Abstract: A distal embolic protection device for dedicated use in cerebral arterial blood vessels is described. The distal embolic protection device comprises a variable-thickness micro-guidewire and a collapsible filtering device mounted on the microguidewire over two mobile attachment points so that in its collapsed configuration, the thickness of the microguidewire and the filtering device at this region is less than or equal to 0.017 inch (0.432 mm) in thickness to be able to pass through existing conventional microcatheters. The mobile attachment points allow for rotatory and longitudinal mobility of the microguidewire while the filtering device is stable thereby decreasing the risk of trauma to the fragile cerebral arterial blood vessels. Preferably, the filtering device comprises an expansion assembly, e.g., a plurality of struts attached to a filter membrane that are in a folded position which self expand to the desired dimensions within the cerebral blood vessels.

Abstract: Medical systems, devices and methods are provided for accessing a bodily opening that, among other things, are safe and reliable, and facilitate manipulation of a medical instrument. The medical access device generally includes an elongated flexible sheath and an expandable frame connected to the distal end of the flexible sheath. The sheath and expandable frame are operable between expanded and collapsed configurations to provide a pathway from a natural orifice to the bodily opening. Medical systems and methods are also provided for delivering the medical device.

Abstract: The present invention provides a device for delivering and/or recovering an object, such as a patent foramen ovale (PFO) occluder. According to one embodiment of the invention, a device contains an outer sleeve and an inner sheath. The inner sheath has a proximal portion and a distal portion; the distal portion of the inner sheath is disposed inside the lumen of the outer sleeve. The distal portion of the inner sheath can expand radially to facilitate retrieval of an object. The distal portion of the inner sheath has a larger diametrical configuration than the proximal portion of the inner sheath. The distal portion of the inner sheath may be in the shape of a cone or similar shape. The distal portion of the inner sheath further includes slits that form flaps which collapse inward and overlap each other as the distal portion is in its unexpanded configuration.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: This disclosure is directed to systems and methods for re-entering the true lumen of a vessel. The re-entry catheters employ deflectable struts to stabilize and support the distal tip in a subintimal location while a passageway back into the true lumen is formed. Re-entry to the true lumen can be effected with a cutting element or with a conventional guidewire.

Abstract: An expandable tip cannula system, comprising: a hollow cannula shaft having a proximal end and a distal end; and an expandable tip mounted at the distal end of the hollow cannula shaft, the expandable tip comprising a plurality of generally-triangular shaped petals held together in a radially-inwardly tapered arrangement between adjacent petals, each petal comprising a nerve sensing electrode disposed therein.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: A method and apparatus for suture-less placement of an occluding patch in which release of the device can be accelerated. In one embodiment, an inactive form of an adhesive is applied on the area of the patch that will come into contact with cardiac tissue; this allows for the introduction and necessary manipulation of the catheter system until activation of the adhesive occurs. In accordance with one aspect of the invention, the adhesive properties of certain polymeric materials are relied upon rather than their ability to cure or harden into a specific shape. In another embodiment, the patch is immediately released utilizing a detaching mechanism on the balloon or the balloon catheter which supports the patch; the patch along with the inflated balloon remain on the cardiac structure occluding the opening.

Abstract: A vascular method is disclosed comprising introducing a first flexible wire into a blood vessel, wherein the blood vessel has a first vessel end and a second vessel end and wherein the first flexible wire has a first end and a second end, sliding an angiotip along the first flexible wire in a direction away from the first end of the wire and toward the second end of the wire, frictionally engaging the first flexible wire with the angiotip, and pulling the first flexible wire through the blood vessel in the direction of the second vessel end, wherein the pulling of the first flexible wire pulls the angiotip through the blood vessel in the direction of the second vessel end.

Abstract: Apparatus and methods are described, including apparatus for treating a cavity in a human body, the apparatus including a delivery tube. A bather device has a collapsed configuration and an expanded configuration, the barrier device moving from the collapsed configuration to the expanded configuration upon being deployed from the delivery tube. A pushing element, slidably disposed within a lumen of the delivery tube, is configured to deploy the barrier device from the delivery tube by pushing the bather device. One or more bather-deployment elements are coupled to the barrier device and to the pushing element, the bather-deployment elements being configured to conformingly contact the barrier device with tissue surrounding the cavity. Other applications are also described.

Abstract: Devices and methods for treating vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus includes an insertion portion and an expandable implant. The expandable implant is configured to be deployed in an aneurysm and is coupled to the insertion portion. The expandable implant has a first portion and a second portion coupled to the first portion. The expandable implant is movable between a first configuration in which the first portion and the second portion are substantially linearly aligned and a second configuration in which the second portion at least partially overlaps the first portion.

Abstract: Transoral obesity treatment devices and related methods for operation thereof are described which occupy space within a stomach and/or stimulate the stomach wall. The transoral obesity treatment devices and related methods are intended to assist a patient in maintaining a healthy body weight. Features of the devices include insertion transorally and without invasive surgery, without associated patient risks of invasive surgery, and without substantial patient discomfort. The life span of these devices may be material-dependent upon long-term survivability within an acidic stomach, but is intended to last one year or longer. The devices have the capacity to vary in size and are desirably self-actuating in that they change shape and/or volume using internal motors or actuators. The changing character of the devices helps prevent the person's stomach from compensating for the implant, such as sometimes happens with static intragastric devices.

Abstract: An occluding device is provided for occluding fluid flow through a lumen of a body vessel. The occluding device includes an expandable tubular body having a tubular wall defining a lumen formed therethrough. The tubular wall has a proximal end extending to a distal end along a longitudinal axis of the tubular body. A plurality of longitudinal slits is formed through the tubular wall to define a plurality of flexible strips bound by a proximal non-slit portion and a distal non-slit portion. A plurality of barbs is disposed on the flexible strips. The tubular body is configured to open radially to engage the barbs with the vessel wall defining an expanded state and to collapse along the longitudinal axis to draw the vessel wall radially inward defining a collapsed state. Occluding material is housed within the lumen of the tubular body and the occluding material is configured to move between a collapsed state and an expanded state with the tubular body.

Abstract: A device for crimping a radially expandable and collapsible prosthetic valve comprises a coiled wire frame having a longitudinal opening extending from a proximal end to a distal end thereof. The opening has a first state and a second state, the opening in the first state having a first diameter dimensioned to receive the prosthetic valve in an expanded or partially crimped configuration therein, and the opening in the second state having a second diameter dimensioned to receive the prosthetic valve in a crimped configuration. The coiled wire frame has a first end coupled to a first member and a second end coupled to a second member. The first member is movable relative to the second member to convert the coiled wire frame from the first state to the second state.

Abstract: A sheathed catheter system is described where the sheath comprises a distal portion and a proximal portion that are moveable axially relative to each other, and relative to a tube carrying a medical device thereon. The distal and proximal sheath portions can be brought together in order to enclose therewithin the medical device. The distal sheath has a proximal section that is configured to bias radially inwardly to minimize an otherwise exposed annular surface catching on protruding surfaces that may exist on the catheter or other medical tool in use at the time, or to minimize scraping the inner native lumen of the patient upon retrieval.

Abstract: An improved adjustable nasal dilator device (1) insertable within the nasal cavity of a human being to improve the flow of air through the nasal passage. The device includes a body (2) comprising a top (3) and bottom (4) frame ends interconnected by a series of spaced flexible ribs (5). The top and bottom frame ends are open and substantially circular, and the diameter of the bottom frame end is greater than the corresponding diameter of the top frame end to provide a body shape for convenient insertion within a nasal cavity.

Abstract: A surgical guide wire or K-wire and method of use are provided. The K-wire or guide wire has opposite end portions and a shank portion in between. One end portion has a deformable end portion that, once outside of a confining guide passage, can be deformed to present a projected forward facing area that is larger than the transverse cross section of the K-wire or guide wire while in the passage. The increased area will provide increased resistance to additional forward axial movement into the surgical site.

Abstract: A method and apparatus for treating a stricture in a body lumen. The method comprises (a) sensing pressure being exerted by a treatment device on the stricture, (b) determining if enough force is being exerted on the stricture, (c) if enough force is being exerted on the stricture, timing the application of enough force, (d) determining if too much force is being exerted by the treatment device on the stricture, (e) if too much force is being applied to the stricture, decrementing the force being applied to the stricture, (f) determining if not enough force is being applied to the stricture, (g) if not enough force is being applied to the stricture incrementing the force being applied to the stricture, and (h) repeating (a)-(g) until (i) a desired pressure has been maintained on the tissue for a desired time.

Abstract: An implant assembly comprises an elongated pusher member, and an implantable device (e.g., a vaso-occlusive device) mounted to the distal end of the pusher member. The implant assembly further comprises an electrolytically severable joint disposed on the pusher member, wherein the implantable device detaches from the pusher member when the severable joint is severed, and a return electrode carried by the distal end of the pusher member (e.g., a coil disposed about the pusher member) in proximity to, but electrically isolated from, the severable joint. The implant assembly further comprises a terminal carried by the proximal end of the pusher member in electrical communication with the severable joint.

Abstract: A device to treat an aneurysm can include a plurality of soft and compressible fill members. A flow conduit can carry the fill members in a liquid flow. A flexible, expandable, and liquid-permeable net or mesh enclosure can be inserted into and to fit within the aneurysm. The net or mesh enclosure can receive and retain the plurality of fill members while openings in the net or mesh enclosure allow enough liquid flow through the net or mesh enclosure to transport the fill members into the net or mesh enclosure. A resulting accumulation of the plurality of fill members within the net or mesh enclosure causes the net or mesh enclosure to expand and to come into contact with and generally conform with an interior wall of the aneurysm. This can substantially occlude the aneurysm and retain the net or mesh enclosure within the aneurysm.

Abstract: A surgical guide wire or K-wire and method of use are provided. The K-wire, or guide wire, has opposite end portions and a shank portion in between. One end portion has a deformable end portion that, once outside of a confining guide passage, can be deformed to present a projected forward facing area that is larger than the transverse cross section of the K-wire, or guide wire, while in the passage. The increased area will provide increased resistance to additional forward axial movement into the surgical site.

Abstract: An air passageway obstruction device includes a frame structure and a flexible membrane overlying the frame structure. The frame structure is collapsible upon advancement of the device into the air passageway, expandable into a rigid structure upon deploying in the air passageway and recollapsible upon removal from the air passageway. The flexible membrane obstructs inhaled air flow into a lung portion communicating with the air passageway. The device may be removed after deployment in an air passageway by recollapsing the device and pulling the device proximally through a catheter.

Abstract: The present invention relates to covered endoprosthetic devices. Covered endoprosthetic devices comprise an endoprosthesis and a sheath. The sheath comprises a central portion and outer portions, wherein the central portion preferentially restricts or causes a restriction of blood flow. Blood flow can be reduced by the central portion of the sheath by varying the permeability of the sheath or by having projections on the sheath that slow blood flow. Permeability may be provided by perforations or holes in the material of the sheath or by varying the polymer structure that makes up the sheath itself. The outer portions of the sheath do not substantially reduce blood flow. Methods of using sheath-covered endoprosthetic devices of the invention to treat aneurysms, especially aneurysms in proximity to small perforator vessels or arteries, are also encompassed.

Abstract: A guidewire including a spreader or at least one centering device which may be used to open occluded vessels or other biological passages, especially chronic total occlusions. The guidewire may be used to either open the lumen or to center a boring device within the lumen, so that the chronic total occlusion can be crossed, and an interventional procedure can then be performed.

Abstract: A cannula (10) receives surgical instruments (120) for performing a surgical procedure on a body (130). The cannula (10) comprises a tube structure (12) defining a passage (16) through which the surgical instruments (120) are inserted into the body (130). The tube structure (12) has a proximal end (20) and a distal end (62). The tube structure (12) includes an expandable portion (40) for enabling an increase in the cross-sectional area of the passage (16) at the distal end (62). The expandable portion (40) of the tube structure (12), when expanded, has a conical configuration.

Abstract: The present invention is a self-expanding dilation plug for use in body modification activities. The plug has a central body and a plurality of arms extending therefrom under constant spring pressure. The plug is inserted into a hole in a person's body part, such as an ear lobe, and allowed to gently stretch the tissue over time. In so doing, trauma and the risk of serious injury associated with the procedure is greatly reduced.

Abstract: A guidewire may include a spreader or at least one centering device which may be used to open occluded vessels or other biological passages, especially chronic total occlusions. The guidewire may be used to either open the lumen or to center a boring device within the lumen, so that the chronic total occlusion can be crossed, and an interventional procedure can then be performed.

Abstract: A vascular occluder includes first and second baffle members which are formed of an expansion device such as a stent across which extends an impermeable membrane. The baffle members are held at a given separation by spacer elements. The separation creates a chamber between the baffle members in which the blood is able to stagnate, thereby creating a second occlusion barrier. One of the baffle members may have an aperture within its membrane for receiving a delivery catheter for delivery of thrombogenic agent into the chamber. The occluder has a given length, thereby making it suitable for implantation in difficult vessel sections and is also able to avoid problems of recanalization of the vessel which can occur with prior art occluders.

Abstract: An intravascular filter for a vessel includes a non-biodegradable apical hub and non-biodegradable struts extending generally distally from the hub. The struts extend radially outward from a longitudinal axis of the hub. The distal ends of the struts exert an expansile force against an interior of the vessel. One or more struts includes one or more time-degrading connectors along its length, which can be formed from a biodegradable element made from a fixation material. Prior to degradation, the fixation material rigidly connects a proximal section to a distal section of the respective strut. After degradation, the fixation material is dissolved or softened, and reveals a link that has a strong resistance to longitudinal movement of the distal section with respect to the proximal section and may have a weak resistance to rotational movement of the distal section with respect to the proximal section, such as a pair of interlocked loops.

Abstract: A stent delivery and deployment system for placement of vascular stents having apertures therein for deployment at intersecting blood vessels. The device employs a guide wire having an angled distal end which is threaded into position at the intersection of a first blood vessel and second blood vessel. With the angled portion of the guide wire threaded into the intersecting blood vessel, the stent may be translated along the guide wire to easily position the aperture in line with the intersecting blood vessel.

Abstract: A delivery device for deploying and resheathing an expandable prosthesis and method of use thereof are described. The delivery device includes a fixed outer sheath and a pusher member that is configured for retracting in a proximal direction and resheathing the prosthesis. The device includes two plates engaging the pusher member, with a first plate configured engage the pusher member to prevent proximal movement and the other plate configured to engage the pusher member for distal movement.

Abstract: An intravascular stent especially suited for implanting in curved arterial portion. The stent retains longitudinal flexibility after expansion. The stent is formed of intertwined meander patterns forming triangular cells. The cells are adapted to provide radial support, and also provide longitudinal flexibility after expansion. The cells also provide increase coverage of a vessel wall. Loops in the stent are disposed and adapted to cooperate, so that after expansion of said stent within a curved lumen, the stent is curved and cells on the outside of the curve open in length, but narrow in width, whereas cells on the inside of the curve shorten in length, but thicken in width to maintain a density of the stent element area which is much more constant than otherwise between the inside and outside of the curve. The stent also minimizes flaring out by eliminating free loops of the radially supporting circumferential bands of loops.

Abstract: Devices and methods are described that can be used to treat various maladies, such as pulmonary vein stenosis hypertension and/or atrial fibrillation. The device may be an implant device having at least one ring and a stabilizer element. In some embodiments, the device can include two or more rings separated by one or more stabilizer element. The ring(s) and at least one stabilizer element provide mechanical pressure against adjacent tissue, e.g., the tissue of a vessel, and the pressure works to inhibit the propagation of the ring to lose position against the wall of said vessel. Methods of implanting the device and methods of treating patients therewith are also provided. Additionally, a delivery apparatus and method may also be provided to deliver such an implant device to a target location within a body, e.g., a vein are artery of a human body.

Abstract: Described herein are vascular remodeling devices that include a proximal section, an intermediate section, and a distal section. During deployment, the proximal section can expand from a compressed delivery state to an expanded state and anchors the device in an afferent vessel of a bifurcation. The distal section expands from the compressed delivery state to an expanded state that may be substantially planar, approximately semi-spherical, umbrella shaped, or reverse umbrella shaped. The distal section is positioned in a bifurcation junction across the neck of an aneurysm or within an aneurysm. The intermediate section allows perfusion to efferent vessels. Before or after the device is in position, embolic material may be used to treat the aneurysm. The distal section can act as a scaffolding to prevent herniation of the embolic material. The device can be used for clot retrieval with integral distal embolic protection.

Abstract: An implant may include a frame and a cover to facilitate endoluminal vessel occlusion, selective release of embolic material toward a target region, and/or endoluminal stenting. The frame of the implant provides radial expansion properties to secure the cover within a body vessel. The cover and/or the frame can occlude flow of a fluid through the body vessel.

Abstract: The internal nasal separator is to be used inside a user's nostrils. It comprises a pair of arms (1), a curved connector (2) used to join the arms (1), which carries out spring functions and a pair of ellipsoid shape end devices (3) built into the ends of both arms (1). The arms (1) are closed together the right distance towards the inside and then the end devices (3) are introduced inside the nostrils towards the deep end to be released and left to rest on the inner walls of the nostrils. This prevents nostrils from contracting upon breathing and keeping the nostrils open.

Abstract: An implant may include a frame and a cover to facilitate endoluminal vessel occlusion, selective release of embolic material toward a target region, and/or endoluminal stenting. The frame of the implant provides radial expansion properties to secure the cover within a body vessel. The cover and/or the frame can occlude flow of a fluid through the body vessel.

Abstract: A stent graft extends in a flow lumen to span a defective portion of the flow lumen and seal the defective portion from further blood contact. The stent graft includes a pair of apertures, from which extensions project into the renal arteries to seal the passage of blood into the renal arteries from the abnormality. The apertures are larger than the opening of the renal arteries, such that the apertures need not be centered with the renal arteries to enable placement of the extensions. The aperture opening and side branch extensions contain hook and loop structures to provide a variably positionable seal of the aperture opening.

Abstract: A medical implant (20) includes first and second ring members (22, 24), each including a resilient framework (26) having a generally cylindrical form. A tubular sleeve (28) is fixed to the first and second ring members so as to hold the ring members in mutual longitudinal alignment, thereby defining a lumen (32) passing through the ring members. A constricting element (30) is fit around the sleeve at a location intermediate the first and second ring members so as to reduce a diameter of the lumen at the location.

Abstract: Devices, systems, and methods for controlling local blood pressure. In an exemplary embodiment of a device for exposing a blood vessel to increased pressure of the present disclosure, the device comprises an anchor configured for placement into a blood vessel and to expand independently from a particle held from flowing away by the anchor, the particle configured to gradually expand due to exposure to blood flow.

Abstract: A medical device and system for modifying a left atrial appendage (“LAA”), as well as related methods, are provided. In accordance with one embodiment, a medical device includes a plurality of frame segments coupled with at least one ring member, the at least one ring member having an inner surface defining notches radially spaced therein, each of the frame segments configured to be positioned within one of the notches of the at least one ring member to collectively form a frame structure. Each frame segment includes a hub portion and at least one leg portion, the hub portion having an upper surface configured to be captured in one of the notches defined in the at least one ring member, and the at least one leg portion extending from the hub portion. With this arrangement, a tissue growth member is coupled to the frame segments.

Abstract: A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

Abstract: In at least one embodiment of the present invention, a method for making an occluding device for occlusion of fluid flow through a lumen of a body vessel is provided. The method comprises attaching a coating to an embolization coil that is substantially straight. The coating is nominally strained on the substantially straight embolization coil. The embolization coil has a pre-curled tension to facilitate the embolization coil being curled within the lumen of the body vessel when deployed. The embolization coil is restrained from curling until deploying to reduce pre-deployment straining of the coating.

Abstract: Methods for treating femoro-popliteal artery of a patient include delivering a self-expanding, woven stent from a delivery system. The methods may include delivering a guidewire to a lesion in the femoro-popliteal artery stem over the guidewire.

Abstract: A delivery assembly (10) for an implant (30) includes a release mechanism with a locking element (52) and a blocking member (56). The locking element (52) includes a latching pin (14) that engages with an eyelet (54) in the implant (30) to attach the implant (30) to a distal end of an inner catheter (36). The blocking member (56) prevents premature disengagement of the latching pin (14) from the implant (30). Withdrawal of the blocking member (56) allows disengagement of the latching pin (14). The locking pin (52) and the blocking member (56) extend along the lumen of the inner catheter (36) from a handle (12) such that a guide wire (34) is also able to extend through the lumen of the inner catheter (36). The locking pin (52) and the blocking member (56) preferably have a crescent-shaped transverse cross section. The release mechanism allows retrieval of the implant (30).

Abstract: A system and method for performing spine surgery, including a tissue distraction assembly. The tissue distraction assembly includes an initial dilator, a secondary dilator, a first expander, and a second expander. The tissue distraction assembly is provided with an overall generally oblong shape. The tissue distraction assembly provides for asymmetrical tissue distraction in a single direction.

Abstract: Provided are devices, systems and methods of selectively controlling air flow into one or more section of a patient's lungs. In particular, the devices may be valve devices having an inner lumen configured to transition between a first diameter and a second diameter smaller than the first diameter to control the airflow through the valve.

Abstract: The current invention describes a device and method for occlusion of a blood vessel to enable contrast-enhanced radiographic images to be obtained proximal to the blood vessel to be occluded, into the direction of flow and upstream from the entry site of the device into the blood vessel.

Abstract: A kit for surgically removing stones comprising: a double barreled sheath including a first barrel and a second barrel joined side-by-side; a first connector which is engaged at the proximal end of the first barrel; a second connector which is engaged at the proximal end of the second barrel; a first rigid tube interconnecting the first barrel with the first connector with the first connector being releasably engaged to the first rigid tube and the first rigid tube, first barrel and first connector being co-axial; a second rigid tube interconnecting the second barrel with the second connector with the second connector being releasably engaged to the second rigid tube and the second rigid tube, second barrel and second connector being co-axial; and a wire basket retriever adapted for insertion into one of the barrels and being releasably engaged with a connector or an actuation device.

Abstract: A delivery and deployment device comprises a sheath having a proximal end, a distal end, and a lumen disposed therebetween; a dilator having a distal end slidingly disposed within the sheath lumen; a valve assembly comprising a valve housing affixed to the sheath and a valve disposed within the housing between the sheath and the dilator; and a valve lubrication mechanism disposed between the valve and the dilator.