Abstract: Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for transversely driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force transverse to the shaft. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Abstract: A method of performing a medical procedure, such as surgery, is provided. A nerve is stimulated in order to adjust the beating of the heart to a first condition, such as a stopped or slowed condition. The medical procedure is performed on the heart or another organ. The stimulation of the nerve is stopped in order to adjust the beating of the heart to a second condition, such as a beating condition. The heart itself may also be stimulated to a beating condition, such as by pacing. The stimulation of the nerve may be continued in order to allow the medical procedure to be continued. A sensor to sense a characteristic of a fluid or tissue, such as an impending contraction, may be also used during the medical procedure. Systems and devices for performing the medical procedure are also provided.

Abstract: An instrument including an elongated shaft and a non-conductive handle is disclosed. The shaft defines a proximal section and a distal section. The distal section forms an electrically conductive tip. Further, the shaft is adapted to be transitionable from a straight state to a first bent state. The shaft is capable of independently maintaining the distinct shapes associated with the straight state and the first bent state. The handle is rigidly coupled to the proximal section of the shaft. The instrument is useful for epicardial pacing and/or mapping of the heart for temporary pacing on a beating heart, for optimizing the placement of ventricular leads for the treatment of patients with congestive heart failure and ventricular dysynchrony and/or for use in surgical ablation procedures.

Abstract: Minimally invasive introducers and methods that can be used for rotationally securing devices within the human body. Introducers can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Abstract: This invention provides a system and method for positioning, manipulating, holding, grasping, immobilizing and/or stabilizing a heart including one or more tissue-engaging devices, one or more suction sources, one or more fluid sources, one or more energy sources, one or more sensors and one or more processors. The system and method may include an indifferent electrode, a drug delivery device and an illumination device. The system's tissue-engaging device may comprise a tissue-engaging head, a support apparatus and a clamping mechanism for attaching the tissue-engaging device to a stable object. The system may be used during various medical procedures including the deployment of an anastomotic device, intermittently stopping and starting of the heart, ablation of cardiac tissues and the placement of cardiac leads.

Abstract: Methods and apparatus employed to locate body vessels and occlusions in body vessels finding particular utility in cardiac surgery, particularly minimally invasive cardiac surgery to locate cardiac arteries and occlusions in cardiac arteries are disclosed. An elongated vessel lumen probe incorporating a lumen probe element at or near the elongated vessel lumen probe distal end is advanced into the vessel lumen. A vessel surface probe manipulated by the surgeon and having a surface probe element sensor is employed to detect the lumen probe element and to follow the progress of the vessel lumen probe element as it approaches and is advanced through or is blocked by an occlusion. In the location of a coronary artery, the surface probe element sensor is moved about against the epicardium over the suspected location of the artery of interest until a surface probe element sensor of the present invention at the surface probe distal end interacts with the lumen probe element of the vessel lumen probe.

Abstract: This invention provides a system and method for positioning, manipulating, holding, grasping, immobilizing and/or stabilizing a heart including one or more tissue-engaging devices, one or more suction sources, one or more fluid sources, one or more energy sources, one or more sensors and one or more processors. The system and method may include an indifferent electrode, a drug delivery device and an illumination device. The system's tissue-engaging device may comprise a tissue-engaging head, a support apparatus and a clamping mechanism for attaching the tissue-engaging device to a stable object. The system may be used during various medical procedures including the deployment of an anastomotic device, intermittently stopping and starting of the heart, ablation of cardiac tissues and the placement of cardiac leads.

Abstract: Methods and apparatus employed to locate body vessels and occlusions in body vessels finding particular utility in cardiac surgery, particularly minimally invasive cardiac surgery to locate cardiac arteries and occlusions in cardiac arteries are disclosed. An elongated vessel lumen probe incorporating a lumen probe element at or near the elongated vessel lumen probe distal end is advanced into the vessel lumen. A vessel surface probe manipulated by the surgeon and having a surface probe element sensor is employed to detect the lumen probe element and to follow the progress of the vessel lumen probe element as it approaches and is advanced through or is blocked by an occlusion. In the location of a coronary artery, the surface probe element sensor is moved about against the epicardium over the suspected location of the artery of interest until a surface probe element sensor of the present invention at the surface probe distal end interacts with the lumen probe element of the vessel lumen probe.

Abstract: This invention provides an organ positioning device and method that employs suction to hold organ tissue to the device. The device allows the organ, for example, heart to be positioned in a desired orientation but otherwise allowing movement of the heart as the heart beats. The device is designed to be relatively atraumatic to heart tissue. Generally, the device comprises a resiliently flexible suction head having a plurality of legs that flex to conform to the surface of the heart. The suction head has vacuum passageways in fluid communication with the legs to apply suction between the legs and the surface of the heart.

Abstract: A device for ablating tissue is provided. The device comprises a conductive element with a channel for irrigating fluid formed therein, which is in contact with a non-conductive microporous interface. All or a portion of the interface may be removable. When the interface is removed, a portion of the conductive element is exposed for use in ablating tissue. Methods of using the device and of removing the interface are also provided.

Abstract: A testicular prosthesis includes a flexible bladder, a fill port, and a plug. The flexible bladder incorporates an interior chamber. The fill port is coupled to the flexible bladder and generally includes a cylindrical tube that extends through the bladder. The cylindrical tube is defined by an interior wall and forms an opening to the interior chamber of the bladder. The plug is a cylindrical member that is coaxial to the bore. A seal is formed between the cylindrical member of the plug and the interior wall of the fill port.

Abstract: Embodiments of the invention provide a vessel tensioning handle and method of placing tension on a section of a vessel being harvested. The handle can include a housing, a bobbin assembly, a vessel tensioning tape, and a tensioning device member. The tensioning device member can be coupled to a cannula that is coupled to the vessel. The method can include using the vessel tensioning tape to place tension on the section of the vessel as the cutting device is advanced over the vessel.

Abstract: Embodiments of the invention provide a vessel support system and a method of vessel harvesting. The system can include a cutting device, a catheter adapted to be inserted into a section of the vessel in order to support the vessel as the cutting device is advanced over the vessel, and a cannula adapted to be coupled to the vessel and adapted to receive the catheter as the catheter is inserted into the section of the vessel. The method can include orienting a cutting device coaxially with the cannula and the catheter and advancing the cutting device over the cannula, the catheter, and the section of the vessel in order to core out the section of the vessel and a portion of the surrounding tissue.

Abstract: Embodiments of the invention provide a cutting device and method of vessel harvesting. The cutting device can include at least one tubular member, a cutting element, and a centering member. The cutting device can include at least one tubular member with a flexible section and a cutting element. The method of vessel harvesting can include spacing a cutting element of the cutting device from the vessel as the cutting element is advanced over the vessel.

Abstract: A method and system for ablating tissue to provide a desired set of lesions. The system includes an ablation apparatus having an elongated shapeable section carrying a mechanism such as an electrode for applying ablation energy along the shapeable section. The shapeable section includes a member of shape memory material having a memorized configuration. The shapeable section is shaped manually or using fixtures to display a configuration corresponding to one of the desired lesions and is then employed to create the desired lesion. Thereafter the shapeable section is heated to cause it to resume its memorized configuration. Shaping, heating and ablating to create lesions are continued as necessary provide the desired set of lesions. In some embodiments of the invention, heating may be accomplished using heating elements built into the shapeable section.

Abstract: This invention provides an organ positioning device and method that employs suction to hold organ tissue to the device. The device allows the organ, for example, heart to be positioned in a desired orientation but otherwise allowing movement of the heart as the heart beats. The device is designed to be relatively atraumatic to heart tissue. Generally, the device comprises a resiliently flexible suction head having a plurality of legs that flex to conform to the surface of the heart. The suction head has vacuum passageways in fluid communication with the legs to apply suction between the legs and the surface of the heart.

Abstract: A system and method for creating lesions and assessing their completeness or transmurality. Assessment of transmurality of a lesion is accomplished by monitoring the impedance of the tissue to be ablated. Rather than attempting to detect a desired drop or a desired increase impedance, completeness of a lesion is detected in response to the measured impedance remaining at a stable level for a desired period of time, referred to as an impedance plateau. The mechanism for determining transmurality of lesions adjacent individual electrodes or pairs may be used to deactivate individual electrodes or electrode pairs, when the lesions in tissue adjacent these individual electrodes or electrode pairs are complete, to create an essentially uniform lesion along the line of electrodes or electrode pairs, regardless of differences in tissue thickness adjacent the individual electrodes or electrode pairs.

Abstract: A method of performing a medical procedure, such as surgery, is provided. A nerve is stimulated in order to adjust the beating of the heart to a first condition, such as a stopped or slowed condition. The medical procedure is performed on the heart or another organ. The stimulation of the nerve is stopped in order to adjust the beating of the heart to a second condition, such as a beating condition. The heart itself may also be stimulated to a beating condition, such as by pacing. The stimulation of the nerve may be continued in order to allow the medical procedure to be continued. A sensor to sense a characteristic of a fluid or tissue, such as an impending contraction, may be also used during the medical procedure. Systems and devices for performing the medical procedure are also provided.

Abstract: Methods and apparatus employed in surgery involving making precise incisions in vessels of the body, particularly cardiac blood vessels in coronary revascularization procedures conducted on the stopped or beating heart are disclosed. Such incisions are created by applying an elongated electrosurgical cutting electrode to the outer surface of the vessel wall in substantially parallel alignment with the body vessel axis, the elongated electrosurgical cutting electrode having a predetermined cutting electrode length exceeding the cutting electrode width. RF energy is applied between the electrosurgical cutting electrode and the ground electrode at an energy level and for a duration sufficient to cut an elongated slit through the vessel wall where the elongated electrosurgical cutting electrode is applied to the surface of the vessel wall.

Abstract: A method of performing a medical procedure, such as surgery, is provided. The spinal cord is stimulated in order to control at least one physiological function. The medical procedure is performed and stimulation of the spinal cord is stopped.