Apparatus and method for treating bleeding arising from left atrial appendage

Abstract

Bleeding arising from the left atrial appendage (LAA) can have fatal consequences because it can result in cardiac tamponade. The present invention provides apparatuses and methods for treating and preventing bleeding arising from the LAA, at the pre-hemorrhage and post-hemorrhage stages. In particular, catheters having inflatable catheter balloons are advanced into the LAA and the inflatable catheter balloons are inflated in and around the LAA in a manner that occludes the LAA ostium and the LAA cavity. Additionally, electromagnetic coils are present within the inflatable catheter balloons to create electromagnetic forces that help to further occlude the LAA ostium firmly. When the catheter balloons are inflated, these electromagnetic coils also expand. Alternatively, the LAA ostium can be occluded using electromagnetic coils present in an inflated endocardial catheter balloon and electromagnetic coils present in an inflated epicardial catheter balloon deployed around the circumference of the LAA ostium epicardially.

Description

CLAIM OF PRIORITY UNDER 35 U.S.C. §119(e)[0001]This application claims the benefit and priority of U.S. Provisional Patent Application No. 61 / 661,350, entitled “NOVEL TECHNOLOGY FOR TREATING HEMORRHAGE FROM LEFT ATRIAL APPENDAGE,” filed on Jun. 19, 2012, the entire contents and disclosures of which are hereby incorporated by reference herein.BACKGROUND[0002]1. Field[0003]The present invention relates generally to apparatuses and methods for treating and preventing bleeding arising from the left atrial appendage using catheters having inflatable catheter balloons, at the pre-hemorrhage and post-hemorrhage stages.[0004]2. Description of the Related Art[0005]The left atrial appendage (LAA) is a small, conical, ear-shaped muscular pouch projecting from the upper anterior portion of the left atrium of the heart. Thus, the LAA lies within the pericardial cavity, and is an extension of the left atrium. The LAA functions as a decompression chamber during left ventricular systole and during ...

AI Technical Summary

Benefits of technology

The present invention provides apparatuses and methods for treating and preventing bleeding arising from the LAA using inflatable catheter balloons. The apparatus includes an inflatable catheter balloon with electromagnetic coils that expand to occlude the LAA ostium. The method involves introducing a catheter into the body cavity, advancing a guide wire tip and catheter sheath to the ostium of the LAA, inflating the balloon, and pulling it from the left atrium to the LAA ostium. The inflated balloon can also be used to puncture the LAA cavity. The technical effects of the invention include improved treatment and prevention of bleeding from the LAA.

Problems solved by technology

Over the past 8 to 10 years, the LAA has become the target of several invasive procedures due to the high likelihood of embolic strokes arising from the LAA.

During these procedures, bleeding arising from the LAA can occur.

Additionally during these procedures, there can be tearing of the LAA.

If the bleeding is severe, cardiac tamponade can result and there may not be sufficient time to transfer the patient to an operating room for the proper care.

Additionally, elderly patients are often not candidates for cardiac surgery due to advanced age and other comorbid issues.

Embolic stroke interrupts blood flow to the brain, thereby causing the affected brain cells to die.

When brain cells die, the abilities controlled by the dying brain cells are compromised and eventually lost.

Additionally, stroke is the leading cause of adult disability and there are currently over four million Americans living with the effects of stroke.

AF patients have a five-fold increased risk of an embolic stroke resulting primarily from thromboembolic events.

Typically, the thrombus formed in the LAA break away from the LAA and accumulates in other blood vessels, thereby blocking blood flow in these blood vessels, and ultimately leading to an embolic stroke.

However, a major drawback of warfarin is the difficulty of maintaining its therapeutic range, and thus, warfarin-administered patients require frequent monitoring and dose adjustments.

However, a major drawback of the WATCHMAN device is the fixation of barbs or wires engaged in the walls of the LAA, thereby causing adverse events.

As shown in the PROTECT-AF trial, a major adverse event is pericardial effusion, which is the abnormal accumulation of fluid in the pericardial cavity, which can negatively affect heart function.

Another adverse event is the tearing of the walls of the LAA by the barb wires, thereby necessitating emergent surgery.

The tearing of the LAA may lead to bleeding, which is an emergent situation that requires quick, decisive action to stop the bleeding and stabilize the patient.

However, like the WATCHMAN device, a major drawback of this approach is the risks of bleeding and tears in the LAA.

Tears and bleeding arising from the LAA is particularly concerning for elderly patients because due to their advanced age, the walls of their LAA are fragile.

As a result, elderly patients are more susceptible to tears and bleeding.

Additionally, elderly patients are not candidates for cardiac surgery due to their advanced age and other significant comorbid issues.