Abstract: A method of making a remotely imagable balloon for use with a balloon catheter, such as might be used for angioplasty procedures. Adhesive and imagable material may be coated onto an inner surface of the balloon before assembly into a balloon catheter and the adhesive may be allowed to cure and fix the imagable material within the balloon. A powder injector for inserting imagable material within a balloon. A curing station for curing light cured adhesive coated along an inner surface of a balloon.

Abstract: The present invention is directed to a polymeric balloon for an intracorporeal catheter having a plurality of spaced apart, remotely imageable layers which facilitate the folding of the balloon. The imageable layer may facilitate imaging the balloon or a portion thereof preferably by fluoroscopic or magnetic resonance based remote imaging systems.

Abstract: A protective coating for a substrate is disclosed having an outer component or module formed of a swellable material and an inner module formed of a plurality of layer or bilayers formed of ceramic material. The coating comprising a plurality of modules comprising a first module comprising a number (m) of bilayers comprising zirconia and alumina wherein (m) is a number greater than 1. The coating further comprises a second module disposed on the first module comprising a number (n) of bilayers comprising zirconia and titania wherein (n) is a number greater than 1. The coating further comprises a third module disposed on the second module comprising a third-module compound capable of forming a hydrate or hydroxide compound upon contact with an oxygen containing environment.

Abstract: Apparatus and methods for delivering an angiogenic agent to a site within the heart. Either using a percutaneous, intraoperative or minimally invasive approach, an elongated member containing an angiogenic agent is guided to a heart wall and the agent is dispensed into heart tissue. Additional fluids or substances can be dispensed in combination with the angiogenic agent to provide visualization and site mapping. In certain embodiments, the angiogenic agent is delivered adjunctively with the administration of energy, such as laser energy or RF energy which disturbs the heart tissue sufficiently to enhance the effects of the angiogenic agent.

Abstract: The present invention is directed to a polymeric balloon for an intracorporeal catheter having a plurality of spaced apart, remotely imageable layers which facilitate the folding of the balloon. The imageable layer may facilitate imaging the balloon or a portion thereof preferably by fluoroscopic or magnetic resonance based remote imaging systems.

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: 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: 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 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 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 and catheter system for irradiating a body lumen wall which comprises providing an elongated, flexible radiation transmission member having an emitting portion at its distal end, advancing the emitting portion to an area adjacent the wall defining the patient's body lumen to be treated by irradiation, and directing radiation through the transmission member while moving the transmission member to cause the emitting portion to irradiate a length of the wall of the body lumen. The transmission member may be rotated independently or in conjunction with longitudinal movement to achieve either selective or uniform irradiation of the wall defining the body lumen. In one embodiment, this invention comprises an elongated flexible shaft, having an inflatable member disposed at the distal end. A radiation transmission member having an emitting portion on its distal end is slidably disposed within the elongated shaft so that the emitting portion resides within the inflatable member.

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 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 method and apparatus are described for percutaneous myocardial revascularization of a human heart. A deflectable elongated flexible lasing apparatus is used which includes a source of laser radiation, an elongated flexible radiation conveying member for conducting the laser radiation to a lens on the distal end of the radiation conveying member for focusing the laser radiation, and control lines for deflecting the distal end of the radiation conveying member. The control lines are secured to the distal end of the radiation conveying member for changing the angle of deflection of the distal end of the radiation conveying member. The lasing apparatus is guided to an area within the patient's heart, and the distal end of the lasing apparatus is directed to an area of interest where the inner wall of the heart is irradiated with laser energy to form a channel through the myocardium for a desired distance. In a preferred embodiment, channels are formed without perforating the epicardium of the heart.

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: 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 method and apparatus are described for percutaneous myocardial revascularization of a human heart. A deflectable elongated flexible lasing apparatus is used which includes a source of laser radiation, an elongated flexible radiation conveying means for conducting the laser radiation to a lens on the distal end of the radiation conveying means for focusing the laser radiation, and control lines for deflecting the distal end of the radiation conveying means. The control lines are secured to the distal end of the radiation conveying means for changing the angle of deflection of the distal end of the radiation conveying means. The lasing apparatus is guided to an area within the patient's heart, and the distal end of the lasing apparatus is directed to an area of interest where the inner wall of the heart is irradiated with laser energy to form a channel through the myocardium for a desired distance. In a preferred embodiment, channels are formed without perforating the epicardium of the heart.

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 and method for detecting breakage in an optical fiber is disclosed. The system includes an acoustic detector coupled to the optical fiber to be monitored for breakage which operates to generate an electrical output signal when the sound of an optical fiber break is detected. A signalling circuit measures the output of the acoustic detector and operates to generate a signal indicative of the output of the acoustic detector, and an indicator circuit is responsive to the output of the signalling circuit to provide an indication of breakage in the optical fiber. In one preferred embodiment, a control circuit is also provided which operates to interrupt light transmission through the optical fiber when breakage of the optical fiber is detected.

Abstract: An optical fiber lasing apparatus includes an optical fiber which terminates in a lens having a convex lens side at its forward end, and having an extended barrel portion secured to the distal portion of the optical fiber. The lens is larger in diameter than the diameter of the optical fiber member.