Abstract: A medical device comprising a substrate and a hydrogel coating disposed over at least a portion of the substrate surface. The hydrogel coating contains an MRI contrast agent and includes inner and outer regions. The inner region comprises a first hydrogel polymer, and the outer region comprises a second hydrogel polymer that can be the same as or different from the first hydrogel polymer. The inner region exhibits more absorption upon hydration than does the outer region. Examples of hydrogel polymers include polysaccharide and polypeptide hydrogel polymers such as alginic acid, hyaluronic acid, chitin, carboxymethyl cellulose, hydroxypropyl cellulose, collagen, and gelatin, as well as salts and copolymers thereof. Upon insertion or implantation of the medical device into a patient, the hydrogel coating is differentiable from the environment surrounding the hydrogel coating under magnetic resonance imaging.

Abstract: A radiopaque implantable prosthesis including a polymeric prosthesis made from ePTFE having a node and fibril structure and a radiopaque filler integral with at least a portion of the node and fibril structure of the ePTFE. A method of making the prosthesis is also provided.

Abstract: A temporary bioabsorbable-radiopaque marker for use on an implantable endoprosthesis. The bioabsorbable-radiopaque marker is adapted to be disposed on or adjacent an implantable endoprosthesis in a body lumen for a predetermined amount of time until the bioabsorbable and radiopaque materials are absorbed or dispersed in the body.

Abstract: The invention concerns a marker intended to facilitate the location of a determined area of an internal organ during secondary surgical procedures where an earlier surgical procedure has been performed, whereby the said internal organ can be native just as it can be a synthetic or autonomic implant and/or a combination of such organs and in this part the area of intervention can be the transition of an anastomosis, whereby to facilitate the said location the marker (4) comprises a part (5) designed as an implant for securing to the area of intervention during a primary operation to form a tactile barrier or boundary for the surgeon during the secondary operation between the area of intervention and the surrounding tissue. The invention also concerns an implant such as a graft provided with such a marker.

Abstract: X-ray imageable articles, for instance surgical implements or parts therefore which are used in minimally invasive surgical procedures, may be prepared by a process including the steps of:

Abstract: A method for securing a radiopaque marker to an implant is disclosed. The method includes compressing a ball of radiopaque material into an opening defined by the implant.

Abstract: An expandable stent and delivery system therefor is provided for treating vascular diseases such as partially occluded blood vessels and aneurysms. The delivery system includes proximal, intermediate and distal cylindrical members disposed about an elongated core member. The proximal, intermediate, and distal cylindrical members are spaced apart such that first and second gaps are formed. The expandable stent includes anchor members which are formed by winding a radiopaque coil onto a threaded portion of a strut member of the expandable stent. The expandable stent is mounted on the intermediate cylindrical member with the anchor members disposed within the gaps between the cylindrical members. A deployment catheter is used to compress and constrain the stent about the intermediate cylindrical member to thereby interlock the stent onto the core member.

Abstract: The invention comprises:

Abstract: A stent may be formed of at least one structural material having a pattern including at least one serpentine structure which extends about the longitudinal axis of the stent. The structure is formed of a plurality of struts. Adjacent struts are interconnected by end portions having inner turns and outer turns. At least some of the end portions are elongated and other end portions are non-elongated and have a predetermined length. The inner turns of the elongated end portions are substantially unaligned longitudinally with the inner turns of the non-elongated end portions. At least one of said elongated end portions is configured to serve as a fiducial marker.

Abstract: A coating for a prosthesis, for example a stent, and a composition for forming the coating is disclosed. The coating can serve as a primer, allowing substances, such as polymers, to be effectively secured by the prosthesis. Alternatively, the coating can serve as a reservoir, allowing for the local and sustained release of a therapeutic substance to biological tissues. The composition can be formed from an ethylene vinyl alcohol copolymer and a dimethylsulfoxide solvent, with or without a therapeutic substance. Alternatively, the composition can be formed from an ethylene vinyl alcohol copolymer, a dimethylsulfoxide solvent, and a wetting fluid, with or without a therapeutic substance. The composition is applied to a surface of the prosthesis and essentially all of the dimethylsulfoxide solvent or dimethylsulfoxide solvent/wetting fluid is removed or allowed to evaporate to form the coating.

Abstract: A stent system is disclosed which comprises a stent made of a conventional metal alloy, such as stainless steel, coated with a nonconductive layer, in turn coated by a layer more radiodense than stainless steel, which system enhances radiopacity without permitting galvanic corrosion.

Abstract: An endoluminal device including a prosthesis and at least one indicator member affixed to the prosthesis that can be remotely monitored to indicate a change in pressure or morphology of the prosthesis. The indicator member may be an optical fiber, a strain gauge, or a first material having a first magnetic resonance imaging (MRI) susceptibility value that contrasts with a second MRI susceptibility value of a second material that comprises one or more remaining members of the prosthesis. A prosthesis monitoring system includes an endoluminal device as well as a subcutaneous electronics package and external electronics. Methods of detecting endoleaks or changes in morphology involve implanting an endoluminal device with the indicator and detecting information from the indicator.

Abstract: A medical device and method of providing same, comprises a first stent body and a second stent body wherein the medical device is formed when the at least one first marker portion and the at least one second marker portion of the stent bodies are positioned in a predetermined alignment wherein the first stent body and the second stent body are aligned along substantially the same longitudinal axis and at least a portion of the first end region and at least a portion of the second end region of the respective stent bodies are overlappingly arranged to provide the medical device with a longitudinal length that is less than the sum of the first stent body length and the second stent body length.

Abstract: A longitudinally flexible stent having high visibility under fluoroscopy for implanting in a body lumen. The stent includes a plurality of radiopaque interconnecting elements, configured to be expandable and encapsulated by polymeric material in a coil-like configuration, that are connected to a plurality of cylindrical elements at least at distal and proximal ends of the stent such that the radiopaque interconnecting elements are visible under fluoroscopy to enable identification of the position, diameter, and length of the stent at the implantation site. Alternatively, the stent includes a plurality of radiopaque interconnecting elements having a polymeric material filled with a radiopaque material attached to the cylindrical elements of the stent at least at the distal and proximal ends of the stent.

Abstract: A stent in the form of a thin-walled, multi-cellular tubular structure is provided. The tubular structure has a longitudinal axis and the stent includes a plurality of circumferential sets of strut members. Each set of the strut members is longitudinally displaced from each other and connected to each other by longitudinally extending links. Each set of the strut members forms a closed and cylindrical portion of the stent. Further, each set of the strut members includes a plurality of connected curve sections and diagonal sections. The sets of the strut members further include end sets of strut members located at each end of the stent and central sets of strut members located between the end sets of the strut members. The diagonal sections of the end sets of the strut members have a center portion and two ends.

Abstract: A medical device and system capable of providing on-demand delivery of biologically active material to a body lumen patient, and a method of making such medical device. A first coating layer comprising a biologically active material and optionally a polymeric material is disposed on the surface of the medical device. A second coating layer comprising magnetic particles and a polymeric material is disposed on the first coating layer. The second coating layer, which is substantially free of a biologically active material, protects the biologically active material prior to delivery. The system includes the medical device and a source of energy, such as an electromagnetic or mechanical vibrational energy. When the patient is exposed to the energy source, the magnetic particles move out of the second coating layer and create channels therein through which the biologically active material can be released.

Abstract: A stent includes a marker mount defined by a pair of fingers. The fingers are preferably oriented parallel to the longitudinal axis of the stent. The fingers preferably each include a retainer at their respective ends, and the retainers of each pair of fingers preferably define a composite barb. A tubular marker can be forced over the bifurcated barb and onto the fingers. The marker is preferably provided with a ceramic coating to prevent galvanic corrosion between the stent and the marker.

Abstract: A tubular implant having an axial end to which is attached a ring of spoons of a material different from that of the implant. In another aspect, the invention provides a method of attaching elements to an axial end of a tubular implant comprising the steps of providing said elements on one end of a support tube having a radius substantially that of the implant in its unexpanded configuration, abutting the implant and elements end-to-end, fixing the elements to the implant; and parting the elements from the support tube. In a third aspect, the invention provides an implant carrying an element of another material, the element and implant having complementary tapered mating surfaces for achieving a taper form fit of the element onto the implant.

Abstract: A stent configuration wherein a radiopaque material is completely encapsulated in a skin of biocompatible material to prevent the exposure of radiopaque materials to living tissue and to prevent galvanic corrosion between disparate metals. The stent is initially formed and rendered radiopaque after which all surfaces are coated with the biocompatible material.

Abstract: A stent delivery system includes an inner tubular member on which a stent is loaded, an outer jacket extending over said inner tubular member, the retraction of which causes deployment of the stent, and a handle adapted to move the jacket relative to the inner tubular member. The constructions of the inner tubular member and outer jacket and the handle provide increased control of the relative movement of the outer jacket relative to the inner tubular member, and prevention of premature release of the stent from the deployment instrument, and greater control over stent deployment via visual and auditory feedback at the proximal end of the instrument, among other advantages.

Abstract: Disclosed is a stent having improved characteristics of its structural design and improved radiopacity characteristics. Specifically, the present invention is a stent that has circumferential sets of strut members at the ends of the stent and central sets of strut members that are longitudinally placed between the end sets of strut members. Optimal radiopacity is achieved when the end sets of strut members are more radiopaque as compared to the radiopacity of the central sets of strut members. Also disclosed is the concept of adjusting the strut width of the curved sections of the end and central sets of strut members so that equal strain in all curved sections is achieved as the stent is expanded even though the diagonals sections of the end sets of strut members are shorter than the diagonal sections of the central sets of strut members.

Abstract: A tubular stent formed from a plurality of cylindrical rings and connecting links where selected connecting links are of comparatively high mass in relation to the other links. The high-mass links have sufficient mass to be visible during a fluoroscopy procedure when formed from a moderately radiopaque material such as stainless steel. The high-mass links being arranged in a spiral pattern along the length of the stent to ensure that the stent is fluoroscopically visible regardless of the stents orientation during the implantation procedure.

Abstract: Disclosed is a very small diameter intravascular stent, or aneurysm cover, which may be used to occlude, or partially occlude, an aneurysm in the human brain. The stent is comprised of a thin-walled skeletal tubular member formed of interconnected sinusoidal members to thereby form a pattern of cells along the skeletal tubular member. The stent also includes anchor members, which are comprised of a longitudinal leg member having a radiopaque coil disposed about the leg member, which serve to retain the stent during delivery of the stent.

Abstract: An endoluminal device for deployment in a body lumen includes a radially expandable stent, a graft attached to the stent, and a plurality of indicator members affixed to the graft and adapted to form a normal pattern in response to a normal pressure differential and an abnormal pattern in response to an abnormal pressure differential across the graft. By forming different patterns at different pressure differentials, the indicator members enable the detection of a change in pressure which could be evidence of a leak. A system for detecting a change in pressure differential includes the endoluminal device and an imaging system for displaying the indicator members. A method for detecting a change in pressure includes the steps of identifying the normal pattern, implanting the device, imaging the indicator members, and comparing the imaged pattern with the normal pattern to determine whether the normal pressure or an abnormal pressure differential exists.

Abstract: The invention provides a stent is made from a material operable to perform a stent's desired therapeutic functions, and also made from a material that has a radioopacity that substantially preserves the appearance of the stent when the stent is viewed under a CT imaging beam. Such a stent can allow for follow-up of the stent and the surrounding blood-vessel on CT.

Abstract: The present invention avoids a patient receiving a double dose of a therapeutic agent when a coated stent is overlapped with another coated stent within a vessel. A stent having a therapeutic coating on a portion of the stent is delivered within a vessel such that the portion of the stent not having a therapeutic coating is inserted within or overlaps a second coated stent. A radiopaque marker on the stent or delivery catheter guides positioning of the stent such that there is minimal or no overlap of the therapeutic coatings on the two stents.

Abstract: An endoprosthesis, such as a stent, having a layer that can enhance the biocompatibility of the endoprosthesis, and methods of making the endoprosthesis are disclosed.

Abstract: A stent graft has a tubular wall (1) defining a main lumen with at least one fenestration (15) in the wall. A tube (17) extends from the fenestration into the main lumen and is in fluid communication with the main lumen. An extension leg stent graft can be deployed from a branch vessel into the fenestration to seal into the tube. A flared guide (89) associated with the fenestration can be provided interiorly or exteriorly. There is also disclosed a bifurcated intraluminal prosthesis having a body (1), a first leg (7) and a second leg (17), the first leg extending from the body and the second leg extending into the body.

Abstract: A stent or intraductal medical device is provided having radiopaque marker material deposited on the surface of the stent or medical device to assist visualization of the device during implantation. A method for depositing a radiopaque material on an implantable medical device such as a stent is also described. The radiopaque material may be deposited on the medical device by dipping or immersion, or the radiopaque material may be applied to the device using micro-injection or electrodeposition. The radiopaque material may coat the entire surface of the stent, or only a portion of the stent, or it may be applied to cavities or microdepots formed in the outer surface of the medical device. Excess radiopaque material may be removed from the device by centrifugation or shaking, and the radiopaque material may be heated to bond the material to the surface of the device.

Abstract: A radiopaque nitinol stent for implantation in a body lumen is disclosed. The stent is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element including tungsten. The added tungsten in specified amounts improve the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same strut pattern coated with a thin layer of gold. Furthermore, the nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: A seamless, self-expanding implantable device having a low profile is disclosed along with methods of making and using the same. The implantable device includes a frame cut out of a single piece of material that is formed into a three-dimensional shape. The implantable device may comprise an embolic filter, stent, or other implantable structure. The present invention also allows complicated frame structures to be easily formed from planar sheets of starting material, such as through laser cutting, stamping, photo-etching, or other cutting techniques.

Abstract: Apparatus and methods are provided for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. The apparatus comprises a catheter in communication with an end effector which induces a temperature rise in an annulus of tissue surrounding the leaflets of a valve or in the chordae tendineae sufficient to cause shrinkage, thereby causing the valves to close more tightly. Mechanical clips can also be implanted over the valve either alone or after the thermal treatment. The clips are delivered by a catheter and may be configured to traverse directly over the valve itself or to lie partially over the periphery of the valve to prevent obstruction of the valve channel. The clips can be coated with drugs or a radiopaque coating. The catheter can also incorporate sensors or energy delivery devices, e.g., transducers, on its distal end.

Abstract: The present invention relates to an occlusion device for treating an aneurysm, its use and a method for treating an aneurysm. The occlusion device comprises a detachable filling element and at least one radioactive source. The detachable filling element and the radioactive source are adapted to be inserted into a vessel at least in close proximity of a neck of an aneurysm. The radioactive source stimulates neointima formation for obstructing the neck of the aneurysm or filling up the aneurysm.

Abstract: A temporary bioabsorbable-radiopaque marker for use on an implantable endoprosthesis. The bioabsorbable-radiopaque marker is adapted to be disposed on or adjacent an implantable endoprosthesis in a body lumen for a predetermined amount of time until the bioabsorbable and radiopaque materials are absorbed or dispersed in the body.

Abstract: A composite stent having a substrate tube made of stainless steel, a nickel-cobalt-chromium-molybdenum alloy, or chonichrome with at least one metal cladding tube is disclosed. Specifically, the substrate tube is placed within a metal cladding tube made of platinum, gold, tantalum, tungsten, platinum-iridium, palladium, or nickel-titanium, preferably with an interference fit therebetween. The composite, laminate tube then undergoes a series of rolling or cold drawing processes interspersed with heat treating to release built up stresses. When the final diameter of the laminate tube is reached, the cladding has been laminated to the exterior of the substrate tube by a bond generated from the rolling and/or cold drawing operations. The finished laminate tube is then cut by laser cutting or chemical etching to form a suitable stent pattern.

Abstract: The present invention concerns novel stent apparatuses for use in treating lesions at or near the bifurcation point in bifurcated cardiac, coronary, renal, peripheral vascular, gastrointestinal, pulmonary, urinary and neurovascular vessels and brain vessels. More particularly, the invention concerns a stent apparatus with at least one side opening which may further comprise an extendable stent portion laterally extending from the side opening and at least partly in registry with the wall of the side opening.

Abstract: The stent for angioplasty has a body (10) in the form of a generally tubular casing capable of being dilated in use from a radially-contracted position to a radially-expanded position. The body (10) includes a support structure (12) made from a first material capable of withstanding this dilation without losing its structural integrity. A structure (14) made from a second material which has been rendered radioactive following the exposure of the stent itself to a neutron flux is associated with at least a portion of the carrying structure (12).

Abstract: The present invention relates to an intraluminal medical device formed of a first base material and having a second material inlaid in the base material wherein at least one of said first material and said second material is more radiopaque than the other. The second material may be inlaid in the first either by swaging, rolling, or by coextruding the two materials. The second radiopaque material forms a substantially smooth surface with the first base material.

Abstract: A stent is formed from a series of radially aligned expandable rings. The rings are formed of a radio-transparent material that are linked by a radiopaque spine. A thin but very bright fluoroscopic image is thereby created, without compromising the strength of the stent. The small cross-section of the illuminated spine also serves to minimize interference with the image of the lesion when the stent is being positioned thereover. In the event galvanic corrosion causes the radiopaque spine to become detached from the radio-transparent ring elements, their expanded state precludes their shifting within the lumen. While the sandwiched position of the spine against the lumen wall prevents it from shifting as well.

Abstract: The present invention is directed to a stainless steel stent which is substantially nickel-free and possesses improved elongation and mechanical properties, including resistance to corrosion. The stent can be embodied in a substrate with one or more metallic claddings overlaying the substrate. The substrate and claddings can include radiopaque materials and stainless steel.

Abstract: Disclosed is an implantable or insertable medical device comprising (a) a substrate and (b) a hydrogel polymer coating at a least a portion of the surface of the substrate, wherein the hydrogel polymer is adapted to render the medical device visible under magnetic resonance imaging (MRI) upon insertion or implantation of the medical device into a patient. Also disclosed is the use of such a hydrogel coated implantable or insertable medical device in a medical procedure, wherein during or after insertion or implantation of the medical device in a patient, the position of the medical device is viewed under MRI. The use of a hydrogel polymer for coating a medical device wherein the hydrogel polymer is adapted to render a medical device coated with the hydrogel polymer visible under MRI and a hydrogel polymer adapted to render a medical device coated therewith visible under MRI are also disclosed.

Abstract: The hydrogel for the treatment of aneurysms acts as a carrier for both a radiopaque agent allowing the hydrogel to be visualized under fluoroscopy and a therapeutic agent such as one or more human growth factors. The hydrogel is delivered through a catheter into the aneurysm, where the hydrogel becomes more viscous upon reaching body temperature, or upon exposure to bodily fluids, to block blood flow into the aneurysm. In addition to stopping blood flow into the aneurysm, the delivery of human growth factors to the aneurysm site promotes the growth of a cellular layer across the neck of the aneurysm. The hydrogel may be of a type that dissolves over time or one which remains as a permanent occlusive agent within the aneurysm.

Abstract: The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Abstract: A stent having marker tabs formed from a micro-alloyed combination of materials provides for more precise placement and post-procedural visualization in a vessel, by increasing the radiopacity of the stent under X-ray fluoroscopy. A unique micro-alloying process is utilized to form the tabs, comprising a first alloy and a second alloy, wherein one of these alloys is radiopaque. This substantially eliminates the possibility of galvanic action between the tab and the stent. This process is also applicable to other medical devices.

Abstract: A method and apparatus for inhibiting vascular restenosis using a radioactive implantable medical device and a radiosensitizer agent. In one embodiment, the method of the invention includes implanting a medical device at a blood vessel site that has undergone a procedure to open a stenosed region within a blood vessel. The medical device contains a radioisotope to emit a radioactivity to a tissue mass at the blood vessel site. The method further includes delivering a radiosensitizer agent to the tissue mass at the blood vessel site. The radiosensitizer agent increases a therapeutic response of the tissue mass to the radioactivity emitted by the radioisotope.

Abstract: A preferred embodiment of a stent provides a folded strut section that provides both structural rigidity and reduction in foreshortening of the stent mechanism. A flexible section provides flexibility for delivery of the stent mechanism. In a second embodiment, flexible section columns are angled with respect to each other, and to the longitudinal axis of the stent. These relatively flexible sections are oppositely phased in order to negate any torsion along their length. In yet another embodiment, the flexible connector can take on an undulating shape (like an “N”), but such that the longitudinal axis of the connector is not parallel with the longitudinal axis of the stent. Finally, a new method is disclosed for making stents. Further embodiments provide living hinge connectors and connections along the length of the radial strut member.

Abstract: A method for implanting a medical set in a human blood vessel, the medical set comprising a prosthesis adapted to be introduced in the vessel, the prosthesis having a first end and a second end, and being adapted to be disposed against an inner wall of the vessel at least at one of the ends, the prosthesis comprising a tubular sleeve and a strap adapted to be disposed against the vessel at a location adjacent one of the ends of the tubular sleeve, the strap having a hemostatic covering for reducing any blood leakage at the location of the strap.

Abstract: A stent system is disclosed which comprises a stent made of a conventional metal alloy, such as stainless steel, treated with chains of peptides (“anchors”) which comprise functionality to bind to the metal surface and to bind to other peptides (which other peptides are termed “recognition” peptides) and recognition peptides, which comprise one end which binds to (“recognizes”) the anchor peptide and one end which is bound to a radiodense dye, which system enhances radiopacity relative to the stent alone.

Abstract: A prosthesis (18) comprising stents (7,8) sutured to a graft (5) comprising a tube of biocompatible material. The stents are attached to the inside surface of the tube and there is at least one fenestration (10) in the tube corresponding to an intersecting artery opening. A further stent (1) extends proximally and may have caudally facing barbs (2). Each fenestration includes one or more radiopaque markers (11) defining a periphery of the fenestration. A release mechanism for the prosthesis includes trigger wires (15,17) stitched into a fold (16) on the material to retain the prosthesis in a partially compressed state during deployment. A delivery device (20) has a sheath (26) to hold the compressed prosthesis during insertion and a top cap (24) to retain the top stent (1).

Abstract: The device comprises a prosthesis designed as a hollow body compressed against the action of restoring spring forces to a cross section reduced relative to an expanded use position, and held in this position by a strippable sheath. After the sheath is stripped, the prosthesis automatically expands to a cross section corresponding to the use position. The sheath, which can be a meshwork in the approximate form of crocheted material, extends over the entire length of the prosthesis and consists of at least one continuous thread and at least one drawstring. The prosthesis, held in the radially compressed position by the sheath, can be mounted displaceably on a feed wire or non-axially-displaceably on the insertion end of a probe or a catheter.