Abstract: An occlusion catheter system includes a proximal hub having an inflation connection port and an inflation pathway. An inflation catheter member is connected to the proximal hub and has an inflation lumen. A stiffener member defines a longitudinal axis. The proximal end of the stiffener member is connected to the proximal hub. The stiffener member extends through a portion of the inflation lumen. An occlusion balloon has a proximal balloon end and a distal balloon end. A distal catheter member is positioned substantially on the longitudinal axis and is connected to the distal end of the stiffener member. An atraumatic tip is positioned on a distal end of the distal catheter member. The atraumatic tip has a substantially circular profile in a relaxed configuration. A pressure sensor is connected to the occlusion catheter system distally relative to the occlusion balloon and is connected to a processor by electrical wiring.

Abstract: A monitoring, managing and protecting system is provided that includes a monitoring probe working in conjunction with an ablating device. The probe is configured to be positioned in close proximity to a region of non-targeted tissue proximate an ablation site of targeted tissue and to be operatively connected to an electrical response assessment system or component. The probe includes an elongate shaft having proximal and distal ends, with a handle disposed at the proximal end thereof and a tissue monitoring and protecting apparatus disposed at the distal end thereof. The ablating device includes an elongate shaft having proximal and distal ends, with a handle mounted at the proximal end thereof and an ablation element mounted at the distal end thereof. The monitoring probe measures electrical characteristics of the non-targeted tissue and/or of the tissue between the monitoring electrode and the ablation electrode.

Abstract: A balloon catheter is disclosed which allows easier fusion-bonding between an inner tube shaft and an outer tube shaft and in which the inner tube shaft can be prevented from being warped when the inner tube shaft passes through a stenosed site, and a method of manufacturing such a balloon catheter. The balloon catheter includes an inner tube shaft having a first layer and a second layer located on an inner surface side of the first layer. The outer tube shaft is fusion-bonded to the first layer and recessed toward the inner tube shaft side. The first layer is formed of a material having higher optical absorption property than the outer tube shaft and the second layer. The second layer is formed of a material having a melting point higher than that of the first layer.

Abstract: Devices and methods for delivering treatment fluids or particulates such as, stem cells, drugs, Botox and like, to an inner lining of a bladder for treatment of urinary tract disorders, including over-active bladder. A balloon delivery system can include an inflation balloon having a plurality of micro-needles configured to pierce and otherwise puncture an inner bladder wall so as to deliver the treatment fluid to bladder tissue. The treatment fluid can be directly injected into the bladder tissue using the micro needles. Alternatively, the micro needles can be fabricated of bioabsorbable or bioresorbable materials such that the micro needles can remain embedded within the bladder tissue to deliver the treatment fluid or particulate.

Abstract: A balloon catheter (10) with a shaft (14,24) extending in a longitudinal direction and having a proximal end and a distal end and an inflatable balloon positioned along the shaft. The balloon (12) includes at least one portion connected to the shaft and adapted for moving toward the proximal end thereof when the balloon is inflated. Related aspects are disclosed.

Abstract: A container (200) for containing a coupling medium for transdermal delivery of a medicament and a transducer unit (100) for use with the container (200) are disclosed. The transducer unit (100) has a transducer (108) with an output face (110), and the container comprises a chamber (214) for receiving the coupling medium and a contact surface (212) for contacting the output face (110) of the transducer (108). The container (200) is attachable to the transducer unit (100) and is arranged such that, upon attachment of the container (200) to the transducer unit (100), an acoustic coupling for ultrasound transmission is formed between the output face (110) of the transducer (108) and the contact surface (212).

Abstract: A system for use with an endoscopic device. The system can include a shaft having a proximal end, a distal end, and at least one output port, wherein a portion of the shaft is surrounded by a single polyurethane expandable material, wherein the polyurethane expandable material is expandable from a diameter of at least approximately 5.0 mm to a diameter of approximately 25 mm. The system can also include a manifold connected to the proximal end of the shaft, the manifold including one or more fluid coupling ports for receiving an injected fluid, wherein at least one of the one or more fluid coupling ports is in fluid communication with the at least one output port and wherein when received, the system is configured to convey the injected fluid from the manifold to the shaft resulting, at least in part, in expanding the polyurethane expandable material.

Abstract: Catheter assemblies and methods for making and using catheter assemblies are disclosed. An example a catheter assembly includes a catheter shaft and a balloon attached to the catheter shaft. The balloon includes a body and a proximal waist portion. The proximal waist portion has a proximal end. The catheter assembly also has a fiber braid including one or more individual filaments disposed along the balloon. The fiber braid has a proximal end aligned with the proximal end of the waist portion. The catheter assembly also has a polymer sleeve disposed on the catheter shaft, wherein in the polymer sleeve abuts the proximal end of the balloon waist and the proximal end of the braid.

Abstract: Balloon catheters that includes inner and outer elongate shafts, each of which is secured relative to an end of an inflatable member. The inner and outer elongate shafts are secured relative to one another at one more discrete connection locations. The balloon bonding locations are disposed radially inward relative to an outer dimension of the outer elongate shaft.

Abstract: A system for treating a bifurcation includes a first radially expandable stent and a second radially expandable stent. The first stent has a side hole and a plurality of lateral elements extending from the side hole. The second stent has a plurality of axial elements extending away from the proximal end of the second stent. The axial elements of the second stent interdigitate with the lateral elements of the first stent when both stents have been expanded.

Abstract: Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

Abstract: In some examples, a catheter includes an elongated body including a proximal portion and a distal portion. The elongated body includes an inner liner, an outer jacket, a structural support member positioned between at least a portion of the inner liner and at least a portion of the outer jacket, and an expandable member coupled to the structural support member at the distal portion of the elongated body. The expandable member may be configured to expand radially outward, e.g., to engage a clot within vasculature of a patient.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter. The catheter may include a catheter shaft and a balloon. The balloon may comprise a cone portion, a waist portion, and a body portion. A fiber braid may be disposed along the balloon. An inner surface of the waist portion may be thermally bonded to an outer surface of the catheter shaft and an inner surface of the fiber braid may be adhesively bonded to an outer surface of the waist portion.

Abstract: An expandable balloon, for insertion in a vessel of the human or animal body, is movable between a collapsed condition and an expanded condition. The balloon includes a plaque disrupting formation arranged to be on an outer surface of the balloon when in the expanded condition. When in the expanded condition, the balloon has a centre line which follows a substantially helical path.

Abstract: Systems, devices, and methods including balloon catheters are described. In one embodiments, a balloon catheter assembly may comprise a tubular member having a proximal portion and a distal portion with a lumen extending between the proximal portion and the distal portion and a balloon member having a proximal waist portion, a distal waist portion, and an expandable region therebetween, the balloon member disposed proximate the distal portion of the tubular member and bonded to tubular member. The assembly may further comprise a first sleeve member covering a first portion of the tubular member and a portion of the balloon member proximal waist portion and a second sleeve member covering a second portion of the tubular member and a portion of the first sleeve member.

Abstract: In some embodiments, an apparatus includes an introducer sheath and a dilator. The introducer sheath can include a body portion and a tip portion. The body portion can be coupled to the tip portion via a seal portion. The dilator can be configured to be inserted into a lumen defined by the introducer sheath such that the dilator can engage with the tip portion and translate the tip portion relative to the body portion such that the tip portion moves the seal portion from a biased neutral configuration to an extended configuration for delivery of the apparatus to a location in a patient's body. The seal portion can have a larger outermost diameter in the neutral configuration than in the extended configuration.

Abstract: A medical device for the treatment and irrigation of a sinus opening is described. The device allows for single-handed operation to access, dilate and irrigate a sinus opening. The device includes a sinus guide catheter, a guiding element, a balloon dilation catheter, a balloon catheter movement mechanism and a guiding element movement mechanism. A method for treating a sinus opening and irrigating a sinus is also described.

Abstract: A balloon catheter prevents detachment of a balloon from an inner shaft without using a conventional sleeve or heat-shrinkable tube. The balloon catheter includes a balloon, an inner shaft, and a tip having a proximal end portion that covers an outer periphery of a distal end of the balloon. The distal end of the balloon is sandwiched between the inner shaft and the proximal end portion of the tip, thereby joining the distal end of the balloon to the inner shaft and the tip.

Abstract: Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.

Abstract: A radiopaque balloon with a composite wall having a radiopaque adhesive affixing inner and outer layers of the balloon. The radiopaque adhesive provides a radiographic image of the balloon wall with or without the use of a radiopaque contrast media to inflate the balloon. A radiographically fainter image is provided as the balloon is inflated with well-defined edges of a balloon image, and the total radiopacity of the balloon does not change as the balloon is inflated. Also, a method of imaging a balloon wall and a method of imaging a radiopaque adhesive between two layers of a balloon wall are provided.

Abstract: A medical device may include a catheter, an expandable member, a cover, and an actuator. The catheter may include a longitudinal axis, proximal and distal ends, and a cover lumen extending from the proximal to the distal end. The expandable member may include proximal and distal ends and may be disposed on a distal section of the catheter. The cover may include a first region that may be disposed along the expandable member, and a second region that may extend along a length of the catheter beyond the proximal end of the expandable member towards the proximal end of the catheter. A first end of the cover may invert into the cover lumen. The actuator may be coupled to the first end of the cover and configured to move the first end of the cover towards the proximal end of the catheter along the longitudinal axis of the catheter.

Abstract: A balloon catheter assembly is provided with an outer catheter, an inner catheter, an outer adapter and a balloon, and is configured such that the balloon resides entirely within a predetermined volume having an outer diameter substantially equal to or less than the outside diameter of the distal end of the outer catheter when the balloon is in a deflated configuration. Methods of using and steering the catheter assemblies are also provided.

Abstract: A process for manufacturing an electrical lead having one or more electrodes includes providing an elongate member having at least one polymeric region and further having at least one electrical conductor that extends along at least a part of a length of the elongate member and that is contained in a wall of the elongate member. A length of the at least one electrical conductor is accessed at the at least one polymeric region. An electrically conductive adhesive is applied to the length of the at least one electrical conductor that has been accessed.

Abstract: A medical flow restrictor that may be used to exclude a saccular aneurysm from the circulatory system. The device, a thin walled, foil-like shell, is compacted for delivery. The invention includes the device, electroforming fabrication methods, delivery assemblies, and methods of placing, and using, the device. A device with an aneurysm lobe and an artery lobe self-aligns its waist at the neck of an aneurysm as the device shell is pressure expanded. Negative pressure is used to collapse both the aneurysm lobe and the artery lobe, captivating the neck of the aneurysm and securing the device. The device works for aneurysms at bifurcations and aneurysms near side-branch arteries. The device, unlike endovascular coiling, excludes the weak neck of the aneurysm from circulation, while leaving the aneurysm relatively empty. Unlike stent-based exclusion, the device does not block perforator arteries. This exclusion device can also limit flow through body lumens or orifices.

Abstract: A balloon catheter including an elongated catheter main body portion and a balloon provided on the distal portion of the catheter main body portion. The balloon is inflatable to expand radially outward into an inflated state and deflatable to contract radially inward into a deflated state. The catheter main body portion includes a hollow outer tube and a hollow inner tube disposed within the outer tube. The balloon includes a contact portion that contacts the outer surface of the inner tube and a vane portion protruding from the contact portion radially outward when the balloon is in the deflated state. The contact portion of the balloon includes a connecting portion that connects the balloon to the catheter main body portion.

Abstract: Systems and methods for treating eating disorders using electro-physiologically active transducer intragastric balloon system (“EAT system”) are described herein. The EAT System includes an intragastric balloon that is configured to operate in a typical fashion and further modified to include an integrated electro-physiological stimulation unit. The stimulation unit is configured to generate impulses using a transducer that are suitable for stimulating sensory receptors located around the stomach. In particular, transducer transmits mechanical waves through the fluid within the IG balloon and its outer shell to any receptors of the vagus nerve system that are located in the vicinity of the IG balloon. Controlled stimulation of the vagus nerve fibers using the stimulation unit can effectively produce appetite controlling sensations of satiety beyond the typical efficacy period of an unmodified IG balloon.

Abstract: Method and system for treating a patient using a compressible, pressure-attenuating device. According to one embodiment, the system is used to treat urinary tract disorders and comprises an access device, a delivery device, a pressure-attenuating device, and a removal device. The access device may be used to create a passageway to an anatomical structure, such as the patient's bladder. The delivery device may be inserted through the passageway created by the access device and may be used to deliver the pressure-attenuating device to the anatomical structure. The removal device may be inserted through the passageway created by the access device and may be used to view the bladder and/or to capture, to deflate and to remove the pressure-attenuating device.

Abstract: A balloon catheter (10) with a shaft (14,24) extending in a longitudinal direction and having a proximal end and a distal end and an inflatable balloon positioned along the shaft. The balloon (12) includes at least one portion connected to the shaft and adapted for moving toward the proximal end thereof when the balloon is inflated. Related aspects are disclosed.

Abstract: An improved balloon catheter structure includes a beveled distal tip, a reinforced distal portion, and an elastic or split sleeve over at least a portion of the balloon. The balloon may have a short length and a marker at its midline. The catheters are particularly useful for crossing through stent walls at vessel bifurcations.

Abstract: Balloon catheter includes an outer shaft including a hypotube and a monolithic multilayer distal outer member and having an inflation lumen defined therethrough, a balloon in fluid communication with the inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multilayer distal outer member has a proximal end portion and a distal end portion. The monolithic multilayer distal outer member has an inner layer comprising a first polymer having a tensile strength greater than about 8,000 psi and an outer layer comprising a second polymer having a flexural modulus of less than about 130,000 psi at room temperature. A proximal end of the monolithic multilayer distal outer member is coupled to the hypotube. The monolithic multilayer distal outer member is necked to a reduced diameter along at least a portion of a length thereof. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic multilayer distal outer member.

Abstract: Balloon catheter includes an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and a monolithic inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The monolithic inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through the balloon to form a tip.

Abstract: Balloon catheter includes an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through at least a portion of the balloon.

Abstract: A system and method for conditioning surfaces of a body in vivo includes providing an electrical energy source, coupling the electric energy source to the surface, and delivering electropositive current from the electrical energy source to the surface so as to generate a sub-threshold current density on the surface. In preferred embodiments, the sub-threshold electropositive current density is between about 0.001 and about 1.0 mA/cm2.

Abstract: According to aspects of the present disclosure, a system may include a loading device including an exterior surface. The system may also include an expandable member mounted on the exterior surface of the loading device. The expandable member may be configured to selectively transition between a collapsed state and an expanded state. The system may also include a covering mounted on the expandable member. The covering may extend around the expandable member and the loading device. The loading device may be configured to position the expandable member and the covering for mounting on an exterior surface of an elongate introduction sheath.

Abstract: Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a tubular restraint. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as percutaneous nephrostomy or urinary bladder access.

Abstract: Embodiments of the present invention are directed to a rigid connector which joins an inflation lumen to an inflatable element in a medical device. The connector comprises a shaft fluidly connected to a crossbar. Preferably one embodiment provides a stable junction through which an inflation fluid may pass and inflate an inflatable element which is not co-linear with the axis of inflation. The junction maintains a generally rigid, fixed angle in relation to the axis of the inflation lumen, which in many embodiments is perpendicular to said axis. This fixed orientation creates a robust structure which is resistant to deflection when forces are encountered during its use within tubular and non-tubular structures within the human body. Such a structure maintains a rigid orientation between the inflatable element and the catheter body.

Abstract: Thrombus removal apparatus includes a balloon catheter with a short balloon at a distal end thereof. An aspiration catheter is disposed coaxially over the balloon catheter. The balloon catheter includes a plurality of holes for the administration of lytic agent. The apparatus does not seal off completely the zone of the vessel around the thrombus, thereby allowing movement of blood within the vessel. The balloon is shaped so that it can be pulled along the vessel in an upstream direction so as to drag against the vessel walls for assisting in the removal of the thrombus.

Abstract: The present invention provides a balloon catheter comprising: an elastic catheter tube in which a second tube is slidably inserted into a first tube; and an elasticity restriction means for restricting the elasticity of the catheter tube with an elasticity rate thereof by connecting the first tube and the second tube, or a balloon catheter in which an inflation lumen and a guide wire lumen of a catheter tube are integrated.

Abstract: A balloon catheter prevents detachment of a balloon from an inner shaft without using a conventional sleeve or heat-shrinkable tube. The balloon catheter includes a balloon, an inner shaft, and a tip having a proximal end portion that covers an outer periphery of a distal end of the balloon. The distal end of the balloon is sandwiched between the inner shaft and the proximal end portion of the tip, thereby joining the distal end of the balloon to the inner shaft and the tip.

Abstract: The embodiments disclosed herein relate to balloon catheter assemblies. The balloon catheter assemblies can include a hub, an elongated member, and an inflation balloon. The balloon catheter assemblies can also include a support wire having a proximal end that is longitudinally displaceable within a sleeve that is disposed in the catheter hub. A distal end of the support wire may be coupled to the inflation balloon at one or more positions.

Abstract: Electrode placement and connection systems are described which allow for the electrical connection and maintenance of one or more electrodes positioned on a substrate which is subjected to a variety of mechanical stresses. Electrodes may also be formed on flexible circuit assemblies integrated within or along the hood. The circuit assemblies may also provide structural support to the hood during delivery and/or deployment. Such a system may include an imaging hood having an aperture through which transparent fluid is flowed and one or more electrodes positioned along or about the hood. As the hood is configured between a low-profile and opened configuration, these electrodes may remain electrically coupled despite the mechanical stresses subjected to the electrodes and the connections thereto.

Abstract: The embodiments disclosed herein relate to balloon catheter assemblies. The balloon catheter assemblies can include a plurality of ports, a junction hub, an elongated member, and an inflation balloon. The balloon catheter assemblies can also include a reinforced tubular shaft extending through the inflation balloon. The balloon catheter assemblies can also include a retaining mechanism that can be removably attached to the junction hub.

Abstract: An elongate medical device handle may comprise a body defining an interior, an exterior, and a connector port extending between the interior and the exterior and defining an axis. The connector port comprises a portion having a polygonal cross-section taken transverse to the axis. In an embodiment, the polygonal cross-section may comprise a star shape. In an embodiment, a connector, such as a fluid connector, may be secured in the connector port using an adhesive.

Abstract: A camera system (1) for monitoring the inside of a body (1), includes: a camera support tube (13) of which one end part (13a) is inserted into the body; a camera unit (11) which joins with the support tube inside the body; a camera side cable (12) which is connected to the camera unit, and is drawn out toward the outside of the body through the camera support tube; a control system (3) which includes at least a display (18); and a string-like member (38) which directly or indirectly fixes the camera support tube to the body surface.

Abstract: A waste management system includes a waste transport device and a waste collection device. The waste transport device includes a collection member with a distal end opening having a first cross-sectional area and a proximal end opening having a second cross-sectional area less than the first cross-sectional area, a retention cuff disposed about an outer surface of the collection member, and a first section having a lumen in fluid communication with a lumen of the collection member.

Abstract: A semi-compliant fiber-reinforced medical balloon having a folded wall thickness of from about 0.0010 to about 0.0060 inches and a rated burst pressure of at least 15 atmospheres and exhibiting compliance in the radial direction of from 0.5% expansion per atmosphere to rated burst pressure of the balloon includes a base balloon formed from a semi-elastic polymer about 1.0% expansion per atmosphere when pressurized from a fully inflated diameter to the material having an elongation to break of from about 10% to about 20%, a fiber layer is disposed over the base balloon with fibers having an elongation to break of from about 10% to about 20% and an outer layer formed from a semi-elastic polymer material having an elongation to break of from about 10% to about 20% disposed over the fiber layer.

Abstract: An apparatus for vascular denervation, comprising a catheter configured for delivery into a vessel of a patient. A balloon is mounted on a distal tip of the catheter, the balloon being configured to be inflatable and further configured so that, upon inflation, the balloon adopts a shape that includes a first edge and a second edge that wind around each other in a double helix, the first edge and the second edge being separated from each other by a first crease and a second crease that also wind around each other in a double helix. A first electrode is attached to the balloon and is located to extend along the first edge.

Abstract: The invention provides methods for the treatment of vaginal laxity which include delivering a cell-containing composition to the vagina. The composition can include fat tissue to provide a bulking effect to reduce the size of the vaginal opening. The cells can provide healing and revascularization of the vaginal treatment area to sustain the bulking provided by the fat. The invention also provides systems and compositions useful for performing the method, and can include instruments and devices for removal of autologous adipose tissue from a patient (e.g., by liposuction), equipment for the enrichment of cells from adipose tissue, mechanical processing of adipose tissue, and the mixing of cells and processed adipose tissue. Devices for the delivery of the cell compositions to the vagina can also be included in the system.

Abstract: An apparatus for medical diagnosis and/or treatment is provides. The apparatus includes a flexible substrate forming an inflatable body and a plurality of force sensing elements disposed on the flexible substrate. The plurality of force sensing elements are disposed about the inflatable body such that the force sensing elements are disposed at areas of minimal curvature of the inflatable body in a deflated state.

Abstract: A medical balloon (10) of a balloon catheter assembly (70) includes a balloon wall (22) formed of at least two layers (30, 32). The first layer (30) is made of an impervious polymeric material. The second layer (32), which is integral with the first layer (30) is made of a radiopaque and/or echogenic material and a polymeric material. In the preferred embodiment, there is provided 60 to 80% by weight of radiopaque material in the second layer (32). It has been found that these concentrations of radiopaque material provide good visibility of the balloon under ultrasonic imaging.