Abstract: An apparatus and methods tissue restoration are provided. The apparatus may include a catheter shaft extending from a proximal end to a distal tip, a plurality of serial balloons positioned on a translucent distal segment of the catheter shaft proximal to the distal tip and positioned inside of and concentric with a second distal balloon, the plurality of serial balloons in fluid communication with an inflation source via a first lumen, each of the plurality of serial balloons having a selectively expandable outermost radial surface. The plurality of serial balloons may include a translucent material, a series of isolated volumetric regions positioned between the plurality of serial balloons and recessed from the outermost radial surfaces of the serial balloons. The apparatus may include a distal balloon positioned around the plurality of serial balloons, and a light fiber positioned in the catheter shaft and extending through the translucent distal segment.

Abstract: An attachment system for detachably attaching an additional channel to an endoscope, the attachment system comprising: a sleeve for receiving a distal end of the endoscope and a distal end of the additional channel in use, the sleeve having: a sleeve body defining a sleeve channel, through which the distal end of the endoscope and the distal end of the additional channel will extend in use, and having a first open end and a second open end; a rupture mechanism for rupturing the sleeve body to allow separation of the distal end of the additional channel from the distal end of the endoscope.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: An apparatus and methods tissue restoration are provided. The apparatus may include a catheter shaft extending from a proximal end to a distal tip, a plurality of serial balloons positioned on a translucent distal segment of the catheter shaft proximal to the distal tip and positioned inside of and concentric with a second distal balloon, the plurality of serial balloons in fluid communication with an inflation source via a first lumen, each of the plurality of serial balloons having a selectively expandable outermost radial surface. The plurality of serial balloons may include a translucent material, a series of isolated volumetric regions positioned between the plurality of serial balloons and recessed from the outermost radial surfaces of the serial balloons. The apparatus may include a distal balloon positioned around the plurality of serial balloons, and a light fiber positioned in the catheter shaft and extending through the translucent distal segment.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: The present invention includes a medical device providing for the measurement and/or monitoring of the thermal conditions and/or environment existing across a substantial portion of a thermal element disposed on the medical device and the corresponding tissue region being treated by the device. The medical device of the present invention may generally include an elongate body having a thermal element coupled thereto for providing thermal energy to a desired tissue region, as well as a thermocouple array providing a plurality of temperature measurement positions about the thermal element. The thermocouple array may include one or more thermocouple elements arranged as a mesh or wire structure disposed about a substantial portion of the surface area of the thermal element.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, having a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system comprises a PID (Proportional Integral Derivative) controller or other pressure-sensing device that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted. In one embodiment, an intermediate console is placed between the console and the balloon catheter and coupled thereto.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system may include controller that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

Abstract: Medical devices and methods for deriving an indication of occlusion of a blood vessel from one or more physiologic sensor are disclosed. The physiological parameters contemplated for implementation in accordance with embodiments of the disclosure may include pressure, flow, force, temperature, or tension. An exemplary device comprises a catheter having an expandable chamber coupled to a distal end portion of the catheter shaft. In various embodiments, one or more physiologic sensors may be disposed on the catheter shaft and electrically coupled to control electronics that may be provided in a console for measurement of a physiologic signal. Alternatively, an external sensor may be disposed in fluid communication with a lumen of the catheter to derive a physiological parameter such as pressure via mechanical coupling of pressure distal to the expandable chamber to the fluid in the lumen.

Abstract: The present invention may include a medical device having a handle, a catheter coupled to the handle, and an expandable element coupled to the catheter. The medical device may also include first and second elongate bodies that traverse a length of the handle and catheter. A housing may be disposed within the handle, wherein the housing defines a first opening able to receive a portion of the first elongate body, a second opening able to receive a portion of the second elongate body, and a third opening opposite the first and second openings able to receive a portion of both the first and second elongate bodies. A separation element may be disposed within the housing, with the separation element defining a path able to receive a portion of the second elongate body, and whereby a portion of the first elongate body forms a loop around the separation element.

Abstract: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. One or more sensors may be disposed between the balloons or the vacuum return lumen, to detect leaks and control the flow of fluid through the device. Examples of sensors include pressure and temperature sensors, optical sensors, magnetic flow switches and flow meters.

Abstract: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. One or more sensors may be disposed between the balloons or the vacuum return lumen, to detect leaks and control the flow of fluid through the device. Examples of sensors include pressure and temperature sensors, optical sensors, magnetic flow switches and flow meters.

Abstract: The present invention includes a medical device providing for the measurement and/or monitoring of the thermal conditions and/or environment existing across a substantial portion of a thermal element disposed on the medical device and the corresponding tissue region being treated by the device. The medical device of the present invention may generally include an elongate body having a thermal element coupled thereto for providing thermal energy to a desired tissue region, as well as a thermocouple array providing a plurality of temperature measurement positions about the thermal element. The thermocouple array may include one or more thermocouple elements arranged as a mesh or wire structure disposed about a substantial portion of the surface area of the thermal element.