Abstract: A non-compliant fiber-reinforced medical balloon comprises a first fiber layer and a second fiber layer embedded in a continuous matrix of thermally-weldable polymer material defining a barrel wall, cone walls and neck walls. The fibers of the first fiber layer run substantially parallel to one another and substantially parallel to the longitudinal axis. The fibers of the first fiber layer have a pattern of different lengths and are divisible into a first group and a second group based on length.

Abstract: Systems and methods for restructure and stabilization of bones that provide an anti-microbial effect are disclosed herein. A device includes a delivery catheter having an inner void for passing at least one light sensitive liquid, and an inner lumen; an expandable member releasably engaging the distal end of the delivery catheter; at least one channel positioned in the expandable member; and a light conducting fiber sized to pass through the inner lumen of the delivery catheter and into the expandable member, wherein, when the light conducting fiber is in the at least one channel, the light conducting fiber is able to disperse light energy to provide an anti-microbial effect. When the light conducting fiber is in the expandable member, the light conducting fiber is able to disperse the light energy to initiate hardening of the light sensitive liquid within the expandable member to form a photodynamic implant.

Abstract: Outer jacket embodiments for reinforcing liquid core laser ablation catheter embodiments discussed herein may be used to improve the robustness of the laser ablation catheter embodiments. Method embodiments for making reinforced laser ablation catheters having outer jackets are also discussed.

Abstract: Diffusion and infusion resistant implantable devices and methods for reducing pulsatile pressure are provided. The implantable device includes a balloon implantable within a blood vessel of a patient, e.g., the pulmonary artery. The balloon is injected with a fluid mixture comprising a constituent fluid(s) and a diffusion-resistant gas to provide optimal balloon volume and limit fluid diffusion throughout multiple cardiac cycles. The fluid mixture may be pressurized such that the balloon is transitionable between an expanded state and a collapsed state responsive to pressure fluctuations in the blood vessel.

Abstract: To provide a bioabsorbable stent including: a first tubular unit containing a plurality of cells coupled to each other, each of the cells formed from substantially linear parts and a substantially circular arc part and having a substantially U shape which opens to one end in the axial direction of the stent; and a second tubular unit having the same shape as that of the first tubular unit, the second tubular unit containing a plurality of cells each of which has a substantially U shape which opens to a direction opposite to the opening direction of the opposing first cell. The first tubular unit and the second tubular unit are alternately arranged in sequence to surround a central axis of the stent. Coupling members couple substantially linear parts in some of the opposing cells in the respective neighboring tubular units.

Abstract: A safety balloon catheter includes a catheter having a stretch valve, a connector, a balloon inflated with an inflation fluid, a hollow inflation lumen extending through the catheter to the balloon and conveying inflation fluid thereto and therefrom, a hollow second lumen, and a balloon drainage port fluidically connecting the balloon to the second lumen. The stretch valve has a hollow base fixed in the second lumen at a proximal catheter end and shaped to permit a fluid therethrough and a hollow plug slidably positioned in the second lumen at a given distance from the base to, in a steady state, prevent inflation fluid from passing through the drainage port and, when actuated, slide within the second lumen to permit inflation fluid to pass through the drainage port and into the second lumen. The connector connects the base and the plug and has a length greater than the given distance.

Abstract: There is provided an apparatus for extraction of at least one object from a cavity. The apparatus includes a sleeve including an inflatable section configured to surround the at least one object during inflation; a handle configured to enable a user to hold the sleeve, the handle defining a holding edge of an opening at a first portion of the sleeve; and a handle-mount mounted to a peripheral area around the opening, the handle-mount being for attachment of a pump used for inflating the inflatable section. There is also provided a pressure limitation apparatus configured to operate with a birth assistance device when attached via a conduit.

Abstract: Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Abstract: A medical device includes an expandable conduit, a prosthetic heart valve and a delivery device, including a balloon catheter. The expandable conduit may include one or more inner or outer sleeves supported by a frame or stent. The sleeve(s) may be a bioprosthetic tissue wrapped, molded or sewn about the frame or stent. Coupled to an end of the expandable conduit is the prosthetic heart valve. The conduit and heart valve may be crimped on the balloon catheter for percutaneous deployment. The frame may be constructed of an expandable material for the conduit portion and an expandable material for the prosthetic heart valve portion. The prosthetic heart valve can be anchored at the native heart valve and then the conduit can be expanded into place to protect the aorta.

Abstract: An apparatus for the treatment of acid reflux disease has an implantable movement restriction device adapted to be at least partly invaginated by a patient's stomach fundus wall. A substantial part of the outer surface of the movement restriction device is adapted to rest against the stomach wall without injuring the latter in a position between the patient's diaphragm and at least a portion of the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient's stomach towards the patient's diaphragm is restricted, to thereby prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax, so as to maintain the supporting pressure against the patient's cardia sphincter muscle exerted from the patient's abdomen. The movement restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm.

Abstract: Remodeling of body tissue using a bioabsorbable implant that maintains or otherwise mechanically assists a more permanent implant or other treatment take, for example, by the treatment causing fibrosis. For example, the apparatus and methods can be used for hernia, organ prolapse and cosmetic purposes, such as breast and face lifts.

Abstract: Configurations are described for assisting in the execution of a percutaneous procedure while protecting the vascular pathway to the operational theater, which may comprise diseased tissue. A railed sheath may be controllably expandable and collapsible, and may comprise two or more elongate rail structures configured to assist in the distribution of loads to associated diseased tissue structures, while also contributing to the deployment of percutaneous tools by maintaining alignment of such tools with the railed catheter and associated anatomy.

Abstract: Apparatus for rupturing muscle fibres in a lower oesophageal sphincter comprises a balloon catheter. A multi-electrode impedance planimetry measuring system comprising a pair of stimulating electrodes and sensing electrodes is located on the catheter within the balloon for monitoring the diameter of the balloon when the balloon is inflated with a liquid saline solution from a reservoir through a flowmeter under the control of a microprocessor. The microprocessor computes the minimum diameter value from signals read from the sensing electrodes each time the cumulative volume of the liquid saline solution in the balloon increases by a predefined unit volume. The microprocessor computes a curve of a plot of the minimum diameter values against the corresponding cumulative volume values and determines the slope at each computed minimum diameter value. Rupture of the muscle fibres of the sphincter is determined at the point of inflection of the curve.

Abstract: An embolectomy device includes a pair of elongate spine members extending in a substantially parallel configuration along a longitudinal axis of the device, a first plurality of clot engaging structures having first ends attached to a first one of the spine members and second ends attached to other one of the spine members, and a second plurality of clot engaging structures having first and second ends attached to the respective first and second spine members offset 180° from the first plurality of attached clot engaging structures, such that, when the embolectomy device is unsheathed within in a blood vessel alongside a clot, one of the first and second plurality of the clot engaging structures contact and compress against a wall of the blood vessel to provide a biasing force to facilitate engagement of the other one of the first and second plurality of the clot engaging structures with the clot.

Abstract: The vascular occlusion balloon catheter has a balloon, a main lumen, and a balloon expanding lumen. The balloon catheter has an air discharge passage. The air discharge passage has a distal end opening located at a position distal from the balloon and a proximal end communicating with an inner portion of the balloon. The distal end opening of the air discharge passage is positioned inside a portion disposed proximally from a distal end of the balloon catheter. The air discharge passage communicates with the main lumen at the distal end opening of the air discharge passage. The area of a cross section of the air discharge passage orthogonal to an axial direction of the balloon catheter is set to 200 ?m2 to 450 ?m2. The length of the air discharge passage is set to 1.0 to 3.0 mm.

Abstract: A device and method to treat an overgrowth of yeast in a body cavity and inflammatory and/or hemorrhagic conditions of a body cavity. The device comprising a shell, removal means, and a freezable filler contained in a chamber within the shell. When the filler is frozen and the device inserted into the body cavity, the shell cools the body cavity to a temperature that inhibits the replication of yeast and provides relief to symptoms. An external cooling component extending from the shell provides cooling at the body cavity opening. An expandable bladder in the shell provides tamponade treatment for body cavity hemorrhaging.

Abstract: An volume filling device for treatment of obesity is placed outside the stomach wall of the patient to reduce the inner volume of the stomach, thereby affecting the patient's appetite. By providing the volume filling device outside the stomach wall, contact with stomach acids is avoided, thereby increasing the life of the device.

Abstract: An apparatus for use in a stomach of a subject includes a balloon adapted for placement in the stomach and having an opening to an interior of the balloon, an internal tube in the interior of the balloon with a proximal end coupled to the opening of the balloon, and an inflation tube. The inflation tube has a distal end in the interior of the balloon and a proximal end that can receive a fluid on an exterior of the balloon. The inflation tube can stretch from the stomach to a mouth of the subject to facilitate inflation of the balloon and has a resting position that is substantially within the interior of the balloon. The internal tube is disposed around at least a portion of the inflation tube that is in the interior of the balloon.

Abstract: A stent device includes generally cylindrical rings aligned along a longitudinal axis, and interconnected by interconnecting members. Each interconnecting member includes a first coupling end, a second coupling end, and an elongate portion therebetween. The first coupling end, the elongate portion, and the second coupling end combine in either a first orientation or a second orientation, which are substantially mirror images. For each interconnecting member, the first coupling end can intersect with a midpoint of a transition region of a substantially repeating curved segment on one of the rings, and the second coupling end can intersect with a midpoint of a curved segment of a different and immediately adjacent ring. The interconnecting members can be arranged in rows extending longitudinally along the device. Along each row, consecutive interconnected members alternate between the first orientation and the second orientation. A cover may be provided over the stent device.

Abstract: The present disclosure pertains to assemblies, devices and systems for shockwave generation and to methods of using the same.

Abstract: Devices and methods for treating obesity are provided. More particularly, intragastric devices and devices for inflating and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.

Abstract: Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.

Abstract: Described is a needle for subcision procedures having a concave cutting tip comprising two or more cutting edges wherein the concave cutting tip is at the cutting end of a shaft of the needle and wherein a handle is disposed at an angle relative to the axis defined by the center of the shaft of the needle. The cutting edges may be sharp interior edges within the circumference of the needle.

Abstract: An adjustable implant is disclosed herein. The adjustable implant may comprise a shell including membrane and a base and having a first diameter in a plane parallel to the base. A band may be disposed within the shell. The band may have a first end and a second end connected to a spool. The band may be in a round (e.g., elliptical) configuration having a second diameter in the plane that is less than the first diameter. By wrapping the band onto the spool, the diameter of the band may be decreased and the height of the implant may be increased. By unwrapping the band from the spool, the diameter of the band may be increased and the height of the implant may be decreased.

Abstract: A balloon catheter includes a one-piece extrusion having inner and outer tubular walls, where the inner tubular wall defines a wire guide lumen, and a clearance extending between the inner and outer tubular walls forms an inflation lumen. A balloon is attached to the outer tubular wall and to the inner tubular wall, such that the inflation lumen is in fluid communication with the balloon and the wire guide lumen extends through the balloon. A method of making the balloon catheter is also disclosed.

Abstract: The present invention is directed to compositions and methods for delivering a tissue scaffold comprising a perfluorocarbon emulsion to an individual in need of tissue expansion.

Abstract: A growth stent and methods for making and using the same. The growth stent may be delivered to treat early stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a patient.

Abstract: A magnet assembly apparatus for obesity treatment and a use method of the same are disclosed. The magnet assembly apparatus for obesity treatment according to the present invention is a magnet assembly apparatus for obesity treatment which can be injected by an oral approach into the stomach of a patient. The magnet assembly apparatus comprises a first sphere having a first diameter and silicon-coated on the outside; and a second sphere having a second diameter bigger than the first diameter, which is a magnetic substance having a magnetic force of a predetermined value.

Abstract: An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous elastic frame, a liner, and a jacket.

Abstract: A non-compliant fiber-reinforced medical balloon comprises a first fiber layer and a second fiber layer embedded in a continuous matrix of thermally-weldable polymer material defining a barrel wall, cone walls and neck walls. The fibers of the first fiber layer run substantially parallel to one another and substantially parallel to the longitudinal axis. The fibers of the first fiber layer have a pattern of different lengths and are divisible into a first group and a second group based on length.

Abstract: According to some embodiments, a method of treating a subject having diabetes or symptoms associated with diabetes is provided. The method includes delivering a neuromodulation catheter within a vessel (e.g., hepatic artery) having surrounding nerves that innervate the liver (e.g., sympathetic nerves of the hepatic plexus). The method may also include modulating (e.g., disrupting, ablating, stimulating) the nerves by mechanical compression, energy delivery, or fluid delivery.

Abstract: The foregoing application describes a system and method of performing a minimally invasive surgical operation. More specifically, the invention involves the use of disposable cannula and slender dilators of variable lengths, which incorporate a source of illumination to carry light to a surgical site and video capabilities for capturing and displaying images from a CMOS or CCD camera device. According to one embodiment, fiber optics run semi-circumferentially or along walls of the cannula/dilator and terminate at about a centimeter from the distal end of the cannula/dilator, thereby preventing illumination from “bottoming out” at the floor of the incision. According to one alternate embodiment, the light fibers may be fashioned in an annulus around one or more camera chips to provide illumination and video of the surgical site.

Abstract: A method of replacing a nucleus pulposus material wherein curable nucleus pulposus material is injected into a balloon in an intervertebral space

Abstract: A medical device for reducing the volume of a left atrial appendage (LAA) may include an elongate shaft having a distal portion, and a volume-reducing means expandable from a collapsed to an expanded state, the volume-reducing means being releasably attached to the distal portion. The volume-reducing means may include an actuatable frame and an impermeable covering disposed over the frame. The volume-reducing means may be sized to fit within the LAA in the expanded state while maintaining an open fluid flow path from a distal region through the ostium of the LAA. A medical device may include a second volume-reducing means to be placed within and substantially occlude a distalmost region of the LAA. A method may include inserting a volume-reducing means into the LAA, expanding the volume-reducing means, and positioning the volume-reducing means such that an open fluid flow path is maintained through an entire cycle of the heart.

Abstract: Methods and systems for automated control of the inflation of an inflatable retention member, e.g. a balloon, in a catheter are disclosed. One catheter is preferably a rectal or anal catheter, and the inflation is controlled by a controller. A plurality of predetermined inflation levels are provided, and for each of level, a pumping time threshold and a pressure level threshold are defined. The pressure in the balloon is continuously measured during the inflation. An inflation level is selected form said plurality of inflation levels, and an electric pump is used to inflate the inflatable retention member. Operation of the electric pump is continued until one of the pumping time threshold and pressure level threshold of the selected inflation level has been reached.

Abstract: A surgical apparatus for application of surgical clips to body tissue is provided. The surgical apparatus includes a housing, a drive assembly, a trigger, and a shaft assembly. The trigger is operatively connected with the drive assembly. The drive assembly is at least partially positioned within the housing. The shaft assembly extends distally from the housing and has a first tubular member pivotally connected with a second tubular member located distally from the first tubular member. An articulation mechanism is operatively connected between the first and second tubular members, and includes a gear rack, at least one gear, and a gear segment, respectfully connected with each other to pivot the second tubular member about the pivot axis. The gear rack and at least one gear are located within the first tubular member. The gear segment extends proximally from the second tubular member.

Abstract: An embodiment includes a system comprising: a substrate of a medical device; an un-foamed polyurethane coating directly contacting the substrate and fixedly attached to the substrate; a thermoset polyurethane shape memory polymer (SMP) foam, having first and second states, which directly contacts the polyurethane coating and fixedly attaches to the polyurethane coating; wherein the polyurethane coating fixedly attaches the SMP foam to the substrate. Other embodiments are described herein.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include a containment assembly for cement containment and/or a balloon assembly for maintaining vertebral height. A containment assembly comprising a containment jacket adapted to be deployed inside bone; and a dividing wall that separates the interior of the containment jacket into a proximal region and a distal region, the dividing wall having an opening for providing access to the distal region from the proximal region.

Abstract: A wearable device or apparatus is used for monitoring biometric data of a user and enabling biofeedback indications in response to biometric data received. In one embodiment, the wearable device includes at least one sensor, a button, at least one processor having a memory unit coupled to the at least one sensor and a feedback mechanism. The feedback mechanism can include a biofeedback indicator.

Abstract: A method for treating urinary incontinence is provided. The method includes providing a device having an expandable portion having an outer surface, a first electrode, and a second electrode, the first and second electrodes coupled to the outer surface of the expandable portion and configured to cause a contraction of a muscle in communication with the electrodes. The method further includes causing the expandable portion to inflate such that the first and second electrodes contact vaginal walls and causing a contraction of a muscle in communication with the electrode.

Abstract: A system for delivering bone graft material into an interbody fusion device (IBFD) in an intradiscal space of a spine, the IBFD having an open-frame with a hollow interior and an opening through its proximal end communicating with the interior. Included is an elongate channel having a lumen extending therethrough, the distal end being in engagement with the IBFD to align the lumen with the opening through the proximal end of the IBFD. An adjustable block is movably attached to the channel, the block having plural chambers containing bone graft material, the chambers being individually sequentially alignable with the lumen. A plunger pushes graft material from each chamber, through the lumen and into the IBFD. A distal end of a tamper is configured to be inserted through each chamber and the lumen and into the IBFD interior for tamping graft material deposited into the interior of the IBFD.

Abstract: A fiber-reinforced device, such as an inflatable medical balloon, includes a cylindrical central portion (1301). The balloon includes first and second tapered or conical end portions (1303a,1303b) connected to the cylindrical central portion along a central longitudinal axis extending from a first end of the balloon to a second end of the balloon. In one embodiment, the balloon includes a single continuous fiber (1313a) running substantially parallel to the longitudinal axis along the central portion and radially around a portion of the end portions, or both. The balloon comprises a second fiber (1315) extending radially around the central portion of the balloon, which may be part of the single continuous fiber. Related methods are described.

Abstract: An intragastric balloon (10) for use in the stomach including a sealed container and separated expandable foaming substances within the sealed container, wherein the substances are adapted to expand and cure to a foam when mixed.

Abstract: An intragastric device comprising: an inflation magnet provided within a capsule and configured to move towards a first end of a capsule during activation of the intragastric device by applying a magnetic field externally to a user after swallowing the intragastric device; a first chamber and a second chamber physically separated by a partition having a through hole; a separator connected to the inflation magnet and sealing the through hole before activation of the intragastric device, wherein activation of the intragastric device moves the separator to unseal the through hole to allow a chemical reaction between a first chemical stored in the first chamber and a second chemical stored in the second chamber; a balloon secured to the capsule and collapsed against the capsule before activation of the intragastric device; and an expandable volume configured to expand when the balloon is inflated by a gaseous product of the chemical reaction.

Abstract: A non-compliant high strength balloon (10) includes a reinforcement member (30) formed of a sleeve of woven or braided strengthening elements (32, 34). There are provided circumferential strengthening elements (32) which are pre-tensed in order to remove any undulations within the strengthening elements (32) and to ensure that these have a precise annular size. On the other hand, the longitudinal strengthening elements (34) have undulations therein. The pre-tensing of the strengthening elements (32) ensures that the balloon will not stretch during pressurization thereof, which can occur when the circumferential strengthening elements have undulations therein, which will be natural artefacts of a weaving or braiding process. The undulations in the longitudinal strengthening elements (34) provides the balloon with increased longitudinal flexibility.

Abstract: A catheter that includes a balloon. The balloon has an elastic inner layer and an elastic outer layer. The inner layer and the outer layer are inflatable and deflatable in response to a change of internal pressure of the balloon. The catheter includes a tubular reinforcement member positioned between the inner layer and the outer layer of the balloon in the radial direction of the balloon. At least part of the reinforcement member is not directly fixed to the inner and outer layers. The reinforcement member includes a wire-shaped member. The first end portion and the second end portion of the reinforcement member include ring-shaped inflation restrictors fused to the wire-shaped member. The inflation restrictors restrict inflation of the first and second end portions of the reinforcement member in the radial direction when the inner and outer layers inflate.

Abstract: A steerable tube (100), comprising a hollow elongate tubular member (1) having a proximal end (2), distal end (3), a wall surface disposed between said proximal (2) and distal end (4), a bend-resistive zone (6) flanked by a proximal bendable zone (4) that forms a controller and a distal bendable zone (5) that forms an effector that moves responsive to movements of the controller, whereby the wall of the tubular member (1) in the bend-resistive zone (6) comprises a structure that is a plurality of longitudinal slits (7), forming a plurality of longitudinal strips (8, 8?), the wall of the tubular member (1) in the proximal bendable zone (4) and the distal bendable zone (5) comprises a structure that is a plurality of longitudinal wires (9, 9?, 10, 10?), at least one strip (8) is in connection with a wire (9) in the proximal bendable zone (4) and a wire (10) in the distal bendable zone (5), such that translation by said wire (9) in the controller is transmitted via the strip (8) to said wire (10) in the effector

Abstract: A medical implant comprises a slurry of bone particles that are injected into a vertebral body under pressure. The liquid component of the slurry may be aspirated while the slurry is being injected so that the bone particles of the slurry pack into the central area of the vertebral body to provide structural support. The injected slurry may be agitated during the procedure to maximize the structural strength of the implant after the procedure.

Abstract: An intravascular balloon catheter that may include, for example, a first elongate member having a proximal end, an opening at the distal end and a lumen therebetween, a balloon defining a cavity, the balloon having a proximal waist sealingly attached to the first elongate member proximal the distal end, a distal waist, and a tubular portion therebetween, a second elongate member having a proximal end, a distal end and a lumen therebetween, the second elongate member disposed in the first elongate member and sealingly attached to the balloon distal waist, and a stopper attached to the second elongate member and disposed in the balloon cavity distal the distal end of the first elongate member, the stopper having an outer profile that prevents movement of the first elongate member thereover the first elongate member having an inner diameter at the distal end large enough to permit the passage of fluid therethrough over the second elongate member.

Abstract: Improved methods and devices for performing an endoscopic surgery are provided. Systems are taught for operatively treating gastrointestinal disorders endoscopically in a stable, yet dynamic operative environment, and in a minimally-invasive manner. Such systems include, for example, an endoscopic surgical suite. The surgical suite can have a reversibly-expandable retractor that expands to provide a stable, operative environment within a subject. The expansion can be asymmetric around a stabilizer subsystem to maximize space for a tool and an endoscope to each be maneuvered independently to visualize a target tissue and treat the target tissue from outside the patient in a minimally invasive manner.