Angiographic catheter

Abstract

A catheter for improving angiography that includes a tapered end, a plurality of flush holes, a hydrophilic coating, and a shaft with at least one curve. The angiographic catheter further includes a radiopaque material along a curved portion to improve visualization during angiography. The angiographic catheter does not include a balloon to reduce irritation during a procedure.

Description

ANGIOGRAPHIC CATHETER

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 604,396, filed on November 30, 2023, the entire contents of which is incorporated by reference in its entirety.

[0003] BACKGROUND

[0004] Catheter angiography uses a catheter in combination with fluoroscopic guidance and an injection of contrast material to examine blood vessels in a body. Generally, during catheter angiography, a catheter is inserted into a blood vessel through a small incision on a patient’s skin. The catheter is guided to a targeted examination area within a patient’s body, then contrast material is injected through the catheter, and images are captured using an imaging component. Catheter angiography helps determine whether an intervention or surgery is necessary by providing a clear and accurate picture of blood vessels. Additionally, physicians use catheter angiography to identify the presence and extent of abnormalities and conditions including aneurysms, atherosclerotic disease, arteriovenous malformation, coronary artery disease, pulmonary embolism, coronary artery disease, valvular heart disease, pericardial and myocardial disease, and congenital heart disease.

[0005] Types of angiographic catheters include selective angiographic catheters and non- selective angiographic catheters. Generally, non-selective catheters are designed to stay inserted in an originally punctured vessel or only advance to the aorta. Selective catheters are used when moving from an original vessel or from an artery that branches from the aorta. Many selective angiographic catheters do not have side holes and have a limit on the maximum flow rate. Most non-selective angiographic catheters include multiple ports along the side and end of the angiographic catheters.

[0006] FIELD OF THE INVENTION

[0007] The present invention is generally directed to catheters, and more specifically to angiographic catheters.

[0008] DESCRIPTION OF RELATED ART

[0009] Medical devices for accessing blood vessels are generally known. These blood vessel-accessing devices include catheters and are used for various diagnostic and surgical procedures (e.g., cardiac procedures). Problems that can occur during cardiac catheterization include (1) hematoma / retroperitoneal bleeding, (2) pseudoaneurysm, (3) arteriovenous fistula, (4) dissection, (5) thrombosis and embolism, (6) radial artery occlusion, (7) death, (8) myocardial infarction, (9) stroke, (10) dissection and perforation of the great vessels, (11) aeroembolism, (12) acute renal failure, (13) infection, (14) radiation injury, and (15) arrhythmia. Additionally, many catheters include balloons that can cause irritation or ischemia of the myocardium and blood vessels around the pelvis. There is a need for catheters to fit in the distal aorta, adequately opacify all vessels on injections, and track appropriately given the steepness and tortuosity of the pelvis.

[0010] Therefore, there is a need for an angiographic catheter without a balloon to address the aforementioned problems and improve catheter angiography.

[0011] BRIEF SUMMARY

[0012] In some embodiments, an angiographic catheter is disclosed. The angiographic catheter includes a tapered end, a radiopaque curve, a plurality of flush holes, a braided shaft, and hydrophilic coating. The angiographic catheter is usable in the distal aorta.Advantageously, the angiographic catheter improves opacification, selection, and trackability during surgical operations and similar medical procedures.

[0013] In some embodiments, an angiographic catheter is disclosed. The angiographic catheter includes a shaft, a plurality of flush holes, at least one curved portion, a tapered end, and a port. The port is operable to receive a fluid injection device. The plurality of flushholes is in fluid communication with the port. The plurality of flush holes uniformly distributes fluid received from the port.

[0014] In some embodiments, the shaft is braided. In some embodiments, the angiographic catheter includes a hydrophilic coating. In some embodiments, the plurality of flush holes includes at least two flush holes. The at least two flush holes are staggered around the at least one curved portion. In some embodiments, the at least one curved portion includes a radiopaque material. In some embodiments, the tapered end is about 1.75 meters from the shaft. In some embodiments, the angiographic catheter does not include a balloon. In some embodiments, the angiographic catheter has a size between about 5 French to about 7 French (outer diameter between about 1.67 millimeters to about 2.33 millimeters). In some embodiments, the plurality of flush holes includes at least one flush hole on a first surface of the angiographic catheter and at least one hole on a second surface of the angiographic catheter. The first surface and the second surface are on opposite sides of angiographic catheter. In some embodiments, the distributed fluid includes a contrast element. In some embodiments, the tapered end is curved. In some embodiments, the shaft is double-walled. In some embodiments, the angiographic catheter further includes a radiopaque material including at least one of barium, bismuth, or iridium.

[0015] In some embodiments, the angiographic catheter includes a shaft, a plurality of flush holes, at least one curved portion, a tapered end, and a port. The shaft, the plurality of flush holes, the at least one curved portion, the tapered end, and the port are covered with a hydrophilic coating. The port is operable to receive a fluid injection device. The plurality of flush holes is in fluid communication with the port. The plurality of flush holes uniformly distributes fluid received from the port.

[0016] In some embodiments, the shaft is braided. In some embodiments, the plurality of flush holes includes at least two flush holes. The at least two flush holes is staggered around the at least one curved portion. In some embodiments, the at least one curved portionincludes a radiopaque material. In some embodiments, the plurality of flush holes includes at least one flush hole on a first surface of the angiographic catheter. The plurality of flush holes includes at least one flush hole on a second surface of the angiographic catheter. The first surface is an opposite surface of the second surface. In some embodiments, the distributed fluid includes a contrast element. In some embodiments, the tapered end is curved.

[0017] BRIEF DESCRIPTION OF THE VIEW OF THE DRAWING

[0018] The embodiments illustrated, described, and discussed herein are illustrative of the present invention. As these embodiments of the present invention are described with reference to illustrations, various modifications, or adaptations of the methods and or specific structures described may become apparent to those skilled in the art. It will be appreciated that modifications and variations are covered by the above teachings and within the scope of the appended claims without departing from the spirit and intended scope thereof. All such modifications, adaptations, or variations that rely upon the teachings of the present invention, and through which these teachings have advanced the art, are considered to be within the spirit and scope of the present invention. Hence, these descriptions and drawings should not be considered in a limiting sense, as it is understood that the present invention is in no way limited to only the embodiments illustrated.

[0019] FIG. 1 illustrates an angiographic catheter according to at least one embodiment of the present invention.

[0020] DETAILED DESCRIPTION

[0021] These descriptions are presented with sufficient details to provide an understanding of one or more particular embodiments of broader inventive subject matters. These descriptions expound upon and exemplify particular features of those particular embodiments without limiting the inventive subject matters to the explicitly described embodiments and features. Considerations in view of these descriptions will likely give riseto additional and similar embodiments and features without departing from the scope of the inventive subject matters. Although the term “step” may be expressly used or implied relating to features of processes or methods, no implication is made of any particular order or sequence among such expressed or implied steps unless an order or sequence is explicitly stated.

[0022] Any dimensions expressed or implied in the drawings and these descriptions are provided for exemplary purposes. Thus, not all embodiments are within the scope of the drawings and these descriptions are made according to such exemplary dimensions. The drawings are not made necessarily to scale. Thus, not all embodiments are within the scope of the drawings and these descriptions are made according to the apparent scale of the drawings with regard to relative dimensions in the drawings.

[0023] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the presently disclosed subject matter pertains. Although any methods, devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the presently disclosed subject matter, representative methods, devices, and materials are now described.

[0024] Following long-standing patent law convention, the terms "a", "an", and "the" refer to "one or more" when used in the subject specification, including the claims. Thus, for example, reference to "a device" can include a plurality of such devices, and so forth.

[0025] Unless otherwise indicated, all numbers expressing quantities of components, conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about". Accordingly, unless indicated to the contrary, the numerical parameters set forth in the instant specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently disclosed subject matter.

[0026] As used herein, the term "about", when referring to a value or to an amount of mass, weight, time, volume, concentration, and / or percentage can encompass variations of, in some embodiments + / -20%, in some embodiments + / -10%, in some embodiments + / -5%, in some embodiments + / -1%, in some embodiments + / -0.5%, and in some embodiments + / - 0.1%, from the specified amount, as such variations are appropriate in the presently disclosed subject matter.

[0027] In some embodiments, as shown in FIG. 1, the present invention includes an angiographic catheter 100 with a shaft 102, a plurality of flush holes 104, a first curve 106, a tapered end 108, and a port 110. The plurality of flush holes 104 is designed to release a fluid (e.g., a contrast element) received via the port 110. In some embodiments, the plurality of flush holes releases the fluid in a uniform manner. In some embodiments, each flush hole of the plurality of flush holes is substantially circular. For example, and without limitation, in some embodiments, the angiographic catheter includes an end hole and at least two flush holes in a staggered orientation about three centimeters from the tip of the catheter. In some embodiments, the plurality of flush holes includes at least two flush holes. In some embodiments, the plurality of flush holes includes at least five flush holes. In some embodiments, at least one flush hole is positioned along a shaft of the angiographic catheter. In some embodiments, the plurality of flush holes includes a pluralities of flush holes. The pluralities of flush holes includes at least two flush holes positioned on opposing surfaces of the angiographic catheter. In some embodiments, the pluralities of flush holes on the opposing surfaces are horizontally or vertically aligned. In some embodiments, the pluralities of flush holes on the opposing surfaces are offset.

[0028] The first curve 106 includes a radiopaque material for visualization during catheter angiography. In some embodiments, the angiographic catheter includes a plurality of curves. Advantageously, this improves the usability of the catheter as a selective catheter for branch vessels.

[0029] In some embodiments, the angiographic catheter further includes a hydrophilic coating that improves the catheter tracking over the aortic bifurcation. The hydrophilic coating covers an entire external surface of the angiographic catheter. In some embodiments, the shaft is braided. Advantageously, this improves the torquability. In some embodiments, the angiographic catheter includes a horizontal distance of about 1.75 cm between the tapered end and the shaft.

[0030] In some embodiments, the angiographic catheter does not include a balloon. Advantageously, this reduces the irritation caused by the angiographic catheter when positioned within a patient. In some other embodiments, the angiographic catheter includes a plurality of curves. In some embodiments, the angiographic catheter includes a wire. For example, and without limitation, the wire includes a diameter of about .45 millimeters (about 0.018 inches) or about .35 millimeters (about .014 inches).

[0031] In another embodiment, a flush catheter is disclosed. The flush catheter includes a plurality of side holes designed to release a contrast element. Advantageously, the flush catheter is designed to uniformly release a contrast element or similar fluid after the contrast element is injected into the catheter. In some embodiments, the end of the flush catheter is rounded. Advantageously, this prevents the catheter tip from entering a vessel and keeps the shaft in a central position. In some embodiments, the flush catheter includes an end hole that allows the flush catheter to glide over a wire and / or to inject contrast.

[0032] In some embodiments, a selective catheter is disclosed. The selective catheter includes a rotational stiffness that improves the selection of a vessel while maintaining flexibility to advance to the targeted vessel. For further example, and not limitation, in some embodiments, the catheter is thick-walled (e.g., double-walled). Alternatively, the catheter is thin-walled.

[0033] In some embodiments, the angiographic catheter includes a synthetic and / or a semisynthetic polymer. For example, and not limitation, the angiographic catheter includespolyester, nylon, polyvinylchloride (PVC), polyethylene (PE), fluoropolymers (PTFE), polyurethane, silicon, and other similar polymers. In some embodiments, the angiographic catheter further includes a radiopaque material such as barium, bismuth, and iridium. In some embodiments, the angiographic catheter includes a hydrophilic coating. In some embodiments, an outer layer of the angiographic catheter includes a low-friction material. The angiographic catheter further includes a reinforcement layer (e.g., stainless steel braid).

[0034] In some embodiments, the end of the angiographic catheter includes an over-bent end (angle is smaller outside the body than inside) or an under-bent end (angle of catheter tip is larger outside the body). In some other embodiments, the angiographic catheter includes a size between about 5 to about 7 French (outer diameter between about 1.67 millimeters to about 2.33 millimeters). In other embodiments, the angiographic catheter includes a size of at least 4 French (outer diameter of at least 1.33 millimeters). In some embodiments, the angiographic catheter includes a tip length of about one centimeter, at least one hook curve, and at least one lumen. In some embodiments, the shaft of the angiographic catheter has a uniform stiffness for the entire length of the shaft. Advantageously, the angiographic catheter improves opacification, selection and trackability.

[0035] In some embodiments, a method for generating an angiogram utilizing an angiographic catheter is disclosed. For example, and without limitation, the method includes a retrograde common femoral artery puncture. The puncture can be created utilizing ultrasound guidance. The angiographic catheter is inserted via the puncture and positioned in a distal aorta of a patient. Contrast material (e.g., dye) is injected (e.g., manually or assisted) through and flushed out of the angiographic catheter. An imaging device (e.g., x-ray equipment) captures an image of the contrast material passing through an artery. The angiographic catheter is further designed to track into common femoral and / or superficial femoral artery. In some embodiments, the angiographic catheter is swappable for a sheath orused for further angiography. Advantageously, the angiographic catheter enables effective opacification and subsequent selection of contralateral iliac arteries.

[0036] Particular embodiments and features have been described with reference to the drawings. It is to be understood that these descriptions are not limited to any single embodiment or any particular set of features, and that similar embodiments and features may arise, or modifications and additions may be made without departing from the scope of these descriptions and the spirit of the appended claims.

[0037] These and other changes can be made to the disclosure in light of the above Detailed Description. While the above description describes certain embodiments of the disclosure, and describes the best mode contemplated, no matter how detailed the above appears in text, the teachings can be practiced in many ways. Details of the system may vary considerably in its implementation details, while still being encompassed by the subject matter disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the disclosure with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the disclosure to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the disclosure encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the disclosure under the claims.

Claims

CLAIMSWhat is claimed is:

1. An angiographic catheter comprising: a shaft; a plurality of flush holes; at least one curved portion; a tapered end; and a port; wherein the port is operable to receive a fluid injection device; and wherein the plurality of flush holes is in fluid communication with the port; wherein the plurality of flush holes uniformly distributes fluid received from the port.

2. The angiographic catheter of claim 1, wherein the shaft is braided.

3. The angiographic catheter of claim 1 further including a hydrophilic coating.

4. The angiographic catheter of claim 1, wherein the plurality of flush holes includes at least two flush holes, wherein the at least two flush holes is staggered around the at least one curved portion.

5. The angiographic catheter of claim 1, wherein the at least one curved portion includes a radiopaque material.

6. The angiographic catheter of claim 1, wherein the tapered end is about 1.75 centimeters from the shaft.

7. The angiographic catheter of claim 1, wherein the angiographic catheter does not include a balloon.

8. The angiographic catheter of claim 1, wherein a size of the angiographic catheter is between about 5 French to about 7 French.

9. The angiographic catheter of claim 1, wherein the plurality of flush holes includes at least one flush hole on a first surface of the angiographic catheter, wherein the plurality of flush holes includes at least one flush hole on a second surface of the angiographic catheter, wherein the first surface is an opposite surface of the second surface.

10. The angiographic catheter of claim 1, wherein the distributed fluid includes a contrast element.

11. The angiographic catheter of claim 1, wherein the tapered end is curved.

12. The angiographic catheter of claim 1, wherein the shaft is double-walled.

13. The angiographic catheter of claim 1 further comprising a radiopaque material, wherein the radiopaque material includes at least one of barium, bismuth, or iridium.

14. An angiographic catheter comprising: a shaft; a plurality of flush holes; at least one curved portion; a tapered end; and a port; wherein the shaft, the plurality of flush holes, the at least one curved portion, the tapered end, and the port are covered with a hydrophilic coating; wherein the port is operable to receive a fluid injection device; and wherein the plurality of flush holes is in fluid communication with the port; wherein the plurality of flush holes uniformly distributes fluid received from the port.

15. The angiographic catheter of claim 14, wherein the shaft is braided.

16. The angiographic catheter of claim 14, wherein the plurality of flush holes includes at least two flush holes, wherein the at least two flush holes is staggered around the at least one curved portion.

17. The angiographic catheter of claim 14, wherein the at least one curved portion includes a radiopaque material.

18. The angiographic catheter of claim 14, wherein the plurality of flush holes includes at least one flush hole on a first surface of the angiographic catheter, wherein the plurality of flush holes includes at least one flush hole on a second surface of the angiographic catheter, wherein the first surface is positioned on an opposing side of the angiographic catheter relative to the second surface.

19. The angiographic catheter of claim 14, wherein the distributed fluid includes a contrast element.

20. The angiographic catheter of claim 14, wherein the tapered end is curved.

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