Dynamically curved access tool for complex arch anatomy and radial access

Abstract

The intravascular device includes an elongated outer catheter body having a catheter proximal end, a catheter distal end, and a catheter lumen extending between the catheter proximal end and the catheter distal end. The intravascular device further includes an elongated inner articulation member slidably disposed within the catheter lumen. The inner articulation member has a proximal member end and an articulatable distal member end. The intravascular device further includes a control assembly mechanically coupled to the catheter proximal end and the proximal member end. The control assembly is configured to translate the outer catheter body distally over the inner articulation member to articulate the distal member end.

Description

[Technical field]

[0001] The present disclosure relates generally to medical devices and intravascular medical procedures, and more particularly to devices and methods for controlling deflection at a distal end of a catheter. [Background technology]

[0002] Therapeutic or diagnostic catheters are commonly used to perform medical procedures within very tight spaces inside a patient's body. Most of these medical procedures require precise catheter navigation. To access a target site within the human body from a remote location, a catheter is typically passed through one or more body lumens, such as the vascular system, to reach the target site. When using the vascular system, the catheter is inserted percutaneously or through a relatively small incision in the patient's body into an artery or vein. The catheter is then threaded through the patient's vascular system to reach the desired target site. Often, a pathway is created through the vascular system to the target site using a delivery device, such as a guide catheter or a long sheath, through which the therapeutic or diagnostic catheter can be guided to the target site.

[0003] The usefulness of guide catheters is largely limited by their ability to navigate tight bends in the vasculature, such as through small vessels and around the aortic arch. Access to the great vessels away from the aortic arch poses challenges, especially when anatomical features require the device to follow a highly tortuous or poorly supported path. To overcome some of these challenges, selective catheters have been developed that are pre-shaped to guide the guide catheter or long sheath by providing an internal guide rail over which the guide catheter or long sheath can traverse a selected path to reach the intended target location of the guide catheter or long sheath. Such pre-shaped selective catheters may have multiple axially spaced bends that allow access to the great vessels beginning at the aortic arch. In many cases, diagnostic catheters are used for the same purpose as selective catheters, with the selective catheters generally differing only in length to fit inside the guide catheter or long sheath. For example, diagnostic and selective catheters have been developed with various types of pre-shaped distal ends (e.g., Simmons, Headhunter, Vitek, Bentson, Newton, Berenstein shapes) to aid in navigating both the twists and branches common to a patient's arterial or venous system and to maintain their shape after placement within the target cavity (e.g., a heart chamber). However, because the pre-shaped curves are fixed into the selective catheter at the time of manufacture, the radius, degree of curvature, and overall shape generally cannot be altered in situ. Anatomical differences require extensive pre-operative planning to determine the appropriate curvature of the selective catheter. Current practice requires guessing and selecting an existing shape that is the closest approximation to the patient's anatomy.

[0004] In one particular therapeutic procedure, a stent may be placed into one or more carotid arteries or their branches using a guide catheter to treat atherosclerosis. Disease processes occurring within these vessels cause the inner vessel walls to deteriorate, and diseased material that detaches from the inner vessel walls may be swept throughout the arterial system, successively reducing the vessel diameter, and may lodge within the vascular structures, causing cessation of blood flow in blocked areas and tissue death due to lack of oxygen. This disease process is a major cause of strokes, heart attacks, and other debilitating or fatal events. As carotid atherosclerosis progresses, the risk of stroke increases, necessitating interventions to prevent stroke or death from blood clots or vascular debris lodged in the brain, especially in association with disease of the internal carotid artery branches, which serve the brain or the common carotid artery that precedes it in the circulation. It should be noted that stroke is the third most common cause in developing countries. 85% of all strokes are ischemic in nature (due to impaired cerebral circulation), and 20-30% of all ischemic strokes are caused by atherosclerotic occlusive disease of the carotid artery. In the case of atherosclerotic occlusive disease of the internal or common carotid arteries, one procedure performed by an interventionalist (interventional radiologist, vascular surgeon, or interventional cardiologist) is the placement of a stent, which is an expanding cylindrical wire or plastic mesh that supports and stabilizes the diseased area of ​​the artery, and an inflatable balloon is used to momentarily widen the entire inner diameter of the blood vessel in the area of ​​the stenosis, a treatment called angioplasty.

[0005] Carotid stenting is a challenging procedure because access to the left or right carotid artery may depend on the anatomical location of the aortic arch. For example, referring to Figures 1A-1C, a typical human has an aortic arch 10 with three major arterial branches emerging from the aortic arch 10, including a first arterial branch 12 forming the left subclavian artery (LSA) 14 and left vertebral artery (LVA) 16, a second arterial branch 18 forming the left common carotid artery 20 (LCCA), and a third arterial branch (the brachiocephalic artery) forming the right subclavian artery (RSA) 24, right vertebral artery (RVA) 26, and right common carotid artery (RCCA) 28.

[0006] There are three types of arches, defined by the height h of the apex of the aortic arch 10 from the base location where the brachiocephalic trunk 22 attaches to the aortic arch 10. In a type I arch, the height h is insignificant (h is less than the diameter of the LCCA 20 or RCCA 28), as shown in FIG. 1A. In a type II arch, the height h increases significantly (h is between 1 and 2 times the diameter of the LCCA 20 or RCCA 28), as shown in FIG. 1B, and in a type III arch, the height h increases even more (h is more than 2 times the diameter of the LCCA 20 or RCCA 28), as shown in FIG. 1C. As the height of the aortic arch 10 increases, procedures within the carotid artery become increasingly difficult due to the tortuous nature of the arterial connections to the aortic arch 10. For example, as shown in Figure 1C, a type III severe aortic arch can make it difficult to access the LCCA 20 or RCCA 28 due to the very acute angles of the origin of the second arterial branch 18 or third arterial branch 22. The bovine arch is another example of difficult anatomy, where the LCCA (18) originates from the brachiocephalic trunk (22).

[0007] For example, an interventionist can choose between a femoral approach or a radial approach when accessing one of the arterial branches from the aortic arch 10. As shown in FIG. 2A, during a femoral approach, a catheter 30 can be introduced into the femoral artery, up the abdominal aorta to the descending aorta, and around the aortic arch 10 to one of the three arterial branches of the aortic arch 10. In contrast, as shown in FIG. 2B, during a radial approach, a catheter 30 can be introduced into the radial artery, through it, through the brachial artery and the axillary artery, then along the RSA 24, and finally into the aortic arch 10. In one method, the catheter 30 is inserted into a selected one of the arterial branches from the aortic arch 10 to provide a stable platform through which an interventional device (e.g., a stent delivery device) is introduced into the diseased artery. Alternatively, the catheter 30 may function as a diagnostic catheter for injecting contrast media into one of the major arterial branches extending from the aorta. Often, selective catheters having pre-bent or pre-shaped distal ends may be used to facilitate proper orientation of the guide catheter within the aortic arch 10 and subsequent introduction of the guide catheter into the associated arterial branches of the aortic arch 10.

[0008] Interventional procedures at or above the neck are challenging, especially when faced with severe aortic arches, such as type III or bovine arches, or when the LCCA emerges from the arch at an acute angle. Interventional devices introduced through the guide catheter are often relatively stiff, and due to the tortuosity of the vessels beginning at the aortic arch 10, the catheter 30 along with the interventional device may become unstable and be extruded into the aortic arch 10. It is therefore important to introduce the catheter 30 distally into the arterial branches of the aortic arch as far as possible to provide a stable platform for the interventional devices to move to their intended treatment location.

[0009] However, stroke intervention devices are becoming larger and larger, and as a result, the guide sheaths that provide a support platform for these larger intervention devices must become larger and more supportive. Although newer, more supportive and flexible guide catheter designs have been developed and continue to be developed, the challenge of traversing unsupported anatomical bends remains. Even if a selective catheter is used to facilitate proper orientation of the guide catheter within the aortic arch 10, the statically placed bend at the distal end of the selective catheter prevents the selective catheter from advancing distally deep into the selected arterial branch of the aortic arch 10 to achieve greater stability to further facilitate advancement of large supportive intervention devices over the selective catheter.

[0010] Thus, there is a continuing need for improved means for maneuvering a guide catheter within an anatomical vessel, such as one of the arterial branches from the aortic arch. Summary of the Invention

[0011] According to a first aspect of the invention, an intravascular device comprises an elongate outer catheter body having a catheter proximal end, a catheter distal end, and a lumen extending between the catheter proximal end and the catheter distal end. In one embodiment, the catheter distal end has one or more infusion openings. In another embodiment, the catheter distal end includes a distal wire tip. In yet another embodiment, the catheter distal end is configured to be inserted into a branch of aortic arch of a human.

[0012] The intravascular device further includes an elongate inner articulation member slidably disposed within the lumen of the outer catheter body, the inner articulation member having a proximal member end and an articulatable distal member end.

[0013] The intravascular device further comprises a control assembly mechanically coupled to the catheter proximal end and the proximal member end. The control assembly is configured to distally translate the outer catheter body over the inner articulation member to articulate the distal member end. In one embodiment, the control assembly is configured to articulate the distal member end into a single curved planar shape. In another embodiment, the control assembly is configured to articulate the distal member end into multiple curved shapes. In yet another embodiment, the control assembly is a manually operated control assembly. In yet another embodiment, the control assembly is releasably coupled to the catheter proximal end. In yet another embodiment, the control assembly further comprises at least one pull wire operably connected between the distal member end and the control assembly, where the control assembly is configured to articulate the distal member end by tensioning the pull wire(s).

[0014] According to a second aspect of the invention, an intravascular device includes an elongated inner articulating member configured to be slidably disposed within a lumen of an outer catheter body having a proximal catheter end, a distal catheter end, and a lumen extending between the proximal catheter end and the distal catheter end. In one embodiment, the distal catheter end is configured to be inserted into a branch of the aortic arch of a human. The inner articulating member has a proximal member end and an articulatable distal member end.

[0015] The intravascular device further comprises a control assembly mechanically coupled to the proximal member end. The control assembly is further configured to be releasably coupled to the catheter proximal end. The control assembly is further configured to distally translate the outer catheter body over the inner articulation member to articulate the distal member end. In one embodiment, the control assembly is configured to articulate the distal member end into a single curved planar shape. In another embodiment, the control assembly is configured to articulate the distal member end into multiple curved shapes. In yet another embodiment, the control assembly is a manually operated control assembly. In yet another embodiment, the control assembly is releasably coupled to the catheter proximal end. In yet another embodiment, the intravascular device further comprises at least one pull wire operably connected between the distal member end and the control assembly, where the control assembly is configured to articulate the distal member end by tensioning the at least one pull wire.

[0016] According to a third aspect of the present invention, there is provided a method of performing a medical procedure on a patient using an intravascular device including an elongate outer catheter body having a catheter distal end and a catheter lumen, and an elongate inner member slidably disposed within the catheter lumen, the inner member having a distal member end.

[0017] The method includes introducing an intravascular device into the patient's vasculature (e.g., femoral or radial approach). The method further includes advancing the intravascular device distally within the patient's vasculature until the catheter distal end is adjacent a vascular opening within the vasculature. In one method, the blood vessel is an arterial branch extending from the patient's aortic arch (e.g., a type III aortic arch) (e.g., one of a first arterial branch forming the patient's left subclavian artery (LSA) and left vertebral artery (LVA), a second arterial branch forming the patient's left common carotid artery (LCCA), and a third arterial branch forming the patient's right subclavian artery (RSA), right vertebral artery (RVA), and right common carotid artery (RCCA). If the arterial branch is the third arterial branch, advancing the catheter distal end further into the blood vessel can include advancing the catheter distal end into the RCCA. Alternatively, the catheter distal end is inserted into the vascular opening by sliding the catheter distal end distally relative to the distal member end.

[0018] The method further includes actively articulating the distal member end such that the catheter distal end is directed toward the vascular opening. The method further includes inserting the catheter distal end into the vascular opening and sliding the catheter distal end distally relative to the distal member end such that the catheter distal end is advanced further into the blood vessel. One method may further include advancing a guide catheter over the intravascular device while the catheter distal end remains within the blood vessel until the guide catheter reaches a target treatment site, and removing the intravascular device from the guide catheter while the guide catheter is at the target treatment site. The method may further include introducing a treatment device through the guide catheter until the treatment device reaches the target treatment site, and performing a treatment procedure at the target treatment site using the treatment device. Another method may further include removing the inner member from the lumen of the outer catheter body, advancing the guide catheter through the lumen of the outer catheter body while the catheter distal end remains within the blood vessel until the guide catheter reaches the target treatment site, and removing the intravascular device from the guide catheter while the guide catheter is at the target treatment site. This other method may further include introducing a therapeutic device through the lumen of the outer catheter body until the therapeutic device reaches the target treatment site, and performing a therapeutic procedure at the target treatment site using the therapeutic device. An optional method further includes delivering a contrast agent into the blood vessel via the catheter assembly.

[0019] Other and further aspects and configurations of the embodiments will become apparent from the following detailed description considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0020] The drawings illustrate the design and utility of preferred embodiments of the disclosed invention, with similar elements being referenced by common numerals. It should be noted that the figures are not drawn to scale, and elements of similar structure or function are represented by similar numerals throughout the figures. It should also be noted that the figures are intended only to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention, or as limitations on the scope of the invention, which is defined solely by the appended claims and their equivalents. Also, illustrated embodiments of the disclosed invention need not have all aspects or advantages shown. Moreover, aspects or advantages discussed in connection with a particular embodiment of the disclosed invention are not necessarily limited to that embodiment, and may be implemented in other embodiments, even if not illustrated.

[0021] In order to better understand how the above and other advantages and objects of the disclosed invention are obtained, a more particular description of the disclosed invention briefly described above will be rendered by reference to specific embodiments which are illustrated in the accompanying drawings, with the understanding that these drawings depict only typical embodiments of the invention and therefore should not be considered as limiting its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0022] [Figure 1] 1A, 1B, and 1C are plan views of an exemplary Type I aortic arch of a patient, an exemplary Type II aortic arch of a patient, and an exemplary Type III aortic arch of a patient, respectively. [Diagram 2] Figure 2A is a plan view of a catheter introduced into a patient's Type III aortic arch via a femoral approach. Figure 2B is a plan view of a catheter introduced into a patient's Type III aortic arch via a right radial artery approach, including a plan view of the catheter of Figure 2A, particularly showing the catheter distal end in a curved configuration. [Diagram 3]Figure 3A is a plan view of an intravascular device configured in accordance with an exemplary embodiment of the present invention, specifically shown in a straight configuration, Figure 3B is a plan view of the intravascular device of Figure 3A, specifically shown in a curved configuration, and Figure 3C is a plan view of the intravascular device of Figure 3A, specifically shown in a curved, extended configuration. [Figure 4] 4A-4G are plan views of different distal ends of the intravascular device of FIG. 3A. [Diagram 5] FIG. 5 is a plan view of one exemplary distal end of an intravascular device exhibiting a compound curvature. [Figure 6] FIG. 6 is a plan view of an exemplary inner articulation member of the intravascular device of FIG. 3A. [Figure 7] 7 is a plan view of one particular configuration of the distal end of the inner articulation member of FIG. 6. FIG. [Figure 8] FIG. 8 is a perspective view of an exemplary embodiment of a control assembly that may be used with the intravascular device of FIG. 3A. [Figure 9] 9 is a longitudinal cross-sectional view of the control assembly of FIG. 8. FIG. [Figure 10] FIG. 10 is a perspective view of another exemplary embodiment of a control assembly that may be used with the intravascular device of FIG. 3A. [Figure 11] 11 is a longitudinal cross-sectional view of the control assembly of FIG. [Figure 12] 12A-12F are plan views of the distal end of the intravascular device of FIG. 3A, specifically shown in a series of different configurations. [Figure 13] FIG. 13 is a flow chart illustrating one exemplary method of performing a therapeutic procedure on a patient using the intravascular device of FIG. [Figure 14] 14A-14I are plan views illustrating different steps used by the method of FIG. 13 to perform a therapeutic procedure on a patient. [Figure 15] FIG. 15 is a flow chart illustrating one exemplary method of performing a diagnostic procedure on a patient using the intravascular device of FIG. [Figure 16]16A-16G are plan views illustrating different steps used by the method of FIG. 15 to perform a therapeutic procedure on a patient. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] With reference to Figures 3A-3C, one embodiment of an intravascular device 100 configured in accordance with an embodiment of the present invention will now be described. In the illustrated embodiment, the intravascular device 100 is described as a rail (particularly used as an alternative to a conventional selective or diagnostic catheter) for advancing a guide catheter to a target treatment site within a patient's body, which guide catheter is then used to guide a treatment device (e.g., a catheter or other instrument) to the target treatment site. The intravascular device 100 helps to facilitate delivery of a relatively stiff device through unsupported curves, particularly through a Type III aortic arch via a femoral approach or any aortic arch configuration via a radial approach. However, it should be understood that the intravascular device 100 can take the form of any device, including a selective catheter, a guidewire, or a working catheter itself, intended to perform a medical procedure (therapeutic or diagnostic) that can benefit from accessing a vascular orifice (e.g., an orifice of an arterial branch away from a patient's aortic arch).

[0024] In contrast to selective catheters that have a static curvature that is in a static position on the catheter, or even conventional steerable catheters that prevent the catheter from advancing distally into the blood vessel through the aperture, intravascular device 100 can be shaped to point the distal end of intravascular device 100 toward or within the vascular aperture, and the distal end of intravascular device 100 is advanced distally relative to the shaped curvature, thereby facilitating advancement of the distal end of the intravascular device within the blood vessel while the shaped curvature remains in position in the tortuous anatomical structure through which the curvature facilitates passage.

[0025] To this end, the elongate intravascular device 100 generally includes an outer catheter body 102, an inner articulation member 104 slidably disposed within the outer catheter body 102, and a control assembly 106. The outer catheter body 102 generally has a proximal end 108, a distal end 110, and a lumen 112 within which the inner articulation member 104 is slidably disposed. The inner articulation member 104 generally has a proximal end 114 and a distal end 116. The control assembly 106 is mechanically coupled to the proximal end 108 of the outer catheter body 102 and the proximal end 114 of the inner articulation member 104 and is configured to articulate the inner articulation member 104 to form a curve in the inner articulation member via the energy transmission elements (and in particular the pull wire or pull wires) and thus via the elongated intravascular device 100 (see FIG. 3B ), and to translate the outer catheter body 102 axially 120 along the longitudinal axis 118 relative to the inner articulation member 104 (see FIG. 3C ). In the embodiment shown in FIG. 3B , the curve formed by the inner articulation member 104 is shown as a simple curve (single bend), but as described in more detail below, the curve formed by the inner articulation member 104 may be a complex curve with multiple bends. Optionally, the control assembly 106 may be configured to translate the outer catheter body 102 rotationally 122 about the longitudinal axis 118 relative to the inner articulation member 104.

[0026] The outer catheter body 102 can be constructed in a manner similar to most intravascular catheter shafts and can be constructed from a variety of materials using a variety of construction processes. The outer catheter body 102 is substantially soft or flexible such that when advanced into the patient, the outer catheter body 102 conforms to, adopts, or matches the shape or curvature of the patient's blood vessel. Alternatively, the outer catheter body 102 can be semi-rigid, i.e., by being made of a stiff material or reinforced with a coating or coil to limit the amount of bending.

[0027] The outer catheter body 102 is preferably about 2 French to 9 French in diameter and 80 cm to 150 cm in length. The outer catheter body 102 preferably has a circular cross-sectional shape. However, other cross-sectional shapes such as oval, rectangular, triangular, and various customized shapes can also be used. The outer catheter body 102 is preferably pre-molded from an inert, resilient plastic material (e.g., Pebax®, polyethylene, polyurethane, polyamide, Hytrel® (polyester)) that retains its shape at body temperature and does not soften significantly. Alternatively, the outer catheter body 102 can be made from a variety of materials, including, but not limited to, metals and polymers.

[0028] The outer catheter body 102 may be constructed from multiple layers of material and / or multiple tubular structures that exhibit low bending stiffness while providing high axial stiffness along the longitudinal axis of the outer catheter body 102. Preferably, the outer catheter body 102 has adequate torsional stiffness so that it can rotate independently from the inner articulating member 104. Typical designs include a braided plastic composite structure composed of a Nitinol spine encapsulated in a braid and any flexible, pliable, or suitable polymeric material, laser cut hypotubes, or biocompatible polymeric materials, or low durometer plastics (e.g., Nylon-12, Pebax®, polyurethane, polyethylene, etc.).

[0029] The lumen 112 is disposed throughout the entire length of the outer catheter body 102. At least a portion of the lumen 112 of the outer catheter body 102 that extends through the outer catheter body 102 may be formed by an inner polymeric tube (e.g., 0.001 inch thick polytetrafluoroethylene (PTFE)). The distal end 110 of the outer catheter body 102 terminates at an atraumatic distal tip 124. In one embodiment shown in FIG. 4A, the catheter distal tip 100 has a preformed curve. In other embodiments shown in FIGS. 4B-4G, the catheter distal tip 100 has a straight configuration. In the embodiments shown in FIGS. 4A-4B and 4G, the atraumatic distal tip 124 is closed or sealed, and in the embodiments shown in FIGS. 4C-4F, the atraumatic distal tip 124 has at least one injection opening 126 in fluid communication with the lumen 112 of the outer catheter body 102 to allow for optional contrast injection. In the embodiment shown in Figures 4F-4G, intravascular device 100 includes a distal wire tip 128 that facilitates entry into the vascular opening.

[0030] 5, the distal end 116 of the inner articulating member 104, and therefore the distal end 110 of the outer catheter tube 102 (shown in FIGS. 3A-3C), is configured to be gradually articulated from a straight configuration to a curved configuration into a multi-curved planar shape. In this embodiment, the distal end 116 of the inner articulating member 104 can be articulated into a Simmons-type shape, in particular a proximal curve 130 that bends in a plane to mimic the curvature of a typical aortic arch, and a distal curve 130 that bends in the same plane but in an opposite direction from the proximal curve 130, so that the distal end 116 of the inner articulating member 104, and therefore the distal end 110 of the outer catheter body 102, points towards the ostia of the arterial branches branching off from the patient's aortic arch, as described in more detail below. It should be understood that the multiple curved configurations shown in FIG. 5 are merely exemplary and alternative embodiments of the distal end 116 of the inner articulation member 104 may include only a single curve, or may include different types of compound curves having different shapes or different numbers of bends, including bends that are out of plane with respect to one another, or even multiple compound bends.

[0031] With reference to FIG. 6, the inner articulation member 104 is functionally divided into three sections: a distal articulation section 134 , an intermediate transition section 136 , and a proximal shaft section 138 .

[0032] The distal articulation section 134 preferably allows for a moderate degree of axial compression and optimal lateral flexibility. The distal articulation section 134 has several portions of differing stiffness. In one exemplary embodiment shown in FIG. 7, the distal articulation section 134 includes a relatively flexible distal articulation region 140 forming the distal curve 132, a relatively flexible proximal articulation region 144 forming the proximal curve 130, and a relatively inflexible non-articulation region 142 located between the proximal articulation region 144 and the distal articulation region 140.

[0033] 7, the distal articulation section 134 is formed of a slotted (e.g., micromachined or laser cut) hypotube that tailors the flexibility, bend arc length, minimum bend radius, and bending plane of the distal articulation section 134. In particular, the slotted hypotube has slots 146 that are strategically sized and positioned such that the articulation section 134 forms a proximal curve 130 that coincides with the proximal articulation region 144 and a distal curve 132 that coincides with the distal articulation region 140. The distal articulation section 134 further includes a pair of helical struts 148 disposed in and adding lateral stiffness to the non-articulation region 142 such that the proximal articulation region 144 and distal articulation region 140 of the distal articulation section 134 articulate predictably about the non-articulation region 142 to form the proximal curve 130 and distal curve 132. In an alternative embodiment, instead of a laser cut hypotube, the distal articulation section 134 can be formed by having a different outer tube constructed from a suitable polymer material (e.g., Pebax®). In this alternative case, the distal articulation section 134 can include a braided layer (e.g., 16 strands of 0.0005 inch by 0.003 inch spring temper 304V stainless steel wire braided at 68 picks per inch (ppi) in a 2-over-2 pattern) embedded within the outer polymer tube to increase axial stiffness and elastic properties, can include coils with various pitches, or can include slotted (e.g., micromachined) hypotubes to adjust the flexibility and bending surface of the distal articulation section 134.

[0034] As briefly described above, the energy transmission conduit(s) are mechanical energy transmission conduits, and in particular take the form of one or more pull wires that extend within the inner articulation member 104. In the illustrated embodiment, a single pull wire 150 is used. In the illustrated embodiment, the distal articulation section 134 comprises a distal tip ring 152 to which the distal end of the pull wire 150 is attached, and a central lumen 153 through which the pull wire 150 extends back to the control assembly 106. Tension in the pull wire 150 via manipulation of the control assembly 106 (as described in more detail below) causes the distal articulation section 134 to transform from a straight configuration to a curved configuration.

[0035] The pull wire 150 may be a metal wire, cable, or filament, or may be a polymer wire, cable, or filament. The pull wire 150 may also be made of natural or organic materials or fibers. The pull wire 150 may be any type of suitable wire, cable, or filament capable of supporting various types of loads without deformation, significant deformation, or breakage. Although the mechanical energy transmission conduit(s) have been described as being a pull wire, it should be understood that the mechanical energy transmission conduit should not be limited to a pull wire. For example, the mechanical transmission conduit(s) may take the form of a small diameter tube or rod that is axially stiff but laterally flexible. Additionally, in alternative embodiments of the intravascular device 100, non-mechanical, e.g., fluid transmission conduits (e.g., hydraulic or pneumatic), electrical transmission conduits (i.e., wires), electromagnetic energy (e.g., light) transmission conduits, etc., may be used as energy transmission conduits. Essentially, any energy transmission conduit capable of transmitting any energy from the proximal end 114 to the distal end 116 of the internal articulation member 104 to articulate the distal articulation section 134 to form the proximal curve 130 and the distal curve 132 can be used.

[0036] The pull wires 150 are slidably disposed and float within a central lumen 153 extending through the inner articulation member 104 to apply differential forces along the distal end 116 of the inner articulation member 104 to create the proximal and distal curves 130, 132. In an alternative embodiment, two pull wires may extend through two pull wire lumens (not shown) extending through the inner articulation member 104. In this case, the pull wire lumens may be constructed of a low friction material or may simply be unsupported tubular cavities within which the pull wires each float, and may be provided in 180 degree circumferentially spaced apart relationship on the inner articulation member 104.

[0037] As described in further detail below, a proximal end of the pull wire 150 is operatively coupled to the control assembly 106 and a distal end of the pull wire 150 is fixed to the distal end 116 of the inner articulation member 104 such that manipulation of the pull wire 150 via manual actuation of the control assembly 106 applies or varies a force or tension to the distal end 116 of the inner articulation member 104, which may articulate to create the proximal curve 130 and the distal curve 132. In the illustrated embodiment, the portion of the outer catheter body 102 surrounding the distal articulation section 134 of the inner articulation member 104 is resilient such that releasing the pull wire 150 via manual actuation of the control assembly 106 releases the force or tension within the distal articulation section 134 of the inner articulation member 104, allowing the distal articulation section 134 to return to a straight configuration.

[0038] The intermediate transition section 136 resists axial compression to clearly define the proximal end of the distal articulation section 134 and transfers movement of the pullwire 150 to the distal articulation section 134 while maintaining lateral flexibility to enable the intravascular device 100 to track across tortuous anatomy. The intermediate transition section 136 may be formed from a slotted hypotube or an outer tube constructed from a suitable polymeric material (e.g., Pebax®).

[0039] The proximal shaft portion 138 gradually transitions the inner articulation member 102 from the intermediate transition section 136 to the stiffer remainder of the inner articulation member 102 by having sections of different stiffness formed by having different sections of a slotted hypotube configuration or different outer tubes constructed from a suitable polymer material (e.g., Pebax®). To increase the axial stiffness of any polymer tube segment, the proximal shaft section 138 can include a double braid layer (e.g., sixteen 0.0005 inch by 0.003 inch spring temper 304V stainless steel wires braided at 68 picks per inch (ppi) in a 2-over-2 pattern) embedded within the outer polymer tube.

[0040] As briefly discussed above, the control assembly 106 is configured to articulate the distal end 116 of the inner articulation member 104 between straight and curved configurations, translate the outer catheter body 102 along a longitudinal axis 118 over the inner articulation member 104, and optionally rotate the outer catheter body 102 about the longitudinal axis 118 relative to the inner articulation member 104. In the illustrated embodiment, the control assembly 106 is a manually operated control assembly (i.e., an interventionalist operates the control assembly 106 with one or both hands). In an alternative embodiment, the control assembly 106 may be automated, for example via a robotic device.

[0041] At least a portion of the control assembly 106 may be releasably coupled to the outer catheter body 102 if the intravascular device 100 is to function as a rail for the subsequent introduction of a guide catheter or other device. Thus, the control assembly 106, along with the inner articulating member 104 coupled thereto, may be withdrawn from the lumen 112 of the outer catheter body 102, leaving the outer catheter body 102 within the patient's vasculature to be used as a rail for a subsequently introduced guide catheter. The inner articulating member 104, along with the attached control assembly 106, may be packaged and sold with the outer catheter body 102 to form the intravascular device 100, or the inner articulating member 104, along with the attached control assembly 106, may be packaged and sold as a stand-alone device and then coupled to the outer catheter body 102 to form the intravascular device 100. In an alternative embodiment, the outer catheter body 102 of the intravascular device 100 takes the form of a guide catheter. In this case, the inner articulating member 104, with the control assembly 106 attached, may be packaged and sold as an introducer and then coupled to a guide catheter 102 to form the intravascular device 100. Thus, the control assembly 106, with the inner articulating member 104 coupled thereto, may be withdrawn from the lumen 112 of the guide catheter 102, leaving the guide catheter 102 within the patient's vasculature for the subsequent introduction of a therapeutic device therethrough.

[0042] 8 and 9, an exemplary embodiment of a control assembly 106a that may be used with intravascular device 100 shown in Figures 3A-3B will be described. Control assembly 106 generally includes a frame 154, a rotational actuator 156 supported by frame 154, and a compound axial translation / articulation actuator 158 supported by frame 154.

[0043] The frame 154 includes at least one sliding rod 160 (in this case four sliding rods), a proximal end cap 162 that secures the proximal ends of the sliding rods 160 relative to one another, and a distal end cap 164 that secures the distal ends of the sliding rods 160 relative to one another. As best shown in FIG. 9 , the distal end cap 164 has a lumen 166 through which the proximal end 114 of the inner articulation member 104 is slidably disposed, and a reduced boss 168 having an annular ridge 170.

[0044] The rotational actuator 156 comprises a nose 172 having a distal lumen 174 within which the proximal end 108 of the outer catheter body 102 is secured, and a proximal annular cavity 176 within which the annular ridge 170 of the reduced boss 168 is rotatably disposed. Thus, the nose 172 can be rotated in both directions 196 about the longitudinal axis 118 relative to the distal end cap 164, thereby rotating the outer catheter body 102 about the longitudinal axis 118 relative to the frame 154. Where at least a portion of the control assembly 106a is releasably coupled to the proximal end 108 of the outer catheter body 102, the nose 172 can be releasably coupled to the proximal end 108 of the outer catheter body 102 using, for example, a threaded arrangement (not shown).

[0045] The axial translation / articulation actuator 158 comprises a housing 180 having at least one lumen 182 (four lumens in this case) through which the sliding rod 160 of the frame 154 is slidably disposed. The housing 180 further has a distal opening 184 within which the proximal end 114 of the inner articulation member 104 is secured. Thus, the frame 154 can be axially translated along the longitudinal axis 118 in both directions 198 relative to the housing 180 of the axial translation / articulation actuator 158, thereby axially translating the outer catheter body 102 along the longitudinal axis 118 relative to the inner articulation member 104.

[0046] 9, housing 180 also has a reduced diameter lumen 186 in communication with distal opening 184, through which pullwire 150 is slidably disposed. Axial translation / articulation actuator 158 further includes a rotary gear in the form of a pinion collar 188 rotatably slidable about housing 180, and a linear gear in the form of a rack 190 axially slidable within housing 180. Pinion collar 188 has internal threads 192, and the rack has a linear array of teeth 194 that engage with the internal threads 192 of pinion collar 188. Rack 190 has a lumen 196 within which a proximal end of pullwire 150 is mounted.

[0047] Thus, the pinion collar 188 can rotate in both directions 199 about the longitudinal axis 118 relative to the housing 180, thereby translating the pull wire 150 proximally within the inner articulation member 104 increasing articulation of the distal end 116 of the inner articulation member 104, or translating the pull wire 150 distally within the inner articulation member 104 decreasing articulation of the distal end 116 of the inner articulation member 104.

[0048] Although only one particular embodiment of the control assembly 106a has been described, it should be understood that any control assembly capable of translating the outer catheter body 102 distally over the inner articulation member 104 and articulating the distal end 116 of the inner articulation member 104 between straight and curved configurations may be used.

[0049] 10 and 11, an alternative embodiment of a control assembly 106b is described. Similar to the control assembly 106a described above, the control assembly 106b is mechanically coupled to the proximal end 108 of the outer catheter body 102 and the proximal end 114 of the inner articulation member 104. The control assembly 106b includes a frame 202 and a compound axial translation / articulation actuator 204 supported by the frame 202.

[0050] The frame 202 comprises at least one sliding rod 206 (in this case, two sliding rods) and a distal end cap 208 that secures the distal ends of the sliding rods 206 relative to one another. As best shown in FIG. 11 , the distal end cap 208 has a distal opening 210 within which the proximal end 108 of the outer catheter body 102 is mounted, and a through lumen 212 through which the proximal end 114 of the inner articulation member 104 is slidably disposed. When at least a portion of the control assembly 106b is releasably coupled to the proximal end 108 of the outer catheter body 102, the nose distal end cap 208 can be releasably coupled to the proximal end 108 of the outer catheter body 102 using, for example, a threaded arrangement (not shown).

[0051] The axial translation / articulation actuator 204 is configured to be manually gripped by an operator and includes an ergonomically shaped handle body 214 to allow the operator to more easily manipulate the outer catheter body 102 and the inner articulation member 104. In the illustrated embodiment, the handle body 214 has a rounded rectangular cross-section, but in alternative embodiments, the handle body 214 may have any cross-section (e.g., circular or hexagonal cross-section) that allows the operator to grip it securely. The handle body 214 has at least one blind lumen (not shown) (in this case, two blind lumens) within which the sliding rod 206 of the frame 202 is slidably disposed. The proximal end 114 of the inner articulation member 104 is attached to the handle body 214 via a connector 216. Thus, the distal end cap 208 and attached frame 202 are axially translated along the longitudinal axis 118 in both directions 222 relative to the axial translation / articulation actuator 204, thereby enabling the outer catheter body 102 to be axially translated along the longitudinal axis 118 relative to the inner articulation member 104.

[0052] The handle body 214 has a lumen 218 in communication with the connector 216, through which the pull wire 150 is slidably disposed. The axial translation / articulation actuator 204 further includes a sliding mechanism 220 axially slidably disposed within an exterior slot 223 of the handle body 214. A proximal end of the pull wire 150 is attached to the sliding mechanism 220. Thus, the sliding mechanism 220 can be slid proximally relative to the handle body 214 along the longitudinal axis 118 in both directions 224, thereby translating the pull wire 150 proximally within the inner articulation member 104, which increases the articulation of the distal articulation section 134 of the inner articulation member 104, and the sliding mechanism 220 can be slid distally along the longitudinal axis 118 relative to the handle body 214, thereby translating the pull wire 150 distally within the inner articulation member 104, which decreases the articulation of the distal end 116 of the inner articulation member 104.

[0053] 12A-12F, one technique for manipulating the control assembly 106 to perform a series of articulation and axial translation operations will be described. As shown in FIG. 12A, the distal end 110 of the outer catheter tube 102 is in its proximal-most position relative to the inner articulation member 104, and the distal end 116 of the inner articulation member 104, and thus the distal end 110 of the outer catheter tube 102, is in a straight configuration. In this configuration, when the intravascular device 100 includes the control assembly 106a (see FIGS. 8-9), the housing 180 of the axial translation / actuation actuator 158 is in its distal-most position relative to the frame 154, and the pinion collar 188 rotates about the longitudinal axis 118 in a neutral position relative to the housing 180 of the axial translation / articulation actuator 158. When the intravascular device 100 includes a control assembly 106b (see Figures 10-11), the handle body 214 of the axial translation / actuation actuator 204 is in its most distal position relative to the frame 202, and the sliding mechanism 220 is in its most distal position relative to the handle body 214 of the axial translation / articulation actuator 204.

[0054] 12B-12D, the distal end 116 of the inner articulation member 104 of the intravascular device 100, and thus the distal end 110 of the outer catheter tube 102, may then be gradually transformed from a straight configuration to a curved configuration. In this particular embodiment, the curved configuration has a Simmons-like shape consisting of a proximal curved section 130 and a distal curved section 132 (see FIG. 12D). If the intravascular device 100 includes a control assembly 106a (see FIGS. 8-9), during transformation from the straight configuration to the curved configuration, the pinion collar 188 rotates about the longitudinal axis 118 relative to the housing 180 of the axial translation / articulation actuator 158 from a neutral position to a curved actuated position. When intravascular device 100 includes control assembly 106b (see FIGS. 10-11), slide mechanism 220 is moved from its distal-most position to its proximal-most position relative to handle body 214 of axial translation / articulation actuator 204.

[0055] 12E-12F, the distal end 100 of the outer catheter tube 102 is gradually moved from its proximal-most position to its distal-most position relative to the inner articulation member 104. If the intravascular device 100 includes a control assembly 106a (see FIGS. 8-9), this is accomplished by translating the frame 154 distally, thereby moving the housing 180 of the axial translation / actuation actuator 158 from its distal-most position to its proximal-most position relative to the frame 154. If the intravascular device 100 includes a control assembly 106b (see FIGS. 10-11), this is accomplished by translating the frame 202 distally, thereby moving the handle body 214 of the axial translation / actuation actuator 204 from its distal-most position to its proximal-most position relative to the frame 202.

[0056] 13 and 14A-14H, one exemplary method 300 of performing a medical procedure on a patient using an intravascular device 100 will be described. In method 300, the medical procedure is a therapeutic procedure (e.g., placement of a stent) performed on one of blood vessels 404 (i.e., one of a first arterial branch 404a forming a left subclavian artery (LSA) 406 and a left vertebral artery (LVA) 408 extending from the patient's aortic arch 402, a second arterial branch 404b forming a left common carotid artery (LCCA) 410 extending from the patient's aortic arch 402, and a brachiocephalic artery 404c forming a right subclavian artery (RSA) 412, a right vertebral artery (RVA) 414, and a right common carotid artery (RCCA) 416 extending from the patient's aortic arch 402). Use of intravascular device 100 is suitable for accessing the second and third branches 404b, 404c extending from a type III aortic arch, as shown in Figures 14A-14I, although intravascular device 100 may also be used to access the first branch 404a extending from a type III aortic arch, or any of the branches extending from a type I aortic arch or a type II aortic arch.

[0057] The method 300 initially includes introducing the intravascular device 100 into the patient's vasculature, in this case via a femoral approach (step 302) (see FIG. 14A). The method 300 further includes advancing the intravascular device 100 distally within the patient's vasculature (step 304) until the distal end 114 of the outer catheter body 102 is adjacent a vascular opening in the patient's vasculature, in this case around the patient's aortic arch 402 and adjacent the opening 418 of the third arterial branch 404c (see FIG. 14B). In the illustrated method, the intravascular device 100 is advanced distally until the distal end 114 of the outer catheter body 102 is proximal to the patient's aortic valve 420.

[0058] The method 300 further includes manipulating the intravascular device 100 such that the distal end 110 of the outer catheter body 102 faces toward a vascular ostium, in the illustrated method, toward an ostium of a third arterial branch 404c extending from the patient's aortic arch 402. In particular, the method 300 includes actively articulating (step 306) the distal end 116 of the inner articulation member 104 via manipulation of the control assembly 106 (see FIG. 14C ).

[0059] In one method, the articulated distal end 116 of the inner articulating member 104 can be articulated to a proximal curve 126 that bends in a plane to mimic the curvature of the patient's aortic arch 402, and a distal curve 128 that bends in the same plane but in an opposite direction from the proximal curve 126, so that the distal end 116 of the inner articulating member 104, and therefore the distal end 110 of the outer catheter body 102, faces toward the ostium of the third arterial branch 404c extending from the patient's aortic arch 402. In the alternative, the articulated distal end 116 of the inner articulation member 104 is articulated into a single curve that directs the distal end 116 of the inner articulation member 104, and thus the distal end 110 of the outer catheter body 102, toward the ostium of the third arterial branch 404c extending from the patient's aortic arch 402, while the portion of the inner articulation member 104 along the length of the patient's aortic arch 402 is passively articulated by pressure exerted on the inner articulation member by the inner wall of the aortic arch 402.

[0060] If the aperture of the third arterial branch 404c is not in the plane of the distal curve 128 of the articulated distal end 116 of the inner articulation member 104, the method 30 can include a step (step 308) of actively rotating the distal end 110 of the outer catheter body 102 about the longitudinal axis 118 while the distal end 116 of the inner articulation member 104 is articulating until the aperture of the third arterial branch 404c is in the plane of the distal curve 128 of the articulated distal end 116 of the inner articulation member 104.

[0061] The method 300 further includes inserting the distal end 110 of the outer catheter body 102 into a vascular opening, in the illustrated method, into the opening of a third arterial branch 404c extending from the patient's aortic arch 402. In particular, the distal end 110 of the outer catheter body 102 is inserted into the opening of the third arterial branch 404c (step 310) by distally translating the distal end 110 of the outer catheter body 102 relative to the distal end 116 of the inner articulation member 104 (see FIG. 14D).

[0062] Importantly, as the distal end 110 of the outer catheter body 102 translates distally relative to the distal end 116 of the inner articulation member 104, the articulated distal end 116 of the inner articulation member 104 imposes a dynamic curvature on the outer catheter body 102. That is, as the outer catheter body 102 translates distally relative to the inner articulation member 104, the curvature imposed on the outer catheter body 102 by the articulated distal end 116 of the inner articulation member 104 remains stationary relative to the patient's aortic arch 402, but moves relative to the outer catheter body 102 itself. Thus, in contrast to selective catheters which have a static curvature that cannot move relative to the body of the selective catheter and therefore may prevent or impede the distal end of the selective catheter from being introduced into the vascular aperture, the dynamic curvature imposed on the outer catheter body 102 by the articulated distal end 116 of the inner articulation member 104 does not impede the introduction of the distal end 110 of the outer catheter body 102 into the vascular aperture (in this case the aperture of the third arterial branch 404c).

[0063] The method 300 further includes pulling the intravascular device 100 proximally (step 312) such that the dynamic curvature of the outer catheter body 102 is clamped against the outer curvature of the patient's aortic arch 402 (i.e., the portion of the wall of the aortic arch 402 from which the arterial branch 404 extends) (see FIG. 14E). As a result, the aortic arch 402 supports, and thus stabilizes, the distal end of the intravascular device 100, and the distal end 110 of the outer catheter body 102 is advanced further distally into a third arterial branch 404c extending from the patient's aortic arch 402 (in this case, into the RCCA 416).

[0064] The method 300 further includes translating the distal end 110 of the outer catheter body 102 distally relative to the distal end 116 of the inner articulation member 104 (step 314) such that the distal end 110 of the outer catheter body 102 is advanced further into the blood vessel (in this case, further into the RCCA 416 at the therapeutic target site 422) (see FIG. 14F). In this manner, the distal end of the intravascular device 100 is further anchored within the patient's aortic arch 402 while also providing access to the therapeutic target site 422 within the RCCA 416.

[0065] The method 300 further includes advancing the guide catheter 424 over the intravascular device 100 (step 316) while the distal end 110 of the outer catheter body 102 remains within the RCCA 416 until the distal end of the guide catheter 424 reaches the target treatment site 422 (see FIG. 14G). In the illustrated method, this can be accomplished by detaching the control assembly 106a or control assembly 106b from the proximal end 108 of the outer catheter body 102, removing the inner articulation member 104 from the lumen 112 of the outer catheter body 102 by pulling the detached control assembly 106a or detached control assembly 106b, and threading the distal end of the guide catheter 424 over the proximal end 108 of the outer catheter body 102.

[0066] Method 300 further includes removing intravascular device 100 (particularly, outer catheter body 102 of intravascular device 100) from guide catheter 424 (step 318) (see FIG. 14H) while the distal end of guide catheter 424 remains at the target treatment site 422, and introducing treatment device 426 (and in this case, a stent delivery catheter) through guide catheter 424 (step 320) (see FIG. 14I) until the distal end of treatment device 426 is located at the target treatment site 422.

[0067] In another embodiment in which the outer catheter body 102 of the intravascular device 100 takes the form of a guide catheter, instead of advancing the guide catheter 424 over the intravascular device 100 in step 316, removing the intravascular device 100 from the guide catheter 424 in step 318, and introducing a treatment device 426 through the guide catheter 424 in step 320, the method 300 alternatively includes removing the inner articulation member 104 from the lumen 112 of the outer catheter body 102 (step 322) and introducing the treatment device 426 (in this case a stent delivery catheter) through the lumen 112 of the outer catheter body 102 until a distal end of the treatment device 426 is located at the target treatment site 422.

[0068] Finally, the method 300 includes performing a therapeutic procedure at the target treatment site 422 using the treatment device 426, and in particular, placing a stent within the RCCA 416 at the target treatment site 422 (step 326).

[0069] 15 and 16A-16G, another exemplary method 350 of performing a medical procedure on a patient using intravascular device 100 is described. In method 350, the medical procedure is a diagnostic procedure (e.g., the introduction of a contrast (e.g., angiographic) agent) performed on one of arterial branches 404. Notably, in contrast to method 300 described above with respect to FIG. 13, in which intravascular device 100 is used as a stable rail over which a guide catheter is introduced and a separate therapeutic device is used to perform the medical procedure, intravascular method 350 uses intravascular device 100 itself to perform the medical procedure.

[0070] The method 350 initially includes introducing (step 352) the intravascular device 100 into the patient's vasculature, in this case via a radial approach (see FIG. 16A). The method 350 further includes advancing (step 354) the intravascular device 100 distally within the patient's vasculature, in this case through the RSA 410, through the third arterial branch 404c, and into the aortic arch 402 adjacent the orifice 428 of the second arterial branch 404b, until the distal end 114 of the outer catheter body 102 is adjacent a vascular orifice within the patient's vasculature (see FIG. 16B). In the illustrated method, the intravascular device 100 is advanced distally until the distal end 114 of the outer catheter body 102 is proximal to the patient's aortic valve 416.

[0071] The method 350 further includes manipulating the intravascular device 100 so that the distal end 110 of the outer catheter body 102 faces toward a vascular opening (in the illustrated method, the opening of a second arterial branch 404b extending from the patient's aortic arch 402).

[0072] In particular, the method 350 includes the step of actively articulating the distal end 116 of the inner articulation member 104 (step 356) (see FIG. 16C). In the illustrated method, articulation of the distal end 116 of the inner articulation member 104 can be accomplished in the same manner as described above with respect to step 306 of the method 300. In this manner, the articulated distal end 116 of the inner articulation member 104 articulates into a single curve that directs the distal end 116 of the inner articulation member 104, and thus the distal end 110 of the outer catheter body 102, toward the ostium of the second arterial branch 404b extending from the patient's aortic arch 402, while the portion of the inner articulation member 104 that resides along the length of the RSA 410 and the second arterial branch 404b passively articulates due to pressure imposed on the inner articulation member 104 by the inner wall of the RSA 410 and the second arterial branch 404b.

[0073] If the bore of the second arterial branch 404b is not in the plane of the curvature of the articulated distal end 116 of the inner articulation member 104, the method 350 may include rotating the distal end 110 of the outer catheter body 102 about the longitudinal axis 118 while the distal end 116 of the inner articulation member 104 is articulating (step 358) until the bore of the second arterial branch 404b is in the plane of the curvature of the articulated distal end 116 of the inner articulation member 104. In the illustrated method, the rotation of the outer catheter body 102 about the longitudinal axis 118 may be performed in the same manner as described above with respect to step 308 of method 300.

[0074] The method 350 further includes inserting the distal end 110 of the outer catheter body 102 into a vascular aperture (in the illustrated method, the aperture of a second arterial branch 404b extending from the patient's aortic arch 402). In particular, the distal end 110 of the outer catheter body 102 is inserted into the aperture of the second arterial branch 404b by distally translating the distal end 110 of the outer catheter body 102 relative to the distal end 116 of the inner articulation member 104 (step 360) (see FIG. 16D). Distal translation of the distal end 110 of the outer catheter body 102 relative to the distal end 116 of the inner articulation member 104 can be accomplished in the same manner as described above with respect to step 310 of method 300, with the same result of imposing a dynamic curvature on the outer catheter body 102 by the articulated distal end 116 of the inner articulation member 104 that does not impede introduction of the distal end 110 of the outer catheter body 102 into the vascular aperture (in this case the aperture of the second arterial branch 404b).

[0075] The method 350 further includes pulling the intravascular device 100 proximally (step 362) such that the dynamic curvature of the outer catheter body 102 is clamped against the outer curvature of the patient's aortic arch 402 (i.e., the portion of the wall of the aortic arch 402 from which the arterial branch 404 extends) (see FIG. 16E). As a result, the aortic arch 402 supports, and thus stabilizes, the distal end of the intravascular device 100, and the distal end 110 of the outer catheter body 102 is advanced further distally into the second arterial branch 404c extending from the patient's aortic arch 402 (in this case, into the LCCA 408).

[0076] The method 350 further includes translating the distal end 110 of the outer catheter body 102 distally relative to the distal end 116 of the inner articulation member 104 (step 364) such that the distal end 110 of the outer catheter body 102 is advanced further into the blood vessel (in this case, further into the LCCA 408 at the diagnostic target site 430) (see FIG. 16F). In this manner, the distal end of the intravascular device 100 is further secured within the patient's aortic arch 402 while also providing access to the diagnostic target site 430 within the LCCA 408. Finally, the method 350 includes introducing a contrast agent into the LCCA 408 via the intravascular device 100 (step 366) (see FIG. 16G).

[0077] While specific embodiments have been shown and described herein, those skilled in the art will understand that they are not intended to limit the disclosed invention, and it will be apparent to those skilled in the art that various changes, substitutions, and modifications (e.g., various part dimensions, combinations of parts) can be made without departing from the scope of the disclosed invention, which is defined solely by the following claims and their equivalents. Accordingly, the specification and drawings should be regarded in an illustrative sense, and not in a restrictive sense. The various embodiments shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed invention, which may fall within the scope of the appended claims.

Claims

1. an elongated inner articulation member configured to be slidably disposed within a lumen of an outer catheter body having a proximal catheter end, a distal catheter end, and a lumen extending between the proximal catheter end and the distal catheter end, the elongated inner articulation member having a proximal member end and an articulatable distal member end; a control assembly mechanically coupled to the proximal member end, the control assembly being further configured to be releasably coupled to the catheter proximal end and further configured to distally translate the outer catheter body over the inner articulation member to articulate the distal member end; An intravascular device comprising:

2. The intravascular device of claim 1 , wherein the control assembly is configured to articulate the distal member end into a single curved planar shape.

3. The intravascular device of claim 1 , wherein the control assembly is configured to articulate the distal member end into multiple curved shapes.

4. The intravascular device of claim 1 , wherein the control assembly is a manually operated control assembly.

5. The intravascular device of claim 1 , wherein the catheter distal end is configured for insertion into a branch of a human aortic arch.

6. 10. The intravascular device of claim 1, further comprising at least one pull wire operably connected between the distal member end and the control assembly, the control assembly configured to articulate the distal member end by applying tension to the at least one pull wire.

7. The intravascular device of claim 1 , wherein the catheter distal end has one or more injection openings.

8. The intravascular device of claim 1 , wherein the catheter distal end includes a distal wire tip.

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