Abstract: Methods and delivery devices for maximizing injectate dispersion in lesioned tissue using needle-based injection devices are herein disclosed. The delivery devices include injection devices with modified needle tip configurations. The needle tip configurations can include multiple circumferential openings.

Abstract: A guiding catheter system employs a flexible shaft having a preformed bend at a distal end. An ultrasound transducer is mounted proximal to the pre-formed bend. The ultrasound transducer has a field of view directed to a distal tip of the guiding catheter. The guiding catheter includes an open lumen adapted for the introduction of payloads through the catheter system. The guiding catheter system can be used to direct a smaller guiding catheter or guide wire into a destination vessel from a heart chamber. In one application, the guiding catheter system is used to introduce a guiding catheter into the coronary sinus ostium from the right atrium.

Abstract: An echogenic medical device, such as a needle catheter, which produces an improved ultrasonic image of the device, and a method of performing a medical procedure using a device of the invention. One aspect is directed to a catheter which reduces artifacts in the ultrasound image of the catheter. In one embodiment, the catheter has a spherical distal tip. Another aspect of the invention is directed to an echogenic catheter with echogenic portions arranged in an array to facilitate determination by ultrasonic imaging of the rotational orientation of the catheter relative to a desired location within the patient.

Abstract: Methods and apparatuses for the image guidance and documentation of medical procedures. One embodiment includes combining small field of view images into a recorded image of with a large field of view and aligning the small field of view real time image with the recorded image through correlation of imaging data. A location and orientation determination system may be used to track the imaging system and provide a starting set of image alignment parameters and/or provide change updates to a set of image alignment parameters, which is then further improved through correlating imaging data. The recorded image may be selected according to real time measurement of a cardiac parameter during an image guided cardiac procedure. Image manipulations planned based on the recorded image can be stored and applied to the real time information. The position of the medical device may be determined and recorded through manipulating a cursor in a 3-D image space shown in two non-parallel views.

Abstract: The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

Abstract: The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

Abstract: Various apparatuses and methods are described to treat vulnerable plaque with the use of combination drug therapy. In one embodiment, the apparatus has an elongated catheter body adapted for insertion in a body lumen, with a drug delivery device attached near a distal portion of the elongated body. The drug delivery device is configured to deliver a therapeutic or biologically active agent to stabilize a vulnerable plaque. In another embodiment, a drug eluting stent is delivered and deployed in conjunction with a second apparatus that delivers drug in pressurized retrograde perfusion. Still another embodiment uses a uniquely shaped balloon to deploy a stent while utilizing a drug infusion needle to inject drug into the vessel wall through a hollow guide wire.

Abstract: An apparatus for delivering devices. The apparatus comprises a catheter with an elongated shaft having a first lumen and a second lumen extending therethrough. The apparatus further comprises a distal section with a lumen in communication with a port in a distal end of the catheter and with the first lumen and the second lumen. The first lumen is configured for a first device and the second lumen is configured for a second device to be disposed therein. The apparatus further comprises a proximal adapter coupled to the elongated shaft with a first port in communication with the first lumen and a second port in communication with the second lumen.

Abstract: Various devices and methods for improving intravascular imaging are disclosed. In one embodiment, fluid dispersion devices are included on a catheter to improve dispersal of a flush solution within a flow of fluid (e.g., blood) in a vessel. In other embodiments, a catheter includes at least one inflatable balloon to selectively partially occlude a vessel to be imaged and/or treated in order to minimize the refractory effects of blood on the imaging/treatment process. In one embodiment, a catheter may image/treat at least a portion of a vessel by moving an imaging/treatment device in a distal direction relative to a proximal section of the catheter.

Abstract: A medical device and method are provided for positioning and supporting a therapeutic tool within the heart or other body cavity. The device has a tubular member through which a cage can be extended. The cage supports the positioning and delivery of a tool to a targeted treatment or diagnosis area within the heart or other body cavity. Markers on the device facilitate accurate positioning and delivery of the tool.

Abstract: A deflectable catheter assembly is disclosed. The assembly comprises a catheter shaft having a catheter proximal section and a catheter distal section, and at least one lumen extending therethrough. The catheter distal section is more flexible than the catheter proximal section. A tendon is disposed within a first lumen of said catheter shaft. The first lumen is approximately centrally located within the catheter shaft at the catheter proximal section. The first lumen is located off-center of the catheter shaft at the catheter distal section. The tendon is able to deflect the catheter distal section when being pulled on. A catheter handle is coupled to the catheter shaft at the catheter proximal section, the catheter handle includes a control mechanism to control the tendon.

Abstract: Embodiments include an infusion-occlusion system having a delivery catheter, a guide catheter adapted to receive the delivery catheter, and a guidewire with an occlusion device adapted to be received within the guide catheter. The guide catheter of the catheter kit may be provided with an occlusion device at the distal end of the guide catheter. The delivery catheter may have an accessory lumen, coaxial and/or co-linear lumen, a supporting mandrel, and/or an occlusion device at its distal end. Moreover, according to embodiments, occlusion devices may be a single material or a composite balloon having an inner liner and an outer layer of different materials, a high compliance low pressure balloon, and/or a filter device that restricts particles from passing through but does not restrict fluid, such as blood. An inflation device with a large volume and low volume syringe can be used to inflate the balloon.

Abstract: A guiding catheter system employs a flexible shaft having a preformed bend at a distal end. An ultrasound transducer is mounted proximal to the pre-formed bend. The ultrasound transducer has a field of view directed to a distal tip of the guiding catheter. The guiding catheter includes an open lumen adapted for the introduction of payloads through the catheter system. The guiding catheter system can be used to direct a smaller guiding catheter or guide wire into a destination vessel from a heart chamber. In one application, the guiding catheter system is used to introduce a guiding catheter into the coronary sinus ostium from the right atrium.

Abstract: A catheter assembly having a balloon disposed at the distal end thereof and a therapeutic substance delivery assembly, including a needle in fluid communication with a therapeutic substance delivery lumen for allowing a therapeutic substance to be injected into a diseased physiological lumen. A deflector is positioned along an inside wall of the delivery lumen, positioned, such that as a bend region forms caused by the movement of the delivery lumen, the deflector bends to rest on the outside curvature of the bend. As the needle is made to travel through the bend, the ribbon helps to bounce the needle tip off the wall of the delivery lumen, allowing the needle to travel through the bend without digging into and/or gouging the delivery lumen wall.

Abstract: The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

Abstract: The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.