger rod can move through the opening in the flexible cap-like structure in the forward (emptying) direction until the entry end of the plunger rod contacts (adjoins) the inner push surface of the plunger head. As the entry end of the plunger rod moves forward through the opening in the flexible cap-like structure, the elongated flexible arm is radially deflected outward by the entry end of the plunger rod, and as the entry end moves through the opening in the flexible cap-like structure, the flexible cap-like structure snaps into the annular locking groove of the plunger rod to lock the plunger rod in the plunger engagement member (PEM). The entry end of the plunger rod may include an entry side of a curved shape to facilitate the radial deflection of the elongated flexible arm outward.

[0013] The number of elongated flexible arms may be 2n (where n=1, 2, 3, ...), and the elongated flexible arms may have the same size and shape and may be angularly equidistant from each other; that is, the elongated flexible arms may be angularly and equidistantly distributed around the longitudinal axis of the PEM. The number of elongated flexible arms may, for example, be selected from the group consisting of four (4) elongated flexible arms, six (6) elongated flexible arms, and eight (8) elongated flexible arms.

[0014] Configuration #2 and Configuration #3: Locked by snap fit / socket, released by socket

[0015] The distal end of the plunger rod may include: an entry tip including a number N of fins and segmented (discrete, discontinuous) locking grooves, the fins being angularly distributed around the longitudinal axis of the plunger rod and extending radially outward from the longitudinal axis of the plunger rod, the segmented locking grooves being circumferentially formed in the distal end between the N fins and the remainder of the plunger rod. The plunger engagement member (PEM) includes a perforated cylindrical member having an inner wall and a number N of ribs, the ribs extending radially inward from the inner wall toward the longitudinal axis of the perforated cylindrical member and being configured to lock the N fins respectively. The PEM also includes a number S of socket grooves or grooves formed circumferentially in the perforated cylindrical member. The S socket grooves are designed as a three-dimensional curve (helix) that surrounds the longitudinal axis of the perforated cylindrical member at a constant radial distance from the longitudinal axis. The helical grooves are designed such that they enable rotational movement of the PEM to the angle of rotation required to lock the fins in the ribs of the PEM and / or (depending on the configuration) unlock the fins from the ribs of the PEM.

[0016] The PRM comprises: a hollow cylindrical body through which a plunger rod can move; and a number S of spigot pins or other means of suitable geometry extending radially inwardly from the inner wall of the hollow cylindrical body. The S spigot pins can respectively engage with the S spigot slots of the PEM, so that the PEM rotates relative to the stationary PRM.

[0017] The PEM is rotatable relative to the PRM between a locked angular position, in which the N fins are respectively aligned with the N ribs and are thus respectively locked by the N ribs, so that the plunger head can be retracted by the plunger rod, and a released angular position, in which the N fins are respectively misaligned with the N ribs, so that the plunger rod can be released from the plunger head when the PEM is linearly retracted by the plunger rod to a rest (stowed) position in the PRM. Each of the S socket slots is designed to enable the PEM to rotate from the locked angular position to the released angular position when the PEM is linearly moved to the rest (stowed) position in the PRM, and to enable the PEM to rotate from the released angular position to the locked angular position when the PEM is linearly moved away from the rest position in the PRM.

[0018] Rotating the PEM from the locked angle position to the released angle position may include rotating the PEM clockwise (or counterclockwise) by a release angle (γ), and rotating the PEM from the released angle position to the locked angle position may include rotating the PEM counterclockwise (or clockwise) by a lock angle (γ), wherein the value of the release angle / lock angle (γ) is γ=180° / N. For example, for N=4, the value of the lock angle is γ=180° / 4=45°. The value of N may be selected from the group consisting of N=2, N=3, N=4, N=5, and N=6 (where N is the number of fins in the plunger rod and ribs in the PEM).

[0019] The distal end of the plunger rod may also include a push flange. The push flange may have a diameter greater than the inner diameter of the perforated cylindrical member of the PEM, so that as the plunger rod moves forward in the disposable reservoir, the PEM can be pushed in the forward direction (i.e., in the reservoir emptying direction) in unison with the plunger rod. The N fins of the plunger rod include N pulling platforms, respectively, and when the PEM is in a locked angle position, the PEM is sandwiched between the push flange and the N pulling platforms, and when the plunger rod is retracted (pulled back) in the disposable reservoir, the PEM can move in the backward direction (in the reservoir refilling direction) in unison with the plunger rod. The entry end of the plunger rod may be shaped as a segmented hemispherical end, a segmented conical end, or a cruciform Philips screwdriver head.

[0020] Configuration #2: Connects via snap fit, disconnects via socket

[0021] In some embodiments, the plunger rod can be locked in the PEM by using a snap-fit ​​connection tool and can be released from the PEM by using a socket connection tool. In these embodiments, the PEM provides both a snap-fit ​​tool for locking the plunger rod in the PEM and a socket tool for facilitating the release of the plunger rod from the PEM. The snap-fit ​​connection tool may include a snap-fit ​​feature of the distal end of the plunger rod and the PEM, and the socket release tool may include a socket feature of the same PEM and a PRM. The snap-fit ​​connection in these embodiments is also an irreversible snap-fit ​​connection, which means that once the plunger rod is locked in / by the PEM by snap-fitting the plunger rod to the PEM, the plunger rod can only be released from the PEM by using the PRM.

[0022] The PEM may be initially positioned at the distal end of the disposable reservoir, and the plunger rod may be locked in / by the PEM at a locked angular position by moving the plunger rod forward through the PRM in the disposable reservoir until the N fins of the plunger rod are snap-fitted by the N ribs of the PEM, respectively. When the plunger rod is locked in / by the PEM, the plunger rod may be released from the PEM by retracting the PEM to a rest (stowed) position in the PRM, thereby imparting a twisting motion to the PEM relative to the PRM from the locked angular position to the released angular position, thereby releasing the plunger rod from the PEM.

[0023] To facilitate snap-fitting of the N ribs of the PEM into the segmented locking grooves in the distal end of the plunger rod, the perforated cylindrical member of the PEM can be reversibly expanded radially outward by the N fins of the plunger rod pushing the N rigid ribs, or the perforated cylindrical member of the PEM can be rigid (non-expandable) and the N ribs can be reversibly compressed by the N fins, or the N ribs of the PEM can be reversibly compressed by the N fins of the plunger rod and the perforated cylindrical member of the PEM can also be reversibly expanded radially outward.

[0024] Configuration #3: Connect and disconnect via a socket

[0025] In other embodiments, the PEM may be initially stowed in the PRM in a released angular position, in which case the plunger rod may be locked in / by the PEM by moving the plunger rod linearly forward through the PRM, causing the plunger rod to linearly move the PEM away from the stowed position in the PRM while imparting a torsional motion relative to the PRM that rotates the PEM from the released angular position to the locked angular position. When the plunger rod is locked in / by the PEM, the plunger rod may be released from the PEM by retracting the PEM to a rest (stowed) position in the PRM, imparting a torsional motion relative to the PRM that rotates the PEM from the locked angular position to the released angular position. The socket connection in these embodiments is also a non-reversible connection, meaning that once the plunger rod is locked in / by the PEM, the plunger rod can only be released from the PEM by using the PRM.

[0026] According to another aspect of the present invention, a disposable reservoir is provided, which has a plunger engagement member (PEM) and a plunger release member (PRM), as shown in the relevant figures and as described herein, and an additional plunger rod that can be engaged with the PEM and can be released from the PEM by the PRM, as shown in the relevant figures and as described herein.

[0027] Disposable reservoirs including PEM and PRM (Configuration #1, Configuration #2, and Configuration #3)

[0028] A disposable reservoir capable of being releasably coupled to a reusable portion of a drug delivery device is also provided, wherein the disposable reservoir comprises a plunger head. The plunger head comprises a plunger engagement member (PEM) and is bidirectionally movable between a proximal end of the disposable reservoir and a distal end of the disposable reservoir in unison with the PEM, and the PEM is configured to engage a plunger rod of the reusable portion of the drug delivery device. The disposable reservoir further comprises a plunger release member (PRM) configured to release the plunger rod from the PEM when the PEM is retracted to a stowed position in the PRM.

[0029] The plunger rod is configured to be locked by or in the PEM by moving the plunger rod forward through the PRM in the disposable reservoir until the plunger rod is snap-fitted by the PEM, and the plunger rod can be released from the PEM by retracting the PEM to a stowed position, in which the PRM deflects the PEM (out of the way) to release the plunger rod from the PEM.

[0030] The PEM can be initially positioned at the distal end of the disposable reservoir, and the plunger rod can be initially locked by the PEM in a locked angular position by moving the plunger rod forward through the PRM in the disposable reservoir until the plunger rod is snap-fitted by the PEM. The plunger rod can be released from the PEM by retracting the PEM to a stowed position in the PRM to cause twisting movement of the PEM relative to the PRM from the locked angular position to the released angular position.

[0031] The PEM may be initially stowed in the PRM in a released angular position, and the plunger rod may be locked by the PEM by moving the plunger rod forward through the PRM so that the plunger rod linearly moves the PEM away from the stowed position in the PRM while rotating the PEM from the released angular position to the locked angular position. The plunger rod may be released from the PEM by retracting the PEM back to the stowed position in the PRM so that the PEM rotates from the locked angular position back to the released angular position. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Various exemplary embodiments and aspects are shown in the accompanying drawings, with the intention that these examples are not limiting. It should be understood that for simplicity and clarity of illustration, the elements shown in the drawings referenced below are not necessarily drawn to scale. In addition, where deemed appropriate, reference numerals repeated in the drawings indicate identical, corresponding, or similar elements. In the drawings:

[0034] Figure 1A-Figure 1C shows a snap-fit ​​locking of a plunger rod (150) in a plunger engagement member (140) according to an example embodiment;

[0035] Figure 1D-1G A plunger tip (130) is shown according to an example embodiment;

[0036] Figure 2A-2D A plunger rod (150) and a plunger engagement member (140) as part of a plunger head (130) are shown according to example embodiments;

[0037] Figure 2E-2F An example 4-arm plunger engagement member (140) is shown in accordance with an example embodiment;

[0038] Figure 2G-Figure 2I An example 6-arm plunger engagement member (140) is shown in accordance with an example embodiment;

[0039] Figure 3A-3C An example plunger release member (190) is shown according to an example embodiment;

[0040] Figure 4 The position of the plunger engagement member (140) relative to the plunger release member (190) is shown;

[0041] Figure 5A-Figure 5B Demonstrating, according to an example embodiment, unlocking the plunger rod (150) from the plunger engagement member (140) snap fit by using a plunger release member (190);

[0042] Figure 6A-6B Demonstrating that the plunger rod (150) is unlocked from the plunger engagement member (140) when the disposable portion of the pump device is coupled (attached) to the reusable portion of the pump device;

[0043] Figure 7 An example plunger rod (700) is shown according to some embodiments;

[0044] Figure 8A-8B An example plunger engagement member (810) is shown according to some embodiments;

[0045] Figure 9A-9B An example plunger release member (900) is shown according to some embodiments;

[0046] Figure 10A-10B shows a plunger rod (700) in a plunger engagement member (810) when the plunger engagement member (810) is in a stowed position in a plunger release member (900), according to some embodiments;

[0047] Fig. 10C shows the plunger rod (700) locked in the plunger engagement member (810) when the plunger engagement member (810) is away from the stowed position in the plunger release member (900), according to some embodiments;

[0048] Figure 10D-10E Schematically illustrating a plunger engagement member (1016) in an unlocked (released) angular position relative to a fin (1070) of a plunger rod and a plunger engagement member (1016) in a locked angular position relative to a fin (1070) of a plunger rod, respectively, according to an example embodiment;

[0049] Figures 11A-11I Various stages of operation of a pump device according to an example embodiment are shown, including coupling of a disposable portion (1100) of the pump device to a reusable portion (1110) of the pump device, and separation of the disposable portion (1100) from the reusable portion (1110);

[0050] Figure 12A-12M Various stages of operation of a pump device according to an example embodiment are shown, including coupling of a disposable portion (1200) of the pump device to a reusable portion (1210) of the pump device and separation of the disposable portion (1200) from the reusable portion (1210); and

[0051] Figures 13A-13FVarious positions of plunger engagement member (1310) in plunger release member (1330) are shown, according to example embodiments.

[0052] Detailed Description of the Invention

[0053] The following description provides various details of the exemplary embodiments. However, this description is not intended to limit the scope of the claims, but rather to explain various principles of the invention and exemplary ways of implementing the invention.

[0054] The detailed description and related drawings generally disclose three example configurations:

[0055] (1) Configuration #1, which includes a snap-fit ​​connection mechanism that is used to both lock the plunger rod of the pump device in or by the plunger head of the pump device and to release the plunger rod from the plunger head (see, e.g., Figure 1A-1G , Figure 2A-2I , Figure 3A-3C , Figure 4 , Figure 5A-Figure 5B as well as Figure 6A-6B );

[0056] (2) Configuration #2, which is similar to Configuration #1, including a snap-fit ​​connection feature for locking the plunger rod of the pump device in or by the plunger head of the pump device, and also including a socket mechanism for releasing the plunger rod from the plunger head (see, e.g., Figure 7 , Figure 8A-8B , Figure 9A-9B , Figure 10A-10C as well as Figures 11A-11I ),as well as

[0057] (3) Configuration #3, which includes a socket mechanism that is used to both lock the plunger rod of the pump device in or be locked by the plunger head of the pump device and to release (unlock) the plunger rod from the plunger head (see, e.g. Figure 7 , Figure 8A-8B , Figure 9A-9B , Figure 10A-10C , Figure 12A-12M as well as Figures 13A-13F ).

[0058] The three configurations have in common that a plunger engagement member (PEM) is added to the plunger head of the pump device, which is designed to engage and lock the distal end of the plunger rod of the pump device, and in addition, a stationary plunger release member (PRM) is added, which is designed to unlock the distal end of the plunger rod from the plunger head. Configuration #2 and Configuration #3 have in common a socket mechanism that is used to rotate the PEM relative to the PRM, for example, to unlock the plunger rod from the plunger head (according to Configuration #2), and to lock and unlock the plunger rod relative to the plunger head (according to Configuration #3). The socket mechanism used herein is not used in a conventional manner, which means that the socket pin and slot are not used as a locking tool. Instead, they are only used to rotate the PEM relative to the stationary PRM, whether it is rotated from an "unlocked" angular position to a "locked" angular position and back to an unlocked angular position (as described in conjunction with Configuration #3), or only from a locked angular position to an unlocked angular position (as described in conjunction with Configuration #2).

[0059] Figure 1A-Figure 1C A drug delivery device 106 (see FIG. Figure 1C ) is a cross-sectional view of a reusable portion 110 and a disposable drug reservoir 120. The drug delivery device includes a reusable portion 110 and a disposable drug reservoir 120. The reusable portion 110 and the disposable drug reservoir 120 can be releasably coupled to each other (122, 124), such as by using a magnet (i.e., using magnetic attraction), a snap-fit ​​connector, a socket connector, etc. For example, a permanent magnet can be fixedly embedded in the reusable portion 110 or in the disposable drug reservoir 120, and a metal plate that can be magnetically attracted to the magnet can be fixedly embedded in the other part, so that when the reusable portion 110 and the disposable drug reservoir 120 are brought close to each other, the permanent magnet will magnetically attract the metal plate.

[0060] The disposable reservoir 120 includes a plunger head 130 that can slide bidirectionally in the axial direction of the reservoir 120. The plunger head 130 includes a plunger engagement member (PEM) 140. The reusable portion 110 includes a plunger rod 150. The plunger rod 150 includes a threaded section 152 and a distal end 160 that is not threaded. The distal end 160 (of the plunger rod 150) and the plunger engagement member 140 are capable of releasably engaging. The disposable reservoir 120 also includes a bottom cover 190, which has a central opening through which the plunger rod 150 can move bidirectionally. (The bottom cover 190 is an axisymmetric object that serves as a plunger release member (PRM).) Figure 1A-Figure 1CAs shown, the PRM 190 and PEM 140 of the disposable reservoir 120 are separate components, the PRM 190 is attached (fixedly mounted) to the proximal end 126 of the reservoir 120, and the PEM 140 can slide bidirectionally in the reservoir 120 between the proximal end 126 and the distal end 128 of the reservoir 120 (the PEM 140 can be moved by the plunger rod 150 when the plunger rod 150 is connected to the PEM 140).

[0061] The reusable portion 110 includes an electric motor-based drive system that includes an electric motor 170 and a gear system 180 driven or powered by the electric motor 170. The gear system 180 may include one or more gears and a nut. The nut is held axially in place and includes an external thread or profile that couples with the gears of the gear system 180. The internal threads of the nut engage the threaded section 152 of the plunger rod 150. The configuration of the gear system 180 is such that when the nut is rotated by the gear, the nut moves the plunger rod 150 linearly through the concentric hole in the PRM 190 without rotating the plunger rod 150. (The same gear / nut configuration is applicable to all plunger rods operating according to any configuration disclosed herein, such as plunger rods 700, 1112, 1212, and 1300.) Using the gear system 180, the electric motor 170 can move the plunger rod 150 linearly and bidirectionally in the axial direction of the plunger rod (i.e., along the longitudinal axis 154 of the plunger rod 150). The plunger rod 150 and the plunger head 130 can be coupled via the PEM 140 so that they can move in unison bidirectionally in the disposable reservoir 120 when and while the disposable reservoir 120 and the reusable part 110 are coupled to each other, and the plunger rod 150 and the plunger head 130 can be released from each other to enable the disposable reservoir 120 to be separated from the reusable part 110.

[0062] The disposable reservoir 120 can be filled with liquid medicine from the vial 100. The vial 100 rests in the vial adapter 102, and the vial adapter 102 can be releasably connected to the disposable reservoir 120 by a Luer-type connector 104. Two sealing O-rings 132 and 134 prevent the liquid medicine from leaking from the reservoir 120.

[0063] Figure 1A The reusable portion 110 and disposable reservoir 120 are shown before the reusable portion 110 and disposable reservoir 120 are coupled to each other, the plunger rod 150 is stowed (fully retracted) in the reusable portion 110 in a "standby" position, and the plunger head 130 is also in a "standby" (i.e., reservoir pre-filled) position, in which the plunger head 130 is positioned at the distal end 128 of the reservoir 120. Figure 1B, the reusable portion 110 and the disposable reservoir 120 are coupled to each other, but the plunger rod 150 is still stowed (fully retracted) in the reusable portion 110 in the "standby" position, and the plunger head 130 is also in its "standby" position. Figure 1C , the drug delivery device 106 is in the "ready" position when the plunger rod 150 is fully extended from the reusable portion 110 and engages the PEM 140 at the distal end 128 of the reservoir 120. When the drug delivery device 106 is in the "ready" position, the plunger rod 150, and therefore the plunger head 130, can be retracted backward (e.g., by the electric motor 170) to fill the reservoir 120 with the medicament, and then forward again during medical treatment to empty the reservoir 120. ("Backward" means moving the plunger head 130 in the direction from the distal end 128 to the proximal end 126, i.e., in the opposite direction of the direction 136.)

[0064] Typically, the plunger rod 150 and the PEM 140 can be releasably engaged using, for example, a snap-fit ​​connection mechanism or a socket connection mechanism, or a combination of a snap-fit ​​connection and a socket connection. The snap-fit ​​connection mechanism can be or include, for example, an annular snap-fit ​​connection feature (including a snap-fit ​​"lip" or segmented lip), or a cantilevered snap-fit ​​connection feature, or a combination of an annular snap-fit ​​connection feature and a cantilevered snap-fit ​​connection feature.

[0065] Configuration #1: Locking and unlocking the plunger rod via snap fit

[0066] refer to Figure 1A-1G , the snap-fit ​​connection includes the distal end 160 of the plunger rod 150 and the plunger engagement member (PEM) 140 . Figure 1D-1G The plunger tip 130 is shown without the PEM and without the O-rings 132 and 134 . Figure 1D-1E and Figure 1G The internal receiving ("pushing") concave surface 138 (also shown in FIG. Figure 2B-2C ).

[0067] Also refer to Figure 2A The distal end 160 of the plunger rod 150 includes an entry tip 210 and an annular locking groove 220 formed circumferentially in the distal end 160 between the entry tip 210 and the remainder of the plunger rod 150. The entry tip 210 may have a convex shape, such as a hemispherical shape (e.g., Figure 2A , Figure 2C , Figure 2D For example, the entry end 210 may be conical, or the entry end 210 may be a truncated cone, a pyramid, a frustum of a cone, or the like.

[0068] Figure 2B Shows the PEM 140 before it is snap - fit (snap - fitting) into the annular locking groove 220 of the plunger rod 150. Figure 2C Is a 3D cross - sectional view showing the PEM 140 snap - fit into the proper position in the plunger rod 150 (i.e., snap - fit into the annular locking groove 220). Refer to Figure 2B , the PEM 140 includes an annular base 250 and a plurality of identical elongated and flexible arms 260. The plurality of elongated flexible arms 260 extend circumferentially from the annular base 250 and may be equidistant from each other angularly. The elongated flexible arms 260 extend from the annular base 250 at an acute angle and bend (converge) inwardly towards the central axis 142 of the plunger engagement member 140. Thus, the plurality of elongated flexible arms 260 form a flexible cap - like structure (as for example Figure 2F-2H shown), which flexible cap - like structure has a central opening 144 at its apex, and the central opening 144 is defined by a snap - fit lip that can be snap - fit into the annular locking groove 220. The plunger engagement member 140 is concentrically and fixedly embedded in the plunger head 130 such that the two objects can move consistently in the disposable reservoir 120 in the emptying direction (direction 124) of the reservoir and in the opposite direction (i.e., in the filling direction of the reservoir, which is the direction opposite to direction 124). Figure 2C Shows the plunger rod 150 snap - fit by the PEM 140.

[0069] Figure 2E Shows a cross - sectional view of the 4 - arm PEM 140, and Figure 2F shows a three - dimensional view of the 4 - arm PEM 140. (As shown in other figures and as described herein, the PEM 140 may include a different number of elongated flexible arms.) Refer to Figure 2E , each elongated flexible arm 260 includes a proximal section 262 that extends from the annular base 250 at an acute angle α (where 0° < α < 90°, for example α = 60°) relative to the annular base 250. Each elongated flexible arm 260 also includes a distal section 264 that extends continuously from the proximal section at a smaller acute angle β (i.e., 0° < β < α, for example β = 45°) relative to the annular base 250. The distal sections (264) of the plurality of elongated flexible arms 260 or the entire flexible arms are constructed (e.g., sized, shaped, and made of material) in such a way that the flexible arms can be locked into the annular locking groove 220 of the plunger rod 150 and can be retracted by the plunger rod 150 towards the proximal end 126 of the disposable reservoir 120. Each elongated flexible arm 260 also includes a pulling or contact surface 266. Each pulling surface 266 can be perpendicular to the central axis 142 of the plunger engagement member 140 so that the pulling surface 266 engages with the annular pulling platform ("shoulder") 222 of the plunger rod 150 (see Figure 2D) to maximize the pulling contact surface between them.

[0070] When the plunger rod 150 is retracted (e.g., pulled back) in the reservoir 120, the pulling surface 266 (the pulling surface 266 of each flexible arm 260) enables the annular pulling platform 222 of the plunger rod 150 to move the plunger engagement member 140 (and therefore the plunger head 130) back (backward) in the reservoir 120 in unison with the movement of the plunger rod 150 as the elongated flexible arm 260 snaps (snap-fits) into the annular locking groove 220. The plunger rod 150 can be controllably retracted in the reservoir 120, for example, to fill an empty reservoir 120 with a medicament, or to release the plunger rod 150 from the plunger head 130 in preparation for separating the disposable reservoir 120 from the reusable portion 110. By causing the annular pulling platform 222 of the plunger rod 150 to contact the pulling surface 266 of the elongated flexible arm 260 and then pulling the distal section 264 of the elongated flexible arm 260 by the plunger rod 150 as the plunger rod 150 retracts (moves rearwardly) in the reservoir 120, the annular pulling platform 222 pulls the PEM 140 in unison with the movement of the plunger rod 150 in the rearward (filling) direction.

[0071] The annular locking groove 220 may also include a conical surface 230 ( Figure 2A and Figure 2D ), depending on the design details of the PEM 140 and the plunger 150, the conical surface 230 may enable the distal end 160 of the plunger rod 150 to move in the forward (emptying) direction 136 ( Figure 1A ) is moved further through the central opening 144 in the flexible cap until the entry end 210 of the plunger rod 150 contacts the internal receiving ("pushing") concave surface 138 ( Figure 1D , Figure 2B-2C ) (located or received in the internal receiving recess 138). The plunger rod 150 contacts the receiving recess 138 of the plunger head 130 so that the plunger rod 150 can move in the forward (emptying) direction, that is, in the direction 136 ( Figure 1A ) pushes the plunger head 130. That is, when the flexible cap-like structure of the PEM 140 snaps (snap-fits) into the annular locking groove 220 of the plunger rod 150, the entry end 210 of the plunger rod 150 can push the receiving concave surface 138 of the plunger head 130 to slide the plunger head 130 forward (in the emptying direction 136) to expel the drug from the reservoir. The receiving concave surface 138 is centered in the plunger head 130 (i.e., the concave surface 138 is located on the axis 142, see Figure 2B ), and in addition, the concave profile of the receiving concave surface 138 rigidly (or elastically) matches the convex profile of the entry end 210 of the plunger rod 150. When the plunger rod 150 is extended (ie, in the emptying direction 136 ( Figure 1A) When moving upward (i.e., in the emptying direction 136), two mechanical features (i.e., the centered concave surface 138 and the concave-convex complementary profile) can be used to avoid generating non-uniform mechanical stresses (e.g., bending, compression, and / or shear stresses) in the plunger head 130, PEM 140, or the plunger rod 150.

[0072] When the entry end 210 moves forward (in the emptying direction 136, Figure 1A ) through the central opening 144 of the flexible cap structure ( Figure 1B 、 Figure 2B 、 Figure 2E 、 Figure 2F ), the elongate flexible arms 260 are capable of deflecting radially outwardly reversibly through the entry end 210 of the plunger rod 150, and when the entry end 210 moves past the central opening 144 of the flexible cap structure in a manner that prevents the plunger rod 150 from being released from the PEM 140 when the plunger rod 150 retracts (moves backward) in the reservoir 120, the elongate flexible arms 260 can snap (snap-fit) into the annular locking groove 220 of the plunger rod 150. To endow the PEM 140 with this ability, the diameter D3 of the opening 144 in the PEM 140 when at rest (i.e., when the flexible arms 260 are not deflected but are in their rest or stress-free position) (see, for example, Figure 2E 、 Figure 2F ) is less than the diameter D1 of the end point 210 (see Figure 2D ), and is similar to or greater than the diameter D2 of the "neck" of the annular locking groove 220 ( Figure 2D ). Thus, when the plunger rod 150 retracts backward in the reservoir 120, in order for the plunger rod 150 to be able to retract into the PEM 140 (and thus the plunger head 130), the value of the diameter D3 satisfies the condition D3 < D1. (The value of the diameter D3 may additionally satisfy the condition D3 ≥ D2, but may also be slightly less than the diameter D2.)

[0073] The entry end 210 of the plunger rod 150 includes a curved "entry side" that enables the entry end 210 to deflect the elongate flexible arms 260 radially outwardly, away from the central axis 142 of the PEM 140 ( Figure 1A 、 Figure 2B ). The diameters D4 and D5 in the PEM 140 ( Figure 2E ) facilitate the release of the plunger rod 150 from the PEM 140, as further described below, for example, in connection with Figure 3A-3B 、 Figure 4 and Figure 5A-Figure 5B . Briefly, in order for the flexible arms 260 to deflect radially outwardly, the outer diameter D7 of the concentric cylindrical body 320 ( Figure 3A 、 Figure 4) is smaller than the inner diameter D5 of the annular base 250 of the PEM 140, and preferably larger than the diameter D4, so that the elongated flexible arm 260 can be deflected by the cylindrical body 320 pushing the proximal section 262 laterally. If the outer diameter D7 of the cylindrical body 320 is smaller than the diameter D4, the elongated flexible arm 260 can be deflected by the cylindrical body 320 pushing the distal section 264 laterally.

[0074] The number of elongated flexible arms 260 that the PEM 140 may include may be 2n (where n=1, 2, 3, ..., etc.). The elongated flexible arms 260 are of the same size and shape, and they may be angularly equidistant from each other on the annular base 250. The plunger engagement member (PEM) 140 may include, for example, four flexible arms, six flexible arms, eight flexible arms, etc. (Other numbers of flexible arms may be used. For example, the PEM 140 may include an odd number of elongated flexible arms, such as three flexible arms, five flexible arms, etc.)

[0075] See also Figure 2C (For example), the snap-fit ​​connection mechanism comprising the PEM 140 and the distal end 160 of the plunger rod 150 is irreversible in the sense that there is no "retraction side" provided for the distal end 160 of the plunger rod 150 that would enable the distal end 160 to "self-disengage" from the PEM 140 (release itself from the PEM 140), i.e., by sliding "itself" out of the PEM 140. (If the distal end 160 of the plunger rod 150 included a retraction side, the plunger rod 150 would not be able to pull back on the PEM 140, and therefore the plunger head 130, to fill the reservoir 120 with the drug.) However, the plunger rod 150 can be released from the PEM 140 by using the plunger release member (PRM) 190 of the disposable reservoir 120 as an auxiliary (ejection) member. (PRM 190 is mechanically separate from PEM 140 and functions independently of PEM 140.) The snap-fit ​​release function required to release (disengage) plunger rod 150 from PEM 140 is to Figure 3A-3C The manner shown is given to PRM 190, which will be described below. (PRM 190 ('escape' element or ring) Figure 1A-Figure 1C , Figure 3A-3B , Figure 4 , Figure 5A-Figure 5B as well as Figure 6A-6B . )

[0076] Figure 2E and Figure 2F An example plunger engagement member (PEM) comprising four elongated flexible arms 260 is depicted. Figure 2G-Figure 2IA PEM is depicted that includes six elongated flexible arms 260. However, a number of elongated flexible arms other than four or six may be used. The number of flexible arms of the PEM may depend on one or more of the following parameters:

[0077] (1) Electrical parameters of the pump device;

[0078] (2) electrical parameters of the power source (e.g., battery) that powers the pump device;

[0079] (3) Mechanical parameters of the flexible arm, and

[0080] (4) Mechanical friction between the plunger tip and the cylindrical body of the disposable reservoir in which the plunger tip moves.

[0081] The electrical parameters of the pump device may be, for example, the motor (e.g. Figure 1A The electrical energy required for the motor 170 (e.g., plunger rod 150) to drive the plunger rod (e.g., plunger rod 150) back and forth, for example, a predetermined number of times. The electrical parameters of the power source can be, for example, the total power capacity of the power source or the battery efficiency. The mechanical parameters of the flexible arm can be or can relate to the ability of the flexible arm to deflect (flex) radially outward to a desired distance at least a desired number of times without losing its flexing ability. Additionally or alternatively, the mechanical parameters of the flexible arm can be or can relate to the ease of flexion of the flexible arm. Additionally or alternatively, the mechanical parameters of the flexible arm can be or can relate to the size, shape, and material of the flexible arm. For example, the stiffer the flexible arm, the fewer the number of flexible arms that can be used to avoid overloading the motor. The easier the flexible arms are to flex (deflect), the larger their number can be. In another example, the larger the capacity of the power source (e.g., battery), the larger the number of flexible arms that can be used, and so on.

[0082] Figure 3A shows a cross-sectional view of the PRM 190, and Figure 3BA three-dimensional view of the PRM 190 is shown. The PRM 190 includes an outer cylindrical body 310 and a hollow cylindrical body 320. The cylindrical body 310 has an inner diameter D6 and the cylindrical body 320 has an outer diameter D7, where D7<D6. The cylindrical body 320 includes a hole 330 through which the plunger rod 150 can move freely. The cylindrical body 320 also includes a flange 312. The flange 312 protrudes outward from the cylindrical body 310 and surrounds the cylindrical body 310 to form an "L" shaped object with the cylindrical body 310 around the axis 142, which enables the PRM 190 to be attached to the proximal end 126 of the reservoir 120. The cylindrical bodies 310 and 320 are interconnected by an annular base 340. The annular base 340 protrudes outwardly from the cylindrical body 320 and surrounds the cylindrical body 320 to form an "L" shaped object with the cylindrical body 320 around the axis 142. The inner wall 350 of the cylindrical body 310, the outer wall 360 of the cylindrical body 320, and the annular base 340 define an open annular channel (OAC) 370 around the cylindrical body 320 and the axis 142. The open annular channel (OAC) 370 provides a docking station that is configured to receive the PEM 140 during and after the plunger rod 150 is disengaged from the PEM 140 (to stow the PEM 140).

[0083] The cylindrical body 320 is configured to be Figure 1A ) When the plunger rod 150 is fully retracted in the reservoir 120 and the annular base 250 of the PEM 140 is moved to a rest (stowed) position in the OAC 370, the elongated flexible arms 260 are deflected radially outward, thereby enabling the plunger rod 150 to be released from the flexible cap-like structure of the PEM 140. The open annular channel 370 is configured to receive (accommodate) the plunger head 130, a portion of the annular base 250 of the PEM 140, and a portion of the elongated flexible arms 260. The length L of the cylindrical body 320 ( Figure 3B ) are design parameters for determining the first contact points on the flexible arms 260 that the concentric cylindrical body 320 of the PRM 190 contacts when the PEM 140 moves to the stowed position in the PRM 190.

[0084] Release the plunger rod 150 from the PEM 140

[0085] As described herein, the diameter D1 ( Figure 2D ) is greater than the diameter D3 ( Figure 2E-2F) so that the entry end 210 of the plunger rod 150 can deflect the flexible arms 260 of the PEM 140 radially outward, after which the flexible arms 260 recover (return) to their previous (initial, resting, non-deflected) state to snap fit into the annular locking groove 220 of the plunger rod 150.

[0086] The PRM 190 is stationary within the reservoir 120, while the PEM 140 is bi-directionally movable axially (longitudinally) within the reservoir 120 between the proximal end 126 of the reservoir and the distal end 128 of the reservoir. Figure 4 , when the PEM 140 is moved rearwardly (retracted in direction 410) by the plunger rod 150 along the axis 142 (which is also the longitudinal axis of the reservoir 120), the PEM 140 moves toward the stowed position in the open annular channel (OAC) 370. During the movement of the PEM 140 toward the stowed position in the OAC 370, the circular leading edge 322 of the cylindrical body 320 contacts the inner wall of the proximal segment 262 of the PEM 140 at a deflection joint (i.e., at a deflection joint in each proximal segment 262), such as at a deflection joint 420 in the middle segment of the proximal segment 262. Further movement of the PEM 140 in this direction (in direction 410) will cause the circular leading edge 322 ( Figure 3C and Figure 4 ) radially outwardly deflects the proximal section 262 of each flexible arm 260, thereby radially outwardly deflecting the entire corresponding elongated flexible arm 260. The greater the outward deflection 430 of the flexible arm 260, the greater the value of the diameter D3 of the opening 144 ( Figure 2F and 2H ). The plunger rod 150 may be released from the PEM 140 when the value of D3 (becomes) greater than D1, where D1 is the diameter of the entry end 210 of the plunger rod 150. Depending on the design details of the PEM 140 and the PRM 190, the maximum radially outward deflection 430 of the flexible arm 260 occurs when the PEM 140 resides in the stowed position in the PRM 190, either fully or partially (depending on the design details). Therefore, the PEM 140 and the PRM 190 are designed such that the condition D3>D1 is satisfied when the PEM 140 is stowed in the PRM 190, i.e., when the PEM 140 rests in the open annular channel (OAC) 370 in the PRM 190.

[0087] Figure 5A and Figure 5B2D and 3D cross-sectional views of the PEM 140 (and plunger head 130) are shown, respectively, in a stowed position in a PRM 190 that serves as a docking station for the PEM 140 and the plunger head 130. When the PEM 140 (and the plunger head 130) are in the stowed position in the PRM 190, the deflection of the flexible arm 260 of the PEM 140 is maximum (D3>D1), so that the plunger rod 150 can be easily released (pulled apart or broken) from the PEM 140, and thus released from the plunger head 130, such as by the motor 170 ( Figure 1A ).

[0088] Fig. 6A The pump device 600 is depicted with the disposable reservoir 120 coupled to the reusable portion 110 and the plunger engagement member (PEM) 140 about to be stowed in the plunger release member (PRM) 190 (which also serves as a docking station). Fig. 6A , the entry point 210 of the plunger rod 150 is still snap-fitted by the PEM 140, so the plunger rod 150 cannot yet be released from the PEM 140 by the motor 170, and thus the disposable reservoir 120 cannot be separated from the reusable portion 110. (In order to separate the disposable reservoir 120 from the reusable portion 110, the plunger rod 150 must first be released from the plunger head 130, i.e., from the PEM 140.) The motor 170 may further retract the plunger rod 150 in the direction 610 by a distance 620 to stow the PEM 140 in the PRM 190 (docking station), as shown. Figure 6B shown.

[0089] Figure 6B Pump device 600 is depicted with disposable reservoir 120 still coupled to reusable portion 110, but PEM 140 stowed in docking station (within PRM 190). Figure 6B , the entry point 210 of the plunger rod 150 is no longer snap-fitted by the PEM 140, so the plunger rod 150 can now be released from the PEM 140, and the disposable reservoir 120 can be separated from the reusable portion 110 by moving the disposable reservoir 120 away from the reusable portion 110 in the direction 630 (e.g., manually). Therefore, stowing the PEM 140 in the PRM 190 by the motor 170 automatically ejects the plunger rod 150 from the PEM 140. Therefore, when the plunger rod 150 pulls the PEM 140 into the stowed position in the PRM 190, the PRM 190 ejects the plunger rod 150 from the PEM 140 by acting as both an ejection tool and a stowage tool. (The ejection of the plunger rod 150 from the PEM 140 is in Figure 5A-Figure 5B is shown more clearly in .)

[0090] Features shared by Configuration #2 and Configuration #3

[0091] Configuration #2 and Configuration #3 utilize a socket connection tool. As described herein, the difference between Configuration #2 and Configuration #3 is that in Configuration #2, the plunger rod can be locked (retained) in the plunger engagement member (PEM) by using a snap-fit ​​feature and can be released from the PEM by using a socket feature, while in Configuration #3, the plunger rod can be both locked (retained) in the PEM and released from the PEM by using a socket feature.

[0092] In some embodiments, the distal end of the plunger rod includes an entry tip including a number N of fins equidistantly spaced apart at an angle, extending radially outward from the longitudinal axis of the plunger rod. The distal end of the plunger rod also includes a segmented circumferential locking groove formed circumferentially in the distal end by the N fins, between the N fins and the remainder of the plunger rod.

[0093] Figure 7 Depicted is an example plunger rod 700 according to some embodiments, Figure 8A-8B An example plunger tip 800 including an example plunger engagement member (PEM) 810 is depicted according to some embodiments, and Figure 9A-9B An example plunger release member (PRM) 900 is depicted in accordance with some embodiments. PEM 810 and PRM 900 together constitute a mechanism in which PEM 810 is a generally cylindrical male object with a circumferential socket groove or recess, and PRM 900 is a generally cylindrical female object with an internal radial socket pin, and the two objects are designed to mate and unmate with each other through a twisting motion.

[0094] A spigot slot (or groove) is formed circumferentially in the perforated cylindrical member 840 of the PEM 800. The spigot slot is designed as a three-dimensional curve (helix) that encircles the longitudinal axis 830 of the perforated cylindrical member at a constant radial distance from the longitudinal axis 830. The helical slot (e.g., slot 850) is designed so that rotational (torsional) movement of the PEM 800 about its longitudinal axis 830 can be achieved by the helical slot to the rotation angle required to lock the fin (e.g., fin 724) in the PEM 800 and / or (depending on the configuration) unlock the fin from the PEM.

[0095] refer to Fig. 8A , the PEM 810 can be fixedly embedded in or attached to the front section 890 of the plunger tip 800, or the PEM 810 can be manufactured as a part of the plunger tip 800 (for example by using plastic injection molding) so that these two different objects (PEM, plunger tip) can move in unison in the disposable reservoir in the emptying direction of the reservoir and in the opposite direction (i.e., in the filling direction of the reservoir).

[0096] The plunger rod 700, plunger head 800 and PRM 900 can be used in at least two configurations described herein (i.e., configuration #2 and configuration #3). In configuration #2, the plunger rod 700 can be engaged with the PEM 810 by using a snap-fit ​​connection and can be disengaged (released) from the PEM 810 by using a socket mechanism, which includes a number S of spiral socket grooves and the same number of socket radial pins, which can be inserted into the socket grooves and can slide in the socket grooves. The socket groove is designed as a three-dimensional curve (helix) that surrounds the longitudinal axis of the perforated cylindrical member of the PEM at a constant radial distance from the longitudinal axis. The spiral groove of the PEM is designed so that the groove can rotate the PEM around its longitudinal axis by a rotation angle that is required to lock the fins in the PEM and / or (depending on the configuration) unlock the fins from the PEM. In configuration #3, the plunger rod 700 can both engage with (be locked by) and disengage from (release) the PEM 810 by using a socket mechanism.

[0097] refer to Figure 7 , the plunger rod 700 includes a distal end 710 that includes an entry tip 720. For example, the entry tip 720 includes four fins 722, 724, 726, and 728 that are equally spaced apart in angle. (The entry tip 720 may include any suitable number N of fins that are spaced apart in angle.) The fins 722, 724, 726, and 728 extend radially outward (away) from the longitudinal axis 730 of the plunger rod 700. The distal end 710 of the plunger rod 700 also includes a segmented locking groove 740 that is circumferentially formed in the distal end 710 between the fins 722, 724, 726, and 728 and the conical surface 770. The circumferential locking groove 740 is segmented by fins 722, 724, 726, and 728, which are circumferentially distributed with multiple recesses in an alternating manner so that every two adjacent fins are separated by a recess. For example, fins 724 and 726 are adjacent fins that extend radially outward from the longitudinal axis 730 and are separated by recess 750. (In contrast, Figure 2A and Figure 2D The circumferential locking groove 220 in the embodiment is a continuous groove.)

[0098] The fins 722, 724, 726, and 728 and the recesses therebetween form a cross-shaped object resembling a Phillips screwdriver head. The entry end 720 can be generally shaped as a segmented hemispherical end, a segmented conical end, or a cross-shaped Phillips screwdriver head. Each of the example fins 722, 724, 726, and 728 has a curved "entry side" to impart the snap-fit ​​capability mentioned herein in conjunction with Configuration #2 to the fin. In Configuration #3, the fins do not require a curved entry side to engage the PEM or release the fins from the PEM. Therefore, in Configuration #3, each fin can have a curved entry side, although the curved entry side will be rarely or not used in this case because the configuration does not require snap-fit ​​deflection capability.

[0099] refer to Figure 8A-8B , the plunger engagement member (PEM) 810 includes a perforated cylindrical member 840 having an inner wall 812 and four ribs 820. The ribs 820 extend radially inward from the inner wall 812 of the PEM 810 toward the longitudinal axis 830 of the plunger head 800. The ribs 820 are angularly equidistantly spaced or distributed around the inner wall 812 of the PEM 810 around the longitudinal axis 830 of the plunger head 800 (and the cylindrical body 840). The ribs 820 are interspersed with the same number (four in this example) of recesses in an alternating manner, so that every two adjacent ribs 820 are separated by one recess. (The PEM may include a number N of ribs (such as ribs 820), and a corresponding number N of recesses.)

[0100] The ribs 820 of the PEM 810 are designed to lock the fins 722 , 724 , 726 , and 728 of the plunger rod 700 , respectively. According to configuration #2, locking of the fins 722, 724, 726 and 728 by the ribs 820 can be achieved by snap-fitting the distal end 710 of the plunger rod 700 by the PEM 810, or according to configuration #3, locking of the fins 722, 724, 726 and 728 by the ribs 820 can be achieved by inserting the plunger rod 700 into the PEM 810 while rotating the plunger head 800 (and therefore the PEM 810) about its longitudinal axis 830 from a "release" position to a "locked" position, in which the fins 722, 724, 726 and 728 are free to pass through the recesses between the ribs 820, respectively, and in the "locked" position, the ribs 820 of the PEM 810 are aligned with the fins 722, 724, 726 and 728, respectively, thereby locking or retaining the fins.

[0101] The PEM 810 also includes four spigot grooves 850, 860, 870, and 880. The spigot grooves 850, 860, 870, and 880 are formed on the outer circumference of the cylindrical body 840 and are generally arranged as spiral grooves. Figure 8A-8BIn the example PEM shown, each spigot spirals in a counterclockwise direction about the longitudinal axis 830 of the PEM 810 toward an axial forward section 890 of the plunger head 800. The PEM 810 is an axial rearward section of the plunger head 800. (The "front section 890" is the section of the plunger head 800 that is generally forward of the distal end 720 of the plunger rod 700 when the plunger rod 700 is coupled to the PEM 810 and the plunger head 800 is moved to expel medication from the disposable reservoir. The "rear section 810" is the section of the PEM that is generally rearward of the distal end 720 of the plunger rod 700 when the plunger rod 700 is coupled to the PEM 810 and the plunger head 800 is moved in a forward direction to expel medication from the disposable reservoir.)

[0102] Each socket slot is located at the proximal / rear end 892 of the PEM 810 ( Figure 8B ) and at the distal / front end 894 ( Figure 8B ) and each spigot is curved about axis 830 between its entry point and its endpoint. For example, spigot 850 has an entry point 852 at rear end 892 of PEM 810 and an endpoint 854 at front end 894 of PEM 810. Similarly, spigot 860 has an entry point 862 ( Figure 8B ) and an endpoint at the front end 894 of the PEM 810 ( Figure 8A-8B Similarly, the socket slot 870 has an entry point at the rear end 892 of the PEM 810 ( Figure 8A-8B ) and at the end point 894 at the front end 894 of the PEM 810 ( Figures 8A-8B Similarly, the receptacle slot 880 has an entry point 882 at a rear end 892 of the PEM 810 and an end point 884 at a front end 894 of the PEM 810.

[0103] refer to Figure 9A-9B , the plunger release member (PRM) 900 includes a hollow cylindrical body 910 having a hole 920. The cylindrical body 910 also includes an external flange (platform) 930. The platform 930 protrudes circumferentially outward from the cylindrical body 910 and surrounds the cylindrical body 910 to form an "L"-shaped object around the longitudinal axis 940 of the cylindrical body 910 together with the cylindrical body 910. The "L"-shaped object enables the PRM 900 to be attached (mounted) to the proximal end 126 of the reservoir 120. The cylindrical body 910 also includes an inner flange (platform) 950. The platform 950 protrudes circularly inward from the inner wall 952 of the cylindrical body 910 toward the longitudinal axis 940 of the cylindrical body 910. The platform 950 has a diameter D8 (see Fig. 10A ).

[0104] The cylindrical body 910 also includes four spigot radial pins 960, 970, 980, and 990, the number of which (four) corresponds to the four spigot slots 850, 860, 870, and 880. The spigot pins 960, 970, 980, and 990 are configured to enter the spigot slots 850, 860, 870, and 880, respectively, via their entry points. For example, the spigot pin 960 may enter the spigot slot 850 via entry point 852, the spigot pin 970 may enter the spigot slot 860 via entry point 862, the spigot pin 980 may enter the spigot slot 870 via its entry point, and the spigot pin 990 may enter the spigot slot 880 via entry point 882.

[0105] A socket connector is typically a connector in which one portion of the connector can be linearly moved relative to another portion by rotating that portion relative to the other portion. To achieve this feature, one portion of the socket connector includes a helical groove and another portion of the socket connector includes a guide pin. Pushing the helical groove linearly against the guide pin causes rotational movement of one portion of the connector relative to the other portion. Figure 8A-8B as well as Figure 9A-9B , the helical design of the spigot slots 850, 860, 870 and 880 (in combination with the spigot pins 960, 970, 980 and 990) enables the PEM 810 (and thus the entire plunger head 800) to rotate about the longitudinal axis 830 when the PEM 810 is engaged with the PRM 900 and is linearly moved relative to the PRM 900 by the plunger rod 700. For example, when the PEM 810 is engaged with the PRM 190, rotation of the PEM 810 relative to the PRM 190 is achieved by linearly pushing the PEM 810 against the PRM 900 when the plunger rod 700 is to be released from the PEM 810 (according to configuration #2), or linearly pushing the PEM 810 away from the PRM 900 (pushing the PEM 810 out of the PRM 900) to lock the plunger rod 700 in the PEM 810 (according to configuration #3).

[0106] In configuration #2, the plunger rod 700 can be engaged with the PEM 810 using a snap-fit ​​connection (thus, no rotation of either part relative to the other is required), and the plunger rod 700 can be released from the PEM 810 by rotating the PEM 810 in a “release” direction to release the distal end 710 of the plunger rod 700 from the ribs 820 of the PEM 810. In configuration #3, the PEM 810 can be rotated in a “lock” direction to engage the plunger rod 700 with the PEM 810, wherein each fin of the plunger rod 700 is locked by a corresponding rib 820 of the PEM 810, and the PEM 810 can be rotated in the “release” direction to release the plunger rod 700 from the PEM 810.

[0107] In both Configuration #2 and Configuration #3, rotating the PEM 810 in the "release" direction is accomplished by retracting the PEM 810 axially rearward by the plunger rod 700, during which process the spigot slots 850, 860, 870, and 880 are rotationally guided to the "release" angular position by the spigot pins 960, 970, 980, and 990, respectively, of the PRM 900. In Configuration #3, rotating the PEM 810 in the "lock" direction (i.e., in the direction opposite to the "release" direction) is accomplished by pushing the PEM 810 axially forward by the plunger rod 700, during which process the spigot slots 850, 860, 870, and 880 are rotationally guided to the "lock" angular position by the spigot pins of the PRM 900.

[0108] As described herein, the PRM 900 is fixedly mounted to the end 126 of the reservoir 120, meaning that the PRM 900 is stationary within the reservoir 120. Fig. 8A and Fig.9A , after the socket pins 960, 970, 980 and 990 enter the socket slots 850, 860, 870 and 880 respectively via the corresponding entry points, the PEM 810 can be pushed linearly (axially) in the first direction by the plunger rod 700 (i.e., according to configuration #2, so as to facilitate the disengagement of the plunger rod 700 from the PEM 810), thereby rotating the PEM 810 from the locked angular position of each of the four ribs 820 locking one of the fins 722, 724, 726 and 728 to a released (unlocked) angular position, in which the fins 722, 724, 726 and 728 are not locked by the ribs, and therefore, the plunger rod 700 can be disconnected from the PEM 810.

[0109] When the socket pins 960, 970, 980, and 990 reside in the socket slots 850, 860, 870, and 880, respectively, the PEM 810 can be pushed longitudinally (axially) by the plunger rod 700 in the second direction (i.e., to facilitate engagement of the plunger rod 700 with the PEM 810 according to Configuration #3) to rotate the PEM 810 from a released angular position in which none of the plunger rod's fins are locked by the ribs 820 to a locked angular position in which all of the fins 722, 724, 726, and 728 are locked by the ribs 820, respectively. The fins 722, 724, 726, and 728 can then be released from the ribs 820 by rotating the PEM 810 in the opposite direction (i.e., in the first direction) (by both the plunger rod 700 and the socket pins), e.g., as described herein in connection with Configuration #2.

[0110] In configuration #2, the cylindrical member 840 of the PEM 810 is reversibly expandable (and / or the ribs 820 are reversibly compressible) to achieve engagement between the plunger rod and the PEM 810 by snap-fitting the N ribs into the segmented locking grooves 740 of the plunger rod 700 as the plunger rod 700 is linearly moved in the PEM 800 (e.g., by the motor 170). In this configuration, the plunger rod 700 can be released from the PEM 800 by rotating the PEM 800 about its axis (830) from a "locked" ("snap-fit") position to a "released" position. In configuration #3, the PEM 800 (including the cylindrical member 840 and the ribs 820) is made of a rigid (non-expandable) material and is composed of N ribs (e.g., such as Fig. 8A ) locks N fins (e.g., as shown in Figure 7 820) is performed by rotating the PEM 800 about the longitudinal axis 830 in a first direction (e.g., counterclockwise) relative to the entry end 720 of the plunger rod 700 until the fins 722, 724, 726, and 728 reach a "locked" position in which each fin is locked by one of the ribs 820. In this configuration, the plunger rod 700 can be released from the PEM 800 by rotating the PEM 800 about its axis (830) in the opposite direction (e.g., clockwise) from the "locked" position to the "released" position.

[0111] The fins, ribs, and recesses formed by the ribs are configured so that the plunger rod 700 can transition from a locked angular position, in which the fins are respectively aligned with and locked by the ribs to enable the PEM 800 (and therefore the plunger head) to move rearwardly in unison with the retraction movement of the plunger rod 700, to an unlocked (released) angular position, in which the fins are respectively aligned with the recesses to enable the entry end 720 of the plunger rod 700 to be released from the PEM 800 (and therefore from the plunger head).

[0112] refer to Figure 7 and Fig. 10A , the distal end 710 of the plunger rod 700 also includes a push flange 760. PRM 900 ( Figure 9A-9B) The flange (platform) 950 has an inner diameter D8, the flange 760 of the plunger rod 700 has an outer diameter D9, and the PEM 810 has an inner diameter D10. The values of D8, D9, and D10 are selected such that D10 < D9 < D8, so that when the plunger rod 700 is axially moved in the direction 1010 (e.g., by the motor 170) (without moving the PEM 810 at this stage), the entry end 720 of the plunger rod 700 linearly (axially) moves through the inner flange (platform) 950 of the PRM 900 and then through the cylindrical member 840 of the PEM 810 until the flange 760 contacts (abuts) the cylindrical member 840 of the PEM 810 at 1020. From this point on, further linearly moving the plunger rod 700 in the direction 1010 starts to move the PEM 810 in the same direction (in the direction 1010). The socket slots and pins are designed such that the linear displacement of the PEM 810 (and thus the plunger head 800 as a whole) in the direction 1010 is converted into a rotational movement (1030) of the PEM 810 about its axis (axis 830). When the PEM 810 is further linearly pushed, the PEM 810 continues its rotational movement about the axis 830 until the socket slots respectively disengage (move away from) the stationary socket pins.

[0113] The diameter D9 of the flange 760, by being greater than the inner diameter D10 of the cylindrical member 840, enables the flange 760 to push the PEM 810 (which is part of the plunger head) in the forward (emptying) direction 1010 together with the plunger rod 700 when the plunger rod 700 is moved forward by the motor 170 in the reservoir 1020. In both configuration #2 and configuration #3, when the plunger rod 700 is locked in the PEM 810 / locked by the PEM 810, the PEM 810 is tightly clamped between the pushing flange 760 of the plunger rod 700 and the pulling platform of the fin 720 and can move bidirectionally in the reservoir 2020 in unison with the plunger rod 700: moving in the direction 1010 to empty the reservoir 120 and moving in the opposite direction to fill the reservoir 120.

[0114] Fig. 10B An initial state is shown in which the fins 722, 724, 726, and 728 of the plunger rod 700 are unlocked by the ribs 820, such that by linearly moving the plunger rod, the plunger rod 700 can be retracted from the PEM 810. For example, the fin 722 freely moves bidirectionally through the recess 1040 formed by the ribs 820 / 1 and 820 / 2. Similarly, the fin 728 freely moves bidirectionally through the recess 1050 formed by the ribs 820 / 4 and 820 / 1. Fig. 10CThe final angular state is shown, wherein the socket slots have respectively left (moved away from) the stationary socket pins, and the PEM 810 has been rotated relative to the fins 722, 724, 726 and 728 of the plunger rod 700 to an angular position where the fins 722, 724, 726 and 728 are respectively locked by the ribs 820 of the PEM 800.

[0115] Fig. 10D An example initial angular position (γ) of an example PEM 1060 relative to the fins of an example plunger rod is schematically shown. For example, the PEM 1060 includes four ribs (1062, 1064, 1066, and 1068), and thus the plunger rod includes four fins 1070. The initial angular position (angle γ) of the PEM 1060 relative to the plunger rod (and thus the fins 1070) is referred to herein as an "unlocked angular position" or "released angular position" because none of the fins 1070 are locked by the ribs of the PEM, and thus, in this angular position of the PEM 1060 relative to the plunger rod, the fins 1070 can be retracted from the PEM 1060. Although the value of the angle δ between each two adjacent ribs is constant, the value of the angle γ between a rib and the fin adjacent to the rib varies according to the linear (axial) distance traveled by the plunger rod (and thus the PEM). The value of δ depends on the number of ribs (r) of the PEM and can be calculated as follows: δ = 360° / r. Fig. 10D In the example shown, there are four ribs (r=4), so δ=360° / 4=90°. The value of γ can be calculated as follows: γ=δ / 2. Continuing with the above example, γ=δ / 2=90° / 2=45°.

[0116] Fig.10E The plunger rod 700 linearly pushes the PEM 1060 to rotate the PEM 1060 counterclockwise (CCW) by an angle γ=45°, Fig. 10D The unlocking / release angle position shown in Fig. 10B 1070) is rotated to a locked angle position (which corresponds to the unlocked / released angle position shown in FIG. Fig. 10C The PEM 1060 is schematically shown after the fins 1072 are locked by the ribs 1068. Fig.10E The four "black and white" dashed line patterns shown in FIG. 1 , such as black and white dashed line pattern 1080, represent the distal regions of the fins that overlap (ie, contact) the distal regions of the ribs, respectively. Fig. 10D fins and ribs do not overlap.) Fig. 10B , Fig. 10C and Fig. 10CA fin structure comprising four fins is shown, and a corresponding rib structure comprising four ribs. However, the fin structure of the plunger rod may comprise less than four fins (e.g. three fins) or more than four fins (e.g. five fins), wherein the rib structure has the same number of ribs.

[0117] Figures 11A-11I Stages of operation of the pump device according to configuration #2 are shown. Fig.11A A disposable portion (reservoir) 1100 of a pump device is shown before it is coupled to a reusable portion 1110 of the pump device. The reservoir 1100 includes a plunger head 1102 that is bi-directionally movable in the reservoir 1100. The plunger head 1102 includes a plunger engagement member (PEM) 1104 that is configured as or includes a snap-fit ​​connection (locking) mechanism.

[0118] The disposable part (reservoir) 1100 also includes a plunger release member (PRM) 1106 that is stationary in the disposable part 1100, that is, the PRM 1106 is fixedly mounted in the proximal end of the disposable part 1100 and cannot move relative to the disposable part 1100. The reusable part 1110 of the pump device includes a plunger rod 1112 and an electric motor 1114 for bidirectional linear movement of the plunger rod 1112, etc. The plunger rod 1112 includes a distal end 1116, which, like the distal end 710 of the plunger rod 700, includes a push flange and a plurality of fins. The PRM 1106 includes a socket pin. (Two socket pins of the PRM 1106 are shown at 1108.) The disposable part 1100 is connected to the medical vial 1120 via a vial adapter 1130. To begin operating the pump device, the disposable part 1100 is moved (1118) toward the reusable part 1110 to couple them, for example, magnetically.

[0119] Initially (e.g., before the disposable and reusable portions are coupled), the plunger rod 1112 is stowed (fully retracted) in the reusable portion 1110. When the disposable portion 1100 is coupled to the reusable portion 1110, as shown in FIG. Fig. 11B As shown, the electric motor 1114 is controllably operated to move (extend) the plunger rod 1112 forward in direction 1111, thereby engaging the plunger rod 1112 with the PEM 1104 (and therefore with the plunger head 1102). The engagement of the plunger rod 1112 with the PEM 1104 is achieved by snap-fitting the ribs of the PEM 1104 to the fins of the distal end 1116 of the plunger rod 1112, so that the ribs of the PEM 1104 lock the fins of the plunger rod 1112, respectively.

[0120] Referring to configuration #2, a PEM (e.g., PEM 1104) may be initially positioned in the distal end of the reservoir, such as, for example Figure 11A-1C However, the PEM may initially be in any intermediate position in the reservoir between the PRM (e.g., PRM 1106) and the distal end of the reservoir. If the PEM is initially positioned at an intermediate position between the PRM and the distal end of the reservoir, the plunger rod may be required to push the PEM (and therefore the plunger head) to the distal end of the reservoir to ensure that the distal end of the plunger rod (e.g., distal end 1116) is properly snap-fitted by the PEM.

[0121] Fig. 11C The distal end 1116 of the plunger rod 1112 is shown fully extended and locked by the PEM 1104 by being snap-fitted by the PEM 1104. Fig.11D The fins of the plunger rod 1112 are shown in an angularly locked position in which the fins of the plunger rod are locked by the ribs of the PEM 1104. ) At this stage, the electric motor 1114 is controllably operated to retract the plunger rod 1112 rearwardly in direction 1113. Since the fins of the plunger rod 1112 are locked by the ribs of the PEM 1104, the retraction of the plunger rod 1112 causes the plunger head 1102 to move with the plunger rod 1112, which creates a suction force in the reservoir 1100, which causes the reservoir 1100 to fill with the medicament. ( Fig.11E A reservoir 1100 filled with a medicament is shown. )

[0122] refer to Fig.11E , the PEM 1104 is retracted from the distal end of the reservoir 1100 (withdrawn by the plunger rod 1112) within the reservoir 1100, only until the socket pin 1140 ( Fig. 11B ) are respectively adjacent to the entry point of the slot in the PEM 1104. Further retraction of the PEM 1104 beyond the abutment point, such as to the stowed position of the PEM 1104 in the PRM 1106, will cause the socket pin 1140 of the PRM 1106 to cooperate with the socket slot in the PEM 1104 to move the PEM 1104 about its axis from Fig.11D The locking angle position shown is rotated to Fig.11H The unlocked (released) angular position shown is not desirable at this stage. At this stage, the electric motor 1114 ( Fig.11A ) can be controllably operated to move (extend) the plunger rod 1112 linearly (axially) forward in direction 1115 to empty the reservoir 1100, for example, by delivering the medicament from the reservoir 1100 to an infusion site of a patient. When the plunger rod 1112 is moved linearly forward in direction 1115 (e.g., by the electric motor 1114), the flange 1150 of the plunger rod 1112 pushes the PEM 1104 in the same direction to deliver the medicament in the reservoir 1100 to a person in need thereof.

[0123] Fig.11F The reservoir 1100 is shown in its empty state with the plunger rod 1112 fully extended. At this stage, the electric motor 1114 is controllably operated to retract the plunger rod 1112 linearly rearwardly in direction 1117 to release the plunger rod 1112 from the PEM 1104 (and therefore from the plunger head 1102). To release the plunger rod 1112 from the PEM 1104, the plunger rod 1112 is fully retracted (rather than Fig.11E The plunger rod is partially retracted) to operably engage the PEM 1104 with the PRM 1108 so that the socket pin 1140 and the socket slot in the PEM 1104 rotate the PEM 1104 from a locked angular position to an unlocked (released) angular position while the PEM 1104 is linearly moved in the direction 1117 by the plunger rod 1112.

[0124] Fig.11G The plunger rod 1112 is shown fully retracted within the reservoir 1100 , in which position the PEM 1104 is fully stowed within the PRM 1106 . Fig.11H The ribs of the PEM 1104 are shown in an unlocked angular position in which the plunger rod 1112 ( Fig.11D ) can be released from the PEM 1104. At this stage, the plunger rod 1112 can be fully retracted back into the reusable part 1110 by the electric motor, and the disposable part 1100 is separated (disconnected) from the reusable part 1110. Fig.11I The plunger rod 1112 is shown fully retracted (fully stowed) in the reusable portion 1110, the PEM 1104 is fully stowed in the PRM 1106, and the reusable portion 1110 is separated from the disposable portion 1100. Thus, stowing the PEM 1104 in the PRM 1106 by the motor 1114 automatically ejects the plunger rod 1112 from the PEM 1104. Thus, the PRM 1106, by serving as both an ejection tool and a stowage tool, ejects the plunger rod 1112 from the PEM 1104 as the plunger rod 1112 pulls the PEM 1104 into the stowed position in the PRM 1106. (Ejection of the plunger rod 1112 from the PEM 1104 is performed by longitudinally rotating the PEM 1104 relative to the plunger rod 1112.)

[0125] Figure 12A-12M Stages of operating a pump device according to configuration #3 are shown. Fig. 12AA disposable portion (reservoir) 1200 of a pump device is shown before it is coupled to a reusable portion 1210 of the pump device. The reservoir 1200 includes a plunger head 1202 that is bi-directionally movable in the reservoir 1200. The plunger head 1202 includes a plunger engagement member (PEM) 1204 that is configured as or includes a socket connection mechanism.

[0126] The disposable portion (reservoir) 1200 also includes a plunger release member (PRM) 1206 that is stationary in the disposable portion 1200, i.e., the PRM 1206 is fixedly mounted in the proximal end of the disposable portion 1200 and cannot move relative to the disposable portion 1200. The reusable portion 1210 of the pump device includes, among other things, a plunger rod 1212 and an electric motor 1214 for bidirectional linear movement of the plunger rod 1212. The plunger rod 1212 includes a distal end 1216, similar to the distal end 710 of the plunger rod 700, and the distal end 1216 of the plunger rod 1212 includes a push flange and a plurality of fins. The PRM 1206 includes a socket pin. (The socket pin of the PRM 1206 is in Figure 12G and Fig.12J ) To begin operating the pump device, the disposable portion 1200 is moved in a direction 1218 toward the reusable portion 1210 to, for example, magnetically couple the disposable portion 1200 and the reusable portion 1210. Initially (e.g., before the disposable portion 1200 and the reusable portion 1210 are coupled), the plunger rod 1212 is stowed (fully retracted) in the reusable portion 1210, and the PEM 1204 is fully stowed in the PRM 1206.

[0127] When the disposable portion 1200 is coupled to the reusable portion 1210, as Fig. 12B As shown, the electric motor 1214 is controllably operated to move (extend) the plunger rod 1212 forward in direction 1211 to engage the distal end 1216 of the plunger rod 1212 with the PEM 1204 (and therefore with the plunger head 1202). The engagement of the distal end 1216 of the plunger rod 1212 with the PEM 1204 is achieved by using a socket mechanism that enables ribs in the PEM 1204 to rotate relative to fins in the distal end 1216 of the plunger rod 1212 from an unlocked angular position to a locked angular position, such that in the angularly locked position, the ribs of the PEM 1204 lock the fins of the plunger rod 1212, respectively.

[0128] In configuration #3, the PEM 1204 is initially positioned (stowed) in the proximal end of the reservoir 1200, wherein the socket pins of the PRM 1206 have rested (occupied) in the helical socket grooves of the PEM 1204, respectively, as shown in FIG. Figure 12A-2CLinear movement of the PEM 1204 away from the initial (stowed) position causes the socket mechanism, i.e., the slot in the PEM 1204 together with the pin 1208 in the PRM 1206 ( Figure 12G and Fig.12J ), rotating the PEM 1204 from the unlocked angular position to the locked angular position.

[0129] Fig. 12C The distal end 1216 of the plunger rod 1212 is shown residing in the PEM 1204 in a pre-lock state (ie, before the PEM 1204 is pushed against the socket pin 1208 to rotate the PEM 1204 into a locked angular position). Fig.12D The distal end 1216 of the plunger rod 1212 (and thus the fins of the plunger rod 1212 ) is shown still unlocked by the ribs of the PEM 1204 .

[0130] Fig.12E The PEM 1204 is shown to be linearly moved away from the stowed position in the PRM 1206 (by the electric motor 1214) by a distance 1201, and then rotated from the unlocked angular position to the locked angular position. In the locked angular position, the fins of the plunger rod 1212 are locked by the ribs of the PEM 1204, respectively, as shown in FIG. Fig.12F At this stage, the electric motor 1214 is controllably operated to move the plunger rod 1212 further forward in direction 1213, ready to fill the reservoir 1200 with medicament by drawing medicament from the medicament vial.

[0131] Figure 12G The PEM 1204 is shown at the distal end of the reservoir 1200, and the vial 1220 is coupled to the reservoir 1200 via a vial adapter. Since the fins of the plunger rod 1212 are locked by the ribs of the PEM 1204 at this stage, the retraction of the plunger rod 1212 in the direction 1215 causes the plunger head 1202 to move in unison with the plunger rod 1212 in the direction 1215. The movement of the plunger head 1202 in the direction 1215 creates a suction force in the reservoir 1200, which fills the reservoir 1200 with the medicament. ( Fig.12H A reservoir 1200 filled with a medicament is shown. )

[0132] refer to Fig.12H, the PEM 1204 is retracted in the reservoir 1200 from the distal end of the reservoir 1200 (withdrawn by the plunger rod 1212), only to a point where the spigot pins of the PRM 1206 respectively abut the entry points of the slots in the PEM 1204. (At this point the reservoir 1200 is full of medicament.) Further retraction of the PEM 1204 beyond the abutment point, e.g., to a stowed position of the PEM 1204 in the PRM 1206, will cause the spigot pins 1208 in the PRM 1206 and the slots in the PEM 1204 to cooperate to move the PEM 1204 about its axis from the distal end of the reservoir 1200 to the distal end of the reservoir 1200. Fig.12F The locking angle position shown is rotated to Figure 12L The unlocked (released) angular position shown is not desired at this stage. At this stage, the electric motor 1214 can be controllably operated to move (extend) the plunger rod 1212 linearly (axially) forward in direction 1217, as shown in FIG. Fig.12I As shown, the reservoir 1200 is emptied, for example, by delivering the medicament from the reservoir 1200 to an infusion site of a patient. When the plunger rod 1212 is moved linearly forward in direction 1217 (e.g., by the electric motor 1214), the flange 1230 of the plunger rod 1212 pushes the PEM 1204 in the same direction to deliver the medicament in the reservoir 1200 to a person in need.

[0133] Fig.12J The reservoir 1200 is shown in its empty state with the plunger rod 1212 fully extended. At this stage, the electric motor is controllably operated to retract the plunger rod 1212 linearly rearwardly in direction 1219 to release the distal end 1216 of the plunger rod 1212 from the PEM 1204 (and therefore from the plunger head 1202). In order to release the distal end 1216 of the plunger rod 1212 from the PEM 1204, the plunger rod 1212 is fully retracted (rather than Fig.12H The plunger rod 1212 is partially retracted) to (re)engage the PEM 1204 with the PRM 1206, thereby causing the socket pin 1208 and the socket slot in the PEM 1204 to rotate the PEM 1204 from a locked angular position to an unlocked (released) angular position, while the PEM 1204 is linearly moved in direction 1219 by the plunger rod 1212.

[0134] Figure 12K The plunger rod 1212 is shown fully retracted in the reservoir 1200, and Figure 12LThe plunger rod 1212 is shown released from the ribs of the PEM 1204 after the PEM 1204 (relative to the plunger rod) is rotated to an unlocked angular position in which the plunger rod 1212 can be released from the PEM 1204. At this stage, the plunger rod 1212 can be fully retracted back and stowed in the reusable portion 1210 by the electric motor, and the disposable portion 1200 can be separated (disconnected) from the reusable portion 1210, as shown. Figure 12M Thus, the PEM 1204 is retracted into the PRM 1206 by the motor 1214 to be combined with Fig.11G The plunger rod 1212 is automatically ejected from the PEM 1204 in a similar manner as described.

[0135] Figure 12K The plunger rod 2112 is shown fully retracted within the reservoir 1200 , in which position the PEM 1204 is fully stowed within the PRM 1206 . Figure 12L The four ribs of the PEM 1204 are shown in an unlocked angular position where the plunger rod 1212 can be released from the PEM 1204. At this stage, the plunger rod 1212 can be fully retracted back by the electric motor and stowed in the reusable part 1210, and the disposable part 1200 can be separated (disconnected) from the reusable part 1210. Figure 12M The plunger rod 1212 is shown fully retracted (fully stowed) in the reusable portion 1210 , the PEM 1204 is fully stowed in the PRM 1206 , and the disposable portion (reservoir) 1200 is separated from the reusable portion 1210 .

[0136] Figures 13A-13F Demonstrated is the use of a socket feature to lock the plunger rod 1300 into the plunger engagement member (PEM) 1310 of the plunger head 1320 according to configuration #3. Fig.13A 1 is a cross-sectional view of a PEM 1310 shown in a stowed position in a plunger release member (PRM) 1330. As described herein in connection with Configuration #2 and Configuration #3, when the PEM is in the stowed position in the PRM, the PEM is in an unlocked (released) angular position, meaning that the plunger rod has not been locked by the PEM. Additionally, when the PEM is in the stowed position in the PRM, each socket pin of the PRM is located at an end point of a corresponding socket slot in the PEM.

[0137] refer to Fig.13A , the socket pin 1340 of the PRM 1330 is located at the end point of the socket slot 1350 in the PEM 1310. (The end point of the socket slot 1350 is at Fig. 13C ) At this stage, the socket pins (eg, pins 1340) are each farthest from the entry point of the socket slot. Fig. 13BA cross-sectional view of a three-dimensional assembly including a plunger rod 1300, a PEM 1310, and a PRM 1330 is shown.

[0138] For example, an electric motor is used to move in a direction 1360 ( Fig. 13B ) causes the flange 1302 of the plunger rod 1300 to push the PEM 1310 in the same direction (1360), and thus causes the PEM 1310 to rotate in a counter-clockwise (CCW) direction 1380 ( Fig. 13C When the PEM 1310 begins to rotate in the CCW direction, the endpoints of the socket slots are separated from the socket pins, respectively, and the distance between the endpoint of each slot and the corresponding socket pin increases as the PEM 1310 continues to rotate in the CCW direction (1380). Fig. 13C The PEM 1310 is shown in an intermediate state, wherein the socket pin is positioned approximately in the middle of the socket slot. As an example, Fig. 13C The socket pin 1340 is shown in an intermediate state, wherein the socket pin 1340 is approximately in the middle of the socket slot 1350. Fig.13D Shown from different perspectives Fig. 13C component and an additional socket pin (pin 1390), which, like socket pin 1340, reaches approximately the middle of the corresponding socket slot (slot 1392).

[0139] As the plunger rod 1300 continues to move linearly in direction 1360, the flange 1302 of the plunger rod 1300 continues to push the PEM 1310 in the same direction. Due to the linear (axial) movement of the PEM 1310, the pin of the PRM 1330 continues to rotate the PEM 1310 in the CCW direction until the PEM 1310 reaches its locked angular position. When the PEM 1310 reaches its locked angular position, the fins of the plunger rod 1300 are locked by the ribs of the PEM 1310, respectively, such as Fig.12F As shown. ( Fig.12F The PEM 1204 is shown in its locked angular position, in which the fins of the plunger rod 1212 are respectively locked by the ribs of the PEM 1204.

[0140] Fig.13EThe PEM 1310 (and thus the plunger head 1320 as a whole) is shown in its locked angular position, wherein the spigot pins of the PRM 1330 are respectively positioned at the entry points of the spigot slots in the PEM 1310, ready to be retained by the spigot slots. For example, the spigot pin 1340 is positioned at the entry point 1352 of the spigot slot 1350. When the PEM 1310 reaches its locked angular position, further movement of the PEM 1310 in direction 1360 causes the PEM 1310 to move linearly to the distal end of the reservoir without further rotation in the CCW direction or the clockwise (CW) direction. (As the PEM 1310 moves between the proximal and distal ends of the reservoir, the PEM 1310 does not rotate in either direction (CCW or CW), but rather maintains its locked angular position.)

[0141] With respect to Configuration #2 and Configuration #3, the number of socket pins and socket slots is not limited to any particular number (e.g., two, three, or four), and the number of socket pins is the same as the number of socket slots such that each particular socket slot is associated with one socket pin, and vice versa.

[0142] According to some embodiments, the disposable reservoir contains levodopa or carbidopa, or a combination of levodopa and carbidopa.

[0143] Compared to conventional disposable parts (reservoirs), the benefits of the disposable parts (reservoirs) of the present invention including PEM and PRM are at least as follows:

[0144] 1. Reduce the cost of goods (COGS) associated with the disposable portion of the pump device (the reservoir);

[0145] 2. The smaller portion is embedded or included in the disposable portion (reservoir);

[0146] 3. Improve product sustainability;

[0147] 4. Since the lead screw (plunger rod) is part of the reusable part of the pump device, the advancement system is more accurate, enabling the pump device to be operated with higher precision and smaller or tighter tolerances;

[0148] 5. Ability to design round syringes instead of oval syringes or syringes with other shapes;

[0149] 6. Simplified assembly process of disposable part (reservoir);

[0150] 7. Support the concept of pre-filled reservoirs;

[0151] 8. Lead screw positioning and position monitoring are more accurate;

[0152] 9. More efficient occlusion control due to enhanced control over the position of the lead screw (plunger rod), and

[0153] 10. Improved drug delivery system concepts.

[0154] The articles "a" and "an" are used herein to refer to one or more than one (e.g., at least one) grammatical object of an article, depending on the context. For example, "element" may mean one element or more than one element, depending on the context. The term "including" is used herein to mean the phrase "including but not limited to" and is used interchangeably with the phrase "including but not limited to". Unless the context clearly indicates otherwise, the terms "or" and "and" are used herein to mean the terms "and / or" and are used interchangeably with the terms "and / or". The term "such as" is used herein to mean the phrase "such as but not limited to" and is used interchangeably with the phrase "such as but not limited to".

[0155] Exemplary embodiments of the present invention have been described so that it will be apparent to those skilled in the art that modifications of the disclosed embodiments will be within the scope of the present invention. Therefore, alternative embodiments may include functionally equivalent objects / articles. For example, the PEM and / or PRM and / or the plunger rod may have a different design (e.g., different shapes, sizes, and / or materials) than shown in the accompanying drawings. The features of certain embodiments may be used together with other embodiments shown herein. The present disclosure is described in conjunction with a pump device including a disposable reservoir and a reusable portion. However, the present disclosure may be related to other types of "two-part" devices, pumps, syringes, therapeutic drug dispensing devices, etc. (e.g., the present disclosure may be implemented by other types of "two-part" devices, pumps, syringes, therapeutic drug dispensing devices, etc., used with other types of "two-part" devices, pumps, syringes, therapeutic drug dispensing devices, etc. or used for other types of "two-part" devices, pumps, syringes, therapeutic drug dispensing devices, etc.). Therefore, the scope of the appended claims is not limited by the disclosure herein.

Claims

1. A pump device for delivering a medicament, comprising: - a disposable reservoir comprising a plunger head capable of bidirectional movement within the disposable reservoir between a proximal end of the disposable reservoir and a distal end of the disposable reservoir; as well as - a reusable part comprising a plunger rod, wherein the plunger rod and the plunger head are configured such that the plunger rod can be releasably locked in the plunger head when the disposable reservoir and the reusable part are coupled to each other.

2. The pump device according to claim 1, wherein: The plunger head includes a concentric plunger engagement member (PEM) that is bi-directionally movable in unison (together) with the plunger head between the proximal end of the disposable reservoir and the distal end of the disposable reservoir, and wherein the disposable reservoir also includes a perforated plunger release member (PRM) that is concentrically and fixedly mounted to the proximal end of the disposable reservoir, and wherein the plunger rod includes a distal end and is bi-directionally movable through the perforated PRM, and wherein the distal end of the plunger rod is lockable in the PEM and releasable from the PEM by the PRM when the disposable reservoir and the reusable portion are coupled to each other.

3. The pump device according to claim 1, wherein: The plunger rod can be locked in and released from the PEM by using a snap-fit ​​connection means, or a socket connection means, or a combination of a snap-fit ​​connection means and a socket connection means.

4. The pump device according to claim 3, wherein: The snap-fit ​​connection tool includes an annular snap-fit ​​feature, or a cantilevered snap-fit ​​connection feature, or a combination of an annular snap-fit ​​feature and a cantilevered snap-fit ​​connection feature.

5. The pump device according to claim 3, wherein: The snap-fit ​​connection means comprises the distal end of the plunger rod, the PEM and the PRM.

6. The pump device according to claim 5, wherein: The distal end of the plunger rod includes an entry tip and an annular locking groove, which is circumferentially formed in the distal end between the entry tip and the rest of the plunger rod, and wherein the PEM includes an annular base and flexible arms, which extend circumferentially from the annular base and bend inwardly toward the central axis of the PEM to form a flexible cap-like structure with an opening, which can be snap-fitted into the annular locking groove.

7. The pump device according to claim 6, wherein: The PRM comprises an outer (external) cylindrical body and a concentric inner (internal) hollow cylindrical body, the plunger rod being movable through the outer cylindrical body and the concentric inner hollow cylindrical body, wherein the outer cylindrical body and the concentric inner hollow cylindrical body define an open annular channel between the outer cylindrical body and the concentric inner hollow cylindrical body, and wherein the inner hollow cylindrical body is configured to deflect the flexible arms of the PEM radially outward to release ("break out") the plunger rod from the PEM when the PEM is retracted by the plunger rod to a stowed position in the open annular channel.

8. The pump device according to claim 6, wherein: The entry tip is selected from the group consisting of a hemispherical tip, a conical tip, and a truncated trapezoid.

9. The pump device according to claim 6, wherein: Each flexible arm comprises a proximal section extending from the annular base at an acute angle α relative to the plane of the annular base (where α<90°) and a distal section extending continuously from the proximal section at an acute angle β relative to the annular base (where β<α).

10. The pump device according to claim 9, wherein The distal section of the flexible arm is configured to snap fit into the annular locking groove of the plunger rod.

11. The pump device according to claim 10, wherein The annular locking groove includes an annular pulling platform for pulling the PEM in a rearward direction in unison with the plunger rod by pulling the distal section of the flexible arm as the plunger rod is retracted in the disposable reservoir.

12. The pump device according to claim 6, wherein: The annular locking groove also includes a conical surface to enable the plunger rod to move in a forward direction through the opening in the flexible cap-like structure until the entry end of the plunger rod contacts an inner push surface of the plunger head.

13. The pump device according to claim 6, wherein: As the entry end of the plunger rod moves forward through the opening in the flexible cap-like structure, the flexible arms are deflected radially outward by the entry end of the plunger rod, and as the entry end moves past the opening in the flexible cap-like structure, the flexible cap-like structure snaps into the annular locking groove to lock the plunger rod in the plunger engagement member (PEM).

14. The pump device according to claim 6, wherein: The entry end of the plunger rod includes an entry side that is curvilinearly shaped to deflect the flexible arms radially outward.

15. The pump device according to claim 6, wherein The number of flexible arms is 2n (where n=1, 2, 3, . . . etc.), and wherein the flexible arms are of the same size and shape and are angularly equidistant from each other.

16. The pump device according to claim 6, wherein: The number of flexible arms is selected from the group consisting of four (4) flexible arms, six (6) flexible arms, and eight (8) flexible arms.

17. The pump device according to claim 3, wherein: The snap-fit ​​connection is an irreversible snap-fit ​​connection.

18. The pump device according to claim 2, wherein: The distal end of the plunger rod comprises: an entry tip comprising a number N of fins angularly distributed about the longitudinal axis of the plunger rod and extending radially outwardly from the longitudinal axis of the plunger rod and a segmented (discrete, discontinuous) locking groove formed circumferentially in the distal end between the N fins and the remainder of the plunger rod, and Wherein, the plunger engagement member (PEM) comprises: - a perforated cylindrical member having an inner wall; - a number N of ribs extending radially inwardly from the inner wall towards the longitudinal axis of the perforated cylindrical member and configured to lock the N fins, respectively; and - a number S of spigot slots formed circumferentially in said perforated cylindrical member.

19. The pump device according to claim 18, wherein Each of the S socket grooves is designed as a spiral, which surrounds the longitudinal axis of the perforated cylindrical member at a constant distance from the longitudinal axis of the perforated cylindrical member, and the socket groove enables the PEM to rotate around the longitudinal axis of the perforated cylindrical member by a rotation angle, and the rotation angle is suitable for locking the N fins by the N ribs and for unlocking the N fins from the N ribs.

20. The pump device of claim 18, wherein: The PRM includes a hollow cylindrical body and a number S of socket pins, the plunger rod being movable through the hollow cylindrical body, the S socket pins extending radially inward from the inner wall of the hollow cylindrical body, wherein the S socket pins are respectively engageable with the S socket slots of the PEM to allow the PEM to rotate relative to the PRM.

21. The pump device of claim 20, wherein: The PEM is rotatable relative to the PRM between a locked angular position and a released angular position, In the locked angular position, the N fins are aligned with and locked by the N ribs, respectively, so that the plunger head can be retracted by the plunger rod, and In the release angular position, the N fins are respectively misaligned with the N ribs, so that when the PEM is linearly retracted by the plunger rod to a stowed position in the PRM, the plunger rod can be released from the plunger head, Wherein, each of the S socket slots is designed to enable the PEM to rotate from the locked angle position to the released angle position when the PEM is linearly moved to the stowed position in the PRM, and to enable the PEM to rotate from the released angle position to the locked angle position when the PEM is linearly moved away from the stowed position in the PRM.

22. The pump device of claim 21, wherein Rotating the PEM from the locked angle position to the released angle position includes rotating the PEM clockwise (or counterclockwise) by a release angle (γ), and wherein rotating the PEM from the released angle position to the locked angle position includes rotating the PEM counterclockwise (or clockwise) by a lock angle (γ), wherein the value of the release angle / lock angle (γ) is γ=180° / N.

23. The pump device of claim 22, wherein: The value of N is selected from the group consisting of N=2, N=3, N=4, N=5 and N=6.

24. The pump device of claim 21, wherein: The distal end of the plunger rod further includes a push flange having a diameter greater than an inner diameter of the perforated cylindrical member so as to push the PEM in a forward direction in unison with the plunger rod as the plunger rod moves forward in the disposable reservoir.

25. The pump device of claim 24, wherein: The N fins include N pulling platforms, and wherein, in the locked angular position, the PEM is clamped between the push flange and the N pulling platforms, and the PEM is movable in a rearward direction in unison with the plunger rod when the plunger rod is retracted in the disposable reservoir.

26. The pump device of claim 18, wherein: The entry tip is shaped as a segmented hemispherical tip, a segmented conical tip, or a cross-shaped Phillips screwdriver head.

27. The pump device of claim 21, wherein: The PEM is initially positioned at the distal end of the disposable reservoir, and the plunger rod can be locked by the PEM in the locked angular position by moving the plunger rod forward through the PRM in the disposable reservoir until the N fins of the plunger rod are respectively snap-engaged by the N ribs of the PEM, and wherein the plunger rod can be released from the PEM by retracting the PEM to the stowed position in the PRM to cause a twisting movement of the PEM relative to the PRM from the locked angular position to the released angular position.

28. A pump device according to claim 27, wherein The perforated cylindrical member of the PEM is reversibly expandable by the N fins of the plunger rod to facilitate a snap fit of the N ribs of the PEM into the segmented locking grooves in the distal end of the plunger rod.

29. The pump device of claim 27, wherein: The N ribs of the PEM are reversibly compressible by the N fins to facilitate a snap-fit ​​of the N ribs of the PEM into the segmented locking grooves in the distal end of the plunger rod.

30. The pump device of claim 21, wherein: The PEM is initially in the stowed position in the PRM at the release angle position, and wherein the plunger rod can be locked by the PEM by moving the plunger rod forward through the PRM so that the plunger rod linearly moves the PEM away from the stowed position in the PRM while rotating the PEM from the release angle position to the locked angle position, and wherein the plunger rod can be released from the PEM by retracting the PEM to the stowed position in the PRM so as to rotate the PEM from the locked angle position to the release angle position.

31. A disposable reservoir releasably connectable to a reusable portion of a drug delivery device, the disposable reservoir comprising: a plunger head comprising a plunger engagement member (PEM) and bi-directionally movable between a proximal end of the disposable reservoir and a distal end of the disposable reservoir in unison with the PEM, the PEM being configured to engage a plunger rod of the reusable portion of the drug delivery device; as well as A plunger release member (PRM) is fixedly attached to the proximal end of the disposable reservoir, the PRM being configured to release the plunger rod from the PEM when the PEM is moved by the plunger rod to a stowed position in the PRM.

32. The disposable reservoir of claim 31, wherein: The plunger rod can be locked by or in the PEM by moving the plunger rod forward in the disposable reservoir, through the PRM, until the plunger rod is snap-engaged by the flexible arms of the PEM, and wherein the plunger rod can be released from the PEM by retracting the PEM to the stowed position, in which the PRM deflects the flexible arms of the PEM to release the plunger rod from the PEM.

33. The disposable reservoir of claim 31, wherein: The PEM is initially positioned at the distal end of the disposable reservoir, and the plunger rod is initially lockable by the PEM in a locked angular position by moving the plunger rod forward in the disposable reservoir, through the PRM, until the plunger rod is snap-engaged by the PEM, and wherein the plunger rod is releasable from the PEM by moving the PEM to the stowed position in the PRM to cause twisting movement of the PEM relative to the PRM from the locked angular position to a released angular position.

34. The disposable reservoir of claim 31, wherein: The PEM is initially stowed in the PRM in a released angular position, and wherein the plunger rod can be locked by the PEM by moving the plunger rod forward through the PRM so that the plunger rod linearly moves the PEM away from the stowed position in the PRM while rotating the PEM from the released angular position to a locked angular position, and wherein the plunger rod can be released from the PEM by moving the PEM back to the stowed position in the PRM so as to rotate the PEM from the locked angular position back to the released angular position.

35. The apparatus of claim 1 or claim 31, wherein: The disposable reservoir contains levodopa or carbidopa, or a combination of levodopa and carbidopa.

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