Abstract: A method of deploying a stent includes providing a delivery system with the stent loaded in a reduced diameter configuration between an inner catheter and an outer sheath, the stent including a covering positioned on a luminal wall surface thereof, the inner catheter including a radially outwardly extending protrusion that extends into the covering but does not intersect a plane along the stent luminal wall surface, advancing the delivery system to a stenting site, and withdrawing the outer sheath to deploy the stent at the stenting site.

Abstract: An implantable device is provided for controlling hemorrhage in a body cavity, comprising an expandable balloon and a conduit for supplying a physiologically compatible fluid to inflate the balloon. When the balloon tamponade device is implanted or inserted into the body cavity, it is inflated with a physiologically suitable fluid, so that the balloon generally conforms to the body cavity and exerts compressive force against the walls, tissues or structures of the body cavity to control hemorrhage. The balloon may have a deforming means to limit expansion of the balloon in a direction to facilitate expansion of the balloon in another direction. The device may have additional tubes within the conduit, or a plurality of separate lumens within the conduit or tubes to allow drainage and irrigation to the body cavity. There is also provided a cuff for attachment of an external traction to the balloon tamponade, to facilitate the compressive effect of the device.

Abstract: A tissue treatment apparatus for restoring patency in a body vessel is provided. The tissue treatment apparatus includes an elongated catheter dimensioned for insertion within a body vessel having an at least partial occlusion. Proximal and distal expandable segments are mounted to the elongated catheter and are positionable adjacent the occlusion and are configured to transition from a first condition to a second expanded condition. A mesh in operative engagement with the proximal and distal expandable segments is expandable radially outwardly from the catheter upon corresponding transition of the proximal and distal expandable segments to the second condition. The mesh includes a conductive material adapted to transmit electrosurgical energy to treat and facilitate removal of the occlusion, to thereby assist in restoring patency within the body vessel.

Abstract: The present invention provides a medical device having an catheter body defining proximal and distal portions, and a guidewire lumen at least partially disposed within and movable within the catheter body. The medical device may include an expandable element defining a proximal end and a distal end, wherein the proximal end is coupled to the distal portion of the catheter body and the distal end is coupled to the guidewire lumen. In addition, an actuator element may be coupled to the guidewire lumen for longitudinal movement thereof, and a tensioning element may further be coupled to the guidewire lumen to bias the guidewire lumen and/or the expandable element towards a particular geometric configuration.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

Abstract: A medical device for blood flow restoration and/or for use as an implantable member in a human vessel includes a self-expanding member, a guidewire, and a connection mechanism. The self-expanding member includes a plurality of cells and filaments having specific ranges of thicknesses, widths, and heights. The self-expanding member can take on a volume-reduced coiled form with overlapped edges, and can generate optimal radial forces against a vessel wall and/or thrombus when deployed and expanded.

Abstract: The present invention provides a method to treat sinusitis, a method for improved medication delivery to the sinus mucosa, and a method for staunching bleeding of the sinus mucosa comprising of comprising compressing sinus mucosa of a sinus of a patient against bone tissue of the sinus to a predetermined level without damaging the bone tissue. The present invention further provides a method to treat nasal polyposis comprising compressing nasal polyps contained within the nasal cavity against its lining to reduce volume of the nasal polyps. The present invention provides a method to treat chronic urethral syndrome comprising compressing interior surfaces of an urethra in order to stimulate and cause excretion out of urethral mucosa located along length of the urethra. The present invention further provides additional methods relating to drug delivery and visualization.

Abstract: Disclosed are vertebroplasty methods that include cauterizing an inner cavity of a vertebra of a mammal, such as a human, and injecting bone cement into the vertebra. Systems and kits for performing such methods are also disclosed.

Abstract: A breast cavity spacer device, such as for use with a percutaneous lumpectomy, is provided. The device includes a body having a projection on one end. The body has a bore extending there through. A catheter is disposed at least partially within the bore. A balloon member is fluidly coupled on one end of the catheter, the balloon member having an elliptical shape.

Abstract: Devices, systems, and methods for lead delivery. In at least one exemplary embodiment of a catheter for delivering a lead within a mammalian body of the present disclosure, the catheter comprises an elongated tube comprising a wall extending from a proximal end to a distal end, a lead delivery channel within the elongated tube, the lead delivery channel defining an outlet for delivering a lead, a balloon chamber positioned at or near the distal end of the elongated tube, and at least one balloon positioned within the balloon chamber, the at least one balloon capable of inflation to reversibly anchor the elongated tube within a mammalian body when at least a portion of the elongated tube is positioned therein.

Abstract: According to aspects of the present disclosure, a retrieval catheter assembly for retrieving an intragastric balloon may include a tubular member configured to pass through a wall of the intragastric balloon. The retrieval catheter assembly may also include a retrieval member coupled to the tubular member and movable between an undeployed configuration and a deployed configuration. In the undeployed configuration the retrieval member may be substantially aligned with the tubular member. In the deployed configuration at least a portion of the retrieval member may diverge from the tubular member and may be configured to engage the wall of the intragastric balloon.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: A treatment instrument for medical use includes a tubular insertion portion that includes a curvable flexible part, the tubular insertion portion being insertable into a body of a patient; and a dilating body that is provided at an outer circumference of the flexible part, the dilating body being configured to dilate in a radial direction relative to the flexible part. The tubular insertion portion includes a reduced-diameter part that is provided at a distal end of the tubular insertion portion in an axial direction, the reduced-diameter part having an outer diameter that is smaller than an outer diameter of the tubular insertion portion at a location proximal of the reduced-diameter part. A distal part of the dilating body is fixed to at least the reduced-diameter part.

Abstract: A method and apparatus for suture-less placement of an occluding patch in which release of the device can be accelerated. In one embodiment, an inactive form of an adhesive is applied on the area of the patch that will come into contact with cardiac tissue; this allows for the introduction and necessary manipulation of the catheter system until activation of the adhesive occurs. In accordance with one aspect of the invention, the adhesive properties of certain polymeric materials are relied upon rather than their ability to cure or harden into a specific shape. In another embodiment, the patch is immediately released utilizing a detaching mechanism on the balloon or the balloon catheter which supports the patch; the patch along with the inflated balloon remain on the cardiac structure occluding the opening.

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: An expandable medical balloon comprising an inner layer formed of a polymer material having a first flexural modulus, an intermediate layer formed of a material having a second flexural and an outer layer formed of a material having a third flexural modulus, wherein the flexural modulus of the inner layer and outer layer is 50,000 psi to about 80,000 psi, the flexural modulus of the intermediate layer is about 130,000 to about 230,000 psi and the calculated burst strength of the balloon determined on a 90 degree bend in the balloon is about 35,000 psi or higher.

Abstract: Transoral obesity treatment devices and related methods for operation thereof are described which occupy space within a stomach and/or stimulate the stomach wall. The transoral obesity treatment devices and related methods are intended to assist a patient in maintaining a healthy body weight. Features of the devices include insertion transorally and without invasive surgery, without associated patient risks of invasive surgery, and without substantial patient discomfort. The life span of these devices may be material-dependent upon long-term survivability within an acidic stomach, but is intended to last one year or longer. The devices have the capacity to vary in size and are desirably self-actuating in that they change shape and/or volume using internal motors or actuators. The changing character of the devices helps prevent the person's stomach from compensating for the implant, such as sometimes happens with static intragastric devices.

Abstract: A cutting balloon assembly and a method for fabrication of the assembly is described. The cutting balloon assembly comprises a delivery catheter, an expandable balloon mounted on the catheter distal end, and a scoring mesh disposed around the expandable balloon. The scoring mesh comprises interlacing filaments that extend from a mesh proximal end towards a mesh distal end, form distal filament loops at said mesh distal end, and then return to the mesh proximal end. At least a part of the interlacing filaments forms one or more permanent links with neighboring filaments between the mesh proximal end and the mesh distal end.

Abstract: A self expanding cannula with improved drainage properties based upon its greater length is provided, along with methods of using the cannula in cardiopulmonary bypass.

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: Catheter system, devices and methods for diagnosing and treating lateral stenosis causing back pain and or leg pain. The devices comprise a tubular part for insertion into a working cannula to self-position itself safely within the foramen, and minimize the risk of displacement medially or laterally, to prevent nerve or dura injury. An expandable membrane is configured to maintain the catheter device within the foramen. Expansion of this membrane would decompress the nerve within the foramen by opening the foraminal canal as the membrane expands.

Abstract: A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

Abstract: A method of treating a patient's joint having opposing joint surfaces includes providing an elongate member having a proximal end, a distal end and an expandable member near the distal end. The expandable member is positioned in the joint between the joint surfaces and expanded so as to separate the joint surfaces away from one another into a distracted position. The joint is manipulated while in the distracted position so that the joint is distracted and in flexion. A diagnostic or therapeutic procedure is then performed on the joint while maintaining the joint in the flexed and distracted position.

Abstract: Certain aspects of the present invention provide devices for occluding vascular vessels. In some preferred forms, these devices are able to move from a first condition to a less compact, second condition in a vascular vessel so as to fully or partially prevent fluid from passing through the vessel. One such device includes a frame and a flexible sheet material. The device also includes an occluding material that is located in an interior region of the frame. The flexible sheet material and frame are associated with one another such that when the device is in the second condition in the vascular vessel, the sheet material is positioned in the vessel lumen so as to block fluid flow through the lumen.

Abstract: The present invention comprises the provision and use of a novel endoscopic device which is capable of stabilizing, straightening, expanding and/or flattening the side wall of a body lumen and/or body cavity so as to better present the side wall tissue for examination and/or treatment during an endoscopic procedure. The present invention also comprises the provision and use of a novel endoscopic device capable of steadying and/or stabilizing the distal tips and/or working ends of instruments inserted into a body lumen and/or body cavity, whereby to facilitate the use of those instruments.

Abstract: Embodiments disclosed herein relate to methods, devices, and computer systems thereof for reducing stomach volume in a subject. In certain embodiments, a subject receives a stomach-volume-reducing device that optionally includes at least one reservoir configured to release at least one appetite suppressant. In an embodiment, the stomach-volume-reducing device is responsive to one or more environmental conditions of the subject, for example, pH or chemical chemicals in the stomach of the subject. In an embodiment, the stomach-volume-reducing device controls hunger in the subject.

Abstract: Reinforced angioplasty balloon having an external elastic sheath. The elastic sheath maintains, along its length, a substantially uniform circular cross-section during balloon inflation and forces a deflated balloon into a compacted, substantially circular, wingless profile.

Abstract: A method and apparatus for treating a stricture in a body lumen. The method comprises (a) sensing pressure being exerted by a treatment device on the stricture, (b) determining if enough force is being exerted on the stricture, (c) if enough force is being exerted on the stricture, timing the application of enough force, (d) determining if too much force is being exerted by the treatment device on the stricture, (e) if too much force is being applied to the stricture, decrementing the force being applied to the stricture, (f) determining if not enough force is being applied to the stricture, (g) if not enough force is being applied to the stricture incrementing the force being applied to the stricture, and (h) repeating (a)-(g) until (i) a desired pressure has been maintained on the tissue for a desired time.

Abstract: Methods, devices and systems for delivering a device assembly into a gastric or other space within the body, allowing the device to expand to occupy volume within the gastric space and, after an effective period of time, delivering a substance or stimulus to begin breakdown of the expanded device so that it may release from the body.

Abstract: The invention relates to a method for producing a bioactive surface on the balloon (3) of a balloon catheter (1). According to said method, the surface of the balloon (3) is at least partially wetted with a first solution of an active substance (8) and the section of the surface of the balloon (3) wetted with the first solution of an active substance (8) is then wetted with a second, saturated solution of the active substance (28). The invention further relates to a balloon (3) of a balloon catheter (1) the surface of which is at least partially coated with an active substance (11), the coating (11) being homogeneous and brittle in the entire coated region.

Abstract: Devices and methods are disclosed for providing access to a central compartment of a hip joint. The devices can access the central compartment by distracting all or a portion of the labrum. The labrum can be distracted by advancing a device underneath the bottom edge of the labrum, and using the device to further distract the labrum. Some devices can move underneath the labrum to provide a gap for other devices to access the central compartment.

Abstract: Methods and apparatus for closing a left atrial appendage are described. The methods rely on introducing a closure tool from a location beneath the rib cage, over an epicardial surface, and to the exterior of the left atrial appendage. The closure device may then be used to close the left atrial appendage, preferably at its base, by any one of a variety of techniques. A specific technique using graspers and a closing loop is illustrated.

Abstract: A balloon delivery catheter apparatus including a catheter tubing defining a lumen therethrough, a balloon disposed near a distal end of the catheter tubing and moving between deflated and inflated states, and a core wire having a proximal end attached to the catheter tubing inside the lumen and extending distally away and substantially co-axially with the catheter tubing through the balloon to a distal free end. Proximal and distal balloon control bands are concentrically arranged around respective proximal and distal end portions of the balloon. A coil disposed around the core wire has a proximal end attached to at least one of the distal end portion of the balloon and the distal balloon control band.

Abstract: A method of repairing a fractured articular bone at a fracture site has the steps of mixing a bone glue, inserting an expandable balloon into the fracture site, inflating the expandable balloon at the fracture site, applying the bone glue to the fracture site while the expandable balloon is inflated, curing the bone glue at the fracture site while the expandable balloon is inflated, deflating the expandable balloon after the bone glue has cured, and removing the deflated expandable balloon from the fracture site and from the articular bone. The bone glue combines a biologically dissolvable glue with an actual or artificial particulate bone graft.

Abstract: Embodiments herein comprise a hemostatic composition comprising a plurality of liquid expandable articles capable of expanding upon contact with a liquid. A suitable composition comprises a plurality of liquid-expandable articles that may be mechanically uncoupled from one another and therefore may be capable of moving independently from one another. The plurality of liquid-expandable articles may comprise a compressed material capable of a high-degree of expansion upon liquid contact.

Abstract: An extractable device is used to insert a flowable material into a vertebral body. The device comprises a filling member and a flowable material. The filling member is made of a flexible wall which includes a holding portion and an injection port via which the flowable material is injected into the holding portion after insertion into the vertebral body. The holding portion is provided with an opening which is releasably closed by a closure device so as to make the opening substantially resistant to the passage of material there through. Once the flowable material in the holding portion increases in viscosity, the closure device is released, thereby enabling the filling member to be extracted from the vertebral body so as to leave only the material in the vertebral body. The flowable material should be a material capable of setting to a hardened condition.

Abstract: An implantable device includes at least one solid structure having an external surface and a volume beneath the surface. One or more of a first conductor or set of conductors is disposed externally and/or internally on or within the structure and an array of elongate electrically conductive elements are disposed radially outwardly within the volume. A breach is detected when a conductive fluid intrudes into the volume through the surface.

Abstract: An inflatable bone tamp for performing a minimally invasive surgical procedure includes an inner shaft that incorporates a longitudinally extensible section. The predetermined longitudinally extensible section permits greater control over the elongation of the inflatable portion of the inflatable bone tamp, thereby allowing performance characteristics to be tailored to specific procedures and/or situations. The predetermined longitudinally extensible section can be implemented in various ways, such as a spring, elastomer, or mechanical linkage, among others.

Abstract: A balloon dissector includes a cannula, an expandable bladder, and a cord. The cannula defines a lumen between proximal and distal ends. The expandable bladder is configured to expand when fluid is injected into the lumen and includes an inner surface, a proximal base, and a retainer. The proximal base is selectively coupleable to the distal end of the cannula in a sealing relationship. The retainer is positioned on the inner surface of the expandable bladder. The cord includes a first end, a second end, and a central portion. The one end of the cord extends from the proximal end of the cannula. The cord extends through the lumen of the cannula and through the retainer of the bladder returning into the lumen. The cord configured to draw the expandable bladder into the lumen after the expandable bladder is expanded.

Abstract: Transoral three-dimensionally orthogonal intragastric spring systems, devices, methods of operation and manufacture are provided. A transoral three-dimensionally orthogonal intragastric spring system and/or device (and related methods of manufacture and operation) may reduce obesity or weight by stimulating the stomach walls of the patient. The three-dimensionally orthogonal intragastric spring device may be a purely mechanical device comprising a flexible body which in response to an input force in one direction, may deform and cause a resultant displacement in an orthogonal direction, thereby exerting a pressure on the inner stomach walls of the patient. Alternatively, a three-dimensionally orthogonal intragastric spring device may include a variable size balloon configured to occupy volume in the patient's stomach, thereby reducing the amount of space in the patient's stomach.

Abstract: The present invention relates to devices and systems that alter intracranial compliance, cerebral blood flow and/or intracranial pressure pulsatility/waveform by oscillating the contraction and expansion of a compressible composition within the cranial or spinal cavities such that they increase intracranial capacity. The contraction and expansion of the compressible composition in the oscillating compliance devices can be due to an individual's intracranial pressure, the result of the expansion and compression of a reservoir which is mediated by the contractility of the heart or driven by a pump gaited to a biorhythm. The invention also relates to methods for protecting an individual's brain from abnormal arterial pulsations and for altering an individual's cerebral blood flow using the devices and systems of the invention.

Abstract: A balloon catheter includes a catheter tube and an inflatable balloon. The ends of the balloon are attached to the catheter tube. The outside surface of the balloon in an uninflated state is provided with a relief structure which in an inflated state of the balloon is substantially disappeared. A method for producing such a relief structure is by winding a wire helically around the outer surface of the balloon.

Abstract: The present invention provides various systems, a kit, and a method for accessing, sampling within, and visualization of areas within the mediastinal cavity for assisting a surgeon in performing a mediastinoscopy procedure. The access system includes one or more preferably toroidal balloons that can be expanded to dilate and protect the inner walls of a bodily conduit. Instruments pass through hollow spaces within the expanded toroidal balloons. The proximally positioned balloons are expanded first and the unexpanded balloons to be positioned distally are passed through them and subsequently expanded. The sampling system includes an instrument with a rounded head having two or more jaws and a slit therein at the distal end of an elongated tubular body. The visualization system includes a 360° camera that can be positioned from proximal to distal a target site and can also do a U-turn about its axis of extension.

Abstract: A prostate immobilizing balloon having a central seating area that on full inflation cups the prostate to hold it during treatment is combined with a gas lumen, a locking member and one or more fiducial markers. Methods of using same are also provided.

Abstract: Systems for controlling obesity utilize a number of space occupiers positioned in the stomach to reduce the effective volume of the stomach. Such arrangements provides sufficient stomach volume consumption to induce weight loss, but enable use of space occupiers that are proportioned to minimize the threat of obstruction even if they should migrate into the intestine. In general, numerous small volume space occupiers are placed in the stomach such that the total volume equals or exceeds the single volume of prior art single unit space occupiers. However, each individual space occupier is proportioned so that it will pass without obstruction if it moves into the intestine.

Abstract: An embolic protection device is provided for deployment within a body vessel to collect embolic debris there from. The device includes a filter for collecting the embolic debris and a frame for supporting the filter. The frame generally defines a closed loop that has a collapsed state and an opened state. Furthermore, the frame includes a tube portion that receives an opening means to open the closed loop from the collapsed state to the opened state.

Abstract: Systems for controlling obesity utilize a number of space occupiers positioned in the stomach to reduce the effective volume of the stomach. Such arrangements provides sufficient stomach volume consumption to induce weight loss, but enable use of space occupiers that are proportioned to minimize the threat of obstruction even if they should migrate into the intestine. In general, numerous small volume space occupiers are placed in the stomach such that the total volume equals or exceeds the single volume of prior art single unit space occupiers. However, each individual space occupier is proportioned so that it will pass without obstruction if it moves into the intestine.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon. The balloon comprises a balloon layer having an outer surface, the balloon layer including a base layer, a first reinforcing layer and a second reinforcing layer. The base layer is formed of a polymer material. The first reinforcing layer is one of either a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. The second reinforcing layer is one of either at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon and a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric.

Abstract: A catheter having an elongated shaft which has a multilayered distal tip with a first layer formed of a polyimide first material and a second layer formed of a polymeric second material. In one embodiment the multilayered distal tip is a separate member, distal to the distal end of a proximal portion of the shaft. In another embodiment, the shaft has an outer tubular member, and a multilayered inner tubular member with a distal end which forms the multilayered distal tip of the shaft. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. In one embodiment, the polymeric second material is a polyamide material.

Abstract: A medical treatment tool includes: an insert portion at least a part of which is provided by a flexing portion that is adapted to be flexed, the insert portion being adapted to be inserted into a human body of a patient; and an inflatable body provided on an outer circumference of the flexing portion, the inflatable body being inflated in a radial direction of the flexing portion. An axial distal end portion of the inflatable body is fixed to the insert portion while a proximal end portion of the inflatable body is axially movable relative to the insert portion.