Abstract: Devices, systems, and methods controllably cool blood vessels and other body lumens. The blood vessel will often be treated for atherosclerotic or other diseases by inflating a balloon so as to engage the surrounding luminal wall. Controlled cooling of the balloon effected by a change in phase of a cryogenic fluid within the balloon typically a change from a liquid phase to a gas phase can be provided with a controlled, gradual inflation of the balloon. A single control system can be used for any of a variety of alternative selectable balloon catheters having significantly differing cooling fluid flow characteristics.

Abstract: The invention provides surgical systems and methods for ablating heart tissue within the interior and/or exterior of the heart. A plurality of probes is provided with each probe configured for introduction into the chest for engaging the heart. Each probe includes an elongated shaft having an elongated ablating surface of a predetermined shape. The elongated shaft and the elongated ablating surface of each probe are configured to ablate a portion of the heart. A sealing device affixed to the heart tissue forms a hemostatic seal between the probe and the penetration in the heart to inhibit blood loss therethrough.

Abstract: Systems and methods stabilize corneal tissue after treatment of the corneal tissue. For example, thermokeratoplasty may be applied to the corneal tissue to address disorders associated with abnormal shaping of the cornea. To stabilize the desired structural changes caused by the treatment, embodiments apply ophthalmic formulations that help to inhibit wound healing. Wound healing may occur in response to the application of the treatment and may produce further structural changes that mitigate or alter the desired effects of the treatment.

Abstract: A method of treating cardiac tissue is provided, including positioning a first chamber of a medical device adjacent an atrial wall; directing a cryogenic coolant into the first chamber; anchoring the first chamber to the atrial wall through cryoadhesion; directing a distal portion of the medical device into the coronary sinus; and positioning a cardiac lead through at least a portion of the coronary sinus with the distal portion. The method may include measuring a temperature of the first chamber; removing the first chamber from the atrial wall once a predetermined threshold temperature of the first chamber is reached; anchoring a second chamber of the medical device to a portion of the coronary sinus; and/or perfusing blood flow through at least a portion of the second chamber.

Abstract: A medical system is provided, including a catheter body having a proximal portion and a distal portion; a shaft slidably disposed within a portion of the catheter body, the shaft defining a distal tip; a fluid injection tube coupled to the distal portion of the catheter body and the distal tip of the shaft, the fluid injection tube being transitionable from a first geometric configuration to a second geometric configuration; a membrane coupled to the shaft and enclosing at least a portion of the fluid injection tube therein; and a coolant source in fluid communication with the fluid injection tube. The first geometric configuration may be substantially linear, the second geometric configuration may be substantially helical, and the membrane may be tensioned across at least a portion of the fluid injection tube in the second geometric configuration.

Abstract: A medical treatment system, including a catheter body defining a fluid flow path therethrough; an expandable element disposed on the catheter body, the expandable element defining a cooling chamber therein in fluid communication with the fluid flow path; a plurality of electrodes disposed on the expandable element; a cryogenic fluid source in fluid communication with the fluid flow path; and a radiofrequency energy source in electrical communication with the plurality of electrodes. A method of treating a cardiac tissue site proximate an orifice, including substantially occluding the orifice with an expandable element; powering a plurality of electrodes coupled to the expandable element to reach a predetermined target temperature; circulating a coolant through the expandable element to freeze portions of the cardiac tissue site located between the plurality of electrodes; and ablating the non-frozen portions of the tissue site with the plurality of electrodes.

Abstract: A cryogenic wand for ablating tissue comprising a cryogenic ablation tube closed at a distal end and including an ablation zone, the ablation tube in fluid communication with and coupled proximally to at least one of two segments that are rotatably repositionable with respect to one another, wherein the two segments are fluidically sealed so that fluid entering a first of the at least two segments passes therethrough and enters a second of the at least two segments.

Abstract: A medical device, including an elongate body having a proximal portion and a distal portion; a shaft at least partially disposed within the elongate body; an expandable element at the distal portion of the elongate body; and a fluid delivery conduit defining a deflectable segment movably coupled to the shaft, the deflectable segment being transitionable from a substantially linear configuration to a substantially curvilinear configuration.

Abstract: The invention relates to an anastomosis ring and to an anastomosis ring assembly for connecting hollow organs made from human or animal tissue. The anastomosis ring includes a first support ring and a second support ring, which can be coupled with the first support ring for fixating the tissue, so that the support rings are essentially disposed fixated relative to one another. The anastomosis ring is at least partially made form a biofragmentable material which disintegrates after a predetermined time period in a human or animal body. In order to facilitate better tissue connection the anastomosis ring includes at least one energy delivery element connectable with an energy source. The energy delivery element is configured to fuse the tissue at least partially through delivering energy during operations.

Abstract: An applicator for cryoablating tissue to form linear (i.e. straight line and curvilinear) lesions in targeted tissue includes a fluid refrigerant delivery system having a source of a fluid refrigerant and a tubular cryoablation segment. Structurally, the segment has an open proximal end and a distal end, and is formed with a lumen. Also, the segment is formed with at least one distal port and at least one proximal port, with each port connected in fluid communication with the segment's lumen. The proximal end of the tubular segment is operably connected in fluid communication with the source of fluid refrigerant. For the system, the ports can be selectively sized to outflow liquid refrigerant through the distal and proximal ports at a substantially same mass flow rate.

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: Catheter apparatuses, systems, and methods for cryogenically modulating neural structures of the renal plexus by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a catheter treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver a cryo-applicator to a renal artery via an intravascular path. Cryogenic renal neuromodulation may be achieved via application of cryogenic temperatures to modulate neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.

Abstract: A system, device and method for dilating an anatomical structure. Systems, devices and methods may comprise a therapeutic component configured to treat a paranasal sinus. Specific embodiments may use high frequency pressure waves and/or cryogenic temperatures.

Abstract: Probe based low temperature lesion formation apparatus, systems and methods include, in one embodiment, a surgical probe having a relatively short shaft (e.g., between 3-12 cm) defining a distal portion and a proximal portion, an inflatable cryogenic element, defining an exterior surface, associated with the distal portion of the shaft; and at least one temperature sensor on the exterior of the inflatable cryogenic element. In another embodiment, a method of forming a lesion in a tissue structure includes the steps of positioning an inflatable cryogenic element on the tissue structure with a temperature sensor between a portion of the inflatable cryogenic element and a portion of the tissue surface, supplying cryogenic fluid to the inflatable cryogenic element, maintaining pressure within the inflatable cryogenic element below about 100 mm Hg, and measuring tissue temperature with the temperature sensor.

Abstract: A cryosurgical instrument, in particular a biopsy instrument for transbronchial biopsy, having an elongated instrument base body with a distal and proximal end, in relation to the operational position, a cooled section close to the distal end and which removes tissue, said section being designed such that surrounding biological material adheres thereto, by means of cryoadhesion, when said instrument is in use in the cooled state, and a security section provided at a distance from the tissue removal section and which comprises means for preventing or reducing the adhesion of biological material.

Abstract: Device and method significantly that improves the safety and procedural success of the existing art by being able to be less traumatic to vascular tissue, improving atrial contact with the ablation surface, improving positioning and geometrical precision of the ablation pattern, improving steerability and deliverability of the ablation device and by improving localization and geometric precision of the ablation device. The risk of pulmonary vein fibrosis/stenosis will also be substantially lowered. Finally, expansion of the eligible atrial fibrillation population will inherently increase due to the improved components and methods of the present invention.

Abstract: A balloon arrangement provided at a distal end of the catheter is configured for deployment within a vessel and comprises a distal balloon and a proximal balloon spaced apart from the distal balloon. An ablation arrangement is provided at the distal end of the catheter and configured to ablate target tissue proximate the vessel. A vessel deformation arrangement comprises at least a portion of the balloon arrangement and is configured to draw a wall segment of the vessel and the target tissue inwardly towards the ablation arrangement. The vessel deformation arrangement may include a port provided in a section of the shaft between the distal and proximal balloons. The port and balloon arrangement are configured to cooperatively draw the wall segment of the vessel and the target tissue inwardly towards the ablation arrangement in response to a negative pressure developed at the port.

Abstract: A cryosurgical instrument that is selectively positioned in a patient tissue by rotation. The instrument includes: a manipulation section that permits a user to rotate the instrument; a cryogen supply portion; and a positioning section having a sharp tip at an end and a helical configuration, the positioning section configured to receive cryogen and to permit the received cryogen to cool the positioning section. The positioning section urges the cryosurgical instrument deeper into the patient when the instrument is rotated in a first direction, via the manipulation section, and urges the cryosurgical instrument outward when the instrument is rotated in a second direction that is opposite the first, via the manipulation section.

Abstract: A catheter includes a cryoablation tip with an electrically-driven ablation assembly for heating tissue. The cryoablation tip may be implemented with a cooling chamber through which a controllably injected coolant circulates to lower the tip temperature, and having an RF electrode at its distal end. The RF electrode may be operated to warm cryogenically-cooled tissue, or the coolant may be controlled to conductively cool the tissue in coordination with an RF treatment regimen.

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: In some implementations, a method of ablating body tissue includes (a) locating an inflatable balloon portion of a cryotherapy balloon catheter at a treatment site internal to a patient's body, and inflating the inflatable balloon portion; (b) employing electrodes that are disposed on an expandable surface of the inflatable balloon portion to electrically characterize body tissue at the treatment site; (c) ablating the body tissue by supplying a cryotherapy agent to the inflatable balloon portion to cool the body tissue to a therapeutic temperature; (d) employing the electrodes to determine whether the ablating caused desired electrical changes in the body tissue; and (e) repeating (c) and (d) when it is determined that the ablating did not cause the desired electrical changes.

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 method and apparatus for creating and accessing an anatomic space between a heart and a pericardial sac. The apparatus includes a catheter having a cryoadhesion member situated on the distal tip of the catheter. The cryoadhesion member is utilized to adhere to the pericardial sac and to retract the sac to create a tent like structure. The catheter allows introduction of an instrument to access the pericardial sac by puncture. The access to the pericardial sac allows delivery of a device, a drug, a biologic or other substance to the heart or the space around the heart.

Abstract: A cryosurgical system adapted for treatment of fibroadenomas within the breast of a patient. The system includes cryoprobes and a control system which operates the cryoprobes to accomplish freezing in two stages, including a high power freeze and a low power freeze.

Abstract: A medical device and method are provided for mapping and therapeutic treatment, which may include a source of cryogenic fluid, a balloon or other expandable member in fluid communication with the source of cryogenic fluid, and a plurality of electrodes on the expandable member. The medical device may include a catheter or elongate body, and the electrodes may take the form of longitudinal strips. The expandable member may take the form of an inner and outer balloon, and the electrodes may be on the outer balloon. The electrodes may be on a proximal or distal conical portion of the expandable member, or both. An electrical insulator may be provided covering a portion of the electrodes.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter arrangement includes a flexible shaft having a length sufficient to access a patient's renal artery relative to a percutaneous access location. A cooling arrangement is provided at a distal end of the shaft and dimensioned for deployment within a renal artery. The cooling arrangement is configured to freeze tissue of a wall of the renal artery while target tissue adjacent the renal artery wall including perivascular renal nerve tissue remains unfrozen. A microwave emitter is configured to propagate microwave energy through the frozen renal artery wall to heat the unfrozen target tissue to a temperature sufficient to ablate perivascular renal nerve tissue included within the target tissue with no or negligible thermal damage to at least an inner wall of the renal artery.

Abstract: A method of ablating tissue is provided, including positioning an expandable element of a catheter in a blood vessel; inflating the expandable element with a volume of refrigerant to substantially occlude the blood vessel; measuring the volume of refrigerant used to inflate the expandable element; correlating the measured volume to an inflated dimension of the expandable element; defining at least one of a target pressure within the expandable element and a target flow rate for refrigerant delivery to the expandable element based at least in part on the inflated dimension; regulating refrigerant delivery to the expandable element to attain the at least one defined target pressure within the expandable element or defined target flow rate for fluid delivery to the expandable element; and ablating at least a portion of the blood vessel with the expandable element.

Abstract: A medical device includes a catheter body having a first injection lumen, a second injection lumen, and an exhaust lumen, where the first injection lumen provides a fluid flow rate greater than a fluid flow rate provided by the second injection lumen; an expandable element coupled to the catheter body in fluid communication with the first and second injection lumens; a cryogenic fluid source in fluid communication with the first and second injection lumens; a valve in fluid communication with the first and second injection lumens to selectively allow fluid flow to at least one of the first and second injection lumens; a pressure sensor in fluid communication with an interior defined by the expandable element; and a controller in communication with the pressure sensor programmed to regulate fluid flow through the first injection lumen based at least in part on a signal from the pressure sensor.

Abstract: An intravascular catheter is provided, including a flexible elongate body; an expandable element positioned on the elongate body; a substantially linear thermal segment located distally of the expandable element; a first fluid flow path in fluid communication with the expandable element; and a second fluid flow path in fluid communication with the substantially linear thermal segment.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

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 cryoablation system includes a catheter for insertion into patient vasculature. The catheter includes a coolant transfer tube configured to receive and transfer coolant from a coolant source to an expansion element coupled to a distal portion of the catheter. The expansion element is in fluid communication with the coolant transfer tube and at least one coolant outtake region within the catheter. The coolant outtake region is configured and arranged to receive and transfer coolant from the expansion element to a reduced pressure region. A coolant-flow regulation system is at least partially disposed in the catheter. The coolant-flow regulation system is configured and arranged for regulating a rate of coolant flow within the cryoablation system by providing an adjustable pressure differential along the at least one coolant outtake region. A control module is coupled to the catheter. The control module includes a processor for controlling the coolant-flow regulation system.

Abstract: A cryoplasty catheter and method for preventing or slowing reclosure of a lesion following angioplasty. The cryoplasty catheter includes a shaft having proximal and distal ends and a dilatation balloon disposed at the distal end. An intake lumen and exhaust lumen are defined by the shaft to deliver coolant to the balloon and to exhaust or drain coolant from the balloon. The method in accordance with the present invention includes cooling a lesion to aid in remodeling the lesion through dilatation and/or freezing a portion of the lesion adjacent the dilatation balloon to kill cells within the lesion to prevent or retard restenosis.

Abstract: A catheter includes a cryoablation tip with an electrically-driven ablation assembly for heating tissue. The cryoablation tip may be implemented with a cooling chamber through which a controllably injected coolant circulates to lower the tip temperature, and having an RF electrode at its distal end. The RF electrode may be operated to warm cryogenically-cooled tissue, or the coolant may be controlled to conductively cool the tissue in coordination with an RF treatment regimen.

Abstract: A medical device, system and method are provided for thermal medical treatment. A medical device for cryogenic treatment may include a tip and a thermal guard or shield. The tip may be at a distal end of a catheter shaft, having a distal surface and lateral surfaces. The thermal guard may be coupled to the catheter proximal of the distal tip, surrounding the longitudinal axis and exposing the distal surface, to resist heat transfer from body fluids to the lateral surfaces of the tip. An efficiency of heat transfer from selected tissue to be treated to the distal surface of the cryogenic tip is thereby increased.

Abstract: A method for performing cryotherapy on a target tissue region in a body includes positioning a first cooling element in a first location in a body adjacent a target tissue region, positioning a second cooling element in a second location in the body adjacent the target tissue region, and cooling the respective first and second cooling elements so as to cool the target tissue region.

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: An isotherm sensor tracks space vehicle temperatures by a thermal protection system (TPS) material during vehicle re-entry as a function of time, and surface recession through calibration, calculation, analysis and exposed surface modeling. Sensor design includes: two resistive conductors, wound around a tube, with a first end of each conductor connected to a constant current source, and second ends electrically insulated from each other by a selected material that becomes an electrically conductive char at higher temperatures to thereby complete an electrical circuit. The sensor conductors become shorter as ablation proceeds and reduced resistance in the completed electrical circuit (proportional to conductor length) is continually monitored, using measured end-to-end voltage change or current in the circuit. Thermocouple and/or piezoelectric measurements provide consistency checks on local temperatures.

Abstract: Described here are systems and methods for affecting tissue within a body to form a lesion. Some systems comprise tissue-affecting devices, devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, and devices that help position the tissue-affecting devices along the target tissue. The methods described here comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here are used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of a heart. Methods of closing, occluding, and/or removing the left atrial appendage are also described.

Abstract: A cryotherapy balloon catheter includes a compliant cryotherapy balloon comprising a distal balloon section dimensioned for placement within a renal artery and a proximal balloon section dimensioned to abut against an ostium of the renal artery and extend into at least a portion of the abdominal aorta. The compliant balloon has a diameter that varies non-uniformly along a length of the compliant balloon, such that a diameter at the proximal balloon section is larger than a diameter of the distal balloon section. The cryotherapy balloon catheter may be configured to deliver cryogenic therapy to at least the ostium of the renal artery sufficient to irreversibly terminate renal sympathetic nerve activity, such as by causing neurotmesis of renal nerve fibers and ganglia at the ostium of the renal artery.

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: In a method, a device and an apparatus system for therapy of prostate cancer, in the course of a therapy session the prostate of a patient is subjected at different locations to a diagnostic examination with regard to the presence of a tumor, and in the case of a positive diagnosis the prostate is therapeutically treated at the corresponding location during the therapy session. The device has a hollow needle, a biopsy needle carrying an extraction element at its forward end that serves to extract a tissue sample, and a therapy element serving to therapeutically act at a location of the prostate. The biopsy needle or the optical waveguide and the therapy element are designed so that they can be inserted into the hollow needle. The apparatus system includes a diagnostic unit and a therapy unit for focal therapy treatment of the prostate, the diagnostic unit including a device for histological assessment of prostate tissue.

Abstract: Multi-directional deflectable catheter apparatuses, systems, and methods for achieving 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 catheter 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 or electrical renal neuromodulation may be achieved via direct and/or via indirect application of thermal and/or electrical energy to heat or cool, or otherwise electrically modulate, neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.

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 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: A cryosurgery device for dispensing a liquid refrigerant from a container having a valve stem extending outwardly therefrom. The device includes an actuator adapted to seat on the valve stem of the container in order to depress the valve stem to release the refrigerant from the container. The actuator includes an inner passageway having opposed ends disposed therein, one of the ends of the passageway being in fluid communication with the valve stem. An applicator tube is mounted to the actuator at the other end of the inner passageway. A cap is disposed on the top of the container. The actuator is movably positioned on the cap and a shield is attached to the cap to completely receiving the applicator tube. Liquid refrigerant can only be dispensed when the actuator is positioned properly and the applicator tube is disposed within the shield means.

Abstract: The present invention provides devices and methods for the treatment of atrial fibrillation. In one embodiment a deflectable sheath catheter includes an elongate catheter body having proximal and distal ends, the distal end having a distal tip region that includes a plurality of flexible segments with varying degrees of stiffness. A handle portion can be located at the proximal end of the catheter body to provide a steering mechanism that causes the distal tip region to deflect according to a compound curve.