Abstract: Instruments and methods for removing tissue from a patient's thoracic cavity during surgery, for example VATS, while reducing re-inflation of the lungs. Embodiments include an instrument comprising a first structure defining a first lumen and a second structure defining a second lumen. The first structure includes a first proximal end portion comprising a first proximal port to the first lumen, and a first distal end portion comprising a first distal port to the first lumen. The second structure includes a second proximal end portion comprising a second proximal port to the second lumen, and a second distal end portion comprising a second distal port to the second lumen. The instrument is configured to be inserted into a patient with the first and second distal end portions located in the cavity to facilitate suction of tissue through the first lumen, and entry of make-up gas into the cavity through the second lumen.

Abstract: An instrument and method for placement of vascular grafts. Embodiments of the instrument comprise an elongated shaft, a clamp and a tip. The shaft includes a distal end portion, a proximal end portion, and optionally a handle at the proximal end portion. The clamp and/or the shaft are configured to removably couple the clamp to the distal end portion of the shaft. The tip and/or the instrument are configured to removably couple the tip to the instrument. In embodiments the tip covers the clamp.

Abstract: An amnion tissue delivery system for delivering amnion tissue into a location within a patient is described. The location within a patient may be a tube, vessel, lumen, orifice, fistula, aneurysm, or chamber. The amnion tissue delivery system employs a catheter and extendable element, such as a removable stent-like structure, in a configuration such that extension of the extendable section deploys the amnion tissue at the desired location. A method for delivery of amnion tissue within a patient is also described. The method includes placing the catheter within the patient using a minimally invasive, endoluminal and/or extraluminal procedure to position tissue, followed by deploying the extendable element to deliver the amnion tissue at the desired location.

Abstract: The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto. At least part of the eccentric enlarged abrading heads in the system have a tissue removing surface—typically an abrasive surface. In certain embodiments, the abrading heads may be at least partially hollow. Preferably the eccentric enlarged abrading heads have centers of mass spaced radially from the rotational axis of the drive shaft, facilitating the ability of the system of eccentric abrading heads to work together to open the stenotic lesion to a diameter substantially larger than the outer resting diameter of the enlarged abrading heads when operated at high speeds. Therefore, certain embodiments comprise a system having unbalanced centers of mass to not only stimulate greater rotational diameters but also arranged in a manner whereby a debris-removing augering effect occurs.

Abstract: The present system is directed in various embodiments to methods, devices and systems for sensing, measuring and evaluating compliance in a bodily conduit. In other embodiments, the methods, devices and systems sense, measure, determine, display and/or interpret compliance in a bodily conduit and/or a lesion within the bodily conduit. In all embodiments, the sensing, measuring, determining, displaying and/or interpreting may occur before, during and/or after a procedure performed within the bodily conduit. An exemplary conduit comprises a blood vessel and an exemplary procedure comprises a vascular procedure such as atherectomy, angioplasty, stent placement and/or biovascular scaffolding.

Abstract: The present system is directed in various embodiments to rotational atherectomy systems and methods generally. More specifically, a method for methodically softening and disrupting calcification within the wall of a biological conduit or lumen. This result is achieved by use of at least one eccentric head that, during high-speed rotation within the exemplary lumen, produces a combination of a low-frequency orbital motion comprising a force that is exerted against the lumen wall, with concomitant deflection of same, and a high-frequency pulsatile frequency, also with concomitant exertion of force against the lumen wall and deflection of same. These force-driven deflections produce shockwaves within the layers of the exemplary artery's wall layers, resulting in systematic disruptions of any calcification within the intimal and/or medial layers of the subject artery. In addition, any calcification within the occlusion is also softened and disrupted, increasing compliance of the vessel and/or lesion.

Abstract: A rotational atherectomy system is disclosed, comprising: an elongated, flexible spin-to-open drive shaft having a distal end for insertion into a vasculature of a patient and having a proximal end opposite the distal end remaining outside the vasculature of the patient; a concentric or eccentric abrasive element, preferably a solid crown, attached to the drive shaft proximate the distal end of the drive shaft; an electric motor rotatably coupled to the proximal end of the drive shaft, the electric motor being capable of rotating the drive shaft in a spin-to-open direction; and control electronics for monitoring and controlling the rotation of the electric motor. When an obstruction at the distal end is detected by the applied torque and/or current reaching a predetermined maximum allowed level and with the drive shaft opened to a maximum allowed outer diameter, power to the motor is eliminated.

Abstract: The present system is directed in various embodiments to rotational atherectomy systems and methods generally. More specifically, a method for methodically softening and otherwise disrupting calcification located within atherosclerotic plaque, lesion or occlusion and/or within the wall of a biological conduit or lumen. For example, calcification within the occlusion and/or intimal and/or medial layer walls of a blood vessel, e.g., an artery, may be methodically softened or otherwise disrupted with various embodiments of the present invention. The softening and/or disruption of the calcification in the walls of the exemplary artery is accomplished in conjunction with abrading removal of any occlusion located on the interior surface of the exemplary artery and, therefore, located within the artery's lumen.

Abstract: The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto. At least part of the eccentric enlarged abrading heads in the system have a tissue removing surface—typically an abrasive surface. In certain embodiments, the abrading heads may be at least partially hollow. Preferably the eccentric enlarged abrading heads have centers of mass spaced radially from the rotational axis of the drive shaft, facilitating the ability of the system of eccentric abrading heads to work together to open the stenotic lesion to a diameter substantially larger than the outer resting diameter of the enlarged abrading heads when operated at high speeds. Therefore, certain embodiments comprise a system having unbalanced centers of mass to not only stimulate greater rotational diameters but also arranged in a manner whereby a debris-removing augering effect occurs.

Abstract: The present system is directed in various embodiments to methods, devices and systems for sensing, measuring and evaluating compliance and/or elastance in a bodily conduit. In other embodiments, the methods, devices and systems sense, measure, determine, display and/or interpret compliance and/or elastance in a bodily conduit and/or a lesion within the bodily conduit using fractional flow reserve and/or flow velocity measurements as well as resistance to flow calculations in certain embodiments. In all embodiments, the sensing, measuring, determining, displaying and/or interpreting may occur before, during and/or after a procedure performed within the bodily conduit. An exemplary conduit comprises a blood vessel and an exemplary procedure comprises a vascular procedure such as atherectomy, angioplasty, stent placement and/or biovascular scaffolding.

Abstract: The present system is directed in various embodiments to methods, devices and systems for sensing, measuring and evaluating compliance in a bodily conduit. In other embodiments, the methods, devices and systems sense, measure, determine, display and/or interpret compliance in a bodily conduit and/or a lesion within the bodily conduit. In all embodiments, the sensing, measuring, determining, displaying and/or interpreting may occur before, during and/or after a procedure performed within the bodily conduit. An exemplary conduit comprises a blood vessel and an exemplary procedure comprises a vascular procedure such as atherectomy, angioplasty, stent placement and/or biovascular scaffolding.

Abstract: The invention provides a rotational atherectomy system, device and method comprising a flexible, elongated, rotatable drive shaft with a pre-curved abrasive section disposed within a catheter that deforms the abrasive section to a substantially straight profile and, when the abrasive section is moved distally out of the catheter, the abrasive section resumes its pre-curved profile. Directional ablation is achieved by rotation of the drive shaft along its pre-curved axis as the abrasive section is urged against a portion of the lumen wall.

Abstract: A rotational atherectomy system is disclosed, comprising: an elongated, flexible spin-to-open drive shaft having a distal end for insertion into a vasculature of a patient and having a proximal end opposite the distal end remaining outside the vasculature of the patient; a concentric or eccentric abrasive element, preferably a solid crown, attached to the drive shaft proximate the distal end of the drive shaft; an electric motor rotatably coupled to the proximal end of the drive shaft, the electric motor being capable of rotating the drive shaft in a spin-to-open direction; and control electronics for monitoring and controlling the rotation of the electric motor. When an obstruction at the distal end is detected by the applied torque and/or current reaching a predetermined maximum allowed level and with the drive shaft opened to a maximum allowed outer diameter, power to the motor is eliminated.

Abstract: Methods and devices for sculpting bones, particularly in preparation for implanting prosthetic devices to replace articulating bone joint surfaces. Improved bone removal devices including burr mills driven by gears and loop drives are provided. Reciprocating cutters and belt cutters are also provided. Some devices have either integral or removable expandable portions to vary the force and bone resection depth. Devices can have irrigation ports and plenums to remove bone fragments. Some cutters are dual cutters, adapted to remove bone in two or more regions, such as the knee joint, simultaneously.

Abstract: The present invention is directed in various methods, devices and systems relating to providing a balloon on a sheath in combination with orbital atherectomy in order reduce the number of steps in the procedure. In certain embodiments, the balloon comprises adjunctive low pressure balloon for prevention of vessel trauma during dilatation.

Abstract: Methods and devices for sculpting bones, particularly in preparation for implanting prosthetic devices to replace articulating bone joint surfaces. Improved bone removal devices including burr mills driven by gears and loop drives are provided. Reciprocating cutters and belt cutters are also provided. Some devices have either integral or removable expandable portions to vary the force and bone resection depth. Devices can have irrigation ports and plenums to remove bone fragments. Some cutters are dual cutters, adapted to remove bone in two or more regions, such as the knee joint, simultaneously.

Abstract: The invention provides a rotational and/or axially translatable atherectomy system, device and method having a flexible, elongated drive shaft or catheter having an expandable and collapsible conical coil with a cutting edge on the coil's large diameter proximal end. When retracted, the coil's sections are collapsed around each other, held together in the retracted position by a sheath that, when distally retracted, allows the coil to automatically expand. The coil is expanded at a point distal to the occlusion, then pulled proximally to cut the occluding material near the lumen wall. The proximal pulling force may be combined with low-speed rotation and/or translation and/or axial vibration at low to ultrasonic frequency.

Abstract: The invention provides a system, device and method for localized application of therapeutic agents within a biological conduit. A preferred biological conduit comprises a blood vessel. A preferred device comprises a high-speed rotational atherectomy device having, in various embodiments, a flexible, elongate non-rotatable therapeutic agent delivery sheath having a lumen therethrough and a flexible, elongated, rotatable, drive shaft with at least one flexible eccentric enlarged abrading head disposed within lumen of the delivery sheath. The operator may actuate a controlled amount or dose of one or more therapeutic agents to release from the distal end of the delivery sheath lumen during high-speed rotation of the drive shaft.

Abstract: Methods and devices for sculpting bones, particularly in preparation for implanting prosthetic devices to replace articulating bone joint surfaces. Improved bone removal devices including burr mills driven by gears and loop drives are provided. Reciprocating cutters and belt cutters are also provided. Some devices have either integral or removable expandable portions to vary the force and bone resection depth. Devices can have irrigation ports and plenums to remove bone fragments. Some cutters are dual cutters, adapted to remove bone in two or more regions, such as the knee joint, simultaneously.

Abstract: Methods and devices for sculpting bones, particularly in preparation for implanting prosthetic devices to replace articulating bone joint surfaces. Improved bone removal devices including burr mills driven by gears and loop drives are provided. Reciprocating cutters and belt cutters are also provided. Some devices have either integral or removable expandable portions to vary the force and bone resection depth. Devices can have irrigation ports and plenums to remove bone fragments. Some cutters are dual cutters, adapted to remove bone in two or more regions, such as the knee joint, simultaneously.