Drug delivery devices

Abstract

The therapeutic agent delivery device includes a disposable part and a reusable part that removably carries the disposable part. The reusable part includes a drive mechanism having a guide, a rotational actuator, and a follower drivingly coupled to the rotational actuator and movably coupled to the guide. The rotational actuator is operable to rotationally drive the follower, which thereby follows the guide and translates the drive mechanism. The drive mechanism thereby translates a syringe assembly of the disposable part from a stored configuration to a deployed configuration.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) None applicable.

[0002] (Field of the Invention) The present disclosure relates to therapeutic drug delivery devices, and more particularly to portable therapeutic drug delivery devices such as syringe pens.

Background Art

[0003] Patients suffering from several different diseases must frequently inject themselves with drugs. To enable a person to administer a drug conveniently and accurately, various devices, widely known as syringe pens or injection pens, have been developed. Generally, these pens include a cartridge containing a piston and a pharmaceutical solution for one or more doses. A drive member extending from within the base of the syringe pen and operably connected to a typically more rearward mechanism of the pen that controls the movement of the drive member is typically movable forward to advance the piston within the cartridge in a manner that dispenses the drug contained from an outlet at the end of the opposing cartridge through a needle that penetrates a stopper at its opposite end. In disposable pens, after using the pen to deplete the supply of drug within the cartridge, the user may discard the entire pen and then initiate use of a replacement pen. In reusable pens, after using the pen to deplete the supply of drug within the cartridge, the pen is disassembled, the used cartridge is replaced with a new cartridge, and the pen is reassembled for subsequent use.

[0004] It is considered desirable to provide a therapeutic drug delivery device having improved features such as providing a reusable device that facilitates the ease of drug dispensing and / or the ease of replacing a used cartridge with a new cartridge.

Summary of the Invention

Means for Solving the Problems

[0005] According to another embodiment of the present disclosure, a therapeutic drug delivery device includes a housing having a distal end and a proximal end, and a syringe assembly supported by the housing. The syringe assembly includes a chamber having a passage, a therapeutic drug to be delivered in the passage, and a needle communicating with the passage. A cap covers the proximal end of the housing, and the cap is translationally translatable relative to the housing and fixed to the syringe assembly. A compression spring connects the housing to the cap. The syringe assembly and cap may be translationally translatable relative to the housing from a housing configuration to a deployed configuration. In the housing configuration, the needle is positioned proximal to the distal end of the housing. In the deployed configuration, the needle extends at least partially distally from the distal end of the housing. A compression spring biases the syringe assembly and cap away from the deployed configuration toward the housing configuration.

[0006] According to further embodiments of the present disclosure, a therapeutic drug delivery device includes a disposable portion and a reusable portion that detachably carries the disposable portion. The disposable portion includes a first housing and a syringe assembly carried by the first housing. The syringe assembly includes a chamber having a passage, a therapeutic drug to be delivered in the passage, and a needle communicating with the passage. The reusable portion includes a second housing and a locking mechanism carried within the second housing. One of the disposable portion and the locking mechanism includes a track, and the other of the disposable portion and the locking mechanism includes a projection that is movable along the track. The locking mechanism is operable to move the projection along the track, thereby locking the disposable portion within the reusable portion. [Brief explanation of the drawing]

[0007] The above-mentioned advantages and objectives of the present invention, as well as other advantages and objectives, and methods for achieving them, will become more apparent and the invention itself will be better understood by referring to the following description of embodiments of the present invention made in connection with the accompanying drawings. [Figure 1] This is a top perspective view of a therapeutic drug delivery device according to one embodiment of the present disclosure. [Figure 2] Figure 1 is a bottom perspective view of the drug delivery device, showing the disposable portion separated from the reusable portion. [Figure 3] Figure 1 shows a cross-sectional view of a drug delivery device along line 3-3, where the syringe assembly is shown in its housing configuration. [Figure 4] Figure 1 is a cross-sectional view of the distal end of the drug delivery device, with the syringe assembly shown in an unfolded configuration. [Figure 5] Figure 1 is a schematic diagram of the electronic assembly of a drug delivery device. [Figure 6] This is a detailed cross-sectional view of the proximal end of the drug delivery device located within line 6 in Figure 3. [Figure 7] This is a cross-sectional view of the proximal end of a drug delivery device along line 7-7 in Figure 1. [Figure 8] This is a cross-sectional view of the proximal end of a drug delivery device along line 8-8 in Figure 1. [Figure 9] Figure 1 is a detailed cross-sectional view of the proximal end of the therapeutic drug delivery device in its first configuration. [Figure 10] Figure 1 is a cross-sectional view of the first configuration of the proximal end of the drug delivery device. [Figure 11] Figure 1 is a detailed cross-sectional view of the second configuration at the proximal end of the drug delivery device. [Figure 12] Figure 1 is a cross-sectional view of the second configuration at the proximal end of the drug delivery device. [Figure 13] Figure 1 is a detailed cross-sectional view of the third configuration at the proximal end of the drug delivery device. [Figure 14] This is a cross-sectional view of the third configuration at the proximal end of the drug delivery device shown in Figure 1. [Figure 15] Figure 1 is a detailed cross-sectional view of the fourth configuration at the proximal end of the drug delivery device. [Figure 16] This is a cross-sectional view of the fourth configuration at the proximal end of the drug delivery device shown in Figure 1. [Figure 17] Figure 1 is a perspective view of the drug delivery mechanism of a drug delivery device. [Figure 18] It is a detailed cross-sectional view of a therapeutic agent delivery device within line 18 of FIG. 3. [Figure 19] It is a cross-sectional perspective view of a therapeutic agent delivery mechanism and a syringe assembly according to an embodiment of the present disclosure. [Figure 20] It is a cross-sectional view of the therapeutic agent delivery mechanism and the syringe assembly of FIG. 19, and the therapeutic agent delivery mechanism is illustrated in a storage configuration. [Figure 21] It is a cross-sectional view of the therapeutic agent delivery mechanism and the syringe assembly of FIG. 19, and the therapeutic agent delivery mechanism is illustrated in an extended configuration. [Figure 22] It is a perspective view of the disposable portion of the therapeutic agent delivery device of FIG. 1. [Figure 23] It is a cross-sectional view of the disposable portion along line 23-23 of FIG. 22. [Figure 24] It is an exploded perspective view of the disposable portion of FIG. 22. [Figure 25] It is a perspective view of the disposable portion according to an embodiment of the present disclosure. [Figure 26] It is an exploded perspective view of the disposable portion of FIG. 25. [Figure 27] It is a side view of the disposable portion of FIG. 25 in a first configuration. [Figure 28] It is a side view of the disposable portion of FIG. 25 in a second configuration. [Figure 29] It is a side view of the disposable portion of FIG. 25 in a third configuration. [Figure 30] It is an exploded perspective view of the disposable portion according to another embodiment of the present disclosure. [Figure 31] It is a detailed side view of the disposable portion of FIG. 30. [Figure 32] It is a perspective view of the fixing mechanism of the therapeutic agent delivery device of FIG. 1. [Figure 33] It is a cross-sectional view of the fixing mechanism along line 33-33 of FIG. 32. [Figure 34] It is a side view of the fixing mechanism of FIG. 32 and the disposable portion in a first configuration. [Figure 35]Figure 32 is a side view of the fixing mechanism and the disposable part in the second configuration. [Figure 36] Figure 32 is a side view of the fixing mechanism and the disposable part in the third configuration. [Figure 37] Figure 32 is a side view of the fixing mechanism and the disposable part in the fourth configuration. [Figure 38] Figure 32 is a side view of the fixing mechanism and the disposable part in the fifth configuration. [Figure 39] Figure 32 is a side view of the fixing mechanism and the disposable part in the sixth configuration. [Figure 40] This is a cross-sectional view of a fixing mechanism according to one embodiment of the present disclosure. [Figure 41] Figure 40 is a side view of the fixing mechanism and the disposable part in the second configuration. [Figure 42] Figure 40 is a side view of the fixing mechanism and the disposable part in the third configuration. [Figure 43] Figure 40 is a side view of the fixing mechanism and the disposable part in the fourth configuration. [Figure 44] Figure 40 is a side view of the fixing mechanism and the disposable part in the fifth configuration. [Figure 45] Figure 40 is a side view of the fixing mechanism and the disposable part in the sixth configuration. [Figure 46] Figure 40 is a side view of the fixing mechanism and the disposable part in the seventh configuration.

[0008] Throughout the drawings, corresponding reference numerals indicate corresponding parts. While the drawings represent embodiments of the present invention, they are not necessarily to scale, and certain features may be exaggerated or omitted in some drawings in order to better illustrate and explain the present invention. [Modes for carrying out the invention]

[0009] The therapeutic drug delivery device according to this disclosure carries and dispenses one or more therapeutic drugs, which may also be referred to as drugs or pharmacologics. Such therapeutic drugs include, for example, epinephrine, anesthetics, analgesics, steroids, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptides (GIP), GIP analogs, GIP derivatives, GIP / GLP-1 combination agonists such as tilzepatide, basal insulin, oxintomodulin analogs, oxintomodulin derivatives, therapeutic antibodies including, but not limited to, IL-23 antibody analogs or derivatives such as mirikizumab, IL-17 antibody analogs or derivatives such as ixekizumab, pain-related therapeutic drugs such as galcanezumab or rasmiditan, or lebrikizumab, and any therapeutic drugs that can be delivered by the device described herein. The therapeutic drug delivery devices described herein are operated by a user (e.g., a healthcare professional, caregiver, or another person) in a manner generally described herein to deliver one or more therapeutic drugs to a patient (e.g., another person or user).

[0010] Any directional references used with respect to any part of the figure, such as right or left, up or down, or top or bottom, are for illustrative purposes only and do not limit the disclosure or any of its components to any particular location or spatial orientation.

[0011] Figures 1 to 4 illustrate a therapeutic drug delivery device 100 according to an exemplary embodiment of the present disclosure. Exemplarily, the therapeutic drug delivery device 100 has a syringe pen-like shape, but other shapes may be used instead. The therapeutic drug delivery device 100 generally includes a reusable portion 102, which may also be referred to as a drive portion, and a disposable portion 104, which may also be referred to as a drug-carrying portion or cartridge. The reusable portion 102 facilitates the delivery of the therapeutic drug 106 (Figures 3 and 4) from the disposable portion 104. In addition, the disposable portion 104 is detachably coupled to the reusable portion 102 so that it can be removed and discarded after the therapeutic drug 106 has been delivered from the disposable portion 104. Another disposable portion (not shown—e.g., having the same or different characteristics as the disposable portion 104) is then attached to the reusable portion 102, thereby preparing the therapeutic drug delivery device 100 for subsequent use.

[0012] The drug delivery device 100 also includes a proximal end 108 and a distal end 110 on the opposite side. During use of the drug delivery device 100, the proximal end 108 is located further away from the patient and is configured to be operated by the user, while the distal end 110 is located closer to the patient and is configured to deliver the drug 106 to the patient. The drug delivery device 100 also includes a longitudinal axis A extending between the proximal end 108 and the distal end 110. These and other features of the drug delivery device 100 are described in further detail below.

[0013] Referring particularly to the cross-sectional views in Figures 3 and 4, the internal components and other features of the reusable portion 102 and the disposable portion 104 are illustrated. Generally, the reusable portion 102 includes a housing 112 that movably carries a user input unit 114 and a drive mechanism 116 (both shown in Figure 3). The user input unit 114 is operable (e.g., pressable) by the user to actuate the drive mechanism 116. The drive mechanism 116 translates distally by which it drives the syringe assembly 118 of the disposable portion 104. More specifically, the drive mechanism 116 drives the syringe assembly 118 so that it can translate from a housing configuration (Figure 3) to a deployed configuration (Figure 4). In the housing configuration, the needle 120 of the syringe assembly 118 is positioned proximal to the distal end 122 of the disposable portion 104. In other words, in the housing configuration, the needle 120 is housed within the device 100. In the deployed configuration (Figure 4), the needle 120 extends at least partially distally from the distal end 122 of the disposable portion 104. As a result, in the deployed configuration, the needle 120 is configured to puncture the patient's skin.

[0014] Referring particularly to Figure 3, the drive mechanism 116 of the reusable portion 102 also includes a plunger mechanism or a drug delivery mechanism 124. The drug delivery mechanism 124 is operable to release the drug 106 from the syringe assembly 118. More specifically, when the syringe assembly 118 is in the deployed configuration, the drug delivery mechanism 124 is operable to distally translate the shaft or plunger 126 of the syringe assembly 118. The plunger 126 distally drives a piston 128, which is transported within the drug delivery passage 130 of the syringe assembly 118, thereby releasing the drug 106 through the needle 120. Additional details of these components are described below.

[0015] Referring particularly to Figure 4, the distal end 110 of the device 100 further includes a fastening mechanism 132 for selectively fastening the disposable portion 104 to the reusable portion 102. The fastening mechanism 132 also facilitates easy attachment of the disposable portion 104 to the reusable portion 102 and easy removal of the disposable portion 104 from the reusable portion 102. The components and features of the fastening mechanism 132 are described in further detail below.

[0016] Referring to Figure 5, in addition to the components described above, the drug delivery device 100 also includes an electronic assembly 134 that facilitates the operation of the device 100 in the manner described herein. The electronic assembly 134 is operably coupled to a power source 138, such as a battery, and includes an electronic controller 136 that receives power from there. The electronic controller 136 is also operably coupled to a user input 114 and one or more sensors 140. As will be described in more detail below, the sensors 140 may, for example, sense the operation of components of the device 100, the relative positions of components of the device 100 to each other, and / or the position of the device 100 relative to a patient. The controller 136 is further operably coupled to a drive mechanism 116 (Figure 3), a drug delivery mechanism 124 (Figure 3), and a locking mechanism 132 (Figure 4).

[0017] In some embodiments, as will be described in more detail below, some components of the electronic assembly 134 are supported by a reusable portion 102 and some components are supported by a disposable portion 104 (both shown in Figures 1 and 4). For example, the disposable portion 104 may include an identifier 142 (e.g., an RFID transmitter or EEPROM) to facilitate the provision of characteristics of the therapeutic agent 106 to the reusable portion 102. Such characteristics may include, for example, the type and / or quantity of the therapeutic agent 106 supported by the syringe assembly 118. The reusable portion 102 may use the characteristics of the therapeutic agent 106 to determine, for example, whether a patient associated with the reusable portion 102 has been authorized to use the therapeutic agent 106 or has been prescribed the therapeutic agent 106. In another example, the disposable portion may include a fixed device 144 operably coupled to the controller 136. The fixing device 144 can initially prevent the syringe assembly 118 from moving from the housing configuration to the deployed configuration, and the controller 136 can actuate the fixing device 144 to allow the syringe assembly 118 to move from the housing configuration to the deployed configuration. In other embodiments, each component of the electronics assembly 134 is supported by a reusable portion 102. In some embodiments, the controller 136 is operably coupled to one or more of the other components of the electronics assembly 134 by a wired connection. In some embodiments, the controller 136 is operably coupled to one or more of the other components of the electronics assembly 134 by a wireless connection.

[0018] Referring here to Figures 6 to 8, the proximal end 108 of device 100, specifically the user input section 114 and the proximal portion of the drive mechanism 116, is shown in more detail. The drive mechanism 116 includes a carriage 146 (Figure 6) which is translatably supported within the housing 112 of the reusable section 102. The carriage 146 supports a first actuator 148 which is operably coupled to an electronic controller 136 (Figure 5). The first actuator 148 may be a rotary actuator, more specifically an electric motor, which is driveably coupled to a transmission or reduction gear. The actuator 148 is driveably coupled to a gear train 150, more specifically to a first gear 152 which is driveably coupled to a second gear 154. The second gear 154 is fixed to a driven section 156, which is rotatably supported by the carriage 146. Therefore, the carriage 146, actuator 148, gear train 150, and driven part 156 are all translatable together within the housing 112 of the reusable part 102. Exemplarily, the carriage 146, actuator 148, gear train 150, and driven part 156 are translatable in a driving direction 158 (Figure 6) substantially parallel (i.e., parallel ±10 degrees) to the longitudinal axis A of the device 100.

[0019] The driven portion 156 is movably coupled to the guide 160, which is fixed to the housing 112 of the reusable portion 102. A compression spring 162 biases the driven portion 156 distally and engages it with the guide 160. In general, the driven portion 156 and the guide 160 include features that facilitate the translation of the driven portion 156 relative to the guide 160 when the driven portion 156 rotates about a rotation axis R1 that is substantially parallel (i.e., parallel ±10 degrees) to the longitudinal axis A of the device 100. More specifically, the driven portion 156 includes two radially outward-extending projections 164 that move along an angular trajectory 166 defined by the guide 160, or along a wall facing substantially the proximal side, as the driven portion 156 rotates by the actuator 148. Projections 164 move simultaneously along two similar sections, or halves thereof, of the track 166. Referring specifically to Figures 7 and 8, each half of the track 166 includes a plateau section 168 connected to the cliff section 170 at its edge 172, a valley section 174 connected to the cliff section 170 on the opposite side of the plateau section 168, and a sloping section 176 connected to the valley section 174 on the opposite side of the cliff section 170. Each sloping section 176 is also connected to the plateau section 168 of the other half of the track 166.

[0020] In the exemplary embodiment, the various parts of the track 166 are as follows: The cliff section 170 is substantially parallel (i.e., parallel ± 10 degrees) to the longitudinal axis A of the device 100. The plateau section 168 and the valley section 174 are substantially perpendicular (i.e., perpendicular ± 10 degrees) to the longitudinal axis A of the device 100. The inclined section 176 extends spirally with respect to the longitudinal axis A of the device 100.

[0021] In other embodiments, the driven portion 156 and / or the guide 160 may have different forms. For example, the track 166 may have a different shape. More specifically, the track may include an additional inclined portion (not shown) instead of the cliff portion 170, and such an inclined portion may extend spirally in the opposite direction to the inclined portion 176. In another example, the driven portion 156 may include a different number of projections 164, and / or the guide 160 may include a track 166 having a different number of similar sections. In yet another example, the driven portion 156 may include a track 166 that movably receives one or more projections 164 formed on the guide 160.

[0022] Referring particularly to Figure 6, the proximal end 108 of the device 100 also includes features for selectively preventing the movement of the user input section 114 relative to the housing 112 of the reusable portion 102, thereby preventing the operation of the user input section 114. More specifically, the user input section 114 includes a snap hook 178 extending through an opening 180 formed in the guide 160. The hook 178 engages with the guide 160 and holds the user input section 114 in a pressed position relative to the housing 112. Referring particularly to Figures 6 and 8, the driven portion 156 includes a leg 182 (Figure 8) that engages and disengages the hook 178 from the guide 160 as the driven portion 156 rotates relative to the guide 160. When the hook 178 is disengaged from the guide 160, a compression spring 184 extends, pushing the user input section 114 in an elevated position relative to the housing 112. These features are described in more detail in the following paragraphs.

[0023] Referring to Figures 9 to 16, the movement of various components at the proximal end 108 of device 100 and some configurations are as follows. Device 100 may remain in some of the configurations for a certain period of time, while other configurations are shown for illustrative purposes, and device 100 may simply transition through those configurations without remaining in any particular configuration for a period of time. Figures 9 and 10 illustrate a first configuration of the components at the proximal end 108 of device 100. In the first configuration, the snap hook 178 of the user input section 114 engages with the guide 160, holding the user input section 114 in a pressed configuration, and the user input section 114 is not operable by the user. In the first configuration, the leg portion 182 (Figure 10) of the driven portion 156 is positioned away from the hook 178, and the projection 164 (Figure 10) of the driven portion 156 is positioned within the base portion 168 (Figure 8) of the guide 160.

[0024] As shown in Figures 11 and 12, the first actuator 148 (Figure 6) drives the driven portion 156 to rotate (exemplified clockwise when viewed from the proximal end 108) so that the device 100 moves to the second configuration. By moving to the second configuration, the legs 182 of the driven portion 156 engage with the hook 178 of the user input portion 114, releasing it from the guide 160, and the compression spring 184 (Figure 11) extends, pushing the user input portion 114 to the raised configuration. However, the legs 182 of the driven portion 156 align with the hook 178, and the driven portion 156 thereby prevents the operation of the user input portion 114. In the second configuration, the projection 164 of the driven portion 156 remains positioned within the base portion 168 of the guide 160 (all shown in Figure 8).

[0025] Next, as shown in Figures 13 and 14, the first actuator 148 (Figure 6) drives the driven portion 156 to rotate (in the same direction, exemplary, clockwise when viewed from the proximal end 108) so that the device 100 moves to the third configuration. In the third configuration, the legs 182 of the driven portion 156 are positioned away from the hook 178 of the user input portion 114, and the driven portion 156 thereby enables the operation of the user input portion 114. In the third configuration, the projection 164 of the driven portion 156 (one projection 164 is visible in Figure 14) remains positioned within the base portion 168 (Figure 8) of the guide 160.

[0026] As shown in Figures 15 and 16, when the user input 114 is activated, the first actuator 148 (Figure 6) drives the driven part 156 to rotate (in the same direction, exemplary, clockwise when viewed from the proximal end 108) so that the device 100 moves to the fourth configuration. By moving to the fourth configuration, the projection 164 of the driven part 156 (one projection 164 is visible in Figure 16) moves over the edge 172 and cliff portion 170 (Figure 8) of the guide 160. This action extends the spring 162 (Figure 15), allowing the driven part 156 to be pushed distally until the projection 164 of the driven part 156 engages with the valley portion 174 (Figure 8) of the guide 160. The driven part 156 thereby pushes the carriage 146 (Figure 6) distally. The carriage 146 pushes the syringe assembly 118 (Figures 3 and 4) from its retracted configuration to its deployed configuration, which then allows the syringe assembly 118 to deliver the therapeutic drug to the patient. Furthermore, the operation of the user input unit 114 re-engages the snap hook 178 of the user input unit 114 with the guide 160, which holds the user input unit 114 in the pressed configuration.

[0027] Although not specifically illustrated, the first actuator 148 then rotatably drives the driven portion 156 so that the device 100 moves into the first configuration. More specifically, the projection 164 of the driven portion 156 moves over the inclined portion 176 of the guide 160 (Figure 8) to move the driven portion 156. The syringe assembly 118 returns from the deployed configuration to the retracted configuration, and the disposable portion 104 can be replaced with a new disposable portion 104.

[0028] Continuing to refer to Figures 9 to 16 in general, and further to Figure 5, the electronic assembly 134 may transition the device 100 through the above configurations when it detects one or more states. For example, the sensor 140 of the electronic assembly 134 may include a proximity sensor for detecting the removal of one or more components of a disposable part 104 from the device 100, such as a needle shield (shown elsewhere). When the removal of the needle shield from the disposable part 104 is detected, the device 100 can transition from a first configuration to a second configuration. As another example, the sensor 140 may include a contact sensor for detecting contact between the distal end 110 of the device 100 and the patient's skin. When contact with the patient's skin is detected, the device 100 can transition from a second configuration to a third configuration. In some embodiments, the electronic assembly 134 may facilitate illumination of the user input 114 to indicate that the user input 114 is ready for operation. As yet another example, the sensor 140 may include a contact sensor or proximity sensor for detecting the operation of the user input 114.

[0029] Figures 17 and 18 illustrate the drug delivery mechanism 124 of device 100. In the cross-sectional view of Figure 18, the drug delivery mechanism 124 is also illustrated adjacent to other components of device 100, such as the carriage 146, syringe chamber 186, and piston 128.

[0030] Continuing to refer to Figures 17 and 18, the drug delivery mechanism 124 is supported by a carriage 146 on the housing 112 of the reusable portion 102 and translates with it. The drug delivery mechanism 124 includes a second actuator 188 operably coupled to an electronic controller 136 (Figure 5). The second actuator 188 may be a rotary actuator, more specifically an electric motor, drivably coupled to a transmission or reduction gear. The actuator 188 is drivably coupled to a gear train 190, more specifically to a first gear 192 drivably coupled to a second gear 194. The second gear 194 includes a female thread 196 (Figure 18) coupled to a male thread 198 of a plunger 126. The plunger 126 is rotatably fixed but translatable relative to the carriage 146 (Figure 18). Specifically, the plunger 126 is coupled to the carriage 146 via a key-and-slot interface, and more specifically, the plunger 126 includes an external slot 200 for receiving a key 202 (Figure 18) formed on the carriage 146. The plunger 126 also includes a ram 204 for engaging with the piston 128 of the syringe assembly 118.

[0031] Referring further to Figures 17 and 18, the movement of the various components of the drug delivery mechanism 124 is as follows: The actuator 188 is powered to rotatably drive the gear train 190 relative to the carriage 146. Thereafter, the plunger 126 translates relative to the second gear 194 and the carriage 146. The plunger 126 pushes the piston 128 distally within the syringe chamber 186. As described above, this movement of the piston 128 causes the syringe assembly 118 to deliver the drug from the needle (shown elsewhere).

[0032] Referring to Figures 1 to 18 in general, the controller 136 (Figure 5) can sequentially activate the drive mechanism 116 and the drug delivery mechanism 124 when it detects one or more states. More specifically, in some embodiments, the drive mechanism 116 is activated to move the syringe assembly 118 from a housing configuration to an unfolded configuration, and then the drug delivery mechanism 124 is activated to drive the plunger 126 and piston 128, thereby delivering the drug 106 from the needle 120. In these embodiments, the sensor 140 of the electronics assembly 134 may include a position sensor, such as an encoder (not shown) coupled to an actuator 148, to determine whether the syringe assembly 118 is in a housing configuration or an unfolded configuration. When it is detected that the syringe assembly 118 is in an unfolded configuration, the drug delivery mechanism 124 may be activated to deliver the drug 106 from the needle 120. After delivering the therapeutic agent 106, the drive mechanism 116 is activated again to allow the syringe assembly 118 to move from the deployed configuration to the retracted configuration, and then the therapeutic agent delivery mechanism 124 is activated again to retract the plunger 126 from the syringe assembly 118. More specifically, when it detects that the syringe assembly 118 has returned to the retracted configuration, the therapeutic agent delivery mechanism 124 is activated to retract the plunger 126 from the syringe assembly 118.

[0033] Figures 19–21 illustrate a therapeutic drug delivery mechanism 224 according to another exemplary embodiment of the present disclosure. The therapeutic drug delivery mechanism 224 may be used in place of the therapeutic drug delivery mechanism 124 (both shown elsewhere) of the therapeutic drug delivery device 100. Thus, the therapeutic drug delivery mechanism 224 is considered to be supported by a carriage 146 (both shown elsewhere) of a drive mechanism 116. Furthermore, the therapeutic drug delivery mechanism 224 and the drive mechanism 116 may be operated using a set of procedures similar to those described above. The therapeutic drug delivery mechanism 224 is also illustrated as being coupled to a syringe assembly 118, more specifically, a syringe chamber 186 and a piston 128.

[0034] Continuing to refer to Figures 19-21, the drug delivery mechanism 224 includes a second actuator 188 of the electronic equipment assembly 134 (Figure 5). The actuator 188 is drivably coupled to a gear train 290 (Figure 19), more specifically to a first gear 292 which is drivably coupled to a second gear 294. The second gear 294 is drivably coupled to a non-circular drive shaft 306, more specifically to a square drive shaft 306. The drive shaft 306 is rotatable relative to the carriage 146 of the drive mechanism 116 (both shown elsewhere) and is fixed translatably relative to the carriage 146. The drive shaft 306 is rotatably driven by the gear train 290. The drive shaft 306 is drivably coupled to an intermediate shaft 308, which is received in a non-circular cross-sectional opening 310 of the intermediate shaft 308, more specifically to a square cross-sectional opening 310. This allows the intermediate shaft 308 to rotate with the drive shaft 306 relative to the carriage, but to translate relative to the drive shaft 306. The intermediate shaft 308 includes a male thread 312 and a female thread 314. The male thread 312 is coupled to the female thread 316 of the outer shaft 318, and the female thread 316 is coupled to the male thread 320 of the inner shaft or plunger 322. The outer shaft 318 is fixed to the carriage, for example, via a mounting bracket (not shown). The plunger 322 is rotatably fixed to the outer shaft 318 via a sleeve 324. More specifically, one or both of the plunger 322 and the outer shaft 318 are coupled to the sleeve 324 via a key and slot interface (not shown). As a result, the plunger 322 and the outer shaft 318 are rotatably fixed to the sleeve 324 and therefore to each other. The plunger 322 also includes a ram 326 for engaging with the piston 128 of the syringe assembly 118.

[0035] Referring further to Figures 19-21, and more specifically to Figures 20 and 21, the movement of the various components of the drug delivery mechanism 224 is as follows: A rotary actuator 188 is powered to drive the gear train 290, the drive shaft 306, and the intermediate shaft 308 rotatably relative to the outer shaft 318 and the carriage (shown elsewhere). The intermediate shaft 308 thereby rotates and translates relative to the outer shaft 318, and the plunger 322 thereby translates relative to the intermediate shaft 308. The plunger 322 pushes the piston 128 distally within the syringe chamber 186. As described above, this movement of the piston 128 causes the syringe assembly 118 to deliver the drug 106 (both shown elsewhere) from the needle 120.

[0036] Figures 22 to 24 illustrate the disposable portion 104 of the device 100. Referring particularly to the cross-sectional view in Figure 23 and the exploded view in Figure 24, the disposable portion 104 includes a housing 400 having a proximal end 402 (Figure 23) and a distal end 404. A proximal cap 406 covers the proximal end 402 of the housing 400. The proximal cap 406 is fixed to the syringe assembly 118 and movable relative to the housing 400, thereby allowing the proximal cap 406 and the syringe assembly 118 to move together relative to the housing 400. As a result, the drive mechanism 116 (Figure 6) pushes the proximal cap 406 distally, moving the syringe assembly 118 from the housing configuration to the deployed configuration.

[0037] Continuing to refer to Figures 23 and 24, the disposable portion 104 includes a compression spring 408 internally. The compression spring 408 is compressed between an internal flange 410 (Figure 23) in the housing 400 and the internal end wall 412 (Figure 23) of the proximal cap 406. The compression spring 408 biases the syringe assembly 118 and the proximal cap 406 away from the deployed configuration and toward the retracted configuration. As a result, the compression spring 408 pushes the syringe assembly 118 and the proximal cap 406 from the deployed configuration to the retracted configuration after the needle 120 has delivered the therapeutic agent 106 (Figure 23) and the drive mechanism 116 (Figure 6) has moved proximal within the housing 112 of the reusable portion 102 (Figure 3).

[0038] At the distal end 404 of the housing 400, the disposable portion 104 carries a needle shield 414, a shield puller 416, and a base cap 418. The needle shield 414, shield puller 416, and base cap 418 initially cover the needle 120 of the syringe assembly 118. The needle shield 414, shield puller 416, and base cap 418 are fixed to each other and are removable together from the housing 400, facilitating the delivery of the therapeutic agent 106 from the needle 120. The distal end 404 defines an axial opening 423 into which the proximal portion of the base cap 418 is inserted. A rib 425 may be disposed along the inner surface of the housing 400 and extends radially inward. The rib may extend axially from the distal surface. The radial range of the ribs 425 is sized to reduce the cross-sectional area of ​​the axial opening 423 compared to the size of such a ribless axial opening. Two or more ribs 425 may be included, for example, arranged to be spaced apart from each other in the circumferential direction. The smaller cross-sectional area defined by one or more ribs 425 can prevent an object of a certain size from entering the axial opening 423 after the base cap 418 has been removed.

[0039] Referring particularly to Figure 24, the housing 400 also includes features for securing the disposable portion 104 to the reusable portion 102 (both shown in Figure 3) via a fixing mechanism 132. More specifically, the housing 400 includes one or more projections 420 and one or more magnetic elements 422 (e.g., one or more permanent magnets) for coupling with the fixing mechanism 132 and the reusable portion 102. These features will be described in more detail below.

[0040] Figures 25–27 illustrate a disposable portion 504 according to another exemplary embodiment of the present disclosure. The disposable portion 504 may be used in place of the disposable portion 104 of device 100 (both shown elsewhere). The disposable portion 504 is substantially similar to the disposable portion 104, and similar features are identified by similar reference numbers. In contrast to the disposable portion 104, the disposable portion 504 further includes a mechanism 526 for removing the disposable portion 504 after delivery of a therapeutic agent (not shown). More specifically, the removal mechanism 526 allows the syringe assembly 518 (Figure 26) to move from a housing configuration to a deployed configuration and return to the housing configuration only once. In the exemplary embodiment, the removal mechanism 526 includes a guide 528 defined by the housing 500 and one or more protrusions 530 (exemplarily three protrusions 530, one of which is shown in Figure 27) defined by the proximal cap 506. The guide 528 includes one or more raceways 532 (exemplarily, three raceways 532), or slots, each of which movably receives one of the projections 530. Each raceway 532 includes a first raceway portion 534 and a second raceway portion 536. The first raceway portion 534 extends substantially parallel (i.e., parallel ± 10 degrees) to the longitudinal axis B of the disposable portion 104. The first raceway portion 534 is coupled to the second raceway portion 536 at the distal end 538, and the second raceway portion 536 extends spirally with respect to the longitudinal axis B.

[0041] Referring to Figures 27 to 29, the operation of the exclusion mechanism 526 is as follows: As shown in Figure 27, each projection 530 is received at one proximal end 540 of the first track portion 534 when the syringe assembly 518 (Figure 26) is initially in the housing configuration. As shown in Figure 28, when the proximal cap 506 and syringe assembly 518 (Figure 26) are translated distally relative to the housing 500 and the syringe assembly 518 moves to the deployment configuration, each projection 530 moves along the first track portion 534 and reaches the distal end 538 of the associated track 532. As shown in Figure 29, when the cap 506 and syringe assembly 518 (Figure 26) are translated proximally relative to the housing 500 and the syringe assembly 518 returns to its housing configuration, the cap 506 pivots relative to the housing 500, for example due to torsional energy stored by the compression spring 508 (Figure 26). As a result, each projection 530 moves along the second track portion 536 and reaches the proximal end 542 of the second track portion 536 of the associated track 532. Once each projection 530 reaches the proximal end 542 of the second track portion 536, each projection 530 may be prevented from moving away from the proximal end 542 by, for example, a snap feature (not shown) and / or interference between each projection 530 and the associated track 532.

[0042] In other embodiments, the exclusion mechanism 526 may take other forms. For example, the proximal cap 506 may define a guide including one or more orbitals, and the housing 500 may include one or more projections that are movably received by the orbital 532.

[0043] Figures 30 and 31 illustrate a disposable part 604 according to yet another exemplary embodiment of the present disclosure. The disposable part 604 may be used in place of the disposable part 104 of device 100 (both shown elsewhere). The disposable part 604 is substantially similar to the disposable part 104, and similar features are identified by similar reference numbers. In contrast to the disposable part 104, the disposable part 604 further includes a fixing device 144 of the electronic assembly 134 (Figure 5), as briefly described above. Generally, the fixing device 144 first prevents the base cap 618, and consequently the shield puller 614 and needle shield 616 (both shown in Figure 30) from being removed from the housing 600. The fixing device 144 thereby prevents the syringe assembly 618 from moving from the housing configuration to the deployed configuration. The controller 136 (Figure 5) acts on the fixing device 144 to allow the syringe assembly 618 to move from the housing configuration to the deployed configuration. In some embodiments, the controller 136 activates the fixation device 144 when it determines that one or more conditions are met. For example, the controller 136 may activate the fixation device 144 when it determines that the disposable portion 604 has been coupled to the reusable portion 102 (Figures 1 to 18) and / or when it determines that the patient associated with the reusable portion 102 has been prescribed a therapeutic drug (not shown).

[0044] Continuing to refer to Figures 30 and 31, the fixing device 144 includes, exemplary, a retainer 644, more specifically, a molded wire, and a release device 646 (Figure 31), more specifically, a wire made of one or more shape memory materials. The retainer 644 is supported by the housing 600 and extends in part around it. The retainer 644 includes one or more laterally extending feet 648 (exemplary, two feet 648). The base cap 618 includes one or more openings 650 (exemplary, two openings 650 - Figure 31), each of which openings 650 initially receives one of the feet 648. The release device 646 is also supported by the housing 600 and extends in part around it. The release device 646 also extends in close proximity to the feet 648 of the retainer 644. The release device 646 is activatable, for example, by receiving thermal energy from the controller 136 (Figure 5), and more specifically, is retractable. Upon activation, the release device 646 pulls the foot 648 of the retainer 644 out of the opening 650 of the base cap 618. This action allows the base cap 618, the shield puller 614, and the needle shield 616 to be removed from the disposable portion 604, which allows the therapeutic agent (not shown) to be delivered through the needle.

[0045] Figures 32 and 33 illustrate the fixing mechanism 132 of device 100. The fixing mechanism 132 is supported within the housing 112 of the reusable portion 102 and adjacent to the distal end 110 (all shown in Figure 3). The fixing mechanism 132 includes a third actuator 700 operably coupled to an electronic controller 136 (Figure 5). The third actuator 700 may be a rotary actuator, more specifically an electric motor, drivably coupled to a transmission or reduction gear. The actuator 700 is drivably coupled to a gear train 702, more specifically to a first gear 704 drivably coupled to a second gear 706. The second gear 706 is either integrally formed with the proximal cylinder 708 or otherwise fixed to the proximal cylinder 708. The proximal cylinder 708 is rotatably coupled to a distal cylinder 710, which is fixed to the housing 112 of the reusable portion 102. The proximal cylinder 708 rotates relative to the distal cylinder 710 about a fixed rotation axis R2 that is substantially parallel (i.e., parallel ±10 degrees) to the longitudinal axis A of the device 100.

[0046] Continuing to refer to Figures 32 and 33, the proximal cylinder 708 and the distal cylinder 710 include features that facilitate the selective fixation of the disposable portion 104 to the reusable portion 102 (both shown in Figure 3). More specifically, the inner surface 712 of the distal cylinder 710 includes one or more guide tracks 714 (exemplarily, two guide tracks 714—only one guide track 714 is visible in Figures 32 and 33) or slots for receiving the projection 420 of the disposable portion 104. Similarly, the inner surface 716 of the proximal cylinder 708 (Figure 33) includes one or more fixed tracks 718 (exemplarily, two fixed tracks 718—only one fixed track 718 is visible in Figure 33) or slots for receiving the projection 420 of the disposable portion 104. As will be described in more detail below, the proximal cylinder 708 rotates relative to the distal cylinder 710 to selectively align and misalign the fixed track 718 with respect to the lead track 714. These movements allow and prevent the projection 420 of the disposable portion 104 from moving between the lead track 714 and the fixed track 718, respectively, facilitating the selective fixation of the disposable portion 104 to the reusable portion 102.

[0047] Referring further to Figures 32 and 33, each lead track 714 of the distal cylinder 710 includes an inverted, roughly funnel shape. More specifically, each lead track 714 includes a tapered distal portion 720 and a relatively narrow proximal portion 722. Each distal portion 720 tapers in width as it moves proximal. More specifically, each distal portion 720 includes two opposing, spirally extending walls 724 that connect to the proximal portion 722. As a result, the walls 724 are configured to orient the projection 420 of the disposable portion 104 toward the proximal portion 722 when the disposable portion 104 is connected to the reusable portion 102. The proximal portion 722 of each lead track 714 may have a width slightly greater than the width of the projection 420 of the disposable portion 104. The proximal portion 722 of each lead track 714 may be substantially parallel to the longitudinal axis A (i.e., parallel ±10 degrees).

[0048] Referring particularly to Figure 33, each fixed track 718 of the proximal cylinder 708 includes an inlet portion 726, a fixed portion 728, and an outlet portion 730. The inlet portion 726 of each fixed track 718 is selectively alignable with one of the lead tracks 714, facilitating the reception of the projection 420 of the disposable portion 104 from the lead track 714. The inlet portion 726 of each fixed track 718 may be substantially parallel to the longitudinal axis A (i.e., parallel ± 10 degrees). Thus, the inlet portion 726 may be referred to as the longitudinal portion. On the opposite side of the lead track 714, the inlet portion 726 of each fixed track 718 is coupled to the fixed portion 728. The fixed portion 728 may be substantially perpendicular to the longitudinal axis A (i.e., perpendicular ± 10 degrees). Thus, the fixed portion 728 may be referred to as the lateral portion. On the opposite side of the entrance section 726, the fixed section 728 of each fixed track 718 is connected to the exit section 730. The exit section 730 of each fixed track 718 may extend spirally with respect to the longitudinal axis A and away from the fixed section 728. Thus, the exit section 730 may be referred to as a spiral section. The exit section 730 can be selectively aligned with one of the lead tracks 714, facilitating the transfer of the projection 420 of the disposable section 104 to the lead track 714.

[0049] Referring to Figures 34 to 39, the movement and some configurations of the fixing mechanism 132 and the disposable part 104 are as follows. The fixing mechanism 132 and the disposable part 104 may remain in some configurations for a certain period of time, while other configurations are shown for illustrative purposes, and the fixing mechanism 132 and the disposable part 104 may simply transition through those configurations without remaining in any configuration for a certain period of time. Figure 34 illustrates a first configuration or initial configuration of the fixing mechanism 132 and the disposable part 104. In the first configuration, the disposable part 104 is removed from the fixing mechanism 132 and the reusable housing 112 (Figure 3).

[0050] The disposable portion 104 is advanced proximal to the fixing mechanism 132, as shown in Figure 35, to reach a second configuration. In the second configuration, the housing 400 of the disposable portion 104 is received within the distal cylinder 710 and the proximal cylinder 708. In the second configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 35) also enters the lead track 714 of the distal cylinder 710 (one lead track 714 is visible in Figure 35). In the second configuration, the lead track 714 of the distal cylinder 710 is aligned with the inlet portion 726 of the fixed track 718 of the proximal cylinder 708 (one inlet portion 726 is visible in Figure 35).

[0051] The disposable portion 104 is advanced further proximal to reach a third configuration, as shown in Figure 36. In the third configuration, the base cap 418 of the disposable portion 104 abuts against the retaining mechanism 132 and the distal end 110 (shown elsewhere) of the device 100. In the third configuration, a projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 36) also crosses the inlet portion 726 of the retaining track 718 of the proximal cylinder 708 (one inlet portion 726 and one retaining track 718 are visible in Figure 36). A magnetic element 422 of the disposable portion 104 (one magnetic element 422 is visible in Figure 36) may also magnetically couple with one or more magnetic elements of the reusable portion 102 (e.g., a ferromagnetic portion of the housing 112 or a ferromagnetic component supported within the housing) to hold the disposable portion 104 in the third configuration.

[0052] As shown in Figure 37, a third actuator 700 is powered, causing the proximal cylinder 708 to rotate relative to the distal cylinder 710 (exemplifiedly counterclockwise when viewed from the proximal end 108 of the device 100 - as shown elsewhere), and as a result, the locking mechanism 132 moves to a fourth configuration. In the fourth configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 37) is positioned within the locking portion 728 of the locking track 718 of the proximal cylinder 708 (one locking portion 728 and one locking track 718 are visible in Figure 37). This prevents the disposable portion 104 from being removed from the reusable portion 102, and the locking mechanism 132 can remain in the fourth configuration until the therapeutic agent 106 is delivered from the syringe assembly 118 (both shown in Figure 3).

[0053] As shown in Figure 38, the proximal cylinder 708 then rotates relative to the distal cylinder 710 (in the same direction, exemplary, counterclockwise when viewed from the proximal end 108), and as a result, the fixing mechanism 132 moves to a fifth configuration. In the fifth configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 38) is positioned within the outlet portion 730 of the fixed track 718 of the proximal cylinder 708 (one outlet portion 730 and one fixed track 718 are visible in Figure 38). As a result, the proximal cylinder 708 begins to push the projection 420 and the disposable portion 104 distally, discharging the disposable portion 104.

[0054] The proximal cylinder 708 rotates further relative to the distal cylinder 710 (in the same direction, exemplary, counterclockwise when viewed from the proximal end 108) to reach a sixth configuration as shown in Figure 39. In the sixth configuration, the exit portion 730 of the fixed track 718 of the proximal cylinder 708 (one exit portion 730 and one fixed track 718 are visible in Figure 39) is aligned with the lead track 714 of the distal cylinder 710 (one lead track 714 is visible in Figure 39). In the sixth configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 38) is positioned within the lead track 714 of the distal cylinder 710. The magnetic element 422 may also magnetically couple with one or more magnetic elements of the reusable portion 102 to hold the disposable portion 104 in the sixth configuration, or the user may pull the disposable portion 104 distally to remove it from the fixing mechanism 132 and the reusable portion 102.

[0055] Continuing to refer to Figures 34 to 39 in general, and further to Figure 5, the electronic equipment assembly 134 can transition the fixing mechanism 132 and the disposable part 104 through the above configuration when it detects one or more states. For example, the sensor 140 of the electronic equipment assembly 134 may include a proximity sensor for detecting the position of the disposable part 104 relative to the reusable part 102. Such a sensor may be a magnetic field sensor, such as a Hall effect sensor, for detecting the magnetic element 422 of the disposable part 104. When it is detected that the disposable part 104 has been inserted into the reusable part 102 and is arranged in a third configuration (Figure 36), the fixing mechanism 132 can transition to a fourth configuration (Figure 37) to fix the disposable part 104 to the reusable part 102. In another embodiment, the sensor 140 of the electronic equipment assembly 134 may include a proximity sensor for detecting the position of the syringe assembly 118, more specifically, whether the syringe assembly 118 is in an deployed configuration or a retracted configuration. When the locking mechanism 132 detects that the syringe assembly 118 has moved from the deployed configuration to the retracted configuration (i.e., that the syringe assembly 118 has delivered the therapeutic agent 106 to the patient), the locking mechanism 132 may transition from the fourth configuration (Figure 37) to the fifth configuration (Figure 38) and the sixth configuration (Figure 39) to facilitate the removal of the disposable portion 104 from the reusable portion 102. Alternatively, the controller 136 may cause the locking mechanism 132 to transition from the fourth configuration to the fifth and sixth configurations after a predetermined period following the activation of the user input unit 114 (Figure 3). The predetermined period may be based, for example, on a typical period for delivering the therapeutic agent 106 to the patient.

[0056] The fastening mechanism 132 can be modified in various ways. For example, the fastening mechanism 132 may include one or more projections, and the disposable portion 104 may include one or more trajectories for receiving the projections. As another example, with reference hereto to Figures 40–46, a fastening mechanism 832 according to another exemplary embodiment of the present disclosure is illustrated. The fastening mechanism 832 may be used in place of the fastening mechanism 132. Thus, the fastening mechanism 832 is considered to be supported by the housing 112 of the reusable portion 102 (both shown elsewhere). The fastening mechanism 832 is substantially similar to the fastening mechanism 132, and similar features are identified by similar reference numbers.

[0057] Referring particularly to Figure 40, the fixing mechanism 832 includes the distal cylinder 810 and the proximal cylinder 808, each having a different lead trajectory 814 and fixed trajectory 818 than those of the distal cylinder 810 and the proximal cylinder 808. Specifically, the inner surface 812 of the distal cylinder 810 includes three lead trajectories 814 (only two lead trajectories 814 are visible in Figure 40), and the inner surface 816 of the proximal cylinder 808 includes three fixed trajectories 818. Each lead trajectory 814 of the distal cylinder 810 has an inverted, roughly funnel shape. More specifically, each lead trajectory 814 includes a tapered distal portion 820 and a relatively narrow proximal portion 822. Each distal portion 820 tapers in width as it moves proximal. Each fixed trajectory 818 of the proximal cylinder 808 includes a distal portion 820, an inlet / outlet portion 834, and a fixed portion 828. The distal portion 820 of each fixed track 818 is selectively alignable with one of the lead tracks 814, facilitating the reception of the projection 420 of the disposable portion 104 from the lead track 814. The distal portion 820 of each fixed track 818 is coupled to an inlet / outlet portion 834. The inlet / outlet portion 834 of each fixed track 818 may extend spirally with respect to the longitudinal axis A. Thus, the inlet / outlet portion 834 may be referred to as the spiral portion. On the opposite side of the distal portion 820, the inlet / outlet portion 834 of each fixed track 818 is coupled to a fixed portion 828. The fixed portion 828 may be substantially perpendicular to the longitudinal axis A (i.e., perpendicular ± 10 degrees). Thus, the fixed portion 828 may be referred to as the lateral portion. The fixed portion 828 terminates on the opposite side of the inlet / outlet portion 834.

[0058] Referring to Figures 41 to 46, the movement and some configurations of the fixing mechanism 832 and the disposable part 104 are as follows. The fixing mechanism 832 and the disposable part 104 may remain in some configurations for a certain period of time, while other configurations are shown for illustrative purposes, and the fixing mechanism 832 and the disposable part 104 may simply transition through those configurations without remaining in any configuration for a certain period of time. Although not specifically illustrated, in the first or initial configuration, the disposable part 104 is removed from the fixing mechanism 832 and the reusable housing 112 (Figure 3).

[0059] The disposable portion 104 is advanced proximal to the fixing mechanism 832, as shown in Figure 41, to reach a second configuration. In the second configuration, the housing 400 of the disposable portion 104 is received within the distal cylinder 810 and the proximal cylinder 808. In the second configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 41) also enters the lead track 814 of the distal cylinder 810 (one entire lead track 814 is visible in Figure 41). In the second configuration, the lead track 814 of the distal cylinder 810 is aligned with the distal portion 820 of the fixed track 818 of the proximal cylinder 808 (one entire fixed track 818 is visible in Figure 41).

[0060] The disposable portion 104 is advanced further proximal to reach a third configuration, as shown in Figure 42. In the third configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 42) moves to the distal portion 820 of the fixed track 818 of the proximal cylinder 808 (one entire fixed track 818 is visible in Figure 42). The magnetic elements 422 of the disposable portion 104 (four magnetic elements 422 are visible in Figure 42) can also magnetically couple with one or more magnetic elements of the reusable portion 102 to hold the disposable portion 104 in the third configuration.

[0061] As shown in Figure 43, the proximal cylinder 808 rotates relative to the distal cylinder 810 (exemplified clockwise when viewed from the proximal end 108 of the device 100 - as shown elsewhere), and as a result, the locking mechanism 832 moves to a fourth configuration. In the fourth configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 42) is positioned within the inlet / outlet portion 834 of the locking track 818 of the proximal cylinder 808 (one entire locking track 818 is visible in Figure 43). As a result, the proximal cylinder 808 pulls the disposable portion 104 further proximal into the locking mechanism 832.

[0062] As shown in Figure 44, the proximal cylinder 808 rotates further relative to the distal cylinder 810 (in the same direction, exemplary, clockwise when viewed from the proximal end 108), and as a result, the locking mechanism 832 moves to a fifth configuration. In the fifth configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 44) is positioned within the locking portion 828 of the locking track 818 of the proximal cylinder 808 (one locking portion 828 is visible in Figure 44). This prevents the disposable portion 104 from being removed from the reusable portion 102, and the locking mechanism 832 can remain in the fifth configuration until the therapeutic agent 106 is delivered from the syringe assembly 118 (both shown in Figure 3).

[0063] As shown in Figure 45, the proximal cylinder 808 then rotates relative to the distal cylinder 810 (in the opposite direction, exemplary, counterclockwise when viewed from the proximal end 108) to reach the sixth configuration. In the sixth configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 45) is positioned within the inlet / outlet portion 834 of the fixed track 818 of the proximal cylinder 808 (one entire fixed track 818 is visible in Figure 45). As a result, the proximal cylinder 808 begins to push the projection 420 and the disposable portion 104 distally, discharging the disposable portion 104.

[0064] As shown in Figure 46, the proximal cylinder 808 rotates further relative to the distal cylinder 810 (in the same direction, exemplary, counterclockwise when viewed from the proximal end 108) to reach a seventh configuration. In the seventh configuration, the projection 420 of the disposable portion 104 (one projection 420 is visible in Figure 46) is positioned within the distal portion 820 of the fixed track 818 of the proximal cylinder 808 (an entire fixed track 818 is visible in Figure 46). In the seventh configuration, the distal portion 820 of the fixed track 818 is aligned with the lead track 814 of the distal cylinder 810 (an entire lead track 814 is visible in Figure 46). The magnetic element 422 may also magnetically couple with one or more magnetic elements of the reusable portion 102 to hold the disposable portion 104 in the seventh configuration, or the user may pull the disposable portion 104 distally to remove it from the fixing mechanism 832 and the reusable portion 102.

[0065] When the electronic equipment assembly 134 (Figure 5) detects one or more states in a manner similar to that described above in relation to the fixing mechanism 832, it may cause the fixing mechanism 132 and the disposable part 104 to transition through the above configuration.

[0066] While embodiments of this disclosure refer to reusable and disposable portions, any embodiment disclosed herein may be employed in a single disposable device. In this example, the first housing and the second housing are referred to as the housing.

[0067] While the present invention has been illustrated and described in terms of preferred embodiments, the present invention may be modified within the spirit and scope of this disclosure. Accordingly, this application is intended to encompass any modifications, uses, or adaptations of the present invention that utilize its general principles. Furthermore, this application is intended to encompass any such deviations from this disclosure that fall within known or customary practices in the art to which the present invention relates.

[0068] Various embodiments, including but not limited to those described below, are described in the description of this disclosure. 1. A therapeutic drug delivery device comprising: a housing including a distal end and a proximal end; a syringe assembly supported by the housing, the syringe assembly including a chamber including a passage and a needle communicating with the passage; a cap covering the proximal end of the housing, the cap being translatable relative to the housing and fixed to the syringe assembly; and a compression spring connecting the housing to the cap, wherein the syringe assembly and cap are translatable relative to the housing from a housing configuration to an unfolded configuration, in the housing configuration the needle is positioned proximal to the distal end of the housing, and in the unfolded configuration the needle extends at least partially distally from the distal end of the housing, and the compression spring biases the syringe assembly and cap away from the unfolded configuration toward the housing configuration. 2. A therapeutic drug delivery device according to Embodiment 1, wherein one of the housing and the cap includes a track having a first track portion and a second track portion, and the other of the housing and the cap includes a projection, the projection being movably received by the track, the projection traversing the first track portion when the syringe assembly is translated relative to the housing from a housing configuration to an unfolded configuration, and the projection traversing the second track portion when the syringe assembly is translated relative to the housing from an unfolded configuration. 3. The drug delivery device according to embodiment 2, wherein the projection is prevented from moving further along the trajectory after crossing the second trajectory portion. 4. A therapeutic drug delivery device according to any one of embodiments 1 to 3, further comprising: a base cap removably coupled to the distal end of a housing and concealing a needle in a housing configuration; and a fixing device coupled to the base cap and selectively preventing the removal of the base cap from the housing. 5. The therapeutic drug delivery device according to embodiment 4, comprising: a retainer detachably coupled to a base cap and selectively preventing the removal of the base cap from the housing; and a release device coupled to the retainer, the release device being operable to remove the retainer from the base cap, thereby enabling the removal of the base cap from the housing. 6. The therapeutic drug delivery device according to embodiment 5, wherein the release device includes a wire, and the release device is operable by extending or retracting the wire. 7. A therapeutic drug delivery device according to embodiment 6, wherein the wire comprises one or more shape memory materials and expands or contracts upon receiving thermal energy. 8. A therapeutic drug delivery device according to any one of embodiments 1 to 7, wherein the distal end of the housing includes a distal end opening, and the inner surface of the housing includes one or more ribs extending radially inward. 9. A therapeutic drug delivery device comprising: a disposable portion comprising a first housing and a syringe assembly supported by the first housing, the syringe assembly comprising a chamber including a passage and a needle communicating with the passage; and a reusable portion removably supporting the disposable portion, the reusable portion comprising a second housing and a locking mechanism supported within the second housing, wherein one of the disposable portion and the locking mechanism includes a track, and the other of the disposable portion and the locking mechanism includes a projection movable along the track, and the locking mechanism is operable to move the projection along the track, thereby locking the disposable portion within the reusable portion. 10. The therapeutic drug delivery device according to embodiment 9, wherein the fixing mechanism includes a cylinder, the cylinder removably receiving a disposable portion and rotating relative to a second housing to actuate the fixing mechanism, thereby fixing the disposable portion within the reusable portion. 11. The drug delivery device according to embodiment 10, wherein the drug delivery device is elongated along a longitudinal axis extending between a disposable portion and a reusable portion, and the cylinder is rotatable with respect to a second housing about a fixed axis of rotation, the fixed axis of rotation being substantially parallel to the longitudinal axis. 12. The therapeutic drug delivery device according to embodiment 10, wherein in the first case, the cylinder rotates relative to the second housing to activate a locking mechanism, thereby securing the disposable portion within the reusable portion, and in the second case, the cylinder rotates relative to the second housing to disengage the locking mechanism, thereby allowing the disposable portion to be removed from the reusable portion. 13. The drug delivery device according to embodiment 12, wherein the cylinder rotates in a first direction relative to the second housing in the first example, and the cylinder rotates in a first direction relative to the second housing in the second example. 14. The drug delivery device according to embodiment 12, wherein the cylinder rotates in a first direction relative to the second housing in the first example, and the cylinder rotates in a second direction relative to the second housing in the second example, the second direction being opposite to the first direction. 15. The therapeutic drug delivery device according to embodiment 10, wherein the fixing mechanism further includes a rotary actuator, the rotary actuator is actuated to drive a cylinder rotatably relative to a second housing, and the rotary actuator thereby actsuates the fixing mechanism to fix the disposable portion within the reusable portion. 16. The therapeutic drug delivery device according to embodiment 10, wherein the orbit includes a helical portion and a lateral portion coupled to the helical portion, and the fixing mechanism is operable to move a projection along the lateral portion of the orbit, thereby fixing the disposable portion within the reusable portion. 17. The therapeutic drug delivery device according to embodiment 16, wherein the fixation mechanism is further operable to move a projection along a helical portion of the track, thereby enabling the disposable portion to be detached from the reusable portion. 18. The therapeutic drug delivery device according to embodiment 10, wherein the fixing mechanism includes a track, the disposable portion includes a projection, the track is a fixed track, the fixing mechanism further includes a lead track fixed to a second housing, and the fixed track is selectively alignable with the lead track to allow the projection to move from the lead track to the fixed track. 19. A therapeutic drug delivery device according to any one of embodiments 9 to 17, wherein the reusable portion further comprises a first magnetic element, and the disposable portion further comprises a second magnetic element, the second magnetic element being magnetically coupled with the first magnetic element to hold the disposable portion in the reusable portion. 20. The therapeutic drug delivery device according to embodiment 19, wherein a second magnetic element magnetically couples with a first magnetic element to hold the disposable portion in the reusable portion before the fixing mechanism fixes the disposable portion in the reusable portion. 21. The therapeutic drug delivery device according to embodiment 19, wherein the reusable portion further includes a sensor configured to detect a second magnetic element and thereby detect the arrangement of a disposable unit within the reusable portion. 22. A therapeutic drug delivery device according to any one of embodiments 9 to 20, wherein the reusable portion further includes a sensor configured to detect the placement of a disposable unit within the reusable portion. 23. The therapeutic drug delivery device according to embodiment 22, wherein when a sensor detects the placement of a disposable unit within a reusable portion, a locking mechanism is activated to move a projection relative to a track, thereby locking the disposable portion within the reusable portion. 24. The drug delivery device according to embodiment 22, wherein the sensor is a magnetic field sensor. 25. A therapeutic drug delivery device according to any one of embodiments 9 to 23, wherein the first housing includes a distal end, and the syringe assembly is translatable relative to the first housing from a housing configuration to an unfolded configuration and back to the housing configuration, in the housing configuration the needle is positioned proximal to the distal end of the first housing, and in the unfolded configuration the needle extends at least partially distally from the distal end of the first housing to deliver a therapeutic drug, and when the syringe assembly is translated back from the unfolded configuration to the housing configuration a locking mechanism releases a disposable portion, thereby allowing the disposable portion to be removed from the reusable portion. 26. A therapeutic drug delivery device according to any one of embodiments 1 to 7, wherein the distal end of the housing includes a distal end opening, and the inner surface of the housing includes one or more ribs extending radially inward. 27. A drug delivery device according to any one of embodiments 1 to 26, wherein the passage is configured to transport a drug.

Claims

1. A drug delivery device, A housing including the distal end and the proximal end, A syringe assembly supported by the housing, wherein the syringe assembly is A chamber including a passageway, A syringe assembly including a needle communicating with the aforementioned passage, A cap covering the proximal end of the housing, wherein the cap is translationally translatable relative to the housing and fixed to the syringe assembly, The housing is connected to the cap by a compression spring, A therapeutic drug delivery device wherein the syringe assembly and the cap are translationally movable relative to the housing from a housing configuration to an unfolded configuration, in the housing configuration the needle is positioned proximal to the distal end of the housing, and in the unfolded configuration the needle extends at least partially distally from the distal end of the housing, and the compression spring biases the syringe assembly and the cap away from the unfolded configuration toward the housing configuration.

2. A therapeutic drug delivery device according to claim 1, wherein one of the housing and the cap includes a track having a first track portion and a second track portion, and the other of the housing and the cap includes a projection, the projection being movably received by the track, the projection traversing the first track portion when the syringe assembly is translated relative to the housing from the housing configuration to the deployment configuration, and the projection traversing the second track portion when the syringe assembly is translated relative to the housing from the deployment configuration to the housing.

3. The drug delivery device according to claim 2, wherein the projection is prevented from moving further along the trajectory after crossing the second trajectory portion.

4. A base cap is detachably coupled to the distal end of the housing and covers the needle in the housing configuration, A therapeutic drug delivery device according to any one of claims 1 to 3, further comprising a fixing device coupled to the base cap and selectively preventing the removal of the base cap from the housing.

5. The aforementioned fixed device A retainer that is removably coupled to the base cap and selectively prevents the base cap from being removed from the housing, A therapeutic drug delivery device according to claim 4, comprising a release device coupled to the retainer, the release device being operable to remove the retainer from the base cap, thereby enabling the base cap to be removed from the housing.

6. The drug delivery device according to claim 5, wherein the release device includes a wire, and the release device is operable by extending or retracting the wire.

7. The therapeutic drug delivery device according to claim 6, wherein the wire comprises one or more shape memory materials and expands or contracts when it receives thermal energy.

8. The therapeutic drug delivery device according to claim 1, wherein the distal end of the housing includes a distal end opening, and the inner surface of the housing includes one or more ribs extending radially inward.

9. A drug delivery device, It is a disposable part, The first housing and A syringe assembly supported by the first housing, wherein the syringe assembly is A chamber including a passageway, A disposable part, including a syringe assembly, which includes a needle communicating with the aforementioned passage, A reusable portion that detachably supports the disposable portion, wherein the reusable portion is The second housing and A reusable portion comprising a fixing mechanism supported within the second housing, One of the disposable portion and the fixing mechanism includes a track, and the other of the disposable portion and the fixing mechanism includes a projection that is movable along the track, and the fixing mechanism is operable to move the projection along the track, thereby fixing the disposable portion within the reusable portion. The fixing mechanism includes a cylinder, which removably receives the disposable portion and rotates relative to the second housing to actuate the fixing mechanism, thereby fixing the disposable portion within the reusable portion. In the first case, the cylinder rotates relative to the second housing to activate the locking mechanism, thereby securing the disposable portion within the reusable portion; in the second case, the cylinder rotates relative to the second housing to disengage the locking mechanism, thereby allowing the disposable portion to be removed from the reusable portion. A drug delivery device wherein, in the first example, the cylinder rotates in a first direction relative to the second housing, and in the second example, the cylinder rotates in a first direction relative to the second housing.

10. The drug delivery device according to claim 9, wherein the drug delivery device is elongated along a longitudinal axis extending between the disposable portion and the reusable portion, and the cylinder is rotatable with respect to the second housing about a fixed axis of rotation, the fixed axis of rotation being substantially parallel to the longitudinal axis.

11. The drug delivery device according to claim 9, wherein the cylinder rotates in a first direction relative to the second housing in the first case, and the cylinder rotates in a second direction relative to the second housing in the second case, the second direction being opposite to the first direction.

12. The therapeutic drug delivery device according to claim 9, wherein the fixing mechanism further includes a rotary actuator, the rotary actuator is actuated to drive the cylinder rotatably relative to the second housing, and the rotary actuator thereby actsuates the fixing mechanism to fix the disposable portion within the reusable portion.

13. The therapeutic drug delivery device according to claim 9, wherein the track includes a helical portion and a lateral portion coupled to the helical portion, and the fixing mechanism is operable to move the projection along the lateral portion of the track, thereby fixing the disposable portion within the reusable portion.

14. The therapeutic drug delivery device according to claim 13, wherein the fixing mechanism is further operable to move the projection along the helical portion of the track, thereby enabling the disposable portion to be detached from the reusable portion.

15. The therapeutic drug delivery device according to claim 9, wherein the fixing mechanism includes the track, the disposable portion includes the projection, the track is a fixed track, the fixing mechanism further includes a lead track fixed to the second housing, and the fixed track is selectively alignable with the lead track to allow the projection to move from the lead track to the fixed track.

16. The therapeutic drug delivery device according to any one of claims 9 to 14, wherein the reusable portion further comprises a first magnetic element, and the disposable portion further comprises a second magnetic element, the second magnetic element magnetically coupling with the first magnetic element to hold the disposable portion in the reusable portion.

17. The therapeutic drug delivery device according to claim 16, wherein the second magnetic element magnetically couples with the first magnetic element to hold the disposable portion in the reusable portion before the fixing mechanism fixes the disposable portion in the reusable portion.

18. The therapeutic drug delivery device according to claim 16, wherein the reusable portion further includes a sensor configured to detect the second magnetic element and thereby detect the arrangement of a disposable unit within the reusable portion.

19. The therapeutic drug delivery device according to claim 9, wherein the reusable portion further includes a sensor configured to detect the placement of a disposable unit within the reusable portion.

20. The therapeutic drug delivery device according to claim 19, wherein when the sensor detects the placement of the disposable unit within the reusable portion, the fixing mechanism is activated to move the projection relative to the track, thereby fixing the disposable portion within the reusable portion.

21. The therapeutic drug delivery device according to claim 19, wherein the sensor is a magnetic field sensor.

22. The therapeutic drug delivery device according to claim 9, wherein the first housing includes a distal end, the syringe assembly is translatable relative to the first housing from a housing configuration to a deployed configuration and back to the housing configuration, in the housing configuration the needle is positioned proximal to the distal end of the first housing, and in the deployed configuration the needle extends at least partially distally from the distal end of the first housing to deliver a therapeutic drug, and when the syringe assembly is translated back from the deployed configuration to the housing configuration the locking mechanism releases the disposable portion, thereby allowing the disposable portion to be removed from the reusable portion.

23. The therapeutic drug delivery device according to claim 1, wherein the distal end of the housing includes a distal end opening, and the inner surface of the housing includes one or more ribs extending radially inward.

24. The drug delivery device according to claim 1 or 9, wherein the passage is configured to transport a drug.

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