Abstract: A method for cerebral and systemic cooling by providing a nebulized liquid having a boiling point of 38-300° C. The nebulized liquid is delivered as a mist or a spray via the nasal and/or oral cavities of a patient. The mist causes cooling by direct heat transfer through the nasopharynx and hematogenous cooling through the carotids and the Circle of Willis. Compositions and medical devices for cerebral and systemic cooling are also provided. Cooling assemblies, and methods of use, are also provided that include flexible balloon assemblies that are inserted to various locations in a patient's body. The flexible balloons are then infused with a liquid having a temperature between about ?20° C. and about 37° C. The flexible balloon assemblies can be inserted into the nasal cavity, oral cavity, throat, stomach, and other locations to effect cerebral cooling.

Abstract: Embodiments of the present disclosure present systems, devices and methods for ISF glucose monitoring that more accurately reflects the blood glucose levels by introducing a treatment element allowing stable and accurate prediction of blood glucose levels based measured glucose levels from interstitial fluid.

Abstract: An energy delivery probe is provided that may include any of a number of features. One feature of the energy delivery probe is that it can apply energy to tissue, such as a prostrate, to shrink, damage, denaturate the prostate. In some embodiments, the energy can be applied with a vapor media. The energy delivery probe can include a vapor delivery member configured to extend into a transition zone prostate tissue. A condensable vapor media can be delivered from the vapor delivery member into the transition zone tissue, wherein the condensable vapor media can propagate interstitially in the transition zone tissue and be confined in the transition zone tissue by boundary tissue adjacent to the transition zone tissue. Methods associated with use of the energy delivery probe are also covered.

Abstract: Devices, systems and methods for removing heat from subcutaneously disposed lipid-rich cells are disclosed. In selected embodiments, suction and/or heat removal sources are coupled to an applicator. The applicator includes a flexible portion and a rigid portion. The rigid portion includes a thermally conductive plate and a frame coupling the thermally conductive plate and the flexible portion. An interior cavity of the applicator is in fluid communication with the suction source, and the frame maintains contiguous engagement between the heat removal source and the thermally conductive plate.

Abstract: A device and method for delivering a treatment solution includes a bi-directional catheter comprising at least a first lumen and a second lumen, wherein the first lumen comprises a proximal end having an inflow portal and a distal end having an outflow portal, and the second lumen comprises a side wall having at least one inflow portal allowing for fluid communication from an outer surface of the side wall to an inner surface of the side wall and the second lumen further comprises a proximal end having an outflow portal. The device and method further include a pump having an input channel, a reservoir for receiving and containing the treatment solution, a cooling apparatus for cooling the treatment solution, and an output channel. The outflow portal of the second lumen of the catheter is in fluid communication with the input channel of the pump and the output channel of the pump is in fluid communication with the inflow portal of the first lumen.

Abstract: A method for cerebral and systemic cooling by providing a nebulized liquid having a boiling point of 38-300° C. The nebulized liquid is delivered as a mist or a spray via the nasal and/or oral cavities of a patient. The mist causes cooling by direct heat transfer through the nasopharynx and hematogenous cooling through the carotids and the Circle of Willis. Compositions and medical devices for cerebral and systemic cooling are also provided. Cooling assemblies, and methods of use, are also provided that include flexible balloon assemblies that are inserted to various locations in a patient's body. The flexible balloons are then infused with a liquid having a temperature between about ?20° C. and about 37° C. The flexible balloon assemblies can be inserted into the nasal cavity, oral cavity, throat, stomach, and other locations to effect cerebral cooling.

Abstract: A method for exchanging heat with a patient's spinal column incident to spinal surgery or to relieve a patient for a hypoxia condition of the spine. A closed loop heat exchange catheter is percutaneously advanced into the retroperitoneal space of the patient, and then heat exchange fluid is circulated through the catheter to cool the spinal column.

Abstract: The present disclosure comprises handle assemblies for intravascular treatment devices. In one embodiment, a handle assembly comprises an actuator for deflecting a distal region of an intravascular treatment device. In one embodiment, a handle assembly comprises a rotator for rotating an intravascular treatment device independently of the handle assembly. In one embodiment, a handle assembly comprises a rotation limiting element for limiting independent rotation of an intravascular treatment device relative to the handle assembly. Methods and systems for intravascular delivery, deflection and placement of an intravascular treatment device via a handle assembly of the present invention are also provided.

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: Systems and methods are disclosed for therapeutically heating a target zone of a collagenous support tissue within a patient body. In exemplary embodiments, the present invention provides electronically determining an acceptable or unacceptable contact condition between an energy source and a first tissue layer disposed proximally to the target zone. Upon determining an acceptable contact condition, the target zone is irradiated or otherwise heated for a finite time period with energy. A determination of an unacceptable contact condition causes cessation of irradiating.

Abstract: Methods and apparatus are provided for thermally-induced renal neuromodulation. 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. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.

Abstract: The present invention encompasses a device for changing the temperature of the kidney during laparoscopic surgery or during organ transportation or transplantation.

Abstract: A device and associated method for providing vestibular stimulation to an individual includes active elements positioned on or proximate an ear insert. The active elements include but are not limited to at least one electrode, at least one thermometer, and at least one thermoelectric transducer. The device includes a computerized control module regulating the active elements. The device incorporates an ear insert that allows the active elements to engage the individual's ear canal and therefore access the individual's vestibular system. Vestibular stimulation applied to the individual is customized for directly stimulating desired regions of the brain for therapeutic or diagnostic purposes.

Abstract: Methods and apparatus for temperature modification of selected body regions including an induced state of local hypothermia of the brain region for neuroprotection. A heat exchange catheter is provided with heat transfer fins projecting or extending outward from the catheter which may be inserted into selected blood vessels or body regions to transfer heat with blood or fluid in the selected blood vessels or body regions. Another aspect of the invention further provides methods and apparatus for controlling the internal body temperature of a patient. By selectively heating or cooling a portion of the catheter lying within a blood vessel, heat may be transferred to or from blood flowing within the vessel to increase or decrease whole body temperature or the temperature of a target region. Feed back from temperature sensors located within the patient's body allow for control of the heat transfer from the catheter to automatically control the temperature of the patient or of the target region within the patient.

Abstract: A catheter assembly for treatment of cardiac arrhythmia. The catheter assembly includes a catheter body and an ablative energy source. The catheter body includes a proximal portion, an intermediate portion, and a distal portion. The intermediate portion extends from the proximal portion and defines a longitudinal axis. The distal portion extends from the intermediate portion and includes an ablation section and a tip. The ablation section forms a loop defining a diameter greater than an outer dimension of a pulmonary vein ostium. The tip extends distally from the ablation section and is configured to locate a pulmonary vein. Finally, the ablative energy source is associated with the ablation section. With this configuration, upon activation of the energy source, the ablation section ablates a desired lesion pattern. In one preferred embodiment, the ablation section forms a distally decreasing radius helix, whereas the tip includes a relatively linear leader section.

Abstract: An implantable heating apparatus for a living being of the present invention includes a heating unit, a control unit for controlling operations of the heating unit and an induction driven charge/discharge unit for powering the heating unit. The induction driven charge/discharge unit is composed of a core, a coil set wrapping around the core in at least three axial directions and an energy storing unit for electrically coupling to the coil set. Such that when an external alternate magnetic field is approaching the induction driven charge/discharge unit, the coil set is able to generate induction current that can be stored in the energy storing unit.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: Systems for removing heat from a subject's subcutaneous lipid-rich regions, such as tissue, organs, cells, and so forth, are described herein. In various embodiments, the system includes a treatment device and a controller for controlling a treatment process. The controller is configured to detect and compensate for an interruption in the treatment process.

Abstract: Methods include determining whether an infection is in proximity to an implanted rechargeable medical device. If an infection is determined to be present, the recharge process is allowed to sufficiently heat the device to facilitate clearing of the infection. Additional methods include monitoring temperature in proximity to an implantable rechargeable device in connection with recharging the device. If the monitored temperature falls outside a desired range, one or more parameters associated with recharge energy are modified to cause the temperature to reside within the desired range. The desired temperature range, may be a range that can facilitate treatment of a condition in proximity to the implanted device without causing undesired damage to the patient's tissue surrounding the implanted device.

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: The variable stiffness heating catheter includes a heating catheter shaft including at least one electrically conductive member, a reinforcing tube with apertures formed around the surface of the reinforcing tube, and at least one coaxial outer layer of a polymer, metal, or both for providing desired variations in stiffness along at least a portion of the length of the shaft. The apertures can be formed as axial or helical slits in the surface of the reinforcing tube, and the reinforcing tube can also be formed to be tapered at the point where the apertures are formed in the reinforcing tube to provide a heating catheter that is torqueable and pushable at the proximal end, yet soft and flexible at the distal end.

Abstract: Methods for treating a network of organs including generating a map of at least a portion of the network of organs using a rendering system; selecting at least one treatment location within the luminal passageway of the network of organs; and applying an energy therapy to the treatment location to treat the smooth muscle tissue, where the energy therapy applied to the respective treatment location is defined by a plurality of parameters that are associated with a map. Such a system allows for historical or ideal treatment parameters to be identified, visually or otherwise to actual treatment locations. Also, control systems and methods for delivery of energy that may include control algorithms that prevent energy delivery if a fault is detected and may provide energy delivery to produce a substantially constant temperature at a delivery site. In some embodiments, the control systems and methods may be used to control the delivery of energy, such as radio frequency energy, to body tissue, such as lung tissue.

Abstract: Method, system and apparatus for monitoring target tissue temperatures wherein temperature sensors are configured as passive resonant circuits each with a unique resonating signature at monitoring temperatures extending below a select temperature setpoint. The resonant circuits are configured with an inductor component formed of windings about a ferrite core having a Curie temperature characteristic corresponding with a desired temperature setpoint. By selecting inductor winding turns and capacitance values, unique resonant center frequencies are detectable. Temperature monitoring can be carried out with implants at lower threshold and upper limit temperature responses. Additionally, the lower threshold sensors may be combined with auto-regulated heater implants having Curie transitions at upper temperature limits.

Abstract: Disclosed herein are devices and related methods for using those devices in the relieving and/or treating of pain, discomfort, and/or inflammation in the pelvic region using targeted pressure and temperature delivery. The devices and methods for using those devices to deliver targeted pressure and temperature therapy internally to patients through their rectal or vaginal cavities are disclosed.

Abstract: Methods and apparatus for the prevention and treatment of shivering encountered during therapeutic temperature regulation are disclosed that utilize an active system of counterwarming such that the timing and intensity of warmth provided to selected body areas is regulated dynamically in response to such factors as the extent of cooling applied to the core, the degree of shivering encountered, and patient temperature. Additionally, methods and apparatus are disclosed for the measurement and quantification of shivering for use in this and other applications.

Abstract: A substrate that contains an exothermic coating is provided. More specifically, the exothermic coating includes one or more components (e.g., carbon, oxidizable metal, moisture-retaining particles, etc.) that are durably adhered to the substrate. To provide the desired durability, the exothermic coating includes the combination of a certain amount of a polymer latex and polysaccharide. When appropriately selected and incorporated into the exothermic coating, the present inventors have discovered that these components may interact synergistically to improve binding capacity.

Abstract: The invention relates to a mapping catheter for determination of data of an area of an organ embodied as a flat surface, especially of the heart, to be presented graphically, with at least one thermosensor essentially aligned in the direction of the longitudinal axis of the mapping catheter for determination of temperature-related data which is arranged at a tip of the mapping catheter being provided in the distal area of the mapping catheter for introduction into the organ.

Abstract: Systems and methods for accurate temperature modification of a patient, or selected regions thereof, including inducing hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette attached to the circulatory flow lines of the catheter, the heat exchange cassette being sized to engage a cavity within a control unit. A temperature measurement scheme for obtaining body core temperature is provided, including methods of obtaining and analyzing temperature data to provide feedback to the control unit for use in controlling the heating and cooling of the heat exchange medium so as to heat or cool a patient to a desired target temperature.

Abstract: Devices and methods of treatment of tissue, such as skin tissue and subcutaneous tissue, with thermal control elements are disclosed. Some disclosed devices and methods employ local deformation of tissue in small areas. Devices and methods employing local deformation are used to produce fractional thermal treatments. Some devices and methods are external to a subject's skin others are beneath the subject's skin in the subcutaneous tissue.

Abstract: A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Abstract: A catheter system and method are provided which change the temperature of a fluid, such as blood, by heat transfer. Selective cooling or heating of an organ may be performed by changing the temperature of the blood feeding the organ. The catheter system includes an inlet lumen and an outlet lumen structured and arranged to carry a working fluid having a temperature different from the adjacent blood. The outlet lumen is configured to induce turbulence in the adjacent fluid passing adjacent the outlet lumen.

Abstract: A method for increasing metabolism of a subject's body in order to lose weight, comprising: a) contacting a part of the body with a cooling element to remove heat from the body; and b) repeating or continuing (a) so as to remove enough heat in total to lose at least 1 kilogram of body weight.

Abstract: A method of localized cell heating introduces a plurality of ferroelectric comprising particles into a target region of a patient, and applies a time varying electrical field to the target region. The ferroelectric particles absorb energy from the electrical field and heat the target region in response, such as to a temperature sufficient to induce apoptosis of cancer cells in the target region. A ferroelectric hyperthermia-based cancer treatment system includes a time varying electrical field source for applying a time varying electrical field to a plurality of ferroelectric particles disposed in a target cancer containing region of a patient. A composition of matter includes a particle having a ferroelectric portion, the particle being non-toxic, slowly biodegradable in body fluids, and less than 15 ?m in its maximum dimension.

Abstract: Method, system and apparatus for carrying out a controlled heating of dermis to achieve a percentage of linear collagen shrinkage. Implants are employed which preferably are configured as a thermal barrier defining support of an outwardly disposed support surface which carries one or more heater segments. Located along heating channels at the interface between dermis and next adjacent subcutaneous tissue, the structure protects the latter from thermally induced damage while directing heat energy into the former.

Abstract: There is provided a method for controlling the movement of bile and/or gall stones in the biliary duct. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the tissue wall) at least one portion of the tissue wall to influence the movement of bile and/or gallstones in the biliary duct, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the movement of bile and/or gallstones in the biliary duct. The method can be used for restricting or stopping the movement of bile and/or gallstones in the biliary duct, or for actively moving the fluid in the biliary duct, with a low risk of injuring the biliary duct.

Abstract: There is provided a method for controlling a flow of urine in the urinary passageway of a patient's urethra, ureter, renal pelvis or bladder. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the urinary tissue wall) at least one portion of the urinary tissue wall to influence the flow in the urinary passageway, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the urinary passageway. The method can be used for restricting or stopping the flow in the urinary passageway of a urinary incontinent patient, or for actively moving the urine in the urinary passageway, with a low risk of injuring the urethra, ureter, renal pelvis or bladder.

Abstract: Methods for treating a network of organs including generating a map of at least a portion of the network of organs using a rendering system; selecting at least one treatment location within the luminal passageway of the network of organs; and applying an energy therapy to the treatment location to treat the smooth muscle tissue, where the energy therapy applied to the respective treatment location is defined by a plurality of parameters that are associated with a map. Such a system allows for historical or ideal treatment parameters to be identified, visually or otherwise to actual treatment locations. Also, control systems and methods for delivery of energy that may include control algorithms that prevent energy delivery if a fault is detected and may provide energy delivery to produce a substantially constant temperature at a delivery site. In some embodiments, the control systems and methods may be used to control the delivery of energy, such as radiofrequency energy, to body tissue, such as lung tissue.

Abstract: Systems and methods are disclosed for treatment of metabolic disorders such as type 2 diabetes and obesity by stimulation of the small intestine to modulate hormone production. Methods include applying an appropriate signal to a region of the small intestine to modulate hormone production. The method may involve applying a signal to the nerves that innervate the small intestine. Devices for delivering the signal are disclosed.

Abstract: Systems and methods of tissue remodeling or altering a surface of a skin of a patient are provided. A method includes increasing myostatin activity in a target tissue. Methods can include increasing myostatin activity in a target tissue in addition to various tissue remodeling techniques, including cryogenic cooling of target tissue for tissue remodeling.

Abstract: Methods and apparatus are provided for thermally-induced renal neuromodulation. 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. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.

Abstract: A catheter particularly useful for ablation lesions within a tubular region of or near the heart is provided. The catheter comprises an elongated flexible tubular catheter body having an axis and proximal and distal ends. An ablation assembly is mounted at the distal end of the tubular body. The ablation assembly has a preformed generally circular curve having an outer surface and being generally transverse to the axis of the catheter body. The ablation assembly comprises a flexible tubing having proximal and distal ends that carries a tip electrode at its distal end. An electrode lead wire extends through the catheter body and into the ablation assembly and has a distal end connected to the tip electrode. In use, the distal end of the catheter is inserted into the heart of a patient.

Abstract: Catheter devices and methods for intravascular heating and/or cooling of human or veterinary patients. The catheter devices generally comprise catheters having inflow and outflow lumens and at least one curvilinear balloon connected to the inflow and outflow lumens such that heat exchange fluid may be circulated through the balloon(s). The catheter is inserted into the vasculature and heated or cooled fluid is circulated through the balloon(s) to heat or cool blood flowing in heat-exchange proximity to the balloon(s), thereby affecting heating or cooling of all or a portion of the patient's body.

Abstract: System method and apparatus for accurately carrying out the in situ heating of a targeted tissue. Small implants are employed with the targeted tissue which exhibit an abrupt change of magnetic permeability at an elected Curie temperature. The permeability state of the implant is monitored utilizing a magnetometer. The implants may be formed as a setpoint temperature determining component combined with a non-magnetic heater component to enhance the tissue heating control of the system. With the system, a very accurate quantum of heat energy can be supplied to a neoplastic lesion or tissue carrying infectious disease so as to maximize the induction of heat shock proteins. The system also may be utilized in conjunction with non-magnetic arterially implanted stents for the hyperthermia therapy treatment of restenosis and in conjunction with the mending of boney tissue.

Abstract: Disclosed herein is a system to stimulate at least a part of the vestibular system of a patient to induce a sensation of anorexia to promote weight loss. The system can include a thermal element, a power source, a conduit, and a control unit configured to regulate the temperature of the thermal element, the duration in which the thermal element is applied, the duration in between thermal stimuli, and/or the number of stimulus cycles to promote a sensation of anorexia in a patient while avoiding or minimizing undesirable side effects such as nausea, vomiting, nystagmus, or vertigo. Methods of using the system are also disclosed.

Abstract: Methods for reducing kidney damage induced by radiographic contrast medium or another nephrotoxic drug or substance administered to or generated by a patient include reducing the temperature of the patient by positioning an endovascular heat exchange device in a blood vessel of the patient and adjusting the temperature of the device to cause a reduction in the patient's temperature. The patient's temperature may be reduced prior to, during, and/or after, the administration of the contrast medium. The methods may also include administering an anti-shivering mechanism to the patient to reduce shivering caused by the reduction in the patient's temperature. The methods may also include disrupting the laminarity of blood flow around the device to enhance the temperature exchange between the device and the blood flowing around the device. The endovascular heat exchange device may be an endovascular heat exchange catheter.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: Methods and related systems for modulating neural activity by blocking conduction in peripheral neural structures with thermal stimuli are disclosed. Methods and systems for reversing effects of thermal blocking stimuli and/or for producing substantially permanent conduction block are also disclosed.

Abstract: A catheter includes multiple primary leads to deliver energy for ligating a hollow anatomical structure. Each of the primary leads includes a resistive element located at the working end of the catheter. Separation is maintained between the leads such that each lead can individually receive power. The catheter can include a lumen to accommodate a guide wire or to allow fluid delivery. Energy is applied until the diameter of the hollow anatomical structure is reduced to the point where occlusion is achieved. In one embodiment, a balloon is inflated to place the resistive elements into apposition with a hollow anatomical structure and to occlude the structure before the application of energy. The inflated balloon impairs blood flow and facilitates the infusion of saline, or medication, to the hollow anatomical structure in order to reduce the occurrence of coagulation and to improve the heating of the structure by the catheter.

Abstract: A catheter (4) may be introduced into the body of a patient to provide electromagnetic power, such as RF power, directly to a stent (2) to cause heating of surrounding tissue for ablation. The stent may have a conducting portion (14) and insulated portions (13). Struts (15) on the catheter may be deployed by a balloon (103) to contact the stent. The stent may have radial or sector segments (16) which may be individually powered for treating asymmetric tumours.

Abstract: A diversion catheter for use during ablation procedures includes a distal occlusion device such as a diversion balloon. The diversion balloon blocks blood flowing through a cardiac vein. The diversion catheter employs ports proximal and distal to the diversion balloon. The proximal and distal ports are in fluid communication so that blood flow through the cardiac vein is diverted through the distal and proximal ports and away from a cardiac surface intended for ablation.