Abstract: Medical devices and method for manufacturing medical devices are discloses. An example medical device may include a medical device body formed from one or more multi-melting point polymeric filaments. Each of the filaments may include a polymeric blend comprising a first block polymer and a second polymer. The polymeric blend may have a first melting point and a second melting point less than the first melting point. The medical device body may be heat set at a temperature within 10° C. of the second melting point.

Abstract: The invention relates to multi-component shape memory threads, fibers, tubes, or tapes, which includes at least two shape-memory polymeric (SMP-N) components. Each of the at least two SMP-N components is of at least 1% of the total weight, and N is a positive integer starting from 1, and the SMP-N components have a selectively engineered shape recovery temperature (Tr) between approximately 0° C. to 130° C. Also, when TrN and TrN+1 are higher than room temperature, the threads, fibers, tubes, or tapes are configured to assume a substantially helical configuration upon heating to above TrN and lower than TrN+1 by a stimulus when an elongation of the threads, fibers, tubes, or tapes is approximately 30% to approximately 300%, and having a coil diameter from 0.5 to 10 mm and a number of the turns per cm from 5 to 30.

Abstract: An example medical device for treating a body lumen is disclosed. The medical device includes an expandable scaffold including first and second regions, each of the first and second regions include a plurality of interstices located therein. The medical device also includes a covering spanning each of the plurality of interstices of the first region. The second region is free of the covering. A biodegradable gripping material is disposed on an outer surface of the covering. Further, the expandable scaffold is configured to shift from a collapsed state to an expanded state and the second region is configured to contact an inner surface of the body lumen in the expanded state. Additionally, the gripping material is designed to initially prevent migration of the expandable scaffold upon implantation in the body lumen until the second region is secured to the inner surface of the body lumen.

Abstract: The present invention relates to stents made of a magnesium alloy degradable under physiological conditions having an inorganic coating comprising magnesium fluoride and having an organic coating. The stents according the invention can additionally be coated with at least one antiinflammatory, antiproliferative, antiangiogenic, antirestenotic, and/or antithrombogenic active agent.

Abstract: A variety of nanoparticles or microparticles may be used to treat diseases such as restenosis or blood clots. For example, a nanoparticle or microparticle may include a core having a biodegradable polymer, an exterior having hydrophilic moieties. and a therapeutic agent. The nanoparticles may include targeting moieties that target the nanoparticle or microparticle to an arterial lesion. The nanoparticle or microparticle may include an exterior shell around the core to increase stability of the nanoparticle or microparticle. The nanoparticle or microparticle may include a magnetic particle to allow targeted delivery of the nanoparticle or microparticle via a magnetic field. The nanoparticles or microparticles may be coated on a medical device, such as a catheter balloon or a stent, or may be delivered systemically or locally to patients in need thereof.

Abstract: Biodegradable compositions containing from 10.0 to 95.0 weight percent iron for use in preparing medical devices. These biodegradable compositions exhibit properties that make them suitable for use as medical devices for implantation into a body of a patient. The compositions also include one or more elements selected from manganese, magnesium, zirconium, zinc and calcium. The compositions can be prepared using a high energy milling technique and high energy mechanical alloying followed by compaction and sintering, film deposition techniques, such as, pulsed laser deposition (PLD), as well as melting, casting, homogenization and extrusion methods. The resulting compositions and the medical devices formed therefrom are useful in various surgical procedures, such as but not limited to orthopedic, craniofacial and cardiovascular.

Abstract: An implant device for use in achieving spinal fusion, includes an implant having an implant body. The device includes a graded radiopacity calibration tool integrated with the implant body. The tool has a plurality of graded levels of radiopacity representative of a range of bone density parameter amounts. Each of the graded levels corresponds to a different bone density parameter amount. A method is provided that uses the device to determine a degree of one of bone maturity, strength, osteoporotic state, state of healing and state of degrading bone tissue based on a comparison of a bone at the site in the image and radiopacity correlated from a calibration standardized curve defined by the standard, with a range of grey levels representative of degrees of one of the bone maturity, the strength, the osteoporotic state, the state of healing and the state of degrading bone tissue.

Abstract: An example medical device for treating a body lumen is disclosed. The medical device includes an expandable scaffold including first and second regions, each of the first and second regions include a plurality of interstices located therein. The medical device also includes a covering spanning each of the plurality of interstices of the first region. The second region is free of the covering. A biodegradable gripping material is disposed on an outer surface of the covering. Further, the expandable scaffold is configured to shift from a collapsed state to an expanded state and the second region is configured to contact an inner surface of the body lumen in the expanded state. Additionally, the gripping material is designed to initially prevent migration of the expandable scaffold upon implantation in the body lumen until the second region is secured to the inner surface of the body lumen.

Abstract: Methods for preparing oriented polymer tubes, such as biodegradable polymer tubes suitable for in vivo use, are provided herein. The disclosed methods provide alternatives to the typical extrusion/expansion methods by which oriented polymeric tubes for such uses are commonly produced. Advantageously, the disclosed methods can provide more homogeneous molecular orientation of crystallizable polymers within the tube walls, which can endow such polymeric tubes with enhanced strength (e.g., resistance to compression) and toughness.

Abstract: Iron-based biodegradable metals and the method of fabricating are disclosed. The iron-based biodegradable metals, which have an accelerated degradation rate and a yield strength similar to stainless steel, comprises a composite structure of multiple iron layers separated by thin alloying metallic layers. The composite structure are built layer by layer using additive manufacturing technologies. The iron-based biodegradable metals can be fabricated into a small diameter tube for laser cutting into implantable bare metal stents or drug eluting stents with biodegradable polymer coating. The iron-based biodegradable metals can be fabricated and/or machined into orthopedic implants.

Abstract: A growth stent and valve and methods for making and using the same. The growth stent and valve may be delivered to treat early stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent and valve can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent and valve advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a patient.

Abstract: An MRI apparatus 1 comprising an image producing unit 101 for producing a plurality of axial images D1 to D10 in a plurality of slices defined in a body part to be imaged containing a blood vessel; a classifying unit 102 for classifying the plurality of axial images D1 to D10 into a plurality of classes I to IV based on which a portion of the imaged body part each of the plurality of axial images D1 to D10 represents; and a defining unit 103 for defining a search region for searching for a blood vessel from within an axial image based on within which of the plurality of classes I to IV the axial image falls.

Abstract: A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

Abstract: A system for delivery of a medical device includes a delivery member and a medical device, which is mounted to the delivery member and releasably retained in a delivery configuration for endoluminal delivery of the medical device toward a treatment site in a human vessel. The delivery member includes an elongated first portion configured to extend outside of the body from a first percutaneous access site and an elongated second portion configured to extend outside the body from a second percutaneous access site to allow positioning of the medical device at the treatment site by manipulation of the first portion and second portion from outside of the body.

Abstract: A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

Abstract: The present invention relates to a biostable polyurethane or polyurea comprising: (a) a soft segment comprising a polysiloxane of the general formula (I); and (b) greater than 0 and less than 40 wt % of a hard segment which is a reaction product of a diisocyanate and a linear difunctional chain extender, processes for their preparation and their use in the manufacture of biomaterials, devices, articles or implants.

Abstract: Devices for non-invasive, label-free separation of particles in liquid, including circulating tumors cells in blood, are provided. Embodiments of the disclosure provide for devices employing magnetic fluids and magnets for separation of circulating tumor cells from blood. Methods for separation of particles including circulating tumor cells are also provided.

Abstract: A method for preparing a laminate coronary stent comprising: providing a stent framework; and depositing a plurality of layers on said stent framework to form said laminate coronary stent; wherein at least one of said layers comprises a bioabsorbable polymer.

Abstract: Biodegradable, magnesium alloys and composites, articles produced therefrom, methods of making the same, and methods of using the same are described.

Abstract: A dilation device for an intrabody lumen, for example, a urethra partially occluded by an enlarged prostate in the form of a curved element configured to be implanted around the lumen and add resilience to the lumen, and a method for dilating such a lumen by implanting a dilation device around the outside of the lumen with at least part of the dilation device embedded in surrounding, thereby preventing clinically significant compression of the lumen. Also, an implantation device for such a dilation device in the form of a mounting device configured to carry the dilation device; and a releasably attached movable holder, with the mounting device and holder configured to deliver the dilation device though a working channel to a desired position in a lumen, and to implant the dilation device through a wall of the lumen to a position surrounding the lume.

Abstract: A vascular prosthesis is described, having blunted wire ends. The blunted wire ends can take on a variety of configurations including end caps, bent ends, curved ends, or eyelets. The novel ends provide a smooth surface to contact the blood vessel walls thereby reducing the risk of trauma during placement of the prosthesis.

Abstract: Treatment of an aneurysm or other vascular defect can be facilitated or enhanced by a galvanic cell formed by an implantable medical device configured to be implanted at or within the aneurysm or other vascular defect. The implantable medical device can include a primary structure including an anodic metal and a cathodic metal. The anodic metal and the cathodic metal each form a fraction of a total surface area of the primary structure. A galvanic cell formed by the anodic metal and the cathodic metal is configured to induce a galvanic voltage within blood for a duration of time to promote thrombosis. The thickness of the anodic metal can be less than or equal to 5 ?m, for example, to provide galvanic activity for between 5 and 30 minutes.

Abstract: Disclosed is a patch system for use in a patient with a damaged heart. The patch comprises both a biodegradable engineered collagen scaffold to provide structural support to the injured heart and therapeutic agents, which are delivered by the patch to the heart. The scaffold consists of a dense collagen lamella produced by plastic compression with biomechanical properties that make it compatible with beating heart tissue, e.g. stiffness in a predefined range. One therapeutic agent, Fstl1, is shown to induce cardiomyocyte proliferation and enhance cardiac regeneration after injury. The patch can also be loaded with functionalized nanoparticles to yield multi-modal imaging capabilities in vivo. Also disclosed is a method for implanting the patch onto a patient's heart.

Abstract: Disclosed herein are biodegradable medical devices comprising biodegradable materials (e.g., magnesium-calcium alloys) having an adjustable rate of degradation that can be used in various applications including, but not limited to, drug delivery applications, cardiovascular applications, and orthopedic applications to make biodegradable and biocompatible devices. Also disclosed herein are methods of making biodegradable medical devices comprising biodegradable materials by using, for instance, hybrid dry cutting/hydrostatic burnishing.

Abstract: The present invention relates to the field of medical instruments. Specifically, a biodegradable cross-linked polymer and a manufacturing method therefor are provided. The cross-linked polymer is obtained by bonding crosslinkable reactive groups to terminal groups of a biodegradable prepolymer having two or more arms and further subjecting the prepolymer to thermal polymerization and/or light irradiation. The cross-linked polymer has an elastic modulus of 10-4,500 MPa, and a degradation rate of 3-36 months. A biodegradable vascular stent and a preparation method therefor are also provided. The vascular stent is formed by laser cutting of polymeric tubing having a three-dimensional cross-linked network structure. The vascular stent has ample mechanical strength, a high elastic modulus at body temperature, and a regulatable degradation rate.

Abstract: A bioabsorbable implant including an elongated metallic element having more than 50% by weight a metal and being substantially free of rare earth elements, the elongated metallic element defining at least a portion of the bioabsorbable implant and including a wire formed into a discrete bioabsorbable expandable metal ring; at least two biostable ring elements, each biostable ring element having a biostable and radio-opaque metallic alloy, the bioabsorbable expandable metal ring being disposed adjacent to at least one of the biostable ring elements; at least one flexible longitudinal connector including a bioabsorbable polymer, the connector being disposed between at least two adjacent rings; and a coating having at least one pharmaceutically active agent disposed over at least a portion of one ring.

Abstract: A stent-graft comprising a tubular, radially self-expandable, braided structure comprising elongate bioabsorbable filaments, a bioabsorbable adhesive means, and a permanent graft disposed and adhered with the adhesive means to at least a portion of the structure and forming a stent-graft assembly, the permanent graft and the tubular structure are coextensive along at least a portion of the stent-graft.

Abstract: A device and methods of use thereof are disclosed herein for a biodegradable optical fiber and a method of producing a device including a biodegradable optical fiber. A device is disclosed that includes: a biodegradable optical fiber including; a biodegradable optically functional inner fiber including an optically-transmitting cladding in contact with and surrounding an optically-transmitting core, wherein the inner fiber is biodegradable on a first time scale; and an outer layer in contact with and surrounding the optically-transmitting cladding, wherein the outer layer is biodegradable on a controllably-defined delayed time scale, and the controllably-defined delayed time scale is of greater duration than the first time scale.

Abstract: A degradable polyester stent is disclosed, which includes a polyester composite, wherein the polyester composite is produced from a biodegradable polyester and a metal-based material. A method of preparing the degradable polyester stent is also disclosed. The method can improve the mechanical properties of the biodegradable copolymer stent and can achieve the radiopacity of the main body and the overall of the stent.

Abstract: A medical device for insertion into a bodily vessel to treat an aneurysm (201), the device comprising: a mechanically expandable device (202) expandable from a first position to a second position, said mechanically expandable device (202) is expanded radially outwardly to the second position such that the exterior surface of said mechanically expandable (202) engages with the inner surface of the vessel so as to maintain a fluid pathway through said vessel; and a membrane (203) expandable from a first position to a second position in response to expansion of said mechanically expandable device (202), said membrane (203) obstructing blood circulation to the aneurysm (201) when expanded to the second position, and at least a portion of the membrane (203) is secured to the mechanically expandable device (202) to maintain the position of the membrane (203) relative to the mechanically expandable device (202) when expanded to the second position.

Abstract: A bimetal composite wire including, in cross-section, an outer shell or tube formed of a first biodegradable material and an inner core formed of a second biodegradable material. When formed into a stent, for example, the first and second biodegradable materials may be different, and may have differing biodegradation rates. In a first embodiment, the first biodegradable material of the shell may degrade relatively slowly for retention of the mechanical integrity of a stent during vessel remodeling, and the second biodegradable material of the core may degrade relatively quickly. In a second embodiment, the first biodegradable material of the shell may degrade relatively quickly, leaving a thinner structure of a second biodegradable material of the core that may degrade relatively slowly.

Abstract: The present invention is directed to stents made of a magnesium alloy degradable under physiological conditions and an outer polymeric coating. Herein, the stents according to the invention can be additionally coated with at least one anti-inflammatory, antiproliferative, antiangiogenic, antirestenotic and/or antithrombogenic active agent.

Abstract: Novel bioabsorbable, nasal spreader graft implant devices are disclosed. The devices are useful in rhinoplasty and nasal reconstruction surgical procedures, as well as other surgical procedures. The devices have biodegradable core plates and biodegradable spreader plates or tissue ingrowth plates. The plates may have tissue ingrowth properties.

Abstract: A medical device includes a multi-layered structure comprising an inner layer disposed within an outer layer, wherein each of the inner and outer layers has respective inner and outer surfaces. The multi-layered structure further comprises at least offset located between the inner and outer layers or formed in the inner and/or outer layers to define at least one gap therebetween such that a majority of the outer surface of the inner layer is spaced apart from the inner surface of the outer layer. The multi-layered structure is configured to be deployed within a lumen such that at least a portion of the outer layer is configured to engage the lumen and the at least one gap is configured to promote thrombosis between the inner and outer layers.

Abstract: A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

Abstract: A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

Abstract: This invention relates to stents, a type of implantable medical device, with an antiproliferative coating and a prohealing luminal coating and methods of fabricating stents with an antiproliferative coating and a prohealing luminal coating.

Abstract: Stents or scaffolds made from magnesium or magnesium alloys including additives or barrier coatings that modify the corrosion rate of the stent are disclosed. Methods of forming barrier coatings that modify the corrosion rate of the stent are disclosed.

Abstract: Methods of controlling the degradation profile of a biodegradable stent scaffolding are disclosed. A bioabsorbable scaffold having a plurality of particles incorporated into the scaffolding that accelerate the absorption of the scaffolding after an induction time during degradation is disclosed.

Abstract: Described are preferred extracellular matrix composites including a first extracellular matrix material having a second extracellular matrix material deposited thereon. The preferred materials are made by culturing cells in contact with an extracellular matrix graft material in a fashion to cause the cells to biosynthesize and deposit extracellular matrix components on the material. The cells are then removed to provide the extracellular matrix composite material.

Abstract: A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

Abstract: The invention provides a system and method for localized application of therapeutic substances within a biological lumen and to the wall of the lumen. In various embodiments, a biodegradable tubular prosthesis comprising a plurality of pores is deployed within a biological lumen. Subsequent to, or in conjunction with, the deployment of the prosthesis, a drug-eluting balloon comprising at least one therapeutic agent is expanded within the lumen of the tubular prosthesis, thereby releasing the agent(s) from the balloon and delivering them to the prosthesis pores. The at least one therapeutic agent is then allowed to diffuse through the pores to the lumen wall.

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: The embodiments relate generally to medical devices and to methods of their manufacture. One aspect provides devices including chitosan fibers that are a free of chemical cross linking. Another aspect provides a method of manufacturing such devices.

Abstract: Methods of treating congenital heart defects in infants and children with bioabsorbable polymer stents are described. The treatments reduce or eliminate the adverse affects of congenital heart defects or may be palliative.

Abstract: A medical device that can be wrapped around a segment of an artery downstream of an arteriovenous fistula. The wrap, when used in this manner, creates a stenosis for reducing retrograde flow at the fistula. Sutures are positioned in holes present in the upper and lower halves or connecting ends of the wrap, after which the sutures are pulled to oppose the two sides in order to create a stenosis. When the surgeon is satisfied that the stenosis is appropriate, the sutures are tied in place.

Abstract: Medical devices, such as endoprostheses, and methods of making the devices are described. In some embodiments, a medical device includes an elongated hollow body formed of a polymeric matrix containing one or more regions of a pre-determined weight percent of carbon nanotubes in general alignment in a pre-determined orientation. The medical device can have a compressed state with a first transverse dimension and an expanded state with a second relatively greater transverse dimension.

Abstract: Stents and methods of fabricating stents with prohealing layers and drug-polymer layers are disclosed.

Abstract: Medical devices and methods of fabricating such medical devices, such as stents, formed at least in part from a metal matrix composite including bioceramic particles dispersed within an erodible metal are disclosed.

Abstract: An intermixed particulate bioresorbable material including cathodic particles and anodic particles bound to each other, wherein the anodic and cathodic particles are made respectively of an anodic and a cathodic material, the anodic and cathodic materials forming a galvanic couple. The anodic and cathodic particles are present in a predetermined ratio and the anodic particles, cathodic particles and predetermined ratio are such that bioresorption of said stent is promoted by galvanic corrosion between said anodic and cathodic materials. Also, a medical device, such as a stent, manufactured using the bioresorbable material and a method of manufacturing the bioresorbable material and the medical device.