Abstract: An improved therapeutic adhesive patch for application to the heel is described for treating or preventing heel disorders or conditions, such as cracked heel.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.

Abstract: A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.

Abstract: A fluid pathway assembly includes a needle insertion mechanism, a fluid conduit, and a fluid pathway connection. The fluid pathway assembly may further include a drug container to hold a drug fluid prior to initiation of the injection. The assembly may include a carrier disposed along at least a portion of the fluid pathway assembly, and/or a drug container. The fill-finish cartridge functions to retain the components of the fluid pathway assembly in a sterile condition, while allowing for easy integration of the fluid pathway assembly and the drug container into a standard fill-finish process. Methods of constructing a cartridge, filling a drug container included in a cartridge, and incorporating the same into a drug delivery device are disclosed.

Abstract: A fluid pathway connection includes a piercing member, a connection hub, and a sliding pierceable seal, wherein the sliding pierceable seal is configured to move from a first position, where the piercing member is initially retained within a sterile cavity between the connection hub and the sliding pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. The fluid pathway connection may further be configured to move to a third position where one or more interconnects and/or one or more corresponding contacts are permitted to transmit a signal to the user. Such fluid pathway connections may be integrated into a drug container having a barrel and a plunger seal. A drug delivery pump includes such integrated fluid pathway connections and drug containers.

Abstract: A replaceable fluid restriction mechanism 500, 1500 includes: an aperture 520A residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture 520A when the fluid pathway connection is open; an entry point 520B of a fluid channel 520C configured such that the flow of drug fluid can travel through aperture 520A to the entry point 520B and through the fluid channel 520C to an exit point 520D; and an outlet aperture 514 of a port 512 through which the flow of drug fluid may travel after exiting the exit point 520D, wherein a fluid conduit 30 is connected to the fluid restriction mechanism at the outlet aperture. A configurable fluid restriction mechanism 500, 1500 includes a plurality of fluid channels 520C, 521C, 522C, 523C, selectable to align with the entry point 520B and an exit point 520D of the fluid restriction mechanism.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.

Abstract: The present invention provides devices and methods for establishing aseptic connections between two or more components or subassemblies. The devices may be used in medical devices such as drug delivery pumps (10). In some embodiments, a connection is made between a drug container (50, 1050, 2050) and a fluid pathway connection assembly (300, 1300, 2300). The fluid pathway connection assembly may include a connection hub (312, 1312, 2312), a piercing member (316, 1316, 2316), and a piercing member retainer (314, 1314, 2314). The assembly may further include a first film (318, 1318, 2318) covering a cavity (312A, 1312A, 2312A), thereby maintaining the aseptic condition of the cavity. The drug container may hold a fluid drug and include a pierceable seal (326, 1326, 2326). A second film (322, 1322, 2322) may cover a recess (328, 1328, 2328) formed by the seal and thereby maintain the aseptic condition of the interior of the chamber.

Abstract: An improved therapeutic adhesive patch for application to the heel is described for treating or preventing heel disorders or conditions, such as cracked heel.

Abstract: A replaceable fluid restriction mechanism includes: an aperture residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture when the fluid pathway connection is open; an entry point of a fluid channel configured such that the flow of drug fluid can travel through aperture to the entry point and through the fluid channel to an exit point; and an outlet aperture of a port through which the flow of drug fluid may travel after exiting the exit point, wherein a fluid conduit is connected to the fluid restriction mechanism at the outlet aperture. A configurable fluid restriction mechanism includes a plurality of fluid channels, selectable to align with the entry point and an exit point of the fluid restriction mechanism.

Abstract: The present invention provides devices and methods for establishing aseptic connections between two or more components or subassemblies. The devices may be used in medical devices such as drug delivery pumps (10). In some embodiments, a connection is made between a drug container (50, 1050, 2050) and a fluid pathway connection assembly (300, 1300, 2300). The fluid pathway connection assembly may include a connection hub (312, 1312, 2312), a piercing member (316, 1316, 2316), and a piercing member retainer (314, 1314, 2314). The assembly may further include a first film (318, 1318, 2318) covering a cavity (312A, 1312A, 2312A), thereby maintaining the aseptic condition of the cavity. The drug container may hold a fluid drug and include a pierceable seal (326, 1326, 2326). A second film (322, 1322, 2322) may cover a recess (328, 1328, 2328) formed by the seal and thereby maintain the aseptic condition of the interior of the chamber.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.

Abstract: The present invention provides devices and methods for establishing aseptic connections between two or more components or subassemblies. The devices may be used in medical devices such as drug delivery pumps (10). In some embodiments, a connection is made between a drug container (50, 1050, 2050) and a fluid pathway connection assembly (300, 1300, 2300). The fluid pathway connection assembly may include a connection hub (312, 1312, 2312), a piercing member (316, 1316, 2316), and a piercing member retainer (314, 1314, 2314). The assembly may further include a first film (318, 1318, 2318) covering a cavity (312A, 1312A, 2312A), thereby maintaining the aseptic condition of the cavity. The drug container may hold a fluid drug and include a pierceable seal (326, 1326, 2326). A second film (322, 1322, 2322) may cover a recess (328, 1328, 2328) formed by the seal and thereby maintain the aseptic condition of the interior of the chamber.

Abstract: A fluid pathway connection includes a piercing member, a connection hub, and a sliding pierceable seal, wherein the sliding pierceable seal is configured to move from a first position, where the piercing member is initially retained within a sterile cavity between the connection hub and the sliding pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. The fluid pathway connection may further be configured to move to a third position where one or more interconnects and/or one or more corresponding contacts are permitted to transmit a signal to the user. Such fluid pathway connections may be integrated into a drug container having a barrel and a plunger seal. A drug delivery pump includes such integrated fluid pathway connections and drug containers.