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`Coaxial Guide Catheter for Interventional Cardiology Procedures
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`Medtronic Exhibit 1501
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`Attorney Docket No. 2005.86USOZ
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`Abstract of the Disclosure
`
`A coaxial guide catheter to be passed through guide catheter having a first lumen, for use
`
`with interventional cardiology devices that are insertable into a branch artery that branches off
`
`from a main artery. The coaxial guide catheter is extended through the lumen of the guide
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`catheter and beyond the distal end of the guide catheter and inserted into the branch artery. The
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`deVice assists in resisting axial and shear forces exerted by an interventional cardiology deVice
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`passed through the second lumen and beyond the flexible distal tip portion that would otherwise
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`tend to dislodge the guide catheter from the branch artery.
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`Attorney Docket No. 2005.86US02
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`COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`Field of the Invention
`
`The present invention relates generally to catheters used in interventional cardiology
`
`procedures. More particularly the present invention relates to methods and apparatus for
`
`increasing backup support for catheters inserted into the coronary arteries from the aorta.
`
`Background of the Invention
`
`Interventional cardiology procedures often include inserting guidewires or other
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`instruments through catheters into coronary arteries that branch off from the aorta. For the
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`purposes of this application, the term "interventional cardiology devices" is to be understood to
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`include but not be limited to guidewires, balloon catheters, stents and stent catheters.
`
`In
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`coronary artery disease the coronary arteries may be narrowed or occluded by atherosclerotic
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`plaques or other lesions. These lesions may totally obstruct the lumen of the artery or may
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`dramatically narrow the lumen of the artery. Narrowing is referred to as stenosis. In order to
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`diagnose and treat obstructive coronary artery disease it is commonly necessary to pass a
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`guidewire or other instruments through and beyond the occlusion or stenosis of the coronary
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`artery.
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`In treating a stenosis, a guide catheter is inserted through the aorta and into the ostium of
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`the coronary artery. This is sometimes accomplished with the aid of a guidewire. A guide
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`catheter is typically seated into the opening or ostium of the artery to be treated and a guidewire
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`Attorney Docket No. 2005.86US02
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`or other instrument is passed through the lumen of the guide catheter and inserted into the artery
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`beyond the occlusion or stenosis. Crossing tough lesions can create enough backward force to
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`dislodge the guide catheter from the ostium of the artery being treated. This can make it difficult
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`or impossible for the interventional cardiologist to treat certain forms of coronary artery disease.
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`Prior attempts to provide support to the guiding catheter to prevent backward
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`dislodgement from the coronary ostium (referred to as "backup support") fall generally into four
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`categories.
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`First are guiding catheters that, through a combination of shape and stiffness, are
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`configured to draw backup support from engaging the wall of the aortic arch opposing the ostium
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`of the coronary artery that is being accessed. Examples of this approach can be found in U.S.
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`Patent No. 6,475,195 issued to Yoda and U.S. Patent No. 5,658,263 issued to Dang et al. These
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`guiding catheters all share the common limitation that a guide catheter stiff enough to provide
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`adequate backup support is often too stiff to be safely inserted into the aorta without the
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`possibility of causing damage to the aortic wall. In addition, attempts to deep seat the guide
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`catheter have been made but the rigid nature of the guide catheter creates the risk that the guide
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`catheter may damage the coronary artery wall or that the guide catheter may occlude the
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`coronary artery and interfere with blood flow to the heart muscle.
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`Second are guiding catheters that include a retractable appendage. The appendage in
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`these catheters can be extended to engage the opposing wall of the aortic arch to provide backup
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`support or the appendage may be placed under tension to stiffen a bend in the catheter to provide
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`backup support. Examples of this approach may be found in U.S. Patent Nos. 4,813, 930 issued
`
`2
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`Attorney Docket No. 2005.86US02
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`to Elliot; 5,098,412 issued to Shiu; and 6,860,876 issued to Chen. These guiding catheters tend
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`to be somewhat mechanically complex and have not been widely adopted by practitioners.
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`Third are guide catheters that have a portion that seeks to expand laterally to grip the
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`interior wall of the ostium of the coronary artery to provide a force acting in opposition to the
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`backward forces created when trying to maneuver a therapeutic device past a lesion or blockage
`
`in the coronary artery. These devices can include a balloon secured to a guidewire or a catheter
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`or another device for expanding to grip the walls of the coronary artery from within. Examples
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`of this approach may be found in U.S. Patent Nos. 4,832,028 issued to Patel; 6,595,952 issued to
`
`Forsberg; and U.S. Published Application No. 2005/0182437 by Bonnette et al. Again, these
`
`devices tend to be mechanically complex and can completely occlude the coronary ostium thus
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`stopping perfusion of the coronary artery.
`
`A fourth technique includes the placement of a smaller guide catheter within a larger
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`guide catheter in order to provide added support for the crossing of lesions or for the distal
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`delivery of balloons and stents. This technique has been described in an article by Takahashi
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`entitled "New Method to Increase a Backup Support of Six French Guiding Coronary Catheter,"
`
`published in Catheterization and Cardiovascular Interventions, 63:452-456 (2004). This
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`technique is used in order to provide a method of deep seating the guide catheter within the
`
`ostium of the coronary artery. Deep seating refers to inserting the catheter more deeply into the
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`ostium of the coronary artery than typically has been done before. Unfortunately, deep seating
`
`by this technique with a commonly available guide catheter creates the risk that the relatively
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`Attorney Docket No. 2005.86US02
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`stiff, fixed curve, guide catheter will damage the coronary artery. This damage may lead to
`
`dissection of the coronary artery when the catheter is advanced past the ostium.
`
`Several other problems arise when using a standard guide catheter in this catheter-in-a(cid:173)
`
`catheter fashion. First, the inner catheters must be substantially longer than the one hundred
`
`centimeter guide catheter. Second, a new hemostasis valve must be placed on the inner guide
`
`catheter which prevents the larger guide catheter from being used for contrast injections or
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`pressure measurements. Third, the smaller guide catheter still must be inserted into the coronary
`
`vessel with great care since the smaller guide catheter has no tapered transition or dilator at its tip
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`and does not run over a standard 0.014 inch guidewire.
`
`Thus, the interventional cardiology art would benefit from the availability of a system
`
`that would be deliverable through standard guide catheters for providing backup support by
`
`providing the ability to effectively create deep seating in the ostium of the coronary artery.
`
`Summary of the Invention
`
`The present invention is a coaxial guide catheter that is deliverable through standard
`
`guide catheters by utilizing a guidewire rail segment to permit delivery without blocking use of
`
`the guide catheter. The coaxial guide catheter preferably includes a tapered inner catheter that
`
`runs over a standard 0.014 inch coronary guidewire to allow atraumatic placement within the
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`coronary artery. This feature also allows removal of the tapered inner catheter after the coaxial
`
`guide catheter is in place. The tapered inner catheter provides a gradual transition from the
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`Attorney Docket No. 2005.86US02
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`standard 0.014 inch diameter guidewire to the diameter of the coaxial guide catheter which is
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`typically five to eight French.
`
`The coaxial guide catheter preferably can be delivered through commonly existing
`
`hemostatic valves used with guide catheters while still allowing injections through the existing Y
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`adapter.
`
`In addition, the coaxial guide catheter preferably has an inner diameter that is
`
`appropriate for delivering standard coronary treatment devices after it is placed in the coronary
`
`artery.
`
`In one embodiment, the coaxial guide catheter is made in at least three sizes
`
`corresponding to the internal capacity of 8 French, 7 French, and 6 French guide catheters that
`
`are commonly used in interventional cardiology procedures. An 8 French catheter has an
`
`internal diameter greater than or equal to 0.088 inches. A 7 French catheter has an internal
`
`diameter greater than or equal to 0.078 inches. A 6 French guide catheter has an internal
`
`diameter greater than or equal to 0.070 inches. Thus, for three exemplary sizes the effective
`
`internal diameter of the coaxial guide catheter may be as follows. For a 7 French in 8 French
`
`coaxial guide catheter the internal diameter should be greater than or equal to 0.078 inches. For
`
`a 6 French in 7 French coaxial guide catheter the internal diameter should be greater than or
`
`equal to 0.070 inches. For a 5 French in 6 French coaxial guide catheter the internal diameter
`
`should be greater than or equal to 0.056 inches.
`
`Interventional cardiology procedures are typically carried out under fluoroscopy or
`
`another x-ray or imaging technique. Therefore, one embodiment of the coaxial guide catheter of
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`Attorney Docket No. 2005.86US02
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`the present invention includes a radiopaque marker at its distal tip to facilitate positioning and
`
`manipulation of the coaxial guide catheter.
`
`The present invention generally includes the coaxial guide catheter and a tapered inner
`
`catheter. The coaxial guide catheter includes a tip portion, a reinforced portion, and a
`
`substantially rigid portion. The coaxial guide catheter will generally have an overall length of
`
`preferably approximately 125 cm, though this should not be considered limiting.
`
`In one embodiment, the tip portion may include a soft tip and a marker band. The soft tip
`
`is tapered and may be formed from a low durometer polymer or elastomer material such as
`
`polyether block amide polymer, (PEBA, Pebax®) the marker band may be formed from a
`
`platinum iridium alloy sandwiched between the Pebax® that extends from the bump tip and a
`
`PTFE liner.
`
`In one embodiment, the reinforced portion may be reinforced, preferably with metallic
`
`fibers in a braided or coiled pattern. The braided or coiled portion is lined by a PTFE liner and
`
`may be covered on its exterior with Pebax®. The braided or coiled portion may extend
`
`approximately 20 to 110 cm in length.
`
`In one exemplary embodiment, the braided portion
`
`extends approximately 32 to 36 cm.
`
`Preferably, the rigid portion may be advantageously formed from a stainless steel or
`
`Nitinol tube. The rigid portion may be joined to the braid or coil portion by welding. The rigid
`
`portion may include a cutout portion and a full circumference portion. For example, the cutout
`
`portion may include a section where about 45% of the circumference of the cylindrical tubular
`
`structure has been removed. The cutout portion may also include a section where 75-90% of the
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`Attorney Docket No. 2005.86US02
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`circumference of the tubular structure has been removed. In one exemplary embodiment, the
`
`portion having approximately 45% removed may extend for approximately 75 cm and the
`
`portion having 75-90% of the structure removed extends for about 15 cm. The full
`
`circumference portion of the rigid portion is typically located at the most proximal end of the
`
`coaxial guide catheter.
`
`The rigid portion may include a plurality of radially oriented slits or other cuts in its distal
`
`portion to increase and control the flexibility of the rigid portion
`
`In an exemplary embodiment, the tapered inner catheter generally includes a tapered
`
`inner catheter tip and a cutout portion. The tapered inner catheter tip includes a tapered portion
`
`and a straight portion. The tapered portion is typically at the most distal end of the tapered inner
`
`catheter. Both the straight portion and the tapered portion are pierced by a lumen through which
`
`a guidewire may be passed.
`
`The cutout portion supports a track passing along the concave side thereof that continues
`
`from the lumen that passes through the straight portion and the tapered portion. The tapered
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`inner catheter may also have a clip or snap attachment at its proximal end to releasably join the
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`tapered inner catheter to the coaxial guide catheter.
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`In operation, the tapered inner catheter is inserted inside and through the coaxial guide
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`catheter. The tapered inner catheter is positioned so that the tapered inner catheter tip extends
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`beyond the tip portion of the coaxial guide catheter. The coaxial guide catheter-tapered inner
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`catheter combination may then be inserted into a blood vessel that communicates with the aorta.
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`The coaxial guide catheter-tapered inner catheter combination may be threaded over a preplaced
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`0.014 inch guidewire. The tapered inner catheter-coaxial guide catheter combination is advanced
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`up the aorta until the tapered inner catheter is passed into the ostium of a coronary artery over the
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`guidewire. Once the coaxial guide catheter-tapered inner catheter combination has been inserted
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`sufficiently into the ostium of the coronary artery to achieve deep seating the tapered inner
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`catheter may be removed. During this entire process at least part of the coaxial guide catheter(cid:173)
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`tapered inner catheter combination is located inside of the guide catheter.
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`Once the tapered inner catheter is removed a cardiac treatment device, such as a
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`guidewire, balloon or stent, may be passed through the coaxial guide catheter within the guide
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`catheter and into the coronary artery. As described below, the presence of the coaxial guide
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`catheter provides additional backup support to make it less likely that the coaxial guide catheter
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`guide catheter combination will be dislodged from the ostium of the coronary artery while
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`directing the coronary therapeutic device past a tough lesion such as a stenosis or a chronic
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`arterial occlusion.
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`A guide catheter inserted into the ostium of a branch artery where it branches off from a
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`larger artery is subject to force vectors that tend to dislodge the distal end of the guide catheter
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`from the ostium of the branch artery when a physician attempts to direct a guidewire or other
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`interventional cardiology device past an occlusive or stenotic lesion in the branch artery. This
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`discussion will refer to a guide wire but it is to be understood that similar principles apply to
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`other interventional cardiology devices including balloon catheters and stent catheters.
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`One of the forces that acts on the guide catheter is an axial force substantially along the
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`axis of the branch artery and the portion of the guide catheter that is seated in the ostium. This
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`force vector is a reactive force created by the pushing back of the guide wire against the guide
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`catheter as the physician tries to force the guidewire through or past the lesion. It tends to push
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`the distal end of the catheter out of the ostium in a direction parallel to the axis of the branch
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`artery and the axis of the distal end of the guide catheter.
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`Another of the force vectors that acts on the guide catheter is a shearing force that tends
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`to dislodge the distal end of the guide catheter from the ostium of the branch artery in a direction
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`perpendicular to the axis of the branch artery and the axis of the distal end of the guide catheter.
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`This force vector arises from curvature of the guide catheter near its distal end and the guide wire
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`pushing on the curved portion of the guide catheter as the physician applies force to the
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`guidewire. The coaxial guide catheter of the present invention assists in resisting both the axial
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`forces and the shearing forces that tend to dislodge a guide catheter from the ostium of a branch
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`artery.
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`The system 1s deliverable usmg standard techniques utilizing currently available
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`equipment. The present invention also allows atraumatic placement within the coronary artery.
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`Further, the invention is deliverable through an existing hemostatic valve arrangement on a guide
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`catheter without preventing injections through existing Y adapters. Finally, the invention has an
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`inner diameter acceptable for delivering standard coronary devices after it is placed in the blood
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`vessel.
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`Brief Description of the Drawings
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`Fig. 1 is a schematic depiction of the coaxial guide catheter and a tapered inner catheter
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`in accordance with the present invention;
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`Fig. 2 is schematic depiction of the coaxial guide catheter and tapered inner catheter
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`assembled in accordance with the present invention;
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`Fig. 3 is a plan view of a guide catheter, the coaxial guide catheter, and a treatment
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`catheter in accordance with the present invention;
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`Fig. 4 is a sectional view of the coaxial guide catheter in accordance with the present
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`invention;
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`Fig. 5 is a cross sectional view of the coaxial guide catheter and tapered inner catheter in
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`accordance with the present invention;
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`Fig. 6 is another cross sectional view of the coaxial guide catheter and tapered inner
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`catheter in accordance with the present invention;
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`Fig. 7 is a schematic view of a guide catheter and a guidewire located in an aortic arch
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`and a coronary artery and the guide catheter and guidewire in a second position depicted in
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`phantom;
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`Fig. 8 is a schematic view of a guide catheter, a guidewire, a coaxial guide catheter in
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`accordance with the present invention and a tapered inner catheter located in the aortic arch and
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`coronary artery;
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`Fig. 9 is a schematic view of a guide catheter, a guidewire and a coaxial guide catheter in
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`accordance with the present invention located in the aortic arch and coronary artery;
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`Fig. 10 is a flat pattern for making relief cuts in a curved rigid portion of the coaxial
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`guide catheter in accordance with the present invention;
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`Fig. 11 is a detailed view taken from Fig. 1 O;
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`Fig. 12 is a plan view of the rigid portion in accordance with the present invention;
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`Fig. 13 is an elevational view of the rigid portion;
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`Fig. 14 is a sectional view of the rigid portion taken along section line 14-14 of Fig. 13;
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`and
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`Fig. 15 is a sectional view of the rigid portion taken along section line 15-15 of Fig. 13.
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`Fig. 16 is