EP-4017423-B1 - ANNULOPLASTY SYSTEMS

EP4017423B1EP 4017423 B1EP4017423 B1EP 4017423B1EP-4017423-B1

Inventors

GREENAN, TREVOR, M.
HAGGARD, Matthew, A.
UONG, Do, D.
RODRIGUEZ, Leonardo, R.
BRECHTEL, Clara

Dates

Publication Date: 20260506
Application Date: 20200818

Claims (15)

An annuloplasty system comprising: an elongated first member (210) having a first tensile member attachment point and a second tensile member attachment point that is separate and spaced apart from the first tensile member attachment point; at least two first member anchors (212, 214) configured to anchor the first member (210) to a posterior side of a mitral valve annulus in at least two separate locations in a left atrium of a heart, the elongated first member with the first and the second tensile member attachment points (216) being configured to be delivered together into the left atrium and manipulated together before being attached to the posterior side of mitral annulus; a second member (310) that is separate from the first member (210) and is configured to not directly contact the first member (210); at least one second member anchor (314, 316) configured to anchor the second member (310) to an anterior side of the mitral valve annulus in the left atrium; a third member that is separate from the first member (210) and the second member (310) and is configured to not directly contact the first member or the second member; at least one third member anchor configured to anchor the third member to the anterior side of the mitral valve annulus in the left atrium; a first flexible tensile member (526) configured to span between the first member and the second member in a first straight line such that tension may be applied to the first tensile member to draw the first member and the second member toward one another and bring the posterior side and the anterior side of the mitral valve annulus into closer approximation, and a second flexible tensile member (530) configured to span directly between the first member and the third member in a second straight line such that tension may be applied to the second tensile member independently from the tension applied to the first tensile member to draw the first member and the third member toward one another and bring the posterior side and the anterior side of the mitral valve annulus into closer approximation, wherein all of the elements of the annuloplasty system are configured to be deployed into the left atrium through a catheter.
The annuloplasty system of claim 1, wherein the first member (210) is elongated and capable of taking on a curved shape.
The annuloplasty system of claim 2, wherein the first member (210) comprises a series of slits that allows the first member to flex.
The annuloplasty system of claim 1, wherein the first member (210) comprises at least two extended features, each configured to engage either the first tensile member (526) or the second tensile member (530).
The annuloplasty system of claim 1, further comprising an anchor guide mounted to the first member (210) and configured to guide the at least one first member anchor into heart tissue.
The annuloplasty system of claim 5, wherein the anchor guide is configured to guide the at least one first member anchor in a generally perpendicular manner relative to the first member in an anterior-posterior direction.
The annuloplasty system of claim 5, wherein the anchor guide comprises a lead that extends from adjacent the first member and through the catheter to a proximal end of the catheter.
The annuloplasty system of claim 5, wherein the anchor guide is foldable relative to the first member, thereby allowing the anchor guide to generally lie flat against the first member (210) when loading the first member (210) and anchor guide into the catheter.
The annuloplasty system of claim 1, wherein the first member comprises at least one hinge, thereby enabling the first member to be foldable along at least one discrete hinge axis.
The annuloplasty system of claim 1, wherein the first tensile member (526) and the second tensile member (530) are two separate tensile members.
The annuloplasty system of claim 1, wherein the system is configured to have the first tensile member (526) pre-attached to at least one of the first member (210) and the second member (310) prior to the first member (210) or the second member (310) being deployed from the catheter.
The annuloplasty system of claim 1, wherein the system is configured to achieve a dimensional reduction of a mitral valve annulus in an anterior-posterior direction that can be different on a lateral side verses a medial side.
The annuloplasty system of claim 1, wherein the at least two first member anchors are configured to be delivered through the same delivery catheter together with the elongated first member (210) into the left atrium before being attached to the posterior side of mitral annulus.
The annuloplasty system of claim 1, wherein the annuloplasty system is configured to be delivered solely from a left atrium side of the mitral valve.
The annuloplasty system of claim 1, wherein no part of the annuloplasty system extends into the left ventricle cavity.

Description

FIELD Embodiments of the disclosure relate generally to implanted medical devices. Specifically, the present invention relates to an annuloplasty system for repairing a mitral valve. BACKGROUND The mitral valve is located at the junction between the left atrium and the left ventricle of the heart. During diastole, the valve opens, in order to allow the flow of blood from the left atrium to the left ventricle. During systole, when the left ventricle pumps blood into the body via the aorta, the valve closes to prevent the backflow of blood into the left atrium. The mitral valve is composed of two leaflets (the posterior leaflet and the anterior leaflet), which are located at the mitral annulus, the annulus being a ring that forms the junction between the left atrium and the left ventricle. The mitral valve leaflets are tethered to papillary muscles of the left ventricle via chordae tendineae. The chordae tendineae prevent the mitral valve leaflets from averting into the left atrium during systole. Mitral valve regurgitation is a condition in which the mitral valve does not close completely, resulting in the backflow of blood from the left ventricle to the left atrium. In some cases, regurgitation is caused by dilation of the mitral annulus, and, in particular, by an increase in the anteroposterior diameter of the mitral annulus. Alternatively or additionally, mitral regurgitation is causes by dilation of the left ventricle that, for example, may result from an infarction. The dilation of the left ventricle results in the papillary muscles consistently tethering the mitral valve leaflets into an open configuration, via the chordae tendineae. Prior art methods and devices exist for treating mitral regurgitation. They involve either replacing or repairing the mitral valve. Replacing the valve is typically done either transapically or transseptally. Repairing the valve typically falls into one of four categories: leaflet clip; direct annuloplasty; indirect annuloplasty or chordae repair. Direct and indirect annuloplasty both involve reshaping the mitral annulus and or the left ventricle of a subject so that the anterior and posterior leaflet coapt properly. For some annuloplasty applications, a ring is implanted in the vicinity of (e.g., on or posterior to) the mitral annulus. The purpose of the ring is to reduce the circumference of the mitral annulus. US 20160338829A1 relates to surgical methods of securing tissue anchors for reducing the size of an orifice through a tissue and, more particularly, methods of securing tissue anchors for reducing the circumferential orifice of the mitral valve during an annuloplasty surgical procedure. US 20110166649A1 relates to percutaneous repair of a mitral valve of a patient. In light of the above prior art, it is desirable to provide improved systems and methods for treating mitral valve regurgitation. SUMMARY The invention is defined in the appended claims. According to aspects of the disclosure, systems and methods for performing an annuloplasty procedure are provided. In some embodiments, a method includes introducing a catheter into a left atrium of a heart, deploying a first member from the catheter, anchoring the first member to a posterior side of a mitral valve annulus in the left atrium, deploying a second member from the catheter, anchoring the second member to an anterior side of the mitral valve annulus in the left atrium, deploying a flexible tensile member from the catheter, attaching the tensile member to both the first member and the second member and applying tension to the tensile member to draw the first member and the second member toward one another and bring the posterior side and the anterior side of the mitral valve annulus into closer approximation. In some embodiments, a method of performing an annuloplasty procedure includes the steps of introducing a catheter into a left atrium of a heart and deploying a first member from the catheter. The first member is anchored to a posterior side of a mitral valve annulus in the left atrium. A second member is deployed from the catheter and anchored to an anterior side of the mitral valve annulus in the left atrium. A flexible tensile member is deployed from the catheter and attached to both the first member and the second member. Tension is applied to the tensile member to draw the first member and the second member toward one another and bring the posterior side and the anterior side of the mitral valve annulus into closer approximation. In some embodiments, the second member is deployed and anchored separately from the first member. The step of anchoring the first member may include attaching at least two separate anchors by screwing them into the annulus. The method may further include deploying a separate third member from the catheter, anchoring the third member to an anterior side of the mitral valve annulus in the left atrium, attaching a tensile member to both the first member and the third member, a