WO 2007/138572
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`PCT /IL2007 /000615
`
`embodiments, the proximal portion of the substantially tubular implant is attached
`
`below the inner rim of the cardiac valve annulus.
`
`According to the teachings of the present invention, there is also provided a
`
`substantially tubular cardiac valve augmenting implant configured for implantation in
`
`5
`
`a mammalian heart comprising: a) a substantially tubular wall defining a lumen,
`
`comprising a proximal portion with a proximal end, a distal portion with a distal end,
`
`an outer surface and a luminal surface; and b) associated with the distal end, a ring(cid:173)
`
`shaped component thicker in the radial direction than the wall wherein the tubular
`
`wall is fashioned of substantially impermeable materials. Although, the method of the
`
`10
`
`present invention is potentially implementable with many substantially tubular
`
`implant (for example, with a tube of tissue from an animal source), it is advantageous
`
`to implement the method of the present invention using a substantially tubular cardiac
`
`valve augmenting implant of the present invention.
`
`Generally, the proximal portion of the tubular wall of a substantially tubular
`
`15
`
`implant of the present invention is configured for attachment to a cardiac valve
`
`annulus (i.e., near the valve seat edge of the incision used to detach the cardiac valve)
`
`and functions as an extender that relocates the valve distally (i.e., lowers the valve
`
`into the ventricle).
`
`In embodiments, a ring-shaped component associated with the distal end of the
`
`20
`
`substantially tubular wall of a substantially tubular implant of the present invention
`
`functions as a prosthetic valve annulus, and in embodiments can be considered as an
`
`annuloplasty ring. In embodiments, the ring-shaped component is a prior-art
`
`annuloplasty ring associated with a substantially tubular wall.
`
`In embodiments, at least a portion of the ring-shaped component is secured to
`
`25
`
`the distal end of the substantially tubular wall by methods, including but not limited
`
`to, sewing, adhesion, gluing, suturing, riveting, stapling or welding.
`
`The cross section of the ring (substantially perpendicular to the lumen of the
`
`ring) is of any suitable shape, including but not limited to round, oval, ovoid, square,
`
`rectangular, L-shaped and T-shaped.
`
`30
`
`In embodiments, the thickness of the ring-shaped component in the radial
`
`direction is at least about 1 millimeter, at least about 2 millimeter and even at least
`
`about 3 millimeter. In embodiments, the thickness of the ring-shaped component in
`
`the radial direction is no more than about 6 millimeter.
`
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`In embodiments, the ring-shaped component has a height of at least about 0.4
`
`millimeter. In embodiments, the ring-shaped component has a height of no more than
`
`about 2.5 millimeter.
`
`In embodiments, the ring-shaped component associated with the distal end of
`
`5
`
`the substantially tubular wall is configured for attachment of the periphery of a
`
`cardiac valve, that is to say, the periphery of a substantially intact cardiac valve or
`
`components thereof are attachable to the ring-shaped component. In embodiments, the
`
`ring-shaped component is piercable, that is can be pierced without substantially
`
`degrading structural properties of the ring-shaped component, e.g. by sutures or
`
`10
`
`staples used to secure a valve to the ring-shaped component.
`
`In embodiments, the ring-shaped component protrudes into the lumen of the
`
`substantially tubular wall, in embodiments by at least about l millimeter, at least
`
`about 2 millimeter and even at least about 3 millimeter. In embodiments, the ring(cid:173)
`
`shaped component protrudes into the lumen of the substantially tubular wall by no
`
`15 more than about 5 millimeter. In such a way, in embodiments the ring-shaped
`
`component defines a ledge to which the periphery of a cardiac valve is attachable. In
`
`embodiments, the ring-shaped component is substantially flush with the outer surface
`
`of the substantially tubular wall.
`
`In embodiments, the ring-shaped component protrudes outwards from the
`
`20
`
`outer surface of the substantially tubular wall, in embodiments by at least about 1
`
`millimeter, at least about 2 millimeter and even at least about 3 millimeter. In
`
`embodiments, the ring-shaped component protrudes outwards from the outer surface
`
`of the substantially tubular wall, by no more than about 5 millimeter. In such a way,
`
`in embodiments the ring-shaped component defines a ledge to which the periphery of
`
`25
`
`a cardiac valve is attachable. In embodiments, the ring-shaped component is
`
`substantially flush with the luminal surface of the wall.
`
`In embodiments,
`
`the ring-shaped component 1s substantially flat.
`
`In
`
`embodiments, the ring-shaped component is not flat, e.g. curved.
`
`In embodiments, the ring-shaped component describes a circle or an oblate
`
`30
`
`circle. In embodiments, the ring-shaped component describes an ellipse or an oblate
`
`ellipse. In embodiments, the ring-shaped component describes an ovoid or an oblate
`
`ovoid.
`
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`
`PCT /IL2007 /000615
`
`In embodiments, the ring-shaped component 1s substantially rigid, that 1s
`
`substantially non-deformable both axially and radially.
`
`In embodiments, the ring-shaped component 1s substantially radially non(cid:173)
`
`expandable, that is, is not configured for increasing a circumference in the manner of
`
`5
`
`a stent or the like. In embodiments, the ring-shaped component is substantially
`
`radially non-collapsible, that is, is not configured for decreasing a circumference in
`
`the manner of a stent or the like.
`
`In embodiments, the ring-shaped component is substantially axially rigid.
`
`In embodiments, the ring-shaped component is substantially flexible, that is, is
`
`10
`
`deformable without changing circumference.
`
`In embodiments, the ring-shaped component is substantially uniform, having
`
`substantially uniform properties around the circumference.
`
`In embodiments, the ring-shaped component comprises at least two sectors, a
`
`first sector and a second sector more flexible than the first sector. In embodiments, the
`
`15
`
`first sector is substantially rigid. In embodiments, the first sector is substantially
`
`flexible and the second sector even more flexible.
`
`The ring:-shaped component is fashioned of any suitable material or materials,
`
`including monolithic, woven, braided, molded, stamped and laminated materials. In
`
`embodiments, the ring shaped component comprises, essentially consists of or even
`
`20
`
`consists of materials such as nitinol, stainless steel shape memory materials, metals,
`
`synthetic biostable polymer, a natural polymer, an inorganic material, titanium,
`
`pyrolytic carbon, a plastic, a titanium mesh and polydimethylsiloxane. Suitable
`
`biostable polymers
`
`include polymers
`
`such as polyolefins, polyethylenes,
`
`polytetrafluoroethylenes, polycarbonates, polyurethanes, fluorinated polyolefins,
`
`25
`
`chlorinated polyolefins, polyamides, acrylate polymers, acrylamide polymers, vinyl
`
`polymers, polyacetals, polyethers, aromatic polyesters, polyetherether ketones,
`
`polysulfones, silicone rubbers, thermoset materials, polyesters and/or combinations
`
`thereof.
`
`In embodiments, the thickness of the tubular wall is at least 0.05 millimeter at
`
`30
`
`least about 0.1 millimeter and even at least about 0.2 millimeter. In embodiments, the
`
`thickness of the tubular wall is no more than about 2 millimeter, no more than about 1
`
`millimeter and even no more than about 0.5 millimeter.
`
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`
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`
`5
`
`10
`
`In embodiments the cross-sectional area of the lumen at the proximal end of
`the substantially tubular wall is less than about 28.3 cm2 (equivalent to a circular
`lumen having a diameter of about 6 cm), less than about 19.6 cm2 (equivalent to a
`circular lumen having a diameter of about 5 cm) and even less than about 15.9 cm2
`(equivalent to a circular lumen having a diameter of about 4.5 cm).
`
`In embodiments the cross-sectional area of the lumen at the proximal end of
`the substantially tubular wall is greater than about 1.8 cm2 (equivalent to a circular
`lumen having a diameter of about 1.5 cm), greater than about 3.1 cm2
`( equivalent to a
`circular lumen having a diameter of about 2 cm), greater than about 4.9 cm2
`( equivalent to a circular lumen having a diameter of about 2.5 cm) and even greater
`than about 7 .1 cm2
`
`( equivalent to a circular lumen having a diameter of about 3 cm).
`
`In embodiments, the cross-sectional area of the lumen at the proximal end of
`
`the substantially tubular wall is substantially equal to the cross-sectional area of the
`
`lumen at the distal end of the substantially tubular implant.
`
`15
`
`In embodiments, the cross-sectional area of the lumen at the proximal end of
`
`the substantially tubular implant is greater than the cross-sectional area of the lumen
`
`at the distal end of the substantially tubular implant. In embodiments, the cross(cid:173)
`
`sectional area of the lumen at the distal end of the substantially tubular implant is less
`
`than about 90%, less than about 80%, less than about 70% and even less than about
`
`20
`
`60% of the cross-sectional area of the lumen at the proximal end of the substantially
`
`tubular implant.
`
`In embodiments exceptionally suitable, for example, for implantation in a
`
`25
`
`human heart, the cross-sectional area of the lumen at the proximal end of the
`substantially tubular implant is between about 15.9 cm2 (equivalent to a circular
`lumen having a diameter of about 4.5 cm) and about 7.1 cm2 (equivalent to a circular
`lumen having a diameter of about 3 cm) and the cross-sectional area of the lumen at
`the distal end of the substantially tubular implant is between about 5.3 cm2 (equivalent
`to a circular lumen having a diameter of about 2.6 cm) and about 8.6 cni2 ( equivalent
`
`to a circular lumen having a diameter of about 3.3 cm)
`
`30
`
`In embodiments, the luminal surface is substantially smooth, allowing a
`
`smooth flow of blood through the lumen.
`
`In embodiments, the proximal portion of the substantially tubular wall IS
`
`radially expandable. In embodiments, the proximal portion of the tubular wall IS
`
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`17
`
`PCT /IL2007 /000615
`
`radially elastic. In such a way, the proximal portion can be stretched to smoothly
`
`conform to the size of a native cardiac valve annulus
`
`In embodiments, the substantially tubular wall is axially bendable.
`
`In embodiments, the length (rest length, that is length in an unstressed state) of
`
`5
`
`the substantially tubular wall and the ring-shaped component together is greater than
`
`about 2 millimeter and even greater than about 3 millimeter. In embodiments, the
`
`length of the substantially tubular wall and the ring-shaped component is less than
`
`about 30 millimeter, less than about 25 millimeter and even less than about l 0
`
`millimeter.
`
`10
`
`In embodiments, the substantially tubular wall is axially extensible. In
`
`embodiments, the substantially tubular wall is reversibly axially extensible and
`
`compressible. In embodiments, the substantially tubular wall is elastically axially
`
`extensible and compressible. In embodiments, the axial extensibility is from about 2
`
`mm to about 12 mm. In embodiments, the axial extensibility is at least about 1.3
`
`15
`
`times, at least about 1.5 times and even at least about 2 times the length the of the
`
`tubular wall.
`
`In embodiments, the substantially tubular wall is substantially radially non(cid:173)
`
`expandable, that is, is not configured for increasing a circumference. In embodiments,
`
`the substantially tubular wall is substantially radially non-collapsible, that is, is not
`
`20
`
`configured for decreasing a circumference.
`
`In embodiments, the substantially tubular wall is substantially radially rigid,
`
`that is, substantially radially non-deformable.
`
`In embodiments, the substantially tubular wall is substantially radially
`
`flexible, that is, is deformable without changing circumference.
`
`25
`
`In embodiments, the substantially tubular wall consists essentially of one
`
`material.
`
`In embodiments, the distal portion of the substantially tubular wall consists
`
`essentially of a first material and the proximal portion of the substantially tubular wall
`
`consists essentially of a second material.
`
`30
`
`In embodiments, at
`
`least one
`
`impermeable material from which the
`
`substantially tubular wall is fashioned essentially consists of polyester (e.g., Dacron).
`
`In embodiments, at least one impermeable material from which the substantially
`
`tubular wall is fashioned essentially consists of woven polyester (e.g., Dacron).
`
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`WO 2007/138572
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`18
`
`PCT /IL2007 /000615
`
`In embodiments, at least one impermeable material comprises a tissue from an
`
`animal source. In embodiments, the tissue is selected from the group consisting of
`
`serous tissue, pericardium, pleura and peritoneum. In embodiments, the animal source
`
`is a source from the group consisting of bovine, porcine, equine and human.
`
`5
`
`In embodiments, the substantially tubular wall
`
`is radially pleated, m
`
`embodiments the radial pleating being such that the substantially tubular wall 1s
`
`axially bendable and substantially radially rigid, analogously to a concertina.
`
`In embodiments, the apparatus further comprises at least one reinforcement
`
`component
`
`functionally associated with
`
`the
`
`substantially
`
`tubular wall.
`
`In
`
`10
`
`embodiments, the at least one reinforcement component provides the substantially
`
`tubular wall, at least in part, with axial bendability. In embodiments, the at least one
`
`reinforcement component provides the substantially tubular wall, at least in part, with
`
`axial extensibility. In embodiments, the at least one reinforcement component
`
`provides the substantially tubular wall, at least in part, with radial rigidity.
`
`15
`
`In embodiments, at least one reinforcement component is encased within the
`
`substantially tubular wall. In embodiments, at least one reinforcement component is
`
`secured to the outside surface of the substantially tubular wall. In embodiments, at
`
`least one the reinforcement component is secured to the luminal surface of the
`
`substantially tubular wall.
`
`20
`
`In embodiments, at least one the reinforcement component comprises a helical
`
`coil coaxial with the substantially tubular wall, such as a parallel-walled or conical
`
`helical spring.
`
`In embodiments, at
`
`least one reinforcement component comprises a
`
`reinforcement ring coaxial and associated with the substantially tubular wall. In
`
`25
`
`embodiments, at
`
`least one reinforcement component comprises a series of
`
`reinforcement rings coaxial and associated with the substantially tubular wall.
`
`The present invention also provides for the manufacture of implants such as
`
`annuloplasty apparatus and cardiac valve augmenting implants such as described
`
`herein. Thus according to the teachings of the present invention there is also provided
`
`30
`
`for the use of a sheet of an implantable material for the manufacture of a cardiac valve
`
`augmenting implant, the implant including a wall comprising the material, the wall
`
`delimited by two edges each having a shape of a closed curve and defining a lumen.
`
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`19
`
`PCT /IL2007 /000615
`
`In embodiments, the wall is substantially annular. In embodiments, a first edge
`
`is a periphery of the wall and a second edge is a periphery of the hole of the wall.
`
`In embodiments, the wall is substantially tubular. In embodiments, a first edge
`
`is a periphery of a proximal end of the wall and a second edge is a periphery of a
`
`5
`
`distal end of the wall.
`
`In embodiments, the second edge is configured to be secured. to an excised
`
`cardiac valve and a first edge is configured to be secured to a mitral valve seat, e.g., in
`
`proximity of a mitral valve annulus.
`
`According to the teachings of the present invention there is also provided a
`
`lO method of producing a cardiac implant, comprising: a) providing a sheet of
`
`implantable material; and b) fashioning the material in the shape of a wall of the
`
`cardiac implant, the wall delimited by two edges each having a shape of a closed
`
`curve and defining a lumen.
`
`In embodiments, the wall is substantially annular._ In embodiments, a first edge
`
`15
`
`is a periphery of the wall and a second edge is a periphery of the hole of the wall.
`
`In embodiments, the wall is substantially tubular. In embodiments, a first edge
`
`is a periphery of a proximal end of the wall and a second edge is a periphery of a
`
`distal end of the wall.
`
`In embodiments, the second edge is configured to be secured to an excised
`
`20
`
`cardiac valve and a first edge is configured to be secured to a mitral valve seat.
`
`Unless otherwise defined, all technical and scientific terms used herein have
`
`the same meaning as commonly understood by one of ordinary skill in the art to
`
`which this invention belongs. Although methods and materials similar or equivalent to
`
`25
`
`those described herein can be used in the practice or testing of the present invention,
`
`suitable methods and materials are described below. In case of conflict, the patent
`
`specification, including definitions, will control. In addition, the materials, methods,
`
`and examples are illustrative only and not intended to be limiting.
`
`As used herein, the terms "comprising" and "including" or grammatical
`
`30
`
`variants thereof are to be taken as specifying the stated features, integers, steps or
`
`components but do not preclude the addition of one or more additional features,
`
`integers, steps, components or groups thereof This term encompasses the terms
`
`"consisting ot'' and "consisting essentially ot''.
`
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`20
`
`PCT /IL2007 /000615
`
`The phrase "consisting essentially of' or grammatical variants thereof when
`
`used herein are to be taken as specifying the stated features, integers, steps or
`
`components but do not preclude the addition of one or more additional features,
`
`integers, steps, components or groups thereof but only if the additional features,
`
`5
`
`integers, steps, components or groups thereof do not materially alter the basic and
`
`novel characteristics of the claimed composition, device or method.
`
`As used herein, the indefinite articles "a" and "an" mean "at least one" or "one
`
`or more".
`
`BRIEF DESCRIPTION OF THE ORA WINGS
`
`The invention is herein described, by way of example only, with reference to
`
`the accompanying drawings. With specific reference now to the drawings in detail, it
`
`is stressed that the particulars shown are by way of example and for purposes of
`
`illustrative discussion of the preferred em!Jodiments of the present invention only, and
`
`15
`
`are presented in the cause of providing what is believed to be the most useful and
`
`readily understood description of the principles and conceptual aspects of the
`
`invention. In this regard, no attempt is made to show structural details of the invention
`
`in more detail than is necessary for a fundamental understanding of the invention, the
`
`description taken with the drawings making apparent to those skilled in the art how
`
`20
`
`the several forms of the invention may be embodied in practice.
`
`In the drawings:
`
`FIG. I (prior art) is a schematic depiction of a healthy heart in cross section;
`
`FIGS. 2A and 2B (prior art) depict a mitral valve of a healthy heart;
`
`FIGS. 3A and 3B (prior art) depict a mitral valve of a heart suffering from
`
`25
`
`ischemic mitral regurgitation related to incomplete coaptation of the leaflets of the
`
`mitral valve;
`
`FIG. 4 shows an aerial view of an improperly functioning mitral valve with a
`
`detached anterior leaflet, according to an embodiment of the invention;
`
`FIGS. 5-6 show an annuloplasty apparatus being deployed in the mitral valve
`
`30
`
`shown in Figure 4, according to an embodiment of the invention;
`
`FIGS. 7, 8A and 8B show augmentation of the anterior mitral valve leaflet
`
`using the annuloplasty apparatus shown in Figures 5-6, according to an embodiment
`
`of the invention; and
`
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`PCT /IL2007 /000615
`
`FIGS 9, lOA and lOB show reconstruction of both the anterior and posterior
`
`mitral valve leaflets using the annuloplasty apparatus shown in Figures 5-6, according
`
`to an embodiment of the invention.
`
`FIG. 11 depicts an aerial view of an improperly functioning mitral valve,
`
`5
`
`severed from a valve annulus about the periphery of the valve so as to leave the valve
`
`leaflets associated through the commissures so that the valve is substantially intact,
`
`according to embodiments of the invention;
`
`FIGS. 12A-12F depict various stages of an embodiment of the method of the
`
`present invention where the tissue surrounding a mitral valve such as depicted in
`
`l 0
`
`Figure 11 is augmented with an implant that is substantially a ring such as depicted in
`
`Figure 5, the method leading to valve relocation downwards into the left atrium and
`
`increased leaflet coaptation;
`
`FIG. 13 depicts a substantially tubular cardiac valve augmenting implant,
`
`according to embodiments of the invention;
`
`15
`
`FIGS. 14A and 14B depict mitral valve leaflets being attached to the valve
`
`augmenting implant of Figure 12, according to embodiments of the invention.
`
`FIG. 15 depicts the valve augmenting implant of Figure 4 implanted in a heart,
`
`in cross section;
`
`FIG. 16 depicts the valve augmenting implant of Figure 4 implanted in a heart,
`
`20
`
`in cross section subsequent to continued remodeling;
`
`FIGS.17A-17E, 18A-18D, 19A-19Dand20A-20Cdepictembodimentsofthe
`
`substantially tubular valve augmenting implant of the present invention;
`
`FIG. 21 depicts an embodiment of a valve attached to a substantially tubular
`
`valve augmenting implant of the present invention;
`
`25
`
`FIGS. 22A, 22B and 22C depict embodiments of attachment of the proximal
`
`portion of a substantially valve augmenting implant of the present invention relative
`
`to a cardiac valve annulus; and
`
`FIGS. 23A, 23B and 23C depict embodiments of ring-shaped components of
`
`substantially tubular valve augmenting implants of the present invention, in top view,
`
`30
`
`cross section and perspective.
`
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`22
`
`PCT /IL2007 /000615
`
`DESCRIPTION OF EMBODIMENTS
`
`The present invention relates to methods and devices for treatments of cardiac
`
`valves by tissue augmentation that in embodiments are useful for improving cardiac
`
`leaflet coaptation, especially of the mitral valve. Generally, according to the teachings
`
`5
`
`of the present invention the subvalvular apparatus is preserved.
`
`The principles and uses of the teachings of the present invention may be better
`
`understood with reference to the accompanying description, Figures and examples. In
`
`the Figures, like reference numerals refer to like parts throughout.
`
`Before explaining at least one embodiment of the invention in detail, it is to be
`
`10
`
`understood that the invention is not limited in its application to the details set forth
`
`herein. The invention can be implemented with other embodiments and can be
`
`practiced or carried out in various ways.
`
`Embodiments of the present invention successfully address at least some of
`
`the shortc~mings of the prior art by providing a simple method of augmenting cardiac
`
`15
`
`valve leaflets. Thus, the teachings of the present invention allow a cardiac leaflet to be
`
`augmented and therefore embodiments are useful for treating a condition where
`
`cardiac valve augmentation is beneficial, such as mitral valve insufficiency, for
`
`example ischemic mitral regurgitation.
`
`Embodiments of the present invention successfully address at least some of
`
`20
`
`the shortcomings of the prior art by providing a simple method of augmenting the
`
`tissue around a cardiac valve. In embodiments, this leads to cardiac valve relocation
`
`that improves leaflet coaptation. Thus, the teachings of the present invention allow a
`
`cardiac valve to be augmented and therefore embodiments are useful for treating a
`
`condition where cardiac valve relocation is beneficial, such as mitral valve
`
`25
`
`insufficiency, for example ischemic mitral regurgitation.
`
`As noted above and depicted in Figures 3A and 3B, in a heart 50 suffering
`
`from ischemic mitral regurgitation mitral valve 26 and associated chordae 46 and 48
`
`are patent. The insufficient coaptation of leaflets 38 and 40 that leads to the
`
`regurgitation of blood is a result of deformation of mitral valve annulus 34 and
`
`30 misdirected pulling forces applied through chordae 46 and 48 to leaflets 38 and 40,
`
`both resulting from necrosis and consequent deformation of the wall of left ventricle
`
`28. In such cases, the regurgitation may be treated by improving leaflet coaptation.
`
`Embodiments of the present invention are useful in augmenting cardiac valve leaflets,
`
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`WO 2007/138572
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`23
`
`PCT /IL2007 /000615
`
`especially for
`
`treating a condition where such augmentation
`
`is beneficial.
`
`Embodiments of the present invention are useful in augmenting the tissue surrounding
`
`a cardiac valve, especially for treating a condition where such augmentation is
`
`beneficial. In order to simplify understanding the teachings of the present invention
`
`5
`
`embodiments of the present invention will be discussed in the context of treating a
`
`mitral valve suffering from ischemic mitral regurgitation where the teachings of the
`
`present invention are directed to increasing leaflet coaptation and thus treat the
`
`ischemic mitral regurgitation, such as mitral valve 50 depicted in Figures 3A and 3B.
`
`By treating a condition is meant curing the condition, treating the condition,
`
`10
`
`preventing the condition, treating symptoms of the condition, curing symptoms of the
`
`condition, ameliorating symptoms of the condition, treating effects of the condition,
`
`ameliorating effects of the condition, and preventing results of the condition.
`
`Leaflet Augmentation
`
`15
`
`A first aspect of the present invention relates to augmentation of a cardiac
`
`leaflet, for example a posterior mitral valve leaflet. A mitral valve leaflet is detached,
`
`an annuloplasty ring with an attached membrane implanted in the substantially usual
`
`way, and the leaflet reattached to the membrane, effectively augmenting the leaflet,
`
`that in embodiments improves
`
`leaflet coaptation. An embodiment of leaflet
`
`20
`
`augmentation in accordance with a method of the present invention is discussed with
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`reference to Figures 4, 5, 6, 7, 8A, 8B, 9, lOA and lOB.
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`Referring to Figure 4, an aerial view of a malfunctioning mitral valve 26 is
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`shown along with mitral valve annulus 34 and adjacent left atrium floor tissue 52.
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`Posterior leaflet 40 has been left intact while anterior leaflet 38 has been surgically
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`25
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`incised, separated from annulus 34 and is shown floating in lumen 36.
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`Figure 5 shows an annuloplasty apparatus 54 of the present invention
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`including a ring 56 and a membrane 58 substantially coplanar with ring 56. It is seen
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`that membrane 58 partially covers the lumen of ring 56 around the entire periphery of
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`the lumen of the ring 56.
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`30
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`Ring 56 may be rigid, fashioned from any one or more of various materials,
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`for example, titanium, stainless steel, pyrolytic carbon and various plastics, as noted
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`above. Alternatively, ring 56 may be flexible, fashioned from any one or more of
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`PCT /IL2007 /000615
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`various materials, including a titanium mesh, Dacron, silicon rubber, polyethylene,
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`and polytetrafluorethylene, as noted above
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`Membrane 58 covers ring 56 and is configured so as to allow sutures or the
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`like to pass through membrane 58 without substantial tearing of membrane 58,
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`5
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`allowing annuloplasty apparatus 54 to be secured in heart tissue such as annulus 34 or
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`in proximity thereof with sutures 60. In embodiments, annuloplasty apparatus 54 is
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`secured to heart tissue by passing sutures 60 through membrane 58 preferably
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`proximate to ring 56, for example through membrane 58 and looping around ring 56.
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`In Figure 5, membrane 58 covers ring 56 and sutures 60 have been passed
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`l O
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`through ring 56 and through mitral valve annulus 34.
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`Figure 6 shows annuloplasty apparatus 54 fully sutured to the vicinity of
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`mitral valve annulus 34 with inverted mattress knots in sutures 60. Membrane 58
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`extends inwards to partially obstruct lumen 36.
`Figures 7 shows anterior leaflet 38 exposed along with a portion of membrane
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`15
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`58a that has been trimmed to be suitable for attachment of anterior leaflet 38 thereto.
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`Figure 8A shows an annular edge 62 of an anterior leaflet 38 attached to a
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`trimmed portion 58a of membrane 58 with sutures 64.
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`Figure 8B shows a cross sectional long axis view of heart 50, with
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`annuloplasty apparatus 54 after anterior leaflet 38 has been augmented in accordance
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`20 with the teachings of the present invention. Ring 56 of annuloplasty apparatus 54 is
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`secured to the vicinity of mitral annulus 34 with sutures 60 to function substantially as
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`a prior art annuloplasty ring. Membrane 58 of annuloplasty apparatus 54 is trimmed to
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`two portions. Portion 58b above posterior leaflet 40 is trimmed to close with ring 56
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`so as not to interfere with blood flow through mitral valve 26 and proper functioning
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`25
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`of posterior leaflet 40. Anterior leaflet 38 is secured to portion 58a of membrane 58
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`with sutures 64 through annular edge 62 where anterior leaflet 38 was removed from
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`annulus 34. Portion 58a effectively augments anterior leaflet 38, increasing the
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`surface area and the length of anterior leaflet 38. Augmentation of anterior leaflet 38
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`restores and increases coaptation surface 42 between leaflets 38 and 40 ( compare with
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`30
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`Figure 3B). As depicted in Figure 8B, coaptation surface 42 has a length of
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`approximately l O to 12 millimeters
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`It is expected that in embodiments, due to the extent of augmentation of
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`coaptation 42 between augmented anterior leaflet 38 and posterior leaflet 40,
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`continued remodeling of heart 50 will not result m clinically significant loss or
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`reduction of coaptation
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`In certain pathologies, a posterior leaflet 40 is severely misaligned or, as seen
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`in rheumatic hearts or hearts suffering from mitral annular calcification, severely
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`5 misshapen. In other instances, a posterior leaflet 40 includes tissue defects, e.g.,
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`congenital defects, following debridement of endocarditis and following excision of
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`cardiac tumors. In such cases, an annuloplasty apparatus of the present invention such
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`as 54 is implanted in heart 50 substantially as described above but membrane 58 is
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`trimmed substantially differently so that the portion of membrane 58 close to posterior
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`10
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`leaflet 40 acts as a prosthetic posterior leaflet as depicted in Figures 9, lOA and 10B.
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`In Figure 9 is seen how annuloplasty apparatus 54 is secured to mitral annulus
`34 with inverted mattress sutures 60 and membrane 58 trimmed to two portions 58a
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`proximate to anterior leaflet 38 and 58b proximate to posterior leaflet 40.
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`In Figure 1 OA, is seen that anterior leaflet 38 is secured to portion 58a of
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`15 membrane 58 with sutures 64, substantially as described above.
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`In Figure 1 OB is seen how anterior leaflet 38 augmented with portion 58a of
`membrane 58 coapts with portion 58b of membrane 58 at coaptation surface 42 rather
`than with posterior leaflet 40.
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`As noted above, it is expected that in embodiments, due to the extent of
`augmentation of coaptation 42 between augmented anterior leaflet 38 and membrane
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`20
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`portion 58b, continued remodeling of heart 50 will not result in clinically significant
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`loss or reduction of coaptation
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`Augmentation of tissue surrounding a cardiac valve
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`25
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`As noted above, an additional aspect of the present invention relates to
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`augmentation of the tissue surrounding a cardiac valve. Generally, an implant
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`including a wall, the wall delimited by two edges each in the shape of a closed curve
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`and defining a lumen. (e.g., a tube or annulus) is provided as a cardiac valve
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`augmenting implant. The cardiac valve is detached from the valve annulus and
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`30
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`secured to one edge of the implant while the