Abstract: A prosthetic valve device, a method for making a valve device, and a method for implanting a valve device into a recipient are provided. The valve device includes at least one flexible member formed at least partially from a woven layer. The woven layer includes a first material and a second material being at least partially woven together. The at least one flexible member is movable between a first position that permits fluid flow in a first direction and a second position that substantially prevents fluid flow in a second direction. The valve has a first, unexpanded configuration and a second, expanded configuration.

Abstract: Described are vascular valve devices having valve elements formed of flexible material and at least one removable frame element. Also described are methods for using such devices in the vascular system and in particular in the venous system to treat venous insufficiency.

Abstract: An introducer sheath has an inner fluorocarbon liner, a reinforcing member disposed radially outwardly from the liner, and a polymeric intermediate layer positioned longitudinally over the reinforcing member and inner liner. A heat shrink layer formed of a block copolymer having cross-linked and non-cross-linked functional groups comprises an outer layer of the sheath. During for of the introducer sheath, the intermediate layer is melted and compressed in the heat shrink layer in a manner such that the inner surface of the intermediate layer bonds to the outer surface of the inner liner through spacings of the reinforcing member, and the outer surface of the intermediate layer bonds with non-cross-linked active functional groups of the heat shrink layer.

Abstract: An embolic protection device generally includes an elongated hub and at least one projection. The projection defines a tortuous pathway between the hub and the vessel wall to prevent emboli from following the pathway and passing beyond the device. The tortuous pathway is structured to permit the bodily fluid to follow the pathway and pass beyond the device.

Abstract: The present disclosure provides embodiments of a method for characterizing microbial populations. Exemplified by methods for characterizing microbiota in vaginal samples, the methods provided herein are widely applicable to the characterization of microbial communities. Also provided are probiotic regimens and methods for selecting appropriate probiotic regimens based on the normal vaginal microbiota of a subject. Reagents and kits for detecting normal vaginal microbiota and diagnosing pathogenic microorganisms in the vagina are also provided.

Abstract: A pessary applicator for positioning a pessary inside a vaginal cavity. The pessary applicator includes an outer member disposed co-axially with an inner member for insertion of the pessary into the vaginal cavity. The inner member is slidable within the outer member wherein at least 15% of a length of the pessary remains in the outer member when the inner member is fully engaged with the outer member to define a remaining portion of the pessary. The remaining portion of the pessary requires a force of less than about 0.30 N to be removed from the pessary applicator. Alternatively, when the inner member is fully engaged with the outer member to define a remaining portion of the pessary, the remaining portion of the pessary requires a force of less than about 0.04 N/mm to be removed from the outer member.

Abstract: A pessary applicator for positioning a pessary inside a vaginal cavity. The pessary applicator includes an outer member, an inner member which is slidable within the outer member, and a pessary which is housed within the pessary applicator. The inner member has an effective length of less than about 58 mm.

Abstract: A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Abstract: Medical devices with one or more bioactive agents are provided for regulating fluid flow through a body vessel. Medical devices according to the invention can comprise prosthetic valves that include a bioactive agent.

Abstract: An apparatus for providing percutaneous access to a vessel of a patient over a wire guide. An outer sleeve of the apparatus has proximal and distal open ends, and has a lumen extending longitudinally therethrough. An inner sleeve has proximal and distal open ends, and has a lumen extending longitudinally therethrough. The inner sleeve is sized to be received within the lumen of the outer sleeve. The inner sleeve has a main body portion having a distal portion that tapers toward its distal open end. The tapered distal portion extends distal to the distal open end of the outer sleeve to provide a generally smooth diametrical transition between the outer sleeve and the wire guide. A more rigid stiffening cannula has proximal and distal open ends, and has a lumen extending longitudinally therethrough. The lumen of the stiffening cannula is sized to receive the wire guide therethrough.

Abstract: A delivery system, including a balloon catheter having a balloon with distal and proximal ends and a guide catheter for delivering the balloon catheter to a treatment site, is disclosed. The balloon tapers from at least one of the distal and proximal ends of the balloon to an active region on the surface of the balloon. The active region has a diameter D1 which is greater than a diameter of the balloon at one or more of the distal and proximal ends of the balloon. Preferably, one or more of the lengths L1, which is the distance from the proximal end of the balloon to the active region, and L2, which is the distance from the distal end of the balloon to the active region, are between three to thirty times the diameter D1.

Abstract: A pessary applicator for positioning a pessary inside a vaginal cavity. The pessary applicator includes an outer member, an inner member, a pessary, and a pessary positioning member. The outer member is disposed co-axially with the inner member for insertion of the pessary into the vaginal cavity. The inner member includes a first end, a second end, and an interior surface. The inner member is slidable within the outer member. The pessary is at least partially housed within the inner member. The pessary positioning member is positioned within the inner member. The pessary positioning member includes a pessary pushing surface positioned between the first end and the second end of the inner member.

Abstract: A multiple-sided valve for implantation within a body vessel comprising a frame comprising a bioabsorbable material is provided. The devices can be pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material, or a bioabsorbable material, including a collagen-based material such as small intestinal submucosa (SIS), may be attached to the frame to form an occlusion device, a graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Abstract: Prosthetic valves for regulating fluid flow through a body vessel are described. The valves include a valve member that includes at least a portion that is capable of moving to selectively permit and substantially prevent fluid flow through the body vessel, either alone or with one or more additional valve members. A cannula is associated with the valve and permits a controlled amount of fluid flow through the valve, such as retrograde flow while the valve member substantially prevents fluid flow through the body vessel.

Abstract: A filter to capture blood clots includes a hub with a passageway through which a wire guide is received. The filter also includes a plurality of primary struts and a plurality of secondary struts that extend from the hub. Each primary strut terminates with a hook to anchor the filter in the blood vessel when the filter is deployed in the blood vessel. The secondary struts center the filter in the blood vessel as the secondary struts engage the interior of the blood vessel during deployment of the filter in the vessel.

Abstract: An apparatus and method for use in the percutaneous placement of a medical device, such as a tracheostomy tube. An elongated hollow tube has an inflatable dilator balloon mounted thereon. The balloon comprises a distal portion, an intermediate portion and a proximal portion. The medical device is carried on the intermediate portion. At least a segment of the distal portion has an inflated outer diameter that is at least as large as the outer diameter of the medical device. The inflated outer diameter of the intermediate portion is sized relative to an internal diameter of the medical device to hold the medical device thereon. An inflation assembly is provided to enable the balloon to be selectively inflated and deflated. A body opening is dilated with the inflated dilator balloon, and the medical device may be percutaneously placed across the dilated opening. Following placement of the device, the dilator balloon may be deflated and withdrawn from the apparatus through a lumen of the medical device.

Abstract: A removable vena cava filter configured for simplified delivery to and retrieval from the vena cava of a patient is disclosed. The filter includes struts configured to be arranged in consistent orientation together between expanded (opened) and collapsed (closed) configurations, thereby minimizing entanglement of the struts. Each of the struts has a circumferential bend relative to the longitudinal axis of the filter. The circumferential bends allow for consistent orientation of the struts when moved between the expanded and collapsed configurations and when placed in the closed configuration of the filter.

Abstract: A composition and methods for reducing malodor in a human. The composition includes one or more bacteria selected from the group consisting of Lactobacillus iners and all clones with at least 97% sequence similarity to Lactobacillus iners as determined by sequences from 16S rRNA genes. The method includes administering a safe and effective amount of the composition.

Abstract: The present invention provides a wire guide having a wire core and a braided sheath. The wire core includes a proximal end and distal end, wherein the braided sheath is attached to the distal end of the wire core and serves as a flexible pulling section. The braided sheath is woven of a plurality of strands and may be made of various material based on the application, such as stainless steel, a shape memory alloy, or a radiopaque material. The wire guide has a flexible tip at the proximal end opposite the flexible pulling section. A stiff section is provided between the flexible tip and the flexible pulling section to allow manipulation of the wire guide through a body lumen. Proximate the distal end of the wire core a tapered section is provided to increase flexibility of the wire guide toward the distal end. The braided sheath is received over and attached to the wire core. In addition, a shoulder is provided in the wire core providing a smooth transition from the wire core to the braided section.

Abstract: A composition and methods for maintaining and restoring normal urogenital flora in humans. The composition includes one or more bacteria selected from the group consisting of Lactobacillus iners, all clones with at least 97% sequence similarity to Lactobacillus iners, Atopobium spp, and all clones with at least 90% sequence similarity to Atopobium spp as determined by sequences from 16S rRNA genes. The method for maintaining includes administering a safe and effective amount of the composition. The method for restoring includes administering a safe and effective amount of an antibiotic and subsequently administering a safe and effective amount of the composition.