BACKGROUND

Catheters are commonly used, tube-like medical devices used to access various lumens and passages in the body while minimizing disruption to other tissue. One common use of catheters is to access the circulatory system, or any body cavity or organ usually through a needle puncture, from which access site the catheter is navigated to a target site for a treatment or diagnostic procedure. The access site can be in any number of locations. Common access locations are a femoral artery, a femoral vein, a brachial artery, a radial artery, a carotid artery, a brachial vein, a jugular vein, or through the skin directly into body cavities and organs to name a few. The location of the access site can be chosen based on many considerations, including the injury risk to the nearby anatomy, the injury risk to the vasculature, body cavity, or organ that needs to be navigated to, the difficulty of navigating the catheter to the target location, the number of catheter exchanges required, and the number and type of catheter manipulations required, to name a few.

One common access site is the radial artery. Radial access has been known for at least 25 years. The radial access catheters that are commercially available, however, are configured for only coronary applications. Hence, the use of radial access for peripheral vascular applications has been limited by having to use catheters designed for coronary applications or peripheral vascular catheters designed for transfemoral access. Also, many commercially available catheters are provided in flush or selective configurations, but not both or not for both flush and selective application in a single configuration. Hence, it is often the case that a catheter for one purpose needs to be exchanged (e.g., retracted and replaced) for another catheter for a different purpose to complete a procedure. This need for catheter exchange complicates and prolongs the procedure and increases the risk of injury to the patient. Hence, safer, more easily used and manipulated catheters, and more multi-functional catheters which require fewer exchanges may be desirable.

References of interest include: WO2006019640, US20130190619, U.S. Pat. Nos. 8,753,329, 8,403,912, 8,353,849, 7,799,013, 6,335,026, 6,132,417, 6,086,548, 5,957,911, 5,876,385, 5,215,540, and 4,033,331.

SUMMARY

The present disclosure is related to medical devices and methods, particularly catheters. Catheters with at least two curved portions near their distal ends are provided. The catheters can be advanced to either the brachiocephalic or left subclavian artery, typically via radial artery access. The lengths of the straight and curved portions and the curvatures of the curved portions are selected so that after a guidewire is initially advanced through the right brachiocephalic or left subclavian artery to access the ascending or descending thoracic aorta, the catheter can be introduced over the guidewire into the ascending or descending aorta, retracted therefrom, and simply rotated to access the descending or ascending aorta, respectively. From the descending aorta, the abdominal aorta and its branch arteries, the iliac arteries, and the arteries of the lower extremities may be conveniently accessed as well. The catheters may be used for flush aortography, selective and subselective branch catheterization, or both. Hence, the catheters provided herein perform many functions:

1. Through the right brachiocephalic or left subclavian artery, they may provide access to both the ascending and descending aorta and further, be advanced through the descending aorta into the abdominal aorta and its branches including to the lower extremity circulation.
2. The same catheter may be used for aortic flush injections.
3. The same catheter may be rotated and manipulated to access any number of selective or sub-selective branch arteries including those of the lower extremities.
4. The same catheter may be used for selective or sub-selective arteriograms or intravascular pressure measurements.
All these functions may be performed by a single catheter without any need for catheter exchange, e.g., withdrawing the catheter from any location so a second or further catheter with different functionality may be introduced in its place.

Aspects of the present disclosure provide catheters for accessing the ascending aorta and the descending aorta of a patient without removal from the brachiocephalic or left subclavian artery. An exemplary catheter may comprise (i) a distal end portion, (ii) a first curved portion proximal of the distal end portion, the first curved portion being biased to be curved with a first radius of curvature from 5 to 20 mm, (iii) a curve transition portion proximal of the first curved portion, (iv) a second curved portion proximal of the transition portion, the second curved portion being biased to be curved in a direction opposite the first curved portion and with a second radius of curvature from 5 to 15 mm, and (v) an elongate portion proximal of the second curved portion.

The distal end portion of the catheter may comprise an atraumatic tip or may be tapered. The elongate portion of the catheter may be biased to be straight. The catheter may further comprise a guidewire lumen, one or more side ports, and/or a hydrophilic coating. Typically, an outer diameter of the catheter may be between 3 and 8 Fr, and an inner diameter of the catheter may be between 0.018″ and 0.038″. The catheter may have an overall length of between 100 and 150 cm. The elongate portion may have a length of at least 80 to 200 cm, or a length in a range between 80 to 200 cm.

A first embodiment of the catheters may be provided. This first embodiment may have the following dimensions. The distal end portion may have a length of 1 to 7 mm, preferably 2 to 6 mm, for example, 2.5 mm. The transition portion may have a length of 1 to 8 mm, preferably 2 to 7 mm, for example, 2.5 mm. The first curved portion may have a length of 2 to 8 mm, preferably 3 to 7 mm, for example, 4 mm. The second curved portion may have a length of 4 to 20 mm, preferably 5 to 17 mm, for example, 14 mm. The first radius of curvature of the first curve portion may be from 5 to 20 mm or 10 to 20 mm, preferably 12 to 17 mm, for example 14.5 mm or 15 mm. The second radius of curvature of the second curved portion may be from 7 to 15 mm, preferably 8 to 13 mm, for example, 11 mm. The first curved portion may have a curvature of 10° to 30°, preferably a curvature of 12° to 17°, for example, a curvature of 15°. The second curved portion may have a curvature of 50° to 90°, preferably a curvature of 60° to 80°, for example, a curvature of 74°. The distal end portion may have an angle of 120° to 170° relative to the curve transition portion, preferably an angle of 140° to 160°, for example, and angle of 155°. The curve transition portion may have an angle of 90° to 125° relative to the elongate portion, preferably an angle of 95° to 115°, for example, an angle of 105°. The distal end portion may have an angle of 95° to 150° relative to the elongate portion, preferably an angle of 105° to 140°, for example an angle of 130°.

A second embodiment of the catheters may be provided. This second embodiment may have the following dimensions. The distal end portion may have a length of 1 to 7 mm, preferably 2 to 6 mm, for example, 6 mm. The transition portion may have a length of 2 to 10 mm, preferably 3 to 9 mm, for example, 8 mm. The first curved portion may have a length of 3 to 12 mm, preferably 4 to 11 mm, for example, 6 mm. The second curved portion may have a length of 3 to 15 mm, preferably 4 to 12 mm, for example, 8 mm. The first radius of curvature of the first curve portion may be from 5 to 15 mm, preferably 6 to 13 mm, for example 8.2 mm. The second radius of curvature of the second curved portion may be from 5 to 15 mm, preferably 6 to 13 mm, for example 8.25 mm. The first curved portion may have a curvature of 20° to 60°, preferably a curvature of 30° to 50°, for example, a curvature of 40°. The second curved portion may have a curvature of 20° to 60°, preferably a curvature of 30° to 50°, for example, a curvature of 36°. The distal end portion may have an angle of 110° to 160° relative to the curve transition portion, preferably an angle of 120° to 155°, for example, an angle of 143°. The curve transition portion may have an angle of 110° to 160° relative to the elongate portion, preferably an angle of 120° to 155°, for example an angle of 142°. The distal end portion may have an angle of 80° to 130° relative to the elongate portion, preferably an angle of 90° to 120°, for example, an angle of 103°.

Aspects of the present disclosure provide methods of accessing an ascending aorta and a descending aorta of a patient. An exemplary method may comprise the steps of (i) advancing a catheter through a subclavian artery so that a distal tip of the catheter is at or adjacent the ascending aorta or the descending aorta, with a distal port of the catheter oriented toward the ascending aorta or the descending aorta, and (ii) rotating the catheter about its longitudinal axis such that the distal port of the catheter is oriented toward the other of the ascending aorta or the descending aorta.

The subclavian artery may be the left subclavian artery or the brachiocephalic artery.

The method may further comprise a step of advancing a guidewire into the ascending aorta or the descending aorta with the distal port of the catheter oriented toward the ascending aorta or the descending aorta.

The method may further comprise a step of further advancing the catheter into the ascending aorta or the descending aorta with the distal port of the catheter oriented toward the ascending aorta or the descending aorta.

The method may further comprise a step of advancing a guidewire into the other of the ascending aorta or the descending aorta with the distal port of the catheter oriented toward the other of the ascending aorta or the descending aorta.

The method may further comprise a step of further advancing the catheter into the other of the ascending aorta or the descending aorta with the distal port of the catheter oriented toward the other of the ascending aorta or the descending aorta.

The method may further comprise a step of comprising advancing the catheter through a radial artery into the brachiocephalic or left subclavian artery. The catheter may be advanced through the radial artery via an access site at a wrist of the patient.

The other of the ascending aorta or the descending aorta may be the descending aorta, and the method may comprise further advancing the catheter into the abdominal aorta through the descending aorta. The method may further comprise a step of rotating the catheter about the longitudinal axis thereof to position the distal port of the catheter to face the celiac artery, the superior mesenteric artery, the right renal artery, the left renal artery, the hepatic artery, or the like of the patient. The method may further comprise a step of positioning the distal port of the catheter to face a first renal artery ostium and advancing a guidewire into a first renal artery. The method may further comprise a step of rotating the catheter so that the distal port of the catheter faces a second renal artery ostium and advancing a guidewire into the second renal artery.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

