Abstract: A gastrointestinal implant device (2800) comprises a planar proximal element (220) configured to reside in a stomach to resist distal migration, a distal element (222) configured to reside in an intestine to resist proximal migration and one or more tethers (224) coupling the planar proximal element to the distal element.

Abstract: A system and associated method for concentrating and separating components of different densities from fluid containing cells using a centrifuge includes a container defining a cavity for receiving the fluid. The container has a top, a sidewall extending from the top, and a bottom disposed opposite the top and in sealing engagement with the sidewall. An insert is slidably disposed in the cavity of the container and defines a lumen through the insert. The lumen, which includes a hole and a funnel-shaped upper portion in fluid communication with the hole, forms an open fluid path between opposite ends of the insert. The insert has a density such that upon centrifugation a selected component of the fluid resides within the lumen. A container port is disposed in the top of the container to transfer the fluid into the container and to withdraw a fluid component other than the selected component from the container.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA) to exclude the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. An implant is delivered via transcatheter delivery into the LAA. The implant includes a conformable structure comprising a foam body and internal support. The support includes anchors that penetrate the foam body and anchor the implant to the walls of the LAA. The implant provides compliance such that it conforms to the native configuration of the LAA.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: A bone marrow aspiration device and associated method includes an introducer needle assembly and an aspiration needle assembly. The introducer needle assembly includes an introducer cannula having proximal and distal ends, each end including an opening, and a screw assembly coupled to the introducer handle. The screw assembly includes a threaded tube and a lead screw receivable in the threaded tube. An outer cover is disposed around and in sealing engagement with the threaded tube and the lead screw. The aspiration needle assembly is receivable in the introducer cannula and includes an aspiration cannula forming a channel for aspirating bone marrow and including a flexible portion that extends from a distal end along a length of the aspiration cannula. A length of the aspiration cannula that extends beyond the distal end of the introducer cannula is adjustable by advancing the lead screw into or reversing the lead screw out of the threaded tube.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA) to exclude the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. A foam implant is delivered via transcatheter delivery into the LAA and anchored using an internal locking system of the implant. The locking system includes deployable anchors that can be deployed after deployment of the foam implant from the delivery catheter and expansion of the foam within the LAA. The implant location can thus be verified before deploying the anchors to secure the implant. The locking system can be reversible to allow retraction of the anchors and repositioning or retrieval of the implant.

Abstract: A system and associated method for concentrating and separating components of different densities from fluid containing cells using a centrifuge includes a container defining a cavity for receiving the fluid. The container has a top, a sidewall extending from the top, and a bottom disposed opposite the top and in sealing engagement with the sidewall. An insert is slidably disposed in the cavity of the container and defines a lumen through the insert. The lumen, which includes a hole and a funnel-shaped upper portion in fluid communication with the hole, forms an open fluid path between opposite ends of the insert. The insert has a density such that upon centrifugation a selected component of the fluid resides within the lumen. A container port is disposed in the top of the container to transfer the fluid into the container and to withdraw a fluid component other than the selected component from the container.

Abstract: A bone marrow aspiration device and associated method includes an introducer needle assembly and an aspiration needle assembly. The introducer needle assembly includes an introducer cannula having proximal and distal ends, each end including an opening, and a screw assembly coupled to the introducer handle. The screw assembly includes a threaded tube and a lead screw receivable in the threaded tube. An outer cover is disposed around and in sealing engagement with the threaded tube and the lead screw. The aspiration needle assembly is receivable in the introducer cannula and includes an aspiration cannula forming a channel for aspirating bone marrow and including a flexible portion that extends from a distal end along a length of the aspiration cannula. A length of the aspiration cannula that extends beyond the distal end of the introducer cannula is adjustable by advancing the lead screw into or reversing the lead screw out of the threaded tube.

Abstract: A bone marrow aspiration device and associated method includes an introducer needle and an aspiration needle. The introducer needle includes an introducer cannula and a removable introducer stylet that includes a sharp tip to penetrate bone. The aspiration needle includes an optionally flexible aspiration cannula and a blunt stylet. The aspiration needle is receivable in the introducer cannula when the introducer stylet is removed from the introducer needle. The aspiration cannula forms a channel for aspirating bone marrow when the stylet is removed. The aspiration device also includes a locking mechanism to lock the aspiration cannula to the introducer cannula when the aspiration cannula is received in the introducer cannula, whereby the aspiration cannula can be advanced distally relative to the introducer cannula in a controlled manner, and whereby pulling the aspiration cannula proximally causes the introducer cannula to move proximally with the aspiration cannula.

Abstract: A gastrointestinal implant device (2800) comprises a planar proximal element (220) configured to reside in a stomach to resist distal migration, a distal element (222) configured to reside in an intestine to resist proximal migration and one or more tethers (224) coupling the planar proximal element to the distal element.

Abstract: A bone marrow aspiration device and associated method includes an introducer needle and an aspiration needle. The introducer needle includes an introducer cannula and a removable introducer stylet that includes a sharp tip to penetrate bone. The aspiration needle includes an optionally flexible aspiration cannula and a blunt stylet. The aspiration needle is receivable in the introducer cannula when the introducer stylet is removed from the introducer needle. The aspiration cannula forms a channel for aspirating bone marrow when the stylet is removed. The aspiration device also includes a locking mechanism to lock the aspiration cannula to the introducer cannula when the aspiration cannula is received in the introducer cannula, whereby the aspiration cannula can be advanced distally relative to the introducer cannula in a controlled manner, and whereby pulling the aspiration cannula proximally causes the introducer cannula to move proximally with the aspiration cannula.

Abstract: The present invention relates to methods and articles for anchoring within a natural bodily lumen. An anchor is adapted to provide differing radially-outward forces along its length, a securing force and a transitional force. Production of these forces can be controlled by varying a physical property of the anchor, such as its stiffness, thickness, or shape. For example, the stiffness of an elongated anchor can be varied from a relatively soft value at its proximal and distal ends to a relatively stiff value at its center by varying the diameter of wire forming the anchor, thereby tailoring it to an intended application. Such force tailoring can be combined with external barbs and used to reliably anchor other instruments, such as feeding tubes and intestinal sleeves.

Abstract: A physiologic sensor module includes at least one wearable sensor that is configured for wearing on a human body part and for measuring at least one biological signal. The module further includes at least one controller communicatively coupled to the wearable sensor and configured to receive the biological signal from the wearable sensor. The controller is further configured to process the biological signal in real-time, extract one or more clinical features from the biological signal, and based on the clinical features, determine detection of anaphylaxis.

Abstract: An injector module includes a housing, a reservoir, a superelastic needle, and an actuator. The reservoir is positioned in the housing and stores epinephrine therein. The superelastic needle is positioned within the housing in a retracted position and is fluidly coupled with the reservoir. The superelastic needle has a gauge between eighteen and twenty-five. The actuator is configured to apply an actuator force on the superelastic needle such that the superelastic needle is moved from the retracted position to an injecting position where a tip of the superelastic needle protrudes from the housing between about fifteen millimeters and about thirty-five millimeters.

Abstract: A gastrointestinal implant device (2800) comprises a planar proximal element (220) configured to reside in a stomach to resist distal migration, a distal element (222) configured to reside in an intestine to resist proximal migration and one or more tethers (224) coupling the planar proximal element to the distal element.

Abstract: A physiologic sensor module includes at least one wearable sensor that is configured for wearing on a human body part and for measuring at least one biological signal. The module further includes at least one controller communicatively coupled to the wearable sensor and configured to receive the biological signal from the wearable sensor. The controller is further configured to process the biological signal in real-time, extract one or more clinical features from the biological signal, and based on the clinical features, determine detection of anaphylaxis.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. The device may have a thromboresistant cover at a proximal end. The frame may have recapture struts inclining radially outwardly from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame and into the foam to engage tissue.