Adjustable annuloplasty ring

Abstract

One version of an annuloplasty ring has a dimensionally adjustable remodeled core within an outer suture permeable interface for attaching the ring to a valve ring. The inner core has a dimensionally adjustable section formed by short spaced apart tubular segments that can be moved toward and away from each other, for example, on a track. Alternatively, a short segment separated by a compressible connector may be used. One or more cords may be attached to one side of the dimensionally adjustable section and pulled from the other side to contract the section. A plurality of cords may be connected at different locations around the loop to provide certain control of the location where the loop contracts. An adjustment handle having a flexible shaft can be operated from outside the body to adjust the ring after implantation.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 365,758, filed on June 2, 2022, the contents of which are expressly incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to annuloplasty rings, and more particularly to an adjustable mitral annuloplasty ring and delivery system. Background Art

[0004] In vertebrates, the heart is a hollow muscular organ with four pumping chambers: left and right atria and left and right ventricles, each with its own one-way valve. The natural heart valves are identified as the aortic, mitral, tricuspid, and pulmonary valves, each with flexible leaflets that engage each other to prevent reverse flow.

[0005] A variety of surgical techniques may be used to repair a diseased or damaged valve. A common repair technique that is effective in treating insufficiency is annuloplasty, which often involves reshaping or remodeling the annulus by attaching a prosthetic annuloplasty repair segment or ring to the annulus. The procedure is performed while the patient's heart is stopped and cardiopulmonary bypass ("extracorporeal circulation") is used. For example, the goal of a posterior mitral annulus repair is to move the posterior mitral valve leaflet forward toward the anterior leaflet to improve leaflet coaptation. Annuloplasty rings may be rigid, flexible, or semirigid, and a "reshaped" annuloplasty ring typically has a "substantially rigid" or "semirigid" inner core because it will flex to a lesser extent, but resist deformation, when subjected to stresses exerted on the inner core by the mitral annulus of a functioning human heart.

[0006] Currently, during mitral valve repair surgery, the size of the annuloplasty ring is determined by comparing different sizer templates to the patient's anatomy until the surgeon determines which one looks correct based on, for example, anterior leaflet area or length, intercommissural distance, etc. However, unlike aortic valve replacement, where the goal is to implant the largest valve that will safely fit the patient's anatomy, mitral valve repair surgery implants a repair device that is slightly smaller than the annulus to reduce the circumference, or more importantly, the anteroposterior (AP) diameter of the valve and restore leaflet coaptation. The surgeon must make an "educated guess" as to how much downsizing is appropriate for any given patient and their particular disease state. If the wrong size repair product is selected, the result can be a poor outcome in the form of residual mitral regurgitation (MR), insufficient coaptation length, high pressure gradients, or systolic anterior motion (SAM). If any of these conditions are discovered once the patient is off cardiopulmonary bypass, the surgeon must make the difficult decision of continuing with the pump, with its associated morbidity and mortality, or leaving the patient with a suboptimal repair, with its associated sequelae.

[0007] In view of the above challenges, it would be desirable to have an annuloplasty device that could be adjusted once the patient is off cardiopulmonary bypass to fine-tune the AP diameter of the mitral valve, thereby correcting small errors in the inherently imprecise sizing process. Such a ring has the potential to reduce poor mitral valve repair and the need to return to cardiopulmonary bypass in many situations. Once adjusted, the delivery system attachments could be detached, leaving the patient with an annuloplasty device customized to their specific anatomy.

[0008] In an attempt to change the shape of the prosthetic device, adjustable annuloplasty devices are available from Edwards Lifesciences Corp. of Irvine, CA, such as the Mitral and Tricuspid Valve Reconstruction Systems Other adjustable annuloplasty rings can be found in US Pat. Nos. 8,142,495, 8,349,002, and 9,107,749.

[0009] Modern annuloplasty rings, such as the Edwards Physio Annuloplasty rings, have a very specific 3-dimensional shape, which has been shown to be important for maintaining and restoring anatomy and minimizing leaflet stress. Adjustable devices have not successfully combined orifice reduction with 3-dimensional remodeling. Some adjustable devices are too complex, while others have a ring core element that is completely rigid and does not appear to accommodate any shape changes except in the AP direction. In addition, it is difficult to achieve the optimal size of the mitral annulus while the heart is on extracorporeal circulation; this sometimes results in an annulus that is either oversized or undersized, which can lead to postoperative complications.

[0010] While a variety of designs are currently available or have been proposed in the past, there is a need for an annuloplasty ring whose shape can be adjusted to achieve repair of a malfunctioning valve while avoiding negative consequences. Summary of the invention

[0011] The present application discloses an adjustable annuloplasty ring system that is surgically implanted under extracorporeal circulation but can be slightly adjusted on a beating heart off extracorporeal circulation to optimize the annulus size and reduce complications due to rings that are too small or too large. An adjustable annuloplasty ring and methods for adjusting and locking the device are disclosed. The ring is surgically implanted like a normal annuloplasty ring, and then, if necessary, the patient is sutured, the heart restarted, and the size adjusted under visualization.

[0012] Disclosed herein is a mitral annuloplasty ring and a shape adjustment system for implantation at a mitral valve annulus surrounding anterior and posterior leaflets. The mitral valve annulus is D-shaped, with a straighter anterior side adjacent to the anterior leaflet opposite a more rounded posterior side adjacent to the posterior leaflet. Viewed from the atrial side, the posterior leaflet defines a P1 region, a P2 region, and a P3 region in CCW order.

[0013] A first exemplary system includes an annuloplasty ring defining a peripheral shape around a central orifice, the peripheral shape being D-shaped, wherein a straighter anterior side adapted for implantation adjacent to an anterior leaflet is opposed to a more rounded posterior side adapted for implantation adjacent to a posterior leaflet. The annuloplasty ring has an inner core and a suture permeable interface surrounding the inner core and extending around the peripheral shape. The inner core has a plurality of arcuate segments on a posterior side that are linearly or circumferentially compressible to achieve contraction of the ring when the size of the anterior side cannot be adjusted. The system further includes a proximal control handle having a flexible shaft extending therefrom, the distal end of the shaft being adapted to engage an access port in the ring. At least two tension filaments extend from the control handle through the flexible shaft and the access port, and extend around the inner core of the ring to independent anchor points, wherein an actuator on the control handle is configured to apply tension to the filaments and contract the inner core by bringing at least two of the arcuate segments closer together.

[0014] In a first system, the peripheral shape may be open and define two free ends, and the access port may be located at one of the free ends, or on the atrial side of the ring spaced from one of the free ends.The actuator is preferably a rotatable ring.

[0015] The anchor points may be positioned so that arcuate segments of at least the P2 and P3 regions adjacent to the posterior leaflet are independently adjustable. Alternatively, there are three tension filaments extending around the inner core of the ring to different anchor points, and there is one actuator on the control handle for each tension filament. In the case of three filaments, the anchor points may be positioned so that arcuate segments of the P1, P2, and P3 regions adjacent to the posterior leaflet are independently adjustable.

[0016] The arcuate segments may include short core members that slide relative to curved struts of an aperture therethrough, or the arcuate segments may include short core members separated by linear or circumferentially compressible segments and both made of silicone.

[0017] A second exemplary system includes an annuloplasty ring defining a peripheral shape around a central orifice, the peripheral shape being D-shaped, wherein a straighter anterior side adapted for implantation adjacent to an anterior leaflet is opposed to a more rounded posterior side adapted for implantation adjacent to a posterior leaflet. The annuloplasty ring has an inner core and a suture permeable interface surrounding the inner core and extending around the peripheral shape. The inner core has a size-adjustable section from only the P2 region to the P3 region adjacent to the posterior leaflet, the size-adjustable section being capable of linear or circumferential compression to achieve contraction of the ring when the size of the P1 region and the anterior side cannot be adjusted. The system further includes a proximal control handle having a flexible shaft extending therefrom, the distal end of the shaft being adapted to engage an access port in the ring. At least one tension filament extends from the control handle through the flexible shaft and the access port, and around the inner core of the ring to an anchor point. An actuator on the control handle is configured to apply tension to the filament and constrain the size-adjustable section of the inner core.

[0018] In a second system, the peripheral shape may be open and define two free ends, and the access port may be located at one of the free ends, or on the atrial side of the ring spaced from one of the free ends.The actuator is preferably a rotatable ring.

[0019] There are three tension filaments extending around the inner core of the ring to different anchor points, and for each tension filament there is one actuator on the control handle. The size adjustable section may include a short core member that slides relative to a curved strut passing through an orifice therein or a short core member separated by a linearly compressible section, both of which are made of silicone.

[0020] A further understanding of the nature and advantages will become apparent by reference to the remaining portions of the specification and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The features and advantages of the present disclosure will be appreciated as they become better understood with reference to the specification, claims, and accompanying drawings, in which:

[0022] Figure 1 Atrial plan view of the mitral valve and leaflets, with common nomenclature acronyms indicating common anatomical features;

[0023] Figure 2 is a schematic diagram of the three-dimensional shape of the mitral valve annulus, wherein several anatomical landmarks are indicated;

[0024] Figures 3A to 3E is an orthogonal view of an exemplary annuloplasty ring of the present application;

[0025] Figure 4A is an atrial plan view of an open or C-shaped annuloplasty ring having a sizable section in its posterior region, and Figure 4B is a plan view of the annuloplasty ring after being tightened to reduce the size of the adjustable segment;

[0026] Figure 5 yes Figure 4A Schematic diagram of an annuloplasty ring after implantation and connection to a sizing mechanism / delivery system extending through the left atrium and out of the body;

[0027] Figure 6 is an atrial plan view of an alternative open or C-shaped annuloplasty ring having a resizable section around most of its posterior region;

[0028] Figure 7 Yes Bonding Figure 6 Schematic diagram of an annuloplasty ring sizing mechanism / delivery system;

[0029] Fig. 8A is an atrial plan view of another open or C-shaped annuloplasty ring having a sizable section in its posterior region, and Figure 8B is a plan view of the annuloplasty ring after being tightened to reduce the size of the adjustable segment;

[0030] Fig. 9 yes Fig. 8A Schematic diagram of an annuloplasty ring after implantation and connection to a sizing mechanism / delivery system extending through the left atrium and out of the body;

[0031] Fig.10 is an atrial plan view of a closed or D-shaped annuloplasty ring with a sizable posterior segment, and Fig.11 is a schematic diagram of a sizing mechanism / delivery system engaging an annuloplasty ring;

[0032] Fig. 12A is an atrial plan view of another closed or D-shaped annuloplasty ring having a sizable posterior segment, and Fig. 12B is a plan view of an annuloplasty ring with the outer suture interface shown in phantom to illustrate its adjustable inner core;

[0033] Fig.13 yes Fig. 12A Schematic diagram of an annuloplasty ring after implantation and connection to a sizing mechanism / delivery system extending through the left atrium and out of the body; and

[0034] Fig.14 is a perspective view of another closed or D-shaped annuloplasty ring having a sizable posterior segment, and Fig.14A This is an enlarged view of its cross section. DETAILED DESCRIPTION

[0035] The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV (e.g., atrioventricular valves), respectively. Although correction of the mitral valve annulus is the primary focus of this application, it should be understood that certain features of the annuloplasty ring described herein are equally applicable to treating the tricuspid valve TV, and therefore the claims should not be limited to the mitral valve ring unless expressly limited.

[0036] The term "axis" with reference to the annuloplasty ring shown and other non-circular or non-flat rings refers to a line that passes generally through the center of mass of the perimeter of the ring when viewed in a plan view. The direction of the "axial" or "axis" can also be viewed as parallel to the average direction of blood flow within the valve orifice and therefore within the ring implanted in the valve orifice. In other words, the implanted mitral valve ring is oriented about a central flow axis that is aligned along the average direction of blood flow through the mitral valve annulus from the left atrium to the left ventricle. The plan views of the annuloplasty ring shown herein are viewed from the atrial side in the direction of blood flow. Thus, for orientation purposes, the atrial side of the ring is up and the ventricular site is down.

[0037] Figure 1is a schematic perspective view from the atrial side of the mitral valve MV, with the posterior portion facing downward and the anterior portion facing upward. The mitral valve MV primarily includes a pair of coapted leaflets, an anterior leaflet AL and a posterior leaflet PL, which are fixed to the fibrous mitral valve annulus MA around their outer edges. The encircling mitral valve annulus MA is often described as D-shaped, with a slightly straighter side adjacent to the anterior leaflet AL and a more rounded or convex side adjacent to the posterior leaflet PL. The mitral valve annulus MA is typically viewed as having: a major axis X, which intersects both the first posterior scallop P1 and the third posterior scallop P3 approximately at the commissures AC, PC; and a minor axis Y, which intersects the intermediate posterior scallop P2 and roughly bisects it. The central flow axis Z is arbitrarily defined at the intersection of the major axis X and the minor axis Y.

[0038] The leaflets are shaped so that the line of coaptation resembles a smile that is generally parallel to the posterior side of the mitral annulus MA. The anterior leaflet AL spans a smaller peripheral side around the mitral annulus MA than the posterior leaflet PL, but the anterior leaflet AL has a convex free edge that extends farther into the orifice defined by the mitral annulus MA. On the other hand, the posterior leaflet PL has a generally concave free edge. Two commissures - the anterior commissure AC and the posterior commissure PC - generally define the intersection of the line of coaptation between the two leaflets AL, PL and the mitral annulus MA. The posterior leaflet is divided into three sectors or cusps sometimes identified as P1, P2 and P3, which begin at the anterior commissure AC and continue in a counterclockwise direction to the posterior commissure PC. By convention, the major axis of the mitral valve annulus intersects both the first posterior scallop P1 and the third posterior scallop P3 approximately at the commissures AC, PC, and the minor axis intersects and approximately bisects the intermediate posterior scallop P2. The anterior leaflet also has scallops or zones labeled A1, A2, and A3, as shown in FIG. Figure 1 As indicated in .

[0039] As shown, the mitral valve annulus has a kidney-shaped or rounded D shape around its periphery. The anterior mitral valve leaflet AL is attached to the slightly straight anterior fibrous portion of the mitral valve annulus, which constitutes approximately one-third of the total circumference of the mitral valve annulus. The anterior fibrous annulus, with its two ends referred to as the left fibrous triangle LT and the right fibrous triangle RT, forms part of the central fibrous skeleton of the heart. The arcuate muscle portion of the mitral valve annulus constitutes the remainder of the mitral valve annulus, and the posterior leaflet PL is attached to the arcuate muscle portion. The anterior commissure AC and the posterior commissure PC are located just behind each fibrous triangle.

[0040] Figure 2 Schematic diagram of the three-dimensional shape of the mitral valve annulus, in which several anatomical landmarks are indicated. Specifically, the anterior leaflet AL is separated from the posterior leaflet PL by the left triangle LT and the right triangle RT. The three-dimensional shape is a bit like a saddle, in which the triangles LT and RT are located in the valley, and the leaflets AL and PL stand up.

[0041] like Figures 3A to 3C As seen in FIG. 1 , an exemplary annuloplasty ring 30 has a posterior portion 32 opposite an anterior portion 34 with side segments 36, 38 disposed therebetween. Some nomenclature has a portion that generally surrounds the posterior leaflet PL ( Figure 2 ) extending posterior portion 32 of the posterior leaflet PL extending between leaflet commissures AC and leaflet commissures PC, but generally bisected by minor axis Y and extending around at least the medial posterior scallop P2 of the posterior leaflet PL. Major axis X and minor axis Y are indicated, and when the annuloplasty ring 30 is implanted, the major axis and minor axis coincide with the same axis of the native mitral valve annulus so that blood will flow into the page generally parallel to the flow axis Z passing through the middle of the ring. The plan view shape of the annuloplasty ring 30 is a kidney shape or a rounded D shape so as to fit the peripheral shape of a typical mitral valve annulus.

[0042] The annuloplasty ring 30 may be three-dimensional having an upwardly arched portion in the posterior portion 32 and an upwardly arched portion in the anterior portion 34, as shown in FIG. Figure 3A and 3C Preferably, the distance C that the front portion 34 bends upward from the reference plane P is greater than the degree of upward curvature D of the front portion 34. The side segments 36, 38 can be located in the reference plane P so that the ring 30 is partially flat and has two opposing upwardly arched portions to form a saddle shape to a certain extent, so as to better fit the native mitral valve annulus, as shown in FIG. Figure 2 The shape of the ring 30 is similar to that of the Physio ® available from Edwards Lifesciences of Irvine, CA. The shape of the annuloplasty ring.

[0043] Figure 3D and 3E For Figure 3C . In the preferred example, the ring construction includes an adjustable inner core 40 as will be described and is surrounded by a suture permeable interface. In the illustrated example, the inner core 40 is shown as solid and rectangular, wherein its axial dimension is greater than its radial dimension, but other configurations are possible. As will be explained below, the material of the inner core 40 is a resilient plastic material, such as stainless steel or titanium alloy, or a resilient plastic metal, a resilient plastic polymer, such as nylon (polyamide), polyacetal (e.g., Thus, the annuloplasty ring 30 is a remodeling ring that, when adjusted in size, maintains its general shape to resist the forces associated with the normal circulation of the heart.

[0044] The suture permeable interface may include an elastic sleeve 42 that tightly surrounds the core, and a fabric cover (not shown), such as a polyethylene terephthalate (PET) fabric cover. In a preferred embodiment, the elastic sleeve 42, which may be silicone rubber, is generally tubular and molded with a radially outwardly extending flange 44 to facilitate suturing the ring 30 to the mitral valve annulus. The ring 30 may be secured to the inner fiber flange of the mitral valve annulus with sutures, staples or other such devices. In a typical operation, the surgeon anchors the suture array through the annulus and then threads it through corresponding locations around the interface on the outside of the ring 30. The ring is lowered along the suture array to the annulus before the sutures are knotted.

[0045] In degenerative mitral regurgitation, the main cause of regurgitation is dilation of the MV annulus. Typically, the dilation of the annulus is located in the P2 area to the P3 area. The annulus needs to be reshaped to the appropriate size to support the surgically reshaped annulus and reduce the time to implement the reinforcement ring / band.

[0046] Figure 4A is an atrial plan view of an open or C-shaped annuloplasty ring 50 with a core having a size-adjustable section 52 in the posterior region of the annulus, particularly the P2 to P3 region, and Figure 4B is a plan view of an annuloplasty ring after tightening to reduce the adjustable section (arrow). The adjustable-size section 52 includes a plurality of short posterior arcuate sections 53 that can be contracted toward each other. In this manner and by using a tightening wire 54 inserted through one free end 56a of the ring 50, the ring can be precisely sized to a desired shape. The tightening wire 54 can extend through the arcuate section 53 around the entire periphery of the interior of the ring 50 to a second free end 56b where it is anchored, for example, at a crimping sleeve or knot 59. The arcuate section 53 can slide over a curved strut 55 that is anchored to the core 51 on one side of the adjustable-size section 52. A second curved strut 57 over which the arcuate section 53 slides can be embedded in the core 51 on the other side of the adjustable-size section 52 for stability. By tightening at the P2 to P3 region of the annulus rather than in the P1 region, it is possible to correct the actual dilation area. Additionally, this tightening may eliminate the need to create a fold in the annulus. (Note: the need to apply a fold carries with it increased surgical risk, increased surgical skill required to create the fold, and increased time to apply the fold to the annulus.)

[0047] The tightening wire 54 may alternatively be connected to a curved strut 55 that passes through the arcuate section 53. The arcuate section 53 slides over the curved strut 55, which is anchored into the core 51 on the side of the size adjustable section 52 opposite the free end 56a. A second curved strut 57 over which the arcuate section 53 slides may be embedded in the core 51 on the other side of the size adjustable section 52 for stability.

[0048] The sizing of the ring 50 can be performed using conventional methods and then, during application, tightened to optimize the repair. The ability to tighten the annulus in the P2 to P3 region provides greater stability for the repair in this weakened location.

[0049] Figure 5 yes Figure 4A Schematic diagram of an annuloplasty ring 50 in FIG. 5 after implantation (anchored to the annulus by sutures or a retaining clip) and connected to a sizing mechanism / delivery system 60 that extends through the left atrium and out of the body. The delivery system 60 has an elongated flexible sheath 62 that engages a first free end 56a of the ring 50 and extends out of the body to a proximal handle 64. A rotary adjustment control dial 66 or other such actuator is connected to pull or create tension on the tightening wire 54 to reduce the size of the annuloplasty ring 50. The sheath 62 can be passed through an introducer 70 having an internal hemostatic valve therein. The introducer 70 then extends through a perforation in the left atrium wall, which can be tightened around the sheath 62 using a quilted purse-string suture 72 passed through a purse-string hemostat 74. The sizing adjustable section 52 can then be adjusted inwardly to pull one side of the posterior leaflet PL toward the anterior leaflet AL.

[0050] Placement of the annuloplasty ring 50 is typically performed on a stopped, relaxed heart, during which it is difficult to adequately assess the effectiveness of the ring / band in the effective orifice of the correctly sized MV, and it is also difficult to optimize the coaptation of the leaflets to reduce or eliminate MR. Therefore, final adjustment and optimization of the adjustable annuloplasty ring 50 can be accomplished on a beating heart using the delivery system 60, using echo guidance to optimize the adjustment of the ring. Sizing of the ring will follow conventional methods, as the adjustable ring can be optimized several millimeters in either direction. Once optimization is complete, the ring 50 can be locked, the tightening wire 54 and delivery system 60 removed, and finally the hemostatic introducer 70 removed, while the purse-string sutures 72 are tightened to minimize bleeding and allow final closure of the atrial wall incision.

[0051] Figure 6is an atrial plan view of an alternative open or C-shaped annuloplasty ring 80 having a size-adjustable section surrounding a majority of its posterior region. Annuloplasty ring 80 is somewhat similar to ring 50 described above, but also incorporates adjustability in the P1 region to correct prolapse in the P1 region after atrial closure. Due to the more fibrous nature of the annulus at the anterior region, adjustment is generally not required in the anterior region. Specifically, annuloplasty ring 80 has a fabric cover 82 surrounding an inner core 84, which is at least partially made of linear or circumferentially compressible elastic (e.g., silicone) sections 86. Core 84 has a hollow inner lumen through which a plurality (e.g., three) tension filaments 88 pass.

[0052] Tension filaments 88 emerge from the inner lumen at a port 90 located on the atrial side adjacent to one free end 92 of the ring 80. Each tension filament 88 extends a predetermined distance around the ring 80 where it is secured to the core 84. Preferably, each tension filament 88 extends through a cable sheath that terminates short of the filament's anchor point so that tension on the filament compresses discrete segments of the ring 80. For example, one of the tension filaments 88 may extend clockwise (CW) all the way around the ring 80 to an anchor point at the distal end of the P1 segment. The associated cable sheath terminates at the proximal end of the P1 segment and is secured to the core 84 so that tension on the filament independently compresses only the P1 segment. This can be accomplished independently with two additional filaments 88 for the P2 segment and the P3 segment to provide individual sizing for each of the three segments. In this way, greater size reductions may be achieved, as well as being able to adjust the band to correct coaptation issues and increase / decrease the size of the ring 80 in specific areas of the mitral annulus.

[0053] In addition to size adjustability in multiple discrete sections, the ring 80 has a flexible joint 94 at the posterior commissure marker to reduce stress on the suture / tissue in the portion of the ring extending from the posterior commissure marker toward the posterior triangle. This is a location where cracking can occur due to excessive stress. Positioning the port 90 at the location on the ring 80 for adjustment allows the device to pass through an existing surgical incision without the need to create an additional insertion site. After removal of the tensioning device, closure of the wound in this location can be completed with a continuous atrial closure suture. This location also has the advantage of not placing additional loads on the MV triangle during adjustment, which could harm the MV.

[0054] Figure 7 Yes Bonding Figure 6Schematic diagram of a sizing mechanism / delivery system 100 for annuloplasty ring 80. Delivery system 100 has an elongated flexible sheath 102 that engages port 90 of ring 80 and extends through the left atrium and out of the body through an access incision to a proximal handle 104. Multiple (e.g., three) rotational adjustment control dials 106 or other such actuators are connected to pull or create tension on tension filaments 88 to reduce the size of different sections of annuloplasty ring 80. Sheath 102 can be passed through an introducer 70 having an internal hemostatic valve, such as described above for Figure 5 As described, the introducer is then passed through the puncture in the left atrium wall, which can be tightened around the sheath 62 using a quilted purse-string suture 72 passed through a purse-string hemostat 74, also as described above.

[0055] Fig. 8A is an atrial plan view of yet another open or C-shaped annuloplasty ring 120 having a sizable section in only the P2 to P3 regions thereof, and Figure 8B is a plan view of the annuloplasty ring after being tightened to reduce the size of the adjustable section. Again, no adjustment is required in the anterior region, and no adjustment is required in the P1 region. Ring 120 can be constructed as described elsewhere herein, with a fabric cover (not shown) surrounding an inner core 122 made at least in part of a compressible section 124. Compressible section 124 can be elastic (e.g., silicone), for example Figure 6 86 in the figure, or may be telescoped or otherwise folded to enable linear or circumferential compression. For example, several short core members 126 may be kept aligned by one or more internal curved struts 128. The struts 128 may pass through holes in the core members 126 and provide sliding movement therebetween.

[0056] The core 122 and core member 126 have a hollow inner lumen through which a tension wire or filament 130 passes. The filament 130 enters through a port 132 on the atrial side near one free end 134a of the ring 120 and extends to an anchor point 136 located outside the midpoint of the ring 120; for example, anywhere from the midpoint of the P2 segment to the second free end 134b. The pulling tension on the filament 130 pulls the anchor point 136 in a counterclockwise (CCW) direction and causes the P2 segment to the P3 segment to be linearly or circumferentially compressed by the core member 126 sliding on the strut 128.

[0057] Figure 8BRing 120 is shown after the P2 segment to P3 segment has been compressed or folded linearly or circumferentially. After compression to the desired degree, a hemostatic clip 138 may be installed at port 132 to lock the tension filament 130 in place. Clip 138 may be made of a material such as cobalt-chromium so as to hold up well even at low temperatures of tissue during open heart surgery. For example, a clip such as disclosed in U.S. Pat. No. 9,498,202, the contents of which are expressly incorporated herein, may be used.

[0058] Fig. 9 yes Fig. 8A Schematic diagram of annuloplasty ring 120 in FIG. 1 after implantation and connection to a sizing mechanism / delivery system 140 extending out of the body. As described above, delivery system 140 has a proximal handle 142 from which a flexible shaft or sheath 144 extends distally into the body to reach access port 132. A sizing actuator 146, such as an adjustment control dial as shown, is built into handle 142 for adjusting the size of ring 120 from outside the body and while the heart is beating. The sizing adjustable section 124 can then be adjusted inwardly using the actuator adjustment control dial 146 to pull one side of the posterior leaflet PL toward the anterior leaflet AL.

[0059] Fig.10 is an atrial plan view of a closed or D-shaped annuloplasty ring 150 having a sizable posterior segment, and Fig.11 1 is a schematic diagram of a sizing mechanism / delivery system 152 for engaging annuloplasty rings. In the closed ring 150, an access port 154 is provided to which the distal end of a flexible shaft 156 of the delivery system 152 is removably attached. The access port 154 is located in the center of the P2 segment. The delivery system 152 has a proximal handle 158 with a plurality of adjustment dials 158 for different segments of the ring 150. For example, a plurality of cable sheaths (not shown) may extend from the handle 158 through the shaft 156 and into the port 154. Each cable sheath then extends around the interior of the ring core to a specific location from which a tension filament extends to a more distal anchor point. Pulling the tension filaments enables sizing of multiple segments in the ring 150. For example, each of the P1 and P3 zones may be adjusted individually. Adjustment of the P2 zone may also be made independently by moving the access port 154 to a position between the P1 and P2 zones, such as indicated by dashed line 160.

[0060] Fig. 12A is an atrial plan view of another closed or D-shaped annuloplasty ring 170 having a sizable posterior segment, and Fig. 12Bis a plan view of an annuloplasty ring with an outer suture interface 172 shown in phantom to illustrate its adjustable inner core 174. The outer cover or suture interface 172 may be a tube of flexible material such as silicone or polypropylene and a fabric exterior. Fig. 12B The inner core 174 includes a plurality of telescoping segments 176 that are connected in series to achieve linear or circumferential compression of the back side of the ring 170. The telescoping segments 176 can extend from the triangular position around the triangular position to the triangular position, as shown, approximately three-quarters of the way across the circumference of the ring. The front side is solid and non-adjustable.

[0061] Fig.13 yes Fig. 12A Schematic diagram of annuloplasty ring 170 in FIG. 1 after implantation and connected to a sizing mechanism / delivery system 180 extending out of the body. As previously described, actuators 182 on the proximal handle are connected to multiple invaginated segments 176 within the ring 170 via tension filaments (not shown) to achieve contraction of different segments of the ring after implantation and under visualization. The sheath of the delivery system 180 can engage the entry point 184 of the ring 170 at a central rear position or at various other positions as described herein.

[0062] Fig.14 is a perspective view of another closed or D-shaped annuloplasty ring 190 having a sizable posterior section, and Fig.14A is an enlarged view of a cross section thereof. Annuloplasty ring 190 includes a core wire 192 that is partially surrounded by a segmented ring body 194. There are two telescoping regions 196 of exposed wire. The regions 196 of exposed wire can be expanded to the desired ring size when contracted, and can then be locked by tightening screws 198 to tighten the wire in place. For example, a sliding or expanding sleeve 200 of an elastomeric body such as rubber can be used to apply a frictional holding force to the wire core 192 to avoid premature contraction. The ring body segments 194 can be pulled together on the wire 192 using tethers or filaments as explained elsewhere herein. That is, using an entry point at the center of the rear segment, two filaments can be extended along or through the wire core 192 and anchored to the rest of the core. Or one or more filaments can extend from a triangle around the interior of the ring to an anchor point that pulls one or more segments to contract the ring.

[0063] While the foregoing is a complete description of the preferred embodiments, various alternatives, modifications and equivalents may be used. In addition, it will be apparent that certain other modifications may be practiced within the scope of the appended claims.

Claims

1. A mitral annuloplasty ring and shape adjustment system for implantation at a mitral valve annulus surrounding anterior and posterior leaflets, the mitral valve annulus being D-shaped, wherein a straighter anterior side adjacent to the anterior leaflet is opposed to a rounder posterior side adjacent to the posterior leaflet, and the posterior leaflet defines a P1 area, a P2 area, and a P3 area in CCW order as viewed from the atrial side, the mitral annuloplasty ring and shape adjustment system comprising: An annuloplasty ring defining a peripheral shape around a central orifice, the peripheral shape being a D-shape with a straighter anterior side adapted for implantation adjacent the anterior leaflet opposed to a rounder posterior side adapted for implantation adjacent the posterior leaflet, the annuloplasty ring having an inner core and a suture-permeable interface surrounding the inner core and extending around the peripheral shape, the inner core having a plurality of arcuate segments on the posterior side that are linearly or circumferentially compressible to effectuate contraction of the ring when the size of the anterior side cannot be adjusted, the system comprising: a proximal control handle having a flexible shaft extending therefrom, the distal end of the shaft adapted to engage an access port in the ring; and at least two tension filaments extending from the control handle through the flexible shaft and the access port and around the inner core of the ring to separate anchor points, wherein an actuator on the control handle is configured to apply tension to the filaments and to contract the inner core by bringing at least two of the arcuate segments closer together.

2. The system of claim 1, wherein the peripheral shape is open and defines two free ends.

3. A system according to claim 1 or claim 2, wherein the access port is located at one of the free ends.

4. The system of claim 1 or claim 2, wherein the access port is located on the atrial side of the ring spaced apart from one of the free ends.

5. The system of any one of claims 1 to 4, wherein the actuator is a rotatable ring.

6. The system of any one of claims 1 to 5, wherein there are three tension filaments extending around the inner core of the ring to different anchor points, and there is one actuator on the control handle for each tension filament.

7. The system of any one of claims 1 to 6, wherein the anchor points are positioned such that arcuate segments of at least the P2 and P3 regions adjacent to the posterior leaflet are independently adjustable.

8. The system of any one of claims 1 to 5, wherein there are three tension filaments extending around the inner core of the ring to different anchor points, and there is one actuator on the control handle for each tension filament.

9. The system of claim 8, wherein the anchor points are positioned such that arcuate segments adjacent the P1, P2, and P3 regions of the posterior leaflet are independently adjustable.

10. The system of any one of claims 1 to 9, wherein the arcuate segment comprises a short core member that slides relative to a curved strut of an aperture therethrough.

11. The system of any one of claims 1 to 9, wherein the arcuate segments comprise short core members separated by linear or circumferentially compressible segments and each made of silicone.

12. A mitral annuloplasty ring and shape adjustment system for implantation at a mitral valve annulus surrounding anterior and posterior leaflets, the mitral valve annulus being D-shaped, wherein a straighter anterior side adjacent to the anterior leaflet is opposed to a rounder posterior side adjacent to the posterior leaflet, and the posterior leaflet defines, in CCW order, a P1 area, a P2 area, and a P3 area, as viewed from the atrial side, the mitral valve annuloplasty ring and shape adjustment system comprising: An annuloplasty ring defining a peripheral shape around a central orifice, the peripheral shape being a D-shape with a straighter anterior side adapted for implantation adjacent the anterior leaflet opposed to a rounder posterior side adapted for implantation adjacent the posterior leaflet, the annuloplasty ring having an inner core and a suture permeable interface surrounding the inner core and extending around the peripheral shape, the inner core having a size-adjustable section adjacent only the P2 region to the P3 region of the posterior leaflet, the size-adjustable section being linearly or circumferentially compressible to effectuate contraction of the ring when the size of the P1 region and the anterior side cannot be adjusted, the system comprising: a proximal control handle having a flexible shaft extending therefrom, the distal end of the shaft being adapted to engage an access port in the ring; and at least one tension filament extending from the control handle through the flexible shaft and the access port and around the inner core of the ring to an anchor point, wherein an actuator on the control handle is configured to apply tension to the filament and cause the resizable section of the inner core to contract.

13. The system of claim 12, wherein the peripheral shape is open and defines two free ends.

14. A system according to claim 12 or claim 13, wherein the access port is located at one of the free ends.

15. The system of claim 12 or claim 13, wherein the access port is located on the atrial side of the ring spaced from one of the free ends.

16. The system of any one of claims 12 to 15, wherein the actuator is a rotatable ring.

17. The system of any one of claims 12 to 16, wherein there are three tension filaments extending around the inner core of the ring to different anchor points, and there is one actuator on the control handle for each tension filament.

18. The system of any one of claims 12 to 17, wherein the size adjustable section comprises a short core member that slides relative to a curved strut extending through an aperture therethrough.

19. The system of any one of claims 12 to 17, wherein the size-adjustable section comprises short core members separated by linearly compressible segments.

20. The system of any one of claims 12 to 19, wherein the core member and linearly compressible section are both made of silicone.

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