Abstract: A catheter system and method for selectively cooling or freezing target neuronal tissue to induce lesions along the neuroaxis and produce cryoanalgesia by impairing nerve conduction of the targeted neuronal tissue. The system includes a catheter that has cryogenic capability for variable cooling or freezing of neuronal tissue. The catheter also includes temperature sensing and electrodiagnostic capabilities. A pressurized fluid source is included for inflating a portion of the catheter body. The system includes electrodiagnostic equipment for stimulating and monitoring sensory evoked potentials in the patient. The method involves placement of the catheter tip in the subarachnoid space of the spinal canal and location of the tip on the neuronal target using imaging and electrodiagnostic techniques.

Abstract: A closed loop heat exchange catheter can be placed in the rectum of a patient to or warm the patient.

Abstract: Apparatus and methods for cooling selected regions within a body are described herein. An implantable cooling system is used to cool regions of the brain, spinal cord, fibrous nerve bodies, e.g., vagus nerve, etc. down to about 30° C. to diminish nerve impulses which control seizures or chronic pain. The system includes an implantable unit containing a pumping mechanism and/or various control electronics. It also has a heat exchanger attachable to a tubular body organ, such as the superior vena cava or the inferior vena cava, through which the heat is effectively dissipated. Also included is a heat pump such as a Peltier junction configured to be placed into contact with the region of tissue to be cooled. The heated portion of the Peltier junction is cooled by a liquid heat transfer medium which absorbs the heat from the junction and dissipates it into the tubular body organ.

Abstract: An intravascular heat transfer device is provided with a mixing-inducing surface formed by an easily manufacturable process. The device can have a plurality of elongated, articulated segments, each having a mixing-inducing exterior surface. A flexible joint connects adjacent elongated, articulated segments. The device may be conveniently formed, e.g., by vapor deposition or molding, and further lacks undercuts so that the same may be conveniently removed from, e.g., a two-part mold.

Abstract: A method and apparatus is provided for heating or cooling at least a selected portion of a patient's body. The method begins by inserting a catheter having a balloon into the colon or stomach of the patient. A heated or chilled fluid is conducted through a supply lumen of the catheter and into the balloon. The fluid is evacuated from the balloon through a return lumen of the catheter.

Abstract: Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patent's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and eletrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Abstract: Systems for phase-change particulate slurry cooling equipment and methods to induce hypothermia in a patient through internal and external cooling are provided. Subcutaneous, intravascular, intraperitoneal, gastrointestinal, and lung methods of cooling are carried out using saline ice slurries or other phase-change slurries compatible with human tissue. Perfluorocarbon slurries or other slurry types compatible with human tissue are used for pulmonary cooling. And traditional external cooling methods are improved by utilizing phase-change slurry materials in cooling caps and torso blankets.

Abstract: An intravascular heat exchange catheter is disclosed that has a non-straight heat exchange element.

Abstract: The invention provides a method and system for treating disorders in parts of the body. A particular treatment can include on or more of, or some combination of: ablation, nerve modulation, three-dimensional tissue shaping, drug delivery, mapping stimulating, shrinking and reducing strain on structures by altering the geometry thereof and providing bulk to particularly defined regions. The particular body structures or tissues can include one or more of or some combination of region, including: the bladder, esophagus, vagina, penis, larynx, pharynx, aortic arch, abdominal aorta, thoracic, aorta, large intestine, sinus, auditory canal, uterus, vas deferens, trachea, and all associated sphincters. Types of energy that can be applied include radiofrequency, laser, microwave, infrared waves, ultrasound, or some combination thereof.

Abstract: A method, device, and system for treatment of urinary tract disorders is provided. The device includes a catheter having multiple lumens for insertion into a urinary bladder and for providing fluid flow within the bladder and within the fluid reservoir within the urethra. The device further includes an anchor to be placed within the bladder. A port hub having multiple ports is connected at a proximal end of the catheter. A method of treatment includes providing heated fluid to a urinary bladder and to a fluid reservoir for insertion into an adjacent organ such as the urethra. Simultaneous treatment or separate treatment may be done. Optionally, a medicated solution may be added to the heated fluid. Additionally, pressure may be adjusted so as to optimize the therapeutic effect.

Abstract: A system for exchanging heat with the body of a patient for cooling or warming the patient provides for automatic temperature control in accordance with the monitored temperature of the patient. The system comprises a temperature control module and temperature probes for making body core temperature measurements. The body core temperature measurements are used to control the temperature of fluid circulating within the fluid circuit.

Abstract: Methods, systems, and computer program products for providing thermal therapies or internal thermal massage therapy for treating prostatitis by expanding and contracting a treatment balloon with inflation media and currently applying heat to a portion of the prostatic urethra.

Abstract: A catheter for exchanging heat with a body fluid is disclosed. The catheter includes a main shaft and a heat exchange region having a plurality of heat exchange elements each having a length and opposed ends. Each of the elements is attached on at least one of its ends to the shaft and disposed so that when inserted in a fluid body cavity having body fluid therein, the body fluid may circumferentially surround each heat exchange element along a portion of the length of the heat exchange element. The catheter includes a fluid circulation path therein, which desirably includes the hollow lumen within each of heat exchange elements. The heat exchange elements may be connected at two points along the shaft using manifolds that are in fluid communication with fluid flow paths within the shaft. Alternatively, the heat exchange elements may be connected at only one point and be permitted to float in a proximal or distal direction with respect to the catheter.

Abstract: A method of promoting blood vessel growth includes the steps of providing a cryocatheter having a thermally transmission region; placing the cryocatheter proximate an area of tissue to be treated; cooling the thermally transmissive region of the cryocatheter proximate the area of tissue to a temperature sufficient to injure the area of tissue; allowing the area of tissue to warm; and removing the cryocatheter from the area of tissue. Prior, during or after the cooling step, the area of tissue can be mechanically traumatized, and drugs can be injected into the tissue.

Abstract: An endovascular heat transfer device which can have a smooth exterior surface, or a surface with ridges and grooves. The device can have a plurality of elongated, articulated segments, with each having such a surface. A flexible joint connects adjacent elongated, articulated segments. The flexible joints can be bellows or flexible tubes. An inner lumen is disposed within the heat transfer segments. The inner lumen is capable of transporting a pressurized working fluid to a distal end of the heat transfer element.

Abstract: Systems, apparatus, and methods for treating spinal tissue and other body structures in open and endoscopic spine surgery to relieve symptoms, such as neck or back pain. In particular, the present invention provides methods for the controlled heating of various tissues in or around the vertebral column, including various interspinous tissues, such that spinal ligaments and cartilage surrounding the vertebrae and the facet joints are shrunk or tightened to stabilize the vertebral column of a patient. Thermal energy is applied to the target tissue in a subablation mode of an electrosurgical system to cause shrinkage of the tissue, thereby stiffening the interspinous tissue and stabilizing the vertebral column. In an exemplary embodiment, a high frequency RF voltage can be applied between one or more active electrode(s) and one or more return electrode(s) to heat a target interspinous tissue to within a temperature range at which irreversible shrinkage of the tissue occurs.

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

Abstract: The present invention relates to catheters for selectively cooling or warming tissue within a patient's vasculature. The present invention utilizes novel heat exchanging devices, which reside inside the catheter body for selectively altering the temperature of fluid that flows through the catheter shaft. In addition, the present invention utilizes novel pumping devices, which reside within a patient's vasculature for withdrawing oxygenated blood into the catheter body where heat exchange occurs across a heat transfer interface for selective cooling or warming of the blood occurs. The present invention can be used in a multiplicity of medical disciplines where it is advantageous to selectively alter the temperature of tissue, including beating heart applications, as well as stopped heart medical interventions.

Abstract: The invention provides a medical device having a thermister for temperature measurement, irrigation/aspiration ports for fluid exchange and application of therapeutic modalities, a pressure manometer for pressure measurement, and an external system for control of temperature, pressure, and flow rate. When applied to the central nervous system (CNS), this device can be used in hypothermia or hyperthermia applications, the exchange of cerebral spinal fluid (CSF), the application of treatment modalities, and the insertion of a ventriculostomy or ventriculostomy-like unit. When applied to spinal cord applications, this device can provide temperature control and a method for application of treatment modalities by using a venting device placed in the space surrounding the spinal cord, a device with similar instrumentation to measure temperature and pressure. A device for ultrasound localization of the CNS device is described. A device for a fiber optic endoscope for visualization and localization is also described.

Abstract: The present invention provides a body temperature control device capable of efficiently controlling body temperature, and a temperature controller using this device.

Abstract: The heat exchange catheters comprise a catheter body having a heat exchange structure formed over a distal region thereof. Heat exchange structure comprises an elastic chamber or balloon which conforms closely to the catheter body when uninflated and which expands to enhance the available heat transfer surface when heat exchange medium is introduced. The elastic structures may consist of elastomeric sheets or membranes or may comprise non-distensible sheets or membranes having elastic elements in order to control expansion and contraction. Methods for fabrication and use are also disclosed.

Abstract: Various embodiments of open system heat exchange catheters and methods of use are disclosed. The various catheters can be used with various ablative surgical devices. One specific exemplary use is in conjunction with cryosurgical probes involving ablation of the prostate, in which the integrity of the urethra is desired to be maintained. Other uses involve various heating ablative devices. In one embodiment an injection tube assembly is used to provide heat exchange fluid through the urethra to the bladder where it is then expelled via a suprapubic suction tube. In other embodiments a coaxial tube assembly is utilized which defines a passageway for either expelling the bladder fluid or for providing access to an endoscope. In other embodiments a double lumen assembly is utilized that defines a passageway for expelling bladder fluid.

Abstract: In an electrosurgical system which is operable within the frequency range of from 100kHz to 50MHz and which has a handheld instrument with an elongate instrument shaft, the distal end of the shaft carries a bipolar electrode assembly for use in a conductive fluid field. The electrode assembly has an active electrode and, set back from the active electrode, a return electrode coated with an insulative dielectric layer. The insulative layer may be made of a plastics or a ceramic material and acts as the dielectric of a capacitor when the electrode assembly is immersed in the conductive fluid. One of the effects of the insulative layer is to provide a more uniformly distributed electric field over the return electrode than is obtained with an exposed return electrode, yielding improved tissue desiccation and vaporisation characteristics. The active electrode may have a similar dielectric covering.

Abstract: A medical balloon catheter assembly includes a balloon having a permeable region and a non-permeable region. The balloon is constructed at least in part from a fluid permeable tube such that the permeable region is formed from a porous material which allows a volume of pressurized fluid to pass from within a chamber formed by the balloon and into the permeable region sufficiently such that the fluid may be ablatively coupled to tissue engaged by the permeable region. The non-permeable region is adapted to substantially block the pressurized fluid from passing from within the chamber and outwardly from the balloon. The porous material may be a porous fluoropolymer, such as porous polytetrafluoroethylene, and the pores may be created by voids that are inherently formed between an interlocking node-fibril network that makes up the fluoropolymer. Such voids may be created according to one mode by expanding the fluoropolymer.

Abstract: Flexible treatment catheters are configured to be inserted into a body lumen or cavity to deliver heated fluid through at least one fluid lumen therein to thermally treat or ablate a targeted site in a biological subject. The flexible treatment catheters can include improved thermally insulated regions comprising a mixture formed of liquid elastomeric (such as a polyurethane) mixture (which transitions to a solid state) and miniaturized hollow plastic bodies positioned between the outer wall of the treatment catheter and the fluid lumen. The thermally insulated region is configured such that, measured ex vivo, the treatment catheter can present a maximum temperature of below about 45° C. on the external surface of the outer wall of the treatment catheter when the treatment catheter circulates fluid having an inlet temperature of above or between about 60°-62° C.

Abstract: A method and apparatus for performing hypothermia of a selected organ without significant effect on surrounding organs or other tissues. A flexible catheter is inserted through the vascular system of a patient to place the distal tip of the catheter in an artery feeding the selected organ. A compressed refrigerant is pumped through the catheter to an expansion element near the distal tip of the catheter, where the refrigerant vaporizes and expands to cool a flexible heat transfer element in the distal tip of the catheter. The heat transfer element cools the blood flowing through the artery, to cool the selected organ, distal to the tip of the catheter.

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 an inlet lumen and an outlet lumen to circulate working fluid wherein at least one of the inlet or outlet lumens is shaped to induce mixing in the body fluid flowing pass it. In one embodiment, at least one lumen is shaped to induce turbulence flow in the body fluid.

Abstract: A method for treating endometrial hyperplasia or uterine cancer in menopausal women including performing endometrial ablation in a menopausal woman to thereby ablate substantially all of the endometrium, and administering a hormone therapy of unopposed estrogen. A method is also provided including performing endometrial ablation in a menopausal woman using a thermal ablation technique, and administering a hormone therapy comprising unopposed estrogen.

Abstract: A catheter system for controlling the body temperature of a patient by modifying the temperature of blood flowing within a blood vessel of the patient. The catheter system comprises a catheter body having a heat exchange region in contact with the blood; and a temperature probe having a distal end that extends from the catheter body, thereby monitoring the temperature of blood flowing within the blood vessel.

Abstract: A method and apparatus is provided for determining an effective thermal mass of a patient. The effective thermal mass is employed to determine a gain factor used in a feedback control system controlling patient temperature. The method begins by inducing hypothermia or hyperthermia in at least a selected portion of the patient with a device having a heat transfer surface. Next, power is transferred between the device and the patient. A change in temperature over time, which arises in the selected portion of the patient, is measured while performing the step of inducing hypothermia or hyperthermia. Finally, an effective thermal mass is calculated based on the measured power and the measured temperature change over time.

Abstract: Various intravascular heat exchange catheters are disclosed that have non-straight heat exchange elements.

Abstract: A connector assembly for catheters having closed loop flow circuits, such as some balloon catheters and heat exchange catheters. The connector assembly comprises first and second connector bodies that may be connected and disconnected from one another. When the connector bodies are disconnected, a syringe or negative pressure source may be attached to withdraw residual fluid from the catheter's closed loop circuit and to deflate any expandable portion of the closed loop circuit (e.g., balloon or expandable heat exchanger). A one way flow valve prevents make up air or other fluid from entering the catheter while the negative pressure is being applied. Also disclosed are sterility barrier assemblies for all types of catheters.

Abstract: Apparatus and methods for cooling selected regions within a body are described herein. An implantable cooling system is used to cool regions of the brain, spinal cord, fibrous nerve bodies, e.g., vagus nerve, etc. down to about 30° C. to diminish nerve impulses which control seizures or chronic pain. The system includes an implantable unit containing a pumping mechanism and/or various control electronics. It also has a heat exchanger attachable to a tubular body organ, such as the superior vena cava or the inferior vena cava, through which the heat is effectively dissipated. Also included is a heat pump such as a Peltier junction configured to be placed into contact with the region of tissue to be cooled. The heated portion of the Peltier junction is cooled by a liquid heat transfer medium which absorbs the heat from the junction and dissipates it into the tubular body organ.

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: Methods, systems, and computer program products measure electrical activity of the cardiac tissue proximate the lesion site during an ablation treatment, and then compare the measurements to determine whether the lesion is clinically efficacious so as to be able to block myocardial propagation. The methods can include obtaining the measurements and performing the ablation therapy while the subject is experiencing atrial fibrillation and may measure the standard deviation of the electrogram signal.

Abstract: The invention provides a single-use, disposable circulation set for a heat transfer catheter.

Abstract: A method and apparatus is provided for heating or cooling at least a selected portion of a patient's body. The method begins by inserting a catheter through the urethra and into the bladder of the patient. A heated or chilled fluid is conducted through a supply lumen of the catheter and into the bladder. The fluid is evacuated from the bladder through a return lumen of the catheter. Finally, a quantity of urine is monitored which flows out of the bladder and through the return lumen of the catheter.

Abstract: An apparatus having an inflatable balloon near a distal end of a multi-lumen catheter, with a plurality of blood flow passageways formed through the interior of the balloon from a proximal face of the inflated balloon to a distal face of the inflated balloon. A heat transfer solution is introduced through a supply lumen of the catheter to inflate the balloon in a selected blood vessel; this allows blood to flow through the blood flow passageways of the balloon, from one exterior face of the balloon to another exterior face. The heat transfer solution continues to circulate around the blood flow passageways inside the balloon, to change the blood temperature, eventually exiting the balloon through a return lumen of the catheter.

Abstract: Electrode assemblies and associated systems employ a nonporous wall having an exterior for contacting tissue. The exterior peripherally surrounds an interior area. The wall is essentially free of electrically conductive material. The wall is adapted to assume an expanded geometry having a first maximum diameter and a collapsed geometry having a second maximum diameter less than the first maximum diameter. The assemblies and systems include a lumen that conveys a medium containing ions into the interior area. An element free of physical contact with the wall couples the medium within the interior area to a source of electrical energy to enable ionic transport of electrical energy from the source through the medium to the wall for capacitive coupling to tissue contacting the exterior of the wall.

Abstract: The present invention provides an apparatus and a method for producing a virtual electrode within or upon a tissue to be treated with radio frequency alternating electric current, such tissues including but not limited to liver, lung, cardiac, prostate, breast, and vascular tissues and neoplasms. An apparatus in accord with the present invention includes a supply of a conductive or electrolytic fluid to be provided to the patient, an alternating current generator, and a processor for creating, maintaining, and controlling the ablation process by the interstitial or surficial delivery of the fluid to a tissue and the delivery of electric power to the tissue via the virtual electrode.

Abstract: The present invention provides an apparatus and a method for producing a virtual electrode within or upon a tissue to be treated with radio frequency alternating electric current, such tissues including but not limited to liver, lung, cardiac, prostate, breast, and vascular tissues and neoplasms. An apparatus in accord with the present invention includes a supply of a conductive or electrolytic fluid to be provided to the patient, an alternating current generator, and a processor for creating, maintaining, and controlling the ablation process by the interstitial or surficial delivery of the fluid to a tissue and the delivery of electric power to the tissue via the virtual electrode.

Abstract: An introducer sheath for a catheter includes an angling membrane formed at its distal end and an inflate/deflate mechanism formed at its proximal end to deploy the angling membrane. The sheath further includes two hollow body shafts connected at the distal end and can concentrically accommodate the catheter inside the shafts for positioning the catheter in a patient's vena cava system. The introducer sheath is used for positioning at least a portion of the catheter in the inferior vena cava from a chest or neck insertion point. Once the catheter's heat exchange elements are firmly positioned in the inferior vena cava, the angling membrane can be deflated and the angling introducer sheath removed leaving the catheter in place.

Abstract: A medical device for controlling the temperature of a region of brain tissue. Selective cooling of the brain is achieved by lowering the localized blood temperature of the internal blood vessel. The medical device controls the localized temperature of the brain by cradling the blood vessel and transferring thermal energy between the medical device and the blood vessel.

Abstract: A system, method and apparatus for temperature regulation of physiological fluids is disclosed. In an exemplary system for use in cardiopulmonary procedures, blood is entered into a proportionally long, narrow disposable container, is heated or cooled to a desired temperature, and exits from an opposite end. The disposable container includes a pair of long, flat surfaces facing each other in relatively, close proximity. The blood is transitioned from transport tubing into a thin laminar flow layer and back into tubing, inside the container. This container is placed in a heat exchange device having thermoelectric modules that contact the majority of surface area, opposite the blood side in the container. The thermoelectric modules act as fully reversible heat pumps and move heat from one side of the module to the other, dependant on the direction of the current supplied to the modules. Feedback from sensors in the fluid path independently control each thermoelectric module.

Abstract: A multi-purpose electrode mechanism for detection and control of changes in brain state includes a shaft portion and extendible elements structured for insertion into target tissue of the brain of a subject patient, cooling means configured to operatively apply cooling therapy to the target tissue, stimulation means having at least one electrical contact structured to operatively apply electrical stimulation therapy to the target tissue, sensing means including at least one sensor monitoring a biological signal of the subject patient, control means responsive to the sensing means wherein the control means is structured to, in response to signals from the sensing means that indicate the presence of a pre-determined physiological condition or occurrence of an undesirable state change, automatically cause the cooling means and/or the stimulation means to initiate or terminate the cooling therapy and/or the electrical stimulation therapy respectively and an energy source for powering the various components of the

Abstract: A method for treating cardiac arrest includes defibrillating the patient and/or ventilating the patient and/or administering a cardiac arrest drug such as epinephrine to resuscitate the patient, and then cooling the patient using one or more cooling catheter positioned in the central venous system of the patient.

Abstract: Disclosed is an apparatus and method for preventing secondary ischemic injury in the brain. The apparatus includes an interstitial brain-cooling probe that is placed into an ischemic region of the brain by stereotaxic surgical technique, and a control console. The control console provides a source of cooling fluid to the interstitial brain-cooling probe, and controls the flow of cooling fluid according to signals received from a temperature sensor mounted on the interstitial brain-cooling probe. The interstitial brain-cooling probe cools an ischemic region of the brain from within the ischemic region, and cooling is substantially limited to the ischemic region. Cooling is provided for a period of time greater than one hour.

Abstract: Methods and apparatus for selectively applying electrical energy to a target location within a patient's body, particularly including tissue in the spine. In a method of the invention high frequency (RF) electrical energy is applied to one or more active electrodes on an electrosurgical probe in the presence of an electrically conductive fluid to remove, contract or otherwise modify the structure of tissue targeted for treatment. In one aspect, a dura mater and spinal cord are insulated from the electrical energy by an insulator positioned on a non-active side of the probe. In another aspect, a plasma is aggressively formed in the electrically conductive fluid by delivering a conductive fluid to a distal end portion of the probe and aspirating the fluid from a location proximal of the return electrode.

Abstract: A method and apparatus is provided for heating or cooling at least a selected portion of a patient's body. The method begins by inserting a catheter having a balloon into the colon or stomach of the patient. A heated or chilled fluid is conducted through a supply lumen of the catheter and into the balloon. The fluid is evacuated from the balloon through a return lumen of the catheter.