Abstract: In embodiments there is described a cardiovascular tube-shaped lockable and expandable bioabsorbable scaffold having a low immunogenicity manufactured from a crystallizable bioabsorbable polymer composition or blend.

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 method of making a medical device includes compressing a prosthesis, e.g., a therapeutic agent-carrying stent or stent-graft, to a catheter without contacting an outer surface of the prosthesis, e.g., by electromagnetically compressing the prosthesis.

Abstract: A biocompatible material may be configured into any number of implantable medical devices including intraluminal stents. Polymeric materials may be utilized to fabricate any of these devices, including stents. The stents may be balloon expandable or self-expanding. The polymeric materials may include additives such as drugs or other bioactive agents as well as radiopaque agents. By preferential mechanical deformation of the polymer, the polymer chains may be oriented to achieve certain desirable performance characteristics.

Abstract: An expandable stent for implanting in a body lumen, such as a coronary artery, peripheral artery, or other body lumen. In one aspect, the stent includes a butterfly pattern to which connecting links are attached. In another aspect, the stent embodies a non-directional structure. One embodiment is a stent in which one or both ends are more flexible than the center portion. Also, the stent may have a non-uniform drug coating. Another embodiment relates to a stent having ends that are more radiopaque than the center portion.

Abstract: An x-ray marker for medical implants made of a biocorrodible metallic material, wherein the x-ray marker composite comprises 1-40 weight parts of a carrier matrix having a melting point greater than or equal to 43° C., which comprises 90 weight-percent or more triglycerides; and 60-99 weight parts of a radiopaque marker component, which is embedded in the carrier matrix.

Abstract: An endoprosthesis, in particular, an intraluminal endoprosthesis, e.g., a stent, having a basic mesh and a functional element attached to a carrier structure, the functional element having a different material composition than the material of the basic mesh in at least a portion of its volume. The carrier structure is arranged on the basic mesh in the first essentially finger-shaped end and protrudes away from the mesh essentially like a projection. The functional element is arranged on an area of the carrier structure protruding away from the base body and at least partially surrounds the area of the carrier structure.

Abstract: A method to quantify the radial endoluminal irregularity of aortoiliac arteries is provided. Radial endoluminal outlines of a vessel of interest are determined. The cross sectional area is determined for the area outlined by each endoluminal outline. Using this cross sectional area a shape is selected that has substantially the same area as the endoluminal outline. Subsequently, the shape is fitted to the endoluminal outline. In one aspect, the irregularity index is calculated as the ratio of the endoluminal outline and the outline of the fitted shape. In another aspect, the irregularity index is calculated as the ratio of at least a part of the endoluminal outline and the outline of the fitted shape that corresponds to the same part of the endoluminal outline. The irregularity index is visualized using a color scheme, a range of numbers, or a set of labels.

Abstract: The smart textile vascular graft is used with an electrical control unit. The vascular graft includes a tube structure formed of a textile material. At least one active fiber is incorporated in the textile material. The active fiber provides electrical coupling thereof to the electrical control unit to provide for transmission of a control signal between the active fiber and control unit. The active fiber has at least one physical characteristic which is variable and corresponds to the control signal to provide communication between the active fiber and electrical control unit relating to the physical characteristic.

Abstract: An improved stent design and stent delivery catheter assembly for repairing a main vessel and a side branch vessel forming a bifurcation. The stent includes rings aligned along a common longitudinal axis and connected by links, where the stent has one or more portals for aligning with and partially expanding into the opening to the side branch vessel. The stent is implanted at a bifurcation so that the main stent section is in the main vessel, and the portal section covers at least a portion of the opening to the side branch vessel. A second stent can be implanted in the side branch vessel and abut the expanded central section to provide full coverage of the bifurcated area in the main vessel and the side branch vessel. Radiopaque markers on the stent and on the tip of the delivery catheter assist in aligning the portal section with the opening to the side branch vessel.

Abstract: An improved stent design and stent delivery catheter assembly for repairing a main vessel and a side branch vessel forming a bifurcation. The stent includes rings aligned along a common longitudinal axis and connected by links, where the stent has one or more portals for aligning with and partially expanding into the opening to the side branch vessel. The stent is implanted at a bifurcation so that the main stent section is in the main vessel, and the portal section covers at least a portion of the opening to the side branch vessel. A second stent can be implanted in the side branch vessel and abut the expanded central section to provide full coverage of the bifurcated area in the main vessel and the side branch vessel. Radiopaque markers on the stent and on the tip of the delivery catheter assist in aligning the portal section with the opening to the side branch vessel.

Abstract: A stent comprises at least one curve deployment section. The at least one curve deployment section comprises at least one expansion ring having a circumferential length, a longitudinal length and comprising a first circumferential section and a second circumferential section. The first circumferential section comprises an expansion column and the second circumferential section comprises at least two expansion columns longitudinally offset from one another. The expansion column of the first circumferential section is engaged to the at least two expansion columns of the second circumferential section.

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: Disclosed herein are stents with degradable part and/or sections of the stent. The degradable portions of the disclosed stents can provide increased surface area for a period of time for bioactive material deposition or enhanced radiopacity at various locations along the length of the stent. The stents of the present invention also can stent portions of a vessel that are damaged by stent implantation but do not necessarily require long term stenting by providing degradable end sections on the stents of the present invention.

Abstract: High radiopacity is achieved in a polymeric marker by combining a polymeric resin, a powdered radiopaque agent having uniformly shaped particles of a specific particle size distribution and a wetting agent. The method to produce the marker calls for the blending and pelletization of these materials followed by extrusion onto support beading. The resulting supported tubing is subsequently cut to length with the beading still in place. After ejection of the beading remnant the marker is slipped into place on the device to be marked and attached by melt bonding. Marking of a guidewire allows lesions to be measured while the marking of balloon catheters allow the balloon to be properly positioned relative to a lesion.

Abstract: A stent is provided with a multi-layer structure, combining one or more mesh layers with one or more film layers. The film layer(s) are configured to substantially prevent growth of an inner lining of a blood vessel, where the stent is placed, through the mesh layer(s). The end-to-end length of the film layer(s) may be greater than the lengths of the mesh layer(s) by at least about 0.5 mm. The mesh and film layers include a radiopaque portion adjacent their ends to provide an X-ray indication of whether the mesh layer(s) have expanded beyond the ends of the film layer(s). If the stent includes inner and outer film layers and a middle mesh layer, the film layers may be sealed together adjacent the ends, encasing and fixing in place the middle layer. The mesh layer may be constructed to be more compliant adjacent its distal end and to expand more rapidly in response to expansion of a balloon catheter as compared to a middle portion of the mesh layer.

Abstract: A radiopaque composition and implant comprising a mixture of a polymer, such as polyetherketone (PEEK), polyetherketone (PEK), polyetherketoneketone (PEKK), polyetherimide, or polyphenylsulfone, and bismuth trioxide (BiO3) is provided. The mixture comprises BiO3 of about twenty to thirty percent (20% to 30%) by weight. The composition is useful in radiopaque implants for mammals including humans, such as in catheters, stents, screws, anchors, dental caps and posts, bone and joint replacements, and the like. The composition is also useful for radiopaque markers in implants and for radiopaque articles used in surgical and other in vivo procedures. The radiopaque items can be easily identified and located in a patient's body via X-ray examination or fluoroscopy.

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: 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 or other intraluminal medical device may be constructed utilizing a series of anvil bridges interposed between a series of fixed bridges to reduce the likelihood of deformation during stent loading and stent deployment without sacrificing overall stent flexibility. The stent comprises a plurality of hoops interconnected by a plurality of fixed bridges. The stent also comprises a plurality of anvil bridges, which transmit forces only when the stent is subjected to compressive axial loading. The stent may also comprise markers formed from housings integral with the stent and marker inserts having a higher radiopacity than the stent. This design provides for more precise placement and post-procedural visualization in a vessel, by increasing the radiopacity of the stent under X-ray fluoroscopy. The housings are formed integral to the stent and the marker inserts are made from a material close in the galvanic series to the stent material and sized to substantially minimize the effect of galvanic corrosion.

Abstract: A endovascular graft having sensing devices attached thereto to facilitate measurement of pertinent parameters within the vasculature into which the graft is implanted. Power sources and transmitters may be attached to the graft to facilitate transmission of measurements to a receiving device outside the patient's body. The sensing devices, may be electrically passive or integrated devices with measurement and transmission capability. The sensing devices may be attached to specific locations on the graft material or attached to the lumen, thereby providing pertinent parameters from critical points inside the vasculature, or may be dispersed over the surface of the graft material or within the lumen to provide a profile of pertinent parameters. The sensing devices may be attached to the graft material with one suture using a running stitch to minimize graft bulk and may be coated with a material to inhibit or control tissue growth.

Abstract: A process comprising the steps of providing a precursor for an implantable medical device, at least a portion of the precursor made of a shape memory material, the shape memory material having a receptacle for receiving a marker therein, the shape memory material having an austenitic and a martensitic phase; enlarging the receptacle while the shape memory material is in the martensitic phase; inserting a marker in the receptacle while the shape memory material is in the martensitic phase; and thereafter transforming the precursor to the austenitic phase.

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: A medical device that inhibits distortion of medical resonance images taken of the device. In particular, various structures are utilized to allow visibility proximate, and inside of, a tubular member, such as a stent. In one embodiment, the stent does not contain electrically conductive loops. In an alternative embodiment, rings in the stent are arranged such that current in one ring portion is opposed by current in another ring portion.

Abstract: A tubular prosthesis device for use within the body. The device includes, a metal filament material formed of metal outer member having an exposed outer surface and a core within the extended outer member formed of a different metal than the outer member. The core is secured within and substantially enclosed by the outer member. The device can be reduced to a small size for introduction into the body lumen and expandable to a sufficiently large size to engage the wall of the body lumen. Stents formed of composite wires are shown.

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: A temporary and retrievable radiopaque marker and discrete radiopaque marker for use on an implantable endoprosthesis. The elongate marker has a proximal end, a distal end, and a thickness. At least a portion of the marker is radiopaque and the marker is removably-attached to the implantable endoprosthesis.

Abstract: An endovascular graft having one or more sensors attached to its internal and external surface, one or more power sources attached to its external surface and one or more transmitters attached to its external surface, the sensors capable of measuring pertinent parameters and each transmitter capable of transmitting signals containing pertinent parameters to one or more receiving devices located outside the patient's body. The sensors may measure pressure, temperature, blood flow, electrical potential, or any combination thereof. The sensors may be attached at specific locations on the graft material, thereby providing pertinent parameters from critical points inside the vasculature, or may be attached to form an array of sensors over the internal and external surface of the graft material, thereby providing a complete profile of pertinent parameters throughout the vasculature covered by the endovascular graft.

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 present invention provides a lumen support prosthesis composed of interlocking radial modules which is fabricated fully assembled from a signal piece shape, without welding or bonding. The prosthesis comprises at least one locking mechanism, allowing for one-way sliding of the radial modules and expansion of the prosthesis from a collapsed state, but inhibits radial recoil from the expanded diameter. The prosthesis may be fabricated from biologically degradable materials which have certain medical advantages.

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: The present invention provides improved prostheses and methods for their endolumenal placement within body lumens, particularly blood vessels. In one embodiment, the prosthesis of the present invention comprises a plurality of radially expansible rings having, a plurality of beams connecting axially remote points on adjacent rings, and a plurality of expansion joints connecting axially proximate points on adjacent rings. The beams maintain the remote points at a fixed distance when the prosthesis is radially expanded and the expansion joints allow for relative movement of the proximate points during delivery of the prosthesis. The combination of the beams and expansion joints minimizes the risk of injury to the body lumen during delivery of the prosthesis to a target site and provides improved tracking capabilities.

Abstract: A radiopaque stent may be prepared by providing a stent preform, providing a particulate radiopaque material on at least a portion of the stent preform, pressing the particulate radiopaque material into a desired portion of the stent preform and processing the stent preform into a stent.

Abstract: A medical device includes a catheter and a stent mounted on the catheter, the stent having a hollow, cylindrical body made with a plurality of rings. The rings each extend circumferentially around the cylindrical body and include an undulating series of peaks and valleys. The rings are joined together by a series of links which are shaped and arranged to promote longitudinal flexibility as the stent is delivered on the catheter and effective scaffolding after deployment. In one aspect of the invention, the rings are provided with inflection points on some portions of the rings which extend in a generally circumferential direction for a short distance. A link is joined at one end at the inflection point on one ring and also joined at a second end at a second inflection point on an adjacent ring. This construction allows the crimped stent to flex longitudinally when it is subjected to bending forces such as those encountered during delivery of the stent and catheter through a tortuous coronary artery.

Abstract: A method for placing a stent into a main vessel such that the stent side hole aligns with a branch vessel ostium comprises inserting a main vessel guidewire into the main vessel and a branch vessel guidewire into the main vessel until a distal end of the branch vessel guidewire passes into the branch vessel. A catheter system is positioned over the main vessel guidewire and the branch vessel guidewire. The catheter system is advanced over the guidewires until the catheter body passes beyond the ostium of the branch vessel and the side member extends into the branch vessel. Marker separation is observed to indicate the catheter body passed beyond the ostium and the side member extends into the branch vessel. The balloon is inflated to deploy the stent with the side hole being aligned with the ostium. The balloon is deflated, and the catheter system is withdrawn.

Abstract: A stent or other intraluminal medical device having markers formed from housings integral with the stent and marker inserts having a higher radiopacity than the stent provides for more precise placement and post-procedural visualization in a vessel, by increasing the radiopacity of the stent under X-ray fluoroscopy. The housings are formed integral to the stent and the marker inserts are made from a material close in the galvanic series to the stent material and sized to substantially minimize the effect of galvanic corrosion.

Abstract: The bifurcating double stent apparatus (10) of the present invention comprises a generally cylindrical main stent (12), a generally cylindrical branch stent (15), which are shown as fully dilated in a subject main vessel (8), and a subject branch vessel (7). The main stent (12) is deployed prior to the branch stent (15) which is then aligned with the side opening (16) of the main stent (12), and attached at that location.

Abstract: An expandable stent and delivery system is provided for enhancing luminal dilation of a blood vessel. The delivery system includes proximal, intermediate and distal cylindrical members disposed on and spaced apart along an elongated core member such that first and second gaps are formed. The expandable stent includes proximal and distal anchor members which align with the gaps. The expandable stent is mounted on the intermediate cylindrical member, and the anchor members are disposed within the gaps thereby locking the stent onto the core member.

Abstract: A stent for endovascular placement in the body having radiopaque markers in the shape of sleeves attached to struts of the stent. In a preferred embodiment, radiopaque sleeve markers are attached surrounding the terminal end of struts at the ends of a stent so that the location within the body of the stent can be identified by fluoroscopy or other methods. Upon placement of the sleeve marker on the stent strut, the marker is attached to the strut by a snap-fit mechanism, or by deforming or changing the shape of the marker and/or the strut to inhibit removal of the marker.

Abstract: A radiopaque nitinol medical device such as a stent for use with or 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 selected from the group of chemical elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium. 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. Another embodiment includes a balloon expandable stent made from a radiopaque and MRI compatible alloy such as nitinol and includes a ternary element selected from the group of chemical elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, hafnium, osmium, zirconium, niobium, or molybdenum.

Abstract: A stent or other intraluminal medical device having markers formed from housings integral with the stent and marker inserts having a higher radiopacity than the stent provides for more precise placement and post-procedural visualization in a vessel, by increasing the radiopacity of the stent under X-ray fluoroscopy. The housings are formed integral to the stent and the marker inserts are made from a material close in the galvanic series to the stent material and sized to substantially minimize the effect of galvanic corrosion. The housings are also shaped to minimize their impact on the overall profile of the stent. The stent or other intraluminal medical device may also be fabricated from an alloy having a higher radiopacity without sacrificing any properties of the base alloy forming the stent or other intraluminal medical device.

Abstract: An implant delivery system is disclosed. The delivery system includes an elongated member having an implant mounting location. A self-expandable implant is mounted at the implant mounting location. The implant is held in a compressed orientation by a retractable sheath. An interlock structure prevents the implant from deploying prematurely as the sheath is retracted. The interlock structure includes radio-opaque markers that identify the position of the implant.

Abstract: An expandable frame for an embolic filtering device used to capture embolic debris in a body lumen. The expandable frame also includes a filtering element. A nickel-titanium alloy is used to form the frame. Due to limited heat treatment, the frame exhibits linear pseudoelasticity when positioned inside the body lumen. The nickel-titanium alloy includes a ternary element such as iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium so that the frame is also radiopaque.

Abstract: A stent made of metallic and/or non-metallic material that can be implanted into tubular structures or other body cavities is coated with nanoscale particles that consist of a paramagnetic core and at least one shell adsorbed to it which is durably bonded to the stent surface. This coating makes it possible to selectively and homogeneously heat up the implant by applying an alternating magnetic field with a clinically tolerable combination of field strength and frequency, thereby achieving high power absorption and, on the one hand, a temperature level that enhances the growing-in of the implant by enhancing cell proliferation, on the other hand, a temperature range in which a restenosed implant can be regenerated. Also, it facilitates position detection.

Abstract: A stent has a surface with an irregular coating formed on that surface. The irregular coating provides coating islands, especially coating islands that are substantially round. In some embodiments, the coating islands are arranged at a greater spacing in regions involving a greater degree of local stretching of the stent surface upon stretching of the stent than in regions involving a lesser degree of local stretching of the stent surface. In other embodiments, the coating islands are smaller in regions involving a greater degree of local stretching of the stent surface upon stretching of the stent than in regions involving a lesser degree of local stretching of the stent surface.

Abstract: The present device has increased longitudinal flexibility in a stent by having some curved sections of each circumferential set of strut members being unconnected to the curved sections of the adjacent circumferential set of strut members with the other curved sections being connected by highly flexible, undulating longitudinal connecting links. The present device prevents flaring of the unconnected strut members by having a shorter longitudinal length for the unconnected strut members, and may have generally shorter longitudinal lengths for all the strut members in the circumferential sets of strut members at the stent ends to reduce the tendency for end flaring of the stent. Finally, the stent demonstrates that the flexible longitudinal connecting links of the curved sections of the sets of strut members are connected at a point that is close to the line where the diagonal sections join the curved sections, thus further reducing the propensity for end flaring.

Abstract: A medical stent is sized for placement in a ureter. The stent includes a first section which includes a first material, defines a lumen, and includes a first coil completing at least one revolution. A second section of the stent includes a second material, defines a lumen, and includes a second coil completing at least one revolution. A third section defines a lumen and is located between the first and second sections. The third section includes a co-extrusion of the first and second materials. One of the first or second sections is harder than the other section.

Abstract: A stent combined with a positioning apparatus to effectively place the stent at a precise deployment site within a narrowed vascular region such as an artery. The stent is maneuvered through the vessel and is guided by a guiding catheter up the vessel to where the narrowing is located. Upon exiting the guiding catheter and approaching the deployment site within the coronary artery, a deployment site locator expands to contact the vascular structure and, thereby, effectively position the stent at the deployment site within the narrowed vessel. This system apparatus and method is particularly useful for stent placement at an ostium (origin) of a vessel.

Abstract: A expandable prosthesis having an imageable structure comprising one or more elements visually distinguishable by an external (e.g., radiographic or ultrasonic) imaging system, the structure being located about a first axis that corresponds to a structural feature of the prosthesis that is configured to perform a specific function particular to that axis. The imageable structure is configured to assist in the rotational orientation of the prosthesis during placement within the implantation site. In one embodiment, the prosthesis comprises a venous valve that includes imageable elements or structure, such as a pair of radiopaque markers, that defines the orifice of the valve structure such that the orifice can be oriented with a particular anatomical feature under imaging, such as to align the orifice with the long axis of the vessel.

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.