Abstract: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. In the first case, the coolant also inflates the balloon, and spent coolant is returned to the handle via a return passage extending through the body of the catheter. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. Various configurations, such as surface modification of the balloon interface, or placement of particles, coatings, or expandable meshes or coils in the balloon interface, may be employed to achieve this function.

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 and apparatus for detecting plaque proximate an area of a human body is described, the method comprising the steps of moving one or more electrically sensitive sensors substantially near an area where plaque may be present, obtaining electrical signal readings from the sensors, and determining the presence or absence of plaque. The presence or absence of the plaque corresponds to the electrical signal readings. Another aspect of the invention provides a method for inhibiting plaque formation and passivating plaque formed on a lumenal surface of a body lumen. A cooling device is positioned at the lumenal surface at a point proximate to a plaque formation. The lumenal surface is cooled at the point proximate to the plaque formation to inhibit the progression of plaque formation in which the lumenal surface is cooled to a temperature of less than about zero degrees Celsius. As another aspect, a method is provided for reducing the risk of plaque rupture in a vessel.

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: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. In the first case, the coolant also inflates the balloon, and spent coolant is returned to the handle via a return passage extending through the body of the catheter. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. Various configurations, such as surface modification of the balloon interface, or placement of particles, coatings, or expandable meshes or coils in the balloon interface, may be employed to achieve this function.

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 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 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 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: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. In the first case, the coolant also inflates the balloon, and spent coolant is returned to the handle via a return passage extending through the body of the catheter. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. Various configurations, such as surface modification of the balloon interface, or placement of particles, coatings, or expandable meshes or coils in the balloon interface, may be employed to achieve this function.

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 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 cryogenic catheter having an elongate outer member and a plurality of inner members disposed within the elongate outer member is provided. The inner members define at least one cryogenic path through the outer member. At least one of the inner members has at least one controllable opening formed thereon to selectively release cryogenic fluid. The inner members also include an overtube and an injection tube slideably disposed to one another.