Therapeutic agent delivery device with user input device

Abstract

A therapeutic agent delivery device includes a disposable portion and a reusable portion that detachably carries the disposable portion. The reusable portion includes a drive mechanism. The drive mechanism translates a syringe assembly of the disposable portion from a stowed configuration to a deployed configuration. A user input device actuates the drive mechanism. The user input device includes a first configuration prior to actuation and a second configuration. In the first configuration, the drive mechanism prevents actuation of the user input device and in the second configuration, the drive mechanism allows actuation of the user input device. Methods of moving a user input device of a therapeutic agent delivery device are also described, including sensing aspects of the device prior to allowing the user input device to be actuated.

Description

[0001] Cross-reference to related applications

[0002] not applicable. Technical Field

[0003] This disclosure relates to therapeutic agent delivery devices, and more particularly to portable therapeutic agent delivery devices, such as pen injectors. Background Technology

[0004] Patients with a variety of different conditions often have to self-administer medications. To allow for convenient and accurate self-administration, various devices widely known as pen injectors or injection pens have been developed. Typically, these pens are equipped with a cartridge containing a piston and one or more doses of liquid medication. A drive member, extending from the base of the pen injector and operably connected to a mechanism—usually located further back in the pen—that controls the movement of a drive member, can move forward to advance the piston in the cartridge, thereby dispensing the contained medication, typically through a needle penetrating a stopper at the opposite end of the cartridge, from an outlet at the opposite end. In disposable pens, after the pen has been used and the medication in the cartridge has been depleted, the entire pen is discarded by the user, who can then begin using a replacement pen. In reusable pens, after the pen has been used and the medication supply in the cartridge has been depleted, the pen is disassembled, the used cartridge is replaced with a new one, and the pen is reassembled for subsequent use.

[0005] It is desirable to provide a therapeutic agent delivery device with improved features, such as a reusable device that facilitates drug dispensing and / or facilitates the replacement of used cartridges with new cartridges. Summary of the Invention

[0006] According to one embodiment of this disclosure, a therapeutic agent delivery device includes a disposable portion and a reusable portion. The disposable portion includes a first housing having a distal end and a syringe assembly carried by the first housing. The syringe assembly includes a chamber having a channel and a needle communicating with the channel. The syringe assembly is translatable from a retracted configuration relative to the first housing to an extended / operational configuration. In the retracted configuration, the needle is positioned proximally relative to the distal end of the first housing; in the extended configuration, the needle extends at least partially distally from the distal end of the first housing. The reusable portion detachably carries the disposable portion. The reusable portion includes a second housing, a drive mechanism carried by the second housing and coupled to the syringe assembly, and a user input device. The user input device is carried by the second housing and operatively coupled to the drive mechanism. In response to actuation of the user input device, the drive mechanism is configured to translate the syringe assembly relative to the first housing from the retracted and extended configurations. The user input device includes a first configuration and a second configuration prior to actuation, in which a drive mechanism prevents actuation of the user input device, and in which a drive mechanism allows actuation of the user input device.

[0007] According to another embodiment, a method for moving a user input device of a therapeutic agent delivery device is described. The delivery device includes a syringe assembly carried by a housing. The syringe assembly includes a chamber having a channel and a needle communicating with the channel. The syringe assembly is translatable relative to the housing from a retracted configuration to an extended configuration, in which the needle is positioned proximally relative to a distal end of the housing, and in the extended configuration, the needle extends at least partially distally from the distal end of the housing. A drive mechanism is carried by the housing and coupled to the syringe assembly. A user input device is carried by the housing and operatively coupled to the drive mechanism. In response to actuation of the user input device, the drive mechanism is configured to translate the syringe assembly relative to a first housing from the retracted and extended configurations. The user input device includes a first configuration and a second configuration prior to actuation. In the first configuration, the drive mechanism prevents actuation of the user input device, while in the second configuration, the drive mechanism allows actuation of the user input device. The method includes the following steps: providing a user input device for a therapeutic agent delivery device in a first configuration; detecting the presence of a needle shield, wherein the needle shield is detachably coupled to a distal end of a housing and blocks the needle in a retracted configuration, wherein the therapeutic agent delivery device prevents actuation of the user input device when a sensor detects that the needle shield is coupled to the distal end of the first housing; and actuating the user input device to a second configuration when a sensor detects that the needle shield has detached from the distal end of the housing. Attached Figure Description

[0008] The above and other advantages and objects of the present invention, and their implementation methods, will become more apparent from the following description of embodiments of the present invention in conjunction with the accompanying drawings, and the present invention itself will be better understood, wherein:

[0009] Figure 1 This is a top perspective view of a therapeutic agent delivery device according to an embodiment of the present disclosure.

[0010] Figure 2 for Figure 1 The bottom perspective view of the therapeutic agent delivery device shown; the disposable portion detachable from the reusable portion is also shown.

[0011] Figure 3 For along Figure 1 A transverse sectional view of the therapeutic agent delivery device taken by line 3-3; showing the syringe assembly in a retracted configuration.

[0012] Figure 4 for Figure 1 A transverse sectional view of the distal end of the therapeutic agent delivery device shown; the syringe assembly in its deployed configuration is also shown.

[0013] Figure 5 for Figure 1 A schematic diagram of the electronic components of the therapeutic agent delivery device shown.

[0014] Figure 6 for Figure 3 Detailed transverse sectional view of the proximal end of the therapeutic agent delivery device within line 6.

[0015] Figure 7 For along Figure 1 The cross-sectional view of the proximal end of the therapeutic agent delivery device, taken from line 7-7.

[0016] Figure 8 For along Figure 1 A cross-sectional view of the proximal end of the therapeutic agent delivery device, taken from line 8-8.

[0017] Figure 9 For the first configuration Figure 1 A detailed transverse cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0018] Figure 10 For the first configuration Figure 1 A cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0019] Figure 11 For the second configuration Figure 1 A detailed transverse cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0020] Figure 12 For the second configuration Figure 1 A cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0021] Figure 13 For the third configuration Figure 1 A detailed transverse cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0022] Figure 14 For the third configuration Figure 1 A cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0023] Figure 15 For the fourth configuration Figure 1 A detailed transverse cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0024] Figure 16 For the fourth configuration Figure 1 A cross-sectional view of the proximal end of the therapeutic agent delivery device shown.

[0025] Figure 17 for Figure 1 A perspective view of the therapeutic agent delivery mechanism of the therapeutic agent delivery device shown.

[0026] Figure 18 for Figure 3 A detailed cross-sectional view of the therapeutic agent delivery device within line 18.

[0027] Figure 19 This is a perspective transverse sectional view of the therapeutic agent delivery mechanism and syringe assembly according to an embodiment of the present disclosure.

[0028] Figure 20 for Figure 19 A cross-sectional view of the therapeutic agent delivery mechanism and syringe assembly shown; the therapeutic agent delivery mechanism shown is in a retracted configuration.

[0029] Figure 21 for Figure 19 A cross-sectional view of the therapeutic agent delivery mechanism and syringe assembly shown; the therapeutic agent delivery mechanism shown is in an unfolded configuration.

[0030] Figure 22 for Figure 1 A perspective view of the disposable portion of the therapeutic agent delivery device shown.

[0031] Figure 23 For along Figure 22 A cross-sectional view of the discardable portion cut off by line 23-23.

[0032] Figure 24 for Figure 22 An exploded perspective view of the discardable portion.

[0033] Figure 25 This is a perspective view of a discardable portion according to an embodiment of the present disclosure.

[0034] Figure 26 for Figure 25An exploded perspective view of the discardable portion.

[0035] Figure 27 For the first configuration Figure 25 The discardable part of the side view.

[0036] Figure 28 For the second configuration Figure 25 The discardable part of the side view.

[0037] Figure 29 For the third configuration Figure 25 The discardable part of the side view.

[0038] Figure 30 This is an exploded perspective view of a discardable portion according to another embodiment of this disclosure.

[0039] Figure 31 for Figure 30 A detailed side view of the discardable portion.

[0040] Figure 32 for Figure 1 A perspective view of the fixing mechanism of the therapeutic agent delivery device shown.

[0041] Figure 33 For along Figure 32 The transverse sectional view of the fixing mechanism is taken from line 33-33.

[0042] Figure 34 For the first configuration Figure 32 Side view of the fixed mechanism and the disposable part shown.

[0043] Figure 35 For the second configuration Figure 32 Side view of the fixed mechanism and the disposable part shown.

[0044] Figure 36 For the third configuration Figure 32 Side view of the fixed mechanism and the disposable part shown.

[0045] Figure 37 For the fourth configuration Figure 32 Side view of the fixed mechanism and the disposable part shown.

[0046] Figure 38 For the fifth configuration Figure 32 Side view of the fixed mechanism and the disposable part shown.

[0047] Figure 39 For the sixth configuration Figure 32 Side view of the fixed mechanism and the disposable part shown.

[0048] Figure 40This is a cross-sectional view of the fixing mechanism according to an embodiment of the present disclosure.

[0049] Figure 41 For the second configuration Figure 40 Side view of the fixed mechanism and the disposable part shown.

[0050] Figure 42 For the third configuration Figure 40 Side view of the fixed mechanism and the disposable part shown.

[0051] Figure 43 For the fourth configuration Figure 40 Side view of the fixed mechanism and the disposable part shown.

[0052] Figure 44 For the fifth configuration Figure 40 Side view of the fixed mechanism and the disposable part shown.

[0053] Figure 45 For the sixth configuration Figure 40 Side view of the fixed mechanism and the disposable part shown.

[0054] Figure 46 For the seventh configuration Figure 40 Side view of the fixed mechanism and the disposable part shown.

[0055] In several views, corresponding reference characters denote corresponding components. Although the accompanying drawings represent embodiments of the invention, they are not necessarily drawn to scale, and some features may be exaggerated or omitted in some drawings for better illustration and explanation of the invention. Detailed Implementation

[0056] The therapeutic agent delivery device according to this disclosure can carry and dispense one or more therapeutic agents, also referred to as drugs or pharmaceuticals. Such therapeutic agents may include, for example, adrenaline, anesthetics, analgesics, steroids, insulin, insulin analogs such as lispro insulin or glargine insulin, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptides (GIP), GIP analogs, GIP derivatives, combinations of GIP / GLP-1 agonists such as tezepatide, basal insulin, gastrin analogs, gastrin derivatives, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mikizumab, IL-17 antibody analogs or derivatives, such as ixekizumab, therapeutic agents for pain-related treatment, such as galcanezumab, lasmiditan, or lebrikizumab, and any therapeutic agent capable of being delivered via the device described herein. The therapeutic agent delivery device according to this disclosure is typically operated by a user (e.g., a healthcare professional, caregiver, or other person) in the manner described herein to deliver one or more therapeutic agents to a patient (e.g., another person or user).

[0057] Any directional references used in any of the accompanying drawings, such as right or left, top or bottom, are intended for ease of description and do not limit the invention or any part thereof to any particular location or spatial orientation.

[0058] Figure 1-4 A therapeutic agent delivery device 100 according to an exemplary embodiment of the present disclosure is shown. Exemplarily, the therapeutic agent delivery device 100 has the shape of a pen syringe, although other shapes may be used alternatively. Generally, the therapeutic agent delivery device 100 includes a reusable portion 102 and a disposable portion 104, the reusable portion 102 also referred to as a drive portion, and the disposable portion 104 also referred to as a drug-carrying portion or cartridge. The reusable portion 102 facilitates the delivery of therapeutic agent 106 from the disposable portion 104. Figure 3 and Figure 4 Furthermore, the disposable portion 104 is detachably coupled to the reusable portion 102, such that after the therapeutic agent 106 has been delivered from the disposable portion 104, the disposable portion 104 can be detached from the reusable portion 102 and discarded. Another disposable portion (not shown, for example, having the same or different features as the disposable portion 104) can then be attached to the reusable portion 102, thereby preparing the therapeutic agent delivery device 100 for subsequent use.

[0059] The therapeutic agent delivery device 100 also includes a proximal end 108 and an opposing distal end 110. During use of the therapeutic agent delivery device 100, the proximal end 108 is located further from the patient and configured to be actuated by the user, while the distal end 110 is located closer to the patient and configured to deliver the therapeutic agent 106 to the patient. The therapeutic agent 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 therapeutic agent delivery device 100 will be described in further detail below.

[0060] For details, please refer to the following: Figure 3 and Figure 4 A cross-sectional view showing the internal components and other features of the reusable portion 102 and the disposable portion 104. Generally, the reusable portion 102 includes a housing 112 that movably carries the user input device 114 and the drive mechanism 116 (both within...). Figure 3 (As shown in the diagram). The user input device 114 can be actuated by the user (e.g., pressed) to actuate the drive mechanism 116. The drive mechanism 116 is thus translated distally to drive the syringe assembly 118 of the disposable portion 104. More specifically, the drive mechanism 116 moves the syringe assembly 118 from a retracted configuration (as shown in the diagram). Figure 3 Driven to the unfolded configuration by translation ( Figure 4 In the retracted configuration, the needle 120 of the syringe assembly 118 is positioned proximally relative to the distal end 122 of the disposable portion 104. In other words, in the retracted configuration, the needle 120 is retracted into the device 100. In the extended configuration ( Figure 4 The needle 120 extends distally, at least partially, from the distal end 122 of the disposable portion 104. As a result, in the unfolded configuration, the needle 120 is configured to pierce the patient's skin.

[0061] For details, please refer to the following: Figure 3 The drive mechanism 116 of the reusable portion 102 also includes a plunger mechanism or a therapeutic agent delivery mechanism 124. The therapeutic agent delivery mechanism 124 is actuable to discharge therapeutic agent 106 from the syringe assembly 118. More specifically, when the syringe assembly 118 is in an deployed configuration, the therapeutic agent delivery mechanism 124 is actuable to distally translate the shaft or plunger 126 of the syringe assembly 118. The plunger 126 distally drives a piston 128 carried in a therapeutic agent carrying channel 130 of the syringe assembly 118, causing the therapeutic agent 106 to be discharged via the needle 120. Further details of these components are described below.

[0062] Brief and detailed reference Figure 4The distal end 110 of the device 100 also includes a securing mechanism 132 for selectively securing the disposable portion 104 to the reusable portion 102. The securing mechanism 132 also facilitates easy attachment of the disposable portion 104 to the reusable portion 102 and removal of the disposable portion 104 from the reusable portion 102. The components and features of the securing mechanism 132 will be described in further detail below.

[0063] refer to Figure 5 In addition to the components described above, the therapeutic agent delivery device 100 also includes an electronic assembly 134 to facilitate operation of the device 100 in the manner described herein. The electronic assembly 134 includes an electronic controller 136 operatively coupled to and receiving power from a power source 138 (e.g., a battery). The electronic controller 136 is also operatively coupled to a user input device 114 and one or more sensors 140. As described further below, the sensors 140 can sense, for example, actuation of components of the device 100, the position of components of the device 100 relative to each other, and / or the position of the device 100 relative to the patient. The controller 136 is further operatively coupled to a drive mechanism 116 (… Figure 3 ), therapeutic agent delivery mechanism 124 ( Figure 3 ) and fixed mechanism 132 ( Figure 4 ).

[0064] In some embodiments, and as further described in detail below, some components of electronic assembly 134 are carried by reusable portion 102, while some components are carried by disposable portion 104 (both are in reusable portion 102). Figure 1 and Figure 4(As shown in the diagram). For example, the disposable portion 104 may include an identifier 142 (e.g., an RFID transmitter or EEPROM) to provide characteristics of the therapeutic agent 106 to the reusable portion 102. These characteristics may include, for example, the type and / or volume of the therapeutic agent 106 carried 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 is authorized to use or has been prescribed the therapeutic agent 106. As another example, the disposable portion may include a fixation device 144 operatively coupled to a controller 136. The fixation device 144 may initially prevent the syringe assembly 118 from moving from a retracted configuration to an extended configuration, and the controller 136 may actuate the fixation device 144 to allow the syringe assembly 118 to move from the retracted configuration to the extended configuration. In another embodiment, each component of the electronic assembly 134 is carried by the reusable portion 102. In some embodiments, the controller 136 is operatively coupled to one or more other components of the electronic assembly 134 via a wired connection. In some embodiments, the controller 136 is operatively coupled to one or more other components of the electronic component 134 via a wireless connection.

[0065] For reference Figure 6-8 The proximal end 108 of the device 100 is shown in further detail, particularly the proximal portion of the user input device 114 and the drive mechanism 116. The drive mechanism 116 includes a bracket 146. Figure 6 The bracket 146 is translatably supported within the housing 112 of the reusable portion 102. The bracket 146 carries a first actuator 148, which is operatively coupled to an electronic controller 136. Figure 5 The first actuator 148 may be a rotary actuator, more specifically an electric motor, which is drivably coupled to a transmission or reducer. The actuator 148 is drivably coupled to a gear train 150, more specifically, a first gear 152 is drivably coupled to a second gear 154. The second gear 154 is fixed relative to a driven member 156, and the driven member 156 is rotatably supported by a bracket 146. Thus, the bracket 146, actuator 148, gear train 150, and driven member 156 can translate together within the housing 112 of the reusable portion 102. Exemplarily, the bracket 146, actuator 148, gear train 150, and driven member 156 can translate along a driving direction 158 (…). Figure 6 Translation, the driving direction 158 is substantially parallel to the longitudinal axis A of the device 100 (i.e., parallel ±10 degrees).

[0066] A follower 156 is movably coupled to a guide 160, which is fixed relative to the housing 112 of the reusable portion 102. A compression spring 162 forces the follower 156 to move distally and engage with the guide 160. Generally, the follower 156 and the guide 160 include features that facilitate translation of the follower 156 relative to the guide 160 when the follower 156 rotates relative to the guide 160 about a rotation axis R1 that is substantially parallel to the longitudinal axis A (i.e., parallel ±10 degrees) of the device 100. More specifically, the follower 156 includes two radially outwardly extending protrusions 164 that move along an inclined track 166 defined by the guide 160 or a wall generally facing proximal when the follower 156 is driven to rotate by the actuator 148. The protrusions 164 move simultaneously along two similar segments or halves of the track 166. See details. Figure 7 and Figure 8 Each half of track 166 includes a raised platform-shaped portion 168 connected at edge 172 to the cliff-shaped portion 170, a valley-shaped portion 174 connected to the cliff-shaped portion 170 opposite to the raised platform-shaped portion 168, and a sloping portion 176 connected to the valley-shaped portion 174 opposite to the cliff-shaped portion 170. Each sloping portion 176 is also connected to the raised platform-shaped portion 168 of the other half of track 166.

[0067] In the illustrated embodiment, the various portions of track 166 are as follows: Cliff-shaped portion 170 is substantially parallel to the longitudinal axis A of device 100 (i.e., parallel ±10 degrees). Platform-shaped portion 168 and valley-shaped portion 174 are substantially perpendicular to the longitudinal axis A of device 100 (i.e., perpendicular ±10 degrees). Slope-shaped portion 176 extends spirally relative to the longitudinal axis A of device 100.

[0068] In other embodiments, the follower 156 and / or guide 160 may take different forms. For example, the track 166 may have different shapes. More specifically, the track may include an additional ramp-shaped portion (not shown) instead of the cliff-shaped portion 170, and this ramp-shaped portion may extend spirally in the opposite direction to the ramp-shaped portion 176. As another example, the follower 156 may include a different number of protrusions 164 and / or the guide 160 may include a track 166 with a different number of similar segments. As yet another example, the follower 156 may include a track 166 that movably receives one or more protrusions 164 formed on the guide 160.

[0069] Now for specific reference Figure 6The proximal end 108 of the device 100 also includes a feature structure for selectively preventing movement of the user input device 114 relative to the housing 112 of the reusable portion 102, and thus preventing activation of the user input device 114. More specifically, the user input device 114 includes one or more latching hooks 178 (two shown) extending through an opening 180 formed in the guide 160. The hooks 178 engage the guide 160 and hold the user input device 114 in a press-fit configuration relative to the housing 112. Referring now specifically... Figure 6 and Figure 8 The follower 156 includes a support leg 182. Figure 8 When the follower 156 rotates relative to the guide 160, the outrigger 182 engages and releases the hook 178 from the guide 160. When the hook 178 disengages from the guide 160, the compression spring 184 extends and pushes the user input device 114 into a raised configuration relative to the housing 112. These features will be described in further detail in the following paragraphs.

[0070] refer to Figure 9-16 The movement of the components of the device 100 at the proximal end 108 and several configurations are as follows. Although the device 100 may remain in some configurations for a period of time, other configurations are shown for illustrative purposes, and the device 100 may simply transition through these configurations rather than remain in them for a period of time. Figure 9 and Figure 10 A first configuration of the component at the proximal end 108 of the device 100 is shown. In this first configuration, the latch hook 178 of the user input device 114 engages the guide 160 and holds the user input device 114 in a press configuration, and the user input device 114 cannot be activated by the user. In this first configuration, the leg 182 of the follower 156 ( Figure 10 ) is set away from the hook 178, and the protrusion 164 of the follower 156 ( Figure 10 ) is set in the raised platform-shaped portion 168 of the guide member 160 ( Figure 8 ).

[0071] like Figure 11 and Figure 12 As shown, the first actuator 148 ( Figure 6 The driven member 156 (illustratively, clockwise when viewed from the proximal end 108) can be rotated, causing the device 100 to move to the second configuration. Moving to the second configuration causes the leg 182 of the driven member 156 to engage with and release the hook 178 of the user input device 114 from the guide 160, and compresses the spring 184. Figure 11 ) Extend and push the user input device 114 into a raised configuration, wherein the user input device extends from the distal position ( Figure 9The pressing configuration in the middle moves to a position closer to the proximal side than the distal side. Figure 11 (In the raised configuration). However, the leg 182 of the follower 156 is aligned with the hook 178, and the follower 156 thereby prevents actuation of the user input device 114. In the second configuration, the protrusion 164 of the follower 156 is held in the raised platform portion 168 of the guide 160 (all within). Figure 8 (as shown in the image).

[0072] Next, as follows Figure 13 and Figure 14 As shown, the first actuator 148 ( Figure 6 The actuator 156 (rotating in the same direction, e.g., clockwise when viewed from the proximal end 108) can be driven to rotate, moving the device 100 to a third configuration. In the third configuration, the leg 182 of the actuator 156 is positioned away from the hook 178 of the user input device 114, and the actuator 156 thereby allows actuation of the user input device 114. In the third configuration, the protrusion 164 of the actuator 156 (a protrusion 164 in...) Figure 14 (As can be seen in the image) It is held in the raised platform-shaped portion 168 of the guide member 160. Figure 8 ).

[0073] like Figure 15 and Figure 16 As shown, after the user input device 114 is activated, the first actuator 148 ( Figure 6 The driven member 156 (in the same direction, e.g., clockwise when viewed from the proximal end 108) can be rotated, causing the device 100 to move to the fourth configuration. Moving to the fourth configuration causes a protrusion 164 of the driven member 156 (a protrusion 164 in...) to rotate, thus moving the device 100 to the fourth configuration. Figure 16 (As can be seen) the movement crosses the edge 172 of the guide 160 and the cliff-shaped portion 170. Figure 8 This action allows spring 162 (). Figure 15 ) Extend and push the follower 156 distally until the protrusion 164 of the follower 156 engages the valley-shaped portion 174 of the guide 160. Figure 8 The follower 156 thus pushes the bracket 146 to the distal end. Figure 6 The bracket 146 holds the syringe assembly 118 ( Figure 3 and Figure 4 From the collapsed configuration to the expanded configuration, the syringe assembly 118 can then deliver the therapeutic agent to the patient. Actuation of the user input device 114 also causes the latch hook 178 of the user input device 114 to re-engage with the guide 160, which holds the user input device 114 in the press configuration.

[0074] Although not specifically stated, the first actuator 148 can drive the driven member 156 to rotate, causing the device 100 to move to the first configuration. More specifically, the protrusion 164 of the driven member 156 moves over the ramp-shaped portion 176 of the guide member 160. Figure 8 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.

[0075] Continue with overall reference Figure 9-16 And additional reference Figure 5 Electronic component 134 can cause device 100 to switch configurations as described above upon detection of one or more conditions. For example, sensor 140 of electronic component 134 may include a proximity sensor for detecting the detachment of one or more parts of disposable portion 104 from device 100, such as the detachment of a needle guard (shown elsewhere) from device 100. When the detachment of the needle guard from disposable portion 104 is detected, device 100 can switch from a first configuration to a second configuration. As another example, sensor 140 may include a contact sensor for detecting contact between distal end 110 of device 100 and patient skin. Upon detection of contact with patient skin, device 100 can switch from a second configuration to a third configuration. In some embodiments, electronic component 134 may facilitate illumination of user input device 114 to indicate that user input device 114 is ready for activation. As yet another example, sensor 140 may include a contact sensor or proximity sensor for detecting actuation of user input device 114.

[0076] Figure 17 and Figure 18 The therapeutic agent delivery mechanism 124 of the device 100 is shown. Figure 18 In the cross-sectional view, the therapeutic agent delivery mechanism 124 is also shown as other components adjacent to the device 100, such as the bracket 146, the syringe chamber 186, and the piston 128.

[0077] Continue to refer to Figure 17 and Figure 18 The therapeutic agent delivery mechanism 124 is supported by a bracket 146 and translates together with the bracket 146 relative to the housing 112 of the reusable portion 102. The therapeutic agent delivery mechanism 124 includes components operably coupled to an electronic controller 136. Figure 5 The second actuator 188 is a rotary actuator, more specifically an electric motor, drivably coupled to a transmission or reducer. The actuator 188 is drivably coupled to a gear train 190, more specifically, a first gear 192 is drivably coupled to a second gear 194. The second gear 194 includes an internal thread 196 (…). Figure 18The plunger 126 is connected to the external thread 198 of the plunger 126. The plunger 126 is fixed in rotation with respect to the bracket 146 / not rotatably fixed relative to the bracket 146, but can translate relative to the bracket 146. Figure 18 Specifically, plunger 126 is connected to bracket 146 via a keyway interface; more specifically, plunger 126 includes a key 202 accommodating a key formed on bracket 146. Figure 18 The plunger 126 also includes an outer groove 200. The plunger 126 further includes a push head 204 for engaging the piston 128 of the syringe assembly 118.

[0078] Further reference Figure 17 and Figure 18 The movement of the components of the therapeutic agent delivery mechanism 124 is as follows. The actuator 188 is energized to drive the gear train 190 to rotate relative to the carrier 146. The plunger 126 thereby translates relative to the second gear 194 and the carrier 146. The plunger 126 distally pushes the piston 128 in the syringe chamber 186. As described above, this movement of the piston 128 causes the syringe assembly 118 to deliver the therapeutic agent from the needle (shown elsewhere).

[0079] General Reference Figure 1-18 Controller 136 ( Figure 5 The drive mechanism 116 and the therapeutic agent delivery mechanism 124 can be sequentially actuated upon detection of one or more conditions. More specifically, in some embodiments, the drive mechanism 116 is actuated to move the syringe assembly 118 from a retracted configuration to an deployed configuration, and thereafter the therapeutic agent delivery mechanism 124 is actuated to drive the plunger 126 and piston 128, thereby delivering therapeutic agent 106 from the needle 120. In these embodiments, the sensor 140 of the electronics 134 may include a position sensor, such as an encoder (not shown) coupled to the actuator 148, for determining whether the syringe assembly 118 is in a retracted or deployed configuration. When the syringe assembly 118 is detected to be in a deployed configuration, the therapeutic agent delivery mechanism 124 can be actuated to deliver therapeutic agent 106 from the needle 120. After the delivery of the therapeutic agent 106, the drive mechanism 116 is actuated again to allow the syringe assembly 118 to move from an deployed configuration to a retracted configuration, and then the therapeutic agent delivery mechanism 124 is actuated again to retract the plunger 126 from the syringe assembly 118. More specifically, the therapeutic agent delivery mechanism 124 is actuated to retract the plunger 126 from the syringe assembly 118 upon detecting that the syringe assembly 118 has returned to the retracted configuration.

[0080] Figure 19-21A therapeutic agent delivery mechanism 224 according to another exemplary embodiment of this disclosure is shown. The therapeutic agent delivery mechanism 224 can be used in place of the therapeutic agent delivery mechanism 124 of the therapeutic agent delivery device 100 (both shown elsewhere). In this way, the therapeutic agent delivery mechanism 224 will be carried by a bracket 146 of the drive mechanism 116 (both shown elsewhere). The therapeutic agent delivery mechanism 224 and the drive mechanism 116 can also be operated in a similar sequence as described above. The therapeutic agent delivery mechanism 224 is also shown as coupled to the syringe assembly 118, and more specifically, coupled to the syringe chamber 186 and the piston 128.

[0081] Continue to refer to Figure 19-21 The therapeutic agent delivery mechanism 224 includes a second actuator 188 of electronic component 134. Figure 5 Actuator 188 is drivably coupled to gear train 290. Figure 19 More specifically, the first gear 292 is drivably coupled to the second gear 294. The second gear 294 is drivably coupled to a non-circular drive shaft 306, more specifically a square drive shaft 306. The drive shaft 306 is rotatable relative to the bracket 146 of the drive mechanism 116 (both shown elsewhere) and is fixed / not translatably fixed relative to the bracket 146 in terms of translation. The drive shaft 306 is rotatably driven by the gear train 290. The drive shaft 306 is drivably coupled to an intermediate shaft 308, and the drive shaft 306 is received in a non-circular cross-sectional opening 310 of the intermediate shaft 308, more specifically a square cross-sectional opening 310. Thus, the intermediate shaft 308 is rotatable relative to the bracket along with the drive shaft 306, but is translatable relative to the drive shaft 306. The intermediate shaft 308 includes an external thread 312 and an internal thread 314. An external thread 312 is connected to an internal thread 316 of an outer shaft 318, which in turn is connected to an external thread 320 of an inner shaft or plunger 322. The outer shaft 318 is fixed relative to a bracket, for example, by a mounting bracket (not shown). The plunger 322 is fixed in rotation relative to the outer shaft 318 by a sleeve 324. More specifically, one or both of the plunger 322 and the outer shaft 318 are connected to the sleeve 324 via a keyway interface (not shown). As a result, the plunger 322 and the outer shaft 318 are fixed in rotation relative to the sleeve 324 and therefore fixed in rotation relative to each other. The plunger 322 also includes a push head 326 for engaging the piston 128 of the syringe assembly 118.

[0082] Further reference Figure 19-21 For more specific references Figure 20 and Figure 21The movement of the components of the therapeutic agent delivery mechanism 224 is as follows. A rotary actuator 188 is energized to drive the gear train 290, drive shaft 306, and intermediate shaft 308 to rotate relative to the outer shaft 318 and the bracket (shown elsewhere). The intermediate shaft 308 thus rotates and translates relative to the outer shaft 318, and the plunger 322 thus 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 therapeutic agent 106 (both shown elsewhere) from the needle 120.

[0083] Figure 22-24 The disposable portion 104 of the device 100 is shown. See details. Figure 23 sectional view and Figure 24 The exploded diagram shows that the discardable portion 104 includes a proximal end 402 ( Figure 23 The housing 400 has a distal end 404 and a proximal end 404. A proximal cap 406 covers the proximal end 402 of the housing 400. The proximal cap 406 is fixed relative 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 Push the proximal cap 406 distally to move the syringe assembly 118 from the retracted configuration to the unfolded configuration.

[0084] Continue to refer to Figure 23 and Figure 24 The disposable portion 104 internally includes a compression spring 408. The compression spring 408 is compressed within an internal flange 410 in the housing 400. Figure 23 ) and the inner end wall 412 of the proximal cap 406 ( Figure 23 Between ), the compression spring 408 biases the syringe assembly 118 and the proximal cap 406 away from the unfolded configuration and toward the retracted configuration. As a result, the therapeutic agent 106 is delivered through the needle 120. Figure 23 And drive mechanism 116 ( Figure 6 In the reusable section 102 ( Figure 3 After the syringe assembly 118 and the proximal cap 406 are moved proximally within the housing 112, the compression spring 408 pushes the syringe assembly 118 and the proximal cap 406 from the unfolded configuration to the retracted configuration.

[0085] At the distal end 404 of the housing 400, a disposable portion 104 includes 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 conceal the needle 120 of the syringe assembly 118. The needle shield 414, shield puller 416, and base cap 418 are fixed relative to each other and are detachable together from the housing 400 to facilitate delivery of therapeutic agent 106 from the needle 120. The distal end 404 defines an axial opening 423 into which a proximal portion of the base cap 418 is inserted. Ribs 425 may be provided along an inner surface of the housing 400 and extend radially inward. Ribs may extend axially from the distal surface. The radial extent of the ribs 425 is dimensioned to reduce the cross-sectional area of ​​the axial opening 423 relative to the size of the axial opening without such ribs. More than one rib 425 may be included and arranged, for example, circumferentially spaced apart from each other. A small cross-sectional area defined by one or more ribs 425 can prevent objects of a certain size from entering the axial opening 423 after the base cap 418 is removed.

[0086] For details, please refer to the following: Figure 24 The housing 400 also includes a feature structure for securing the disposable portion 104 to the reusable portion 102 via a fixing mechanism 132 (both are in Figure 3 (As shown in the diagram). More specifically, the housing 400 includes one or more protrusions 420 and one or more magnetic elements 422 (e.g., one or more permanent magnets) for coupling to the fixing mechanism 132 and the reusable portion 102. These features will be described in further detail below.

[0087] Figure 25-27 A disposable portion 504 according to another exemplary embodiment of the present disclosure is shown. The disposable portion 504 may be used in place of the disposable portion 104 of the device 100 (both are shown elsewhere). The disposable portion 504 is generally similar to the disposable portion 104, with similar features indicated by similar reference numerals. Unlike the disposable portion 104, the disposable portion 504 also includes a mechanism 526 (not shown) for locking the disposable portion 504 after delivery of the therapeutic agent. More specifically, the locking mechanism 526 allows only the syringe assembly 518 ( Figure 26 The mechanism moves from the stowed configuration to the unfolded configuration and back to the stowed configuration only once. In the illustrated embodiment, the locking mechanism 526 includes a guide 528 defined by the housing 500 and one or more protrusions 530 defined by the proximal cap 506 (schematically, three protrusions 530, one of which is in...). Figure 27(shown in the diagram). The guide 528 includes one or more tracks 532 (schematically, three tracks 532) or guide grooves, and each track 532 movably receives a protrusion 530. Each track 532 includes a first track portion 534 and a second track portion 536. The first track portion 534 extends substantially parallel to the longitudinal axis B of the discardable portion 104 (i.e., parallel ±10 degrees). The first track portion 534 is coupled to the second track portion 536 at its distal end 538, and the second track portion 536 extends helically relative to the longitudinal axis B.

[0088] refer to Figure 27-29 The operation of the locking mechanism 526 is as follows. For example... Figure 27 As shown, when syringe assembly 518 ( Figure 26 When initially in the retracted configuration, each protrusion 530 is received at the proximal end 540 of one of the first track portions 534. (As...) Figure 28 As shown, when the proximal cap 506 and syringe assembly 518 ( Figure 26 As the syringe assembly 518 moves distally relative to the housing 500 and into the deployed configuration, each protrusion 530 moves along the first track portion 534 and reaches the distal end 538 of the associated track 532. Figure 29 As shown, when the cap 506 and syringe assembly 518 ( Figure 26 When the syringe assembly 518 is translated proximally relative to the housing 500 and returns to the retracted configuration, for example due to the compression spring 508 ( Figure 26 The stored torsional energy causes the cap 506 to pivot relative to the housing 500. As a result, each protrusion 530 moves along the second track portion 536 and reaches the proximal end 542 of the associated track 532. When each protrusion 530 reaches the proximal end 542 of the second track portion 536, movement away from the proximal end 542 can be prevented, for example, by a snap-fit ​​feature structure (not shown) and / or interference between each protrusion 530 and the associated track 532.

[0089] In other embodiments, the locking mechanism 526 may take other forms. For example, the proximal cap 506 may define a guide including one or more tracks, and the housing 500 may include one or more protrusions movably received by the tracks 532.

[0090] Figure 30 and Figure 31A disposable portion 604 according to another exemplary embodiment of the present disclosure is shown. The disposable portion 604 can be used in place of the disposable portion 104 of device 100 (both are shown elsewhere). The disposable portion 604 is generally similar to the disposable portion 104, with similar features indicated by similar reference numerals. Unlike the disposable portion 104, the disposable portion 604 also includes a securing device 144 for the electronic component 134. Figure 5 As briefly described above. Generally, the retaining device 144 initially prevents the base cap 618 from detaching from the housing 600, and thus prevents the shield puller 614 and the needle shield 616 (both of which are...) from detaching. Figure 30 (As shown in the diagram) detaches from the housing 600. The retaining device 144 thereby prevents the syringe assembly 618 from moving from the retracted configuration to the extended configuration. Controller 136 ( Figure 5 The controller 136 actuates the retaining device 144 to allow the syringe assembly 618 to move from a retracted configuration to an extended configuration. In some embodiments, the controller 136 activates the retaining device 144 when it determines that one or more conditions have been met. For example, the controller 136 may activate the retaining device 144 when it determines that the disposable portion 604 has been coupled to the reusable portion 102. Figure 1-18 The fixation device 144 is activated when it is determined that a patient associated with the reusable part 102 has been prescribed a treatment (not shown).

[0091] Continue to refer to Figure 30 and Figure 31 The fixing device 144 schematically includes a retainer 644 (more specifically, a shaped wire / profiled wire) and a release device 646. Figure 31 (More specifically, a wire made of one or more shape memory materials). The retainer 644 is carried by and partially extends around the housing 600. The retainer 644 includes one or more laterally extending legs 648 (schematically, two legs 648). The base cap 618 includes one or more holes 650 (schematically, two holes 650). Figure 31 Each hole 650 initially receives a foot 648. The release device 646 is also carried by the housing 600 and extends at least partially around the housing 600. The release device 646 also extends near the foot 648 of the retainer 644. For example, via the controller 136 ( Figure 5 The device receives heat energy, which can actuate, more specifically, retract the release device 646. Actuation causes the release device 646 to pull the foot 648 of the retainer 644 out of the hole 650 of the base cap 618. This action allows the base cap 618, the shroud puller 614, and the needle shroud 616 to detach from the disposable portion 604, which allows for the delivery of therapeutic agents from the needle (not shown).

[0092] Figure 32 and Figure 33 The fixing mechanism 132 of the device 100 is shown. The fixing mechanism 132 is carried within the housing 112 of the reusable portion 102 and is adjacent to the distal end 110 (both are located within the housing 112 of the reusable portion 102). Figure 3 (As shown in the diagram). The fixing mechanism 132 includes components operably coupled to the electronic controller 136 ( Figure 5 The third actuator 700 is a rotary actuator, more specifically an electric motor, drivably coupled to a transmission or reducer. 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 integrally formed with or fixed relative to the proximal cylinder 708. The proximal cylinder 708 is rotatably coupled to a distal cylinder 710, which is fixed relative to the housing 112 of the reusable portion 102. The proximal cylinder 708 rotates relative to the distal cylinder 710 about a fixed axis of rotation R2 that is substantially parallel to the longitudinal axis A (i.e., parallel ±10 degrees) of the device 100.

[0093] Continue to refer to Figure 32 and Figure 33 The proximal cylinder 708 and the distal cylinder 710 include features that facilitate selective attachment of the disposable portion 104 to the reusable portion 102 (both are located on the proximal cylinder 708 and the distal cylinder 710). Figure 3 (shown in the diagram). More specifically, the inner surface 712 of the distal cylinder 710 includes one or more guide rails 714 (schematically, two guide rails 714, in...). Figure 32 and Figure 33 Only one guide rail 714 is visible in the middle, or a guide groove, for receiving the protrusion 420 of the discardable portion 104. Similarly, the proximal cylinder 708 ( Figure 33 The inner surface 716 includes one or more fixed tracks 718 (illustratively, two fixed tracks 718, in...). Figure 33 Only one fixed track 718 (visible in the middle) or guide groove is used to receive the protrusion 420 of the disposable portion 104. As described in further detail below, the proximal cylinder 708 rotates relative to the distal cylinder 710 to selectively align and misalign the fixed track 718 with the guide track 714. These actions respectively allow and prevent the protrusion 420 of the disposable portion 104 from moving between the guide track 714 and the fixed track 718, which facilitates selectively securing the disposable portion 104 to the reusable portion 102.

[0094] Further reference Figure 32 and Figure 33Each guide rail 714 of the distal cylinder 710 comprises an inverted, generally funnel-shaped section. More specifically, each guide rail 714 comprises a tapered distal portion 720 and a relatively narrow proximal portion 722. The width of each distal portion 720 gradually decreases towards the proximal side. More specifically, each distal portion 720 comprises two counter-spiral extending walls 724 connected to the proximal portion 722. As a result, when the disposable portion 104 is connected to the reusable portion 102, the walls 724 are configured to guide the protrusions 420 of the disposable portion 104 toward the proximal portion 722. The width of the proximal portion 722 of each guide rail 714 may be slightly larger than the width of the protrusions 420 of the disposable portion 104. The proximal portion 722 of each guide rail 714 may be substantially parallel to the longitudinal axis A (i.e., parallel ±10 degrees).

[0095] For details, please refer to the following: 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 aligned with a guide track 714 to receive the protrusion 420 of the discardable portion 104 from there. 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. Opposite to the guide track 714, the inlet portion 726 of each fixed track 718 is connected 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 transverse portion. Opposite to the inlet portion 726, the fixed portion 728 of each fixed track 718 is connected to the outlet portion 730. The outlet portion 730 of each fixed track 718 may extend spirally relative to the longitudinal axis A and away from the fixed portion 728. Thus, the outlet section 730 can be referred to as the spiral section. The outlet section 730 is selectively aligned with a guide rail 714 to facilitate the transfer of the protrusion 420 of the discardable section 104 there.

[0096] refer to Figures 34-39 The movement and several configurations of the fixing mechanism 132 and the disposable part 104 are as follows. Although the fixing mechanism 132 and the disposable part 104 may remain in some configurations for a certain period of time, other configurations are shown for illustrative purposes, and the fixing mechanism 132 and the disposable part 104 may simply transition through these configurations rather than remain in these configurations for a certain period of time. Figure 34 A first configuration or initial configuration of the fixing mechanism 132 and the disposable portion 104 is shown. In the first configuration, the disposable portion 104 is detached from the fixing mechanism 132 and the reusable housing 112. Figure 3 ).

[0097] The disposable portion 104 is advanced proximally toward the fixing mechanism 132 to achieve the second configuration, such as... Figure 35 As shown. In the second configuration, the housing 400 of the reposable portion 104 is received in the distal cylinder 710 and the proximal cylinder 708. In the second configuration, the protrusion 420 of the reposable portion 104 (a protrusion 420 in Figure 35 (As can be seen in the middle) It has also entered the guide rail 714 of the distal cylinder 710 (one guide rail 714 in Figure 35 (See image). In the second configuration, the guide rail 714 of the distal cylinder 710 is aligned with the entrance portion 726 of the fixed rail 718 of the proximal cylinder 708 (one entrance portion 726 is in...). Figure 35 (See in the middle).

[0098] The discardable portion 104 is further advanced proximally to reach the third configuration, such as... Figure 36 As shown. In the third configuration, the base cap 418 of the removable portion 104 abuts the fixing mechanism 132 and the distal end 110 of the device 100 (shown elsewhere). In the third configuration, the protrusion 420 of the removable portion 104 (a protrusion 420 in Figure 36 (As can be seen in the image) It has also passed through the entrance portion 726 of the fixed track 718 near the cylinder 708 (an entrance portion 726 and a fixed track 718 in...) Figure 36 (See in). Magnetic element 422 of the disposable portion 104 (one magnetic element 422 in...) Figure 36 (As can be seen in the image) It can also be magnetically coupled to one or more magnetic elements of the reusable portion 102 (e.g., the ferromagnetic portion of the housing 112 or the ferromagnetic component carried in the housing) to retain the disposable portion 104 in the third configuration.

[0099] like Figure 37 As shown, when the third actuator 700 is energized, the proximal cylinder 708 rotates relative to the distal cylinder 710 (illustratively, counterclockwise when viewed from the proximal end 108 of the device 100, shown elsewhere), causing the fixing mechanism 132 to move to the fourth configuration. In the fourth configuration, the protrusion 420 of the discardable portion 104 (a protrusion 420 in...) Figure 37 (As can be seen in the image) a fixed portion 728 is provided in the fixed track 718 of the near-side cylinder 708 (a fixed portion 728 and a fixed track 718 are in...) Figure 37 (See image). This prevents the disposable portion 104 from detaching from the reusable portion 102, and the securing mechanism 132 can remain in the fourth configuration until the therapeutic agent 106 is delivered from the syringe assembly 118 (both are visible). Figure 3 (as shown in the image).

[0100] like Figure 38As shown, the proximal cylinder 708 then rotates relative to the distal cylinder 710 (in the same direction, illustratively, counterclockwise when viewed from the proximal end 108), causing the fixing mechanism 132 to move to the fifth configuration. In the fifth configuration, the protrusion 420 of the discardable portion 104 (a protrusion 420 in...) Figure 38 (As can be seen in the image) is located in the outlet portion 730 of the fixed track 718 near the cylinder 708 (an outlet portion 730 and a fixed track 718 are located in the ... Figure 38 (See in the image). As a result, the proximal cylinder 708 begins to push the protrusion 420 and the discardable portion 104 distally to exclude the discardable portion 104.

[0101] The proximal cylinder 708 rotates further relative to the distal cylinder 710 (in the same direction, illustratively, counterclockwise when viewed from the proximal end 108) to achieve a sixth configuration, as shown below. Figure 39 As shown. In the sixth configuration, the exit portion 730 of the fixed track 718 of the proximal cylinder 708 (an exit portion 730 and a fixed track 718 in) Figure 39 (visible in the middle) and the guide rail 714 of the distal cylinder 710 (one guide rail 714 in Figure 39 (See in the image) Alignment. In the sixth configuration, the protrusion 420 of the discardable portion 104 (one protrusion 420 in...) Figure 38 (See in the middle) is disposed in the guide rail 714 of the distal cylinder 710. The magnetic element 422 may also be magnetically coupled to one or more magnetic elements of the reusable part 102 to hold the disposable part 104 in the sixth configuration, although the user can pull the disposable part 104 distally to separate the disposable part 104 from the fixing mechanism 132 and the reusable part 102.

[0102] Continue with overall reference Figures 34-39 And additional reference Figure 5 The electronic component 134 can switch the fixing mechanism 132 and the disposable portion 104 via the above configuration upon detecting one or more conditions. For example, the sensor 140 of the electronic component 134 may include a proximity sensor for detecting the position of the disposable portion 104 relative to the reusable portion 102. Such a sensor may be, for example, a magnetic field sensor, such as a Hall effect sensor, for detecting the magnetic element 422 of the disposable portion 104. When it is detected that the disposable portion 104 has been inserted into the reusable portion 102 and is in the third configuration ( Figure 36 The fixed mechanism 132 can be converted to the fourth configuration. Figure 37The disposable portion 104 is secured to the reusable portion 102. As another example, the sensor 140 of the electronic component 134 may include a proximity sensor for detecting the position of the syringe assembly 118, more specifically, detecting whether the syringe assembly 118 is in an deployed or retracted configuration. Upon detection that the syringe assembly 118 has moved from the deployed configuration to the retracted configuration (i.e., the syringe assembly 118 has delivered the therapeutic agent 106 to the patient), the securing mechanism 132 can be released from the fourth configuration (…). Figure 37 ) to the fifth configuration ( Figure 38 ) and the sixth configuration ( Figure 39 This allows for the separation of the disposable portion 104 from the reusable portion 102. Alternatively, the controller 136 can be located at the user input device 114. Figure 3 After a predetermined time period following the actuation of the device, the fixation mechanism 132 is switched from the fourth configuration to the fifth and sixth configurations. This predetermined time period may be based, for example, on a typical time period for delivering the therapeutic agent 106 to the patient.

[0103] The fixing mechanism 132 can be modified in a variety of ways. For example, the fixing mechanism 132 may include one or more protrusions, and the reposable portion 104 may include one or more tracks for receiving the protrusions. As another example, see now. Figures 40-46 The diagram illustrates a fixing mechanism 832 according to another exemplary embodiment of the present disclosure. Fixing mechanism 832 can be used in place of fixing mechanism 132. In this way, fixing mechanism 832 will be carried by a housing 112 of the reusable portion 102 (both are shown elsewhere). Fixing mechanism 832 is generally similar to fixing mechanism 132, and similar features are indicated by similar reference numerals.

[0104] For details, please refer to the following: Figure 40 The fixing mechanism 832 includes a distal cylinder 810 and a proximal cylinder 808, each having a guide rail 814 and a fixed rail 818 that are different from the guide rails and fixed rails of the distal cylinder 810 and the proximal cylinder 808, respectively. Specifically, the inner surface 812 of the distal cylinder 810 includes three guide rails 814 (in... Figure 40(Only two guide rails 814 are visible in the middle), the inner surface 816 of the proximal cylinder 808 includes three fixed rails 818. Each guide rail 814 of the distal cylinder 810 includes an inverted, generally funnel-shaped section. More specifically, each guide rail 814 includes a tapered distal portion 820 and a relatively narrow proximal portion 822. The width of each distal portion 820 gradually decreases towards the proximal side. Each fixed rail 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 rail 818 is selectively aligned with one guide rail 814 to receive the protrusion 420 of the discardable portion 104 from there. The distal portion 820 of each fixed rail 818 is coupled to the inlet / outlet portion 834. The inlet / outlet portion 834 of each fixed rail 818 may extend spirally relative to the longitudinal axis A. Thus, the inlet / outlet portion 834 may be referred to as a spiral portion. Opposite to the distal portion 820, the inlet / outlet portion 834 of each fixed track 818 is connected to the 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 transverse portion. The fixed portion 828 terminates opposite to the inlet / outlet portion 834.

[0105] refer to Figures 41-46 The movement and several configurations of the fixing mechanism 832 and the reusable portion 104 are as follows. Although the fixing mechanism 832 and the reusable portion 104 can be held for a period of time in some configurations, other configurations are shown for illustrative purposes, and the fixing mechanism 832 and the reusable portion 104 can simply transition through these configurations rather than being held in these configurations for a period of time. Although not specifically shown, in the first or initial configuration, the reusable portion 104 is disengaged from the fixing mechanism 832 and the reusable housing 112 ( Figure 3 Separation.

[0106] The disposable portion 104 is advanced proximally toward the fixing mechanism 832 to achieve the second configuration, such as... Figure 41 As shown. In the second configuration, the housing 400 of the reposable portion 104 is received in the distal cylinder 810 and the proximal cylinder 808. In the second configuration, the protrusion 420 of the reposable portion 104 (a protrusion 420 in Figure 41 (As can be seen in the middle) It has also entered the guide rail 814 of the distal cylinder 810 (a complete guide rail 814 in Figure 41 (See image). In the second configuration, the guide rail 814 of the distal cylinder 810 is aligned with the distal portion 820 of the fixed rail 818 of the proximal cylinder 808 (a complete fixed rail 818 is visible in the image). Figure 41 (See in the middle).

[0107] The discardable portion 104 is further advanced proximally to achieve a third configuration, such as... Figure 42 As shown. In the third configuration, the protrusion 420 of the discardable portion 104 (a protrusion 420 in Figure 42 (As can be seen in the image) has moved to the distal portion 820 of the fixed track 818 of the near cylinder 808 (a complete fixed track 818 in...) Figure 42 (See image). The discardable portion 104 contains magnetic elements 422 (four magnetic elements 422 in...). Figure 42 (As can be seen in the image) It can also be magnetically coupled to one or more magnetic elements of the reusable portion 102 to retain the disposable portion 104 in the third configuration.

[0108] like Figure 43 As shown, the proximal cylinder 808 rotates relative to the distal cylinder 810 (illustratively, clockwise when viewed from the proximal end 108 of the device 100 – shown elsewhere), causing the fixing mechanism 832 to move to a fourth configuration. In the fourth configuration, the protrusion 420 of the removable portion 104 (a protrusion 420 in…) Figure 42 (As can be seen) is set in the inlet / outlet portion 834 of the fixed track 818 on the near-side cylinder 808 (a complete fixed track 818 in Figure 43 (As can be seen in the middle). As a result, the proximal cylinder 808 has pulled the disposable portion 104 further into the fixing mechanism 832.

[0109] like Figure 44 As shown, the proximal cylinder 808 rotates further relative to the distal cylinder 810 (in the same direction, e.g., clockwise when viewed from the proximal end 108), causing the fixing mechanism 832 to move to the fifth configuration. In the fifth configuration, the protrusion 420 of the discardable portion 104 (a protrusion 420 in...) Figure 44 (As can be seen in the image) is set in the fixed part 828 of the fixed track 818 of the near-side cylinder 808 (one fixed part 828 is in...) Figure 44 (See image). This prevents the disposable portion 104 from detaching from the reusable portion 102, and the securing mechanism 832 can remain in the fifth configuration until the therapeutic agent 106 is delivered from the syringe assembly 118 (both are visible). Figure 3 (as shown in the image).

[0110] like Figure 45 As shown, the proximal cylinder 808 then rotates relative to the distal cylinder 810 (in the opposite direction, e.g., counterclockwise when viewed from the proximal end 108) to achieve a sixth configuration. In the sixth configuration, the protrusion 420 of the discardable portion 104 (a protrusion 420 in...) Figure 45 (As can be seen) is set in the inlet / outlet portion 834 of the fixed track 818 on the near-side cylinder 808 (a complete fixed track 818 in Figure 45 (See in the image). As a result, the proximal cylinder 808 begins to push the protrusion 420 and the discardable portion 104 distally to exclude the discardable portion 104.

[0111] like Figure 46 As shown, the proximal cylinder 808 is further rotated relative to the distal cylinder 810 (in the same direction, e.g., counterclockwise when viewed from the proximal end 108) to achieve a seventh configuration. In the seventh configuration, the protrusion 420 of the discardable portion 104 (a protrusion 420 in...) Figure 46 (As can be seen in the image) is located in the distal portion 820 of the fixed track 818 set in the near cylinder 808 (a complete fixed track 818 is in the image). Figure 46 (See image). In the seventh configuration, the distal portion 820 of the fixed track 818 is aligned with the guide track 814 of the distal cylinder 810 (a complete guide track 814 is visible in the image). Figure 46 (See in the image). Magnetic element 422 may also be magnetically coupled to one or more magnetic elements of reusable portion 102 to hold disposable portion 104 in the seventh configuration, although the user may pull disposable portion 104 to the distal end to detach disposable portion 104 from fixing mechanism 832 and reusable portion 102.

[0112] Electronic component 134 ( Figure 5 This allows the fixing mechanism 832 and the disposable part 104 to switch through the above configuration in a manner similar to that described above in conjunction with the fixing mechanism 132 when one or more conditions are detected.

[0113] While various aspects of this disclosure refer to reusable and disposable portions, any aspect disclosed herein can be used for a single-use device. In this example, the first housing and the second housing will be referred to as the housing.

[0114] While the invention has been shown and described with preferred embodiments, modifications are possible within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or modifications of the invention using its general principles. Furthermore, this application is intended to cover deviations from this disclosure in known or conventional practice within the art to which this invention pertains.

[0115] This disclosure describes several aspects, including but not limited to the following:

[0116] 1. A therapeutic agent delivery device comprising: a disposable portion including: a first housing including a distal end; a syringe assembly carried by the first housing, the syringe assembly including: a chamber including a channel; a needle communicating with the channel; the syringe assembly being translatable relative to the first housing from a collapsed configuration to an expanded configuration, wherein in the collapsed configuration the needle is positioned proximally relative to the distal end of the first housing, and in the expanded configuration the needle extends at least partially distally from the distal end of the first housing; and a reusable portion detachably carrying the disposable portion, the reusable portion including: a second housing; and a syringe assembly carried by the second housing. A drive mechanism carried and coupled to the syringe assembly; a user input device carried by the second housing and operably coupled to the drive mechanism, wherein, in response to actuation of the user input device, the drive mechanism is configured to translate the syringe assembly from the retracted configuration and the extended configuration relative to the first housing, wherein the user input device includes a first configuration and a second configuration prior to actuation, in the first configuration the drive mechanism prevents actuation of the user input device, and in the second configuration the drive mechanism allows actuation of the user input device.

[0117] 2. The therapeutic agent delivery device according to aspect 1, wherein the user input device can be actuated by a user to actuate the rotary actuator of the drive mechanism.

[0118] 3. The therapeutic agent delivery device according to aspect 2, wherein in a first configuration, the driven member of the drive mechanism is configured to contact the user input device to prevent actuation of the user input device, and in a second configuration, the driven member is configured to disengage from the user input device and allow actuation of the user input device.

[0119] 4. The therapeutic agent delivery device according to any one of aspects 2-3, wherein the second housing includes a distal end, and in the deployed configuration, the needle extends distally at least partially from the distal end of the second housing, the reusable portion further including a sensor configured to detect contact between the distal end of the second housing and the skin of a subject, wherein when the sensor does not detect contact between the distal end of the second housing and the skin of the subject, the reusable portion prevents actuation of the user input device, and when the sensor detects contact between the distal end of the second housing and the skin of the subject, the reusable portion allows actuation of the user input device.

[0120] 5. The therapeutic agent delivery device according to any one of aspects 2-4, wherein the disposable portion further includes a needle shield detachably coupled to the distal end of the first housing and shielding the needle in the retracted configuration, and the reusable portion further includes a sensor configured to detect the needle shield, wherein when the sensor detects that the needle shield is coupled to the distal end of the first housing, the reusable portion prevents actuation of the user input device, and when the sensor detects that the needle shield is detached from the distal end of the first housing, the reusable portion allows actuation of the user input device.

[0121] 6. The therapeutic agent delivery device according to any one of aspects 1-5, wherein in the first configuration, the user input device is in a distal position, and in the second configuration, the user input device is in a position more proximal than the distal position.

[0122] 7. The therapeutic agent delivery device according to aspect 6, wherein the drive mechanism includes a guide, and the user input device includes one or more hook-shaped members that engage the guide when the user input device is in the first configuration.

[0123] 8. The therapeutic agent delivery device according to aspect 7, wherein the drive mechanism includes a follower rotatable relative to the guide, a portion of the follower engaging the one or more hook-shaped members of the user input device during rotation to release the one or more hook-shaped members from the guide, thereby allowing the user input device to move to the second configuration.

[0124] 9. The therapeutic agent delivery device according to aspect 8, wherein when the one or more hook-shaped members are released from the guide, a spring provides a biasing force to move the user input device proximally to the second configuration.

[0125] 10. The therapeutic agent delivery device according to aspect 8, wherein the chamber of the syringe assembly contains a therapeutic agent.

[0126] 11. A method of user input device for a mobile therapeutic agent delivery device, the delivery device comprising: a syringe assembly carried by a housing, the syringe assembly including a chamber including a channel and a needle communicating with the channel, the syringe assembly being translatable relative to the housing from a retracted configuration to an extended configuration, in the retracted configuration the needle being positioned proximally relative to a distal end of the housing, and in the extended configuration the needle extending at least partially distally from the distal end of the housing; a drive mechanism carried by the housing and coupled to the syringe assembly; a user input device carried by the housing and operatively coupled to the drive mechanism, wherein, in response to actuation of the user input device, the drive mechanism is configured to cause the syringe assembly to move from the retracted configuration. The method includes the steps of: providing a user input device in the first configuration relative to a first housing, wherein the actuation mechanism prevents actuation of the user input device in the first configuration and in the second configuration allows actuation of the user input device in the second configuration; detecting the presence of a needle shield, wherein the needle shield is detachably coupled to a distal end of the housing and shields a needle in a retracted configuration, wherein the actuation mechanism prevents actuation of the user input device when a sensor detects that the needle shield is coupled to the distal end of the first housing; and actuating the user input to the second configuration when the sensor detects that the needle shield is disengaged from the distal end of the housing.

[0127] 12. The method according to aspect 11, wherein when in the first configuration, the user input device is in a distal position, and when in the second configuration, the user input device is in a position closer to the side than the distal position.

[0128] 13. The method according to any one of aspects 11-12, further comprising: detecting contact between the distal end of the housing and the subject's skin, wherein when the sensor does not detect contact between the distal end of the housing and the subject's skin, the therapeutic agent delivery device prevents actuation of the user input device, the actuation step further comprising: actuating the user input device to the second configuration when the sensor detects that the needle shield has separated from the distal end of the housing, and when the sensor detects contact between the distal end of the housing and the subject's skin.

Claims

1. A therapeutic agent delivery device, the therapeutic agent delivery device comprising: Disposable portion, said disposable portion includes: Including the first housing at the distal end; A syringe assembly carried by a first housing, the syringe assembly comprising: Including the chambers of the passage; A needle connected to the channel; The syringe assembly is translatable from a retracted configuration relative to the first housing to an extended configuration, in which the needle is positioned proximally relative to the distal end of the first housing, and in the extended configuration, the needle extends distally at least partially from the distal end of the first housing. A reusable portion that detachably carries a disposable portion, the reusable portion comprising: Second shell; The drive mechanism, which is carried by the second housing and connected to the syringe assembly, A user input device, carried by a second housing and operatively coupled to a drive mechanism, wherein, in response to actuation of the user input device, the drive mechanism is configured to translate the syringe assembly relative to the first housing from a retracted configuration to an extended configuration. The user input device includes a first configuration and a second configuration prior to actuation. In the first configuration, a drive mechanism prevents actuation of the user input device; in the second configuration, a drive mechanism allows actuation of the user input device. In the first configuration, the user input device is located at a distal position; in the second configuration, the user input device is located at a position closer to the side than at a distal position. The drive mechanism includes a guide member, and the user input device includes one or more hook-shaped members. When the user input device is in a first configuration, the hook-shaped members engage the guide member, and The drive mechanism includes a follower rotatable relative to the guide, a portion of which engages one or more hook-shaped members of the user input device during rotation to release the one or more hook-shaped members from the guide, thereby allowing the user input device to move to the second configuration.

2. The therapeutic agent delivery device according to claim 1, wherein, The user input device can be actuated by the user to actuate the rotary actuator of the drive mechanism.

3. The therapeutic agent delivery device according to claim 2, wherein, In the first configuration, the driven element of the drive mechanism is configured to contact the user input device to prevent actuation of the user input device; in the second configuration, the driven element is configured to disengage from the user input device and allow actuation of the user input device.

4. The therapeutic agent delivery device according to claim 2 or 3, wherein, The reusable portion also includes a sensor configured to detect contact between the distal end of the first housing and the subject's skin. When the sensor does not detect contact between the distal end of the first housing and the subject's skin, the reusable portion prevents actuation of the user input device; when the sensor detects contact between the distal end of the first housing and the subject's skin, the reusable portion allows actuation of the user input device.

5. The therapeutic agent delivery device according to claim 2 or 3, wherein, The disposable portion also includes a needle guard detachably attached to the distal end of the first housing and shielding the needle in a retracted configuration. The reusable portion also includes a sensor configured to detect the needle guard. When the sensor detects that the needle guard is attached to the distal end of the first housing, the reusable portion prevents actuation of the user input device; when the sensor detects that the needle guard has detached from the distal end of the first housing, the reusable portion allows actuation of the user input device.

6. The therapeutic agent delivery device according to any one of claims 1 to 3, wherein, When the one or more hook-shaped members are released from the guide, the spring provides a biasing force to move the user input device proximally to the second configuration.

7. The therapeutic agent delivery device according to any one of claims 1 to 3, wherein, The chamber of the syringe assembly contains a therapeutic agent.

8. A method for moving a user input device of the therapeutic agent delivery device according to claim 1, the method comprising the steps of: Provides a user input device in a first configuration to the therapeutic agent delivery device; The presence of a needle shield is detected, wherein the needle shield is detachably attached to the distal end of the first housing and shields the needle in a retracted configuration. When the sensor detects that the needle shield is attached to the distal end of the first housing, the therapeutic agent delivery device prevents the user from actuating the input device. as well as When the sensor detects that the needle guard has detached from the distal end of the first housing, the user input device is actuated to the second configuration.

9. The method according to claim 8, wherein, In the first configuration, the user input device is in the far side position; in the second configuration, the user input device is in a position closer to the side than the far side position.

10. The method according to claim 8 or 9, further comprising: The sensor detects contact between the distal end of the first housing and the subject's skin. When the sensor does not detect contact between the distal end of the first housing and the subject's skin, the therapeutic agent delivery device prevents the user from activating the device.

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