Abstract: Improved methods and apparatuses related to laser-assisted intra-coronary transmyocardial revascularization (ITMR), and more particularly, to improved methods and apparatuses for directing an interventional catheter device, via percutaneous or other entry into the vasculature, for example at the femoral artery, over the aortic arch, through the ascending aorta and over the coronary ostia such that the laser delivery means can be positioned inside a coronary artery and laser energy is used to create a plurality of small channels through the coronary artery into the tissue of the myocardium. An proximal hub portion and method of using it are described, the proximal hub portion adapted for attachment to a central, elongated lumen portion, the proximal hub portion optionally having a plurality of branched extending arms, the sheath and associated branched arms having individual blood loss seals and individually capable of receiving a laser delivery means, visualization or marking means, or other tools.

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 spiral catheter apparatus for access to, and laser or other treatment within, cavities and organs in the human body, the apparatus comprising a flexible, main catheter shaft defining a central axis of the apparatus, the catheter shaft having a proximal end, a distal end and a first hollow lumen region extending therethrough, the catheter shaft further having a spiral portion adjacent the distal end with a selected curvilinear shape, the curvilinear shape defining an inner arcuate sidewall and an outer arcuate sidewall, the catheter shaft flexible enough to assume a temporarily elongated shape such that the apparatus can be extended through at least a portion of the body in the temporarily elongated shape and will assume the selected curvilinear shape when extended into a body cavity or organ, the selected curvilinear shape serving to securely position the apparatus adjacent a selected surface within the body cavity or organ, at least the spiral portion of the catheter shaft having a plurality of guide holes

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 bow shaped, integrated wire catheter apparatus and method of use for access to, and laser or other treatment within, cavities and organs in the human body, the apparatus having a curvilinear shape but flexible enough to assume a generally elongated shape such that the apparatus can be extended through the vasculature in the generally elongated shape and can assume the curvilinear shape when extended into a body cavity or organ, the curvilinear shape serving to securely position the apparatus adjacent a selected surface within the body cavity or organ for laser or other treatment with a laser delivery device or other functional device thereon, the apparatus having a central axis, the apparatus comprising a main catheter shaft having a proximal end and an apex seeking and stabilizing distal end, the main catheter shaft having material of construction or other mechanism or means for causing a portion of the catheter shaft to have a bowed shape adjacent its distal end, the main catheter shaft having at least on

Abstract: A method of and apparatus for performing a transmyocardial revascularization procedure is disclosed which utilizes two laser power sources. A first laser source provides a coagulating or blanching effect on tissue and a second laser source capable of tissue ablation are supplied to a combined optical fiber bundle comprising a plurality of fibers which can be moved axially or rotatively by the operating physician. As the distal end of the fiber bundle is moved forward, bursts of laser energy therefrom may be programmed to first penetrate the epicardium with minimal bleeding and thereafter provide channels or pockets in the myocardium for causing or stimulating angiogenesis.

Abstract: A transmyocardial revascularization (TMR) enhanced treatment for coronary artery disease and other medical procedures utilizing a source of laser energy and a laser delivery means attached thereto, the treatment or other medical procedure being one in which the coronary artery is temporarily occluded during a surgical procedure, the enhanced treatment comprising the steps of positioning the laser delivery means adjacent the distal anatomy of the heart muscle, delivering laser energy to the distal anatomy of the heart muscle through the laser delivery means to create at least one TMR channel communicating oxygenated blood from the left ventricle to myocardium of the distal anatomy of the heart muscle, such that during treatment or other medical procedure in which the coronary artery is temporarily occluded, the distal anatomy of the heart is essentially continuously supplied with oxygenated blood, and performing the treatment or other medical procedure in which the coronary artery is temporarily occluded durin

Abstract: A method of selecting laser parameters for performing laser-assisted transmyocardial revascularization (TMR) 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

Abstract: An apparatus for performing a laser myocardial revascularization of a human heart comprises a hand-held device with an elongated flexible lasing assembly including an axially movable fiber bundle which can be placed into the chest cavity of a patient. At the distal head end of the device laser energy from the distal end of the fiber bundle is initially reduced to form a relatively small opening in the epicardium of the heart. The fiber bundle is moved through the opening so that lasing with full laser power takes place beneath the epicardium to form a larger channel through the myocardium that extends into the left ventricular cavity. After the channel has been formed, the optical fiber bundle is retracted from the channel and back through the small epicardium opening so as to minimize operative bleeding and allow sealing of the epicardium after the apparatus is removed.

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: A minimally invasive surgical apparatus for providing access to the inside of a chamber of the heart for performing TMR on anterior and posterior walls therein. A unitary or a two piece trocar assembly is positioned through the chest wall. An obturator with a tissue piercing blade at one end is used to saw, pierce or otherwise cut a hole through the epicardium into and through myocardium. Once the trocar assembly extends into the heart chamber, a laser delivery device with deflection means is introduced into the chamber. Deflection or curvature of the end of the laser delivery device can be controlled by angulation control components, such that TMR channels can be created at various positions on the anterior and posterior walls of the chamber. Rotation control components for the fiber or other laser delivery devices will allow the surgeon to rotate the fiber once a predetermined deflection or curvature has been imparted to the distal end of the laser delivery device.

Abstract: A shaped catheter for accessing and treating preselected surfaces of cavities and organs within the human body, the apparatus including a tubular, shaped outer sheath with at least one guide hole and a tubular, flexible inner sleeve with a distal opening disposed adjacent the distal end, the inner sleeve slidably disposed within the outer sheath such that the distal opening of the inner sleeve can be operatively positioned adjacent the at least one of the guide holes and a laser delivery device or other functional device can be extended through the distal opening of the inner sleeve and through the guide hole on the outer sheath into the body cavity or organ. Providing a plurality of guide holes on the outer sheath will allow sequential treatment of the preselected surface within the body cavity or organ. Multiple TMR channels can be created or treatment at a number of sites can be made without moving or otherwise repositioning the outer sheath. The invention is also a method of use of such apparatus.

Abstract: A laser connector and electronic security system for a laser delivery system controls connection of the delivery system to a source of laser energy for medical procedures by storing encrypting codes to allow access by authorized, unused, delivery assemblies. The connector is specially dimensioned to further control delivery system access to the source, and the electronic security system utilizes EEPROM memory to allow storage and accumulation of information about the laser parameters used in the medical procedure. The connector and electronic security system is particularly suitable for pulsed laser transmyocardial revascularization (TMR) procedures and enables automatic power level calibration in accordance with the connected delivery system specifications, maximum time of usage settings, storage of the number/power level of the pulses delivered, and storage of the total number of TMR channels created.

Abstract: The method for combined mechanical/laser myocardial revascularization of a human heart includes: inserting a mechanical piercing device and an elongated flexible lasing apparatus into the chest cavity of a patient; mechanically piercing, micro-tearing or spreading the epicardium of the heart; and then lasing from beneath the epicardium through the myocardium.

Abstract: A spiral catheter apparatus and method of use for access to, and laser or other treatment within, cavities and organs in the human body, the apparatus having a spiral member with a selected curvilinear shape, but flexible enough to assume a temporarily elongated shape such that the spiral member can be extended through the vasculature in the temporarily elongated shape and will assume the selected curvilinear shape when extended into a body cavity or organ, the spiral member formed of a superelastic or other material, the selected curvilinear shape serving to securely position the spiral member adjacent a selected surface within the body cavity or organ for laser or other treatment with a laser delivery device or other functional device on a selected surface, the apparatus further having a main catheter shaft with at least two hollow lumens extending therethrough, the first lumen for slidably guiding the main catheter shaft over the spiral member into a first position adjacent the selected surface, and the se

Abstract: Improved methods and apparatuses related to laser-assisted transmyocardial revascularization, and more particularly, to improved methods and apparatuses for precisely positioning a fiber-optic or other waveguide adjacent the area or areas to be lased, including at positions adjacent the posterior epicardial and endocardial surfaces of the heart and at trans-septal positions within the chambers of the heart, thereby making possible the creation of channels in myocardial tissue at precisely the positions in the heart where ischemia or infarction or other have rendered such treatment desirable or necessary. These methods and apparatuses can be adapted for use in surgical applications throughout the human body or in animals for transmitting laser energy precisely, at predetermined positions and to predetermined depths.