Abstract: A surgical device is provided for both ablating a channel in a patient's tissue and also delivering a therapeutic agent. The device includes an elongated multi-lumen tube, an elongated tissue ablating assembly, and a therapeutic agent delivery assembly. The therapeutic agent is capable of being delivered into the channel and/or to the surrounding tissue. The device may further include a second multi-lumen tube also capable of delivering therapeutic agents. A method is also provided for using such a surgical device to ablate a channel in a patient's tissue and also deliver a therapeutic agent to the tissue, for example, for transmyocardial revascularization or other procedures.

Abstract: The present invention contemplates a surgical device for both ablating a channel in a patient's tissue and also delivering a therapeutic agent. The device includes an elongated multi-lumen tube, an elongated tissue ablating assembly, and a therapeutic agent delivery assembly. The therapeutic agent is capable of being delivered into the channel and/or to the surrounding tissue. The device may further include a second multi-lumen tube also capable of delivering therapeutic agents. Although suitable for many operations, the device is particularly well suited for transmyocardial revascularization operations. The present invention also contemplates a procedure for using such a surgical device to ablate a channel in a patient's tissue and also deliver a therapeutic agent.

Abstract: A system for treating a patient's heart which comprises a means to form channels in the heart wall and a means to deliver a therapeutic or diagnostic agent into the channels. Additionally, the system may comprise a means to retain the agent within the channels for a useful period of time. The system may be configured to be introduced percutaneously or intraoperatively. The system generally comprises an elongated, flexible lasing transmission means having a laser radiation emitting means and an delivery lumen opening at the distal end. Practice of the invention comprises forming channels in the heart wall and delivering a therapeutic or diagnostic agent into the channel. Gene therapy agents of this invention comprise vectors for transferring genetic information to the heart tissue in vivo or harvested cells which have been genetically engineered in vitro. Additionally, the invention may comprise retaining the agent within the channels, for example, by incorporating the agent in a viscous carrier.

Abstract: An intraluminal catheter with an elongated tubular shaft with proximal, intermediate, and distal shaft sections for positioning a therapeutic or diagnostic device within a patient's body region such as a heart chamber. The intermediate shaft section has greater flexibility than the proximal or distal shaft sections, and is preferably of sufficient flexibility to easily assume the curvature of the patient's aortic arch, and reduce the force of contact between the catheter distal end and tissue defining the patient's body region to thereby reduce restriction on the rotation of the catheter. The flexible intermediate shaft section is preferably of a length to occupy a significant portion of the aortic arch, and the catheter overall length is preferably sufficient to have a catheter proximal extremity extending out of the patient and a distal extremity extending at least into an aortic passageway adjacent the patient's left ventricle.

Abstract: An apparatus and method of intraoperative myocardial revascularization of the myocardium of the heart of a patient. A catheter apparatus comprising an elongated catheter, an elongated laser wave guide slidably disposed within a lumen of the catheter, and an ultrasonic transducer secured to the distal end of the elongated laser wave guide, is inserted into the patient. The distal end of the lasing apparatus is guided to the portion of the patient's heart wall in which channels will be formed, and the ultrasonic transducer is activated to create brief pulses of ultrasonic energy. The transducer receives a returned ultrasonic echo from the heart wall. The ultrasonic echo is processed by signal processing elements.

Abstract: An laser device for forming channels within an outer wall of a patient's heart which has an elongated optical fiber, a lens or probe tip secured to the distal end of the optical fiber and means to limit the penetration of the probe tip or lens. Preferably, an outer support sleeve is secured to the proximal portion of the probe tip and a distal portion of the optical fiber proximal to the probe tip. In one preferred embodiment of the invention, a helical coil is disposed between the distal portion of the optical fiber and the proximal portion of the probe tip to ensure a better bond therebetween, particularly when the optical fiber has a lubricous fluoropolymer coating.

Abstract: An intraluminal catheter with an elongated tubular shaft with proximal, intermediate, and distal shaft sections for positioning a therapeutic or diagnostic device within a patient's body region such as a heart chamber. The intermediate shaft section has greater flexibility than the proximal or distal shaft sections, and is preferably of sufficient flexibility to easily assume the curvature of the patient's aortic arch, and reduce the force of contact between the catheter distal end and tissue defining the patient's body region to thereby reduce restriction on the rotation of the catheter. The flexible intermediate shaft section is preferably of a length to occupy a significant portion of the aortic arch, and the catheter overall length is preferably sufficient to have a catheter proximal extremity extending out of the patient and a distal extremity extending at least into an aortic passageway adjacent the patient's left ventricle.

Abstract: A system for treating a patient's heart which comprises a means to form channels in the heart wall and a means to deliver a therapeutic or diagnostic agent into the channels. Additionally, the system may comprise a means to retain the agent within the channels for a useful period of time. The system may be configured to be introduced percutaneously or intraoperatively. The system generally comprises an elongated, flexible lasing transmission means having a laser radiation emitting means and an delivery lumen opening at the distal end. Practice of the invention comprises forming channels in the heart wall and delivering a therapeutic or diagnostic agent into the channel. Gene therapy agents of this invention comprise vectors for transferring genetic information to the heart tissue in vivo or harvested cells which have been genetically engineered in vitro. Additionally, the invention may comprise retaining the agent within the channels, for example, by incorporating the agent in a viscous carrier.

Abstract: An intravascular device for forming a channel within a patient's ventricular wall which engages the tissue of the ventricular wall to prevent undesirable movement of the channel forming device while forming the channel.

Abstract: The invention is directed to an introducer which is formed of a relatively rigid tubular member having an inner lumen and an elongated slot in the distal portion of the introducer. The introducer is particularly suitable for introducing an elongated channel forming device having radially extending arms for limiting the depth of penetration into a guiding or delivery catheter. By pulling the channel forming member into the inner lumen of the introducer, the radially extending arms are bent or folded forwardly into the inner lumen and they remain in this position until they extend out the distal end of the guiding or delivery catheter.

Abstract: The method for intra-operative myocardial revascularization of a human heart includes a inserting a portion of an elongated flexible lasing apparatus into the chest cavity of a patient, and lasing channels from the epicardium through the myocardium of the heart, without mechanical tearing of the heart tissue. The apparatus is guided to an area exterior to a ventricle of the patient's heart, and the distal end of the optical fiber apparatus is directed to an area of interest where the exterior wall of the heart is irradiated with laser energy to form a channel through the myocardium.

Abstract: A system for treating a patient's heart which comprises a means to form channels in the heart wall and a means to deliver a therapeutic or diagnostic agent into the channels. Additionally, the system may comprise a way to retain the agent within the channels for a useful period of time. The system may be configured to be introduced percutaneously or intraoperatively. The system generally comprises an elongated, flexible lasing transmission catheter that emits laser radiation and has delivery lumen opening at the distal end. Practice of the invention comprises forming channels in the heart wall and delivering a therapeutic or diagnostic agent into the channel. Gene therapy agents of this invention comprise vectors for transferring genetic information to the heart tissue in vivo or harvested cells which have been genetically engineered in vitro. Additionally, the invention may comprise retaining the agent within the channels, for example, by incorporating the agent in a viscous carrier.

Abstract: An optical fiber device for forming channels within a wall of a patient's heart, and particularly the epicardium, which has an elongated optical fiber, a probe tip secured to the distal end of the optical fiber and an outer support tube secured to the proximal portion of the probe tip and a distal portion of the optical fiber proximal to the probe tip. In another embodiment the optical fiber device has an elongated optical fiber, a probe tip secured to the distal end of the optical fiber and a radiating step or projection on the exterior of the probe tip to act as a stopping surface to control the depth of penetration of the probe tip into tissue.

Abstract: The method for intra-operative myocardial revascularization of a human heart includes a inserting a portion of an elongated flexible lasing apparatus into the chest cavity of a patient, and lasing channels from the epicardium through the myocardium of the heart, without mechanical tearing of the heart tissue. The apparatus is guided to an area exterior to a ventricle of the patient's heart, and the distal end of the optical fiber apparatus is directed to an area of interest where the exterior wall of the heart is irradiated with laser energy to form a channel through the myocardium.

Abstract: A shapeable optical fiber apparatus includes an optical fiber, a support structure secured over a distal end portion of the optical fiber, and terminates in a lens at its distal end. The transition area between the lens and optical fiber is reinforced with a sleeve that is adhesively bonded to the lens and fiber. The shapeable optical fiber apparatus may be carried within an inflatable balloon dilation catheter, which may be used for balloon angioplasty after a laser cutting procedure using the shapeable optical fiber apparatus to remove a portion of stenosis in the patient's vasculature.