Abstract: Catheter devices and uses thereof are provided that include inner and outer tubular members, each having proximal and distal ends, where the distal end of the outer tubular member is shaped, including at least one curve, such as a Judkins right curve or an Amplatzer left curve. At least a portion of the inner tubular member is coaxially positioned within the outer tubular member. The control mechanism has a housing with a means to seal an inner luminal space thereof, where the control mechanism is coupled to the proximal ends of the outer tubular member and the inner tubular member. The control mechanism is operable to extend and retract the distal end of the inner tubular member from the shaped distal end of the outer tubular member.

Abstract: A sensing guidewire device used to measure physiological parameters within a living body. In one embodiment, the device is used to measure the fractional flow reserve (FFR) across a stenotic lesion in a patient's vasculature. The device includes a sensor that is adapted to be affixed near the distal end of a guidewire. The guidewire contains a corewire, processed to enclose electrical conductors in a sealed, off-centered interstice or channel, with an outer diameter approximate to the outer diameter of the device, running substantially the full length of the device, and has a homogenous outer surface. The enclosed eccentric channel provides space for electrical conductors to move freely. The corewire can have a tapered segment to create desirable flexibility. A solid connector comprised of alternating conductive and insulating elements for connecting the conductors to an external device is disclosed.

Abstract: A cryoablation catheter system comprises a cryoablation catheter having a shaft, a guidewire lumen member and an expandable balloon attached to the shaft and the guidewire lumen member, and an auxiliary device configured for use in combination with the cryoablation catheter, the auxiliary device including a location sensor configured to provide a sensor output indicative of a location of the location sensor within a localization volume responsive to a localization field. A user-accessible relative position indicator is located on one or both of the cryoablation catheter and the auxiliary device and is configured to provide an indication of a relative position of the cryoballoon and the location sensor.

Abstract: A cryoablation catheter comprises a tubular shaft having a shaft distal end and a shaft lumen, a tubular guidewire lumen member extending within the shaft lumen and forming a guidewire lumen extending between the guidewire lumen member proximal end and the guidewire lumen member distal end, an expandable cryoballoon having a proximal portion attached to the shaft distal end and a distal portion attached to the guidewire lumen member distal end, and a cryoablation catheter location sensor configured to generate a cryoablation location signal when in the cryoablation catheter location sensor is within a magnetic localization field.

Abstract: A sensing guidewire device used to measure physiological parameters within a living body. In one embodiment, the device is used to measure the fractional flow reserve (FFR) across a stenotic lesion in a patient's vasculature. The device includes a sensor that is adapted to be affixed near the distal end of a guidewire. The guidewire contains a corewire, processed to enclose electrical conductors in a sealed, off-centered interstice or channel, with an outer diameter approximate to the outer diameter of the device, running substantially the full length of the device, and has a homogenous outer surface. The enclosed eccentric channel provides space for electrical conductors to move freely. The corewire can have a tapered segment to create desirable flexibility. A solid connector comprised of alternating conductive and insulating elements for connecting the conductors to an external device is disclosed.

Abstract: A balloon catheter for an intravascular catheter system includes a cryogenic balloon that is formed from a blend of polyurethane and polyamide block copolymer. The percentages of polyurethane and polyamide block copolymer can vary. For example, the cryogenic balloon can be formed from greater than 50% polyurethane and less than 50% polyamide block copolymer; greater than 75% polyurethane and less than 25% polyamide block copolymer; or approximately 85% polyurethane and approximately 15% polyamide block copolymer. Additionally, a ratio of a change in inflation pressure (in psi) to a change in outer diameter (in mm) of the cryogenic balloon, and a ratio of outer diameter (in mm) of the cryogenic balloon to inflation pressure (in psig) can be varied to form the desired cryogenic balloon.

Abstract: A cryoablation catheter comprises a catheter shaft, a guidewire lumen disposed within the catheter shaft, a cryoballoon having a first end connected to the catheter shaft and an opposite second end connected to the guidewire lumen, the cryoballoon configured to transition between a deflated state and an inflated state, the cryoballoon having a maximum circumference in the inflated state, a proximal electrode array having a plurality of proximal electrodes arranged around the cryoballoon and located proximally of the maximum circumference of the cryoballoon, and a distal electrode array having a plurality of distal electrodes arranged around the cryoballoon and located distally of the maximum circumference of the cryoballoon. The cryoablation catheter has no electrodes located at the maximum circumference of the cryoballoon.

Abstract: An intravascular catheter system for treating a condition in a body includes a catheter shaft, a first inflatable balloon and a plurality of electrodes. The first inflatable balloon is positioned near a distal end of the catheter shaft. The first inflatable balloon moves between an inflated state and a substantially deflated state. In the inflated state, the first inflatable balloon has a maximum circumference. The plurality of electrodes are attached to the first inflatable balloon away from the maximum circumference of the first inflatable balloon. In some embodiments, the plurality of electrodes are attached to the inner surface of the first inflatable balloon. In various embodiments, the intravascular catheter system can also include two or more flex circuits that substantially face one another when the first inflatable balloon is in the substantially deflated state.

Abstract: A cryogenic balloon catheter system includes a cryoballoon, a guidewire lumen that extends through and is secured to the cryoballoon, an injection line receiver and a fluid injection line. The injection line receiver is fixedly secured to the guidewire lumen so that movement of the guidewire lumen moves the injection line receiver. The injection line receiver includes an interior chamber. The fluid injection line delivers cryogenic fluid to the interior chamber. In certain embodiments, the fluid injection line extends into the injection line receiver and allows relative movement between the fluid injection line and the injection line receiver. The fluid injection line is not affixed to the injection line receiver. The fluid injection line is not affixed to the guidewire lumen. The injection line receiver can include one or more injection line sealers that are positioned around the fluid injection line.

Abstract: A steering assembly for steering, navigating, articulating and/or positioning a catheter includes a steering ring having a first edge surface, a second edge surface and a side surface. The steering ring includes one or more notches formed within the side surface. The notches are spaced apart and extend to one of the first edge surface and the second edge surface. The steering ring can also include one or more apertures formed within the side surface. In one embodiment, the steering ring can include one or more lattice structures formed within the side surface. In certain embodiments, the lattice structures can form at least approximately 10%, 25% and/or 50% of the side surface.

Abstract: A sensing guidewire device used to measure physiological parameters within a living body. In one embodiment, the device is used to measure the fractional flow reserve (FFR) across a stenotic lesion in a patient's vasculature. The device includes a sensor that is adapted to be affixed near the distal end of a guidewire. The guidewire contains a corewire, processed to enclose electrical conductors in a sealed, off-centered interstice or channel, with an outer diameter approximate to the outer diameter of the device, running substantially the full length of the device, and has a homogenous outer surface. The enclosed eccentric channel provides space for electrical conductors to move freely. The corewire can have a tapered segment to create desirable flexibility. A solid connector comprised of alternating conductive and insulating elements for connecting the conductors to an external device is disclosed.

Abstract: One aspect of the present disclosure relates to a tissue imaging device that includes a catheter body, a hood, and a visualization assembly. The catheter body includes a distal end portion, a proximal end portion, and at least one lumen extending between the distal and proximal end portions. The catheter body includes at least one drainage port having a first opening and at least one infusion port having a second opening. The first and second openings are located about a lateral aspect of the catheter body. The hood projects distally from the distal end portion and is configured to self-expand into an expanded deployment state that defines an open area therein. The visualization assembly is disposed within the open area and extends distally from the distal end portion of the catheter body.

Abstract: A device and method for precisely delivering dosage of radiation from a radiation source to a treatment site of a vessel is provided herein. In one embodiment, the device includes a catheter which inserts into a vessel lumen of the body. The catheter includes an adjuster section for altering a portion of the radiation emitting radially from the radiation source so that the radiation source delivers an asymmetrical radiation profile to the vessel. The device can also include a catheter supporter which inhibits rotational deformation in the catheter between a catheter distal end and a catheter proximal end. This allows the delivery section to be precisely rotated to properly position the adjuster section within the vessel lumen.

Abstract: A method for forming a balloon for a dilation catheter is provided herein. The method includes the steps of: (i) positioning a tube in a preconditioned mold; (ii) expanding the tube in a preconditioned mold to form a parison; (iii) positioning the parison in a balloon mold; and (iv) expanding the parison within the balloon mold to form the balloon. Thus, the tube is initially expanded into a parison in the preconditioned mold. Subsequently, the parison is expanded into a balloon in the balloon mold. Because of this unique manufacturing process, polyester block copolymers can be formed into balloons. Some of these polyester block copolymers could not be formed into a balloon using prior art blow molding processes. The resulting balloon exhibits superior characteristics, including relatively thin and consistent walls, soft texture, low uninflated crossing profile, expansion in a predictable fashion, and good tensile strength.

Abstract: A method for forming a balloon for a dilation catheter is provided herein. The method includes the steps of: (i) positioning a tube in a preconditioned mold; (ii) expanding the tube in a preconditioned mold to form a parison; (iii) positioning the parison in a balloon mold; and (iv) expanding the parison within the balloon mold to form the balloon. Thus, the tube is initially expanded into a parison in the preconditioned mold. Subsequently, the parison is expanded into a balloon in the balloon mold. Because of this unique manufacturing process, polyester block copolymers can be formed into balloons. Some of these polyester block copolymers could not be formed into a balloon using prior art blow molding processes. The resulting balloon exhibits superior characteristics, including relatively thin and consistent walls, soft texture, low uninflated crossing profile, expansion in a predictable fashion, and good tensile strength.

Abstract: A delivery device and method for delivering a dosage of radiation from a radiation source to a treatment site of a vessel is provided herein. The delivery device includes a catheter and a delivery area. The catheter is suitable for being inserted into a vessel lumen of the vessel and includes a delivery lumen for receiving the radiation source. The delivery area also receives the radiation source. The delivery area includes an attenuator section for attenuating a portion of the radiation emitting from the radioactive area so that the delivery area emits an eccentric radiation profile. The delivery device can also include a catheter supporter which inhibits rotational deformation in the catheter between a catheter distal end and a catheter proximal end. This allows the delivery area to be precisely rotated to properly position the attenuator section within the vessel lumen.

Abstract: A device and method for precisely delivering dosage of radiation from a radiation source to a treatment site of a vessel is provided herein. In one embodiment, the device includes a catheter which inserts into a vessel lumen of the body. The catheter includes an adjuster section for altering a portion of the radiation emitting radially from the radiation source so that the radiation source delivers an asymmetrical radiation profile to the vessel. The device can also include a catheter supporter which inhibits rotational deformation in the catheter between a catheter distal end and a catheter proximal end. This allows the delivery section to be precisely rotated to properly position the adjuster section within the vessel lumen.

Abstract: A device and method for precisely delivering dosage of radiation from a radiation source to a treatment site of a vessel is provided herein. In one embodiment, the device includes a catheter which inserts into a vessel lumen of the body. The catheter includes an adjuster section for altering a portion of the radiation emitting radially from the radiation source so that the radiation source delivers an asymmetrical radiation profile to the vessel. The device can also include a catheter supporter which inhibits rotational deformation in the catheter between a catheter distal end and a catheter proximal end. This allows the delivery section to be precisely rotated to properly position the adjuster section within the vessel lumen.

Abstract: A swivel tip assembly (100) includes a housing (110) having a passageway (128) with proximal (112) and distal (114) openings. Spherical member (106) and bushing (108), which is captured by the housing (110), provide a swivel joint. A wire (102), which is coupled to the spherical member (106), is attached to the distal end of a catheter (50). The swivel joint allows the housing (110) to swivel or rotate freely thereby minimizing the opportunity of grabbing the guide wire (116) as the catheter (504) is being pushed or pulled along the guide wire (116).

Abstract: A method for forming a balloon for a dilation catheter is provided herein. The method includes the steps of: (i) positioning a tube in a preconditioned mold; (ii) expanding the tube in a preconditioned mold to form a parison; (iii) positioning the parison in a balloon mold; and (iv) expanding the parison within the balloon mold to form the balloon. Thus, the tube is initially expanded into a parison in the preconditioned mold. Subsequently, the parison is expanded into a balloon in the balloon mold. Because of this unique manufacturing process, polyester block copolymers can be formed into balloons. Some of these polyester block copolymers could not be formed into a balloon using prior art blow molding processes. The resulting balloon exhibits superior characteristics, including relatively thin and consistent walls, soft texture, low uninflated crossing profile, expansion in a predictable fashion, and good tensile strength.