Drug delivery system with adjustable injection time, and use method

Abstract

To provide a drug delivery system that enables a user to adjust an injection time within an allowable range calculated on the basis of drug information.SOLUTION: A drug delivery device is configured to inject a drug over an injection time within an allowable range calculated on the basis of information related to the drug to be injected. Specifically, the described drug delivery device enables identification of the drug to be injected 502, calculation or determination of the allowable range of the injection time of the identified drug 504, determination of individualization injection time within the allowable range of the injection time 508, and setting of a delivery speed of a drive part such that the drug is discharged over the individualization injection time 510.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 875,716, filed July 18, 2019, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to drug delivery systems, and more particularly to drug delivery systems that allow a user to adjust infusion times within a calculated tolerance range based on drug information. [Background technology]

[0003] Prefilled hypodermic syringes offer several advantages to the home market. These advantages include the fact that prefilled syringes can be prepared with more accurate doses for each drug. Furthermore, prefilled syringes are easier to operate by simply advancing the syringe stopper. Aside from the cost of the specific drug used, prefilled syringes can also be more economically manufactured. As a result, all these advantages make prefilled syringes more commercially attractive.

[0004] Nevertheless, pre-filled syringes also have some serious drawbacks in the market. Specifically, some users may be afraid of exposed needles or feel that they are essentially unable to perform injections. Due to the aversion to exposed needles and the health and safety issues that may be associated, various types of injectors and other devices have been developed with the specific purpose of hiding needles from users and automating injection procedures to assist users in performing injections.

[0005] In particular, automatic drug delivery devices control the speed of drug driver components to accurately deliver the entire amount of drug within a predetermined injection time. A wide variety of drugs are delivered to patients by drug delivery devices, and the properties of the delivered drug, such as viscosity and dosage, affect the injection time. For some drugs, maximum and / or minimum injection times are targeted to reduce injection pain or improve drug efficacy. Patients may have personal preferences regarding injection times. For example, some patients may prefer faster injection times to quickly complete drug delivery. Other patients may find slower injection times more comfortable. Summary of the Invention [Means for solving the problem]

[0006] Some aspects of the present disclosure include a drug delivery system including 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 accept 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 release 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 range of infusion times for the identified drug, (c) determine an individualized infusion time within the acceptable range of infusion times, and (d) set a speed of the driver such that the drug is released from the reservoir for the individualized infusion time.

[0007] In some forms, the controller calculates or determines the tolerance range for the infusion time based at least in part on the drug information.

[0008] In some forms, the drug information includes at least one of viscosity, dosage, minimum infusion time to achieve efficacy, maximum infusion time to achieve efficacy, minimum infusion time to reduce injection pain, and maximum infusion time to reduce injection pain.

[0009] In some forms, the controller includes a memory containing a drug information dataset having a list of expected medications, each expected medication associated with medication information, and calculating or determining the acceptable range of infusion times for the identified medication includes accessing the drug information dataset, determining that the identified medication is a expected medication in the list of expected medications, and receiving medication information associated with the identified medication in the drug information dataset.

[0010] In some embodiments, the drug delivery system includes an input device operatively coupled to the controller, the controller being further programmed to receive a preferred infusion rate from the input device, and the individualized infusion time is based on the preferred infusion rate.

[0011] In some forms, the input device includes two or more relative infusion rate options, each relative infusion rate option equal to a percentage of the longest possible infusion time within a range of allowable infusion times, and the preferred infusion rate is the relative infusion rate option selected using the input device.

[0012] In some embodiments, the input device includes a touch screen and the controller causes the input device to display two or more relative infusion rate options.

[0013] In some forms, each of the two or more relative infusion rate options is displayed as one of a written adjective, a percentage of the longest possible infusion time, and a point on a sliding scale.

[0014] In some forms, two or more relative infusion rates are associated with each unique physical button on the drug delivery device.

[0015] In some embodiments, the identifier is an RFID tag or an NFC tag.

[0016] Another aspect of the present disclosure includes 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 the drug delivery system based on reading an identifier on the reservoir with a reader of the drug delivery system. The method may further include calculating an acceptable range of infusion times for the identified drug. The method may further include receiving a preferred infusion rate from an input device of the drug delivery system. The method may further include determining an individualized infusion time within the acceptable range of infusion times based on the preferred infusion rate. The method may further include setting a speed of a drive of the drug delivery system such that the drug is released from the reservoir over the individualized infusion time.

[0017] In some forms, calculating the tolerance range of infusion times for the identified medication includes receiving the medication information from an identifier on the reservoir.

[0018] In some forms, the drug information includes at least one of viscosity, dosage, minimum infusion time to achieve efficacy, maximum infusion time to achieve efficacy, minimum infusion time to reduce injection pain, and maximum infusion time to reduce injection pain.

[0019] In some forms, calculating the tolerance for the infusion time for the identified medication includes accessing a medication information dataset provided in a memory of the controller, determining that the identified medication is an expected medication in a list of expected medications, and receiving medication information associated with the identified medication in the medication information dataset.

[0020] In some forms, the drug information includes at least one of viscosity, dosage, minimum infusion time to achieve efficacy, maximum infusion time to achieve efficacy, minimum infusion time to reduce injection pain, and maximum infusion time to reduce injection pain.

[0021] In some forms, the method further includes presenting two or more relative infusion rate options, each relative infusion rate option equal to a percentage of the longest possible infusion time within a range of allowable infusion times, enabling selection of one of the two or more relative infusion rate options, and using the selected relative infusion rate option as the preferred infusion rate.

[0022] In some embodiments, the method further includes causing the input device to display two or more relative infusion rate options on a touch screen.

[0023] In some forms, each of the two or more relative infusion rate options is displayed as one of a written adjective, a percentage of the longest possible infusion time, and a point on a sliding scale.

[0024] In some forms, enabling selection of one of the two or more relative infusion rate options includes associating the two or more relative infusion rates with unique physical buttons on the drug delivery device.

[0025] In some embodiments, reading the identifier on the reservoir includes reading an RFID tag or an NFC tag.

[0026] The above needs are met, at least in part, by providing the embodiments described in the following detailed description, particularly when studied in conjunction with the drawings. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a schematic diagram of a drug delivery system including a drug delivery device according to various embodiments of the present invention. [Figure 2] FIG. 1 is a side elevational view of an exemplary embodiment of a drug delivery device including an autoinjector and a cassette. [Figure 3A] FIG. 3 is a front elevation view of the exemplary embodiment of the autoinjector of FIG. 2. [Figure 3B] FIG. 3B is an elevational view of a first side of the autoinjector of FIGS. 2 and 3A. [Figure 3C] FIG. 3C is a rear elevational view of the autoinjector of FIGS. 2-3B. [Figure 3D] FIG. 3D is an elevational view of a second side of the autoinjector of FIGS. 2-3C. [Figure 3E] FIG. 3E is an elevational view of a first end of the autoinjector of FIGS. 2-3D. [Figure 3F] FIG. 3C is an elevational view of a second end of the autoinjector of FIGS. 2-3F. [Figure 3G] FIG. 3B is a side cross-sectional view of the autoinjector device of FIGS. 2 to 3F. [Figure 4] FIG. 3 is an exploded perspective view of the exemplary embodiment of the cassette of FIG. 2. [Figure 5] 10 is a flowchart illustrating decision logic for infusing a drug over a personalized infusion time using an autoinjector, according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0028] Those skilled in the art will understand that elements in the figures are drawn for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially feasible embodiments are often not shown in order to unduly distract from the illustrations of these various embodiments. Furthermore, it will be appreciated that certain acts and / or steps may be described or shown in a particular chronological order, although those skilled in the art will understand that such specificity with respect to order is not actually required. It will also be understood that the terms and phrases used herein have the ordinary technical meaning, as set forth above, that would be ascribed to such terms and phrases by those skilled in the art, unless a different specific meaning is explained herein.

[0029] A drug delivery system and method is provided that allows the infusion time at which a drug is released to be personalized to suit the user's preferences within the acceptable infusion time range for the drug being infused. Patients benefit from this system by being able to tailor the infusion time to suit their personal preferences (i.e., minimize total infusion time, deliver the drug at the most comfortable rate), while still delivering the drug at an infusion time that is effective for the drug.

[0030] Referring now to the drawings, and particularly to FIG. 1 , a general example of a system 100 including a drug delivery device 102 is provided. The drug delivery device 102 may be in the form of an auto-injector, and thus is adapted for handheld use and application to a patient's skin. The drug delivery device 102 includes a housing 110 within which are disposed assemblies or structures for introducing a delivery cannula into a patient and for ejecting a drug or agent from a reservoir 112 through the delivery cannula into the patient. According to certain embodiments, the same assembly or structure for introducing the delivery cannula into a patient can also eject the drug or agent from the reservoir through the delivery cannula into the patient. The drug delivery device 102 may also include assemblies or structures for connecting the delivery cannula to a reservoir, for retracting the delivery cannula into the housing 110 through an opening (not shown) in the housing 110, or for deploying other structures to prevent contact with the delivery cannula once it is removed from the patient. Any number of additional assemblies and structures are possible. Accordingly, the specific embodiments of the drug delivery device 102 described below are examples and not limitations.

[0031] Thus, the drug delivery device 102 includes a reservoir 112 (such as a reservoir provided in cassette 200, described below) and a delivery cannula 114 having a first end 116 (e.g., a proximal end) that may be fluidly connected or connectable to 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 with a beveled edge that may be sized so that the second end 118 of the needle 114 is received under the skin to deliver a subcutaneous injection of the agent in the reservoir 112. The first end 116 of the needle 114 may be disposed through a wall 120 of the reservoir 112 and thus be fluidly connected to the reservoir 112. Alternatively, the first end 116 of the needle 114 may be disposed only partially through the wall 120 (which may be, for example, a resealable septum or stopper) such that the first end 116 of the needle 114 cannot be fluidly connected until the second end 118 of the needle 114 is inserted into the patient. Thus, in such a situation, the first end 116 of the needle 114 may be described as being fluidly connectable with the reservoir 112, although it will be understood that there are other mechanisms by which the first end 116 of the needle 114 may be, but does not, be fluidly connectable with the reservoir 112.

[0032] The drug delivery device 102 includes a shield 122 (e.g., a needle shield) that can be deployed to restrict access to the second end 118 of the needle 114 at least after the injection is completed. According to certain embodiments, the shield 122 may have a biasing element 124 (e.g., a spring) that urges the shield 122 to extend from the housing 110 such 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 activated. Indeed, according to certain embodiments of the drug delivery device 102, insertion of the needle 114 may be activated by placing the distal end 126 of the shield 122 on or against the patient's skin.

[0033] 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, e.g., so that the distal end 126 of the shield 122 extends from the housing 110 a sufficient distance to limit or prevent contact with the second end 118 of the needle 114 after the needle 114 has been removed or released from the patient's skin. In some embodiments, the lock 128 may be coupled to a controller (e.g., the controller 150 described in further detail below), which can selectively activate or deactivate the lock 128 based on different types of information about the drug delivery device 102, including operating state information, condition information, and / or identification 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 the lock 128 is deactivated by the controller 150 , the lock 128 may be configured to allow movement of the needle shield 122 relative to the housing 110 .

[0034] 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 to eject the drug or agent from the reservoir 112 through the delivery cannula 114 and into the patient. The driver 130 may include a source of pressurized gas or a source of material that undergoes a phase change, such that the exhaust gas or phase change material provides a motive force that can be applied to the reservoir 112 to eject the drug from the reservoir 112. According to other embodiments, the driver 130 may include an electromechanical system, such as a motor. Other embodiments of the driver 130 are also possible.

[0035] In one embodiment, driver 130 includes a motor controlled by controller 150, and the infusion time during which the drug is expelled may be set by controller 150. The decision logic implemented by controller 150 and driver 130 to set the infusion time is described in detail below in FIG. 5. In other embodiments, the same decision logic may be implemented by controller 150 of driver 130 that does not include a motor but instead relies on other controllable force-generating components (e.g., a pressurized gas system). Driver 130 may include various components described below with respect to driver 340 of FIG. 3G.

[0036] In one embodiment, the driver 130 is coupled to the plunger 131 and / or a stopper 132 (e.g., a wall) disposed within the reservoir 112 and is operable to move the stopper 132 distally toward the delivery cannula 114. According to such an embodiment, the stopper 132 may be a stopper attached to the distal end of the plunger 131 and received within the bore 134. The plunger 131 together with the driver 130 may move the stopper 132 within the bore 134 of the drug delivery device 102 along the longitudinal axis from the proximal end of the bore 134 to the distal end of the bore 134, thereby ejecting the medicament from the reservoir 112.

[0037] In some embodiments, the driver 130 may also cooperate with the stopper 132 and / or the bore 134 to move the reservoir 112 relative to the housing 110 in order to move the second end 118 of the needle 114 relative to the housing 110 and toward the patient. According to 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 embodiments in which the driver cooperates with the bore 134, the driver may include one component (e.g., a first spring) that cooperates with the bore 134 to move the reservoir 112 and 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 bore 134.

[0038] 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 such that the stopper 132 cannot advance and expel the medication from the reservoir 112 to the patient. In some embodiments, the lock 135 may be coupled to a controller (e.g., the 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 operational state information, condition information, and / or identification information, according to one or more of the methods described above. 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 135 may be configured to allow movement of the plunger 131 relative to the housing 110.

[0039] The driver 130 may be associated with an actuator 140. The actuator 140 may activate the controller 150, causing the driver 130 to insert the needle 114 and eject the drug from the reservoir 112 through the needle 114 into the patient. According to some embodiments, the actuator 140 may be the needle shield 122 as described above. According to other embodiments, such as the one shown in FIG. 1 , the actuator 140 may be a button that a user or patient can manually press once the drug delivery device 102 is placed on or against the patient's skin. A lock 141 may be coupled to the actuator 140, the lock 141 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., the controller 150 described in more detail below), which may selectively activate or deactivate the lock 141 based on different types of information about the drug delivery device 102, including operating status information, condition information, and / or identification 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. When activated by the actuator 140, the controller 150 may control the drive 130 according to the decision logic described with respect to FIG.

[0040] The drug delivery device 102 may also include a removable sterility 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. As shown in FIG. 1 , the signal cap 144 may be removably attached to the distal end of the housing 110. In some embodiments, the signal cap 144 may form an interference fit or a snap fit with the distal end of the housing 110. Frictional forces associated with an interference fit or a snap fit can be overcome by manually pulling the signal cap 144 away from the housing 110. When attached to the drug delivery device 102, the signal cap 144 can reduce the risk of contamination of the delivery cannula 114 and other elements disposed within the drug delivery device 102.

[0041] Additionally, the drug delivery device 102 may include a heating element 146, which is coupled to the exterior of the reservoir 112 and configured to heat the medication within the reservoir 112, for example, by conductive heating. The heating element 146 may be coupled to the controller 150 such 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 operational status information, condition information, and / or identification information. In some embodiments, the heating element 146 may include a conductive coil wound around the exterior of the reservoir 112. In other embodiments, the heating element may include a conductive coil wound around the cannula 114. Alternatively or additionally, a cooling element (not shown) may be coupled to the reservoir 112 and controllable by the controller 150 in a manner similar to the heating element 146.

[0042] The drug delivery device 102 may also include an output unit 147, coupled to the housing 110 and configured to communicate information related to the drug delivery device 102 to the patient or user. The output unit 147 may be coupled to the controller 150 such that the controller 150 can selectively activate or deactivate the output unit 147 based on different types of information related to the drug delivery device 102, including operating status information, condition information, and / or identification 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 for use 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 touchscreen. In other embodiments, the input unit 148 may be a separate device from the output unit 147, such as a keyboard or buttons.

[0043] A combination of input unit 148 and output unit 147 (such as a single touch screen) or two units 147 and 148 working together can be used to implement the decision logic described with respect to FIG. 5 and to inform the user of information calculated or received by controller 150 as part of the decision logic described with respect to FIG. 5. For example, output unit 147 may inform the user of the identified drug contained in the reservoir. Output unit 147 may display the calculated tolerance range for the identified drug and / or display relative infusion rate options to the user. Relative infusion rate options may be displayed as written adjectives (e.g., slow, medium, fast), percentages (25%, 50%, or 75% of the maximum possible infusion time), or points on a sliding scale. Input unit 146 may be used to select a preferred infusion rate (e.g., medium, 50% of the maximum possible infusion time, the midpoint on a sliding scale). In some cases, input unit 146 may have a unique physical button (such as rate select switch 316, described below) associated with each relative infusion rate option. Output unit 147 may display the preferred infusion rate selected by the user or may display the personalized infusion time determined by the controller. In some embodiments, output unit 147 may display a timer counting down from the personalized infusion time so that the user knows how much time is left until the infusion is complete.

[0044] As shown in FIG. 1 , 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, along with at least a portion of the delivery cannula 114, are disposed within the housing 110. Also disposed within the housing 110 are a controller 150, a communication module 152 (e.g., a wireless transmitter), and at least one sensor or switch. According to the embodiment shown in FIG. 1 , four sensors are included: a temperature sensor 160, a skin sensor 162, at least one orientation sensor 164, and a fingerprint sensor 165. Each of the sensors 160, 162, 164, and 165 can generate sensor data (e.g., raw or unprocessed data) regarding a respective measured characteristic or aspect of the drug delivery device 102. The sensor data can represent at least one of a condition or operating state of the drug delivery device 102. Additionally, 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 sensor data generated by the sensors 160, 162, 164, and 165 and determine the condition and / or 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 fabricated separately and combined once the components are placed within the housing 110. According to an embodiment, each electrical component may be incorporated into the structure of device 102 in association with that electrical component (e.g., sensor 162 and sensor 164 may be incorporated into shield 122). In some embodiments, controller 150, communications module 152, one or more of sensors 160, 162, 164, 165, and / or switch 166 may be packaged together within signal cap 144.

[0045] Controller 150 may include at least one processor 170 (e.g., a microprocessor) and memory 172 (e.g., random access memory (RAM), non-volatile memory such as a hard disk, flash memory, removable memory, non-removable memory, etc.). Controller 150 may also include or be coupled to a power source, such as a battery. Processor 170 may be programmed to perform the actions controller 150 is adapted to perform, and 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 at least one processor 170, may cause at least one processor 170 to perform the actions controller 150 is adapted to perform. Alternatively, controller 150 may include other circuitry that performs the actions controller 150 is adapted to perform. In particular, controller 150 may be adapted to execute the decision logic described below with respect to FIG. 5.

[0046] Communications module 152 (i.e., reader) may be any of a number of different communications modules used to receive information from a cassette (such as cassette 200, described below) having a reservoir containing the medication to be infused. For example, the communications module may be a QR code reader, an RFID tag reader, or a near field communications (NFC) reader. Communications module 152 is used to identify the medication to be infused by reading an identifier (e.g., a QR code, RFID tag, or NFC tag) provided on a cassette (such as cassette 200, described below) having a reservoir.

[0047] In some embodiments, the memory 172 of the controller 150 can store a drug dataset having a list of expected drugs, each expected drug being associated with drug information. The drug dataset may be stored in the memory 172 prior to commencing execution of any of the methods described below. The drug information may include, by way of example and without limitation, viscosity (at room temperature or various viscosities associated with various temperatures), dosage, minimum infusion time to achieve drug efficacy, maximum infusion time to achieve drug efficacy, minimum infusion time to reduce injection pain, and maximum infusion time to reduce injection pain. Using this information, the controller 150 can calculate an acceptable range of infusion times for the identified drugs, and, once a preferred infusion rate is received from the input unit 148, can determine an individualized infusion time within the acceptable range of infusion times based on the preferred infusion rate.

[0048] In other embodiments, the above-described drug information may be contained within an identifier (e.g., a QR code, RFID tag, or NFC tag) provided on a cassette having a reservoir (such as cassette 200, described below). In such embodiments, a complete drug data set is not required; only the drug information associated with the particular drug contained in the reservoir need be provided.

[0049] The temperature sensor 160 may be located in proximity to the reservoir 112 so that it can determine the temperature of the drug within the reservoir 112. Alternatively, the temperature sensor 160 may simply be located within the housing 110 so that it can determine the approximate temperature of the drug within the reservoir 112 and the drug delivery device 102 as a whole. According to one embodiment, the temperature sensor 160 may be an on-board temperature sensor 160 attached to the processor 170.

[0050] The skin sensor 162 may be attached to or associated with the shield 122 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 may be a capacitance sensor, a resistance sensor, or an inductance sensor. In accordance with the above discussion, depending on the design and operation of the drug delivery device 102 used to drive the drive unit 130, the skin sensor 162 or the switch 166 (attached to or associated with the actuator 140) may be used to determine when the drug delivery device 102 is activated or actuated. Also, signals from the skin sensor 160 may be used to determine when the drug delivery device 102 is actuated even if the shield 122 is not used as the actual actuator. The underlying assumption is that movement of the shield 122 necessarily correlates with activation of the device 102.

[0051] Orientation sensors 164, of which there may be at least two as shown, may be associated with the shield 122 (or with the portion of the housing 110 adjacent the shield 122) and the controller 150 (which may be located at the opposite end of the drug delivery device 102 or the housing 110 from the shield 122, as shown). The orientation sensors 164 may be, for example, magnetometers. In particular, the orientation sensor 164 associated with the controller 150 may be an on-board magnetometer. The orientation sensors 164 may be used to determine the orientation of the drug delivery device 102 (particularly the housing 110) relative to the injection site (or particularly relative to the placement of the drug delivery device 102 on or relative to the patient's skin).

[0052] 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, some components of the drug delivery device 102 may be located outside the drug delivery device 102.

[0053] 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. Furthermore, 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 outside the module 130 so that a user or a patient can interact with them.

[0054] Separating the controller 150, communications module 152, and other components into modules may allow the modules to be used with multiple instances of the drug delivery device 102. In this regard, the modules may be considered reusable portion / module combinations of the drug delivery device 102 (which may be referred to as the drug delivery device 102 for purposes of this disclosure), while the drug delivery device 102 may be considered disposable portions of the drug delivery device 102. By separating more expensive components into the reusable module 400 and less expensive components (including certain sensors) into the disposable drug delivery device 102, the overall cost of the autoinjector may be optimized. This arrangement of components and the drug delivery device 102 within modules may also facilitate manufacturing and sterilization of the drug delivery device 102 and the modules.

[0055] Referring to FIG. 2, an embodiment of another general example of a system 100′ is provided, which may be the same as or different from the general example of a system 100 described with respect to FIG. 1. As shown, the autoinjection system or device 100′ may include a removable cassette 200 and an autoinjector or injector 300. Various embodiments of the cassette 200 may be configured to contain a medication to be injected into a user by the autoinjector 300. In various other embodiments, the cassette 200 may be configured for use in training a user to operate the autoinjector 300 (a training cassette). The autoinjector 300 may be configured to automatically deliver an injection upon activation by a user or other person. Various embodiments of the autoinjector 300 may have a cassette door 308 that may be configured to pivot between an open position and a closed position to allow insertion of the cassette 200 into the autoinjector 300. In some embodiments, the cassette door 308 may include a “cassette” icon (not shown) that indicates the insertion entry point for the cassette 200 .

[0056] 3A-3G collectively, various embodiments of autoinjector 300 may include a casing 302 having a handle portion 304 and a cassette receiving portion 306 aligned with the handle portion 304. To assist patients with dexterity challenges, the handle portion 304 of the autoinjector casing 302 may define an ergonomically shaped handle 305 having a soft grip area 305S. The cassette receiving portion 306 includes the cassette door 308 described above. The cassette door receives the cassette 200 in an open position and aligns the cassette 200 with the drive, and aligns with other structures and components of the autoinjector 300 in a closed position. The cassette door 308 may include a "cassette" icon indicating an insertion entry point for the cassette 200. The cassette receiving portion 306 of the casing 302 may include windows 310A, 310B on its sides that align with the windows of the cassette 200 when the cassette door 308 is closed with the cassette 200 properly installed therein. In one or more embodiments, the windows 310A, 310B may be dual-layered.

[0057] 3A, 3B, 3D, and 3F, autoinjector 300 may further include a user interface 312 and an audio speaker (not shown). The audio speaker may be disposed within casing 302 and may provide various audible indicators. The audio speaker may audibly communicate with the external environment through a speaker opening 314 formed in cassette-receiving portion 306 of casing 302. The visual and audible indicators produced by user interface 312 and audio speaker may inform the user of the progress of the injection process, completion of injection, the occurrence of any errors, and other information when autoinjector 300 is ready for use.

[0058] A user interface 312 (best shown in FIG. 3A ) may be located in the cassette-receiving portion 306 of the casing 302 and provide various visual indicators. The user interface 312 corresponds to and may be used to perform the same functions as the input unit 148 and output unit 147 described with respect to FIG. 1 . For example, the user interface 312 may inform the user of the identified drug contained in the reservoir. The user interface 312 may display a calculated tolerance range for the infusion time for the identified drug and / or display relative infusion rate options to the user. The relative infusion rate options may be displayed as written adjectives (e.g., slow, medium, fast), percentages (25%, 50%, or 75% of the maximum possible infusion time), or points on a sliding scale. The user interface 312 may be used to select a preferred infusion rate (e.g., medium, 50% of the maximum possible infusion time, the midpoint on the sliding scale). (Alternatively, a preferred infusion rate may be selected using rate select switch 316, as described below.) User interface 312 may display the preferred infusion rate selected by the user or may display the personalized infusion time determined by the controller. In some embodiments, user interface 312 may display a timer counting down from the personalized infusion time so that the user knows how much time is left until the infusion is complete.

[0059] The autoinjector 300 may further include one or more of a set / mute switch 315, a speed select switch 316, a start button 307, and an eject button 317. The set / mute switch 315 (FIG. 3B) may be located in the cassette receiving portion 306 of the casing 302. The mute switch 315 allows the user to turn all synthesized sounds on and off except for error sounds and may be made to respond in real time so that the sounds are immediately muted when the user begins the injection process and turns the mute switch off. The mute switch 315 may also be made to slide toward a "mute" icon to mute the audio speaker. A light indicator may be provided to confirm the "mute" status.

[0060] A speed selector switch 316 (FIGS. 3A and 3B) may be located in the cassette receiving portion 306 of the casing 302. The speed selector switch 316 may be configured to allow a user to select from among multiple relative injection rate options. The relative injection rate option selected by the user may be used as the preferred injection rate in the decision logic described in FIG. 5. The speed selector switch 316 may include three switch positions. Other embodiments of the speed selector switch may include two switch positions or four or more switch positions. In still other embodiments, the speed selector switch may be infinitely variable. The autoinjector 300 may also include one or more demo cassettes to allow a user to experiment with selecting different relative injection rate options as the preferred injection rate.

[0061] A start button 307 may be located at the free end of the handle 305. The button 307 may be made of a translucent material that allows lighting effects to illuminate the button as a signal. An eject button 317 (FIG. 3D) may be located in the cassette receiving portion 306 of the casing 302. In some embodiments, the eject button 317 may be controlled by the autoinjector's 300 microprocessor 350 (FIG. 3G), which may be programmed to eliminate accidental input during the injection process.

[0062] 3E, the cassette receiving portion 306 and cassette door 308 of the casing 302 may form a proximal end wall 318 of the autoinjector 300. The proximal end wall 318 may be configured as a wide, flat, and stable base for easily placing the autoinjector 300 on a support surface after removal of the shield remover 240 or when the autoinjector 300 does not contain a cassette 240. The portion of the proximal end wall 318 formed by the cassette door 308 may include an aperture 308A sized and shaped to allow the shield remover 240 to be removed from the cassette 200 and ejected through the aperture 308A when the cassette 200 is installed in the autoinjector 300. The proximal end wall of the autoinjector 300 may further include a target light 320.

[0063] As shown in FIGURE 3G, various embodiments of autoinjector 300 may include a chassis 301 disposed within a casing 302 for supporting a powered needle insertion drive 330, a powered drive 340, a microprocessor 350, a battery 360 for powering drives 330, 340, and microprocessor 350, and a skin sensor 380. Casing 302 may define an ergonomically shaped handle portion 304 and a cassette receiving portion 306. Chassis 301 may include support surfaces 301s for supporting one or more cassettes 200 within autoinjector 300 and for aligning cassette 200, or a selected one of the one or more cassettes 200, with powered drive 330 and powered drive 340, respectively.

[0064] A detector 370 (i.e., a reader) may be provided on or within the cassette support surface 301s for detecting the presence of and / or information about the cassette 200. The detector 370 corresponds to the communication module 152 described with reference to FIG. 1 and may be used to perform the same functions. In particular, the detector 370 may be used to read the identifier 211 of the cassette 200, as will be described in more detail below. The detector 370 may be coupled to the microprocessor 350 (i.e., the controller 350) to enable it to transmit signals or data to the microprocessor 350. The microprocessor 350 corresponds to the controller 150 described with reference to FIG. 1 and may be used to perform the same functions.

[0065] The insertion driver 330 may include an insertion rack 332, an insertion driver motor 331, and an insertion driver gear train 333 for transmitting the rotational motion of the insertion driver motor 331 to drive the rack 332. The insertion rack may include a tab configuration, for example, including proximal and distal tabs 332p and 332d, respectively, that mates with the cassette 200. The driver 340 may include a driver motor 341, a plunger rod 342, a lead screw 343, and a driver gear train 344. The plunger rod 342 is driven by the driver motor 341 via the lead screw 343 and the driver gear train 344 and may be coupled to a plunger 264 of a medication container 260 contained within the cassette 200. The autoinjector 300 may be used to perform multiple injections.

[0066] 3G, the microprocessor 350 of the autoinjector 300 may be programmed with instructions that, when executed by the microprocessor 350, allow for the control and monitoring of various operations and functions of the autoinjector 300. For example, but not by way of limitation, the microprocessor 350 may be programmed with instructions for controlling the drives 330, 340. Specifically, the microprocessor 350 may be programmed with instructions for implementing the decision logic described below with respect to FIG.

[0067] In various other embodiments, the autoinjector 300 may include other types of drives and means for actuating and sequencing the drives. The drives in such embodiments may be implemented as separate, distinct mechanisms or may be combined into a single mechanism. The drives in such embodiments may be powered by, but not limited to, a motor, a mechanical mechanism (e.g., a resilient member such as a spring), a gas pressure mechanism, a gas release mechanism, or any combination thereof. Various transmission mechanisms may be used to transmit power to the cassette to cause the drug injection. Additionally, the actuating and sequencing means may include various mechanical and electromechanical configurations and may be combined with the microprocessor described above or used alone. The autoinjector in such embodiments may be made reusable to perform multiple injections or may be designed for single, disposable use.

[0068] Referring now to FIG. 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 simple injection of the drug using an auto-injector and can be made for single-use, disposable use. In various embodiments, the locking cap 230 and cover 250 of the cassette 200 may be configured to prevent removal of the drug container 260 from the cassette 200, thereby preventing needle protrusion before and after use of the cassette 200 and preventing the drug container 260 from being removed or replaced from the cassette 200. Additionally, the locking cap 230 and cover 250 protect the drug container 260 during delivery and transport. The cassette cap 240 of various embodiments may be configured to remove a needle shield 266 that covers an 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 such that the cassette cap 240 cannot be rotated or turned, thereby preventing damage to the injection needle by the needle shield 266. Various embodiments of the inner sleeve 220 may be configured to position the drug container 260 within the cassette housing 210 in either a needle-hidden position or a needle-injection position during an injection cycle of the autoinjector. In various other embodiments, the outer housing 210 and inner sleeve 220 of the cassette 200 may include one or more locking features to protect the drug container 260 and prevent unintentional needle exposure or damage.

[0069] Cassette 200 may include an identifier 211 on outer housing 210. Identifier 211 may be positioned such that detector 370 can read identifier 211 when cassette 200 is placed in autoinjector 300. Identifier 211 may be, for example, a QR code, an RFID tag, or an NFC tag. Identifier 211 identifies the drug contained within cassette 200. Identifier 211 may further include drug information associated with the particular drug contained within cassette 200. For example, the identifier may provide drug information including, but not limited to, viscosity (at room temperature or various viscosities associated with various temperatures), dosage, minimum injection time to achieve efficacy, maximum injection time to achieve efficacy, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.

[0070] 5 illustrates a method 500 for injecting a drug over a personalized infusion time using an autoinjector (such as autoinjector 300 or drug delivery device 102). At box 502, method 500 includes identifying a drug contained in a reservoir of a drug delivery system, which may be based on reading the drug information by a reader of the drug delivery system. At box 504, method 500 includes calculating or determining an infusion time tolerance range for the identified drug. At box 506, method 500 includes receiving a preferred infusion rate from an input device of the drug delivery system. At box 508, method 500 includes determining an personalized infusion time within the infusion time tolerance range, which may be based on the preferred infusion rate. At box 510, method 500 includes setting a delivery rate of a drive of the drug delivery system such that the drug is released from the reservoir over the personalized infusion time.

[0071] In box 504, calculating or determining an acceptable range of infusion times for the identified drug may include receiving drug information from an identifier on the reservoir. Alternatively or additionally, in box 504, calculating or determining an acceptable range of infusion times for the identified drug may include accessing a drug information dataset provided in a memory of the controller, determining that the identified drug is an expected drug in a list of expected drugs, and receiving drug information associated with the identified drug in the drug information dataset. In either case, the drug information may include at least one of viscosity, dosage, minimum infusion time to achieve drug efficacy, maximum infusion time to achieve drug efficacy, minimum infusion time to reduce injection pain, and maximum infusion time to reduce injection pain.

[0072] The method 500 may further include presenting two or more relative infusion rate options, each relative infusion rate option equal to a percentage of the longest possible infusion time within a range of allowable infusion times; enabling selection of one of the two or more relative infusion rate options; and using the selected relative infusion rate option as a preferred infusion rate. Each of the two or more relative infusion rate options may be displayed as one of a written adjective, a percentage of the longest possible infusion time, and a point on a sliding scale. The method 500 may further include causing the input device to display the two or more relative infusion rate options on a touchscreen. Alternatively or additionally, selecting one of the two or more relative infusion rate options may include associating the two or more relative infusion rates with unique physical buttons on the drug delivery device. Identifying the drug contained in the reservoir of the drug delivery system based on reading by a reader of the drug delivery system may include reading an RFID tag or an NFC tag.

[0073] Those skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially feasible embodiments are often not shown so as to not overly distract from the views of these various embodiments. The same reference numerals may be used to describe like or similar parts. Furthermore, while several examples have been disclosed herein, any feature of any example may be combined with or substituted for other features of other examples. Furthermore, while several examples have been disclosed herein, changes may be made to the disclosed examples without departing from the scope of the claims.

[0074] The above description describes various drug delivery devices and methods of using drug delivery devices. It should be clear that the drug delivery device or method can further include the use of the drugs described below, but it should be noted that the following list should not be considered exhaustive or limiting. The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with a drug for treatment. The primary container can be a cartridge or a pre-filled syringe.

[0075] For example, the drug delivery device, or more specifically, the reservoir of the device, may be loaded with a colony-stimulating factor, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). In various other embodiments, the drug delivery device may be used with various pharmaceutical agents, such as erythropoiesis-stimulating agents (ESAs), which may be in liquid or lyophilized form.ESAs include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), and Silapo® (epoetin any molecule that stimulates red blood cell production, such as epoetin zeta, Binocrit® (epoetin alfa), epoetin alfa hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, and their respective The following patents or patent applications are incorporated herein by reference in their entirety: U.S. Pat. No. 4,703,008, U.S. Pat. No. 5,441,868, U.S. Pat. No. 5,547,933, U.S. Pat. No. 5,618,698, U.S. Pat. No. 5,621,080, U.S. Pat. No. 5,756,349, U.S. Pat. No. 5,767,078, U.S. Pat. No. 5,773,569, U.S. Pat. No. 5,955,422, U.S. Pat. No. 5,986,047 Nos. 6,583,272, 7,084,245 and 7,271,689, and PCT Publication Nos. WO 91 / 05867, WO 95 / 05465, WO 96 / 40772, WO 00 / 24893, WO 01 / 81405 and WO 2007 / 136752, or variants or analogs thereof.

[0076] The ESA may be an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" refers to any protein that directly or indirectly activates the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. 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 iota, epoetin zeta, and analogs thereof, PEGylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1 / hematide), and mimetic antibodies. Exemplary erythropoiesis-stimulating proteins include erythropoietin, darbepoietin, erythropoietin agonist variants, and peptides or antibodies that bind to and activate the erythropoietin receptor (as well as compounds reported in U.S. Patent Application Publication Nos. 2003 / 0215444 and 2006 / 0040858, the entire disclosures of each of which are incorporated herein by reference), and the following patents or patent applications, the entire disclosures of which are incorporated herein by reference: U.S. Patent No. 4,703,008; U.S. Patent No. 5,441,868; U.S. Patent No. 5,547,933; U.S. Patent No. 5,547,933; US Patent No. 5,618,698, US Patent No. 5,621,080, US Patent No. 5,756,349, US Patent No. 5,767,078, US Patent No. 5,773,569, US Patent No. 5,955,422, US Patent No. 5,830,851, US Patent No. 5,856,298, US Patent No. 5,986,047, US Patent No. 6,030,086, US Patent No. 6,310,078, US Patent No. 6,391,633, US Patent No. 6,583,272, US Patent No. 6,586,398, US Patent No. 6,900,292,U.S. Patent Nos. 6,750,369, 7,030,226, 7,084,245 and 7,217,689, U.S. Patent Application Publication Nos. 2002 / 0155998, 2003 / 0077753, 2003 / 0082749, 2003 / 0143202, 2004 / 0009902, 2004 / 0071694, U.S. Patent Application Publication No. US Patent Application Publication No. 2004 / 0091961, US Patent Application Publication No. 2004 / 0143857, US Patent Application Publication No. 2004 / 0157293, US Patent Application Publication No. 2004 / 0175379, US Patent Application Publication No. 2004 / 0175824, US Patent Application Publication No. 2004 / 0229318, US Patent Application Publication No. 2004 / 0248815, US Patent Application Publication No. 2004 / 0266690, US Patent Application Publication No. 2005 / 0019914, US Patent Application Publication No. 2005 / 0026834, U.S. Patent Application Publication No. 2005 / 0096461, U.S. Patent Application Publication No. 2005 / 0107297, U.S. Patent Application Publication No. 2005 / 0107591, U.S. Patent Application Publication No. 2005 / 0124045, U.S. Patent Application Publication No. 2005 / 0124564, U.S. Patent Application Publication No. 2005 / 0137329, U.S. Patent Application Publication No. 2005 / 0142642, U.S. Patent Application Publication No. 2005 / 0143292, U.S. Patent Application Publication No. 2005 / 01538 79, U.S. Patent Application Publication No. 2005 / 0158822, U.S. Patent Application Publication No. 2005 / 0158832, U.S. Patent Application Publication No. 2005 / 0170457, U.S. Patent Application Publication No. 2005 / 0181359, U.S. Patent Application Publication No. 2005 / 0181482, U.S. Patent Application Publication No. 2005 / 0192211, U.S. Patent Application Publication No. 2005 / 0202538, U.S. Patent Application Publication No. 2005 / 0227289, U.S. Patent Application Publication No. 2005 / 0244409,U.S. Patent Application Publication No. 2006 / 0088906 and U.S. Patent Application Publication No. 2006 / 0111279, and PCT Publication Nos. WO 91 / 05867, WO 95 / 05465, WO 99 / 66054, WO 00 / 24893, WO 01 / 81405, WO 00 / 61637, WO 01 / 36489, WO 02 / 014356, and 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 / 024 761, 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 Brochure, International Publication No. 2005 / 021579 pamphlet, International Publication No. 2005 / 025606 pamphlet, International Publication No. 2005 / 032460 pamphlet, International Publication No. 2005 / 051327 pamphlet, International Publication No. 2005 / 063808 pamphlet, International Publication No. 2005 / 063809 pamphlet, International Publication No. 2005 / 070451 pamphlet, International Publication No. 2005 / 081687 pamphlet, International Publication No. 2005 / 084711 pamphlet, International Publication No. 2005 / 103076 pamphlet,Examples include the erythropoietin molecules or variants or analogs thereof disclosed in WO 2005 / 100403, WO 2005 / 092369, WO 2006 / 50959, WO 2006 / 02646 and WO 2006 / 29094.

[0077] Examples of other pharmaceuticals for use with the device include, but are not limited to, antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab), and Prolia™ (denosumab); other biologics such as Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, PEGylated filgastriim, PEGylated G-CSF, PEGylated hu-Met-G-CSF), Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF), and Nplate® (romiplostim); and small molecule drugs such as Sensipar® (cinacalcet). The device may also be used with therapeutic antibodies, polypeptides, proteins, or other chemicals such as iron, e.g., ferumoxytol, iron dextran, ferric gluconate, and ferric iron oxide. The pharmaceutical agent may be in liquid form or may be reconstituted from a lyophilized form.

[0078] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof.

[0079] As disclosed in PCT Publication WO 03 / 002713, each of which is individually and specifically incorporated herein by reference in its entirety, including OPGL-specific antibodies having either a light chain of SEQ ID NO:2 set forth in Figure 2 of said publication and / or a heavy chain of SEQ ID NO:4 set forth in Figure 4 of said publication; with regard to OPGL-specific antibodies and antibody-related proteins, in particular those having the sequences set forth in said publications, specifically but not limited to those set forth above (9H7, 18B2, 2D8, 2E11, 16E1, and 22B3), including but not limited to the antibodies described in said publications, which are incorporated herein in their entirety, OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, and related proteins, including fully humanized and human OPGL-specific antibodies, in particular fully humanized monoclonal antibodies;

[0080] TN8-19-1 through TN8-19-40, TN8-19 con1, and TN8-19, each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in U.S. Patent Application Publication No. 2004 / 0181033 and PCT Publication No. WO 2004 / 058988. myostatin-binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies, particularly those described in the above publications, which are incorporated herein by reference in their entirety, particularly in part, with particular reference to myostatin-specific peptibodies, including, but not limited to, the mTN8-19 family of peptibodies, including those of SEQ ID NOs: 305-351, including con2; the mL2 family of SEQ ID NOs: 357-383, the mL15 family of SEQ ID NOs: 384-409, the mL17 family of SEQ ID NOs: 410-438, the mL20 family of SEQ ID NOs: 439-446, the mL21 family of SEQ ID NOs: 447-452, the mL24 family of SEQ ID NOs: 453-454, and the peptibodies of SEQ ID NOs: 615-631;

[0081] 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, L2H15, L2H16, L2H17, L2H18, L2H19, L2H20, L2H21, L2H22, L2H23, L2H24, L2H25, L2H26, L2H27, L2H28, L2H29, L2H30, L2H31, L2H32, L2H33, L2H34, L2H35, L2H36, L2H37, L2H38, L2H39, L2H40, L2H41, L2H42, L2H43, L2H44, L2H45, L2H46, L2H47, L2H48, L2H49, L2H50, L2H51, L2H52, L2H53, L2H54, L2H55, L2H56, L2H57, L2H58, L2H59, L2H60, L2H61, L2H62, L2H63, L2H64, L2H65, L2H66, L2H67, L2H68, L2H69, L2H69, L2H70, L2H71, L2H72, L2H73, L2H74, L2H75, L2H76, L , L2H11, L2H12, L2H13, L2H14, L3H1, L4H1, L5H1, L6H1, IL-4 receptor-specific antibodies, particularly antibodies such as those described in the above publications, particularly those that inhibit activities mediated by IL-4 and / or IL-13 binding to the receptor, including those described in the above publications, which are particularly related in part to those set forth in the above publications and are incorporated herein by reference in their entirety, IL-4 receptor-specific antibodies, peptibodies, and related proteins,

[0082] Interleukin 1-receptor 1 ("IL1-R1")-specific antibodies, peptibodies, and related proteins, including, but not limited to, those set forth in U.S. Patent Application Publication No. 2004 / 097712, i.e., 15CA, 26F5, 27F2, 24E12, and 10H7, each of which is individually and specifically incorporated by reference in its entirety, in part, IL1-R1-specific binding proteins, particularly those described in the above publications, which are incorporated by reference in their entirety, particularly with reference to monoclonal antibodies;

[0083] The sequences of the following publications, each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the following publications, in particular those sequences described in the following publications: 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 Ang2-specific antibodies and peptibodies, including, but not limited to, those described in PCT Publication No. WO 03 / 057134 and U.S. Patent Application Publication No. 2003 / 0229023, each of which is incorporated herein by reference in its entirety, particularly in part with respect to Ang2-specific antibodies and peptibodies, including, but not limited to, Ab526, Ab528, Ab531, Ab541, Ab542, Ab543, Ab544, Ab545, Ab546, Ab547, Ab548, Ab549, Ab550, Ab551, Ab552, Ab553, Ab554, Ab555, Ab556, Ab557, Ab558, Ab559 ... Ang2-specific antibodies, peptibodies, and related proteins, including anti-Ang2 antibodies and formulations such as those described in PCT Publication WO 2003 / 030833, which is incorporated by reference in its entirety with respect to 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 those described in PCT Publication WO 2003 / 030833, which is incorporated by reference in its entirety with respect to AblP;

[0084] NGF-specific antibodies, peptibodies, and related proteins, including, but not limited to, those described in U.S. Patent Application Publication No. 2005 / 0074821 and U.S. Patent No. 6,919,426, each of which is individually and specifically incorporated herein by reference in its entirety, specifically including, but not limited to, the NGF-specific antibodies 4D4, 4G6, 6H9, 7H2, 14D10, and 14D11 set forth in the above publications, and NGF-specific antibodies and related proteins thereto, as disclosed in the above publications, each of which is individually and specifically incorporated herein by reference in its entirety, specifically including, but not limited to, the NGF-specific antibodies 4D4, 4G6, 6H9, 7H2, 14D10, and 14D11 set forth in the above publications,

[0085] humanized and fully human antibodies, including, but not limited to, humanized and fully human monoclonal antibodies, particularly including, but not limited to, human CD22-specific IgG antibodies, such as, for example, a dimer of human-mouse monoclonal hLL2 gamma chain disulfide linked to a human-mouse monoclonal hLL2 kappa chain, including, but not limited to, the human CD22-specific fully humanized antibody of epratuzumab (CAS Registry Number 501423-23-0); CD22-specific antibodies, peptibodies, and related proteins, 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;

[0086] The IGF-1 specific antibodies 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, L29H29, L30H30, and L31H are disclosed in PCT Publication WO 06 / 069202, each of which is individually and specifically incorporated herein by reference in its entirety. IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including, but not limited to, IGF-1R-binding fragments and derivatives thereof, such as those described in the above publications, which are incorporated herein by reference in their entireties, with respect to IGF-1 receptor-specific antibodies and related proteins;

[0087] Also among the non-limiting examples of anti-IGF-1R antibodies for use in the methods and compositions of the present invention are each of those described below.

[0088] U.S. Patent Application Publication No. 2006 / 0040358 (published February 23, 2006), U.S. Patent Application Publication No. 2005 / 0008642 (published January 13, 2005), and U.S. Patent Application Publication No. 2004 / 0228859 (published November 18, 2004) (including, but not limited to, Antibody 1A (DSMZ Accession No. DSM ACC 2586), Antibody 8 (DSMZ Accession No. DSM ACC 2589), Antibody 23 (DSMZ Accession No. DSM ACC 2588), and Antibody 18 described in the above publications).

[0089] including, but not limited to, antibodies 2F8, A12, and IMC-A12, described in 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;

[0090] PCT Publication No. 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).

[0091] These include, but are not limited to, antibody 7C10, chimeric antibody C7C10, antibody h7C10, antibody 7H2M, chimeric antibody *7C10, antibody GM 607, humanized antibody 7C10 version 1, humanized antibody 7C10 version 2, humanized antibody 7C10 version 3, and antibody 7H2HM, which are described in U.S. Patent Application Publication No. 2005 / 0084906 (published April 21, 2005).

[0092] U.S. Patent Application Publication No. 2005 / 0249728 (published November 10, 2005), U.S. Patent Application Publication No. 2005 / 0186203 (published August 25, 2005), U.S. Patent Application Publication No. 2004 / 0265307 (published December 30, 2004), and U.S. Patent Application Publication No. 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 described therein);

[0093] U.S. Patent No. 7,037,498 (issued May 2, 2006), U.S. Patent Application Publication No. 2005 / 0244408 (published November 30, 2005), and U.S. Patent Application Publication No. 2004 / 0086503 (published May 6, 2004), and Cohen, et al. (2005), Clinical Cancer Res. 11:2063-2073, including, but not limited to, each of the antibodies produced by hybridomas having ATCC deposit numbers PTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793, and antibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and 4.17.3, e.g., antibody CP-751,871;

[0094] including, but not limited to, antibody 19D12, as described in U.S. Patent Application Publication No. 2005 / 0136063 (published June 23, 2005) and U.S. Patent Application Publication No. 2004 / 0018191 (published January 29, 2004), and antibodies comprising a heavy chain encoded by the polynucleotide of plasmid 15H12 / 19D12 HCA(γ4) deposited with the ATCC under accession number PTA-5214 and a light chain encoded by the polynucleotide of plasmid 15H12 / 19D12 LCF(κ) deposited with the ATCC under accession number PTA-5220,

[0095] With respect to the aforementioned antibodies, peptibodies, and related proteins that specifically target the IGF-1 receptor, 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, which are described in U.S. Patent Application Publication No. 2004 / 0202655 (published October 14, 2004), each of which is incorporated herein by reference in its entirety;

[0096] B-7 related protein 1-specific antibodies, peptibodies, related proteins, and the like ("B7RP-1," also referred to in the literature as B7H2, ICOSL, B7h, and CD275), particularly B7RP-specific fully human monoclonal IgG2 antibodies, particularly fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, particularly those that inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1, particularly on activated T cells, and particularly as disclosed in the following publications, each of which is individually and specifically incorporated herein by reference in its entirety: 16H (within which the light chain variable region sequence and heavy chain variable region sequence are set forth in SEQ ID NO: 1 and SEQ ID NO: 7, respectively); 5D (within which the light chain variable region sequence and heavy chain variable region sequence are set forth in SEQ ID NO: 2, respectively); and SEQ ID NO:9), 2H (having therein light chain variable region sequences SEQ ID NO:3 and SEQ ID NO:10, respectively), 43H (having therein light chain variable region sequences SEQ ID NO:6 and SEQ ID NO:14, respectively), 41H (having therein light chain variable region sequences SEQ ID NO:5 and SEQ ID NO:13, respectively), and 15H (having therein light chain variable region sequences SEQ ID NO:4 and SEQ ID NO:12, respectively), and those disclosed in U.S. Patent Publication No. 2008 / 0166352 and PCT Publication No. WO 07 / 011941, each of which is incorporated by reference in its entirety, with respect to such antibodies and related proteins, including, but not limited to, the antibodies set forth in the following publications:

[0097] IL-15 specific antibodies, peptibodies, and related proteins, particularly antibodies, particularly humanized monoclonal antibodies, such as those disclosed in U.S. Patent Application Publication Nos. 2003 / 0138421, 2003 / 023586, and 2004 / 0071702, and U.S. Patent Application Publication No. 7,153,507, each of which is incorporated herein by reference in its entirety, for IL-15 specific antibodies and related proteins, including, inter alia, peptibodies, including, but not limited to, HuMax IL-15 antibodies and related proteins, such as 146B7;

[0098] IFNγ-specific antibodies, peptibodies, and related proteins, etc., particularly human IFNγ-specific antibodies, particularly fully human anti-IFNγ antibodies, such as, for example, IFNγ-specific antibodies, particularly fully human anti-IFNγ antibodies, such as those described in U.S. Patent Application Publication No. 2005 / 0004353, which is incorporated herein by reference in its entirety with respect to the antibodies designated 1118, 1118*, 1119, 1121, and 1121* in the following patent publication: The entire 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 complementarity-determining regions, are individually and specifically incorporated herein by reference in their entirety as disclosed in the aforementioned publications and in Thakur et al. (1999), Mol. Immunol. 36:1107-1115, respectively. Additionally, the descriptions of the properties of these antibodies provided in the above publications are 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: 31, as disclosed in the aforementioned publications. A specific antibody contemplated is antibody 1119, disclosed in the aforementioned U.S. Patent Application Publication, having the complete heavy chain of SEQ ID NO: 17, disclosed in the aforementioned U.S. Patent Application Publication, and the complete light chain of SEQ ID NO: 18, disclosed in the aforementioned U.S. Patent Application Publication.

[0099] TALL-1 specific antibodies, peptibodies, and related proteins, such as those described in U.S. Patent Application Publication Nos. 2003 / 0195156 and 2006 / 0135431, each of which is incorporated herein by reference in its entirety, as disclosed in the following publications, each of which is individually and specifically incorporated herein by reference in its entirety, and other TALL specific binding proteins, particularly those described in U.S. Patent Application Publication Nos. 2003 / 0195156 and 2006 / 0135431, each of which is incorporated herein by reference in its entirety with respect to TALL-1 binding proteins, particularly the molecules in Table 4 and Table 5B:

[0100] Parathyroid hormone ("PTH")-specific antibodies, peptibodies, and related proteins, such as those described in U.S. Pat. No. 6,756,480, which is incorporated herein by reference in its entirety, with particular reference in part to proteins that bind PTH;

[0101] Thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, and related proteins, such as those described in U.S. Pat. No. 6,835,809, which is incorporated herein by reference in its entirety, with particular reference in part to proteins that bind to TPO-R;

[0102] Hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, and related proteins, including those that target the HGF / SF:c-Met axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF), as described in U.S. Patent Application 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 incorporated by reference in its entirety with particular reference in part to proteins that bind HGF;

[0103] TRAIL-R2 specific antibodies, peptibodies, related proteins, etc., such as those described in U.S. Pat. No. 7,521,048, which is incorporated herein by reference in its entirety, with particular reference in part to proteins that bind TRAIL-R2;

[0104] Activin A-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, those described in U.S. Patent Application Publication No. 2009 / 0234106, which is incorporated herein by reference in its entirety, with particular reference to proteins that bind activin A;

[0105] TGF-β specific antibodies, peptibodies, related proteins, etc., including, but not limited to, those described in U.S. Pat. No. 6,803,453 and U.S. Patent Application Publication No. 2007 / 0110747, each of which is incorporated by reference in its entirety, with particular reference in part to proteins that bind TGF-β;

[0106] Amyloid β protein-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, those described in PCT Publication WO 2006 / 081171, which is particularly related in part to proteins that bind to amyloid β protein and is incorporated herein by reference in its entirety. One contemplated antibody is the antibody disclosed in the above publication having a heavy chain variable region comprising SEQ ID NO:8 and a light chain variable region having SEQ ID NO:6.

[0107] c-Kit-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, those described in U.S. Patent Application Publication No. 2007 / 0253951, which is incorporated herein by reference in its entirety, with particular reference in part to proteins that bind c-Kit and / or other stem cell factor receptors;

[0108] OX40L-specific antibodies, peptibodies, related proteins, and the like, including, but not limited to, those described in U.S. Patent Application Publication No. 2006 / 0002929, which is incorporated herein by reference in its entirety, with particular reference in part to proteins that bind OX40L and / or other ligands of the OX40 receptor;

[0109] Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon beta-1a), Bexxar® (tositumomab, an anti-CD22 monoclonal antibody), Betaseron® (interferon beta), Campath® (alemtuzumab, an anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-alpha4beta7 mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Humatopeptide® (anti-HER2 / neu(erbB2) receptor mAb), Rope® (somatropin, human growth hormone), Humira® (adalimumab), insulin in solution, Infergen® (interferon alfacon-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP), Kineret® (anakinra), Leukine® (sargamostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lymphostat B, belimumab, anti-BlySmAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), Soliris™ (eculizumab), pexelizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (lerdelimumab), TheraCim hR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem® (IDM-1), OvaRex® (B43.13), Nuvion® (vigilizumab), cantuzumab mertansine (huC242-DM1), NeoRecormon® (epoetin beta), Neumega® (oprelvekin, human interleukin-11), Neulasta® (PEGylated filgastrim, PEGylated G-CSF, PEGylated hu-Met-G-CSF), Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF), Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit® (epoetin alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP 1Ib / Ilia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Rituxan® (rituximab, anti-CD20mAb), Tarceva® (erlotinib), Roferon-A® (interferon alfa-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 146B7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri® (natalizumab, anti-α4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Vectibix® (panitumumab), Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (the Fc portion of human IgG1 and the extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (the Ig domain of VEGFR1 fused to IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23 mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO148 (golimumab, anti-TNFα mAb), HGS-ETR1 (mapatuzumab, 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 mAb, anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25 mAb (HuMax-TAC), anti-CD3 mAb (NI-0401), adecatumumab, anti-CD30mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38 mAb (HuMax CD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF idiopathic pulmonary fibrosis stage 1 fiblogen (FG-3019), anti-CTLA4 mAb, anti-Eotakisin 1 mAb (CAT-213), anti-FGF8 mAb, anti-Gangri-O-SID GD2 mAb, anti-Gangri-O-SID GM2 mAb, anti-GDF-8-Hyto 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 (CNTO1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 receptor mAb, anti-Integrin receptor mAb (MDX-018, CNTO95), anti-IP10 ulcerative colitis mAb (MDX-1100), anti-LLY antibody, BMS-66513, anti-mannos receptor / hCGβ mAb (MDX-1307), anti-mesotrindsFv-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 mitochondrial mAb (HGS-ETR2), anti-TWEAK mAb, anti-VEGFR / Flt-1 mAb, anti-ZP3 mAb (HuMax-ZP3), NVS antibody 1st batch, and NVS antibody 2nd batch, other examples of natanpaku substance.

[0110] Sclerostin antibodies, such as, but not limited to, romosozumab, brosozumab, or BPS804 (Novartis), may also be included. Further therapeutic agents may be included, such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX, or XGEVA. Additionally, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9) may be included in the device.Such PCSK9-specific antibodies include those described in the following patents or patent applications, each of which is incorporated by reference in its entirety for all purposes: U.S. Patent No. 8,030,547, U.S. Patent Application Publication No. 2013 / 0064825, WO 2008 / 057457, WO 2008 / 057458, WO 2008 / 057459, WO 2008 / 063382, International Publication No. 2008 / 133647, International Publication No. 2009 / 100297, International Publication No. 2009 / 100318, International Publication No. 2011 / 037791, International Publication No. 2011 / 053759, International Publication No. 2011 / 053783, International Publication No. 2008 / 125623, International Publication No. International Publication No. 011 / 072263, International Publication No. 2009 / 055783, International Publication No. 2012 / 0544438, International Publication No. 2010 / 029513, International Publication No. 2011 / 111007, International Publication No. 2010 / 077854, International Publication No. 2012 / 088313, International Publication No. 2012 / 101251, International These include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab) and molecules, variants, analogs, or derivatives thereof as disclosed in Publication Nos. 2012 / 101252, WO 2012 / 101253, WO 2012 / 109530, and WO 2001 / 031007.

[0111] Also included are talimogene laherparepvec or other oncolytic HSVs for the treatment of melanoma or other cancers. Examples of oncolytic HSVs include, but are not limited to, talimogene laherparepvec (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., 19:5138-5143), G207, 1716, NV1020, NV12023, NV1034, and NV1042 (Vargehes et al. (2002), Cancer Gene Ther., 9(12):967-978).

[0112] TIMPs are also included. TIMPs are endogenous tissue inhibitors of metalloproteinases (TIMPs) that are important in many natural processes. TIMP-3 is expressed by various cells and / or present in the extracellular matrix, inhibits all major cartilage-degrading metalloproteinases, and may play a role in many connective tissue degrading diseases, including rheumatoid arthritis and osteoarthritis, as well as cancer and cardiovascular conditions. The amino acid sequence of TIMP-3 and the DNA sequence encoding TIMP-3 are disclosed in U.S. Patent No. 6,562,596, issued May 13, 2003, the disclosure of which is incorporated herein by reference. A description of TIMP mutations can be found in U.S. Patent Application Publication No. 2014 / 0274874 and PCT Application Publication No. WO 2014 / 152012.

[0113] Also included are antagonistic antibodies to the human calcitonin gene-related peptide (CGRP) receptor and bispecific antibody molecules that target the CGRP receptor and other headache targets. More information regarding these molecules can be found in PCT Application No. WO 2010 / 075238.

[0114] Additionally, bispecific T cell-engaging (BiTE®) antibodies, such as BLINCYTO® (blinatumomab), can be used in the device. Alternatively, APJ macromolecular agonists, such as apelin or analogs thereof, can be included in the device. Information regarding such molecules can be found in WO 2014 / 099984.

[0115] 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 may 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. Patent Application 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 a particularly preferred embodiment, the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated A5 in U.S. Patent No. 7,982,016.

[0116] Although the drug delivery devices, methods, and their components have been described in terms of exemplary embodiments, the drug delivery devices, methods, and their components are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention, as describing every possible embodiment would be impractical, if not impossible. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments will still fall within the scope of the claims defining the invention. For example, components described herein with reference to a particular type of drug delivery device, such as an on-body injector drug delivery device, or other types of drug delivery devices, can also be utilized in other types of drug delivery devices, such as an autoinjector drug delivery device.

[0117] Those skilled in the art will understand that various modifications, variations and combinations can be made to the above-described embodiments without departing from the scope of the present invention, and that such modifications, variations and combinations are to be construed as falling within the scope of the inventive concept.

Claims

1. a reservoir adapted to contain a drug; an identifier having drug information; a drug delivery device adapted to receive the reservoir; a reader adapted to read said drug information; a driver adapted to release the drug from the reservoir; a controller operatively coupled to the reader and the driver, the controller comprising: (a) identifying the drug contained in the reservoir based on the drug information; (b) calculating or determining an acceptable range of infusion times for the identified medication; (c) determining an individualized infusion time within said tolerance range of infusion times; (d) setting the delivery rate of the driver such that the drug is released from the reservoir over the individualized infusion time. a controller that is programmed to A drug delivery system comprising:

2. The drug delivery system of claim 1 , wherein the controller calculates or determines the tolerance range for infusion time based at least in part on the drug information.

3. 3. The drug delivery system of claim 2, wherein the drug information includes at least one of viscosity, dosage, minimum injection time to achieve drug efficacy, maximum injection time to achieve drug efficacy, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.

4. the controller includes a memory containing a drug information dataset having a list of predicted drugs, each predicted drug being associated with drug information; calculating or determining the tolerance for infusion time for the identified medication includes accessing the medication information dataset, determining that the identified medication is a predicted medication in the list of predicted medications, and receiving the medication information associated with the identified medication in the medication information dataset. The drug delivery system according to any one of claims 1 to 3.

5. the drug delivery system further comprising an input device operatively coupled to the controller; the controller is further programmed to receive a preferred infusion rate from the input device; the individualized infusion time is based on the preferred infusion rate; The drug delivery system according to any one of claims 1 to 4.

6. 6. The drug delivery system of claim 5, wherein the input device includes two or more relative infusion rate options, each relative infusion rate option equal to a percentage of the longest possible infusion time within the range of acceptable infusion times, and the preferred infusion rate is the relative infusion rate option selected using the input device.

7. 7. The drug delivery system of claim 6, wherein the input device includes a touch screen, and the controller causes the input device to display the two or more relative infusion rate options.

8. 8. The drug delivery system of claim 6 or 7, wherein each of the two or more relative infusion rate options is displayed as one of a written adjective, a percentage of the longest possible infusion time, and a point on a sliding scale.

9. The drug delivery system of claim 6 , wherein the two or more relative infusion rates are associated with respective unique physical buttons on the drug delivery device.

10. The drug delivery system according to any one of claims 1 to 9, wherein the identifier is an RFID tag or an NFC tag.

11. 1. A method of preparing a drug delivery device for delivering a drug product, comprising: (a) identifying a drug contained in a reservoir of a drug delivery system based on reading an identifier on the reservoir by a reader of the drug delivery system; (b) calculating tolerances for infusion times for the identified medications; (c) receiving a preferred infusion rate from an input device of the drug delivery system; and (d) determining an individualized infusion time within the tolerance range of infusion times based on the preferred infusion rate; (e) setting a delivery rate of a drive of the drug delivery system such that the drug is released from the reservoir over the individualized infusion time; A method comprising:

12. The method of claim 11 , wherein calculating the tolerance range for infusion times for the identified medication includes receiving medication information from the identifier on the reservoir.

13. 13. The method of claim 12, wherein the drug information includes at least one of viscosity, dosage, minimum infusion time to achieve efficacy, maximum infusion time to achieve efficacy, minimum infusion time to reduce injection pain, and maximum infusion time to reduce injection pain.

14. 14. The method of claim 11, wherein calculating the tolerance for infusion time for the identified medication comprises accessing a medication information dataset provided in a memory of the controller; determining that the identified medication is a predicted medication in a list of predicted medications; and receiving medication information associated with the identified medication in the medication information dataset.

15. The method of any one of claims 12 to 14, wherein the drug information includes at least one of viscosity, dosage, minimum injection time to achieve efficacy, maximum injection time to achieve efficacy, minimum injection time to reduce injection pain, and maximum injection time to reduce injection pain.

16. 16. The method of claim 11, further comprising: presenting two or more relative infusion rate options, each relative infusion rate option equal to a percentage of the longest possible infusion time within the range of allowable infusion times; enabling selection of one of the two or more relative infusion rate options; and using the selected relative infusion rate option as the preferred infusion rate.

17. 17. The method of claim 16, further comprising causing the input device to display the two or more relative infusion rate options on a touch screen.

18. 18. The method of claim 17, wherein each of the two or more relative infusion rate options is displayed as one of a written adjective, a percentage of the longest possible infusion, and a point on a sliding scale.

19. 19. The method of any one of claims 16 to 18, wherein enabling selection of one of the two or more relative infusion rate options comprises associating the two or more relative infusion rates with unique physical buttons on the drug delivery device.

20. The method of any one of claims 11 to 19, wherein reading an identifier on the reservoir comprises reading an RFID tag or an NFC tag.

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