Abstract: A balloon catheter has a central tube that is configured to both structurally support and inflate a balloon membrane. The central tube has a lumen and sidewall inflation ports that provide a path for inflating the balloon. The lumen of the central tube is obstructed by a distal end piece, nose piece, or other structure to prevent fluid from exiting a distal end of the central tube. The central tube is configured such that, during inflation, inflation media is allowed to pass through an elongated shaft of the catheter, into a proximal open end of the central tube, and through the inflation ports into the balloon. The central tube can slide longitudinally in relation to the shaft to longitudinally elongate and/or truncate the balloon.

Abstract: A method of manufacturing a tissue expander for implanting into a body of a living subject can include mixing granules of a solute with an elastomer. The method can further include forming a matrix with the elastomer. The granules can be embedded within the elastomer. The elastomer can define boundaries of a plurality of chambers within the matrix. The method can further include curing the elastomer, such that the boundaries of the matrix are permeable to water at a temperature between a desired temperature range.

Abstract: Devices, methods and kits for preventing or reducing non-target microparticles deposition and embolization, in conjunction with delivering microparticles (e.g., embolization material) via a blood vessel to a target bodily part. Applicable for entrapping infiltrated microparticles within heart right atrium. Entrapping device includes: filter; and filter collapsing mechanism sized for positioning in catheter lumen of a filter delivering catheter, and having proximal end actuatable from outside of subject. Filter configured for positioning within heart right atrium, for self-expanding and covering right atrium inlet opening, and configured, when expanded, to collect embolic material delivered to target organ and infiltrated into outflow vessel thereof draining to right atrium.

Abstract: A dialysis sheath is used with a catheter that cleans clots from a synthetic blood vessel or fistula. The dialysis sheath comprises a main hollow body and a stop mechanism. The main body has a lower portion for insertion into the synthetic blood vessel or fistula. The stop mechanism is movable between (i) a first position in which the stop mechanism is adjacent to or within a surface of the main hollow body and (ii) a second position in which the stop mechanism radially protrudes from the main hollow body. The stop mechanism is configured to engage an inner surface of the synthetic blood vessel or fistula to maintain the lower portion of the dialysis sheath within the synthetic blood vessel or fistula when the dialysis sheath is moved to a different position. The stop mechanism can be fluid-actuated and include a balloon-like structure.

Abstract: A medical device may include an elongated body having a distal elongated body portion and a central longitudinal axis. The medical device may include a balloon positioned along the distal elongated body portion. The balloon may be configured to receive a fluid to inflate the balloon such that an exterior balloon surface contacts a calcified lesion within a patient's vasculature. The medical device may include one or more pressure wave emitters positioned along the central longitudinal axis of the elongated body. The one or more pressure wave emitters may be configured to propagate at least one pressure wave through the fluid to fragment the calcified lesion. At least one pressure wave emitter may include an optical fiber configured to transmit laser energy into the balloon. The laser energy may be configured to create a cavitation bubble in the fluid.

Abstract: In some examples, a catheter includes an expandable member configured to expand radially outward from a collapsed configuration to an expanded configuration. The expandable member is configured to be expanded and contracted in a controlled manner, e.g., in response to user actuation or automatically under the control of control circuitry of a device. For example, in some examples, control circuitry of a device can be configured to control the expandable member to expand and contract according to a predetermined expansion frequency or according to an expansion frequency determined based on a cardiac cycle of a patient.

Abstract: A tissue expander is disclosed herein. The tissue expander may comprise a shell defining a chamber, and having a flexible wall and a port disposed through the flexible wall. The shell may also include a channel disposed through the flexible wall. A first syringe containing a first volume of a liquid may be connected to the chamber of the tissue expander via the channel. A second syringe containing a second volume of the liquid may be connected to the chamber via the port at least approximately one week after the first volume of liquid is injected. The first volume of liquid may be injected more quickly than the second volume of liquid.

Abstract: The invention provides an improved indwelling urinary catheter of the inflatable type having a unique, low profile device by which to retain the catheter within the bladder, so that urine can be removed therefrom while avoiding obstruction to the descending fetal vertex during the process of labor and delivery. Thus, making it better suited for obstetrical applications. The retaining device consumes less obstructing volume in the bladder than that which would ordinarily be consumed by a conventional Foley-style balloon, whereby both the frequency and severity of fetal vertex obstruction and its resulting increased time of labor, operative delivery and injury to maternal urologic tissue can be reduced. The obstetrical foley retains the tradition Foley-style balloon distal to the improved low-profile laboring balloon for insufflation in the event a surgical delivery by cesarean section is indicated.

Abstract: The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.

Abstract: A medical device comprises a catheter and an aspiration pump. The catheter has a hybrid reinforcement to improve performance characteristics. The aspiration pump is cycled to improve aspiration efficacy.

Abstract: Flexible intubation assemblies and methods for using and making the same are provided.

Abstract: This invention is directed to a device and a method for controlling fecal incontinence. The device of this invention is easily inserted into the rectum, and is designed for remaining where required in the rectum, above the dentate line and hemorrhoidal vein area, despite the peristaltic movements of the intestine.

Abstract: A valve planning tool comprising: (a) a stem having a distal end and a proximal end, (b) an anchor indicator located at the distal end, and (c) a balloon located proximal of the anchor indicator, the balloon including: (i) a retracted state and (ii) a deployed state; wherein the balloon is inflatable from the retracted state to the deployed state and the balloon is substantially non-compliant so that the balloon is only inflatable to one size.

Abstract: A medical device that delivers therapeutic agent to the tissue within the bodily passageway while simultaneously permitting flow of bodily fluids past the location of treatment. The medical device includes an inflatable balloon and optionally one or more balloon wall openings that are configured to allow fluid in the interior of the inflatable balloon to flow through the inflatable balloon when the inflatable balloon is pressurized by the fluid in the interior of the inflatable balloon. During the inflation of the inflatable balloon at the treatment site, the flow of blood through the blood vessel is maintained across the treatment site by use of one or more bypass passageways in the medical device.

Abstract: Hydraulically expandable spinal rods and methods of use thereof are disclosed. The spinal rod may include a piston rod, a static rod, and a hydraulic pressure chamber for accepting hydraulic fluid and causing the piston rod to move in an expansion direction relative to the static rod. Upon connection of the piston and static rods to a patient's spinal column, the hydraulic spinal rod may be expanded to aid in correction of an underlying spinal deformity.

Abstract: The present invention relates to devices for treating or managing fecal or bowel incontinence and methods employing them. Such a device can form a seal with at least a portion of the bowel to prevent unwanted discharge of fecal matter from the rectum.

Abstract: A balloon catheter is described having a reinforced, co-axial, duel lumen design. In some embodiments, the balloon catheter includes a purging mechanism designed to purge air from the balloon.

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

Abstract: A workspace device including (a) a body having a wall defining an internal volume, collapsible to fit through a laparoscopic passageway in an abdominal wall to an abdominal cavity and expand therein; (b) a first opening defined in said body; (c) a tool channel contiguous with said first opening and extending from said body and configured to remain, at least in part, outside of abdominal wall and sized to receive a laparoscopic tool therein therein; and (d) the body defining an orifice configured to lie in said abdominal cavity when said body is inserted therein, said orifice sized to receive tissue with a minimal cross-sectional area that is twice a minimal cross-sectional area of said first opening, thereby defining a workspace volume to process said tissue in said cavity while said body is not collapsed, using a tool inserted through said first opening.

Abstract: According to various aspects and embodiments, a growth adaptive expandable stent is provided. The expandable stent includes a stent structure having a cylindrical shape that is self-expanding in a radial direction and includes a plurality of cylindrical rings disposed along a longitudinal axis of the stent structure. The stent structure is configured to exert a continuous outward radial force over time when implanted such that a diameter of the stent structure expands from a first value to a second value that is at least about 1.5 times the first value.

Abstract: The disclosure relates to devices and methods for the treatment of edema that uses an impeller with a balloon that may be mounted on the impeller housing. The invention provides devices and methods for treatment of edema that use an indwelling catheter with an impeller to lower pressure at an outlet of a lymphatic duct and a balloon on the impeller to guide and to restrict blood flow. The balloon restricts return flow from the jugular and guides that flow into the impeller cage. By funneling the flow into the impeller cage, a rate of flow down the vessel may be increased, resulting in a lateral pressure decrease effecting the lymphatic outlet. Because the lymphatic outlet is subject to a pressure decrease, fluids in the lymphatic system drain to the outlet and into the circulatory system.

Abstract: The invention refers to endovascular catheters and methods useful to endovascular surgery. In particular, it refers to support catheters with balloons that are used for the placement or the forwarding of the guidewire through demanding tortuosity and important vascular stenoses in cases where the guidewire needs the best possible backup support of the catheter. This is achieved with the development of an endovascular support catheter with a mobile balloon, which has the ability to move along the body of the catheter, at its distal part. The movement of the balloon is achieved with the use of two mobile external rings, one inner wire circuit, and one control handle which is found at the proximal end of the device. The mobile balloon allows the catheter to move inside the vessel even when it is inflated and basically anchored within the vessel.

Abstract: A medical device for treating a vein, including component parts thereof, wherein the device comprises a vein stretching member; a vein stretching member for use with the device; a kit of parts including the device and one or more vein stretching member and a method for treating a vein including use of the device.

Abstract: A balloon catheter which allows for faster preparation and effective purging of air. The balloon catheter includes an elongated, flexible catheter having an inner lumen. A balloon member is secured to an outer surface of a distal portion of the catheter such that an inner surface of the balloon member and an outer surface of the catheter define an inflatable balloon interior. The catheter has an inflation lumen connected to an inflation port and extending distally to a distal end in fluid communication with the inflatable balloon interior. One or more purge apertures are provided in a wall of the catheter, each forming a fluid path between the inflatable balloon interior and the inner lumen of the catheter to allow for purging air from the catheter prior to use in a medical procedure.

Abstract: A temporary low profile intraluminal catheter for infusing agents into, or extracting fluids from, a bodily lumen featuring securement structure, wherein the securement structure allows the catheter to be placed with minimal intrusion into the bodily lumen is disclosed. With such design affording a more efficient, verifiable placement of the catheter with less complication due to infection and biofilm related issues, among other types of complications.

Abstract: Various aspects of the present disclosure are directed toward systems, methods, and apparatuses that include an occlusion device having a barrier member. The barrier member may include an enlargeable portion and a tail portion extending from the enlargeable portion. The enlargeable portion and the tail portion are releasably coupled to the delivery catheter such that the tail portion is radially unsupported and collapsible upon deployment.

Abstract: An apparatus for treating obesity in a human or animal mammal patient. The apparatus comprising a first volume filling device segment and a second volume filling device segment. The first and second volume filling device segments are adapted to be assembled into an implantable volume filling device of a controlled size. Each one of the first and second volume filling device segment comprises at least one interconnecting structure. The interconnecting structure of the second volume filling device segment is adapted to be formed fitted, such that the first and second volume filling device segment can be assembled into the volume filling device. The assembled volume filling device is adapted to be at least substantially invaginated by a stomach wall portion of a patient, with the outer surface of the device resting against the stomach wall, such that the volume of the food cavity is reduced in size.

Abstract: An occluder device is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the device including a compliant balloon defining a fluid-tight balloon chamber and a balloon channel forming a longitudinal passage from a proximal to a distal side of the balloon, the balloon including a fluid port for filling a fluid into the balloon chamber. A tip and a base are coupled to the distal and the proximal sides of the balloon, respectively. At least one connecting strut is attached to the tip and to the base. An elongate actuator is disposed longitudinally slidable in the balloon channel and connected to the tip, and longitudinally slidable with respect to the base so as to set a distance between the tip and the base. A lock is configured to maintain the distance between the tip and the base. Other embodiments are also described.

Abstract: A bariatric device includes an esophageal member having an esophageal surface that is configured to generally conform to the shape and size of a portion of the esophagus and an anchoring technique anchoring the esophageal member to the portion of the esophagus. The bariatric device includes a cardiac member having a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach and a connector connected with the esophageal member and the cardiac member to cause strain to be applied by the cardiac member to the cardiac portion of the stomach. The strain applied by the cardiac member to the cardiac portion of the stomach causes satiety in the absence of food. The connector is adapted to pass through the gastroesophageal junction while leaving a continuous portion of the gastroesophageal junction substantially unrestrained.

Abstract: An apparatus includes a first stent graft that is at least partially insertable into a first blood vessel. The first stent graft has a first end, a second end, an inside surface, and an outside surface. The apparatus also includes an inflatable fill structure fixed to a portion of the outside surface of the first stent graft. The inflatable fill structure includes an outer membrane that is configured to extend beyond the first end of the first stent graft when the inflatable fill structure is in a filled state.

Abstract: This invention is directed to compositions and methods for treating a condition of the heart. In an embodiment, the invention is directed to a method of treating a subject in need thereof, wherein the method comprises ablating at least one nerve of the renal artery of the subject; and administering to the subject a therapeutically effective amount of cells.

Abstract: A forceps instrument comprises, for the support of at least one pivotally supported branch, a bearing insert which is inserted into a base in order to support at least one pivotable branch. The bearing insert may be inserted transversely with respect to the pivot axis into a corresponding compartment of the base and fixed there in the compartment, due to detent action. The bearing insert comprises two bearing elements, including cylindrical journals, which are arranged on bearing parts of the bearing insert, without being in contact with each other, the bearing parts having the form of plates, that are oriented parallel to each other. The two journals come into engagement with corresponding openings of the branch, in which case the distance remaining between the end sides of the journals can be used for the arrangement of miscellaneous elements, including a cutting knife.

Abstract: An occluder device is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the device including a compliant balloon defining a fluid-tight balloon chamber and a balloon channel forming a longitudinal passage from a proximal to a distal side of the balloon, the balloon including a fluid port for filling a fluid into the balloon chamber. A tip and a base are coupled to the distal and the proximal sides of the balloon, respectively. At least one connecting strut is attached to the tip and to the base. An elongate actuator is disposed longitudinally slidable in the balloon channel and connected to the tip, and longitudinally slidable with respect to the base so as to set a distance between the tip and the base. A lock is configured to maintain the distance between the tip and the base. Other embodiments are also described.

Abstract: A tissue expander having an integrated drain includes a shell having an opening and one or more drainage holes, and an injection port disposed in the opening of the shell and forming a fluid-tight seal with the shell. The injection port includes a needle guard having a needle guard base with a top surface. The injection port includes a moveable barrier membrane overlying the top surface of the needle guard base. The moveable barrier membrane is moveable between a first position for inflating and deflating the shell with a first fluid and a second position for draining a second fluid from outside the shell. A magnet is coupled with the moveable barrier membrane, and a compressible spring is connected with the magnet. The compressible spring is compressed for storing energy as the moveable barrier membrane moves from the first position to the second position.

Abstract: A minimally invasive blood clot capturing invention made of nitinol. The nitinol is shaped into a plurality of fingers to form a frame for a basket and funnel to capture and remove blood clots. The basket and funnel being delivered to the blood clot by a catheter. The basket and funnel are capable of being collapsed within a catheter, capable of being deployed into a blood vessel, and capable of being retracted into the catheter for removal from the blood vessel.

Abstract: Embodiments herein relate to systems and methods for intravascular lesion disruption. In an embodiment, a catheter system for imparting pressure to induce fractures upon a vascular lesion within or adjacent a blood vessel wall is included. The system includes a catheter configured to advance to a vascular lesion, the catheter including an elongate shaft that defines at least a first orifice for fluid flow; a balloon, coupled to the elongate shaft, that surrounds the first orifice where the balloon can expand from a collapsed configuration suitable for advancing the catheter through a patient's vasculature to a first expanded configuration suitable for anchoring the catheter in position relative to a treatment site; and a propulsion system configured to propel a fluid from the first orifice toward the balloon wall to create an inertial impulse in a vessel wall to transfer momentum to the vascular lesion. Other embodiments are also included herein.

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: 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: 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: Apparatus and methods for an endovascular catheter that can be inserted within tortuous body anatomies and then selectively stiffened and fixed in place. In a particular embodiment, this stiffness is reversible. The stiffness or a comparable mechanical characteristic of the catheter assembly may be adjusted to a relatively low value during insertion (so that it easily navigates a guide wire or the like), and then subsequently adjusted to a relatively high value in situ to keep the catheter assembly substantially fixed in place (i.e., during delivery of an interventional device).