Abstract: A balloon assist device is disclosed which includes an inner body and a balloon bonded to the inner body. The inner body extends along an axis from a proximal end to a distal end and the cross-section of the inner body partially encloses the axis. The balloon assist device also includes an inflation tube in sealed communication with the volume enclosed by the inner body and the sheath. The balloon assist device may also include a pusher for sliding the balloon assist device along the catheter. The pusher may extend parallel to the axis from the proximal end of the balloon assist device in a proximal direction. The inflation tube may also be used as a pusher. The inner body of the balloon assist device may be a split cylinder extending along the axis from the proximal end to the distal end.

Abstract: Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Abstract: Fluid control devices, systems, and methods are useful for articulating catheters and other elongate flexible structures. A modular manifold architecture includes plate-mounted valves to facilitate fluid communication along a plurality of fluid channels included in one or more multi-lumen shafts for articulating actuators comprising balloons within a balloon array, with the balloons often mounted on two or more extruded multi-lumen shafts. Valve/plate modules can be assembled in an array, and a proximal interface of the shaft(s) may have ports for accessing the balloon channels distributed along an axis of the interface. By aligning and engaging the proximal interface with a receptacle that traverses the plates of the manifold assembly, the ports can be quickly and easily sealed to associated channels of the various valve/plate modules using a quick-disconnect fitting.

Abstract: Articulation devices and methods include balloon arrays interacting with elongate skeletal support structures so as to locally alter articulation of the skeleton. The skeleton may include a helical coil, and the array can be under control of a processor. Inflation fluid may be directed to the balloons from an inflation system including valves controlled by the processor. The articulation structures can be employed in minimally invasive medical catheter systems.

Abstract: The present invention relates to a vascular closure device for sealing a puncture site in a vascular wall comprising a sheath (10) having a distal end and at least one proximal end, wherein the sheath (10) comprises a tubular body (100). The vascular closure device (1) is characterized in that at least one distal balloon member (11) is firmly arranged at the distal end of the tubular body (100) of the sheath (10) and at least one expandable anchor member (12) is firmly arranged proximal to the distal balloon member (11) on the tubular body of the sheath (10), wherein at least the distal side of the distal balloon member (11) is a pressure area for applying pressure on the outside of the vascular wall. Furthermore a method of positioning of a vascular closure device (1) is described.

Abstract: The present invention relates to an implantable apparatus and methods of use thereof for treating congestive heart failure. An apparatus of this invention may be anchored by implantation of a section of the apparatus within in a branch pulmonary artery, for example the left pulmonary artery, which then positions and anchors another section, for example a device frame section of the apparatus within the main pulmonary artery. A medical device may be attached to the anchored device frame.

Abstract: Articulation devices, systems, methods for articulation, and methods for fabricating articulation structures will often include simple balloon arrays, with inflation of the balloons interacting with elongate skeletal support structures so as to locally alter articulation of the skeleton. The skeleton may include a simple helical coil. Liquid inflation fluid may be directed to the balloons from an inflation fluid canister, and may vaporize within the articulation system, with the inflation system preferably including valves controlled by a processor. The articulation structures can be employed in minimally invasive medical catheter systems.

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: 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 proximal member having a proximal end, a distal end, and a proximal diameter. The guide extension catheter may additionally include a collar member attached to an extension portion of the proximal member, where the extension portion may be located at the distal end of the proximal member. The extension portion may allow a delivery device to be inserted through the guide extension catheter to extend along a surface of the extension portion and align with a lumen of a distal sheath of the guide extension catheter.

Abstract: A device includes a first end portion, a second end portion, an intermediate portion, and a graft material. The first end portion has a first end diameter. The second end portion has a second end diameter smaller than the first end diameter. The first end portion comprises a first material. The second end portion comprises a second material different than the first material. The intermediate portion is between the first end portion and the second end portion. The intermediate portion tapers between the first end portion and the second end portion. The graft material is coupled to at least the intermediate portion.

Abstract: Medical devices, systems, and methods provide improved control over the flexing of an articulated catheter adjacent a therapeutic or diagnostic tool by laterally bending the catheter so as to anchor an articulated portion of the catheter locally relative to an internal tissue site. Alternative embodiments may be used for a wide variety of non-medical applications, including with borescope systems and for other industrial applications.

Abstract: Atherectomy catheter devices having a C-shaped balloon opposite a cutting window out of which a rotating cutter may extend and a proximal annular balloon. The C-shaped first balloon may be used to drive the cutter against a vessel and to deploy the cutter by assisting in deflecting a nosecone (distal tip) to expose the distal-facing cutting edge of the cutter. The proximal annular balloon may be used to occlude blood flow. The device may pulled, pushed or rotated in a vessel with the balloons inflated or deflated.

Abstract: An apparatus includes a flexible catheter which may have a plurality of lumens extending from a proximal end to a distal end, a suction opening in fluid communication with a first lumen, a plurality of irrigating openings in fluid communication with a second lumen, a dilator in fluid communication with a third lumen and an occluding balloon in fluid communication with the fourth lumen. The catheter may be used to dilate an ostium, occlude the ostium, irrigate a sinus, and suction a sinus.

Abstract: The invention relates to systems and methods for intracranial vessel access. In particular, a system including a co-axial combination of a steerable variable thickness microwire operatively supporting a tapered larger bore support and larger bore distal access catheter is described. Methods of advancing the intracranial access system through the vasculature are also described.

Abstract: An apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient, the apparatus including a single lumen catheter having a proximal end and a distal end, and a high pressure balloon attached to the distal end of the catheter. The high pressure balloon is fabricated from a semi-compliant material that has an average rated burst pressure of between about 15 and about 27 atmospheres of pressure and exhibits a dumbbell-shaped outer periphery when inflated to a first atmospheric pressure and a substantially linear outer periphery when inflated to a second atmospheric pressure.

Abstract: Transcatheter methods are disclosed for introducing a large transcatheter implant or other device into an artery from an adjacent vein, for example from the inferior vena cava into the abdominal aorta. Such an access route can be formed by direct puncture through the adjoining vessels. In addition, methods and devices are also disclosed for closing arteriovenous fistulas or other cardiovascular passageways.

Abstract: A system for cardiopulmonary bypass, including: a cardiopulmonary bypass reservoir configured to store a blood; a pump in fluid communication with the cardiopulmonary bypass reservoir configured to provide pressure to the system; an oxygen source including a pressure regulator configured to regulate an oxygen pressure; an oxygenator fluidly connected to the pressure regulator of the oxygen source via an sweep gas inlet, wherein the sweep gas inlet is configured to have a sub atmospheric pressure and the oxygenator is configured to oxygenate the blood; a vacuum regulator fluidly connected to the oxygenator via an sweep gas outlet, and configured to provide the sub atmospheric pressure; a flow restrictor fluidly connected to the sweep gas inlet and configured to allow for a pressure drop from the oxygen source to the oxygenator; and an arterial filter fluidly connected to a blood outlet of the oxygenator and to the cardiopulmonary bypass reservoir.

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

Abstract: The invention provides method of fabricating a scaffold comprising a fluidic network, including the steps of: (a) generating an initial vascular layer for enclosing the chamber and providing fluid to the cells, the initial vascular layer having a network of channels for fluid; (b) translating the initial vascular layer into a model for fluid dynamics analysis; (c) analyzing the initial vascular layer based on desired parameters selected from the group consisting of a characteristic of a specific fluid, an input pressure, an output pressure, an overall flow rate and combinations thereof to determine sheer stress and velocity within the network of channels; (d) measuring the sheer stress and the velocity and comparing the obtained values to predetermined values; (e) determining if either of the shear stress or the velocity are greater than or less than the predetermined values, and (f) optionally modifying the initial vascular layer and repeating steps (b)-(e).

Abstract: A medical device for anchoring itself and other medical devices while channeling blood flow through the center of a vessel proximal to the device's target area to minimize debris and the pressure necessary to move blood proximal to the device. The medical device also provides superior recoil reduction capabilities. A doughnut-shaped balloon that may be inflated and deflated by increasing and decreasing pressure within the balloon, having two passages therethrough, dimensioned for blood flow and a delivery device. A method for using the device.

Abstract: An embolic material blocking catheter includes a handle assembly, an elongated element having a lumen, and a deployable embolic material blocking element. The embolic material blocking catheter is configured to accommodate insertion of a treatment catheter into the lumen to position a treatment device distal to the embolic material blocking element for administering a treatment at a treatment site and/or convey embolic material blocked by the embolic material blocking element for extraction from the patient.

Abstract: Method of forming a multiple balloon catheter includes extruding a tube and a plurality of ribs through a die to form a monolithic element that spans between first and second ends with the plurality of ribs extending along the length of the tube to define a corresponding number of a plurality of channels that extend along the length of the tube. Positioning a portion of the tube into a mold and constricting a proximal end portion and a distal end portion of the tube that is positioned in the mold. Inflating the tube to produce an inner balloon having a body portion that spans between proximal and distal end portions and cutting the inner balloon to separate the inner balloon from a remainder of the tube. Disposing an outer balloon including a plurality of holes around the inner balloon and aligning the plurality of holes with the plurality of channels.

Abstract: In one representative embodiment, a method of perfusing organs in a patient's body is provided. The method comprises isolating the visceral arteries and the visceral veins from blood circulating through the patient's heart and perfusing the visceral arteries, the visceral veins, and the abdominal organs with a perfusion fluid that is fluidly separated from the blood circulating through the patient's heart. While the visceral arteries and the visceral veins are isolated, and the visceral arteries, the visceral veins, and the abdominal organs are being perfused, the patient's blood is allowed to continue to circulate through the heart.

Abstract: Inflatable multi-chambered devices are provided for repairing or replacing spinal discs and distracting neighboring vertebral elements. Also included are cushioning devices that may be used in a joint replacement device cushioning system. Further included are kits and systems that include such devices, methods for making such devices, and methods of treating patients in need of such devices. Examples further include cosmetic augmentation and restoration devices.

Abstract: An angioplasty apparatus and method including a balloon stent, for facilitating accurate placement of a lumen stent for dilating a stenotic site, the apparatus includes arcuate, low pressure, anchor and/or marker and guide balloon segment(s) connected to a stent deployment catheter at at least one of a proximal and distal end of a wire mesh stent with circumferential gaps in the anchor and/or marker balloon segment or segments to facilitate blood flow and contrast media during a stenting procedure. Optimal positioning of a stent at a stenotic lumen site is facilitated by selective injection of marker fluid into one or more low pressure, anchor and/or marker balloon segment(s).

Abstract: Thrombus removal systems and devices and methods of using the same. In an exemplary embodiment of a thrombus removal system of the present disclosure, the thrombus removal system comprises an umbrella catheter comprising an umbrella catheter tube and an umbrella positioned at least partially within the umbrella catheter tube when in a compressed configuration and positioned external to the umbrella catheter tube when in a deployed configuration, and a balloon catheter configured to fit around at least part of the umbrella catheter, the balloon catheter comprising a balloon catheter tube and a balloon coupled thereto, the balloon capable of inflation within a lumen of a mammalian vessel to substantially or completely occlude the lumen of the mammalian vessel, wherein the thrombus removal system is configured to disrupt and/or dissolve and remove at least a portion of a thrombus positioned within the lumen of the mammalian vessel.

Abstract: An inflatable balloon is provided. The balloon includes a central lumen open at both ends of the balloon and connected to a gap formed in one sidewall of the balloon. This arrangement may provide the balloon with a generally C-shaped profile with the open central lumen within the balloon along a center axis thereof, such as to allow for perfusion. The balloon may also include an inflation port offset from a central axis and a shaft including an inflation lumen connected to the inflation port. A sheath may also be provided with a window through which the balloon may project in use.

Abstract: Embodiments of the invention provide shaped masses (SM) comprising one or more drugs such as proteins or polypeptides and methods for forming and delivering such SM's. One embodiment provides a SM comprising a drug e.g., a protein or polypeptide having a biological activity in the body of a mammal. The SM is formed by compression of a precursor material (PM) comprising the drug wherein an amount of biologically active drug in the SM is a minimum level to that in the PM. Drugs which may be incorporated into the SM include insulin, incretins and immunoglobulins e.g., interleukin neutralizing antibodies or TNF-?-inhibiting antibodies. Embodiments of the invention are particularly useful for the oral delivery of drugs which would be degraded within the GI tract, wherein the SM containing the drug is formed as or incorporated into a tissue penetrating member which is inserted into the intestinal wall after oral ingestion.

Abstract: An occluding catheter for preventing stroke by occluding blood flow through right and left carotid arteries is provided. The occluding catheter includes a shaft that has a proximal end and a distal end, and a proximal occluding balloon carried by the shaft. The proximal occluding balloon is inflated to occlude blood flow through one of the right carotid artery and the left carotid artery. A distal occluding balloon is carried by the shaft and is inflated to occlude blood flow through one of the right carotid artery and the left carotid artery that is not occluded by the proximal occluding balloon. The shaft has a segment that is located between the proximal occluding balloon and the distal occluding balloon. Also provided is an alternative arrangement with a single occluding balloon, and an associated method of diverting emboli from cerebral circulation.

Abstract: A bulbous valvuloplasty balloon is described that maintains its bulbous shape in its final deployed configuration along with the method of use for post dilation of a TAVR device. The bulbous balloon has two larger diameter bulb segments located on each side of a smaller diameter waist and can be used to post dilate a TAVR device that has been implanted at the site of a stenotic aortic valve. The post dilation causes deformation of the underlying tissues residing outside of the TARV stent structure.

Abstract: Deflectable guide catheters and methods, including methods for using defectable guide catheters to perform transnasal procedures within the ear, nose, throat, paranasal sinuses or cranium. Some deflectable guide catheters of the present invention comprise a substantially rigid tube, a helical spring attached to and extending from the distal end of the substantially rigid tube, a tubular plastic inner jacket, an outer plastic jacket substantially covering at least the helical spring member. The spring member is deflectable to cause the distal portion of the guide catheter to deflect to a curved configuration. In embodiments for transnasal use the deflectable guide catheter may have a length of less than 25 cm.

Abstract: The invention relates to a valve used in medical procedures. More specifically the invention relates to an introducer sheath valve used in minimally invasive and conventional surgical procedures. The valve may accommodate a wide range of surgical implement diameters, shapes, and multiple implements without imposing the high frictional forces of known valves.

Abstract: Aneurysms are treated by filling at least one double-walled filling structure with a curable medium within the aneurysm. The filling structures may be delivered over balloon deployment mechanisms in order to shape and open tubular lumens therethrough. Scaffolds are placed into the tubular lumens in order to help maintain the shape, anchor the filling structures in place, and provide improved blood flow transition into and out of the tubular lumens.

Abstract: A fistula management device for preventing enteric contents from leaking out of a bowel via a fistula opening in the bowel. The device comprises a tubular body that defines a main fluidic passageway extending from a first axial end to a second axial end of the tubular body. Inflatable cuffs are located at each of the first and second axial ends of the tubular body for creating a fluid seal between the first and second axial ends of the tubular body and inner walls of a bowel.

Abstract: A balloon catheter having a balloon with a shape for treating a vessel at a bifurcation, includes an oblique proximal end of the balloon, and a catheter shaft which is at least partially eccentric to a central axis of the balloon. Markers used for longitudinal and rotational alignment are included on the catheter shaft. A torque transmission element may be used for transmitting torque from the stiff proximal segment of the catheter to the distal flexible balloon segment of the catheter.

Abstract: A catheter is provided including a first lumen and a second lumen. A first member is disposed for relative movement within the first lumen and defines a cavity. A second member is disposed for relative movement within the second lumen. The cavity of the first member is configured for disposal of the second member. The catheter may include an elongated tubular body that includes the first lumen and the second lumen. The first member may have a distal portion that extends beyond the distal end of the body. The distal portion may include the cavity. The cavity may be defined by a member lumen. The first and second members may include tubular stylettes. The second member may include a guidewire.

Abstract: A valvuloplasty system includes a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the valve. The shock wave generator is moveable within the balloon to vary shock wave impingement on the valve.

Abstract: A system for bypassing an anastomosis site in a hollow organ is provided. The system includes a sleeve configured for spanning the anastomosis site at an internal surface of the hollow organ and a band configured for attachment to an external surface of the hollow organ and limiting migration of the sleeve beyond the anastomosis site.

Abstract: A system and method for treating a vessel is provided. A catheter system includes an inner elongated element and an outer elongated element positioned coaxially with respect to the inner elongated element. A proximal occlusion element is positioned at and is flush with the distal end of the outer elongated element. A distal occlusion element is positioned at a distal end of the inner elongated element. The distal end of the inner elongated element is distal to and movable with respect to the outer elongated element distal end. One or both of proximal occlusion element and distal occlusion element is a compliant balloon, configured to form a funnel shape upon proximal movement of the outer elongated element and/or the inner elongated element.

Abstract: Apparatus and methods are described including inserting a catheter into a subject's body via a vein of the subject's groin. The catheter is advanced distally such that a distal end of the catheter is disposed inside the subject's renal vein. Respective stabilizing portions of the catheter stabilize the catheter by being in contact with inner walls of, respectively, an iliac vein of the subject, and a vena cava of the subject. Subsequently, a medical device is deployed inside the renal vein by retracting the distal end of the catheter, such that the distal end of the catheter is in a retracted state, in which the respective stabilizing portions of the catheter still stabilize the catheter by being in contact with the inner walls of, respectively, the subject's iliac vein and the subject's vena cava. Other applications are also described.

Abstract: A device includes a first end portion, a second end portion, an intermediate portion, and a graft material. The first end portion has a first end diameter. The second end portion has a second end diameter smaller than the first end diameter. The first end portion comprises a first material. The second end portion comprises a second material different than the first material. The intermediate portion is between the first end portion and the second end portion. The intermediate portion tapers between the first end portion and the second end portion. The graft material is coupled to at least the intermediate portion.

Abstract: A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided, which enhances the accuracy of the placement. Anchors and placement wires are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to preassembled percutaneous valve devices as well as a modular prosthetic valve device. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a preassembled percutaneous valve device may be placed in accordance with the invention.

Abstract: A method of using a multichannel cannula to perform kyphoplasty includes inserting a stabilizing wire into a vertebra damaged by a compression fracture and inserting, over the stabilizing wire, a cannula. The cannula includes a first channel having open proximal and distal ends, and is configured to receive the stabilizing wire, and a second channel having an inlet portal and an exit portal that are in fluid communication. The cannula further includes an expandable portion configured to expand away from the cannula from an outer wall of the second channel. The method also includes inflating the expandable portion to create a void in the bone and to restore the height of the vertebra, and then deflating the expandable portion. When the void has been created, bone cement is delivered through the second channel into the void via the exit portal to at least partially fill the void.

Abstract: A subintimal recanalization catheter system for recanalizing a blood vessel. The system includes a support catheter and a balloon catheter configured to extend through the support catheter. The support catheter includes a tubular portion and an extension segment extending distal of the distal opening of the tubular portion. The balloon catheter, having a balloon secured to a distal portion thereof, is positionable through the tubular portion of the support catheter to position the balloon alongside the extension segment. The system is configured to be advanced into a subintimal space between a first tissue layer and a second tissue layer of a blood vessel wall where the balloon may be inflated against the extension segment to cause a distal portion of the catheter shaft of the balloon catheter to deflect toward the vessel lumen within the subintimal space to facilitate reentry into the vessel lumen.

Abstract: Procedures may be performed on the heart after the installation of a mitral valve fixation device. In order to prepare the heart for such procedures, the fixation device may be removed or disabled in minimally invasive ways (e.g., through an endovascular procedure), without requiring open access to the heart. The fixation device may be partitioned so that one portion may remain attached to each leaflet of the mitral valve. In another example, the leaflets may be cut along the edges of the distal element(s) of the fixation device, so as to cut the fixation device from the leaflet(s). Systems and devices for performing such procedures endovascularly are disclosed. Fixation devices with improved access to a release harness are also disclosed.

Abstract: The invention presents methods and systems for accessing a pericardial space and preventing strokes arising from a left atrial appendage (“LAA”) by achieving a complete occlusion of the LAA using an epicardial approach without creating a puckering of the LAA ostium. A complete occlusion of the LAA is desired because blood clots arising from the LAA often leads to embolic strokes. Due to the peculiar anatomy of the LAA ostium, traditional LAA ligation techniques using sutures can lead to puckering, thus compromising the occlusion of the LAA. The invention achieves a complete occlusion and a more effective hemostatic seal with the use of inflatable balloons having electromagnetic coils internally, as well as hydrogels, sponges, and caliber tubes attached to the respective balloon's exterior, anchoring balloons, a closure device having a suture looped through two semi-rigid hollow tube that can be coated with hydrogel or silicone, and locking mechanisms.

Abstract: A valvuloplasty catheter has a dog-bone shaped balloon with semi-compliant smaller diameter waist and non-compliant larger diameter bulbous end regions. The balloon centers across the valve with the waist adjacent to the annulus. One bulbous region serves to hyperextend the valve leaflets and the other assists in stabilizing the balloon position to reduce migration. The semi-compliant waist increases in diameter as fluid enters the balloon until it comes into contact with the valve annulus. The pressure within the balloon per unit of volume delivery has a greater slope after contact with the annulus than before resulting in a change in slope for the pressure versus volume curve. The diameter of the balloon and annulus are determined at this inflection point when the balloon contacts the annulus.

Abstract: In another embodiment, a method is provided for positioning a graft device in an ascending aorta of a patient. In the method, access is provided to a peripheral venous site. A first catheter is advanced through the peripheral venous site to a right atrium of the patient. Access is provided to the left atrium across an intra-atrial septum. The first catheter is advanced through to a left atrium of a patient. A second catheter is advanced from the first catheter through a left ventricle and the aorta to a peripheral arterial site. A graft device disposed on, over or within the second catheter is advanced from the peripheral venous site or the peripheral arterial site until the graft device reaches an ascending aorta of the patient. The graft device is positioned at a treatment site within the ascending aorta. The first and second catheters are removed from the patient.

Abstract: Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. According to aspects illustrated herein, there is provided a device for repairing a fractured bone that includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the delivery catheter having an inner void for passing at least one reinforcing material, and an inner lumen for accepting a light pipe, wherein a distal end of the inner lumen terminates in an optical lens; a conformable member releasably engaging the distal end of the delivery catheter, the conformable member moving from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light pipe and the at least one reinforcing material.

Abstract: A light-diverting catheter tip is provided according to embodiments disclosed herein. The light-diverting catheter tip may be coupled with the distal tip of a laser catheter and divert at least a portion of the light exiting the distal tip of the laser catheter such that the spot size of the laser beam on an object after exiting the catheter tip is larger than the spot size of the light entering the catheter without the catheter tip. The catheter tip may be removably coupled with the catheter or constructed as part of the catheter. In other embodiments, the catheter tip may conduct fluid and/or divert fluid at the tip of the laser catheter.