Abstract: This invention relates to devices, such as cannulas or needles, which are used for inserting expandable structures, such as medical balloons, into interior regions of a human or animal body, as well as methods for their use. In various embodiments, insertion devices described herein are capable of flaring at their tip to ease insertion and removal of expandable structures and reduce the risk of damaging such expandable structures during their insertion, inflation and removal. In other embodiments, insertion devices described herein are capable of directionally guiding and/or inhibiting expansion of an expandable structure within an interior region of an animal or human body to create optimally placed cavities for repair, augmentation and/or treatment of fractured and/or diseased bone.

Abstract: Devices intended for deployment into interior body regions employ a catheter tube, which carries an expandable structure. The catheter tube extends along a first axis, while the expanded geometry of the structure is oriented about a second axis, which is not aligned with the first axis. The asymmetry between the two axes permits deployment of the expandable structure in a symmetric fashion with respect to the natural axis of a targeted interior body region, even when the targeted interior body region is either asymmetric in geometry or otherwise requires access along a path that is not aligned with the natural axis. The structure can include spaced apart end regions, which provide a non-conical diameter transition between the diameter of the catheter tube and the larger diameter of the expanded structure.

Abstract: Systems and methods treat fractured or diseased bone by deploying more than a single therapeutic tool into the bone. In one arrangement, the systems and methods deploy an expandable body in association with a bone cement nozzle into the bone, such that both occupy the bone interior at the same time. In another arrangement, the systems and methods deploy multiple expandable bodies, which occupy the bone interior volume simultaneously. Expansion of the bodies form cavity or cavities in cancellous bone in the interior bone volume.

Abstract: A structure adapted to assume an expanded geometry having a desired configuration when used in bone includes material that limits the expanded geometry. The structure undergoes stress when expanded during its first use in bone. As a result, the structure can not be relied upon to reach its desired configuration during subsequent use in bone. Accordingly, the structure is packaged in a sterile kit, which verifies to the physician or user that the device packaged within it is sterile and has not be subjected to prior use. The physician or user is thereby assured that the expandable structure meets established performance and sterility specifications, and will have the desired configuration when expanded for use.

Abstract: Systems and methods for delivering material into bone deploy a cannula through soft tissue to establish a subcutaneous path into bone. A material is introduced into bone through the cannula. The systems and methods advance a tamping instrument through the cannula to urge material residing in the cannula into bone. The introducing step delivers material at a pressure no greater than about 360 psi.

Abstract: A method for treating bone employs a tool comprising an outer catheter tube having a distal end and an inner catheter tube extending within the outer catheter tube and having a distal end region that extends beyond the distal end of the outer catheter tube. The tool includes an expandable structure having a proximal end secured to the distal end of the outer catheter tube and a distal end secured to the distal end region of the inner catheter tube. Thus, the distal end region of the inner catheter tube is enclosed within the expandable structure. The method manipulates the tool to introduce the expandable structure into bone while in a generally collapsed geometry. The method causes the expandable structure to assume an expanded geometry inside bone.

Abstract: Systems and methods treat fractured or diseased bone by deploying more than a single therapeutic tool into the bone. In one arrangement, the systems and methods deploy an expandable body in association with a bone cement nozzle into the bone, such that both occupy the bone interior at the same time. In another arrangement, the systems and methods deploy multiple expandable bodies, which occupy the bone interior volume simultaneously. Expansion of the bodies form cavity or cavities in cancellous bone in the interior bone volume.

Abstract: Systems and methods for delivering material into bone deploy a cannula through soft tissue to establish a subcutaneous path into bone. A material is introduced into bone through the cannula. The systems and methods advance a tamping instrument through the cannula to urge material residing in the cannula into bone. The introducing step delivers material at a pressure no greater than about 360 psi.

Abstract: A thin wall catheter introducer system for penetrating through intravascular tissue walls and for facilitating the introduction of a catheter through the tissue wall is disclosed. In one embodiment, the system includes a sheath having a thin wall tubular member and a wire braid positioned about the tubular member for reinforcing the tubular member. The wire braid may include at least two intertwined wires wound about the tubular member. In another embodiment, the system includes a dilator for penetrating through an incision in an intravascular wall of a patient. The dilator may include a first tubular member and a reinforcing member which is positionable about the first tubular member to substantially inhibit buckling or kinking of the first tubular member. In yet another embodiment, the system includes a vascular access system for use in dilating and penetrating through an incision in an intravascular tissue wall and for facilitating introduction of a catheter into the incision.

Abstract: A tube body includes an interior bore to carry a material flow into bone. The tube body includes a dispensing end having an opening communicating with the bore to dispense the material flow. One embodiment provides a cutting element, which extends in the opening to permit passage of the material flow and to sever the material flow in response to rotation of the tube body. Another embodiment deflects the dispensing end from the main axis of the tube body, to facilitate targeted introduction of flowable material, even when the access path does not align the tube body along the natural geometric axes of the treatment site. Another embodiment provides a connector having a rotating fitting, which releasably connects the tube body to a cement injecting tool. The rotating fitting allows the physician to rotate the injection nozzle assembly to control orientation and position in the treatment site, without rotating the associated injection tool itself.

Abstract: Devices intended for deployment into interior body regions employ a catheter tube, which carries an expandable structure. The catheter tube extends along a first axis, while the expanded geometry of the structure is oriented about a second axis, which is not aligned with the first axis. The asymmetry between the two axes permits deployment of the expandable structure in a symmetric fashion with respect to the natural axis of a targeted interior body region, even when the targeted interior body region is either asymmetric in geometry or otherwise requires access along a path that is not aligned with the natural axis. The structure can include spaced apart end regions, which provide a non-conical diameter transition between the diameter of the catheter tube and the larger diameter of the expanded structure.

Abstract: An assembly is provided for suturing an incision in a tissue wall of a patient with a suture material. The assembly comprises a carrier member, a distal member interconnected to the carrier member, and a guide member positioned about and moveable along the carrier member. The guide member guides an access device through the tissue wall at two or more different locations adjacent to the incision in the tissue wall such that suture material is threadable through and into the tissue wall at a first location and through and back out of the tissue wall at a second location.

Abstract: A catheter lab imaging apparatus for imaging a heart region of a patient positioned thereon. The apparatus includes a catheter lab table, an x-ray imager positioned about the table and including a transmitter and a receiver, the transmitter being pivotable relative to the table to image the patient along predetermined imaging axes, a catheter lab table pad for supporting the patient on the table. The pad includes a top radiolucent layer defining a top surface of the pad and bottom radiolucent layer defining a bottom surface of the pad, the bottom layer being joined to the top layer around the periphery thereof to define at least one sealed chamber for supporting the patient. The pad may further include at least one interior seam positioned within the chamber to limit separation between the top layer and the bottom layer, wherein each of the interior seams is positioned such that each of the predetermined imaging axes avoids intersection with all of the interior seams when a patient is positioned on the pad.

Abstract: A guiding catheter capable of selective blood perfusion, position detecting, and enhanced contrast media injection. The catheter generally comprises an elongated tubular member for guiding contrast media or medical instruments into a selected blood vessel. The tubular member includes at least one perfusion port in a sidewall thereof for allowing passive blood perfusion of the blood vessel while the catheter is seated in a vascular ostium. The catheter further comprises a closure member positioned adjacent the perfusion port and movable between at least first and second positions to open and at least partially close the perfusion port. An actuating member is operatively connected to the closure member and extends proximally therefrom toward a proximal end of the tubular member, whereby the actuating member is selectably moveable to move the closure member between the first and second positions.

Abstract: A horn connectable to an energy source to amplify ultrasound displacement is connected to a transmitter formed of material having relatively high mechanical Q for transmitting ultrasonic energy therethrough at a frequency f, the transmitter having a horn-shaped configuration of length that is a multiple of a half-wavelength .lambda./2, and preferably this horn-shaped configuration is comprised of multiple horn segments, each of a length substantially equal to a multiple of .lambda./2, where .lambda.=c/f (c is the speed of sound in the high Q material). The transmitter has a proximal end of cross-sectional diameter D.sub.1 connected to the horn and a distal end of cross-sectional diameter D.sub.2, where D.sub.1 >D.sub.2. Ultrasonic energy transmitted through the transmitter drives a tip which is coupled to the transmitter by means of a flexible connector.

Abstract: An ultrasonic imaging catheter comprises a catheter body having a distal end and a proximal end. An ultrasonic imaging transducer is located within the distal end and is arranged to produce an image in an image plane which is generally normal to the axial direction of the catheter. An ultrasonically opaque element is attached to the catheter body and disposed through the image plane so that an image artifact or marker appears on the resulting ultrasonic image. The artifact corresponds to the location on the catheter where the element is located. A fluoroscopic marker is also provided on the catheter body, typically located proximally of the region where the ultrasonic imaging transducer and other components are located. The fluoroscopic marker has a geometry selected so that the marker has a unique appearance depending on the rotational orientation of the catheter when viewed by fluoroscopy.