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: 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: 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 material is provided that uses controlled electrical current derived from two dissimilar galvanic materials to drive oligodynamic metal ions into solution. Exemplary materials include carbon and silver.

Abstract: A cryogenic catheter includes a flexible member having an elongate, thermally-transmissive region and a cryogenic fluid path through the flexible member to the thermally-transmissive region. The thermally-transmissive region can be deformable from a linear configuration to an arcuate configuration and can include multiple thermally-transmissive elements having a first side exposed to the cryogenic fluid path and a second side exposed to points exterior to the flexible member. The thermally-transmissive elements can be rigid or flexible longitudinal strips. Alternatively, annular, cylidrical, or wedge-shaped metallic structures disposed in a spaced-apart relationship can define the thermally-transmissive region. In other embodiments the thermally-transmissive region is defined by a helical coil that is at least partially embedded in the flexible member. The helical coil can also define at least a portion of the cryogenic fluid path through the flexible member and include a gas expansion or boiling chamber.

Abstract: A cryogenic catheter includes a flexible member having an elongate, thermally-transmissive region and a cryogenic fluid path through the flexible member to the thermally-transmissive region. The thermally-transmissive region can be deformable from a linear configuration to an arcuate configuration and can include multiple thermally-transmissive elements having a first side exposed to the cryogenic fluid path and a second side exposed to points exterior to the flexible member. The thermally-transmissive elements can be rigid or flexible longitudinal strips. Alternatively, annular, cylindrical, or wedge-shaped metallic structures disposed in a spaced-apart relationship can define the thermally-transmissive region. In other embodiments the thermally-transmissive region is defined by a helical coil that is at least partially embedded in the flexible member. The helical coil can also define at least a portion of the cryogenic fluid path through the flexible member and include a gas expansion or boiling chamber.

Abstract: An iontophoretic material is provided that uses controlled electrical current derived from two dissimilar galvanic materials to drive oligodynamic metal ions into solution to kill microorganisms on and near the material. Iontophoretic structures or material associated with a medical device are partially or completely covered with one or more covering layers that alter physical, mechanical, chemical, or biological properties of the device and/or the iontophoretic material. In addition to being partially coated or completely enveloped by iontophoretic material or structures, all or a portion of a medical device can be integrated with, impregnated by, or fabricated from an iontophoretic material.

Abstract: An iontophoretic structure for medical devices is provided that uses controlled electrical current derived from two dissimilar galvanic materials to drive oligodynamic metal ions into solution to kill bacteria on and near the device to which the structure is affixed. In one embodiment, a first galvanic material separated from a second galvanic material by a resistive material produces an anti-bacterial current flow when placed in contact with an electrolytic fluid. In another embodiment, a cylindrical elastomeric catheter incorporates a first and a second galvanic material separated by a resistive material which controls a current flow between the galvanic materials when the catheter is immersed in an electrolytic fluid. The galvanic materials can be dissimilar metal powders embedded in a conductive polymer substrate that forms an iontophoretic composite material, or dissimilar metals arranged in layers separated by a resistive layer.

Abstract: An iontophoretic structure for medical devices is provided that uses controlled electrical current derived from two dissimilar galvanic materials to drive oligodynamic metal ions into solution to kill bacteria on and near the device to which the structure is affixed. In one embodiment, a first galvanic material separated from a second galvanic material by a resistive material produces an anti-bacterial current flow when placed in contact with an electrolytic fluid. In another embodiment, a cylindrical elastomeric catheter incorporates a first and a second galvanic material separated by a resistive material which controls a current flow between the galvanic materials when the catheter is immersed in an electrolytic fluid. The galvanic materials can be dissimilar metal powders embedded in a conductive polymer substrate that forms an iontophoretic composite material, or dissimilar metals arranged in layers separated by a resistive layer.

Abstract: A meniscectomy knife includes a preformed cutting trace through which a cutting element moves in response to motion producing means disposed on a handle. The cutting trace defines an arc having a size and shape which closely correspond to the lines of stress along a meniscus in the meniscal region of a human knee joint.

Abstract: The invention provides a catheter for ice mapping and ablation and a method of ablation using the catheter. The catheter includes at least two conduits for circulating a refrigerating fluid adjacent an ablation device located at the end of a catheter. The refrigerated ablation device is used to chill a localized region of myocardial tissue, thereby permitting the resulting change in electrical activity to be determined. In response to the test results, the ablation device may be used to make a lesion in the myocardial tissue to correct a cardiac arrhythmia. In one embodiment, the ablation device is an electrode which uses radio frequency energy to ablate the myocardial tissue. Alternatively, the ablation device is an electrode adapted for direct current ablation. In another embodiment, the electrode is replaced with an optical fiber in communication with a laser which uses the laser's light energy to ablate tissue.

Abstract: An iontophoretic structure for medical devices is provided that uses controlled electrical current derived from two dissimilar galvanic materials to drive oligodynamic metal ions into solution to kill bacteria on and near the device to which the structure is affixed. In one embodiment, a first galvanic material separated from a second galvanic material by a resistive material produces an anti-bacterial current flow when placed in contact with an electrolytic fluid. In another embodiment, a cylindrical elastomeric catheter incorporates a first and a second galvanic material separated by a resistive material which controls a current flow between the galvanic materials when the catheter is immersed in an electrolytic fluid. The galvanic materials can be dissimilar metal powders embedded in a conductive polymer substrate that forms an iontophoretic composite material, or dissimilar metals arranged in layers separated by a resistive layer.

Abstract: The invention provides a catheter for ice mapping and ablation and a method of ablation using the catheter. The catheter includes at least two lumens for circulating a refrigerating fluid adjacent an ablation device located at the end of a catheter. The refrigerated ablation device is used to chill a localized region of myocardial tissue, thereby permitting the resulting change in electrical activity to be determined. In response to the test results, the ablation device may be used to make a lesion in the myocardial tissue to correct a cardiac arrhythmia. In one embodiment, the ablation device is an electrode which uses radio frequency energy to ablate the myocardial tissue. Alternatively, the ablation device is an electrode adapted for direct current ablation. In another embodiment, the electrode is replaced with an optical fiber in communication with a laser which uses the laser's light energy to ablate tissue.

Abstract: The invention provides a catheter for ice mapping and ablation and a method of ablation using the catheter. The catheter includes at least two lumens for circulating a refrigerating fluid adjacent an ablation device located at the end of a catheter. The refrigerated ablation device is used to chill a localized region of myocardial tissue, thereby permitting the resulting change in electrical activity to be determined. In response to the test results, the ablation device may be used to make a lesion in the myocardial tissue to correct a cardiac arrhythmia. In one embodiment, the ablation device is an electrode which uses radio frequency energy to ablate the myocardial tissue. Alternatively, the ablation device is an electrode adapted for direct current ablation. In another embodiment, the electrode is replaced with an optical fiber in communication with a laser which uses the laser's light energy to ablate tissue.

Abstract: A surgical tool for operating within a body cavity through a small diameter opening includes a substantially rigid member which is elongated along a first axis and which has a cross-sectional dimension to fit within the opening. A head is mounted on one end of the rigid member for movement in at least one plane through an angle with respect to the first axis. An operable control member is mounted on an opposite end of the rigid member for having at least one degree of manipulability. The control member is coupled to the head member through the rigid member such that manipulation of the control member through an angle with respect to the first axis causes movement of the head member through a corresponding angle. Accordingly, the head member can be steered within a body cavity by control external to the body cavity. In some embodiments, the control member is manipulable to a second degree for actuating an actuating member mounted on the head.

Abstract: An intra aortic balloon pumping device comprises a pumping balloon, an attached inflation catheter, a supporting member which is disposed within and extends from the catheter into the balloon. The balloon membrane of the invention resists the formation of membrane folds in the tail section of the balloon. This characteristic of the balloon membrane is believed to result from the addition of tension to the balloon membrane. Tension may be applied to the membrane by ensuring that the portion of the support member which is disposed within the balloon is equal to the length of the outer curve of the balloon wall such that it resides on an outer curve of the wall. Alternatively, tension may be applied by extending the support member within the balloon.

Abstract: A mechanism stretches and slightly twists an intraaortic balloon to a stretched and wrapped state prior to insertion or removal. One embodiment includes a member which extends through a catheter from the handle to the balloon, and which advances to extend the balloon while slightly twisting it. A spiral drive screw assembly in the handle defines a precise ratio of balloon extension to twist, and also defines fixed total amounts of twist and extension delivered by the member. The mechanism permits the balloon to be fully untwisted once it is inserted and to be recompacted, following use, for removal from the patient. The device is of particular utility for a large diameter or non-cylindrical balloon, and for inserting a balloon along an arterial path having a narrow passage or sharp curve.

Abstract: A blood pump having a toroidal shaped chamber concentrically positioned around a cylindrically shaped hydraulic pump. The toroidal chamber has two toroidal shaped portions, one portion having a substantially rigid external wall and the other having an external wall formed of a flexible membrane. The chamber has an inlet and output port suitable for connection to a blood flow supply. The flexible wall portion of the toroidal chamber is enclosed within a hydraulic chamber, fluidically coupled to the hydraulic pump. The hydraulic pump is controlled so that an increase of pressure in the hydraulic chamber results in a decrease of volume in the toroidal chamber, thus providing for pumping of the blood through that portion of the chamber. The toroidal shape provides for optimal non-coagulating flow, while the rigid wall of the chamber, together with the flexible membrane provide for membrane motion along only one axis, normal to the circumference of the toroid, preventing damage to the membrane.

Abstract: A system for detecting leakage in a device having a fluid-driven membrane inserted in the body, for example, a balloon pump, includes a fluid drive circuit with a moisture remover having a capacity just sufficient to remove water vapor entering the circuit due to intrinsic permeability of the membrane. An in-line humidity sensor responds quickly to an increase in vapor pressure, indicating a leak, and activates a shut-down circuit to prevent leakage of the drive fluid into the body. The system is employed in a balloon pump driven by a pulsating air source.