This patent document relates to medical devices. More particularly, but not by way of limitation, this patent document relates to balloon catheters.
During a percutaneous coronary interventional (PCI) procedure, a solution containing dye or contrast agent is often injected into a main coronary artery through a guide or diagnostic catheter. The contrast agent can be fluorescent, enabling the coronary artery and its branches to be visualized, thereby allowing for identification of a stenosis. The use of a contrast agent, however, creates a certain amount of risk, especially in patients with kidney disease. For instance, patients commonly require revascularization of more than a single vessel, but when there is danger of contrast-induced renal failure, the vessels must be treated on separate visits, which is costly and inconvenient but necessary to avoid kidney failure. General dialysis is not an adequate solution because the concentration of contrast agent in the blood is low at dialysis locations, e.g., at a wrist or forearm, and flow rates of dialysis procedures are too high for patients undergoing PCI procedures.
The present inventor recognizes that there is a need to reduce the incidence of contrast-associated kidney failure and other issues caused by PCI procedures that employ contrast agents. Based on the understanding that renal issues induced by contrast agents can be prevented if the contrast agents do not travel to the kidneys, the inventor conceived and developed new devices and methods for collecting and filtering contrast-heavy blood, or selectively collecting and discarding contrast-heavy blood altogether. A balloon catheter defining a distal port and either a proximal port or proximal valve can be used to filter contrast agent from blood collected in the coronary sinus or discard the contrast-heavy blood in a controlled manner, respectively, such that only contrast-free or contrast-reduced blood enters the right atrium during a PCI procedure that employs contrast material. Depending on the number of ports included in the catheter, the number of lumens defined within the catheter can also vary. Two or more lumens can each be independently coupled with an external device configured to inflate the catheter balloon, filter contrast-heavy blood, or receive discarded contrast-heavy blood.
These and other embodiments and features of the present balloon catheters and related methods will be set forth, at least in part, in the following Detailed Description. This Overview is intended to provide non-limiting embodiments of the present subject matter—it is not intended to provide an exclusive or exhaustive explanation of the disclosed embodiments. The Detailed Description below is included to provide further information about the present balloon catheters and methods.
In the drawings, like numerals can be used to describe similar features and components throughout the several views. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in this patent document.
The drawings are not necessarily to scale. Certain features and components may be shown exaggerated in scale or in schematic form, and some details may not be shown in the interest of clarity and conciseness.
This patent document discloses multi-lumen balloon catheters configured to prevent contrast-heavy blood injected into a patient's coronary artery from traveling to the patient's kidneys. Contrast agents utilized to assess blood flow and occlusions during PCI procedures may be provided as a solution, the concentration of which may be the highest in a patient's coronary sinus, which is a collection of veins joined together to form a large vessel that collects blood from the heart muscle. From the coronary sinus, contrast-heavy blood flows into the right atrium and eventually to the kidneys. By blocking blood flow from the coronary sinus to the right atrium and removing contrast-heavy blood from the sinus, either temporarily or permanently, the balloon catheters of the present invention can reduce or eliminate the likelihood of contrast-associated nephropathy caused by PCI procedures.
As further shown, the catheter 210 may generally comprise an elongate tube member, which can define one or more preformed curvatures configured specifically for insertion into the coronary sinus ostium 202. In various embodiments, the catheter 210 may define a longitudinal curve positioned proximal to the balloon 212. Such a preformed curve may define an arc of about 30° to about 50° over a length of about 7.0 to 11.0 cm. In some examples, the catheter 210 may define one or more additional curved portions, e.g., a distal hook of about 50° to 70° spanning a length of about 0.5 to 2.0 cm. The rigidity of the elongate tube member may vary along its length, such that certain portions are more flexible, and thus amenable to manipulation, than other portions, which may comprise more rigid materials and/or reinforcement components. The catheter 210 may comprise a soft distal tip portion, and in some examples, the catheter 210 may transition from less pliable to more pliable moving distally along its length. The proximal portion 216 can be the straightest and most rigid portion of the catheter in various embodiments. The length of the elongate tube defined by the catheter 210 can range from about 15 cm to about 130 cm. The cross-sectional diameter of the catheter 210 may also vary, ranging from about 3F, 4F, 5F, 6F, 7F, 8F or larger. Methods of forming the catheter 210 may involve extruding one or more components.
In operation, contrast-heavy blood collected in the coronary sinus 202 flows into the distal portion 218 of the catheter 210 via distal port 214, which defines the distally terminal portion of a first lumen 226. The contrast-heavy blood is moved proximally through the first lumen 226, traveling from the coronary sinus 202 to the filtration device 222, which separates the contrast agent from the blood. After filtration, the contrast-free or contrast-reduced blood is returned to the right atrium 204 through a second lumen 228, which terminates at proximal port 220, positioned within the right atrium 204. Prior to its recirculation, the contrast-free or contrast-reduced blood may be mixed with an amount of water and/or saline to maintain a constant blood volume within the patient.
A third lumen 230 connects the inflation device 224 to the balloon 212, such that inflation device 224 can inflate the balloon prior to injection of the contrast agent, and deflate the balloon after removal of the contrast-heavy blood. In various embodiments, the balloon 212 can remain inflated even when no contrast agent is being injected. Air and/or liquid inflation materials may be used to expand the balloon 212.
As further shown, the second and third lumens 228, 230 can define distinct channels within the catheter 210, while the first lumen 226 can comprise the remainder of the interior volume of the catheter. In some examples, the second and third lumens 228, 230 can be integrated into the external walls of the catheter 210. In additional examples, the first lumen 226 can also comprise a distinctly-defined tube within the interior volume of the catheter 210. Regardless of the specific arrangement, the lumens 226, 228, 230 may define independent channels within the catheter 210. The proportion of available channel volume occupied by each lumen may vary. In some examples, the first lumen 226 occupies the greatest proportion of total volume within the catheter 210, while in additional examples, the first and second lumens 226, 228 each occupy an equal proportion of the total channel volume, such that the rate contrast-heavy blood removal approximately matches the rate of contrast-free or contrast-reduced blood replenishment. The configuration of the balloon 212 can also vary. The balloon 212 is spherical in the example shown, but the balloon may also be conical, square, elongate, tapered, stepped, offset, rectangular, and/or combinations thereof.
Filtration device 222 may be configured to perform multiple varieties of filtration. For example, filtration device 222 may include a centrifuge configured to separate contrast agent from liquid. In some examples, filtration device 222 may be configured to perform dialysis or continuous veno-venous hemodiafiltration (CVVHD). The balloon catheter 210 can be coupled with any filtration means known to one skilled in the art. Various contrast agents may also be used, and may impact the type of filtration performed. For example, contrast agents may be radiopaque and can be water soluble or water insoluble. Particular contrast agents employed may include metrizamide, iopamidol, iothalamate sodium, iodamide sodium, meglumine, and metals and metal oxides such as titanium, gold, silver, stainless steel, oxides thereof, aluminum oxide, and/or zirconium oxide.
In operation, contrast-heavy blood collected in the coronary sinus 402 flows into the distal portion 418 of the catheter 410 via distal port 414, which defines the distally terminal portion of the first lumen 426. The contrast-heavy blood is moved proximally through the first lumen 426, and depending on the configuration of the valve 421, travels from the coronary sinus 402 directly into the right atrium 404 or to the drainage device 423, e.g., a drainage bag. The valve 421 can be switched between a first, open configuration that allows blood to flow into the right atrium 404, and a second, closed configuration that prevents blood from entering the right atrium 404. In the closed configuration, contrast-heavy blood bypasses the right atrium 404 and continues to flow through the first lumen 426 to the drainage device 423, where the contrast-heavy blood can be deposited and discarded. To replace the discarded blood and maintain an approximately constant fluid level within the patient, saline can be administered to the patient. The valve 421 can be kept in the open configuration when no contrast agent remains in the patient, thereby allowing the contrast-free or contrast-reduced blood to flow freely into the right atrium via the first lumen 426. In various embodiments, the balloon catheter 410 may be positioned such that the valve 421 is positioned to funnel contrast-free or contrast-reduced blood directly into the right atrium 404 when in the open configuration, such that no blood is deposited into the inferior or superior vena cava.
The second, inflation lumen 430 connects the inflation device 424 to the balloon 412, such that inflation device 424 can inflate the balloon prior to injection of the contrast agent. The balloon 412 can remain inflated, under the control of the inflation device 424, such that the valve 421 comprises the only access point into the right atrium 404 during and/or after a PCI procedure.
Various contrast agents may also be used with the catheter 410. For example, contrast agents may be radiopaque and can be water soluble or water insoluble. Particular contrast agents employed may include metrizamide, iopamidol, iothalamate sodium, iodamide sodium, meglumine, and metals and metal oxides such as titanium, gold, silver, stainless steel, oxides thereof, aluminum oxide, and/or zirconium oxide.
The above Detailed Description is intended to be illustrative and not restrictive. The above-described embodiments (or one or more features or components thereof) can be used in varying combinations with each other unless clearly stated to the contrary. For example, the balloon catheter of
In Example 1, a method for preventing contrast-associated nephropathy may involve inserting a catheter into a patient's coronary sinus and blocking blood flow from the coronary sinus into the patient's right atrium. The blood may contain a contrast agent. The method may further involve draining the blood from the coronary sinus through a first lumen defined by the catheter while the blood flow is blocked, filtering the contrast agent from the blood which passes through the catheter, and returning contrast-free or contrast-reduced blood to the right atrium through a second lumen defined by the catheter. The second lumen can terminate in a port proximal to the coronary sinus.
In Example 2, the method of Example 1 can optionally be configured such that blocking blood flow comprises inflating a balloon coupled with the catheter and positioned between the coronary sinus and the right atrium.
In Example 3, the method of Example 2 can optionally be configured such that the catheter further comprises an inflation lumen coupled with an external inflation device and the balloon, the inflation lumen configured to direct an inflation substance into the balloon in response to activation of the inflation device.
In Example 4, the method of any one or any combination of Examples 1-3 can optionally be configured such that the catheter defines a distal port configured to receive blood from the coronary sinus and direct the blood into the first lumen.
In Example 5, a method for preventing contrast-associated nephropathy comprises inserting a catheter into a patient's coronary sinus, blocking blood from flowing into the patient's right atrium from the coronary sinus, and selectively draining blood from the coronary sinus into the right atrium through a first lumen defined by the catheter while the blood flow is blocked.
In Example 6, the method of Example 5 can optionally be configured such that selectively draining the blood comprises switching the catheter between an open configuration and a closed configuration by opening and closing a valve defined by the catheter.
In Example 7, the method of Example 6 can optionally be configured to further comprise maintaining the valve in the closed configuration when the blood contains a contrast agent, and depositing the blood into a drainage device coupled with the first lumen.
In Example 8, the method of Example 7 can optionally be configured to further comprise administering an amount of saline into the patient's blood stream.
In Example 9, the method of Example 6 can optionally be configured to further comprise maintaining the valve in the open configuration when the blood does not contain a contrast agent, and releasing the blood directly into the right atrium.
In Example 10, the method of any one or any combination of Examples 5-9 can optionally be configured such that blocking blood from flowing into the patient's right atrium comprises inflating a balloon coupled with the catheter and positioned between the coronary sinus and the right atrium.
In Example 11, the method of Example 10 can optionally be configured such that the balloon is never deflated.
In Example 12, the method of Example 10 can optionally be configured such that the catheter further comprises an inflation lumen coupled with an external inflation device and the balloon, the inflation lumen configured to direct an inflation substance into the balloon in response to activation of the inflation device.
In Example 13, the method of any one or any combination of Examples 5-12 can optionally be configured such that the catheter defines a distal port configured to receive blood from the coronary sinus.
In Example 14, the method of Example 6 can optionally be configured such that the valve is coupled with a control device configured to switch the valve between the open and closed configurations in response to administration of the contrast agent.
In Example 15, a balloon catheter comprises an elongate tube member defining a first lumen and configured for insertion into a patient's coronary sinus and a distal port defined by the elongate tube member, where the distal port is configured to receive blood from the coronary sinus. The catheter further comprises an inflatable balloon configured to block the blood from flowing into the patient's right atrium from the coronary sinus when inflated, and a valve positioned proximal to the balloon, where the valve is configured to switch between an open configuration and a closed configuration.
In Example 16, the balloon catheter of Example 15 can optionally be configured such that in the open configuration, the valve is configured to release the blood directly into the right atrium.
In Example 17, the balloon catheter of any one or any combination of Examples 15-16 can optionally be configured such that in the closed configuration, the valve is configured to deposit the blood into a drainage device coupled with a proximal end of the first lumen.
In Example 18, the balloon catheter of any one or any combination of Examples 15-17 can optionally be configured to further comprise an inflation lumen coupled with an external inflation device and the balloon, the inflation lumen configured to direct an inflation substance into the balloon in response to activation of the inflation device.
In Example 19, the balloon catheter of any one or any combination of Examples 15-18 can optionally be configured such that the elongate tube member includes a longitudinal preformed curve positioned proximal to the inflatable balloon.
In Example 20, the balloon catheter of Example 19 can optionally be configured such that the longitudinal preformed curve defines an arc of 30 degrees to 50 degrees, inclusive, over a length of 7.0 cm to 11.0 cm, inclusive.
Closing Notes:
The above Detailed Description includes references to the accompanying drawings, which form a part of the Detailed Description. The Detailed Description should be read with reference to the drawings. The drawings show, by way of illustration, specific embodiments in which the present balloon catheters and related methods can be practiced. These embodiments are also referred to herein as “examples.”
Certain terms are used throughout this patent document to refer to particular features or components. As one skilled in the art will appreciate, different people may refer to the same feature or component by different names. This patent document does not intend to distinguish between components or features that differ in name but not in function. For the following defined terms, certain definitions shall be applied unless a different definition is given elsewhere in this patent document. The terms “a,” “an,” and “the” are used to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” The term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B.” All numeric values are assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” refers to a range of numbers that one of skill in the art considers equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” can include numbers that are rounded to the nearest significant figure. The recitation of numerical ranges by endpoints includes all numbers and sub-ranges within and bounding that range (e.g., 1 to 4 includes 1, 1.5, 1.75, 2, 2.3, 2.6, 2.9, etc. and 1 to 1.5, 1 to 2, 1 to 3, 2 to 3.5, 2 to 4, 3 to 4, etc.). The terms “patient” and “subject” are intended to include mammals, such as for human or veterinary applications. The terms “distal” and “proximal” are used to refer to a position or direction relative to an operating physician. “Distal” and “distally” refer to a position that is distant from, or in a direction away from, the physician. “Proximal” and “proximally” refer to a position that is near, or in a direction toward, the physician.
The scope of the present balloon catheters and methods should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended; that is, a device or method that includes features or components in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.
This non-provisional patent document claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No. 62/630,468, entitled “BALLOON CATHETER FOR CONTRAST AGENT FILTRATION AND REMOVAL” and filed on Feb. 14, 2018, which is herein incorporated by reference in its entirety.
Number | Date | Country | |
---|---|---|---|
62630468 | Feb 2018 | US |