Abstract: Arcuate fixation members with varying configurations and/or features are provided, along with additional components for use therewith in provided fixation systems and intervertebral implant systems. The arcuate fixation members may be of varying lengths, cross sectional geometries, and/or cross sectional areas, and may be configured with various features such as heads configured to accept other fixation system components, tabs to allow arcuate fixation member-in-arcuate fixation member or fixation anchor-in-arcuate fixation member configurations. Applications of fixation systems and intervertebral implants systems utilizing arcuate fixation members are particularly suitable when a linear line-of-approach for delivering fixation members is undesirable.

Abstract: An insertion mechanism and methods of assembly and operation of a drug pump may include an insertion mechanism housing; a housing cap; a manifold guide; an insertion biasing member initially held in an energized state; a retraction biasing member connected to a hub connected to a proximal end of a needle; and, optionally, a clip retainer. The retraction biasing member is held initially in an energized state between the hub and manifold guide. A manifold has a manifold body and one or more septa defining a manifold header. The retraction biasing member may be held initially energized between the hub and the clip retainer. The needle is advanced by the insertion biasing member(s) from the initial configuration to an administration configuration, opening a fluid pathway from the manifold header to the target. The pump may include an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion 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: Arcuate fixation members with varying configurations and/or features are provided, along with additional components for use therewith in provided fixation systems and intervertebral implant systems. The arcuate fixation members may be of varying lengths, cross sectional geometries, and/or cross sectional areas, and may be configured with various features such as heads configured to accept other fixation system components, tabs to allow arcuate fixation member-in-arcuate fixation member or fixation anchor-in-arcuate fixation member configurations. Applications of fixation systems and intervertebral implants systems utilizing arcuate fixation members are particularly suitable when a linear line-of-approach for delivering fixation members is undesirable.

Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.

Abstract: A fill-finish cartridge includes a carrier, a fluid pathway connection, a needle insertion mechanism, and a drug container. The cartridges enable drug containers to be filled with pharmaceutical treatments using standard filling equipment and process systems, while maintaining the sterility and container integrity of the fluid pathway. The fill-finish cartridges of the present invention can be nested or removably housed in fill-finish trays for batch filling in standard operating processes. As such, the adaptable fillfinish cartridges of the present invention may be flexibly inserted, attached, mounted, or otherwise removably positioned in fill-finish trays. These embodiments, accordingly, may provide novel and cost-efficient assemblies and cartridges which are readily integrated into drug filling processes. Methods of assembly, manufacture, and use are also provided.

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: Embodiments described include devices and methods for forming a porous polymer material. Devices disclosed and formed using the methods described a spacer for spinal fusion, craniomaxillofacial (CMF) structures, and other structures for tissue implants.

Abstract: An insertion mechanism (200) for a drug pump (10, 1300) includes an insertion mechanism (200) housing (202, 1202, 2202, 3202); a sleeve (220, 1220, 2220, 3220); a rotational biasing member (210, 1210, 2210, 3210) initially held in an energized state; a retraction biasing member (216, 1216, 2216, 3216) and a hub (212, 1212, 2212, 3212) connected to a proximal end of a needle (214, 1214, 2214, 3214), wherein the retraction biasing member (216, 1216, 2216, 3216) is held initially in an energized state between the hub (212, 1212, 2212, 3212) and the sleeve (220, 1220, 2220, 3220). The needle (214, 1214, 2214, 3214) is inserted into a target tissue by the rotational biasing member (210, 1210, 2210, 3210) and interaction between the hub (212, 1212, 2212, 3212) and housing (202, 1202, 2202, 3202). Retraction of the needle (214, 1214, 2214, 3214) is caused by decompressing or de-energizing of the retraction biasing member (216, 1216, 2216, 3216).

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: Embodiments described include devices and methods for forming a porous polymer material. Devices disclosed and formed using the methods described a spacer for spinal fusion, craniomaxillofacial (CMF) structures, and other structures for tissue implants.

Abstract: An intervertebral implant for insertion into an intervertebral disc space between adjacent vertebral bodies or between two bone portions. The implant includes a spacer portion, a plate portion operatively coupled to the spacer portion and one or more blades for securing the implant to the adjacent vertebral bodies. The blades preferably include superior and inferior cylindrical pins for engaging the adjacent vertebral bodies. The implant may be configured to be inserted via a direct lateral trans-psoas approach. Alternatively, the implant may be configured for insertion via an anterior approach.

Abstract: An intervertebral implant for insertion into an intervertebral disc space between adjacent vertebral bodies or between two bone portions. The implant includes a spacer portion, a plate portion operatively coupled to the spacer portion and one or more blades for securing the implant to the adjacent vertebral bodies. The blades preferably include superior and inferior cylindrical pins for engaging the adjacent vertebral bodies. The implant may be configured to be inserted via a direct lateral trans-psoas approach. Alternatively, the implant may be configured for insertion via an anterior approach.

Abstract: Provided herein is a fluid pathway connection assembly, e.g., for connecting a fluid flowpath within a drug delivery device for delivery of a medicament to a target site. The fluid pathway connection assembly comprises a hollow needle piercing member, a sleeve fixedly engaged with the piercing member and a pierceable seal configured to sealingly engage the piercing member or the sleeve. Upon, sealing engagement, the piercing member or the sleeve and the pierceable seal form a volume within which a portion of the piercing member is disposed. The fluid pathway connection assembly is activated by relative movement between the piercing member and the pierceable seal and activation causes the piercing member to pierce the pierceable seal, thereby establishing a fluid flowpath through the pierceable seal. Upon incorporation of the assembly into a sealed fluid flowpath, the volume is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein.

Abstract: Arcuate fixation members with varying configurations and/or features are provided, along with additional components for use therewith in provided fixation systems and intervertebral implant systems. The arcuate fixation members may be of varying lengths, cross sectional geometries, and/or cross sectional areas, and may be configured with various features such as heads configured to accept other fixation system components, tabs to allow arcuate fixation member-in-arcuate fixation member or fixation anchor-in-arcuate fixation member configurations. Applications of fixation systems and intervertebral implants systems utilizing arcuate fixation members are particularly suitable when a linear line-of-approach for delivering fixation members is undesirable.

Abstract: Power and control systems for a drug delivery device allow for the activation, control of, and communication with the drug delivery device. The power and control system allows for a delay between device activation, and optionally needle insertion, and commencing drug delivery. The delay may be for a predetermined time. In addition, the power and control system may communicate with one or more external sensors and devices. The inputs from the sensors and devices may automatically, or on demand, adjust the delivery parameters of the device. The power and control systems may control a drive system that delivers a fluid at a variable rate or profile, allowing for the delivery to be tailored to maximize the effectiveness of the treatment.

Abstract: The present disclosure relates to a spinal implant. The spinal implant may be used for lateral insertion into an intervertebral disc space. For example, the spinal implant may include a spacer body to which a plate is fixed. The intervertebral spacer body may include a pair of opposite sides having a pyramid-shaped teeth to fuse to bone. The plate defines at least one upper and lower borehole that each receives a screw. Each screw attaches the plate to a vertebral body between which the intervertebral spacer body is inserted. The boreholes may include locking threads that are adapted to lock the screws into place by engaging complementary locking threads of head of the screw.

Abstract: Arcuate fixation members with varying configurations and/or features are provided, along with additional components for use therewith in provided fixation systems and intervertebral implant systems. The arcuate fixation members may be of varying lengths, cross sectional geometries, and/or cross sectional areas, and may be configured with various features such as heads configured to accept other fixation system components, tabs to allow arcuate fixation member-in-arcuate fixation member or fixation anchor-in-arcuate fixation member configurations. Applications of fixation systems and intervertebral implants systems utilizing arcuate fixation members are particularly suitable when a linear line-of-approach for delivering fixation members is undesirable.

Abstract: Devices and methods for establishing aseptic connections between a drug container and a fluid pathway connection for a drug pump are provided. A fluid pathway connection includes a connection hub, a piercing member, a piercing member retainer, and a drug container. The drug container includes a cap, a pierceable seal, and a barrel. The piercing member is at least partially disposed in a sterile chamber defined by the connection hub, and the connection hub is configured to be connected to the drug container while maintaining an aseptic condition of a fluid pathway from the sterile chamber to an interior of the drug container.