Abstract: Exemplary embodiments of the present disclosure relate to devices, systems, and methods for tissue resection in a body lumen of a patient, and may include an elongate body having a cavity at a distal end and a tissue retractor extendable distally from the distal end of the elongate body. The tissue retractor may include an expansion mechanism. The expansion mechanism may include a plurality of arms each having a first end coupled around a distal cap and expandable radially outward from the distal cap such that an anchoring mechanism on a second end of the arms is engageable with selected tissue for resection of the body lumen. The tissue resection device may further include a tissue resecting device.

Abstract: An external catheter stabilizer device for stabilizing and retaining a catheter tube includes a base portion configured to adhesively attach at a patient, a retaining element configured to retain a catheter tube thereat, and a pivot element that pivotally attaches the retaining element to the base portion so as to allow for pivotal movement of the retaining element about a pivot axis generally normal to the patient where the base portion is attached. The retaining element includes a guide pin protruding therefrom and spaced from the pivot element. Pivotal movement of the retaining element relative to the base portion is limited to a selected range via engagement of the guide pin of the retaining element with an arcuate slot at the base portion.

Abstract: A medical device for kyphoplasty procedures is disclosed. The medical device includes a trocar configured for insertion in a vertebral cavity, the trocar having a longitudinal axis that is perpendicular to a second axis, an orifice at a first end of the trocar in, the orifice configured for deploying a balloon tamponade, the balloon tamponade configured for inserting into a second end of the trocar, through the trocar and out of the orifice at a first end of the trocar, and, wherein the balloon tamponade is configured to be inflated such that the balloon tamponade inflates to a greater extent along the second axis than the longitudinal axis of the trocar.

Abstract: A balloon catheter is disclosed having a balloon at a distal portion of a catheter shaft and on a surface of the balloon are elongate bodies which are crystals of a water-insoluble drug having independent long axes. The balloon in a deflated state has a plurality of wing portions in a circumferential direction of the balloon, and a circumferential surface portion along a circumferential direction of the catheter shaft, the plurality of wing portions being folded along the circumferential direction of the balloon. A surface of the circumferential surface portion which faces the plurality of wing portions that are folded has a region in which tip portions are not in contact with the surface of the balloon or with other elongate bodies, and a surface which faces the plurality of wing portions that are folded which faces an outer circumferential side has a region in which the tip portions are in contact with the surface of the balloon or with the other elongate bodies.

Abstract: An apparatus for minimally-invasive, including non-invasive, prevention and/or treatment of hydrocephalus and method for use of the same are disclosed. In one embodiment of the apparatus, a housing is sized for superjacent contact with a skull having a fontanel. Within the housing, a compartment includes a pressure applicator, such as a fluid-filled bladder, under the control of a pressure regulator. The pressure applicator is configured to selectively apply an external pressure to the fontanel. The compartment includes a pressure sensor configured to measure intracranial pulse pressure of the fontanel. Further, in one embodiment, the apparatus can cause pulse pressure modulation by adjusting the intracranial pulse pressure via the pressure applicator. This enables a non-invasive measurement of the pulse pressure and modulation thereof in infants, for example.

Abstract: A delivery system for an implantable medical device includes an outer shaft and an inner shaft translatable within the outer shaft. An internally exposed coil is disposed within the inner shaft and is electrically coupled to an externally exposed coil that can be used to inductively transmit a current flowing through the internally exposed coil. An actuation member extends within the inner shaft and includes a coupler, a force translation rod that extends proximally from the coupler and a plurality of push pull rods that extend distally from the coupler and that releasably couple to the implantable medical device. As the force translation rod moves relative to the internally exposed coil, an impedance varies in accordance with relative position.

Abstract: Inflation devices configured to communicate with remote displays are disclosed herein. Kits including such inflation devices with portable display devices are also disclosed herein. Methods of remotely displaying pressure data from a medical device are also disclosed herein. Devices, kits, and methods of connecting medical devices to remote displays and transferring information to or from linked computers are also disclosed.

Abstract: Tube holding assemblies and methods for using and making the same are provided, including an assembly for holding a nasogastric tube to a patient's head while also being adjustable along a track that may be positioned underneath the patient's nose but above the patient's mouth and about an axis of rotation.

Abstract: A system for performing angioplasty and a method of utilizing same are provided. The system includes a balloon mounted on a catheter shaft and an expandable constraining structure mounted over the balloon. The expandable constraining structure includes a plurality of axial struts crossing a plurality of radially-expandable rings being for constraining said balloon such that isolated balloon regions protrude through openings in said constraining structure when the balloon is inflated.

Abstract: A tissue protector has a body structure having a longitudinal extending thin web. The body structure has an unconstrained first shape configured to form a nerve shield and is configured to shrink about a longitudinal axis to a smaller constrained second shape sized to fit into a lumen of a cannula. Preferably, the second constrained shape is oval or round having a maximum diameter equal or less than an inside diameter of the lumen. The body structure is configured to return to the first shape when the cannula is withdrawn or returned to this shape as the implant advances.

Abstract: The invention includes systems and methods using certain embodiments of a medical device to facilitate child birth through cervical ripening. Certain embodiments of the invention may include an elongated body having a proximal end and a distal end where the distal end terminates in a tip. The tip may be covered by a balloon disposed adjacent to the tip, and an expandable member may be positioned adjacent to the balloon such that when expanded, the expandable member may at least partially cover the balloon, and accommodate the user's finger to guide and place the device through the cervix and into the internal os, where, upon expansion of the balloon, pressure is applied to the internal os to facilitate cervical ripening and child birth.

Abstract: An implant material having an implant surface comprising a plurality of tissue-contacting members arranged in a regular or irregular two-dimensional array, each tissue-contacting member having a convex curved tissue-contacting surface. Methods of preparing and using such implant materials.

Abstract: Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In certain embodiments, the self-righting article a tissue-interfacing components. In some embodiments, each tissue-interfacing component may comprise an electrically-conductive portion configured for electrical communication with tissue and an insulative portion configured to not be in electrical communication with tissue.

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 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: 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: 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 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: 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: 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: 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 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: 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: 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: 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: 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.