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: 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: 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: A needle having a shaft with a distal end defining a distal opening. The shaft has a longitudinal axis that extends through the distal opening and the distal opening has a projected area that is smaller than a cross-sectional area of a section of the shaft proximal to the distal end of the shaft. Also provided are methods of directly delivering a therapeutic agent to a target site using a Huber needle or pencil-point needle.

Abstract: An apparatus for precision pen height control which includes a dispensing member, a fluid dispensing system, a vertical position sensing system, and a vertical position controller The fluid dispensing system is in fluid communication with an opening in the dispensing member via a tubular member. A vertical position sensing system, which includes a diffraction grating and a sensor, is engaged to the tubular member. The sensor is positioned adjacent the diffraction grating The diffraction grating is engaged to a vertical support, which is engaged to the tubular member. The sensor produces a vertical position signal based upon the position of the vertical support The vertical position controller is engaged to the vertical position sensing system, and receives a control signal generated from the vertical position signal. The vertical position controller produces and applies vertical forces to the vertical support in response to the control signal.

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: Catheter devices having an expandable balloon for delivering a therapeutic agent to a body site. The balloon has one or more folds which serve as a reservoir for containing the therapeutic agent. The fold may have any of various configurations to hold the therapeutic agent. In some cases, the balloon comprises one or more lobes that forms the fold(s). The therapeutic agent may be provided in various ways. For example, the therapeutic agent may be contained in packets that rupture upon expansion of the balloon, or as a plurality of discrete bulk masses, or sealed within compartments.

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: 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: A catheter device includes an elongate tubular housing, a cannula, and a flexible proboscis. The cannula defines a cannula lumen which is in fluid communication with a cannula exit port located adjacent the distal end of the elongate housing. The distal tip of the cannula is disposed within the cannula lumen. The cannula defines a proboscis lumen and the cannula has a proboscis exit port in fluid communication with the proboscis lumen. The proboscis exit port is located at the distal tip of the cannula. The flexible proboscis has a distal tip and is disposed within the proboscis lumen.

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: 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: The present invention provides a systems that delivers therapeutic to the inner lumens, chambers, cavities, and vessels of the body. 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.

Abstract: The present invention relates to implantable medical devices and methods that employ these medical devices to treat heart valves. In one embodiment, a medical device is provided comprising a body. The body may have a portion thereof including therapeutic agent and can be configured to support the device proximate a heart valve. Methods in accordance with embodiments of the present invention may also include providing a medical device having a body with at least a portion thereof including a therapeutic agent. These methods may also include positioning the medical device in a location proximate to a downstream surface of the heart valve and securing the device. The therapeutic agent released may then be delivered to the heart valve.

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: Delivery devices with pressure control mechanisms are described herein. In some embodiments an apparatus includes a reservoir configured to contain a fluid, the reservoir having an inlet port and an outlet port. A plunger is disposed within the reservoir such that the reservoir is divided into a first portion and a second portion. The inlet port is in fluid communication with the first portion of the reservoir, and the outlet port is in fluid communication with the second portion of the reservoir. A pressure control device configured to control a pressure of the fluid within the first portion of the reservoir is in fluid communication with the first portion of the reservoir.

Abstract: The invention provides devices that can be used to deliver a therapeutic agent to a treatment site within the vessel of a patient at increased pressure, while limiting the contact with and pressure placed on the vessel walls. Devices according to the invention include an expandable structure arranged around and on a tube having a lumen. The expandable structure may include a sealing ring that makes contact with the interior surface of a vessel to prevent or decrease fluid flow during delivery of a therapeutic agent. This allows delivery of a therapeutic agent with decreased risk of injury to the treatment site. The invention also provides for large lumen diameters, preventing shearing stress on therapeutic agents such as cell slurries.

Abstract: A catheter system comprises a catheter comprising a distal portion, a proximal portion and an inner shaft. The inner shaft comprises a medical device receiving region for receiving and carrying a medical device. The retaining device is at least partially constructed of an electroactive polymer. The retaining device is located on or adjacent to the medical device receiving region. The electroactive polymer of the retaining device has an activated state and an inactivated state. The retaining device is capable of retaining a medical device to the catheter and releasing the medical device from the catheter by transitioning between the activated state and the inactivated state.

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 system is provided. Catheters in this system may include a first elongated shaft and a housing surrounding it wherein the distal end of the housing has a distal contact area shaped in the form of a dome and wherein the first elongated shaft maybe moveable through the distal contact area. The housing may also include internal threads within the distal contact area and may be made from at least two materials with one material being different from the second, the second material being a polymer in some instances. The elongated shaft may also be in the form of a helix and may have a piercing tip. This helix may expand as it is rotated past turns located within the housing.