Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the intraluminal passageways of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's intraluminal passageways. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: This invention is a transfer device and catheter assembly for the delivery of treatment elements to a selected location within the intraluminal passageways of a patient as part of an intraluminal radiation system. The transfer device includes a gate member that permits the treatment elements to leave the transfer device only if the catheter is attached thereto. A pressure indicator provides a visual indication of the fluid pressure within the transfer device, and a pressure relief valve provides for a release of the fluid if the pressure exceeds a predetermined pressure. Transfer device also includes a treatment element detection system, low power indicator, a counter system, and an electromagnetic locking mechanism to prevent the opening or closing of the gate member when less than all of the treatment elements are in the transfer device.

Abstract: An automatic fluid control having a first and second tube members and a slidable valve element capable of moving from a sealed closed position to an open position permitting fluid passage therethrough. In a preferred first embodiment, the elastomeric valve element is slidingly received with a passageway in the first tube. The valve element has a flange portion containing a plurality of slits that, when inverted and stretched, permit fluid to pass therethrough, but when closed, are in contact with the inner wall of the first tube and prevents fluid from passing therethrough. The valve element also can have a rigid plug attached within an opening in the top surface to present a preferably non-deformable contact point for a male luer tip, which, when pressed downward on the valve element, breaks a seal between the valve element and the first tube inner wall.

Abstract: Methods and apparatus are disclosed for treating body tissue whereby a section of tissue is drawn into contact with the open distal end of the first passageway of the apparatus. A tissue treatment fluid is introduced into the second passageway for treating the desired section of tissue retained within the first passageway. Methods and apparatus are also disclosed for positioning a medical device at a desired location within the heart. A portion of the apparatus is retained at a desired location of the heart and a medical device is extended through a passageway of the apparatus for contacting the heart at the desired location.

Abstract: A transfer device and catheter assembly for the delivery of treatment elements to a selected location within the intraluminal passageways of a patient as part of an intraluminal radiation system. The transfer device includes a gate member that permits the treatment elements to have the transfer device only if the catheter is attached thereto. A pressure indicator provides a visual indication of the fluid pressure within the transfer device, and provides for a release of the fluid if the pressure exceeds a predetermined pressure. The catheter also includes detents to secure it to the transfer device and which must be manually activated to remove the catheter from the transfer device. The transfer device includes circuiting that determines whether the treating elements reside within the transfer device based upon the reflectivity of the treating elements. A method for determining whether treating elements reside in the catheter is also disclosed.

Abstract: Methods and apparatus are disclosed for use in procedures related to the electrophysiology of the heart, such as identifying or evaluating the electrical activity of the heart, diagnosing and/or treating conditions associated with the electrophysiology of the heart. An apparatus having thermocouple elements of different electromotive potential conductively connected at a junction is introduced into the interior of the heart and a section of heart tissue is contacted with the junction. An electrical current is passed through the thermocouple elements to reduce the temperature of the junction in accordance with the Peltier effect and thereby cool the contacted heart tissue. The effect of the cooling may be monitored and, if desired the section of heart tissue may be treated.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the intraluminal passageways of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's intraluminal passageways. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: An automatic fluid control having a first and second tube members and a slidable valve element capable of moving from a sealed closed position to an open position permitting fluid passage therethrough. In a preferred first embodiment, the elastomeric valve element is slidingly received with a passageway in the first tube. The valve element has a flange portion containing a plurality of slits that, when inverted and stretched, permit fluid to pass therethrough, but when closed, are in contact with the inner wall of the first tube and prevents fluid from passing therethrough. The valve element also can have a rigid plug attached within an opening in the top surface to present a preferably non-deformable contact point for a male luer tip, which, when pressed downward on the valve element, breaks a seal between the valve element and the first tube inner wall.

Abstract: A sheath introducer for a catheterization or similar procedure comprises a main body having an exterior tapered sidewall, an interior lumen, a beveled top surface and an annular boss extending from the top surface; a rotating section having an exterior sidewall, an interior lumen, a beveled bottom surface having a recessed portion dimensioned so as to be received within the main body annular boss, and a top surface having an annular shoulder extending therefrom creating a recess; a cannula extending from the bottom end of the main body; and, a hemostatic valve having an access port and a fluid tight slit opening and seated within the upper portion and maintained by a cap, the valve being maintained within the rotating section recess and preferably slightly compressed when the rotating section and main body are assembled. When assembled, the rotating section can rotate up to approximately 180.degree., affording approximately a 45.degree.

Abstract: Methods and apparatus are disclosed for use in procedures related to ther electrophysiology of the heart, such as identifying or evaluating the electrical activity of the heart, diagnosing and/or treating conditions associated with the electrophysiology of the heart. An apparatus having thermocouple elements of different electromotive potential conductively connected at a junction is introduced into the interior of the heart and a section of heart tissue is contacted with the junction. An electrical current is passed through the thermocouple elements to reduce the temperature of the junction in accordance with the Peltier effect and thereby cool the contacted heart tissue. The effect of the cooling may be monitored and, if desired, the section of heart tissue may be treated.

Abstract: A flow control valve is described comprised of first and second rigid members and a resilient single or multi stage valve element disposed between the rigid members. A fluid flow path is defined through the rigid members and through or around the valve element to provide a continuous flow path through the valve. The rigid members are movable relative to each other between a first position and a second position. The valve element is sufficiently compressed by the rigid members when they are in the first position so as to close the flow path through or around the valve element. The valve element is sufficiently relaxed when the rigid members are in the second position to allow fluid flow through the flow path through or around the valve element.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: Methods and apparatus are disclosed for use in procedures related to the electrophysiology of the heart, such as identifying or evaluating the electrical activity of the heart, diagnosing and/or treating conditions associated with the electrophysiology of the heart. An apparatus having thermocouple elements of different electromotive potential conductively connected at a junction is introduced into the interior of the heart and a section of heart tissue is contacted with the junction. An electrical current is passed through the thermocouple elements to reduce the temperature of the junction in accordance with the Peltier effect and thereby cool the contacted heart tissue. The effect of the cooling may be monitored and, if desired, the section of heart tissue may be treated.

Abstract: A flow control valve is described comprised of first and second rigid members and a resilient single or multi stage valve element disposed between the rigid members. A fluid flow path is defined through the rigid members and through or around the valve element to provide a continuous flow path through the valve. The rigid members are movable relative to each other between a first position and a second position. The valve element is sufficiently compressed by the rigid members when they are in the first position so as to close the flow path through or around the valve element. The valve element is sufficiently relaxed when the rigid members are in the second position to allow fluid flow through the flow path through or around the valve element.

Abstract: A sheath introducer for a catheterization or similar procedure comprises a body having a upper portion and a lower portion, the lower portion being angled with respect to the upper portion; a curved tapering channel extending through the upper and lower portions; a cannula with a tapered distal end extending at an angle with respect to the upper portion a hemostatic valve having an access port and a fluid tight slit opening and seated within the upper portion and maintained by a cap; and an angled sideport in fluid communication with the channel. Optionally, a wiper flange extends inward within the valve access port which provide an additional fluid tight seal when a catheter is slidingly inserted, removed or maintained within the valve. A dilator can be adapted for use with the introducer by having a bend in the tube portion of the dilator.

Abstract: A blood containment, visualization and tactile confirmation device is provided for use with a vascular entry needle. The device includes a visualization channel and/or a complaint outer wall portion which indicates whether a needle connected to the device has entered a selected blood vessel. The visualization channel is vented to the outside to allow displaced air to escape, but has a gas permeable member to prevent blood from escaping. The visualization channel may have one, two, or more stages, with a first stage chamber which indicates initial penetration of a selected blood vessel, and a second stage chamber which fills more slowly and indicates that the needle remains positioned within the blood vessel. A third stage chamber with entrapped air which compresses slightly due to the heartbeat may also be used. Preferably, a compliant outer wall portion pulses with changes in blood pressure, thereby providing a tactile indication that the needle tip is properly positioned.

Abstract: A fluid control valve assembly including a first tube member, a second tube member and a cylindrical valve element. The first tube member has a narrower diameter passageway connected by a transitional surface to a wider diameter passageway. The narrower passageway acts as a secondary valve sealing surface and the transitional surface acts as a primary valve sealing surface. The valve element includes a primary valve sealing shoulder which forms a seal when in contact with the primary sealing surface of the first tube member; at least one secondary sealing flange which deformingly engages the wall of the narrower passageway; and a plurality of elastomeric bands extending from the base of the valve element. The bands are looped around posts extending upward from the inner wall of the second tube member when the valve assembly is assembled. The elastic bands maintain the valve element in a compressively engaged sealing relationship with the transitional surface of the first tube member.