Abstract: The present invention provides an enhanced method and device to inhibit or reduce the rate of restenosis following angioplasty or stent placement. The invention involves placing a balloon tipped catheter in the area treated or opened through balloon angioplasty immediately following angioplasty. The balloon, which can have a dual balloon structure, may be delivered through a guiding catheter and over a guidewire already in place from a balloon angioplasty. A fluid such as a perfluorocarbon may be flowed into the balloon to freeze the tissue adjacent the balloon, this cooling being associated with reduction of restenosis. The catheter may also be used to reduce atrial fibrillation by inserting and inflating the balloon such that an exterior surface of the balloon is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium.

Abstract: Clamp based low temperature lesion formation apparatus, systems and methods.

Abstract: A removable cryogenic probe appliance is disclosed comprising a proximal portion and a distal portion, the proximal portion being releasably attachable to a cryogenic probe. The appliance further comprises a material having high thermal conductivity for conducting heat between said proximal and distal portions. A cryogenic probe system and methods of forming and using a cryogenic probe of selected shape are also disclosed, comprising providing a plurality of removable cryogenic probe appliances of differing shapes, selecting one of said appliances of the desired shape, and attaching the proximal portion of such selected appliance to a cryogenic probe.

Abstract: A method for applying energy to biological tissue. An electromagnetic energy source is directed to apply the energy to a region of the tissue, so as to ablate a portion of the tissue in the region. Preferably, cooling of tissue in the region is initiated subsequent to the ablation.

Abstract: A cryogenic medical system includes a medical device and a console connectable to the medical device at a connection point. The console controls the temperature of the medical device. The console includes a first cooling system directing coolant to the medical device at a first temperature along a coolant supply line and a second cooling system chilling the coolant within the coolant supply line to a temperature below the first temperature before the coolant reaches the connection point.

Abstract: A cryosurgical probe system includes a fluid supply line connectable at an inlet section to a source of cryogenic fluid; a fluid connector assembly securely connected to an outlet section of the fluid supply line for receiving fluid from the outlet section of the fluid supply line; and, a detachable cryosurgical probe detachably connectable to the fluid connector assembly. The cryosurgical probe system includes the capability of providing return fluid flow.

Abstract: A system for cryoablating target tissue at a treatment site includes a cryo-element that is attached to the distal end of a cryo-catheter. An annular shaped balloon is attached to a cylindrical shaped sleeve and the sleeve is slideably mounted over the cryo-catheter. The distal end of a fill tube is attached to the sleeve to place the lumen of the fill tube in fluid communication with the balloon. In use, the cryo-element is first positioned at the treatment site using the cryo-catheter. Next, the fill tube is used to advance the balloon and sleeve over the cryo-catheter until the balloon is interposed between the cryo-element and the target tissue. Saline solution is then pumped through the fill tube to expand the balloon between the cryo-element and target tissue. A refrigerant is then expanded in the cryo-element which freezes the saline solution and cryoablates the target tissue.

Abstract: The present invention pertains to devices for causing cold-induced necrosis or apoptosis. The present invention includes a cryo therapy apparatus including a core member; a cryoplasty tube coupled to the core member, the cryoplasty tube having a proximal end and a distal end; wherein the distal end includes a coil disposed about at least a portion of the tubular sheath, the coil including at least one opening; an outer tube disposed over at least a portion of the cryoplasty tube; and a cooling member disposed over the coil and coupled to the outer tube. A method of causing cold-induced necrosis is also disclosed.

Abstract: A system for detecting leaks and occlusions in a cryoablation catheter requires monitoring pressure in the catheter at the end of two predetermined time intervals. The catheter includes a catheter tube, a cryo-chamber at the distal end of the catheter, and a supply line for introducing fluid refrigerant into the cryo-chamber. Also included is a pressure sensor mounted in the cryo-chamber for measuring a tip pressure. During the first time interval, fluid refrigerant is prevented from flowing through the catheter while the catheter is evacuated by a vacuum pump. The tip pressure is then measured to detect leaks. During the second time interval, fluid refrigerant is introduced into the cryo-chamber while evacuation continues, and the tip pressure is measured to detect occlusions.

Abstract: Low temperature lesion formation apparatus, systems and methods. The apparatus includes a base member and an inflatable element carried by the base member.

Abstract: A cryosurgical probe system includes a fluid supply line connectable at an inlet section to a source of cryogenic fluid; a fluid connector assembly securely connected to an outlet section of the fluid supply line for receiving fluid from the outlet section of the fluid supply line; and, a detachable cryosurgical probe detachably connectable to the fluid connector assembly. The cryosurgical probe system includes the capability of providing return fluid flow.

Abstract: A cryoablation device having a pressure monitoring system includes an elongated catheter tube that has a central lumen and is formed with a closed distal end. The distal end of a refrigerant supply line is positioned in the central lumen and distanced from the catheter tube's distal end to establish an expansion chamber therebetween. A return line, which can be established between the supply line and the catheter tube or can include a return tube, is provided to exhaust expanded refrigerant from the chamber. First and second pressure sensors are respectively positioned in the supply line upstream from the expansion chamber and in the return line. Typically, both sensors are positioned to remain at extracorporeal locations throughout a cryoablation procedure. Measured pressures are used together with the supply and return line dimensions to analytically estimate the chamber pressure and allow the expansion of refrigerant in the chamber to be monitored.

Abstract: A cryosurgery apparatus is disclosed. The cryosurgery apparatus an introducer having a hollow and a distal portion, the distal portion being sufficiently sharp so as to penetrate into a body, the hollow of the introducer being designed and constructed for containing a plurality of cryoprobes each of the cryoprobes being for effecting cryoablation, such that each of the plurality of cryoprobes is deployable through the distal portion of the introducer when the distal portion is positioned with respect to a tissue to be cryoablated.

Abstract: A dermatological treatment apparatus is disclosed that is cordless and sufficiently compact as to be hand-held. A self-contained housing is configured for gripping by a person's hand for cordless manipulation in a dermatologic treatment procedure. A light source and electrical circuit are contained within the housing. The circuit includes one or more batteries and an electronic control circuit for energizing the light source to produce output light pulses. A light path is within the housing including an aperture through which the output light pulses are propagated out of the housing having properties sufficient for providing efficacious treatment.

Abstract: A device for cryoablating exposed tissue having a contoured contact surface includes a tube-shaped shaft and a flexible, thermally conductive enclosure that is attached to the distal end of the tube-shaped shaft. The enclosure is formed with a wall having an outer surface for contacting the target tissue and an inner surface which establishes and surrounds a cryochamber. A shapeable element is attached to the distal end of the shaft and extends into the cryochamber. The element can be permanently deformed into a pre-selected shape to cause a portion of the enclosure wall to conform to the contour of the target tissue. A high-pressure tube in the shaft passes a refrigerant through the shaft for expansion into the cryochamber. This expansion cools the wall of the enclosure, which in turn, extracts heat from the target tissue resulting in the cryoablation of the target tissue.

Abstract: An expandable apparatus for use with a surgical probe having a temperature-controlled portion includes at least one thermally-conductive elongated extension member and means for thermally connecting and attaching the extension member to the surgical probe. The expandable apparatus further includes means for attaching and moving the extension member between a closed configuration in which the extension member is substantially parallel to the surgical probe and an open configuration in which the extension member extends radially outward from the surgical probe. A method of using the expandable apparatus to ablate tissue that line a body cavity is also disclosed.

Abstract: Disclosed is an apparatus and method for preventing secondary ischemic injury in the brain. The apparatus includes an interstitial brain probe and an introducer sheath, which are placed into an ischemic region of the brain by stereotaxic surgical technique. The interstitial brain probe and introducer sheath provide for thermal coagulation to provide hemostasis, aspiration of blood clots, infusion of therapeutic agents, and localized hypothermia within an ischemic region of the brain. The interstitial brain probe cools an ischemic region of the brain from within the ischemic region, and cooling is substantially limited to the ischemic region. Cooling is provided for a period of time greater than one hour.

Abstract: Methods and apparatus for dermatology treatment are provided which involve the use of continuous wave (CW) radiation, preheating of the treatment volume, precooling, cooling during treatment and post-treatment cooling of the epidermis above the treatment volume, various beam focusing techniques to reduce scattering and/or other techniques for reducing the cost and/or increasing the efficacy of optical radiation for use in hair removal and other dermatological treatments. A number of embodiments are included for achieving the various objectives indicated above.

Abstract: Systems and methods for assessing the formation of an ice ball during a cryoablation procedure are disclosed. The system includes a reference electrode that is placed in contact with the patient and a cryocatheter having a cryotip. An electronic circuit is connected to both the cryotip and the reference electrode to measure the impedance therebetween which can be used to assess the formation of an ice ball during a cryoablation procedure. An exemplary measurement signal has a frequency of approximately 20 khz and an RMS voltage of approximately 0.5V. With the cryotip positioned proximate the target tissue, a reference impedance is measured. Next, the conductive tip member is placed in contact with the target tissue and cooled to form an ice ball. During cooling, impedance measurement(s) are taken and compared with the reference impedance to assess the formation of the ice ball.

Abstract: A medical device is provided having a means for actuating a pair of opposing jaw members. The jaw members are movable relative to one another from a first position, wherein the jaw members are disposed in a spaced apart relation relative to one another, to a second position, wherein the jaw members cooperate to grasp tissue therebetween. An ablation tool is connected to at least one of the jaws members, such that the jaw members are capable of conducting ablation energy through the tissue grasped therebetween.

Abstract: An Intense Pulsed Light apparatus for cosmetic or therapeutic treatment of the skin having a light source is provided with a light guide having an entry face in a rigid light guide component and an exit face in a flexible light guide component adapted to conform to highly curved parts of the body of a patient.

Abstract: A hair removal device (22) includes a cooling surface (34) which is used to contact the skin (6) prior to exposure to hair tissue-damaging laser light (74) passing from a radiation source (36) through a recessed window (46). The window is laterally offset from the cooling surface and is spaced apart from the cooling surface in a direction away from the patient's skin to create a gap between the window and the skin. The window preferably includes both an inner window (46) and an outer, user-replaceable window (48). The laser-pulse duration is preferably selected according to the general diameter of the hair.

Abstract: A method and apparatus to treat Barrett's tissue, a pre-cancerous condition, by removing the epithelium above the lower esophageal sphincter through cryo-ablation. An endoscope with fiber optics is used to view the operation, and a catheter for supplying liquid nitrogen is passed through the lumen of the endoscope. Liquid nitrogen at low pressure is sprayed directly onto the Barrett's tissue through the catheter while the physician views the operation through the fiberoptics of the endoscope and controls the spray via a valve. Freezing is indicated by whiteness and shows that the epithelium has been cryoablated. The apparatus can also be used to treat various other gastrointestinal tract lesions. The catheter is insulated to withstand extremely cold temperatures without becoming stiff and without affecting the inherent flexibility and maneuverability of the endoscope.

Abstract: A waveguide and radiation delivery system is disclosed to be used in topical applications of photodynamic therapy. One preferred embodiment consists of a rectangular waveguide that delivers electromagnetic radiation to a flexible conducting sheet that can be molded to the contours of the treatment sight. The sheet is surrounded by a reflective material or foil, except for the portion of the sheet in contact with the treatment area. That portion is covered with a semi-reflective sheet that is at least translucent with respect to the wavelength used in the treatment. This invention increases the speed and efficiency of the procedure by reducing energy loss due to reflection from the skin surface. It also increases safety by protecting sensitive areas of the body, and is particularly useful for head and neck procedures. Other embodiments include the use of a bladder-type applicator or a rectangular applicator designed to keep the optical fiber a specified distance from the treatment site.

Abstract: The invention provides improved devices, methods, and systems for shrinking of collagenous tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient's own support tissues. This energy gently heats fascia and other collagenous support tissues, causing them to contract. The energy will preferably be applied between a pair of large plate electrodes having cooled flat electrode surfaces separated by an insulating rib or film. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue.

Abstract: A method of cooling an operative surface of a cryoablation device, comprises the steps of providing a primary refrigerant under pressure and pre-cooling the primary refrigerant to a temperature below a critical temperature thereof using a non-charging refrigeration system to liquify the refrigerant in combination with the steps of expanding the pre-cooled primary refrigerant in proximity to an operative surface of the cryoablation device and removing the expanded primary refrigerant from the proximity of the operative surface.

Abstract: A system and method for transferring heat requires a supply tube connected in fluid communication with a capillary tube. A tip member is positioned to surround the distal end of the capillary tube to create a cryo-chamber. In operation, a liquid refrigerant is introduced into the supply tube at a working pressure (e.g. 450 psia). The pressure is then significantly reduced on the liquid refrigerant as it transits through the capillary tube. The refrigerant then exits the distal end of the capillary tube, still in its liquid state. Inside the cryo-chamber, at a pressure of less than about one atmosphere, the refrigerant transitions into its gaseous state. The resultant refrigeration causes heat to transfer into the cryo-chamber.

Abstract: This invention relates to the field of medical instruments and particularly to an apparatus used to apply cryotherapy to an injury. The apparatus is comprised of a vessel, a driver, and a directional controller. The vessel is configured such that when it is filled with a liquid and refrigerated, the resultant frozen solid formed within the vessel can be extruded via an exiting aperture. The driver forms a watertight seal with the vessel, allowing the vessel to be filled with liquid and frozen. The directional controller comprises flexible tabs that exert pressure on the sides of the frozen solid, limiting the movement of the frozen solid to one-way extrusion. The user applies force to the driver, thereby urging the frozen solid past the directional controller and out via the exit aperture.

Abstract: A cryogenic catheter includes an outer flexible member having at least one cryogenic fluid path through the flexible member. The at least one fluid path is defined by a plurality of flexible members disposed within the outer flexible member.

Abstract: The malleable cryosurgical probe includes a cryostat assembly and a cryoprobe assembly. The cryostat assembly includes an elongated shaft assembly having at least one malleable segment thereof and a closed distal end. The shaft assembly includes at least one freezing portion, at least one thermally insulated portion and a thermally insulating element positioned about the thermally insulated portion. A cryostat is operably associated with the elongated shaft assembly. It includes a cryostat inlet for receiving gas entering the cryostat, a cryostat outlet and a heat exchanger positioned between the cryostat outlet and the cryostat inlet. The heat exchanger receives gas from the cryostat inlet and provides heat transfer between gas flowing within the cryostat and fluid exterior thereto. At least one Joule-Thomson nozzle is in fluid communication with the cryostat outlet. The at least one Joule-Thomson nozzle expands gas expelled therefrom.

Abstract: The present invention pertains to devices for causing cold-induced necrosis or apoptosis. The present invention includes a cryo therapy apparatus including a core member; a cryoplasty tube coupled to the core member, the cryoplasty tube having a proximal end and a distal end; wherein the distal end includes a coil disposed about at least a portion of the tubular sheath, the coil including at least one opening; an outer tube disposed over at least a portion of the cryoplasty tube; and a cooling member disposed over the coil and coupled to the outer tube. A method of causing cold-induced necrosis is also disclosed.

Abstract: A cryosurgical system including a housing having a front portion and a rear portion. The front portion and rear portion are connectable to support a fluid supply. A control unit attached to the front portion, and has a regulator assembly connecting the fluid supply to the control unit. A medical device is connected to the control unit, the medical device including a handle, a shaft, and a thermally-transmissive region. The handle, the shaft, and the thermally-transmissive region defining a fluid pathway through the handle, shaft, and thermally-transmissive region. The shaft is malleable to retain a first shape until manipulated to a second shape.

Abstract: An enhanced method and device are provided to treat atrial fibrillation or inhibit or reduce restenosis following angioplasty or stent placement. A balloon-tipped catheter is disposed in the area treated or opened through balloon angioplasty immediately following angioplasty. The balloon, which can have a dual balloon structure, may be delivered through a guiding catheter and over a guidewire already in place. A fluid such as a perfluorocarbon flows into the balloon to freeze the tissue adjacent the balloon, this cooling being associated with reduction of restenosis. A similar catheter may be used to reduce atrial fibrillation by inserting and inflating the balloon such that an exterior surface of the balloon contacts at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium. In another embodiment, blood perfusion is performed simultaneously.

Abstract: A system and method for cryoablating tissue at a target site in a patient includes a cryotip attached to the distal end of a catheter tube. The cryotip is made of a conductive polymer material that is heat set into a spiral configuration. Inside the cryotip is a configuration lumen. The cryotip assumes a straight configuration when a straightening member is positioned in the configuration lumen, and it assumes the spiral configuration when the straightening member is absent from the configuration lumen. The cryotip in the straight configuration is guided through the vasculature of a patient to the target site. At the target site, the straightening member is removed to configure the cryotip into the spiral configuration to contact the cryotip with circumferential tissue around the target site. A refrigerant fluid is then introduced into the expansion chamber of the cryotip to cool the tip to cryoablate the circumferential tissue.

Abstract: A cryogenic catheter includes an outer flexible member having at least one cryogenic fluid path through the flexible member. The at least one fluid path is defined by a plurality of flexible members disposed within the outer flexible member.

Abstract: A system for cryoablating target tissue at a treatment site includes a cryo-element mounted at the distal end of a cryo-catheter. A balloon catheter is provided having a U-shaped balloon attached thereon. The cryo-element is threaded onto a pre-positioned guidewire and advanced within the patient's vasculature until the cryo-element is positioned at the treatment site. Next, the balloon is threaded onto the guidewire and advanced within the patient's vasculature using the balloon catheter. At the treatment site, the U-shaped balloon is interposed between the cryo-element and the target tissue. Saline solution is pumped into the balloon causing the U-shaped balloon to expand and contact both the cryo-element and the surrounding target tissue. Next, a refrigerant is expanded to cool the cryo-element, which in turn, freezes the saline solution. The resulting “ice ball” extracts heat from surrounding tissue resulting in the cryoablation of a substantially circumferential portion of tissue.

Abstract: A cryogenic catheter system provides safe and effective treatment of tissue. The system includes a catheter that is coupled to a console via fluid and electrical umbilicals. The console controls the overall operation of the system based to provide and maintain a predetermined temperature at the catheter tip. The console also controls and monitors operating parameters for providing warning indications to the user and terminating operation of the system in the event of a failure that may compromise patient safety.

Abstract: Cryosurgical apparatus includes an elongate cryoprobe having a cooling portion and an electrically conductive first portion in the region of the cooling portion. A removable sheath having an electrically conductive second portion is received on the cryoprobe with its electrically conductive second portion spaced from the electrically conductive first portion of the cryoprobe. Electrical insulation is interposed between the first portion and the second portion. Coolant material supplied to the cryoprobe produces tissue freezing in the region of the cooling portion. Electromagnetic energy supplied to either the first portion or the second portion, while the other of such first portion or second portion is connected to ground, provides selective heating in tissue surrounding an iceball produced by the cooling portion to control the configuration of the iceball.

Abstract: Methods and apparatus are provided for thermally affecting tissue via either a closed or open device. In each of the closed device embodiments, thermally transmissive fluid is circulated and distributed through into a device, an outer surface of which is in direct thermal contact with a region of tissue to thermally affect the tissue. In each of the open device embodiments, thermally transmissive fluid is circulated through a device and systematically deployed directly onto a region of tissue to irrigate, and, therefore, thermally affect the tissue.

Abstract: A surgical device includes a device body defining a sealed fluid path having a first end and a second end, a refrigerant supply in communication with the first end of the sealed fluid path, and a vacuum source in communication with the second end of the sealed fluid path. Leak detection apparatus can be provided in communication with the sealed fluid path.

Abstract: An enhanced method and device are provided to treat atrial fibrillation or inhibit or reduce restenosis following angioplasty or stent placement. A balloon-tipped catheter is disposed in the area treated or opened through balloon angioplasty immediately following angioplasty. The balloon, which can have a dual balloon structure, may be delivered through a guiding catheter and over a guidewire already in place. A fluid such as a perfluorocarbon flows into the balloon to freeze the tissue adjacent the balloon, this cooling being associated with reduction of restenosis. A similar catheter may be used to reduce atrial fibrillation by inserting and inflating the balloon such that an exterior surface of the balloon contacts at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium. In another embodiment, blood perfusion is performed simultaneously.

Abstract: A cryosurgical probe system includes a fluid supply line connectable at an inlet section to a source of cryogenic fluid; a fluid connector assembly securely connected to an outlet section of the fluid supply line for receiving fluid from the outlet section of the fluid supply line; and, a detachable cryosurgical probe detachably connectable to the fluid connector assembly. The cryosurgical probe system includes the capability of providing return fluid flow.

Abstract: A method is disclosed for treating an aneurysm by cooling a target tissue region of the aneurysm to a temperature below body temperature for a preselected time period. The method entails thickening, strengthening, or increasing the density of a blood vessel wall by cooling the blood vessel wall with a cryogenically cooled device. The method also includes irradiating the inner wall of a blood vessel around an aneurysm with various forms of energy to delay or halt aneurysm formation. An energy-emitting element is disposed on the distal end portion of a catheter device to be disposed proximate the aneurysm. Various forms of energy, including visible light energy, laser light energy, ultrasound, microwave and radiofrequency sources may be used to irradiate and treat the aneurysm.

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: Improved devices, systems, and methods for inhibiting hyperplasia in blood vessels provide controlled and safe cryotherapy treatment of a target portion within a body lumen of a patient. Efficacy of endoluminal cryogenic cooling can be enhanced by limiting cooling of target tissues using a thermal barrier disposed between a dual balloon cryotherapy catheter. Containment of both balloons can be monitored by applying a vacuum within a space between the first and second balloons, and by coupling the vacuum space to a fluid shutoff so as to inhibit flow of cryogenic fluid in response to a change in the vacuum space. Controlled cooling of the vessel can be improved by use of a nebulizer in fluid communication with a cryogenic liquid supply lumen and a gas supply lumen.

Abstract: Cryosurgical apparatus includes an elongate cryoprobe having a cooling portion and an electrically conductive first portion in the region of the cooling portion. A removable sheath having an electrically conductive second portion is received on the cryoprobe with its electrically conductive second portion spaced from the electrically conductive first portion of the cryoprobe. Electrical insulation is interposed between the first portion and the second portion. Coolant material supplied to the cryoprobe produces tissue freezing in the region of the cooling portion. Electromagnetic energy supplied to either the first portion or the second portion, while the other of such first portion or second portion is connected to ground, provides selective heating in tissue surrounding an iceball produced by the cooling portion to control the configuration of the iceball.

Abstract: Cryotreatment devices and methods of ablating tissue within the body are disclosed. A cryotreatment device in accordance with an exemplary embodiment of the present invention includes an elongated member having one or more needle-like ablation tips configured to induce necrosis at a target site within the heart. A cooling fluid such as a cryogen may be injected through a lumen extending into the distal portion of the device. The ablation tips can be configured to pierce and ablate surrounding tissue, blocking electrical stimuli that can cause fibrillations or other arrhythmias of the heart. The device may also include means for controlling the transmural depth at which the ablation tips are inserted into the cardiac tissue. Methods of forming a contiguous line of conduction block in accordance with the present invention are also disclosed.

Abstract: A system and method for cryoablating tissue at a target site in a patient includes a cryotip attached to the distal end of a catheter tube. The cryotip is made of a conductive polymer material that is heat set into a spiral configuration. Inside the cryotip is a configuration lumen. The cryotip assumes a straight configuration when a straightening member is positioned in the configuration lumen, and it assumes the spiral configuration when the straightening member is absent from the configuration lumen. The cryotip in the straight configuration is guided through the vasculature of a patient to the target site. At the target site, the straightening member is removed to configure the cryotip into the spiral configuration to contact the cryotip with circumferential tissue around the target site. A refrigerant fluid is then introduced into the expansion chamber of the cryotip to cool the tip to cryoablate the circumferential tissue.

Abstract: A system for cryoablating target tissue at a treatment site includes an annular shaped balloon attached to the distal end of a first catheter. A cryo-element is attached to the distal end of a second catheter and the second catheter is disposed in the lumen of the first catheter. The cryo-element is positioned at the treatment site using the second catheter. Next, the first catheter is used to advance the balloon over the second catheter to the treatment site where the annular shaped balloon is Interposed between the cryo-element and the target tissue. Saline solution is pumped into the balloon to expand the balloon into contact with the cryo-element and the surrounding target tissue. Next, a refrigerant is expanded to cool the cryo-element, which in turn, freezes the saline solution. The resulting “ice ball” extracts heat from surrounding tissue resulting in the cryoablation of a substantially circumferential portion of tissue.

Abstract: Devices and methods for cold-treating lesions within the body. A temperature monitoring device for use with a cryo therapy apparatus may include a cryo therapy apparatus, one or more tubular members coupled to the cryo therapy apparatus, and a temperature monitoring member coupled to the tubular member. The temperature monitoring member may comprise a retractable needle, an infrared sensor, an ultrasound transmitter, or a stent having a plurality of spikes.