Method and apparatus for delivering an implant without bias to a left atrial appendage

Abstract

A system and method for delivering an implant includes an implant, an actuation shaft, and a concentrically attachable disconnect mount. A distal guide tube is sometimes also provided. A proximal guide tube is also sometimes provided. The implantable device has a proximal, a distal end, and a plurality of supports. The implantable device is moveable between a collapsed and an expanded configuration. The distal guide tube, when provided, is at the distal end of the supports and extends toward the proximal end of the implantable device. The actuation shaft extends through the proximal end of the implantable device and is removeably engageable with the distal guide tube, or the distal end of the device when the distal guide tube is not provided. The disconnect mount is releasably engageable with the proximal end of the implantable device. The disconnect mount is concentrically attachable to the proximal end of the implantable device as well. The implantable device is self-expandable, and is collapsed by engaging the actuation shaft with the distal guide tube while applying a relatively proximal force to the proximal end of the implant with the disconnect mount.

Description

CROSS-REFERENCE TO RELATED U.S. APPLICATIONS [0001] This application claims the benefit of priority from U.S. Provisional No. 60 / 741,111, filed Dec. 1, 2005, which is incorporated by reference, herein.BACKGROUND [0002] Embolic stroke is the nation's third leading killer for adults, and is a major cause of disability. There are over 700,000 strokes per year in the United States alone. Of these, roughly 100,000 are hemorrhagic, and 600,000 are ischemic (either due to vessel narrowing or to embolism). The most common cause of embolic stroke emanating from the heart is thrombus formation due to atrial fibrillation. Approximately 80,000 strokes per year are attributable to atrial fibrillation. Atrial fibrillation is an arrhythmia of the heart that results in a rapid and chaotic heartbeat that produces lower cardiac output and irregular and turbulent blood flow in the vascular system. There are over five million people worldwide with atrial fibrillation, with about four hundred thousand n...

AI Technical Summary

Benefits of technology

The present invention provides a system and method for delivering an implant with reduced bias during implantation. The system includes an implant with a distal guide tube, actuation shaft, and disconnect mount. The implant is designed to contain emboli and can be collapsed and expanded. The actuation shaft is engageable with the distal guide tube and the disconnect mount is engageable with the proximal end of the implant. The method involves applying a concentric force to the implant and a distal force to the distal end or proximal end. The technical effect of this invention is to minimize bias during implantation and ensure accurate placement of the implant.

Problems solved by technology

Embolic stroke is the nation's third leading killer for adults, and is a major cause of disability.

Atrial fibrillation is an arrhythmia of the heart that results in a rapid and chaotic heartbeat that produces lower cardiac output and irregular and turbulent blood flow in the vascular system.

A patient with atrial fibrillation typically has a significantly decreased quality of life due, in part, to the fear of a stroke, and the pharmaceutical regimen necessary to reduce that risk.

The LAA normally contracts with the rest of the left atrium during a normal heart cycle, thus keeping blood from becoming stagnant therein, but often fails to contract with any vigor in patients experiencing atrial fibrillation due to the discoordinate electrical signals associated with atrial fibrillation.

Pharmacological therapies for stroke prevention such as oral or systemic administration of warfarin or the like have been inadequate due to serious side effects of the medications and lack of patient compliance in taking the medication.

Invasive surgical or thorascopic techniques have been used to obliterate the LAA, however, many patients are not suitable candidates for such surgical procedures due to a compromised condition or having previously undergone cardiac surgery.

In addition, the perceived risks of even a thorascopic surgical procedure often outweigh the potential benefits.

The thrombus in the blood stream of the patient can cause embolic stroke.

Unfortunately, using staples or sutures to close off the LAA may not completely close the orifice of the LAA.

Additionally, closing the orifice of the LAA by using staples or sutures may result in discontinuities, such as folds or creases, in the endocardial surface facing the left atrium.

Unfortunately, blood clots may form in these discontinuities and can enter the patient's blood stream, thereby causing health problems.

Moreover, it is difficult to place sutures at the orifice of the LAA and may result in a residual appendage.

For example, an epicardial approach to ligate sutures can result in a residual appendage.

Similarly, thrombus may form in the residual appendage and enter the patient's blood stream causing health problems.

However, some delivery devices can have limited flexibility and can provide off-axis loading that creates moment arms and bending bias.

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