Abstract: The present disclosure provides apparatuses and methods for measuring capacitance as an indication of susceptibility to the formation of a diabetic foot ulcer.

Abstract: Tubular casting processes, such as dip-coating, may be used to form substrates from polymeric solutions which may be used to fabricate implantable devices such as stents. The polymeric substrates may have multiple layers which retain the inherent properties of their starting materials and which are sufficiently ductile to prevent brittle fracture. Parameters such as the number of times the mandrel is immersed, the duration of time of each immersion within the solution, as well as the delay time between each immersion or the drying or curing time between dips and withdrawal rates of the mandrel from the solution may each be controlled to result in the desired mechanical characteristics. Additional post-processing may also be utilized to further increase strength of the substrate or to alter its shape.

Abstract: A braided stent system includes an expansion ring attached to internal and external surfaces of a lumen. A frame of the ring may impart an outwardly expanding radial force to the lumen, the frame including a plurality of elongate members joined at a coupling and at first and second intersections opposite the coupling. A clip can extend from the intersections and can be operable to slidably secure the frame to the inner and outer surfaces of the lumen.

Abstract: An endoluminal prosthesis may include a tubular main graft body including a sidewall and proximal and distal ends. A first stent may be positioned near the proximal end of the main graft body. A second stent may be positioned adjacent to and distal of the first stent. An opening in the sidewall may be positioned longitudinally between a peak of the first stent and a valley of the second stent. A tubular branch may be disposed in the opening. The branch may include first and second end openings. The branch may be flexibly orientable between a retrograde configuration in which the first end opening is oriented toward the distal end and the second end opening is oriented toward the proximal end and an antegrade configuration in which the first end opening is oriented toward the proximal end and the second end opening is oriented toward the distal end.

Abstract: A replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.

Abstract: A method for performing an imaging scan of a subject includes positioning a narrow field-of-view camera at a first imaging position to acquire a first set of imaging information of a first object of interest, positioning the narrow field-of-view camera at a second imaging position to acquire a second set of imaging information of a second object of interest, determining emission counts for the first and second sets of imaging information, and utilizing the determined emission counts to generate a value that indicates a probability of a successful medical procedure being performed on the subject.

Abstract: A prosthesis for monitoring a characteristic of flow includes a first tubular prosthesis having a lumen and a sensor for detecting the characteristic of flow through the lumen. The sensor may be covered with another tubular prosthesis or by a layer of material in order to insulate the sensor from the fluid flow. A pocket may be formed between the tubular prosthesis and the adjacent layer of material or prosthesis and the sensor may be disposed in the pocket.

Abstract: A prosthesis for monitoring a characteristic of flow includes a first tubular prosthesis having a lumen and a sensor for detecting the characteristic of flow through the lumen. The sensor may be covered with another tubular prosthesis or by a layer of material in order to insulate the sensor from the fluid flow. A pocket may be formed between the tubular prosthesis and the adjacent layer of material or prosthesis and the sensor may be disposed in the pocket.

Abstract: A method of manufacturing a tubular medical implant is provided. The method includes forming a hollow first tube with a first diameter and a first plurality of pores formed thereon and a hollow second tube with a second unstretched diameter and a second plurality of pores formed thereon. The second unstretched diameter is greater than the first diameter. At least a portion of the first tube slides within the second tube to create an overlapped area of the first tube and the second tube. The first tube and second tube are then bonded together in the overlapped area.

Abstract: Systems, methods, and apparatuses for assisting with submucosal dissections include a retraction strip body. The retraction strip body is formed at least partially from a deformable material. The retraction strip body is capable of being selectively moved between a first condition and a second condition. In the first condition, the retraction strip body is capable of engaging a target patient tissue. In the second condition, the retraction strip body is capable of retracting the target patient tissue. At least one tissue engagement member is located on the retraction strip body.

Abstract: A prosthetic heart valve provided herein can include a porcine small intestine submucosa (P-SIS) tissue leaflet. The P-SIS tissue can include multiple stacked layers that are tensioned and cross-linked to form a material having a thickness of between 50 microns and 0.33 mm. In some cases, a prosthetic heart valve can include a plurality of leaflets secured together and retained within the expandable tubular member.

Abstract: A bifurcated stem graft (10) comprises a body (100) and a side branch (200) that forms an acute angle with the body (100). The side branch (200) comprises a covering film (220) and a first bare stent (240) only disposed on the covering film (220). Part of the first bare stent (240) is positioned adjacent a boundary line (230) of the body (100) and the covering film (220) and is located in a vertex angle area (250) of the acute angle. Due to the fact that part of the first bare stem (240) is attached to the vertex angle area (250), after the stem (10) is released, the self-expanded part of the first bare stent (240) enables the vertex angle area (250) of the side branch (200) to be effectively supported, the covering film is not prone to shrinkage, and a leading wire can enter easily.

Abstract: A vascular graft with trim lines is described, the trim lines providing a guide for precision shaping of the cuff. The trim lines may be printed or otherwise disposed on a surface of the cuff or included on a template designed for disposition over the cuff. The trim lines may also be disposed on a side of a pocket into which the cuff is positioned for trimming. Also described is an apparatus and method for precise trimming of a vascular graft.

Abstract: The stent-graft described herein generally includes a substrate, a helix disposed about the substrate, a covering disposed over at least a portion of the helix, and a support member coupled to the covering.

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 nonmodular endograft system for treating aortic aneurysms involving bilateral renal arteries can include a main fabric cover that is sealedly coupled, or integral, with first and second branch fabric covers. The system can be configured so that after the main cover is expanded in the aorta, and after the two branch covers are respectively expanded in the renal arteries such that (i) the first cover ostium is substantially aligned with the first renal ostium, and (ii) the second cover ostium is not substantially aligned with the second renal ostium, then aortic blood flows from the main cover into each of the branch covers.

Abstract: This disclosure describes decellularized, biologically-engineered tubular grafts and methods of making and using such decellularized, biologically-engineered tubular grafts.

Abstract: The present embodiments provide an endoluminal prosthesis having modular branches, and systems and methods for facilitating deployment of the endoluminal prosthesis. In one example, the endoluminal prosthesis comprises a graft including a bifurcated body of a biocompatible material. The bifurcated body includes distally extending limbs. Limb extensions can be longitudinally and circumferentially adjusted prior to mating with the limbs to enable an “off-the-shelf” prosthesis that can conform to various complex anatomy. When adjusted and mated, fenestrations in the limb extensions can align with branch vessels.

Abstract: A braided stent system includes an expansion ring attached to internal and external surfaces of a lumen. A frame of the ring may impart an outwardly expanding radial force to the lumen, the frame including a plurality of elongate members joined at a coupling and at first and second intersections opposite the coupling. A clip can extend from the intersections and can be operable to slidably secure the frame to the inner and outer surfaces of the lumen.

Abstract: A medical device can include an elongate manipulation member, and a thrombectomy device connected to the elongate manipulation member. The thrombectomy device can have a first configuration and a second configuration, the thrombectomy device being expandable from the first configuration to the second configuration. The thrombectomy device can include an arcuate marker-mounting projection attached to a portion of the thrombectomy device configured to contact a thrombus. A marker can be coupled to, and extending around, the arcuate marker-mounting projection with the marker and the arcuate marker-mounting projection contacting each other at three discrete locations. A method for engaging a thrombus can include advancing a thrombectomy device to a location radially adjacent to a thrombus in a blood vessel.

Abstract: Disclosed herein are systems and methods for protecting a subject from embolisms during TAVR percutaneous valve procedures. Various embodiments include an intravascular embolism protection device that includes an elongated, compliant wire frame made from a material having a shape-memory function, and a mesh sleeve coupled to the compliant wire frame, the mesh material having a pore size selected to allow blood to pass therethrough while retaining potential emboli. In some embodiments, the embolism protection device has a collapsed state wherein device fits within the lumen of a deployment/retrieval catheter and an expanded state wherein the embolism protection device expands to span the width of the aorta and the distance between the aortic valve and the puncture site in the femoral artery.

Abstract: A soft breast prosthesis is provided, the prosthesis having a surface configuration advantageous for dual plane placement of the prosthesis in a breast.

Abstract: An open frame prosthesis is formed with looped end terminations at its proximal and distal ends. At one end of the prosthesis, the filaments or strands are welded together in pairs to form strand couplings. A plurality of loop segments are connected to the strand couplings, one loop segment for each pair of adjacent strand couplings. In one version of the prosthesis, strands at the opposite end are bent to form looped ends. In another version, loop segments are connected to pairs of strand couplings at both ends of the prosthesis. The loop segments can be connected to the couplings by welding, fusion bonds, or tubes, which are either crimped or heat shrunk.

Abstract: The present disclosure is directed to modified metal materials for implantation and/or bone replacement, and to methods for modifying surface properties of metal substrates for enhancing cellular adhesion (tissue integration) and providing antimicrobial properties. Some embodiments comprise surface coatings for metal implants, such as titanium-based materials, using (1) electrochemical processing and/or oxidation methods, and/or (2) laser processing, in order to enhance bone cell-materials interactions and achieve improved antimicrobial properties. One embodiment comprises the modification of a metal surface by growth of in situ nanotubes via anodization, followed by electrodeposition of silver on the nanotubes. Other embodiments include the use of LENS™ processing to coat a metal surface with calcium-based bioceramic composition layers. These surface treatment methods can be applied as a post-processing operation to metallic implants such as hip, knee and spinal devices as well as screws, pins and plates.

Abstract: The invention relates to admixtures of thermoplastic polyurethane base polymers that resist surface dulling and fluorinated additives and their use in the manufacture of articles, such as medical devices. For example, the admixtures of the invention are useful in the manufacture of blood dwelling medical devices, such as catheters.

Abstract: A method of manufacturing a tubular medical implant is provided. The method includes forming a hollow first tube with a first diameter and a first plurality of pores formed thereon and a hollow second tube with a second unstretched diameter and a second plurality of pores formed thereon. The second unstretched diameter is greater than the first diameter. At least a portion of the first tube slides within the second tube to create an overlapped area of the first tube and the second tube. The first tube and second tube are then bonded together in the overlapped area.

Abstract: Implantable medical grafts fabricated of metallic or pseudometallic films of biocompatible materials having a plurality of microperforations passing through the film in a pattern that imparts fabric-like qualities to the graft or permits the geometric deformation of the graft. The implantable graft is preferably fabricated by vacuum deposition of metallic and/or pseudometallic materials into either single or multi-layered structures with the plurality of microperforations either being formed during deposition or after deposition by selective removal of sections of the deposited film. The implantable medical grafts are suitable for use as endoluminal or surgical grafts and may be used as vascular grafts, stent-grafts, skin grafts, shunts, bone grafts, surgical patches, non-vascular conduits, valvular leaflets, filters, occlusion membranes, artificial sphincters, tendons and ligaments.

Abstract: A nonmodular endograft system for treating aortic aneurysms involving bilateral renal arteries can include a main fabric cover that is sealedly coupled, or integral, with first and second branch fabric covers. The system can be configured so that after the main cover is expanded in the aorta, and after the two branch covers are respectively expanded in the renal arteries such that (i) the first cover ostium is substantially aligned with the first renal ostium, and (ii) the second cover ostium is not substantially aligned with the second renal ostium, then aortic blood flows from the main cover into each of the branch covers.

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.