Abstract: A valve system including an aortic valve and a holder. The holder includes a holder body, which has a central portion, engagable with a holder handle, and downwardly extending leg portions that engage the valve in the areas between the commissure posts. The central portion of the holder further includes a spool located between the commissure posts, rotatable by an attached handle. Rotation of the spool draws in a tensile member passing through the commissure posts, drawing the commissure posts inward toward the spool. The tensile member passes through guides formed in the holder, configured such that they define the maximum available inward deflection of the commissure posts at the point at which the portions of the tensile member between the commissure posts assume straight configurations.

Abstract: A method and apparatus for temporarily immobilizing a local area of tissue. In particular, the present invention provides a method and apparatus for temporarily immobilizing a local area of tissue within a patient's body cavity. In one embodiment, the tissue immobilized is heart tissue to thereby permit surgery on a coronary vessel in that area without significant deterioration of the pumping function of the beating heart. The local area of heart tissue is immobilized to a degree sufficient to permit minimally invasive or micro-surgery on that area of the heart. The apparatus for temporarily immobilizing a local area of tissue includes a first tissue engaging member and a second tissue engaging member coupled to a spreader. The spreader is operated by an actuator to selectively control the movement of the first tissue engager and the second tissue engager.

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 determining a coagulation time, e.g., thrombin time, PT, aPTT, and ACT, of a blood sample deposited in a test cartridge is disclosed. The test cartridge includes a blood receptacle that is open to the atmosphere into which a blood sample is to be deposited, a vacuum port that is open to atmosphere, and a spiral capillary within the test cartridge having a capillary length and cross-section area, a first capillary end of the spiral capillary open to the blood receptacle and a second capillary end of the spiral capillary open to the vacuum port, whereby the spiral capillary is closed to atmosphere. When a blood sample is deposited in the blood receptacle, a vacuum is drawn through the vacuum port and the blood is drawn through the spiral capillary until coagulation occurs. A pressure change is detected, and the coagulation time is measured.

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: Methods and devices for forming an anastomosis between hollow bodies utilize magnetic force to couple anastomotic securing components and connect the lumens of the hollow bodies. End-to-side, side-to-side and end-to-end anastomoses can be created without using suture or any other type of mechanical fasteners, although such attachment means may be used in practicing some aspects of the invention. The securing components have the ability to produce a magnetic field and may include materials or assemblies. A component may also be used to form a port into the lumen of a vessel, the component being attached to the vessel by mechanical and/or magnetic means. Magnetic components may include means for concentrating the magnetic flux between respective components to increase the attraction force, thereby enhancing the security of the anastomosis.

Abstract: An electrocautery device is disclosed. In accordance with one aspect of the invention, the electrocautery electrode/tip is provided with a hollow, conductive tube terminating at its distal end in a ball point type tip. Fluid, preferably conductive fluid, is applied to the proximal end of the hollow electrode/tip, and expelled from the distal end thereof during electrocautery. The ball point distal tip allows the distal tip to be directly applied to the tissue and “rolled” or slid along the tissue. This allows the distal tip to be moved across the tissue without dragging or snagging on the tissue. In addition, the conductive fluid expelled from the distal tip further lubricates the distal tip as it moves across the tissue. If conductive fluid is used, the conductive fluid emanating from the electrode/tip conducts the RF electrocautery energy away from the distal tip so that it is primarily the fluid, rather than the distal tip that actually accomplishes the cauterizing of tissue.

Abstract: A system and method for determining a coagulation time, e.g., TT, PT, aPTT, and ACT, of a test sample deposited in a test cartridge is disclosed. A cartridge housing having upper and lower major sides and a minor sidewall encloses a test chamber having a test chamber pivot element and is provided with a cartridge port for introducing a test sample into the test chamber. Ferromagnetic agitator vane leaflets extend from an agitator pivot element supported by the test chamber pivot element intermediate the upper and lower major sides for rotational motion. The agitator vane leaflets can be swept, in response to an external magnetic field, through the test sample in the absence of coagulation. A timer is started when the agitator movement is commenced whereupon the agitator moves freely. Resistance to agitator movement due to coagulation is detected, and the coagulation time is measured.

Abstract: A system and method for determining a coagulation time, e.g., TT, PT, aPTT, and ACT, of a blood test sample deposited in a test cartridge is disclosed. A cartridge housing having upper and lower major sides and a minor sidewall encloses a test chamber having a test chamber pivot element and is provided with a cartridge port for introducing a test sample into the test chamber,. Ferromagnetic agitator vane leaflets extend from an agitator pivot element supported by the test chamber pivot element intermediate the upper and lower major sides for rotational motion. The agitator vane leaflets can be swept, in response to an external magnetic field, through the test sample in the absence of coagulation. A timer is started when the agitator movement is commenced whereupon the agitator moves freely. Resistance to agitator movement due to coagulation is detected, and the coagulation time is measured.

Abstract: A device for providing suction to tissue is disclosed. A method of suctioning tissue is also disclosed.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: A fresh donor tissue valve isolation annulus size comprising a handle and trigger or crank knob manipulated by the user moves a movable probe into proximity with a stationary probe so that the probes can be inserted into the tissue valve lumen. The user releases the trigger or crank, and a biasing mechanism urges the movable probe away from the stationary probe until the resistance presented by the valve annulus equals the biasing force. A gage coupled to the movable probe displays a measure of the valve annulus diameter as a function of the distance that the movable probe moves away from the stationary probe until restrained from further movement by the fresh tissue valve annulus.

Abstract: A system 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 system and method of making a lesion on living tissue including providing an electrosurgical system, determining a desired lesion depth, selecting a power setting, and applying electrical energy to the living tissue. The system includes an instrument having an electrode at a distal portion thereof, and a power source having multiple available power settings. The power source is electrically connected to the electrode. The step of applying electrical energy includes energizing the electrode at the selected power setting for a recommended energization time period that is determined by reference to predetermined length of time information and based upon the desired lesion depth and the selected power setting. The system preferably further includes a fluid source for irrigating the electrode at an irrigation rate. In this regard, the predetermined length of time information is generated as a function of irrigation rate.

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 a heart positioning device, method and system for positioning, manipulating, holding, grasping, immobilizing and/or stabilizing a heart. The heart positioning device may include a suction head and a shaft with a means for remotely changing the position of the head from a first position axially aligned with the shaft to a second, unaligned position and a sleeve slideably positioned on the shaft and sized to receive the suction head in a compressed condition.

Abstract: A disposable, integrated extracorporeal blood circuit employed during cardiopulmonary bypass surgery performs gas exchange, heat transfer, and microemboli filtering functions in a way as to conserve volume, to reduce setup and change out times, to eliminate a venous blood reservoir, and to substantially reduce blood-air interface. Blood from the patient or prime solution is routed through an air removal device that is equipped with air sensors for detection of air. An active air removal controller removes detected air from blood in the air removal device. A disposable circuit support module is used to mount the components of the disposable, integrated extracorporeal blood circuit in close proximity and in a desirable spatial relationship to optimize priming and use of the disposable, integrated extracorporeal blood circuit. A reusable circuit holder supports the disposable circuit support module in relation to a prime solution source, the active air removal controller and other components.

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 flexible, disposable centrifuge bag for receiving and holding a fluid sample, comprising one or more tubes and upper and lower flexible sheets having doughnut shaped configurations. The upper and lower sheets are superimposed and completely sealed together at their outer perimeters to define an outer perimeter of the centrifuge bag. The inner perimeter of the bag defines a central core. The tubes are sandwiched between the upper and lower sheets and extend from the central core of the centrifuge bag. The upper and lower sheets are sealed together at their inner perimeters such that the tubes are sealed between said upper and lower sheets at the inner perimeter. The bag may be used to harvest platelet rich plasma from whole blood in either a batch method or while simultaneously infusing additional aliquots of whole blood into the bag during centrifugation.