Abstract: The present invention provides devices and methods for the treatment of atrial fibrillation. In one embodiment a deflectable sheath catheter includes an elongate catheter body having proximal and distal ends, the distal end having a distal tip region that includes a plurality of flexible segments with varying degrees of stiffness. A handle portion can be located at the proximal end of the catheter body to provide a steering mechanism that causes the distal tip region to deflect according to a compound curve.

Abstract: Expandable laser catheters for utilizing laser energy to remove obstructions from body passages are described. In one embodiment, the laser catheter includes a shaftway having a distal end including a flexible portion configured in a series of radial folds. Multiple optical fibers, configured to transmit laser energy, extend along the shaftway and are attached to the flexible portion. An inflatable, ring-shaped balloon is attached to the catheter within the flexible portion. In use, the catheter is inserted into a body passage such as an artery, and advanced until the distal end is adjacent to an obstruction. The balloon is inflated to expand the flexible portion and to bring the optical fibers nearer the inner wall of the body passage. Laser energy is directed by the optical fibers toward targeted regions of the obstruction. As the catheter is advanced and the process repeated, a core is formed from the obstruction and contained within the flexible portion.

Abstract: Systems and methods to reduce bioburden on at least a portion of a fluid transfer port include supplying a dose of radiation to the portion in optical communication with at least one source of radiation. In an illustrative example, a medical container, such as a vial or IV bag, receives a dose of ultraviolet (UV) energy substantially at a predetermined region of a fluid transfer site. In some examples, such a sanitization process may precede a fluid transfer operation in which a fluid is transferred into or out of the medical container by passing through the sanitized region. Such fluid transfers may be used in automated or semi-automated pharmaceutical processes, such as drug reconstitution. Various embodiments may further include one or more seal assemblies, each seal assembly having an aperture through which the radiation dose is supplied from the source to a controlled region on the fluid transfer port.

Abstract: Methods and apparatus are disclosed for forming annular lesions in tissue. The methods include introduction of an optical apparatus proximate to a tissue site, via, for example, a catheter. The optical apparatus includes a pattern-forming optical wave guide in communication with a light transmitting optical fiber. Energy is transmitted through the optical fiber, such that radiation is propagated through the optical fiber and the wave guide projects an annular light pattern, e.g., a circle or a halo.

Abstract: Device for implementing a cutting balloon intervention by means of a “cutting balloon” catheter, at the distal end of which is disposed an inflatable balloon with axially running blades mounted thereon, and which has IVUS monitoring, whereby the cutting balloon catheter is combined with an IVUS catheter to form an integrated module.

Abstract: Methods of advancing a laser catheter across an occlusion are described. They may include the steps of advancing a guidewire through a first proximal lumen and a distal lumen of the catheter into a first region of the occlusion, retracting the guidewire from the distal lumen, and advancing a diagnostic device from a second proximal lumen of the catheter to examine the occlusion. The methods may also include retracting the diagnostic device from the distal lumen and advancing the guidewire through the distal lumen. The laser catheter may be activated to create a lumen through the occlusion.

Abstract: The present invention provides a prophylactic light activated treatment method for subjects at risk of a plaque-mediated thrombotic event, such as acute coronary syndromes. In one embodiment, the subject receives a dose of photosensitizer sufficient to result in a concentration of photosensitizer in the neovascularization associated with atherosclerotic disease to permit effective photodynamic therapy. Light of a wavelength that excites the photosensitizer, but that does not to any significant extent penetrate to an adventitial layer of the blood vessel, is applied to the region of the blood vessel. The therapeutic light dose, which may be applied in sequential stages, is sufficient to cause closure of neovasculature leakage and lead to plaque stabilization and reduced adverse clinical outcomes. The present invention further provides light transmission devices and systems useful in carrying out the methods of the present invention.

Abstract: The use of a collagenase containing formulation for degrading collagen within an occlusive atherosclerotic plaque in a chronic fibrotic occlusion, chronically occluded animal tube or cavity. A medical-related apparatus is provided comprising a medical-related device having provided thereto a therapeutic amount of a collagen degrading composition comprising a proteiolytic enzyme containing formulation A method is provided for treating chronically occluded animal tubes and cavities by administering a therapeutic effective amount of a proteolytic enzyme-containing formulation adjacent to an occluding atherosclerotic plaque, waiting for a pre-angioplasty waiting period, followed by crossing the plaque with an angioplasty guide wire.

Abstract: A catheter introduces electrodes in a vein for a minimally invasive treatment of venous insufficiency by the application of energy to cause selective heating of the vein. The catheter is positioned within the vein to be treated, and the electrodes on the catheter are moved toward one side of the vein. RF energy is applied in a directional manner from the electrodes at the working end of the catheter to cause localized heating and corresponding shrinkage of the adjacent venous tissue, which may include commissures, leaflets and ostia. Fluoroscopy or ultrasound may be used to detect shrinkage of the vein. After treating one section of the vein, the catheter can be repositioned to place the electrodes to treat different sections of the vein until all desired venous valves are repaired and rendered functionally competent.

Abstract: The present invention provides devices and methods for the treatment of atrial fibrillation. In one embodiment a deflectable sheath catheter includes an elongate catheter body having proximal and distal ends, the distal end having a distal tip region that includes a plurality of flexible segments with varying degrees of stiffness. A handle portion can be located at the proximal end of the catheter body to provide a steering mechanism that causes the distal tip region to deflect according to a compound curve.

Abstract: Systems and methods to reduce bioburden on at least a portion of a fluid transfer port include supplying a dose of radiation to the portion in optical communication with at least one source of radiation. In an illustrative example, a medical container, such as a vial or IV bag, receives a dose of ultraviolet (UV) energy substantially at a predetermined region of a fluid transfer site. In some examples, such a sanitization process may precede a fluid transfer operation in which a fluid is transferred into or out of the medical container by passing through the sanitized region. Such fluid transfers may be used in automated or semi-automated pharmaceutical processes, such as drug reconstitution. Various embodiments may further include one or more seal assemblies, each seal assembly having an aperture through which the radiation dose is supplied from the source to a controlled region on the fluid transfer port.

Abstract: Improved devices and methods for removing blood from a blood vessel in preparation for endovenous laser ablation are described. The improved methods include one or more of: placing the patient in the Trendelenburg position, applying external compression around the vein, massaging the vein, cooling the vein externally, encouraging spasming of the vein, and removing blood with a suction device.

Abstract: Apparatus and methods are disclosed for vascular stenosis therapy, including enhancing permeability of the vessel wall using ultrasound energy and delivering a therapeutic agent into the arterial wall. Ultrasound energy may also be delivered using transcutaneous techniques and endovascular methods. In some embodiments, ultrasound energy and therapeutic agent application may be combined with angioplasty techniques and with blood flow protection devices to prevent dissipation of the therapeutic agent from the treatment site.

Abstract: A method and apparatus for simultaneous hemoglobin reflectivity measurement and OCT measurement, thrombus detection and treatment, and OCT flushing. A first optical energy for OCT and a second optical energy for hemoglobin may be used.

Abstract: An interventional catheter assembly comprising a catheter for insertion and guidance to a target site in a body lumen or a cavity and an operating head mounted in proximity to a distal end of the catheter and comprising a system for removing obstructive material from the target site is provided. In certain embodiments, the catheter assembly includes at least one aspiration port located proximal to the operating head that communicates with a first sealed lumen for withdrawing fluids and obstructive material from the target site, together with at least one liquid infusion port penetrating the catheter and located proximal to the at least one aspiration port that communicates with a second sealed lumen for supplying fluid to a location in proximity to the target site.

Abstract: The present invention relates to devices and procedures for medical care and pertains in particular to medical devices and techniques for treatment of occlusions, particularly chronic total occlusions in vessels, particularly blood vessels of human or animal subjects.

Abstract: A method and apparatus, of providing endovascular therapy. The steps include arranging optical fibers within a catheter, the catheter having a tip whose length is at least 1 cm and whose diameter of less than 1 millimeter, connecting an excimer laser to the optical fibers; and delivering laser energy from the excimer laser in excess of a fluence of 60-mJ/mm2 at 40 Hertz through the optical fibers. The delivering of the laser energy may be to non-calcified or calcified deposits of an atherosclerotic lesion to ablate the same. The method also includes the step of inserting the catheter through an artery by pushing the same until the tip is in within laser energy striking distance of the atherosclerotic lesion.

Abstract: A method and systems for treating chronic total occlusions, particularly those that are difficult to treat, is disclosed. In this approach, recanalizing the CTO is achieved using a combined antegrade and retrograde approach. The proximal end of the occlusion is penetrated using an antegrade wire, using a traditional approach. Using collateral vessels, the distal end of the occlusion is crossed in a retrograde fashion. By appropriately maneuvering each member and applying radiofrequency energy between the proximal and distal ends of the occlusion, a continuous channel is created.

Abstract: A blood occlusion auger having an in vivo distal auger tool coupled in operative association with an ex vivo auger control for opening and traversing occlusions in a blood vessel The auger control allows the selection of predetermined threshold forces and step-lengths values and operates in successive repetition of identical sequential stages, to traverse occlusions. Once disposed adjacent an occlusion, the auger tool, commanded by the auger control, operates in two states, first to radially dilate the vessel and second to penetrate distally into a furrow.

Abstract: A thrombolysis catheter apparatus is disclosed comprising: (a) an elongated thrombolysis catheter portion comprising a plurality of independently controllable electroactive polymer actuators, which provide a curvature to the thrombolysis catheter based upon received control signals; (b) a control unit coupled to the plurality of actuators and sending the control signals to the plurality of actuators; and (c) an occlusion removal device. Also disclosed is a method of treating an arterial occlusion by advancing the thrombolysis catheter portion through the arterial vasculature of a patient to a position proximate the occlusion, while controlling the shape of the thrombolysis catheter portion using the control unit. The occlusion is then removed using the occlusion removal device.

Abstract: A process and instruments for diminishing an undesired endoluminal structure present at a treatment site in a mammalian treatment subject. The endoluminal can be or include a vascular occlusion, a biofilm or another undesired biological structure. The process can include applying mechanical shockwaves to the endoluminal structure and the endoluminal structure absorbing the applied mechanical shockwaves and becoming diminished, dispersed or weakened. The shockwaves can be generated by pulsed laser energy delivered to an ionizable target via an optical fiber.

Abstract: The laser induced liquid jet generating apparatus irradiates a laser beam on a liquid in a main body, guides the generated liquid jet into a catheter via a nozzle, and generates a flow in the direction opposite the liquid jet. Even by the use of a catheter having a small outside diameter, therefore, the apparatus is enabled to effect powerful laser irradiation without being thermally affected by the laser beam and consequently shatter thrombus, for example, and recover by aspiration the shattered thrombus through the distal end of the catheter.

Abstract: Various embodiments of an eccentric balloon catheter are disclosed. In some embodiments, an eccentric balloon catheter includes an eccentrically positioned guidewire tube, with an interior lumen, that extends at least a portion of the length of the catheter body. Optical fibers may extend the length of the catheter body and may also be eccentrically positioned within the catheter body. An inflatable balloon may be positioned within a window within the catheter body near the distal end of the catheter. When inflated, the balloon and catheter may slide relative to one another. When used within a vessel, an inflated balloon may press against a vessel wall and bias the catheter toward an opposite vessel wall.

Abstract: Light generating devices for illuminating portions of vascular tissue, to render photodynamic therapy. In one embodiment, a light source array preferably including a plurality of light emitting diodes, a focusing lens, and a light diffusing element are included in a distal end of a catheter. A balloon is optionally provided to interrupt blood flow that can block the transmission of light, and to center the apparatus in a blood vessel. Optical fibers optionally direct light from the light source to the diffusing element. The light source array can have a radial or linear configuration and can produce more than one wavelength of light for activating different photoreactive agents. Linear light source elements are particularly useful to treat elongate portions of tissue in a vessel. One embodiment intended for use with a conventional balloon catheter integrates light sources into a guidewire.

Abstract: A medical device for removing a thrombus from a blood vessel and a process thereof is presented. The device comprises an outer sheath with a plurality of lumens. A wire guide inserted through one of the lumens is used to place the device proximate to a thrombus. An optical fiber placed through a second lumen uses laser input to ablate the thrombus in the proximal portion of the second lumen near its proximal end. A vacuum coupled to the distal end of the second lumen is used to remove any ablated residual material. The second lumen may be pivoted around the first lumen to reposition the second lumen proximate to an area of the thrombus that has not yet been ablated.

Abstract: A self-expanding medical occlusion device treats a heart defect in a patient and is inserted into the body in minimally invasive fashion using a catheter system, and includes a braiding of thin threads which exhibits a first preliminarily definable shape as the occlusion device is being inserted into the patient's body and a second preliminarily definable shape in the implanted state, whereby the occlusion device is in a collapsed state in the first shape of the braiding and in an expanded state in the second shape of the braiding. The threads of braiding are composed of a shape memory polymer composite such that braiding deforms from a temporary shape to a permanent shape in consequence of an external stimulus, whereby the temporary shape is given in a first profile form of the braiding and the permanent shape is given in a second profile form of the braiding.

Abstract: A portable hair treatment device 1 includes a hand held portion or wand 2 containing a laser and associated optics for effecting skin treatment. The device includes a main base unit 3 including a recess shaped to receive the hand held unit 2 when not in use. At least one of the base unit 3 and the wand 2 includes a portable power source, e.g. a battery, to enable self-powered use.

Abstract: A system and method for opening a lumen in an occluded blood vessel, e.g., a coronary bypass graft, of a living being. The system comprises an atherectomy catheter having a working head, e.g., a rotary impacting impeller, and a debris extraction sub-system. The atherectomy catheter is located within a guide catheter. The working head is arranged to operate on, e.g., impact, the occlusive material in the occluded vessel to open a lumen therein, whereupon some debris may be produced. The debris extraction sub-system introduces an infusate liquid at a first flow rate adjacent the working head and withdraws that liquid and some blood at a second and higher flow rate, through the guide catheter to create a differential flow adjacent the working head, whereupon the debris is withdrawn in the infusate liquid and blood for collection outside the being's body.

Abstract: The position of a metal marker 5 relative to an optical fiber 6 is fixed, and the metal marker 5 can be moved up close to a target site such as a thrombus. It is preferable that the position, in an optical fiber longitudinal direction, of a front-end face of the optical fiber 6 is coincident with the position, in an optical fiber longitudinal direction, of a front-end face of the metal marker 5. More specifically, since the distance between the target site and the front end of the optical fiber 6 is known by radiography, it becomes unnecessary to use a large quantity of contrast agent and irradiate a laser beam depending on skill and intuition, and therefore an effective laser beam irradiation becomes possible.

Abstract: A laser catheter having a compliant balloon and a plurality of optical fibers extending from a base to a tip of the catheter for plaque removal is disclosed. The laser catheter may include a distal flush lumen extending to the tip. The compliant balloon may extend along a longitudinal axis of the laser catheter and may be positioned radially outward from an inner lumen. A plurality of optical fibers may be positioned between the inner lumen and an outer compliant material jacket. In another embodiment, the compliant balloon may be positioned eccentrically with respect to the inner lumen. The eccentrically positioned compliant balloon may further facilitate removal of plaque within arteries.

Abstract: An improved method and device is provided for safe and efficient low power density endoluminal treatment of venous insufficiency. One such device emits pulsed or continuous energy radially through an optical fiber end with a conical shaped tip for 360° radial emission. In some embodiments, a conical reflective surface is distally spaced opposite to and faces the emitting tip for enhancing radial emission efficiency by reflecting out any designed or remnant forwardly transmitted energy in radial directions. Other devices include flat emitting faces sealed within protective, radiation transparent covers. Laser radiation is transmitted at a wavelength and power such that is it substantially entirely absorbed within the blood vessel wall to sufficiently damage the intravascular endothelium and, in turn, achieve blood vessel closure.

Abstract: To prevent intimal hyperplasia within a dialysis graft, a flexible tube comprising the dialysis graft is coated interiorly before placement with an anticarcinogen or mitosis-inhibiting agent for preventing cell division. The graft can also be irradiated with light energy by directing light into the lumen of the tube that has been grafted in place, thereby preventing or reducing dialysis graft intimal hyperplasia and reducing inflammation. The light source can be a light emitting diode (LED) or a chemical light source, i.e., a chemiluminescent substance for producing cool light energy within the graft to prevent or reduce the symptoms of GIH. When phototherapy is used, the body is exposed to light radiation at the site of the graft in sufficient amount to prevent undesired cell proliferation within the vessels, the graft, or surrounding tissue where the invention is used without detectable damage to body tissue. For various applications, visible light can be used, e.g.

Abstract: Disclosed is a method for removing deposits from an in vivo tissue, such as removing calcified plaque from a calcified aortic valve by removing the deposits with the help of shock waves produced by a light-source such as a laser in an aqueous liquid in proximity of the tissue as well as a shock-wave generating device useful in implementing the method. Disclosed is a minimally invasive valve-sparing treatment of calcific aortic stenosis.

Abstract: An optical fiber tip comprises a core and a recess formed in said core at a distal end of the optical fiber tip, said recess having a vertex within said core.

Abstract: Embodiments of the present invention comprise a fiber optic guidewire having a hypotube with a plurality of openings that provide variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire. In some embodiments, the guidewire further comprises a mandrel disposed within the hypotube, the mandrel cooperating with the optical fibers to permit the distal end of the hypotube to be shaped as desired by a user. Methods of manufacturing and using the guidewire are also disclosed.

Abstract: An improved treatment set and an improved method for endovascular laser treatments are described. The treatment en set comprises an introducer sheath or tip and an optical waveguide for allowing the treatment set to be guided within a blood vessel. The introducer sheath itself acts as the guide wire in one embodiment of the procedure. The introducer includes a means for protecting the tip of the optical fiber while the set is being positioned within the vessel and protecting the introducer tip from damaging the vessel. The method includes the steps of inserting the introducer/optical waveguide combination into a blood vessel to be treated, positioning the distal end of the introducer at a proper position in the blood vessel; advancing the optical fiber through a protective cap and/or means, and irradiating the blood vessel, preferably while withdrawing the treatment set toward the point of insertion.

Abstract: A rotationally vibrating imaging catheter and method of utilization has an array of ultrasound or optical transducers and an actuator along with signal processing, display, and power subsystems. The actuator of the preferred embodiment is a solid-state nitinol actuator. The actuator causes the array to oscillate such that the tip of the catheter is rotated through an angle equal to or less than 360 degrees. The tip is then capable of rotating back the same amount. This action is repeated until the desired imaging information is acquired. The rotationally vibrating catheter produces more imaging points than a non-rotating imaging catheter and eliminates areas of missing information in the reconstructed image. Rotationally vibrating catheters offer higher image resolution than stationary array catheters and greater flexibility and lower costs than mechanically rotating imaging catheters.

Abstract: In some embodiments, without limitation, the invention comprises a catheter having an elongated housing with a channel disposed therein. A laser delivery member is movable and at least partially disposed within the channel. A ramp is disposed within the housing at an angle to its central axis and proximate to its distal end. The ramp is adapted to move the distal end of the laser delivery member outwardly from the central axis of the housing. A guidewire biases the distal end of the laser delivery member generally inwardly toward the central axis of the housing. In some embodiments, without limitation, the offset of the central axis of the tip of the laser delivery member from the central axis of the housing is determined by adjusting the extent to which the laser delivery member travels on the ramp, and disposition of the laser delivery member on the guidewire maintains the offset tip substantially parallel to the central axis of the housing.

Abstract: An endovascular laser treatment device designed to be used with an optical fiber to treat venous diseases such as varicose veins is provided. The device includes a spacer that positions the distal end of the optical fiber away from the inner wall of the blood vessel during delivery of laser energy to provide an even distribution of thermal energy around the vessel, thereby avoiding vessel perforation and incomplete vessel collapse.

Abstract: An endovascular tissue removal device including a lumen including a rotatable terminal hub advanceable in vasculature, at least one fiber extending from the hub for ablating tissue, and an expandable mechanism connected to the fiber for biasing it into position for precisely ablating tissue as the hub rotates.

Abstract: A laser system for a spectroscopic catheter system uses multiple semiconductor gain media having gain peaks at different wavelengths. The output from the gain media is preferably coupled into single-mode fiber using conventional opto-electronic packaging techniques. As a result, the laser oscillator source has a spectral output that is wider than the gain bandwidth of a single medium to enable it to access the entire spectrum of interest, which is presently in the near infrared. Moreover, the semiconductor gain media can be packaged in a stable and controlled environment for long-term performance.

Abstract: This invention is an improved method and device for treating varicose veins 200 or the greater saphenous vein 202. The method comprises the use of infrared laser radiation in the region of 1.2 to 2.2 um in a manner from inside the vessel 200 or 202 such that the endothelial cells of the vessel wall 704 are damaged and collagen fibers in the vessel wall 704 are heated to the point where they permanently contract, the vessel 200 or 202 is occluded and ultimately resorbed. The device includes a laser 102 delivered via a fiber optic catheter 300 that may have frosted or diffusing fiber tips 308, or that may be provided with a protective spacer. A motorized pull back device 104 may be used, and a thermal sensor 600 may be used to help control the power required to maintain the proper treatment temperature.

Abstract: A method of transluminal laser revascularization of cerebral blood vessels having atherosclerotic lesions by introducing into the affected lumen a microcatheter device composed of a plurality of coaxial microcatheters moveably inserted one into the other and guiding through the catheters a laser-powered lightguide optical fiber, the end face of which is positioned at an optimal distance from the occlusive tissues which are then deteriorated by laser radiation at a relatively high laser power from 20 to 35 W.

Abstract: Systems and methods treat superficial venous malformations, such as spider veins. The systems and methods distribute a light-reactive agent, e.g., verteporfin, at or near an inner wall of a vein. The systems and methods activate the light-reactive agent by applying non-thermal light energy at a wavelength that activates the light-reactive agent to cause localize injury to the inner wall of the vein.

Abstract: An endovascular sheath device for use with a thermal treatment apparatus is provided. The device includes a longitudinal tube which is designed to receive a thermal treatment device and is designed to be inserted into a blood vessel. An ultrasonically visible reinforcement element is disposed along the length of the longitudinal tube. The reinforcement element such as a braided wire provides several functions including increased visibility under ultrasound, clearer identification of sheath tip, and increased durability to protect the fiber from needle punctures during tumescent injections into the perivenous space. The wire reinforcement also increases shaft torquability and kink resistance during sheath insertion and withdrawal.

Abstract: Catheters for performing therapeutic and diagnostic procedures within a body, including human or animal body cavities or lumens, and methods for use. One or more distancing member of the catheter can be used to position a sensor or a therapeutic device a minimum distance from a wall of a lumen or cavity. The catheter can include means for actively or passively controlling or modulating its position within the lumen or cavity during a procedure. Methods for using the catheter include nonocclusive deployment in the human gastrointestinal tract for phototherapy procedures, delivering electromagnetic radiation substantially homogeneously or in a desired pattern to the interior of a lumen.

Abstract: Laser catheter systems include catheters, mandrels, guidewires, and fiber optics configured to reduce or remove occlusions in a lumen or vessel of a patient. Rotation or translation of a mandrel, a guidewire, or a catheter can induce relative rotational or translational movement between the mandrel or guidewire and the catheter body, and can cause the distal end of the catheter body to rotate or traverse off of a central axis, such as a central longitudinal axis of a proximal or unbent portion of the catheter body, so as to cause ablation energy from the optical fibers to move in an arc or path.

Abstract: The use of a collagenase containing formulation for degrading collagen within an occlusive atherosclerotic plaque in a chronic fibrotic occlusion, chronically occluded animal tube or cavity. A medical-related apparatus is provided comprising a medical-related device having provided thereto a therapeutic amount of a collagen degrading composition comprising a proteiolytic enzyme containing formulation. A method is provided for treating chronically occluded animal tubes and cavities by administering a therapeutic effective amount of a proteolytic enzyme-containing formulation adjacent to an occluding atherosclerotic plaque, waiting for a pre-angioplasty waiting period, followed by crossing the plaque with an angioplasty guide wire.

Abstract: Apparatus and methods for stimulating revascularization and tissue growth are provided using an apparatus having a directable end region carrying a tissue piercing end effector. The apparatus optionally includes electrodes for depositing RF energy to form a controlled degree of scar tissue formation, means for delivering a controlled amount of a bioactive agent at the treatment site, or both.

Abstract: Apparatus and methods for performing surgery within an organ or vessel are provided. A catheter is provided having a longitudinal axis and an end region carrying an end effector, the end region movable to a series of positions along the longitudinal axis and with an selectable orientation relative to the longitudinal axis. The catheter includes elements for stabilizing the end region of the apparatus within an organ or vessel, and for counteracting reaction forces developed during actuation of the end effector.