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.

Abstract: Adjustable balloon catheter including an inner tubular member having a proximal end portion, a distal end portion, an inflation lumen and a fluid lumen defined therein. An expandable member is coupled to the distal end portion and has an inner chamber defined therein in fluid communication with the inflation lumen, the expandable member transitionable between a deflated and inflated configuration. The expandable member further has an exterior surface, the exterior surface having at least one pore structure defined therein in fluid communication with the fluid lumen. An outer tubular member is movable relative to the inner tubular member, the outer tubular member, the outer tubular member being moveable between an extended position and a retracted position, the outer tubular member being selectively positioned between the extended position and the retracted position to define an exposed length of the working length of the expandable member.

Abstract: The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.

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 distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as ureteroscopy or stone removal.

Abstract: An infusion catheter assembly has the ability to infinitely titrate the length of a porous fluid distribution section in situ. The infusion catheter assembly thereby provides a length of infusion that can be infinitely varied over a prescribed range, to control the effective infusion length and the rate of infusion. Using the infusion catheter assembly, a physician has the capability to treat only the length of the vessel desired, thereby preventing excessive drug/patient exposures. The porous fluid distribution section can include an array of spaced apart apertures that vary in size and/or density along the length of the porous fluid distribution section, such that the flow rate remains essentially constant for a given inlet pressure independent of the effective infusion length.

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The device includes a balloon having micro-needles for delivery of the bioactive agent.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a loading tool. The loading tool may include a tubular member that is configured to be disposed about a balloon catheter. The tubular member may include a distal portion and a proximal portion. The tubular member may be configured to shift between a first configuration and a shortened configuration.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and a retractable outer sheath with a selectively permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during retraction of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: An inflatable structure for use in biological lumens and methods of making and using the same are disclosed. The structure can have an inflatable balloon encircled by a shell. The shell can have proximal and distal tapered necks, longitudinally-oriented flutes, and apertures at the proximal and distal ends of the shell. The apertures can be recessed in the flutes in the necks. The shell can also have fiber reinforced walls.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only upon necking of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: A reperfusion system and method of perfusing a blood vessel using the reperfusion system are provided. A sheath has a sheath wall and a lumen that each extend to a distal end to define a distal opening. A distal portion of the sheath wall has at least one wall opening. A balloon catheter has a lumen that extends to the distal end to define a distal opening. The balloon catheter has an inflatable balloon attached to a distal portion. A conduit has a first end in fluid communication with the lumen of the sheath and a second end in fluid communication with the lumen of the balloon catheter. The reperfusion system is configured to allow blood to enter each of the distal opening and the at least one wall opening of the sheath, flow through the sheath, the conduit, and the balloon catheter, and exit through the distal opening of the balloon catheter. The sheath is introduced into body tissue. The balloon catheter is advanced through the sheath to the blood vessel. The balloon is inflated.

Abstract: Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: A method for facilitating insertion of a balloon-carrying end of a catheter includes folding the balloon-carrying end while the balloon is in an uninflated condition. A length of soluble material is provided about the folded balloon-carrying end of the catheter and the material includes perforations or scalloped regions. Once the folded balloon-carrying end is inserted into a patient, the balloon can be inflated to brake the soluble material and unfold the balloon-carrying end.

Abstract: Embodiments are presented of a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Abstract: A catheter assembly may comprise a guide catheter, a balloon catheter with a steering balloon and a stabilizing balloon and a guide wire. The stabilizing balloon secures the balloon catheter to the guide catheter while the steering balloon secures the catheter assembly to the vessel wall. In another embodiment, the balloon catheter has three balloons engaged to the exterior surface, a steering balloon, a stabilizing balloon and an anchoring balloon.

Abstract: Coaxial balloon catheters are described herein. The balloon catheter can include outer and inner tubes in a coaxial relationship, with a balloon attached to an end thereof. A support sleeve can be disposed around the inner tubular member proximate the proximal end of the balloon. The support sleeve can have a channel formed therein to communicate with an inflation lumen and a balloon interior. The channel may be formed by separation of two longitudinal edges extending through the support sleeve. The support sleeve can include an outward extending portion that is sized to engage the distal end of the outer tube in order to limit relative movement between the inner and outer tubes. The support sleeve can be configured to orient the inner tube eccentrically or concentrically relative to the outer tube. The support sleeve can have an elongate body that can be extended in proximal or distal direction.