Abstract: Apparatus and methods for percutaneously performing myocardial revascularization are provided using a catheter having an end region that is directable to contact a patient's endocardium at a plurality of positions. A cutting head is disposed within a lumen of the catheter and coupled to a drive tube that rotates and reciprocates the drive shaft. One or more stabilizing elements are disposed on the distal end to retain the catheter in position when the cutting head is actuated. The cutting head and drive tube include a lumen through which severed tissue is aspirated. Mechanisms are provided for controlling the maximum extension of the cutting head beyond a distal endface of the catheter, independent of the degree of tortuosity imposed on the catheter. Mechanisms and methods also are provided for providing the operator with information to assess the desirability of treating a proposed site.

Abstract: An embolic element comprises a filament composed of a shape memory material having an unexpanded coil configuration and an expanded random matrix configuration. The embolic element may be delivered to a blood vessel treatment site in its coiled configuration over a delivery wire through a guide catheter (44). Usually, the coiled embolic element will be disposed over a helical section of the delivery wire prior to release. In that way, proper positioning of the embolic element is then expanded to its enlarged configuration by heating or otherwise exposing to a temperature over the transition temperature of the shape memory material.

Abstract: Method and apparatus for utilizing the vascular system as a conduit to reach other vascular and extravascular locations within the body. Included are methods for revascularization wherein the extravascular passageways are formed to permit blood flow between vascular locations. Also included are methods for performing transvascular interstitial surgery (TVIS) wherein extravascular passageways are formed from a blood vessel to another vascular or non-vascular intracorporeal location. Also disclosed are devices usable for forming extravascular passageways in accordance with the invention, or for modifying, valving, maintaining or closing such passageways.

Abstract: A balloon catheter is provided having an expandable distal portion and balloon protector means comprising a first removable sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon, and an optional second removable (outer) sleeve positioned over the inner sleeve, the second (outer) sleeve having a constrictive relationship with the first (inner) sleeve, said first and second sleeves being removed prior to use of the catheter.

Abstract: A breast stabilization device includes a substantially rigid outer member and an inner member joined to the outer member. The inner member is configured to conform to the shape of the female breast. An opening is disposed through the outer and inner members, the opening being centered on the nipple/areolar complex of the breast and exposing at least a portion of the areola surrounding the nipple. A rigid rim may surround the periphery of the opening and may rise above the surface of the outer member. The device stabilizes the breast in an uncompressed or slightly expanded state to allow interventional and imaging procedures to be carried out without compressing the breast. The opening allows access to the breast through the areola and the rim allows one or more instruments to be attached thereto.

Abstract: A folding device for holding and folding an IOL and adapted to allow a surgeon to select between loading the IOL into a removably attached IOL injector and between holding the IOL in a folded state for removal with a separate instrument. The folding device includes a pair of opposing sides, each having an upper surface. A plurality of retaining brackets extend upwardly from the upper surfaces of each side. The brackets are adapted for receiving and removably retaining the IOL injector. A hinge couples the sides together along a fold axis and allows the sides to retain the IOL therebetween. The hinge allows the sides to fold together from a planer position about a first fold direction when using the separate instrument and towards each other about a second fold direction when using the IOL injector.

Abstract: The present invention provides a surgical device having a tissue engaging portion, a shaft member, and a handle assembly. The tissue engaging portion includes first and second opposed jaws for grasping, securing, and occluding body tissue and conduits. The shaft member is operatively coupled to the tissue engaging portion and is capable of being placed in different curvatures. The handle assembly is operatively coupled to both the shaft member and to the tissue engaging portion. The shaft member of the present invention allows the surgeon to bend and adjust the shape of the surgical device to minimize its intrusion and to allow for proper positioning in predetermined body locations. In a preferred embodiment, a portion of the device is disposable.

Abstract: A balloon catheter is provided having an expandable distal portion and balloon protector means comprising a first removable sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon, and an optional second removable (outer) sleeve positioned over the inner sleeve, the second (outer) sleeve having a constrictive relationship with the first (inner) sleeve, said first and second sleeves being removed prior to use of the catheter.

Abstract: A method of manufacturing a rotational atherectomy drive shaft having an asymmetrical tissue removal section. One or more strands of wire are helically wound about an elongated mandrel having an enlarged diameter section with a predetermined shape, thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section. A portion of the drive shaft, including the enlarged diameter tissue removal section, is placed into a first clamp and given a first heat treatment to give the wire turns of the enlarged diameter tissue removal section an initial set, thereby preserving the initial shape of the enlarged diameter tissue removal section of the drive shaft. The drive shaft is then removed from the first clamp and the mandrel is dissolved. The enlarged diameter section of the drive shaft is then deformed to an asymmetrical shape by placing a portion of the drive shaft, including the enlarged diameter tissue removal section, into a second clamp.

Abstract: An ablation device has a burr assembly that is articulated to allow the burr to rotate relative to a longitudinal axis of the driveshaft. The burr is formed in two parts. An inner burr member is coupled to a rotatable driveshaft and has an arcuate region distal to the driveshaft. An outer burr member has an inner cavity in which the inner burr member is positioned. The outer burr member is keyed to the inner burr member, such that the outer burr member rotates with rotation of the driveshaft and inner burr member. However, an inner surface of the outer burr member contacts the arcuate portion of the inner burr member, such that the outer burr member is free to pivot about the arcuate surface of the inner burr member, relative to a longitudinal axis of the driveshaft. Aligned passageways are provided in the driveshaft and inner and outer burr members, to allow a guide wire to extend therethrough.

Abstract: A conically helically shaped embolization coil (10) for occluding a blood vessel, aneurysm, and the like. The embolization coil includes a continuous platinum-tungsten alloy wire strand (11) wound into a longitudinally extending coil (12) having a plurality of tightly spaced turns (13). The longitudinally extending coil is wound into a conically helically shaped coil (15) with a plurality of radially expanding turns (16). Distal turn (17) of the radially expanding turns has a minor diameter (18) less than a minimum diameter (34) of a vessel (32) of which the embolization is to be positioned therein. Uncompressed proximal turn (19) of the radially expanding turns has a major diameter (20) greater than a maximum diameter (33) of the vessel in which the coil to be positioned.

Abstract: A device and method for implanting hair grafts into a patient's scalp is disclosed. The device includes guides, each having an internal passage, which extend downwardly from a base. Spikes extend downwardly from a depressor which is movable with respect to the guides and base. The spikes are movable within a corresponding guide passage to a position where each spike and guide cooperate to dilate a cavity in the scalp. In addition, each spike is movable to engage a hair graft and push the hair graft through the guide into the cavity in the scalp.

Abstract: Apparatus and methods for percutaneously performing myocardial revascularization are provided using a catheter having an end region that is directable to contact a patient's endocardium at a plurality of positions. A cutting head is disposed within a lumen of the catheter and coupled to a drive tube that rotates and reciprocates the drive shaft. One or more stabilizing elements are disposed on the distal end to retain the catheter in position when the cutting head is actuated. The cutting head and drive tube include a lumen through which severed tissue is aspirated. Mechanisms and methods are provided for providing the operator with information to assess the desirability of treating a proposed site. Mechanisms also are provided for controlling the maximum extension of the cutting head beyond a distal endface of the catheter, independent of the degree of tortuosity imposed on the catheter.

Abstract: The endoluminal device delivery assembly and method for release and deployment of an endoluminal therapeutic device at a desired location for treatment within the vasculature of a patient utilizes an elongated flexible tubular catheter with a tubular distal tip formed of a yieldable material mounted to the distal end of the catheter for releasably holding the proximal end of the endoluminal device. The endoluminal device can be dislodged from the tubular distal tip by a pusher member or pressurized fluid to expel the endoluminal device through at the desired location for treatment within the vasculature of a patient. A flexible coil can be mounted to the distal end of the elongated pusher member to provide for improved tracking.

Abstract: An surgical instrument comprises a movable actuation element, at least one working part moved by said actuation element, an apparatus for limiting a transfer of a force transferred via said actuation element to said at least one working part. Said apparatus has at least one wedge surface associated to said actuation element, said wedge surface rising perpendicular to its movement when moving said actuation element. A housing is provided which can be spread apart by said wedge surface by movement thereof, and an elastically spreadable ring circumferentially surrounds said housing in its spreading section, said elastically spreadable ring can close said spread housing when said wedge surface is moved out of its spreading engagement with said housing.

Abstract: A surgical handpiece (940) for actuating a cutting attachment (944). The handpiece includes a housing (942) which contains a motor (52) for driving the cutting attachment. A coupling assembly (948) releasably holds the cutting attachment to the housing and connects the attachment to the motor. A state marker, such as a magnet (1012), is disposed in the housing. The state marker is connected to the coupling assembly to undergo physical displacement when the coupling assembly is transitioned from the run state to the attachment release state. A sensor (960) monitors the physical displacement of the state marker. Whenever the state marker undergoes physical displacement, the output signal from the sensor changes. Thus, an external device can monitor when the handpiece coupling assembly (948) is transitioned from the run to the release state by monitoring the output signal from the sensor (960).

Abstract: The present invention provides for an expandable stent (10 or 20) for use in an artery or other vessel of a human body. The stent structure (10 or 20) maintains the patency of the vessel within which the stent (10 or 20) is expanded radially outward. One embodiment of the present invention is a stent (10) having a multiplicity of frames (12) joined together by at least two undulating longitudinal structures (14L and 14R) which can readily change their length in the longitudinal direction so as to provide increased longitudinal flexibility for the stent (10) for easy passage through and placement within a curved vessel such as a coronary artery. The stent (20) is an embodiment of the present invention having frames (22) joined with longitudinal structures (24B, 24T and 24R) and formed from a single, thin-walled piece of metal by laser cutting or chemical etching.

Abstract: A luminal port assembly insertable into an anatomical passageway includes a housing having a seal which creates a fluid-tight seal between the housing and the tissue of the anatomical passageway. At least one port is provided in the housing. Each port is preferably angularly movable relative to the housing and includes a substantially fluid-tight valved passageway and an insufflation conduit. A mechanism for retaining the luminal port assembly within the anatomical passageway is also provided.

Abstract: This is a device for bridging the neck of either a wide-necked or narrow-necked aneurysm in the vasculature. In general, it is a device used to stabilize the presence of vaso-occlusive devices (such as helically wound coils) in the aneurysm. The device preferably is delivered by a core wire which terminates in an electrolytically severable joint. The core wire will often be insulated. The retainer assembly itself is also attached to the electrolytic joint and typically has a number of array elements which are intended to be resident within the aneurysm after the device is deployed from the distal end of a catheter. After deployment of this retainer, the aneurysm is at least partially filled with a vaso-occlusive device such as helically wound coils.

Abstract: A surgical punch prevents tissue debris associated with punching a hole in a patient's tissue, such as an aorta during an anastomosis procedure, from reentering the patient's bloodstream. The punch includes elements that move the debris away from the cutting site and then capture that debris inside the instrument. The punch also includes means for aligning the punch with the selected site and for atraumatically holding the tissue prior to cutting. Various means for moving the tissue debris and for trapping the tissue debris in the instrument are also disclosed.