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: 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: A container assembly for containing and delivering a medicament is described. The container assembly includes a container having a first end and a second end. The first end includes an opening, and a plunger assembly at least partially disposed in the container. The plunger assembly includes a main body and at least one resilient portion at least partially retained by a groove in the main body. The resilient portion forms a seal with the container. The plunger assembly forms a temperature resilient seal with the container such that the container assembly is operable to contain a medicament between the seal and the opening at: (a) room temperature, and (b) during freeze storage of the medicament. The plunger assembly is moveable relative to the container at room temperature.

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: 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: 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: 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 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: 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: A method and system for creating an aseptic connection is disclosed. The method includes arranging a heating element between a first outer sealing surface and a second outer sealing surface such that the heating element is in contact with the first outer sealing surface and the second outer sealing surface. The method further includes applying opposing forces to the first and second outer sealing surfaces such that the first and second outer sealing surfaces are biased towards each other and heating the heating element to sterilize the first outer sealing surface and second outer sealing surface. The method also includes removing the heating element from between the first seal and second seal while continuing to apply the opposing forces to the first and second outer sealing surfaces such that the aseptic connection is simultaneously formed between the first and second outer sealing surfaces.

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: A drive mechanism (100) for use with a drug container (50) in a drug pump, the drug container (50) having a barrel (58) and a plunger seal (60), including a tether, an electrical actuator (101) and a gear interface. Rotation of the gear interface is controlled by the actuator (101). A gear assembly rotationally engages with the gear interface. The gear assembly includes a main gear and a regulating mechanism. Release of the tether is metered by the gear assembly through the regulating mechanism. A piston (110, 1110, 2110) is connected to the tether and is disposed in the barrel (58) and configured to translate axially within the container. A biasing member is disposed at least partially within the barrel (58) and is retained in an energized state between the piston (110, 1110, 2110) and drive housing, wherein the release of the tether controls the free expansion of the biasing member from its energized state and the axial translation of the piston (110, 1110, 2110).

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: 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 drive mechanism (100) for use with a drug container (50) in a drug pump, the drug container (50) having a barrel (58) and a plunger seal (60), including a tether, an electrical actuator (101) and a gear interface. Rotation of the gear interface is controlled by the actuator (101). A gear assembly rotationally engages with the gear interface. The gear assembly includes a main gear and a regulating mechanism. Release of the tether is metered by the gear assembly through the regulating mechanism. A piston (110, 1110, 2110) is connected to the tether and is disposed in the barrel (58) and configured to translate axially within the container. A biasing member is disposed at least partially within the barrel (58) and is retained in an energized state between the piston (110, 1110, 2110) and drive housing, wherein the release of the tether controls the free expansion of the biasing member from its energized state and the axial translation of the piston (110, 1110, 2110).

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: 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: 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: 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: 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.