Abstract: The present invention advantageously provides a method and system for the improved isolation and corresponding treatment of tissue targeted for cryogenic or other thermal therapy to increase the thermal efficacy and thermal efficiency of the treatment. In particular, the present invention provides methods and systems for improved thermal treatment of target tissue, such as a pulmonary vein and/or regions of the left atrium by reducing the resistive forces and/or increased thermal energy experienced from blood flow exiting the pulmonary vein into the left atrium during treatment.

Abstract: The present invention provides a treatment method to excise a cancerous lesion, such as in the breast, with subsequent ablation of the margin. The method provides for location and excision with ablation under open guidance or guided imaging and for diagnosis by cytology. The method may be a minimally, invasive same day method with diagnosis before or immediately after excision. Also provided is a method of treating close or positive margins of an excisional site of a cancerous lesion in a breast by ablating the margin while monitoring the fluorescence of a fluorophor at the site to determine when ablation of the close or positive margin has occurred.

Abstract: A method of performing a catheter-based procedure can include introducing a delivery sheath inside a patient's body and advancing a secondary sheath through the delivery sheath, toward a treatment site inside the patient's body. The secondary sheath can be distinct from the delivery sheath, coaxial to the delivery sheath along at least a portion of a length of the delivery sheath, and can have a default linear shape that is substantially free of radial bias. The method can further include introducing a catheter through the delivery sheath and secondary sheath, to the treatment site, and performing a procedure at the treatment site with the catheter. Performing the procedure can include performing the procedure while maintaining at a relatively fixed position the secondary sheath.

Abstract: Methods of treating a subject for a cardiac arrhythmia are provided. Aspects of the methods include thoracoscopically producing a cardiac Cox maze III set of lesions in cardiac tissue of the subject in a manner sufficient to treat the subject for the cardiac arrhythmia.

Abstract: Methods and apparatus for cryo-therapy are disclosed herein. This includes a hollow guidewire disposed within a catheter having helical loops contacting tissue. A coolant delivery tube disposed within can have a coolant delivered from a proximal end into the guidewire lumen. The coolant flows back proximally through the guidewire while cooling the guidewire surface and cooling or cryogenically ablating the contacting tissue. To minimize guidewire exposure to surrounding fluids or tissue, insulative barriers can be attached to the guidewire. A coolant delivery tube and return lumen can be integrated from a single extrusion in various configurations. Expandable balloons can also be used to expand the loops of the guidewire to contact the tissue. Also, helical loops with a coolant delivery tube or stem disposed longitudinally within the loops can be used and the loops can also have a variable collapsible cooling region.

Abstract: A prostate therapy system is provided that may include any of a number of features. One feature of the prostate therapy system is that it can access a prostate lobe transrectally. Another feature of the prostate therapy system is that it can image the prostate lobe transrectally. One feature of the prostate therapy system is that it can deliver condensable vapor into the prostate to ablate the prostate tissue. Methods associated with use of the prostate therapy system are also covered.

Abstract: A method of performing cryotherapy on a patient can include positioning an outer surface of a distal portion of a cryotherapy catheter in contact with body tissue to be treated; performing a treatment phase, including regulating a temperature of the outer surface at a treatment value for a first period of time; performing a recovery phase comprising allowing the temperature of the outer surface to warm up to a recovery value that is higher than treatment value but substantially lower than a normal body temperature of the patient; and performing one or more additional treatment phases for a second period of time. Each of the first and second periods of time can be selected to allow a cold front having a cold front temperature to propagate from the outer surface and through a therapeutic portion of a thickness of the body tissue, but not substantially beyond the thickness.

Abstract: A cryoablation catheter assembly includes an expansion element coupled to a distal portion of a catheter that is configured and arranged for insertion into patient vasculature. The catheter includes a guide tube, a coolant transfer tube, and at least one coolant outtake region that each extend along the catheter. The guide tube and the coolant transfer tube extend beyond the distal portion of the catheter. The coolant transfer tube includes a coiled distal that wraps around a portion of the guide tube and defines a plurality of spaced-apart spray apertures. The coolant transfer tube defines a lumen configured and arranged to receive and transfer coolant from a coolant source to the spray apertures. The expansion element is in fluid communication with the at least one coolant outtake region and the plurality of spray apertures.

Abstract: Methods and devices described herein facilitate improved treatment of body organs.

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 method for improving the success of resuscitation efforts following cardiac arrest is provided. Return of spontaneous circulation (ROSC) rates following cardiac arrest is directly related to the coronary perfusion pressure during cardiopulmonary resuscitation (CPR). Selective cooling of the nasal cavity, nasopharynx, oral cavity, oropharynx, retrotonsillar space, mouth, neck face, and/or throat of a patient suffering from cardiac arrest, significantly increases the coronary perfusion pressure which improves ROSC rates. Cooling may be initiated before or during resuscitation efforts including chest compressions, defibrillation and/or administering a vasoconstrictor.

Abstract: Apparatus, systems, and methods for achieving thermally-induced renal neuromodulation by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver a thermal element to a renal artery via an intravascular path. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.

Abstract: A system and method for use with at least one cryoprobe for the treatment of biological tissue controls the energy applied to the tissue. The invention receives live procedure data such as temperature information from locations along the pathway of the cryogenic liquids, and calculates a procedure signature or profile based on the procedure data. In one embodiment, volumetric isotherms are calculated. The procedure signature is compared to a planning signature based on previously acquired image data and estimates of the thermal gradients from models. The system and method are further configured to automatically regulate the application of power based on analysis of the planning data to the procedure data.

Abstract: An intracerebral probe (11) comprising a first part (20) with laser or cryogenic treatment means and further comprising a hollow second part (22) surrounding the first, the first part sliding inside the second part along its longitudinal axis (A); and a plurality of detectors (16) distributed along a portion of the second part (22) in such a manner as to be capable of identifying a brain dysfunction zone along the longitudinal axis (A) of the second part. Advantageously, the probe presents a lateral treatment window enabling the action of the treatment means to be directed. The invention also provides a kit and a treatment system including such a probe, and the use thereof of treating cell dysfunctions that give rise to neurological or psychiatric symptoms.

Abstract: A first trocar as an medical apparatus includes an insertion hole having a projection opening for leading out a biopsy forceps into a body of a subject, a lid body for blocking the projection opening of the insertion hole, and a cooling sheet for cryogenically cooling a biopsy portion arranged in the vicinity of the lid body in a state where the biopsy forceps is stored in the insertion hole, and is capable of easily harvesting a living tissue while retaining morphological change of tissues in a living body under various hemodynamics.

Abstract: The present invention advantageously provides a method and system for cryogenically ablating large areas of tissue within the left atrium. In an exemplary embodiment a cryotherapy device includes a catheter body, a proximal end and a distal end; a first lumen; a second lumen; and an ablation element expandable from a first diameter to a second diameter, the ablation element having a surface portion that conforms to the uneven surface topography of the cardiac tissue. The ablation element can include one or more deformable balloon and/or flexible elements. The surface of the balloon can further be shaped by regulation of pressure within the one or more balloons. In an exemplary method, a tissue ablation device is provided and tissue in the left atrium is ablated with the device, whereby the ablation is created by freezing tissue.

Abstract: Coupler assemblies and methods are disclosed as the coupler assemblies may be used with a catheter. An exemplary coupler assembly includes a spherical linkage coupler for a catheter. The coupler comprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter. The coupler also comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion. The two link arms connect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.

Abstract: A system for ablating tissue comprises an ergonomically shaped handpiece having a proximal end and a distal end. An energy source is near the distal end of the handpiece and is adapted to deliver energy to the tissue and create a zone of ablation that blocks abnormal electrical activity in the tissue. The system also includes a barrier near a front face of the energy source. The barrier is adapted to prevent direct contact between blood and the energy source so that the blood does not coagulate on the front face.

Abstract: The present invention relates to devices and methods for cryosurgery. More particularly, the present invention relates to a cryoprobe which does not form strong adhesive or mechanical bonds with body tissues when such tissues are frozen by cooling action of the probe. Embodiments of the present invention include a cryoprobe having a distal cooling module with an outer surface layer of non-polar molecules, a probe having a distal cooling module with a microscopically smooth outer surface, a cryoprobe comprising a mechanism for coating a distal cooling module thereof with non-polar lubricant during movement of the cryoprobe within body tissues of a patient, and a non-cooling cryosurgery probe with non-adhesive features. Also presented are methods utilizing disclosed cryoprobes to facilitate cryosurgery and to enhance accuracy of cryoablation of user-selected cryoablation targets.

Abstract: The disclosure relates to a cryogenic device for surgical use, which can be used to cool an area of the body and includes: a cryogenic gas supply conduit and a discharge conduit, an end piece comprising a metal tip intended to be brought into contact with the area to be cooled and a gas release chamber and a gas injection nozzle connected to the supply conduit at the one end and opening into the chamber in the direction of the metal tip at the other end. The supply conduit and the discharge conduit are formed in a common flexible extruded tube that is inserted into the end piece.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter is provided. 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.

Abstract: A device for treating esophageal target tissue comprises a catheter, a balloon and a refrigerant delivery device. The catheter has a distal portion and a refrigerant delivery lumen. The balloon is mounted to and the refrigerant delivery device is coupled to the distal portion. The refrigerant delivery device comprises a chamber with the refrigerant delivery lumen opening into the chamber, a refrigerant delivery opening fluidly coupled to the balloon interior, and a distribution passageway fluidly coupling the chamber and the refrigerant delivery opening. A refrigerant is deliverable through the refrigerant delivery lumen, into the chamber, through the distribution passageway, through the refrigerant delivery opening and into the balloon interior so to place the balloon into an expanded, cooled state so that the balloon can press against and cool esophageal target tissue. The medical device may include means for sensing a leak in the balloon.

Abstract: Methods, systems and devices for treatment of musculoskeletal tissue may include one or more of stretching, scoring, cutting, and cryogenic cooling of the tissue. Exemplary usage includes the treatment of compressive neuropathy such as in carpal tunnel syndrome and plantar fasciitis. Other musculoskeletal tissues such as those in the hip, shoulder, and other regions of the body may also be treated.

Abstract: Devices, systems, and methods treat cosmetic defects, and often apply cooling with at least one tissue-penetrating probe inserted through of the skin of a patient. The cooling may remodel one or more target tissue so as to effect a desired change in a composition of the target tissue and/or a change in its behavior. Exemplary embodiments of the cooling treatments will interfere with the nerve/muscle contractile function chain so as to mitigate wrinkles of the skin. Related treatments may be used therapeutically for treatment of back and other muscle spasms, chronic pain, and the like. Some embodiments may remodel subcutaneous adipose tissue so as to alter a shape or appearance of the skin surface.

Abstract: Improved systems, devices, and methods for delivering cryogenic cooling fluid to cryosurgical probes such as cryosurgical endovascular balloon catheters take advantage of the transients during the initiation and termination of cryogenic fluid flow to moderate the treatment temperatures of tissues engaged by the probe. A flow limiting element along a cryogenic fluid path intermittently interrupts the flow of cooling fluid, often cycling both the fluid flow and treatment temperature. This can maintain the tissue treatment temperature within a predetermined range which is above the treatment temperature provided by a steady flow of cryogenic fluid. In another aspect, room temperature single-use cooling fluid cartridges are filled with a sufficient quantity of cryosurgical fluid to effect a desired endovascular cryosurgical treatment.

Abstract: A cryotherapy catheter can include an elongate member and an inflatable balloon portion at a distal end of the elongate member. The inflatable balloon portion can have an external surface and an interior chamber, and the external surface can include a cooling region and a thermally insulated region. The interior chamber can be configured to receive during a cryotherapy procedure a cryogenic agent for extracting heat from body tissue that is in contact with the cooling region. A thermal profiling component can be disposed in the interior chamber and configured to thermally insulate the thermally insulated region from the cryogenic agent to minimize heat extraction by the cryogenic agent from body tissue that is in contact with the thermally insulated region.

Abstract: A cryosurgical probe assembly that includes a gas delivery assembly, including a stem and a fluid conduit subassembly bonded to the stem. The fluid conduit subassembly delivers and returns cooling fluid used for cryogenic cooling. The fluid conduit subassembly, comprises a shaft for providing a heat exchange surface for cryogenic ablation; a housing securely connected to said shaft; and, an insulation element slideably engaged with an inner surface of the shaft and slideably engaged with the stem. The cryosurgical probe assembly includes an adjustable sliding apparatus that includes a slider assembly securely attached to said insulation tube for slideably guiding the insulation tube along said shaft; and, a button assembly operatively connected to the slider assembly for allowing a user to actuate the slider assembly to provide a desired adjustment of the insulation tube relative to the shaft. A handle assembly is positioned about the housing.

Abstract: An actuation system is disclosed for actuating an ablation instrument for an ablation process in a tissue volume. In at least one embodiment, the actuation system includes: an input interface for image data of the tissue volume; an identification unit for identifying a target tissue using the image data; a model production unit for producing process models and/or refined fine process models of expected ablation developments, which is linked to a value derivation unit for deriving model measured values from a process model and/or to a value determination unit for determining measured values representing the ablation progress; a command derivation unit for deriving control commands on the basis of process models and/or for deriving refined control commands on the basis of fine process models; a comparator for comparing measured values and an instrument interface for transmitting control commands and/or refined control commands to the ablation instrument.

Abstract: Sinusitis, enlarged nasal turbinates, tumors, infections, hearing disorders, allergic conditions, facial fractures and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies, endoscopic studies and transillumination studies. Access and occluder devices may be used to establish fluid tight seals in the anterior or posterior nasal cavities/nasopharynx and to facilitate insertion of working devices (e.g., scopes, guidewires, catheters, tissue cutting or remodeling devices, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc.

Abstract: A surgical process for freezing or cauterizing infected tissue, by inserting a transparent sleeve through a small slit in the flesh of a patient and wherein the inserted end of the sleeve is provided with a cone-shaped tip. Monitoring of the sleeve and probe insertion and location of the infected area is achieved by video camera. After removing the solid and rigid probe, a fiber optic tube is inserted into the sleeve whereby ambient light is conducted through the tube. A carbon rod is inserted through the fiber optic tube having its pointed end in contact with the infected area. The carbon rod is connected to a source of cold or heat. In a cold application, the infected area is frozen so when the carbon rod is removed and replaced by a suction device, the frozen area can be fragmented and the particles removed.

Abstract: Systems, methods, and other modalities are described for generating or otherwise handling images or other data indicating (a) an extraction of chemically treated tissue frozen in vivo, (b) a treatment of a tissue sample in a chamber extended into tissue of an organism, and/or (c) cells to which an optical enhancement material was applied in vivo. Several contexts in which such indications facilitate histological evaluation are likewise described.

Abstract: Systems, methods, and other modalities are described for generating or otherwise handling images or other data indicating (a) an extraction of chemically treated tissue frozen in vivo, (b) a treatment of a tissue sample in a chamber extended into tissue of an organism, and/or (c) cells to which an optical enhancement material was applied in vivo. Several contexts in which such indications facilitate histological evaluation are likewise described.

Abstract: A catheter can include a shaft; an inflatable balloon having a proximal end that is anchored to an end of the shaft; an elongate member that is separate from and disposed inside the shaft, extends into an interior chamber of the balloon, and is anchored to a distal end of the balloon; and a spring member that exerts a distally-oriented longitudinal force on the elongate member, relative to the shaft, where the distally-oriented longitudinal force causes the balloon to be biased in an extended position, away from the end of the shaft. The catheter can further include a sheath that surrounds the shaft and balloon before a treatment procedure. The balloon can be configured to be advanced outside the sheath during a treatment procedure and inflated, and the spring member can be configured to facilitate deflation and withdrawal of the balloon into the sheath following the procedure.

Abstract: During cryotherapy, using an endoscope that extends within a patient to a cold treatment site, the device of the invention vacuums gas from the site through radial intake ports to a cylindrical space in an evacuation chamber held elastically circumferentially about the distal end of the endoscope tube that carries the cryoprobe to the site.

Abstract: A probe or catheter, usable with a navigation system, includes a longitudinal lumen that curves outwardly through a sidewall prior to reaching a distal tip of the probe. The distal tip contains a position sensor as part of the navigation system. The lumen provides a working channel that guides a tool into a sidewall of a branched structure without requiring the distal end of the probe to be facing the branched structure.

Abstract: The device of the invention takes the form of a catheter/probe and is a closed loop system in which cryogen is delivered along the length of the catheter/probe to the tip where freezing occurs, and then is recirculated. The device is a tube within a tube and comprises a number of parts including supply and return tubes (internal tubes), outer sheath (external tube) sealed to the inner tubes at one or both ends with a gas filled lumen between the internal and external tubes. The lumen of the external tube is filled with a saturated gas which solidifies upon cooling, thereby creating a vacuum along the length of the catheter and providing for insulation between the inner and outer tubes, and preventing freezing along the length of the probe shaft. Further, the outside surface of the internal tubes is modified to potentiate gas nucleation on the outer surfaces of the internal tubes when cooled.

Abstract: A dual balloon catheter assembly and method of use thereof are provided. The dual balloon catheter assembly may be used in a cryoplasty treatment that is provided in combination with eluting an antiproliferative to reduce and/or eliminate vessel fractures, thereby inhibiting proliferative response after angioplasty.

Abstract: Some embodiments of the invention relate to a system for treating tissue internal to a body, such as heart tissue. For example, the system may be used to ablate tissue as a treatment for atrial fibrillation. In certain embodiments, the system is capable of causing scar tissue to form in ostial areas of the atrium rather than inside the pulmonary vein. In such embodiments, the system may include a tissue treatment member that is operable to form an annular area of ablated tissue along the outer portion of the ostium in an area known as the antrum.

Abstract: A cryogenic medical device for delivery of subcooled liquid cryogen to various configurations of cryoprobes is designed for the treatment of damaged, diseased, cancerous or other unwanted tissues. The device is a closed or semi-closed system in which the liquid cryogen is contained in both the supply and return stages. The device comprises a number of parts including a vacuum insulated outer dewar, submersible cryogen pump, baffled linear heat exchanger, return chamber, and a series of valves to control the flow of the liquid cryogen. The cryogenic medical device promotes the subcooling to any external cryogenic probe.

Abstract: A cryogenic probe design is provided containing, for example, an inner coil injection tube with a continuous flow of circulating liquid and an outer jacket enclosing the inner coil injection tube. A transducer may monitor parameters in the region between the inner coil injection tube and the outer jacket. An outer jacket serves to prevent gas leakage. One or more embodiments of a probe design provide continuous flow for example via a continuous and controlled path from inlet to outlet and an expanded thermally transmissive region. Expanding a thermally transmissive region of the cooling zone may be provided, for example, in one or more embodiments of injection tube designs.

Abstract: An ultrasonic actuator comprises a miniature ultrasonic transducer powered by electromagnetic radiation. The ultrasonic transducer comprises a housing defining a chamber. A liquid mass oscillates within the chamber at a frequency within the ultrasonic range. To cause this oscillation, a source of electromagnetic radiation energizes the liquid mass by exposing a portion of the liquid mass to electromagnetic radiation. The source of electromagnetic radiation thus drives the liquid mass at a frequency within the ultrasonic range.

Abstract: Methods for treating oral, nasal, pharyngeal and/or laryngeal tissue in a subject are described. Methods of the invention may comprise spraying a tissue to be treated with a cryogen and/or using a cryogen to create an isotherm in proximity to the tissue to be treated.

Abstract: A cryotherapy catheter can include an elongate member and an inflatable balloon at a distal end of the elongate member, the elongate member having lumens formed therein to supply cryogenic fluid to a chamber of the balloon and to channel exhaust from the balloon chamber; and a controller programmed to control a first rate at which the cryogenic fluid is supplied to the balloon chamber and a second rate at which exhaust is channeled from the balloon chamber, wherein the controller is programmed to a) develop, during a first phase of a cryotherapy procedure, a first pressure inside the balloon chamber at a value that is greater than an ambient pressure outside and adjacent to a proximal end of the elongate member, and b) develop, during a second phase of the cryotherapy procedure, the first pressure at a value that is less than the ambient pressure.

Abstract: An ablation system for treating atrial fibrillation in a patient comprises an inner shaft having proximal and distal ends as well as a lumen therebetween. A distal tip assembly is adjacent the inner shaft distal end, and the distal tip assembly comprises an energy source and a sensor. The energy source is adapted to deliver energy to a target tissue so as to create a zone of ablation in the target tissue. This blocks abnormal electrical activity and thus reduces or eliminates atrial fibrillation in the patient. The system also has an outer shaft with proximal and distal ends, and a lumen therebetween. The inner shaft is slidably disposed in the outer shaft lumen, and the inner shaft is rotatable, bendable and linearly slidable relative to the outer shaft. The outer shaft is rotatable, bendable and linearly slidable relative to the target tissue.

Abstract: Devices, systems, and methods efficiently dilate and/or cool blood vessels and other body tissues. Controlled cooling with balloon catheters and other probes may be effected by a change in phase of a cryogenic fluid, often after measuring a minimum pulse width for actuating an individual solenoid valve along the cooling fluid path, with the measured pulse width allowing gradual inflation of a balloon without excessive venting of cooling fluid.

Abstract: An intra-atrial ablation therapy apparatus is disclosed. The apparatus comprises a balloon adapted for intra-atrial inflation to fill at least part of the atrium, the balloon being adapted to permit a flow of blood from a pulmonary vein to a mitral valve when inflated in the atrium. The apparatus further comprises an inflation lumen being in fluid communication with the balloon and adapted for conducting an inflation fluid to the balloon. The apparatus also comprises an ablation tool connected to the catheter.

Abstract: Devices, systems and methods relating to delivery systems suitable for positioning various medical components within a patient's body and, more specifically, to delivery systems designed to cooperate with certain therapeutic and diagnostic devices.

Abstract: An ablation system for treating atrial fibrillation in a patient comprises an elongate shaft having proximal and distal ends, a lumen therebetween and a housing adjacent the distal end of the elongate shaft. An energy source is coupled to the housing and is adapted to deliver energy to a target tissue so as to create a zone of ablation in the target tissue that blocks abnormal electrical activity thereby reducing or eliminating the atrial fibrillation in the patient. A sensor is adjacent the energy source and adapted to detect relative position of the energy source to the target tissue or characteristics of the target tissue. The system also has a reflecting element operably coupled with the energy source and adapted to redirect energy emitted from the energy source in a desired direction or pattern.

Abstract: The invention relates to a cryosurgical instrument and a method for separating a tissue sample from surrounding tissue of a biological tissue that is to be treated. The cryosurgical instrument comprises a probe for guiding a probe head on to a biological tissue to be treated, and gas conduits for delivering coolant gas, wherein the probe head is designed in such a way that, in order to collect a tissue sample, a limited region of the tissue can be cooled by means of the gas delivered and can be separated from the surrounding tissue in a state in which it is frozen on the probe head. The instrument is intended to permit reliable removal of a tissue sample without damaging the tissue and to ensure a high degree of safety for the patient. To this end, the instrument has a support means in which the probe is guided and which can be moved relative to the probe in such a way that the surrounding tissue can be counter-supported during separation of the tissue sample.

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. In the first case, the coolant also inflates the balloon, and spent coolant is returned to the handle via a return passage extending through the body of the catheter. 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. Various configurations, such as surface modification of the balloon interface, or placement of particles, coatings, or expandable meshes or coils in the balloon interface, may be employed to achieve this function.