High-capacity drug delivery devices

Abstract

The present invention provides devices and methods related to the delivery of pharmaceuticals to patients. [Solution] The drug delivery device may include a control assembly and a plug-in assembly. The control assembly has a first connector and a motor for rotating the first connector. The plug-in assembly has a transfer needle for receiving a drug therein, a chamber for receiving the drug from the transfer needle, a piston that is movable within the chamber, and a second connector operably connected to the piston. The plug-in assembly is detachably connectable to the control assembly, and when the plug-in assembly is connected to the control assembly, the first connector is operably connected to the second connector. When the plug-in assembly is connected to the control assembly and the motor rotates the first connector, the second connector also rotates and the piston moves axially within the chamber.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the priority of U.S. Provisional Patent Application No. 63 / 381,029, filed on April 22, 2022, the disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to drug delivery devices and related methods, and more particularly to new designs for administering large amounts of drugs to patients.

Background Art

[0003] Pharmaceuticals can be delivered to patients via pumps at different volumes and rates. Many existing drug pumps are designed to deliver small amounts of pharmaceuticals. Attempts to use existing pumps to deliver larger amounts result in more frequent pump cycles, which increase the temperature of the device due to the friction generated during the pumping process. The increase in pump temperature can damage sensitive pharmaceuticals such as protein drugs that may denature. The pump components often come into contact with the pharmaceuticals, thus jeopardizing sterility. These components also cannot be reused in future injections. Therefore, there is a need for an improved pump for delivering large amounts of drugs using reusable pump components that do not contact the pharmaceuticals and do not generate excessive heat.

Summary of the Invention

[0004] The aforementioned needs are met by various embodiments of the disclosed drug delivery devices. In one embodiment, a drug delivery device for administering a drug to a patient includes a control assembly and a plug-in assembly. The control assembly has a first connector and a motor configured to rotate the first connector. The plug-in assembly has a transport needle configured to receive a drug therein, a chamber configured to receive the drug from the transport needle, a piston movable within the chamber, and a second connector operably connected to the piston. The plug-in assembly is detachably connectable to the control assembly, and when the plug-in assembly is connected to the control assembly, the first connector is operably connected to the second connector. When the plug-in assembly is connected to the control assembly and the motor rotates the first connector, the second connector also rotates and the piston moves axially within the chamber.

[0005] According to another aspect of the present disclosure, a drug delivery system includes a control assembly, a plug-in assembly, a drug container, and an infusion patient interface. The control assembly has a first connector and a motor configured to rotate the first connector. The plug-in assembly has a transport needle configured to receive a drug therein, a chamber configured to receive the drug from the transport needle, a piston movable within the chamber, and a second connector operably connected to the piston. The drug container has a drug therein and is connectable to the plug-in assembly so that the transport needle is in fluid communication with the drug in the drug container. The infusion patient interface contacts the injection site and is configured to deliver the drug from the chamber to the injection site. The plug-in assembly is detachably connectable to the control assembly, and when the plug-in assembly is connected to the control assembly, the first connector is operably connected to the second connector. When the plug-in assembly is connected to the control assembly and the motor rotates the first connector, the second connector also rotates, and the piston moves axially within the chamber.

[0006] Another aspect of the present disclosure describes a method for injecting a pharmaceutical product using a drug delivery device. The drug delivery device has a plug-in assembly that is detachably coupled to a control assembly. The method includes the steps of: introducing a pharmaceutical container into the drug delivery device; coupling the plug-in assembly to the control assembly such that a first connector on the control assembly operably engages with a second connector on the plug-in assembly, and a transfer needle on the plug-in assembly is in fluid communication with the pharmaceutical product in the pharmaceutical container; and operating a motor to cause the first connector to rotate in a first rotational direction.

[0007] Another aspect of the present disclosure describes a method for assembling a drug delivery device. This method includes introducing a drug container into the drug delivery device; connecting a plug-in assembly to a control assembly such that a first connector on a control assembly operably engages with a second connector on a plug-in assembly, and a transfer needle on the plug-in assembly is in fluid communication with the drug in the drug container; positioning a patient interface over an injection site; and connecting the patient interface to a plug-in assembly. [Brief explanation of the drawing]

[0008] This application will be better understood in conjunction with the accompanying drawings. For illustrative purposes, exemplary embodiments of the subject matter are shown in the drawings, but the subject matter of this disclosure is not limited to the specific methods, devices, and systems disclosed. The drawings are as follows:

[0009] [Figure 1] A schematic diagram of a drug delivery device according to one aspect of this disclosure is shown. [Figure 2] A perspective view of a drug delivery device according to another aspect of this disclosure is shown. [Figure 3] A cross-sectional view of a control assembly according to one aspect of this disclosure is shown. [Figure 4] Another cross-sectional view of the control assembly shown in Figure 3 is presented. [Figure 5]Another cross-sectional view of the control assembly shown in Figure 3 is presented. [Figure 6] A perspective view of a plug-in assembly according to one aspect of this disclosure is shown. [Figure 7] Another perspective view of the plug-in assembly shown in Figure 6. [Figure 8] Figure 6 shows a cross-sectional view of the plug-in assembly. [Figure 9] This shows a cross-sectional view of a plug-in assembly in which the piston is in a first position, according to one aspect of the present disclosure. [Figure 10] This is a cross-sectional view of a plug-in assembly in which the piston is in a second position, according to one aspect of the present disclosure. [Figure 11] This disclosure illustrates a process using a drug delivery device according to one aspect of this disclosure. [Figure 12] A perspective view of a drug delivery device according to another aspect of the present disclosure is shown, in which the plug-in assembly is engaged with the control assembly. [Figure 13] Figure 12 shows a perspective view of the drug delivery device, with the plug-in assembly disengaged from the control assembly. [Figure 14] Figure 12 shows a cross-sectional view of the plug-in assembly of the drug delivery device.

[0010] Aspects of this disclosure will be described in detail with reference to the drawings, in which similar reference numerals refer to similar elements throughout unless otherwise specified. [Modes for carrying out the invention]

[0011] One or more pharmaceuticals can be delivered to a patient through a drug delivery device. The pharmaceuticals can be stored within the drug delivery device or in components operably connected to the drug delivery device. The drug delivery device typically includes a mechanism for delivering the pharmaceutical, which may include a pump, a motor, etc., and a patient interface through which the pharmaceutical is delivered, which may typically include one or more needles, catheters, etc. In some embodiments, it may be desirable to reuse one or more components of the drug delivery device, for example, an electronic component. In such scenarios, the drug delivery device may include disposable and reusable parts. The disposable and reusable parts may be configured to selectively engage or disengage from each other. Before use, the disposable and reusable parts may engage with each other to deliver the pharmaceutical to the patient, and after use, the disposable part may be separated from the reusable part and discarded. The reusable part can then be reused together with another disposable part.

[0012] In some situations, it may be necessary to deliver a large quantity of pharmaceuticals to a patient that exceeds the capacity of existing drug delivery devices. Embodiments described throughout this application disclose a drug delivery device configured to deliver a large quantity of pharmaceuticals while maintaining a relatively small size. The disclosed embodiments show the drug delivery device as an assembly of at least two components, one of which is intended to be reusable and the other may be intended to be disposable.

[0013] Figure 2 shows an exemplary embodiment of drug delivery device 1. The drug delivery device may generally include a control assembly 10 and a plug-in assembly 100 configured to selectively engage and disengage from the control assembly 10. The plug-in assembly 100 may include a patient interface that can deliver a drug to a patient. The patient interface may be located on the plug-in assembly 100, or alternatively, on a separate infusion set connected to the plug-in assembly 100 via an infusion line.

[0014] A drug container 2 containing a drug can be connected to or be part of a drug delivery device 1. The drug can be transferred from the container 2 to the patient via a plug-in assembly 100 by a control assembly 10. In some embodiments, the plug-in assembly 100 can be designed to be disposable, while the control assembly 10 can be designed to be reused with other plug-in assemblies. The plug-in assembly 100 can be connected to the control assembly 10 before use and detached from the control assembly 10 after use.

[0015] One embodiment of the drug delivery device 1 is shown in Figures 2 to 10. The drug delivery device 1 includes a control assembly 10 and a plug-in assembly 100. Referring to the schematic embodiment shown in Figures 2 to 10 and Figure 1, the control assembly 10 may include a pump actuator operably connected to the 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, DC motor, or servo motor. The motor 14 is configured to selectively rotate the first connector 30 in a first rotational direction, a second rotational direction opposite to the first rotational direction, or both rotational directions. The motor 14 can receive power from a power supply 18 operably connected to it. The power supply 18 may include a battery. The battery may be designed to be removable and replaceable, or it may be intended to be a non-removable component of the control assembly 10. The operation of the motor 14 can be controlled by a controller 22. The controller 22 may include a processor, memory, and programmed instructions for its operation and the operation of other components within the drug delivery device 1. The control assembly 10 defines a receptacle 38 configured to accept a plug-in assembly 100 therein. The drug delivery device 1 can be operably connected to a patient 3 (Schematicly shown in Figure 1) so that one or more pharmaceuticals can be transferred from a container 2 to the patient 3 via the drug delivery device 1.

[0016] To initiate the operation of the drug delivery device 1, a patient 3 (or another individual) can activate the start button 26 on the control assembly 10. The start button 26 can include a push button, a toggle, a switch, a capacitive or resistive touch panel, etc. The start button 26 is operably connected to the controller 22, and activation of the start button 26 can cause the controller 22 to execute one or more pre-programmed tasks. The tasks can include turning on the controller 22, activating 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, activating an indicator 34 (described below) to cause an auditory, visual, and / or tactile feedback, or another desired effect, but are not limited thereto.

[0017] In some embodiments, the drug delivery device 1 can include one or more optional indicators 34 configured to provide feedback to the patient 3. The indicator 34 can be controlled by the controller 22 or can operate passively without requiring control. The indicator 34 can be a visual indicator including a light-emitting component such as a light-emitting diode that can be activated by the controller 22 to turn on the light, turn off the light, sequentially turn on or off the light in a predetermined pattern, and / or change the color of the light.

[0018] In some embodiments, the indicator 34 can include a transparent or translucent window adjacent to the container 2 that allows the patient 3 to see the amount of the pharmaceutical product present in the container 2 (see, for example, FIG. 3).

[0019] In some embodiments, the indicator 34 may include an auditory indicator configured to provide a sound to the patient 3 indicating an action or a warning. The controller 22 can cause the indicator 34 to provide a sound indicating a stop, change the sound provided, etc.

[0020] In some embodiments, the indicator 34 may include a tactile indicator configured to provide the patient 3 with a tactile response such as vibration. The controller 22 can cause the indicator 34 to vibrate, stop vibrating, vibrate in a specific pattern, and so on.

[0021] In some embodiments, the control assembly 10 may optionally include an electronic communications device 42, which may include a transmitter and / or receiver configured to transmit data to and / or receive data from an external computing device (not shown) associated with the operation of the drug delivery device 1 and / or patient 3. The communications device 42 may include components for known communication protocols such as Wi-Fi, Bluetooth, NFC, 3G, 4G, and 5G, and may operate in accordance with them.

[0022] The container 2 containing the pharmaceutical product can be located on or within the drug delivery device 1, or it can be separate from the drug delivery device 1 and instead operably connectable to the drug delivery device 1. In some embodiments, the container 2 can be located within the control assembly 10 (see, for example, Figure 3). The container 2 can be designed to be either not easily detached from the control assembly 10 or to be detachable from the control assembly 10. In embodiments where the control assembly 10 is intended to be reused, the container 2 can be configured for selective engagement and disengagement with the control assembly 10. Thus, before use, the container 2 (containing the pharmaceutical product) is operably connected to the control assembly 10 so that the drug delivery device 1 can transfer some or all of the pharmaceutical product from the container 2 to the patient 3. After the transfer or injection is complete, the container 2 can be removed from the control assembly 10. In some embodiments, the control assembly 10 can then be configured to receive a new container 2. The container 2 may include vials, syringes, cannulas, flexible bags, or bladders, etc. In some embodiments, the pharmaceutical container 2 may be configured to engage with the plug-in assembly before being accepted into the control assembly, as described later.

[0023] Motor 14 operates by rotating a shaft within the motor in a first rotational direction or a second rotational direction opposite to the first rotational direction. The first connector 30 is configured to engage with the shaft of motor 14. When motor 14 acts on the shaft to rotate in the first rotational direction, the first connector 30 also rotates in the first rotational direction, and when motor 14 acts on 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 gearhead having a plurality of teeth extending radially from the gearhead. In some embodiments, the first connector 30 may include one or more projections 36 extending therefrom and spaced apart by a gap 32. The first connector 30 is configured to releasably engage with the second connector 200, as will be further described below.

[0024] Continuing to refer to Figure 1, and further to Figures 6-8, the plug-in assembly 100 includes a main body 104 and an infusion set 180 connected to the main body 104 via an infusion line 192. The infusion set 180 can be any existing infusion set configured to provide an interface with patient 3 and through which a drug can be delivered from a source to the patient. The infusion set 180 includes a contact surface configured to come into contact with patient 3, for example, on the skin of patient 3. In embodiments where the drug is delivered subcutaneously, intravenously, intramuscularly, or otherwise into the body, the infusion set 180 may include a needle or catheter configured to be inserted into patient 3. The drug can be moved into patient 3 through the needle or catheter.

[0025] The infusion line 192 may be any commonly used infusion line, including medical-grade tubing, through which a drug can be transferred to the infusion set 180. The infusion line 192 may be connected to the main body 104, thereby allowing the drug to be transferred from the main body 104 into the infusion line 192 and through the infusion line to the infusion set 180.

[0026] Figure 2 shows an infusion set 180 separated from the plug-in assembly 100 and connected by an infusion line 192. However, in some embodiments, the plug-in assembly 100 may include the infusion set 180 (or an equivalent component) on the main body 104, so as to be understood that the drug delivery device 1 can be positioned directly at the injection site rather than being separated from a separate infusion set 180 by the infusion line 192.

[0027] The body 104 is configured to engage releasably with the control assembly 10. A portion of the body 104 is receivable within a receptacle 38 defined by the control assembly 10. It will be understood that the receptacle 38 may be sized and molded to complement and accommodate the size and shape of the body 104. In some embodiments, the body 104 and the receptacle 38 may be keyed so that the body 104 can only be received within the receptacle 38 in a desired orientation or direction. This can reduce the possibility of improper connection of components resulting in leakage, injury to the user, or improper dispensing.

[0028] The main body 104 includes a pump section 108 and a needle section 112 connected to the pump section 108 via a transfer channel 116. The needle section 112 includes a transfer needle 120 configured to engage with a container 2. The transfer needle 120 has a tip defined at one end configured to be received into the container 2. In some embodiments, the tip may be chamfered to facilitate puncture of the container 2. As shown in Figure 8, in some embodiments, a needle guard 132 may be positioned on the needle section 112 to cover the transfer needle 120 in order to reduce the risk of needle injury to the user. The needle guard 132 may be movable within the needle section 112 between an open position and a closed position. When the container 2 is not connected to the main body 104, the needle guard 132 may be in the closed position, covering the transfer needle 120. When the container 2 is connected to the main body 104, the needle guard 132 may be in the open position, exposing the transfer needle 120 so that it can be received into the container 2. The needle guard 132 may be movable by the container 2 from a closed position to an open position when the container 2 is engaged with the main body 104. The needle guard 132 may include an elastic member (not shown), such as a spring, configured to bias the needle guard 132 to the closed position, so that when the container 2 is disengaged from the main body 104, the elastic member returns the needle guard 132 from the open position to the closed position, covering the transfer needle 120.

[0029] The lumen 124 is defined by the needle 120 and configured to receive a drug from the drug container 2 into it. The drug may move through the lumen 124 into the transfer channel 116. A first valve 128 is located within the needle portion 108 between the lumen 124 and the transfer channel 116. The first valve 128 may be a one-way valve, such as a duckbill valve or another suitable valve type. The first valve 128 is configured to allow fluid (e.g., drug) to flow in one direction but not in a second opposite direction. As shown in Figure 8, the first valve 128 may be configured so that the drug can move from the lumen 124 into the transfer channel 116 but cannot move from the transfer channel 116 back into the lumen 124. The inclusion of the first valve 128 reduces the possibility of drug backflow during use of the device and prevents the drug or any other substance from returning to the transfer needle 120 or the drug container 2.

[0030] The pump section 108 is connected to the needle section 112 via a transfer channel 116. The pump section 108 defines a chamber 140 configured to receive a pharmaceutical from the needle section 112. The chamber 140 is defined by a distal wall 156, a proximal wall 160 spaced apart on the opposite side of the distal wall 156, and a side wall 164 extending between the distal wall 156 and the proximal wall 160. A chamber inlet 168 on the pump section 108 fluidically connects the chamber 140 to the transfer channel 116. As shown in the exemplary embodiment of Figure 8, the chamber inlet 168 may be defined on the distal wall 156. A fluid (e.g., a pharmaceutical) can be moved from the needle section 112 into and through the transfer channel 116, and into the chamber 140 of the pump section 108 through the chamber inlet 168. The fluid can be moved out of the chamber 140 through a chamber outlet 172. The chamber outlet 172 may be defined on the distal wall 156. The chamber outlet 172 can communicate fluidly with the injection line 192. A second valve 176 may be located between the chamber outlet 172 and the injection line 192. The second valve 176 may be similar to, or substantially the same as, the first valve 128. The second valve 176 may be a one-way valve, such as a duckbill valve. The second valve 176 is positioned so that fluid can move from the chamber 140 through the chamber outlet 172 into the injection line 192, but not from the injection line 192 into the chamber 140.

[0031] Referring to Figure 8, the piston 148 is movably positioned within the chamber 140 and configured to selectively move axially along the distribution axis 5 toward or away from the distal wall 156 of the chamber 140. The plunger 144 can be positioned on the piston 148 such that the plunger 144 is between the distal wall 156 and the proximal wall 160. The plunger 144 should be sized to be slidable within the chamber 140 while in contact with the side wall 164. It will be understood that the plunger should adequately prevent the fluid from passing through and moving between the plunger 144 and the side wall 164 so that the fluid in the chamber 140 is held between the distal wall 156 and the plunger 144. The plunger 144 may include any suitable material, coating, film, lamination, and / or treatment that is considered useful or necessary with respect to the particular fluid or pharmaceutical that comes into contact with the plunger 144. The piston 148 can be moved via various mechanisms, for example, via a threaded screw 152 as shown in Figure 8. The screw 152 is rotatable around the distribution shaft 5 and can be fixed axially along the distribution shaft 5. The piston 148 may include complementary threads configured to engage with the threads of the screw 152, so that when the screw 152 is rotated in a first direction around the distribution shaft 5, the piston 148 moves toward the distal wall 156, and when the screw 152 is rotated 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 (described above and shown in Figures 2 and 3).

[0032] The screw 152 may include a second connector 200, or may be operably connected to the second connector 200. The second connector 200 is configured to engage with the first connector 30 described above when the plug-in assembly 100 is connected to the control assembly 10. When engaged, the second connector 200 is rotatable by the motor 14 via the first connector 30. The second connector 200 is connected to the screw 152 such that its proximal wall 160 is between the screw 152 and the connector 200. The screw 152 may be entirely within the chamber 140, while the connector 200 is outside the chamber 140. Such a configuration allows the chamber 140 to maintain a clean or sterile environment from the external environment.

[0033] Referring to the exemplary embodiments in Figures 7 and 8, the second connector 200 may include one or more projections 216 on it, separated by a gap 208. The projections 216 are configured to engage with one or more projections 36 on the first connector 30. When the first connector 30 and the second connector 200 engage with each other, the projections 36 are received in the gap 208 and the projections 216 are received in the gap 32, thereby fixing the first connector 30 and the second connector 200 in a rotational direction relative to each other. In this way, when the two connectors 30, 200 engage and the first connector 30 is rotated by the motor 14, the second connector 200 is also rotated in the same rotational direction. In some embodiments, each projection 216 may terminate with a tapered end 220 configured to facilitate alignment with the respective projections 36 on the first connector 30.

[0034] One or more fluids may be introduced from the pharmaceutical container 2 into the chamber 140 during use. The one or more fluids may contain one or more pharmaceuticals. When the container 2 is engaged with the needle portion 112 and the transfer needle 120 is connected to the container 2, a fluid path is established between the container 2 and the chamber 140 via the transfer channel 116, as described above.

[0035] Referring to Figure 9, once the plug-in assembly 100 is connected to the control assembly 10, the piston 148 can be initially positioned within the chamber 140 such that the plunger 144 contacts the distal wall 156 and substantially no space is defined between the plunger 144 and the distal wall 156. The movement of the piston 148 in the first axial direction along the distribution axis 5 away from the distal wall 156 creates a vacuum within the chamber 140 between the distal wall 156 and the plunger 144, as shown in Figure 10. The vacuum moves the fluid from the vessel 2, out of the vessel 2, through the lumen 124 of the transfer needle 120, through the first valve 128, through the transfer channel 116, and through the chamber inlet 168 into the chamber 140. It will be understood that the further the piston 148 moves away from the distal wall 156, the greater the vacuum created within the chamber 140, and therefore the greater the fluid that moves within it. Although the chamber 140 also includes a chamber outlet 172, it should be noted that during this process, fluid is not introduced into the chamber 140 through the chamber outlet 172 because a second valve 176 is present to prevent fluid from moving toward the chamber 140.

[0036] After the desired amount of fluid has moved into the chamber 140, the piston 148 can be moved along the distribution axis 5 in a second axial direction opposite to the first axial direction. The movement of the piston 148 compresses the fluid in the chamber 140 between the distal wall 156 and the plunger 144, moving the fluid toward and into the chamber outlet 172. The fluid moves from the chamber 140 through the chamber outlet 172, through the second valve 176, into the injection line 192. Some of the fluid may be pushed back into the transfer channel 116 via the chamber inlet 168, but it will be understood that the fluid is prevented from moving beyond the first valve 128 into the lumen 124 or into the pharmaceutical container 2, thereby preventing the fluid from moving in this direction.

[0037] The distance the piston 148 travels in the first and / or second axial directions may depend on the desired amount of fluid to be administered to the patient via the infusion line 192. It will be further understood that the speed and timing of the piston 148's movement can be controlled by the controller 22 described above and adjusted based on the desired administration parameters. The chamber 140 may have a volume smaller than the capacity of the container 2 or the total amount of the desired fluid to be administered to the patient. In such a scenario, 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.

[0038] The drug delivery device 1 may be designed such that the container 2 is pre-loaded within it, eliminating the need for the user to insert the container 2 before use. Alternatively, the container may be provided separately from the control assembly 10 and the plug-in assembly 100. In such a scenario, the user must connect the container 2 to the drug delivery device 1 before engaging the plug-in assembly 100 with the control assembly 10. In some embodiments, such as the exemplary embodiments shown in Figures 3 to 10, the container 2 can be connected to the control assembly 10. After the container 2 is engaged with the control assembly 10, the plug-in assembly 100 can engage with the control assembly 10, and the transfer needle 120 can be fluidly connected to the container 2 as described above.

[0039] The drug can be transferred from the plug-in assembly 100 through the illustrated infusion line 192 to a connected infusion set 180, which can be positioned at the desired injection site. The infusion set 180 may include a contact surface configured to contact the patient and a needle or catheter configured to penetrate the patient's body, through which the drug enters the patient. In some embodiments, such as those shown in Figure 2, the infusion set 180 can be separated from the main body 104 by the infusion line 192, which may be a flexible tube or catheter. In such embodiments, the infusion set 180 is flexibly connected to the plug-in assembly 100, thereby making it easier and / or more convenient to position the infusion set 180 on the patient's body relative to the plug-in assembly 100. It will be understood that the longer and more flexible the infusion line 192, the greater the flexibility at which the infusion set 180 is positioned on the patient relative to the main body 104. Figure 2 shows a drug delivery device 1 having an infusion set 180 separate from the plug-in assembly 100. However, it should be understood that in some embodiments, the drug delivery device 1 may be designed to have the patient contact surface and needle or catheter on the plug-in assembly 100 itself, rather than being connected to the separate infusion set 180 via an infusion line 192.

[0040] Referring to Figure 11, an exemplary infusion process 300 is shown. Process 300 is described with reference to components of exemplary drug delivery device 1, although the steps of process 300 may refer to components of any embodiment described herein. In step 304, the user introduces container 2 into drug delivery device 1. Container 2 can contain one or more infusion pharmaceuticals. In some embodiments, container 2 may be introduced into a control assembly 10, and in other embodiments, such as those described below, container 2 may be introduced into a plug-in assembly.

[0041] In step 308, the plug-in assembly 100 is engaged with the control assembly 10 such that the first connector 30 engages with the second connector 200. At this stage, the motor 14 is operably connected to the piston 148, and the container 2 is in fluid communication with the transfer needle 120. Thus, the drug delivery device 1 is ready to deliver the drug from the container 2.

[0042] In step 312, the infusion line 192 and the connected infusion 180 set can be connected to the plug-in assembly 100. The drug delivery device 1 can be used with different types of infusion lines and infusion sets, and it will be understood that this disclosure does not limit the applicability of various connectable infusion mechanisms. The infusion set 180 can be positioned at a desired injection spot on the body. It will be understood that the step of securing the infusion set 180 to the injection site can be completed before step 312. In some embodiments, the drug delivery device may include an infusion set or equivalent features on a plug-in assembly. In such embodiments, the entire drug delivery device can be positioned at the desired injection site, and separate infusion lines and infusion sets may not be required.

[0043] In step 316, the user can activate the injection by activating the activation button 26 described above. When the activation button 26 is activated, the controller 22 activates the motor 14 to rotate the first connector 30. As the first connector 30 rotates, the operably connected second connector 200 also rotates, and the piston 148 moves axially in the first axial direction within the plug-in assembly 100, moving the pharmaceutical from the pharmaceutical container 2 into the chamber 140. The controller 22 may include pre-programmed commands that indicate how far the piston 148 should move in the first axial direction (and thus how much pharmaceutical to be extracted from the container 2). Once the intended amount of pharmaceutical has been extracted, the controller 22 rotates the motor 14 in the opposite direction, and thus moves the piston 148 in the second axial direction, discharging the pharmaceutical from the chamber 140 through the chamber outlet 172. The steps of moving the piston 148 in a first direction to extract the pharmaceutical product from the container 2, and then moving the piston 148 in a second direction to discharge the pharmaceutical product, can be repeated a number of times as intended, and the controller 22 may include programmed instructions to do so. Once the injection process is complete, the controller 22 may send a signal to the indicator 34 to notify the user that the injection is complete.

[0044] In some embodiments, step 316 can be separated into various user-controllable sub-steps. For example, the user can activate button 26 to move piston 148 in a first axial direction, activate the same (or different) button to move piston 148 in a second axial direction, and / or activate the same (or different) button to move piston 148 again in the first axial direction. This allows the user to control the amount of drug delivered and / or the rate at which the drug is delivered.

[0045] In some embodiments, it may be advantageous to engage the drug container 2 with the plug-in assembly 100 before connecting the plug-in assembly 100 with the control assembly 10. Referring to the exemplary embodiments in Figures 12 to 14, the drug delivery device 400 is shown to have a plug-in assembly 402 configured to receive the container 2 therein. The plug-in assembly 402 is configured to engage with the control assembly 401. Various components of the drug delivery device 400 may be the same as, or substantially the same as, the components described above with respect to the drug delivery device 1. The control assembly 401 may include at least the same features as the control assembly 10.

[0046] Referring to Figure 14, the plug-in 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 to, or substantially the same as, the pump portion 108 described above. The needle portion 412 may define a receptacle 414 configured to receive a container 2 into it. Once the container 2 is inserted into the receptacle 414, the transport needle 420 punctures the container 2, forming a fluid path between the interior of the container 2 and a lumen 424 extending through the transport needle 420. The fluid from the container 2 can be moved through the lumen 424, through the first valve 428, through the transport channel 416, and into the pump portion 408 in a manner similar to that described above with respect to the drug delivery device 1.

[0047] The mechanism for moving fluid from the container 2 to the injection line 192 via the pump section 408 is substantially the same as that described in the previous embodiment. By receiving the container 2 into the plug-in assembly 402, use can be simplified and the number of reusable surfaces that need to be sterilized, cleaned, and / or maintained can be reduced. When in use, the user first inserts the container 2 into the plug-in assembly 402 and then engages the plug-in assembly 402 with the control assembly 401. After the injection is complete, the plug-in assembly 402 can be disengaged from the control assembly 401 and discarded together with the container 2 inside, while the control assembly 401 can be cleaned and reused in another injection.

[0048] While the systems and methods are described in relation to various embodiments of various figures, it will be understood by those skilled in the art that modifications can be made to the embodiments without departing from the broader concept of the invention. Therefore, it will be understood that this disclosure is not limited to any specific embodiment disclosed, but is intended to encompass modifications within the spirit and scope of this disclosure as defined by the claims.

Claims

1. A drug delivery device for administering pharmaceuticals to patients, A control assembly having a first connector and a motor configured to rotate the first connector, A plug-in assembly comprising a transfer needle configured to receive the pharmaceutical product, a pump section having a chamber configured to receive the pharmaceutical product from the transfer needle, a piston movable within the chamber, and a second connector operably connected to the piston, The plug-in assembly is detachably connectable to the control assembly such that when the plug-in assembly is connected to the control assembly, the first connector is operably connected to the second connector. A drug delivery device in which the plug-in assembly is connected to the control assembly, and when the motor rotates the first connector, the second connector also rotates, causing the piston to move axially within the chamber.

2. A drug delivery device according to claim 1, further comprising a patient interface positioned at the injection site, wherein the drug is transferable to the patient through the patient interface.

3. The drug delivery device according to claim 2, wherein the patient interface includes an infusion set having a needle insertable into the injection site, and the infusion set is connected to the plug-in assembly via an infusion line.

4. 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 it 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. The drug delivery device according to claim 1, wherein the first axial movement of the piston moves the drug into the chamber, and the second axial movement of the piston discharges the drug 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 plug-in assembly includes a first valve between the transport needle and the chamber, the first valve being configured to allow the drug to move from the transport needle to the chamber but not from the chamber to the transport needle.

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

8. A drug delivery system, A control assembly having a first connector and a motor configured to rotate the first connector, A plug-in assembly comprising: a transfer needle configured to receive the pharmaceutical substance; a chamber configured to receive the pharmaceutical substance from the transfer needle; a piston movable within the chamber; and a second connector operably connected to the piston. A pharmaceutical container having the pharmaceutical inside, and which can be connected to the plug-in assembly such that the transfer needle is in fluid communication with the pharmaceutical in the pharmaceutical container, The system comprises an injectable patient interface configured to contact the injection site and deliver the pharmaceutical product from the chamber to the injection site, The plug-in assembly is detachably connectable to the control assembly such that when the plug-in assembly is connected to the control assembly, the first connector is operably connected to the second connector. A drug delivery system in which the plug-in assembly is connected to the control assembly, and when the motor rotates the first connector, the second connector also rotates, causing the piston to move axially within the chamber.

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

10. The drug delivery system according to claim 8, wherein the drug container is configured to engage with the plug-in assembly before the plug-in assembly is connected to the control assembly.

11. The drug delivery system according to claim 8, wherein the drug container is configured to engage with the control assembly before the plug-in assembly is connected to the control assembly.

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

13. The drug delivery system according to claim 8, wherein the plug-in assembly and the control assembly are molded such that the plug-in assembly can engage with the control assembly in only one orientation.

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

15. A method of injecting a pharmaceutical product using a drug delivery device, wherein the drug delivery device has a plug-in assembly that is detachably connected to a control assembly, and the method is Introducing the pharmaceutical container into the drug delivery device, The plug-in assembly is connected to the control assembly such that the first connector on the control assembly is operably engaged with the second connector on the plug-in assembly, and the transfer needle on the plug-in assembly is in fluid communication with the pharmaceutical in the pharmaceutical container. A method comprising operating a motor to rotate the first connector in a first rotational direction.

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

17. The invention further includes placing the patient interface on the injection site and connecting the injection interface to the plug-in assembly, The method according to claim 15, wherein the patient interface is configured to receive the drug from the plug-in assembly and to transfer the drug to the injection site.

18. The method according to claim 15, wherein introducing the pharmaceutical container includes connecting the pharmaceutical container to the control assembly before connecting the control assembly to the plug-in assembly.

19. The method according to claim 15, wherein introducing the pharmaceutical container includes connecting the pharmaceutical container to the plug-in assembly before connecting the plug-in assembly to the control assembly.

20. A method for assembling a drug delivery device, Introducing the pharmaceutical container into the drug delivery device, The plug-in assembly is connected to the control assembly such that the first connector on the control assembly is operably engaged with the second connector on the plug-in assembly, and the transfer needle on the plug-in assembly is in fluid communication with the pharmaceutical in the pharmaceutical container. Placing the patient interface on the injection site, A method comprising connecting the patient interface with the plug-in assembly.

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