Drug delivery system with adjustable injection time and method of use
Through the design of the drug delivery system, the customized injection time is calculated using identifiers and controllers, which solves the fear and safety problems caused by the exposure of needles in the prefilled syringe, and adapts to different drug characteristics and patient preferences, achieving a more comfortable and effective Drug delivery.
Patent Information
- Application Number
- CN202080050997.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-07-18
- Filing Date
- 2020-07-16
- Publication Date
- 2024-12-17
- Estimated Expiration
- 2040-07-16
AI Technical Summary
The existing prefilled subcutaneous syringe causes fear and health and safety problems due to exposed needles during the injection process, and the automated drug delivery device is difficult to adapt to the characteristics of different drugs and the patient's personal preferences, which affects the choice of injection time.
A drug delivery system is designed, including a reservoir, identifier, drug delivery device, reader, driver and controller. By reading drug information and receiving preferred injection speed, a custom injection time is calculated and the driver speed is set to Complete drug delivery within an acceptable time.
The system can adjust the injection time according to the drug characteristics and patient preferences, improve injection comfort and efficacy, reduce injection pain, and adapt to the delivery needs of different drugs.
Smart Images

Figure CN114126688B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 875,716, filed on July 18, 2019, which is incorporated herein by reference in its entirety. Technical Field
[0003] The present disclosure relates generally to a drug delivery system, and more particularly to a drug delivery system that allows a user to adjust an injection time within an acceptable range calculated based on drug information. Background Art
[0004] Prefilled hypodermic syringes offer several advantages for the home use market. These advantages include the fact that prefilled syringes can prepare more accurate doses for each medication. Further, prefilled syringes are easier to operate, simply by pushing the stopper of the syringe. In addition to the cost of the specific medication used, prefilled syringes can also be more economical to manufacture. Therefore, all of these advantages make prefilled syringes more commercially attractive.
[0005] However, prefilled syringes also have some significant disadvantages in the market. Specifically, some users are frightened by exposed needles or feel that they are naturally unable to perform injections. Due to the need to circumvent exposed needles and the health and safety issues that may be involved, various types of syringes and other devices have been developed for the specific purpose of hiding the needle from the user and automating the injection task to help the user perform the injection.
[0006] In particular, the automated drug delivery device controls the speed of the drug drive component so as to accurately deliver a full dose of the drug within a predetermined injection time. A wide variety of drugs are delivered to patients via drug delivery devices, and the characteristics of the delivered drug (such as viscosity and dose volume) affect the injection time. For some drugs, a maximum injection time and / or a minimum injection time are targeted in order to reduce injection pain or improve drug efficacy. Patients may have personal preferences regarding injection times. For example, some patients may prefer a faster injection time in order to quickly complete drug delivery. Other patients may find a slower injection time more comfortable. Summary of the invention
[0007] Some aspects of the present disclosure include a drug delivery system comprising a reservoir, an identifier, a drug delivery device, a reader, a driver, and a controller. The reservoir is adapted to contain a drug. The identifier has drug information. The drug delivery device is adapted to receive the reservoir. The reader of the drug delivery device is adapted to read the drug information. The driver of the drug delivery device is adapted to discharge the drug from the reservoir. The controller is coupled to the reader and the driver. The controller is programmed to (a) identify the drug contained in the reservoir based on the drug information, (b) calculate or determine an acceptable injection time range for the identified drug, (c) determine a custom injection time within the acceptable injection time range, and (d) set the speed of the driver so that the drug is discharged from the reservoir within the custom injection time.
[0008] In some forms, the controller calculates or determines an acceptable injection time range based at least in part on the medication information.
[0009] In some forms, the drug information includes at least one of: viscosity, dose volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
[0010] In some forms, the controller includes a memory containing a drug information dataset having a list of possible drugs, each possible drug being associated with drug information, and calculating or determining an acceptable injection time range for the identified drug includes: accessing the drug information dataset, determining that the identified drug is a possible drug in the list of possible drugs, and receiving drug information associated with the identified drug in the drug information dataset.
[0011] In some forms, the drug delivery system includes an input device functionally coupled to the controller. The controller is further programmed to receive a preferred injection rate from the input device. The customized injection time is based on the preferred injection rate.
[0012] In some forms, the input device comprises two or more relative injection rate options, each relative injection rate option equal to a percentage of a longest possible injection time within the acceptable injection time range, and wherein the preferred injection rate is the relative injection rate option selected using the input device.
[0013] In some forms, the input device comprises a touch screen, and wherein the controller causes the input device to display two or more relative injection speed options.
[0014] In some forms, each of the two or more relative injection speed options is displayed as one of: a written adjective, a percentage of the longest possible injection, and a point on a sliding scale.
[0015] In some forms, the two or more relative injection speeds are each a distinct physical button of the drug delivery device.
[0016] In some forms, the identifier is an RFID tag or an NFC tag.
[0017] Other aspects of the disclosure include a method of preparing a drug delivery device for delivering a drug product. The method may include: identifying a drug contained in a reservoir of a drug delivery system based on a reader of the drug delivery system reading an identifier on the reservoir. The method may also include: calculating an acceptable injection time range for the identified drug. The method may also include: receiving a preferred injection speed from an input device of the drug delivery system. The method may also include: determining a custom injection time within the acceptable injection time range based on the preferred injection speed. The method may also include: setting a speed of a driver of the drug delivery system so that the drug is discharged from the reservoir within the custom injection time.
[0018] In some forms, calculating an acceptable injection time range for the identified medication includes receiving medication information from an identifier on the reservoir.
[0019] In some forms, the drug information includes at least one of: viscosity, dose volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
[0020] In some forms, calculating an acceptable injection time range for the identified drug includes accessing a drug information dataset provided in a memory of the controller, determining that the identified drug is a possible drug in a list of possible drugs, and receiving drug information associated with the identified drug in the drug information dataset.
[0021] In some forms, the drug information includes at least one of: viscosity, dose volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
[0022] In some forms, the method further comprises: presenting two or more relative injection rate options, each relative injection rate option equal to a percentage of a longest possible injection time within an acceptable injection time range; allowing selection of one of the two or more relative injection rate options; and using the relative injection rate option selected as the preferred injection speed.
[0023] In some forms, the method further comprises causing the input device to display two or more relative injection speed options on the touch screen.
[0024] In some forms, each of the two or more relative injection speed options is displayed as one of: a written adjective, a percentage of the longest possible injection, and a point on a sliding scale.
[0025] In some forms, allowing selection of one of two or more relative injection speed options comprises associating the two or more relative injection speeds with unique physical buttons of the drug delivery device.
[0026] In some forms, reading the identifier on the receptacle comprises reading an RFID tag or an NFC tag. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The above needs are at least partially met by providing the embodiments described in the following detailed description, particularly when studied in conjunction with the accompanying drawings, in which:
[0028] Figure 1 is a schematic diagram of a drug delivery system including a drug delivery device according to various embodiments of the present invention.
[0029] Figure 2 is an elevational side view of an exemplary embodiment of a drug delivery device including an autoinjector and a cartridge.
[0030] Figure 3A yes Figure 2 A front elevation view of an exemplary embodiment of an automatic injector.
[0031] Figure 3B yes Figure 2 and Figure 3A Elevation view of the first example of an automatic injector.
[0032] Figure 3C yes Figures 2 to 3B Rear elevation view of an automatic injector.
[0033] Figure 3D yes Figures 2 to 3C Elevation view of a second side of the automatic injector.
[0034] Figure 3E yes Figures 2 to 3D An elevational view of a first end of an automatic injector.
[0035] Figure 3F yes Figures 2 to 3F An elevational view of a second end of the automatic injector.
[0036] Figure 3G yes Figures 2 to 3F Cross-sectional side view of an auto-injector device.
[0037] Figure 4 yes Figure 2An exploded perspective view of an exemplary embodiment of a cassette.
[0038] Figure 5 is a flow chart illustrating decision logic for injecting a medication using an auto-injector within a customized injection time according to an exemplary embodiment of the present disclosure.
[0039] The skilled person will understand that the elements in the figure are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative position of some elements in the figure may be enlarged relative to other elements to help improve the understanding of multiple different embodiments of the present invention. Moreover, the commonly used but easily understood elements that are available or necessary in commercially feasible embodiments are usually not drawn to facilitate viewing these multiple different embodiments with less obstruction. It will also be understood that certain actions and / or steps can be described or depicted in a specific order of occurrence, and those skilled in the art will understand that this specificity in terms of sequence is not actually required. It will also be understood that the terms and expressions used herein have the common technical meanings consistent with these terms and expressions as set forth above by those skilled in the art, except for the different specific meanings set forth herein. DETAILED DESCRIPTION
[0040] A drug delivery system and method is provided that allows the injection time at which a drug is expelled to be customized to suit the user's preference within a range of acceptable injection times for injecting the drug. The patient benefits from the system by being able to adjust the injection time to suit personal preference (i.e., minimizing the total injection time to deliver the drug at the most comfortable rate), while still delivering the drug within an injection time that is effective for the drug.
[0041] Referring now to the drawings, and in particular to Figure 1 , a general example of a system 100 including a drug delivery device 102 is provided. The drug delivery device 102 can be in the form of an automatic injector and is therefore suitable for handheld use and against the patient's skin. The drug delivery device 102 includes a housing 110, in which a component or structure for introducing a delivery cannula into the patient's body and ejecting a drug or medicament from a reservoir 112 into the patient's body through the delivery cannula is disposed. According to certain embodiments, the same component or structure for introducing a delivery cannula into the patient's body can also eject a drug or medicament from a reservoir into the patient's body through the delivery cannula. The drug delivery device 102 may also include a component or structure for connecting a delivery cannula to a reservoir, extracting the delivery cannula into the housing 110 through an opening (not shown) in the housing 110, or deploying other structures that will prevent contact with the delivery cannula once the delivery cannula has been removed from the patient. Any number of additional components and structures are possible. Therefore, the specific embodiments of the drug delivery device 102 discussed below are by way of example and not by way of limitation.
[0042] Thus, the drug delivery device 102 includes a reservoir 112 (such as a reservoir disposed in a cassette 200 discussed below) and a delivery cannula 114 having a first end 116 (e.g., a proximal end) that may or can be connected in fluid communication with the reservoir 112 and a second end 118 (e.g., a distal end) that may be inserted into a patient. The delivery cannula 114 may be, for example, a rigid needle having a beveled edge that may be sized such that the second end 118 of the needle 114 is received beneath the skin for subcutaneous injection of the medicament within the reservoir 112. The first end 116 of the needle 114 may be disposed through a wall 120 of the reservoir 112 and thereby be connected in fluid communication with the reservoir 112. Alternatively, the first end 116 of the needle 114 may be disposed only partially through the wall 120 (e.g., the wall 120 may be a resealable septum or plug) such that the first end of the needle 114 may not be connected in fluid communication prior to insertion of the second end 118 of the needle 114 into the patient. In this case, therefore, the first end 116 of the needle 114 may be described as being connectable in fluid communication with the reservoir 112, but it will be appreciated that there are other mechanisms by which the first end 116 of the needle 114 may be connectable in fluid communication with the reservoir 112, but is not connected.
[0043] The drug delivery device 102 includes a shield 122 (e.g., a needle shield) that can be deployed to limit access to the second end 118 of the needle 114 at least after an injection has been completed. According to certain embodiments, the shield 122 can have a biasing element 124 (such as a spring) that causes the shield 122 to extend from the housing 110 so that the distal end 126 of the shield 122 extends beyond the second end 118 of the needle 114 except when the shield 122 is placed against the skin and insertion of the needle 114 is actuated. In fact, according to certain embodiments of the drug delivery device 102, insertion of the needle 114 can be actuated by placing the distal end 126 of the shield 122 on or against the patient's skin.
[0044] The drug delivery device 102 may also include a lock 128 (e.g., a ratchet) coupled to the shield 122 and configured to limit or prevent movement of the shield 122 relative to the housing 110 of the drug delivery device 102, such that the distal end 126 of the shield 122 extends a sufficient distance from the housing 110 to limit or prevent contact with the second end 118 of the needle 114, for example, after the needle 114 has been removed or separated from the patient's skin. In some embodiments, the lock 128 may be coupled to a controller (e.g., a controller 150 described in more detail below), which may selectively activate or deactivate the lock 128 based on different types of information about the drug delivery device 102, including operating state information, status information, and / or identity information. When the lock 128 is activated by the controller 150, the lock 128 may be configured to limit or prevent movement of the needle shield 122 relative to the housing 110. When lock 128 is deactivated by controller 150 , lock 128 may be configured to allow movement of needle shield 122 relative to housing 110 .
[0045] The drug delivery device 102 also includes at least one driver 130 that can be used to insert the second end 118 of the needle 114 into the patient's skin and eject the drug or medicament from the reservoir 112 into the patient's body through the delivery cannula 114. The driver 130 can include a source of pressurized gas or a source of material that undergoes a phase change, so that the escaping gas or phase change material provides power that can be applied to the reservoir 112 to eject the drug from the reservoir. According to other embodiments, the driver 130 can include an electromechanical system, such as, for example, a motor. Other embodiments of the driver 130 are also possible.
[0046] In one embodiment, the driver 130 includes a motor controlled by the controller 150, and the injection time of the extruded drug can be set by the controller 150. Figure 5 The decision logic implemented by the controller 150 and the driver 130 to set the injection time is described in more detail in FIG. 1. In other embodiments, the same decision logic can be implemented by the controller 150 for a driver 130 that does not include a motor but relies on other controllable force generating components (e.g., a pressurized gas system). The driver 130 may include the following Figure 3G The various components of driver 340 are described.
[0047] In one embodiment, the driver 130 can be coupled to a plunger 131 and / or a stopper 132 (e.g., a wall) disposed in the reservoir 112 to move the stopper 132 in a distal direction toward the delivery sheath 114. According to this embodiment, the stopper 132 can be a stopper fixed to the distal end of the plunger 131 and received in the orifice 134. The plunger 131 together with the driver 130 can move the stopper 132 along the longitudinal axis of the drug delivery device 102 through the orifice 134 from the proximal end of the orifice 134 to the distal end of the orifice 134, and thereby eject the medicament from the reservoir 112.
[0048] In some embodiments, the driver 130 may also cooperate with the stopper 132 and / or the orifice 134 to move the reservoir 112 relative to the housing 110 so as to move the second end 118 of the needle 114 relative to the housing 110 and into the patient. According to those embodiments in which the driver 130 cooperates with the stopper 132, this may occur before the first end 116 of the needle 114 is in fluid communication with the reservoir 112. According to those embodiments in which the driver cooperates with the orifice 134, the driver may include one component (e.g., a first spring) that cooperates with the orifice 134 to move the reservoir 112 and the needle 114 relative to the housing 110 and a second component (e.g., a second spring) that cooperates with the stopper 132 to move the stopper 132 relative to the orifice 134.
[0049] The drug delivery device 102 may also include a lock 135 coupled to the plunger 131 and configured to limit or prevent movement of the plunger 131 relative to the housing 110 of the drug delivery device 102 so that the stopper 132 cannot be advanced to discharge the medicament from the reservoir 112 to the patient. In some embodiments, according to one or more of the above methods, the lock 135 may be coupled to a controller (e.g., a controller 150 described in more detail below), which may selectively activate or deactivate the lock 135 based on different types of information about the drug delivery device 102, including operating state information, status information, and / or identity information. When the lock 135 is activated by the controller 150, the lock 135 may be configured to limit or prevent movement of the plunger 131 relative to the housing 110. When the lock 135 is deactivated by the controller 150, the lock 128 may be configured to allow movement of the plunger 131 relative to the housing 110.
[0050] The driver 130 may be associated with an actuator 140. The actuator 140 may activate the controller 150 to cause the driver 130 to insert the needle 114 and eject the drug from the reservoir 112 into the patient through the needle 114. According to some embodiments, the actuator 140 may be a needle shield 122, as described above. According to other embodiments, such as Figure 1In the illustrated embodiment, the actuator 140 may be a button that may be manually depressed by a user or patient once the drug delivery device 102 is positioned to be disposed on or against the patient's skin. The lock 141 may be coupled to the actuator 140 and configured to limit or prevent movement of the actuator 140 such that the actuator 140 cannot be used to activate the driver 130. In some embodiments, the lock 141 may be coupled to a controller (e.g., controller 150) that may selectively activate or deactivate the lock 141 based on different types of information about the drug delivery device 102, including operating state information, status information, and / or identity information. When the lock 141 is activated by the controller 150, the lock 141 may be configured to limit or prevent movement of the actuator 140 relative to the housing 110. When the lock 141 is deactivated by the controller 150, the lock 141 may be configured to allow movement of the actuator 140 relative to the housing 110. Once actuated by the actuator 140, the controller 150 may determine the position of the actuator 140 in accordance with information about the drug delivery device 102. Figure 5 The decision logic described is used to control the driver 130.
[0051] The drug delivery device 102 may also include a removable sterile barrier or signal cap 144 disposed around one or more of the distal end of the housing 110, the needle shield 122, and the second end 118 of the delivery cannula 114. Figure 1 As shown, the signal cap 144 can be removably attached to the distal end of the housing 110. In some embodiments, the signal cap 144 can form an interference fit or a snap fit with the distal end of the housing 110. The friction associated with the interference fit or the snap fit can be overcome by manually pulling the signal cap 144 in a direction away from the housing 110. The signal cap 144 can reduce the risk of contamination of the delivery sheath 114 and other components disposed within the drug delivery device 102 when attached to the drug delivery device 102.
[0052] In addition, the drug delivery device 102 may include a heating element 146 that is coupled to the exterior of the reservoir 112 and is configured to warm the medicament inside the reservoir 112 by, for example, conductive heating. The heating element 146 may be coupled to the controller 150 so that the controller 150 can selectively activate or deactivate the heating element 146 based on different types of information about the drug delivery device 102, including operating state information, status information, and / or identity information. In some embodiments, the heating element 146 may include a conductive coil wrapped around the exterior of the reservoir 112. In other embodiments, the heating element may include a conductive coil wrapped around the sleeve 114. Alternatively or in addition, a cooling element (not shown) may be coupled to the reservoir 112 and may be controlled by the controller 150 in a manner similar to the heating element 146.
[0053] The drug delivery device 102 may also include an output unit 147 coupled to the housing 110 and configured to notify the patient or user of information related to the drug delivery device 102. The output unit 147 may be coupled to the controller 150 so that the controller 150 may selectively activate or deactivate the output unit 147 based on different types of information about the drug delivery device 102, including operating state information, status information, and / or identity information. The output unit 147 may be any device suitable for conveying information to the patient or user, including a display (e.g., a liquid crystal display), a touch screen, a light (e.g., a light emitting diode), a vibrator (e.g., an electromechanical vibration element), a speaker, and / or an alarm, among other devices. The drug delivery device 102 may also include an input unit 148 coupled to the housing 110 and configured to allow the user or patient to input information to be used by the controller 150. In some embodiments, the input unit 148, the output unit 147, and even the fingerprint sensor 165 may be a single device, such as a touch screen. In other embodiments, the input unit 148 may be a device separate from the output unit 147, such as a keyboard or buttons.
[0054] A combined input unit 148 and output unit 147 (such as a single touch screen) or the two units 147 and 148 in cooperation may be used to implement the Figure 5 Describes the decision logic and informs the user as to Figure 5 The information calculated or received by the controller 150 as part of the decision logic described. For example, the output unit 147 can inform the user which drug is identified as contained in the reservoir. The output unit 147 can display the acceptable injection time range calculated for the identified drug and / or can display the relative injection speed options to the user. The relative injection speed options can be displayed as written adjectives (e.g., slow, medium, fast), percentages (25%, 50%, or 75% of the longest possible injection time), or points on a sliding scale. The input unit 146 can be used to select a preferred injection speed (e.g., medium, 50% of the longest possible injection time, a middle point on a sliding scale). In some cases, the input unit 146 can have a unique physical button associated with each relative injection speed option (such as a speed selector switch 316, described below). The output unit 147 can display the preferred injection speed selected by the user or can display a custom injection time determined by the controller. In some embodiments, the output unit 147 can display a timer that counts down from the custom injection time so that the user knows how much time is left before the injection is completed.
[0055] like Figure 1As shown, the reservoir 112, the biasing element 124, the locks 128, 135, 141, the plunger 131, the stopper 132, the driver 130, and the heating element 146 are disposed within the housing 110 along with at least a portion of the delivery cannula 114. The controller 150, the communication module 152 (e.g., a wireless transmitter), and at least one sensor or switch are also disposed within the housing 110. Figure 1 In the illustrated embodiment, four sensors are included: a temperature sensor 160, a skin sensor 162, at least one orientation sensor 164, and a fingerprint sensor 165. The sensors 160, 162, 164, and 165 may each generate sensor data (e.g., raw or unprocessed data) related to a corresponding measured characteristic or aspect of the drug delivery device 102. The sensor data may represent at least one of a condition or an operating state of the drug delivery device 102. In addition, the drug delivery device 102 includes a switch 166. The controller 150 is coupled to the communication module 152, the locks 128, 135, 141, the sensors 160, 162, 164, 165, the heating element 146, the fingerprint sensor 165, the output unit 147, the input unit 148, and the switch 166. The controller 150 may be configured to process the sensor data generated by the sensors 160, 162, 164, and 165 to determine a condition and / or an operating state of the drug delivery device 102. The controller 150, the communication module 152, one or more of the sensors 160, 162, 164, 165, and the switch 166 may be packaged together as a single module, or each component may be manufactured separately and coupled once the components are disposed within the housing 110. According to certain embodiments, each electrical component may be integrated into the structure of the device 102 associated with the electrical component (e.g., the sensors 162 and 164 may be integrated into the shield 122). In some embodiments, the controller 150, the communication module 152, one or more of the sensors 160, 162, 164, 165, and / or the switch 166 may be packaged together inside the signal cap 144.
[0056] The controller 150 may include at least one processor 170 (e.g., a microprocessor) and a memory 172 (e.g., a random access memory (RAM), a non-volatile memory such as a hard disk, a flash memory, a removable memory, a non-removable memory, etc.). The controller 150 may also include or be coupled to a power source, such as a battery. The processor 170 may be programmed to perform actions that the controller 150 is suitable for performing, and the memory 172 may include one or more tangible non-transitory readable memories having executable computer-readable non-transitory instructions stored thereon, which, when executed by the at least one processor 170, may cause the at least one processor 170 to perform actions that the controller 150 is suitable for performing. Alternatively, the controller 150 may include other circuits that perform actions that the controller is suitable for performing. In particular, the controller 150 may be suitable for performing the following with respect to Figure 5 Describe the decision logic.
[0057] The communication module 152 (i.e., reader) can be any of a plurality of different communication modules for receiving information from a cartridge having a reservoir containing a drug to be injected (such as cartridge 200, discussed below). For example, the communication module can be a QR code reader, an RFID tag reader, or a near field communication (NFC) reader. The communication module 152 is used to identify the drug to be injected by reading an identifier (e.g., a QR code, an RFID tag, or an NFC tag) provided on a cartridge having a reservoir (such as cartridge 200, discussed below).
[0058] In some embodiments, the memory 172 of the controller 150 can store a drug data set having a list of possible drugs, each possible drug being associated with drug information. The drug data set can be stored in the memory 172 before any of the methods discussed below are started. By way of example and not limitation, the drug information can include viscosity (at room temperature or multiple viscosities associated with different temperatures), dose volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain. Using this information, the controller 150 can calculate an acceptable injection time range for the identified drug, and once a preferred injection speed is received from the input unit 148, a custom injection time within the acceptable injection time range can be determined based on the preferred injection speed.
[0059] In other embodiments, the drug information discussed above may be included in an identifier (e.g., a QR code, RFID tag, or NFC tag) disposed on a cassette having a reservoir (such as cassette 200, discussed below). In this embodiment, a complete drug data set is not required. Only drug information associated with a specific drug contained within the reservoir needs to be provided.
[0060] The temperature sensor 160 may be disposed proximate to the reservoir 112 so that the temperature of the drug in the reservoir 112 may be determined. Alternatively, the temperature sensor 160 may simply be disposed in the housing 110 so that the approximate temperature of the drug in the reservoir 112 and the drug delivery device 102 may be generally determined. According to an embodiment, the temperature sensor 160 may be an onboard temperature sensor 160 attached to the processor 170.
[0061] The skin sensor 162 can be attached to the shield 122 or associated with the shield to determine when the drug delivery device 102 is placed on or against the patient's skin. According to one embodiment, the skin sensor 162 is a pressure sensor. According to other embodiments, the skin sensor 162 can be a capacitive sensor, a resistive sensor, or an inductive sensor. According to the above discussion, the skin sensor 162 or the switch 166 (which is attached to the actuator 140 or associated with the actuator) can be used to determine when the drug delivery device 102 is activated or actuated, depending on the design and operation of the drug delivery device 102 for actuating the driver 130. It may also be the case that the signal from the skin sensor 160 is used to determine that the drug delivery device 102 has been activated even when the shield 122 is not used as an actual actuator, the underlying assumption being that movement of the shield 122 is necessarily associated with actuation of the device 102.
[0062] An orientation sensor 164 (of which there may be at least two, as shown) may be associated with the shield 122 (or that portion of the housing 110 adjacent to the shield 122) and the controller 150 (which, as shown, may be disposed at the other end of the drug delivery device 102 or housing 110 away from the shield 122). For example, the orientation sensor 164 may be a magnetometer. In particular, the orientation sensor 164 associated with the controller 150 may be an onboard magnetometer. The orientation sensor 164 may be used to determine the orientation of the drug delivery device 102 (in particular, the housing 110) relative to the injection site (or more particularly, relative to the placement of the drug delivery device 102 on or against the patient's skin).
[0063] It will be appreciated that the arrangement of the components of the drug delivery device 102 within the housing 110 is merely one embodiment of the present disclosure. For example, certain components of the drug delivery device 102 may be disposed externally to the drug delivery device 102.
[0064] According to this embodiment, the drug delivery device 102 may include a housing 110, a reservoir 112, a needle 114, a shield 122, a biasing element 124, a lock 128, a driver 130, and a button 140. In addition, sensors 162, 164, and a switch 166 may be disposed within the housing 110. A fingerprint sensor 165, an output unit 147, and an input unit 148 may be disposed on the exterior of the module 130 so that a user or patient may interact with them.
[0065] Separating the controller 150, the communication module 152, and the other components into one module can allow the module to be used with multiple instances of the drug delivery device 102. In this regard, the module can be considered to be the reusable portion of the drug delivery device 102 / module combination (which, for the purposes of this disclosure, may be referred to as the drug delivery device 102), while the drug delivery device 102 can be considered to be the disposable portion of the drug delivery device 102. By isolating the more expensive components into the reusable module 400 and isolating the cheaper components (including certain sensors) into the disposable drug delivery device 102, the overall cost of the auto-injector can be optimized. This arrangement of the components in the module and the drug delivery device 102 can also facilitate the manufacture and sterilization of the drug delivery device 102 and the module.
[0066] Steering Figure 2 , provides another general example embodiment of the system 100 ', which general example is combined with Figure 1 The general example of the system 100 described is the same or different.As shown in the figure, the automatic injection system or device 100 'can include a removable cassette 200 and an automatic syringe or syringe 300.The various embodiments of the cassette 200 can be configured to accommodate the medicine to be injected into the user by the automatic syringe 300.In various other embodiments, the cassette 200 can be configured to be used to train the user to operate the automatic syringe 300 (training cassette).The automatic syringe 300 can be configured to automatically deliver the injection when actuated by the user or some other person.The various embodiments of the automatic syringe 300 can have a cassette door 308, which can be configured to pivot between an open position and a closed position to allow the cassette 200 to be inserted into the automatic syringe 300.In some embodiments, the cassette door 308 can include a "cassette" icon (not shown), which indicates the insertion entry point of the cassette 200.
[0067] Common Reference Figures 3A to 3G, various embodiments of the automatic injector 300 may include a housing 302 having a handle section 304 and a cartridge receiving section 306 inline with the handle section 304. To assist patients with manual dexterity issues, the handle section 304 of the automatic injector housing 302 may define an ergonomically shaped handle 305 having a soft gripping area 305S. The cartridge receiving section 306 includes the cartridge door 308 described above. The cartridge door receives the cartridge 200 when in the open position and aligns the cartridge 200 with the driver and other structures and components of the automatic injector 300 when in the closed position. The cartridge door 308 may include a "cartridge" icon that indicates an insertion entry point for the cartridge 200. The cartridge receiving section 306 of the housing 302 may include windows 310A, 310B on its sides that align with windows of the cartridge 200 when the cartridge door 308 is closed and the cartridge 200 is properly installed therein. In one or more embodiments, the windows 310A, 310B may be dual-layered.
[0068] Still reference Figure 3A , Figure 3B , Figure 3D and Figure 3F , the automatic injector 300 may further include a user interface 312 and an audio speaker (not shown). The audio speaker may be disposed within the housing 302 and provide various audible indicators. The audio speaker may be audibly communicated with the external environment via a speaker hole 314 formed in the cartridge receiving section 306 of the housing 302. The visual and audible indicators generated by the user interface 312 and the audio speaker may tell the user when the automatic injector 300 is ready for use, the progress of the injection process, the completion of the injection, the occurrence of any errors, and other information.
[0069] User interface 312 (in Figure 3A ) can be located in the cassette receiving section 306 of the housing 302 and provide various visual indicators. The user interface 312 is related to Figure 1The input unit 148 and output unit 147 described correspond and can be used to implement the same functions. For example, the user interface 312 can inform the user which drug is identified as contained in the reservoir. The user interface 312 can display the acceptable injection time range calculated for the identified drug and / or can display the relative injection speed options to the user. The relative injection speed options can be displayed as written adjectives (e.g., slow, medium, fast), percentages (25%, 50% or 75% of the longest possible injection time), or points on a sliding scale. The user interface 312 can be used to select a preferred injection speed (e.g., medium, 50% of the longest possible injection time, a middle point on a sliding scale). (Alternatively, as discussed below, the speed selector switch 316 can be used to select a preferred injection speed.) The user interface 312 can display the preferred injection speed selected by the user or can display a custom injection time determined by the controller. In some embodiments, the user interface 312 can display a timer that counts down from the custom injection time so that the user knows how much time is left before the injection is completed.
[0070] The auto-injector 300 may further include one or more of a set / mute switch 315, a speed selector switch 316, a start button 307, and an eject button 317. The set / mute switch 315 ( Figure 3B ) can be located in the cassette receiving section 306 of the housing 302. The mute switch 315 can be configured to allow the user to turn on and off all synthesized sounds except error sounds, and respond in real time so that if the user starts the injection process and changes the mute switch to off, the sound is immediately muted. The mute switch 315 can also be configured to slide toward the "mute" icon to mute the audio speaker. An indicator light can be set to confirm the "mute" state.
[0071] Speed selector switch 316 ( Figure 3A and Figure 3B ) can be located in the cartridge receiving section 306 of the housing 302. The speed selector switch 316 can be configured to allow the user to select from a plurality of relative injection speed options. The relative injection speed option selected by the user can be selected in Figure 5 The speed selector switch 316 may include three switch positions. Other embodiments of the speed selector switch may include two switch positions, or 4 or more switch positions. In other embodiments, the speed selector switch may be of an infinitely variable type. The automatic injector 300 may also be provided with one or more demonstration cassettes to allow the user to experiment as a preferred injection speed by selecting different relative injection speed options.
[0072] A start button 307 may be provided at the free end of the handle 305. The button 307 may be made of a translucent material that allows a lighting effect to illuminate the button as a signal. Figure 3D ) can be located in the cartridge receiving section 306 of the housing 302. In some embodiments, the eject button 317 can be controlled by the microprocessor 350 ( Figure 3G ) control, the microprocessor can be programmed to eliminate accidental inputs during the injection process.
[0073] refer to Figure 3E , the cartridge receiving section 306 and the cartridge door 308 of the housing 302 can form a proximal wall 318 of the auto-injector 300. The proximal wall 318 can be configured as a broad, flat, and stable base to easily position the auto-injector 300 on a support surface after the shield remover 240 is removed or when the auto-injector 300 does not accommodate the cartridge 240. The portion of the proximal wall 318 formed by the cartridge door 308 can include an aperture 308A that is sized and shaped to allow the shield remover 240 to be removed from the cartridge 200 and withdrawn through the aperture 308A when the cartridge 200 is installed in the auto-injector 300. The proximal wall of the auto-injector 300 can further include a target light 320.
[0074] like Figure 3G As shown, various embodiments of the automatic injector 300 may include a base 301 disposed in a housing 302 for supporting an electric needle insertion driver 330, an electric driver 340, a microprocessor 350, a battery 360 for powering the drivers 330, 340, and the microprocessor 350, and a skin sensor 380. The housing 302 may define an ergonomically shaped handle section 304 and a cartridge receiving section 306. The base 301 may include a support surface 301s for supporting one or more cartridges 200 in the automatic injector 300 and aligning the cartridge 200 or a selected one of the one or more cartridges 200 with the electric drivers 330 and 340, respectively.
[0075] Detector 370 (ie, reader) may be disposed on or in cartridge support surface 301s for sensing the presence of cartridge 200 and / or information about the cartridge. Figure 1 The communication module 152 described above corresponds to and can be used to perform the same functions. In particular, the detector 370 can be used to read the identifier 211 of the cassette 200, which will be discussed in more detail below. The detector 370 can be coupled to the microprocessor 350 (i.e., the controller 350) in a manner that allows signals or data to be communicated to the microprocessor 350. The microprocessor 350 and the controller 350 are connected to each other. Figure 1The controller 150 described corresponds and may be used to perform the same functions.
[0076] The insertion driver 330 may include an insertion rack 332, an insertion drive motor 331, and an insertion drive gear train 333 for transmitting the rotational motion of the insertion drive motor 331 to drive the rack 332. The insertion rack may include a tab arrangement including, for example, a proximal tab 332p and a distal tab 332d that dock with the cartridge 200, respectively. The driver 340 may include a drive motor 341, a plunger rod 342, a lead screw 343, and a drive gear train 344. The plunger rod 342 is driven by the drive motor 341 through the lead screw 343 and the drive gear train 344, and may dock with the plunger 264 of the drug container 260 housed in the cartridge 200. The automatic injector 300 may be used to perform multiple injections.
[0077] Still reference Figure 3G , the microprocessor 350 of the automatic injector 300 may be programmed with instructions that, when executed by the microprocessor 350, enable it to control and monitor various operations and functions of the automatic injector 300. For example, but not limited to, the microprocessor 350 may be programmed with instructions for controlling the drivers 330, 340. Specifically, the microprocessor 350 may be programmed with instructions to implement the following regarding Figure 5 Describe the decision logic.
[0078] In various other embodiments, the automatic injector 300 can include other types of drivers and means for starting and sorting the driver. In such embodiments, the driver can be implemented as a separate and different mechanism or combined into a single mechanism. The driver of such embodiments can be powered by a motor, a mechanical mechanism (e.g., an elastic member such as a spring), a pneumatic mechanism, a gas release mechanism, or any combination thereof without restriction. Various transmission mechanisms can be used to transfer power to the cassette to cause the injection of the medicine. In addition, starting and sorting means can include various mechanical and electromechanical arrangements, which can be combined with the microprocessor described above or used alone. In such embodiments, the automatic injector can be configured to be reusable in order to perform multiple injections, or be designed to be used for single disposable use.
[0079] Reference now Figure 4, various embodiments of the cassette 200 may include an outer housing 210, an inner sleeve 220, a drug container 260 for containing a drug, a cassette cap 240, a locking cap 230, and a cover 250. Such embodiments of the cassette 200 facilitate and enable easy injection of the drug using an automatic syringe, and may be configured for single-time disposable use. In various embodiments, the locking cap 230 and the cover 250 of the cassette 200 may be configured to resist removal of the drug container 260 from the cassette 200, thereby preventing needle sticks before and after use of the cassette 200, and also preventing the drug container 260 from being removed or replaced from the cassette 200. In addition, the locking cap 230 and the cover 250 protect the drug container 260 during shipment and transportation. In various embodiments, the cassette cap 240 may be configured to remove the needle shield 266 covering the injection needle associated with the drug container 260. In various other embodiments, the cassette cap 240 may also be configured to engage the outer housing 210 of the cassette 200 so that the cassette cap 240 cannot rotate or twist, thereby preventing the needle shield 266 from damaging the injection needle. Various embodiments of the inner sleeve 220 may be configured to position the drug container 260 in the needle hiding position or the needle injection position within the cassette housing 210 during an injection cycle of the auto-injector. In various other embodiments, the outer housing 210 and the inner sleeve 220 of the cassette 200 may include one or more locking arrangements that protect the drug container 260 and prevent accidental needle exposure or damage.
[0080] The cassette 200 may include an identifier 211 on the outer shell 210. The identifier 211 may be placed so that when the cassette 200 is placed in the automatic injector 300, the identifier 211 can be read by the detector 370. The identifier 211 may be, for example, a QR code, an RFID tag, or an NFC tag. The identifier 211 specifies the drug contained in the cassette 200. The identifier 211 may also include drug information associated with a specific drug contained in the cassette 200. For example, the identifier may provide drug information, including but not limited to viscosity (at room temperature or multiple viscosities associated with different temperatures), dosage volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
[0081] Figure 5A method 500 for injecting a drug within a customized injection time using an automatic injector (such as the automatic injector 300 or the drug delivery device 102) is shown. At frame 502, the method 500 includes identifying a drug contained in a reservoir of a drug delivery system, which can be based on reading drug information by a reader of the drug delivery system. At frame 504, the method 500 includes calculating or determining an acceptable injection time range for the identified drug. At frame 506, the method 500 includes receiving a preferred injection speed from an input device of the drug delivery system. At frame 508, the method 500 includes determining a customized injection time within an acceptable injection time range, which can be based on the preferred injection speed. At frame 510, the method 500 includes setting a delivery speed of a driver of the drug delivery system so that the drug is discharged from the reservoir within the customized injection time.
[0082] At block 504, calculating or determining an acceptable injection time range for the identified drug may include receiving drug information from an identifier on the reservoir. Alternatively or additionally, at block 504, calculating or determining an acceptable injection time range for the identified drug may include accessing a drug information data set provided in a memory of the controller, determining that the identified drug is a possible drug in a list of possible drugs, and receiving drug information associated with the identified drug in the drug information data set. Either way, the drug information may include at least one of the following: viscosity, dose volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
[0083] The method 500 may also include: presenting two or more relative injection speed options, each relative injection speed option being equal to a percentage of the longest possible injection time within an acceptable injection time range; allowing selection of one of the two or more relative injection speed options; and using the relative injection speed option selected as the preferred injection speed. Each of the two or more relative injection speed options may be displayed as one of a written adjective, a percentage of the longest possible injection, and a point on a sliding scale. The method 500 may also include causing an input device to display the two or more relative injection speed options on a touch screen. Alternatively or additionally, selecting one of the two or more relative injection speed options may include associating the two or more relative injection speeds with a unique physical button of the drug delivery device. Identifying a drug contained in a reservoir of the drug delivery system based on a reading by a reader of the drug delivery system may include reading an RFID tag or an NFC tag.
[0084] It will be understood that the elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative position of some elements in the figure may be enlarged relative to other elements to help improve the understanding of multiple different embodiments of the present invention. Moreover, commonly used but easy-to-understand elements that are available or necessary in commercially feasible embodiments are usually not drawn to facilitate viewing these multiple different embodiments with less obstruction. The same reference numerals may be used to describe the same or similar parts. Further, although several examples have been disclosed herein, any feature from any example can be combined with other features from other examples or replaced by other features. In addition, although several examples have been disclosed herein, the disclosed examples may be changed without departing from the scope of the claims.
[0085] The above description describes various drug delivery devices and methods for drug delivery devices. It should be clear that the drug delivery device or method may further include the use of the following listed medicaments, but it should be noted that the following list should not be considered to be all-inclusive or limiting. The medicament will be contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the medicament for treatment. The primary container can be a cartridge or a pre-filled syringe.
[0086] For example, the drug delivery device, or more specifically the reservoir of the device, may be filled with a colony stimulating factor, such as granulocyte colony stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to (filgrastim) and (Pegfilgrastim). In various other embodiments, the drug delivery device can be used with various pharmaceutical products such as erythropoiesis stimulating agents (ESAs), which can be in liquid or lyophilized form. ESAs are any molecules that stimulate erythropoiesis, such as (epoetin α), (darbepoetin α), (Epoetine δ), (methoxy polyethylene glycol-epoetin beta), MRK-2578, INS-22, (Epoetin ζ), (Epoetin β), (Epoetin ζ), (Epoetin α), Epoetin α Hexal, (Epoetin α), (Epoetine θ), (Epoetine θ), and PCT Publication Nos. WO 91 / 05867, WO 95 / 05465, WO 96 / 40772, WO 00 / 24893, WO 01 / 24894, and WO 02 / 06666. 01 / 81405; and WO 2007 / 136752.
[0087] The ESA can be an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding and causing dimerization of the receptor). Erythropoiesis stimulating proteins include erythropoietin and its variants, analogs or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, epoetin alpha, epoetin beta, epoetin delta, epoetin omega, epoetin Epoetin zeta and its analogs, pegylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1 / hematide) and mimetic antibodies. Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind to and activate erythropoietin receptors (and include compounds reported in U.S. Publication Nos. 2003 / 0215444 and 2006 / 0040858, the disclosures of each of which are incorporated herein by reference in their entirety), and erythropoietin molecules or variants or analogs thereof as disclosed in the following patents or patent applications (each of which is incorporated herein by reference in its entirety): U.S. Patent Nos. 4,703,008; 5,441,868; 5,547,933; 5 ,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,830,851; 5,856,298; 5,986,047; 6,030,086; 6,310,078; 6,391,633; 6,583,272; 6,586,398; 6,900,292; 6,750,369; 7,030,226; 7,084,245; and 7,217,689; U.S. Publication Nos. 2002 / 0155998; 2003 / 0077753; 2003 / 0082749;2003 / 0143202;2004 / 0009902;2004 / 0071694;2004 / 0091961;2004 / 0143857;2004 / 0157293;2004 / 0175379;2004 / 0175824;2004 / 0229318;2004 / 0248815;2004 / 0266690;2005 / 0019914;2005 / 0026834;2005 / 0096461;2005 / 0107297;2005 / 0107591;2005 / 01 2005 / 0124564; 2005 / 0137329; 2005 / 0142642; 2005 / 0143292; 2005 / 0153879; 2005 / 0158822; 2005 / 0158832; 2005 / 0170457; 2005 / 0181359; 2005 / 0181482; 2005 / 0192211; 2005 / 0202538; 2005 / 0227289; 2005 / 0244409; 2006 / 0088906; and 2006 / 0111279; and PCT Publication No. WO 91 / 05867;WO95 / 05465;WO 99 / 66054;WO 00 / 24893; WO 01 / 81405; WO 00 / 61637; WO 01 / 36489; WO 02 / 014356; WO 02 / 19963; WO 02 / 20034; WO 02 / 49673; WO 02 / 085940; WO 03 / 029291; WO 2003 / 055526; WO 2003 / 084477; WO 2003 / 094858; WO 2004 / 002417; WO 2004 / 002424; WO 2004 / 009627; WO 2004 / 024761; WO 2004 / 033651; WO 2004 / 035603;WO 2004 / 043382; WO 2004 / 101600; WO 2004 / 101606; WO 2004 / 101611; WO 2004 / 106373; WO 2004 / 018667; WO 2005 / 001025; WO 2005 / 001136; WO 2005 / 021579; WO 2005 / 025606; WO 2005 / 032460; WO 2005 / 051327; WO2005 / 063808; WO 2005 / 063809; WO 2005 / 070451; WO 2005 / 081687; WO 2005 / 084711;WO 2005 / 103076; WO 2005 / 100403; WO 2005 / 092369; WO 2006 / 50959; WO 2006 / 02646; and WO 2006 / 29094. ;
[0088] Examples of other pharmaceutical products for use with the device may include, but are not limited to, antibodies, e.g. (panitumumab), XgevaT M (denosumab) and ProliaT M (denosamab); other biologics, such as (etanercept, TNF receptor / Fc fusion protein, TNF blocker), (Pegfilgrastim, Pegylated filgrastim, Pegylated G-CSF, Pegylated hu-Met-G-CSF), (filgrastim, G-CSF, hu-MetG-CSF) and (romiplostim); small molecule drugs, such as (Cinacalcet). The device can also be used with therapeutic antibodies, peptides, proteins or other chemicals such as iron, for example, nano iron oxide (ferumoxytol), iron dextran, iron gluconate and iron sucrose. The pharmaceutical product can be in liquid form, or can be reconstituted from a lyophilized form.
[0089] Specific illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof:
[0090] OPGL-specific antibodies, peptibodies and related proteins, etc. (also referred to as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, in particular fully humanized monoclonal antibodies, including but not limited to the antibodies described in PCT Publication No. WO 03 / 002713 (the patent is incorporated herein in its entirety with respect to aspects of OPGL-specific antibodies and antibody-related proteins), in particular those having the sequences described therein, in particular but not limited to those specified therein: 9H7; 18B2; 2D8; 2E11; 16E1; and 22B3, including those having sequences such as Figure 2 The light chain of SEQ ID NO: 2 shown in and / or Figure 4 OPGL-specific antibodies having a heavy chain of SEQ ID NO: 4 as shown in , each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the above-mentioned publications;
[0091] Myostatin binding proteins, peptibodies and related proteins, etc., including myostatin-specific peptibodies, particularly those described in U.S. Publication No. 2004 / 0181033 and PCT Publication No. WO 2004 / 058988 (which are incorporated herein by reference in their entirety), particularly in the portion related to myostatin-specific peptibodies, including but not limited to peptibodies of the mTN8-19 family, including those having SEQ ID NOS: 305-351, including TN8-19-1 to TN8-19-40, TN8-19con1 and TN8-19con2; peptibodies of the mL2 family of SEQ ID NOS: 357-383; mL15 family of SEQ ID NOS: 384-409; mL17 family of SEQ ID NOS: 410-438; mL20 family of SEQ ID NOS: 439-446; mL21 family of SEQ ID NOS: 447-452; mL24 family with SEQ ID NOS: 453-454; and those with SEQ ID NOS: 615-631, each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the above-mentioned publications;
[0092] IL-4 receptor specific antibodies, peptibodies and related proteins and the like, particularly those that inhibit activity mediated by binding of IL-4 and / or IL-13 to the receptor, including those described in PCT Publication No. WO 2005 / 047331 or PCT Application No. PCT / US2004 / 37242 and U.S. Publication No. 2005 / 112694 (which are incorporated herein by reference in their entirety, particularly in relation to IL-4 receptor specific antibodies), particularly antibodies as described therein, particularly but not limited to those specified therein: L1H1; L1H2; L1H3; L1H4; L1H5; L1H6; L1H7 ; L1H8; L1H9; L1H10; L1H11; L2H1; L2H2; L2H3; L2H4; L2H5; L2H6; L2H7; L2H8; L2H9; L2H10; L2H11; L2H12; L2H13; L2H14; L3H1; L4H1; L5H1; L6H1, each of which is individually and specifically incorporated herein by reference in its entirety as fully disclosed in the aforementioned publications;
[0093] Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies and related proteins, etc., including but not limited to those described in U.S. Publication No. 2004 / 097712 (which patent is incorporated herein by reference in its entirety, in part relating to IL1-R1 specific binding proteins), particularly monoclonal antibodies, especially but not limited to those specified therein: 15CA, 26F5, 27F2, 24E12 and 10H7, each of which is individually and specifically incorporated herein by reference in its entirety exactly as disclosed in the aforementioned publication;
[0094] Ang2-specific antibodies, peptibodies and related proteins, etc., including but not limited to those described in PCT Publication No. WO 03 / 057134 and U.S. Publication No. 2003 / 0229023 (each of which is incorporated herein by reference in its entirety, particularly in relation to the portions related to Ang2-specific antibodies and peptibodies, etc.), particularly those having the sequences described therein and including but not limited to: L1(N); L1(N)WT; L1(N)1K WT; 2xL1(N); 2xL1(N)WT; Con4(N), Con4(N)1K WT, 2xCon4(N)1K; L1C; L1C 1K; 2xL1C; Con4C; Con4C 1K; 2xCon4C 1K; Con4-L1(N); Con4-L1C; TN-12-9(N); C17(N); TN8-8(N); TN8-14(N); Con 1(N); also including anti-Ang 2 antibodies and formulations, such as those described in PCT Publication No. WO 2003 / 030833 (which is incorporated herein by reference in its entirety), particularly Ab526; Ab528; Ab531; Ab533; Ab535; Ab536; Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558; Ab559; Ab565; AbF1AbFD; AbFE; AbFJ; AbFK; AbG1D4; AbGC1E8; AbH1C12; AblA1; AblF; AblK; AblP; and AblP, in the various permutations thereof described therein, each of which is individually and specifically incorporated herein by reference in its entirety as fully disclosed in the aforementioned publication;
[0095] NGF-specific antibodies, peptibodies and related proteins, etc., specifically including but not limited to those described in U.S. Publication No. 2005 / 0074821 and U.S. Pat. No. 6,919,426 (which patents are incorporated herein by reference in their entirety, particularly with respect to NGF-specific antibodies and related proteins), and in this regard specifically including but not limited to the NGF-specific antibodies designated therein as 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11, each of which is individually and specifically incorporated herein by reference in its entirety as fully disclosed in the aforementioned publications;
[0096] CD22-specific antibodies, peptibodies and related proteins, etc., such as those described in U.S. Pat. No. 5,789,554 (which is incorporated herein by reference in its entirety with respect to CD22-specific antibodies and related proteins), in particular human CD22-specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, in particular including but not limited to human CD22-specific IgG antibodies, such as, for example, a disulfide-linked dimer of a human-mouse monoclonal hLL2 γ-chain and a human-mouse monoclonal hLL2 κ chain, including but not limited to, for example, the human CD22-specific fully humanized antibody in Epratuzumab, CAS Registry No. 501423-23-0;
[0097] IGF-1 receptor specific antibodies, peptibodies and related proteins, etc., such as those described in PCT Publication No. WO 06 / 069202 (which patent is incorporated herein by reference in its entirety regarding IGF-1 receptor specific antibodies and related proteins), including but not limited to those designated as L1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20, L21H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27, L28H28, L29H30, L31H31, L32H32, L33H33, L34H34, L35H35, L36H36, L37H37, L38H38, L39H40, L40H41, L41H42, L42H43, L43H44, L44H45 22. L23H23, L24H24, L25H25, L26H26, L27H27, L28H28, L29H29, L30H30, L31H31, L32H32, L33H33, L34H34, L35H35, L36H36 , L37H37, L38H38, L39H39, L40H40, L41H41, L42H42, L43H43, L44H44, L45H45, L46H46, L47H47, L48H48, L49H49, L50H50, L5 IGF-1-specific antibodies of 1H51, L52H52, and IGF-1R binding fragments and derivatives thereof, each of which is individually and specifically incorporated herein by reference in its entirety exactly as disclosed in the aforementioned publications;
[0098] Also included among non-limiting examples of anti-IGF-1R antibodies useful in the methods and compositions of the invention are each and all of the following:
[0099] U.S. Publication Nos. 2006 / 0040358 (published on February 23, 2006), 2005 / 0008642 (published on January 13, 2005), and 2004 / 0228859 (published on November 18, 2004), including, but not limited to, for example, Antibody 1A (DSMZ Accession No. DSM ACC 2586), Antibody 8 (DSMZ Accession No. DSM ACC 2589), Antibody 23 (DSMZ Accession No. DSM ACC2588), and Antibody 18 described therein;
[0100] PCT Publication Nos. WO 06 / 138729 (published December 28, 2006) and WO 05 / 016970 (published February 24, 2005), and Lu et al. (2004), J. Biol. Chem. 279:2856-2865, including but not limited to antibodies 2F8, A12 and IMC-A12 as described therein;
[0101] PCT Publication Nos. WO 07 / 012614 (published February 1, 2007), WO 07 / 000328 (published January 4, 2007), WO 06 / 013472 (published February 9, 2006), WO 05 / 058967 (published June 30, 2005), and WO 03 / 059951 (published July 24, 2003);
[0102] U.S. Publication No. 2005 / 0084906 (published April 21, 2005), including but not limited to antibody 7C10, chimeric antibody C7C10, antibody h7C10, antibody 7H2M, chimeric antibody *7C10, antibody GM 607, humanized antibody 7C10 variant 1, humanized antibody 7C10 variant 2, humanized antibody 7C10 variant 3, and antibody 7H2HM as described therein;
[0103] U.S. Publication Nos. 2005 / 0249728 (published November 10, 2005), 2005 / 0186203 (published August 25, 2005), 2004 / 0265307 (published December 30, 2004), and 2003 / 0235582 (published December 25, 2003), and Maloney et al. (2003), Cancer Res. 63:5073-5083, including but not limited to the antibodies EM164, resurfaced EM164, humanized EM164, huEM164 v1.0, huEM164 v1.1, huEM164 v1.2, and huEM164 v1.3 as described therein;
[0104] U.S. Patent No. 7,037,498 (issued May 2, 2006), U.S. Publication Nos. 2005 / 0244408 (published November 30, 2005) and 2004 / 0086503 (published May 6, 2004), and Cone et al. (2005), Clinical Cancer Res. 11: 2063-2073, such as antibody CP-751,871, including but not limited to each antibody produced by hybridomas having ATCC Accession Nos. PTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793 as described therein, and antibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and 4.17.3;
[0105] U.S. Publication Nos. 2005 / 0136063 (published June 23, 2005) and 2004 / 0018191 (published January 29, 2004), including but not limited to antibody 19D12 as described therein and an antibody comprising a heavy chain encoded by a polynucleotide in plasmid 15H12 / 19D12HCA(γ4) (deposited with ATCC under No. PTA-5214) and a light chain encoded by a polynucleotide in plasmid 15H12 / 19D12LCF(κ) (deposited with ATCC under No. PTA-5220); and
[0106] U.S. Publication No. 2004 / 0202655 (published Oct. 14, 2004), including but not limited to antibodies PINT-6A1, PINT-7A2, PINT-7A4, PINT-7A5, PINT-7A6, PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3, PINT-11A4, PINT-11A5, PINT-11A7, PINT-11A12, PINT-12A1, PINT-12A2, PINT-12A3, PINT-12A4, and PINT-12A5 as described therein; each and all of which are incorporated herein by reference in their entirety, particularly with respect to the foregoing antibodies, peptibodies, and related proteins, etc., that target the IGF-1 receptor;
[0107] B-7 related protein 1 specific antibodies, peptibodies, related proteins, etc. ("B7RP-1", also referred to in the literature as B7H2, ICOSL, B7h and CD275), in particular B7RP-specific fully human monoclonal IgG2 antibodies, in particular fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, especially those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells, in particular in all of the above aspects, those disclosed in U.S. Publication No. 2008 / 0166352 and PCT Publication No. WO 07 / 011941 (which are incorporated herein by reference in their entirety) for such antibodies and related proteins, including but not limited to the following antibodies designated therein: 16H (wherein having light chain variable sequence and heavy chain variable sequence of SEQ ID NO: 1 and SEQ ID NO: 7, respectively); 5D (wherein having light chain variable sequence and heavy chain variable sequence of SEQ ID NO: 2 and SEQ ID NO: 9, respectively); 2H (wherein having light chain variable sequence and heavy chain variable sequence of SEQ ID NO: 1 and SEQ ID NO: 10, respectively); NO:3 and SEQ ID NO:10); 43H (wherein the light chain variable sequence and the heavy chain variable sequence are SEQ ID NO:6 and SEQ ID NO:14, respectively); 41H (wherein the light chain variable sequence and the heavy chain variable sequence are SEQ ID NO:5 and SEQ ID NO:13, respectively); and 15H (wherein the light chain variable sequence and the heavy chain variable sequence are SEQ ID NO:4 and SEQ ID NO:12, respectively), each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the above-mentioned publications;
[0108] IL-15 specific antibodies, peptibodies and related proteins, etc., such as, in particular, humanized monoclonal antibodies, in particular, such as those disclosed in U.S. Publication Nos. 2003 / 0138421, 2003 / 023586, and 2004 / 0071702; and U.S. Pat. No. 7,153,507 (each of which is incorporated herein by reference in its entirety with respect to aspects of IL-15 specific antibodies and related proteins (including peptibodies)), in particular including, for example, but not limited to, HuMax IL-15 antibodies and related proteins, such as, for example, 146B7;
[0109] IFNγ-specific antibodies, peptibodies and related proteins, etc., especially human IFNγ-specific antibodies, in particular fully human anti-IFNγ antibodies, such as those described in U.S. Publication No. 2005 / 0004353 (the patent is incorporated herein by reference in its entirety for aspects of IFNγ-specific antibodies), in particular, for example, antibodies designated therein as 1118; 1118*; 1119; 1121; and 1121*. The complete sequences of the heavy and light chains of each of these antibodies, as well as the sequences of their heavy and light chain variable regions and complementary determining regions, are each fully as disclosed in the aforementioned publications and Thakur et al. (1999), Mol. Immunol. [Molecular Immunology] 36: 1107-1115, and are individually and specifically incorporated herein by reference in their entirety. In addition, the description of the properties of these antibodies provided in the aforementioned publications is also incorporated herein by reference in their entirety. Specific antibodies include those having a heavy chain of SEQ ID NO: 17 and a light chain of SEQ ID NO: 18; those having a heavy chain variable region of SEQ ID NO: 6 and a light chain variable region of SEQ ID NO: 8; those having a heavy chain of SEQ ID NO: 19 and a light chain of SEQ ID NO: 20; those having a heavy chain variable region of SEQ ID NO: 10 and a light chain variable region of SEQ ID NO: 12; those having a heavy chain of SEQ ID NO: 32 and a light chain of SEQ ID NO: 20; those having a heavy chain variable region of SEQ ID NO: 30 and a light chain variable region of SEQ ID NO: 12; those having a heavy chain sequence of SEQ ID NO: 21 and a light chain sequence of SEQ ID NO: 22; those having a heavy chain variable region of SEQ ID NO: 14 and a light chain variable region of SEQ ID NO: 16; those having a heavy chain of SEQ ID NO: 21 and a light chain of SEQ ID NO: 33; and those having a heavy chain variable region of SEQ ID NO: 14 and a light chain variable region of SEQ ID NO: 21. NO:31, as disclosed in the aforementioned publication. The intended specific antibody is antibody 1119 as disclosed in the aforementioned U.S. publication, which has a complete heavy chain of SEQ ID NO:17 as disclosed therein, and has a complete light chain of SEQ ID NO:18 as disclosed therein;
[0110] TALL-1 specific antibodies, peptibodies and related proteins, and the like, and other TALL specific binding proteins, such as those described in U.S. Publication Nos. 2003 / 0195156 and 2006 / 0135431 (each of which is incorporated herein by reference in its entirety with respect to aspects of TALL-1 binding proteins), particularly the molecules in Table 4 and Table 5B, each of which is individually and specifically incorporated herein by reference in its entirety exactly as disclosed in the aforementioned publications;
[0111] Parathyroid hormone ("PTH")-specific antibodies, peptibodies, and related proteins, etc., such as those described in U.S. Pat. No. 6,756,480 (which is hereby incorporated by reference in its entirety, particularly with respect to proteins that bind PTH);
[0112] Thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, and related proteins, etc., such as those described in U.S. Pat. No. 6,835,809 (which is hereby incorporated by reference in its entirety, particularly with respect to proteins that bind to TPO-R);
[0113] Hepatocyte growth factor ("HGF") specific antibodies, peptibodies and related proteins, etc., including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF) as described in U.S. Publication No. 2005 / 0118643 and PCT Publication No. WO 2005 / 017107, huL2G7 as described in U.S. Patent No. 7,220,410, and OA-5d5 as described in U.S. Patent Nos. 5,686,292 and 6,468,529 and PCT Publication No. WO 96 / 38557, each of which is hereby incorporated by reference in its entirety, particularly with respect to portions that relate to proteins that bind HGF;
[0114] TRAIL-R2-specific antibodies, peptibodies, related proteins, and the like, such as those described in U.S. Pat. No. 7,521,048 (which is hereby incorporated by reference in its entirety, particularly with respect to portions relating to proteins that bind TRAIL-R2);
[0115] Activin A-specific antibodies, peptibodies, related proteins, etc., including but not limited to those described in U.S. Publication No. 2009 / 0234106 (which is incorporated herein by reference in its entirety, particularly with respect to the portions related to proteins that bind to activin A);
[0116] TGF-β-specific antibodies, peptibodies, related proteins, and the like, including, but not limited to, those described in U.S. Pat. No. 6,803,453 and U.S. Publication No. 2007 / 0110747 (each of which is hereby incorporated by reference in its entirety, particularly with respect to portions relating to proteins that bind TGF-β);
[0117] Amyloid-β protein-specific antibodies, peptibodies, related proteins, etc., including but not limited to those described in PCT Publication No. WO2006 / 081171 (which is incorporated herein by reference in its entirety, particularly in relation to the portion relating to proteins that bind to amyloid-β protein). One antibody contemplated is an antibody having a heavy chain variable region comprising SEQ ID NO: 8 and a light chain variable region comprising SEQ ID NO: 6 as disclosed in the above publication;
[0118] c-Kit-specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2007 / 0253951 (which is incorporated herein by reference in its entirety, particularly with respect to portions relating to proteins that bind to c-Kit and / or other stem cell factor receptors);
[0119] OX40L-specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2006 / 0002929 (which is incorporated herein by reference in its entirety, particularly with respect to proteins that bind to OX40L and / or other ligands of the OX40 receptor); and
[0120] Other exemplary proteins include (alteplase, tPA); (darbepoetin alfa); (epoetin alfa, or erythropoietin); GLP-1, (interferon beta-1a); (tositumomab, anti-CD22 monoclonal antibody); (interferon-β); (alemtuzumab, anti-CD52 monoclonal antibody); (Epoetin delta); (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); (etanercept, TNF receptor / Fc fusion protein, TNF blocker); (Epoetin alpha); (cetuximab, anti-EGFR / HER1 / c-ErbB-1); (Somatropin, human growth hormone); (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); (Somatropin, human growth hormone); (adalimumab); insulin in solution; (interferon alfacon-1); (Nesiritide; recombinant human B-type natriuretic peptide (hBNP)); (Anakinra); (sargramostim, rhuGM-CSF); (epatuzumab, anti-CD22 mAb); Benlysta TM (lymphostat B, belimumab, anti-BlyS mAb); (tenecteplase, a t-PA analog); (methoxypolyethylene glycol-epoetin beta); (gemtuzumab ozogamicin); (efalizumab); (certolizumab pegol, CDP 870); Soliris TM (eculizumab); pexelizumab (anti-C5 complement); (MEDI-524); (ranibizumab); (17-1A, edrecolomab); (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); (IDM-1); (B43.13); (viciluzumab); cantuzumabmertansine (huC242-DM1); (Epoetin beta); (Opreleukin, human interleukin-11); (pegylated filgrastim, pegylated G-CSF, pegylated hu-Met-G-CSF); (filgrastim, G-CSF, hu-MetG-CSF); Orthoclone (Muromonab-CD3, anti-CD3 monoclonal antibody); (Epoetin alpha); (infliximab, anti-TNFα monoclonal antibody); (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); (anti-IL6 receptor mAb); (bevacizumab), HuMax-CD4 (zanolimumab); (rituximab, anti-CD20 mAb); (erlotinib); (interferon alfa-2a); (basiliximab); (lumiracoxib); (palivizumab); 146B7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); (natalizumab, anti-α4 integrin mAb); (MDX-1303, anti-anthrax protective antigen mAb); ABthrax TM ; (panitumumab); (omalizumab); ETI211 (anti-MRSA mAb); IL-1trap (Fc portion of human IgG1 and extracellular domain of IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc); (daclizumab); (daclizumab, anti-IL-2Rα mAb); (ibritumomab tiuxetan); (ezetimibe); (atacicept, TACI-Ig); anti-CD80 mAb (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage I fibrinogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-1103); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2RamAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001);Anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; anti-ZP3 mAb (HuMax-ZP3); NVS antibody #1; and NVS antibody #2.
[0121] A sclerostin antibody may also be included, such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis). A therapeutic agent may further be included, such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX, or XGEVA. In addition, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / Kexin type 9 (PCSK9) may also be included in the device. Such PCSK9-specific antibodies include but are not limited to (evolocumab) and (alirocumab) and molecules, variants, analogs or derivatives thereof as disclosed in the following patents or patent applications, each of which is incorporated herein by reference in its entirety for all purposes: U.S. Patent No. 8,030,547, U.S. Publication No. 2013 / 0064825, WO 2008 / 057457, WO 2008 / 057458, WO 2008 / 057459, WO 2008 / 063382, WO 2008 / 133647, WO 2009 / 100297, WO 2009 / 100318, WO 2011 / 037791, WO 2011 / 053759, WO 2011 / 053783, WO 2008 / 125623, WO 2011 / 072263、WO 2009 / 055783、WO 2012 / 0544438、WO 2010 / 029513、WO 2011 / 111007、WO 2010 / 077854、WO 2012 / 088313、WO 2012 / 101251、WO 2012 / 101252, WO 2012 / 101253, WO 2012 / 109530, and WO 2001 / 031007.
[0122] Talimogin (talimogenelaherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers may also be included. Examples of oncolytic HSV include, but are not limited to, latamimogin (U.S. Pat. Nos. 7,223,593 and 7,537,924); OncoVEXGALV / CD (U.S. Pat. No. 7,981,669); OrienX010 (Lei et al. (2013), World J. Gastroenterol. [International Journal of Gastroenterology], 19: 5138-5143); G207; 1716; NV1020; NV12023; NV1034 and NV1042 (Vargehes et al. (2002), Cancer Gene Ther. [Cancer Gene Therapy], 9(12): 967-978).
[0123] TIMP is also included. TIMP is an endogenous tissue inhibitor of metalloproteinase (TIMP) and is important in many natural processes. TIMP-3 is expressed by various cells or present in the extracellular matrix; it inhibits all major cartilage-degrading metalloproteinases and can play a role in many degenerative diseases of connective tissue (including rheumatoid arthritis and osteoarthritis) as well as cancer and cardiovascular disorders. The amino acid sequence of TIMP-3 and the nucleic acid sequence of the DNA encoding TIMP-3 are disclosed in U.S. Patent No. 6,562,596 issued on May 13, 2003, and its disclosure is incorporated herein by reference. A description of TIMP mutations can be found in U.S. Publication No. 2014 / 0274874 and PCT Publication No. WO 2014 / 152012.
[0124] Also included are antagonist antibodies to human calcitonin gene-related peptide (CGRP) receptors and bispecific antibody molecules targeting CGRP receptors and other headache targets. Additional information about these molecules can be found in PCT Application No. WO2010 / 075238.
[0125] Additionally, bispecific T cell engagers can be used in this device Antibodies, e.g. (blinatumomab). Alternatively, a macromolecular APJ agonist such as apelin or an analog thereof may be included in the device. Information on such molecules may be found in PCT Publication No. WO 2014 / 099984.
[0126] In certain embodiments, the medicament comprises a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody. Examples of anti-TSLP antibodies that can be used in such embodiments include, but are not limited to, those described in U.S. Patent Nos. 7,982,016 and 8,232,372 and U.S. Publication No. 2009 / 0186022. Examples of anti-TSLP receptor antibodies include, but are not limited to, those described in U.S. Patent No. 8,101,182. In particularly preferred embodiments, the medicament comprises a therapeutically effective amount of an anti-TSLP antibody designated as A5 in U.S. Patent No. 7,982,016.
[0127] Although the drug delivery device, method and elements thereof have been described according to exemplary embodiments, they are not limited thereto. The detailed description is only interpreted as being exemplary and does not describe every possible embodiment of the present invention, because it would be impractical to describe every possible embodiment if possible. Many alternative embodiments can be implemented using current technology or technology developed after the date of this patent application, and these embodiments still fall within the scope of the claims defining the present invention. For example, the components described herein with reference to certain types of drug delivery devices (such as portable syringe drug delivery devices or other types of drug delivery devices) can also be used in other types of drug delivery devices (such as automatic syringe drug delivery devices).
[0128] Those skilled in the art will appreciate that various modifications, changes and combinations may be made to the embodiments described above without departing from the scope of the present invention, and such modifications, changes and combinations may be considered to be within the scope of the present inventive concept.
Claims
1. A drug delivery system, comprising: a reservoir suitable for containing a drug; an identifier having drug information; a drug delivery device adapted to receive the reservoir; a reader adapted to read the drug information; an actuator adapted to expel the drug from the reservoir; a controller functionally coupled to the reader and the driver, the controller being programmed to: (a) identifying a drug contained in the reservoir based on the drug information, (b) calculate or determine the acceptable time range for the administration of the identified drug, (c) determining a custom injection time within the acceptable injection time range, and (d) setting the delivery speed of the actuator so that the drug is expelled from the reservoir within the customized injection time.
2. The drug delivery system of claim 1, wherein: The controller calculates or determines the acceptable injection time range based at least in part on the medication information.
3. The drug delivery system of claim 2, wherein: The drug information includes at least one of the following: viscosity, dosage volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
4. The drug delivery system according to any one of claims 1 to 3, in, The controller includes a memory containing a drug information data set having a list of possible drugs, each possible drug being associated with drug information; and Calculating or determining the acceptable injection time range of the identified drug includes: accessing the drug information data set, determining that the identified drug is a possible drug in the possible drug list, and receiving drug information associated with the identified drug in the drug information data set.
5. The drug delivery system according to any one of claims 1 to 3, in, The drug delivery system further includes an input device functionally coupled to the controller, wherein the controller is further programmed to receive a preferred injection speed from the input device, and Wherein, the customized injection time is based on the preferred injection speed.
6. The drug delivery system of claim 5, wherein: The input device includes two or more relative injection rate options, each relative injection rate option equal to a percentage of a longest possible injection time within the acceptable injection time range, and wherein the preferred injection rate is the relative injection rate option selected using the input device.
7. The drug delivery system of claim 6, wherein: The input device includes a touch screen, and wherein the controller causes the input device to display the two or more relative injection speed options.
8. The drug delivery system according to any one of claims 6 to 7, wherein: Each of the two or more relative injection speed options is displayed as one of: a written adjective, a percentage of the longest possible injection, and a point on a sliding scale.
9. The drug delivery system of claim 6, wherein: The two or more relative injection speeds are each a distinct physical button of the drug delivery device.
10. The drug delivery system according to any one of claims 1 to 3, wherein: The identifier is an RFID tag or an NFC tag.
11. A method of preparing a drug delivery device for delivering a drug product, the method comprising: (a) identifying a drug contained in a reservoir of a drug delivery system based on a reader of the drug delivery system reading an identifier on the reservoir; (b) Calculate the acceptable injection time range for the identified drug; (c) receiving a preferred injection rate from an input device of the drug delivery system; (d) determining a customized injection time within the acceptable injection time range based on the preferred injection speed; and (e) setting a delivery speed of a driver of the drug delivery system so that the drug is expelled from the reservoir within the customized injection time.
12. The method of claim 11, wherein: Calculating an acceptable injection time range for the identified medication includes receiving medication information from an identifier on the reservoir.
13. The method of claim 12, wherein: The drug information includes at least one of the following: viscosity, dosage volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
14. The method of claim 11, wherein: Calculating an acceptable injection time range for the identified drug includes accessing a drug information data set provided in a memory of a controller of the drug delivery system, determining that the identified drug is a possible drug in a list of possible drugs, and receiving drug information associated with the identified drug in the drug information data set.
15. The method of claim 14, wherein: The drug information includes at least one of the following: viscosity, dosage volume, minimum injection time to achieve drug effect, maximum injection time to achieve drug effect, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.
16. The method of any one of claims 11 to 15, further comprising presenting two or more relative injection speed options, each relative injection speed option equal to a percentage of the longest possible injection time within the acceptable injection time range; allowing selection of one of the two or more relative injection speed options; and using the relative injection speed option selected as the preferred injection speed.
17. The method of claim 16, further comprising causing the input device to display the two or more relative injection speed options on a touch screen.
18. The method of claim 17, wherein: Each of the two or more relative injection speed options is displayed as one of: a written adjective, a percentage of the longest possible injection, and a point on a sliding scale.
19. The method of claim 16, wherein: Enabling selection of one of the two or more relative injection speed options includes associating the two or more relative injection speeds with a unique physical button of the drug delivery device.
20. The method according to any one of claims 11 to 15, wherein: Reading the identifier on the receptacle includes reading an RFID tag or an NFC tag.
