Abstract: The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.

Abstract: An implantable prosthetic device can include a hybrid frame movable between a radially compressed configuration and a radially expanded configuration. The hybrid frame can include a mechanically-expandable first sub-frame comprising a plurality of struts pivotably coupled to one another, and a plastically deformable second sub-frame coupled to the first sub-frame. When the hybrid frame is in the expanded configuration, the second sub-frame can be configured to resist radial compression of the frame.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.

Abstract: Provided herein are the compositions and methods of manufacturing of injectable gels of cross-linked hyaluronic acid associated to a varying degree with hydroxyapatite.

Abstract: A delivery apparatus for an expandable prosthetic heart valve includes a handle, and a shaft having a proximal end portion coupled to the handle and a distal end portion including a delivery capsule. The delivery capsule having an inner surface, an outer surface, and a plurality of elongate and axially extending inner and outer guide rails, the inner guide rails being spaced apart circumferentially around and extending radially inwardly from the inner surface and the outer guide rails being spaced apart circumferentially around and extending radially outwardly from the outer surface. The inner guide rails are configured to engage the prosthetic heart valve in a radially-compressed configuration and the outer guide rails are configured to contact an inner surface of an outer shaft.

Abstract: This disclosure is directed to assemblies, apparatuses, and methods for electrically stimulating the body. In one example, a medical apparatus comprises a handle comprising an electrical connection assembly that is configured to establish an electrical connection between a guidewire and an electrode of an external electrical stimulation generator and that is configured to maintain this electrical connection when the guidewire moves longitudinally relative to the handle, or vice versa. The guidewire may be configured to electrically contact tissue of a patient to deliver electrical stimulation to the tissue. In some examples, the medical apparatus may be included in a medical assembly comprising an introducer device that is configured to facilitate subcutaneous insertion of the medical apparatus. The introducer device may be configured to be electrically connected to electrical stimulation generator and may be configured to electrically contact tissue of the patient.

Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: A docking station for a prosthetic heart valve includes a radially expandable and collapsible frame with a first plurality of struts, an inflow end portion, an outflow end portion, and a longitudinal axis. A sealing member is disposed on the outflow end portion and configured to form a seal between the docking station and a body lumen. The docking station further includes a valve seat coupled to the frame and configured to receive an expandable prosthetic valve. The valve seat includes a second plurality of struts coupled to the frame and extending in a downstream direction and angled inwardly toward the longitudinal axis of the frame.

Abstract: Embodiments of an implantable frame are disclosed. The frame can have a plurality of struts interconnected to each other to form a mesh structure that is radially expandable and compressible. The frame can have a connecting post extending from an end of the frame. The connecting post can have a body portion and a head portion affixed to an end of the body portion. The head portion can have a first edge extending outwardly of the body portion. The first edge can have a substantially flat portion that is substantially perpendicular to the body portion.

Abstract: An implantable prosthetic device can include a hybrid frame movable between a radially compressed configuration and a radially expanded configuration. The hybrid frame can include a mechanically-expandable first sub-frame comprising a plurality of struts pivotably coupled to one another, and a self-expanding second sub-frame coupled to the first sub-frame. When the hybrid frame is in the expanded configuration, the second sub-frame can be configured to resist radial compression of the frame.

Abstract: The disclosure relates to a device for creating an intradermal channel in a skin tissue of a patient, with a thread. The device can include a main body, a penetration element, and a displacement mechanism. The main body can have a lumen. The penetration element can be at a distal end of the main body and have a cannula which is configured to contain the thread in its entirety. The displacement mechanism can have at least a portion thereof permanently contained within the lumen of the main body. The displacement mechanism can be configured to effect a relative motion between the cannula and the thread, thereby to expose at least a portion of the thread to a patient's tissue within an intradermal channel.

Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: The present embodiments relate generally to devices, systems, and methods for delivery systems including nose cones. A delivery system may include a handle and an elongate shaft coupled to the handle. The delivery system may include a nose cone having a distal opening at a distal end and a proximal opening at a proximal end, the proximal opening configured to receive the distal end of the elongate shaft. Projections or threads may couple the nose cone to the distal end of the elongate shaft.

Abstract: A loading apparatus including an outer body, a guide tube, and an annular loading member is disclosed. As one example, the outer body includes an inner conical bore that narrows in diameter from a distal end to a proximal end portion of the outer body and the guide tube includes a distal portion arranged within the proximal end portion of the outer body and a proximal portion extending outward from the outer body. The annular loading member can include a ring portion and a plurality of arms extending outward, in an axial direction relative to a central longitudinal axis of the loading apparatus, from the ring portion, the ring portion coupled to an inner surface of the distal portion of the guide tube.

Abstract: A thermogenic cannabis composition for oral administration, including cannabis extract and at least one thermogenic agent, and method of producing same.

Abstract: Disclosed is an expandable sheath that can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. The disclosed sheaths can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Also disclosed is a sheath having inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer, and a portion of the outer layer overlaps the folded portion of the inner layer and where a first polymer is disposed between the outer layer and the folded portion of the inner layer.

Abstract: A delivery apparatus for an implantable medical device includes a handle, a shaft having a proximal end portion and a distal end portion, the proximal end portion being coupled to the handle, and a nosecone coupled to the distal end portion of the shaft. The nosecone includes a proximal end portion and a distal end portion pivotably coupled to the proximal end portion.

Abstract: Prosthetic valves can have a reinforcement member designed to protect various components of the valve and the surrounding tissues from damage. The reinforcement member can include a suture with a plurality of apertures. Sutures with apertures can be utilized within or as reinforcement members, which can be attached to a prosthetic valve to reinforce the prosthetic valve.

Abstract: A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.