Arch Fulcrum Support Catheter

Abstract

The present disclosure teaches a novel medical device and method of use, employing a unique shape that allows the device to use the lesser (inferior) curve of aortic Arch as a fulcrum of support for a guide catheter, for subsequent prevention of recoil and displacement thereof, while delivering additional catheters or devices into the distal branches of the great vessels. A method for using same.

Claims

1. An endovascular medical device using a vascular arch as a fulcrum for securement, comprising: (a) a tube, comprising: (b) a first segment of at least 20 cm in length and an internal diameter of from 0.1 Fr to 30 Fr, (c) wherein said first segment has a first end comprising an external termination device; (d) a second end terminating in a first bend, (e) wherein said first bend is 90 degrees plus or minus 35 degrees and connected to a second segment of said tube; (f) said second segment of at least 3 cm in length and no more than 35 cm in length and an internal diameter of from 0.1 Fr to 30 Fr, (g) wherein said second segment has a first end terminating in said first bend, and (h) a second end terminating in said second bend, (i) wherein said second bend is 90 degrees plus or minus 60 degrees and connected to a third segment of said tube; (j) said third segment of at least 0.5 cm in length and an internal diameter of from 0.1 Fr to 30 Fr, (k) wherein said third segment has a first end terminating in said second bend and connected to said second segment of said tube, and a second end terminating in a distal hole.

2. The medical device of claim 1, wherein said external termination device comprises a Leur Lock.

3. The medical device of claim 1, wherein said external termination device comprises a diaphragm.

4. The medical device of claim 1, wherein said second segment is semi-ridged.

5. The medical device of claim 1, wherein said second segment comprises a stiffness of between 0.0006 gigapascals (GPa) 117 GPa.

6. A method of using the device set forth in claim 1, the method comprising: (a) attaching said device set forth in claim 1 at the distal end of a delivery system; (b) positioning said delivery system within a body lumen at a target arch; (c) positioning segment three of said device set forth in claim 1 such that the distal end of said segment three extends into a target vessel; (d) positioning segment two of said device set forth in claim 1 such that said segment two's center rests on the fulcrum formed by the top of said target arch while the distal end of said segment three extends into said target vessel; (e) positioning segment one of said device set forth in claim 1 such that the proximal end of said segment one extends down a vessel below the fulcrum formed by the top of said target arch, while said segment two's center rests on the fulcrum formed by the top of said target arch, and said distal end of said segment three extends into said target vessel; and (f) removing said device set forth in claim 1 using said delivery system; (g) advancing additional wires, catheters, or other devices through said tube into the distal vasculature of said target vessel.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0072] FIG. 1 shows an illustration of a side view of the described invention.

[0073] FIG. 2 shows an illustration of a cross-sectional view of one embodiment of the described invention in place with the second segment resting on the arch fulcrum.

DETAILED DESCRIPTION OF THE INVENTION

[0074] The term recoil and displacement, as used herein refers to the phenomenon of catheter prolapse or displacement (slipping forward, back, or down, and out of the desired position) due to a counterforce against the catheter by the advancing wire, second catheter, or other additional device.

[0075] Now referring to FIG. 1, the present invention has five principal elements. The first two of said elements are bends, and three are segments of the tube. More particularly, the first bend 10 connects segment one 100 to segment two 200 at an angle of 90 degrees plus or minus 35 degrees. Segment one 100 has a length of at least 20 cm in length and an internal diameter of from 0.1 French to 30 French.

[0076] Segment two 200 measures at least 3 cm in length and no more than 35 cm in length. Segment two 200 has an internal diameter of from 0.1 French to 30 French. Segment two 200 has a first end which terminated in first bend 10 and a second end which terminates in second bend 20. Second bend 20 has an angle of 90 degrees plus or minus 60 degrees.

[0077] Second bend 20 connects to segment three 30 of tube 1. Segment three 300 measures at least 0.5 cm in length and has an internal diameter of from 0.1 French to 30 French. Segment three 300 has a first end which terminates in second bend 20 and connected to segment two 200 of tube 1, and a second end terminating at distal hole 305.

[0078] Now referring to FIG. 2, the present invention is shown deployed in the aorta. Segment one 100 is deployed downwardly in the ascending aorta 1000, which is located below the fulcrum formed by the arch of the aorta 2000. The middle of segment two 200 is shown resting on the fulcrum formed by the arch of the aorta 2000. Segment three 300 is shown in this example being upwardly deployed into the left subclavian artery 3000.

[0079] According to one embodiment, the middle segment two 200 has ridges to promote stability at the focal point 2000. According to another embodiment, the middle segment two 200 is coated with an elastic material to deform atop the fulcrum point 2000 for improved securement.

[0080] The various components of the described invention may be comprised of one or more materials. Thermoplastics include, but are not limited to, nylon, polyethylene terephthalate (PET), urethane, polyethylene, polyvinyl chloride (PVC) and polyether ether ketone (PEEK).

[0081] Thermosets include, but are not limited to, silicone, polytetrafluoroethylene (PTFE) and polyimide.

[0082] Composites include, but are not limited to, liquid crystal polymers (LCP). LCPs are partially crystalline aromatic polyesters based on p-hydroxybenzoic acid and related monomers. LCPs are highly ordered structures when in the liquid phase, but the degree of order is less than that of a regular solid crystal. LCPs can be substituted for such materials as ceramics, metals, composites and other plastics due to their strength at extreme temperatures and resistance to chemicals, weathering, radiation and heat. Non-limiting examples of LCPs include wholly or partially aromatic polyesters or copolyesters such as XYDAR (Amoco) or VECTRA (Hoechst Celanese). Other commercial liquid crystal polymers include SUMIKOSUPER and EKONOL (Sumitomo Chemical), DuPont HX and DuPont ZENITE'm (E.I. DuPont de Nemours), RODRUN'm (Unitika) and GRANLAR'm (Grandmont).

[0083] According to some embodiments, the angled extension comprises a shape memory polymer (SMP). Shape memory polymers include, but are not limited to methacrylates, polyurethanes, blends of polystyrene and polyurethane, and polyvinylchloride. According to some embodiments, the angled extension of the catheter comprises a shape memory alloy (SMA). Non-limiting examples of shape memory alloys include nickel-titanium (i.e., nitinol).

[0084] According to some embodiments, the described invention can be used in an endovascular procedure in a subject suffering from an anatomical variation in a blood vessel. According to some embodiments, the blood vessel comprises an anatomical variation comprising tortuosity. According to some embodiments, the blood vessel comprises an anatomical variation comprising an acute angulation. According to some embodiments, the acute angulation is an aortic arch variation. According to some embodiments, the aortic arch variation is a bovine arch variation. According to some embodiments the anatomic variation is a Type II aortic arch. According to some embodiments the anatomic variation is a Type III aortic arch. According to some embodiments, the acute angulation is a vertebral artery variation. [0085] While the present invention has been described with reference to the specific embodiments thereof it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adopt a particular situation, material, composition of matter, process, process step or steps, to the objective spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

[0086] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges which may independently be included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either both of those included limits are also included in the invention.

[0087] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials have been described. All publications mentioned herein are incorporated herein by reference to disclose and described the methods and/or materials in connection with which the publications are cited.

[0088] It must be noted that as used herein and in the appended claims, the singular forms a, and, and the include plural references unless the context clearly dictates otherwise.

[0089] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application and each is incorporated by reference in its entirety. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

[0090] While the present invention has been described with reference to the specific embodiments thereof it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adopt a particular situation, material, composition of matter, process, process step or steps, to the objective spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.