Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Annuloplasty device
Reexamination Certificate
1998-07-29
2001-04-17
Snow, Bruce (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Annuloplasty device
Reexamination Certificate
active
06217610
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices, and more particularly to an annuloplasty ring useable for surgical correction of certain disorders of the atrioventricular (i.e., mitral and tricuspid) valves of the human heart.
BACKGROUND OF THE INVENTION
In many patients who suffer from disfunction of the mitral and/or tricuspid valves(s) of the heart, surgical repair of the valve (i.e., “valvuloplasty”) is a desirable alternative to valve replacement. One specific group of patients who are typically candidates for such surgery is children who suffer from congenital valvular anomaly (CVA) or rheumatic valvular disease (RVD).
Remodeling of the valve annulus (i.e., “annuloplasty”) is central to many reconstructive valvuloplasty procedures. In 1968, Dr. Alain Carpentier published studies which demonstrated that such remodeling of the valve annulus might be accomplished by implantation of a prosthetic ring (i.e. “annuloplasty ring”) to stabilize the annulus and to correct or prevent valvular insufficiency that may result from defect disfunction of the valve annulus. Annuloplasty rings are typically constructed of a resilient core covered with a fabric sewing ring. Annuloplasty procedures are performed not only to repair damaged or diseased annuli, but also in conjunction with other procedures, such as leaflet repair.
The prior art has included numerous annuloplasty rings, such as those described in U.S. Pat. Nos.: 4,042,979 (Angell), 4,290,151 (Massana); 4,489,446 (Reed); 4,602,911 (Ahmadi et al.); 5,061,277 (Carpentier et al.); and 5,201,880 (Wright et al.), as well as International Patent Publication WO 91/17721 and Foreign Patent Publication SU 197710.
One problem associated with the anmuloplasty rings of the prior art is that when such annuloplasty rings are implanted into children or adolescents (such as pediatric patients with CVA or RVD) the subsequent growth of the patient may render the annuloplasty ring too small for its intended function, thus abnormally constricting the annulus. The mitral annulus, for example, typically grows from about 16 mm across its longest dimension, to about 34 mm in adults. Follow-up surgery would be necessary to replace the originally implanted annuloplasty ring with a larger ring suitable for the then-current size of the patient. However, the tissue of the heart valve annulus grows into the fabric suture ring by design so that the ring is soon embedded in living tissue, making such replacement surgery problematic. Therefore, reconstructive valvuloplasty surgery on younger patients is often done using just sutures to bolster the annulus, or in conjunction with pieces of woven polyester or other biocompatible material. Such repairs may restore the normal geometry of the annulus, but are unlikely to maintain that geometry without additional structural support, and therefore are associated with less reliable and durable results.
Although some of the annuloplasty rings of the prior art have incorporated means for adjusting the size of the ring at the time of implantation, the inventors are aware of no prior art annuloplasty ring constructed and equipped for post-implantation size adjustment, in situ, to accommodate changes in annular size due to growth of the patient.
SUMMARY OF THE INVENTION
The present invention provides an expandable annuloplasty ring for implantation in a heart valve annulus, comprising a plurality of relatively rigid ring segments defining a periphery of the ring, the ring segments being coupled together to be relatively movable with respect to one another so that the ring may be expanded to accommodate growth of the annulus. Desirably, the ring is adapted to expand upon natural growth of the patient's annulus, or upon application of a dilatation force surgically applied.
The ring periphery may be discontinuous and the ring segments coupled end-to-end by flexible sheaths enabling relative translation movement therebetween. Alternatively, the periphery includes a discontinuity between two of the ring segments, and the ring segments are coupled end-to-end to pivot with respect to one another. There are desirably at least three ring segments and two end-to-end pivoting couples.
In another embodiment, cooperating structure is formed on the ring segments preventing contraction of the ring and allowing expansion thereof, and a fabric covering surrounds the ring segments to enable attachment to the annulus. Each ring segment desirably has two free ends, the ring segments being arranged end to end to define the ring periphery. The ring further preferably includes a plurality of separate coupling members joining adjacent free ends of the ring segments to allow ring expansion but prevent ring contraction in conjunction with the cooperating structure formed on the free ends of the ring segments. In one embodiment, the cooperating structure formed on the ring segments is configured to allow expansion from a first ring size to a second ring size upon application of a first expansion force, and from the second ring size to a third ring size upon application of a second expansion force different in magnitude than the first expansion force.
The present invention further preferably provides an adjustable annuloplasty ring for implantation in a heart valve annulus, comprising a plurality of sequential ring segments defining a periphery of the ring, cooperating structure formed on the ring segments preventing contraction of the ring and allowing expansion thereof, and a fabric covering surrounding the ring segments to enable attachment to the annulus. In one embodiment, the annuloplasty ring may be self-expanding and adapted to spontaneously expand from the forces exerted by growth of the annulus. The fabric covering surrounding the ring segments is preferably radially expandable.
Each ring segment preferably has two free ends, the ring segments being arranged end to end to define the ring periphery, and a plurality of separate coupling members joining adjacent free ends of the ring segments may be provided to allow ring expansion but prevent ring contraction in conjunction with the cooperating structure formed on the free ends of the ring segments. Desirably, at least one of the coupling members is straight and positioned generally between commissures of the ring.
In one embodiment, some of the ring segments have ends with inner channels, and some of the ring segments have ends with solid cross-sections for telescopically inserting in the inner channels of the ring segments. The ring segments having ends with solid cross-sections may include raised protrusions and the ring segments having ends with inner channels detents, wherein the cooperating structure is formed by an interference between the protrusions and the detents.
In another embodiment, a plurality of separate coupling members join the ring segments to allow ring expansion but prevent ring contraction in conjunction with the cooperating structure formed on the ring segments. The coupling members may include raised protrusions and the ring segments detents, wherein the cooperating structure is formed by an interference between the protrusions and the detents.
In a still further embodiment, the cooperating structure may include mating protrusions and detents, wherein expansion and contraction of the ring is regulated by an interference between the protrusions and the detents. A series of mating protrusions and detents may be provided, wherein the ring may be incrementally expanded and prevented from contracting therefrom at least two times.
In a preferred method of repairing a heart valve annulus, an adjustable annuloplasty ring is implanted in the annulus, the ring having a plurality of segments defining a periphery of the ring and being relatively displaceable in a peripheral direction to enable enlargement of the ring, but being restricted from displacement in a peripheral direction to prevent contraction of the ring. The size of the implanted annuloplasty ring may be adjusted by inserting a dilation apparatus into the valve in which the annu
Carpentier Alain
Carpentier Alexandre
Cunanan Crystal
Huynh Van Le
Lam Hung
Condino Debra D.
Cumberbatch Guy L.
Edwards Lifesciences Corporation
Snow Bruce
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