Abstract: Intravascular delivery system is designed for a safe and efficient access to secondary and tertiary vascular structures, such as the branches of the coronary sinus, to enhance the delivery and deployment of various catheters, such as, for example, pacemaker electrical leads. The over-the-wire system features a straight, or alternatively shaped, micro-catheter distal tip of an inner catheter that seamlessly cooperates with a peel-away reinforced outer catheter. The inner catheter and the peel-away reinforced outer catheter are advanced in their engaged mode of operation towards (or beyond) the target site. Subsequently, the inner and outer catheters are disengaged, and the inner catheter is removed from the outer catheter. A pacemaker lead may be advanced over the wire inside the outer catheter to the target site for deployment. Subsequently, the outer catheter is easily split and may be rapidly removed from the blood vessel.

Abstract: Systems and methods for blood flow control are described herein. In some variations, a blood flow control system may comprise a blood flow control device. The blood flow control device may be placed within a body of a patient and may comprise an expandable member and a sensor. The sensor may be configured to measure at least one of a physiologic condition of the patient and a pressure associated with the expandable member. The blood flow control system may include at least one controller communicably coupled to the sensor to: receive data indicative of at least one of the physiologic condition of the patient and the pressure associated with the expandable member from the sensor, compare the received data with target data, identify at least one error based on the comparison, and in response to identifying the error, inhibit at least one function of the blood flow control system.

Abstract: A system for treatment target tissue comprises an ablation device and an energy delivery unit. The ablation device comprises an elongate tube with an expandable treatment element. The system delivers a thermal dose of energy to treat the target tissue. Methods of treating target tissue are also provided.

Abstract: A method for manufacturing a balloon catheter including preparing a tubular parison (20) made of a resin and a mold (30) that has an inner cavity into which the parison (20) is to be inserted and that has a first groove (41) formed on an inner wall surface forming the inner cavity; inserting the parison (20) into the inner cavity of the mold (30); allowing the resin to enter the first groove (41) by introducing a fluid into a lumen (23) of the parison (20) to expand the parison (20); and removing the parison (20) from the mold (30) before the resin reaches a bottom (41a) of the first groove (41).

Abstract: A crimper for altering an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements that define a crimper channel, each of the crimper elements including a non-planar surface that forms a portion of the crimper channel. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper when altering the implantable medical device from the uncompressed state to the compressed state. The crimper also includes handle configured to operate the crimper. Actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed state to the compressed state.

Abstract: An access sleeve can be attached to a medical device having first and second ends, the first end being positioned inside of a patient and the second end being positioned external to a patient. The access sleeve can include a tubular sleeve body having first and second open ends that define a first lumen extending along a longitudinal axis of the sleeve body. An opening in the sleeve body can connect the first lumen to an outer surface of the sleeve body. The access sleeve can be selectively attached to the medical device (e.g., catheter of a heart pump) and inserted into the access site when the medical device is positioned in the patient. The access sleeve can maintain vascular access to a patient's access site such as an arteriotomy and can be removed without disturbing the position of the medical device.

Abstract: The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.

Abstract: Y-stents and delivery apparatus for delivering the Y-stents include a delivery catheter with an open distal end having two, circumferentially opposed extensions separated by two receiving portions which receive an anatomical junction.

Abstract: An intraluminal device including an elongated structure formed of a plurality of wires may be provided. The intraluminal device may include a plurality of sets of looped wires longitudinally located at an intermediate area of the elongated structure. The sets of looped wires may be spaced circumferentially about the elongated structure and may be configured to cooperate with each other to form a plurality of clot entry openings. The intraluminal device may also include at least one grouping of woven wires that may be longitudinally located adjacent to the intermediate area and may be configured such that when an opening force is exerted on the elongated structure, the at least one grouping of woven wires may provide structural support to hold open first interstices between the plurality of sets of looped wires.

Abstract: Disclosed is a system and method for determining a location and configuration of an expandable member. A flexible coil can be provided on a shape changing portion, such as the expandable member, to measure a signal as the shape changes.

Abstract: Described herein are devices, systems, and methods for modifying blood flow and improving tissue oxygenation in an individual. More specifically, described herein are flow modifying implants, delivery systems, and methods of treatment using flow modifying implants. Also described herein are methods for preventing reperfusion injury in an individual using a flow modifying implant to prevent the reperfusion injury.

Abstract: Intravascular delivery system is designed for a safe and efficient access to secondary and tertiary vascular structures, such as the branches of the coronary sinus, to enhance the delivery and deployment of various catheters, such as, for example, pacemaker electrical leads. The over-the-wire system features a straight, or alternatively shaped, micro-catheter distal tip of an inner catheter that seamlessly cooperates with a peel-away reinforced outer catheter. The inner catheter and the peel-away reinforced outer catheter are advanced in their engaged mode of operation towards (or beyond) the target site. Subsequently, the inner and outer catheters are disengaged, and the inner catheter is removed from the outer catheter. A pacemaker lead may be advanced over the wire inside the outer catheter to the target site for deployment. Subsequently, the outer catheter is easily split and may be rapidly removed from the blood vessel.

Abstract: The present disclosure provides apparatuses and methods for treating conditions such as chronic daily headache, cluster headache, tension headache, migraine, or acute headache of a patient. In example methods, a cryotherapy element is introduced into the nasal cavity or pterygopalatine fossa to cool or cryoablate at least one of a nasal nerve tissue or nasal blood vessel. The cryotherapy element may be introduced into the nasal cavity in a collapsed position, and prior to cooling a target treatment site may be expanded to an expanded configuration.

Abstract: A cryotreatment catheter for treating tissue. The catheter may include an outer elongate body, a balloon treatment element coupled to the distal portion of the elongate body with a plurality of balloon lobes radially arranged around the outer elongate body, an inner elongate body rotatably movable within the lumen of the outer elongate body, and a fluid delivery lumen located within the lumen of the outer elongate body and at least partially within the lumen of the inner elongate body. The fluid delivery lumen may be branched at a distal portion into a plurality of linear segments, each linear segment being in fluid communication with one of the plurality of balloon lobes. Each of the balloon lobes may be inflated independently of each other by the linear segments of the fluid delivery lumen.

Abstract: The present invention relates to a tissue protection device for mitral valve cerclage annuloplasty and, more particularly to a tissue protection device for protecting tissues of the body (heart) during mitral valve cerclage annuloplasty that is performed on a mitral valve cerclage patient with mitral regurgitation. The tissue protection device for mitral valve cerclage annuloplasty of the present invention is a hollow cylindrical tube where cerclage sutures (10a, 10b) are inserted, in which a hole (22) is formed at a predetermined portion of the cylindrical tube so that a coronary sinus cerclage suture (10a) inserted in a coronary sinus comes out of the cylindrical tube, and a lower section from the hole is inserted into the tricuspid valve to protect tissues of the tricuspid valve and the ventricular septum.

Abstract: Multilumen implant for application in human and animal vascular systems/bodies, with a substantially tubular element (1) divided into a proximal (2) and a distal section (3), and a fixation element (8) for the fixation of the proximal section (2) in a target vessel, wherein the tubular element (1) branches into two or more lumens (4, 5) in the distal section (3), with the fixation element (8) being at least one clamping ring (8) arranged on the outside of the proximal section (2) of the tubular element (1), and wherein the free end of the proximal section of the tubular element (1) is folded around the clamping ring (8) and embraces the clamping ring (8) in a pocket-like manner.

Abstract: Intravascular delivery system is designed for a safe and efficient access to secondary and tertiary vascular structures, such as the branches of the coronary sinus, to enhance the delivery and deployment of various catheters, such as, for example, pacemaker electrical leads. The over-the-wire system features a straight, or alternatively shaped, micro-catheter distal tip of an inner catheter that seamlessly cooperates with a peel-away reinforced outer catheter. The inner catheter and the peel-away reinforced outer catheter are advanced in their engaged mode of operation towards (or beyond) the target site. Subsequently, the inner and outer catheters are disengaged, and the inner catheter is removed from the outer catheter. A pacemaker lead may be advanced over the wire inside the outer catheter to the target site for deployment. Subsequently, the outer catheter is easily split and may be rapidly removed from the blood vessel.

Abstract: A device and method are described for aspirating within a patient during the delivery of a drug-coated treatment device to help remove drug coating dislodged in a patient's blood. The drug treatment device can be a drug-coated balloon, a drug-coated stent, or similar devices. The device can include an occlusion balloon to help contain the dislodged drug coating and aspiration can be applied proximally, distally, or both proximally and distally of the drug coated balloon during a procedure.

Abstract: The present teachings provide devices and methods of engaging, capturing, and retrieving emboli. Specifically, one aspect of the present teachings provides a device comprising a generally cylindrical body, with its proximal ends joining to a delivery system and a plurality of cells forming its luminal surface. The cylindrical body is configured to axially rotate as it radially expands. Another aspect of the present teachings provides a device comprising two elongated bodies one disposed within the other. As the device expands radially, both elongated bodies are configured to axially rotate independently.

Abstract: Some implementations of an endovascular device include a stent graft with an expandable tubular metallic frame and a covering material disposed on at least a portion of the metallic frame. The stent graft defines a lumen therethrough. In a particular embodiment, a first balloon is disposed around an outer periphery of the stent graft, a second balloon is disposed around the outer periphery of the stent graft and spaced apart from the first balloon, and a third balloon is disposed within the stent graft lumen between the first balloon and the second balloon. The third balloon can be inflated to fully or partially occlude the lumen. The first and second balloons can be individually inflated to fully or partially shunt blood flow from a blood vessel through the stent graft. In some embodiments, sensors and an automated control unit are included to automate the operations of the endovascular device.

Abstract: A clot removal device for removing clot from a body vessel includes an expandable structure having a constrained delivery configuration, an expanded clot engaging deployed configuration, and an at least partially constrained clot pinching configuration, the expandable structure including a proximal section comprising a plurality of struts with opening angles; a mid-section distal of the proximal section and comprising a plurality of struts with opening angles and cells larger than cells of the proximal section, the mid-section being configured to expand a larger radial extent in the deployed configuration than the proximal section to provide clot grip and retention during retraction of the clot; wherein the proximal section is configured to pinch the clot from the body vessel when partially resheathed by a microcatheter.

Abstract: In embodiments of an obstruction removal device, system, and/or method, a removal tool is disposed at a distal end of a delivery tool and configured to at least partially separate an obstruction from an inner surface of a vasculature. An expandable member is also coupled to the delivery tool. The expandable member includes a proximal end that is free or slidably coupled to the delivery tool. The proximal end of the expandable member is configured to invert or slide toward a distal end of the expandable member, thereby causing the expandable member to surround at least a portion of the obstruction and the removal tool so that the obstruction is captured between the expandable member and the removal tool, when the delivery tool is withdrawn from the vasculature to remove the removal tool and the obstruction from the vasculature.

Abstract: A medical device for cooperating with a body surface of a patient includes an elastically deformable substrate having a first surface, a second surface, and a plurality of pores extending from the first surface towards the second surface to define a plurality of spaced-apart projections. A lubricant is provided in the pores. Applying a compressive force to the substrate with the body surface elastically deforms the projections to displace the lubricant out of the pores and provide hydrodynamic lubrication between the medical device and the body surface.

Abstract: A filter having a first set of members and a second set of members defining a trap sized to fit into a blood vessel. Each of the first and second members are configured to resiliently extend from the trap. At least one of the first set of members includes a first surface for engaging the vessel wall such that the at least one of the first set of members resists downstream movement within the vessel. At least one of the second set of members includes a second surface for engaging the vessel wall such that the at least one second member resists upstream movement within the vessel.

Abstract: A balloon for medical treatments such as percutaneous transluminal coronary angioplasty (PTCA), delivery of a vascular stents or stent grafts, employs reinforcement materials that are patterned so as to promote consistent folding of the balloon. Also disclosed are methods and apparatus for biocidal treatment using a balloon, including balloons with fiber fabric reinforcements.

Abstract: A balloon catheter includes an elongated catheter shaft, an expandable balloon connected to the elongated catheter shaft, and a sheath that defines a lumen and includes a therapeutic agent disposed within the lumen. The balloon catheter further includes a first configuration and a second configuration. When in the first configuration, the expandable balloon is disposed distally from the sheath such that an outer surface of the expandable balloon does not contact the lumen. Further, when in the second configuration, at least a portion of the outer surface of the expandable balloon is disposed within the lumen of the sheath such that it contacts the therapeutic agent. At least a portion of the therapeutic agent that contacts the outer surface of the expandable balloon is transferred from the lumen of the sheath to the outer surface of the expandable balloon when the balloon catheter is in the second configuration.

Abstract: An apparatus for performing a medical procedure includes a balloon comprising an inflatable body. A first releasable or frangible connection is provided to maintain the body at a first diameter up to a first inflation pressure, and to release, such as by disconnecting, and thus allow the body to assume a second diameter, such as at a second inflation pressure greater than the first inflation pressure or upon a manual release of the connection by a clinician. Multiple releasable or frangible connections may be provided, including between portions (folds) of the inflatable body of the balloon. This disclosure also pertains to a non-compliant or semi-compliant balloon having a first inflation diameter corresponding to a first range of inflation pressures and a second inflation diameter corresponding to a second inflation pressure greater than the first range of inflation pressures.

Abstract: A method of generating a 4D model includes capturing imagery of a catheter and a vessel as the catheter is directed through the vessel to a location of interest, wherein the catheter is disposed on a guidewire, constructing a 3D time varying reference curve describing a trajectory of the guidewire, and constructing a time varying 3D model of the artery using the reference curve.

Abstract: Intravascular delivery system is designed for a safe and efficient access to secondary and tertiary vascular structures, such as the branches of the coronary sinus, to enhance the delivery and deployment of various catheters, such as, for example, pacemaker electrical leads. The over-the-wire system features a straight, or alternatively shaped, micro-catheter distal tip of an inner catheter that seamlessly cooperates with a peel-away reinforced outer catheter. The inner catheter and the peel-away reinforced outer catheter are advanced in their engaged mode of operation towards (or beyond) the target site. Subsequently, the inner and outer catheters are disengaged, and the inner catheter is removed from the outer catheter. A pacemaker lead may be advanced over the wire inside the outer catheter to the target site for deployment. Subsequently, the outer catheter is easily split and may be rapidly removed from the blood vessel.

Abstract: A balloon dilator device, comprising an annularly shaped, cylindrical type structure having walls that are expandable from a radially collapsed state to a radially expanded state by inflation of a balloon inserted within the annular structure. Once the walls have been expanded, they remain in the expanded state even if the balloon is deflated, because the radially expanded state is a state of minimum mechanical potential energy, and in order to return to the collapsed state, the structure would have to pass a state of higher potential energy. The device walls require sufficient stiffness in their longitudinal direction to enable the device to be pushed into a minimally invasive incision made in the subject. This device stiffness can be achieved either by its mechanical material properties, or by its substantially closed wall structure, or by use of a stiff protector sheath used to protect the walls during insertion.

Abstract: Disclosed are systems, methods, and devices for percutaneous retrieval of objects, such as endovascular devices, from an internal body space. The present inventions have vascular, non-vascular (gastrointestinal), and surgical (laproscopic) applications. The inventions include a retrieval end having one or more compressed states and an expanded state, the retrieval end adopting the expanded state when the retrieval end is deployed into a subject's internal body space, the retrieval end having a mouth through which an object can be passed into an interior space within the retrieval end when the retrieval end is in the expanded state, the mouth being adjustable between an opened state and a closed state; wherein when at least a portion of the retrieval end of the inner sheath is transitioned to a compressed state following capture of the object, the retrieval end exerts an inward force that at least partially collapses or compresses the object.

Abstract: An intrasaccular flow diverter includes a wire structure (e.g., a braided wire or a laser-cut hypotube), a thin-film mesh placed over the wire structure, and crimps fixing the thin-film mesh to the wire structure at each crimp. The wire structure and the thin-film mesh between adjacent crimps are expanded radially to form thin-film covered spheroid structures. When deployed in an aneurysm, the spheroid structures may volumetrically fill the aneurysm sac. An intrasaccular flow diverter with an umbrella structure includes a wire structure with a plurality of crimps along the wire structure, and a thin-film covered umbrella structure at one end of the wire structure. The wire structure between adjacent crimps is expanded radially to form a spheroid structure. When deployed in an aneurysm, the thin-film covered umbrella structure may cover the aneurysm neck.

Abstract: A system includes an adjustable implant configured for implantation internally within a subject and includes a permanent magnet configured for rotation about an axis of rotation, the permanent magnet operatively coupled to a drive transmission configured to alter a dimension of the adjustable implant. The system includes an external adjustment device configured for placement on or adjacent to the skin of the subject having at least one magnet configured for rotation, the external adjustment device further comprising a motor configured to rotate the at least one magnet and an encoder. Rotation of the at least one magnet of the external adjustment device effectuates rotational movement of the permanent magnet of the adjustable implant and alters the dimension of the adjustable implant. Drive control circuitry is configured to receive an input signal from the encoder.

Abstract: A balloon catheter and method for manufacturing are disclosed in which the fracturing of the vicinity of a proximal opening portion formed by an inner shaft can be prevented. A distal side of an inner shaft included by a balloon catheter is disposed in a lumen of an outer distal shaft, and a proximal side of the inner shaft is disposed on an outer surface of an outer proximal shaft, and the inner shaft forms a proximal opening portion which opens on an outer surface side of the outer proximal shaft. The inner shaft has a first region and a second region disposed on a proximal side of the first region. The first region is fixed to the outer surface of the outer proximal shaft. The second region is not fixed to the outer surface of the outer proximal shaft.

Abstract: A system and a method are disclosed for forming an anastomosis between a first layer of tissue and a second layer of tissue of a patient's body. The system includes a first anastomosis device component and a second anastomosis device component configured to interact with the first anastomosis device component. The first anastomosis device component is configured to be delivered to a first lumen inside the patient's body. The second anastomosis device component is configured to be delivered to a second lumen inside the patient's body. The second anastomosis device includes one or more sensors configured to capture sensor data for determining an alignment of the second anastomosis device component relative to the first anastomosis device component, or for characterizing the position or orientation of the second anastomosis device component in three-dimensional space.

Abstract: A tubular braided implant is provided including a braid that can be delivered as a single layer braid, invert into itself during deployment to form at least two nested sacks and include additional braid material that can fill the innermost sack. The additional braid material can loop or coil like a ribbon and/or invert to form smaller and smaller nested sacks. The braid can have a variable braid angle along its length such that when positioned for delivery, the can have a high braid angle near its distal end and a low braid angle near the proximal end. In addition, or as a replacement for the braid material that fills the innermost sack, the implant can include an embolic coil that can loop within the innermost sack.

Abstract: A system, device and method for left atrial appendage occlusion detection is disclosed. The system for occlusion detection comprises a sheath; a delivery system comprising: a delivery catheter extending between a proximal end and a distal end; and a handle coupled to the proximal end of the delivery catheter; a medical tool coupled to a distal end of the delivery catheter at a target location within a portion of an organ of a patient, the medical device comprising a hub including a bore defining an axis, an occluder portion coupled to the hub and an anchor portion extending between a first end and a second end; at least one pressure sensor configured to measure a pressure of the target cavity while blood is suctioned form inside the left atrial appendage; and at least one processor configured to process the pressure measurement acquired from the at least one pressure sensor.

Abstract: Stents generally can include a tubular structure having circumferentially positioned undulating wires that extend over a majority of a length of the stent such that the undulations oscillate circumferentially to define a circumference of the stent. The undulations can wrap over and under adjacent undulations to form an interwoven structure. Additionally, or alternatively, adjacent wires can be joined. Wires forming the stent can be cut from elastic tubing such that each wire has a three-dimensional shape.

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: An example introducer is disclosed. An example introducer includes an inner liner including a lumen, a distal region and at least one folded portion extending along the distal region. The introducer also includes a reinforcing member having a length and including at least one spine extending along the length of the reinforcing member. The introducer also includes a sheath disposed along at least a portion of the introducer, wherein the sheath includes at least one perforation, wherein material adjacent to the at least one folded portion is removed from a distal portion of the introducer to form a tip region. The introducer also includes a tip member disposed along the tip region.

Abstract: A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

Abstract: Treating a treatment area in the vasculature includes a first catheter adapted for positioning at the treatment area, said first catheter including a first balloon having a transient radiopaque material corresponding to the treatment area. A second catheter adapted for positioning at a treatment area includes a treatment that substantially matches the transient radiopaque material, preferably so that the length and/or position of the treatment corresponds to the length and/or position of the transient radiopaque material. Related kits, assemblies, and methods are also described.

Abstract: Disclosed herein are medical devices comprising a single-lobed, thin-walled, expandable body and a flexible, elongated delivery device for treating saccular vascular aneurysms and occluding segments of blood vessels and other biological conduits. The expandable bodies may include gold and other metals that can be compressed, positioned in the lumen of an aneurysm, or other biological conduit and expanded. The external surface of the expandable bodies can be configured to promote local thrombosis and to promote the growth of tissue into and around the surface in order to reduce migration of the expandable body and to occlude and seal the aneurysm or biological conduit. For the treatment of saccular aneurysms, the expandable body may be deployed in combination with one or more coiled wires that contact both the wall of the aneurysm and the expandable body and exert force on the expandable body to aid in sealing the aneurysm neck.

Abstract: Disclosed herein is a bowl-shaped neck bridge with a distal-facing concavity and a central lumen. The neck bridge is inserted and expanded within a cerebral aneurysm. The, embolic members (such as embolic coils, embolic ribbons, or string-of-pearls embolic strands) are inserted through the central lumen into the aneurysm sac.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA) to exclude the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. An implant is delivered via transcatheter delivery into the LAA. The implant includes a conformable structure comprising a foam body and internal support. The support includes anchors that penetrate the foam body and anchor the implant to the walls of the LAA. The implant provides compliance such that it conforms to the native configuration of the LAA.

Abstract: A prosthetic heart valve can include a support structure, an actuator member, and a plurality of leaflets. The support structure can have a plurality of struts and a plurality of rivets. The struts can have openings formed therein. The rivets can have first portions and second portions. The first portions can extend through the openings of the struts, and the second portions are larger than the first portion and the openings of the struts. The struts are pivotable about the rivets to radially expand and compress the support structure. The actuator member can be coupled to the struts of the support structure and configured to selectively actuate expansion and compression of the support structure. The leaflets can be coupled to the support structure and configured to allow unidirectional blood flow through the prosthetic heart valve.

Abstract: The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise a steering line or lines which facilitate bending and steering of the expandable implant through the vasculature of a patient.

Abstract: Systems and methods can involve wedge dissectors attached to strips in turn attached to medical balloons, for forming serrations within vascular wall tissue for angioplasty as well as drug delivery.

Abstract: A catheter for introduction into a body cavity comprises a flexible outer tube with a handle member and proximal and distal ends and a flexible inner tube with a holder. The exterior surface of the outer tube has a first cross sectional shape along at least a portion of its length with the inferior surface having a second cross section shape along at feast a portion of its length. The inner tube has an exterior surface having a third cross section shape along at least a portion of its length. The third cross section shape has a radius less than said second cross section shape and is configured to prevent more than a predetermined rotation when received within in the second cross section shape of the outer tube. The holder has a holder stop proximate its distal face with the distance between the proximal face of the handle member and the stop being equal to the length of the membrane. This ensures that once the stop contacts the handle member, the membrane will be fully deployed.

Abstract: Disclosed is a novel filter and delivery means. The device described within will not interfere with standard practice and tools used during standard surgical procedures and tools such as cannulas, clamps or dissection instruments including valve replacement sizing gages or other surgical procedures where the patient must be put on a heart-lung machine cross-clamping the aorta.