Abstract: A device and method for delivering an object within a patient, wherein the object is delivered in a preferred orientation relative to the delivery site of the patient. The delivery device has an alignment member that allows the object to be delivered intravascularly to the delivery site of the patient, wherein the object is delivered in a pre-determined orientation. The object may, for example, be non-symmetric or include a configuration that requires delivery to the site in only one suitable orientation relative to the delivery site. Such objects may be used, for example, to treat certain defects or injuries in vessels or organs within a patient's body.

Abstract: A sizing catheter and method of measuring a preselected internal opening within a patient to provide a rapid and precise determination of a stretched diameter of the preselected internal opening. The sizing catheter includes a dilation balloon constructed of a thin expandable plastic which is inflatable and is utilized to determine a size of the preselected opening. The dilation balloon is inflated to an inflation threshold, wherein the dilation balloon deforms about the preselected opening and the size of the dilation balloon adjacent the preselected opening approximates a stretched diameter of the preselected opening. The sizing catheter and method may be utilized to determine an appropriate sized occluding device to thereby occlude the preselected opening.

Abstract: A sizing catheter and method of measuring a preselected internal opening within a patient to provide a rapid and precise determination of first and second stretched diameters of the preselected internal opening. The sizing catheter includes a dilation balloon constructed of a thin expandable plastic, which is inflatable and is utilized to determine a size of the preselected opening. The dilation balloon is inflated to an inflation threshold wherein the dilation balloon deforms about the preselected opening and the size of the dilation balloon adjacent the preselected opening approximates the first stretched diameter of the preselected opening. The sizing catheter and method may be utilized to determine an appropriate sized device to be positioned within the preselected opening.

Abstract: A collapsible medical device and associated method for occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from a shape memory metal fabric. The device may be used, for example, to non-surgically treat a patient having a Patent Foramen Ovale (PFO) and resulting paradoxical cerebral emboli. The device is preferably made from a continuous tubular metal fabric and includes two outer occluding portions and a resilient central, spring-like interconnecting member. The metal fabric may be heat treated within a mold in order to substantially set a desired shape of the device. The medical device includes a fastener for attaching to the end of a guide wire or delivery catheter. The medical device having the desired relaxed shape may be collapsed and delivered through a catheter or the like for deployment in a desired channel or opening in a patient's body.

Abstract: A collapsible medical device and associated methods for occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from a heat treatable metal fabric. The metal fabric is formed from a plurality of metal strands and is heat treated within a mold in order to substantially set a desired shape of the device. The medical device includes a fastener for attaching to the end of a guide wire or delivery catheter, wherein the shape of the medical device is formed such that the fastener is attached to the metal fabric within a recess formed in the shape of the medical device. A medical device having a preselected shape is delivered through a catheter or the like for deployment in a desired channel or opening in a patient's body. The medical device may be shaped, for example, to occlude an ASD, PDA, or a VSD.

Abstract: The present invention provides a method of forming a medical device and medical devices which can be formed in accordance with the method. In one embodiment, the method includes the steps of a) providing a metal fabric formed of a plurality of strands formed of a metal which can be heat treated to substantially set a desired shape; b) deforming the metal fabric to generally conform to a surface of a molding element; c) heat treating the metal fabric in contact with the surface of the molding element to substantially set the shape of the fabric in its deformed state; and d) removing the metal fabric from contact with the molding element. The resulting metal fabric will define a medical device which can be collapsed for passage through a catheter or the like for deployment in a channel of a patient's body. Medical devices made in accordance with this method can have varying structures.

Abstract: The present invention provides a snare for intravascular use having an elongate proximal member and a loop-shaped distal segment oriented at an angle to the adjacent portion of the proximal member. The snare may be formed of a superelastic shape memory alloy, which permits the distal segment to be collapsed for passage through a catheter and yet automatically open into its original, unrestrained configuration upon emerging from the distal tip of the catheter.

Abstract: Method for rendering a preformed article lubricious and antithrombogenic and a device being the same. On the surface of the article a thin coating of a biologically compatible, lubricious, hydrophilic polymer including acid groups, is provided. On the coating, ammonium cation, and heparin are applied in the manner that heparin is bound by electrostatic attraction to the ammonium cation of the coating to permit time release of heparin. A buffer solution may be applied in a manner to act to enhance the lubriciousness of the coating.

Abstract: A medical catheter introducer and hemostasis valve assembly consists of a sheath having an elongated tube defining a conduit, a housing disposed at the proximal end of the sheath and further defining a conduit and an orifice, and a flexible elongated dilator sized for insertion through the hub and sheath conduit. The dilator has a tapered distal tip end and defines an axial conduit and an annular ridge having distally- and proximally-directed inclined surfaces. The sheath, when assembled with the dilator, has its distal end immediately adjacent the proximally-directed inclined surface of the ridge. A hemostasis valve for sealing the conduit is disposed in alignment with the conduit, and defines an aperture for passage of dilator and ridge therethrough in sealing engagement, into the conduit, and seals when the dilator is removed. The valve has a housing defining an orifice of a first diameter, and a valve element of a second diameter, greater than the first diameter.

Abstract: The present invention provides a combined needle and dilator comprising a needle having a head with an outer diameter greater than the outer diameter of the body of the needle and a dilating sheath carried about the needle and abutting the rearward needle portion of the needle head. The dilating sheath has a front portion with an outer diameter substantially equal to the outer diameter of the needle head to define, with the head, a generally smooth surface; a body portion with an outer diameter greater than that of the front portion; and a tapered portion disposed between the front and body portions. The tapered portion has an outer surface smoothly merging into the outer surfaces of the front portion and the body portion.

Abstract: A mammography apparatus with a cylindrical section, reciprocating slot grid centered on an axis through a source of x-ray radiation. The slot grid includes a plurality of x-ray radiation absorbing lamellae disposed parallel to and aligned radially from the axis. Adjacent pairs of lamellae define air spaced gaps between the members of the pair. The ratio of the height of each of an adjacent pair of lamellae to the width of the respective defined gap being at least 7:1. The slot grid is set in a travel centered on the axis through the x-ray source. The x-ray source is provided with a predetermined staggered turn on and turn off circuit preventing interspace density artifacts.

Abstract: A medical simulator for enabling demonstration, trial and test of insertion of torqueable elongated members into small body passages that branch from main passages is disclosed. Such torqueable members may be guide wires or catheters which are constructed to cause the distal tip to turn or twist in response to a corresponding motion applied by the operator to a proximal portion of the device.

Abstract: A device for performing percutaneous puncture treatment of a patient includes an elongate radiolucent plastic handle with a central portion and two opposite elongated end portions. A hollow radiopaque needle has a hub at its proximal end which is releasably mounted in the central portion of the handle so that the needle is perpendicular to an axis through the end portions. The distal end of the needle has a puncturing tip. An internal fluid passage in the needle is open to the tip and the hub so that fluid may be drained from a patient's body through the passage when the needle is inserted in the patient's body. The needle and central portion of the handle are aligned under a field of view of a fluoroscope. The handle is held by the grips which are outside of the field of view of the fluoroscope. While the doctor continuously monitors progress of the needle on the fluoroscope, the puncturing tip is inserted through the skin and moved to an internal location for aspiration of fluid.

Abstract: An x-ray apparatus uses an x-ray tube which is pivoted about a pivot axis to provide scanning of an x-ray beam. The pivot axis passes essentially through the center of the focal spot on the target surface of the anode of the tube, is essentially perpendicular to the anode-cathode axis, and is essentially parallel to a film plane defined by the x-ray film. The scanning of the x-ray beam by pivoting the x-ray tube results in improved systems for standard radiography, linear tomography, and large-scale angiography. In standard radiography and large scale angiography systems, moving primary and secondary slots synchronized with the pivoting of the x-ray tube provide efficient removal of secondary radiation. In linear tomography systems, the object and film are moved synchronously with the pivoting of the x-ray tube, and primary and secondary slots which are stationary remove secondary radiation.

Abstract: An x-ray apparatus uses an x-ray tube which is pivoted about a pivot axis to provide scanning of an x-ray beam. The pivot axis passes essentially through the center of the focal spot on the target surface of the anode of the tube, is essentially perpendicular to the anode-cathode axis, and is essentially parallel to a film plane defined by the x-ray film. The scanning of the x-ray beam by pivoting the x-ray tube results in improved systems for standard radiography, linear tomography, and large-scale angiography. In standard radiography and large scale angiography systems, moving primary and secondary slots synchronized with the pivoting of the x-ray tube provide efficient removal of secondary radiation. In linear tomography systems, the object and film are moved synchronously with the pivoting of the x-ray tube, and primary and secondary slots which are stationary remove secondary radiation.

Abstract: A catheter for insertion into the human body and made of a thermoplastic tubing, is preformed to a desired shape by heating it above its free form temperature and allowing it to cool while held in that shape. To hold the catheter in position for such forming .Iadd.and/or for storage before use.Iaddend., a forming board having a catheter receiving groove of the desired shape is used. .[.The.]. .Iadd.In the form of the invention shown, the cross-sectional shape of this groove is wider at the bottom and narrower at the open top where it becomes a part of the board so as to hold the catheter in place during the forming and storage and to allow the catheter to be easily removed thereafter. This .Iadd.particular form of .Iaddend.forming board is made by vacuum forming a sheet of thermosetting plastic .Iadd.or thermoplastic material .Iaddend.over a solid, non-heat responsive, master representation of the exact longitudinal shape of the final preformed catheter.