Abstract: Biocompatible crosslinked polymers, and methods for their preparation and use, are disclosed in which the biocompatible crosslinked polymers are formed from water soluble precursors having electrophilic and nucleophilic functional groups capable of reacting and crosslinking in situ. Methods for making the resulting biocompatible crosslinked polymers biodegradable, or not, are provided, as are methods for controlling the rate of degradation. The crosslinking reactions may be carried out in situ on organs or tissues or outside the body. Applications for such biocompatible crosslinked polymers and their precursors include controlled delivery of drugs, prevention of post-operative adhesions, coating of medical devices such as vascular grafts, wound dressings and surgical sealants. Visualization agents may be included with the crosslinked polymers. Embodiments that include hydrogels having isolated hydrolytically degradable esters are set forth.

Abstract: Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device disposed on a guidewire includes a support hoop disposed from a suspension strut. Alternately, a support hoop having an articulation region may be directly connected to a region proximate the distal end of the guidewire. A blood permeable sac is affixed to the support hoop to form a mouth of the blood permeable sac. The support hoop is disposed obliquely relative to the longitudinal axis of the guidewire and is capable of being properly used in a wide range of vessel diameters. The vascular device collapses during removal to prevent material from escaping from the sac. A delivery sheath and introducer sheath for use with the vascular device of the present invention are also provided.

Abstract: Vascular embolic filtering systems, as well as methods for using the same, are provided. In general, the subject invention includes a system comprised of an embolic filter assembly and a multiple lumen delivery and retrieval sheath, where the embolic filter assembly includes a guide wire with an embolic filter operatively coupled to the distal end of the guide wire for capturing emboli created during interventional procedures within a target vessel. Features of the subject invention provide for the rapid exchange and deployment of embolic filters in a patient's vasculature.

Abstract: Methods and apparatus of forming hydrogel systems in situ are provided using a delivery system configured to deliver two or more fluent prepolymer solutions without premature crosslinking. The delivery system comprises separate first and second lumens coupling first and second inlet ports and first and second outlet ports, respectively, and may include a balloon, flexible distal region, mixing chamber or steerable distal end. Multi-component hydrogel systems suitable for use with the inventive methods and apparatus are also described.

Abstract: Apparatus for sealing a puncture communicating with a blood vessel includes a porous carrier formed from lyophilized hydrogel or other material. The plug may include at least first and second hydrogel precursors and a pH adjusting agent carried by the porous carrier in an unreactive state prior to exposure to an aqueous physiological environment. Once exposed to bodily fluids, the carrier expands as the lyophilized material hydrates to enhance and facilitate rapid hemostasis of the puncture. When the plug is placed into the puncture, the natural wetting of the plug by bodily fluids (e.g., blood) causes the first and second precursors to react and cross-link into an adhesive or “sticky” hydrogel that aids in retaining the plug in place within the puncture.

Abstract: Certain embodiments of the invention include forming a material in situ by introducing into a space within a patient a water soluble polymer precursor of at least about 10,000 molecular weight solubilized in a flowable aqueous solution. Functional groups on the polymer precursor undergo covalent bonding in situ to form a solid and nonbiodegradable material having a swellability less than about 20% v/v and a Young's modulus of at least about 100 kPa within about 30 seconds to about 30 minutes of initiating a chemical reaction of the functional groups to form the solid material.

Abstract: Apparatus and methods are provided for delivering a stent into an ostium. The apparatus includes a catheter including a proximal end, a distal end, and proximal and distal balloons disposed adjacent one another on the distal end. The balloons are expandable independently of one another, and a stent is provided surrounding the balloons. During use, the distal end of the catheter is introduced into a main lumen, and the proximal balloon is inflated to flare a proximal portion of the stent. The distal end is then advanced into the ostium until the flared proximal portion contacts a wall of the main lumen surrounding the ostium. The distal balloon is inflated to expand a distal portion of the stent, e.g., to dilate a lesion within the branch and/or ostium. Thereafter, the balloons are collapsed, and the apparatus is withdrawn, leaving the stent within the ostium.

Abstract: Described herein are systems for packaging dual or multiple-component adhesive systems that provide enhanced convenience and efficacy. In one aspect, the components of such a system may be divided into containers that allow for foolproof mixing schemes to avoid mixing the wrong components while also providing a sterile surface for mixing materials, with the sterile surface having optimal physical properties for mixing the materials, especially in small amounts. Certain embodiments include a surgical delivery system for a medical sealant including a packaging system with a detachable a sterile surface for mixing the sealant as needed for application.

Abstract: Apparatus and methods for sealing a puncture through tissue or otherwise treating a body lumen of a patient. The carrier includes at least one, but not all, of the adherent layer components required to form a tacky or sticky adherent layer on the carrier. The remaining adherent layer precursor(s) are delivered to the carrier in situ to form a sticky and/or tacky adherent layer on the carrier that enhances the attachment and retention of the carrier to tissue surrounding a target treatment location in which the carrier is delivered. The carrier may include hydrogel and/or other porous material, e.g., for releasing one or more agents carried by the carrier at the treatment location.

Abstract: An apparatus for capturing material within a body lumen includes a shaft carrying an expandable basket device on a distal end thereof. The basket device includes a distal basket carried and a proximal basket carried on the shaft such that the proximal basket is proximal to and spaced apart from the distal basket. Each basket includes an open end communicating with an interior of the respective basket and oriented towards one another. In one embodiment, a tubular middle portion extends between the baskets. In another embodiment, the distal basket includes an actuator coupled to the distal basket open end such that movement of the baskets towards one another causes the actuator to direct the distal basket open end inwardly to allow the open end to be received within the proximal basket to facilitate removal of the apparatus after capturing material within the baskets.

Abstract: Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a dry, less hydrated, or substantially deswollen state and rehydrate in a physiological environment to undergo a volumetric expansion and to affect sealing, plugging, or augmentation of tissue, defects in tissue, or of organs. The hydrogel polymers may deliver therapeutic entities by controlled release at the site. Methods to form useful devices from such polymers, and to implant the devices are provided.

Abstract: Methods and apparatus of forming hydrogel systems in situ are provided using a delivery system configured to deliver two or more fluent prepolymer solutions without premature crosslinking. The delivery system comprises separate first and second lumens coupling first and second inlet ports and first and second outlet ports, respectively, and may include a balloon, flexible distal region, mixing chamber or steerable distal end. Multi-component hydrogel systems suitable for use with the inventive methods and apparatus are also described.

Abstract: Certain embodiments include a method of improvising radiological outcomes by introducing a filler to between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, and administering a dose of radioactivity to at least the first tissue location or the second tissue location. Collagen and hyaluronic acid are examples of fillers. Certain embodiments include a medical device having a biocompatible, biodegradable filler material, wherein the device comprises at least a portion that has a shape that substantially conforms to Denovillier's space between the rectum and prostate. Certain embodiments include a kit, the kit comprising a filler and instructions for placing the filler between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location.

Abstract: Apparatus and methods for retrieving a vascular filter from a vessel are provided wherein a retrieval adapter is delivered to a treatment site concurrently along with an interventional device to reduce the number of steps required to remove the vascular filter. The retrieval adapter also reduces the possibility of entangling the vascular filter with a stent disposed within the vessel during removal of the vascular filter. A separate retrieval catheter is also described for use in conjunction with the retrieval adapter.

Abstract: Vascular embolic filtering devices and systems, as well as methods for using the same, are provided. The embolic filtering device includes a guide wire and an associated embolic filter for capturing emboli created during interventional procedures within a target vessel. Features of the subject devices and system provide for delivering of the guide wire independently of the filter, rotating of the guide wire with respect to the filter and limiting or preventing the proximal translation of the filter with respect to the guide wire. The embolic filter is attached to a sheath having either a shorter-length configuration or an extended-length configuration. The guide wire comprises a proximal stop mechanism engageable with the sheath to limit at least the proximal translation of the embolic filter. The subject embolic filter systems provide such guide wires and embolic filters, as well as and an embolic filter delivery, deployment and removal assembly.

Abstract: Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a dry, less hydrated, or substantially deswollen state and rehydrate in a physiological environment to undergo a volumetric expansion and to affect sealing, plugging, or augmentation of tissue, defects in tissue, or of organs. The hydrogel polymers may deliver therapeutic entities by controlled release at the site. Methods to form useful devices from such polymers, and to implant the devices are provided.

Abstract: A method of concentrating proteins from whole blood comprising exposing whole blood to covalently crosslinked hydrogel to remove water from the blood into the hydrogel to thereby concentrate the proteins in the whole blood. The hydrogel may absorb, for example, 50% or 90% of the water from the blood while excluding proteins with a weight of more than about 15,000 Daltons. In some embodiment, the hydrogels are dry, sterile, and spherical.

Abstract: Some aspects of this disclosure relate to a method for crosslinking a biological fluid comprising combining a biological fluid with a crosslinker to covalently crosslink proteins endogenous to the biological fluid to form a crosslinked gel. Examples of a biological fluid are blood, plasma, or serum.

Abstract: Biocompatible crosslinked polymers, and methods for their preparation and use, are disclosed in which the biocompatible crosslinked polymers are formed from water soluble precursors having electrophilic and nucleophilic functional groups capable of reacting and crosslinking in situ. Methods for making the resulting biocompatible crosslinked polymers biodegradable or not are provided, as are methods for controlling the rate of degradation. The crosslinking reactions may be carried out in situ on organs or tissues or outside the body. Applications for such biocompatible crosslinked polymers and their precursors include controlled delivery of drugs, prevention of post-operative adhesions, coating of medical devices such as vascular grafts, wound dressings and surgical sealants. Visualization agents may be included with the crosslinked polymers.

Abstract: A stent includes a first portion including first and second bands of cells that flare outwardly when the stent is expanded from a contracted to a flared condition, and a second portion connected to the first portion by flexible connectors. During use, the stent is introduced into a main vessel in the contracted condition and positioned with the first portion adjacent an ostium and the second portion within a branch vessel extending from the ostium. The first portion is flared, causing first struts of the first set of cells to move from an axial towards a radial and partial circumferential orientation and causing second struts of the second set of cells to move from an axial towards a radial orientation. The stent is expanded further such that the second portion expands within the branch body lumen, and the first and second struts move towards a more circumferential orientation.