Abstract: A cryocatheter system includes a first handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; a second handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; and a catheter having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path. The distal end of the first handle portion is matable with the proximal end of the second handle portion to place the respective first and second fluid flow paths of each handle portion in fluid communication; and the distal end of the second handle portion is matable with the proximal end of the catheter to place the respective first and second fluid flow paths of the second handle portion and the catheter in fluid communication.

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

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

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

Abstract: The present invention pertains to an apparatus for cryosurgery. The apparatus comprises a cryoneedle having a diameter less than 3.2 mm. The apparatus is also comprised of a thermal insulation shell disposed about a portion of the cryoneedle for reduction of heat transfer from surrounding tissues or freezing prevention of surrounding tissues during application of the cryoneedle with the shell. The cryoneedle and shell are configured for insertion into a body of a patient. The present invention pertains to a method for freezing tissues. The method comprises the steps of bringing into contact a cryoneedle having a diameter of less than 3.2 mm with a patient's body. Next, there is the step of flowing the cryofluid through the cryoneedle.

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

Abstract: A coolant system for a cryoablation or treatment probe such as a mapping or ablation catheter, or a treatment wand, includes a compressor and condenser having a low pressure inlet side and a high pressure outlet side, wherein the outlet side passes through a heat exchanger and is cooled by the inlet side and conditioned for injection to a catheter inlet. A vacuum return system connectable to the catheter outlet draws thermally expended coolant from the catheter and returns it to the low pressure inlet side. A motorized pressure regulator between the heat exchanger and the catheter inlet determines the pressure of coolant passing into the catheter and thus regulates the cooling rate for a selected mapping or ablation regimen. The low pressure compressor inlet supply preferentially conditions the pressurized coolant to ambient temperature or lower before injection into the catheter, allowing the coolant to travel through the body at ambient before expansion in the tip.

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

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 provides a medical device to cold treat desired regions. An injection tube with an open distal end, and at least one aperture proximate thereto is disposed inside of a cooling tube, defining a cooling lumen therebetween. A third outer tube member is disposed around the second cooling member, defining a return lumen therebetween. A supply of fluid, regulated by a controller mechanism coupled to the device, flows through the injection lumen, the apertures and the cooling lumen to insulate and cool the fluid supplied into the injection lumen. The supplied fluid flows through the injection lumen and its distal end into the return lumen to cool the surrounding areas external to and proximate the distal end of the device.

Abstract: A cryocatheter system includes a first handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; a second handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; and a catheter having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path. The distal end of the first handle portion is matable with the proximal end of the second handle portion to place the respective first and second fluid flow paths of each handle portion in fluid communication; and the distal end of the second handle portion is matable with the proximal end of the catheter to place the respective first and second fluid flow paths of the second handle portion and the catheter in fluid communication.

Abstract: Disclosed herein is a method of treating mammalian, for example, human, skin afflicted with a sebaceous follicle disorder, for example, acne. The method involves cooling an exposed surface of a region afflicted with the disorder and applying energy, for example, energy from a coherent or incoherent light source, to the region. The applied energy reduces the size and/or density of lesions associated with the disorder in the treated region, and can reduce or otherwise alleviate lesion-associated skin inflammation in the treated region. Cooling preserves the surface, for example, epidermis, of the skin. The method, therefore, is effective at treating the disorder while at the same time avoiding or minimizing thermal damage to the exposed surface of the skin.

Abstract: An apparatus and methods for cutting and removal of biological tissue using pressurized propulsion of ice particles is disclosed. An apparatus for cutting and removal of biological tissue includes: an ice particle generator, for producing ice particles; a particle delivery element, connected to the ice particle generator, for transporting the ice particles from the ice particle generator; an injection handpiece, connected to the particle delivery element, the injection handpiece having an injection outlet; and, a high pressure source, connected to the injection handpiece, for propelling the ice particles in a jet stream of fluid from the injection outlet, under high pressure and at high linear velocity, so as to cut and remove a desired portion of the biological tissue.

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: A catheter for injecting a thermally sensitive gelation material to remote sites within a patient's body by maintaining the thermally sensitive gelation material in a liquid state until it is delivered to a target area within the body.

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

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

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

Abstract: A heat transfer device has first and second elongated, articulated segments, each having a turbulence-inducing exterior surface. A flexible joint connects the first and second elongated, articulated segments. An inner coaxial lumen is disposed within the first and second elongated, articulated segments.

Abstract: An improved apparatus for delivery of cryosurgery fluid in a surgical or other medical environment is disclosed. The preferred apparatus comprises a multiple-layered expanded polytetrafluoroethylene conduit that has a low profile, has low thermal conductivity, and provides exceptional flexibility. A wide variety of treatment instrumentalities may be employed on the end of the conduit to provide medical treatments ranging from direct topical application of cryosurgery fluid to open or closed-system surgical or endosurgical uses.

Abstract: A coolant system for a cryoablation or treatment probe such as a mapping or ablation catheter, or a treatment wand, includes a compressor and condenser having a low pressure inlet side and a high pressure outlet side, wherein the outlet side passes through a heat exchanger and is cooled by the inlet side and conditioned for injection to a catheter inlet. A vacuum return system connectable to the catheter outlet draws thermally expended coolant from the catheter and returns it to the low pressure inlet side. A motorized pressure regulator between the heat exchanger and the catheter inlet determines the pressure of coolant passing into the catheter and thus regulates the cooling rate for a selected mapping or ablation regimen. The low pressure compressor inlet supply preferentially conditions the pressurized coolant to ambient temperature or lower before injection into the catheter, allowing the coolant to travel through the body at ambient before expansion in the tip.

Abstract: The invention is a technique for dynamic measurements of the heat transfer coefficient to the outer layer of the skin surface using a high thermal conductivity metal in an insulating block as the standardized target. The coefficient is dependent on the specific design of the cryogen valve and nozzle, and values up to 11 500 W/m2K values were measured for a 100 ms long spurts. The values for longer spurts are dependent on air humidity, as ice/snow formation then tends to form a thermally insulating layer. The average value of the heat transfer coefficient for a 200 ms long spurt was determined to 8000 W/m2K for conditions of normal room humidity and temperature. The technique enables an improved prediction of the temperature profile and cooling efficiency during therapy, and may thereby contribute to an improved therapeutic outcome.

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: Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material or other flowable material into the body of the patient so that the material contacts the object. The LCST material or other flowable material then forms a gel in the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

Abstract: The present invention provides a method and apparatus for controlling the internal body temperature of a patient. According to the present invention, a catheter is inserted through an incision into a large blood vessel of a patient. By selectively heating or cooling a portion of the catheter lying within the blood vessel, heat may be transferred to or from blood flowing within the vessel and the patient's body temperature may thereby be increased or decreased as desired. The invention will find use in treating undesirable conditions of hypothermia and hyperthermia, or for inducing a condition of artificial hypothermia when desired.

Abstract: A delivery guide frame attachment for a laser scanner mechanism for a laser treatment operation, to permit proper spacing and dimensional stability of the laser scanner with respect to the skin of a patient being treated. The delivery guide frame attachment includes a housing having an upper end and a lower end. The lower end is applyable to the skin of a patient. The upper end is attached to the laser scanner. A chilled fluid supply conduit is arranged in communication with the housing for delivering a chilled fluid onto the skin of a patient when the housing is applied thereto. A chilled fluid containment arrangement in the housing retains and delays escape of chilled fluid from the housing placed on the patient, for a short period during the laser treatment operation.

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

Abstract: A powered surgical handpiece for use with a micro-cutting instrument, includes a motor contained within a housing. The housing includes a motor enclosure surrounding the motor and a sleeve placed about the motor enclosure. An internal passage is formed entirely between the sleeve and the motor enclosure. Finally, the sleeve defines a handling region and forms inlet and outlet ports proximal the handling region which are fluidly connected to the internal passage. During use, a cooling fluid, flows through the internal passage as the cooling fluid circulates from the inlet port to the outlet port. The motor is sealed relative to the cooling fluid by the motor enclosure. Thus, the cooling fluid does not directly contact the motor, but instead serves as a heat exchange medium through which heat generated by the motor is thermally transferred to the cooling fluid via the motor enclosure.

Abstract: A laser treatment device and process with controlled cooling. The device contains a cooling element with high heat conduction properties, which is transparent to the laser beam. A surface of the cooling element is held in contact with the tissue being treated while at least one other surface of the cooling element is cooled by the evaporation of a cryogenic fluid. The cooling is coordinated with the application of the laser beam so as to control the temperatures of all affected layers of tissues. In a preferred embodiment useful for removal of wrinkles and spider veins, the cooling element is a sapphire plate. A cryogenic spray cools the top surface of the plate and the bottom surface of the plate is in contact with the skin. In preferred embodiments the wavelength of the laser beam is chosen so that absorption in targeted tissue is low enough so that substantial absorption occurs throughout the targeted tissue. In a preferred embodiment for treating large spider veins with diameters in the range of 1.

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

Abstract: A cryosurgical instrument including a long, resiliently flexible cable terminating at a freezing unit with a selectively operable thermoelectric cooling device for normally freezing a leading contact tip.

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

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

Abstract: A 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 methods, apparatus, and kits for detection and/or treatment of vulnerable plaque of a blood vessel having a lumen surface. Detection methods include sensing a temperature differential along a lumen surface with temperature sensors that thermally couple the lumen surface. Treatment methods include controlled and safe cryogenic cooling of vulnerable plaque to inhibit release of retained fluid within the vulnerable plaque so as to inhibit acute coronary syndrome and to help maintain patency of a body lumen. Treatment methods may include additional treatments, such as primary treatments or passivation.

Abstract: A medical device for cryotreatment of bodily regions is disclosed. The device comprises an inflatable support structure coupled to the distal end portion of a catheter shaft, the support structure being further enveloped by an expandable membrane to define an expansion chamber between the support structure and the membrane. An inflation lumen is coupled to the support structure to inject an inert, insulating fluid in the support structure, thereby expanding the support structure and the expandable membrane, wherein the resultant expansion chamber formed therebetween is substantially conical in shape. Refrigerant is injected into the expansion chamber, thereby creating localized cooling of tissues adjacent to the expansion chamber, the cooling region being substantially conical in shape.

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

Abstract: The cryosurgical system comprises a Joule-Thomson cryoprobe including a Joule-Thomson nozzle and a cryoprobe outlet. The Joule-Thomson nozzle is in fluid communication with the cryoprobe outlet. A high pressure gas supply line is aligned to supply gas to the Joule-Thomson cryoprobe. An operating cut-off valve is operatively connected to the high pressure gas supply line, the valve being operable to supply and cut off high pressure gas to the Joule-Thomson cryoprobe. A vent valve assembly is operatively connected to the high pressure gas supply line, the vent valve assembly being operable to vent gas from the high pressure supply line immediately upon operation of the operating cut-off valve to cut off high pressure gas to the Joule-Thomson cryoprobe. An interlock controls the vent valve assembly, the interlock being operable to open the vent valve assembly immediately upon operation of the cut-off valve to cut off high pressure gas to the Joule-Thomson cryoprobe.

Abstract: A catheter with three spiral heat exchange elements surrounding a central supply tube and communicating with a source of heat exchange fluid in a closed loop for effecting patient temperature control and at least two infusion lumens for providing access to the central venous blood supply when the catheter is placed in the central venous system. An anchor can be provided to suture or tape the catheter to the skin of a patient.

Abstract: Disclosed are methods and devices for navigating a subarachnoid space in a vertebrate organism including percutaneously introducing a device into the spinal subarachnoid space at an entry location. Navigation of the spinal subarachnoid space is disclosed for the purpose of reaching a desired location in the subarachnoid space or the intracranial space, including areas in and around the spinal cord and brain. Once a desired location is reached, methods and devices for cooling or heating the desired location to cause physiologic changes are suggested.

Abstract: A cryoablation catheter having an expandable cooling chamber in which the cooling fluid, preferably a gas, serves to expand the expandable cooling chamber while simultaneously cooling the chamber.

Abstract: Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material or other flowable material into the body of the patient so that the material contacts the object. The LCST material or other flowable material then forms a gel in the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

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 is directed towards a surgical system and method of use for treating and removing unwanted tissue, preferably from an organ or other internal part of a patient. The system includes a cryosurgical component for first freezing the unwanted living tissue by forming an ice mass which completely encompasses the unwanted living tissue and means for treating the cryogenically-treated tissue and then removing the tissue while it remains in a frozen state. In one embodiment, an ultrasonic device is used to ultrasonically vibrate the cryogenically-treated tissue to break apart the frozen tissue and the frozen broken-up pieces of tissue are removed using a technique, such as an aspiration process.

Abstract: An apparatus and method for treating female stress-induced incontinence and other similar diseases associated with weakening of the pelvic floor muscles. A guiding catheter with temperature sensor(s) is positioned in patient's urethra. An inflatable balloon carried by a forward end of the catheter is inflated to sit in a neck of a bladder. Measuring indicia on the exterior of the catheter is indicative of a distance between the bladder neck and external meatus. A vagina probe member provided with a laser output in a forward portion thereof is then positioned in place such that the laser output is at about a level of the bladder neck, as facilitated by the guiding catheter. The laser output is operationally connected to a medical laser generating and monitoring device that delivers a laser beam to selected areas in the pelvic floor to cause denaturing and recoiling of the tissue collagen in the area surrounding the urethra.

Abstract: A system and method for performing cryosurgery of the prostate while protecting surrounding tissue. Cryosurgical probes are provided with argon gas for cooling and with helium for warming. Probes are inserted into the prostate and supplied with argon gas for cooling, while probes inserted into the surrounding tissue and supplied with helium gas for warming. The warmed probes protect the surrounding tissue from freezing.

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

Abstract: A delivery guide frame attachment for a laser scanner mechanism for a laser treatment operation, to permit proper spacing and dimensional stability of the laser scanner with respect to the skin of a patient being treated. The delivery guide frame attachment includes a housing having an upper end and a lower end. The lower end is applyable to the skin of a patient. The upper end is attached to the laser scanner. A chilled fluid supply conduit is arranged in communication with the housing for delivering a chilled fluid onto the skin of a patient when the housing is applied thereto. A chilled fluid containment arrangement in the housing retains and delays escape of chilled fluid from the housing placed on the patient, for a short period during the laser treatment operation.