Abstract: The present invention provides a stretchable material suitable for use in an inflatable medical device. The stretchable material has at least one reinforcing polymer layer with a top and bottom side forming a porous matrix which is imbibed with a sealing material to infiltrate and substantially seal spaces of the porous matrix and extend beyond the reinforcing polymer layer to form a surface coating.

Abstract: A medical device to be inserted in a defect blood vessel, body cavity, or body duct for treatment thereof is disclosed, wherein it comprises an essentially cylindrically formed elongated resilient sheath device (2) wherein it has a distal end (3) and a proximal end (4), wherein said sheath device (2) along its circumferential surface in the axial direction is provided with a slotted opening (5) having connection with a first bore (6) arranged in the axial direction of said sheath device (2), said first bore (6) having the ability to house an elongated fiber body (7), wherein said sheath device (2) has the ability to be clamped around a major part of the perimeter of said fiber body (7), and wherein said sheath device (2) in its axial direction also is provided with a second bore (8) having the ability to house an injection means (9), as well as a kit containing said medical device, and a method for treatment of defective blood vessels, body cavities, and body ducts by use of said medical device.

Abstract: Pharmaceutical preparations, compositions, systems, and devices including medical devices and diagnostic or therapeutic agents, and methods to treat disease by modification of local tissue environment to modulate the therapeutic index of locally or systemically delivered therapeutic or diagnostic agents. Improved ability to reduce sympathetic nerve activity in the adventitia and perivascular tissues around arteries and veins in the body. Modulation of the local tissue environment around an artery to enable more effective denervation with or without a therapeutic agent. Modulation may include adjustment of the pH of the tissue.

Abstract: An apparatus, including a flexible insertion tube having a distal end for insertion into a body cavity, and first and second conduits configured to deliver first and second fluids, respectively, to the distal end. The distal end includes a first balloon coupled to the first conduit so that the first fluid inflates the first balloon and is delivered, via one or more spray ports in the first balloon, to tissue in the body cavity, a second balloon contained within the first balloon and coupled to the second conduit so that the second fluid inflates the second balloon, and multiple splines including a flexible, resilient material and extending along a longitudinal axis of the distal end, and configured to constrain the second balloon so that inflation of the second balloon creates lobes that form, along the longitudinal axis between the lobes, channels that direct the first fluid to the spray ports.

Abstract: An apparatus includes a delivery catheter having a deployable dynamic valve that dynamically opens and closes in response to relative fluid pressure thereabout, particularly while in an anatomical lumen. The valve is maintained in a collapsed configuration during introduction to a treatment site. The valve is adapted to automatically move from the collapsed configuration to a deployed configuration at the treatment site.

Abstract: Devices, systems, and methods for assessing contact between a treatment element and an area of target tissue using resistive-type and/or capacitive-type contact sensing elements. In one embodiment, a medical system for determining tissue contact includes an elongate body including a distal portion and a proximal portion and a treatment element coupled to the elongate body distal portion. The treatment element may have a first expandable element, a second expandable element, the first expandable element being within the second expandable element, and at least one contact sensing element between the first and second expandable elements. In one example, the device may include a plurality of contact sensing elements arranged in a matrix or in a plurality of linear configurations. In another example, the device may include a layer of conductive microparticles or a contact-sensing film.

Abstract: A device is described for treating a nasal airway by modifying a property of a nasal tissue of or near a nasal valve of the airway, without using a surgical incision or an implant, to decrease airflow resistance or perceived airflow resistance in the nasal airway. Various embodiments include an elongate shaft, a bipolar radiofrequency delivery member extending from one end of the shaft, and a handle attached to the elongate shaft at an opposite end from the radiofrequency delivery member. The radiofrequency delivery member is sized to be inserted into a nose and configured to at least temporarily deform the nasal tissue and deliver radiofrequency energy. The radiofrequency delivery member includes two rows of protruding electrodes disposed on a tissue contact surface, and the device is configured to deliver radiofrequency energy from one row of electrodes to the other row of electrodes.

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 obstruction removal device is described, having one or more engaging members which can engage portions of the clot. The one or more engaging members have a collapsed, delivery state, and an expanded, deployed state which in some embodiments can be locked to maintain its fixed configuration.

Abstract: There is provided a microcatheter having a proximal solution lumen and a distal tip portion with a guidewire lumen. The microcatheter and methods of use thereof allows for introduction of solution into a vessel while manipulating the guidewire and/or the microcatheter itself. The solution may be a contrast solution, for viewing of the vessel, a therapeutic or diagnostic solution, or any other type of solution.

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: Systems, methods, and devices are provided for the treatment of edema. In one aspect a method for implanting an indwelling catheter within a vein of a patient is provided. The catheter can extend from a position upstream of at least one outflow port of a duct of the lymph system to a terminal position downstream of the at least one outflow port. In use, a first restriction can be created within the vein proximal to a distal region of the catheter. The first restriction can define a localized low pressure zone distal of the restriction and within a portion of the vein housing the catheter. The low pressure zone can be adjacent to the at least one outflow port to enable fluid to pass from the at least one lymph duct outflow port into the vein.

Abstract: Systems, methods, and devices are provided for the treatment of edema. In one aspect a method for implanting an indwelling catheter within a vein of a patient is provided. The catheter can extend from a position upstream of at least one outflow port of a duct of the lymph system to a terminal position downstream of the at least one outflow port. In use, a first restriction can be created within the vein proximal to a distal region of the catheter. The first restriction can define a localized low pressure zone distal of the restriction and within a portion of the vein housing the catheter. The low pressure zone can be adjacent to the at least one outflow port to enable fluid to pass from the at least one lymph duct outflow port into the vein.

Abstract: The group of inventions relates to the field of aesthetic, plastic and reconstructive cosmetology/medicine, and more particularly to meso threads used for remedying aesthetic and age-related changes to the skin, and to methods for producing such threads. Proposed is a multicomponent meso thread consisting of a core and a shell. The core is realized in the form of a fibroin thread, and the shell contains hyaluronic acid or a salt thereof or a polyelectrolyte complex of hyaluronic acid or a salt thereof and chitosan or a salt thereof. Also proposed are a variant of the thread having a plastifying agent in the shell, and methods for producing the proposed meso threads.

Abstract: Devices, systems, and methods for specializing, monitoring, and/or evaluating therapeutic nasal neuromodulation are disclosed herein. A targeted neuromodulation system configured in accordance with embodiments of the present technology can include, for example, an evaluation/modulation assembly at a distal portion of a shaft and including a plurality of electrodes. The electrodes are configured to emit stimulating energy at frequencies for identifying and locating target neural structures and detect the resultant bioelectric properties of the tissue. The system can also include a console that maps locations of the target neural structures. The evaluation/modulation assembly can then apply therapeutic neuromodulation energy in a highly tailored neuromodulation pattern based on the mapped locations of the target neural structures. Accordingly, the system provides therapeutic neuromodulation to highly specific target structures while avoiding non-target structures to reduce collateral effects.

Abstract: Methods and apparatus are provided for applying an fragment of a neurotoxin such as the active light chain (LC) of the botulinum toxin (BoNT), such as one of the serotype A, B, C, D, E, F or G botulinum toxins, via permeabilization of targeted cell membranes to enable translocation of the botulinum neurotoxin light chain (BoNT-LC) molecule across the targeted cell membrane to the cell cytosol where a therapeutic response is produced in a mammalian system. The methods and apparatus include use of catheter based delivery systems, non-invasive delivery systems, and transdermal delivery systems.

Abstract: Disclosed embodiments include devices and methods for shaping, bending, and/or volumetrically reducing rigid cartilaginous structures, such as hyaline cartilage in the septum. In the case of septal cartilage, shaping, bending, or reducing the cartilage would be useful for reducing nasal obstruction or to improve the cosmetic appearance of the nose.

Abstract: An access catheter provides access for a large bore stiff therapeutic catheter across the atrial septum from above via the superior vena cava. The access catheter has an expandable member that direct a delivery tube outwards in a radial direction to place a delivery tube opening into direct contact with the fossa ovalis. The braided expandable member allows blood flow to pass when it is expanded; the expandable member provides support against the opposite wall of the right atrium. A hollow dilator tube enters the delivery tube to form a tenting shape to the fossa and a guidewire is passed across the fossa ovalis. Standard procedure allows delivery of the therapeutic catheter over the guidewire.

Abstract: Distal tip designs for bone fixation devices are disclosed. In some embodiments, a system for bone fixation includes a delivery catheter having a proximal end and a distal end; an expandable member having a proximal region and a distal region, wherein the expandable member is releasably attached about the distal end of the delivery catheter at the proximal region of the expandable member; a distal cap attached to the distal region of the expandable member to seal the expandable member; a light conducting fiber; and a light-sensitive liquid; wherein the delivery catheter has an inner void for passage of a light-sensitive liquid into the expandable member to expand the expandable member and an inner lumen for passage of the light conducting fiber into the expandable member to cure the light-sensitive liquid inside the expandable member.

Abstract: Disclosed herein are designs for improved inflatable structures for use during minimally invasive cardiovascular procedures. These inflatable structures facilitate the perfusion of blood through an anatomical structure, such as a heart valve, during the cardiovascular procedure. The inflatable structures are formed of a plurality of balloons arranged radially around a central location. The plurality of balloons form a lumen through which blood flows. Each balloon of the plurality is shaped or configured to stabilize the adjacent balloons, limiting their movement relative to each other. For example, some embodiments can feature balloons with a keystone shape that limits movement of the balloons inward toward the lumen. Some implementations can also include a support coil running through the lumen. The support coil holds enables the lumen to be open to perfusion even in the early stages of balloon inflation.

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: A constraining structure for use with a balloon catheter can include multiple longitudinal struts and multiple, sinusoidal shaped radial rings. The constraining structure can expand to form a pattern of channels including substantially square windows. The constraining structure can modify, restrict, and control a shape and/or size of the balloon when inflated. Inflating the balloon catheter within the constraining structure can provide nonuniform pressure on a vessel wall adjacent the balloon.

Abstract: An object of the present invention is to provide a method of joining resin tubes, in which the degree of freedom of selecting a tube material is large, and further a defect such as stiffness and contraction at joining portions of the tubes is not developed. The method of joining resin tubes according to the present invention is a method of joining resin tubes so that a first tube is joined to a second tube, the first tube and the second tube each being made of synthetic resin, the method comprising: a surface activation step of activating each of a joining region of the first tube and a joining region of the second tube; and an adhesion step of adhering the joining region of the first tube obtained via the surface activation step with the joining region of the second tube obtained via the surface activation step to each other.

Abstract: This disclosure describes embodiments of a kit and its constituent components which together form an apparatus in which fluid communication between a medical device's lumen and the surrounding environment is provided by a conduit cooperatively defined by the medical device and a tubular member into which the device is inserted. The medical device and tubular member are configured to fit together such that an outer surface of the distal region of the medical device cooperates with an inner surface of the tubular member to define the conduit between the side-port of the medical device and a distal end of the tubular member. The conduit is operable to be used for injecting fluid, withdrawing fluid, and measuring pressure, for example. Methods of assembling and using the apparatus are described as well.

Abstract: Assemblies and methods for scoring a stenotic region within a vessel of a patient are disclosed. An assembly can comprise a scoring member and a deployment member. The scoring member can include an elongate push structure and a tubular, self-expanding scaffold. The elongate push structure can be positioned proximal of the self-expanding scaffold and, at its distal end portion, eccentrically coupled with a proximal end portion of the self-expanding scaffold. The deployment member can be removably positioned within a central lumen of the self-expanding scaffold and detachably engageable with a portion of the self-expanding scaffold. The self-expanding scaffold can be movable between a downsized configuration, when receiving axial tension from the deployment member, and an expanded configuration, in the absence of axial tension.

Abstract: Deployment devices include a locking mechanism configured to secure a medical device to the deployment device. Methods of operating a deployment device include securing a medical device positioned at least partially within at least one cannula of the deployment device with a locking mechanism and releasing the medical device and securing at least a portion of the at least one cannula of the deployment device with the locking mechanism.

Abstract: Devices, methods and systems for removing unwanted tissue from within a patient's vasculature system are provided. Specifically, a laser ablation catheter having a tip with an open, arched-shaped cross section is described. The cross section of the tip enhances the catheter's ability to ablate, separate, and/or dilate the various layers within a patient's vasculature, thereby facilitating the removal undesirable lesions and fibrous tissue within a patient's vasculature.

Abstract: Methods and devices described herein facilitate diaphragm entry for posterior access of body organs.

Abstract: A multiwavelength laser-based intense light source is described having applications in incision, excision and ablation of soft tissues with minimal collateral tissue damage. The light source combines the output of a plurality of relatively low power laser sources, emitting radiation in the region of the electromagnetic spectrum bounded by approximately 350 nm to 450 nm, where the combined output may be coupled into a single fiber optic energy delivery device: a standard surgical probe. Spectral and spatial beam combining are used to produce an incoherent light source with relatively low average power at any given wavelength, but with high total power and superior M2 beam quality, targeting multiple chromophores in target tissue and tissue breakdown product chromophores for consistently high and target absorption without indiscriminant char interference throughout a surgical procedure.

Abstract: Catheters or other tubular devices and methods for using them to perform a medical procedure are provided. In an exemplary embodiment, a tubular device includes an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a lumen extending between the proximal and distal ends; an expandable member on the distal end comprising an outer impermeable membrane with an inner surface surrounding a substantially enclosed interior space; and a fiber network within the interior space coupled to the inner surface and configured to limit expansion of the membrane when inflation media is directed into the interior space from the lumen to expand the membrane to an expanded configuration.

Abstract: Methods and devices for treating nasal airways are provided. Such devices and methods may improve airflow through an internal and/or external nasal valve, and comprise the use of mechanical re-shaping, energy application and other treatments to modify the shape, structure, and/or air flow characteristics of an internal nasal valve, an external nasal valve or other nasal airways.

Abstract: Methods for diagnosing sleep apnea are provided herein. In at least one example, a method may be provided including receiving airway image data from a remote end imaging sensor coupled to a nasal tube disposed within an upper airway above a constriction point, and analyzing the airway image data and displaying in a sleep study report the airway image data to identify airway closures related to obstructive sleep apnea.

Abstract: A catheter including an outer tube; a first inner tube disposed within the outer tube; a second inner tube disposed within the outer tube and parallel to the first inner tube, and having an insertion opening at its proximal end and a distal end opening at its distal end; and a first core wire and a second core wire disposed between the first inner tube and an outer tube. The second inner tube extends from a medial region of the catheter to a distal end of the catheter. A distal end of the first core wire is located distal to the insertion opening of the second inner tube, and a distal end of the second core wire is located proximal to the insertion opening of the second inner tube. The second core wire can move between the outer tube and the first inner tube.

Abstract: Heart valve delivery systems and methods for providing a clinician with feedback during a stented prosthetic heart valve delivery procedure. Feedback is provided using piezochromatic indicators incorporated into elements of the delivery device, such as the handle assembly, shaft assembly and capsule to indicate when detrimental forces, or forces nearing those that are detrimental, are being applied to the delivery device during the prosthetic heart valve loading, delivery or deployment procedure. Other embodiments incorporate a feedback indicator to indicate that a delivery device has previously been used and is not in a new condition.

Abstract: Devices, systems, and methods for degassing fluid prior to applying fluid to a treatment site during ablation therapy are provided. In one embodiment, an ablation system can include an elongate body, an ablation element, a heating assembly, and a fluid source. Fluid in the fluid source can be at least partially degassed prior to being provided as part of the system, or, in some embodiments, a degassing apparatus can be provided that can be configured to degas fluid within the system prior to applying the fluid to the treatment site. The degassing apparatus can include one or more gas-permeable and fluid-impermeable tubes disposed therein, which can allow gas to be removed from fluid passing through the apparatus. Other exemplary devices, systems, and methods are also provided.

Abstract: One embodiment provides a balloon catheter which has an inner tube having a main lumen and an outer tube which forms an expansion lumen. A part of the inner tube is connected to the outer tube at a position closer to the proximal end than a balloon, a side hole is open at the connection section, and a weak section is provided to the inner tube a position closer to the distal end than the side hole. The weak section has lower rigidity than the remaining portion of the inner tube. When the balloon is expanded by fluid supplied to the expansion lumen, the weak section is pressed by the fluid pressure to thereby close the main lumen of the inner tube.

Abstract: Devices, systems, and methods for degassing fluid prior to applying fluid to a treatment site during ablation therapy are provided. In one embodiment, an ablation system can include an elongate body, an ablation element, a heating assembly, and a fluid source. Fluid in the fluid source can be at least partially degassed prior to being provided as part of the system, or, in some embodiments, a degassing apparatus can be provided that can be configured to degas fluid within the system prior to applying the fluid to the treatment site. The degassing apparatus can include one or more gas-permeable and fluid-impermeable tubes disposed therein, which can allow gas to be removed from fluid passing through the apparatus. Other exemplary devices, systems, and methods are also provided.

Abstract: The reconstrainment band includes a hollow generally tubular shaped band having proximal and distal ends and having an exterior surface for engaging a stent and an interior surface for engaging a delivery tube. The exterior surface has at least one fin projecting therefrom along the longitudinal axis of the band. The fin has at least one obtusely shaped surface relative to the longitudinal axis and facing one of the ends. The reconstrainment band is included in a delivery device for intraluminally positioning and deploying a radially distensible stent. Reconstrainment of a partially deployed stent is provided by the delivery device.

Abstract: Disclosed herein are embolism protection devices that may be deployed in the peripheral arterial system for the collection of loosened or floating debris, such as embolic material dislodged during or thrombi formed as a result of a peripheral intervention, such as an angioplasty, stenting, or atherectomy. The disclosed embolism protection devices are designed to be inserted distal to lesion in a lower limb artery via one of the arteries of the foot, such as the dorsalis pedis, posterior tibialis, or peroneal (fibular) artery, and they include a compliant mesh portion supported by a compliant wire support member, and the compliant mesh portion extends to form or couples to a solid catheter portion that extends out of the body during use, and that may be coupled to a stopcock or syringe for removal of debris.

Abstract: Various systems and methods are provided for reducing pressure at an outflow of a duct, such as the thoracic duct or the lymphatic duct, for example, the right lymphatic duct. A catheter system can be configured to be at least partially implanted within a vein of a patient in the vicinity of an outflow port of a duct of the lymphatic system. The catheter system includes first and second selectively deployable restriction members each configured to be activated to at least partially occlude the vein within which the catheter is implanted and to thus restrict fluid within a portion of the vein. The catheter system includes an impeller configured to be driven by a motor to induce a low pressure zone between the restriction members by causing blood to be pumped through the catheter when the restriction members occlude the vein.

Abstract: Various systems and methods are provided for reducing pressure at an outflow of a duct, such as the thoracic duct or the lymphatic duct, for example, the right lymphatic duct. A catheter system can be configured to be at least partially implanted within a vein of a patient in the vicinity of an outflow port of a duct of the lymphatic system. The catheter system includes first and second selectively deployable restriction members each configured to be activated to at least partially occlude the vein within which the catheter is implanted and to thus restrict fluid within a portion of the vein. The catheter system includes an impeller configured to be driven by a motor to induce a low pressure zone between the restriction members by causing blood to be pumped through the catheter when the restriction members occlude the vein.

Abstract: A catheter includes a catheter body having a proximal end, a beveled distal end, and a lumen therethrough. The beveled distal end defines an elliptical port for releasing contrast or other media through the lumen and from the elliptical port. The catheter may also be used delivering devices or for aspirating or extracting materials from the vasculature or other body lumens. A fixed guidewire extends distally from the distal end of the catheter body, typically from the distal-most edge of the elliptical port. The fixed wire is typically malleable so that it can be manually formed into a desired shape. The elliptical port may be flat or concave.

Abstract: Methods for modifying a physical characteristic of finished endodontic instruments made from one or more superelastic alloys is described which include heat treating one or more finished endodontic instruments in a salt bath for a specific time (e.g., from about four hours to about six hours), at a specified temperature (e.g., from about 475° C. to about 550° C.), and preferably at a specified pH range.

Abstract: An aortic occlusion device includes a catheter and a balloon mounted along the catheter, wherein the balloon is a narrow profile balloon. The narrow profile balloon comprises an anchored end fixed to the catheter, a movable end distal to the fixed end, a wall extending between the anchored end and the movable end, an inflatable tube located proximate along the wall and circumscribing the wall, and at least one tension wire attached to the movable end and extending through the catheter such that the at least one tension wire is accessible to move the movable end of the balloon towards the anchored end when the catheter is positioned in the aorta.

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: 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: 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.