Abstract: A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

Abstract: A catheter for recanalizing a blood vessel having an occlusion therein via a subintimal pathway. The catheter includes a catheter shaft having an inflatable balloon mounted to the distal end portion of the catheter shaft. A flexible tubular member extends from the catheter shaft and along an exterior of the inflatable balloon. Inflation of the inflatable balloon deflects the flexible tubular member into a deflected configuration away from a longitudinal axis of the catheter shaft to effect re-entry into the true lumen distal of the occlusion.

Abstract: An intravascular balloon catheter device is disclosed having an inner member, an outer member disposed about the inner member and further comprising a balloon. A sheath is disposed about the outer member that moves relative to the balloon so as to selectively expose some or all of the balloon for inflation. A clamp may be used to selectively secure the sheath at a desired position relative to the balloon.

Abstract: A balloon catheter including a shaft and an inflatable balloon attached to the shaft, the catheter includes an open sleeve having a proximal end sealingly attached to the catheter shaft and an open distal end. The sleeve surrounds at least part of the balloon. The sleeve and the balloon are arranged such that inflating the balloon expands the sleeve into an expanded state and deflating the balloon when the sleeve is in the expanded state forms an open cavity between the sleeve and the deflated balloon and creates suction to capture and retain debris within the cavity.

Abstract: The present disclosure provides a delivery system for a self-expanding implant which includes a sheath which surrounds and constrains the implant prior to delivery and a confining element which surrounds the sheath during storage. The confining element preferably includes elongate members running axially along the sheath, which compress the sheath and the stent to reduce hoop stress in the system without promoting undesired adhesion between layers of the sheath.

Abstract: Methods, systems and devices for endometrial ablation. In accordance with a method, a working end of an RF ablation device is positioned in a patient uterus to contact endometrial tissue, the working end comprising a dielectric wall capable of non-expanded and expanded shapes. An indicator mechanism is operatively coupled to the wall and configured to indicate non-expanded and expanded shapes of the wall.

Abstract: A method of using a suction device to remove an object from a subject's body includes extending a suction device into the body through a lumen of a medical device and expanding the suction head from a contracted configuration to an expanded configuration within the body. The suction head may be provided at a distal end of an elongate conduit. The method may also include applying suction to move the object into the expanded suction head, and removing the suction device with the object from the body.

Abstract: A medical device and method for detection, retrieval or elimination of disease-associated toxins and biomarkers is provided. A plurality of magnets is arranged within a flexible sheath forming a flexible wire. The magnets are magnetically attached to each other, end-to-end, and arranged with their magnetic polarities alternating in direction. The magnetization direction of each of the magnets is orthogonal to the length axis of the flexible wire. The medical device is completely self-contained and does not require a bulky external field source able to maintain strong magnetic field gradients (100-10,000 T/m) along the wire, and at a radial distance (˜1 mm) to attract magnetic particles throughout the entire vein diameter at a range of physiologic velocities (1-10 cm/sec). This technology is a major step forward for the clinical relevance of CTC analysis to personalized medicine and introduces a powerful generalizable strategy for enrichment of other rare blood biomarkers.

Abstract: A biomimetic actuation device includes a flexible substrate, conformable for disposition about an object, defining an apex and a base, bearing at least one soft actuator configured to change state from a first state to a second state upon introduction of a pressurized fluid to an internal volume of the at least one soft actuator.

Abstract: A medical system for endovascular temperature control of blood and for recanalization of a blood vessel, the medical system having a catheter, a radially compressible treatment device, in particular a recanalization device, which, in the compressed state, is arranged to be longitudinally movable in the catheter and, by being released from the catheter, is radially expandable for the recanalization of the blood vessel, and a temperature control element for controlling the temperature of blood, wherein the treatment device, in particular the recanalization device, can be positioned distally with respect to the temperature control element in such a way that, during use, blood which is temperature-controlled by the temperature control element flows to the recanalization site in the blood vessel.

Abstract: Catheter for delivery of a medical device such as a stent or filter includes an inner tubular member and an outer tubular member movable relative to the inner tubular member. The outer tubular member is disposed at the distal end of the inner tubular member. The inner tubular member includes a fluid lumen defined therein, the fluid lumen having a fluid flow port directed to the exterior surface of the inner tubular member. A pressure chamber is defined by the inner tubular member, the outer tubular member, a proximal seal and a distal seal, and is in fluid communication with the fluid flow port, wherein fluid introduced through the fluid flow port and into the pressure chamber applies a force on the proximal seal to move the outer tubular member in a proximal direction allowing the medical device constrained by the outer tubular member to be released.

Abstract: Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

Abstract: An apparatus and method for implanting and securing an implanted medical device in a recipient. The implantable medical device of the generally includes an electrode assembly that comprises an elongate carrier member having at least one stimulating electrode positioned thereon. The carrier member further has a fixation structure positioned thereon configured to interact with a portion of the rigid structure to longitudinally secure the carrier member in the recipient.

Abstract: A medical balloon includes an outer layer and an inner layer. The outer layer has a surface texture or formation such as a scoring element. The inner layer is made of a reflow material which during production of the balloon from a raw tubing will soften and flow into internal recesses in the outer layer, thereby filling these recesses and providing support to the outer layer formations so as to avoid flattening of these formations during use of the balloon. The balloon can be manufactured in a single formation step from a raw tubing having the outer and inner reflow layer coextruded.

Abstract: A device for irrigation and/or insufflation during endoscopic surgery/procedures in a body cavity, comprising a first fluid pump device to deliver fluid to the body cavity, a second fluid pump device to move fluid from the body cavity, a control unit connected to the first and/or second fluid pump device, a blood pressure measuring device, wherein the control unit derives a control signal based on a signal from the blood pressure measuring device, and sends the control signal to the first fluid and/or second fluid pump device, wherein the control signal is derived by processing the signal from the blood pressure measuring device using a correlation factor in the device, dependent on the relationship between a blood pressure measurement signal, and a perfusion pressure of the body cavity, wherein the first and/or second fluid pump device controls the pressure in the body cavity based on the control unit's control signal.

Abstract: Devices for the isolation of a selected portion of a vessel are described. In some embodiments, the device has an introducer sheath and a sealing catheter that are movable relative to each other to create an isolated volume with adjustable size and location. The methods for the treatment of vascular aneurysms using the devices are described. The treatment is achieved through the delivery of an effective amount of stabilization agent to an isolated volume that encompass the aneurysm. The device optionally has an aspiration device to improve the effectives of the treatment.

Abstract: A method of bariatric embolization includes deploying an intravascular pressure modulating device at a target location, operating the pressure modulating device to reduce pressure within the fundus, and infusing an embolizing agent into the fundus. Use of the pressure modulating device prevents delivery of the embolizing agent into proximal and distal non-target vessels. The method takes advantage of unique flow and pressure dynamics of the arterial vessels in the stomach.

Abstract: Systems and methods for the treatment of perforator veins for venous insufficiency are described. The systems can include a catheter assembly comprising a proximal hub, a spin lock on the proximal hub, a elongate body overmolded to the proximal hub, and a distal end, the catheter, the elongate body configured to be placed within a perforator vein; an extension tubing having a proximal female hub, a distal male hub, and an elongate body therebetween, the distal male hub having a spin lock thereon, the distal male hub configured to be attached to the proximal hub of the catheter assembly; a syringe filled with a volume of media including cyanoacrylate; and an injector configured to automatically dispense a bolus of the media sufficient to coapt the perforator vein from the syringe upon actuation of a control on the injector. Methods are also disclosed.

Abstract: An atherectomy system for removing a stenotic lesion from within a vessel of a patient is disclosed. The system comprising an atherectomy device for reducing the lesion and a separate elongate drainage catheter for evacuating from the treated vessel embolic particles released into the vessel from the stenotic lesion during its reduction by the atherectomy device during an atherectomy procedure. The atherectomy device and the separate elongate drainage catheter are each configured for introduction into the patient's vasculature though separate openings in at least one peripheral artery of the patient.

Abstract: The present invention is a production method for an expansion balloon (2) for use in a balloon catheter (1), including the steps of; forming a balloon tube (8) by extrusion molding so as to have a cross section orthogonal to an axial direction with the shape of a circle on the outside and the shape of a polygon having a circumcircle on the inside; and placing the balloon tube (8) in a mold to perform biaxially-stretched blow molding to obtain the balloon, whereby it is possible to produce the expansion balloon (2) that has no unevenness in film thickness of a straight pipe part (4) and allows stable folding control by simple processes with favorable molding yields.

Abstract: Systems and methods for treating conditions and diseases of the spine are disclosed herein. A device includes a balloon catheter comprising at least one inner lumen incorporated within an elongated shaft; a distal end having an inner balloon positioned inside and completely surrounded by an outer balloon; and a proximal end having an adapter for passage of at least one of an inflation fluid or a medical instrument; and an optical fiber comprising an outer diameter sized to pass through the inner lumen of the elongated shaft; a nonlinear light-emitting portion of a given length, wherein a portion of a cladding material from the nonlinear light-emitting portion has been removed so that light energy may be emitted along the length of the nonlinear light-emitting portion; and a linear elongated portion for guiding light towards the nonlinear light-emitting portion.

Abstract: An extra-luminal ring (1200) includes a structural member (1202), which assumes a first elongate hollow shape (1206) when in a relaxed state; when deformed to a planar state (1208), generally defines a planar shape (1209) having two first sides (1220A, 1220B) parallel to each other, and two second sides (1222A, 1222B) parallel to each other; and when in the relaxed state, is configured such that the two first sides (1220A, 1220B) are generally straight and parallel with each other, and the two second sides (1222A, 1222B) are curved at least partially around a first longitudinal axis (1230) defined by the first elongate hollow shape (1206).

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a woven fabric layer composed of at least two woven fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: An ingestible gastric volume reduction device (100) is provided that is controllably adjustable between an expanded state and a contracted state. A control subsystem within the device is able to selectively transition the device between both states. Such control can be by way of a biological or chemical sensor (102) in the device, a wireless (RF) receiver (104), or timer. Thus activation of the device whether to expand and fill a gastric volume or to contract to open up the gastric volume may be achieved from internal control (within device) or external control (to the device). The device may be used for patient treatment, by administering the device (e.g., through ingestion) to a gastric region and then controllably increasing and/or decreasing the volume of the device during treatment.

Abstract: A recovery device assembly comprises an actuator element and a mechanically radially expandable and contractible recovery device operably connected to the actuator element is provided. The recovery device has proximal and distal toroidal balloon blocking elements and a central portion between the blocking elements. The recovery device is at least partially placeable in a first, radially collapsed configuration and in a second, radially expanded configuration by manipulation of the actuator element. When in the second, radially expanded configuration, the proximal and distal blocking elements have radial dimensions greater than the radial dimension of the central portion thereby at least partially defining a collection chamber at the central portion. Also provided are methods of isolating an organ and recovering blood from an organ that use the recovery device assembly provided.

Abstract: An endovascular microvalve device for use in a vessel during a therapy procedure includes an outer catheter, an inner catheter displaceable within the outer catheter, and a filter valve coupled to the distal ends of the inner and outer catheters. The valve is constructed of a braid of elongate first filaments coupled together at their proximal ends in a manner that the first filaments are movable relative to each other along their lengths. A filter is provided to the braid formed by electrostatically depositing or spinning polymeric second filaments onto the braided first filaments. The lumen of the inner catheter delivers a therapeutic agent beyond the valve. The device is used to provide a therapy in which a therapeutic agent is infused into an organ.

Abstract: Described here are devices and components for use in performing an atherectomy. Generally, the atherectomy devices may have a handle, a cutter assembly, and a catheter or catheter assembly therebetween. The cutter assembly may include a housing and a cutter comprising a proximal cutter and a distal cutter, each of which may be rotated relative to the atherectomy device to cut occlusive material.

Abstract: The present invention utilizes tetherless microtools to biopsy tissue. The invention provides a device and method for deployment and retrieval of tetherless microtools. The size of the microtools ensures that tissue damage at a site targeted for biopsy is negligible. As such, large numbers of microtools may be deployed ensuring that a true statistical sampling of biologic tissue is performed.

Abstract: A catheter balloon exhibiting improved pressure resistance of the entire membrane is formed of a membrane as a laminate of at least two layers including a polyamide elastomer layer and a polyamide layer, in which the polyamide elastomer layer is disposed at the inner side of the polyamide layer, a refractive index nr1 in the circumferential direction of a cross-section perpendicular to the axis in the inner side surface of the polyamide layer is greater than a refractive index nr2 in the circumferential direction of a cross-section perpendicular to the axis in the inner side surface of the polyamide elastomer layer, and the difference between the refractive index nr1 and the refractive index nr2 is 0.01 or greater.

Abstract: A minimally invasive system and method for providing weight loss by inducing the feeling of satiety whereby an intragastric device is inserted into the gastric lumen via the esophagus and an external magnetic device is used as needed to magnetically attract the intragastric device towards the inner wall of the stomach and impart tactile stimulation sufficient to induce the feeling of satiety.

Abstract: Systems, delivery devices, and methods to treat to ablate, damage, or otherwise affect tissue. The treatment systems are capable of delivering a coolable ablation assembly that ablates targeted tissue without damaging non-targeted tissue. The coolable ablation assembly damages nerve tissue to temporarily or permanently decrease nervous system input. The coolable ablation assembly delivers energy through an inner surface of an airway to damage a target region of tissue such that the damaged target region has a maximum cross-sectional width radially separated from the inner surface of the airway.

Abstract: Systems and methods are provided for positioning and stabilizing an external instrument during insertion of the instrument through the oral cavity (e.g., insertion of a catheter through the oral cavity and into the esophagus or cardia for treatment of gastroesophageal reflux disease (GERD)). The systems and methods provide a gripping tool for association with a bite block, capable of selectively moving between an open position in which the instrument may be inserted or removed, and a closed position in which the external instrument is held in a fixed position.

Abstract: To perform pelvic surgery, a directionally illuminating balloon catheter enters a bladder. The catheter has a multi-lumen shaft. The balloon defines an interior fluidically connected to a balloon inflation lumen and is inflated therethrough. The balloon comprises a light source, a light-radiating surface adjacent the shaft-balloon junction, and a substantially opaque surface disposed at a portion of the balloon other than the light-radiating surface such that the integrated light source illuminates a distal half of the environment outside the balloon. The balloon is inflated while in the bladder. Light from the light source is directed out through the light-radiating surface to illuminate at least a portion of a procedure area opposite the bladder-prostate junction. With the light illuminating the portion of the procedure area, at least a portion of a pelvic surgery is performed at the portion of the procedure area.

Abstract: A stent delivery system wherein, in a gap between an inner tube body and an outer tube body, a sealing member is arranged on the proximal side relative to a distal opening of a lumen, which extends from the proximal end of the inner tube body, and a guide wire leading-out hole. The inner circumferential surface of the sealing member is fixed to the outer circumferential surface of a first proximal tube of the inner tube body, and the outer circumferential surface of the sealing member is in sliding contact with the inner circumferential surface of a second proximal tube of the outer tube body. When blood or the like enters into the stent delivery system via the distal ends of the inner tube body and the outer tube body, progress of the blood or the like toward an operating unit side is inhibited by the sealing member.

Abstract: Dermal filler hydrogel compositions, methods of making them, and methods of using them to treat soft tissue conditions, such as wrinkles, are provided. The compositions contain a crosslinked hyaluronic acid-based polymer and one or more additional ingredients, and are stable to sterilization by heat and/or pressure treatment. The additional ingredients include vasoconstrictive agents, antioxidant agents, such as a ascorbic acid agents, and/or anesthetic agents.

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: A deployment mechanism of a tissue-removing catheter includes a socket member received in a catheter body that is capable of moving longitudinally therein, and a ball member extending distally from the distal end portion of the cutting element and operatively connected to the socket member. The ball member is constrained axially relative to the socket member and is capable of pivoting relative to the socket member for allowing pivoting of the cutting element relative to the socket when the cutting element is moved from a retracted position to a cutting position.

Abstract: Methods, systems and devices for endometrial ablation. In accordance with a method, a working end of an RF ablation device is positioned in a patient uterus to contact endometrial tissue, the working end comprising a dielectric wall capable of non-expanded and expanded shapes. An indicator mechanism is operatively coupled to the wall and configured to indicate non-expanded and expanded shapes of the wall.

Abstract: Renal function may be modulated by an implantable device having one or more leads or catheters disposed near the kidney via the lymphatic system. In one embodiment, lymphatic drainage from the kidney is modulated to increase or decrease tubular reabsorption of salt and water. The renal function modulation therapy may be delivered in an open-loop or closed-loop fashion, with the latter dependent upon a physiological variable such as blood pressure or cardiac output.

Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon can have a composite structure with a non-conductive section and a conductive section. A method for fabricating a semi-permeable ablation balloon using ionizing radiation and an etching process is also disclosed.

Abstract: Apparatus and methods are described, including a method for treating a paranasal sinus of a subject. The method includes forming an artificial hole in a wall of the paranasal sinus, and, via the artificial hole, opening a natural ostium of the paranasal sinus. Other applications are also described.

Abstract: Methods, devices and systems are described for treating venous insufficiency in which the vein is compressed at least partially along a treatment zone. A system can be provided including an injection device, such as a glue gun, that is operably connected to a delivery catheter that can be advanced across a treatment zone in the vein. The delivery catheter can be used to deliver one, two, or more boluses of media (e.g., cyanoacrylate) to occlude the vein along different spaced-apart sections of the treatment zone. External compression can also be applied to the vein by a compression element, such as a hand or multifunctional ultrasound transducer, to occlude portions of the vein along the treatment zone prior to or during the introduction of the boluses of media.

Abstract: A stent delivery catheter including a catheter tubing defining a lumen therethrough, a balloon disposed near a distal end of the catheter tubing and moving between deflated and inflated states, and proximal and distal balloon control bands concentrically arranged around respective proximal and distal end portions of the balloon. The proximal balloon control band has a proximal end located proximally of a proximal end of the balloon and a distal end located adjacent a proximal end of a received unexpanded stent. The distal balloon control band has a proximal end located adjacent a distal end of the received unexpanded stent and a distal end located distally of a distal end of the balloon. The balloon control bands each have a diametric cross-section larger than the balloon in an uninflated state and the unexpanded stent received over the balloon to impede axial movement of the unexpanded stent off of the balloon.

Abstract: A medical device is disclosed. The medical device may include an elongate member having a proximal end and a distal end an expandable end effector assembly extending distally from the distal end of the elongate member. The end effector assembly may include a plurality of end effector units each having an injector for simultaneously delivering material into tissue.

Abstract: The feeding tube system includes an elongated shaft having a proximal portion, an opposing distal portion, and a central opening or lumen extending therethrough. The proximal portion is configured to remain outside a patient's body cavity and includes a first opening through which fluids can be introduced into the lumen. The distal portion is configured for disposing within a patient's body cavity and includes a second opening for discharging fluids from the lumen into the patient's body cavity. An interior retention balloon is provided at the distal portion of the elongated shaft. An external base positioned at the proximal portion of the feeding tube can include at least one exterior base balloon extending therefrom. The interior retention balloon and the at least one exterior base balloon are inflatable.

Abstract: An expandable medical balloon useful for treatment at a vessel bifurcation, the balloon having at least one expanded state, the balloon having at least one inner layer and at least one outer layer, the outer layer having at least one cavity therein through which the inner layer protrudes when the balloon is in its at least one expanded state, and methods of making and using the same.

Abstract: A system and method for inflating an inflatable device is disclosed. The system includes an inflation cylinder configured to hold a gas mixture under pressure, a heating element configured to selectively heat the gas mixture and a temperature sensor configured to measure a temperature of the gas mixture. A control module is coupled to the heating element and the temperature sensor. The the control module controls heating of the gas mixture based on the measured temperature, a mass of the gas mixture and a volume of the inflation cylinder.

Abstract: A bone filling device includes a catheter that defines a longitudinal axis and extends between a proximal end and a distal end. A first lumen extends along the longitudinal axis of the catheter and defines a first passageway. A second lumen extends along the longitudinal axis of the catheter and defines a second passageway. An inflatable body includes a wall that defines a fillable cavity. The fillable cavity is in fluid communication with the first passageway. A bone filler delivery port is continuous with the second passageway and is configured to dispense bone filling material.

Abstract: Catheter for delivery of a medical device such as a stent or filter includes an inner tubular member and an outer tubular member movable relative to the inner tubular member. The outer tubular member is disposed at the distal end of the inner tubular member. The inner tubular member includes a fluid lumen defined therein, the fluid lumen having a fluid flow port directed to the exterior surface of the inner tubular member. A pressure chamber is defined by the inner tubular member, the outer tubular member, a proximal seal and a distal seal, and is in fluid communication with the fluid flow port, wherein fluid introduced through the fluid flow port and into the pressure chamber applies a force on the proximal seal to move the outer tubular member in a proximal direction allowing the medical device constrained by the outer tubular member to be released.

Abstract: A catheter is provided for retrieving an embolus or foreign body from a body lumen. The catheter can have a distal segment which is movable from a reduced outside diameter for positioning at a target site. Further, the catheter can have an enlarged outside diameter suitable for thrombectomy or foreign body retrieval.