Abstract: A biocompatible medical device having a segmented element including a first segment having a first shaped interface and a second segment having a second shaped interface configured to operably couple the first shaped interface. When the first shaped interface is engaging the second shaped interface to form a joined segmented element, the first segment and the second segment cannot be decoupled by movement along an axis through the element. The medical device further includes a locking element configured to engage the joined segmented element with a sliding motion to prevent decoupling of the first segment with respect to the second segment by preventing significant relative movement of the segments with a component of the movement perpendicular to the axis.

Abstract: Thrombectomy catheters are presented that have curved tip portions. A suction lumen extends from at or near the proximal end of the catheter to a suction port at or near the tip portion of the catheter. The curves of the thrombectomy catheter can be selected to place a suction port at or near a vessel wall for the more effective removal of thrombus resulting from directing the suction in the direction of the thrombus. In some embodiments, the tip portion of the catheter can be transitioned from a first configuration for delivery of the catheter into the vessel to a second more curved configuration with a desired design for application of suction. The catheter can be moved in a circumferential and/or lateral direction to cover selected portions of the inner vessel wall. In some embodiments, a partially occlusive structure can be used to reduce and/or redirect flow within the vessel to improve performance of the thrombectomy.

Abstract: Devices for the isolation of a selected portion of a vessel are described. In some embodiments, the device comprises an introducer sheath and a sealing catheter that are movable relative to each other to create an isolated volume with adjustable size and location. The methods for the treatment of vascular aneurysms using the devices are described. The treatment is achieved through the delivery of an effective amount of stabilization agent to an isolated volume that encompass the aneurysm. The device optionally has an aspiration means to improve the effectiveness of the treatment.

Abstract: Methods and devices for the stabilization of heart tissue to treat congestive heart failure using a therapeutic composition are discussed. The therapeutic composition can comprise an elastin stabilization agent, a collagen stabilization agent, or a combination thereof and be applied to the pericardium, to the outer surface of the myocardium, or a combination thereof using a catheter type of device with an attached reservoir. Controlled placement and release of the therapeutic composition can be achieved using a delivery vehicle to formulate the composition.

Abstract: Improved embolism protection devices comprises fibers that can have one configuration for delivery of the device and a second configuration in which the device is deployed for filtering of flow within a vessel. In some embodiments, the fibers can be connected to a fiber support, which is connected to an actuating element. The actuating element controls the transition from the delivery configuration to the deployed configuration. The embolism protection device can comprise a guidewire. The fibers can be attached at one end to a fiber support structure and at another end to the guidewire. A hypotube can be attached to the proximal end of the fibers while the guidewire is attached at the distal end of the fibers with the guidewire extending within a central channel of the hypotube. The hypotube can be used to guide the delivery of treatment structures, such as a balloon and/or a stent.

Abstract: Improved embolism protection devices comprises fibers that can have one configuration for delivery of the device and a second configuration in which the device is deployed for filtering of flow within a vessel. In some embodiments, the fibers can be connected to a fiber support, which is connected to an actuating element. The actuating element controls the transition from the delivery configuration to the deployed configuration. The embolism protection device can comprise a guidewire. The fibers can be attached at one end to a fiber support structure and at another end to the guidewire. A hypotube can be attached to the proximal end of the fibers while the guidewire is attached at the distal end of the fibers with the guidewire extending within a central channel of the hypotube. The hypotube can be used to guide the delivery of treatment structures, such as a balloon and/or a stent.

Abstract: A polypeptide growth factor is associated with a substrate to promote population of the substrate with endothelial cells. In a preferred approach, the growth factor is associated with the substrate by crosslinking under suitably mild conditions such that the growth factor is active following the crosslinking process. Thus, a prosthesis is formed with growth factor crosslinked to the substrate.

Abstract: Collagen crosslinking/stabilization composition optionally in combination with elastin crosslinking composition as treatment of vascular aneurysms, methods of using the compositions, especially with respect to in vivo procedures are described. The treatment is achieved through the delivery of an effective amount of crosslinking/stabilization composition to the site of the aneurysm. The crosslinking/stabilization agent may be embedded in a delivery composition and delivered to the site of aneurysm using a delivery device. The site of the aneurysm may be isolated for treatment using the delivery device. The elastin stabilization agent may be simultaneously or sequentially delivered with the collagen crosslinking/stabilization agent for the treatment of vascular aneurysms in the isolated section of blood vessel.

Abstract: Devices for the treatment of vascular aneurysms are described. The treatment is achieved through the delivery of an effective amount of elastin stabilization agent to an isolated volume at the aneurysm. The elastin stabilization agent maybe embedded in a delivery composition. The device optionally has an aspiration means to improve the effectiveness of the treatment.

Abstract: Various devices are described to provide filtering of flow from the aorta to the left carotid artery and the right carotid artery. The filters can be brought into a desired position through one or more peripheral arteries. A single filter device can provide the desired filtering or a plurality of devices can be used. In particular a single filter device can span between the brachiocephalic artery and the left carotid artery. These filter devices can be used effectively to capture emboli generated during procedures on the heart so that emboli do not travel to the patient's brain where the emboli can cause a stroke or other adverse event. In particular, these filters can be used during percutaneous procedures on the heart, such as endovascular heart valve replacement.

Abstract: Improved medical device have an inorganic substrate and a polymer covering at least a portion of the substrate, in which the polymer forms a structure substantially different from the structure of the substrate. Other medical devices include a flexible composite component with an inorganic substrate and a polymer covering at least over a portion of the substrate. The flexible composite component can be bent, at least, about 100 degrees without extending the material beyond its elastic limit. Corresponding methods include applying a polymer onto an inorganic substrate, such that the polymer does not conform to the shape of the substrate.

Abstract: Delivery vehicles for controlled release of connective tissue stabilization agent for the treatment of vascular aneurysms are described. The delivery vehicle generally is combined with a connective tissue stabilization agent to form a therapeutic composition. The treatment of an aneurysm can be achieved through release of connective tissue stabilization agent from the delivery vehicle to the aneurysm. The connective tissue stabilization agent can be collagen stabilization agent, elastin stabilization agent, or a combination thereof. The aneurysm can be treated individually, simultaneously or sequentially with collagen stabilization agent and elastin stabilization agent embedded in separate delivery vehicles.

Abstract: Biomarkers for diagnosis and monitoring of vascular aneurysms are described in the context of the use of assays to measure a plurality of these biomarkers. Tissue degeneration, particularly elastin and/or collagen degradation, can be monitored within patient blood (serum) and/or urine to diagnose the presence, the progression, or the likelihood of rupture of aneurismal disease. Additionally, enzymes responsible for this degradation and other biomarkers responsible for the activation or inhibition of these enzymes can be monitored additionally or alternatively. Prompt diagnosis can provide the opportunity for intervention and potentially increase the health of patients by tempering the development of debilitating and life-threatening vascular aneurysms.

Abstract: Embolism protection devices can be formed with a biocompatible expandable polymer that can expand upon release within a patient's vessel. Upon release, the structure can be configured to filter flow through the vessel. The material of the embolism protection devices can release one or more biologically active agents, such as a thrombolitic agent, including, for example, tPA. Alternatively or additionally, the embolism protection device can be connected to a tether that elutes one or more biologically active agents.

Abstract: Embolism protection devices can be formed with a biocompatible expandable polymer that can expand upon release within a patient's vessel. Upon release, the structure can be configured to filter flow through the vessel. The material of the embolism protection devices can release one or more biologically active agents, such as a thrombolitic agent, including, for example, tPA. Alternatively or additionally, the embolism protection device can be connected to a tether that elutes one or more biologically active agents.

Abstract: Novel adhesive compositions are described that include an epoxyamine and, preferably, a curing agent. The adhesive composition can be used in surgical settings such as implanting bioprostheses and/or in manufacturing of bioprostheses. Biocompatible substrates can be adhered together by an adhesive bond formed by curing of the epoxyamine adhesive composition.

Abstract: Embolism protection devices can be formed with a biocompatible expandable polymer that can expand upon release within a patient's vessel. Upon release, the structure can be configured to filter flow through the vessel. The material of the embolism protection devices can release one or more biologically active agents, such as a thrombolitic agent, including, for example, tPA. Alternatively or additionally, the embolism protection device can be connected to a tether that elutes one or more biologically active agents.

Abstract: Valved prostheses are described with crosslinked leaflets. At least one of the leaflets has a shape corresponding to a contoured surface. The leaflets are individually attached to the prostheses. Furthermore, in some embodiments, the leaflets do not comprise native leaflet tissue. Methods for forming tissue heart valve prostheses can comprise assembling a plurality of leaflets configured to open and close the valve in response to pressure differentials. Each of the plurality of leaflets is preformed individually when at least partially crosslinked in contact with a contoured surface. The individual crosslinked leaflets can be selected and matched for assembly into a valve. In general, the tissue, when it is crosslinked, has a size and shape approximately the size of a single human heart valve leaflet.

Abstract: In some embodiments, a method for processing tissue comprises the application of a directional load to modify the properties of the tissue. In particular, the directional force is sufficient to increase the rigidity of the tissue asymmetrically relative to an unaligned tissue equivalently processed without being subjected to a load. In some embodiments, a sufficient directional load is applied to increase the rigidity of the tissue relative to an unaligned tissue equivalently processed that is not subjected to the load, in which the load is applied with a load applicator. A connector transfers the load from the load applicator to the tissue. Selectively aligned tissue having asymmetric mechanical properties can be used to form a prosthetic valve. The leaflets are matched with respect to each of their properties to have improved coaptation relative to corresponding tissue leaflets with symmetrical mechanical properties.

Abstract: A composite matrix has a first layer and a second layer. The first layer includes at least about 5 dry weight percent flexibility modifying agent. The second layer includes at least about 5 dry weight percent less flexibility modifying agent than the first layer. A valved prosthesis with flexible leaflets supported by a wall can be formed from the composite materials. In some embodiments, the wall of the prosthesis includes a first layer with at least about 60 weight percent collagen and a second layer with at least about 25 weight percent collagen and at least about 5 weight percent elastin. The leaflets preferably include a first layer with at least about 60 weight percent collagen and a second layer with at least about 25 weight percent collagen and at least about 5 weight percent proteoglycans.