Abstract: A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and expanded. The prosthetic heart valve includes cusp positioners that engage sinus cavities above the valve annulus and rotationally orient the prosthetic valve. Preferred embodiments of the cusp positioners do not occlude the coronary arteries.

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: The invention provides transient devices, including active and passive devices that physically, chemically and/or electrically transform upon application of at least one internal and/or external stimulus. Incorporation of degradable device components, degradable substrates and/or degradable encapsulating materials each having a programmable, controllable and/or selectable degradation rate provides a means of transforming the device. In some embodiments, for example, transient devices of the invention combine degradable high performance single crystalline inorganic materials with selectively removable substrates and/or encapsulants.

Abstract: A delivery system for a stent-graft is disclosed having a tip capture device and a tip release handle mechanism configured to actuate the tip capture device. The tip release handle mechanism includes a rotatable grip component and a tip release actuation component. The grip component may be rotatable in a first direction to transition a proximal stent of the stent-graft from the delivery state to a partially deployed state and rotatable in an opposite, second direction to transition the proximal stent from the partially deployed state to a fully deployed state. The grip component is operably coupled to the tip release actuation component. The delivery system further includes a shaft component operably coupled to the tip release actuation component and the tip capture device.

Abstract: Disclosed is a method comprising: creating one or more pockets within an inferior turbinate of a patient, inserting one or more it that are easily inserted into the one or more pockets, wherein the one or more implants contain one or more therapeutic compounds and the one or more implants do not need to be removed from the inferior turbinate after implantation into the one or more pockets.

Abstract: Provided is a bio-hybrid material that does not cause elution of nickel ions and has an excellent endothelialization ability, a production method therefor, and a stent. The bio-hybrid material (101) used includes an alloy part (11) free of Ni, an organic acid (12) having two or more active esters, and a cytokine (13). The alloy part (11) free of Ni forms an ester bond with the organic acid (12), and the organic acid (12) and the cytokine (13) are immobilized via an amide bond.

Abstract: A delivery catheter (12) for a stent valve (10), the delivery catheter having a distal portion (14) insertable into an anatomy, the distal portion comprising an accommodation region (18) for accommodating a stent-valve for delivery into the anatomy, the delivery catheter further comprising at least one sheath (20; 22) that is translatable between a closed position for at least partly closing the accommodation region and an open position for at least partly opening the accommodation region.

Abstract: The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise a steering line or lines which facilitate bending and steering of the expandable implant through the vasculature of a patient.

Abstract: A system for inducing weight loss ina patient includes (a) an elongated element extending from a proximal end to a distal end, the elongated element separating a duodenum into first and second channels, wherein the elongated element is expandable; and (b) a retainer connected to the elongated element and securing the elongated element in a desired orientation within the duodenum. In the desired orientation, all chyme flowing through the duodenum enters the first channel and the second channel is open to a papilla of vater so that digestive fluids from the papilla of vater enter the second channel.

Abstract: The present invention is a formable dental treatment tray utilizing poly(2-ethyl-2-oxazoline) and a gelatinous active. Blending of the active is accomplished by mixing the Poly(2-ethyl-2-oxazoline) with an active ingredient, such as a peroxide like hydrogen peroxide, carbamide peroxide, sodium perborate, or sodium percarbonate, usually also with water or an appropriate organic solvent. Peroxide concentrations in these new gels can reach a 30% concentration of hydrogen peroxide while maintaining a shelf life of six months at room temperature without developing peroxide decomposition. The gels are applied to an appropriate backing and dried to a gelatinous state. In use, the active is hydrated and regains adhesiveness. Then the tray is pressed and formed around a user's dental arch to form the customizable tray. Multiple active ingredients may be used, with or without peroxide, for accomplishing desired treatment regimens.

Abstract: The present invention is a formable dental treatment tray utilizing poly(2-ethyl-2-oxazoline) and a gelatinous active. Blending of the active is accomplished by mixing the Poly(2-ethyl-2-oxazoline) with an active ingredient, such as a peroxide like hydrogen peroxide, carbamide peroxide, sodium perborate, or sodium percarbonate, usually also with water or an appropriate organic solvent. Peroxide concentrations in these new gels can reach a 30% concentration of hydrogen peroxide while maintaining a shelf life of six months at room temperature without developing peroxide decomposition. The gels are applied to an appropriate backing and dried to a gelatinous state. In use, the active is hydrated and regains adhesiveness. Then the tray is pressed and formed around a user's dental arch to form the customizable tray. Multiple active ingredients may be used, with or without peroxide, for accomplishing desired treatment regimens.

Abstract: The present invention provides systems and methods for deploying implantable devices within the body. The delivery and deployment systems include at least one catheter or an assembly of catheters for selectively positioning the lumens of the implant to within target vessels. Various deployment and attachment mechanisms are provided for selectively deploying the implants.

Abstract: In an apparatus and method for treating an aneurysm, a flow control member is positioned within a blood vessel at least in part upstream of an aneurysm and extending radially inward of the blood vessel wall into the flow path of blood flowing within the blood vessel. The flow control member alters the blood flow path within the blood vessel upstream of the aneurysm to inhibit blood flow to the aneurysm. A retention member may be positioned within the blood vessel at least in part upstream from the aneurysm and having an outer surface engageable with the blood vessel wall. In such an instance, the flow control member is retained by the retention member and extends radially inward of the blood vessel wall upstream from the aneurysm.

Abstract: Compositions comprising a cartilage sheet comprising a plurality of interconnected cartilage tiles and a biocompatible carrier are provided. Methods of manufacturing cartilage compositions comprising a cartilage sheet comprising a plurality of interconnected cartilage tiles are also provided.

Abstract: The invention relates to an endoprosthesis (1), in particular a vascular or cardiac endoprosthesis (1), having a body (2) and also one or more thrombogenic elements (3) that are fixed to the endoprosthesis (1) and that are able to extend a distance away from the body outside the latter. The endoprothesis comprises means (33) for selectively retaining the thrombogenic elements near the body (2). The release of the one or more thrombogenic elements, after the endoprosthesis has been fitted in place by a conventional method via a sheath, promotes thrombosis.

Abstract: An inventive flanged graft for end-to-side anastomosis includes a tubular graft member and a flanged section The type and size of the flanged section is determined by various factors such as identity of the receiving artery, position of the arteriotomy on the receiving artery, and luminal diameter of the graft. The graft is preferably anastomosed to the receiving artery using continuous sutures to join the arteriotomy to the peripheral edges flanged section.

Abstract: Endovascular devices are provided. The endovascular devices include a conformable scaffold with one or more outpocketings. The outpocketing in the endovascular device creates a corresponding outpocketing of a vessel wall, thereby altering local fluid dynamics.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: The present invention relates to the use of a crosslinked, silicon-containing layer containing, substantially consisting of or consisting of silicon, O, C, H, optionally N which can be produced by plasma polymerization and/or crosslinking of organosilicon liquids by a plasma process and/or UV radiation of a wavelength of less than 250 nm, without using metals of an atomic number of more than 14, as a biocompatible surface, for imparting to a surface or providing a surface with a non-genotoxic effect. The invention also relates to correspondingly coated articles and to processes for the production thereof.

Abstract: A magnesium alloy and to a method for the production thereof and implants made thereof. The magnesium alloy includes up to 6.0% by weight Zn, and preferably 2.0 to 4.0% by weight Zn, 2.0 to 10.0% by weight Al, and preferably 3.0 to 6.0% by weight Al, where % by weight Al?% by weight Zn shall apply, the remainder being magnesium containing impurities, which promote electrochemical potential differences and/or the formation of precipitations and/or intermetallic phases, in a total amount of no more than 0.0063% by weight of Fe, Si, Mn, Co, Ni, Cu, Zr, Y, Sc or rare earths having the ordinal numbers 21, 57 to 71 and 89 to 103, Be, Cd, In, Sn and/or Pb as well as P, and the matrix of the alloy is solid solution hardening due to Al and An and is also particle hardening due to the intermetallic phases formed of Mg and Al.

Abstract: An implant comprises a structure that may be implanted into tissue and that has a first material property at normal body temperature. The first material property is variable at elevated temperatures above normal body temperature. The implant also has a plurality of particles dispersed in the structure that are adapted to convert incident radiation into heat energy when irradiated with electromagnetic radiation. The particles are in thermal contact with the structure such that exposure of the particles to incident radiation raises the temperature of the structure thereby changing the first material property relative to the first material property at normal body temperature.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and can include a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

Abstract: The present embodiments provide a branch vessel prosthesis for placement at least partially between a main vessel and a branch vessel of a patient. The branch vessel prosthesis has a graft including a generally tubular body of a biocompatible material. At least one stent is coupled to a proximal region of the graft, and at least one stent is coupled to a distal region of the graft. The proximal region of the graft includes a generally straight configuration in an expanded deployed state that is substantially parallel to a longitudinal axis of a main vessel. The distal region of the graft includes a generally straight configuration in the expanded deployed state that is substantially parallel to a branch vessel. A curvature of a central region varies an angle in which the distal region of the graft is disposed relative to the proximal region.

Abstract: A block copolymer comprising a fluorinated block and a non-fluorinated block and method of making the block copolymer are provided. Also provided herein are a coating on an implantable device comprising the block copolymer and method of using the implantable device.

Abstract: An implantable prosthetic for connection to a fluid flow pathway of a patient. The prosthetic is comprised of a primary tube structure which is in communication with a plurality of secondary tube structures each of which contains filters for trapping embolic particles, such as blood clots, air bubbles, thrombus. etc. within a fluid flow pathway within a patient. The prosthetic also contains a monitoring device to non-invasively the flow of fluids through a patient's fluid flow pathway.

Abstract: The present invention is directed to a largely nickel-free iron alloy or a nickel-free stainless steel having the following composition: 14.0% by wt.-16.5% by wt. chromium 10.0% by wt.-12.0% by wt. manganese ?3.0% by wt.-4.00% by wt. molybdenum 0.55% by wt.-0.70% by wt. nitrogen 0.10% by wt.-0.20% by wt. carbon 0.00% by wt.-2.00% by wt. impurities, such as other metals, semimetals, metal salts and/or non-metals the rest up to 100% by wt. is iron, which is in particular suitable for the production of stents as well as to stents made of this alloy.

Abstract: A cardiovascular conduit system may comprise a connector. The connector may comprise a proximal end adapted to attach to a cardiovascular organ. The proximal end may comprise a first plurality of expandable members, and each member in the first plurality of expandable members may be deployable from a delivery position to a deployed position. The first plurality of expandable members may be dimensioned to deploy inside the cardiovascular organ to secure the connector to the cardiovascular organ. The connector may comprise a distal end adapted to attach to a conduit and an opening extending through the connector. Connectors for cardiovascular conduit systems may also include expandable stents. Connectors may be rotatably secured to a conduit, and the conduit may be reinforced. Methods for forming and using cardiovascular conduit systems are also disclosed.

Abstract: Implants for treating insufficient blood flow to a heart muscle with transmyocardial revascularization are disclosed. Methods of treating insufficient blood flow to a heart muscle with the implant are also disclosed. The implant can have a body with an inner lumen that supports a channel in the heart muscle to allow for increased blood flow through the lumen upon implantation. The implant can include active agents to prevent or inhibit thrombotic closure of the channel, to promote vascularization, or both.

Abstract: Described are hemostasis devices useful for implantation in biopsy tracts, which device comprise highly compact, dried hemostatic sponge elements. Preferred devices also include compacted sponge matrices exhibiting high density and rigidity in combination with high volumetric expandability when wetted. Also described are methods for making and using such devices.

Abstract: A composite material for a medical implant includes a matrix of magnesium or magnesium alloy, and a catalyst which is dispersed within the matrix. The catalyst has the capacity to reduce an amount of hydrogen gas released from the matrix when the matrix is being degraded inside the patient.

Abstract: A one step method for drug coating an interventional device is disclosed by mixing a drug with a phosphorylcholine-linked methacrylate polymer in a liquid and applying the mixture to an interventional device, such as a stent, in a single step.

Abstract: The present invention relates to a preparation method of a tube and a transplantable polymer tube prepared by such method, which includes modifying the inner surface of a tube using plasma. A preparation method of a tube may include preparing a tube, modifying the inner surface of the tube using microplasma so as to have reactivity, forming a thin film layer on the modified surface of the tube to prevent aging or impart adhesiveness, and modifying the surface of the thin film layer using microplasma so as to enhance cell adhesion thereon.

Abstract: A stent-graft includes a short tube graft and patch located inside of a primary graft. The patch forms a smooth and reliably sealed transition between the primary graft and the short tube graft. Accordingly, the disruption to fluid, e.g., blood, flowing through the lumen of the primary graft by the short tube graft is minimal. Further, the patch supports the inner end of the short tube graft. Thus, the patch, the short tube graft and the primary graft form a stable three-dimensional structure.

Abstract: A method of forming a surface layer that includes a hydroxyl polymer on a substrate coating on a medical device is provided.

Abstract: A device for occluding a septal defect is provided. In general, the occluding device has a contracted state that allows the occluding device to be received within a delivery device for deployment to the site of the defect and an expanded state that is achieved when the occluding device is deployed from the delivery device. The occluding device has a proximal portion, which may be substantially circular, a distal portion, which may be substantially ovaloid, and a connecting portion extending between the two. The distal portion may define first and second outer parts at opposite ends of the major axis, which may be bent or curved. The configuration of the proximal and distal portions allow the occluding device to securely engage the septal wall and be kept in position at the septal defect without causing substantial interference with the functioning of adjacent heart structures.

Abstract: A method for electrostatic coating of medical devices such as stents and balloons is described. The method includes applying a composition to a polymeric component of a medical device which has little or no conductivity. The polymeric component could be a material from which the body or a strut of the stent is made or could be a polymeric coating pre-applied on the stent. The polymeric component could be the balloon wall. A charge can then be applied to the polymeric component or the polymeric component can be grounded. Charged particles of drugs, polymers, biobeneficial agents, or any combination of these can then be electrostatically deposited on the medical device or the coating on the medical device. One example of the composition is iodine, iodine, iodide, iodate, a complex or salt thereof which can also impart imaging capabilities to the medical device.

Abstract: Apparatus, systems, and methods for inspecting longitudinal surfaces and sidewalls of cut tubes are disclosed. In some embodiments, the apparatus includes a line camera, the line camera being configured to capture images of longitudinal surfaces of the cut tubes, an area camera joined with the line camera, the area camera being configured to capture images of sidewalls of the cut tubes, a mandrel and drive, a multi-axis motion stage, a vertical motion stage, and a rotating motion stage. In some embodiments, the system includes a camera module, a tube positioning module, a motion control module, and an analysis module. In some embodiments, the method includes positioning a line and area cameras, moving the cut tubes, capturing images of the longitudinal surfaces and sidewalls of the cut tubes, providing comparable images of a template cut tube, and comparing the images of the cut tubes to those of the template cut tube.

Abstract: A bypass device for influencing blood pressure, including an implant with a volumetric chamber, having a connector or connecting means for connecting the volumetric chamber to a natural cardiovascular system, and having an adaptor or adaptation means, by which a change in volume of a volume of the volumetric chamber is enabled or effected upon a pressure change in the cardiovascular system or in the volumetric chamber. According to this invention, a change in volume in a lower pressure range between 50 mmHg and a pressure threshold value amounting to at least 100 mmHg amounts to at most 10 cm3, and in an upper pressure range between the pressure threshold value and 150 mmHg amounts to at least 10 cm3. With the device according to this invention, high blood pressure can be reduced in a carefully directed way.

Abstract: A device including a self-expandable member having a proximal end portion, a main body portion and a distal end portion. Each of the self-expandable portions consists of a plurality of cell structures formed by intersecting strut members. In one implementation, at least one proximal cell structure in the proximal end portion has one or more struts that have a width and/or thickness greater than the width and/or thickness of the majority of strut members in the main body and distal end portions of the expandable member. Attached to at least one of the proximal-most cell structures in the proximal end portion is a proximally extending flexible wire having sufficient length and flexibility to navigate the tortuous vasculature of a patient. In another implementation, the device is delivered to the treatment site through the lumen of a delivery catheter.

Abstract: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: Intravascular cardiac restraining implants designed for treatment of heart disease and heart failure and methods for their use. The disclosed implants can be used to reshape or reinforce a diseased, weakened or distended portion of a patient's heart to counteract heart disease and heart damage. An intravascular cardiac restraining implant may include a first tissue anchor configured for implantation in a first region of a coronary vein, a second tissue anchor configured for implantation in a second region of the coronary vein, and at least one elongate member coupled to the first tissue anchor and the second tissue anchor. In one embodiment, the at least one elongate member may be a spring or a similar device configured for biasing the first and second tissue anchors toward one another, thus reshaping or reinforcing a diseased, weakened or distended portion of a patient's heart.

Abstract: Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm's canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm's canal.

Abstract: Disclosed are methods for securing the intersection formed by two or more crossed strands. The intersection defines at least two sections. The practice of the disclosed methods includes bending a securing material, such as a suture or other suitably biocompatible material, through at least two of the sections formed by the intersection, and joining them to secure the intersection. Also disclosed are devices formed by using securing material to secure the intersection of crossed strands of a medical device, such as a woven stent. The secured intersection or intersections of the resultant device enhance the structural integrity of the device, and may serve to eliminate the possible unwinding or release of unsecured, or free, strand ends. Radiopaque materials, in addition to polymers, may be used as securing material.

Abstract: An apparatus for loading material into a stent strut can comprise a suction pump connected to an opening to a lumen within the stent strut. The stent strut is immersed in the material. As the suction pump draws gas out of the lumen, the material is drawn into side openings to the lumen.

Abstract: A method of fabricating an implantable medical device that includes deforming and heating setting a polymer construct, for use in fabricating the device, in a temperature range in which the crystal nucleation rate is greater than the crystal growth rate is disclosed.

Abstract: The invention provides a method for fabricating an implantable medical device to increase biocompatibility of the device, the method comprising: heat setting a polymer construct, wherein the polymer construct is at a temperature range of from about Tg to about 0.6(Tm?Tg)+Tg such that the set polymer construct comprises a crystalline structure having crystals at a size less than about 2 microns; and fabricating an implantable medical device from the heat set polymer construct.

Abstract: Inkjet print head dies are directly seated upon an exterior of a tubular member so as to face different directions.

Abstract: A spiral wire with shape memory wound to a small circumference for percutaneous introduction into an artery lumen has holding balloons gripping each end to control unwinding that increases and decreases circumference of a concentric graft tube against artery wall without under-sizing that creates dangerous gaps or over-sizing that promotes occlusion re-growth. Inflating holding balloons pushes ends of a plurality of tunnel arcs located at 2 mm intervals in rim around balloon circumferences tightly against graft tube whereupon push-rods within tunnel arcs simultaneously push out sharp circular sutures of memory material that return to original circular shape as they pierce and join graft tube and artery wall.

Abstract: Provided herein re a composition and a coating or a device (e.g., absorbable stent) that includes a PEGylated hyaluronic acid and a PEGylated non-hyaluronic acid biocompatible polymer and the methods of use thereof.

Abstract: Methods of fabricating an implantable medical devices such as stents made from biodegradable polymers are disclosed that reduce or minimize chain scission and monomer generation during processing steps. The method includes processing a poly(L-lactide) resin having an number average molecular weight between 150 to 200 kD in an extruder in a molten state. A poly(L-lactide) tube is formed from the processed resin and a stent is fabricated from the tube. The number average molecular weight of the poly(L-lactide) of the stent after sterilization is 70 to 100 kD.