Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Annuloplasty device
Reexamination Certificate
1999-06-08
2003-08-05
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Annuloplasty device
Reexamination Certificate
active
06602289
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to annuloplasty rings or devices for use in heart surgery, and more particularly to novel annuloplasty rings or devices and methods for their use in minimally invasive heart valve replacement or repair surgery. Most particularly, this invention relates to novel annuloplasty rings or devices for use in mitral valve replacement or repair surgery.
BACKGROUND OF THE INVENTION
Human heart valves, such as mitral and tricuspid valves, are sometimes damaged by disease or aging such that the valves no longer properly function. In such cases, heart valve replacement surgery is often indicated. Heart valve replacements and prostheses have been used for many years and many improvements in both the functionality and ease of implantation have been made thereon over time. As used herein, the term “heart valve replacement” is intended to include any mechanical valve, tissue valve, or other device that may be attached to any annulus of a heart be means of a sewing ring. In general, the heart valve comprises a valve body providing a blood flow passageway and oclude means mounted on the valve body for opening and closing the passageway. The valve body has an external, circumferential outer surface. Its dimensions are slightly smaller than the inner surface of the sewing ring implant. This facilitates the valve's body's mating with the inner surface of the sewing ring implant.
Examples of such heart valve replacement apparatus and methods for implanting such heart valve replacement apparatus have been disclosed in U.S. Pat. Nos. 5,071,431; 4,863,460; 4,743,253; 4,655,773; 4,364,126; 4,204,283; 3,898,999; 3,996,623; 3,859,668; 3,534,411; and 3,143,742. Each and every one of the references cited above is hereby incorporated by reference into this application in their entireties to better describe the state of the art.
In some cardiac valve operations, an annuloplasty ring or valvuloplasty ring is used in the repair of the damaged valve, in order to advantageously avoid, in many cases, heart valve replacement. Examples of such annuloplasty rings or valvuloplasty rings have been disclosed in U.S. Pat. Nos. 5,716,397; 5,607,471; 5,593,424; 5,376,112; 5,306,296; 5,163,954; 5,104,407; 5,064,431; 5,061,277; 4,917,698; 4,489,446; 4,290,151; 4,164,046; 4,042,979; and 3,656,185. Each and every one of the references cited above is hereby incorporated by reference into this application in their entireties to better describe the state of the art.
During conventional heart valve repair, annuloplasty rings, such as the CARPENTIER-EDWARDS CLASSIC® annuloplasty ring, have been used to provide support for the repaired native heart annulus and to remodel the annulus into its proper shape and configuration after valve repair. Like most others, the CARPENTIER-EDWARDS CLASSIC® annuloplasty rings are rigid structures designed to encircle the entire native valve annulus, thus forming a nearly complete circumference at the annular level. The shape of the ring is designed to simulate the shape and configuration of a normal valve. Thus, the abnormally shaped valve, which has undergone repair, can be transformed into a valve with a normal shape and configuration through the incorporation of the annuloplasty device.
Conventional annuloplasty rings are secured to the native annulus by sutures that are placed through the native heart annulus and through the conventional annuloplasty ring. This procedure remodels the valve annulus and prevents post-operative dilation of the annulus, which could lead to breakdown of the repair.
Conventional annuloplasty rings have a number of disadvantages. The most noteworthy technical disadvantage is that the annuloplasty ring must be sutured to the anterior part of the annulus, which is sometimes difficult to accomplish, as a significant portion of the anterior part of the annulus needs to be exposed for the suturing to be completed. This limitation of conventional annuloplasty rings is particularly apparent when minimally invasive surgical approaches are utilized, as exposure to the anterior part of the mitral valve annulus is generally restricted by this approach. Further, rigid, complete annuloplasty rings restrict the normal movement of the annulus of the heart at the point of implantation, limiting normal movement of the valve annulus throughout the cardiac cycle. An additional disadvantage associated with these conventional annuloplasty rings is that normal physiologic movement of the annulus is restricted.
Efforts to address some of the drawbacks associated with the previously discussed annuloplasty rings, have, in some cases, yielded rings which do not completely encircle the circumference of the annulus. One such ring which has been used for such procedures is the COSGROVE-EDWARDS® annuloplasty device. This annuloplasty ring incorporates a flexible piece of material for use only in the posterior part of the annulus for reinforcement. Although some of the drawbacks associated with the CARPENTIER-EDWARDS CLASSIC® style rings are obviated by COSGROVE-EDWARDS® annuloplasty device, these devices still have not proved to be an optimum solution for the cardiac surgeon.
As will be more fully addressed infra, the COSGROVE-EDWARDS® annuloplasty device is different from the instant invention because it: (1) is made entirely of a very flexible material, while the instant invention provides a semi-rigid annuloplasty device to support a repaired annulus in a fixed or semi-fixed position; (2) the present invention contains a support member constructed from a shape memory substance such as NITINOL®, so as to be able to return to its original dimensions after deformation; and (3) does not attach to the anterior mitral valve annulus to permit remodeling in the anterior-to-posterior dimension.
Another such annuloplasty device which has been used for such procedures is the CARPENTIER-EDWARDS PHYSIO® annuloplasty ring. This annuloplasty device is a complete ring which incorporates a flexible piece of material which is attached to the entire annulus of the valve. Although some of the drawbacks associated with the CARPENTIER-EDWARDS CLASSIC® style rings are obviated by CARPENTIER-EDWARDS PHYSIO® annuloplasty ring, this device has failed to offer a solution to all of the aforementioned problems associated with annuloplasty rings currently available.
As will be more fully illustrated infra, the CARPENTIER-EDWARDS PHYSIO® annuloplasty device is different from the instant invention because it: (1) is made entirely of a very flexible material, while the instant invention provides a semi-rigid annuloplasty device to support a repaired annulus in a fixed or semi-fixed position; (2) the present invention contains a support member constructed from a shape memory substance such as NITINOL®, so as to be able to return to its original dimensions after deformation; and (3) requires attachment to the complete mitral valve annulus which is unnecessary and sub-optimal for minimally invasive approaches for heart valve surgery.
The instant invention provides a semi-rigid ring designed to attach to the anterior annulus as a key fixation point, providing anterior-posterior remodeling by its design. The semi-rigidity of the instant device, its shape, and the anterior annular fixation points are all necessary for simultaneously achieving good annular remodeling, physiologic movement of the valve annulus, and ease of implantation. Thus, the instant invention provides an apparatus that achieves all of the benefits of the conventional, complete annuloplasty ring, without unnecessary restriction of the valve annulus, and without the need for placing sutures along the entire circumference of the anterior annulus. A device according to the instant invention also achieves better annular remodeling than the COSGROVE-EDWARDS® annuloplasty device by providing significant anterior-to-posterior fixation and narrowing.
SUMMARY OF THE INVENTION
The present invention is directed to annuloplasty rings or devices for use in heart surgery. More particularly, the present invention dis
Colvin Stephen
Galloway Aubrey
Grossi Eugene
Greenberg & Traurig, LLP
Jackson Suzette J.
S&A Rings, LLC
Sharinn Todd S.
Willse David H.
LandOfFree
Annuloplasty rings of particular use in surgery for the... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Annuloplasty rings of particular use in surgery for the..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Annuloplasty rings of particular use in surgery for the... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3079693