Patent Description:
The present disclosure relates to implantable prosthetic devices. More specifically, the disclosure is directed to an improved prosthetic device implantable by catheter for the treatment of mitral or tricuspid regurgitation.

Mitral regurgitation is a valvular dysfunction that causes blood volume to flow during systole (during left ventricular contraction) from the left ventricle to the left atrium as opposed to a healthy heart where this direction of flow is blocked by the mitral valve. The reverse flow during systole causes pressure to rise in the left atrium. Maintaining a normal cardiac output results in an increased left ventricle pressure.

Treating patients with mitral regurgitation (MR) or tricuspid regurgitation (TR) could require valve replacement in order to reduce or eliminate the regurgitation. For many years, the commonly accepted treatment was surgical repair or replacement of the native valve during open heart surgery. In recent years, a trans-vascular technique has been developed for introducing and implanting a prosthetic heart valve using a flexible catheter in a manner that is less invasive than open heart surgery.

In the trans-vascular technique, the prosthetic is delivered to the target site (aortic valve, mitral valve, tricuspid valve, or other valve) through a catheter while the device is crimped to a low diameter shaft, and expanded/ deployed to the functional size when it is located in the correct position.

The catheter can be advanced to the target site: (a) Through the vascular system, where a catheter is advanced from the femoral vein/ artery or any other blood vessel that allows access to the target site; (b) Trans-apically, where a catheter is advanced through a small incision made in the chest wall and then through the apex; or (c) Trans-atrially, where a catheter is advanced through a small incision made in the chest wall and then through the left or right atrium.

<CIT> discloses an implantable valve replacement system.

<CIT> discloses an apparatus for helping improve operation of a heart valve.

<CIT> discloses a device for the use in the transcatheter treatment of mitral valve regurgitation.

<CIT> discloses methods, devices and systems for performing endovascular repair.

The invention is directed to an annuloplasty device as defined in independent claim <NUM>. Embodiments of the invention disclosed herein are directed towards an annuloplasty device for the treatment of mitral or triscupid regurgitation. The annuloplasty ring comprises a first end and a second end opposite the first end. The annuloplasty ring is configured to have an elongate insertion geometry and an annular operable geometry. The annuloplasty device further comprises a plurality of anchors within the annuloplasty ring. The plurality of anchors is configured to assume a deployment configuration when the annuloplasty ring is in the annular operable geometry. The annuloplasty device comprises at least one leaflet in mechanical communication with the annuloplasty ring at a plurality of points in the elongate insertion geometry. In some embodiments, the at least one synthetic leaflet may comprise a valve frame having a proximal opening and a synthetic leaflet material mechanically coupled to the valve frame. The synthetic leaflet material may be located within the proximal opening. In some embodiments, the valve frame may comprise a shape memory metal. In further embodiments, the synthetic leaflet material may comprise a polymeric material.

In some embodiments, the at least one synthetic leaflet of the annuloplasty ring may comprise a plurality of leaflets. In further embodiments, the plurality of leaflets may have a first leaflet positioned adjacent to the first end of the annuloplasty ring and a second leaflet positioned adjacent to the second end of the annuloplasty ring. In some embodiments, at least a portion of the first leaflet and the second leaflet are mechanically coupled.

In some embodiments, the at least one synthetic leaflet is in mechanical communication with the annuloplasty ring at a plurality of points on a posterior side or an anterior side of a native valve.

In additional embodiments, the annuloplasty device may further comprise a plurality of anchor windows, a coating, a DACRON (i.e., polyethylene terephthalate) coating, a shape memory metal, or a combination thereof. In some embodiments, the at least one synthetic leaflet may comprise one or more lace holes. In further embodiments, the annuloplasty ring may further comprise at least one snap mechanism configured to connect the first end and the second end.

Further embodiments disclosed herein are directed towards the annuloplasty device comprising an anchor device. The anchor device may comprise a leaflet anchor having an anchor body with a first end and a second end. The leaflet anchor may further comprise an anchor portion in mechanical communication with the first end of the leaflet anchor. In some embodiments, the leaflet anchor may further comprise a separating element in mechanical communication with the second end of the leaflet anchor, and a distal portion in mechanical communication with the anchor body between the first end and the second end. In some embodiments, the separating element may be configured to rotate the anchor body. In further embodiments, the anchor portion or the anchor body may comprise a shape memory metal.

Additional examples not forming part of the invention are directed towards a method of delivering the annuloplasty ring in an elongate insertion geometry, where the delivery of the annuloplasty ring utilizes one of a trans-apical approach, trans-septal approach, a trans-femoral approach, a trans-jugular approach, and a trans-atrial approach.

Aspects, features, benefits and advantages of the embodiments described herein will be apparent with regard to the following description, appended claims, and accompanying drawings where:.

The term "about," as used herein, refers to variations in a numerical quantity that can occur, for example, through measuring or handling procedures in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of compositions or reagents; and the like. Typically, the term "about" as used herein means greater or lesser than the value or range of values stated by <NUM>/<NUM> of the stated values, e.g., ±<NUM>%. The term "about" also refers to variations that would be recognized by one skilled in the art as being equivalent so long as such variations do not encompass known values practiced by the prior art. Each value or range of values preceded by the term "about" is also intended to encompass the embodiment of the stated absolute value or range of values.

The term "patient" and "subject" are interchangeable and may be taken to mean any living organism. As such, the terms "patient" and "subject" may include, but is not limited to, any non-human mammal, primate or human. In some embodiments, the "patient" or "subject" is a mammal, such as mice, rats, other rodents, rabbits, dogs, cats, swine, cattle, sheep, horses, primates, or humans. In some embodiments, the patient or subject is an adult, child or infant. In some embodiments, the patient or subject is a human.

When implanting a replacement valve (e.g., an aortic valve, mitral valve, tricuspid valve, or other valve), the replacement valve can include a prosthesis attachment. The prosthesis can be configured to secure the replacement valve in a patient's heart. Additional detail related to prosthetic valves for mitral or tricuspid valve replacement can be found in: <CIT>; <CIT>; and <CIT>.

An implant and delivery system for introduction of a semi-rigid ring for treatment of tricuspid or mitral valve regurgitation includes an annuloplasty ring comprising an outer hollow member with a plurality of segments. In a further embodiment, segments may be adjustable and may cooperate with one another in order to change the outer hollow member from an elongated insertion shaped geometry to an annular operable shaped geometry. The tricuspid annuloplasty ring may include one or more zones comprising internal anchor members located at least partially within the outer hollow member. In one non-limiting embodiment, the tricuspid annuloplasty ring may include up to four different anchor zones, which are further discussed herein. In an embodiment, the internal anchor members may be configured to emerge sequentially from windows (i.e., openings) along the hollow tube, thereby engaging the tissue of the tricuspid valve annulus under treatment, potentially in a predetermined sequence.

Systems and methods are provided for introducing an annuloplasty ring (e.g., while it is housed in a linear shape within the delivery system) in a trans-apical or trans-femoral approach. In an embodiment, the distal tip of the delivery system may be introduced above the annulus. Once the annuloplasty ring is introduced, the plane of the annuloplasty ring may be rotated (e.g., automatically) to be parallel to the plane of the annulus. Once in the proper location, an embodiment may deploy a plurality of anchors. For example, an embodiment may deploy anchors associated with the septal zone, the posterior zone, or the first or second anterior zones.

The annuloplasty ring may then be snapped into a proper shape (e.g., a "D" shape) and introduced to the stabilization tool. The shape is possible because, as discussed herein, the annuloplasty ring comprises an outer hollow member with a plurality of segments, where the segments may be adjustable and may cooperate with one another in order to change the outer hollow member from an annular operable shaped geometry to an elongated insertion shaped geometry and vice versa.

Referring to <FIG>, a top view of an annuloplasty ring <NUM>, as it relates to various embodiments discussed herein, is shown. As shown, the annuloplasty ring <NUM> may have an annular operable shaped geometry where a first end and a second end are in mechanical communication through snap mechanism <NUM>. In an embodiment, the annuloplasty ring has an operable geometry. For example, the hypotube may be annular and/or D-shaped. Additionally, <FIG> illustrates a plurality of anchors <NUM> deployed through a plurality of anchor windows <NUM> of the annuloplasty ring <NUM>. As shown in <FIG>, the annuloplasty ring <NUM> has at least one synthetic leaflet <NUM> in mechanical communication with the annuloplasty ring at a plurality of points on the inner surface of the annuloplasty ring <NUM>. In some embodiments, the synthetic leaflet <NUM> may comprise a valve frame <NUM> having a proximal opening. The at least one synthetic leaflet may further comprise a synthetic leaflet material mechanically coupled to the valve frame, where the synthetic leaflet material is within the proximal opening. As depicted in <FIG>, the at least one synthetic leaflet may comprise a plurality of leaflets, where the plurality of leaflets are mechanically coupled.

The annuloplasty ring may be made of various materials (e.g., a shape memory hypotube (nickel titanium (Ni-Ti) super elastic alloy)) cut to form a plurality of segments. Additionally, the cutting pattern used for laser processing (e.g. the cutting of anchor windows <NUM> through which anchors <NUM> may be deployed) of the annuloplasty ring <NUM> is illustrated in <FIG>.

In an embodiment, the valve frame <NUM> may be made of various materials including, but not limited to, a shape memory metal (e.g. Ni-Ti). The valve frame <NUM> may have a diameter in a range of about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches). The synthetic leaflet material <NUM> may be mechanically coupled to the valve frame <NUM> by suturing (e.g. surgical sutures <NUM>). This configuration may allow the at least one synthetic leaflet to move towards the surface of the annulus upon deployment of the annuloplasty ring. The suture material may be polytetrafluoroethylene (PTFE) or polypropylene sutures. Further embodiments may include a synthetic leaflet material made from a polymeric material (e.g. polyurethane or dried precordium tissue).

Referring to <FIG>, a top view of the annuloplasty ring <NUM>, as it relates to various embodiments discussed herein, is shown. As shown, the annuloplasty ring <NUM> has an elongate insertion geometry where the first end is opposite the second end. In some embodiments, the first end, the second end, or both may have a snap mechanism <NUM>. In some embodiments, the annuloplasty ring <NUM> may have a coating <NUM> (e.g. a DACRON coating) on the inner surface or the outer surface of the annuloplasty ring <NUM>. According to the invention, the annuloplasty ring <NUM> has at least one synthetic leaflet <NUM>. As depicted in <FIG>, the at least one synthetic leaflet may comprise a plurality of leaflets positioned at the first end or the second end of the annuloplasty ring.

Illustrated in <FIG> is a cross section view of an annuloplasty ring in an elongate insertion geometry within a delivery catheter <NUM>.

<FIG> illustrates a side view of a distal end of the delivery catheter <NUM> with the annuloplasty ring <NUM> and the at least one synthetic leaflet <NUM> partially deployed from the distal end of the delivery catheter. Further illustrated in <FIG> is a pull-wire <NUM> that can be in mechanical communication with the annuloplasty ring <NUM>.

<FIG> depict perspective views of the annuloplasty ring <NUM> where the plane of the annuloplasty ring <NUM> (in its annular operable geometry) has been changed to be perpendicular to the longitudinal axis of the delivery catheter <NUM>. As illustrated in <FIG>, the at least one synthetic leaflet <NUM> comprises a plurality of leaflets in mechanical communication. In some embodiments, the plurality of leaflets in mechanical communication are configured to be operably connected to the inner surface of the posterior side <NUM> of the annuloplasty ring <NUM>. In further embodiments, the plurality of leaflets in mechanical communication are configured to be operably connected to the inner surface of the anterior side <NUM> of the annuloplasty ring <NUM>. As illustrated in <FIG>, in some embodiments annuloplasty ring <NUM> may comprise ring element <NUM>.

<FIG> depicts a further embodiment wherein annuloplasty ring <NUM> comprises a plurality of leaflets having one or more lace holes <NUM>. The plurality of leaflets may be configured to be in mechanical communication using a suture lace <NUM> that operably connects the plurality of leaflets through the one or more lace holes <NUM>. In further embodiments, the suture lace <NUM> can be configured to pass through the snap mechanism <NUM> and into the delivery catheter <NUM>.

<FIG> depicts the deployed annuloplasty ring <NUM> and the deployed plurality of anchors <NUM> with at least one synthetic leaflet <NUM> tilted toward the annulus and a native posterior leaflet.

Referring to <FIG>, the annuloplasty ring <NUM>, as it relates to various embodiments discussed herein, is shown. As shown, the annuloplasty ring <NUM> in an annular operable geometry (<FIG>) or an elongate insertion geometry (<FIG>) may comprise a plurality of leaflets <NUM>. In some embodiments, the inner surface of the posterior side of the annuloplasty ring <NUM> may comprise a plurality of leaflets having lace holes that provides mechanical communication for the plurality of leaflets. The plurality of leaflets may be in mechanical communication with the inner surface of the posterior side of the annuloplasty ring <NUM> at a plurality of points.

In a further embodiment, as illustrated in <FIG>, the annuloplasty ring may comprise at least one synthetic leaflet on the inner surface of the posterior side of the annuloplasty ring <NUM>. The at least one synthetic leaflet may be in mechanical communication with the inner surface of the posterior side of the annuloplasty ring <NUM> at a plurality of points. Further, the snap mechanism <NUM> can be located on the anterior side of the annuloplasty ring <NUM>.

In a further embodiment, as illustrated in <FIG>, the inner surface of the posterior side of the annuloplasty ring <NUM> may comprise a plurality of leaflets having lace holes that provide mechanical communication for the plurality of leaflets. The plurality of leaflets may be in mechanical communication with the inner surface of the posterior side of the annuloplasty ring <NUM> at a plurality of points. Further, the inner surface of the anterior side of the annuloplasty ring <NUM> may comprise at least one synthetic leaflet <NUM> in mechanical communication with the inner surface of the annuloplasty ring <NUM>. In some embodiments, as depicted in <FIG>, the inner surface of the annuloplasty ring <NUM> may comprise a plurality of commissure leaflets 200a,b.

In some embodiments, as illustrated in <FIG>, a leaflet anchor <NUM> may be in mechanical communication with the at least one synthetic leaflet <NUM> of the annuloplasty ring <NUM>. In some embodiments, the leaflet anchor <NUM> may mechanically couple one or more native leaflets to the at least one synthetic leaflet <NUM>. This embodiment may allow the one or more synthetic leaflets <NUM> to co-apt, as illustrated in <FIG>.

As illustrated in <FIG>, the leaflet anchor <NUM> may have an anchor body <NUM> with a first end and a second end. The leaflet anchor <NUM> may further comprise an anchor portion <NUM> in mechanical communication with the first end of the leaflet anchor. In further embodiments, the leaflet anchor <NUM> may also include a separating element <NUM> in mechanical communication with the second end of leaflet anchor. Separating element <NUM> can be configured to separate the anchor delivery catheter <NUM> and the leaflet anchor <NUM>. The leaflet anchor <NUM> may also comprise a disk portion <NUM>, where the disk portion is in mechanical communication with the anchor body <NUM> between the first end and the second end. As illustrated in <FIG>, leaflet anchor <NUM> can be configured to deploy from delivery catheter <NUM>, from anchor delivery catheter <NUM>, or a combination thereof. In some embodiments, leaflet anchor <NUM> may be configured to pass through native leaflet <NUM> and the at least one synthetic leaflet <NUM>, wherein anchor portion <NUM> is deployed on a surface of the at least one synthetic leaflet <NUM>. In some embodiments, the disk portion <NUM> can be configured to fix the anchor portion <NUM> to the at least one synthetic leaflet <NUM> and the native leaflet <NUM>.

The annuloplasty ring as described above can be designed and shaped for various functions such as mitral valve replacement. A similar annuloplasty ring can be designed and constructed for tricuspid valve replacement as well. However, a tricuspid ring can be designed with additional features, such as a release zone positioned on the ring assembly at a location that will be adjacent to a patient's atrioventricular node or valves. In certain implementations, the release zone does not have any anchors. Rather, the alternate shape and profile of the release zone provides for interference between the annuloplasty ring and the patient's atrioventricular node or valves, thereby securing the ring assembly in position.

There is provided a method of delivering the annuloplasty ring as substantially described above, the method not forming part of the claimed invention. The annuloplasty ring may be delivered in an elongate insertion geometry, where the delivery of the annuloplasty ring utilizes one of a trans-apical approach, trans-septal approach, trans-femoral approach, trans-jugular approach, or a trans-atrial approach.

This disclosure is not limited to the particular apparatus, systems, devices and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope.

Claim 1:
An annuloplasty device for the treatment of mitral or tricuspid regurgitation, the annuloplasty device comprising:
an annuloplasty ring (<NUM>) comprising a first end and a second end opposite the first end in an elongate insertion geometry, the annuloplasty ring (<NUM>) configured to transition between the elongate insertion geometry and an annular operable geometry;
a plurality of anchors (<NUM>) disposed within the annuloplasty ring (<NUM>), the plurality of anchors (<NUM>) configured to assume a deployment configuration when the annuloplasty ring (<NUM>) is in the annular operable geometry; and
at least one synthetic leaflet (<NUM>) in mechanical communication with the annuloplasty ring at a plurality of points in the elongate insertion geometry.