Radial Access Catheter

Abstract

The device may include an elongate catheter body having a proximal portion and a distal portion, the distal portion having a memorized shape when unconstrained, the memorized shape including a plurality of curvatures arranged to orient the distal portion into the right subclavian artery or the brachiocephalic artery, and also into the left common carotid artery.

Description

[Technical Field]

[0001] (Related Applications) This application claims privilege and priority to U.S. Provisional Application No. 63 / 481,164, filed January 23, 2023, entitled Radial Access Catheter, PCT Application No. PCT / US2023 / 081956, filed November 30, 2023, entitled Inner Support Catheter, and U.S. Provisional Application No. 63 / 516,474, filed July 28, 2023, entitled Inner Support Catheter, all of which are incorporated herein by reference in their entireties. [Background technology]

[0002] Catheter access to areas of a patient's body, such as the heart or brain, is most commonly achieved by entering the patient's vascular system at the femoral artery. Such an approach is desirable, in part, because the relatively large size of the femoral artery provides a relatively direct pathway through the iliac arteries to the aorta, from which various locations can be accessed with the catheter.

[0003] However, in some situations, radial access (i.e., access via the radial artery near the patient's wrist) may be necessary or desirable. Some example advantages of radial access over femoral access may include (1) increased patient comfort due to reduced postprocedural bed rest and hospital stay, (2) reduced incidence of access site complications, including bleeding, pseudoaneurysms, and arteriovenous fistulas, and (3) potential overall cost savings. Additionally, some patients may have relatively tortuous vessels that make femoral access difficult. Navigating a catheter through the aortic arch to access the cerebral vasculature can be challenging for several reasons. First, the aortic arch has a complex anatomical structure that varies from individual to individual. The shape, size, and angle of the aortic arch and its branches can affect the maneuverability and safety of catheter insertion. Second, the aortic arch is subject to hemodynamic forces that can affect catheter movement and stability. Blood flow and pressure within the aortic arch can cause the catheter to bend, twist, or move during navigation. Third, the aortic arch can be a source of emboli that can cause stroke or other complications. Catheter manipulation in the aortic arch can cause plaque or thrombus to detach from the aortic wall or its branches, resulting in embolism. Summary of the Invention

[0004] In some aspects, the technology described herein relates to a selection catheter comprising an elongate catheter body including a distal region having a constrained, linear shape and an unconstrained shape, the distal region comprising a distal first section and a proximal second section that forms a major curve with the proximal second section in the unconstrained shape, wherein in the constrained, linear shape, the distal first section is located distal to the proximal second section, and in the unconstrained shape, the proximal second section is located substantially within a first reference plane and the distal first section is located at least partially outside the first reference plane.

[0005] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal tip of the distal first section is positioned proximal to the major curve.

[0006] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal first section is positioned at an angle within a range of 5 to 25 degrees relative to a first reference plane.

[0007] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal first section is spaced apart from a first reference plane by about 11, 11.01, 11.02, 11.03, 11.04, 11.05, 11.06, 11.07, 11.08, 11.09, 11.1, 11.11, 11.12, 11.13, 11.14, 11.15, 11.16, 11.17, 11. 18, 11.19, 11.2, 11.21, 11.22, 11.23, 11.24, 11.25, 11.26, 11.27, 11.28, 11.29, 11.3, 11.31, 11.32, 11.33, 11.34, 11.35, 11.36, 11.37, 11.38, 11.39, 11.4, 11.41, 11.42, 11.43, 11.44, 11.45, 11.4 6, 11.47, 11.48, 11.49, 11.5, 11.51, 11.52, 11.53, 11.54, 11.55, 11.56, 11.57, 11.58, 11.59, 11.6, 11.61, 11.62, 11.63, 11.64, 11.65, 11.66, 11.67, 11.68, 11.69, 11.7, 11.71, 11.72, 11.73, 11.74 4, 11.75, 11.76, 11.77, 11.78, 11.79, 11.8, 11.81, 11.82, 11.83, 11.84, 11.85, 11.86, 11.87, 11.88, 11.89, 11.9, 11.91, 11.92, 11.93, 11.94, 11.95, 11.96, 11.97, 11.98, 11.99, or 12 degree angles.

[0008] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal tip of the distal first section is positioned within a range of about 0.4 cm to 2.0 cm from the plane of the first reference surface.

[0009] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal tip of the distal first section is positioned away from the proximal second section by a length in the range of about 1 cm to about 2 cm approximately parallel to a first reference plane.

[0010] In some aspects, the technology described herein relates to a selection catheter, wherein the distal first section further comprises a first minor curve.

[0011] In some embodiments, the technology described herein relates to a selection catheter, wherein the first minor curve generally curves away from the proximal second section.

[0012] In some embodiments, the technology described herein relates to a selection catheter, wherein the first minor curve has a curvature that is less than the curvature of the major curve.

[0013] In some embodiments, the technology described herein relates to a selection catheter, wherein the first minor curve has a curve angle within a range of about 90 to about 190 degrees.

[0014] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal first section is in the range of about 3 cm to 8 cm in length.

[0015] In some embodiments, the technology described herein relates to a selection catheter, wherein a distal first section is positioned at an angle in a range of 5 to 25 degrees relative to a first reference plane, a distal tip of the distal first section is positioned within a range of about 0.4 cm to 2.0 cm from the plane of the first reference plane, the distal tip of the distal first section is positioned away from the proximal second section by a length in a range of about 1 cm to about 2 cm approximately parallel to the first reference plane, a first minor curvature has a curvature angle in a range of about 90 to about 190 degrees, and the distal first section is in a length range of about 3 cm to 8 cm.

[0016] In some embodiments, the technology described herein relates to a selection catheter having a stiffness of about 136.76 gf at about 110 mm from the distal tip of the elongate catheter body, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip.

[0017] In some embodiments, the technology described herein relates to a selection catheter, the selection catheter having a stiffness in the range of about 6.75 gf to 20.25 gf at about 10 mm.

[0018] In some embodiments, the technology described herein relates to a selection catheter, the selection catheter having a stiffness in the range of about 11.29 gf to 33.86 gf at about 20 mm.

[0019] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal first section is positioned at an angle of approximately 10.0, 10.05, 10.1, 10.15, 10.2, 10.25, 10.3, 10.35, 10.4, 10.45, 10.5, 10.55, 10.6, 10.65, 10.7, 10.75, 10.8, 10.85, 10.9, 10.95, or 11.0 degrees relative to a first reference plane.

[0020] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal tip of the distal first section is positioned within a range of about 0.1 cm to about 1.0 cm from the plane of the first reference surface.

[0021] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal tip of the distal first section is spaced apart from the proximal second section by a length in the range of about 0.2 cm to about 0.5 cm approximately parallel to a first reference plane.

[0022] In some embodiments, the technology described herein relates to a selection catheter, wherein the distal first section is in the range of about 2 cm to 5 cm in length.

[0023] In some embodiments, the technology described herein relates to a selection catheter, wherein a distal first section is positioned at an angle in a range of 5 degrees to 25 degrees relative to a first reference plane, a distal tip of the distal first section is positioned within a range of about 0.1 cm to 1.0 cm from the plane of the first reference plane, the distal tip of the distal first section is positioned away from the proximal second section by a length in a range of about 0.2 cm to about 0.5 cm approximately parallel to the first reference plane, the first minor curvature has a curvature angle in a range of about 90 to about 190 degrees, and the distal first section is in a length range of about 2 cm to 5 cm.

[0024] In some embodiments, the technology described herein relates to a selection catheter having a stiffness of about 154.85 gf at about 110 mm from the distal tip of the elongate catheter body, about 128.99 gf at about 80 mm from the distal tip, about 38.96 gf at about 20 mm from the distal tip, about 12.08 gf at about 10 mm from the distal tip, and about 6.40 gf at about 5 mm from the distal tip.

[0025] In some embodiments, the technology described herein relates to a selection catheter, the selection catheter having a stiffness in the range of about 6.04 gf to 18.11 gf at about 10 mm.

[0026] In some embodiments, the technology described herein relates to a selection catheter, the selection catheter having a stiffness in the range of about 19.48 gf to 58.44 gf at about 20 mm.

[0027] In some embodiments, the technology described herein relates to a selection catheter comprising an elongate catheter body including a distal region having an unconstrained shape, the distal region comprising a distal first section that forms a major curve with the distal second section in the unconstrained shape, wherein the distal first section is disposed at a non-parallel angle relative to the distal second section, and wherein a distal free end of the distal region is disposed generally in a proximal direction in the unconstrained shape.

[0028] In some embodiments, the technology described herein relates to a selection catheter comprising an elongate catheter body including a distal region having an unconstrained geometric means for accessing the right common carotid artery or the left common carotid artery via radial access, the distal region comprising a distal first section that forms a major curve with a distal second section.

[0029] In some embodiments, the technology described herein relates to a selection catheter, the selection catheter comprising an elongate catheter body having a stiffness in the range of about 68.38 gf to 205.14 gf at about 110 mm from the distal tip, a stiffness in the range of about 55.17 gf to 165.51 gf at about 80 mm from the distal tip, a stiffness in the range of about 11.29 gf to 33.86 gf at about 20 mm, a stiffness in the range of about 6.75 gf to 20.25 gf at about 10 mm, and a stiffness in the range of about 4 gf to 12 gf at about 5 mm.

[0030] In some embodiments, the technology described herein relates to a selection catheter, wherein the elongate catheter body has a stiffness of about 136.76 gf at about 110 mm from the distal tip, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip.

[0031] In some embodiments, the technology described herein relates to a selection catheter, the selection catheter comprising an elongate catheter body having a stiffness in the range of about 77.42 gf to 232.27 gf at about 110 mm from the distal tip, a stiffness in the range of about 64.50 gf to 193.49 gf at about 80 mm from the distal tip of the selection catheter, a stiffness in the range of about 19.48 gf to 58.44 gf at about 20 mm from the distal tip, a stiffness in the range of about 6.04 gf to 18.11 gf at about 10 mm from the distal tip, and a stiffness in the range of about 3.20 gf to 9.60 gf at about 5 mm from the distal tip.

[0032] In some embodiments, the technology described herein relates to a selection catheter, wherein the elongate catheter body has a stiffness of about 154.85 gf at about 110 mm from the distal tip, about 128.99 gf at about 80 mm from the distal tip, about 38.96 gf at about 20 mm from the distal tip, about 12.08 gf at about 10 mm from the distal tip, and about 6.40 gf at about 5 mm from the distal tip.

[0033] In some embodiments, the technology described herein relates to a selection catheter comprising an elongate catheter body having a stiffness of about 136.76 gf at about 110 mm from the distal tip, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip of the elongate catheter body; or the elongate catheter body has a stiffness of about 154.85 gf at about 110 mm from the distal tip, about 128.99 gf at about 80 mm from the distal tip, about 38.96 gf at about 20 mm from the distal tip, about 12.08 gf at about 10 mm from the distal tip, and about 6.40 gf at about 5 mm from the distal tip.

[0034] In some aspects, the technology described herein relates to a catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a memorized shape when unconstrained, the memorized shape comprising a plurality of curvatures arranged to orient the distal portion into the right or left subclavian artery or brachiocephalic artery for accessing the left or right common carotid artery.

[0035] In some aspects, the technology described herein relates to a catheter in which the memorized shape of the distal section is a "U" shape that is further curved in a direction generally perpendicular to the tip of the "U" shape.

[0036] In some embodiments, the technology described herein relates to a catheter, wherein the memorized shape has dimensions within the range of about 3.0 cm to 8.5 cm in length, about 1.5 cm to 3.0 cm in width, and about 1.5 cm to 3.5 cm in height.

[0037] In some embodiments, the technology described herein relates to a catheter, wherein the distal portion further comprises a proximal region, an intermediate region, and a distal region, and wherein a first curve of the plurality of curves is located between the proximal region and the intermediate region and has a curve angle within a range of about 35 degrees to about 75 degrees.

[0038] In some embodiments, the technology described herein relates to a catheter, wherein a second curve of the plurality of curves is located between the intermediate region and the distal region and has a curve angle within a range of about 160 degrees to about 200 degrees.

[0039] In some embodiments, the technology described herein relates to a catheter, some of the multiple curves being located in the distal region and having a curve angle within a range of about 5 degrees to 30 degrees.

[0040] In some aspects, the techniques described herein relate to a method of accessing the left common carotid artery, the method comprising the steps of advancing a distal portion of a selected catheter from the right subclavian artery into the patient's aortic arch, expanding the distal portion of the selected catheter to a memorized shape within the patient's aortic arch, partially retracting a portion of the distal portion of the selected catheter proximally into the right subclavian artery or the brachiocephalic artery and moving a distal region of the distal portion into the left common carotid artery.

[0041] In some aspects, the technology described herein relates to the above method, wherein the memorized shape of the distal portion is a "U" shape that is further curved in a direction generally perpendicular to the tip of the "U" shape.

[0042] In some aspects, the technology described herein relates to a catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a memorized shape when unconstrained, the memorized shape comprising a plurality of curvatures arranged to orient the distal portion into the right subclavian artery or the brachiocephalic artery, and also into the right common carotid artery.

[0043] In some embodiments, the technology described herein relates to a catheter, wherein the memorized shape of the distal portion is a "U" shape having a width in the range of about 0.7 cm to about 2.9 cm.

[0044] In some embodiments, the technology described herein relates to a catheter, the distal portion of which comprises a first curve having a curve angle in the range of about 70 degrees to 140 degrees, and a second curve, a third curve, and a fourth curve, each having a curve angle in the range of about 50 degrees to 140 degrees.

[0045] In some aspects, the technology described herein relates to a method of accessing the right common carotid artery, the method comprising: advancing a distal portion of a selected catheter into a patient's right subclavian or brachiocephalic artery; advancing the distal portion of the selected catheter further distally to bend the distal portion into a memorized shape within the right subclavian or brachiocephalic artery; and advancing the memorized shape further distally so that a portion of the distal portion enters the right common carotid artery.

[0046] In some embodiments, the technology described herein relates to the above method, wherein the memorized shape of the distal portion is a "U" shape having a width within the range of about 0.7 cm to about 2.9 cm.

[0047] In some embodiments, the technology described herein relates to a catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a memorized shape when unconstrained, the memorized shape being arranged to orient the distal portion into the right subclavian artery or the brachiocephalic artery and also into the right common carotid artery, and comprising a major curve having a curvature angle in the range of about 335 degrees to about 350 degrees.

[0048] In some embodiments, the technology described herein relates to a catheter, wherein the major curve has a width within a range of about 0.5 cm to about 2.5 cm.

[0049] In some aspects, the technology described herein relates to a catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a constrained shape and an unconstrained shape that is different from the constrained shape, wherein in the unconstrained shape, the shape of the catheter comprises a plurality of curvatures that at least partially deflect about an axial "X" axis passing through a central lumen of the proximal portion of the catheter, a vertical "Y" axis orthogonal to the "X" axis, and a transverse "Z" axis orthogonal to both the "X" and "Y" axes.

[0050] In some aspects, the technology described herein relates to a catheter, wherein multiple curvatures are arranged to orient a distal portion of the catheter to access a particular target vessel.

[0051] In some aspects, the technology described herein relates to a catheter, wherein the particular target vessel is one of the right common carotid artery and the left common carotid artery.

[0052] In some aspects, the technology described herein relates to a catheter, wherein in an unconstrained configuration, a distal portion of the catheter has a memorized shape, and wherein at least a portion of the memorized shape of the distal portion in the unconstrained configuration comprises a "U" shape, the "U" shape having a proximal portion, an intermediate portion, and a distal portion, the proximal portion of the "U" shape extending at least partially along an "X" axis away from the proximal portion of the catheter, and the distal portion of the "U" shape extending at least partially along the "X" axis toward the proximal portion of the catheter.

[0053] In some aspects, the technology described herein relates to a catheter comprising an elongated catheter means for accessing the common carotid artery, the catheter means comprising a body having a proximal portion and a distal portion, the distal portion having a constrained shape and an unconstrained shape different from the constrained shape, the elongated catheter means having a memorized shape when unconstrained, the memorized shape comprising a plurality of curvatures that orient the distal portion into the right or left subclavian artery or the brachiocephalic artery for accessing the left common carotid artery. [Brief explanation of the drawings]

[0054] The following drawings are included to illustrate examples of certain aspects of the present invention and should not be considered exclusive or limiting. The disclosed subject matter is susceptible to numerous modifications, variations, combinations, and equivalents in form and function, as will occur to those skilled in the art and with the benefit of the present invention. In this disclosure, reference is made to the following drawings:

[0055] [Figure 1] FIG. 1 shows a general overview of some arteries in a typical human.

[0056] [Figure 2A] FIG. 2A is a lateral view of an example of a human aortic arch 24.

[0057] [Figure 2B] FIG. 2B shows a side view of several different examples of the anatomy of the human aortic arch 24.

[0058] [Figure 3] FIG. 3 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0059] [Figure 4] FIG. 4 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0060] [Figure 5] FIG. 5 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0061] [Figure 6] FIG. 6 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0062] [Figure 7] FIG. 7 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0063] [Figure 8] FIG. 8 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0064] [Figure 9] FIG. 9 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0065] [Figure 10] FIG. 10 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0066] [Figure 11] FIG. 11 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0067] [Figure 12] FIG. 12 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0068] [Figure 13] FIG. 13 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0069] [Figure 14] FIG. 14 is a side view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0070] [Figure 15] FIG. 15 is an end view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0071] [Figure 16] FIG. 16 is an end view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0072] [Figure 17] FIG. 17 is a perspective view of a distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0073] [Figure 18] FIG. 18 is a side view of the aortic arch 24 illustrating an example method of use of the selection catheter 100.

[0074] [Figure 19] FIG. 19 is a side view of the aortic arch 24 illustrating an example method of using the selection catheter 100.

[0075] [Figure 20] FIG. 20 is a side view of the aortic arch 24 illustrating an example use of the selection catheter 100.

[0076] [Figure 21] FIG. 21 shows a graph of stiffness characteristics of selected catheters 100 of FIGS. 3-17, according to one example.

[0077] [Figure 22] FIG. 22 is a side view of an example selection catheter 150.

[0078] [Figure 23] FIG. 23 is a side view of an example selection catheter 150.

[0079] [Figure 24] FIG. 24 is a side view of an example selection catheter 150.

[0080] [Figure 25] FIG. 25 is a side view of an example selection catheter 150.

[0081] [Figure 26] FIG. 26 is a side view of an example selection catheter 150.

[0082] [Figure 27] FIG. 27 is an end view of an example selection catheter 150.

[0083] [Figure 28] FIG. 28 is an end view of an example selection catheter 150.

[0084] [Figure 29] FIG. 29 is a side view of a distal portion of a select catheter 160 for accessing the right common carotid artery 30 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0085] [Figure 30] FIG. 30 is a side view of a distal portion of a select catheter 160 for accessing the right common carotid artery 30 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0086] [Figure 31] FIG. 31 is a perspective view of a distal portion of a select catheter 160 for accessing the right common carotid artery 30 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0087] [Figure 32] FIG. 32 is a side view of a distal portion of a select catheter 160 for accessing the right common carotid artery 30 from the right subclavian artery 16 (ie, a right radial access approach), according to one example.

[0088] [Figure 33] FIG. 33 is a side view of the aortic arch 24 illustrating the use of a selection catheter 160 according to one example.

[0089] [Figure 34] FIG. 34 is a side view of the aortic arch 24 illustrating the use of a selection catheter 160 according to one example.

[0090] [Figure 35] FIG. 35 is a side view of the aortic arch 24 illustrating the use of a selection catheter 160 according to one example.

[0091] [Figure 36] FIG. 36 shows a graph of stiffness characteristics of a select catheter 160 according to one example.

[0092] [Figure 37] FIG. 37 is a side view of an example selection catheter 190.

[0093] [Figure 38] FIG. 38 is a side view of the aortic arch 24 illustrating the use of a selection catheter 190 according to one example.

[0094] [Figure 39] FIG. 39 is a side view of selection catheter 200 in a first rotational position relative to plane 200F, according to one example.

[0095] [Figure 40] FIG. 40 is a side view of selection catheter 200 in a first rotational position relative to plane 200F, according to one example.

[0096] [Figure 41] FIG. 41 is an end view of a selection catheter 200 from its distal end, according to one example.

[0097] [Figure 42] FIG. 42 is an end view of a selection catheter 200 from its proximal end, according to one example.

[0098] [Figure 43] FIG. 43 is a perspective view of a selection catheter 200 according to one example.

[0099] [Figure 44] FIG. 44 is a side view of the aortic arch 24 illustrating the use of a selection catheter 200 according to one example.

[0100] [Figure 45] FIG. 45 is a side view of the aortic arch 24 illustrating the use of a selection catheter 200 according to one example.

[0101] [Figure 46] FIG. 46 shows a graph of stiffness characteristics of a select catheter 200 according to one example.

[0102] [Figure 47] FIG. 47 is a side view of a selection catheter 300 in a first rotational position relative to a plane 300F, according to one example.

[0103] [Figure 48] FIG. 48 is a side view of a selection catheter 300 in a first rotational position relative to a plane 300F, according to one example.

[0104] [Figure 49] FIG. 49 is an end view of selection catheter 300 in a first rotational position relative to plane 300F, according to one example.

[0105] [Figure 50]FIG. 50 is an end view of selection catheter 300 in a first rotational position relative to plane 300F, according to one example.

[0106] [Figure 51] FIG. 51 is a perspective view of the selection catheter 300 as seen from the distal end.

[0107] [Figure 52] FIG. 52 is a side view of the aortic arch 24 illustrating the use of a selection catheter 300 according to one example.

[0108] [Figure 53] FIG. 53 is a side view of the aortic arch 24 illustrating the use of a selection catheter 300 according to one example.

[0109] [Figure 54] FIG. 54 shows a graph of stiffness characteristics of a select catheter 300 according to one example.

[0110] [Figure 55] FIG. 55 is a side view of a selection catheter 400 in a first rotational position relative to a plane 400F, according to one example.

[0111] [Figure 56] FIG. 56 is a side view of a selection catheter 400 in a first rotational position relative to a plane 400F, according to one example.

[0112] [Figure 57] FIG. 57 is an end view of a selection catheter 400 from its distal end, according to one example.

[0113] [Figure 58] FIG. 58 is an end view of a selection catheter 400 from its proximal end, according to one example.

[0114] [Figure 59] FIG. 59 is a perspective view of a selection catheter 400 according to one example.

[0115] [Figure 60] FIG. 60 is a side view of the aortic arch 24 illustrating the use of a selection catheter 300 according to one example.

[0116] [Figure 61] FIG. 61 is a side view of the aortic arch 24 illustrating the use of a selection catheter 300 according to one example.

[0117] [Figure 62] FIG. 62 is a side view of an example selection catheter 400.

[0118] [Figure 63] FIG. 63 is a side view of a selection catheter 400 within a larger catheter 80, according to one example.

[0119] [Figure 64] FIG. 64 shows a graph of stiffness characteristics of a select catheter 200 according to one example. DETAILED DESCRIPTION OF THE INVENTION

[0120] It will be understood by those skilled in the art that the present invention is not limited to what has been particularly shown and described herein. Various changes and modifications can be made in light of the teachings herein without departing from the scope, spirit or intent thereof.

[0121] Although various embodiments may be described herein, it is specifically contemplated that any features from different embodiments may be used together in any combination. In other words, features from different embodiments may be mixed and matched with each other. Thus, while every permutation of features from different embodiments may not be explicitly shown or described, it is the intent of the present disclosure to include any and all combinations, particularly as would be recognized by one of ordinary skill in the art.

[0122] The terms used in this disclosure should be construed as permissive and are not intended to be limiting. In the drawings, like numbers refer to like elements. Unless otherwise specified, all of the accompanying drawings are not drawn to scale. Unless otherwise specified, the term "about" is defined to mean ±5% of the stated value.

[0123] The terms distal or distally generally refer to the direction or region toward the end of the device that is within the patient (e.g., away from the physician / clinician), while the terms proximal or proximally refer to the direction or region toward the end of the device that remains outside the patient (e.g., toward or closer to the physician / clinician or the handle / hub of the device).

[0124] Any of the selection catheters described herein may include an elongate catheter body having a proximal portion and a distal portion relative to where a physician may be positioned during a procedure. The selection catheter may include a lumen extending between the proximal and distal ends of the selection catheter, the lumen being large enough for use with at least a guidewire (e.g., a guidewire having an outer diameter of 0.035 inches to 0.038 inches).

[0125] While radial access to a patient's vasculature can have certain advantages, the relatively sharp angles and / or difficult orientation of some arterial connections often make it difficult for physicians to access some locations within the patient's body, particularly regions of the patient's brain.

[0126] FIG. 1 provides a general overview of several arteries in a typical human 10. Radial access typically begins by first entering the radial artery 12 in the patient's arm. Often, the right radial artery 12, rather than the left radial artery 18, is used as the physician's starting point. Physicians and neurointerventionalists typically position the patient head-first on a patient table, with the patient imaging system display to the patient's left. Consequently, it is often easier to access and insert all devices from the right side. Furthermore, depending on the desired location within the patient, the patient's arterial anatomy may offer additional advantages to access via the right radial artery 12. However, access via the left radial artery 18 is also possible and may be desirable.

[0127] For right radial access, the right radial artery 12 is entered first (e.g., via a needle, introducer, and catheter), and a guide catheter is advanced superiorly into the right brachial artery 14 and then into the right subclavian artery 16. Similarly, for left radial access, the left radial artery 18 is entered first, and a catheter is advanced superiorly into the left brachial artery 20 and then into the left subclavian artery 22.

[0128] 2A is a side view of an example of a human aortic arch 24. Once a guide catheter 80 approaches the aortic arch 24 from either the right subclavian artery 16 or the left subclavian artery 22, a select catheter 82 advanced out of the guide catheter 80 can follow various arterial routes, depending on the desired target area. When accessing the arteries of the brain, the right common carotid artery 30 can be used to access the arteries on the right side of the brain, and the left common carotid artery 32 can be used to access the arteries on the left side of the brain.

[0129] As can be seen in FIG. 2A , both common carotid arteries 30, 32 connect to the subclavian arteries 16, 22 at relatively sharp and / or tortuous angles. Many catheters often require significant time before their distal end can be maneuvered into one of the common carotid arteries 30, 32. While certain existing catheters can be manipulated to reach one of the common carotid arteries 30, 32 in some (but not all) patients, this requires significant effort and often requires the catheter to be moved against the brachiocephalic artery 28, aortic root 26, and / or aortic valve walls. In some cases, the aortic valve or vessel wall may be calcified, and if the catheter applies sufficient force against the brachiocephalic artery 28, aortic root 26, and / or aortic valve walls, it may increase the likelihood of embolic material detaching, potentially resulting in stroke or thrombosis. In other words, existing catheters must contact or "bounce" against the walls of the brachiocephalic artery 28, aortic root 26, and / or aortic valve while exerting sufficient force on the vessel wall or valve to make the necessary U-turn from the subclavian artery 16, 22 to the common carotid artery 30, 32.

[0130] FIG. 2B shows side views of several different examples of the anatomical structure of the human aortic arch 24. As previously mentioned, navigation within the aortic arch 24 can be further complicated due to various anatomical variations, such as the different locations of the brachiocephalic trunk 28 and the left common carotid artery 32. For example, FIG. 2B illustrates type I, type II, and type III aortic arch configurations. Type I aortic arch configurations tend to be relatively easy to navigate because the brachiocephalic trunk 28, left common carotid artery 32, and left subclavian artery 22 are uniformly positioned along the aortic arch 24, as shown by the dotted lines. However, in type II and type III aortic arch configurations, the brachiocephalic trunk 28 and left common carotid artery 32 tend to be inferiorly positioned and closer to the aortic root 26, resulting in more abrupt angular changes that must be navigated, as shown by the upper and lower dotted lines in each figure.

[0131] As described in more detail below, several examples of catheters are disclosed that have a memorized or assigned shape that is formed when a particular region of the catheter is unconstrained (e.g., when a portion of the catheter advances out of a larger, outer catheter). These catheters are often referred to as “selection catheters,” and the assigned shape of these catheters allows a physician to more quickly and efficiently access the right common carotid artery 30 or the left common carotid artery 32 from either a right or left radial access approach, as described above. Furthermore, these selection catheters may have a memorized shape that allows a physician to access the right common carotid artery 30 or the left common carotid artery 32 without entering the aortic root 26 and / or contacting the aortic valve, which could dislodge embolic material that could lead to stroke or other complications (especially if the aortic valve is calcified).

[0132] A selective catheter may also be called an access catheter, inner catheter, support catheter, intermediate catheter, or inner support catheter. A "selective catheter" may refer to a catheter intended to assist another catheter (typically a guide catheter) in navigating or selecting through difficult anatomy, such as the aortic arch.

[0133] In use, the guide catheter is navigated to a point near the difficult anatomical structure, after which a "selection" catheter can be threaded through the guide catheter lumen and inserted beyond the distal tip of the guide catheter. From there, the "selection" catheter can have a biasing shape or secondary shape / structure that forms as it becomes distal to the guide catheter. This secondary shape / structure can be specific to the difficult anatomical structure being navigated (e.g., a type III aortic arch), allowing the "selection catheter" to be advanced distally within the difficult target vessel, thus "selecting" this vessel. The guide catheter can then be advanced within the target vessel over the "selection" catheter, or a guidewire can be advanced through the selection catheter. Once the guide catheter has been advanced sufficiently into the target vessel such that the guide catheter will not prolapse upon removal, the user can withdraw the selection catheter proximally from the guide catheter, allowing the procedure to continue with the guide catheter further advanced to a more distal anatomical target (e.g., an aneurysm site, a thrombus, etc.).

[0134] In general, the catheters described herein may be referred to as "selection" catheters that can be used for navigation in a patient's particular vasculature anatomy, although they may also be used for additional purposes during a procedure, such as delivery of intravascular devices, delivery of a bolus of radiopaque contrast agent or dye for imaging purposes, aspiration of blood clots, and other purposes.

[0135] This specification is directed to several features of the selection catheter that can improve its ability to quickly and easily enter a desired blood vessel. Any of these features may be included as part of a single exemplary selection catheter, and any combination of features may be included as part of a single selection catheter (including application of only a single feature). Generally, these features are directed to the unconstrained three-dimensional shape and flexibility or rigidity characteristics of the selection catheter.

[0136] One such feature is a distal region of the selected catheter that curves in at least two different dimensions (i.e., the curvature does not remain substantially within a single plane) when unconstrained by an outer catheter. In one example, the distal region of the selected catheter includes a distal first section that forms a major curve with a distal second section. The distal first section is distal to the distal second section and, when unconstrained, forms a major curve with the distal second section. The distal second section is substantially within a first plane, the distal first section is at least partially outside the first plane, and the distal free end of the distal first section is proximal to the major curve. In other words, the major curve points the distal free end generally proximally, and the distal first section is oriented such that it is not parallel to the distal second section. In another example, the phrase "proximal to the major curve" can mean that the distal tip is closer to the proximal end of the catheter and the major curve is distal to the distal tip. Further details of the selection catheter are provided later in this specification.

[0137] Typically, existing selection catheters curve only or substantially remain in a single plane, which can make it difficult to access some vessels within the aortic arch, particularly in Type II and Type III anatomies, as described above with respect to FIG. 2B. By further providing a curvature along the distal region of the inner catheter that does not remain in a single plane (e.g., a major curvature that positions the distal free end of the catheter in a generally proximal direction while positioning the most distal region non-parallel to the proximally adjacent regions of the selection catheter), various vessels can be more easily accessed, particularly in Type II and Type III anatomies. For example, a selection catheter with a distal region that curves in at least two different dimensions can more easily access the right common carotid artery 30 and the left common carotid artery 32.

[0138] Additionally, the region distal to the primary curve may further comprise a minor curve (i.e., a curve of lesser curvature than the primary curve), which may be curved at a similar orientation, angle, and / or plane as the primary curve (e.g., both the primary and minor curves may be disposed in substantially the same plane), or may be curved at a different orientation, angle, and / or plane than the primary curve (e.g., both the primary and minor curves may be disposed in substantially different planes).

[0139] In another example, a selection catheter may have stiffness characteristics that provide a specific stiffness at a specific distance from its distal tip, which is useful for preventing the selection catheter from losing access when a guidewire is passed through it or a larger catheter is moved over its exterior. For example, some existing selection catheters have a relatively large change in stiffness approximately 8 cm from their distal tip, which can result in the aforementioned loss of access (i.e., the selection catheter may slip out of the desired vessel in which it was originally placed). By limiting this abrupt change, the selection catheter may better maintain access to and position within the desired vessel during the procedure.

[0140] In another example, the size, flexibility, and / or curvature of the unconstrained shape may enable the selection catheter to form an unconstrained shape within the patient's aortic arch 24 without requiring contact with the aortic root 26 or aortic valve wall or applying minimal force to the vessel wall or aortic valve (a force low enough that plaque detachment is highly unlikely). Some existing selection catheters have a two-dimensional quadratic shape, and in order to make the necessary U-turn from the subclavian artery 16, 22 to the common carotid artery 30, 32, the selection catheter must be forced or "bounced" against the aortic root 26 and / or aortic valve while applying sufficient force to the vessel wall or valve, which can dislodge embolic material. In this embodiment, the ability to significantly reduce or avoid such contact with the aorta (and the corresponding force on the vessel wall or valve) can reduce or avoid the risk of dislodgement of embolic material, thereby reducing the risk of stroke, thrombosis, or similar complications during or after the procedure.

[0141] Generally, the selected catheters herein intended for radial access have a length at least sufficient to allow them to enter and navigate the subclavian artery 16, 22 and extend near or into either of the common carotid arteries 30, 32, although they may be longer to allow for further advancement into either of the common carotid arteries 30, 32.

[0142] As previously mentioned, select catheters herein may have a memorized, secondary, unconstrained, or imposed shape along at least a distal portion of the catheter. Such a memorized shape may be achieved in several different ways. For example, a shape memory alloy (e.g., nitinol) that has a heat-set memorized shape at a specific temperature may be used in at least the distal portion of the select catheter. For example, the shape memory alloy may take the form of a braided wire layer, a coiled wire layer, or similar variations and combinations. Often, such a shape memory alloy layer may be disposed between at least an inner polymer layer and an outer polymer layer, which may further affect both shape and stiffness.

[0143] The selection catheters herein generally include a distal section extending from near the distal tip of the selection catheter to a location proximal to the distal tip. For example, the distal section may have a length of approximately 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, 20 cm, and ranges therebetween and beyond. The length of the distal section may vary depending on the stored (or imparted) shape of the distal section and the arterial pathway through which the selection catheter is to be routed.

[0144] 3-17 illustrate the distal portion of a select catheter 100 for accessing the left common carotid artery 32 from the right subclavian artery 16 (i.e., a right radial access approach). In some examples, the unconstrained, or memorized, shape of the select catheter 100 may include several different curvatures that create a shape that is substantially outside of a single plane. In other words, the curvature of the select catheter in this memorized shape may be curved in the XYZ dimensions (e.g., a 3D coordinate system) rather than entirely within the XY dimensions (e.g., a 2D coordinate system). To help illustrate the complexity of these curvatures, FIGS. 3-14 illustrate the distal portion of the catheter 100 in various rotational positions relative to an axis 101 (see FIG. 3 ) that extends through a straight region 102 of the distal portion and the remaining proximal portion (not shown in FIG. 3 ). Note that the arrow on the axis 101 indicates the direction of rotation (clockwise when viewed from the axis or proximal end of the catheter 100).

[0145] Generally, the distal portion of the selection catheter 100 has an unconstrained or memorized shape having a "U" shape, as best seen in the rotated positions of FIGS. 12 and 13 . However, in some instances, the "U" shape also curves or bends in a direction generally perpendicular to the front of the "U" shape (e.g., the bottom of the "U" bends outward toward the viewer). In other words, the planes 103 are shown in FIGS. 3 and 7 as being generally perpendicular to one another. The "U" shape, best seen in FIG. 7 , bends out or away from the plane 103 best seen in FIG. 3 . Once this general shape is formed within the vasculature (e.g., within the aortic arch 24), the selection catheter 100 can be pulled upward in a proximal direction so that the distal end of the selection catheter 100 enters the left common carotid artery 32.

[0146] The memorized shape of the distal portion of the selection catheter 100 can generally be described as having three lengths or regions of the distal portion: a proximal region 102, an intermediate region 106, and a distal region 104.

[0147] 7-9, in some examples, the proximal region 102 is generally straight and is connected at its distal end to the proximal end of the intermediate region 106 via a bend or curve 108. (Note that, as used herein, proximal and distal refer to the proximal and distal positions when the selected catheter is in a constrained, straight configuration (e.g., within another catheter), not relative positions relative to other regions when in an unconstrained, memorized configuration.) The distal end of the intermediate region 106 is connected to the proximal end of the distal region 104 via a bend or curve 110. In some examples, the curve 108 may be considered its own distinct region or may be part of regions 102, 104, and 106, but these should be considered simply different approaches to describing a single shape of the distal portion.

[0148] In this example, curve 108 is generally curved in a first direction, and curve 110 is curved in a second direction different from the first direction. For example, curve 110 may be generally curved in a direction approximately perpendicular to curve 108 (e.g., about 90 degrees). Note that "generally" and "about" are used throughout this specification to mean a positive or negative 15% variation / range in any direction and / or value. This is particularly relevant because intermediate region 106 and distal region 104 may not be perfectly straight and may therefore have additional curvature or curvature orientation.

[0149] 11, in one example, the curve 108 has a curve angle in the range of about 35 degrees to about 75 degrees, such as 35, 45, 55, 65, 75 degrees, and values ​​therebetween. In one specific example, the curve 108 has a curve angle of about 55 degrees.

[0150] As can be seen in FIGS. 15 and 16 , in another example, the curve 110 has a curve angle in the range of about 160 degrees to about 200 degrees. For example, the angles may be 160, 170, 180, 190, 200 degrees, and values ​​therebetween. In one specific example, the curve 110 has a curve angle of about 180 degrees. In some examples, the curve 110 may be a single curve having a single curvature, or may be composed of multiple regions of different curvatures. For example, as can be seen in FIGS. 15 and 16 , the curve 110 begins at the proximal portion on the left side and has a gradual curve in one region and a more abrupt curve in the more distal region.

[0151] In one example, the proximal region 102 has a length ranging from about 20 mm to about 50 mm, such as 20, 25, 30, 35, 40, 45, 50 mm, and any value therebetween. In one specific example, the length is about 38 mm.

[0152] In one example, intermediate region 106 has a length in the expanded configuration ranging from about 15 mm to about 40 mm, such as 15, 20, 25, 30, 35, 40 mm, and any value therebetween. In one specific example, the length is about 27 mm.

[0153] In one example, distal region 104 has a length in the expanded configuration ranging from about 25 mm to about 65 mm, such as 25, 30, 35, 40, 45, 50, 55, 60, 60 mm, and any value therebetween. In one specific example, the length is about 45 mm.

[0154] The distal portion of the select catheter 100 has dimensions in the unconstrained, expanded, memorized configuration within ranges including a length 122 (FIG. 4) of about 3.0 cm to 8.5 cm, a width 124 (FIG. 6) of about 1.5 cm to 3.0 cm, and a height 120 (FIG. 4) of about 1.5 cm to 3.5 cm.

[0155] As best seen in FIGS. 12-14 , in some examples, the distal region 104 may include multiple minor curves 112, 114, and 115 (i.e., curves at smaller angles than the curves 108 and 110). For example, these curves may be in a range of about 5 degrees to about 90 degrees, and may be curved in different planes. Alternatively, in some examples, the curves 112, 114, and 115 may be relatively large, in a range of about 90 degrees to 180 degrees. Another example range is in a range of about 5 degrees to 30 degrees. In some examples, the curves 112, 114, and 115 may be distally followed by a relatively straight segment having a length in a range of 5 mm to 16 mm. While not shown, the catheter 100 may exclude one or more minor curves 112, 114, and 115 in the intermediate region 106 and / or the distal region 104.

[0156] 18-20 show various views of a method of use for the selection catheter 100 of FIGS. 3-17. In one example of a method of use shown in FIGS. 18-20, the guide catheter 80 is advanced via a right radial approach (as described above) so that its distal end is located in or near the brachiocephalic artery 28 (or in the right subclavian artery 16 or aortic arch 24). Next, as shown in FIGS. 18-19, the distal portion of the selection catheter 100 is advanced out of the guide catheter 80 and into the aortic arch 24, thereby assuming an unconstrained, expanded, memorized shape. Once the memorized shape is achieved, the physician can retract the selection catheter 100 proximally, such that part or all of the proximal portion 102 is retracted into the guide catheter 80. Because the intermediate region 106 is sized and shaped similarly to the distance and location of the left common carotid artery 32, proximal movement moves the distal region 104 into the left common carotid artery 32, as shown in FIG. 20.

[0157] Depending on the physician's preference, the selection catheter 100 may then be advanced further distally to move the distal portion of the catheter 100 further up the left common carotid artery 32, and the guide catheter 80 may be advanced into the left common carotid artery 32 to cover the selection catheter 100, or any combination thereof. Depending on the physician's procedure, the selection catheter 100 may be removed and an additional working catheter (or guidewire) may be used for the intended treatment.

[0158] FIG. 21 shows a graph of the stiffness profile of the selection catheter 100 of FIGS. 3-17. In addition to the unconstrained, expanded, memorized configuration of the distal portion of the selection catheter 100, the selection catheter 100 may have a particular stiffness at a particular length from its distal tip, as seen in FIG. 21. In one example of a stiffness profile, the overall stiffness of the proximal region 102 may be less, on average, than the stiffness of the intermediate region 106. The relatively lower stiffness of the proximal region 102 may provide additional flexibility to the portion of the catheter within the tortuous right subclavian artery 16, thereby facilitating the remaining regions' access to the left common carotid artery 32 or the left subclavian artery 22. For example, a distal region 104 of approximately 45 mm may require an increase in the amount of force required to deflect by approximately 0 gf to 100 gf (±50 gf), a middle region 106 of approximately 27 mm may require an increase in the amount of force required to deflect by approximately 100 gf to 120 gf (±50 gf), and a proximal region 102 of approximately 38 mm may generally require a decrease in the amount of force required to deflect by approximately 120 gf to 100 gf (±50 gf).

[0159] Variations in the mechanical configuration of select catheters 100 include, but are not limited to, polymer jacket durometers ranging from 25D to 74D, wall thicknesses from 0.004 inches to 0.011 inches, and / or the use of additional support liners such as PTFE, Filmcast, and / or Pebax, stainless steel, tungsten, platinum, tantalum, Nitinol, and expanded filled tube (DFT) Nitinol metal coils (0.003 inches to 0.018 inches pitch) and / or braid patterns (40 to 120 PPI) strategically positioned around the curvature of the catheter shape and proximal end to optimize shape retention, pushability, torque transmission / torque response, kink resistance, support, and trackability. In some instances, the braided wire may be round (0.001-0.003 inch diameter) or flat (0.001 x 0.003-0.002 x 0.005 inch diameter) wire constructed from stainless steel, nitinol, or expanded filled tube (DFT) nitinol. To enhance trackability, in some instances, a siloxane-based lubricious additive may be added to the polymer extrudate. To improve radiopacity under fluoroscopic intervention, in some instances, barium, tungsten, or other materials may be added to the polymer extrudate. In some instances, marker bands made of any combination of iridium, barium, tungsten, platinum, gold, or other radiopaque materials may also be added for fluoroscopic visibility.

[0160] 22-28 show another example of a selection catheter 150 that is generally similar to the selection catheter 100 described above, including its rigidity, except for slight differences in curvature angle and size.

[0161] In another example, the curve 115 has a somewhat larger curvature, as can be seen in Figures 24-25. For example, the curve 115 has an angle or curvature in the range of about 25 degrees to about 65 degrees, such as 25, 30, 35, 40, 45, 50, 55, 60, 65 degrees, or any value therebetween. In one specific example, the curve 115 has a curvature angle of about 45 degrees.

[0162] In another example, the curve 114 has a somewhat greater curvature, as can be seen in Figures 24 and 25. For example, the curve 114 has an angle or curvature in the range of about 200 degrees to about 300 degrees, such as 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300 degrees, or any value therebetween. In one specific example, the curve 115 has a curvature angle of about 250 degrees.

[0163] In one example, the proximal region 102 has a length ranging from about 10 mm to about 40 mm, such as 10, 15, 20, 25, 30, 35, 40 mm, and any value therebetween. In one specific example, the length is about 20 mm.

[0164] In one example, intermediate region 106 has a length in the expanded configuration ranging from about 50 mm to about 90 mm, such as 50, 55, 60, 65, 70, 75, 80, 85, 90 mm, and any value therebetween. In one specific example, the length is about 67 mm.

[0165] In one example, distal region 104 has a length in the expanded configuration ranging from about 50 mm to about 90 mm, such as 50, 55, 60, 65, 70, 75, 80, 85, 90 mm, and any value therebetween. In one specific example, the length is about 67 mm.

[0166] In some examples, the distal portion has dimensions in the unconstrained, expanded, memorized configuration within a range including a length 122 (FIG. 25) of about 7-10 cm, a width 124 (FIG. 25) of about 1.5 cm-3.0 cm, and a height 120 (FIG. 22) of about 1.5 cm-3.5 cm.

[0167] In another specific example, the length between curves 115 and 114 is within a range of approximately 1.0 cm to 3.5 cm, the length between curves 115 and 110 is within a range of approximately 1.5 cm to 3 cm, and the length between curves 110 and 108 is within a range of approximately 2.0 cm to 5.0 cm.

[0168] 29-32 show the distal portion of a select catheter 160 for accessing the right common carotid artery 30 from the right subclavian artery 16 (i.e., a right radial access approach). In some examples, the unconstrained or memorized shape of the select catheter 160 may include several different curvatures that create a shape that generally lies in a single plane.

[0169] The distal portion of the selection catheter 160 may include several generally straight segments connected to one another via multiple curved segments. The straight segments include a proximal segment 162, a first intermediate segment 164, a second intermediate segment 166, a third intermediate segment 168, and a distal segment 170. These segments may have lengths within the following ranges: proximal segment 162: 4-10 cm, first intermediate segment 164: 0.5-1.5 cm, second intermediate segment 166: 0.1-0.5 cm, third intermediate segment 168: 0.5-1.0 cm, and distal segment 170: 0.5-1.0 cm.

[0170] In one example, the distal portion of the selection catheter 160 may have a length 180 in the range of about 1.5 cm to 6.5 cm, a width 184 in the range of about 1 cm to 3.5 cm, an outer diameter 182 in the range of about 1.700 mm to 1.778 mm, and a distal tip standoff length 165 in the range of about 0.5 cm to 2.5 cm. Thus, in one example, the overall width of the "U" shape of the distal portion, not including the bend 172 and the proximal region 162, is in the range of about 0.7 cm to about 2.9 cm.

[0171] In one example, first curve 172 between segment 162 and segment 164 may have a curve angle in the range of approximately 70 degrees to 140 degrees. Second curve 174, third curve 176, and fourth curve 178 may have a curve angle in the range of approximately 50 degrees to 140 degrees. In one specific example, first curve 172 may have a curve angle of approximately 158 degrees, second curve 174 may have a curve angle of approximately 135 degrees, third curve 176 may have a curve angle of approximately 143 degrees, and fourth curve 178 may have a curve angle of approximately 85 degrees.

[0172] In addition to the unconstrained, expanded, memorized configuration of the distal portion of select catheter 160, it may also have a particular stiffness at a particular length from its distal tip, as seen in Figure 36. For example, segment 170 and curve 178 may have an average stiffness that increases from about 0 gf to about 15 gf (±10 gf), while the remaining segments and curves 168, 176, 166, 174, 164, 172, and 162 may have an average stiffness within the range of about 15 gf to about 75 gf (±50 gf).

[0173] The select catheter 160 can utilize effective inner and outer material transitions around the curvature of the shape. Modifications in the catheter 160 mechanical configuration can include combinations of polymer jacket durometers ranging from 25D to 74D and wall thicknesses ranging from 0.004 inches to 0.011 inches. In some embodiments, nylon can be included at the proximal end, while the distal end can have a more flexible durometer. In one example, additional support liners such as extrusion-etched PTFE, film-cast PTFE, and / or polyamide, metal coils (0.003 inches to 0.018 inches pitch) made of stainless steel, tungsten, platinum, tantalum, nitinol, expanded-filled-tube (DFT) nitinol, and braid patterns (40 to 120 PPI) can be strategically placed around the curvature of the memorized shape. These transitions can help optimize shape retention, pushability, torque transmission / torque response, kink resistance, support, and trackability. The braided wire may be round (0.001-0.003 inch diameter) or flat (0.001 x 0.003-0.002 x 0.005 inch diameter) wire constructed from stainless steel, nitinol, or expanded filled tube (DFT) nitinol. Siloxane-based lubricious additives may be added to the polymer extrusion to enhance trackability. Barium, tungsten, or other materials may be added to the polymer extrusion to improve radiopacity under fluoroscopic intervention.

[0174] In one example of a method of use, shown in FIGS. 33-35 , the guide catheter 80 is advanced via a right radial approach (as described above) so that its distal tip is positioned within the right subclavian artery 16. In FIG. 33 , the selection catheter 160 is advanced out of the guide catheter 80, engaging the lower portion of the right subclavian artery 16, and the upward force causes the tip angle of the selection catheter to point upward. As the distal portion of the selection catheter 160 is advanced further distally, the tip of the selection catheter 160 curves upward toward the right common carotid artery 30, as shown in FIG. 34 . As shown in FIG. 34 , further distal movement moves the distal tip into the right common carotid artery 30, while the proximal curvature and position of the distal portion keeps the distal portion engaged with the luminal wall of the right subclavian artery 16, helping to maintain stability. That is, the shape of the distal portion of the selection catheter 160 causes contact to be made with the wall of the right subclavian artery 16 and maintains contact while the distal tip is moved into the right common carotid artery 30 .

[0175] 37 shows another example of a selection catheter 190 that is similar to the previously described selection catheter 160, including its stiffness, but has a different unconstrained, memorized shape of its distal portion for accessing the right common carotid artery 30 from the right subclavian artery 16. Generally, the memorized shape defines a primary curve and has an elongated distal portion extending from the primary curve.

[0176] First, focusing on the angles shown in Figure 37, the three angles 191, 192, and 193 may be in the range of approximately 10 degrees to 150 degrees. In a more specific example, angle 191 may be in the range of approximately 100 degrees to 150 degrees, angle 192 may be in the range of approximately 30 degrees to 125 degrees, and angle 193 may have a curvature angle in the range of approximately 10 degrees to 25 degrees (or an inner diameter of approximately 335 degrees to 350 degrees), and may also have a curvature diameter in the range of approximately 0.5 cm to 1.5 cm. The example angles described above may be generally in the same plane, but the distal portion may have an additional curvature angle of approximately 0 to 90 degrees in a direction generally perpendicular to the curvature shown in Figure 37.

[0177] In another example, each of segments 194, 195 (length and width in a curved state) and segment 197 may range in length from about 0.5 cm to about 2.5 cm.

[0178] 38 illustrates an example method of use in which the guide catheter 80 is advanced via a right radial approach (as described above) to position its distal end within or near the brachiocephalic artery 28 (or alternatively, the right subclavian artery 16 or the aortic arch 24). The distal portion of the catheter 190 is then advanced out of the guide catheter 80 and into the aortic arch 24, thereby assuming its unconstrained, expanded, memorized configuration. Once the memorized configuration is achieved, the physician can retract the selected catheter 190 proximally so that at least the distal segment 194 is moved into the right common carotid artery 30.

[0179] Depending on the physician's preference, the selection catheter 190 may then be advanced further distally to move the distal portion of the catheter 190 further up the right common carotid artery 30, or the guide catheter 80 may be advanced into the right common carotid artery 30 to cover the selection catheter 190, or any combination thereof. Depending on the physician's procedure, the selection catheter 190 may be removed and an additional working catheter may be used for the intended treatment.

[0180] As previously discussed, existing selection catheters curve only or substantially remain within a single plane, which can make accessing some vessels within the aortic arch difficult, particularly in the case of Type II and Type III anatomies as described above with respect to FIG. 2B. By including a curvature along the distal end of the selection catheter such that at least a portion of the distal region of the selection catheter does not remain within a single plane (e.g., a major curve that positions the distal free end of the catheter in a generally proximal direction while positioning the most distal region of the selection catheter in an orientation that is not parallel to the proximally adjacent regions of the selection catheter), various vessels can be more easily accessed. For example, the right common carotid artery 30 and the left common carotid artery 32 can be more easily accessed.

[0181] 39-43 illustrate an example of a selection catheter 200 having a curved distal region. FIG. 39 is a side view of the selection catheter 200 in a first rotational position relative to a plane 200F. FIG. 40 is a side view of the selection catheter 200 in a second rotational position approximately perpendicular to the position shown in FIG. 39. FIG. 41 is an end view of the selection catheter 200 from the distal end. FIG. 42 is an end view of the selection catheter 200 from the proximal end. FIG. 43 is a perspective view of the selection catheter 200. A reference plane 200F is included in each of these figures to aid in illustrating the shape of the selection catheter 200. In FIG. 39, the reference plane 200F has a face facing toward the viewer, and in FIG. 40, the reference plane 200F has an edge facing toward the viewer.

[0182] In one example, the selection catheter 200 may have a generally elongated shape or body that may or may not have a lumen (e.g., a guidewire lumen) therethrough. In some examples, the selection catheter 200 may have a variety of different structural materials that provide different flexibility, such as an inner wire coil, an inner braided wire, and an outer polymer jacket of different durometer hardness.

[0183] Returning to the example of FIG. 39 , the select catheter 200 may include a distal region 200A and a proximal region 200B. The proximal region 200B may include a proximal catheter hub 207 or similar termination that allows connection to other medical devices and / or access to the internal lumen. The distal region 200A may extend a distance from the proximal region 200B and terminate at the distal tip 211 of the select catheter 200. As described further below, the distal region 200A includes an imparted secondary shape that is formed when at least a portion of the distal region 200A is unconstrained (e.g., unconstrained by a larger, outer catheter). In one example, the distal region, when straightened, may have a length in the range of about 3 cm to about 30 cm.

[0184] In one example, the distal region 200A may include a distal first section 210 (also designated by length 200J) and a proximal second section 208 (also designated by length 200H). The distal first section 210 and the proximal second section 208 may be integral with one another, with the distal first section 210 distally connected to the proximal second section 208 when the select catheter 200 is in a constrained, straight configuration. The adjacent ends of the distal first section 210 and the proximal second section 208 together form a first major curve 204. In one example, the major curve may be defined as either the maximum curve when the distal region 200A is unconstrained or a curve that is greater than 45 degrees.

[0185] 39 and 40, first major curve 204 is formed at the adjacent ends of distal first section 210 and proximal second section 208 and does not remain substantially within a single plane 200F. In one example, as shown in FIG. 39, first major curve 204 may curve generally proximally at about 193 degrees, or with a radius of curvature of about 0.170 inches, when viewed across the plane of reference surface 200F. However, various other angles are possible, such as between 150 degrees and 230 degrees. More specifically, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190 , 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230 degrees. Example radii of curvature include those ranging from 0.14 inches to 0.30 inches, and more specifically, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.20, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, and 0.30 inches. Thus, the tip 211 of the selection catheter 200 is positioned generally proximal to the first major curve 204 when the distal region 200A is unconstrained. In other words, the first major curve 204 repositions the distal tip 211 such that it is not at the most distal position of the selection catheter 200. In some instances, the distal tip 211 may point generally in a proximal direction, as opposed to when the selection catheter 200 is in a generally straight, constrained configuration (e.g., when the selection catheter 200 is forced into a straight configuration).

[0186] 40, first major curve 204 may also curve away from reference plane 200F. FIG. 40 shows reference plane 200F rotated approximately 90 degrees relative to the view of reference plane 200F in FIG. 39. In one example, first major curve 204 forms an angle 200E with reference plane 200F (e.g., with proximal second section 208) within a range of approximately 5 degrees to 25 degrees. In some examples, angle 200E can include approximately 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 degrees. In some examples, the angle 200E may include angles of about 11, 11.01, 11.02, 11.03, 11.04, 11.05, 11.06, 11.07, 11.08, 11.09, 11.1, 11.11, 11.12, 11.13, 11.14, 11.15, 11.16, 11.17, 11.18, 11.19, 11.20, 11.21, 11.22, 11.23, 11.24, 11.25, 11.26, 11.27, 11.28, 11.29, 11.30, 11.31, 11.32, 11.33, 11.34, 11.35, 11.36, 11.37, 11.38, 11.39, 11.40, 11.41, 11.42, 11.43, 11.44, 11.45, 11.46, 11.47, 11.48, 11.49, 11.50, 11.51, 11.52, 11.53, 11.54, 11.55, 11.56, 11.57, 11.58, 11.59, 11.60, 11.61, 11.62, 11.63, 11.64, 11.65, 11.66, 11.67, 11.68, 11.69, 11.70, 1 .23, 11.24, 11.25, 11.26, 11.27, 11.28, 11.29, 11.3, 11.31, 11.32, 11.33, 11.34, 11.35, 11.36, 11.37, 11.38, 11.39, 11.4, 11.41, 11.42, 11.43, 11.44, 11.45, 11.46, 11.47, 11.48, 11.49 ,11.5,11.51,11.52,11.53,11.54,11.55,11.56,11.57,11.58,11.59,11.6,11.61,11.62,11.63,11.64,11.65,11.66,11.67,11.68,11.69,11.7,11.71,11.72,11.73,11.74,11.75,11 These can include .76, 11.77, 11.78, 11.79, 11.8, 11.81, 11.82, 11.83, 11.84, 11.85, 11.86, 11.87, 11.88, 11.89, 11.9, 11.91, 11.92, 11.93, 11.94, 11.95, 11.96, 11.97, 11.98, 11.99, or 12 degrees.

[0187] In this regard, distal first section 210 and its distal tip 211 are disposed proximal to first major curve 204, but are further angled such that distal first section 210 is not parallel to proximal second section 208. In other words, distal tip 211 of distal first section 210 is disposed further from proximal second section 208 than the portion of distal first section 210 at or near first major curve 204.

[0188] 41-43 are alternative views of the distal region 200A of the selection catheter 200 to better illustrate the curvature of the first major curve 204. FIG. 41 is a view from a distal perspective of the distal region 200A when unconstrained, with the first major curve 204 closest to the viewer and the proximal second section 208 extending away from the viewer. In FIG. 42, the proximal second section 208 extends generally toward the viewer, and the first major curve 204 is positioned further away from the viewer. FIG. 43 is another side perspective view of the distal region 200A, with the proximal second section 208 closest to the viewer and the first major curve 204 furthest from the viewer.

[0189] The distal region 200A of the select catheter 200 may also include one or more minor curves. In one example, a minor curve is defined as a curve within a range of approximately 90-190 degrees that is less than the first major curve 204 or away from the proximal second section 208.

[0190] 39 and 41, a minor curvature 206 may be imparted to a portion of distal first section 210 to create an angle 200G between segment 200C and segment 200N. Angle 200G may be any of the minor curvature angles described herein. In some examples, the angle of minor curvature 206 may be in the range of about 90 to about 190 degrees, and specifically, between segment 200C and segment 200N, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, or 190 degrees.

[0191] In one example, the minor curve 206 may remain substantially within a first plane (not shown) such that the entire distal first section 210 (length 200J) may lie substantially within a single plane in the example of Figures 39 and 40, or, similar to the description of the first major curve 204, the minor curve 206 may be curved further from the first plane (not shown) in which the proximal portion of the distal first section 210 substantially lies.

[0192] Depending on the length of distal first section 210 and the curvature of minor curvature 206, tip 211 of distal first section 210 may be positioned at different distances from proximal second section 208. From the perspective of FIG. 39, length 200S (e.g., the distance between tip 211 and proximal second section 208) may be in the range of about 1.3 cm to about 6.3 cm. More specific examples can include about 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.8, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, or 6.3 cm. 40, distance 200D (e.g., another component of the distance between tip 211 and proximal second section 208) may be in the range of about 0.4 cm to 2.0 cm. More specific examples can include about 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 cm. More specific examples can include about 0.8, 0.81, 0.82, 0.83, 0.84, 0.85, 0.86, 0.87, 0.88, 0.89, 0.9, 0.91, 0.92, 0.93, 0.94, 0.95, 0.96, 0.97, 0.98, 0.99, 1, 1.01, 1.02, 1.03, 1.04, 1.05, 1.06, 1.07, 1.08, 1.09, 1.1, 1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, or 1.2 cm.

[0193] Further, as shown in Figures 39 and 40, in one example, the length 200J between the distal tip 211 of the distal first section 210 and the tip of the curved end of the first major curve 204 may be in the range of approximately 3 to 8 cm. More specific examples can include about 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, or 8.0 cm. 39, distance 200S between distal tip 211 and proximal second section 208 may be within the range of about 1 to 2 cm. More specific examples include distances of about 1, 1.01, 1.02, 1.03, 1.04, 1.05, 1.06, 1.07, 1.08, 1.09, 1.1, 1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, 1.20, 1.21, 1.22, 1.23, 1.24, 1.25, 1.26, 1.27, 1.28, 1.29, 1.30, 1.31, 1.32, 1.33, 1.34, 1.35, 1.36, 1.37, 1.38, 1.39, 1.40, 1.41, 1.42, 1.43, 1.44, 1.45, 1.46, 1.47, 1.48, 1.49, 1.50, 1.51, 1.52, 1.53, 1.54, 1.55, 1.56, 1.57, 1.58, 1.60, 1.61, 1.62, 1.63, 1.64, 1.65, 1.66, 1.67, 1.68, 1.69, 1.70, 1.71, 1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.7 4, 1.25, 1.26, 1.27, 1.28, 1.29, 1.3, 1.31, 1.32, 1.33, 1.34, 1.35, 1.36, 1.37, 1.38, 1.39, 1.4, 1.41, 1.42, 1.43, 1.44, 1.45, 1.46, 1.47, 1.48, 1.49, 1.5, 1.51, 1.52, 1.53, 1.54, 1.55, 1.56, 1.57, 1.58, 1.59, 1.6, 1.61, 1.62, 1.63, 1.64, 1.65, 1.66, 1.67, 1.68, 1.69, 1.7, 1.71, 1.72, 1.73, 1.74, 1.75, 1.76, 1 These can include 0.77, 1.78, 1.79, 1.8, 1.81, 1.82, 1.83, 1.84, 1.85, 1.86, 1.87, 1.88, 1.89, 1.9, 1.91, 1.92, 1.93, 1.94, 1.95, 1.96, 1.97, 1.98, 1.99, or 2 cm.

[0194] In one example, the length 200H of the proximal second section 208 can be in the range of about 0.5 cm to 15 cm. More specific examples can include about 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0, 14.5, or 15.0 cm. The proximal second section 208 can be substantially straight or have a relatively gradual curvature along some or all of its length. Length 200K of the straight portion (i.e., the portion excluding first major curve 204), as well as the specific example of length 200H, may be in the range of about 0.5 cm to 15 cm. In one specific example, length 200H is about 6.35 cm, and length 200K is about 5.8 cm.

[0195] In one example, the select catheter, when unconstrained, may have a length of approximately 140 cm (range of approximately 135-145 cm) between the distal tip 211 and the start of the strain relief sleeve connected to the catheter hub 207.

[0196] FIGS. 44 and 45 show various views of the use of the selection catheter 200 of FIGS. 39-43. The guide catheter 80 is advanced via a right radial approach (as described above) so that its distal end is located in or near the brachiocephalic artery 28 (or in the right subclavian artery 16 or aortic arch 24). Next, as shown in FIG. 44, the distal portion of the selection catheter 200 is advanced out of the guide catheter 80 and into the aortic arch 24, thereby assuming an unconstrained, expanded, memorized configuration. Once the memorized configuration is achieved, the physician can retract the selection catheter 200 proximally so that some or all of the proximal second section 208 is back within the guide catheter 80. Because the distal region is sized and shaped similarly to the distance and location of the left common carotid artery 32, proximal movement moves the distal tip 211 into the left common carotid artery 32, as shown in FIG. 45.

[0197] Depending on the physician's preference, the selection catheter 200 may then be advanced further distally, moving the distal portion of the selection catheter 200 further up the left common carotid artery 32, and the guide catheter 80 may be advanced into the left common carotid artery 32 to cover the selection catheter 200. Alternatively or additionally, a guidewire may be advanced through the selection catheter 200 and into the left common carotid artery 32. Alternatively, variations and combinations of these may be implemented. Depending on the physician's procedure, the selection catheter 200 may be removed and an additional working catheter (or guidewire) may be used for the intended treatment.

[0198] As previously mentioned, the selection catheter 200 may have stiffness characteristics that provide a specific stiffness at a specific distance from its distal tip, which is useful in preventing the selection catheter from losing access when advancing a guidewire through the selection catheter or when advancing a larger outer catheter 80 over the selection catheter. By providing specific stiffness variations at specific locations along the length of the selection catheter 200, the selection catheter may better maintain access to the desired vessel during the procedure.

[0199] Table 1 below and Figure 46 show example stiffness characteristics of select catheter 200. Minimum and maximum stiffnesses are provided as well as average stiffnesses at various lengths from the distal tip 211 of select catheter 200. These minimum and maximum values ​​can therefore be thought of as a range of stiffness at any given location in the table or figure.

[0200] In this example data, it can be seen that stiffness increases only slightly between about 0 and 25 mm, increases significantly between about 25 and 45 mm, and then remains relatively constant overall or increases slightly between about 45 and 145 mm. Such stiffness characteristics may be particularly useful for the aforementioned dimensions and curvature of select catheter 200 for accessing left common carotid artery 32 via right subclavian artery 16, as previously described.

[0201] This rigidity, combined with the three-dimensional catheter shape, allows select catheters to "self-form" or achieve a secondary shape / configuration (e.g., a U-shape) without contacting or applying minimal force to the vessel wall (or aortic valve). This can avoid or minimize damage to the vessel wall and plaque detachment. Furthermore, as previously mentioned, this can provide the physician or operator with easier, faster, and more consistent access to the right and left common carotid arteries. In "time saves the brain" situations, such as stroke, this increased speed and consistency can improve patient outcomes by allowing the physician or operator to remove blockages more quickly and reliably. It can also facilitate access to difficult anatomical structures (e.g., a type III aortic arch) and / or anatomical structures inaccessible with prior art catheters.

[0202] Stiffness properties can be generated using standardized test methods such as ASTM D790-17 or ISO 178. The data in Tables 1-3 were generated using a similar test method that combined two-point bending tests from 0 to 20 mm (extremely distal 20 mm) from the distal tip of the catheter and three-point bending tests for distances greater than 20 mm from the distal tip. The three-point bending tests were performed using a 2 cm interval defining the test area, which was centered over the distance of the catheter being tested (e.g., for measurements at 40 mm from the distal tip, the interval spanned a length between 30 and 50 mm from the distal tip of the catheter). In both the two-point and three-point bending tests, a load sensor ("anvil") measured the force required to displace the catheter 1.5 mm within the measurement area, and measurements were taken in grams-force or g / f. Stiffness can be measured using the known formula: force / displacement distance. Depending on the exact testing protocol, force values ​​and curvatures may be higher or lower than those presented herein, but similar stiffness curves or characteristics may be achieved that appear very similar when "normalized" or "scalared." Thus, various other two-point and three-point bend test methods (both standardized and proprietary) may produce "normalized" measurements in grams-force (g / f), but scaled proportionally (e.g., measurements using other test methods with larger displacements may produce larger (e.g., 10% to 100% higher) gram-force measurements, and measurements using test methods with smaller displacements may produce smaller (e.g., 10% to 75% lower) gram-force measurements. Other test parameters, such as gap size, temperature, humidity, etc., may also affect measurements, but the overall stiffness characteristics must be scaled proportionally to remain normalized.

[0203] [Table 1]

[0204] In one example, the selection catheter 200 may have a stiffness in the range of approximately 68.38 gf to 205.14 gf at approximately 110 mm from the distal tip 211. In another example, the selection catheter 200 may have a stiffness in the range of approximately 55.17 gf to 165.51 gf at approximately 80 mm from the distal tip 211 of the selection catheter. In another example, the selection catheter 200 may have a stiffness in the range of approximately 11.29 gf to 33.86 gf at approximately 20 mm from the distal tip 211. In another example, the selection catheter 200 may have a stiffness in the range of approximately 6.75 gf to 20.25 gf at approximately 10 mm from the distal tip 211. In another example, the selection catheter 200 may have a stiffness in the range of approximately 4 gf to 12 gf at approximately 5 mm from the distal tip 211. In another example, the selection catheter 200 may have a stiffness within any of the ranges previously disclosed.

[0205] In another example, the select catheter 200 may have an average stiffness of approximately 136.76 gf at approximately 110 mm from the distal tip 211, approximately 110.34 gf at approximately 80 mm from the distal tip 211, approximately 22.58 gf at approximately 20 mm from the distal tip 211, approximately 13.5 gf at approximately 10 mm from the distal tip 211, and approximately 8 gf at approximately 5 mm from the distal tip 211.

[0206] As previously mentioned, the three-dimensional unconstrained shape and dimensions, and stiffness characteristics may all be included in the same catheter example, and may be employed together in any combination, including alone.

[0207] 47-51 illustrate an example of a selection catheter 300 having a curved distal region. FIG. 47 is a side view of the selection catheter 300 in a first rotational position relative to a plane 300F. FIG. 48 is a side view of the selection catheter 300 in a second rotational position approximately perpendicular to the position shown in FIG. 47. FIG. 49 is an end view of the selection catheter 300 from the distal end. FIG. 50 is an end view of the selection catheter 300 from the proximal end. FIG. 51 is a perspective view of the selection catheter 300. A reference plane 300F is included in each of these figures to aid in illustrating the shape of the selection catheter 300. In FIG. 47, the reference plane 300F faces toward the viewer, and in FIG. 48, the reference plane 300F faces toward the viewer with its edge facing toward the viewer.

[0208] In one example, the selection catheter 300 may have a generally elongated shape or body that may or may not have a lumen (e.g., a guidewire lumen) therethrough. In some examples, the selection catheter 300 may have a variety of different structural materials that provide different flexibility, such as an inner wire coil, an inner braided wire, and an outer polymer jacket of different durometer hardness.

[0209] Returning to the example of FIG. 47, the select catheter 300 may include a distal region 300A and a proximal region 300B. The proximal region 300B may include a proximal catheter hub 307 or similar termination that allows connection to other medical devices and / or access to the internal lumen. The distal region 300A may extend a distance from the proximal region 300B and terminate at the distal tip 311 of the select catheter 300. As described further below, the distal region 300A includes an imparted secondary shape that is formed when at least a portion of the distal region 300A is unconstrained (e.g., unconstrained by a larger, outer catheter). In one example, the distal region, when straightened, may have a length in the range of about 3 cm to about 30 cm.

[0210] In one example, the distal region 300A may include a distal first section 310 (also designated by length 300J) and a proximal second section 308 (also designated by length 300H). The distal first section 310 and the proximal second section 308 may be integral with one another, with the distal first section 310 distally connected to the proximal second section 308 when the select catheter 300 is in a constrained, straight configuration. The adjacent ends of the distal first section 310 and the proximal second section 308 together form a first major curve 304. In one example, the major curve may be defined as either the maximum curve when the distal region 300A is unconstrained or a curve that is greater than 45 degrees.

[0211] 47 and 48, the first major curve 304 is formed at the adjacent ends of the distal first section 310 and the proximal second section 308 and does not remain substantially within a single plane 300F. In one example, as shown in FIG. 47, the first major curve 304 may curve generally proximally at about 192 degrees, or with a radius of curvature of about 0.102 inches, when viewed across the plane of the reference surface 300F. However, various other angles are possible, such as between 160 degrees and 220 degrees. More specifically, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, The radius of curvature can be 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, or 220 degrees. Example radii of curvature include those ranging from 0.08 inches to 0.22 inches, and more specifically, 0.08, 0.09, 0.1, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, or 0.22 inches. Thus, the tip 311 of the selection catheter 300 is positioned generally proximal to the first major curve 304 when the distal region 300A is unconstrained. In other words, the first major curve 304 repositions the distal tip 311 such that it is not at the most distal position of the selection catheter 300. In some instances, the distal tip 311 may point generally proximally as opposed to when the selection catheter 300 is in a generally straight, constrained configuration (e.g., when the selection catheter 300 is forced into a straight configuration).

[0212] 48, the first major curve 304 may also curve away from the reference plane 300F. FIG. 48 shows the reference plane 300F rotated approximately 90 degrees relative to the view of the reference plane 300F in FIG. 47. In one example, the first major curve 304 forms an angle 300E with the reference plane 300F (e.g., with the proximal second section 308) within a range of approximately 5 degrees to 25 degrees. In some examples, the angle 300E can include approximately 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 degrees. In some examples, angle 300E can include approximately 10.0, 10.05, 10.1, 10.15, 10.2, 10.25, 10.3, 10.35, 10.4, 10.45, 10.5, 10.55, 10.6, 10.65, 10.7, 10.75, 10.8, 10.85, 10.9, 10.95, or 11.0 degrees.

[0213] In this regard, the distal first section 310 and its distal tip 311 are disposed proximal to the first major curve 304, but are further angled such that the distal first section 310 is not parallel to the proximal second section 308. In other words, the distal tip 311 of the distal first section 310 is disposed further from the proximal second section 308 than the portion of the distal first section 310 at or near the first major curve 304.

[0214] 49-51 are other views of the distal region 300A of the selection catheter 300, better illustrating the curvature of the first major curve 304. FIG. 49 is a view from a distal perspective of the distal region 300A when unconstrained, with the first major curve 304 closest to the viewer and the proximal second section 308 extending away from the viewer. In FIG. 50, the proximal second section 308 extends generally toward the viewer, and the first major curve 304 is positioned further away from the viewer. FIG. 51 is another side perspective view of the distal region 300A, with the proximal second section 308 closest to the viewer and the first major curve 304 furthest from the viewer.

[0215] The distal region 300A of the select catheter 300 may also include one or more minor curves. In one example, a minor curve is defined as a curve that is less than the first major curve 304 or is within approximately 90-190 degrees from the proximal second section 308.

[0216] Returning to the example of Figures 47 and 48, a minor curve 306 may be imparted to a portion of distal first section 310 to create an angle 300G between segment 300C and segment 300N. Angle 300G may be in the range of about 90 to about 190 degrees, or any of the minor curve angles previously described. In some examples, the angle of minor curvature 306 is 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, or 190 degrees.In some examples, the angle of the minor curve 306 is about 120, 120.01, 120.02, 120.03, 120.04, 120.05, 120.06, 120.07, 120.08, 120.09, 120.1, 120.11, 120.12, 120.13, 120.14, 120.15, 120.16, 120.17, 120.18, 120.19, 120.2, 120.21, 120.22, 120.23, 120.24, 120.25, 120.26, 120.27, 120.28, 120.29, 120.30, 120.31, 120.32, 120.33, 120.34, 120.35, 120.36, 120.37, 120.38, 120.39, 120.40, 120.41, 120.42, 120.43, 120.44, 120.45, 120.46, 120.47, 120.48, 120.49, 120.50, 120.51, 120.52, 120.53, 120.54, 120.55, 120.56, 120.57, 120.58, 120.59, 120.60, 120.61, 120 .23, 120.24, 120.25, 120.26, 120.27, 120.28, 120.29, 120.3, 120.31, 120.32, 120.33, 120.34, 120.35, 120.36, 120.37, 120.38, 120.39, 120.4, 120.41, 120.42, 120.43, 120.44, 120.45, 120.46, 120.47, 120.48, 120.49 ,120.5,120.51,120.52,120.53,120.54,120.55,120.56,120.57,120.58,120.59,120.6,120.61,120.62,120.63,120.64,120.65,120.66,120.67,120.68,120.69,120.7,120.71,120.72,120.73,120.74,120.75,120.76,120.77,120.78,120.79,120.80,120.81,120.82,120.83,120.84,120.85,120.86,120.87,120.88,120.89,120.90,120.91,120.92,120.93,120.94,120.95,120.96,120.97,120.98,120.99,120.100,120.101,120.102,120.103,120.104,120.105,120.106,120.110,120.117,120.118,120.119,120.120,120.130,120.131,120.132,120.133,120.134,120.135,120.136,120.137,12 It can be 0.76, 120.77, 120.78, 120.79, 120.8, 120.81, 120.82, 120.83, 120.84, 120.85, 120.86, 120.87, 120.88, 120.89, 120.9, 120.91, 120.92, 120.93, 120.94, 120.95, 120.96, 120.97, 120.98, 120.99, or 121.00.

[0217] In one example, the minor curve 306 may remain substantially within a first plane (not shown) such that the entire distal first section 310 (length 300J) may lie substantially within a single plane in the example of Figures 47 and 48, or similar to the description of the first major curve 304, the minor curve 306 may be curved further from the first plane (not shown) in which the proximal portion of the distal first section 310 substantially lies.

[0218] Depending on the length of distal first section 310 and the curvature of minor curvature 306, tip 311 of distal first section 310 may be positioned at different distances from proximal second section 308. From the perspective of FIG. 47, length 300S (e.g., the distance between tip 311 and proximal second section 308) may be in the range of about 0.6 cm to about 4 cm. More specific examples include: 0.6, 0.61, 0.62, 0.63, 0.64, 0.65, 0.66, 0.67, 0.68, 0.69, 0.7, 0.71, 0.72, 0.73, 0.74, 0.75, 0.76, 0.77, 0.78, 0.79, 0.8, 0.81, 0.82, 0.83, 0.84, 0.85, 0.86, 0.87, 0.88, 0.89, 0.9, 0.91, 0.92, 0.93, 0.94, 0.95, 0.96, 0.97, 0.98, 0.99, 1.01, 1.02, 1.03, 1.04, 1.05, 1.06, 1.07, 1.08, 1.09, 1.10, 1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, 1.19, 1.20, 1.21, 1.22, 1.23, 1.24, 1.25, 1.26, 1.27, 1.28, 1.29, 1.30, 1.31, 1.32, 1.33, 1.34, 1.35, 1.36, 1.37, 1.38, 1.39, 1.40, 1.41, 1.42, 1.43, 1.44, ,1.02,1.03,1.04,1.05,1.06,1.07,1.08,1.09,1.1,1.11,1.12,1.13,1.14,1.15,1.16,1.17,1.18,1.19,1.2,1.21,1.22,1.23,1.24,1.25,1.26,1.27,1.28,1.29,1.3,1.31,1.32,1.33,1.34,1.35,1.36,1.37,1.38,1.39,1.4,1.41,1.42,1.43,1.44,1.45,1.46,1.47,1.48,1.49,1.50,1.51,1.52,1.53,1.54,1.55,1.56,1.57,1.58,1.59,1.60,1.61,1.62,1.63,1.64,1.65,1.66,1.67,1.68,1.69,1.70,1.71,1.72,1.73,1.74,1.75,1.76,1.77,1.78,1.79,1.80,1.81,1.82,1.83,1.84,1.85,1.86,1.87,1.88,1.89,1.90,1.91,1.92,1.93,1.94,1.95,1.96,1.97,1.98,1.99,1.00,1.01,1.02,1.03,1.0 .45, 1.46, 1.47, 1.48, 1.49, 1.5, 1.51, 1.52, 1.53, 1.54, 1.55, 1.56, 1.57, 1.58, 1.59, 1.6, 1.61, 1.62, 1.63, 1.64, 1.65, 1.66, 1.67, 1.68, 1.69, 1.7, 1.71, 1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, 1.8, 1.81, 1.82, 1.83, 1.84, 1.85, 1.86, 1.87, 1. 88, 1.89, 1.9, 1.91, 1.92, 1.93, 1.94, 1.95, 1.96, 1.97, 1.98, 1.99, 2, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.1, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.2, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40, 2.41, 2.42, 2.43, 2.44, 2.45, 2.46, 2.47, 2.48, 2.49, 2.50, 2.51, 2.52, 2.53, 2.54, 2.55, 2.56, 2.57, 2.58, 2.59, 2.60, 2.61, 2.62, 2.63, 2.64, 2.65, 2.66, 2.67, 2.68, 2.69, 2.70, 2.71, 2.72, 2.73, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.4, 2.41, 2.42, 2.43, 2.44, 2.45, 2.46, 2.47, 2.48, 2.49, 2.5, 2.51, 2.52, 2.53, 2.54, 2.55, 2.56, 2.57, 2.58, 2.59, 2.6, 2.61, 2.62, 2.63, 2.64, 2.65, 2.66, 2.67, 2.68, 2.69, 2.7, 2.71, 2.72, 2.73, 2.74, 2.75, 2.76, 2.77, 2.78, 2.79, 2.8, 2.81, 2.82, 2.83, 2.84, 2.85, 2.86, 2.87, 2.88, 2.89, 2.9, 2.91, 2.92, 2.93, 2.94, 2.95, 2.96, 2.97, 2.98, 2.99, 3, 3.01, 3.02, 3.03, 3.04, 3.05, 3.06, 3.07, 3.08, 3.09, 3.1, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18, 3.19, 3.2, 3.21, 3.22, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, 3.29, 3.3, 3.31, 3.32, 3.33, 3.34, 3.35, 3.36, 3.37, 3.38, 3.39, 3.4, 3.41, 3.42, 3.43, 3.44, 3.45, 3.46, 3.47, 3.48, 3.49, 3.5, 3.51, 3.52, 3.53, 3.54, 3.55, 3.56, 3.57, 3.58, 3.59, 3.6 , 3.61, 3.62, 3.63, 3.64, 3.65, 3.66, 3.67, 3.68, 3.69, 3.7, 3.71, 3.72, 3.73, 3.74, 3.75, 3.76, 3.77, 3.78, 3.79, 3.8, 3.81, 3.82, 3.83, 3.84, 3.85, 3.86, 3.87, 3.88, 3.89, 3.9, 3.91, 3.92, 3.93, 3.94, 3.95, 3.96, 3.97, 3.98, 3.99, or 4 cm.

[0219] 48, distance 300D (e.g., another component of the distance between tip 311 and proximal second section 308) may be in the range of about 0.1 cm to 1.0 cm. More specific examples include distances of about 0.1, 0.101, 0.102, 0.103, 0.104, 0.105, 0.106, 0.107, 0.108, 0.109, 0.11, 0.111, 0.112, 0.113, 0.114, 0.115, 0.116, 0.117, 0.118, 0.119, 0.12, 0.121, 0.122, 0.123, 0.1 24, 0.125, 0.126, 0.127, 0.128, 0.129, 0.13, 0.131, 0.132, 0.133, 0.134, 0.135, 0.136, 0.137, 0.138, 0.139, 0.14, 0.141, 0.142, 0.143, 0.144, 0.145, 0.146, 0.147, 0.148, 0.149, 0.15 ,0.151,0.152,0.153,0.154,0.155,0.156,0.157,0.158,0.159,0.16,0.161,0.162,0.163,0.164,0.165,0.166,0.167,0.168,0.169,0.17,0.171,0.172,0.173,0.174,0.175,0.176, These may include 0.177, 0.178, 0.179, 0.18, 0.181, 0.182, 0.183, 0.184, 0.185, 0.186, 0.187, 0.188, 0.189, 0.19, 0.191, 0.192, 0.193, 0.194, 0.195, 0.196, 0.197, 0.198, 0.199, or 0.2 cm.

[0220] 47 and 48, in one example, length 300J between distal tip 311 of distal first section 310 and the tip of the curved end of first major curve 304 may be in the range of approximately 2 to 5 cm. More specific examples may include approximately 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, and 5 cm. Length 300S between distal tip 311 and proximal second section 308, as viewed from the position of FIG. 47, may be in the range of approximately 0.2 cm to 0.5 cm. More specific examples can include about 2.3, 2.4, 2.4, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, or 6.3 cm.

[0221] In one example, the length 300H of the proximal second section 308 can be in the range of about 0.5 cm to 15 cm. More specific examples can include about 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0, 14.5, or 15.0 cm. More specific examples can include about 5.5, 5.6, 5.7, 5.8, 5.9, 6, 6.1, 6.2, 6.3, 6.4, or 6.5 cm. Proximal second section 308 may be substantially straight or may have a relatively gentle curve along some or all of its length. Length 300K of the straight portion (i.e., the portion excluding first major curve 304) may range from about 0.5 cm to 15 cm, as may specific examples of length 300H. In one specific example, length 300H is about 5.8 cm, and length 300K is about 5.0 cm.

[0222] In one example, the select catheter, when unconstrained, may have a length of approximately 140 cm (range of approximately 135-145 cm) between the distal tip 311 and the start of the strain relief sleeve connected to the catheter hub 307.

[0223] FIGS. 52 and 53 show various views of the use of the selection catheter 300 of FIGS. 47-51. The guide catheter 80 is advanced via a right radial approach (as described above) so that its distal end is located in or near the brachiocephalic artery 28 (or in the right subclavian artery 16 or aortic arch 24). Next, as shown in FIG. 52, the distal portion of the selection catheter 300 is advanced out of the guide catheter 80 and into the aortic arch 24, thereby assuming an unconstrained, expanded, memorized configuration. Once the memorized configuration is achieved, the physician can retract the selection catheter 300 proximally so that some or all of the proximal second section 308 is back within the guide catheter 80. Because the distal region is sized and shaped similarly to the distance and location of the right common carotid artery 30, proximal movement moves the distal tip 311 into the right common carotid artery 30, as shown in FIGS. 52 and 53.

[0224] Depending on the physician's preference, the selection catheter 300 may then be advanced further distally, moving the distal portion of the selection catheter 300 further up the right common carotid artery 30, and the guide catheter 80 may be advanced into the right common carotid artery 30 over the selection catheter 200. Alternatively or additionally, a guidewire may be advanced through the selection catheter 300 and into the right common carotid artery 30. Alternatively, variations and combinations of these may be implemented. Depending on the physician's procedure, the selection catheter 300 may be removed and an additional working catheter (or guidewire) may be used for the intended treatment.

[0225] As previously mentioned, the selection catheter 300 may have stiffness characteristics that provide a specific stiffness at a specific distance from its distal tip, which is useful in preventing the selection catheter from losing access when a guidewire is advanced through the selection catheter or when a larger outer catheter 80 is advanced over the selection catheter. By providing specific stiffness variations at specific locations along the length of the selection catheter 300, the selection catheter can better maintain access to the desired vessel during the procedure.

[0226] Table 2 below and Figure 54 show example stiffness characteristics of select catheter 300. Minimum and maximum stiffnesses are provided as well as average stiffnesses at various lengths from the distal tip 311 of select catheter 300. These minimum and maximum values ​​can therefore be thought of as a range of stiffness at any given location in the table or figure.

[0227] This example data shows that stiffness increases only slightly between about 0 and 15 mm, increases significantly between about 15 and 20 mm, increases only slightly or remains nearly constant between about 20 and 70 mm, and increases significantly between about 70 and 75 mm. Such stiffness characteristics may be particularly useful for the aforementioned dimensions and curvature of select catheter 300 for accessing right common carotid artery 30 via right subclavian artery 16, as previously described.

[0228] This rigidity, combined with the three-dimensional catheter shape, allows select catheters to "self-form" or achieve a secondary shape / configuration (e.g., U-shape) without contacting or applying minimal force to the vessel wall (or aortic valve). This can avoid or minimize damage to the vessel wall and plaque detachment. Furthermore, as previously mentioned, this can provide the physician or operator with easier, faster, and more consistent access to the right and left common carotid arteries. In "time saves the brain" situations, such as stroke, this increased speed and consistency can improve patient outcomes by allowing the physician or operator to remove blockages more quickly and reliably. It can also facilitate access to difficult anatomical structures (e.g., type III aortic arch) and / or anatomical structures inaccessible with prior art catheters.

[0229] [Table 2]

[0230] In one example, the selection catheter 300 may have a stiffness in the range of approximately 77.42 gf to 232.27 gf at approximately 110 mm from the distal tip 311. In another example, the selection catheter 300 may have a stiffness in the range of approximately 64.50 gf to 193.49 gf at approximately 80 mm from the distal tip 311 of the selection catheter. In another example, the selection catheter 300 may have a stiffness in the range of approximately 19.48 gf to 58.44 gf at approximately 20 mm from the distal tip 311. In another example, the selection catheter 300 may have a stiffness in the range of approximately 6.04 gf to 18.11 gf at approximately 10 mm from the distal tip 311. In another example, the selection catheter 300 may have a stiffness in the range of approximately 3.20 gf to 9.60 gf at approximately 5 mm from the distal tip 311. In another example, the selection catheter 300 may have a stiffness within any of the ranges previously disclosed.

[0231] In another example, the select catheter 300 may have an average stiffness of approximately 154.85 gf at approximately 110 mm from the distal tip 311, approximately 128.99 gf at approximately 80 mm from the distal tip 311, approximately 38.96 gf at approximately 20 mm from the distal tip 311, approximately 12.08 gf at approximately 10 mm from the distal tip 311, and approximately 6.40 gf at approximately 5 mm from the distal tip 311.

[0232] As previously mentioned, the three-dimensional unconstrained shape and dimensions, and stiffness characteristics may all be included in the same catheter example, and may be employed together in any combination, including alone.

[0233] 55-63 illustrate an example of a selection catheter 400 intended for use via a femoral artery approach. This selection catheter 400 includes similarities to some of the selection catheters previously described, but may have different dimensions and curvatures and may include a selected length portion having a lubricious coating. This selection catheter 400 will first be described generally and then in more detail with reference to the drawings.

[0234] A low-friction or lubricious coating may be disposed on a portion of the distal region of the inner catheter adjacent to a region of relatively high friction in the distal region. While select catheters may particularly benefit from such a low-friction coating or region, any catheter with a preformed or unconstrained curve that may be deployed through a larger catheter or sheath may also benefit. Thus, this low-friction aspect should not be limited to select catheters alone. Furthermore, any of the catheters described herein may be provided with this low-friction coating.

[0235] In one example of a select catheter, the coating may be disposed only along the curved region (e.g., the primary curve) and not along the very distal length of the inner catheter. In another example, the coating may be disposed only along the curved region and a portion adjacent to the curve (e.g., within a range of about 1 mm to about 10 mm). This creates a first region of relatively increased friction between the distal end of the inner catheter and a short distance thereafter, followed by a second region of relatively decreased friction proximal to the first region, and a third region of relatively increased friction proximal to the second region. Because the select catheter, when unconstrained, tends to assume a preformed curve (e.g., the primary curve), when constrained or straightened within a larger catheter (e.g., a guide catheter or balloon catheter), the curved region tends to exert increased force against the inner lumen of the larger catheter, thus increasing friction. In other words, the curved region tends to press against the wall of the inner lumen of the larger catheter, forcing the region immediately adjacent to the curved region against the opposing surface of the wall of the inner lumen of the larger catheter. Therefore, low-friction or lubricious coatings can be useful to reduce friction in these areas.

[0236] If the low-friction or lubricious coating continues to the distal-most end of the selection catheter and along most of its proximal portion, it will be relatively slippery when positioned within a vessel distal to the aortic arch 24 and may therefore be more susceptible to slipping out of the vessel in which it is positioned when a larger catheter or guidewire is advanced over or through the selection catheter. Thus, high-friction regions on one or both sides of the curved region of the selection catheter may be useful in maintaining the selection catheter within the desired vessel in which it is positioned (e.g., the brachiocephalic artery 28, right common carotid artery 30, or left common carotid artery 32) by increasing friction against the patient's vessel. Thus, the combination of low-friction and high-friction regions may be effective in reducing friction when advancing the selection catheter within a larger catheter and may provide good stability (e.g., staying in place) within the vessel from the aortic arch 24.

[0237] As previously discussed, existing selection catheters curve only or substantially remain within a single plane, which can make accessing some vessels within the aortic arch difficult, particularly in the case of Type II and Type III anatomies, as discussed above with respect to FIG. 2B. By including a curvature along the distal end of the selection catheter such that at least a portion of the distal region of the selection catheter does not remain within a single plane (e.g., a major curve that positions the distal free end of the catheter in a generally proximal direction while positioning the most distal region of the selection catheter in an orientation that is not parallel to the proximally adjacent regions), various vessels can be more easily accessed, particularly in the case of Type II and Type III anatomies. For example, the brachiocephalic trunk 28 and the left common carotid artery 32 can be more easily accessed.

[0238] 55-59 illustrate an example of a selection catheter 400 having a curved distal region. FIG. 55 is a side view of the selection catheter 400 in a first rotational position relative to a plane 400F. FIG. 56 is a side view of the selection catheter 400 in a second rotational position approximately perpendicular to the position shown in FIG. 55. FIG. 57 is an end view of the selection catheter 400 from the distal end. FIG. 58 is an end view of the selection catheter 400 from the proximal end. FIG. 59 is a perspective view of the selection catheter 400. A reference plane 400F is included in both FIGS. 55 and 56 to aid in illustrating the shape of the selection catheter 400. In FIG. 55, the reference plane 400F faces toward the viewer, while in FIG. 4, the reference plane 400F faces toward the viewer with its edge facing toward the viewer.

[0239] In one example, the selection catheter 400 may have a generally elongated shape or body that may or may not have a lumen (e.g., a guidewire lumen) therethrough. In some examples, the selection catheter 400 may have a variety of different structural materials that provide different flexibility, such as an inner wire coil, an inner braided wire, and an outer polymer jacket of different durometer hardness.

[0240] Returning to the example of FIG. 55, the select catheter 400 may include a distal region 400A and a proximal region 400B. The proximal region 400B may include a proximal catheter hub 407 or similar termination that allows connection to other medical devices and / or access to the internal lumen. The distal region 400A may extend a distance from the proximal region 400B and terminate at the distal tip 411 of the select catheter 400. As described further below, the distal region 400A includes an imparted shape that is formed when at least a portion of the distal region 400A is unconstrained (e.g., unconstrained by a larger, outer catheter). In one example, the distal region may have a length of about 3 cm to about 30 cm when straightened.

[0241] In one example, the distal region 400A may comprise a distal first section 410 and a proximal second section 408. The distal first section 410 and the proximal second section 408 may be integral with one another, with the distal first section 410 distally connected to the proximal second section 408 when the select catheter 400 is in a constrained, straight configuration. The adjacent ends of the distal first section 410 and the proximal second section 408 together form a major curve. In one example, the major curve may be defined as either the maximum curve when the distal region 400A is unconstrained or a curve that is greater than 45 degrees.

[0242] 55 and 56, first major curve 404 is formed at the adjacent ends of distal first section 410 and proximal second section 408 and does not remain substantially in a single plane. In one example, as shown in FIG. 55, first major curve 404 may curve approximately 480 degrees in a generally proximal direction when viewed across the plane of reference plane 400F. However, various other angles are possible, such as between 460 degrees and 200 degrees. In more specific examples, the angle may be 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, or 200 degrees. Thus, the tip 411 of the selection catheter 400 is positioned generally proximal of the first major curve 404 when the distal region 400A is unconstrained. In other words, the first major curve 404 repositions the distal tip 411 such that it is not at the most distal position of the selection catheter 400. In some examples, the distal tip 411 may point in a generally proximal direction, as opposed to when the selection catheter 400 is in a generally straight, constrained configuration (e.g., when the selection catheter 400 is forced into a straight shape). In one example, the outer diameter 400M at the first major curve 404 is approximately 0.084 inches.

[0243] 56, first major curve 404 may also curve away from reference plane 400F. FIG. 56 shows reference plane 400F rotated approximately 90 degrees relative to the view of reference plane 400F in FIG. 55. In one example, first major curve 404 creates an angle 400E with reference plane 400F (e.g., with proximal second section 408) within a range of approximately 5 degrees to 25 degrees. In some examples, angle 400E can include approximately 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 degrees.

[0244] In this regard, the distal first section 410 and its distal tip 411 are disposed proximal to the first major curve 404, but are further angled such that the distal first section 410 is not parallel to the proximal second section 408. In other words, the distal tip 411 of the distal first section 410 is disposed further from the proximal second section 408 than the portion of the distal first section 410 at or near the first major curve 404.

[0245] 57-59 are other views of the distal region 400A of the selection catheter 400, better illustrating the curvature of the first major curve 404. FIG. 57 is a view from a distal perspective of the distal region 400A when unconstrained, with the first major curve 404 closest to the viewer and the proximal second section 408 extending away from the viewer. In FIG. 58, the proximal second section 408 extends generally toward the viewer, and the first major curve 404 is positioned further away from the viewer. FIG. 59 is another side perspective view of the distal region 400A, with the proximal second section 408 closest to the viewer and the first major curve 404 furthest from the viewer.

[0246] The distal region 400A of the selected catheter 400 may also include one or more minor curves. In one example, a minor curve is defined as a curve that is less than the first major curve 404 or is within a range of approximately 1 to 45 degrees relative to the reference plane 400F or the proximal portion of the distal region 400A. In some examples, the angle of the minor curve relative to the reference plane 400F or the proximal portion of the distal region 400A can include approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, or 45 degrees.

[0247] 55 and 56, a minor curvature 406 can be imparted to a portion of the distal first section 410 to create an angle 400G relative to a reference plane 400F or a proximal portion of the distal first section 410. The angle 400G can be any of the minor curvature angles previously disclosed.

[0248] In one example, the minor curve 406 may remain substantially within a first plane (not shown) such that the entire distal first section 410 may lie substantially within a single plane in the example of Figures 55 and 56, or similar to the description of the first major curve 404, the minor curve 406 may be curved further from the first plane (not shown) in which the proximal portion of the distal first section 410 substantially lies.

[0249] Depending on the length of distal first section 410 and the curvature of minor curvature 406, tip 411 of distal first section 410 may be positioned at different distances from proximal second section 408. From the perspective of FIG. 55, distance 400C (e.g., a component of the distance between tip 411 and proximal second section 408) may be in the range of about 1.3 cm to about 6.3 cm. More specific examples can include about 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.8, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, or 6.3 cm. 56, distance 400D (e.g., another component of the distance between tip 411 and proximal second section 408) may be in the range of about 0.4 cm to 2.0 cm. More specific examples can include about 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 cm.

[0250] 55 and 56, in one example, the length 400J between the distal tip 411 of the distal first section 410 and the tip of the curved end of the first major curve 404 may be within a range of approximately 5-8 cm. More specific examples may include approximately 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, or 8.0 cm. The distance 400C between the distal tip 411 and the proximal second section 408, as viewed from the position of FIG. 55, may be within a range of approximately 2.3-6.3 cm. More specific examples can include about 2.3, 2.4, 2.4, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, or 6.3 cm.

[0251] In one example, the length 400H of the proximal second section 408 can be in the range of approximately 0.5 cm to 15 cm. More specific examples can include approximately 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0, 14.5, or 15.0 cm. The proximal second section 408 can be substantially straight or can have a relatively gradual curvature along some or all of its length.

[0252] In one example, the selected catheter may have a length of approximately 150 cm (±3 cm) between the distal tip 411 and the start of the strain relief sleeve connected to the catheter hub 407 when unconstrained.

[0253] Figures 60 and 61 illustrate one example of how an example catheter having the unconstrained configuration described above can be used. Referring first to Figure 60, the larger outer catheter 80 can be advanced near or into the patient's aortic arch 24. The select catheter 400 can then be advanced out of the outer catheter 80. As shown in Figure 60, the three-dimensional shape of the first major curve 404 is useful in angulating the distal tip 411 toward a desired vascular opening, such as the brachiocephalic trunk 28 and right common carotid artery 30, left common carotid artery 32, or left subclavian artery 22. Additionally, the minor curve 406 can further assist in positioning the distal tip 411. In Figure 61, the select catheter 400 is advanced further into the brachiocephalic trunk 28 and toward the right common carotid artery 30. At this point, the outer catheter 80 can be advanced over the select catheter 400 into the brachiocephalic trunk 28 and right common carotid artery 30, or a guidewire (not shown) can be advanced through the select catheter 400 into the brachiocephalic trunk 28 and right common carotid artery 30. The outer catheter 80 and / or guidewire can be further advanced to the desired location and treatment can be administered to the patient.

[0254] 62 is a side view of the selection catheter 400. As previously mentioned, in one example, the selection catheter 400 may include a low-friction or lubricious coating 402 disposed on only a portion of the distal region 400A of the selection catheter 400. In some examples, the region without the lubricious coating may have a relatively high coefficient of friction compared to the region with the lubricious coating. For example, the lubricious coating 402 may be disposed along only some or all of the first major curve 404, but not along the distal-most length of the distal first section 410 or along the proximal length of the proximal second section 408. Alternatively, the lubricious coating 402 may extend a short distance (e.g., about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0 cm) distally and / or proximally beyond the first major curve 404. If desired, distinct regions of the lubricious coating 402 may be included on any additional curves, such as the minor curve 406, in a manner similar to that described for the major curve 404.

[0255] As can be seen in FIG. 62 , examples of these lubricious coating 402 placements can include the following: A distal first portion 430A has relatively high friction between the distal tip 411 of the select catheter 400 and a short distance therefrom. This distal first portion 430A is followed by a second portion 430B of the lubricious coating 402, which is proximal to the first portion 430A and has relatively low friction. The second portion 430B can be positioned over part, all, or beyond the first major curve 404. The second portion 430B can be followed by a proximal third portion 430C, which has relatively increased friction against the lubricious coating 402. Furthermore, in one example, a separate section of the lubricious coating 402 can extend along part or all of the minor curve 406 (not shown). In one example, a portion can refer to a section or region that extends along at least a portion of the length of the select catheter 400.

[0256] 62 may include a lubricious coating 402 to create at least one region with a relatively low coefficient of friction, but other techniques may be used to create a similar pattern of coefficient of friction. For example, the outer polymer jacket of the select catheter 400 may include tubular portions that may exhibit different coefficients of friction.

[0257] 62 may include a lubricious coating 402 that completely surrounds the outer surface or circumference of the select catheter 400, while other examples may include a lubricious coating 402 (or equivalent jacket material) along only a portion of the outer surface or circumference of the select catheter 400. In one example, the lubricious coating 402 (or equivalent jacket material) may be disposed along the outer surface of the curved portion, while the inner surface of the curved portion may not include the lubricious coating 402 or may have a higher coefficient of friction.

[0258] FIG. 63 is a side view of a selection catheter 400 within a larger catheter 80. In one example, the selection catheter 400 may assume a preformed curved shape when unconstrained, so that the first major curve 404, in particular, where the first major curve 404 contacts the internal lumen of the larger catheter 80 when constrained or straightened within the larger catheter 80 (e.g., a guide catheter or balloon catheter), may generate a relatively high level of friction, and therefore a relatively high level of force resisting movement, on the internal lumen of the larger catheter 80. The areas marked with enlarged arrows (e.g., F1, F2, F3) in FIG. 63 indicate examples of these regions of relatively high friction. In some examples, the relatively high frictional force may be the same or different in regions F1, F2, and / or F3 and may depend on the degree of curvature of the selection catheter 400. Thus, the second portion 430B of the lubricious coating 402 may encompass at least the area of ​​the central arrow (e.g., F2), but may also encompass the areas of all three arrows, thereby reducing friction and the force required to advance the select catheter 400 through the larger catheter 80.

[0259] In some instances, at least the distal first portion 430A (e.g., the uncoated portion) of the selection catheter 400, having a relatively high friction, may be useful in maintaining the selection catheter 400 within the desired vessel in which it was initially placed (e.g., the brachiocephalic trunk 28, the right common carotid artery 30, or the left common carotid artery 32). The proximal third portion 430C may provide additional friction with a portion of the patient's vessel, thus further securing the position of the selection catheter 400. Thus, the combination of low-friction and high-friction sections may be useful in reducing friction when advancing the selection catheter 400 within the larger catheter 80, and may provide good stability (e.g., staying in place) within the vessel from the aortic arch 24 when advancing the selection catheter 400 partially out of the larger catheter 80.

[0260] In one example, the distal first portion 430A may be in the range of about 4.8 cm to 6.0 cm, and in one specific example, about 5.4 cm. The second portion 430B may have a length in the range of about 1 cm to 5 cm, and in one specific example, about 3.0 cm, when measured with the selection catheter 400 straight.

[0261] In another example, the distal first portion 430A may have a length in the range of about 3.8 to 5.0 cm, and in one specific example, about 4.4 cm. The second portion 430B may have a length in the range of about 1 to 5 cm, and in one specific example, about 3.0 cm, when measured with the selection catheter 400 straightened.

[0262] The distal first portion 430A may exhibit approximately 5 to 15 times the friction of the second portion 430B having the low-friction or lubricious coating 402, and more specifically, approximately 10 times the friction. For example, the distal first portion 430A may have a friction value in the range of approximately 761 gf to 363 gf, and the second portion 430B may have a friction value of approximately 29 gf. The proximal third portion 430C may exhibit 5 to 15 times the friction of the second portion 430B having the low-friction or lubricious coating 402, and more specifically, approximately 10 times the friction, and a friction value in the range of approximately 761 gf to 363 gf. The friction values ​​of the distal first portion 430A and the proximal third portion 430C may be the same or different. These friction gf values ​​can be measured by clamping a specific area, applying a clamping force of approximately 1 lb (±0.2 lb), pulling the sample through the clamps, and recording the friction force value.

[0263] In general, the lubricious coating 402 can be comprised of a variety of different low-friction, lubricious, and / or hydrophilic coatings. One or more such coatings are described in PCT Application No. PCT / US2023 / 067044, filed May 16, 2023, which is incorporated by reference in its entirety. The distal first portion 430A, as well as other portions of the select catheter 400, may be comprised of various thermoplastic polymers, such as poly(amide), poly(ethylene terephthalate), poly(urethane), poly(ether sulfone), poly(carbonate), poly(vinyl chloride), copolymers thereof, and derivatives thereof, such as Pebax.

[0264] The disclosed coatings (e.g., lubricious coating 402, or any coatings on the remainder of select catheter 400) can include multiple coats, such as, for example, a base coat and a top coat. The base coat can act as a "stick" layer between the thermoplastic polymer of select catheter 400 and the top coat. The base coat may be configured to adhere to the catheter and provide bonding sites for the attachment of the top coat. The top coat may be configured to adhere to the base coat and provide lubricity to reduce frictional forces generated when the catheter is moved within the vasculature.

[0265] The base coat may include a polymer that is a copolymer of a first tetrahydrofurfuryl acrylate monomer and at least one other monomer having a functional group capable of further chemical reaction, such as a hydroxyl group, an amine group, or a carboxylic acid group. The at least one other monomer having a hydroxyl group may be hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl acrylate, hydroxypropyl methacrylate, hydroxybutyl acrylate, hydroxybutyl methacrylate, combinations thereof, and derivatives thereof. The at least one other monomer having an amine group may be N-(3-aminopropyl) methacrylamide, 2-aminoethyl methacrylate, 2-aminoethyl methacrylamide, combinations thereof, and derivatives thereof. The at least one other monomer having a carboxylic acid may be acrylic acid, methacrylic acid, beta-carboxyethyl acrylate, combinations thereof, and derivatives thereof.

[0266] The topcoat polymer may comprise a core hydrophilic polymer derivatized with a polymerizable group. The core hydrophilic polymer may be any natural or synthetic polymer, derivatives thereof, and combinations thereof. In some embodiments, the core hydrophilic polymer is at least partially soluble in water.

[0267] The structure of the core hydrophilic polymer may be linear or branched, including graft, star, comb, brush, and dendrimer structures.

[0268] Polymers used in the topcoat can include, but are not limited to, naturally occurring polymers such as proteins, collagen, albumin, fibrin, elastin, polypeptides, oligonucleotides, polysaccharides, hyaluronic acid, gelatin, chitosan, alginate, cellulose, carboxymethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, and dextran.

[0269] Polymers used in the topcoat can include, but are not limited to, synthetic polymers such as poly(ethers), poly(ethylene glycols), poly(ethylene oxides), poly(propylene glycols), poly(lactams), poly(vinylpyrrolidones), poly(acrylates), poly(urethanes), poly(anhydrides), poly(amino acids), poly(carboxylic acids), poly(amides), poly(vinyl alcohols), and poly(phosphazenes).

[0270] The molecular weight of the hydrophilic polymer may be, for example, in the range of about 500 amu to about 100,000 amu or about 1,000 amu to about 40,000 amu.

[0271] Reactive groups, such as, but not limited to, acrylate and / or methacrylate, can be added to the polymer with a derivatizing compound via any suitable reactive moiety, such as hydroxyl, amine, or carboxylic acid. In some embodiments, the derivatizing compound can be a heterobifunctional compound. One moiety can react with the hydroxyl, amine, and / or carboxylic acid groups of the copolymer. The other moiety can be an acrylate or methacrylate group.

[0272] Derivatized compounds can include acryloyl chloride, methacryloyl chloride, 2-isocyanatoethyl acrylate, 2-isocyanatoethyl methacrylate, acrylic acid N-hydroxysuccinimide ester, methacrylic acid N-hydroxysuccinimide ester, heterobifunctional poly(ethylene glycol)s having acrylate and isocyanate groups, combinations thereof, and derivatives thereof.

[0273] Although the lubricious coating 402 is described as being disposed on the exterior surface of a portion of the catheter 400 (e.g., the first major curve 404), any catheter and any unconstrained curve, bend, or corner may have such a coating on a portion, the entire catheter curve, or even beyond the catheter curve. Note that although curve is used below, it should be considered synonymous with the term bend.

[0274] Examples of curvatures include at least 10 degrees, at least 15 degrees, at least 20 degrees, at least 25 degrees, at least 30 degrees, at least 35 degrees, at least 40 degrees, at least 45 degrees, at least 50 degrees, at least 55 degrees, at least 60 degrees, at least 65 degrees, at least 70 degrees, at least 75 degrees, at least 80 degrees, at least 85 degrees, at least 90 degrees, at least 95 degrees, at least 100 degrees, at least 105 degrees, at least 110 degrees, at least 115 degrees, at least 120 degrees, at least 125 degrees, at least 130 degrees, at least 135 degrees, at least 140 degrees, at least 145 degrees, at least 150 degrees, at least 155 degrees, at least 160 degrees, at least 165 degrees, at least 170 degrees, at least 175 degrees, at least 180 degrees, at least 185 degrees, degrees, at least 190 degrees, at least 195 degrees, at least 200 degrees, at least 205 degrees, at least 210 degrees, at least 220 degrees, at least 225 degrees, at least 230 degrees, at least 235 degrees, at least 240 degrees, at least 245 degrees, at least 250 degrees, at least 255 degrees, at least 260 degrees, at least 265 degrees, at least 270 degrees, at least 275 degrees, at least 280 degrees, at least 285 degrees, at least 290 degrees, at least 295 degrees, at least 300 degrees, at least 305 degrees, at least 310 degrees, at least 315 degrees, at least 320 degrees, at least 325 degrees, at least 330 degrees, at least 335 degrees, at least 340 degrees, at least 345 degrees, at least 350 degrees, at least 355 degrees, etc.

[0275] Examples of curvatures are: max 10 degrees, max 15 degrees, max 20 degrees, max 25 degrees, max 30 degrees, max 35 degrees, max 40 degrees, max 45 degrees, max 50 degrees, max 55 degrees, max 60 degrees, max 65 degrees, max 70 degrees, max 75 degrees, max 80 degrees, max 85 degrees, max 90 degrees, max 95 degrees, max 100 degrees, max 105 degrees, max 110 degrees, max 115 degrees, max 120 degrees, max 125 degrees, max 130 degrees, max 135 degrees, max 140 degrees, max 145 degrees, max 150 degrees, max 155 degrees, max 160 degrees, max 165 degrees, max 170 degrees, max 175 degrees, max 180 degrees, max 185 degrees, max The angle may be at most 190 degrees, at most 195 degrees, at most 200 degrees, at most 205 degrees, at most 210 degrees, at most 220 degrees, at most 225 degrees, at most 230 degrees, at most 235 degrees, at most 240 degrees, at most 245 degrees, at most 250 degrees, at most 255 degrees, at most 260 degrees, at most 265 degrees, at most 270 degrees, at most 275 degrees, at most 280 degrees, at most 285 degrees, at most 290 degrees, at most 295 degrees, at most 300 degrees, at most 305 degrees, at most 310 degrees, at most 315 degrees, at most 320 degrees, at most 325 degrees, at most 330 degrees, at most 335 degrees, at most 340 degrees, at most 345 degrees, at most 350 degrees, at most 355 degrees, and the like.

[0276] Examples of curvatures are 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees, 105 degrees, 110 degrees, 115 degrees, 120 degrees, 125 degrees, 130 degrees, 135 degrees, 140 degrees, 145 degrees, 150 degrees, 155 degrees, 160 degrees, 165 degrees, 170 degrees, 175 degrees, 180 degrees, 185 degrees, 190 degrees, The angle may be 195 degrees, 200 degrees, 205 degrees, 210 degrees, 220 degrees, 225 degrees, 230 degrees, 235 degrees, 240 degrees, 245 degrees, 250 degrees, 255 degrees, 260 degrees, 265 degrees, 270 degrees, 275 degrees, 280 degrees, 285 degrees, 290 degrees, 295 degrees, 300 degrees, 305 degrees, 310 degrees, 315 degrees, 320 degrees, 325 degrees, 330 degrees, 335 degrees, 340 degrees, 345 degrees, 350 degrees, 355 degrees, etc.

[0277] Examples of the curvature may include angles of about 10 to 350 degrees, about 20 to 340 degrees, about 30 to 330 degrees, about 40 to 320 degrees, about 50 to 310 degrees, about 60 to 300 degrees, about 70 to 290 degrees, about 80 to 280 degrees, about 90 to 270 degrees, about 100 to 260 degrees, about 110 to 250 degrees, about 120 to 240 degrees, about 130 to 230 degrees, about 140 to 220 degrees, about 150 to 210 degrees, about 160 to 200 degrees, and about 170 to 190 degrees.

[0278] Examples of curvatures are about 10-40 degrees, about 20-50 degrees, about 30-60 degrees, about 40-70 degrees, about 50-80 degrees, about 60-90 degrees, about 70-100 degrees, about 80-110 degrees, about 90-120 degrees, about 100-130 degrees, about 110-140 degrees, about 120-150 degrees, about 130-160 degrees, about 140-170 degrees, about 150-180 degrees, about 160-190 degrees, about 170-200 degrees, about The angle may be 180 to 210 degrees, approximately 190 to 220 degrees, approximately 200 to 230 degrees, approximately 210 to 240 degrees, approximately 220 to 250 degrees, approximately 230 to 260 degrees, approximately 240 to 270 degrees, approximately 250 to 280 degrees, approximately 260 to 290 degrees, approximately 270 to 300 degrees, approximately 280 to 310 degrees, approximately 290 to 320 degrees, approximately 300 to 330 degrees, approximately 310 to 340 degrees, approximately 320 to 350 degrees, or the like.

[0279] As previously mentioned, the selection catheter 400 may have stiffness characteristics that provide a specific stiffness at a specific distance from its distal tip, which is useful in preventing loss of access of the selection catheter when advancing a guidewire through the selection catheter or when advancing a larger, outer catheter 80 over the selection catheter. For example, some existing selection catheters have a relatively large change in stiffness approximately 8 cm from their distal tip, which can result in the aforementioned loss of access. By limiting the abrupt change, the selection catheter may better maintain access to the desired vessel during the procedure.

[0280] Table 3 below and Figure 64 show example stiffness characteristics of select catheter 400. Minimum and maximum stiffnesses are provided as well as average stiffnesses at various lengths from the distal tip 411 of select catheter 400. These minimum and maximum values ​​can therefore be thought of as a range of stiffness at any given location in the table or figure.

[0281] [Table 3]

[0282] In one example, the selection catheter 400 may have a stiffness in the range of approximately 556.4 gf to 1243.8 gf at approximately 100 mm from the distal tip 411. In another example, the selection catheter 400 may have a stiffness in the range of approximately 308.6 gf to 606.5 gf at approximately 80 mm from the distal tip 411 of the selection catheter. In another example, the selection catheter 400 may have a stiffness in the range of approximately 7.0 gf to 520.5 gf at approximately 20 mm. In another example, the selection catheter 400 may have a stiffness in the range of approximately 12.4 gf to 76.1 gf at approximately 10 mm. In another example, the selection catheter 400 may have a stiffness in the range of approximately 11.7 gf to 62.9 gf at approximately 5 mm.

[0283] In another example, the select catheter 400 may have an average stiffness of approximately 900.1 gf at approximately 100 mm from the distal tip 411, approximately 457.6 gf at approximately 80 mm from the distal tip 411, approximately 192.9 gf at approximately 20 mm from the distal tip 411, approximately 44.2 gf at approximately 10 mm from the distal tip 411, and approximately 37.3 gf at approximately 5 mm from the distal tip 411.

[0284] As previously mentioned, the three-dimensional shape, low friction coating, and stiffness characteristics may all be included in the same catheter example, and may be employed together in any combination, including alone.

[0285] The embodiments and alternatives described herein have many advantages and benefits. For example, they can reduce overall procedure time by reducing the time an operator spends attempting to gain access to the target vasculature. In many endovascular procedures, "time saves the brain" means that faster procedures can result in faster treatment (e.g., stroke or aneurysm treatment) and potentially improved neurological outcomes. They can also reduce surface contact and contact forces between the catheter (here, the selection catheter) and the vasculature at or near the aortic arch. This can reduce the likelihood of the catheter scraping or contacting non-target vessels and dislodging potential emboli (e.g., blood clots, hardened tissue, plaque, etc.). This can reduce the likelihood of unintended stroke or embolism. They can also enable access to vasculature that is traditionally inaccessible due to vascular tortuosity or unique anatomical structures. These are examples of the benefits and advantages of these embodiments and should not be considered limiting. Other benefits and advantages to patients, operators, and / or manufacturers are also contemplated.

[0286] In the example catheters and methods herein, it may be desirable to access the right vertebral artery instead of, or in addition to, right common carotid artery access.

[0287] In the example catheters and methods herein, access via the left subclavian artery is achieved using the wider memorized shape of the example described above for access via the right subclavian artery, and access to the left common carotid artery is achieved using the narrower memorized shape.

[0288] Preliminary Claims

[0289] Item 1. A selection catheter comprising an elongate catheter body including a distal region having a constrained, linear shape and an unconstrained shape, the distal region comprising a distal first section and a proximal second section that forms a major curve with the proximal second section in the unconstrained shape, wherein in the constrained, linear shape, the distal first section is located distal to the proximal second section, and in the unconstrained shape, the proximal second section is located substantially within a first reference plane and the distal first section is located at least partially outside the first reference plane.

[0290] Clause 2. The selection catheter of clause 1, wherein a distal tip of the distal first section is positioned proximal to the major curvature.

[0291] Clause 3. The selection catheter of clause 1, wherein the distal first section is positioned at an angle in the range of 5 to 25 degrees relative to the first reference plane.

[0292] Item 4: The distal first section is offset relative to the first reference plane by approximately 11, 11.01, 11.02, 11.03, 11.04, 11.05, 11.06, 11.07, 11.08, 11.09, 11.1, 11.11, 11.12, 11.13, 11.14, 11.15, 11.16, 11.17, 11.18, 11.19, 11.2, 11.21, 11.22, 11.23, 11.24, 11.25, 11.26, 11.27, 11.28, 11.29, 11.30, 11.31, 11.32, 11.33, 11.34, 11.35, 11.36, 11.37, 11.38, 11.39, 11.40, 11.41, 11.42, 11.43, 11.44, 11.45, 11.46, 11.47, 11.48, 11.49, 11.50, 11.51, 11.52, 11.53, 11.54, 11.55, 11.56, 11.57, 11.58, 11.59, 11.60, 11.61, 11.62, 11.63, 11.64, 11.65, 11.66, 11.67, 11.68, 11.69, 11.70, .23, 11.24, 11.25, 11.26, 11.27, 11.28, 11.29, 11.3, 11.31, 11.32, 11.33, 11.34, 11.35, 11.36, 11.37, 11.38, 11.39, 11.4, 11.41, 11.42, 11.43, 11.44, 11.45, 11.46, 11.47, 11.48, 11.49, 11. 5, 11.51, 11.52, 11.53, 11.54, 11.55, 11.56, 11.57, 11.58, 11.59, 11.6, 11.61, 11.62, 11.63, 11.64, 11.65, 11.66, 11.67, 11.68, 11.69, 11.7, 11.71, 11.72, 11.73, 11.74, 11.75, 11.76, 11.77 , 11.78, 11.79, 11.8, 11.81, 11.82, 11.83, 11.84, 11.85, 11.86, 11.87, 11.88, 11.89, 11.9, 11.91, 11.92, 11.93, 11.94, 11.95, 11.96, 11.97, 11.98, 11.99, or 12 degree angle.

[0293] Clause 5. The selection catheter of clause 3, wherein the distal tip of the distal first section is positioned within a range of about 0.4 cm to 2.0 cm from the plane of the first reference surface.

[0294] Item 6. The selection catheter of item 5, wherein the distal tip of the distal first section is positioned at a distance from the proximal second section that is approximately parallel to the first reference plane and is within a range of about 1 cm to about 2 cm.

[0295] Clause 7. The selection catheter of clause 1, wherein the distal first section further comprises a first minor curve.

[0296] Clause 8. The selection catheter of clause 7, wherein the first minor curve generally curves away from the proximal second section.

[0297] Clause 9. The selection catheter of clause 7, wherein the first minor curve has a curvature that is less than the curvature of the major curve.

[0298] Clause 10: The selection catheter according to clause 7, wherein the first minor curve has a curve angle within a range of about 90 to about 190 degrees.

[0299] Clause 11. The selection catheter of clause 1, wherein the distal first section is in the range of about 3 cm to 8 cm in length.

[0300] Clause 12: The selection catheter of clause 9, wherein the distal first section is positioned at an angle within a range of 5 to 25 degrees relative to the first reference plane, the distal tip of the distal first section is positioned within a range of about 0.4 cm to 2.0 cm from the plane of the first reference plane, the distal tip of the distal first section is positioned away from the proximal second section by a length within a range of about 1 cm to about 2 cm substantially parallel to the first reference plane, the first minor curvature has a curvature angle within a range of about 90 to about 190 degrees, and the distal first section has a length within a range of about 3 cm to 8 cm.

[0301] Clause 13. The selection catheter of clause 1, wherein the selection catheter has a stiffness of about 136.76 gf at about 110 mm from the distal tip of the elongate catheter body, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip.

[0302] Clause 14. The selection catheter of clause 1, wherein the selection catheter has a stiffness in the range of about 6.75 gf to 20.25 gf at about 10 mm.

[0303] Clause 15. The selection catheter of clause 14, wherein the selection catheter has a stiffness in the range of about 11.29 gf to 33.86 gf at about 20 mm.

[0304] Clause 16. The selection catheter of clause 3, wherein the distal first section is disposed at an angle of approximately 10.0, 10.05, 10.1, 10.15, 10.2, 10.25, 10.3, 10.35, 10.4, 10.45, 10.5, 10.55, 10.6, 10.65, 10.7, 10.75, 10.8, 10.85, 10.9, 10.95, or 11.0 degrees relative to the first reference plane.

[0305] Clause 17. The selection catheter of clause 3, wherein the distal tip of the distal first section is positioned within a range of about 0.1 cm to about 1.0 cm from the plane of the first reference surface.

[0306] Item 18. The selection catheter of item 17, wherein the distal tip of the distal first section is spaced apart from the proximal second section by a length in the range of about 0.2 cm to about 0.5 cm generally parallel to the first reference plane.

[0307] Clause 19. The selection catheter of clause 1, wherein the distal first section is in the range of about 2 cm to 5 cm in length.

[0308] Clause 20: The selection catheter of clause 9, wherein the distal first section is positioned at an angle within a range of 5 to 25 degrees relative to the first reference plane, the distal tip of the distal first section is positioned within a range of about 0.1 cm to 1.0 cm from the plane of the first reference plane, the distal tip of the distal first section is positioned away from the proximal second section by a length within a range of about 0.2 cm to about 0.5 cm approximately parallel to the first reference plane, the first minor curvature has a curvature angle within a range of about 90 to about 190 degrees, and the distal first section has a length within a range of about 2 cm to 5 cm.

[0309] Clause 21. The selection catheter of clause 1, wherein the selection catheter has a stiffness of approximately 154.85 gf at approximately 110 mm from the distal tip of the elongate catheter body, approximately 128.99 gf at approximately 80 mm from the distal tip, approximately 38.96 gf at approximately 20 mm from the distal tip, approximately 12.08 gf at approximately 10 mm from the distal tip, and approximately 6.40 gf at approximately 5 mm from the distal tip.

[0310] Clause 22. The selection catheter of clause 1, wherein the selection catheter has a stiffness in the range of about 6.04 gf to 18.11 gf at about 10 mm.

[0311] Clause 23. The selection catheter of clause 14, wherein the selection catheter has a stiffness in the range of about 19.48 gf to 58.44 gf at about 20 mm.

[0312] Clause 24. A select catheter comprising an elongate catheter body including a distal region having an unconstrained shape, the distal region comprising a distal first section that forms a major curve with a distal second section in the unconstrained shape, the distal first section being disposed at a non-parallel angle relative to the distal second section in the unconstrained shape, and a distal free end of the distal region being disposed generally in a proximal direction.

[0313] Clause 25: A selective catheter comprising an elongate catheter body including a distal region having an unconstrained geometric means for accessing the right common carotid artery or the left common carotid artery via radial access, the distal region comprising a distal first section that forms a major curve with a distal second section.

[0314] Clause 26: A select catheter comprising an elongate catheter body, the elongate catheter body having a stiffness in the range of about 68.38 gf to 205.14 gf at about 110 mm from the distal tip, a stiffness in the range of about 55.17 gf to 165.51 gf at about 80 mm from the distal tip, a stiffness in the range of about 11.29 gf to 33.86 gf at about 20 mm, a stiffness in the range of about 6.75 gf to 20.25 gf at about 10 mm, and a stiffness in the range of about 4 gf to 12 gf at about 5 mm.

[0315] Clause 27. The select catheter of clause 26, wherein the elongate catheter body has a stiffness of about 136.76 gf at about 110 mm from the distal tip, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip.

[0316] Clause 28: A select catheter comprising an elongate catheter body, the elongate catheter body having a stiffness in the range of about 77.42 gf to 232.27 gf at about 110 mm from the distal tip, a stiffness in the range of about 64.50 gf to 193.49 gf at about 80 mm from the distal tip, a stiffness in the range of about 19.48 gf to 58.44 gf at about 20 mm from the distal tip, a stiffness in the range of about 6.04 gf to 18.11 gf at about 10 mm from the distal tip, and a stiffness in the range of about 3.20 gf to 9.60 gf at about 5 mm from the distal tip.

[0317] Clause 29. The select catheter of clause 28, wherein the elongate catheter body has a stiffness of about 154.85 gf at about 110 mm from the distal tip, about 128.99 gf at about 80 mm from the distal tip, about 38.96 gf at about 20 mm from the distal tip, about 12.08 gf at about 10 mm from the distal tip, and about 6.40 gf at about 5 mm from the distal tip.

[0318] Clause 30. A selected catheter comprising an elongate catheter body, the elongate catheter body having a stiffness of about 136.76 gf at about 110 mm from the distal tip of the elongate catheter body, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip; or the elongate catheter body having a stiffness of about 154.85 gf at about 110 mm from the distal tip, about 128.99 gf at about 80 mm from the distal tip, about 38.96 gf at about 20 mm from the distal tip, about 12.08 gf at about 10 mm from the distal tip, and about 6.40 gf at about 5 mm from the distal tip.

[0319] Clause 31. A catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a memorized shape when unconstrained, the memorized shape comprising a plurality of curvatures arranged to orient the distal portion into the right or left subclavian artery or the brachiocephalic trunk for accessing the left or right common carotid artery.

[0320] Clause 32. The catheter of clause 31, wherein the memorized shape of the distal section is a further curved "U" shape in a direction generally perpendicular to the tip of the "U."

[0321] Clause 33. The catheter of clause 31, wherein the memorized shape has dimensions within the range of about 3.0 cm to 8.5 cm in length, about 1.5 cm to 3.0 cm in width, and about 1.5 cm to 3.5 cm in height.

[0322] Clause 34: The catheter according to clause 31, wherein the distal portion further comprises a proximal region, an intermediate region, and a distal region, and a first curve of the plurality of curves is located between the proximal region and the intermediate region and has a curve angle within a range of about 35 degrees to about 75 degrees.

[0323] Item 35: The catheter according to item 34, wherein a second curve of the plurality of curves is located between the intermediate region and the distal region and has a curve angle within a range of approximately 160 degrees to approximately 200 degrees.

[0324] Clause 36. The catheter of clause 35, wherein some of the plurality of curves are located in the distal region and have a curve angle within a range of about 5 degrees to 30 degrees.

[0325] Clause 37. A method of accessing the left common carotid artery, comprising: advancing a distal portion of a select catheter from the right subclavian artery into the aortic arch of a patient; expanding the distal portion of the select catheter to a memorized shape within the aortic arch of the patient; retracting a portion of the distal portion of the select catheter partially proximally into the right subclavian artery or the brachiocephalic artery and moving a distal region of the distal portion into the left common carotid artery.

[0326] Clause 38. The method of clause 37, wherein the memorized shape of the distal portion is a further curved "U" shape in a direction generally perpendicular to the tip of the "U."

[0327] Clause 39: A catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a memorized shape when unconstrained, the memorized shape comprising a plurality of curvatures arranged to orient the distal portion into the right subclavian artery or the brachiocephalic artery, and also into the right common carotid artery.

[0328] Clause 40. The catheter of clause 39, wherein the memorized shape of the distal section is a "U" shape having a width in the range of about 0.7 cm to about 2.9 cm.

[0329] Clause 41. The catheter of clause 40, wherein the distal portion comprises a first curve having a curve angle in the range of about 70 degrees to 140 degrees, and a second curve, a third curve, and a fourth curve, each having a curve angle in the range of about 50 degrees to 140 degrees.

[0330] Clause 42: A method of accessing a right common carotid artery, comprising: advancing a distal portion of a selected catheter into a patient's right subclavian or brachiocephalic artery; advancing the distal portion of the selected catheter further distally to bend the distal portion into a memorized shape within the right subclavian or brachiocephalic artery; and advancing the memorized shape further distally so that a portion of the distal portion enters the right common carotid artery.

[0331] Clause 43. The method of clause 42, wherein the memorized shape of the distal portion is a "U" shape having a width in the range of about 0.7 cm to about 2.9 cm.

[0332] Item 44. A catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a memorized shape when unconstrained, the memorized shape being configured to orient the distal portion into the right subclavian artery or the brachiocephalic trunk and also into the right common carotid artery, the catheter having a major curve with a curvature angle in the range of about 335 degrees to about 350 degrees.

[0333] Clause 45: The catheter according to clause 44, wherein the major curve has a width in the range of about 0.5 cm to about 2.5 cm.

[0334] Clause 46. A catheter comprising an elongate catheter body having a proximal portion and a distal portion, the distal portion having a constrained shape and an unconstrained shape different from the constrained shape, wherein in the unconstrained shape, the shape of the catheter comprises a plurality of curvatures that at least partially deflect about an axial "X" axis passing through a central lumen of the proximal portion of the catheter, a vertical "Y" axis orthogonal to the "X" axis, and a transverse "Z" axis orthogonal to both the "X" axis and the "Y" axis.

[0335] Clause 47. The catheter of clause 46, wherein the multiple bends are arranged to orient the distal portion of the catheter to access specific target vessels.

[0336] Clause 48. The catheter of clause 47, wherein the specific target vessel is one of the right common carotid artery or the left common carotid artery.

[0337] Clause 49. The catheter of clause 46, wherein in the unconstrained configuration, the distal portion of the catheter has a memorized shape, and wherein at least a portion of the memorized shape of the distal portion in the unconstrained configuration comprises a "U" shape, the "U" shape having a proximal portion, an intermediate portion, and a distal portion, the proximal portion of the "U" shape extending at least partially along the "X" axis away from the proximal portion of the catheter, and the distal portion of the "U" shape extending at least partially along the "X" axis toward the proximal portion of the catheter.

[0338] Clause 50: A catheter comprising an elongate catheter means for accessing the common carotid artery, the catheter means comprising a body having a proximal portion and a distal portion, the distal portion having a constrained configuration and an unconstrained configuration different from the constrained configuration, the elongate catheter means having a memorized configuration when unconstrained, the memorized configuration comprising a plurality of curvatures that orient the distal portion into the right or left subclavian artery or the brachiocephalic trunk for accessing the left common carotid artery.

Claims

1. an elongate catheter body including a distal region having a constrained linear shape and an unconstrained shape; the distal region comprises a distal first section and a proximal second section that form a major curve with the proximal second section in the unconstrained configuration, the distal first section being distal to the proximal second section in the constrained, linear configuration; In the unconstrained configuration, the proximal second section lies substantially in a first reference plane; the distal first section is at least partially outside the first reference plane. Select catheter.

2. The selection catheter of claim 1 , wherein a distal tip of the distal first section is disposed proximal to the major curve.

3. The selection catheter of claim 1 , wherein the distal first section is disposed at an angle in the range of 5 to 25 degrees relative to the first reference plane.

4. The distal first section is at an angle of about 11, 11.01, 11.02, 11.03, 11.04, 11.05, 11.06, 11.07, 11.08, 11.09, 11.1, 11.11, 11.12, 11.13, 11.14, 11.15, 11.16, 11.17, 11.18, 11.19, 11.2, 11.21, 11.22, 11.23, 11.24, 11.25, 11.26, 11.27, 11.28, 11.29, 11.30, 11.31, 11.32, 11.33, 11.34, 11.35, 11.36, 11.37, 11.38, 11.39, 11.40, 11.41, 11.42, 11.43, 11.44, 11.45, 11.46, 11.47, 11.48, 11.49, 11.50, 11.51, 11.52, 11.53, 11.54, 11.55, 11.56, 11.57, 11.58, 11.59, 11.60, 11.61, 11.62, 11.63, 11.64, 11.65, 11.66, 11.67, 11.68, 11.69, 11.70, 11.71, 1 .23, 11.24, 11.25, 11.26, 11.27, 11.28, 11.29, 11.3, 11.31, 11.32, 11.33, 11.34, 11.35, 11.36, 11.37, 11.38, 11.39, 11.4, 11.41, 11.42, 11.43, 11.44, 11.45, 11.46, 11.47, 11.48, 11.49, 11.5 ,11.51,11.52,11.53,11.54,11.55,11.56,11.57,11.58,11.59,11.6,11.61,11.62,11.63,11.64,11.65,11.66,11.67,11.68,11.69,11.7,11.71,11.72,11.73,11.74,11.75,11.76,11.77, 4. The select catheter of claim 3, wherein the select catheter is positioned at an angle of 11.78, 11.79, 11.8, 11.81, 11.82, 11.83, 11.84, 11.85, 11.86, 11.87, 11.88, 11.89, 11.9, 11.91, 11.92, 11.93, 11.94, 11.95, 11.96, 11.97, 11.98, 11.99, or 12 degrees.

5. The selection catheter of claim 3 , wherein the distal tip of the distal first section is positioned within a range of about 0.4 cm to 2.0 cm from the plane of the first reference surface.

6. The selection catheter of claim 5 , wherein the distal tip of the distal first section is spaced apart from the proximal second section by a length in the range of about 1 cm to about 2 cm generally parallel to the first reference plane.

7. The selection catheter of claim 1 , wherein the distal first section further comprises a first minor curve.

8. The selection catheter of claim 7 , wherein the first minor curve generally curves away from the proximal second section.

9. The selection catheter of claim 7 , wherein the first minor curve has a curvature that is less than the curvature of the major curve.

10. The selection catheter of claim 7, wherein the first minor curve has a curve angle in the range of about 90 to about 190 degrees.

11. The selection catheter of claim 1 , wherein the distal first section is in the range of about 3 cm to 8 cm in length.

12. 10. The selection catheter of claim 9, wherein the distal first section is disposed at an angle in a range of 5 to 25 degrees relative to the first reference plane, a distal tip of the distal first section is disposed within a range of about 0.4 cm to 2.0 cm from the plane of the first reference plane, the distal tip of the distal first section is disposed from the proximal second section a length in a range of about 1 cm to about 2 cm generally parallel to the first reference plane, the first minor curvature has a curvature angle in a range of about 90 to about 190 degrees, and the distal first section has a length in a range of about 3 cm to 8 cm.

13. 2. The selection catheter of claim 1, wherein the selection catheter has a stiffness of about 136.76 gf at about 110 mm from the distal tip of the elongate catheter body, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip.

14. 10. The selection catheter of claim 1, wherein the selection catheter has a stiffness in the range of about 6.75 gf to 20.25 gf at about 10 mm.

15. 15. The selection catheter of claim 14, wherein the selection catheter has a stiffness in the range of about 11.29 gf to 33.86 gf at about 20 mm.

16. 4. The catheter of claim 3, wherein the distal first section is disposed at an angle of approximately 10.0, 10.05, 10.1, 10.15, 10.2, 10.25, 10.3, 10.35, 10.4, 10.45, 10.5, 10.55, 10.6, 10.65, 10.7, 10.75, 10.8, 10.85, 10.9, 10.95, or 11.0 degrees relative to the first reference plane.

17. The selection catheter of claim 3 , wherein the distal tip of the distal first section is positioned within a range of about 0.1 cm to about 1.0 cm from the plane of the first reference surface.

18. 18. The selection catheter of claim 17, wherein the distal tip of the distal first section is spaced apart from the proximal second section by a length in the range of about 0.2 cm to about 0.5 cm generally parallel to the first reference plane.

19. The selection catheter of claim 1 , wherein the distal first section is in the range of about 2 cm to 5 cm in length.

20. 10. The selection catheter of claim 9, wherein the distal first section is disposed at an angle in a range of 5 to 25 degrees relative to the first reference plane, a distal tip of the distal first section is disposed within a range of about 0.1 cm to 1.0 cm from the plane of the first reference plane, the distal tip of the distal first section is disposed from the proximal second section a length in a range of about 0.2 cm to about 0.5 cm generally parallel to the first reference plane, the first minor curvature has a curvature angle in a range of about 90 to about 190 degrees, and the distal first section has a length in a range of about 2 cm to 5 cm.

21. 2. The selection catheter of claim 1, wherein the selection catheter has a stiffness of approximately 154.85 gf at approximately 110 mm from the distal tip of the elongate catheter body, approximately 128.99 gf at approximately 80 mm from the distal tip, approximately 38.96 gf at approximately 20 mm from the distal tip, approximately 12.08 gf at approximately 10 mm from the distal tip, and approximately 6.40 gf at approximately 5 mm from the distal tip.

22. 10. The selection catheter of claim 1, wherein the selection catheter has a stiffness in the range of about 6.04 gf to 18.11 gf at about 10 mm.

23. 15. The selection catheter of claim 14, wherein the selection catheter has a stiffness in the range of about 19.48 gf to 58.44 gf at about 20 mm.

24. an elongate catheter body including a distal region having an unconstrained shape; the distal region comprises a distal first section that forms a major curve with a distal second section in the unconstrained configuration; In the unconstrained configuration, the distal first section is disposed at a non-parallel angle relative to the distal second section, and a distal free end of the distal region is oriented generally proximally. Select catheter.

25. an elongate catheter body including a distal region having an unconstrained geometric means for accessing the right common carotid artery or the left common carotid artery via radial access; the distal region comprises a distal first section that forms a major curve with a distal second section; Select catheter.

26. an elongated catheter body; the elongate catheter body has a stiffness in the range of about 68.38 gf to 205.14 gf at about 110 mm from the distal tip, a stiffness in the range of about 55.17 gf to 165.51 gf at about 80 mm from the distal tip, a stiffness in the range of about 11.29 gf to 33.86 gf at about 20 mm, a stiffness in the range of about 6.75 gf to 20.25 gf at about 10 mm, and a stiffness in the range of about 4 gf to 12 gf at about 5 mm; Select catheter.

27. 27. The select catheter of claim 26, wherein the elongate catheter body has a stiffness of about 136.76 gf at about 110 mm from the distal tip, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip.

28. an elongated catheter body; the elongate catheter body has a stiffness in the range of about 77.42 gf to 232.27 gf at about 110 mm from the distal tip, a stiffness in the range of about 64.50 gf to 193.49 gf at about 80 mm from the distal tip, a stiffness in the range of about 19.48 gf to 58.44 gf at about 20 mm from the distal tip, a stiffness in the range of about 6.04 gf to 18.11 gf at about 10 mm from the distal tip, and a stiffness in the range of about 3.20 gf to 9.60 gf at about 5 mm from the distal tip; Select catheter.

29. 29. The select catheter of claim 28, wherein the elongate catheter body has a stiffness of about 154.85 gf at about 110 mm from the distal tip, about 128.99 gf at about 80 mm from the distal tip, about 38.96 gf at about 20 mm from the distal tip, about 12.08 gf at about 10 mm from the distal tip, and about 6.40 gf at about 5 mm from the distal tip.

30. an elongated catheter body; the elongate catheter body has a stiffness of about 136.76 gf at about 110 mm from the distal tip of the elongate catheter body, about 110.34 gf at about 80 mm from the distal tip, about 22.58 gf at about 20 mm from the distal tip, about 13.5 gf at about 10 mm from the distal tip, and about 8 gf at about 5 mm from the distal tip; or the elongate catheter body has a stiffness of about 154.85 gf at about 110 mm from the distal tip, about 128.99 gf at about 80 mm from the distal tip, about 38.96 gf at about 20 mm from the distal tip, about 12.08 gf at about 10 mm from the distal tip, and about 6.40 gf at about 5 mm from the distal tip. Select catheter.

Images