Medicament delivery device and method of operating a medicament delivery device

Abstract

This invention relates to a medication delivery device and a method of operating the medication delivery device, particularly to a delay mechanism of the medication delivery device. The medication delivery device may include a medication chamber configured to contain medication; a plunger configured to move relative to the medication chamber to discharge medication from the medication chamber; a pin configured to move from a first pin position to a second pin position, wherein in the first pin position the pin prevents movement of the plunger, and in the second pin position the pin allows movement of the plunger; an actuation assembly configured to move the pin from the first pin position to the second pin position; and a needle connected to the medication chamber. Medication can flow from the medication chamber to the user through the needle. The actuation assembly may be configured to automatically move the pin after a predetermined time delay. The method includes separating the actuation assembly from the housing of the medication delivery device, thereby moving the pin from the first pin position to the second pin position.

Description

[0001] Cross-references to related applications

[0002] This application is a divisional application of application number 201880038063.2 (PCT application number PCT / US2018 / 038518), filed on June 20, 2018, entitled "Delay Mechanism of Hydraulic Drug Delivery Device".

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 522,649, entitled "Time Delay Mechanism for a Hydraulic Drug Delivery Device," filed June 20, 2017, the entire contents of which are incorporated herein by reference. Background Technology

[0004] The present invention generally relates to a pharmaceutical delivery device, and more specifically, to a delay mechanism for a pharmaceutical delivery device. Summary of the Invention

[0005] In one embodiment, a medication delivery device is provided, the medication delivery device including a medication chamber configured to contain a medication; a plunger configured to move relative to the medication chamber to discharge the medication from the medication chamber; a pin configured to move from a first pin position, wherein the pin prevents movement of the plunger to a second pin position, wherein the pin allows movement of the plunger; an actuation component configured to move the pin from the first pin position to the second pin position; and a needle connected to the medication chamber. The medication can flow from the medication chamber to a user through the needle. The actuation component can be configured to automatically move the pin after a predetermined time delay.

[0006] The actuation assembly may include an adapter connected to the pin; and an actuator configured to move the adapter from a first adapter position to a second adapter position, thereby moving the pin from the first pin position to the second pin position. The adapter may include an internal opening configured to receive at least a portion of the pin. The adapter may include a deflectable flange configured to engage an edge of the pin.

[0007] In another embodiment, the actuation assembly may include a gear having an internal opening configured to receive the adapter. The adapter may be configured to move relative to the gear. The internal opening of the gear may be defined by a threaded peripheral wall, and the adapter may include an external thread configured to engage with the threaded peripheral wall. The actuator may be configured to rotate the gear, and the adapter may be configured to move relative to the gear as the gear rotates. The actuator may include a motor.

[0008] In another embodiment, the drug delivery device may include a drive gear connected to the motor, the drive gear being configured to mesh with the gear such that the motor rotates the drive gear as the motor rotates. The drug delivery device may also include a housing configured to house at least a portion of the drug chamber, the plunger, and the pin. The actuation assembly may be detachably connected to the housing. The adapter may be rotatably fixed relative to the housing.

[0009] The actuation assembly may further include an engagement member connected to the adapter, the engagement member being configured to move relative to the adapter from a first engagement member position to a second engagement member position; and a latching member configured to prevent movement of the engagement member when it is in the first engagement position. When the engagement member is available in the second engagement member position, the adapter is available to move from the first adapter position to the second adapter position. The actuator may include a biasing element configured to push the engagement member toward the second engagement member position.

[0010] In another embodiment, the conveying device may include an actuator configured to move the engaging member from the first engaging member position to the second engaging member position.

[0011] In one embodiment, a drug delivery device is provided, the drug delivery device including a first chamber including a first plunger configured to move relative to the first chamber; and a second chamber fluidly connected to the first chamber. The second chamber is configured to receive fluid from the first chamber when the first plunger moves relative to the first chamber. The drug delivery device may include a third chamber including a third plunger fluidly connected to the first chamber. The third chamber is configured to contain a drug, and the third plunger chamber is configured to move relative to the third chamber when the first plunger moves relative to the first chamber. The drug delivery device may include a biasing element configured to move the first plunger relative to the first chamber; and a needle connected to the third chamber. The needle is configured to provide a channel for the drug to flow from the third chamber to a user when the third plunger moves relative to the third chamber.

[0012] The first chamber may be configured to contain a fluid, wherein at least a portion of the fluid may be delivered from the first chamber to the second chamber when the first plunger moves relative to the first chamber. The second chamber may include a second plunger configured to move relative to the second chamber when the fluid is delivered from the first chamber to the second chamber. The second chamber may include a flexible membrane configured to move relative to the second chamber when the fluid is delivered from the first chamber to the second chamber. The second chamber may include an expandable membrane configured to expand relative to the second chamber when the fluid is delivered from the first chamber to the second chamber. The second chamber may include a venting membrane configured to allow gas to escape from the second chamber, but prevent fluid from leaving the second chamber when the fluid is delivered from the first chamber to the second chamber. When the first plunger moves relative to the first chamber, at least a portion of the fluid may be delivered from the first chamber to the third chamber. The drug delivery device may be configured to deliver fluid from the first chamber to the second chamber before the fluid is delivered from the first chamber to the third chamber.

[0013] The drug delivery device may be configured such that there is a time delay between the time when the first plunger begins to move relative to the first chamber and the time when the third plunger begins to move relative to the third chamber. The first chamber may include a bypass through which fluid flows before being delivered from the first chamber to the third chamber. The first plunger may include a first collar and a body, the first collar having a first collar diameter and the body having a body diameter, wherein the body diameter is smaller than the first collar diameter. The first plunger may include a second collar having a second collar diameter, wherein the body diameter is smaller than the second collar diameter. The second collar diameter may be substantially the same as the first collar diameter. The first chamber may include a distal end between a distal end of the first chamber and the first collar, and the first chamber may include a proximal end between the first collar and the second collar. When the first plunger moves relative to the first chamber, fluid may flow from the distal end into the proximal end through the bypass. The fluid may be delivered from the proximal end of the first chamber to the third chamber.

[0014] The second chamber is fluidly connected to the first chamber via a first channel having a first channel diameter, and the third chamber is fluidly connected to the first chamber via a second channel having a second channel diameter, wherein the first channel diameter may be smaller than the second channel diameter. The first channel may include a first channel length, the second channel may include a second channel length, and the first channel length may be greater than the second channel length. The first channel length may be greater than the second channel length by an amount equal to or greater than the diameter of the third chamber. The flow rate of the fluid from the first chamber to the second chamber may be less than the flow rate of the fluid from the first chamber to the third chamber. The delivery of the fluid to the third chamber may cause the third plunger to move relative to the third chamber, thereby discharging the medication from the third chamber through the needle and to the user.

[0015] The drug delivery device may include a pin configured to move from a first pin position, wherein the pin prevents the first plunger from moving to a second pin position, and wherein the pin allows movement of the first plunger relative to the first chamber. The actuation assembly may be configured to move the pin from the first pin position to the second pin position. Attached Figure Description

[0016] The following detailed description of the delay mechanism of the drug delivery device will be better understood when read in conjunction with the accompanying drawings of exemplary embodiments. However, it should be understood that the invention is not limited to the precise arrangement and means shown.

[0017] In the attached diagram:

[0018] Figure 1 This is a trimetric view of a conveying device according to an exemplary embodiment of the present invention.

[0019] Figure 2 yes Figure 1 The conveying device shown is a top sectional view taken along a plane, and its position and orientation are indicated by line 2-2;

[0020] Figure 3 yes Figure 1 The conveying device shown is a front sectional view taken along a plane, and its position and orientation are indicated by line 3-3;

[0021] Figure 4 yes Figure 1 A side view of the conveying device in oblique axonometric projection, on which a consistent moving assembly according to an exemplary embodiment of the present invention is attached;

[0022] Figure 5 yes Figure 4 A tilted axonometric view of the actuation component;

[0023] Figure 6 yes Figure 4 A cross-sectional oblique axonometric view of an interface adapter component;

[0024] Figure 7 yes Figure 4 Top view, side view, and sectional oblique axonometric view of the actuation component;

[0025] Figure 8 yes Figure 4 A top view, side view, and cross-sectional oblique axonometric drawing of the conveying device and actuation components;

[0026] Figure 9 yes Figure 4 A top view, side view, and cross-sectional oblique axonometric drawing of the conveying device and actuation components;

[0027] Figure 10 yes Figure 1 A side view of the conveying device in oblique axonometric projection, on which a consistent moving assembly according to another exemplary embodiment of the present invention is attached;

[0028] Figure 11 yes Figure 10 Oblique axonometric view of one side of the conveying device and actuation components;

[0029] Figure 12 yes Figure 10 Oblique axonometric view of one side of the conveying device and actuation components;

[0030] Figure 13 This is a top view, a side view, and an oblique axonometric drawing of a conveying device according to another embodiment of the present invention;

[0031] Figure 14 yes Figure 13 A top view and a side view oblique axonometric drawing of the conveying device; and

[0032] Figure 15 yes Figure 13 A top view and a side view oblique axonometric drawing of the conveying device. Detailed Implementation

[0033] Refer in detail to the accompanying drawings, wherein the same reference numerals denote the same elements throughout the text. Figures 1 to 15 A delivery device, generally designated 20, is illustrated according to an exemplary embodiment of the invention. The delivery device 20 may be attached to a user's skin to deliver a substance, such as a drug or agent, to the user. The delivery device 20 may be configured to deliver the agent to the user after a time delay, as explained in more detail below. The delivery device 20 may be configured to subcutaneously deliver an agent to a user after a delay within a selected or predetermined time interval. The delivery device 20 may include a patch 22 that attaches the delivery device 20 to a user's skin. The patch 22 may be an adhesive patch that self-adheres to the user's skin. The delivery device 20 may include a housing 24 attached to the patch 22.

[0034] In one embodiment, the delivery device 20 is a detachable portable insulin delivery pump. The delivery device 20 may be single-use, disposable, and non-reusable. The delivery device 20 can provide therapeutic capability in a small, disposable package, and at least some parts can be manufactured through mass production (e.g., injection molding) and assembly processes, thereby allowing for lower commodity costs. Embodiments of the delivery device 20 can be used in a wide range of applications, including but not limited to clinical applications (e.g., drug administration) and biomedical research (e.g., microinjection into cells, nuclear or organelle transplantation, isolation of single cells or hybridomas, etc.).

[0035] In one embodiment, delivery device 20 is a means for dispensing, delivering, or administering a fluid or reagent to the user or patient. The fluid may be a low-viscosity gel and / or a therapeutic agent. In one embodiment, delivery device 20 is configured to deliver pegfilgrastim (Neulasta®) to a user to stimulate the production of white blood cells in a patient undergoing chemotherapy. Other drugs requiring a time delay include chemotherapy agents, hypertension treatments administered during sleep, antidepressants, and analgesics. In one embodiment, the fluid is an analgesic. In one embodiment, the fluid is any type of insulin. In other embodiments, the fluid may be, but is not limited to, a sedative or analgesic, a hormone, a psychotherapeutic composition, or any other drug or chemical substance whose continuous administration, with or without a time delay, is ideal or effective for use in treating a patient. Delivery device 20 can be used to deliver a single fluid and combinations of two or more fluids (mixed or co-administered). As used herein, a “patient” or “user” can be a human or a non-human animal; the use of delivery device 20 is not limited to human medicine but can be equally applied to veterinary medicine.

[0036] The delivery device 20 can dispense the fluid over a continuous time interval (i.e., basic delivery). In one embodiment, the infusion rate is delivered to the user continuously or nearly continuously over the continuous time interval. As explained in more detail below, the delivery device 20 can dispense the fluid over a continuous time interval, but delivery may not begin until after a selected or predetermined time delay. A time delay may allow a caregiver to administer an initial dose of medication to a patient and attach the delivery device 20, such that a second dose of medication is delivered to the patient according to a selected schedule.

[0037] Reference Figure 2 The delivery device 20 may include a medicine chamber 26 within the housing 24. A plunger 28 may be located within the medicine chamber 26. The plunger 28 may move within the medicine chamber 26 to displace medicine from the medicine chamber 26, as described in more detail below. In one embodiment, the plunger 28 is moved relative to the medicine chamber 26 by fluid pressure (e.g., hydraulic fluid). In another embodiment, the plunger 28 is moved directly or indirectly by a biasing element (e.g., a spring) or pneumatic pressure.

[0038] The delivery device 20 may include a second chamber 30 containing fluid. A second plunger 32 may be located in the second chamber 30. The second chamber 30 may be fluidly connected to the pharmaceutical chamber 26 via a channel. The second plunger 32 may be movable relative to the second chamber 30 to discharge the fluid from the second chamber 30 through the channel and into the pharmaceutical chamber 26. A wall 34 may be located at a proximal end 36 of the second chamber 30. The wall 34 may be fixed relative to the second chamber 30. A biasing element 38 may be located between the fixed wall 34 and a portion of the plunger 32. The biasing element 38 (e.g., a spring or compressed gas) may move from a compressed state to a depressurized state, thereby moving the plunger 32 toward a distal end 40 of the second chamber.

[0039] A latching element, such as a pin 42, may be connected to the second plunger 32 to prevent movement of the second plunger relative to the second chamber 30. In one embodiment, the pin 42 has a circular cross-section. In another embodiment, the pin 42 has a non-circular cross-section, such as a square. The pin 42 may extend through or connect to the housing 24 such that the pin 42 contacts the housing to prevent movement of the second plunger 32 when the pin is in a first pin position. The pin 42 may be movable relative to the second plunger 32. The pin 42 may be movable from the first pin position, in which the pin 42 prevents the second plunger 32 from moving to a second pin position, in which the pin 42 allows movement of the second plunger 32. Disconnecting the pin 42 from the second plunger 32 allows movement of the second plunger relative to the second chamber 30. The pin 42 may also, or alternatively, be connected to the plunger 28 of the medication chamber 26. In one embodiment, the second plunger 32 may include a recess or hole for receiving the pin 42. In another embodiment, the second plunger 32 may include a shoulder or protrusion to engage the pin 42 such that when the pin 42 is in the first pin position, the second plunger 32 is restricted from moving toward the distal end of the second chamber 30.

[0040] When the pin 42 is disengaged from the second plunger 32, the biasing element 38 can move the second plunger 32 toward the distal end 40 of the second chamber 30. This movement of the second plunger 32 relative to the second chamber 30 allows fluid to be expelled from the second chamber 30 through the channel and into the medication chamber 26. Therefore, the biasing element 38 can move each of the second plunger 32 and the plunger 28 relative to the second chamber 30 and the medication chamber 26, respectively. The plunger 28 can separate the medication from the fluid in the medication chamber 26, such that when fluid from the second chamber 30 enters the medication chamber 26, the medication is expelled through a needle 44 and into the user (needle 44 in…). Figure 3 (The best view).

[0041] The delivery device 20 may include a communication module configured to communicate with a remote device. The communication module may be configured to communicate via a wired connection or wirelessly (e.g., Near Field Communication (NFC), Infrared (IR) wireless communication, Bluetooth, or Zigbee). The communication module may communicate with an application on a user's mobile phone or computer. The application may enable the user's phone to provide a signal (e.g., auditory or tactile notification) to notify the user when to begin delivery of medication from the delivery device 20. The communication module may be connected to the latch 42 such that removing the communication module upon being warned to do so will initiate medication delivery. The communication module may send a signal to the application at an appropriate time indicating that the module has been removed. A user may input a signal to the application indicating that the delivery device 20 is connected to the user, and the application may send a second signal after a selected time delay to notify the user to actuate the delivery device 20 by removing the latch 42.

[0042] The delivery device 20 may include a timer configured to notify a user when to begin delivery of the medication and / or when to remove the delivery device 20. The timer may include an alarm to provide an auditory, visual, and / or tactile signal to a user to actuate the delivery device 20 to deliver the medication. The timer may be connected to the latch 42 such that removal of the timer from the delivery device 20 actuates the delivery device. In one embodiment, the timer is an external device attached to the delivery device. In one embodiment, the timer is located within the housing 24.

[0043] Reference Figure 4 A simultaneous motion component 46 can be connected to the conveying device 20, for ease of discussion, as... Figure 4As shown, some components are removed from the conveyor 20. The actuation component 46 can be configured to actuate the conveyor 20 after a selected time delay. The actuation component 46 can be connected to an existing conveyor 20. In one embodiment, a user of the conveyor 20 connects the actuation component 46 to the conveyor 20. In one embodiment, the actuation component 46 is connected to the conveyor 20 during manufacturing, such that the user receives the conveyor 20 while the actuation component 46 is already connected to the conveyor 20. In one embodiment, the actuation component 46 is integrally formed with the conveyor 20. In one embodiment, the actuation component 46 is removably connected to the conveyor 20. In one embodiment, the actuation component 46 is locked to the conveyor 20 and is not intended to be removed from the conveyor 20.

[0044] The actuation component 46 can be configured to move the pin 42 from the first pin position ( Figure 8 Move to the second pin position ( Figure 9 (This will be explained in more detail below.) The actuation component 46 can be configured to delay the start of the delivery 20. For example, the delivery device 20 can be attached to the user, and the user or caregiver can activate the actuation component 46 such that the delivery device 20 is not actuated until a predetermined time delay is set by the actuation component 46. The time delay can be any desired amount of time. The time delay can be approximately 1 second, approximately 5 seconds, approximately 10 seconds, approximately 30 seconds, approximately 1 minute, approximately 5 minutes, approximately 15 minutes, approximately 30 minutes, approximately 45 minutes, approximately 1 hour, approximately 3 hours, approximately 5 hours, approximately 10 hours, approximately 15 hours, approximately 18.5 hours, approximately 20 hours, approximately 24 hours, approximately 36 hours, or approximately 48 hours.

[0045] Reference Figures 4 to 7 The actuation component 46 may include an adapter 48. Figure 7 The adapter 48 is configured to engage the pin 42 (see...). Figure 2The adapter 48 may include an internal opening 50 configured to receive at least a portion of the pin 42. One or more flanges 52 may extend into the internal opening 50. When the pin 42 is in the internal opening 50, the flanges 52 may engage the pin 42. The pin 42 may include a head 54 and a body 57. A neck 59 may be formed between the head 54 and the body 57 of the pin 42. The diameter of the neck 59 may be smaller than the diameter of the head 54 and / or the body 57, such that when the head 54 is in the internal opening 50, the flanges 52 engage the neck 59. The flanges 52 may be resilient, such that when the head 54 enters the internal opening 50 and contacts the flanges 52, the flanges 52 may deflect. When the flanges 52 are adjacent to the neck 59, the flanges 52 may return to their undeflected state. In some embodiments, the adapter 48 includes a magnet, and the pin 42 includes a magnetic or ferromagnetic material, such that the adapter 48 is magnetically connected to the pin 42.

[0046] Reference Figure 5 The actuation assembly 46 may include a gear 56. The gear 56 may be configured to rotate relative to the actuation assembly 46. The actuation assembly may include an actuator 58 configured to rotate the gear 56. In one embodiment, the actuator 58 is a DC motor, such as Precision Microdrives model 103-100 or model 124-002. In another embodiment, the actuator 58 is a cable, a rotatable knob, or a crank. In one embodiment, the actuator 58 is connected to a drive gear 60 that meshes with the gear 56, such that the actuator 58 rotates the drive gear 60, which causes the gear 56 to rotate. In another embodiment, the actuator 58 is connected to the gear 56, such that the electric motor rotates the gear 56.

[0047] Reference Figures 5 to 7The gear 56 may include an internal opening 62 configured to receive the adapter 48. When the gear rotates, the adapter 48 can move relative to the gear 56. The internal opening 62 may be defined by a threaded peripheral wall 64. The adapter 48 may include an external thread 66 configured to engage with the threaded peripheral wall 64, such that relative rotation between the gear 56 and the adapter 48 causes translation of the adapter 48 relative to the gear 56. The actuation assembly 46 may include one or more posts 68. The plurality of posts 68 may be secured to an actuation assembly housing 70. The adapter 48 may include a plurality of openings to slidably receive the plurality of posts 68, such that the adapter 48 can translate relative to the plurality of posts 68 and the gear 56. When the gear 56 rotates, the plurality of posts 68 can rotatably fix the adapter 48 relative to the actuation assembly 46 and / or the gear 56, such that the threaded engagement between the adapter 48 and the gear 56 causes the adapter 48 to translate as the gear rotates.

[0048] Reference Figures 4 to 5 The actuation assembly housing 70 may include a top wall 72 having a plurality of side walls 74 extending away from the top wall 72. A rear wall 76 may be connected to the plurality of side walls 74. A protrusion 78 may be formed at the transition between the side walls 74 and the rear wall 76, such that the side walls 74 can bend independently of the rear wall 76 when the housing 70 is positioned on the conveying device 20. The plurality of side walls 74 may include a first portion 80 and a second portion 82, the first portion 80 being adjacent to the rear wall 76 and the second portion 82 being adjacent to the first portion 80. The first portion 80 may extend further away from the top wall 72 than the second portion 82. The lengths of the first portion 80 and the rear wall 76 may help align the actuation assembly 46 on the conveying device 20 when the actuation assembly 46 is connected to the conveying device 20. When the actuation assembly 46 is connected to the delivery device 20, aligning the actuation assembly 46 on the delivery device 20 ensures that the adapter 48 accommodates a portion of the pin 42. The plurality of sidewalls 74 may include feature 71 ( Figure 4 ), to secure the housing 70 to the conveying device 20. The feature 71 can engage housing feature 73 (in Figure 11(Most clearly seen). In one embodiment, feature 71 of the sidewall may be a protrusion, and feature 73 of the housing may be a recess configured to at least temporarily receive the protrusion. In another embodiment, feature 71 of the sidewall is a recess, and feature 73 of the housing is a protrusion. In yet another embodiment, both features 71 and 73 are holes configured to receive a pin, latch, screw, or fastener. In still another embodiment, features 71 and 73 form a Velcro fastener (e.g., Velcro) or a magnet. Multiple protrusions (not shown) may be formed at the bottom edges of the multiple sidewalls 80 to facilitate gripping the housing for removal. The top wall 72 may include a window 84. The window 84 may allow a user to observe the delivery device 20 ( Figure 1 The contents of a dosage indicator 86 or the drug chamber 26 of the delivery device.

[0049] Reference Figures 8 to 9 When the gear 56 rotates, the adapter 48 can move from the first adapter position ( Figure 8 Move to the second adapter position ( Figure 9 When the adapter 48 moves from the first pin position to the second pin position, the plurality of flanges 52 can contact the head 54 of the pin 42, and move the pin 42 from the first pin position to the second pin position. After the pin 42 is moved to the second pin position, the biasing element 38 ( Figure 2 The second plunger 32 can be moved. When the second plunger 32 is moved by the bias element 38, fluid can be transferred from the second chamber 30 to the drug chamber 26, thereby moving the plunger 28. The drug can be dispensed into the drug chamber 26 from which the plunger 28 can move. In some embodiments, the second plunger 32 does not move until the adapter 48 or actuator 58 stops moving. In some embodiments, the delivery device includes multiple independent movement steps of the actuator 58, followed by movement of the second plunger 28.

[0050] Reference Figures 10 to 12 This illustrates a second embodiment of the actuation assembly, generally designated 88. The actuation assembly 88 may be similar to the first embodiment of the actuation assembly 46, but differs in that the actuation assembly 88 does not include a gear 56.

[0051] The actuation assembly 88 may include a engagement member 90 connected to an adapter 92. The adapter 92 may include an internal opening 50 and a plurality of flanges 52 for engaging the pin 42, as previously described. The engagement member 90 may be positioned relative to a first engagement member of the adapter 92 (…). Figure 11 ) Move to the position of a second joint member ( Figure 12 In one embodiment, the engagement member 90 is slidably connected to the adapter 92 such that the engagement member 90 can slide relative to the adapter 92 along a first axis 100. The engagement member 90 may include an opening 94 to receive the head 54 of the pin when the pin 42 is engaged by the adapter 92.

[0052] The engaging member 90 is movable relative to the actuating assembly 88 along a second axis 102. Figures 11 to 12 The engaging member may include a hole 96 configured to receive a post 98. The post 98 may include a retaining member 104. Figure 12 The retaining member 104 is configured to prevent the engaging member 92 from moving along the second axis 102. The retaining member 104 may be a notch or a portion of the post 98 with a reduced thickness compared to an adjacent portion. The post 98 may include a shoulder at the retaining member 104 such that the retaining member 104 engages with a surface or edge of the engaging member 94 to prevent movement of the engaging member along the second axis 102 when the engaging member is in the first engaging member position. In one embodiment, the second axis 102 is orthogonal to the first axis 100. In another embodiment, the second axis 102 is inclined to the first axis 100.

[0053] The engaging member 90 is movable along the first axis 100 from the first engaging member position. In the first engaging member position, the retaining member 104 prevents the engaging member 90 from moving along the second axis 102 to the second engaging member position. In the second engaging member position, the engaging member is movable along the second axis 102. In one embodiment, the retaining member 104 extends around the periphery of the post 98. In another embodiment, the retaining member 104 is formed only on a portion of the periphery of the post 98 to prevent accidental engagement between the retaining member 104 and the engaging member 90 when the engaging member is moved to the second position. In yet another embodiment, one side of the sidewall of the hole 96 is thicker than the other side, such that the retaining member 104 engages the engaging member 90 only when the engaging member is in the first engaging member position.

[0054] Reference Figures 11 to 12 The actuation assembly 88 may include a biasing element 106 configured to push the adapter 92 toward the second adapter position. In one embodiment, the biasing element 106 is a spring. The actuation assembly 88 may include a substrate 108, and the biasing element 106 may be connected to the substrate 108 and the adapter 92. When the engaging member 90 disengages from the retaining member 104, the biasing element 106 can move the adapter 92 to the second adapter position. Figure 12 When the adapter 92 is from the first adapter position ( Figure 11 Move to the second adapter position ( Figure 12 When the adapter 92 moves the pin 42 from the first pin position to the second pin position, the actuation assembly 88 may include an actuator (not shown) configured to move the engagement member from the first engagement member position to the second engagement member position. In one embodiment, the actuator may be the gear 56 and the actuator 58, such that rotation of the gear 56 moves the engagement member 90 along the first axis 100. In another embodiment, a user may manually move the engagement member by manually engaging it or by engaging an element connected to the engagement member.

[0055] The delay mechanism can be located inside the housing 24, rather than being controlled by an external device to actuate the conveying device 20. For example, see reference... Figures 13 to 15 This illustrates a second embodiment of a conveying device, generally designated 110. The conveying device 110 is similar to the previously described conveying device 20, and... Figures 13 to 15 Some features have been omitted for the sake of discussion. The delivery device 110 can be configured to deliver a drug to a user upon actuation of the delivery device 110 and after a predetermined time delay. One or more features of the delivery device 110 may be selected to provide a desired time delay, as explained in more detail below.

[0056] The delivery device 110 may include a first chamber 112 having a first plunger 114 therein. The first plunger 114 is movable relative to the first chamber 112. The first chamber may include a biasing element 116 configured to push the first plunger 114 toward a distal end 118 of the first chamber 112. As previously described, the first plunger 114 may be held in place at least temporarily by the pin 42, and as previously described, the pin may be moved by one of the actuation components 46, 88. The first chamber 112 may be configured to contain a fluid (e.g., hydraulic fluid).

[0057] The delivery device 110 may include a second chamber 120. The second chamber may be sealed with a membrane. The membrane (not shown) may be a flexible membrane, an expandable membrane, or a breathable membrane. The delivery device 110 may include a second plunger 122 in the second chamber 120. The second plunger 122 may fluidly seal the second chamber 120. The membrane or the second plunger 122 may be configured to move relative to the second chamber 120 as the first plunger 114 moves relative to the first chamber 112. The second chamber 120 may be configured to receive fluid from the first chamber. A first channel 124 may fluidly connect the first chamber 112 to the second chamber 120. When the first plunger 114 moves relative to the first chamber 112, fluid may be transferred from the first chamber 112 to the second chamber 120 through the first channel 124. When fluid enters the second chamber 120, the second plunger 122 may move relative to the second chamber 120. In another embodiment, the second chamber 120 is sealed by a breathable membrane that allows air to escape but prevents liquid from escaping when the fluid is transferred from the first chamber 112.

[0058] The delivery device 110 may include a third chamber 126. A third plunger 128 may be movably positioned within the third chamber 126. The third chamber 126 may be adapted to contain a medication. As previously described, when the third plunger 128 moves relative to the third chamber 126, medication from the third chamber 126 can be delivered to a user via a needle. The third chamber 126 may include an end cap 127 configured to be fluidly connected to the needle 44 and the third chamber 126, such that the medication is delivered from the third chamber 126 to a user via the needle. The third chamber 126 may be configured to expel medication from the third chamber 126 when the first plunger 114 moves relative to the first chamber 112. The third plunger 128 may fluidly seal the third chamber 126, such that the medication in the third chamber 126 is separated from the fluid phase entering the third chamber 126.

[0059] A second channel 130 may fluidly connect the first chamber 112 to the third chamber 126. When the first plunger 114 moves relative to the first chamber 112, at least a portion of the fluid from the first chamber 112 may flow into the third chamber 126. In one embodiment, fluid flows from the first chamber 112 to the second chamber 120 before flowing from the first chamber 112 to the third chamber 126. In one embodiment, a diameter of the first channel 124 is smaller than a diameter of the second channel 130. The length of the first channel 124 may be greater than the length of the second channel 130. The length of the first channel 124 may be equal to or greater than a diameter of the third chamber 126 and greater than the length of the second channel 130.

[0060] The first plunger 114 may include a first collar 132 configured to fluid-tighten the first chamber 112. The first collar 132 may have an outer diameter substantially similar to or slightly larger than the diameter of the first chamber 112, thereby preventing fluid from flowing through the first collar 132. The first plunger 114 may include a body 134 adjacent to the first collar 132. The body 134 may have a diameter smaller than that of the first collar 132 and the first chamber 112, allowing fluid to flow around the body 134. The first plunger 114 may include a second collar 136 having a diameter substantially similar to or the same as that of the first collar 132.

[0061] The first chamber 112 may include a distal end 140 located between the distal end 118 of the first chamber 112 and the first collar 132. A proximal end 142 of the first chamber 112 may be located between a first collar 132 and a second collar 136 of the first plunger 114. The first chamber 112 may include a bypass 138. The bypass 138 may be a notch in a sidewall of the first chamber 112 to allow fluid to flow from the distal end 140 through the bypass 138 into the proximal end 142. The fluid may flow from the proximal end 142 through the second channel 130 and into the third chamber 126. However, in some embodiments, the bypass 138 does not extend the entire length of the first chamber 112, such that fluid does not flow from the distal end 140 to the proximal end 142 until the first collar 132 moves adjacent to the bypass 138.

[0062] Therefore, fluid can flow into the second chamber 120 before it flows into the third chamber 126. Once fluid has begun flowing into the third chamber 126, fluid can flow into both the second chamber 120 and the third chamber 126 simultaneously. The time required for the first plunger 114 to move such that the first collar 132 is adjacent to the bypass 138 can be a selected time delay. The spring constant of the biasing element 116, the friction between the first plunger 114 and the first chamber 112, and the length of the first chamber 112 can be selected to achieve the selected time delay.

[0063] The length, diameter, and / or material of the first channel 124 and the second channel 130, as well as the viscosity of the hydraulic fluid in the first chamber 112, can be selected to change the flow rate through each of the first channel 124 and the second channel 130. The flow rate through the first channel 124 can be slower than the flow rate through the second channel 130. The flow rate through the first channel 124 can at least partially affect the rate of movement of the first plunger 114 relative to the first chamber 112. For example, a shorter first channel 124 can provide a greater flow rate of the fluid through the first channel compared to a longer first channel 124. A relatively larger diameter first channel 124 can allow a greater flow rate of the fluid through the first channel compared to a relatively smaller diameter first channel 124. The flow rate through the first channel 124 can affect a time delay from the start of movement of the first plunger 114 relative to the first chamber 112 until the fluid flows into the third chamber 126. Therefore, the diameter and / or length of the first channel can be selected to achieve a desired time delay. In one embodiment, the time delay is measured from the time the pin 42 is removed until the medication is dispensed from the third chamber 126.

[0064] The delivery time can be the time from when the third plunger 128 begins to move relative to the third chamber 126 until a dose of medication is delivered to the user. To deliver a dose of medication, the third plunger 128 may not need to travel the entire distance of the third chamber 126. The movement of the third plunger 128 relative to the third chamber 126 may be faster than the movement of the second plunger 122 relative to the second chamber 120. In one embodiment, the time delay is longer than the delivery time. In another embodiment, the time delay is equal to the delivery time. In yet another embodiment, the time delay is less than the delivery time.

[0065] Those skilled in the art will understand that changes can be made to the exemplary embodiments shown and described above without departing from their broad inventive concept. Therefore, it should be understood that the invention is not limited to the exemplary embodiments shown and described, but is intended to cover modifications within the spirit and scope of the invention as defined in the claims. For example, specific features of the exemplary embodiments may or may not be part of the claimed invention, and various features of the disclosed embodiments may be combined. The terms “right,” “left,” “lower,” and “upper” denote directions referenced in the drawings. The terms “inward” and “outward” refer to directions toward and away from the geometric center of the pharmaceutical delivery device, respectively. Unless specifically stated herein, the terms “a,” “an,” and “described” are not limited to a single element but should be understood to mean “at least one.”

[0066] It should be understood that at least some of the drawings and descriptions of the present invention have been simplified to focus on elements relevant to a clear understanding of the invention, while elements that those skilled in the art would understand to also constitute part of the invention have been omitted for clarity. However, since such elements are well known in the art, and because they do not necessarily contribute to a better understanding of the invention, descriptions of these elements are not provided herein.

[0067] Furthermore, to a certain extent, the method of the present invention is not dependent on a specific order of the multiple steps set forth herein, and such specific order should not be construed as a limitation of the claims. No claim relating to the method of the present invention should be limited to performing its steps in the written order, and those skilled in the art will readily recognize that these steps can be modified and remain within the spirit and scope of the invention.

Claims

1. A pharmaceutical delivery device, characterized in that, The drug delivery device includes: A pharmacy room is configured to contain a medicine; A plunger is configured to move relative to the pharmaceutical chamber to discharge the pharmaceutical agent from the pharmaceutical chamber; A pin is configured to move from a first pin position to a second pin position, wherein in the first pin position, the pin prevents movement of the plunger, and in the second pin position, the pin allows movement of the plunger; An actuating component is configured to move the pin from the first pin position to the second pin position after a preset time delay, so as to delay the start of delivery, wherein the preset time delay is set by the actuating component. A needle is connected to the medicine chamber, through which the medicine flows from the medicine chamber to a user; A housing configured to accommodate at least a portion of the medication chamber, the plunger, and the pin. The actuation component is detachably connected to the housing, and the actuation component includes: An adapter is connected to the pin; as well as An actuator is configured to move the adapter from a first adapter position to a second adapter position, thereby moving the pin from the first pin position to the second pin position.

2. The drug delivery device as described in claim 1, characterized in that: The adapter includes an internal opening configured to receive at least a portion of the pin.

3. The pharmaceutical delivery device as described in claim 2, characterized in that: The adapter includes a deflectable flange configured to engage with an edge of the pin.

4. The pharmaceutical delivery device as described in claim 1, characterized in that: The actuation assembly further includes a gear having an internal opening configured to receive the adapter, wherein the adapter is configured to move relative to the gear.

5. The pharmaceutical delivery device as described in claim 4, characterized in that: The drug delivery device further includes: a drive gear connected to the actuator, the drive gear being configured to mesh with the gear such that the actuator rotates the gear when the actuator rotates the drive gear.

6. The pharmaceutical delivery device as described in claim 1, characterized in that: The actuation assembly further includes: a engagement member connected to the adapter, the engagement member being configured to move relative to the adapter from a first engagement member position to a second engagement member position; and... A locking element is configured to prevent movement of the engaging member when the engaging member is in the position of the first engaging member. When the connecting member is located at the second connecting member position, the adapter can move from the first adapter position to the second adapter position.

7. The pharmaceutical delivery device as described in claim 6, characterized in that: The actuator includes a biasing element configured to push the engagement member toward the second engagement member position.

8. The pharmaceutical delivery device as described in claim 6, characterized in that: The drug delivery device further includes an actuator configured to move the engagement member from the first engagement member position to the second engagement member position.

9. The pharmaceutical delivery device as described in claim 1, characterized in that: The actuation component is configured to automatically move the latch upon actuation after a predetermined time delay.

10. The pharmaceutical delivery device as claimed in claim 1, characterized in that: The drug delivery device also includes an adhesive patch for attaching the drug delivery device to a user's skin, wherein the housing is attached to the adhesive patch.

11. The pharmaceutical delivery device as claimed in claim 1, characterized in that: The drug delivery device is configured for single use.

12. The pharmaceutical delivery device as claimed in claim 1, characterized in that: The medication includes insulin.

13. The pharmaceutical delivery device as claimed in claim 1, characterized in that: The drug delivery device is configured to dispense the drug over a continuous time interval to provide basic delivery of the drug.

14. The pharmaceutical delivery device as claimed in claim 1, characterized in that: The drug delivery device also includes a biasing element, wherein the plunger is configured to move directly or indirectly via the biasing element.

15. A pharmaceutical delivery device, characterized in that, The drug delivery device includes: A pharmacy room is configured to contain a medicine; A plunger is configured to move relative to the pharmaceutical chamber to discharge the pharmaceutical agent from the pharmaceutical chamber; A pin is configured to move from a first pin position to a second pin position, wherein in the first pin position, the pin prevents movement of the plunger, and in the second pin position, the pin allows movement of the plunger; An actuation component is configured to move the pin from a first pin position to a second pin position after a preset time delay to delay the start of delivery, wherein the preset time delay is set by the actuation component; and A needle is connected to the medicine chamber, through which the medicine flows from the medicine chamber to a user.

16. The pharmaceutical delivery device as described in claim 15, characterized in that: The actuation component includes: An adapter, connected to the pin; and An actuator is configured to move the adapter from a first adapter position to a second adapter position, thereby moving the pin from the first pin position to the second pin position.

17. The pharmaceutical delivery device as described in claim 16, characterized in that: The adapter includes an internal opening configured to receive at least a portion of the pin.

18. The pharmaceutical delivery device as claimed in claim 17, characterized in that: The adapter includes a deflectable flange configured to engage with an edge of the pin.

19. The pharmaceutical delivery device as described in claim 16, characterized in that: The actuation assembly further includes a gear having an internal opening configured to receive the adapter, wherein the adapter is configured to move relative to the gear.

20. The pharmaceutical delivery device as described in claim 19, characterized in that: The drug delivery device further includes: a drive gear connected to the actuator, the drive gear being configured to mesh with the gear such that the actuator rotates the gear when the actuator rotates the drive gear.

21. The pharmaceutical delivery device as described in claim 16, characterized in that: The actuation component further includes: A connecting member, connected to the adapter, the connecting member being configured to move relative to the adapter from a first connecting member position to a second connecting member position; and A locking element is configured to prevent movement of the engaging member when the engaging member is in the position of the first engaging member. When the connecting member is located at the second connecting member position, the adapter can move from the first adapter position to the second adapter position.

22. The pharmaceutical delivery device as described in claim 21, characterized in that: The actuator includes a biasing element configured to push the engagement member toward the second engagement member position.

23. The pharmaceutical delivery device as described in claim 21, characterized in that: The drug delivery device further includes an actuator configured to move the engagement member from the first engagement member position to the second engagement member position.

24. The pharmaceutical delivery device as described in claim 15, characterized in that: The actuation component is configured to automatically move the latch upon actuation after a predetermined time delay.

25. The pharmaceutical delivery device as described in claim 15, characterized in that: The drug delivery device further includes: a housing configured to accommodate at least a portion of the drug chamber, the plunger, and the pin, wherein the actuation component is detachably connected to the housing.

26. The pharmaceutical delivery device as described in claim 25, characterized in that: The drug delivery device also includes an adhesive patch for attaching the drug delivery device to a user's skin, wherein the housing is attached to the adhesive patch.

27. The pharmaceutical delivery device as described in claim 15, characterized in that: The drug delivery device is configured for single use.

28. The pharmaceutical delivery device as described in claim 15, characterized in that: The medication includes insulin.

29. The pharmaceutical delivery device as described in claim 15, characterized in that: The drug delivery device is configured to dispense the drug over a continuous time interval to provide basic delivery of the drug.

30. The pharmaceutical delivery device as described in claim 15, characterized in that: The drug delivery device also includes a biasing element, wherein the plunger is configured to move directly or indirectly via the biasing element.

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