Abstract: A guidewire for guiding and exchanging body insertable catheters includes a body insertable guide section and an exchange section, both formed of flexible wire. In one embodiment, a pin connector at the distal end of the exchange section includes a truncated conical head, a shank, and a groove between the head and the shank. A socket connector is attached to the proximal end of the guide section. Four indentations are formed in the socket connector, spaced apart angularly 90.degree. from one another. The maximum diameter of the conical head is greater than the distance between opposed nodules. As, the pin connector is insertable into the socket, it temporarily elastically deforms the socket as the head moves past the nodules. The nodules become captured within the groove, to allow rotation of the exchange section relative to the guide section while preventing any substantial axial relative movement of the sections.

Abstract: This invention relates to an angioplasty device that is formed from a hollow metallic tube, a balloon affixed adjacent the distal end of the tube and being in fluid communication with the lumen of the tube, a flexible distal segment connected to the distal end of the tube and a removable hub connected adjacent to the proximal end of the tube. The tube is preferably formed from a superelastic material such as nickel-titanium alloy. This invention also relates to various methods of using this angioplasty device.

Abstract: A process for assembling a balloon catheter involves selectively concentrating laser energy along an annular fusion bond site at contiguous surface portions of a length of catheter tubing and a shaft or neck portion of a dilatation balloon. The laser energy wavelength, and the polymeric materials of the balloon and catheter, are matched for high absorption of the laser energy to minimize conductive heat transfer in axial directions away from the bond site. This minimizes crystallization and stiffening in regions near the bond site, permitting fusion bonds to be located close to the proximal and distal cones of the dilatation balloon while preserving the soft, pliant quality of the cones. The disclosure further is directed to an embodiment of a balloon catheter assembled according to the process.

Abstract: An open weave fixation device is secured to a distal end region of a catheter or other diagnostic or treatment device, for either temporarily or permanently fixing the device within a body cavity. In one approach, the fixation element is constructed of braided, helically wound filaments of resilient stainless steel. A sheath surrounds the catheter and fixation element to elastically deform the element into a reduced radius configuration to facilitate insertion and deployment. With the fixation element positioned as desired, the sheath is withdrawn to permit the fixation element to self-expand against body tissue, thus to secure the fixation element and catheter. In all alternative arrangement, a dilatation balloon surrounds a catheter near its distal end, and in turn is surrounded by a plastically deformable fixation element. Following desired positioning, the balloon is dilated to permanently deform the fixation element into contact with body tissue.

Abstract: A balloon dilatation catheter is disclosed having a multisectioned inner tube having a soft bumper tip, a multisectioned outer tube and a balloon with its distal neck connected to the bumper tip and its proximal neck connected to the outer tube. The various sections of the inner tube and outer tube may be formed from different materials or different grades of the same material. In addition, each section may have different outer diameters. The outer tube is bonded directly to the inner tube at the distal end of the outer tube. Preferably this bond is accomplished by thermal bonding.

Abstract: A dilation-drug delivery catheter comprises a dilation portion for dilating a stenosis and a drug delivery portion for delivering antithrombolytic, antiproliferative, or any other type of medication, to the dilation site. The drug delivery portion of the catheter is located within the dilation portion, which can be retracted to reveal the drug delivery portion, after dilation. Occlusion balloons are preferably provided on the drug delivery portion to isolate the dilation site during drug delivery.

Abstract: A guidewire for guiding and exchanging body insertable catheters includes a body insertable guide section and an exchange section, both formed of flexible wire. In one embodiment, a pin connector at the distal end of the exchange section includes a truncated conical head, a shank, and a groove between the head and the shank. A socket connector is attached to the proximal end of the guide section. Four indentations are formed in the socket connector, spaced apart angularly 90.degree. from one another. The maximum diameter of the conical head is greater than the distance between opposed nodules, as the pin connector is insertable into the, it temporarily elastically deforms the socket as the head moves past the nodules. The nodules become captured within the groove, to allow rotation of the exchange section relative to the guide section while preventing any substantial axial relative movement of the sections.

Abstract: A storage container for catheters having a separable portion of the front wall detachable from the container to ease removal of the catheter from the container is disclosed. The top portion is preferably separated from the side walls along external score lines at the intersection of the front and side walls. The separable portion of the front wall is preferably hinged on the bottom edge, which is perforated, easing complete separation of the separable portion from the front wall. Internal score lines on the inside surface of the separable portion of the front wall, parallel and proximate the external score lines are preferably provided to form flaps when the top portion of the front wall is detached from the container. The flaps prevent the top of the catheter package from falling out of the container. The separable portion of the front wall enables the catheter to be easily removed from the storage container without it being damaged.

Abstract: A diagnostic catheter comprises an inner layer of 100 percent polyamide over which is a braided metal wire sleeve and an outer layer formed as a blend of either the polyamide and PEBA along with a suitable radiopaque filler or, alternatively, a blend of PEBA having different durometers. Affixed either directly to the end of the above tubular body or to a stem member secured to that tubular body is a soft-tip formed from a blend of PEBA whose hardness is such that the catheter can be considered as having an atraumatic tip. The resulting catheter exhibits excellent torque and column strength characteristics while providing a relatively large diameter lumen for a given outside diameter.

Abstract: An intravascular material delivery dilation catheter having a pair of longitudinally spaced inflatable balloons with a drug delivery region defined therebetween. The catheter is ideally suited for use after a PTCA procedure, wherein the proximate balloon seals the blood vessel while the distal balloon is uniquely contoured when inflated to define fluid communication paths therepast and proximate a blood vessel to be treated. The distal balloon, when inflated, has four lobes but could also be textured. Each lobe is separated from the next by a groove, which groove in combination with the blood vessel inner wall forms a fluid communication path therebetween. Upon inflation of both balloons in a blood vessel, a medicament such as heparin can be injected, via the drug delivery region between the inflated balloons, wherein the medicament flows past the distal balloon at a selected rate.

Abstract: An open weave fixation device is secured to a distal end region of a catheter or other diagnostic or treatment device, for either temporarily or permanently fixing the device within a body cavity. In one approach, the fixation element is constructed of braided, helically wound filaments of resilient stainless steel. A sheath surrounds the catheter and fixation element to elastically deform the element into a reduced radius configuration to facilitate insertion and deployment. With the fixation element positioned as desired, the sheath is withdrawn to permit the fixation element to self-expand against body tissue, thus to secure the fixation element and catheter. In an alternative arrangement, a dilatation balloon surrounds a catheter near its distal end, and in turn is surrounded by a plastically deformable fixation element. Following desired positioning, the balloon is dilated to permanently deform the fixation element into contact with body tissue.

Abstract: This disclosure is directed to the design of a dilatation catheter having two or more associated fluidcarrying tubes, the operative or distal end of one of which supplies fluid to inflate an expansible balloon and the operable or distal end of the other of which supplies an injectable dye or contrast enhancing fluid adjacent the proximal end of the balloon.

Abstract: A small diameter dilatation catheter for coronary angioplasty is achieved by providing first and second elongated flexible, thin-wall tubes, each having one or more reinforcing wires encapsulated in the walls thereof and dimensioned such that the second tube may be coaxially disposed within the lumen of the first tube. The preferred material from which the two tubes are fabricated is polyimide. The longitudinally extending reinforcing wires provide the requisite "pushability" characteristics required by PTCA dilatation catheters. The balloon or inflation member has its proximal end bonded to the outer surface of the outer tube and its distal end bonded to the outer surface of the inner tube. Inflation fluid then may be perfused between the I.D. of the outer tube and the O.D. of the inner tube.

Abstract: An atherectomy catheter is provided with an improved high speed rotating cutting head is disclosed in which the cutting head has a generally oval-shaped nose portion which includes a plurality of radially disposed excising openings extending along and rearward from a point near the center of the nose. The openings are elongated but do not extend beyond the elliptical portion of reduced diameter, and, therefore, do not damage the lining of the vessel involved.

Abstract: An atherectomy catheter device includes an improved guidewire system including a guidewire port member secured to the distal tip portion of the outer tubular member of an atherectomy catheter of the coaxial type having large and small concentrically disposed elongated flexible tubular members with a rotating cutter member fixed to the distal end of the inner tubular member. The guidewire is spaced from the cutter head yet controls the cutter disposition relative to the vessel lumen of interest. The inner and outer tubular members are constructed to simultaneously provide flushing liquid and aspirate the cutting site. A method of using the improved catheter is also disclosed.

Abstract: A device for measuring the depth below skin level of a blood vessel that has been punctured in the course of a catheterization or other interventional vascular procedure comprises a tubular member having a proximal end and a distal end portion that is preferably tapered to a small outer diameter. The lumen may have a stepped diameter extending between the proximal and distal ends. A first portion of the lumen is distally located and is of a diameter generally equal to the diameter of a guidewire with which the measuring device is used. The second segment of the lumen is of a substantially larger diameter. A side entry port is made through the wall of the tubular member at the distal base of the larger diameter section of the lumen. Graduated markings on the side wall of the tubular member extend from the side entry port toward the proximal end of the instrument.

Abstract: A method of producing laminated inflatable, substantially inextensible expander members having composite properties enhancing their use on intravascular catheters, such as angioplasty catheters is described. Diverse polymeric compounds of differing properties are coextruded to create a multilayer parison. The parison is subsequently drawn and expanded in a blow molding operation to yield an expander member exhibiting enhanced properties including lubricity, burst-strength, limited radial expansion, bondability, and rupture characteristics.

Abstract: An open weave fixation device is secured to a distal end region of a catheter or other diagnostic or treatment device, for either temporarily or permanently fixing the device within a body cavity. In one approach, the fixation element is constructed of braided, helically wound filaments of resilient stainless steel. A sheath surrounds the catheter and fixation element to elastically deform the element into a reduced radius configuration to facilitate insertion and deployment. With the fixation element positioned as desired, the sheath is withdrawn to permit the fixation element to self-expand against body tissue, thus to secure the fixation element and catheter. In an alternative arrangement, a dilation balloon surrounds a catheter near its distal end, and in turn is surrounded by a plastically deformable fixation element. Following desired positioning, the balloon is dilated to permanently deform the fixation element into contact with body tissue.

Abstract: An apparatus for deploying a radially self-expanding stent includes proximal and distal sleeves respectively containing proximal and distal end portions of the stent in a reduced radius delivery configuration. The sleeves can abut one another and thus contain the entire length of the stent, or may be used in combination with an outer catheter surrounding the sleeves and containing the medial region of the stent. In either event, once the stent and sleeves are positioned at the intended fixation site, the sleeves are moved axially with respect to one another to permit radial self-expansion of the stent only over its medial region, while the sleeves continue to contain the axially outward regions of the stent. Eventually, upon sufficient movement of the sleeves axially relative to one another, the stent becomes totally free of the sleeves, resulting in radial expansion over the entire stent length.

Abstract: The guide catheter system for use in the treatment of coronary artery disease includes a first single-lumen catheter of a relatively large internal diameter to pass a second guide catheter therethrough. The first guide catheter comprises an elongated flexible tube having a stainless steel braid embedded in the wall thereof for imparting desired torqueability characteristics to it. The first guide catheter is intended to be inserted at an appropriate point in the vascular system and then advanced until its distal end reaches the coronary ostium. The second guide catheter is fabricated by extruding a plastic, such as polyurethane thermoplastic resin over a tubular Teflon.RTM. core and because it is to be used within the lumen of the first catheter, it need not include a braided structure within its walls to prevent it from kinking.