Large volume drug delivery device

Abstract

Devices and methods related to delivery of agents to a patient are disclosed. A drug delivery device may include a control assembly and an insertion assembly. The control assembly has a first connector and a motor for rotating the first connector. The insert assembly has a delivery needle for receiving a medicament therein, a chamber for receiving the medicament from the delivery needle, a piston movable within the chamber, and a second connector operably connected to the piston. The insert assembly is removably coupleable to the control assembly such that the first connector is operably coupled to the second connector when the insert assembly is coupled to the control assembly. When the insert assembly is coupled with the control assembly, and when the motor rotates the first connector, the second connector also rotates, and the piston moves axially within the chamber.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 381,029, filed Oct. 26, 2022, the disclosure of which is hereby incorporated by reference in its entirety. Technical field

[0003] The present disclosure generally relates to drug delivery devices and related methods, and more particularly to novel designs for administering large volumes of drugs to a patient. Background art

[0004] Drugs can be delivered to a patient via a pump in different volumes and rates. Many existing drug pumps are designed to deliver small volumes of medicaments. Attempting to use an existing pump to deliver larger volumes results in more frequent pump cycles, which increase the temperature of the device due to the friction caused during the pumping step. The increase in pump temperature can damage sensitive drugs, such as protein drugs that may denature. The pump components are typically in contact with the medicament, thus compromising sterility. These components also cannot be reused in future injections. Accordingly, there is a need for an improved pump for delivering large volumes of drugs that has reusable pump components that do not contact the medicament and do not generate excessive heat. Summary of the invention

[0005] Aspects of the drug delivery device disclosed herein meet the foregoing needs. According to one aspect, a drug delivery device for administering a medicament to a patient includes a control assembly and an insertion assembly. The control assembly has a first connector and a motor configured to rotate the first connector. The insertion assembly has a delivery needle configured to receive the medicament therein, a chamber configured to receive the medicament from the delivery needle, a piston capable of moving within the chamber, and a second connector operably connected to the piston. The insertion assembly is removably couplable to the control assembly such that when the insertion assembly is coupled to the control assembly, the first connector is operably coupled to the second connector. When the insertion assembly is coupled to the control assembly, and when the motor rotates the first connector, the second connector also rotates, and the piston moves axially within the chamber.

[0006] In another aspect of the present disclosure, a drug delivery system includes a control assembly, an insertion assembly, a medicament container, and an infusion patient interface. The control assembly has a first connector and a motor configured to rotate the first connector. The insertion assembly has a delivery needle configured to receive the medicament therein, a chamber configured to receive the medicament from the delivery needle, a piston movable within the chamber, and a second connector operably connected to the piston. The medicament container has the medicament therein and is capable of being coupled to the insertion assembly such that the delivery needle is in fluid communication with the medicament in the medicament container. The infusion patient interface is configured to contact an injection site and deliver the medicament from the chamber to the injection site. The insertion assembly is removably coupled to the control assembly such that when the insertion assembly is coupled to the control assembly, the first connector is operably coupled to the second connector. When the insertion assembly is coupled to the control assembly and when the motor rotates the first connector, the second connector also rotates and the piston moves axially within the chamber.

[0007] In another aspect of the present disclosure, a method of injecting a medicament using a drug delivery device is described. The drug delivery device has an insertion assembly removably coupled to a control assembly. The method includes the steps of: introducing a medicament container into the drug delivery device; coupling the insertion assembly to the control assembly such that a first connector on the control assembly is operably engaged with a second connector on the insertion assembly and such that a delivery needle on the insertion assembly is in fluid communication with the medicament in the medicament container; and actuating a motor to rotate the first connector in a first rotational direction.

[0008] In another aspect of the present disclosure, a method of assembling a drug delivery device is described. The method includes introducing a medicament container into the drug delivery device; coupling the insertion assembly to the control assembly such that a first connector on the control assembly is operably engaged with a second connector on the insertion assembly and such that a delivery needle on the insertion assembly is in fluid communication with the medicament in the medicament container; positioning a patient interface onto an injection site; and coupling the patient interface to the insertion assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present application will be further understood when read in conjunction with the accompanying drawings. For purposes of illustrating the subject matter, exemplary aspects of the subject matter are shown in the drawings; however, the presently disclosed subject matter is not limited to the specific methods, devices, and systems disclosed. In the drawings:

[0010] Figure 1 A schematic view of a drug delivery device according to one aspect of the present disclosure is shown;

[0011] Figure 2 An angled view of a drug delivery device according to another aspect of the present disclosure is shown;

[0012] Figure 3 Shows a cross-sectional view of a control assembly according to one aspect of the present disclosure;

[0013] Figure 4 Shows Figure 3 another cross-sectional view of the control assembly;

[0014] Figure 5 Shows Figure 3 another cross-sectional view of the control assembly;

[0015] Figure 6 Shows an angled view of an insertion assembly according to one aspect of the present disclosure;

[0016] Figure 7 Shows Figure 6 another angled view of the insertion assembly;

[0017] Figure 8 Shows Figure 6 a cross-sectional view of the insertion assembly;

[0018] Figure 9 Shows a cross-sectional view of an insertion assembly with a piston in a first position according to one aspect of the present disclosure;

[0019] Figure 10 Shows a cross-sectional view of an insertion assembly with a piston in a second position according to one aspect of the present disclosure;

[0020] Figure 11 Shows a method of using a drug delivery device according to one aspect of the present disclosure;

[0021] Figure 12 Shows an angled view of a drug delivery device according to another aspect of the present disclosure, wherein the insertion assembly is engaged with the control assembly;

[0022] Figure 13 Shows Figure 12 an angled view of the drug delivery device, wherein the insertion assembly is disengaged from the control assembly; and

[0023] Figure 14 Shows Figure 12 a cross-sectional view of the insertion assembly of the drug delivery device.

[0024] Aspects of the present disclosure will now be described in detail with reference to the accompanying drawings, where like reference numerals always refer to like elements unless otherwise specified. Detailed Description

[0025] One or more medicaments may be delivered to a patient via a drug delivery device. The medicament may be stored within the drug delivery device or within a component that is operatively connected to the drug delivery device. The drug delivery device generally includes a mechanism for delivering the medicament, which may include a pump, a motor, etc., and generally includes a patient interface through which the medicament is delivered, and the patient interface may include one or more needles, catheters, etc. In some aspects, it may be desirable to reuse one or more components of the drug delivery device, such as electronic components. In such scenarios, the drug delivery device may include a disposable portion and a reusable portion. The disposable portion and the reusable portion may be configured to selectively engage or disengage with each other. Before use, the disposable portion and the reusable portion may be engaged with each other to deliver the medicament to the patient; after use, the disposable portion may be separated from the reusable portion and discarded. Then, the reusable portion may be used again with another disposable portion.

[0026] In some cases, it may be necessary to deliver a larger volume of medicament to a patient than the volume of existing drug delivery devices. The embodiments described throughout this patent application disclose drug delivery devices that are configured to deliver a larger volume of medicament while maintaining a relatively small size. The embodiments disclosed herein show the drug delivery device as an assembly of at least two components, where one component may be intended to be reusable and the other component may be intended to be disposable.

[0027] Figure 2 An exemplary embodiment of a drug delivery device 1 is shown. The drug delivery device generally may include a control assembly 10 and an insertion assembly 100 that is configured to selectively engage and disengage with the control assembly 10. The insertion assembly 100 may include a patient interface through which the medicament may be delivered to the patient. The patient interface may be provided on the insertion assembly 100 or, alternatively, may be provided on a separate infusion set that is connected to the insertion assembly 100 via an infusion line.

[0028] A medicament container 2 containing the medicament may be connected to or be part of the drug delivery device 1. The medicament may be moved from the container 2 through the control assembly 10 and through the insertion assembly 100 to the patient. In some aspects, the insertion assembly 100 may be designed to be disposable, while the control assembly 10 may be designed to be reused with other insertion assemblies. The insertion assembly 100 may be connected to the control assembly 10 before use and then disconnected from the control assembly 10 after use.

[0029] Figures 2 to 10 An embodiment of a drug delivery device 1 is shown. The drug delivery device 1 includes a control assembly 10 and an insertion assembly 100. Referring to Figures 2 to 10 the embodiment of Figure 1In the schematic diagram shown, the control assembly 10 may include a pump actuator operably connected to a first connector 30. The pump actuator may be a motor 14. The drug delivery device 1 may include any suitable type of motor 14, such as a stepper motor, a DC motor, a servo motor, etc. The motor 14 is configured to selectively rotate the first connector 30 in a first rotational direction, in a second rotational direction opposite to the first rotational direction, or in both rotational directions. The motor 14 may receive electrical power from a power source 18 operably connected thereto. The power source 18 may include a battery. The battery may be designed to be removable and replaceable, or is intended to be a non-removable component of the control assembly 10. The operation of the motor 14 may be controlled by a controller 22. The controller 22 may include a processor, a memory, and programmed instructions for its operation and the operation of other components in the drug delivery device 1. The control assembly 10 defines a socket 38 configured to receive an insertion assembly 100 therein. The drug delivery device 1 is capable of being operably connected to a patient 3 (schematically shown in Figure 1 such that one or more medicaments may be delivered from a container 2 to the patient 3 via the drug delivery device 1.

[0030] To initiate the operation of the drug delivery device 1, the patient 3 (or another individual) may actuate a start button 26 on the control assembly 10. The start button 26 may include a button, a toggle device, a switching device, a capacitive or resistive touch panel, etc. The start button 26 is operably connected to the controller 22, and actuation of the start button 26 may cause the controller 22 to perform one or more pre-programmed tasks. The tasks may include, but are not limited to, causing the controller 22 to turn on, actuating the motor 14, changing the rotational speed of the motor 14, stopping the movement of the motor 14, receiving and / or transmitting data between the drug delivery device 1 and an external computing device, actuating an indicator 34 (described below) to cause an auditory, visual, and / or tactile feedback or another desired effect.

[0031] In some aspects, the drug delivery device 1 may include one or more optional indicators 34 configured to provide feedback to the patient 3. The indicators 34 may be controlled by the controller 22 or may operate passively without control. The indicator 34 may be a visual indicator including a light-emitting component (such as a light-emitting diode) that may be activated by the controller 22 to turn on the light, turn off the light, turn on or off the light successively in a predetermined pattern, and / or change the color of the light.

[0032] In some aspects, the indicator 34 may include a transparent or translucent window adjacent to the container 2 that allows the patient 3 to observe the amount of medicament present in the container 2 (see, for example Figure 3 ).

[0033] In some aspects, the indicator 34 may include an audible indicator configured to provide a sound to the patient 3 indicating an action or a warning. The controller 22 may cause the indicator 34 to provide a sound, stop providing the sound, change the sound provided, and the like.

[0034] In some aspects, the indicator 34 may include a tactile indicator configured to provide a tactile response, such as vibration, to the patient 3. The controller 22 may cause the indicator 34 to vibrate, stop vibrating, vibrate in a particular pattern, and the like.

[0035] In some aspects, the control assembly 10 may optionally include an electronic communicator 42, which may include a transmitter and / or a receiver configured to send and / or receive data related to the operation of the drug delivery device 1 and / or the patient 3 to / from an external computing device (not shown), respectively. The communicator 42 may include components for operating according to known communication protocols or known communication protocols, such as Wi-Fi, Bluetooth, NFC, 3G, 4G, 5G, and the like.

[0036] The container 2 containing the medicament may be provided on or in the drug delivery device 1 or may be separate from the drug delivery device 1 and instead operatively connectable to the drug delivery device 1. In some aspects, the container 2 may be provided in the control assembly 10 (see, for example Figure 3 ). The container 2 may be designed to be not easily removable from the control assembly 10 or, alternatively, may be removable from the control assembly 10. In embodiments where the control assembly 10 is intended to be reused, the container 2 may be configured to selectively engage with and disengage from the control assembly 10. Thus, before use, the container 2 (containing the medicament therein) may be operatively connected to the control assembly 10 such that the drug delivery device 1 can deliver some or all of the medicament from the container 2 to the patient 3. After the delivery or injection is completed, the container 2 may be removed from the control assembly 10. In some aspects, the control assembly 10 may be configured to then receive a new container 2. The container 2 may include a vial, a syringe, a cannula, a flexible bag or bladder, and the like. In some aspects, the medicament container 2 may be configured to engage with an insertion assembly before being received in the control assembly, as will be described later.

[0037] The motor 14 is operated by rotating a shaft within the motor in a first rotational direction or in a second rotational direction opposite the first rotational direction. The first connector 30 is configured to engage with the shaft of the motor 14. When the motor 14 actuates the shaft to rotate in the first rotational direction, the first connector 30 also rotates in the first rotational direction; when the motor 14 actuates the shaft to rotate in the second rotational direction, the first connector 30 also rotates in the second rotational direction. The first connector 30 may include a gear head having a plurality of teeth extending radially from the gear head. In some aspects, the first connector 30 may include one or more protrusions 36 extending therefrom and spaced apart by a gap 32. The first connector 30 is configured to releasably engage with a second connector 200, as will be further described below.

[0038] Continuing reference Figure 1 And further reference Figures 6 to 8 , the insertion assembly 100 includes a body 104 and an infusion device 180 connected to the body 104 via an infusion line 192. The infusion device 180 can be any existing infusion device that is configured to provide an interface with the patient 3 and deliver a medicament from a source to the patient through the interface. The infusion device 180 includes a contact surface that is configured to contact the patient 3, such as on the skin of the patient 3. In embodiments where the medicament is to be delivered subcutaneously, intravenously, intramuscularly, or otherwise in the body, the infusion device 180 may include a needle or catheter configured to be inserted into the patient 3. The medicament can move through the needle or catheter into the patient 3's body.

[0039] The infusion line 192 can be any conventional infusion line that includes medical-grade tubing through which the medicament can move to the infusion device 180. The infusion line 192 can be connected to the body 104 such that the medicament can move from the body 104 into the infusion line 192 and through the infusion line to reach within the infusion device 180.

[0040] It should be understood that although Figure 2 shown is an infusion device 180 separate from the insertion assembly 100 and connected by an infusion line 192, in some embodiments, the insertion assembly 100 may include the infusion device 180 (or its equivalent) on the body 104, thus allowing the drug delivery device 1 to be positioned directly at the injection site rather than being spaced apart from a separate infusion device 180 by the infusion line 192.

[0041] The body 104 is configured to releasably engage with the control assembly 10. A portion of the body 104 is receivable within a socket 38 defined by the control assembly 10. It should be understood that the size and shape of the socket 38 may be configured to be complementary to and receive the size and shape of the body 104. In some aspects, the body 104 and the socket 38 may be keyed such that the body 104 can only be received within the socket 38 in a desired orientation or direction. This can reduce the likelihood of improper connection of the components, which would result in leakage, injury to the user, or improper drug administration.

[0042] The body 104 includes a pump portion 108 and a needle portion 112 connected to the pump portion 108 via a delivery channel 116. The needle portion 112 includes a delivery needle 120 configured to engage with the container 2. The delivery needle 120 defines a tip at one end thereof, which is configured to be received within the container 2. In some aspects, the tip may be angled to facilitate piercing of the container 2. As Figure 8 shown, in some aspects, a needle guard 132 may be provided on the needle portion 112 to cover the delivery needle 120, thereby reducing the risk of needle injury to the user. The needle guard 132 is movable within the needle portion 112 between an open position and a closed position. When the container 2 is not connected to the body 104, the needle guard 132 may be in the closed position, in which the delivery needle 120 is covered. When the container 2 is connected to the body 104, the needle guard 132 may be in the open position, in which the delivery needle 120 is exposed and receivable within the container 2. When the container 2 engages with the body 104, the needle guard 132 is capable of moving from the closed position to the open position by the container 2. The needle guard 132 may include an elastic member (not shown) such as a spring, which is configured to bias the needle guard 132 in the closed position such that when the container 2 is disengaged from the body 104, the elastic member moves the needle guard 132 from the open position back to the closed position to cover the delivery needle 120.

[0043] A lumen 124 is defined by the needle 120 and is configured to receive a medicament from the medicament container 2 therein. The medicament may be caused to move through the lumen 124 into the delivery channel 116. A first valve 128 is provided in the needle portion 108 between the lumen 124 and the delivery channel 116. The first valve 128 may be a one-way flow valve, such as a duckbill valve or another suitable valve type. The first valve 128 is arranged such that fluid (e.g., medicament) is allowed to flow in one direction but not in a second, opposite direction. As Figure 8As shown, the first valve 128 can be arranged such that the medicament can move from the inner cavity 124 into the delivery channel 116, but cannot move from the delivery channel 116 into the inner cavity 124. The inclusion of the first valve 128 reduces the likelihood of medicament backflow during use of the device to prevent the medicament or any other substance from moving back into the delivery needle 120 or the medicament container 2.

[0044] The pump section 108 is connected to the needle section 112 via the delivery channel 116. The pump section 108 defines a chamber 140 that is configured to receive the medicament from the needle section 112. The chamber 140 is defined by a distal wall 156, a proximal wall 160 spaced apart from the opposite distal wall 156, and side walls 164 extending between the distal wall 156 and the proximal wall 160. A chamber inlet 168 on the pump section 108 fluidly connects the chamber 140 to the delivery channel 116. As Figure 8 shown in an exemplary aspect, the chamber inlet 168 can be defined in the distal wall 156. Fluid (e.g., medicament) can be moved from the needle section 112 into the delivery channel 116 and through the delivery channel and through the chamber inlet 168 into the chamber 140 of the pump section 108. Fluid can be moved out of the chamber 140 through a chamber outlet 172. The chamber outlet 172 can be defined in the distal wall 156. The chamber outlet 172 can be in fluid communication with an infusion line 192. A second valve 176 can be provided between the chamber outlet 172 and the infusion line 192. The second valve 176 can be similar or substantially the same as the first valve 128. The second valve 176 can be a one-way valve, such as a duckbill valve. The second valve 176 is arranged such that fluid can be moved from the chamber 140 through the chamber outlet 172 into the infusion line 192, but cannot move from the infusion line 192 into the chamber 140.

[0045] Referring Figure 8 to, a piston 148 is movably disposed within the chamber 140 and is configured to axially move selectively toward or away from the distal wall 156 of the chamber 140 along a dispensing axis 5. A plunger 144 can be disposed on the piston 148 such that the plunger 144 is located between the distal wall 156 and the proximal wall 160. The size of the plunger 144 should be set such that it can slide within the chamber 140 while contacting the side walls 164. It should be understood that the plunger should be sufficient to prevent liquid from moving past itself between the plunger 144 and the side walls 164 such that any liquid in the chamber 140 remains between the distal wall 156 and the plunger 144. The plunger 144 can include any suitable material, coating, membrane, laminate, and / or treatment that is considered useful or necessary relative to the particular fluid or medicament that will contact the plunger 144. The piston 148 can be moved via various mechanisms, e.g., as Figure 8As shown, it moves via a screw 152 having threads thereon. The screw 152 can rotate about a dispensing axis 5 and can be axially fixed along the dispensing axis 5. The piston 148 can include complementary threads configured to engage the threads of the screw 152 such that when the screw 152 rotates about the dispensing axis 5 in a first direction, the piston 148 moves toward the distal wall 156, and when the screw 152 rotates in a second direction opposite to the first direction, the piston 148 moves toward the proximal wall 160. The screw 152 can be actuated by a motor 14 (as described above and shown in Figure 2 and Figure 3 .

[0046] The screw 152 can include or be operatively connected to a second connector 200. The second connector 200 is configured to engage the above-described first connector 30 when the insertion assembly 100 is connected to the control assembly 10. When engaged, the second connector 200 can be rotated via the first connector 30 by the motor 14. The second connector 200 is connected to the screw 152 such that the proximal wall 160 is located between the screw 152 and the connector 200. The screw 152 can be entirely within the chamber 140 while the connector 200 is outside the chamber 140. Such an arrangement allows the chamber 140 to maintain a clean or sterile environment relative to the external environment.

[0047] Referring to Figure 7 and Figure 8 for exemplary aspects, the second connector 200 can include one or more protrusions 216 thereon separated by a gap 208. The protrusions 216 are configured to engage one or more protrusions 36 on the first connector 30. When the first connector 30 and the second connector 200 are engaged with each other, the protrusions 36 are received in the gap 208 and the protrusions 216 are received in the gap 32 to rotationally fix the first connector 30 and the second connector 200 relative to each other. Thus, when the two connectors 30 and 200 are engaged and the first connector 30 is rotated by the motor 14, the second connector 200 also rotates in the same rotational direction. In some aspects, each protrusion 216 can terminate in a wedge-shaped end 220 configured to facilitate alignment with a corresponding protrusion 36 on the first connector 30.

[0048] During use, one or more fluids can be introduced from the medicament container 2 into the chamber 140. The one or more fluids can include one or more medicaments. When the container 2 is engaged with the needle portion 112 and the delivery needle 120 is connected to the container 2, a fluid passage is established between the container 2 and the chamber 140 via the delivery channel 116 as described above.

[0049] Referring to Figure 9, when the insertion assembly 100 is connected to the control assembly 10, the piston 148 can be first positioned within the chamber 140 such that the plunger 144 contacts the distal sidewall 156, and substantially no space is defined between the plunger 144 and the distal sidewall 156. The movement of the piston 148 away from the distal sidewall 156 along the dispensing axis 5 in the first axial direction creates a vacuum within the chamber 140 between the distal sidewall 156 and the plunger 144, as Figure 10 shown. The vacuum causes fluid from the container 2 to move out of the container 2, through the lumen 124 of the delivery needle 120, past the first valve 128, through the delivery channel 116, and into the chamber 140 through the chamber inlet 168. It should be understood that the farther the piston 148 moves away from the distal sidewall 156, the more vacuum is created within the chamber 140 and thus the more fluid moves therein. It should be noted that although the chamber 140 also includes a chamber outlet 172, due to the presence of the second valve 176, fluid is not introduced into the chamber 140 through the chamber outlet 172 during this process, which prevents fluid from moving in the direction towards the chamber 140.

[0050] After the desired amount of fluid has moved into the chamber 140, the piston 148 can be moved along the dispensing axis 5 in a second axial direction opposite to the first axial direction. The movement of the piston 148 compresses the fluid within the chamber 140 between the distal sidewall 156 and the plunger 144 and causes the fluid to move towards and into the chamber outlet 172. The fluid moves out of the chamber 140 through the chamber outlet 172 and into the infusion line 192 through the second valve 176. It should be understood that a portion of the fluid can be forced back into the delivery channel 116 via the chamber inlet 168, but fluid is prevented from moving back through the first valve 128 into the lumen 124 or into the medicament container 2, which prevents fluid from moving in that direction.

[0051] The distance by which the piston 148 moves in the first axial direction and / or the second axial direction can depend on the desired amount of fluid to be dispensed into the infusion line 192 for administration to a patient. It should also be understood that the rate and timing of the movement of the piston 148 can be controlled by the aforementioned controller 22 and can be adjusted based on the desired administration parameters. The chamber 140 can have a volume that is less than the volume of the container 2 or the total volume of the desired fluid to be administered to the patient. In such scenarios, the movement of the piston 148 in the first axial direction and then in the second axial direction can be repeated until the desired amount of fluid has been administered.

[0052] The drug delivery device 1 can be designed such that the container 2 is pre-loaded therein and the user does not need to insert the container 2 before use. Alternatively, the container can be provided separately from the control assembly 10 and the insertion assembly 100. In such scenarios, the user must connect the container 2 to the drug delivery device 1 before engaging the insertion assembly 100 with the control assembly 10. In some aspects, such as Figures 3 to 10In the exemplary embodiment shown, the container 2 may be connected to the control assembly 10. After the container 2 is engaged with the control assembly 10, the insertion assembly 100 may be engaged with the control assembly 10, and the delivery needle 120 may be in fluid communication with the container 2, as previously described.

[0053] The medicament may move from the insertion assembly 100 through the depicted infusion line 192 to the connected infusion set 180, which may be placed at a desired injection site. The infusion set 180 may include a contact surface configured to contact the patient and a needle or catheter configured to pierce the patient's body and through which the medicament enters the patient's body. In some aspects, such as Figure 2 shown, the infusion set 180 may be separated from the body 104 by the infusion line 192, which may be a flexible tube or catheter. In such aspects, the infusion set 180 is flexibly connected to the insertion assembly 100, which allows the infusion set 180 to be placed on the patient's body more easily and / or conveniently relative to the insertion assembly 100. It should be understood that the longer and more flexible the infusion line 192, the more flexible the position of the infusion set 180 relative to the body 104 on the patient. Although Figure 2 shown with the infusion set 180 separated from the insertion assembly 100, it should be understood that in some aspects, the drug delivery device 1 may be designed to have a patient contact surface and a needle or catheter on the insertion assembly 100 itself rather than being connected to a separate infusion set 180 via the infusion line 192.

[0054] Reference Figure 11 is made to the exemplary infusion method 300. Although method 300 is described with reference to the components of the exemplary drug delivery device 1, the steps of method 300 may be made with reference to the components of any of the embodiments described herein. In step 304, the user introduces the container 2 into the drug delivery device 1. The container 2 may contain one or more medicaments for infusion. In some aspects, the container 2 may be introduced into the control assembly 10; in other aspects, as will be described below, the container 2 may be introduced into the insertion assembly.

[0055] In step 308, the insertion assembly 100 is engaged with the control assembly 10 such that the first connector 30 is engaged with the second connector 200. At this stage, the motor 14 is operatively connected to the piston 148, and the container 2 is in fluid communication with the delivery needle 120. Thus, the drug delivery device 1 is ready to deliver the medicament from the container 2.

[0056] In step 312, the infusion line 192 and the connected infusion set 180 can be connected to the insertion assembly 100. It should be understood that the drug delivery device 1 can be used with different types of infusion lines and infusion sets, and the present disclosure does not limit the applicability of different connectable infusion mechanisms. The infusion set 180 can be positioned at a desired infusion site on the body. It should be understood that the step of securing the infusion set 180 to the infusion site can be completed prior to step 312. In some aspects, the drug delivery device can include an infusion set or its equivalent feature on the insertion assembly. In such aspects, the entire drug delivery device can be placed at the desired infusion site and a separate infusion line and infusion set may not be required.

[0057] In step 316, the user can initiate the infusion by actuating the aforementioned start button 26. When the start button 26 is actuated, the controller 22 activates the motor 14 to rotate the first connector 30. When the first connector 30 rotates, the operatively connected second connector 200 also rotates, and the piston 148 axially moves in the first axial direction within the insertion assembly 100, thereby causing the medicament from the medicament container 2 to move into the chamber 140. The controller 22 can include pre-programmed instructions that indicate how far the piston 148 should move in the first axial direction (and thus how much medicament to extract from the container 2). Once the expected amount of medicament has been extracted, the controller 22 causes the motor 14 to rotate in the opposite rotational direction, thus causing the piston 148 to move in the second axial direction to discharge the medicament from the chamber 140 through the chamber outlet 172. The steps of moving the piston 148 in the first direction to extract the medicament from the container 2 and then moving the piston 148 in the second direction to discharge the medicament can be repeated the expected number of times, and the controller 22 can include programmed instructions for operating in such a manner. When the infusion process is complete, the controller 22 can transmit a signal to the indicator 34 to provide the user with a notification that the infusion is complete.

[0058] In some aspects, step 316 can be divided into various sub-steps that can be controlled by the user. For example, the user can actuate the button 26 to move the piston 148 in the first axial direction, actuate the same (or different) button to then move the piston 148 in the second axial direction, and / or actuate the same (or different) button to move the piston 148 in the first axial direction again. This can allow the user to control the amount of medicament being delivered and / or the rate at which the medicament is being delivered.

[0059] In some aspects, it may be advantageous to engage the medicament container 2 with the insertion assembly 100 before coupling the insertion assembly 100 to the control assembly 10. Refer to Figures 12 to 14Exemplary aspects thereof show a drug delivery device 400 having an insertion assembly 402 configured to receive a container 2 therein. The insertion assembly 402 is configured to engage with a control assembly 401. Various components of the drug delivery device 400 may be similar or substantially the same as the components described above with respect to the drug delivery device 1. The control assembly 401 may at least include the same features as the control assembly 10.

[0060] Reference Figure 14 , the insertion assembly 402 of the drug delivery device 400 includes a pump portion 408 and a needle portion 412. The pump portion 408 may be similar or substantially the same as the pump portion 108 described above. The needle portion 412 may define a socket 414 configured to receive the container 2 therein. When the container 2 is inserted into the socket 414, the delivery needle 420 pierces the container 2 and forms a fluid path between the interior of the container 2 and the lumen 424 extending through the delivery needle 420. Fluid from the container 2 may be caused to move through the lumen 424 in a manner similar to that described above with respect to the drug delivery device 1, past a first valve 428, through a delivery channel 416, and into the pump portion 408.

[0061] The mechanism for moving fluid from the container 2 through the pump portion 408 to the infusion line 192 is substantially the same as that described in the previous embodiments. Receiving the container 2 within the insertion assembly 402 may simplify use and reduce the reusable surfaces that need to be sterilized, cleaned, and / or maintained. In use, the user may first insert the container 2 into the insertion assembly 402 and then engage the insertion assembly 402 with the control assembly 401. After the infusion is complete, the insertion assembly 402 may be disengaged from the control assembly 401 and disposed of along with the container 2 therein, while the control assembly 401 may be cleaned and reused in another infusion.

[0062] Although the systems and methods have been described in connection with various embodiments of multiple figures, those skilled in the art will understand that changes may be made to the embodiments without departing from their broad inventive concept. Accordingly, it should be understood that the present disclosure is not limited to the particular embodiments disclosed, but is intended to cover modifications within the spirit and scope of the present disclosure as defined by the claims.

Claims

1. A drug delivery device for administering a medicament to a patient, the device comprising: A control assembly having a first connector and a motor configured to rotate the first connector; An insertion assembly having a delivery needle configured to receive a medicament therein and a pump portion, the pump portion having a chamber configured to receive the medicament from the delivery needle, a piston movable within the chamber, and a second connector operably connected to the piston; And Wherein the insertion assembly is removably couplable to the control assembly such that when the insertion assembly is coupled to the control assembly, the first connector is operably coupled to the second connector, and Wherein when the insertion assembly is coupled to the control assembly and when the motor rotates the first connector, the second connector also rotates and the piston moves axially within the chamber.

2. The drug delivery device according to claim 1, further comprising a patient interface disposed at an injection site, through which the medicament can move to the patient.

3. The drug delivery device according to claim 2, wherein the patient interface includes an infusion set having a needle that can be inserted into the infusion site, and the infusion set is connected to the insertion assembly via an infusion line.

4. The drug delivery device according to claim 1, wherein the motor is configured to rotate the first connector in a first rotational direction to move the piston in a first axial direction, and to rotate the first connector in a second rotational direction opposite to the first rotational direction to move the piston in a second axial direction opposite to the first axial direction, wherein the movement of the piston in the first axial direction moves the medicament into the chamber, and the movement of the piston in the second axial direction discharges the medicament from the chamber.

5. The drug delivery device according to claim 1, wherein the piston is completely located within the chamber.

6. The drug delivery device according to claim 1, wherein the insertion assembly includes a first valve between the delivery needle and the chamber, the first valve being configured to allow the medicament to move from the delivery needle to the chamber, but not to allow the medicament to move from the chamber to the delivery needle.

7. The drug delivery device according to claim 1, wherein the chamber is configured to receive the medicament through a chamber inlet and discharge the medicament through a chamber outlet, and the insertion assembly has a second valve configured to allow the medicament to move out of the chamber through the chamber outlet, but not to allow the medicament to move into the chamber through the chamber outlet.

8. A drug delivery system, comprising: A control assembly having a first connector and a motor configured to rotate the first connector; An insertion assembly having a delivery needle configured to receive a medicament therein, a chamber configured to receive the medicament from the delivery needle, a piston movable within the chamber, and a second connector operably connected to the piston; And A medicament container having the medicament therein and couplable to the insertion assembly such that the delivery needle is in fluid communication with the medicament in the medicament container; And An infusion patient interface configured to contact an injection site and deliver the medicament from the chamber to the injection site, Wherein the insertion assembly is removably couplable to the control assembly such that when the insertion assembly is coupled to the control assembly, the first connector is operably coupled to the second connector, and Wherein when the insertion assembly is coupled to the control assembly and when the motor rotates the first connector, the second connector also rotates and the piston moves axially within the chamber.

9. The drug delivery system according to claim 8, wherein the medicament container has a first volume, the chamber has a second volume, and the first volume is greater than the second volume.

10. The drug delivery system according to claim 8, wherein the medicament container is configured to engage with the insertion assembly before the insertion assembly is coupled to the control assembly.

11. The drug delivery system according to claim 8, wherein the medicament container is configured to engage with the control assembly before the insertion assembly is coupled to the control assembly.

12. The drug delivery system according to claim 8, further comprising a first valve between the medicament container and the chamber and a second valve between the chamber and the patient interface, wherein the first valve is configured to allow the medicament to move from the medicament container to the chamber, but not allow the medicament to move from the chamber to the delivery needle, and the second valve is configured to allow the medicament to move from the chamber to the patient interface, but not allow the medicament to move from the patient interface into the chamber.

13. The drug delivery system according to claim 8, wherein the shapes of the insertion assembly and the control assembly are arranged such that the insertion assembly can engage with the control assembly in only one orientation.

14. The drug delivery system according to claim 8, the drug delivery system being configured to transmit a signal to a computing device indicating the operation of the drug delivery device.

15. A method of injecting a medicament using a drug delivery device having an insertion assembly that can be removably coupled to a control assembly, the method comprising: Introduce a medicament container into the drug delivery device; Couple the insertion assembly to the control assembly such that a first connector on the control assembly is operably engaged with a second connector on the insertion assembly and such that a delivery needle on the insertion assembly is in fluid communication with the medicament in the medicament container; and Actuate the motor to rotate the first connector in a first rotational direction.

16. The method according to claim 15, further comprising actuating the motor to rotate the first connector in a second rotational direction opposite to the first rotational direction.

17. The method according to claim 15, further comprising positioning the patient interface at the injection site and coupling the injection interface to the insertion assembly, wherein the patient interface is configured to receive the medicament from the insertion assembly and deliver the medicament to the injection site.

18. The method according to claim 15, wherein introducing the medicament container includes coupling the medicament container to the control assembly before coupling the control assembly to the insertion assembly.

19. The method according to claim 15, wherein introducing the medicament container comprises coupling the medicament container to the insertion assembly before coupling the insertion assembly to the control assembly.

20. A method of assembling a drug delivery device, the method comprising: Introduce a medicament container into the drug delivery device; Couple the insertion assembly to the control assembly such that a first connector on the control assembly is operably engaged with a second connector on the insertion assembly and such that a delivery needle on the insertion assembly is in fluid communication with the medicament in the medicament container; Position the patient interface on the injection site; And Couple the patient interface to the insertion assembly.

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