Dynamic curve access tool for complex arch anatomy and radial access

Abstract

To provide a device and method for controlling deflection at a distal end of a catheter.SOLUTION: An intravascular device 100 comprises an elongated outer catheter body 102 having a proximal catheter end 108, a distal catheter end 110, and an inner catheter lumen extending between the proximal catheter end and the distal catheter end. The intravascular device further comprises an elongated inner articulating member 104 slidably disposed within the inner catheter lumen. The inner articulating member has a proximal member end and an articulatable distal member end. The intravascular device further comprises a control assembly 106 mechanically coupled to the proximal catheter end and the proximal member end. The control assembly is configured for distally translating the outer catheter body over the inner articulating member, and for articulating the distal member end.SELECTED DRAWING: Figure 3-1

Description

Technical Field

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

Background Art

[0002] Therapeutic or diagnostic catheters are commonly used to perform medical procedures within the very narrow spaces within a patient's body. Most of these medical procedures require accurate catheter navigation. To access a target site within a human body from a remote location, a catheter typically passes 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 passed through the patient's vascular system to reach the desired target site. In many cases, a delivery device, such as a guide catheter or a long sheath, is used to create a path through the vascular system to the target site, through which a therapeutic or diagnostic catheter can be guided to the target site.

[0003] The utility of a guiding catheter is highly limited by its ability to successfully navigate through narrow blood vessels and around tight bends within the vascular system, such as around the aortic arch. Access to large blood vessels distant from the aortic arch poses challenges, especially due to anatomical features, when the device has to follow a very curved or poorly supported path. To overcome some of these challenges, an internal guide rail has been provided that can cross the selected path of a guiding catheter or long sheath over which a guiding catheter or long sheath has been selected and reach the intended target position of the guiding catheter or long sheath, thereby developing a selectively preformed catheter that is preformed to guide a guiding catheter or long sheath. Such a preformed selective catheter can have a plurality of axially spaced bends that enable access to large blood vessels starting from the aortic arch. In many cases, diagnostic catheters are used for the same purpose as selective catheters, and selective catheters generally differ only in length so as to fit inside a guiding catheter or long sheath. For example, various types of preformed distal ends (e.g., Simmons, Headhunter, Vitek, Bentson, Newton, Berenstein shapes) have been developed for diagnostic and selective catheters to assist in successfully traversing both torsions and bifurcations common to a patient's arterial or venous system and maintain their shape even after being placed within a target cavity (e.g., a heart chamber). However, since the preformed bends are fixed to the selective catheter during manufacturing, the radius, degree of curvature, and overall shape generally cannot be changed in situ. Due to anatomical differences, extensive preoperative planning is required to determine the appropriate curvature of the selective catheter. In current medical practice, it is necessary to estimate and select an existing shape that is the closest approximation to the patient's anatomical shape.

[0004] In one particular treatment, to treat atherosclerosis, a stent may be placed in one or more carotid arteries or their branches using a guiding catheter. In the course of the disease that occurs within these blood vessels, the inner wall of the blood vessel deteriorates, and the diseased substances detached from the inner wall of the blood vessel are washed away throughout the arterial system while sequentially reducing the blood vessel diameter, remaining within the blood vessel construction part, and the blood flow in the blocked area may stop, causing tissue death due to oxygen deficiency. This disease process is the main cause of stroke, heart attack, and other debilitating or fatal events. As atherosclerosis of the carotid artery progresses, the risk of stroke increases, and in particular, an intervention is required to prevent stroke or death caused by a blood clot or blood vessel fragment remaining in the brain, especially in relation to diseases of the internal carotid artery branches that supply the brain or the common carotid artery preceding it in the circulatory pathway. It should be noted that stroke is the third most common cause in developing countries. 85% of all strokes are essentially ischemic (due to cerebral circulatory disorders), 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 carotid artery or the common carotid artery, one treatment performed by an intervention specialist (interventional radiologist, vascular surgeon, or interventional cardiologist) is the placement of a stent, which is an expandable cylindrical wire or plastic mesh that supports and stabilizes the diseased part of the artery and is called angioplasty, a treatment in which an inflatable balloon is used to instantaneously expand the balloon sent through the entire inner diameter of the blood vessel in the narrowed area to improve the stenosis (narrowing) of the artery.

[0005] Access to the left or right carotid artery can be difficult because it may depend on the anatomical arrangement of the aortic arch. For example, referring to FIGS. 1A-1C, a typical human has a aortic arch 10 with three main arterial branches emerging from the aortic arch 10, including a first arterial branch 12 forming the left subclavian artery (LSA) 14 and the left vertebral artery (LVA) 16, a second arterial branch 18 forming the left common carotid artery 20 (LCCA), and a third arterial branch (brachiocephalic artery) forming the right subclavian artery (RSA) 24, the right vertebral artery (RVA) 26, and the right common carotid artery (RCCA) 28.

[0006] There are three types of aortic arches defined by the height h of the top of the aortic arch 10 from the base position where the brachiocephalic artery 22 attaches to the aortic arch 10. In a type I aortic arch, as shown in FIG. 1A, the height h is not significant (h is less than the diameter of the LCCA 20 or the RCCA 28). In a type II aortic arch, as shown in FIG. 1B, the height h is significantly increased (h is between 1 and 2 times the diameter of the LCCA 20 or the RCCA 28). In a type III aortic arch, as shown in FIG. 1C, the height h is further increased (h is greater than 2 times the diameter of the LCCA 20 or the RCCA 28). 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, in the severe aortic arch of type III as shown in FIG. 1C, the angle of origin of the second arterial branch 18 or the third arterial branch 22 is very acute, which may make access to the LCCA 20 or the RCCA 28 difficult. The bovine type aortic arch is another example of difficult anatomy, where the origin of the LCCA (18) emerges from the brachiocephalic artery (22).

[0007] For example, when accessing one of the arterial branches from the aortic arch 10, an interventional specialist can choose between a femoral approach or a radial approach. As shown in FIG. 2A, during the femoral approach, the catheter 30 is introduced into the femoral artery, ascends the abdominal aorta to reach the descending aorta, and can reach 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 the radial approach, the catheter 30 is introduced into the radial artery, passes through it, through the brachial artery and the axillary artery, then along the RSA 24, and finally enters into the aortic arch 10. In one method, to provide a stable platform through which an intervention device (e.g., a stent delivery device) is introduced into the diseased artery, the catheter 30 is inserted into a selected one of the arterial branches from the aortic arch 10. In another method, the catheter 30 can function as a diagnostic catheter for injecting a contrast agent into one of the main arterial branches extending from the aorta. In many cases, a selective catheter with a pre-bent or pre-shaped distal end can 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 in the neck or above the neck are difficult, especially when faced with a severe aortic arch such as a type III or bovine arch, or when the LCCA exits the arch at an acute angle. The intervention device introduced through the guide catheter is often relatively stiff, and due to the tortuous portion of the blood vessels starting from the aortic arch 10, the catheter 30 can become unstable with the intervention device and may be pushed out into the aortic arch 10. Therefore, it is important to introduce the catheter 30 as far distally as possible into the arterial branches of the aortic arch to provide a stable platform for the intervention device to move to its intended treatment position.

[0009] However, stroke intervention devices are getting larger and, as a result, the guide sheaths that provide a support platform for these larger intervention devices must be larger and more supportive. Newer, more supportive and flexible guide catheter designs have been developed and are continuing to be developed, but the problem of crossing unsupported anatomical bends remains. Even when selective catheters are used to facilitate proper orientation of the guide catheter within the aortic arch 10, the curvature statically disposed 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 so as to achieve greater stability to further facilitate the advancement of a large supportive intervention device over the selective catheter.

[0010] Accordingly, there remains a continuing need for improved means for manipulating a guide catheter within an anatomical blood 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 injection 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 the human aortic arch.

[0012] The intravascular device further comprises an elongate inner articulating member slidably disposed within the lumen of the outer catheter body. The inner articulating member has a proximal member end and an articulable distal member end.

[0013] The intravascular device further comprises a control assembly mechanically coupled to the proximal end of the catheter and the proximal member end. The control assembly is configured to translate the outer catheter body distally over the inner articulating member and 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 a multi-curved shape. 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 proximal end of the catheter. In yet another embodiment, the device further comprises at least one pull wire operably connected between the distal member end and the control assembly, wherein the control assembly is configured to articulate the distal member end by applying tension to the pull wire(s).

[0014] According to a second aspect of the present invention, the intravascular device comprises an elongated inner articulating member configured to be slidably disposed within the lumen of an 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 is configured to be inserted into a branch of the human aortic arch. The inner articulating member has a proximal member end and an articulable 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 proximal end of the catheter. The control assembly is further configured to translate the outer catheter body distally over the inner articulating member and 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 a multi-curved shape. 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 proximal end of the catheter. 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, wherein the control assembly is configured to articulate the distal member end by applying tension to 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 has a distal member end.

[0017] This method includes the step of introducing an intravascular device into a patient's vasculature (e.g., a femoral approach or a radial approach). The method further includes the step of advancing the intravascular device distally within the patient's vasculature until the distal end of the catheter is adjacent to a vascular pore within the vasculature. In one method, the vessel is an arterial branch extending from the patient's aortic arch (e.g., a type III aortic arch), such as 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). When the arterial branch is the third arterial branch, the step of further advancing the distal end of the catheter into the vessel can include the step of advancing the distal end of the catheter into the RCCA. In another method, the distal end of the catheter is inserted into the vascular pore by sliding the distal end of the catheter distally with respect to the distal member end.

[0018] This method further includes the step of actively articulating the distal member end such that the distal end of the catheter is directed toward the vascular pore. This method further includes the steps of inserting the distal end of the catheter into the vascular pore and sliding the distal end of the catheter distally relative to the distal member end such that the distal end of the catheter further advances into the blood vessel. One method can further include the steps of advancing a guide catheter over the intravascular device while the distal end of the catheter 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 method can further include the steps of 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 can further include the steps of removing an inner member from the lumen of the outer catheter body, advancing a guide catheter through the lumen of the outer catheter body while the distal end of the catheter 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 can further include the steps of introducing a treatment device through the lumen of the outer catheter body until the treatment device reaches the target treatment site and performing a treatment procedure at the target treatment site using the treatment device. An optional method further includes the step of 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 when considered in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0020] The drawings illustrate the design and utility of the preferred embodiments of the disclosed invention, and like elements are referred to by common reference numerals. It should be noted that the figures are not drawn to scale, and elements of similar structure or function are represented by like reference 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 a comprehensive description of the invention or as a limitation on the scope of the invention, which is defined only by the appended claims and their equivalents. Also, the illustrated embodiments of the disclosed invention need not have all of the aspects or advantages shown. Further, aspects or advantages described in connection with a particular embodiment of the disclosed invention are not necessarily limited to that embodiment and may be practiced in other embodiments even if not shown.

[0021] To better understand how the above and other advantages and objects of the disclosed invention are obtained, a more specific description of the disclosed invention briefly described above will be made with reference to the specific embodiments shown in the accompanying drawings. It is understood that these drawings show only typical embodiments of the invention and thus should not be considered as limiting its scope, and that the invention will be described and explained with additional specificity and detail by using the accompanying drawings.

[0022]

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[0023] Referring to FIGS. 3A - 3C, an embodiment of an intravascular device 100 constructed 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 (specifically, used as an alternative to a conventional selective catheter or diagnostic catheter) for advancing a guide catheter to a target treatment site within a patient's body, and the guide catheter is then used to direct a treatment device (e.g., a catheter or other instrument) to the target treatment site. The intravascular device 100 is particularly useful for facilitating the delivery of a relatively stiff device through an unsupported curvature, 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, guide wire, or working catheter itself, that is intended to perform a medical procedure (treatment or diagnosis) that can benefit from accessing a vascular pore (e.g., the pore of an arterial branch remote from the patient's aortic arch).

[0024] In contrast to a selective catheter having a static curvature in a static position on the catheter, or even a conventional steerable catheter that prevents the catheter from advancing distally into the blood vessel through a pore, the intravascular device 100 can be shaped such that the distal end of the intravascular device 100 is directed toward or into a vascular pore, and the distal end of the intravascular device 100 is advanced distally relative to the shaped curvature, thereby facilitating the advancement of the distal end of the intravascular device within the blood vessel while the shaped curvature remains positioned at the location of a tortuous anatomical structure that the curvature facilitates passage through.

[0025] For this purpose, the elongated intravascular device 100 generally comprises an outer catheter body 102, an inner articulating 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 articulating member 104 is slidably disposed. The inner articulating 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 articulating member 104 to articulate the inner articulating member 104 such that, via an energy transfer element (and in particular one or more pull wires), and thus via the elongated intravascular device 100 (see FIG. 3B), a bend is formed in the inner articulating member and the outer catheter body 102 is translated axially 120 along the longitudinal axis 118 relative to the inner articulating member 104 (see FIG. 3C). In the embodiment shown in FIG. 3B, the bend formed by the inner articulating member 104 is shown as a simple bend (a single bend), but as will be described in more detail below, the bend formed by the inner articulating member 104 may be a complex bend with multiple bends. Optionally, the control assembly 106 may be configured to translate the outer catheter body 102 relative to the inner articulating member 104 in a rotational direction 122 about the longitudinal axis 118.

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

[0027] The outer catheter body 102 preferably has a diameter of about 2 French to 9 French and a length of 80 cm to 150 cm. The outer catheter body 102 preferably has a circular cross-sectional shape. However, other cross-sectional shapes can also be used, such as elliptical, rectangular, triangular, and various customized shapes. The outer catheter body 102 is preferably preformed from a plastic material (e.g., Pebax®, polyethylene, polyurethane, polyamide, Hytrel® (polyester)) that retains its shape at body temperature and is inert, elastic, and does not significantly soften. 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 composed of a plurality of material layers and / or a plurality of tube structures that exhibit low bending rigidity while providing high axial rigidity along the longitudinal axis of the outer catheter body 102. Preferably, the outer catheter body 102 has an appropriate torsional rigidity so that it can rotate independently of the inner articulating member 104. Typical designs include a nitinol spine encapsulated in a braid and a braided plastic composite structure composed of any flexible, compliant, or suitable polymer material, laser-cut hypo-tubes, or biocompatible polymer materials, or low durometer plastics (e.g., nylon-12, Pebax®, polyurethane, polyethylene, etc.).

[0029] The inner lumen 112 is disposed over 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 can be formed by an inner polymeric tube (e.g., polytetrafluoroethylene (PTFE) having a thickness of 0.001 inches). The distal end 110 of the outer catheter body 102 terminates at a non-traumatic distal tip 124. In one embodiment shown in FIG. 4A, the catheter distal end 100 has a pre-formed curvature. In other embodiments shown in FIGS. 4B-4G, the catheter distal end 100 has a straight configuration. In the embodiments shown in FIGS. 4A-4B and 4G, the non-traumatic distal tip 124 is closed or sealed, and in the embodiments shown in FIGS. 4C-4F, the non-traumatic 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 agent injection. In the embodiments shown in FIGS. 4F-4G, the intravascular device 100 includes a distal wire tip 128 that facilitates entry into a vascular pore.

[0030] Referring to FIG. 5, the distal end 116 of the inner articulating member 104 (shown in FIGS. 3A-3C), and thus the distal end 110 of the outer catheter tube 102, is configured to gradually articulate from a straight configuration to a curved configuration to assume a planar shape of a plurality of curves. In this embodiment, the distal end 116 of the inner articulating member 104 can articulate to a proximal curve 130 that bends in a plane, particularly to mimic the curvature of a typical aortic arch, and a distal curve 130 that bends in the same plane but on the opposite side of the proximal curve 130, such that the distal end 116 of the inner articulating member 104, and thus the distal end 110 of the outer catheter body 102, is oriented towards the pore of the arterial branch that branches from the patient's aortic arch. The plurality of curved configurations shown in FIG. 5 are merely exemplary, and it should be understood that alternative embodiments of the distal end 116 of the inner articulating member 104 can include only a single curve, or different shapes or different numbers of bends including out-of-plane bends or even multiple compound curves including multiple compound curves that are different from one another.

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

[0032] The distal joint motion section 134 preferably allows for a moderate degree of axial compression and optimal lateral flexibility. The distal joint motion section 134 has several portions of different stiffnesses. In an exemplary embodiment shown in FIG. 7, the distal joint motion section 134 includes a relatively flexible distal joint motion region 140 that forms a distal curvature 132, a relatively flexible proximal joint motion region 144 that forms a proximal curvature 130, and a relatively inflexible non-joint motion region 142 located between the proximal joint motion region 144 and the distal joint motion region 140.

[0033] In the embodiment shown in FIG. 7, the distal articulation section 134 is formed of a slotted (e.g., micro-machined or laser-cut) hypo tube that adjusts the flexibility, bend arc length, minimum bend radius, and bend surface of the distal articulation section 134. In particular, the slotted hypo tube has strategically sized and positioned slots 146 such that the articulation section 134 forms a proximal bend 130 that coincides with the proximal articulation region 144 and a distal bend 132 that coincides with the distal articulation region 140. The distal articulation section 134 further includes a pair of helical struts 148 disposed in the non-articulation region 142 and adding lateral stiffness thereto such that the proximal and distal articulation regions 144 and 140 of the distal articulation section 134 articulate predictably around the non-articulation region 142 to form the proximal bend 130 and the distal bend 132. In an alternative embodiment, instead of a laser-cut hypo tube, the distal articulation section 134 can be formed by having a different outer tube composed of a suitable polymeric material (e.g., Pebax®). In this alternative case, to enhance the axial stiffness and elastic properties, the distal articulation section 134 can include a braided layer (e.g., 16 pieces of 0.0005 inch × 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 polymeric tube, can include coils having various pitches, or can include a slotted (e.g., micro-machined) hypo tube to adjust the flexibility and flexion surface of the distal articulation section 134.

[0034] As briefly described above, the energy transmission conduit(s) is a mechanical energy transmission conduit and, in particular, takes the form of one or more pull wires extending within the inner articulating member 104. In the illustrated embodiment, a single pull wire 150 is used. In the illustrated embodiment, the distal articulating section 134 includes 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. The tension of the pull wire 150 via the operation of the control assembly 106 (as will be described in more detail below) deforms the distal articulating section 134 from a straight configuration to a curved configuration.

[0035] The pull wire 150 may be a metal wire, cable, or filament, or it 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 can be any type of suitable wire, cable, or filament that can support various types of loads without deformation, significant deformation, or breakage. Although the mechanical energy transmission conduit(s) has been described as 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) can take the form of a small-diameter tube or rod that is axially rigid but laterally flexible. Further, in alternative embodiments of the intravascular device 100, non-mechanical conduits, such as fluid transmission conduits (e.g., hydraulic or pneumatic), electrical transmission conduits (i.e., electrical wires), electromagnetic energy (e.g., light) transmission conduits, etc., can be used as the energy transmission conduit. In essence, any energy transmission conduit that can transmit any energy from the proximal end 114 to the distal end 116 of the inner articulating member 104 can be used to articulate the distal articulating section 134 to form the proximal curvature 130 and the distal curvature 132.

[0036] To apply different forces along the distal end 116 of the inner articulating member 104 to generate the proximal bending portion 130 and the distal bending portion 132, the pull wire 150 is slidably disposed and floats within a central lumen 153 that extends through the inner articulating member 104. In an alternative embodiment, two pull wires may extend through two pull wire lumens (not shown) that extend through the inner articulating member 104. In this case, the pull wire lumens may be constructed of a low friction material or may simply be unsupported tubular cavities in which the pull wires float internally, and may be provided in the inner articulating member 104 in a circumferentially spaced-apart relationship of 180 degrees.

[0037] As will be described in more detail below, the proximal end of the pull wire 150 is operably coupled to the control assembly 106, and the distal end of the pull wire 150 is fixed to the distal end 116 of the inner articulating member 104. Thus, the operation of the pull wire 150 via manual operation of the control assembly 106 applies or changes the force or tension to the distal end 116 of the inner articulating member 104 that can articulate to generate the proximal bending portion 130 and the distal bending portion 132. In the illustrated embodiment, since the portion of the outer catheter body 102 surrounding the distal articulating section 134 of the inner articulating member 104 is elastic, when the pull wire 150 is released via manual operation of the control assembly 106, the force or tension inside the distal articulating section 134 of the inner articulating member 104 is released, allowing the distal articulating section 134 to return to a straight configuration.

[0038] The intermediate transition section 136 clearly defines the proximal end of the distal articulating section 134 and resists axial compression while transmitting the movement of the pull wire 150 to the distal articulating section 134, while maintaining lateral flexibility so that the intravascular device 100 can track through tortuous anatomical structures. The intermediate transition section 136 can be formed from an outer tube constructed of a slotted hypo tube or a suitable polymeric material (e.g., Pebax®).

[0039] The proximal shaft portion 138 gradually transitions by having the inner joint motion member 102 transition from the intermediate transition section 136 to the more rigid remaining portion of the inner joint motion member 102, with different sections of a slotted hypotube configuration or different outer tubes made of a suitable polymeric material (e.g., Pebax®). To increase the axial rigidity of any polymeric tube segment, the proximal shaft section 138 can comprise a double braided layer (e.g., 16 pieces of 0.0005 inch × 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 polymeric tube.

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

[0041] When the intravascular device 100 functions as a rail for the subsequent introduction of a guide catheter or other device, at least a portion of the control assembly 106 can be releasably coupled to the outer catheter body 102. Thus, the control assembly 106, together with the inner articulating member 104 coupled thereto, can be withdrawn from the lumen 112 of the outer catheter body 102, leaving the outer catheter body 102 within the patient's vasculature and using it as a rail for a subsequently introduced guide catheter. The inner articulating member 104, together with the attached control assembly 106, can be packaged and sold together with the outer catheter body 102 to form the intravascular device 100, or the inner articulating member 104, together with the attached control assembly 106, can 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, together with the attached control assembly 106, is packaged and sold as an introducer and then coupled to the guide catheter 102 to form the intravascular device 100. Thus, the control assembly 106, together with the inner articulating member 104 coupled thereto, can be withdrawn from the lumen 112 of the guide catheter 102, leaving the guide catheter 102 within the patient's vascular structure and allowing a treatment device to be subsequently introduced therethrough.

[0042] Referring now to FIGS. 8 and 9, an exemplary embodiment of a control assembly 106a that can be used with the intravascular device 100 shown in FIGS. 3A-3B will be described. The control assembly 106 generally includes a frame 154, a rotary actuator 156 supported by the frame 154, and a compound axial translation / articulation actuator 158 supported by the frame 154.

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

[0044] The rotary actuator 156 includes a nose 172 having a distal lumen 174 within which the proximal end 108 of the outer catheter body 102 is fixed, 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 bidirectionally 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. When 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 configuration (not shown).

[0045] The axial translation / articulation actuator 158 includes a housing 180 having at least one lumen 182 (in this case, four lumens) through which the sliding rods 160 of the frame 154 are slidably disposed. The housing 180 further has a distal opening 184 within which the proximal end 114 of the inner articulating member 104 is fixed. Thus, the frame 154 can be axially translated bidirectionally 198 along the longitudinal axis 118 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 articulating member 104.

[0046] As best shown in FIG. 9, housing 180 also has a reduced-diameter lumen 186 that communicates with distal opening 184, through which pull wire 150 is slidably disposed. Axial translation / articulation actuator 158 further includes a rotary gear in the form of a pinion collar 188 that is rotatably slidable about housing 180, and a linear gear in the form of a rack 190 that is axially slidable within housing 180. Pinion collar 188 has an internal thread 192, and the rack has a straight row of teeth 194 that engage internal thread 192 of pinion collar 188. Rack 190 has a lumen 196 within which the proximal end of pull wire 150 is internally attached.

[0047] Thus, pinion collar 188 can be rotated bidirectionally 199 about longitudinal axis 118 relative to housing 180, thereby advancing pull wire 150 proximally within inner articulation member 104 to increase the articulation of distal end 116 of inner articulation member 104, or advancing pull wire 150 distally within inner articulation member 104 to decrease the articulation of distal end 116 of inner articulation member 104.

[0048] Although only one specific embodiment of control assembly 106a has been described, it should be understood that any control assembly can be used that axially translates outer catheter body 102 distally over inner articulation member 104 and articulates distal end 116 of inner articulation member 104 between a straight configuration and a curved configuration.

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

[0050] Frame 202 includes at least one sliding rod 206 (in this case, two sliding rods) and a distal end cap 208 that fixes the distal ends of the sliding rods 206 to each other. As best shown in FIG. 11, the distal end cap 208 has a distal opening 210 to which the proximal end 108 of the outer catheter body 102 is internally attached, and a through lumen 212 through which the proximal end 114 of the inner articulating 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, for example, using a threaded configuration (not shown).

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

[0052] The handle body 214 has a lumen 218 that communicates with the connector 216, and the pull wire 150 is slidably disposed through this lumen. The axial translation / articulation actuator 204 further includes a sliding mechanism 220 that is axially slidably disposed within an outer slot 223 of the handle body 214. The 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 in a bi-directional 224 along the longitudinal axis 118, 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 relative to the handle body 214 along the longitudinal axis 118, 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] Referring now to FIGS. 12A-12F, one technique for operating 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 most proximal 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 most distal position relative to the frame 154, and the pinion collar 188 is in a neutral position relative to the housing 180 of the axial translation / articulation actuator 158 and rotates about the longitudinal axis 118. When the intravascular device 100 includes the control assembly 106b (see FIGS. 10-11), the handle body 214 of the axial translation / articulation 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] As shown in FIGS. 12B - 12D, the distal end 116 of the inner articulating member 104 of the intravascular device 100, and thus the distal end 110 of the outer catheter tube 102, can then be gradually deformed from a straight configuration to a curved configuration. In this particular embodiment, the curved configuration has a Simmons - like shape consisting of a proximal bend 130 and a distal bend 132 (see FIG. 12D). When the intravascular device 100 includes the control assembly 106a (see FIGS. 8 - 9), during deformation from the straight configuration to the curved configuration, the pinion collar 188 rotates about the longitudinal axis 118 from a neutral position to a curved actuation position relative to the housing 180 of the axial translation / articulation actuator 158. When the intravascular device 100 includes the control assembly 106b (see FIGS. 10 - 11), the sliding mechanism 220 is moved from its most distal position to its most proximal position relative to the handle body 214 of the axial translation / articulation actuator 204.

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

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

[0057] 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). Method 300 further includes advancing the intravascular device 100 distally within the patient's vasculature until the distal end 114 of the outer catheter body 102 is adjacent to a vascular pore within the patient's vasculature, in this case around the patient's aortic arch 402 and adjacent to the pore 418 of the third arterial branch 404c (step 304) (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] Method 300 further includes the step of manipulating intravascular device 100 such that the distal end 110 of outer catheter body 102 faces the vascular orifice, which in the illustrated method faces the orifice of a third arterial branch 404c extending from the aortic arch 402 of the patient. In particular, method 300 includes the step (step 306) of actively articulating the distal end 116 of inner articulating member 104 via manipulation of control assembly 106 (see FIG. 14C).

[0059] In one method, the articulated distal end 116 of inner articulating member 104 can articulate to a proximal curvature 126 that bends in a plane to mimic the curvature of the aortic arch 402 of the patient, and a distal curvature 128 that bends in the same plane but opposite the proximal curvature 126, such that the distal end 116 of inner articulating member 104, and thus the distal end 110 of outer catheter body 102, faces the orifice of a third arterial branch 404c extending from the aortic arch 402 of the patient. In another method, the articulated distal end 116 of inner articulating member 104 is articulated to a single curvature that directs the distal end 116 of inner articulating member 104, and thus the distal end 110 of outer catheter body 102, toward the orifice of a third arterial branch 404c extending from the aortic arch 402 of the patient, while the portion of inner articulating member 104 that lies along the length of the aortic arch 402 of the patient is passively articulated by the pressure exerted on the inner articulating member by the inner wall of the aortic arch 402.

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

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

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

[0063] Method 300 further includes pulling the intravascular device 100 in the proximal direction (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 (in this case, into the RCCA 416) extending from the patient's aortic arch 402.

[0064] 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 articulating member 104 such that the distal end 110 of the outer catheter body 102 advances further intravascularly (in this case, further into the RCCA 416 at the treatment target site 422) (see FIG. 14F). In this way, the distal end of the intravascular device 100 is further fixed within the patient's aortic arch 402 while also providing access to the treatment target site 422 within the RCCA 416.

[0065] Method 300 further includes advancing a guide catheter 424 over the intravascular device 100 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 (step 316) (see FIG. 14G). In the illustrated method, this can be accomplished by removing the control assembly 106a or control assembly 106b from the proximal end 108 of the outer catheter body 102, pulling the removed control assembly 106a or removed control assembly 106b, removing the inner articulating member 104 from the lumen 112 of the outer catheter body 102, and passing the distal end of the guide catheter 424 beyond the proximal end 108 of the outer catheter body 102.

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

[0067] In another embodiment where 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 the treatment device 426 through the guide catheter 424 in step 320, method 300 alternatively includes the step of removing the inner articulating member 104 from the lumen 112 of the outer catheter body 102 (step 322), and the step of introducing the treatment device 426 (in this case, the stent delivery catheter) through the lumen 112 of the outer catheter body 102 until the distal end of the treatment device 426 is positioned at the target treatment site 422.

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

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

[0070] Method 350 initially includes a step (step 352) of introducing the intravascular device 100 into the patient's vasculature (in this case, via a radial approach) (see FIG. 16A). Method 350 further includes a step (step 354) of advancing 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 to the orifice 428 of the second arterial branch 404b) until the distal end 114 of the outer catheter body 102 is adjacent to a blood vessel 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] Method 350 further includes a step of manipulating the intravascular device 100 so that the distal end 110 of the outer catheter body 102 faces towards a blood vessel orifice (in the illustrated method, the orifice of the second arterial branch 404b extending from the patient's aortic arch 402).

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

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

[0074] Method 350 further includes the step of inserting the distal end 110 of the outer catheter body 102 into a vascular pore (in the illustrated method, the pore of the 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 pore of the second arterial branch 404b by translating the distal end 110 of the outer catheter body 102 distally relative to the distal end 116 of the inner articulating member 104 (step 360) (see FIG. 16D). The distal translation of the distal end 110 of the outer catheter body 102 relative to the distal end 116 of the inner articulating member 104 can be achieved in the same manner as described above with respect to step 310 of method 300, and the same result of imposing dynamic curvature on the outer catheter body 102 by the articulating distal end 116 of the inner articulating member 104 is obtained, which does not prevent the distal end 110 of the outer catheter body 102 from being introduced into the vascular pore (in this case, the pore of the second arterial branch 404b).

[0075] Method 350 further includes the step of 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 further advanced distally into the second arterial branch 404c (in this case, into the LCCA 408) extending from the patient's aortic arch 402.

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

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

Claims

**Claim 1** An elongated 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, An elongated inner articulating member slidably disposed within the lumen of the outer catheter body, the inner articulating member having a proximal member end and an articulable distal member end, A control assembly mechanically coupled to the catheter proximal end and the proximal member end, the control assembly configured to translate the outer catheter body distally over the inner articulating member and to articulate the distal member end, An intravascular device comprising the above components. **Claim 2** The intravascular device according to claim 1, wherein the control assembly is configured to articulate the distal member end into a single-curved planar shape. **Claim 3** The intravascular device according to claim 1, wherein the control assembly is configured to articulate the distal member end into a multi-curved shape. **Claim 4** The intravascular device according to claim 1, wherein the control assembly is a manually operated control assembly. **Claim 5** The intravascular device according to claim 1, wherein the control assembly is releasably coupled to the catheter proximal end. **Claim 6** The intravascular device according to claim 1, wherein the catheter distal end has one or more injection openings. **Claim 7** The intravascular device according to claim 1, wherein the catheter distal end includes a distal wire tip. **Claim 8** The intravascular device according to claim 1, wherein the catheter distal end is configured to be inserted into a branch of the human aortic arch. **Claim 9** The intravascular device according to 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. **Claim 10** An elongated inner articulating member configured to be slidably disposed within the lumen of an 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, the elongated inner articulating member having a proximal member end and an articulable distal member end, A control assembly mechanically coupled to the proximal member end, further configured to be releasably coupled to the catheter proximal end, further configured to translate the outer catheter body distally over the inner articulating member, and further configured to articulate the distal member end. An intravascular device comprising the above. **Claim 11** The intravascular device according to claim 10, wherein the control assembly is configured to articulate the distal member end into a single-curved planar shape. **Claim 12** The intravascular device according to claim 10, wherein the control assembly is configured to articulate the distal member end into a multi-curved shape. **Claim 13** The intravascular device according to claim 10, wherein the control assembly is a manually operated control assembly. **Claim 14** The intravascular device according to claim 10, wherein the control assembly is releasably coupled to the catheter proximal end. **Claim 15** The intravascular device according to claim 10, wherein the catheter distal end is configured to be inserted into a branch of the human aortic arch. **Claim 16** The intravascular device according to claim 10, further comprising at least one pull wire operably connected between the distal member end and the control assembly, wherein the control assembly is configured to articulate the distal member end by applying tension to the at least one pull wire. **Claim 17** A method of performing a medical procedure on a patient using an intravascular device including an elongated outer catheter body having a catheter distal end and a catheter lumen, and an elongated inner member slidably disposed within the catheter lumen and having a distal member end, the method comprising: introducing the intravascular device into the patient's vasculature; advancing the intravascular device distally within the patient's vasculature until the catheter distal end is adjacent to a vascular pore within the vasculature; actively articulating the distal member end so that the catheter distal end is directed toward the pore of the blood vessel; inserting the catheter distal end into the pore of the blood vessel; sliding the catheter distal end distally relative to the distal member end so that the catheter distal end further advances into the blood vessel. A method comprising the above steps. **Claim 18** The method of claim 17, wherein the distal end of the catheter is inserted into the hole in the blood vessel by sliding the distal end of the catheter distally with respect to the distal member end.

19. The method of claim 17, wherein the blood vessel is an arterial branch extending from the aortic arch of the patient.

20. The method of claim 19, wherein the arterial branch is one of a first arterial branch forming the left subclavian artery (LSA) and the left vertebral artery (LVA) of the patient, a second arterial branch forming the left common carotid artery (LCCA) of the patient, and a third arterial branch forming the right subclavian artery (RSA), the right vertebral artery (RVA), and the right common carotid artery (RCCA) of the patient.

21. The method of claim 19, wherein the aortic arch is a type III aortic arch.

22. The method of claim 19, wherein the intravascular device is introduced into the vascular system of the patient via a femoral approach.

23. The method of claim 19, wherein the intravascular device is introduced into the vascular system of the patient via a radial approach.

24. The method of claim 20, wherein the arterial branch is a third arterial branch, and the step of further advancing the distal end of the catheter into the blood vessel includes advancing the distal end of the catheter into the RCCA.

25. Advancing the guide catheter over the intravascular device while the distal end of the catheter remains within the blood vessel until the guide catheter reaches the target treatment site; Removing the intravascular device from the guide catheter while the guide catheter is at the target treatment site; The method of claim 17, further comprising.

26. Introducing a treatment device through the guide catheter until the treatment device reaches the target treatment site; Performing a treatment procedure at the target treatment site using the treatment device; The method of claim 25, further comprising.

27. 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 distal end of the catheter remains within the blood vessel until the guide catheter reaches the target treatment site; removing the intravascular device from the guide catheter while the guide catheter is at the target treatment site; The method of claim 17, further comprising. **Claim 28** introducing a treatment device through the lumen of the outer catheter body until the treatment device reaches the target treatment site; performing a treatment procedure at the target treatment site using the treatment device; The method of claim 27, further comprising. **Claim 29** The method of claim 17, further comprising delivering a contrast agent into the blood vessel through the catheter assembly.

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