Abstract: An elongated steerable catheter for placement within a heart chamber, organ aperture or other body opening and having at least one center tube with hollow passageway for guiding a laser delivery means or other functional device to selected surfaces of a heart chamber, organ aperture or other body cavity for laser or other treatment thereon, particularly adapted for laser-assisted percutaneous transmyocardial revascularization (TMR), is disclosed herein. The steerable catheter has a handle portion at its proximal end and a controllably deflectable end portion at its distal end. The elongated center tube has a distal end, in the region where a curvature is to be formed, and a shim anchor sleeve is slidably disposed over the center tube. The shim anchor sleeve is attached to the inside wall of the outer jacket and coupled to the distal end of the center tube with a bendable shim member which extends between the distal tip of the steerable catheter and the sleeve over the center tube.

Abstract: A method for improving blood flow in the heart provides a catheter system with an outer catheter defining at least one lumen and an inner catheter defining at least one lumen with proximal and distal portions. An introducer is coupled to the distal portion of the inner catheter. The introducer has a tissue piercing distal end. A resistive heater element is positioned in the introducer. The catheter system is introduced into a patient's vasculature. The inner catheter is then introduced through the a lumen of the outer catheter to a selected heart site. The tissue piercing distal end of the introducer is then advanced into an interior of the heart at the selected heart site. Energy is delivered to the selected heart site from the resistive heater element to create a blood conducting pathway and/or stimulate angiogenesis.

Abstract: An apparatus and method for creating drug-filled pockets within muscle tissue, such as myocardium of the heart for increasing angiogenesis. More particularly, the apparatus has an excising assembly with a dilator tip for penetrating and advancing through the surface and body of a muscle or organ, such as the heart. Preferably, the dilator tip has a low level laser optical fiber emission to ease the passage of the excising assembly and provide thermal damage which also stimulates angiogenesis. More preferably, the dilator tip also disperses a pharmacologically active substance as the apparatus is passed through the tissue and/or creates pockets. The excising assembly is connected to a hand-held control device from which the operator pushes a switch to activate a punching mechanism within the excising assembly. The punching mechanism cuts a discrete piece of muscle tissue and traps it within the excising assembly leaving a pocket in the remaining muscle tissue.

Abstract: Improved methods and devices related to laser-assisted transmyocardial revascularization (TMR), and more particularly, to improved methods and devices for creating branched TMR channels through myocardium in which a single opening is made in an epicardial surface with a plurality of channel branches, having predetermined geometries extending into and through myocardium, depending therefrom. A method of creating branched TMR channels comprises piercing an epicardial surface mechanically or with laser energy, directing laser energy through the opening in a first predetermined angular orientation with respect to the epicardial surface to create a first channel and delivering laser energy in a second predetermined angular orientation to create a second branch. A plurality of branches can thus be created in a single channel structure.

Abstract: Apparatus for treating a patient's heart by stimulating revascularization of the heart or creating channels in the heart. The apparatus includes a catheter, a laser energy source coupled to the catheter, and a control circuit. The control circuit is configured to cause the laser energy source to deliver an output of laser energy over a first time period shorter than a heart beat cycle.

Abstract: A method of visualizing and treating the heart by providing a balloon end contact scope with a main lumen, an essentially transparent contact viewing portion, and integral laser delivery means or other equipment channel suitable for viewing the heart; precisely positioning the contact viewing portion in contact with a portion of the heart adjacent the position to be viewed; and visualizing the heart. The scope may have a gripping surface particularly suitable for percutaneous use. For MIS use, the scope tents the pericardial sac. The method can be used to place a guide wire or tether to the heart to locate a fluoroscopic or other visualization means or to perform additional visualization, fluoroscopic marking or other interventional procedures. The method also comprises the step of delivering laser energy to a portion of the heart to effect transmyocardial revascularization.

Abstract: A TMR energy delivery device is introduced through a first minimally invasive penetration of a patient's chest. Sufficient energy if delivered from the wave guide to the wall of the heart to form a channel through at least a portion of the wall. The device includes a visualization device or camera with a rigid portion and a distal end portion that is flexible, a cup member coupled to a distal end of the flexible distal portion, and a vacuum source coupled to the cup member for providing mechanical stability against the heart wall.

Abstract: A treatment tool such as a catheter, MIS or other surgical tool apparatus for placement within a heart chamber, organ aperture or other body opening and axial ranging therein, the apparatus particularly adapted for laser-assisted percutaneous transmyocardial revascularization (MTR). At the distal end of the tool is an annular ultrasound transducer with associated structure, positioned to transmit ultrasound signals substantially axially aligned with the axis of the treatment tool to the cardiovascular tissue, the transducer further receiving returning signals from the cardiovascular tissue to be treated. In a preferred embodiment, the transducer comprises a piezoelectric crystal material. The transducer assembly is attached to the distal tip of the tool such that a laser delivery means or other functional device can be extended through the lumen of the tool and the annular ultrasound transducer.

Abstract: A laser surgery device for performing laser myocardial revascularization procedures on a human heart comprises a hand-held body portion with a forwardly extending probe member with an enlarged head end assembly including a piercing tip. A movable fiber bundle connected to a laser source extends through the body portion and the probe member with its distal tip at the head end assembly. A control button on the body portion enables the device to move the distal tip forwardly from the head end, and selectable stop members are provided on the body portion to provide different travel distances for the optical fiber bundle during a procedure. The body portion has a rotatable nose-piece with an internal ratchet mechanism which enables the device user to rotate the probe member and its head end to a selected optimum position before commencing a procedure.

Abstract: A heart stabilizer and suture control device for stabilizing the heart and for occluding a preselected portion of coronary artery by developing a downward force on the heart and simultaneously developing an upward force across a coronary artery in a predetermined position. The device has at least two stabilization pads, the stabilization pads each having an operative size and shape, and each having a first end and a second end and a lower contacting surface. The second ends have suture retaining grooves, and the stabilization pad has a suture locking means for securing the distal end of a suture means thereto. The device also comprises a linking member locking the two stabilization pads an operative distance apart. The device has suture means with a proximal end coupled to the linking member and extending from the first end to the suture retaining groove of the second end, the suture means having a distal end which can be locked to the stabilization pad with the suture locking means thereon.

Abstract: A device for use in laser surgical procedures for moving axially an optical fiber element that is connected at its proximal end to a source of laser energy. The distal end of the fiber elements with a cooperating piercing tip member has a tapered configuration so that it is capable of penetrating soft tissue of membrane such as the myocardium or epicardium of a human heart during the revascularization procedure. Various combinations of bundled optical fiber elements are disclosed which provide different tapered distal end designs that can be used in various surgical procedures.

Abstract: An apparatus for treating a heart by stimulating revascularization of the heart or creating channels in the heart, the apparatus comprising an artificial energy source for causing a first created heartbeat and a revascularization device for creating a first revascularization event in the heart, the revascularization device being controllable to provide a first revascularization event to occur at a selected time in relation to the first created heartbeat.

Abstract: A drug delivery apparatus for dispensing a predetermined amount of one or more drugs into a laser created opening in the human body, the apparatus consisting of a laser delivery means such as an optical fiber or fiber bundle, a drug conduit which transfers the one or more drugs, drug solutions or other substances to the distal end of the laser delivery means, and the laser delivery means disposed essentially coaxially with the drug conduit. Laser delivery means is used to create a TMR channel or other opening in the body. Dispensed drug or other substance travels through the drug conduit and emanates from the drug conduit to be delivered into the TMR channel or other laser created opening. Drug is dispensed by manually or automatically activating an electric motor which actuates a piston element. A method of use is also disclosed.

Abstract: An apparatus for treating a heart by stimulating revascularization of the heart or creating channels in the heart, the apparatus comprising a sensor, an artificial energy source for causing a first created heartbeat, and a revascularization device coupled to the sensor for creating a first revascularization event in the heart, the revascularization device being controllable to cause the first revascularization event to occur at a selected time in relation to the first created heartbeat if the sensor has detected the first created heartbeat.

Abstract: An apparatus for creating revascularization channels in tissue, such as the myocardium of the heart, mechanically cuts the channels using a hand piece with easily removable cutting tip assemblies having angled, sharpened edges to allow rapid tip replacement. The cutting tip assembly has an inner needle within an outer hollow needle with each needle attached to the hand piece for independent rotation and axial movement. The inner needle may be hollow, or formed with a pointed tip, and may rotate counter to the outer needle to enhance gripping and storage of the tissue excised by the outer needle. The hand piece may attach a cylindrical magazine of cutting tip assemblies or one cutting tip assembly. The cutting tip assembly may be heated to provide thermal damage to the heart muscle during the creation of the channel, providing some of the advantages of the laser method of TMR.

Abstract: A semi-automatic cardiac tissue removal device for obtaining biopsy samples and/or creating revascularization pathways in the myocardium of the heart, mechanically cuts the pathways using a handpiece with a cutting tip assembly having a hollow needle with an angled, sharpened edge rotatable mounted around a separately advancable stylet. The stylet defines a piercer to spread the myocardium prior to insertion of the needle and to allow creation of a pathway only within the myocardium. The stylet further defines a plug at the cutting edge of the needle to finish the cutting cleanly and to plug the hollow needle thereby forming a closed chamber for excised tissue. A single button on the left or right handed handpiece actuates movement of the stylet into the myocardium, movement of the needle into the path produced by the piercer, and rotation of the needle to cut tissue.

Abstract: A method of selecting laser parameters for performing laser-assisted myocardial revascularization to avoid inducing undesired cardiac arrhythmia without synchronization of delivery of laser energy and the patient's cardiac cycle, the method comprising the steps of minimizing the power level of laser energy used, thereby decreasing the overall trauma to the heart, selecting a pulse frequency as great as possible while avoiding adverse summation effects, selecting a pulse width as wide as possible to prevent excessively high peak powers per pulse and not so wide as to cause undesired thermal damage, selecting an energy flux rate, shaping the front end of each pulse of laser energy to provide efficient, non-explosive TMR channeling, and correcting the selected power level, pulse width, pulse frequency and energy flux rate for mechanical events, including method of access to the heart, position of selected portions of myocardium in the heart, temporal duration of the procedure, natural movement of the heart, spec

Abstract: A drug delivery apparatus for dispensing predetermined volumes of drug, drug solution or other substances into an opening, such as a TMR channel in the human heart, or other laser treated area within the human body, the apparatus consisting of a bifurcated needle with a laser inlet for guiding a laser delivery means, such as an optical fiber or fiber bundle, to adjacent a surface of the human heart or other body structure for creating an opening, such as a TMR channel, or other laser treated area thereon. A drug inlet is for receiving the drug and transmitting the drug to the TMR channel or other laser treated area. Optionally, a piercing tip and/or suction device assists in positioning the apparatus adjacent the tissue to be treated. Drug is dispensed by manually or automatically actuating a piston or syringe element. A method of use is also disclosed.