Methods and devices for heart valve treatments
An implant is sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant, when deployed, engages a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The implant is deployed into the left atrium through an intravascular access path that extends from a right atrium through a septum and into a left atrium.
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This application is a divisional of co-pending U.S. patent application Ser. No. 10/695,433, filed Oct. 28, 2003, which is a continuation of International Patent Application Serial No. PCT/US02/31376, entitled “Methods and Devices for Heart Valve Treatment”, having an international filing date of Oct. 1, 2002 and a priority date of Oct. 1, 2001, based upon the benefit of U.S. Provisional Patent Application Ser. No. 60/326,590, filed Oct. 1, 2001 and entitled “Methods and Systems for Herat Chamber Endocardial and Epicardial Scaffold Therapies.”
FIELD OF THE INVENTIONThis invention relates to methods and devices to improve the function of heart valves. More particularly, the invention relates to methods and devices to treat mitral valve regurgitation.
BACKGROUND OF THE INVENTIONThe opening and closing of heart valves occur primarily as a result of pressure differences. For example, the opening and closing of the mitral valve occurs as a result of the pressure differences between the left atrium and the left ventricle. During ventricular diastole, when ventricles are relaxed, the venous return of blood from the pulmonary veins into the left atrium causes the pressure in the atrium to exceed that in the ventricle. As a result, the mitral valve opens, allowing blood to enter the ventricle. As the ventricle contracts during ventricular systole, the intraventricular pressure rises above the pressure in the atrium and pushes the mitral valve shut.
The high pressure produced by contraction of the ventricle could push the valve leaflets too much and evert them. Prolapse is a term used to describe this condition. This is normally prevented by contraction of the papillary muscles within the ventricle, which are connected to the mitral valve leaflets by the chordae tendineae (chords). Contraction of the papillary muscles is simultaneous with the contraction of the ventricle and serves to keep healthy valve leaflets tightly shut at peak contraction pressures exerted by the ventricle.
Valve malfunction can result from the chords becoming stretched, and in some cases tearing. When a chord tears, the result is a flailed leaflet. Also, a normally structured valve may not function properly because of an enlargement of the valve annulus. This condition is referred to as a dilation of the annulus and generally results from heart muscle failure. In addition, the valve may be defective at birth or because of an acquired disease.
SUMMARY OF THE INVENTIONThe present invention provides a group of medical devices designed to improve heart valve function. The medical devices may be used individually, or in combination to supplement damaged valves, replace damaged valves, or improve damaged valves function. The medical devices include leaflet retainers, a neo-annulus, neo-leaflet, and a framework. In addition, the present invention includes novel methods for surgically treating heart valves.
One aspect of the invention provides heart implant comprising an implant structure sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant structure includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
Another aspect of the invention provides a system comprising an implant structure sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant structure includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The system also includes an access tool sized and configured to establish an intravascular access path that extends from a right atrium through a septum and into a left atrium. The system further includes a deployment tool sized and configured to deploy the implant structure through the intravascular path into the left atrium and position the implant structure in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
Another aspect of the invention provides a method comprising deploying a guide wire through an vasculature path into a: right atrium, and introducing the guide wire through a septum from the right atrium into a left atrium. The method includes advancing a catheter over the guide wire and releasing from the catheter a heart implant sized and configured to be positioned in the left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The method positions the implant in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
Another aspect of the invention provides a system comprising a guide wire sized and configured to be deployed through an vasculature path into a right atrium and through a septum from the right atrium into a left atrium. The system includes a catheter sized and configured to be introduced into the left atrium along the guide wire. The system further includes an implant structure carried within the catheter. The implant structure being sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant structure includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
Another aspect of the invention provides a method comprising deploying a catheter through an vasculature path into a right atrium, through a septum and into a left atrium. The method includes releasing from the catheter a heart implant sized and configured to be positioned in the left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The method includes positioning the implant in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
In one embodiment, the implant or implant structure is sized and configured so that, in use, the portion spans the left atrium.
In one embodiment, the implant or implant structure is sized and configured so that, in use, the portion changes the shape of the native mitral heart valve annulus.
In one embodiment, the implant or implant structure comprises, at least in part, nitinol, dacron, polytetrafluoroethylene, silicon, polyurethane, human pericardium, or animal pericardium.
In one embodiment, the implant or implant structure comprises, at least in part, a super elastic material.
These devices may be delivered to the heart via open heart surgery, through the chest, or through a remote blood vessel. Examples of delivery through a remote blood vessel include the use of guidewires and catheters. They can be advanced into the right atrium through the superior or inferior vena cava (transluminally, via a peripheral venous insertion site, such as the femoral or jugular vein), or into the left ventricle through the aorta. The left atrium can be accessed from the right atrium through the septum. Alternatively, the left atrium can be accessed from the left ventricle through the mitral valve using a transluminal procedure gaining access via a peripheral arterial insertion site, such as the femoral artery. Echo techniques are used to determine whether a patient is experiencing regurgitation, and various imaging techniques can be used to position the device.
The devices shown may be anchored within the left atrium using barbs, staples, adhesives, magnets, etc. In addition, the devices may be coated with various materials to either promote (Dacron) or inhibit (heparin) tissue growth around the devices, to prevent thrombosis, or coated with other desired materials to encourage other desirable characteristics. Anchoring can also be done on the opposite (ventricular) side of the valve.
While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention it will become apparent to one of ordinary skill in the art that many modifications, improvements and sub combinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof.
Claims
1. A heart implant comprising
- an implant structure sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets, the implant structure including a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
2. A heart implant according to claim 1
- wherein the implant structure is sized and configured so that, in use, the portion spans the left atrium.
3. A heart implant according to claim 1
- wherein the implant structure is sized and configured so that, in use, the portion changes the shape of the native mitral heart valve annulus.
4. A heart implant according to claim 1
- wherein the implant structure comprises, at least in part, nitinol, dacron, polytetrafluoroethylene, silicon, polyurethane, human pericardium, or animal pericardium.
5. A heart implant according to claim 1
- wherein the implant structure comprises, at least in part, a super elastic material.
6. A system comprising
- an implant structure sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets, the implant structure including a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function,
- an access tool sized and configured to establish an intravascular access path that extends from a right atrium through a septum and into a left atrium, and
- a deployment tool sized and configured to deploy the implant structure through the intravascular path into the left atrium and position the implant structure in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
7. A system according to claim 6
- wherein the implant structure is sized and configured so that, in use, the portion spans the left atrium.
8. A system according to claim 6
- wherein the implant structure is sized and configured so that, in use, the portion changes the shape of the native mitral heart valve annulus.
9. A system according to claim 6
- wherein the implant structure comprises, at least in part, nitinol, dacron, polytetrafluoroethylene, silicon, polyurethane, human pericardium, or animal pericardium.
10. A system according to claim 6
- wherein the implant structure comprises, at least in part, a super elastic material.
11. A method comprising
- deploying a guide wire through an vasculature path into a right atrium,
- introducing the guide wire through a septum from the right atrium into a left atrium,
- advancing a catheter over the guide wire, releasing from the catheter a heart implant sized and configured to be positioned in the left atrium above the plane of a native mitral heart valve annulus having leaflets, the implant including a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function, and
- positioning the implant in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
12. A method according to claim 11
- wherein the implant is positioned so that the portion spans the left atrium.
13. A method according to claim 11
- wherein the implant is positioned so that the portion changes the shape of the native mitral heart valve annulus.
14. A method according to claim 11
- wherein the heart implant comprises, at least in part, nitinol, dacron, polytetrafluoroethylene, silicon, polyurethane, human pericardium, or animal pericardium.
15. A method according to claim 11
- wherein the heart implant comprises, at least in part, a super elastic material.
16. A system comprising
- a guide wire sized and configured to be deployed through an vasculature path into a right atrium and through a septum from the right atrium into a left atrium,
- a catheter sized and configured to be introduced into the left atrium along the guide wire, and
- an implant structure carried within the catheter, the implant structure being sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets, the implant structure including a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
17. A system according to claim 16
- further including a grasping instrument sized and configure to be introduced through the catheter to position the implant structure within the left atrium.
18. A system according to claim 16
- further including a grasping instrument sized and configure to be introduced through the catheter to reposition the implant structure within the left atrium.
19. A system according to claim 16
- wherein the implant is positioned so that the portion spans the left atrium.
20. A system according to claim 16
- wherein the implant is positioned so that the portion changes the shape of the native mitral heart valve annulus.
21. A system according to claim 16
- wherein the heart implant comprises, at least in part, nitinol, dacron, polytetrafluoroethylene, silicon, polyurethane, human pericardium, or animal pericardium.
22. A system according to claim 16
- wherein the heart implant comprises, at least in part, a super elastic material.
23. A method comprising
- deploying a catheter through an vasculature path into a right atrium, through a septum and into a left atrium,
- releasing from the catheter a heart implant sized and configured to be positioned in the left atrium above the plane of a native mitral heart valve annulus having leaflets, the implant including a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function, and
- positioning the implant in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function.
24. A method according to claim 23
- further including deploying a grasping instrument through the catheter to reposition the implant structure within the left atrium.
Type: Application
Filed: Oct 25, 2007
Publication Date: Jun 12, 2008
Applicant:
Inventors: John A. Macoviak (La Jolla, CA), Robert T. Chang (Belmont, CA), Timothy R. MacHold (Moss Beach, CA), David A. Rahdert (San Francisco, CA), Rick A. Soss (Durlingame, CA)
Application Number: 11/977,493
International Classification: A61F 2/24 (20060101);