Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve

Abstract

A device, kit and method may include or employ an implantable device (e.g., annuloplasty implant) and a tool operable to implant such. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). The tissue anchors may be guided into precise position by an intravascularly or percutaneously deployed anchor guide frame of the tool and embedded in an annulus of the orifice. Constriction of the orifice may be accomplished via a variety of structures, for example by cinching a flexible cable or via a anchored annuloplasty ring, the cable or ring attached to the tissue anchors. The annuloplasty ring may be delivered in an unanchored, generally elongated configuration, and implanted in an anchored generally arch, arcuate or annular configuration. Such may approximate the septal and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve, to move the posterior leaflet anteriorly and the anterior leaflet posteriorly, thereby improving leaflet coaptation to eliminate mitral regurgitation.

Description

RELATED APPLICATIONS[0001]This application claims benefit under 35 U.S.C. 119(e) to U.S. provisional patent application Ser. No. 61 / 278,232, filed Oct. 1, 2009.BACKGROUND[0002]1. Field[0003]This disclosure is generally related to percutaneous or minimally invasive surgery, and more particularly to percutaneously deployed medical devices suitable for constricting tissue or a bodily orifice, such as a mitral valve.[0004]2. Description of the Related Art[0005]Cardiac surgery was initially undertaken only by performing a sternotomy, a type of incision in the center of the chest, which separates the sternum (chest bone) to allow access to the heart. In the previous several decades, more and more cardiac operations are performed using a percutaneous technique, which is a medical procedure where access to inner organs or other tissue is gained via a catheter.[0006]Percutaneous surgeries benefit patients by reducing surgery risk, complications, and recovery time. However, the use of percuta...

AI Technical Summary

Benefits of technology

[0042]The implant kit may further include a plurality of fasteners, each fastener movable along a respective one of the guide lines to a position where at least some of the fasteners secure the implant member to the tissue under tension in the deployed configuration. Each of the fasteners may include a unidirectional clutch that in use allows the fastener to advance along a respective one of the guide lines toward a respective one of the embedded tissue anchors and prevents the fastener from retreating along the guide line away from the respective embedded tissue anchor. The plurality of fasteners and the implant member may be provided in a unitary structure. The at least some of the fasteners may each be fastenable to a respective one of the guide lines to secure the implant member to the tissue under tension in the deployed configuration. The at least some of the fasteners may each be fastenable to a respective one of the embedded tissue anchors to secure the implant member to the tissue under tension in the deployed configuration.

Problems solved by technology

However, the use of percutaneous technologies also raises some particular challenges.

Medical devices used in percutaneous surgery need to be deployed via narrow tubes called catheter sheaths, which significantly increase the complexity of the device structure.

As well, doctors do not have direct visual contact with the medical tools used once they are placed within the body, and positioning the tools correctly and operating the tools successfully can often be very challenging.

Improper function of any one of these structures, alone or in combination can lead to mitral regurgitation.

The mechanical valve carries the risk of thromboembolism and requires anticoagulation with all of its potential hazards, whereas the biological prosthesis suffers from limited durability.

Another hazard with replacement is the risk of endocarditis.

Such a procedure is expensive, requires considerable time, and is associated with high morbidity and mortality.

Due to the risks associated with this procedure, many of the sickest patients are denied the potential benefits of surgical correction of mitral regurgitation.

In addition, patients with moderate, symptomatic mitral regurgitation are denied early intervention and undergo surgical correction only after the development of cardiac dysfunction.

Furthermore, the effectiveness of such procedures is difficult to assess during the procedure and may not be known until a much later time.

Hence, the ability to make adjustments to or changes in the prosthesis function to obtain optimum effectiveness is extremely limited.

Both approaches suffer from several problems as a result of attempting to reshape the mitral annulus using an alternative method.

Devices that deform the coronary sinus, while suitable for percutaneous procedures, are not effective in controlling the leakage of the mitral valve as the forces are not applied from the correct opposite sides of the valve, which are the lateral annulus and the septal annulus.

The devices of the second type are not easily adapted to a percutaneous procedure.

Pulling applied along a different direction will distort the mitral valve but will not achieve the optimal approximation of the two leaflets.

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