Abstract: This disclosure is related to devices and related methods for isolating a treatment region in a human body from fluid pressure. In various embodiments, an implantable device for isolating a treatment region in a human body from fluid pressure comprises a first elongated segment, and a second elongated segment, and one or more branch segments in fluid communication with one of the first elongated segment and the second elongated segment. The elongated segments have a combined cross section that is substantially conformable to an intraluminal cross section of a body lumen into which they are implanted. A method of installing an implantable medical device into the body of a patient comprises deploying a first elongated segment, deploying a second elongated segment, and deploying one or more branch segments in a target region of a vasculature.

Abstract: The present disclosure describes systems for endoluminal devices utilizing a sleeve for constraining an expandable device toward a constrained configuration suitable for endoluminal delivery to a treatment site along vasculature; and a mechanism for retracting at least a portion of the sleeve.

Abstract: A composite stent graft has a balloon expandable stent portion, a tubular graft material portion inside or outside of the balloon expandable stent portion and self expanding stents associated with the tubular graft material portion. Part of the balloon expandable stent portion can extend beyond the proximal end of the tubular graft material portion. The tubular graft material can be polytetrafluoroethylene, dacron, polyamide, sub intestinal mucosa or any other suitable biocompatible material. A method of deploying which includes flaring a part of the balloon expandable stent portion is also discussed.

Abstract: The present disclosure relates to an endoluminal prosthesis, such as a stent graft that includes one or more fenestrations to accommodate endovascular disease, such as an aneurysm in cases where one or more side branches is involved. In one aspect, the prosthesis includes fenestrations that are pivotable to accommodate the dynamic geometry of the aortic branches.

Abstract: A delivery device for delivering a stent-valve to an anatomical site for implantation, the delivery device comprising a stent-holder (24) having at least one element for engaging the stent-valve for retaining an axial position of the stent-valve when carried on the delivery device, the element selected from a projection (84b) and/or a generally step-shaped surface, and wherein the element further comprises a ramp portion (84a, 84c) facing, or provided on a side of the element that faces, (i) a proximal direction of the device, and/or (ii) away from a distal end of the device.

Abstract: An illustrative stent may comprise an elongated tubular balloon having a first end and a second end and an intermediate region disposed therebetween. The elongated tubular balloon may have an inner wall and an outer wall, the inner wall and the outer wall connected at the first end and the second end to define an enclosed inflation chamber between the inner wall and the outer wall. The stent may further include an inflation valve.

Abstract: A sheet structure formed from an extracellular matrix (ECM) composition that includes acellular ECM derived from small intestine submucosa (SIS) tissue, gentamicin and vancomycin. The sheet structure is configured to modulate inflammation of damaged biological tissue and induce cell and tissue proliferation, bioremodeling of the damaged biological tissue, and regeneration of new tissue and tissue structures with site-specific structural and functional properties, when the tissue structure is delivered to the damaged biological tissue.

Abstract: The present disclosure relates to an endoluminal prosthesis, such as a stent graft that includes one or more fenestrations to accommodate endovascular disease, such as an aneurysm in cases where one or more side branches is involved. In one aspect, the prosthesis includes fenestrations that are pivotable to accommodate the dynamic geometry of the aortic branches. In another aspect, the pivotable fenestrations include a first perimeter, a band of flexible material attached and surrounding the first perimeter, and a second perimeter attached to and surrounding the band of flexible material. The first perimeter, band of flexible material, and second perimeter have a geometric shape. In one aspect, the prosthesis includes at least three pivotable fenestrations.

Abstract: Apparatus and methods are described including, using a computer processor (28), automatically identifying whether a given pixel (111) within an image corresponds to a portion of an object. A set of concentric circles (132a-c) that are disposed around the pixel are sampled, and a first function is applied to each of the circles such that the circles are defined by a first set of rotationally invariant descriptors. A second function is applied to the set of circles to generate a second set of descriptors, each of which represents a difference between respective pairs of the circles. A third function is applied such that the second set of descriptors becomes rotationally invariant. The processor identifies whether the given pixel corresponds to the portion of the object, based upon the first and second sets of rotationally invariant descriptors. Other applications are also described.

Abstract: A control system for deploying a stent graft (20) including a resilient ring stent (22) at one end, provides a delivery shaft (30) carrying the stent graft with the ring stent adjacent a proximal end (33) of the shaft for insertion into a lumen; a retractable sleeve (36) for containing the stent graft on the delivery shaft; a control handle (38) adjacent the distal end (34), of the delivery shaft; and stent peak (50, 52) and valley (70, 72) control wires extending from the proximal end of the delivery shaft to peak and valley controllers (58; 74, 76) at the control handle. Use of the control wires effects movement and/or rotation of the graft allowing fine control of deployment in the lumen.

Abstract: This document describes intralumenal stent graft devices with integrated anchor members that are selectively deployable in situ. The deployment of the anchor members is also reversible, to thereby facilitate retrieval of the stent graft device. These stent graft devices are well-suited for sealing and repairing defects in a body lumen wall. Such defects can include, but are not limited to, aneurysms and lumen wall openings. In some embodiments, the intralumenal stent graft devices provided herein are well-suited for use in the GI tract including the colon. That is the case because the integrated anchor members provide the stent graft devices with a high level of migration resistance, whereby the stent grafts can remain resiliently located in a desired position within the GI tract despite the peristaltic movements of the GI tract.

Abstract: A stent-graft includes a graft material having a main body, a first leg, a second leg, and a transition region where the first leg and the second leg meet the main body. A main body transition stent is coupled to the main body. A transition stent support including a gusset is coupled to the graft material such that a transition apex of the main body transition stent is interposed between the gusset and the graft material, the transition apex being aligned with the transition region. The transition apex, which is susceptible to failure, is stabilized by the gusset in combination with a supporting ligament. The gusset and supporting ligament prevent flexing of the transition apex and the associated failure thereof.

Abstract: An apex capture device includes a proximal apex capture portion that includes a nose and a plurality of tines extending distally from the nose. The apex capture device further includes a distal apex capture portion, a plurality of bosses, an elongate member and a lumen to which the proximal apex capture portion is fixed. In an embodiment, the apex capture device can include a bare stent and at least one suprarenal barb.

Abstract: A stent/graft assembly includes a tubular graft connected in substantially end-to-end relationship with a generally tubular stent. Free ends of the stent and graft extend in opposite directions from the end-to-end connection during a pre-deployment orientation of the assembly.

Abstract: A delivery device system for delivering a low profile prosthesis and a method for releasably retaining a prosthesis on the device are described. The delivery device comprises a prosthesis disposed about the proximal end of the inner cannula. In a first configuration the prosthesis is releasably secured to the inner cannula in a radially inwardly contracted low profile delivery configuration and in a second configuration the prosthesis is at least partially radially outwardly deployed. First and second trigger wires extend longitudinally and circumferentially about the prosthesis in helical configurations. The first trigger wire is helically wound in a clockwise direction and the second trigger wire is helically wound in a counter-clockwise direction. When the first and second helical trigger wires are in a tensioned condition, the prosthesis is releasably secured to the inner cannula in a radially inwardly contracted low profile delivery configuration.

Abstract: An implantable tissue filler including a particulate material suspended in a carrier, the particulate material having more than about 70% by weight magnesium and about 2-20% by weight lithium, wherein the particulate material is substantially free of rare earth metals.

Abstract: Provided are a stent to be placed in the bile duct and a process for producing the stent, the stent hollow being less apt to be blocked even when the stent is placed in the bile duct for a long period. The inner peripheral surface of the stent is coated with a resin layer with resistance to sludge formation that includes a polymer obtained by polymerizing 2-methoxyethyl acrylate. This stent is produced by applying a coating fluid that contains 0.1-0.5 mass % polymer obtained by polymerizing 2-methoxyethyl acrylate, to the inner peripheral surface of a stent.

Abstract: A tubular seal includes an outflow end region and an inflow end region. The inflow end region is a portion of a polymeric web retaining a woven fabric, wherein the woven fabric has a non-linear edge defining an interface between the inflow end region and the outflow end region.

Abstract: A stent assembly adapted to carotid arterial placement that includes a self-expanding support element comprising metal struts constructed to be positioned in a body lumen and expanded from a retracted state to an expanded state, and a knitted cover disposed over an exterior of the support element and along an entire length thereof, wherein the knitted cover comprises a single polymer fiber having a diameter of at least 40 nanometers to 30 microns, wherein the self-expanding support element and knitted cover together have apertures sized 20 microns to smaller than 100 microns in diameter to block larger debris when the stent assembly is placed in a carotid artery and expanded to the expanded state. Methods of stenting a carotid artery by applying the stent assembly to the carotid artery of a patient in need of treatment and expanding the stent assembly in situ are disclosed.

Abstract: Methods and devices for treating a lung are disclosed. The method may include deploying a catheter into a blood vessel directing blood towards a portion of the lung, and discharging a media into the blood vessel through the catheter, the media may be configured to at least partially block the flow of blood within the portion of the lung.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: A stent graft adaptor has an outer graft tube and an inner graft tube with the inner graft tube substantially concentric with and within the outer graft tube. A joining member extends between the inner tube and the outer tube. The joining member can be a continuous fold of graft material extending from a proximal end of the outer tube to a proximal end of the inner tube. The inner tube has at least one self expanding stent on an outer surface thereof and the outer graft tube has at least one self expanding stent on an inner surface. The outer surface of the outer tube provides a sealing surface to engage against the wall of a vessel and the inner tube provides a sealing surface to engage with a corresponding sealing surface of a stent graft deployed through it. The outer sealing surface can include barbs.

Abstract: Example stent grafts and methods for placement thereof are provided. An example stent graft may include (a) a main body stent graft defining a lumen having an inlet defined at a proximal end of the main body stent graft and having an outlet defined at a distal end of the main body stent graft, (b) a visceral-vessel opening defined in a sidewall of the main body stent graft between the proximal end and the distal end of the main body stent graft, (c) a diaphragm disposed within the lumen of the main body stent graft and coupled to the main body stent graft, wherein a first renal inlet, a second renal inlet, an infrarenal inlet and a visceral inlet are defined in the diaphragm and (d) a visceral chamber defined by a sidewall coupled to the visceral inlet and to the visceral-vessel opening.

Abstract: A flexible stent graft for deployment in a body vessel at a treatment site that includes a tubular body of graft material having circumferential crimps with alternative troughs and crests along its length, and a stent system comprising a plurality of circumferential turns which are attached at the crest.

Abstract: A stent comprising a stent body and a plurality of cells is disclosed. Each cell includes two structural members extending in an undulating pattern. Each structural member includes a plurality of cell segments defining a plurality of peaks and valleys therebetween. A first segment and a second segment defining a first peak, the second segment and a third segment defining a first valley, the third segment and a fourth segment defining a second peak, the fourth segment and a fifth segment defining a second valley, the fifth segment and a sixth segment defining a third peak. The first peak, the second peak and the first valley include a first radius of curvature. The third peak and the second valley include a second radius of curvature. The first radius of curvature is larger than the second radius of curvature.

Abstract: The invention relates to an encapsulating chamber for secreting cells, comprising a closed shell made of a semi-permeable membrane, said membrane comprising at least one layer of porous biocompatible polymer, and one layer of non-woven biocompatible polymer.

Abstract: The present disclosure provides composite prosthetic devices including two or more layers of electrospun polymers and methods of preparation thereof. In some embodiments, the two or more layers can be porous and in other embodiments, one or more components is nonporous. The composite prosthetic devices can include various materials and the properties of the prosthetic devices can be tailored for use in a range of different applications.

Abstract: A medical device configured for placement in a blood vessel, in which an elastic tube extends between first and second expandable anchoring stents. The elastic tube is constructed of a resilient material that deflects outward in response to increased blood pressure of a heart beat and that moves back inward as the blood pressure drops, thereby aiding the heart's pumping action.

Abstract: Stent-grafts for treating thoracic aortic aneurysms and abdominal aortic aneurysms include graft portions having inflatable channels and graft extensions. The graft extensions include an undulating wire stent and porous, but substantially fluid impermeable, polytetrafluoroethylene (PTFE) graft materials.

Abstract: A stent graft prosthesis includes spaced stent elements for location on a tubular graft. First and second stent elements are located in first and second locations on the graft. The second stent element includes a saddle shaped stent. The first stent element includes a ring shaped stent. Optionally a third stent element is also present. The tubular graft includes a graft sleeve. The prosthesis can be used for treatment of vascular disorders such as aortic aneurysm.

Abstract: Various stents and stent-graft systems for treatment of medical conditions are disclosed. In one embodiment, an exemplary stent-graft system may be used for endovascular treatment of a thoracic aortic aneurysm. The stent-graft system may comprise proximal and distal components, each comprising a graft having proximal and distal ends, where upon deployment the proximal and distal components at least partially overlap with one another to provide a fluid passageway therebetween. The proximal component may comprise a proximal stent having a plurality of proximal and distal apices connected by a plurality of generally straight portions, where a radius of curvature of at least one of the proximal apices may be greater than the radius of curvature of at least one of the distal apices. The distal component may comprise a proximal z-stent coupled to the graft, where the proximal end of the graft comprises at least scallop formed therein that generally follows the shape of the proximal z-stent.

Abstract: An implantable prosthetic valve can comprise an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end, a leaflet structure positioned within the frame and secured thereto, and an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises an inflow edge secured to the frame at a first location, an outflow edge comprising a plurality of alternating projections and notches, wherein the projections are secured to the frame at a second location, and the notches are not directly secured to the frame, an intermediate portion between the inflow edge and the outflow edge that comprises a plurality of openings.

Abstract: A fenestrated aortic cuff is configured to be delivered endovascularly to a target region, deployed, fastened, and sealed to a vessel wall, e.g., in a neck region of an aortic aneurysm. Example fenestrated cuffs provide a suitable landing zone for a commercially available endograft, which may be, in some cases, positioned below or above the renal arteries in order to complete exclusion of an abdominal aortic aneurysm (AAA) or a thoracic aortic aneurysm (TAA), respectively, from systematic circulation. In some cases, fenestrated cuff function is facilitated and improved by employing active fixation and sealing mechanisms, including, e.g., helical fasteners, which may allow deployment of the fenestrated cuff in short neck regions with limited sealing area.

Abstract: The present invention provides a body lumen graft base that is a thin film, has adequate flexibility and low permeability, and can be inserted in a catheter with a small diameter. The body lumen graft base of the present invention is obtained by subjecting at least one surface of a woven fabric comprising a fiber having a total fineness of 1 to 80 decitex and a single fiber fineness of less than 0.1 decitex to press treatment using a calender machine.

Abstract: A stent/graft assembly includes a tubular graft connected in substantially end-to-end relationship with a generally tubular stent. Free ends of the stent and graft extend in opposite directions from the end-to-end connection during a pre-deployment orientation of the assembly. However, the graft is inverted during deployment so that free ends of the graft and the stent extend in substantially the same direction from the end-to-end connection in a post-deployment orientation. Thus, at least a portion of the stent is disposed within at least a portion of the graft in a post-deployment orientation of the assembly.

Abstract: A prosthetic valve assembly that includes a stent, a tissue sleeve and an anchoring mechanism. By loading the three components of the valve assembly into a delivery catheter in a series formation, such that no two components are located within each other, the size of the delivery catheter can be reduced.

Abstract: A device (200) for implantation in or near an annulus of a tricuspid valve comprising at least one blood flow control element (202) adapted to capture a volume of blood therein. Optionally or alternatively, the blood flow control element is adapted to allow at least some volume of blood (406) to regurgitate through the annulus during at least some part of systole. Optionally or alternatively, the device comprises a relatively rigid annulus with an arc length of less than 300 degrees. Optionally or alternatively, the relatively rigid annulus comprises a plurality of tissue fixation elements positioned along no more than 300 degrees of a circumference of the annulus, for example to avoid damaging conduction pathways between an atria and a chamber.

Abstract: A prosthesis for monitoring a stenosis in the prosthesis comprises a tubular prosthesis having a proximal portion, a distal portion, and a lumen extending therebetween. A sensor is coupled to the tubular prosthesis and disposed at an effective predetermined location on the tubular prosthesis so that the sensor may sense a presence of the stenosis in the lumen.

Abstract: An endoluminal prosthesis including a radially expandable support member having interior and exterior surfaces and a wall with openings, a first covering member including a biocompatible polymer material at least partially positioned against the interior surface, and a second covering member including a biocompatible polymer material at least partially positioned against the exterior surface. The first covering member attaches to the second covering member at predetermined bonding locations within less than all of the openings thereby leaving unbonded regions.

Abstract: Some embodiments are directed to a stent graft comprising a first stent graft having a first and a second stent and a first and a second inner graft supported by the first stent, and an outer graft. The second inner graft can be spaced apart from the first inner graft so that a portion of the first stent is not covered by either the first inner graft or the second inner graft. A first and second portion of the outer graft can be attached to the first stent, the outer graft being unsupported by the stent between the first and second portions so as to form a fillable space between the outer graft, the first inner graft, and the second inner graft. Some embodiments further comprise a second stent graft deployable within the inside of the first stent graft to sealingly cover the uncovered portion of the first stent.

Abstract: An endo-urethral prosthesis characterized in that it comprises a set of guides (100) defining an internal space (201) in a urinary channel, and one or more support elements (110) for supporting the internal wall of the urinary tract, the guides comprising recessed areas and protruding areas, said protruding areas forming locking regions (21) for holding the support elements in place, in a position that allows them to support the internal wall of the urinary tract.

Abstract: A system for facilitating deployment of an endoluminal prosthesis may include a main tubular graft body including a proximal end opening, a distal end opening, a lumen, and a sidewall. A branch may extend from the sidewall and may include a first end opening, a second end opening, and a lumen. A fenestration may be disposed in the sidewall and positioned distal of the second end opening of the branch. A wire segment may include a proximal portion positioned proximal of the proximal end opening and a distal portion positioned distal of the distal end opening. The wire segment extend through the fenestration and through the lumen of the branch in a preloaded configuration.

Abstract: In one embodiment according to the present invention, a stent is described having a generally cylindrical body formed from a single woven nitinol wire. The distal and proximal ends of the stent include a plurality of loops, some of which include marker members used for visualizing the position of the stent. In another embodiment, the previously described stent includes an inner flow diverting layer.

Abstract: An anchoring device for use within a vascular structure includes a head having a first surface and a second surface meeting at a common plane, and an anchor including a shaft having a longitudinal axis, a first end connected at a junction to the first surface of the head, and a free end. A harbor space is bounded by the shaft of the anchor, the first surface of the head, a first theoretical plane perpendicular to the longitudinal axis at a spaced distance from the junction and a second theoretical plane tangential to the head at a point in the common plane. The harbor space has an are sufficient to receive a portion of a stented device therein.

Abstract: A prosthetic heart valve (300) for replacing a native valve includes a collapsible and expandable stent (306) having a proximal end (302) and a distal end (304), and a valve assembly (308) including a plurality of leaflets (310), the valve assembly (308) being disposed within the stent. The heart valve (300) further includes a first plurality of elongated legs (320) coupled to the stent (306) and transitionable from an extended configuration to a relaxed configuration. A first sealing portion (322) connected to the first plurality of legs (320) forms a sealing structure (350) when the legs (320) transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.

Abstract: An endograft includes a main body having a wall separating interior and exterior surfaces and adapted to be inserted within the vessel. The main body is characterized by a single proximal opening and two distal openings and at least one aperture extending through the wall. At least one stent is secured to the main body that upon expansion pressure fits the main body into the vessel. An open tunnel is secured to the interior surface of the main body around the main body aperture and secured somewhere along the tunnel length to provide fluid communication between the interior and exterior surfaces of the main body through the aperture and with the vascular branch in proximity to the main body aperture. The insertion of a sleeve positioned partly within the tunnel and extending beyond the exterior surface of the main body into the vascular branch assures to the vascular branch.

Abstract: The present disclosure includes an endoprosthesis delivery system comprising an elongate member, such as a catheter, an endoprosthesis, a covering member disposed about the endoprosthesis, and at least one flexible element situated between the endoprosthesis and the covering member. The covering member can extend beyond an end of the endoprosthesis. In operation, as the covering member is removed, the flexible element can guide the covering member over the end of the endoprosthesis to prevent entanglement between the end of the endoprosthesis and the covering member.

Abstract: A wall, for example the wall of a vascular graft, has multiple channels within it. The channels may be used to hold drugs or reinforcing fibers. The channels may have a predetermined roughness. The channels may be formed by coextrusion using a soluble material, for example, to define the channels and then dissolving them to open the channels in the extrudate.

Abstract: A system may include an endoluminal prosthesis and a guide wire. The prosthesis may include a tubular body including a graft material wall, a proximal end opening, a distal end opening, and a lumen extending longitudinally therein. The prosthesis may include first and second fenestrations in the graft material wall. The first and second fenestrations may be spaced from one another circumferentially about the tubular body. The guide wire may have a first end and a second end both extending from a region proximal of the proximal end opening. The guide wire may enter the proximal end opening, exit the first fenestration, partially traverse an exterior surface of the prosthesis, enter the second fenestration, and exit the proximal end opening. No portion of the guide wire may extend distally beyond the distal end opening.

Abstract: The present embodiments provide stent-grafts. In one embodiment, a stent has proximal and distal ends, a plurality of strut segments disposed between the proximal and distal ends that enable expansion of the stent from a compressed state to a deployed state, and a series of distal apices disposed at the distal end of the stent. At least a portion of a first distal apex overlaps with graft material. First and second sutures are each coupled between a portion of the first distal apex and the graft material. The first and second sutures are positioned at different longitudinal zones that lack an axial overlap with one another.