Abstract: Myocardial revascularization catheters and methods are provided herein. Catheters in accord with the present invention may include an outer shaft and an inner shaft where the inner shaft may be slidably and rotatably disposed in the outer shaft and the distal movement of the inner shaft may be arrested by the engagement of stops and catches located within the inner and outer shaft Methods in accord with the current invention may include providing a therapeutic, providing a radiopaque contrast media, injecting the therapeutic through a lumen into the myocardium of the heart, and injecting the radiopaque contrast media through a lumen into myocardium of the heart. In this example, the location of the injection the radiopaque material may be chosen to indicate the injection point of the injection of the therapeutic.

Abstract: A catheter system includes a catheter having a proximal end, a distal end, and a lumen extending therein. An administering portion is disposed at the distal end of the catheter and is configured to administer a bolus of liquid in response to positive pressure in a distal portion of the lumen. The catheter system of the present invention has a dead space of less 0.32 cc and preferably less than 0.15 cc in which residual therapeutic agents remain after delivery. The present invention also includes a method of administering a liquid to a treatment site. The distal end of the catheter is transluminally positioned proximate the treatment site. The catheter is charged by placing a bolus of the liquid in the lumen A positive pressure is created to drive the bolus to the administering tip to express the bolus from the distal end of the catheter.

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 an elongated configuration, a second member pivotally coupled to the first member at a pivot area of the first member, and a manipulation member extending through either a first lumen or a second lumen of the first member. The second member of this device may have a first region on one side of the pivot area and a second region on a different side of the pivot area. The medical device may also include a third member slidable within one of the lumens of the first 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: A therapeutic catheter is provided. This therapeutic catheter may include an outer tube with a distal piercing end and a first lumen which may have a stop positioned within it. The first lumen may also have a plug positioned within it wherein the stop may have an inside diameter smaller than the inside diameter of the first lumen and the plug may be sized to prevent travel of the stop outside of the distal end of the outer tube.

Abstract: A catheter system includes a catheter having a proximal end, a distal end, and a lumen extending therein. An administering portion is disposed at the distal end of the catheter and is configured to administer a bolus of liquid in response to positive pressure in a distal portion of the lumen. The catheter system of the present invention has a dead space of less 0.32 cc and preferably less than 0.15 cc in which residual therapeutic agents remain after delivery. The present invention also includes a method of administering a liquid to a treatment site. The distal end of the catheter is transluminally positioned proximate the treatment site. The catheter is charged by placing a bolus of the liquid in the lumen A positive pressure is created to drive the bolus to the administering tip to express the bolus from the distal end of the catheter.

Abstract: Myocardial revascularization catheters and methods are provided herein. Catheters in accord with the present invention may include an outer shaft and an inner shaft where the inner shaft may be slidably and rotatably disposed in the outer shaft and the distal movement of the inner shaft may be arrested by the engagement of stops and catches located within the inner and outer shaft Methods in accord with the current invention may include providing a therapeutic, providing a radiopaque contrast media, injecting the therapeutic through a lumen into the myocardium of the heart, and injecting the radiopaque contrast media through a lumen into myocardium of the heart. In this example, the location of the injection the radiopaque material may be chosen to indicate the injection point of the injection of the therapeutic.

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: 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 elongate shaft having a distal end, a proximal end, and a lumen therethrough. The elongate shaft includes a first curved portion proximate the distal end of the elongate shaft. The first curved portion of the elongate shaft defines a first plane. The elongate shaft also includes a second curved portion disposed between the distal end of the elongate shaft and the first curved portion of the elongate shaft. The second curved portion of the elongate shaft defines a second plane. The second plane intersects the first plane at an angle.

Abstract: An injection catheter assembly is provided. This assembly can include an outer elongated member having a proximal end, a distal end, and an external diameter and an inner elongated member having a proximal region and a distal region. The inner elongated member may be positioned at least partially within the outer elongated member, may have a piercing tip at the end of the proximal region and may be rotatable within the outer elongated member with the degree of rotation of the inner elongated member adjusting the distance that the piercing tip can extend from the distal end of the outer elongated member.

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: A catheter adapted to deliver therapeutic or diagnostic agents to a target tissue of a human body is disclosed. A catheter in accordance with the present invention comprises a first elongate shaft having a proximal end, a distal end, and a lumen extending therethrough, a second elongate shaft disposed within the lumen of the first elongate shaft, the first elongate shaft including a first helical member comprising a plurality of turns, the second elongate shaft including a second helical member comprising a plurality of turns.

Abstract: A therapeutic catheter is provided. This therapeutic catheter may include an outer tube with a distal piercing end and a first lumen, this first lumen may have a stop positioned within it. The first lumen may also have a plug positioned within it wherein the stop may have an inside diameter smaller than the inside diameter of the first lumen and the plug may be sized to prevent travel of the stop outside of the distal end of the outer tube.

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 elongate shaft having a distal end, a proximal end, and a lumen therethrough. The elongate shaft includes a first curved portion proximate the distal end of the elongate shaft. The first curved portion of the elongate shaft defines a first plane. The elongate shaft also includes a second curved portion disposed between the distal end of the elongate shaft and the first curved portion of the elongate shaft. The second curved portion of the elongate shaft defines a second plane. The second plane intersects the first plane at an angle.

Abstract: Guide catheters which can be used in percutaneous myocardial revascularization (PMR) to deliver therapeutic catheters to difficult to reach heart chamber wall regions. Some guide catheters include distal regions which can be bent under control from the proximal region of the catheter. One steerable guide catheter has a flexible distal region, a more proximal, less flexible intermediate region, a first lumen for receiving a therapeutic catheter, and an elongate manipulation member slidably disposed in a second, blind lumen. The elongate manipulation member can be secured off-center near the distal end of the flexible distal region. The distal region can be bent by retracting the manipulation member and straightened by pushing the manipulation member. Controllably bendable guide catheters according to the present invention can be nested inside other, similar guide catheters. The invention also includes means for resisting free rotation of guide catheters relative to other adjacent catheters or tubes.

Abstract: Therapeutic catheters for increasing myocardial blood perfusion in procedures including percutaneous myocardial revascularization (PMR), which can include tips for cutting into the myocardium to stimulate a healing response and/or for injecting angiogenic substances. PMR catheters can include an outer shaft slidably housing an inner shaft having a distal therapeutic tip. The outer shaft can be slidably disposed in a guide catheter and have an expandable atraumatic distal tip for presenting an enlarged distal profile against the heart chamber wall. The enlarged atraumatic profile can reduce the likelihood of the outer shaft penetrating undesirably into the myocardium. One expandable distal tip expands radially when forced against the endocardium. Another expandable tip expands when unconstrained by the guide catheter. Yet another expandable tip expands when manipulated by an elongate manipulation member.

Abstract: Guide catheters which can be used in percutaneous myocardial revascularization (PMR) to deliver therapeutic catheters to difficult to reach heart chamber wall regions. Some guide catheters include distal regions which can be bent under control from the proximal region of the catheter. One steerable guide catheter has a flexible distal region, a more proximal, less flexible intermediate region, a first lumen for receiving a therapeutic catheter, and an elongate manipulation member slidably disposed in a second, blind lumen. The elongate manipulation member can be secured off-center near the distal end of the flexible distal region. The distal region can be bent by retracting the manipulation member and straightened by pushing the manipulation member. Controllably bendable guide catheters according to the present invention can be nested inside other, similar guide catheters. The invention also includes means for resisting free rotation of guide catheters relative to other adjacent catheters or tubes.

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: A catheter system includes a catheter having a proximal end, a distal end, and a lumen extending therein. An administering portion is disposed at the distal end of the catheter and is configured to administer a bolus of liquid in response to positive pressure in a distal portion of the lumen. The catheter system of the present invention has a dead space of less 0.32 cc and preferably less than 0.15 cc in which residual therapeutic agents remain after delivery. The present invention also includes a method of administering a liquid to a treatment site. The distal end of the catheter is transluminally positioned proximate the treatment site. The catheter is charged by placing a bolus of the liquid in the lumen A positive pressure is created to drive the bolus to the administering tip to express the bolus from the distal end of the catheter.

Abstract: A catheter is disclosed which includes an over-the-wire type balloon catheter, with a guide wire, wherein the catheter incorporates an axially movable inner tubular member which extends proximally through a proximal manifold lumen. The inner tubular member extends distally beyond the distal end of the outer tubular member with the balloon member distal waist affixed to the inner tubular member proximate the distal end. The catheter incorporates axial tension members which function to transmit force to the distal tip when the movable inner tubular member is oscillated axially. The axial tension members are preferably a plurality of wires, each having a proximal end affixed to the outside diameter of the inner tubular member proximate the manifold, and each having a distal end affixed to the outside diameter of the inner tubular member a substantial distance distal of the manifold.