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: 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 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,

Abstract: A delivery catheter system for delivering a substance delivery member into a patient's left ventricle which includes a first delivery catheter with a shaped distal extremity configured to be aligned with or parallel to a longitudinal axis or long dimension of the patient's left ventricle and a second delivery catheter slidably and rotatably disposed within an inner lumen of the first delivery catheter which has a shaped distal shaft section and an inner lumen configured to slidably receive a substance delivery member such as an elongated cannula slidably disposed within a polymer sheath. The shaped distal section of the first delivery catheter is shaped or is shapeable within the patient's heart chamber.

Abstract: An apparatus for performing transmyocardial revascularization provides a closed-chest formation of a channel in a wall of a heart. An articulating scope in one embodiment includes a flexible distal portion which provides for a coupling of a surface of the heart to the distal portion. The articulating distal portion is coupled to a control member to provide articulation. Movement of the control member causes deflection, including articulation, of the generally flexible working end of the scope. The coupler may be a two way valve to provide both vacuum and flushing solutions. The articulating scope can be supported by a scope holder that is table mounted or mounted to the patient. An access port provides for the introduction of tools and instruments. An adaptor couples the access port with a handle. The handle provides a working channel for the introduction of an energy delivery device.

Abstract: An intracorporeal device generally having an elongate shaft with an asymmetric radiopaque marker disposed upon or within the distal end thereof. The radiopaque marker member enables the user to determine the orientation of the distal end of the device under fluoroscopic and similar imaging techniques. In certain embodiments the device is configured as a delivery catheter system having multiple delivery catheters, some or all of which may have radiopaque marker members disposed upon or within their distal ends. The delivery catheter system is configured in some embodiments to deliver an elongated diagnostic or therapeutic device to a desired location within a patient's heart.

Abstract: The invention is directed to an intracorporeal device for myocardial revascularization of a patient's heart tissue by at least one burst of RF energy over an interval of about 1 to about 500 msec, preferably about 30 to about 130 msec. The intracorporeal device has an elongated insulated, electrical conducting shaft with an uninsulated distal tip which is configured to emit RF energy. The uninsulated distal tip has a diameter of about 0.025 to about 0.2 inch, preferably about 0.04 to about 0.08 inch and a length of about 0.1 to about 5 mm, preferably about 1.5 to about 3.5 mm.

Abstract: A viewing and treatment apparatus for performing minimally invasive surgery through an opening in a patient's chest, the apparatus includes a visualization scope with an elongated portion and a distal end, and a working device such as a tissue ablation energy delivery device. The working device is encompassed within a working channel that communicates with the distal end of the scope. In one embodiment, a bronchoscope is used whose catheter shafting includes an introducer sleeve at the distal section of the scope for providing stability during introduction to a patient's chest while stabilizing the treatment and visualization distal ends of the scope at a treatment site. This embodiment can include a needle piercing assembly that cooperatively works with the working device such as for drug delivery.

Abstract: A guiding catheter system for delivering an elongated therapeutic or diagnostic device into a patient's left ventricle which includes a first guiding catheter with a shaped distal extremity configured to be aligned with or parallel to a longitudinal axis or long dimension of the patient's left ventricle and a second guiding catheter slidably and rotatably disposed within an inner lumen of the first guiding catheter which has a shaped distal shaft section and an inner lumen configured to slidably receive an elongated therapeutic or diagnostic device such as a tissue ablation device, e.g. an optical fiber connected to a laser source, an ultrasonic energy emitting device or a radio frequency energy emitting device. The shaped distal section of the first guiding catheter is shaped or is shapable within the patient's heart chamber.

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: The disclosure is directed to a tissue ablation device comprising an elongate probe, with a tissue ablation member located at the deflectable distal end of the probe, which is configured to access a patient's heart. The elongate probe is attached at its proximal end to a handpiece which is ergonomically designed to fit within the hand of the operator. The handpiece houses an advancement mechanism which is mechanically coupled to the tissue ablation member and can be used to axially translate the tissue ablation member in relation to the elongate probe. An activation mechanism is housed within the advancement mechanism and is coupled to the advancement mechanism in such a manner that the operator can simultaneously activate and advance the tissue removal member with one finger or thumb. The handpiece also houses a deflection actuator which applies tension to a tensile member which deflects the distal end of the probe.

Abstract: A steerable drug delivery catheter and method of use, particularly adapted for percutaneous use. The distal end of the drug delivery catheter is deflectable. The catheter has a relative movement compensation mechanism for maintaining positioning between the distal end of the drug delivery catheter and the distal end of the drug delivery device therein.

Abstract: A catheter system with an outer catheter body defining at least one lumen and an inner catheter body defining at least one lumen with proximal and distal portions. An introducer is coupled to the distal portion of the inner catheter body. The introducer has a tissue piercing distal end. A resistive heater element is positioned in the introducer. The outer catheter is introduced into a patient's vasculature. The inner catheter is then introduced through the 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. In an alternative embodiment, a heart treatment apparatus includes a handpiece with a proximal and a distal end and an elongated member defining at least one lumen coupled to the handpiece distal end.

Abstract: A viewing and treatment apparatus for performing minimally invasive surgery through an opening in a patient's chest, the apparatus includes a visualization scope with an elongated portion and a distal end, and a working device such as a tissue ablation energy delivery device. The working device is encompassed within a working channel that communicates with the distal end of the scope. In one embodiment, a bronchoscope is used whose catheter shafting includes an introducer sleeve at the distal section of the scope for providing stability during introduction to a patient's chest while stabilizing the treatment and visualization distal ends of the scope at a treatment site. This embodiment can include a needle piercing assembly that cooperatively works with the work device such as for drug delivery.

Abstract: Computer controlled apparatus and method for enhancing myocardial revascularization using direct vessel implants includes a probe for insertion into a proposed graft site to determine the condition of the site using criteria such as oxygen levels, contractility and pressure/flow rate differentials in conjunction with the parameters of the selected vessel graft. Transmyocardial revascularization procedures are performed to increase flow rates when needed and to supplement graft treatment where desired. A coring device creates the opening for the graft and correlates the size of the opening with contractility conditions and vessel conditions. Reinforcement sleeves may be placed around grafts, particularly vein grafts, to avoid excess compression of the graft. Graft site preparation and TMR treatment enhance angiogenesis and collateralization of the implant, and angiogenic drugs may be used to increase such effects.

Abstract: Apparatus and method for creating pathways in tissue and destroying the cored tissue to avoid release of the cored tissue within the body. The apparatus has a coring mechanism and a tissue vaporization mechanism. The apparatus is useful in creating revascularization pathways in the myocardium. The apparatus and methods are adaptable for either surgical or percutaneous procedures.

Abstract: The invention is directed to a system and method for revascularization of a patient's heart tissue by at least one burst of RF energy over an interval of about 1 to about 500 msec, preferably about 30 to about 130 msec. The device preferably has an elongated insulated, electrical conducting shaft with an uninsulated distal tip which is configured to emit RF energy. A method is described for myocardial revascularization of a human heart in which an elongated flexible device is used which includes a radiofrequency ablation device. In some embodiments, the device is configured to be introduced percutaneously, on other embodiments, the device is configured to be introduced intraoperatively. The RF energy emitter is advanced to a position adjacent a desired area of the heart wall. The device is activated, moving tissue to form a revascularization channel.

Abstract: A method for treating myocardium using at least one mechanical or electromagnetic energy functional device for forming a network of branched, interconnecting passages in a boundary between endocardium and myocardium, thereby enhancing blood flow into the treated zone, and a device for selectively treating ischemic myocardium tissue comprising a tube having proximal end and distal end, and at least one hollow lumen and defining an axis, at least two mechanical or electromagnetic energy functional devices disposed within the tube, the at least two mechanical or electromagnetic energy functional devices each having a distal end disposed adjacent the distal end of the central tube, and a deflecting member adjacent the distal portion of the central tube for deflecting the distal end of each of the at least two mechanical or electromagnetic energy functional devices away from the axis, for enabling treatment of selective areas of ischemic or hibernating myocardium tissue.

Abstract: The apparatus 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 auto-piercing, micro-tearing or spreading the epicardium of the heart; and then lasing from beneath the epicardium through the myocardium.

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. A handle is described for a flexible optical fiber device which greatly facilitates delivery of the distal end of the optical fiber device to a desired location on the exterior of a patient's heart.