CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No. 12/028,452 Filed Feb. 8, 2008, which is a continuation of U.S. application Ser. No. 10/893,143 filed Jul. 15, 2004, now U.S. Pat. No. 7,329,279; which application is a continuation-in-part of U.S. application Ser. No. 10/746,280, filed Dec. 23, 2003. These applications are incorporated by reference as if fully set forth herein.
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OF THE INVENTION
Heart valve surgery is used to repair or replace diseased heart valves. Valve surgery is an open-heart procedure conducted under general anesthesia. An incision is made through the patient's sternum (sternotomy), and the patient's heart is stopped while blood flow is rerouted through a heart-lung bypass machine.
Valve replacement may be indicated when there is a narrowing of the native heart valve, commonly referred to as stenosis, or when the native valve leaks or regurgitates. When replacing the valve, the native valve is excised and replaced with either a biologic or a mechanical valve. Mechanical valves require lifelong anticoagulant medication to prevent blood clot formation, and clicking of the valve often may be heard through the chest. Biologic tissue valves typically do not require such medication. Tissue valves may be obtained from cadavers or may be porcine or bovine, and are commonly attached to synthetic rings that are secured to the patient's heart.
Valve replacement surgery is a highly invasive operation with significant concomitant risk. Risks include bleeding, infection, stroke, heart attack, arrhythmia, renal failure, adverse reactions to the anesthesia medications, as well as sudden death. Two to five percent of patients die during surgery.
Post-surgery, patients temporarily may be confused due to emboli and other factors associated with the heart-lung machine. The first 2-3 days following surgery are spent in an intensive care unit where heart functions can be closely monitored. The average hospital stay is between 1 to 2 weeks, with several more weeks to months required for complete recovery.
In recent years, advancements in minimally invasive surgery and interventional cardiology have encouraged some investigators to pursue percutaneous replacement of the aortic heart valve. See, e.g., U.S. Pat. No. 6,168,614. In many of these procedures, the replacement valve is deployed across the native diseased valve to permanently hold the valve open, thereby alleviating a need to excise the native valve and to position the replacement valve in place of the native valve.
In the endovascular aortic valve replacement procedure, accurate placement of aortic valves relative to coronary ostia and the mitral valve is critical. Some self-expanding valve anchors have had very poor accuracy in deployment, however. In a typical deployment procedure, the proximal end of the stent is not released from the delivery system until accurate placement is verified by fluoroscopy. The stent often jumps to another position once released, making it impossible to know where the ends of the stent will be after release with respect to the native valve, the coronary ostia and the mitral valve.
Also, visualization of the way the new valve is functioning prior to final deployment is very desirable. Due to the jumping action of some self-expanding anchors, and because the replacement valve is often not fully functional before final deployment, visualization of valve function and position prior to final and irreversible deployment is often impossible with these systems.
Another drawback of prior art self-expanding replacement heart valve systems is their relative lack of radial strength. In order for self-expanding systems to be easily delivered through a delivery sheath, the metal needs to flex and bend inside the delivery catheter without being plastically deformed. Expandable stent designs suitable for endovascular delivery for other purposes may not have sufficient radial strength to serve as replacement heart valve anchors. For example, there are many commercial arterial stent systems that apply adequate radial force against the artery wall to treat atherosclerosis and that can collapse to a small enough of a diameter to fit inside a delivery catheter without plastically deforming. However when the stent has a valve fastened inside it, and that valve must reside within the heart, as is the case in aortic valve replacement, the anchoring of the stent to vessel walls takes significantly more radial force, especially during diastole. The force to hold back arterial pressure and prevent blood from going back inside the ventricle during diastole will be directly transferred to the stent/vessel wall interface. Therefore, the amount of radial force required to keep the self-expanding stent/valve in contact with the vessel wall and not sliding is much higher than in stents that do not have valves inside of them. Moreover, a self-expanding stent without sufficient radial force will end up dilating and contracting with each heartbeat, thereby distorting the valve, affecting its function and possibly causing it to migrate and dislodge completely. Simply increasing strut thickness of the self-expanding stent is not a good solution as it increases profile and/or a risk of plastic deformation of the self-expanding stent.
In view of drawbacks associated with previously known techniques for endovascularly replacing a heart valve, it would be desirable to provide methods and apparatus that overcome those drawbacks.
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OF THE INVENTION
One aspect of the present invention provides methods for replacing a native aortic valve. Such methods involve endovascularly delivering a replacement valve and an anchor having an expandable braid. Delivery is preferably made to a site within the native aortic valve. Delivery is preferably made by actively foreshortening the anchor to radially expand the anchor to an expanded shape to secure the anchor at the anchor site. In some embodiments, the methods further include the step of locking the anchor in an expanded shape. In some embodiments, the methods include expanding a first step region of the anchor to a first diameter and a second region of the anchor to a second diameter larger than the first diameter.
In some embodiments, the foreshortening step of the methods herein comprises actively foreshortening the anchor to radially expand the anchor to an expanded shape to secure the anchor at the anchor site while avoiding interference with a mitral valve. In some embodiments, the foreshortening step comprises actively foreshortening the anchor to radially expand the anchor to a radially symmetrical expanded shape, a bilaterally symmetrical expanded shape or an asymmetrical expanded shape.
In some embodiments, the anchor is allowed to self-expand prior to the foreshortening step. In some embodiments, the foreshortening step comprises applying a proximally directed force on a deployment system interface at a proximal end or a distal end of the anchor. In some embodiments, the foreshortening step comprises applying a distally directed force on a deployment system interface at a proximal end of the anchor.
Incorporation By Reference
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
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The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
FIGS. 1A and 1B are schematic top views of an anchor and valve apparatus in accordance with the present invention. FIG. 1 illustrates the apparatus in a collapsed delivery configuration within a delivery system. FIG. 1B illustrates the apparatus in an expanded configuration partially deployed from the delivery system.
FIGS. 2A-2F are schematic isometric views detailing an anchor of the apparatus of FIG. 1 in the collapsed delivery configuration and the expanded deployed configuration, as well as the full apparatus in the deployed configuration.
FIG. 3 is a schematic top view of an apparatus for fabricating braided anchors in accordance with the present invention.
FIGS. 4A-4D are schematic top views illustrating a method of using the apparatus of FIG. 3 to fabricate a braided anchor of the present invention.
FIGS. 5A-5O are schematic detail views illustrating features of braid cells at an anchor edge.
FIGS. 6A-6E illustrate further features of braid cells at an anchor edge.
FIGS. 7A-7J are schematic detail views terminations for one or more wire strands forming anchors of the present invention.
FIGS. 8A and 8B are schematic side views of alternative embodiments of the anchor portion of the apparatus of the present invention.
FIGS. 9A-9E are schematic side views of further alternative embodiments of the of the anchor portion of the apparatus of the present invention.
FIGS. 10A-10D are schematic views of different weave configurations.
FIGS. 11A-11E are schematic side views of various braided anchor configurations.
FIGS. 12A-12E are schematic side views of a deployment process.
FIGS. 13A and 13B illustrate a braided anchor in the heart.