Abstract: A bendable sheath and a delivery system using the bendable sheath. The bendable sheath comprises a tube body (3). The tube body (3) comprises a distal end and a proximal end. A tube wall of the tube body (3) is connected to a pull wire (8). One end of the pull wire (8) extends towards the proximal end of the tube body (3), and the other end is connected to the tube body (3) near the distal end of the tube body (3). The pull wire (8) comprises at least a section thereof disposed freely outside the tube body (3) and near the distal end of the tube body (3). The pull wire (8) in the bendable sheath comprises the section disposed freely outside the sheath tube body (3) and, when pulled, the section is disposed so as to facilitate the application of force. The section moves relative to the tube body (3), such that a force application point is adaptively changed.

Abstract: A medical device delivery system can include a dilator including a tip having a taper in a distal direction, a coupler, and a flap that radially protrudes from the tip. The flap can be configured to bend against a body lumen to cover at least a portion of the delivery system when the dilator is tracked through the body lumen. A medical device delivery system can include a dilator including a tip having a lumen and a coupler having a lumen. The coupler can be configured to securely connect to the tip such that the lumen of the tip is aligned with the lumen of the coupler to allow a guide wire to pass therethrough. Methods for loading a medical device into a delivery catheter are also disclosed.

Abstract: The current document is directed to improved PTA methodologies that significantly decrease the risks of persistent blood-vessel-wall distention and subsequent restenosis and the risks of PTA-induced dissection, hematoma, and pseudoaneurysm when used to treat blood vessels. Similar improved percutaneous-transluminal-interventional methods are used to treat non-vascular vessels. The improved methods include initial selection of balloon length and inflation pressure for initial treatment of primary lesions to minimize the risks of over-inflation and generation of undesirable localized forces during balloon inflation. The improved methods further include higher-pressure treatment of remaining secondary lesions that also minimizes the risks of over-inflation and generation of undesirable localized forces. The improved methods can be practiced using differently sized balloons and conventional instrumentation, but may be facilitated by use of balloon-length-adjustable catheters.

Abstract: A method is disclosed for removing a vascular occlusion, such as a clot, from a blood vessel. A tubular sheath is inserted into the vessel and a self-expanding Nitinol mesh filter is deployed from a distal end of the tubular sheath at a location proximal to a clot. An inner catheter is advanced through the tubular sheath and through the mesh filter for contacting the clot. An expandable agitation element is provided along a distal end portion of the inner catheter for cutting or chopping the clot, thereby facilitating removal of the clot and improving blood flow through the vessel. Resulting clot particles are captured by the mesh filter. Negative pressure may be applied along a proximal end portion of the sheath for aspirating remaining particles. Certain embodiments of the method are well-suited for treating deep vein thrombosis and do not require the use of thrombolytic drugs.

Abstract: Methods of quickly and easily implanting a quick-connect heart valve prosthesis during a surgical procedure are provided. The heart valve may include a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A system and method for deployment includes an integrated handle shaft and balloon catheter. A safety member disposed between the balloon catheter and handle shaft prevents premature catheter advancement prior to heart valve placement at the annulus, and also may prevent premature balloon inflation prior to full catheter advancement.

Abstract: A uterine manipulator includes an elongated shaft, a colpotomy cup supported on the elongated shaft, a distal shaft extending distally from the colpotomy cup to a distal tip, and a rollable sleeve supported on the distal tip.

Abstract: A percutaneous valve delivery system may include an outer sheath and an inner catheter disposed within the outer sheath. The inner catheter may include a plurality of lumens formed therein. A tubular extension may extend distally from a distal end of the inner catheter, wherein the tubular extension is axially movable relative to the inner catheter. A nose cone may be attached to the tubular extension. A handle may be attached to the outer sheath, wherein the handle is configured to shift the outer sheath between a first position and a second position relative to the inner catheter. A valve replacement implant may be releasably coupled to the inner catheter.

Abstract: A cannula and method include a shaft portion having a proximal end, a distal end, a longitudinal axis and a lumen extending from the proximal end to the oppositely disposed distal end along the longitudinal axis. A hub is attached to the proximal end of the shaft portion and includes a transverse portion, which extends transversely relative to the longitudinal axis of the shaft portion. An opaque marker is disposed on the transverse portion at a position corresponding to an expanded size of an expandable element such that the opaque marker indicates the expanded size in an imaging system image.

Abstract: The present invention relates to a catheter apparatus with an anchoring device to stabilize the catheter tip when in use, such as when infusing, injecting, or delivering substances, devices or other catheters into a patient. The apparatus according to various embodiments deploys an anchoring device that stabilizes the catheter tip and enables adjustment of the blood flow during use.

Abstract: A percutaneous thrombus extraction device for removing a thrombus from within a blood vessel includes a flexible outer sheath defining a first passage between a proximal end and a distal end. An inner sheath is movably positionable within the first passage. The inner sheath defines a second passage between a proximal end and a distal end. The inner sheath is moveable in a radial direction between a collapsed configuration and an expanded configuration along a length of the inner sheath defined between the proximal end and the distal end. A catheter is movably positionable within the second passage, and has an expandable body at a distal end portion of the catheter. The expandable body is movable between a collapsed configuration and an expanded configuration.

Abstract: A double-balloon catheter device for gastrointestinal anastomosis. The double-balloon catheter device for gastrointestinal anastomosis includes a liquid injection assembly, a double-balloon assembly, and a supporting device (15) connecting the liquid injection assembly and the double-balloon assembly. The liquid injection assembly includes a first balloon liquid injection connection port (2), a guide wire connection port (3), and a second balloon liquid injection connection port (4). The double-balloon assembly includes a double-balloon catheter device (5), and includes a first balloon (6) and a second balloon (7) that can expand-and that are respectively disposed on the two ends of the double-balloon catheter device (5). The double-balloon catheter device (5) is provided with a first balloon liquid injection channel (51), a guide wire channel (52), and a second balloon liquid injection channel (53).

Abstract: The methods and devices disclosed herein promote temporal control of balloon inflation patterns. The devices include a covering for a portion of the balloon that compresses the balloon portion during the inflation process. This enables the distal portion of a balloon to be inflated prior to the proximal portion of a balloon, creating a tapered shape at lower inflation pressures. This is especially useful during transvascular implantation procedures, as it prevents dislodgement of an implant mounted on the balloon. As inflation continues, pressure exerted on the balloon by the covering is overcome such that the proximal region of the balloon inflates, forming a shape with generally straighter sides than the tapered shape, thereby expanding the cardiovascular device.

Abstract: Delivery devices for delivery of a stented prosthetic heart valve. Various delivery devices include an outer sheath assembly including an outer sheath connected to a capsule that is advanced proximally to retain the prosthetic valve, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper to provide a smooth transition of the capsule over the prosthetic valve during loading and recapture procedures. The bumper is expandable from a first position to a second position in which a distal end of the bumper is expanded to increase its diameter. The bumper can be biased in the second, expanded position so that the bumper automatically transitions to the expanded position upon retraction of the outer sheath.

Abstract: Catheter-supported therapeutic and diagnostic tools can be introduced into a patient body with a sheath slidably disposed over the tool. Once the tool is aligned with a target tissue, a first fluid-driven actuator can move the sheath axially from over the tool, for example, to allow a stent, stent-graft, prosthetic valve, or other self-expanding tool, to expand radially within the cardiovascular system, without having to transmit large deployment forces along the catheter shaft and sheath from outside the patient. A second fluid-driven actuator can be arranged in opposition to the first actuator to control release of the expanding tool or to recapture the tool within the sheath. The first and/or second actuators may comprise a balloon having a diameter larger than the sheath to provide the desired deployment and recapture forces with moderate fluid pressure.

Abstract: A balloon dissector assembly includes a balloon dissector having an elongate shaft, a handle disposed on a proximal portion of the elongate shaft, and a dissection balloon supported on a distal portion of the elongate shaft. The dissection balloon includes a substantially cylindrical shape having a deflated condition in which the dissection balloon includes a first diameter between the proximal and distal ends, an inflated condition in which the dissection balloon includes a second diameter between the proximal and distal ends, and a plurality of intermediate conditions in which the balloon transitions from the deflated condition to the inflated condition progressively from the proximal end to the distal end.

Abstract: The invention relates to a device for the introduction of an implant (1) into blood vessels of the human body, said device comprising an implant (1), a pusher or insertion wire (14), and a tube-like sheathing (13), wherein the implant (1) is capable of being deformed inside a microcatheter in a manner that allows it to assume a shape of reduced diameter and, after omission of such external constraint exerted by the microcatheter, expand at the placement site and adapt to the blood vessel diameter, and wherein the implant (1) being provided at the proximal end with connection elements (6) attaching it to a retaining element (15) by means of which the implant (1) is coupled to the pusher wire (14), and wherein the retaining element (15) is provided with peripheral cutouts (16) into which the connecting elements (6) are fitted, with the tube-like sheathing (13) being drawn in a form-closed manner over the retaining element (15) with fitted connection elements (6) such that the connection elements (6) are secured

Abstract: An access sheath is provided. The access sheath comprises: an outer sheath extending in one direction and having a cavity formed along a longitudinal axis of the outer sheath; and an inner sheath arranged in the cavity of the outer sheath, and having a plurality of balloons configured to expand, wherein the outer sheath includes: an outer body formed of a first material; and an elastic connection part formed of a second material which is more flexible than the first material of the outer body, and wherein a diameter of the outer sheath increases by the elastic connection part which expands according to an expansion of the balloons.

Abstract: A percutaneous thrombus extraction device for removing a thrombus from within a blood vessel includes a flexible outer sheath defining a first passage between a proximal end and a distal end. An inner sheath is movably positionable within the first passage. The inner sheath defines a second passage between a proximal end and a distal end. The inner sheath is moveable in a radial direction between a collapsed configuration and an expanded configuration along a length of the inner sheath defined between the proximal end and the distal end. A catheter is movably positionable within the second passage, and has an expandable body at a distal end portion of the catheter. The expandable body is movable between a collapsed configuration and an expanded configuration.

Abstract: A needle system for providing fluidic and/or instrument access to an internal body structure. Exemplary embodiments may include non-linear needles having anatomically appropriate lengths and curvatures. Some exemplary embodiments may include a pivotable base, which may assist in stabilizing the needle system with respect to a body structure and/or may be reconfigurable into a safety guard position. Exemplary needle systems may include expandable conduits providing fluidic and/or instrument pathways into internal body structures.

Abstract: An imaging system is provided comprising an imaging probe and at least one delivery device. The imaging probe comprises an elongate shaft, a rotatable optical core and an optical assembly. The elongate shaft comprises a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion. The rotatable optical core is positioned within the lumen of the elongate shaft and comprises a proximal end and a distal end. The rotatable optical core is configured to optically and mechanically connect with an interface unit. The optical assembly is positioned in the elongate shaft distal portion and proximate the rotatable optical core distal end. The optical assembly is configured to direct light to tissue and collect reflected light from the tissue. The imaging probe is constructed and arranged to collect image data from a patient site. The at least one delivery device is constructed and arranged to slidingly engage the imaging probe.

Abstract: A thrombectomy device including a delivery catheter; a tapered dilator catheter configured to be movably disposed within the delivery catheter; and an expandable aspiration funnel configured to be movably disposed within the delivery catheter in a retracted position and at least partially outside the delivery catheter in an extended position, the funnel comprising a non-permeable covering, a diameter of a distal end of the funnel being greater in the extended position than in the retracted position, the funnel being configured to adapt its shape and length to a surrounding blood vessel such that the funnel lengthens as it narrows to retain a thrombus within the funnel. The invention also includes methods of using the device.

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: A stent-graft having a smaller compacted diameter suitable to allow the stent-graft to be transported through a body conduit to a desired site. The stent-graft is deployed at the desired site by self-expanding to a first larger diameter from the smaller compacted diameter. The stent-graft has at least one flared end when self-expanded to the first larger diameter. The stent graft is further diametrically expandable by the application of force such as the inflation of a catheter balloon within the stent-graft to a still larger, maximum second diameter that is equal to about the maximum diameter of the flared end.

Abstract: Devices, systems, and methods used to seal a treatment area to prevent embolic agents from migrating are described. The concept has particular benefit in allowing liquid embolic to be used with a variety of intravascular therapeutic applications, including for occluding aneurysms and arteriovenous malformations in the neurovasculature.

Abstract: A vascular graft includes deformable sleeves that include an electrical component. The electrical component can be variable-resistance or piezoelectric, in embodiments, such that deformation of the sleeves due to pressure changes create or modify an electrical signal. A transponder can then transmit information relating to the pressure inside and outside of the vascular graft.

Abstract: An apparatus and method are provided for accessing and/or removing material from a body lumen. The apparatus includes a tubular sheath including a shaft having a proximal end and an expandable distal end that is expandable between a collapsed configuration and an expanded, tapered configuration. A treatment member can be introduced into the body lumen through the tubular sheath. The treatment member includes one or more expandable members to interact with the material to be removed from the body lumen.

Abstract: A catheter has an expansile tip that can be delivered in a constricted form. The increased tip diameter facilitates the aspiration and removal of large clot volumes by increasing the area of the catheter tip that applies aspiration to the clot. The tip comprises a support frame which can be cut from a metal or polymer tube, covered with a thin polymer sleeve 909 containing highly elastic properties. This construction provides good pushability and high compressive resistance. The cut pattern can contain axial connections of the support frame and ring members, which will provide a large level of axial support, lateral flexibility and hoop strength to withstand aspiration. The tip of the device can contain a section proximal of the highly flexible area that can expand to except clot. This potential to increase body diameter facilitates the retrieval of large volume clots while the construction of the catheter provides good column stiffness to avoid axial collapse and still maintain good flexibility.

Abstract: A stent graft device that includes a frame, a cover material covering the frame, and an anchoring member having an adjustable geometry is provided. The anchoring member may be incorporated as part of the frame or coupled thereto. The anchoring member may be formed of a material having a tensile strength such that it can be bent, straightened, or otherwise changed in shape. Tissue growth over and/or around the anchoring member anchors the stent graft device within a lumen. During removal of the stent graft device, the geometry of the anchoring member changes to allow the anchoring member to be removed from the tissue growth along a removal path with minimal trauma. The design and/or shape of the anchoring member is not particularly limited so long as the anchoring member has an adjustable geometry that permits tissue overgrowth and subsequent removal from the tissue overgrowth with minimal trauma.

Abstract: The methods and devices disclosed herein promote temporal control of balloon inflation patterns. The devices include a covering for a portion of the balloon that compresses the balloon portion during the inflation process. This enables the distal portion of a balloon to be inflated prior to the proximal portion of a balloon, creating a tapered shape at lower inflation pressures. This is especially useful during transvascular implantation procedures, as it prevents dislodgement of an implant mounted on the balloon. As inflation continues, pressure exerted on the balloon by the covering is overcome such that the proximal region of the balloon inflates, forming a shape with generally straighter sides than the tapered shape, thereby expanding the cardiovascular device.

Abstract: A stretchable-diameter inserter, for hemodynamic studies and related operations, is characterized in that it comprises an inserter tube, a hemostatic valve designed for preventing blood from exiting the patient toward the operator, a side line including a faucet, adapted to be used for performing blood taking and infusion operations and two dilatators: a first dilatator having a smaller cross-section and a second dilatator having a larger cross-section.

Abstract: An implant with an open-worked, hollow cylindrical main structure composed of a multiplicity of crosspieces, wherein the implant adopts a compressed state and an expanded state. So as to achieve a greater level of radial rigidity and an increased collapse pressure in the expanded state compared to conventional implants, wherein the deliverability is not adversely affected at the same time, the density of the crosspieces in the expanded state is greater than the density of the crosspieces in the compressed state, at least in one portion of the implant. The invention further provides a system including a catheter with a balloon and an implant of the type disclosed above.

Abstract: A device for introduction into a body vessel includes a main elongated element, a balloon positioned at the main elongated element distal end, a distal connecting element positioned at the distal end of the balloon to receive a guidewire during use, and a longitudinally movable sheath positioned external to the main elongated element, a position of the sheath distal end with respect to the balloon defining an exposed portion of the balloon that expands when fluid is delivered to the balloon through the inflation lumen.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement through the atrial septum into the left atrium. The distal end of the sheath is expanded using a radial dilator. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of atrial implants, valve repair, or the like.

Abstract: A dilation device comprises an elongate shaft, an inflatable balloon, and a resilient tube. The inflatable balloon is disposed along the shaft. The resilient tube is also disposed along the shaft and is positioned to encompass at least part of the inflatable balloon. The resilient tube is configured to impose an inwardly directed resilient bias on at least a portion of the exterior of the inflatable balloon. At least part of the resilient tube is secured to one or both of the elongate shaft or the inflatable balloon.

Abstract: Segmented scaffolds composed of disconnected scaffold segments are delivered to an implant site on a delivery balloon. The segments are crimped to the balloon and separated from each other by gaps. When the balloon is inflated the gaps between the disconnected scaffold segments stay constant. Pillowed or banded balloons are used to deliver the segments.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a push member having a proximal portion with a proximal stiffness, a distal portion with a distal stiffness different from the proximal stiffness, and a transition portion disposed between the proximal portion and the distal portion. The transition portion may provide a smooth transition between the proximal stiffness and the distal stiffness. The push member may have a first outer diameter. A distal tubular member may be attached to the push member. The distal tubular member may have a second outer diameter larger than the first outer diameter.

Abstract: An expandable implant for treating bone preferably in a minimally invasive manner includes a preferably cylindrical core element extending along a longitudinal axis and preferably a plurality of nestable, expandable sleeves extending along a longitudinal axis for placement radially about the core element. The plurality of nestable sleeves are sequentially insertable over the core element in such a manner that a first nestable sleeve is inserted over the core element and each subsequently inserted nestable sleeve is received between the core element and the previously inserted nestable sleeve such that the insertion of each additional sleeve causes each previously inserted sleeve to outwardly expand.

Abstract: The present disclosure relates generally to medical implant devices for use within a patient's body and, more particularly, relates to systems and methods for resheathing vascular devices. In some embodiments, a stent delivery system includes a stent expandable from a compressed configuration to an expanded configuration. The stent has a proximal end and a distal end and an anchoring element having a proximal portion and a distal portion, wherein the anchoring element engages the stent in the expanded configuration.

Abstract: Embodiments disclose uterine manipulators, dye delivery systems and fornix delineators that address several issues, such as minimizing surgical error, minimizing loss of parts inside a patients, enabling easy manipulation of a patient's anatomy, securing and removing the device into and from the patient atraumatically, preventing loss of pnuemoperitoneum, and securing the device fastener and components efficiently and atraumatically. An embodiment includes a uterine manipulator having a fornix delineator, uterine shaft, outer tube, fastener, handle, inlet, tip, ring and connecting string, and/or occluder.

Abstract: The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low or insignificant straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

Abstract: A flexible stent structure includes a plurality of axially spaced strut portions defining generally tubular axial segments of the stent and constructed to be radially expandable. A helical portion is interposed axially between two strut portions and has a plurality of helical elements connected between circumferentially spaced locations on the two strut portions. The helical elements extend helically between those locations and the length of a helical element is sufficient so that, when the stent is in a radially expanded state, it can simultaneously withstand repeated axial compression or expansion and bending.

Abstract: A multi-lumen catheter including a generally cylindrical body enclosing a first and second lumen separated by a generally planar septum. A first and second tip section extend from a distal end of the body. The first and second tip section may each include a generally planar surface. The second tip section may include a first segment extending from the distal end of the body to a transition segment and a second segment extending from the transition segment to a distal end of the second tip section.

Abstract: A balloon trocar includes a cannula assembly including a cannula and an outer sleeve fitting over the cannula. The distal end of the outer sleeve is proximal to the distal end of the cannula. A balloon is coupled to a distal portion of the sleeve and a distal portion of the cannula. The outer surface of the cannula includes a plurality of longitudinal channels for transmitting gas or fluid to the balloon. A bolster having a gel pad at its distal portion is slidably mounted to the cannula assembly and may be locked in a desired position. In use, the trocar is inserted into an incision through a body wall and into a body cavity. The balloon is inflated and the cannula assembly pulled proximally against the incision while the bolster is slid distally to the body wall and locked in place to seal the incision with the compressed balloon.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: The present invention is directed in various methods, devices and systems relating to providing a balloon on a sheath in combination with orbital atherectomy in order reduce the number of steps in the procedure. In certain embodiments, the balloon comprises adjunctive low pressure balloon for prevention of vessel trauma during dilatation.

Abstract: A system for providing access across a site of obstruction is provided. The system may include a sleeve, having a distal portion that can move from an inverted position to an everted position. A balloon situated within the sleeve can be extended so as to evert sleeve. A pathway can extend across a juncture between the distal portion and the remaining portion of the sleeve so as to provide access across the site of obstruction. A method for providing access across the site of obstruction is also provided.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.

Abstract: A device (1) comprises a sheath (9) for protecting a balloon catheter (2) from contamination with bodily fluids and other matter during the carrying out of a procedure or investigation at a remote site in a human or animal body. The sheath (9) defines a catheter accommodating portion (14) and a balloon accommodating portion (15) for accommodating a catheter (4) and a balloon (8) of the balloon catheter (2) therein. The sheath (9) is of a flexible material having a closed distal end (11) and a proximal opening (13) at a proximal end (10) thereof to a hollow interior region (12) within which the balloon catheter (2) is accommodated. A guide wire engaging distal portion (19) engages and locates a guide wire (7) within the sheath (9). The balloon accommodating portion (15) permits inflating of the balloon (8) to a predefined volume.

Abstract: Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.