Abstract: A modified medical device for delivery of a pharmaceutically active material is described. The present inventors have found that many conventional medical devices contain a metallic or polymeric component that comes into contact with a pharmaceutically active material during use, and that the contact substantially reduce the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to the metallic or polymeric component that are effective to diminish such a substantial reduction in pharmaceutical effectiveness.

Abstract: A direct injection system with a small diameter that can be easily placed at a desired treatment location is provided, where the system comprises an outer guide catheter having a predefined bend at the distal end. For example, the outer guide catheter may be no larger than a 7 Fr catheter. According to the invention, various mechanisms may be used to alter the curvature of the predefined bend in the catheter, allowing an operator to easily place the distal end of an injection catheter at a desired treatment location. Alternatively, the injection catheter itself has a predefined bend at the distal end, wherein the curvature can be adjusted by adjusting the position of the injection catheter within a guide catheter.

Abstract: A method and medical system to take electrical readings includes an electrocardiogram (ECG) monitor, an electrode coupled to the monitor via a first lead and a needle such as an injection needle. The needle has a proximal end coupled to the monitor, where the monitor is able to measure an electrical pattern between the electrode and a distal end of the needle. In one example, the medical system is used to detect the contact, penetration, health and perforation of tissue at a target site.

Abstract: A modified medical device for delivery of a pharmaceutically active material is described. The present inventors have found that many conventional medical devices contain a metallic or polymeric component that comes into contact with a pharmaceutically active material during use, and that the contact substantially reduce the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to the metallic or polymeric component that are effective to diminish such a substantial reduction in pharmaceutical effectiveness.

Abstract: A therapeutic delivery catheter system method or kit for delivery of therapeutic to a target location is provided. In various embodiments of the present invention the invention may include a catheter with a therapeutic delivery lumen and a therapeutic delivery orifice. The lumen and the orifice may be in fluid communication with each other and may be configured such that therapeutic delivered therethrough may be done at pressures mimicking pressures existing or otherwise normal at the target locations receiving the therapeutic. In some embodiments the catheter may be part of a kit that may include instructions regarding the proper manner of operation of the catheter. These instructions may include suggested target pressures for therapeutic delivery as well as delivery times, and suggested lengths of time for the device to reside at the target area after delivery to allow for proper uptake of the therapeutic.

Abstract: Devices and methods for delivering therapeutic or diagnostic agents to a target tissue of a human body are disclosed. A catheter in accordance with the present invention includes an injection catheter assembly having a first elongated member with a proximal end, a distal end, an external surface, and an inside surface defining a first lumen. The catheter includes a second elongated member having a proximal region and a distal region. The second elongated member is positioned at least partially within the first elongated member. The second elongated member has a second helical member fixed to an end. The catheter also includes a third elongated member. The third elongated member defines a lumen along a portion of the length of the first elongated member. The third elongated member has a first helical member. The second helical member is longitudinally moveable within the lumen of the first helical member to move the second elongated member longitudinally.

Abstract: A catheter having a drug delivery unit at the distal end thereof. The drug delivery unit includes an actuator capable of assuming an activated and an inactivated configuration. The drug delivery unit also includes a receptacle capable of accepting a therapeutic agent. The actuator and receptacle are in communication with each other such that the actuator transmits force to the receptacle and the receptacle accepts force from the actuator in an activated configuration of the actuator. Also provided is a method of delivering a therapeutic agent to a target site using the catheter of the present invention.

Abstract: An elongate medical device that may be used for performing medical procedures on a patient is provided. This elongate medical device may include a first member having a distal end, an outer surface, and a first lumen, where the first member may have an elongated configuration such that the length of the first member is at least ten times greater than the width of the first member. The elongate medical device may also have a second member positioned within the first member and a hood stop. The hood stop in this device may be positioned within the first member and may have a distal region and a shoulder region where the shoulder region may be configured to limit the travel of the first member or the second member past the hood stop.

Abstract: Many conventional pharmaceutical articles contain seemingly inert components that come into contact with a pharmaceutically active material during use, which contact substantially reduces the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to these incompatible components, which are effective to diminish the reduction in pharmaceutical effectiveness.

Abstract: The present invention provides methods, systems, and devices that deliver therapeutic to the inner lumens, chambers, cavities, and vessels of the body. In one embodiment, a therapeutic delivery device for delivery of therapeutic to a target site within the body of a patient is provided. This device may include a catheter, an expandable multi-port housing fluidly coupled to the catheter and a sheath. The multi-port housing in this device may be sized to travel within a lumen of a patient and may be adapted to expand from a first configuration to a second configuration. The multi-port housing may also contain at least two ejection ports coupled to an internal lumen of the multi-port housing. In some embodiments the multi-port housing is a bladder, while in others it is a frame or a group of outwardly extending arms. In each case, the device is configured to deliver therapeutic to a remote site in the body of a patient.

Abstract: An apparatus and method for catheter-based sensing and injection at a target site within a patient's body. An injection catheter is equipped with electrodes at its distal end which contact the surface of a target site, such as an AV node of the heart. Electrical signals detected at the target site by the electrodes are fed via leads to the proximal end of the catheter, where they are received by a monitor, such as an EKG monitor. If the electrical signals satisfy predetermined criteria, a needle within the catheter is extended into the target site, and a therapeutic agent is injected into the target site.

Abstract: Devices and methods for performing improved percutaneous myocardial revascularization (PMR) procedures. One device includes a preassembled PMR drug delivery catheter and a drug neutralizing vial. The vial assembly allows prepping the PMR catheter by flushing drug through distal needle, and into a vial cavity where the drug is neutralized by a neutralizing agent. One set of devices includes needles having protrusions secured to the distal regions of drug delivery tubes. One needle has outward protruding barbs engaging the inner tube wall while another needle has outward threads which can screw into the tube inner wall. Radiopaque marker bands are also included in the present invention which are asymmetrically distributed on the catheter shaft, allowing a treating physician to determine under fluoroscopy whether the catheter distal region is pointed away or toward the treating physician, as well as determining whether the catheter distal region is rotated toward or away from the treating physician.

Abstract: An apparatus and method for catheter-based sensing and injection at a target site within a patient's body. An injection catheter is equipped with a electrodes at its distal end which contact the surface of a target site, such as an AV node of the heart. Electrical signals detected at the target site by the electrodes are fed via leads to the proximal end of the catheter, where they are received by a monitor, such as an EKG monitor. If the electrical signals satisfy predetermined criteria, a needle within the catheter is extended into the target site, and a therapeutic agent is injected into the target site.

Abstract: An apparatus for the injection of therapeutic and other agents at a target site within a patient's body. A catheter including a first elongated shaft having a distal end and a proximal end and a lumen extending therebetween. The catheter also including a second elongated shaft slidingly disposed in the first elongated shaft, the second elongated shaft having a distal end and a proximal and a lumen extending therebetween. The catheter further including a third elongated shaft disposed in and attached to the second elongate shaft, the third elongated shaft to move in a one-to-one relationship with the first elongated shaft and the second elongated shaft to maintain a predetermined needle deployment length as each are subjected to various bend configurations.

Abstract: Many conventional pharmaceutical articles contain seemingly inert components that come into contact with a pharmaceutically active material during use, which contact substantially reduces the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to these incompatible components, which are effective to diminish the reduction in pharmaceutical effectiveness.

Abstract: A system and method for simply and reliably determining the location and orientation of a medical device within a patient's body. A medical device, such as a catheter, has bending indicators on or imbedded in its wall, and passes through an anatomical reference of known orientation relative to a target site within the patient. Information from the tube bending indicators permits determination of the orientation of a feature, such as an orifice, at the distal end of the medical device relative to the anatomical reference. From the known orientation of the anatomical reference, and information on the location and orientation of the distal end of the medical device obtained from fluoroscopic imaging from a single direction, the physician may reliably determine the orientation of the distal feature relative to the target site, eliminating the need for imaging from multiple directions.

Abstract: The present invention generally relates to a medical device for delivering a therapeutic agent to an internal portion of a patient's body. The medical device includes a shaft and a self-expanding delivery member in operative communication with the shaft. The delivery member is shaped from a porous material that is capable of releasing a therapeutic agent to an internal portion of a patient's body. The medical device further includes a therapeutic agent delivery lumen in fluid communication with the delivery member to fluidly connect the delivery member with a therapeutic agent source. A retention member may also be provided to selectively collapse the delivery member.

Abstract: A catheter handpiece apparatus and method for delivering a desired dose with minimal potential for contamination of the injected substance and rapid, accurate delivery of the desired dose. In one embodiment, a carriage assembly affixed to an inner lumen is slidably located within a handpiece housing equipped with an outer lumen. The carriage assembly receives a dose carpule. An actuator knob cocks the carriage assembly and a spring-powered actuator mechanism. After the catheter is maneuvered to a desired injection site and a desired dose is set, depressing a first trigger causes the inner lumen tip to extend beyond the outer lumen into the injection site. Depressing a second trigger causes the actuator mechanism to push the desired dose from the dose carpule through the inner lumen into the injection site. A second embodiment provides a catheter handpiece with a carriage assembly cocking lever and an operator-powered dose delivery mechanism.

Abstract: Many conventional pharmaceutical articles contain seemingly inert components that come into contact with a pharmaceutically active material during use, which contact substantially reduces the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to these incompatible components, which are effective to diminish the reduction in pharmaceutical effectiveness.

Abstract: A modified medical device for delivery of a pharmaceutically active material is described. The present inventors have found that many conventional medical devices contain a metallic or polymeric component that comes into contact with a pharmaceutically active material during use, and that the contact substantially reduce the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to the metallic or polymeric component that are effective to diminish such a substantial reduction in pharmaceutical effectiveness.