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Patent Application Titled "Method for Increased Uptake of Beneficial Agent and Ejection Fraction by Postconditioning Procedures" Published Online

June 26, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- According to news reporting originating from Washington, D.C., by VerticalNews journalists, a patent application by the inventor Ehrenreich, Kevin (San Francisco, CA), filed on June 6, 2013, was made available online on June 12, 2014.

The assignee for this patent application is Abbott Cardiovascular Systems Inc.

Reporters obtained the following quote from the background information supplied by the inventors: "Usually, the term 'postconditioning' refers to a method during which the blood flow in an artery is stopped and started for multiple cycles immediately after re-opening initial blood flow in an occluded blood vessel, such as from a ST segment elevation myocardial infarction ('STEMI'). The postconditioning technique is generally used to reduce reperfusion injury in a person suffering from an ischemic event. Currently, physicians perform postconditioning techniques for the purpose of reducing reperfusion injury with a conventional angioplasty catheter. At this time, there is no catheter on the marketplace designed to perform postconditioning techniques in a blood vessel of a subject. Further, angioplasty catheters have been known to be modified or configured to locally deliver therapeutic agents to the vasculature of a subject. There is a need for methods and devices for increased uptake of drugs and other agents into the tissue of subjects.

"The disclosed subject matter addresses these needs by providing methods and devices to perform postconditioning in a blood vessel and which exhibits increased uptake of the beneficial agent into the system of the subject. The methods and device also improve ejection fraction of a subject after an ischemic event.

"The present invention provides methods for using a catheter to deliver beneficial agents during postconditioning of a blood vessel with the benefit of increast tissue uptake and have been known to be drug delivery devices in addition to A conventional angioplasty balloon catheter is not optimized to sequentially inflate and deflate for multiple cycles. Further the rapid exchange catheter is not designed to locally deliver a beneficial agent to distal to the balloon or ischemic site. Therefore, a need exists for a reperfusion device that is adapted to locally deliver a beneficial agent to synergistically improve inhibition of reperfusion injury."

In addition to obtaining background information on this patent application, VerticalNews editors also obtained the inventor's summary information for this patent application: "In accordance with one aspect of the disclosed subject matter, a method for improving tissue uptake of a beneficial agent is provided. It has surprisingly been found that the methods and device for postconditioning of the subject matter described herein result in an increased uptake of beneficial agent into the tissue of a subject. The method includes locally administering a beneficial agent to the vasculature of a subject during sequential cycles of inflating and deflating a balloon. The term 'cycle' refers to one inflation followed by one deflation of the balloon. For ease of discussion, multiple cycles may sometimes be referred to as be referred to as postconditioning throughout the present disclosure.

"In some embodiments, the balloon is sequentially inflated and deflated for at least two cycles and preferably more than eight cycles. The catheter is configured to inflate in less than four seconds and deflate in less than five seconds. In some embodiments, for example, the balloon can be inflated in less than one second. In one embodiment, the balloon can be deflated in one minute or less. Accordingly, one cycle of inflation and deflation can occur in less than two seconds. The inflation and deflation in rapid and efficient succession modulates the blood flow through the blood vessel of the subject.

"A beneficial agent can be administered during the inflation part of the cycle, the deflation part of the cycle or both during inflation and deflation. It has been found that the method for administering a beneficial agent as described can result in a four-fold increase in tissue uptake of the beneficial agent. In other embodiments, the increase in uptake is greater than one-hundred fold. On average, in some embodiments, the increased uptake is at least forty-fold.

"The method can also exhibit a concentration of beneficial agent in blood plasma at least one hour after cessation of administration. In one embodiment, the method can exhibit a plasma concentration of beneficial agent at least two hours after cessation of administration of the beneficial agent and inflation and deflation of the balloon.

"Various beneficial agents can be employed with the method and device described. The beneficial agents can be selected from the group consisting of: a calpain inhibitor, pH stabilizing agent, or an endothelin receptor blocker. In other embodiments, the beneficial agent can be a biomaterial. In some embodiments the beneficial agent is a zinc chelator. The zinc chelator is a pendant group to a polymer or a pendant group to a biomaterial. In some embodiments, the beneficial agent can be a formulation of a zinc chelator and a vasodilator. The formulation having zinc chelator can be employed to modulate tissue remodeling. In this regard, the formulation can be administered to a coronary vasculature to modulate an infarcted area of a tissue. Suitable vasodilators can include acetohydroxamic acid, N-(methyl)mercaptoacetamide, 3-Hydroxy-pyran-4-one, 1-Hydroxy-1H-pyridin-2-one, 3-Hydroxy-1-methyl-1H-pyridin-2-one, 3-Hydroxy-2-methyl-pyridin-4-one, 3-Hydroxy-1,2-dimethyl-1H-pyridin-4-one, 1-Hydroxy-1H-pyridine-2-thione, 3-Hydroxy-2-methyl-pyran-4-thione, 3-Hydroxy-1H-pyridin-2-one, 3-Hydroxy-pyran-4-thione, 3-Hydroxy-1-methyl-1H-pyridine-2-thione, and 3-Hydroxy-1,2-dimethyl-1H-pyridine-4-thione.

"In another aspect, a method for improving ejection fraction is described. In accordance with the method a catheter is introduced to the ischemic lumen of a subject. The catheter includes an inflation lumen and an separate dedicated deflation lumen disposed between a proximal end and a distal end of the catheter and a balloon disposed on the catheter. The method includes sequentially inflating and deflating the balloon for at least two cycles. It has been found that the method improves the ejection fraction to at least 30%.

BRIEF DESCRIPTION OF THE DRAWINGS

"A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and are not necessarily drawn to scale, with some components and features being exaggerated for clarity. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.

"FIGS. 1A and 1B are schematic views of exemplary postconditioning techniques in accordance with the disclosed subject matter;

"FIG. 2 is a schematic illustration of synergistic mechanical postconditioning and local beneficial agent therapy in accordance with one embodiment of the disclosed subject matter;

"FIG. 3 is a graph illustrating results of a comparative study of tissue uptake of beneficial agent in various tissues, in accordance with the disclosed subject matter;

"FIG. 4 is a graph illustrating plasma concentrations of beneficial agent after postconditioning in accordance with the disclosed subject matter;

"FIG. 5 is a graphical presentation of a comparison of ratios of infarct size to area at risk, in accordance with the disclosed subject matter;

"FIG. 6 is a graphical presentation of a comparison of ejection fractions, in accordance with the disclosed subject matter;

"FIGS. 7 and 8 are schematic views of the system in accordance with one embodiment of the disclosed subject matter;

"FIG. 9A-9C are schematic illustrations of the catheter shaft in accordance with embodiments of the disclosed subject matter;

"FIG. 10 is a graphical presentation of a comparison of physician/operator focus or attention allocation, in accordance with the disclosed subject matter;

"FIG. 11 is a graph illustrating the results from a comparison study of inflation and deflation times, in accordance with the disclosed subject matter;

"FIGS. 12A and 12B are cross sectional views of the catheter shaft in accordance with one embodiment of the disclosed subject matter;

"FIGS. 13A and 13B are perspective views of embodiments of balloons in accordance with the disclosed subject matter;

"FIGS. 14A and 14B are cross sectional views of some embodiments of the handle in accordance of with the disclosed subject matter;

"FIGS. 14C to 14R are perspective views of various embodiments of handles in accordance with the disclosed subject matter;

"FIG. 15 is an exploded view of fluid circuit in accordance with one embodiment of the disclosed subject matter;

"FIGS. 16A to 16C are schematic illustrates of a pulse valve in accordance with the disclosed subject matter;

"FIG. 17 is a side view of the fluid circuit in accordance with the disclosed subject matter;

"FIGS. 18A to 18T are perspective views of exemplary components of the fluid circuit of FIG. 17;

"FIGS. 19A to 19C are block diagrams illustrating the inflation fluid flow through the fluid circuit in accordance with one embodiment of the disclosed subject matter;

"FIGS. 20A to 20N are side views of some embodiments of an arming device in accordance with the disclosed subject matter;

"FIG. 21 is a graphical presentation of a comparison of contrast employed, in accordance with the disclosed subject matter; and

"FIG. 22 is a graphical presentation of a series of steps in the reperfusion cycle, depicting delivery of contrast distal the balloon, in accordance with the disclosed subject matter."

For more information, see this patent application: Ehrenreich, Kevin. Method for Increased Uptake of Beneficial Agent and Ejection Fraction by Postconditioning Procedures. Filed June 6, 2013 and posted June 12, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1788&p=36&f=G&l=50&d=PG01&S1=20140605.PD.&OS=PD/20140605&RS=PD/20140605

Keywords for this news article include: Surgery, Cardiology, Angioplasty, Reperfusion, Blood Vessels, Cardio Device, Catheterization, Medical Devices, Blood Transfusion, Transfusion Medicine, Abbott Cardiovascular Systems Inc., Cardiovascular Surgical Procedures.

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Source: Politics & Government Week


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