Abstract: Apparatus and methods for sealing a puncture communicating with a blood vessel are provided that include introducing a porous carrier formed from lyophilized hydrogel or other material into the puncture. The plug may include at least one of 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: Some aspects of this disclosure relate to a method of treating an ophthalmic disease affecting an eye of a patient comprising forming a covalently-crosslinked hydrogel in situ at a peri-ocular, intra-ocular, or intra-vitreal site for controlled release of a therapeutic agent.

Abstract: Implantable materials may be used in an iatrogenic site. Applications include radiopaque materials for fiducial marking. For instance, a method of treating fiducially marking a patient comprising placing a fiduciary marker in the patient at a tissue in the patient, said marker comprising a collection of pharmaceutically acceptable, covalently-crosslinked hydrolytically biodegradable hydrogel particles into the tissue of the patient, the collection comprising a plurality of the particles having a covalently attached radiopaque agent, with the radiopaque agent being present in the collection at a concentration of at least about 0.1% w/w.

Abstract: Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device comprises one or more support hoops connected near a distal end of a guide wire, each support hoop having an articulation region, and a blood permeable sac affixed to the support hoop or hoops to form a mouth of the blood permeable sac. The mouth of the sac closes when the apparatus is collapsed for removal to prevent material from escaping from the sac.

Abstract: Compositions and methods are provided to control the release of relatively low molecular weight therapeutic species through hydrogels by first dispersing or dissolving such therapeutic species within relatively hydrophobic rate modifying agents to form a mixture. The mixture is formed into microparticles that are dispersed within bioabsorbable hydrogels, so as to release the water soluble therapeutic agents in a controlled fashion. Methods of using the compositions of the present invention in therapeutic systems are also provided.

Abstract: Serial-solvent biomaterials are described. Embodiments include materials made in an organic solvent that are stripped of the solvent and used in a patient, where they imbibe water and form a hydrogel. These materials are useful for, among other things, delivering therapeutic agents, tissue augmentation, and radiological marking.

Abstract: Some aspects of this disclosure relate to a method of treating an opthalmic disease affecting an eye of a patient comprising forming a covalently-crosslinked hydrogel in situ at a peri-ocular, intra-ocular, or intra-vitreal site for controlled release of a therapeutic agent.

Abstract: Apparatus are provided for accessing and/or removing material from a body lumen. The apparatus includes a tubular sheath including a shaft having a proximal end and an expandable distal end that is expandable between a collapsed configuration and an expanded, tapered configuration. In one embodiment, the expandable member include inner and outer membranes attached together and to the shaft. Optionally, the inner membrane may include a reinforcement layer and/or the outer membrane may have a longer chord length than the inner membrane, to enhance the expandable member expanding such that a distal opening is defined by the expandable member having s a relatively large diameter tapering proximally to a lumen of the shaft. Optionally, the apparatus may include a dilator and/or one or more treatment devices receivable in the lumen of the shaft.

Abstract: Methods for sealing a puncture communicating with a blood vessel are provided that include introducing a porous carrier formed from lyophilized hydrogel or other material into the puncture. 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: Materials and methods of treating an eye with a hydrogel formed on the eye. Embodiments are provided that include post-keratectomy bandages. A method of treating a patient by application of a hydrogel bandage to a cornea by providing a first hydrogel precursor in a dry form immobilized in a first deposit at a first location in a well, providing a second hydrogel precursor in a dry form immobilized in a second deposit at a second location in the well, mixing the deposits together to form a mixture, and transferring at least some of the mixture to the cornea, with the mixture forming a covalently crosslinked hydrogel on the cornea.

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: Implantable materials may be used in an iatrogenic site. Applications include radioopaque materials for fiducial marking. Applications include a method of treating a patient with a pharmaceutically acceptable implant system comprising implanting a collection of pharmaceutically acceptable, covalently-crosslinked hydrogel particles, wherein the collection comprises a plurality of sets of the particles, with the sets having different rates of biodegradation.

Abstract: Methods are provided for making freeze dried hydrogel and structures therefrom that may be introduced into a patient's body for medical applications. Precursor components are combined to initiate crosslinking. The combined precursor components are placed in a chilled tray, and allowed to crosslink to a desired level of complete crosslinking before and/or after being placed onto the tray. The partially crosslinked hydrogel is frozen and freeze dried. After freeze drying, the hydrogel is conditioned to substantially complete crosslinking, and formed into one or more structures, e.g., plugs, hemostatic, or other medical devices. For example, the hydrogel may be cut, machined, rolled, folded, compressed, and/or cored into that may be loaded into delivery devices that may be introduced into a body to implant or otherwise deliver the structures into the body, e.g., to seal a puncture or other passage through tissue.

Abstract: A stent includes a first flaring portion including first and second sets of cells that flare outwardly when the stent is expanded from a contracted to a flared condition, and a second main portion connected to the first flaring portion. During use, the stent is introduced into a main vessel in the contracted condition and positioned with the first portion adjacent an 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 second portion resists expansion when the first portion is flared. 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.

Abstract: Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device comprises one or more support hoops connected near a distal end of a guide wire, each support hoop having an articulation region, and a blood permeable sac affixed to the support hoop or hoops to form a mouth of the blood permeable sac. The mouth of the sac closes when the apparatus is collapsed for removal to prevent material from escaping from the sac.

Abstract: Implantable materials may be used in an iatrogenic site. Applications include radioopaque materials for fiducial marking. Applications include a method of treating a patient with a pharmaceutically acceptable implant system comprising implanting a collection of pharmaceutically acceptable, covalently-crosslinked hydrogel particles, wherein the collection comprises a plurality of sets of the particles, with the sets having different rates of biodegradation.

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: Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device comprises one or more support hoops connected near a distal end of a guide wire, each support hoop having an articulation region, and a blood permeable sac affixed to the support hoop or hoops to form a mouth of the blood permeable sac. The mouth of the sac closes when the apparatus is collapsed for removal to prevent material from escaping from the sac.

Abstract: An embodiment is a medical prosthesis for blocking or reducing tear flow through a punctum or canaliculus of a human eye and delivering a drug to the eye that comprises a dehydrated covalently crosslinked synthetic hydrophilic polymer hydrogel with dimensions to pass through a puncta lacrimali, with the dehydrated hydrogel absorbing physiological water to swell to at least 1 mm in cross-sectional width and conformably fit a canaliculus, with the hydrogel comprising a therapeutic agent dispersed through the hydrogel for release to an eye, with the hydrogel having a water content of at least about 50% by weight or volume when allowed to fully hydrate in vitro in physiological saline.

Abstract: Apparatus and methods are provided for use in filtering emboli from a vessel such as the ascending aorta, wherein a vascular device comprises a support hoop having an articulation region connected near a distal end of an elongated member, a blood permeable sac affixed to the support hoop so that the support hoop forms a mouth of the blood permeable sac, a guide wire, and a delivery sheath. The articulation region comprises a reduced thickness region of the support hoop that prevents kinks from forming in the support hoop when the apparatus is contracted to its delivery state, and curved regions that close the mouth of the sac to prevent material escaping from the sac when the apparatus is collapsed for removal.