Systems and methods for applying pressure to bodily organ

Abstract

To provide structures and methods for tightening a belt, and for ensuring that the belt minimizes any risk of coronary compression (e.g. compression of vessels to limit or prevent flow).SOLUTION: Among other things, there are disclosed belts 20 or bands that can be used in treatments for tricuspid valve regurgitation. In some embodiments, such belts 20 may be heat-set in a particular configuration to effectively decrease tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tensioning sutures for applying tightening to belts 20 when deployed, and structure for effectively distributing force during such tightening. Tensioning members, protective members, and devices and methods for open-surgical placement (e.g. around a heart for annuloplasty) are also disclosed.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates generally to a device for insertion into a patient's body to apply compression to an organ as a method of treating the patient. In particular, embodiments of a belt for application at least partially around an organ are disclosed. [Background technology]

[0002] In the treatment of tricuspid regurgitation (TR), it has been proposed to place a belt or band around the heart, specifically in the atrioventricular (AV) groove of the heart. When properly positioned, this belt constricts the heart, narrowing the tricuspid annulus and alleviating the condition of TR. To narrow the tricuspid valve, the belt must overcome pressure from the heart, which varies from patient to patient and can be considered an unfortunate side effect that must be managed.

[0003] The use of sutures to tension the belt when needed has been proposed. However, several problems have been identified with this method. For example, tightening the belt can create excessive pressure on the AV groove and / or coronary artery vessels or other tissues, potentially restricting coronary flow and negatively affecting cardiac function. Furthermore, when tightening is performed using sutures attached to the belt, the sutures can be located anywhere within the belt and can move freely both axially and laterally. Therefore, there is a lack of control over the suture relative to the belt and the biological structure of the heart. Summary of the Invention [Problem to be solved by the invention]

[0004] Generally speaking, there is a need for structures and methods for tightening the belt and for ensuring that the belt minimizes the risk of coronary artery compression (e.g., compression of blood vessels that restricts or blocks flow). [Means for solving the problem]

[0005] Disclosed herein are, among other things, devices and methods for treating conditions including tricuspid regurgitation. Such devices include a band or belt for placement along the AV groove of the heart, which may comprise a heat-settable mesh tube having a first open end, a second open end, and a lumen extending therethrough along the longitudinal axis of the tube from the first open end to the second open end. The tube may be configured as a longitudinal loop for placement along the AV groove around the heart. A first suture portion is within the tube, secured to the tube adjacent the first open end, and extends through the lumen toward the second open end. The first suture portion is connected to the tube by a plurality of retaining elements within the lumen and is longitudinally movable relative to the tube through the retaining elements. In some embodiments, a second suture portion is within the tube, parallel to the first suture portion and spaced apart from the first suture portion. The second suture portion may be secured to the tube adjacent the first open end and extend through the lumen toward the second open end. The second suture portion may be connected to the tube by a plurality of retaining elements within the lumen and be longitudinally movable relative to the tube through the retaining elements. Pulling the first and / or second suture portions tightens the tube and reduces the loop area such that the tube contracts longitudinally at least at selected locations along the tube.

[0006] In certain embodiments, the first and second suture portions each extend through the second open end of the tube, with a portion of each of the first and second suture portions outside the tube so that they can be pulled to tighten the tube. Alternatively, the first and second suture portions can be part of a single tensioned suture having an intermediate portion between the first and second suture portions. A locking suture can be attached to the intermediate portion of the tensioned suture. A ring can be placed within the tube adjacent the second open end, and the tensioned suture can be folded over and threaded through the ring, with the first and second suture portions on one side of the ring and the intermediate portion on the other side of the ring. In one embodiment, the ring can include a rounded engagement portion around which the tensioned suture is folded and / or first and second straight sides parallel to the tube adjacent the second open end. The first and second linear sides can be connected to the tube by one or more respective retaining elements. The locking suture can include a plurality of protrusions for use in retaining tension applied to the locking suture and transferred to the first and second suture portions. In one example, the locking suture has a portion within the tube and a portion that exits the tube through the first open end, with the protrusions located along a portion of the length of the locking suture within the tube and adjacent the first open end, or otherwise not on the portion of the locking suture within the tube.

[0007] An example of the mesh of the tube is a heat-settable material such as Nitinol. In some embodiments, the mesh is heat-set so that the cross-section of the tube assumes a barbell shape, an oval shape, or a flat ribbon shape when the tube reaches body temperature. Furthermore, some embodiments involve the mesh being heat-set to a shape having a first region with a first hoop diameter and a first cross-sectional dimension and a second region with a second hoop diameter and a second cross-sectional dimension when the tube reaches body temperature. The first hoop diameter can be larger than the second hoop diameter, and the first cross-sectional dimension can be larger than the second cross-sectional dimension. The inner portion between the first and second regions can include a contour adapted to fit at least a portion of the atrioventricular groove. Another example involves the mesh being heat-set to a saddle shape with one or more lower rounded contour regions when the tube reaches body temperature. At least one of the lower rounded contour regions can be adapted to fit closely within the atrioventricular groove.

[0008] Disclosed are devices that minimize the risk of coronary artery compression when the belt is tensioned, and methods that achieve therapeutic effects of reducing tricuspid and / or mitral valve regurgitation while applying belt force over a wide enough arc of the AV groove to avoid excessive pressure on the coronary arteries. Belt embodiments as disclosed herein should not exert inward (i.e., toward the heart) pressure greater than coronary artery pressure during ventricular diastole, when coronary flow is expected to be highest. Belt embodiments are also shaped and / or configured to minimize any trauma to areas adjacent to the belt (e.g., by ensuring the belt has no sharp edges) and (if necessary) minimize the risk of the belt slipping on or around the heart when positioned and tightened. Some disclosed belt embodiments also allow for controlled positioning of sutures or other tensioning elements to optimally distribute the force or pressure exerted by or otherwise associated with the tensioning element. In certain embodiments, the ends of the belt are configured (e.g., tapered) to be easily retracted into the delivery catheter or other device if retraction or modification is necessary. The belt, in some embodiments, is stretchable or compressible to fit compactly over the delivery frame and within the delivery catheter or other device, and assumes a desired shape or configuration when placed around the heart to effectively distribute tension, pressure, or force. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a top view of a belt according to an embodiment invented herein. [Figure 1A] FIG. 1A is a perspective view of a mesh tube for the belt of FIG. [Figure 2] FIG. 2 is a cross-sectional view of the belt of FIG. 1 taken along line II-II and looking in the direction of the arrows. [Figure 3A] FIG. 3A is a perspective view of a cross section of the belt of FIG. 1 that has been heat set into a particular shape. [Figure 3B]FIG. 3B is a perspective view of a cross section of the belt of FIG. 1 that has been heat set into a particular shape. [Figure 4] FIG. 4 is a perspective view of a cross section of the belt of FIG. 1 that has been heat set into a particular shape. [Figure 5] FIG. 5 is a perspective view of a cross section of the belt of FIG. 1 that has been heat set into a particular shape. [Figure 6] FIG. 6 is a perspective view of a cross section of the belt of FIG. 1 that has been heat set into a particular shape. [Figure 7] FIG. 7 is a plan view of an embodiment of a belt having a single tensioning suture. [Figure 8] FIG. 8 is a plan view of an embodiment of a belt having two tensioning suture portions. [Figure 9] FIG. 9 is a plan view of an embodiment of a belt having two tensioning suture portions. [Figure 10] FIG. 10 is a plan view of an embodiment of a belt having two tensioning suture portions. [Figure 11] FIG. 11 is a plan view of an embodiment of a belt having two tensioning suture portions with intermediate loops. [Figure 12] FIG. 12 is a plan view of an embodiment of a belt having two tensioning suture portions with intermediate loops and additional structure. [Figure 13] FIG. 13 is a schematic diagram of one embodiment of a tensioning member. [Figure 14] FIG. 14 is a partial perspective view of one embodiment of a protective member. [Figure 15] FIG. 15 is a top view of one embodiment of a protective member. [Figure 16] FIG. 16 is a top view of one embodiment of a protective member. [Figure 17] FIG. 17 is a partial side view of one embodiment of a protective element having a tensioning element. [Figure 18] FIG. 18 is a top view of one embodiment of a protective element having a tensioning element. [Figure 19] FIG. 19 is a partial side view of one embodiment of a protective member. [Figure 20A] FIG. 20A is a schematic diagram of a method and apparatus for manufacturing a protective member. [Figure 20B] FIG. 20B is an end view of the protective member of FIG. 20A. [Figure 20C] FIG. 20C is an end view of the protective member of FIG. 20A. [Figure 21] FIG. 21 is a schematic diagram of one embodiment of a protective member. [Figure 22] FIG. 22 is a perspective view of the end of a protective element having an embodiment of a locking disc. [Figure 23] FIG. 23 is a partial cross-sectional view of the locking mechanism. [Figure 24] FIG. 24 is a perspective view of a stabilizing plate for holding and / or adjusting tensioning members and / or protective members under tension. [Figure 25] FIG. 25 is a perspective view of the stabilizing plate of FIG. 24 with additional structure, tensioning members and protective members. [Figure 26] 26 is a perspective view of the stabilizing plate of FIG. 25 together with a guide tool. [Figure 27] FIG. 27 is a schematic diagram illustrating an embodiment of a mechanism for tightening and / or adjusting the tension of the tensioning member and / or protective member. [Figure 28] FIG. 28 is a schematic diagram illustrating an embodiment of a mechanism for tightening and / or adjusting the tension of the tensioning member and / or protective member. DETAILED DESCRIPTION OF THE INVENTION

[0010] While the present invention may be embodied in many different forms, for the purposes of facilitating an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same, without any intention, however, to limit the scope of the invention. Any changes and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein, are contemplated as would normally occur to one skilled in the art to which the invention pertains.

[0011] Referring now to the drawings, there is shown one embodiment of a belt 20 for use in applying compression to a body organ. As will be described below, the belt 20 may be particularly adapted for application to the atrioventricular (AV) groove of the heart in the treatment of tricuspid regurgitation (TR). While the present invention may focus on such uses and placements, it will be understood that the structures and methods of the present invention may be used in many situations, treatments, implants, or purposes.

[0012] The belt 20 in the illustrated embodiment is a flexible mesh tube 22 of a biocompatible material having opposite open ends 24, 26 and a natural diameter (i.e., the diameter the tube has when unstressed and not after being heat-set) about a lumen 28 extending between the tapered or otherwise narrowed open ends 24, 26. As discussed further below, one or more sutures or other tensioning members are connected to the belt 20 to apply tension to the belt 20. Such tension can tighten the belt 20 within the AV groove for treatment of TR. The mesh of the tube 20 may be formed of strands, wires, or fibers 36 separated by gaps 38, or may be formed by cutting, etching, stamping, or otherwise removing portions of a thin sheet to form the gaps 38. The mesh allows the belt 20 to expand longitudinally under tension along its length or central axis A, thereby decreasing its diameter in the expanded areas, and to compress longitudinally under compression or tension relief along its length or central axis A, thereby increasing its diameter in the compressed areas.

[0013] It will be appreciated that the mesh of tube 22 can be made from many available natural or synthetic, strong, biocompatible materials. In certain embodiments, the mesh of belt 20 is made from nitinol, e.g., one or more individual nitinol wires (as strands 36) secured and / or wound around one another to form gaps 38. Belt 20 in the embodiment illustrated in FIG. 1 has an initial cylindrical shape having a length L and a diameter D measured across longitudinal axis A. During manufacture, or at least prior to use, belt 20 embodiments made from a heat-settable material (e.g., nitinol), can be heat-set into the shape it will assume when placed within the body. In that example, belt 20 has its initial (e.g., cylindrical) form at room temperature and assumes the heat-set shape when packed for delivery, inserted into the body, and brought to or near body temperature.

[0014] As an example of a desirable heat-set shape, in FIG. 3, the belt 20 is shown in a heat-set, flat ribbon shape. The flat ribbon shape can be a nitinol mesh that has been heat-set to have a desired width w (from side 40 to side 42) while having an initial length L when the belt 20 is deployed. The width w should be determined as follows to ensure that the pressure from the belt 20 does not exceed coronary artery pressure, e.g., approximately 30 mmHg, during ventricular diastole. The stress on the cross section of the belt 20 for a particular tensile force F is σ = F / (t−w), where t is the mesh thickness of the belt 20 and w is the width of the belt 20 as defined above. The hoop stress equation relates that stress to a desired pressure P as σ = Pr / t, where t is as defined above and r is the radius of the AV groove. Equalizing these expressions for cross-sectional stress yields F / t=Pr / t. Cancelling and rearranging yields w=F / Pr. Using an experimentally determined tension of 0.4 pounds (1.8 N), a vascular pressure of 0.58 psi (30 mmHg), and an AV groove radius of 2 inches (51 mm), the width w of the belt 20 is determined to be 0.35 inches (8.9 mm). It will be understood that a different value for the width w of the belt 20 can be determined by the above method for variations related to a particular patient, such as differences in AV groove radius or vascular pressure. Thus, a belt 20 having a width w appropriate for a particular patient will be custom-made. The width w is configured by heat-setting the belt 20, for example, one of the braided nitinol wires, so that the belt 20 assumes the width w when heat (i.e., body heat) is applied by the body.

[0015] Preferably, the belt 20 is heat-set to assume a flattened state, as in the previous example, to distribute the forces from the tensioning member throughout the belt. Flattening of the initial cylindrical cross-section can range from simply elliptical (FIG. 3A, relatively high width w) to creating a ribbon-like cross-section in which the opposing sides 40, 42 of the belt 20 are parallel and closely adjacent to one another (FIG. 3B, relatively low width w). In FIG. 3A, the belt 20 is shown having an oval or elliptical cross-section with ends 44, 46 intersecting and separated by a major axis, with an intermediate portion between the ends 44, 46, and a width w along or at least substantially parallel to the minor axis. In FIG. 3B, the ends 44, 46 are similarly intersecting and separated by a major axis, with a width w along or parallel to the minor axis. The ends 44, 46 provide locations for one or more sutures for fastening, as discussed further below.

[0016] In certain embodiments, the flattened belt 20 may be heat-set to have enlarged, rounded ends 50, 52 on either side of the longitudinal axis A. When viewed in cross section, the example belt 20 resembles a dog bone or barbell. By way of example, the intermediate portion 54 of the belt 20 between the ends 50, 52 is flat, with mesh at least approximately planar on each side 40, 42 between the ends 50, 52, with the sides 40, 42 adjacent to or touching each other. The ends 50, 52 are rounded or curved, e.g., having a circular or elliptical cylindrical cross-section. In some illustrated embodiments (e.g., FIG. 4 ), the ends 50, 52 have the same configuration. The enlarged ends 50, 52 provide additional surface area for engaging and gripping the underlying tissue within the AV groove. Because the ends 50, 52 are rounded, they reduce the possibility of sharp corners or other surfaces that could potentially cause trauma to adjacent cardiac tissue. Preferably, there is no atrial appendage or leaflet (atrial appendage) as such a surface may overlie the belt 20 within the AV groove.

[0017] In another embodiment, the belt 20 is heat-set to have a cross-section that defines a region 60 with a larger hoop diameter on one side and a region 62 with a tighter / smaller hoop diameter. Region 60 is designed for placement over the ventricular wall, which is thicker than the atrial tissue and experiences higher chamber pressures. The thicker cross-section of region 60 has the advantage of a more secure hold against the ventricular tissue, as the higher chamber pressures tolerate the thicker material. Region 62 is designed for placement over the atrial wall, which experiences a thinner AV groove and lower chamber pressures. The thinner region 62 may allow the intermediate portion 64 of the belt 20 to fit more closely into the AV groove. As seen in the example of FIG. 5, the intermediate portion 64 may include a contour 66 on the side 42 that fits at least a portion of the AV groove.

[0018] In another embodiment, belt 20 is heat-set into a ring shape that follows or approximates the natural curve of the heart's exterior, allowing belt 20 to have a natural position or fit around the heart. For example, an image of the heart can be taken to model the heart, and the image can be used to create a curve in belt 20, which can then be heat-set into belt 20. Such an embodiment facilitates placement because belt 20 assumes the shape of the heart when deployed. In that shape, belt 20 will better fit over the heart and conform to the contours of the heart before final tensioning of belt 20, similar to fitting an oval peg into a hole of corresponding size and shape.

[0019] In another embodiment, the belt 20 is heat-set into a three-lobed (ridged) or saddle-shaped configuration. FIG. 6 shows an example of a cross-sectional shape that would allow three sutures, for example, one along each lobe, to distribute the load laterally along the AV groove. This shape addresses the fact that the AV groove itself does not lie on a single plane. The shape of the belt 20, as shown in FIG. 6, allows the belt 20 to fit more naturally into the AV groove during deployment. Furthermore, when used with three tensioning sutures, the lobes space the sutures and distribute the compressive forces exerted by the sutures. In this example, the belt 20 has an upper flat region 70 and one or more lower contoured portions, such as two side lobes 72, and a middle lobe 74. The middle lobe 74 is preferably rounded, e.g., a partial cylinder or a rounded ridge, to fit closely within the AV groove. The side lobe portions 72 are rounded, e.g., at least a portion of which has essentially the same curvature as the mid-lobe portion 74, and the ends 76 are also rounded. Such end regions provide a more secure engagement without sharp corners, as described above with respect to the dog-bone shape. More generally, the path of the belt 20 can be heat-set into a non-planar, three-dimensional shape that better traces the path of the AV groove of the heart.

[0020] In any of these embodiments, the belt 20 can be heat-set to provide a greater width w of the belt 20 in areas of the belt that will be positioned over areas of the heart where arteries are more likely to pass underneath. The greater width allows for less pressure to be applied to the belt 20 when tensioned, which is preferably over the area of ​​the heart where arteries pass. The belt 20 can be narrower in areas that will be located over or near the tricuspid annulus of the heart. The narrower width allows for more pressure to be applied to the belt 20 when tensioned, thereby directing the greater pressure where it is needed to treat tricuspid regurgitation.

[0021] In any of the belt embodiments disclosed herein, tension is applied by one or more sutures passing through the belt. "Suture" refers not only to its general definition, but also to any biocompatible wire or filament having sufficient flexibility and tensile strength to pass through a belt for use in a procedure such as TR treatment and to pull the belt in tension when deployed as discussed herein. Furthermore, "suture" refers not only to a completely separate entity, but also to one or more portions of such entities. Pulling or otherwise placing the suture in tension applies a compressive force to the belt, which in turn applies a compressive force to the AV groove of the heart.

[0022] In embodiments in which only one tensioning suture is attached or otherwise connected to the belt 20 (e.g., FIG. 7 ), the suture 78 may float within the belt 20 through the lumen 28. One end of the tensioning suture 78 is, in certain embodiments, fixed to the belt 20 at or near one end 24 of the belt 20 (and a locking mechanism M is attached or otherwise connected to the belt 20). The suture 78 passes through the lumen 28, exits the end 26 of the belt 20, and passes through the locking mechanism M. The tensioning suture 78 within the belt 20 can move both axially and laterally relative to the belt 20. Pulling on the end of the tensioning suture 78 passing through the locking mechanism, with the other end fixed to the belt 20, moves a portion of the suture 78 within the belt 20. The end 24, along with the suture 78, is pulled along the axis A, reducing the length of the belt 20 and placing it under tension. The locking mechanism M acts to hold the suture 78, and therefore the belt 20, in tension around the heart.

[0023] In the embodiment shown in FIG. 8 , the belt 20 includes two parallel sutures or suture portions 80, 82 therein for providing tension. The use of two sutures 80, 82 has been found to provide a more consistent tension to the belt 20 and to be more effective in distributing pressure or force when tightening or cinch- ing the belt 20 around the heart than is possible with a single suture floating within the belt 20. For example, by applying force through two separate sutures, the risk of the belt 20 rotating or pivoting during tightening or cinching can be reduced or eliminated, for example, by rotating the belt about an end (e.g., 44, 46, 50, or 52) so that the flat belt 20 rises or stands on one edge. It has also been found that the use of two sutures 80, 82 with the belt 20 is more effective when the sutures 80, 82 are laterally confined, i.e., maintained apart from one another. It has been found that two floating sutures tend to stay together due to minimal potential energy or being pulled together during installation or tightening of belt 20. When the sutures stay together, they tend to behave like a single thick suture, which negates the force application and distribution and other benefits of having two sutures.

[0024] The sutures 80, 82 are attached to the belt 20 at opposite locations across the longitudinal axis of the belt 20; in the illustrated embodiment, the sutures 80, 82 are attached to the inside of the belt 20. In embodiments in which the belt 20 is heat-set into a particular shape, the sutures 80, 82 are positioned after heat-setting. A series of retaining elements 84 surround the sutures 80, 82 at various locations along the belt 20. In certain embodiments, the elements 84 are threads or filaments that are knotted around each suture 80, 82 and threaded through the mesh of the belt 20. For example, the retaining element 84 in the form of a filament 86 is threaded through the mesh one or more times, around the suture 80, and back through the mesh, and then secured by knotting, heat sealing, or other methods. In the illustrated embodiment, the filament 86 is threaded or looped around the suture 80 at least two times and secured to or adjacent the belt 20, for example, on the outer surface of the belt 20. It will be appreciated that securing the filament 86 to itself and to the belt 20 (e.g., by knotting) allows the filament 86 some slack or flexibility to allow the suture 80 to move longitudinally through the passageway 88 through the respective retention element 84 with minimal resistance. Similar to the tube 100 shown in FIG. 10 , in certain embodiments, a respective tube for each tensioning suture 80, 82 can be provided through a lumen of the belt 20. Each tensioning suture is threaded through the tube either initially or after the tube is placed within the belt 20. The filament 86 can be threaded through the mesh of the belt 20, for example, two or more times, around the tube, tightened snugly around the tube, and knotted or otherwise secured to form the securing element 84. The tube can then be slid from the retaining element 84 over each tensioning suture. The snug fit of the retaining element 84 around the tube makes it easier to tie or secure the retaining element and ensures that the retaining element has slack relative to the tensioning suture when the tube is removed. There is a similar or identical retaining or securing element 84 for the suture 82.

[0025] In other embodiments, the retaining element may be or include a ring, tube, or sheath attached to the belt 20. A filament, as described above, acts as the ring. In the example of a belt 20 made of meshed nitinol wire, the internal guide ring (92 in FIG. 9) may also be formed using the individual wires that form the mesh of the belt 20 (e.g., such a ring may be formed when the mesh for the belt 20 is formed). The ring 92 has an opening or passage 94 sized to allow the suture 80 or 82 to pass longitudinally through the ring with minimal resistance. The metal surface of the ring 92 may offer significantly less resistance to the longitudinal passage of the suture 80, 82 than the filament retaining element 84, especially when the metal (e.g., nitinol wire) is smoothed as shown for use in the belt 20 to limit or eliminate damage or irritation to adjacent tissue. In other embodiments, a tube or sheath 100 can be attached to the inside of the belt 20 (e.g., FIG. 10) in a location similar to the individual filament retaining elements 84 or ring retaining elements 92, with a passageway sized to allow the suture 80 or 82 to pass longitudinally through the ring with minimal resistance. Several individual tubes can be disposed within the belt 20, but separated from one another by gaps, particularly if such tubes are less longitudinally compressible than the belt 20, and if a single tube 100 is used as the retaining element, such tube is compressible so as not to restrict deformation of the belt 20 when it is placed under tension.

[0026] The securing or retaining elements 84, in the illustrated embodiment, are evenly spaced along the belt 20. Because the sutures 80, 82 are intended to remain tensioned or essentially straight within the retaining elements 84 along the belt 20, the retaining elements 84 may be spaced relatively far from one another, for example, up to 5 millimeters, up to 10 millimeters, up to 15 millimeters, up to 20 millimeters from one another in certain embodiments, or may be close enough together that, when the belt is installed, any slack that may exist in one or both of the sutures 80, 82 will prevent one of the sutures 80, 82 from touching the other. Furthermore, the locations of the retaining elements 84, in one embodiment, are staggered along the sutures 80, 82, i.e., such that a plane perpendicular to the longitudinal axis of the belt 20 passes through one retaining element 84 holding one suture 80 and between the retaining elements 84 holding the other suture 82, and in certain embodiments is midway between the retaining elements 84 holding the other suture 82 (e.g., FIG. 8 ). The staggering may allow belt 20 to be folded, compressed, or otherwise packed into a delivery device with retaining elements 84 offset from one another, providing a lower profile for the delivery device. In other embodiments, retaining elements 84 may be symmetrical in belt 20 or only slightly offset (e.g., by 1-3 millimeters, such that the plane passing through retaining element 80 with suture 80 passes immediately adjacent to retaining element 82 with suture 82). In such cases, tension from sutures 80, 82 is applied to belt 20 through retaining elements 84 at or near the same location on sides 40, 42 of belt 20.

[0027] In other embodiments, one or both of the sutures 80, 82 can be woven through the mesh of the belt 20 along two lines transverse to the longitudinal axis of the belt 20. In one example, the suture 80 is secured to one end 24 of the interior of the belt 20, passed out through the mesh of the belt 20, extended a length along the outside of the belt 20, and then passed back through the mesh to the interior of the belt 20 a length (which may be the same or different from the length extended along the outside of the belt 20). The weave continues through the length of the belt 20. The suture 82 can be similarly or identically woven through the other side of the belt 20. It has been found that such a weave creates relatively high friction between the sutures 80, 82 and the belt 20, and that when the sutures 80, 82 are tightened, the tension applied to the belt 20 may not be uniform, causing portions of the belt 20 to contract around the heart while other portions remain relatively loose. Thus, while weaving sutures 80, 82 through belt 20 may be effective under certain circumstances, other embodiments disclosed herein operate in a more effective manner.

[0028] FIG. 11 illustrates another embodiment of a belt 20 similar or identical to the belt 20 embodiment described above, including a mesh tube 22 having narrowed ends 24, 26. In this embodiment, a single suture S extends through the belt 20, with a first suture portion 80 extending along one side or end of the belt 20 and a second suture portion 82 extending along the opposite side or end of the belt 20. As with the other belt embodiments described herein, the suture S is secured to the tube 22 at end 24, e.g., as shown in FIG. 11, with the ends of suture portion 80 and suture portion 82 secured to the tube 22 or to a locking mechanism M adjacent to or connected to the tube 22. From their secured ends, each suture portion 80, 84 extends toward end 26 and is retained to the tube 22 by one or more retaining elements 84, as described above. In this embodiment, when suture portions 80, 82 approach or reach end 26, suture S returns through lumen 28 of belt 20 to form loop 85. Loop 85 in this embodiment extends from lumen 28 through end 24 (and through locking mechanism M, if present) to the exterior of tube 22 of belt 20. Loop 85 can be connected to tension line T, such as by a hook, grip, or other structure that can be part of a system for delivering belt 20. Following deployment of belt 20, as described below, tension line T can preferably be released from loop 85 and pulled out. This embodiment provides redundancy so that if one of suture portions 80, 82 fails, the other suture portion will maintain tension on belt 20.

[0029] In another embodiment, the belt 20 (FIG. 12) is configured similarly to the above-described embodiment and has a retaining element 184 similar or identical to the retaining element 84 described above. It will be understood that the belt 20 may be made, shaped, and / or configured similarly as described above with respect to a particular shape or set of embodiments. A first suture or suture portion 180 passes through the retaining element 184 along one side 140 of the belt 20, and a second suture or suture portion 182 passes through the retaining element 184 along another side 142 of the belt 20, e.g., the opposite side of the suture or suture portion 180 across the longitudinal axis A of the belt 20. A locking suture 210 is connected to the suture portions 180, 182 at or adjacent one end 226 of the belt 20, and the suture portions 180, 182 pass through a ring 212 at or adjacent that end 226 of the belt 180.

[0030] In the illustrated embodiment, suture portions 180, 182 are part of a single tensioning suture S. Suture portions 180, 182 are each secured (e.g., by a blanket stitch) to end 224 of belt 20 as described above for sutures 80, 82. Suture portion 180 passes through retaining element 184 on one side of belt 20 (e.g., the top as seen in FIG. 12 ), then central loop 214 of suture S passes through ring 212 at or near the other end 226 of belt 20, and the remainder of suture S passes through retaining element 184 on the opposite side of belt 20 (e.g., the bottom as seen in FIG. 12 ) and is secured at end 224 of belt 20. The loop 214 that passes through the ring 212 is secured to the end 222 of the locking suture 210, and the suture S is folded back over a portion of the ring 212 (i.e., makes a 180 degree turn around and through the ring 212) so that the suture portions 180, 182 are on one side of the ring 212 and the loop 214 is on the other. It will be appreciated that in other embodiments, the suture portions 180, 182 may be separate tensioning sutures that each pass through the ring 212 and are attached to the locking suture 210 as described above.

[0031] The locking suture 210 in the illustrated embodiment includes a series of knots, beads, or other protrusions 230, which in the illustrated embodiment are evenly spaced along the entire length of the suture 210 from the belt 220 to the locking mechanism M. In other embodiments, the protrusions 230 may be present on only a portion of the locking suture 210, for example, only a portion of the locking suture 210 from within the belt 220 to the locking mechanism M, at least one-third to one-half from the ring 212. It has been found that a tensioned or tightened belt (e.g., belt 20) may need to have a length between 60 and 80 percent of the belt's initial length L, and therefore, a length of the locking suture 210 (e.g., between 80 and 40 percent of the initial length of the suture 210 within the belt) must extend out of the belt and into or through the locking mechanism M. Therefore, it is advantageous to place the protrusions on at least 40-80 percent of the suture 210 adjacent to the mechanism M and entering the belt 20, and thus on the portion of the suture that has the potential to be pulled through the end of the belt and the locking mechanism.

[0032] The ring 212 in the illustrated embodiment comprises a rounded (e.g., circular) portion 250 around which the tensioning suture or suture portions 180, 182 are folded, and two straight sides 252, 254 that connect to each other and to the rounded portion 250. The ring 212 may be made of biocompatible wire or other sturdy material and is relatively inflexible to effectively transfer tension from the locking suture 210 to the suture portions 180, 182. The outer surface 256 of the ring 212 is rounded (e.g., made of wire with a round cross section) and smooth in certain embodiments to reduce friction between the ring 212 and the suture portions 180, 182 during use. The cross-sectional diameter of the wire used in embodiments of ring 212 has a substantial effect on the friction between ring 212 and suture portions 180, 182, and experimental testing has revealed that for a suture having a diameter of 0.35 millimeters and made of ultra-high molecular weight polyethylene (UHMWPE), the wire used to make ring 212 should have a diameter of 0.53 millimeters (0.021 inches) or greater.

[0033] The sides 252 and 254 are integral or monolithic with the rounded portion 250 and, in this embodiment, are straight and joined to one another at an apex 258. The straightness of the sides 252, 254 is intended to closely match the narrowing sides 240, 242 of the belt 20 at the end 226 of the belt 20, and in certain embodiments, the angle between the sides 252, 254 at the apex 258 is between 5 and 30 degrees. The sides 252, 254 may be initially separate and joined at the apex 258 by welding, adhesive, or other techniques, or may be formed and joined to one another and to the rounded portion 250. The ring 212 is retained to the sides 240, 242 of the belt 20 by a retaining element 260 similar or identical to the retaining element 84 embodiment described above.

[0034] The embodiment of the belt 20 having the ring 212 offers several advantages, such as low friction between the tensioning sutures 180, 182 and the belt 20, and the locking suture 210 having protrusions 230 that are less likely to snag on the belt 20. This design allows for tightening of the belt 20 to approximately 50 percent of its original length, which will provide sufficient reduction of the tricuspid annulus in TR treatment. Also, as discussed above with respect to FIG. 11 , failure of one suture portion 180 or 182 still allows the other suture portion to tension the belt 20.

[0035] The use of belt 20 will now be described, such as for placement and tightening within or along a patient's AV groove for treatment of TR or the like. It will be understood that other locations and situations are possible for use of the belt according to the present invention. The following will be described with particular reference to the embodiment of FIG. 12. However, it will be understood that the method described below is applicable to belt 20 according to the other embodiments described herein, the primary difference being the absence of ring 212 and / or locking suture 210.

[0036] Belt 20 is delivered to the AV groove by a delivery system (not shown), which may include an introducer such as that disclosed in PCT Application No. PCT / US2017 / 058245, filed October 25, 2017, which is incorporated by reference in its entirety. Belt 20 exits the delivery system, loops around the heart, and is positioned within the AV groove. Belt 20 and suture portions 180, 182 thus circumnavigate the heart.

[0037] Once the placement of the belt 20 is deemed satisfactory, the user tightens the belt 20 to reduce the tricuspid annulus of the heart. The user pulls the locking suture 210 using a suitable tool (not shown), causing the locking suture 210 to exit the end 224 of the belt 20 and travel through the locking mechanism M. As the locking suture 210 is pulled, the loop 214 is also pulled, and the tension in the locking suture 210 tensions the suture portions 180, 182 through the ring 212. In this manner, the suture portions 180, 182 are pulled through their respective retaining elements 184. As the suture portions 180, 182 are pulled, the radius of the suture portions 180, 182 around the heart decreases, urging the belt 20 inward against the heart, with the ends of the suture portions 180, 182 secured to the end 224 of the belt 20 compressing the belt 20 longitudinally. As the length of the belt 20 is compressed, the mesh of the belt 20 expands somewhat in width, thereby providing flexibility to limit or reduce pressure exerted on the coronary arteries or other structures.

[0038] The locking suture 210 is tensioned until the desired amount of tricuspid valve reduction is achieved. In certain embodiments, as described above, that amount is achieved by reducing the length of the belt 20 by up to 60 percent of the original length of the belt 20. Once cinching or tightening is complete, the locking mechanism M is activated to hold the locking suture 210 in tension. Removal of delivery and other tools and completion of the procedure can then occur.

[0039] The structures or other features described above, along with other structures or features described above with respect to any embodiment, may be included alone or in any combination in a device according to the present invention.

[0040] In keeping with the device features described above, similar or identical devices may be used in open surgical procedures for treating body organs or tissues, particularly (but not exclusively) cardiac surgery. Specifically, a surgically delivered annuloplasty device is disclosed for placement on the epicardial surface of the heart, e.g., around the AV groove, during an open-chest surgical approach. The device is positioned and secured around the heart after exposing the epicardial space, e.g., via a sternotomy or chest incision. The device can be tightened to constrain the annular dimensions of one or both of the tricuspid and mitral valves. Constraining these dimensions draws the leaflets closer together, allowing them to seal better and reducing regurgitation through either valve.

[0041] Described below are devices having similar or identical features to the sutures or other tensioning elements 78, 80, 82, 180, 182 and / or belt 20 therearound described above. It will be appreciated that devices such as those described above may be used in open surgical approaches. While the following embodiments are developed with a particular focus on such approaches, it will be appreciated that they (or their features) may be used with other approaches or with other embodiments described herein.

[0042] The device as described below (starting with the embodiment of device 300 illustrated in FIG. 13 ) includes a tensioning member 302 that wraps around the heart, preferably at the level of the AV groove. The tensioning member 302 is preferably a high-strength surgical suture material, such as braided suture made from high-molecular-weight polyethylene, but may also be made of bioabsorbable materials, such as wire, other surgical suture materials, braided ribbons of such materials, biocompatible or bioabsorbable fabric bands, or bands made with biological products, such as resorbable sutures or small intestine submucosal (SIS) tissue. The tensioning member 302 can be tightened or shortened to apply additional tension or pressure to the heart, or loosened or lengthened to relieve such tension or pressure. In this way, the annular dimensions of the heart and the amount of constraint on the valve(s) requiring treatment can be controlled.

[0043] In certain embodiments, the tensioning member 302 is used without a cover, belt (e.g., the belt embodiment described above), or other protective member. In open surgery, the surgeon can simply manipulate the tensioning member 302 to surround the heart (schematically indicated by H in FIG. 13 ), e.g., position it over or within the AV groove. For example, the surgeon can manually wrap or position the tensioning member 302 around the heart using existing tools (such as a grasping tool like a hemostat or a threading tool like a needle) and / or their hands. Holding the tensioning member 302 under tension around the heart can be achieved by tying a knot and / or by using a retaining piece or tool, as described below. When the tensioning member 302 is tightened around the heart, excess slack is gathered at the junction of the ends 304, 306 of the tensioning member 302. This excess slack can be threaded through a lock or buckle (discussed further below) to gather in the pericardial space around the heart. Alternatively, once the desired amount of force or constraint has been established around the heart, it may be cut away with a cutting tool.

[0044] In the embodiment of FIG. 13 , each end 304, 306 of tensioning member 302 is fixedly attached to a respective buckle 310, 312. Each buckle 310, 312 then slides along the opposite end of tensioning member 302. For example, buckle 310 slides along end 304, and buckle 312 slides along end 306. As buckles 310, 312 are moved apart (as shown by arrow A), tensioning member 302 is pulled tighter, contracting the area where the tensioning member contacts and applying a force or constraint to the heart. Conversely, as buckles 310, 312 are moved closer together (arrow B), tensioning member 302 relaxes, expanding the area within the tensioning member and reducing or eliminating the force on the heart. One or more tools may be provided to hold, guide, or apply force to one or both buckles as they are pulled apart or closer together to adjust tension while minimizing lateral forces on the heart.

[0045] The tensioning member 302 is preferably designed to apply a load across the outer surface of the heart. Accordingly, it may be significantly wider than its height, e.g., a ribbon- or band-like structure (as described above in connection with the examples of FIGS. 3-6). Such ribbons or bands may also have sufficient lateral stiffness to prevent or inhibit twisting during use and ensure that they contact the heart with their extended dimensions rather than narrow edges. By way of example, the tensioning member 302 may be woven with, molded into, or have lateral stiffening members 318 (shown as ribs in FIG. 14 ) to provide such lateral stiffness. The ribs 318 may extend along some or all of the top and / or bottom of the tensioning member 302. The stiffness of each individual rib 318 may be greater than or comparable to the stiffness of the tensioning member 302. The ribs 318 prevent or minimize the ability or chance of the tensioning member 302 to fold on its side or rotate entirely onto a narrow edge by increasing the torque required to do so.

[0046] In the specific embodiment shown in FIG. 15 , the tensioning member 302′ is an elastic fibrous structure that has a natural uncompressed diameter or inner dimension but can be stretched or expanded to a larger dimension for placement around the heart. In that embodiment, the tensioning member 302′ can be initially formed as a complete loop or can have its ends pre-connected to form a complete loop. The tensioning member 302′ is pre-selected based on the size of the patient's heart so that it elastically constrains the heart after placement. The tensioning member 302′ is expanded during placement around the heart as desired by the surgeon, and can be placed around the heart in its initial uncompressed dimension or in a state somewhat larger than its initial uncompressed dimension, thereby engaging and applying force to cardiac tissue. The elastic material for this embodiment can include a braided structure made of nitinol, which is heat-set in a shortened state but is highly stretchable when placed around the heart.

[0047] As previously mentioned, the tensioning member can be used by itself in open surgery. In some embodiments, the tensioning member (e.g., a suture or tensioning member 302, 302′ as discussed above) can be threaded through a belt 20 (as discussed above) or other protective member 320 (e.g., FIG. 16 ). The protective member 320 in the following context can be or include a belt 20 of the characteristics described and illustrated above. For example, the protective member 320 can be shortened or extended beyond the tensioning member 302, 302′ threaded therethrough to completely cover the entire length of the tensioning member 302 (with associated compression or expansion of the area encompassed by the tensioning member 302), even as it is adjusted to the heart size and / or degree of restraint desired by the surgeon. A mesh belt, as described above, which can be stretched or contracted in length (e.g., expands as it shortens) to better spread the contact force applied to the heart or organ, can be used as the protective member 320.

[0048] In certain embodiments, similar to the tensioning member 302 embodiments described above, the protective member 320 is made of a memory material that resists twisting and maintains its expanded dimensions (rather than narrow edges) to maintain contact with the heart. The protective member 320 is preferably readily visible under any of a number of imaging techniques, such as fluoroscopy, CT scan, ultrasound imaging, and / or magnetic resonance imaging. With particular regard to MRI, the protective member 320 can be made of a material that does not result in localized heating or the generation of electric field stimulation during scanning. To do so, the protective member 320 may be made of a non-conductive material and coated to prevent such effects.

[0049] Similar to the belt 20 described above, the protective member 320 can also have one or more tensioning members, as described above, extending therethrough. In certain embodiments, the protective member 320 has a guide member for guiding the tensioning member or members within the protective member 320. The guide member can also hold the tensioning members at opposite ends of the cross section of the protective member 320 (see FIGS. 8, 9, 11, and 12), allowing for better distribution of the applied force of the tensioning members 302, as described above. As the protective member 320 expands, the tensioning members 302 are spread further apart.

[0050] Such guide members may be the same as or similar to the structures shown in FIGS. 8, 9, 11, and 12 described above. For example, they may be suture loops (FIGS. 8, 11, and 12) or rings (FIG. 9) attached at multiple locations on the protective member. In other embodiments, the protective member 320 may have guide loops heat-welded or heat-set into the structure (e.g., in a braided structure, onto one or more of the braided filaments) to facilitate passage of the tensioning member. Such heat-set guide loops may be positioned similarly to the suture loops seen in the figures above. As a further alternative, the protective member 320 may have a guide coil 330 wound therein to allow passage of the tensioning member 302. The coil 330 may be wound around the filament or material of the protective member 320 to define a lumen 332 through which the tensioning member 302 passes.

[0051] Several possible treatments (mechanical, chemical, or composition application) are contemplated for the tensioning member and / or protective member. For example, the entire tensioning member (e.g., tensioning member 302) and / or protective member (e.g., belt 20 or other protective member 320) (or at least the surface that contacts the heart) can be treated to promote tissue ingrowth. The surface may be textured or have a Velcro®-like loop structure to encourage tissue growth onto or into the surface. As another example, the surface (e.g., the pericardial surface) can be treated to prevent pericardial adhesion by being smooth and / or made of or having a coating that resists tissue ingrowth. As a further example, one or both of the tensioning member and protective member can be treated or coated with an antibacterial agent to create infection resistance or with an anti-inflammatory agent to resist inflammation and the formation of pericardial adhesions.

[0052] The protective elements (including the belt 20) described above are single units, with separate ends tied together or joined together to form a continuous ring. In the embodiment shown in FIG. 18 , the protective element 420 is divided into two ring halves 422, 424, but is otherwise consistent with embodiments disclosed herein. That is, each half is constructed in a manner disclosed herein, e.g., each half is constructed of a mesh tube with a lumen and has a respective suture or tensioning member 426, 428. The two ring halves 422, 424 allow the physician to independently control the protection and restraint around the respective right and left sides of the heart. As seen in FIG. 18 , the tensioning members 426, 428 are engaged to the ring halves 422, 424 by forming respective loops within the ring halves 422, 424, allowing for independent tensioning and restraint around a portion of the heart.

[0053] The two ring halves 422, 424 may be joined at the location where the right heart (RH) meets the left heart (LH) (schematically indicated by H in FIG. 18 ). Anchors 430 to the heart may be placed at these joints or locations, preferably to secure each half 422, 424 to the heart independently of the other. The anchors 430 may be sutures or small cork-like anchors known for securing soft tissue that can be inserted into the wall of the heart. One or more sets of tensioning members 426 may be threaded through the half ring 422 around the right side of the heart, and another independent set of tensioning members 428 may be threaded through the half ring 424 around the left side of the heart. These two sets of tensioning members 426, 428 may be independently tightened to selectively control the force or constraint on either the mitral (left heart) or tricuspid (right heart) annulus.

[0054] In some embodiments, the protective element may be or include an inflatable balloon or bladder that is inflated to exert a restraining force on the cardiac tissue. In FIG. 19 , protective element 520 includes a series of individual balloons or bladders 522 connected together (by sutures or other flexible connecting elements) to form segments or sections of an annuloplasty device that allow for localized application of force or restraint to the heart. The tensioning element and / or protective element may, by way of example, extend through a single radially expanding balloon, as known in the art, allowing inflation of at least the side of the balloon facing the cardiac tissue. A left balloon or bladder and a right balloon or bladder may also be provided to allow independent control of either side of the cardiac tissue, as described above with respect to protective element 420.

[0055] As discussed above with respect to belt 20, the protective element in various embodiments can be shaped or configured differently (e.g., wider) in certain portions of the AV groove where the risk of coronary artery occlusion is higher. Similarly, the protective element in various embodiments can be heat-set into various shapes, such as a saddle shape, to fit into a saddle-shaped AV groove.

[0056] A specific example of a protective element 620 (FIGS. 20A-20C) may be or include a flattened, belt-like fabric 622 that is heat-set in place. Multiple passages 624 are formed in the fabric 622 to allow multiple (e.g., two or three) tensioning members to pass through the protective element 620 generally parallel to one another. The protective element 620 may be made from nitinol filaments or strips that are heat-set on parallel mandrels 626 to form multiple distinct passages. In the illustrated embodiment, the cross section of the protective element 620 has three lumens 624 for passing three independent tensioning members. FIG. 20B shows a basic weave with three channels or passages 624, while FIG. 20C shows two side passages 624 with additional loops. A central passage between the side passages for the additional loops can also be used.

[0057] The tensioning and / or protective members described herein may also include auxiliary arms to provide additional tension or restraint to the heart at locations other than those acted upon by the main portion of the tensioning and / or protective member. In the embodiment shown schematically in FIG. 21 , the tensioning and / or protective member 720 includes such auxiliary arms 722 joined to a main member 724. The auxiliary arms 722 can pivot or otherwise adjust relative to the main member 724. While the main member 724 is wrapped around the AV groove or another desired location on the heart, the auxiliary arms 722 can be wrapped around another location, such as lower on the ventricle. In this embodiment, the arms 722 join with the main member 724 near the junction of the right and left hearts when the protective member 720 is deployed. In such an embodiment, the arms 722 may be threaded lower on the ventricular wall, thereby constraining the heart at the papillary muscle anchor points and further improving the ability of one or both of the mitral and tricuspid valve cusps to close properly.

[0058] Tensioning and / or protection elements as disclosed herein are intended to provide ease of initial placement and adjustment when they are placed. The free ends of the tensioning and / or protection elements disclosed herein can be pulled to tighten around the heart, temporarily held to allow a surgeon to evaluate placement, tension magnitude, or other factors, and then easily adjusted before permanent fixation or easily removed if retrieval is indicated.

[0059] Embodiments of the tensioning member preferably include two parallel members or sections connected together or adjacent at their ends (e.g., 304, 306 in FIG. 13 or 80, 82 in FIGS. 8, 9, 11). The ends can be pulled through sliding holes or loops in the ends of the protective member and / or tensioning member. The holes or loops can be or include any of a number of structures. For example, the tensioning member may itself include a loop through which the adjacent or connected ends are threaded (similar to a noose knot). When the surgeon threads the end through the loop, the loop on the tensioning member is held securely, thereby tightening the tensioning member.

[0060] In a similar arrangement, the parallel ends (e.g., 304, 306) of the tensioning member are threaded through corresponding holes 800 in a button-like disk 802 secured to one end of the tensioning member or protective member (FIG. 22). A surgeon can pull ends 304, 306 through their respective holes 800 to tighten the tensioning member (and optional protective member) around the heart. Once a sufficient amount of tension is applied by pulling, the two ends can be held or joined together (i.e., a knot or joint is formed at location 804). When the two ends 304, 306 are tied or joined together, the joint at 804 cannot pass through hole 800, thus locking the tensioning member at a desired length. As an alternative to a separate disk 802, a pair of parallel loops can be heat set into the end of a protective element (e.g., a nitinol braided protective element) to form holes 800 that prevent passage of the knotted or bonded ends 304, 306 and function to hold tension.

[0061] In that instance, the two ends 304, 306 can be temporarily held or joined with a temporary clamp (e.g., a hemostat) or other locking device to prevent reverse passage through hole 800. This allows the surgeon to temporarily set a level of constraint by pulling ends 304, 306 through hole 800 to observe the physiological response before finally locking the length of the tensioning member.

[0062] Other types of locking structures can be fixedly attached to one end of the tensioning member (e.g., 302) and / or the protective member (e.g., 320). One example of such a locking structure 900 is shown schematically in FIG. 23. The lock 900 includes a body 902 having a cylindrical cross-section to minimize the end surface area on the implantable lock. The body 902 defines a passageway or chamber 904 having opposing openings 906, 908. Within the passageway 904 is a bar or jaw 910 pivotally secured to the body 902 by an axis or pivot point 912. The engaging end of the jaw 910 may include a roughened or toothed portion 914 for engaging a suture or other tensioning member passing through the passageway 904. A spring 916 is secured to an interior surface 918 of body 902 within passageway 904 and contacts a surface of jaw 910 opposite roughened portion 914, biasing jaw 910 away from surface 918 toward and against an opposing surface 920 within passageway 904. A button 922 is connected to body 902 such that it contacts (or can be contacted by) the lever end of jaw 910 opposite axis or pivot point 912.

[0063] One or more adjustable ends (e.g., 304, 306) of one or more tensioning members (e.g., 302) can pass through passageway 904 via openings 906, 908. As described above, the locking structure 900 in the illustrated embodiment is normally closed by the biasing force of spring 916. Portions of the suture or tensioning member can slide along or into and out of the locking structure 900 by pressing button 922 to pivot jaw 910 and move the engagement end away from the surface of passageway 904. When button 922 is released, jaw 910 pivots under the bias of spring 916 such that roughened portion 914 presses the suture or tensioning member against the surface of passageway 904. The locking structure 900 is thus locked, and the adjustable ends of the tensioning members are secured within the locking structure 900, holding the tensioning members at a particular length and magnitude of constraint against the heart. Movement of the tensioning member is restricted until button 922 is pressed, pivoting jaw 910 to release the lock, thereby allowing the tensioning member to slide through lock 900 and adjust its overall length. Thus, lock 900 can have a temporary locked position that allows it to be unlocked and further adjusted as needed, but can also be permanently locked if desired. Lock 900 can have a shape or particular exterior surface that allows for interfacing with a holding or gripping tool to facilitate manipulation of lock 900 and the tensioning member therethrough.

[0064] In other embodiments, the locking structure can be normally open, for example, with a spring (e.g., 916) biasing the jaws to an open position that allows the tensioning member to slide through until actuated by a tool or handle designed to press the jaws 910 against or otherwise engage the tensioning member. Such a tool can include clamping jaws (e.g., hemostat). In some embodiments, multiple jaws 910 can be provided within the lock 900 that pivot or move together like a hemostat. Other types of locking structures can be used, such as those described in Application No. 16 / 394,192 (filed April 25, 2019) and PCT Application No. US2019 / 032216 (filed May 14, 2019), which are incorporated herein by reference in their entireties.

[0065] The open surgical systems described herein include the ability to adjust the annuloplasty implant during placement as well as control, evaluate, and provide information regarding the system's tightness and its effectiveness. As described above, a tensioning member (with or without a protective member) can be initially positioned around the heart and deployed under tension to provide correction for a valve problem or other cardiac problem. Tension can be applied in many ways, for example, by pulling an adjustable end of the tensioning member while supporting or pulling in the opposite direction against another portion of the tensioning member and / or a locking structure, sliding loop, or disk connected thereto (as described above). The adjustable end of the tensioning member can also be pulled with a ratcheting pulling tool or the like designed for one-handed operation.

[0066] One example of a structure that can be used to assist in tightening the tensioning member and / or protective member is shown in FIGS. 24-26. A suture or tensioning member 302 is shown extending from a protective member or belt (e.g., 20, 320). Each free end 304, 306 of the tensioning member 302 is tied or otherwise secured to a spool 950. A stabilizing plate 952 is also provided and includes a well (opening) 954, a stabilizing arm 956, and a recess 958 between the arm 956 and the well 954. The well 954 has dimensions approximately the same as the maximum outer dimension of the base of the spool 950, allowing the spool 950 to be inserted into the well 954. In certain embodiments, the spool 950 has a tight fit with the inner wall of the well 954 to prevent the spool 950 from rotating relative to the plate 952 after insertion. The arm 956 is separated from the body of the plate 952 by a slot 960, and in the embodiment shown, both the slot 960 and the arm 956 are substantially parallel to the recess 958. The well 954 and the arm 956 are in portions of the plate 952 that are coplanar in this embodiment, while the recess 958 is curved (e.g., cylindrical) out of their plane. The recess 958 has a concave surface 962 that is below the plane of the remainder of the plate 952 (as seen in Figures 24-26).

[0067] Also shown is a guide tool 970, which includes a central shaft or bar 972 and end portions 974, 976. End portions 974, 976 are enlarged compared to shaft 972 and may be substantially circular with a diameter approximately twice the width of shaft 972. End portion 974 has a side surface 980 that is substantially parallel to the longitudinal axis of shaft 972 and includes a gap or slot 978, which is rectangular in the illustrated embodiment. End portion 976 includes a gap or slot 982 and has a side surface 984 that is also rectangular in the illustrated embodiment but is oblique (e.g., approximately 30-45 degrees) to the longitudinal axis of shaft 972.

[0068] In one example use, the protective element 20, 320 is mechanically positioned around the heart (e.g., via open surgery), with the slack in the tensioning element 302 accommodating size variations and facilitating positioning. The spool 950 (to which the end of the tensioning element 302 is attached) is placed in the well 954 of the stabilizing plate 952, with the tensioning element entering the slot 960, passing between the arm 956 and the remainder of the plate 952, and over the recess 958. The surgeon can then pre-tension the protective element and tensioning element by gathering the tensioning element slack into one or more loops around the spool 950. Alternatively, if there is excessive slack in the tensioning element, a portion of the tensioning element can be removed, and the tensioning element can be retieded or otherwise reconnected to the spool 950. The recess 958 facilitates manipulation of the tensioning element (whether by hand or with a tool) by maintaining space between the plate 952 and the tensioning element. The recess 958 therefore allows a finger or tool to easily move under the tensioning member to grasp the tensioning member.

[0069] The guide tool 970 is positioned so that end 974 generally faces the spool 950, the shaft 972 intersects the recess 958, and end 976 is adjacent to the arm 956. A gap 982 faces away from the arm 956. The guide tool 970 is also positioned so that the tensioning member 302 passes through or around the gaps 978, 982 as it travels from the slot 960 to the spool 950. The surgeon can then fine-tune the tension of the tensioning member by winding (to tighten) or unwinding (to loosen) the tensioning member around the spool 950. The guide tool 970 ensures that the tensioning member stays in place and does not twist as it is wound or unwound from the spool. Once the desired tension is achieved, the guide tool 970 can be removed. The spool 950, plate 952, and / or tool 970 may be made of a biocompatible material, and at least the spool 950 and plate 952 may remain in the body after the procedure is completed.

[0070] Other devices for taking up slack and pulling on the adjustable end of the tensioning member to tighten the tensioning member (and / or protective member) around the heart are contemplated. For example, a spool 1000 can be rotatably attached to the end of the protective member or tensioning member, with the adjustable end of the tensioning member secured or looped around the spool. As the spool is rotated (e.g., directly using a grasping or rotating tool, or remotely through the use of a long, flexible torque coil), the adjustable end of the tensioning member is drawn around the spool to take up slack and / or tighten it. Such a spool allows for better mechanical isolation of the cardiac tissue from the application of force.

[0071] An implantable miniature motor and / or transmission 1002 can be used with the spool 1000 or other structure to tighten the tensioning member. As shown schematically in FIG. 27 , the motor and / or transmission 1002 can rotate a drive shaft 1004 (e.g., forming a worm gear drive) connected to the spool 1000, which rotates the spool 1000 (as indicated by the arrow) to pull slack in the tensioning member. In certain embodiments, the motor and / or transmission 1002 can be remotely controlled. In this manner, adjustability of the tension in the tensioning member(s) (and therefore the force on the heart) can be maintained even after implantation is complete and the surgical site is closed. Alternatively, instead of a spool, an implanted linear slide 1010 ( FIG. 28 ) can be connected to the adjustable end of the tensioning member and also connected to the motor and / or transmission 1002. Whether the motor and / or transmission 1002 rotates or linearly moves the shaft 1004, the slide 1010 moves toward the motor and / or transmission 1002 to take up slack in the tensioning member and increase tension.

[0072] Apparatus and methods for measuring the amount (length) of tensioning and / or protective member tensioned for clamping are also contemplated. For example, in the above-described embodiment having a motor 1002, the motor mechanism can include an encoder that measures the displacement of the tensioning member. That displacement can be monitored or used to calculate the amount of clamping being applied to the heart. The motor mechanism can also, or alternatively, allow a user to indirectly measure the tension load based on the current draw of the motor. Because current draw increases with increasing tension, these two factors can be correlated to provide an estimate of the tension on the tensioning member.

[0073] As another example, embodiments such as those described herein can include one or more torque sensors attached to the motor shaft or to the spool used to wind the tensioning member to measure the applied tension. A load cell can be placed in line with the tensioning member to measure the tension applied thereto, or the tensioning member can run on a pulley or spool attached to a load cell to measure the tension. The tensioning member and / or guard member can also display increments (e.g., in millimeters or tenths of millimeters) so that the surgeon can directly observe the amount of displacement during tightening. Similarly, the tensioning member can be tightened using a pulling tool or other tensioning tool that has a scale or gauge to measure the displacement or tension.

[0074] During tightening, information or instructions regarding the tension and / or displacement of the tensioning member can be transmitted to or received from a remote monitor or controller. For example, signals from such tension or displacement sensors can be transmitted wirelessly, optically, acoustically, or via wires to a computer, display screen, or other external monitor or controller. The implantable monitor or controller can also collect, store, and send control signals to the motor (as described above), as desired, and in certain embodiments can include a transmitter that periodically transmits collected data (e.g., regarding tension, cardiac function, or other variables) to a remote monitor for access by a clinician. Such a controller and / or monitoring system allows for periodic monitoring of the annuloplasty system without invasive procedures. The system can have a control loop that allows the tensioning member to be tightened or loosened (e.g., via an implanted motor) in response to the observed tension. The system can notify or alarm the patient and / or physician when a change in tension is made or when a change in the observed tension is indicated.

[0075] Another example of a sensor that may be included in an annuloplasty device as described herein is an accelerometer attached to the tensioning member and / or protective member, or a microphone attached to or associated therewith. The accelerometer detects cardiac motion and can be used as a surrogate for direct measurement of stroke volume or ejection fraction. This information can directly adjust the tension of the device or can be used as diagnostic information for managing the patient's heart failure, either pharmacologically or by other means. The microphone can be focused on the valves (mitral and / or tricuspid) and used to assess regurgitation. The signal can be used to direct further adjustments to the annuloplasty device needed to minimize regurgitation.

[0076] In some embodiments, the annuloplasty devices (tensioning members and / or protective members) described herein may include electrodes contacting the right atrium, right ventricle, left atrium, and / or left ventricle. Such electrodes can sense and provide electrogram timing information from each of the chambers and can be used to pace the chambers. Larger electrodes (or a single large electrode) can be incorporated into the device for defibrillation. Electrodes can also be used to sense impedance changes associated with volume changes during the cardiac cycle or fluid overload due to heart failure. Independent regulation of the right and left sides of the heart allows for control of fluid distribution through the heart and body, and this regulation can be directed based on information sensed by the electrodes. If pacing and sensing locations away from the AV groove region are desired, satellite electrodes connected to the annuloplasty device via wire tethers can also be positioned. Additionally, a pulse generator can be incorporated into the annuloplasty device to enable pacing without leads placed within the heart or across the heart valves.

[0077] While particular attention has been given in the above description to the use of the device of the present invention in an open annuloplasty procedure, i.e., by placing a contractile tensioning member(s) and / or protective member around the heart in a direct manner, it will be understood that the structures, steps, and features described above may be used in connection with other body structures, therapeutic methods, or surgical procedures.

[0078] While the present disclosure has been described in detail in the accompanying drawings and the foregoing description, it will be understood that they are illustrative and not restrictive, with only selected embodiments shown and described, and that all equivalents, changes, and modifications that come within the spirit of the disclosure in this specification or the following claims are desired to be protected. It will be understood that features that are particularly described with respect to one or more particular structures or embodiments may be incorporated into or used in other ways in other structures or embodiments as disclosed herein.

[0079] The following numbered descriptions describe specific embodiments that may be useful in understanding the invention. 1. A mesh tube having a first open end and a second open end and a lumen passing through the tube along a longitudinal axis of the tube from the first open end to the second open end, the tube being configured to be looped longitudinally around the heart and positioned along the atrioventricular groove; a first suture portion within the tube, the first suture portion being secured to the tube adjacent the first open end, extending through the lumen toward the second open end, and connected to the tube by a plurality of retaining elements within the lumen such that the first suture portion is longitudinally movable relative to the tube through the retaining elements; a second suture portion within the tube, parallel to and spaced from the first suture portion, the second suture portion secured to the tube adjacent the first open end, extending through the lumen toward the second open end, and connected to the tube within the lumen by a plurality of retaining elements such that the second suture portion is longitudinally movable relative to the tube through the retaining elements; Equipped with A belt for placement along the atrioventricular groove of the heart, wherein tensioning the first and second suture portions causes the tube to contract longitudinally at least at selected locations along the tube, thereby tightening the tube and reducing the area of ​​the loop. 2. The belt of claim 1, wherein the first suture portion and the second suture portion each extend through the second open end of the tube, and a portion of each of the first and second suture portions is outside the tube so that it can be pulled to tighten the tube. 3. The belt of claim 1 or 2, wherein the first suture portion and the second suture portion are part of a single tensioning suture, the tensioning suture having an intermediate portion between the first suture portion and the second suture portion, and further comprising a locking suture attached to the intermediate portion of the tensioning suture. 4. A belt as described in any of 1-3 above, further comprising a ring positioned within the tube adjacent to the second open end, the tensioning suture being folded back and passed through the ring, the first and second suture portions being on one side of the ring, and the intermediate portion being on the other side of the ring. 5. The belt of claim 4, wherein the ring has a rounded engagement portion and the tensioning suture is folded back around the engagement portion. 6. The belt of claim 4, wherein the ring includes first and second linear sides parallel to the tube adjacent the second open end, the first linear side connected to the tube by at least one retaining element, and the second linear side connected to the tube by at least one retaining element. 7. A belt as described in any of claims 3-6 above, wherein the locking suture includes a plurality of protrusions for use in maintaining tension applied to the locking suture and transmitted to the first and second suture portions. 8. The belt of claim 7, wherein the locking suture has a portion within the tube and a portion extending through the first open end, and the protrusion is located up to a portion of the entire length of the locking suture within the tube and adjacent to the first open end, or is not otherwise on the portion of the locking suture within the tube. 9. A belt according to any one of 1-8 above, wherein the mesh is Nitinol. 10. A belt according to any one of 1-9 above, wherein the mesh is heat set so that its cross section assumes a barbell shape when the tube reaches body temperature. 11. A belt according to any one of claims 1-9, wherein the mesh is heat set so that its cross section becomes oval or elliptical when the tube reaches body temperature. 12. A belt according to any one of 1-9 above, wherein the mesh is heat set so that it assumes a flat ribbon shape when the tube reaches body temperature. 13. The belt of any of claims 1-9, wherein the mesh is heat set to a shape having a first region having a first hoop diameter and a first cross-sectional dimension and a second region having a second hoop diameter and a second cross-sectional dimension when the tube reaches body temperature, the first hoop diameter being larger than the second hoop diameter and the first cross-sectional dimension being larger than the second cross-sectional dimension. 14. The belt of claim 13, wherein an intermediate portion between the first region and the second region includes a contour adapted to fit at least a portion of the atrioventricular groove. 15. A belt as described in any one of claims 1-9, wherein the mesh is heat-set to assume a saddle shape having one or more lower rounded contoured regions when the tube reaches body temperature, at least one of the lower rounded contoured regions being adapted to fit closely within the atrioventricular groove. 16. A belt according to any one of claims 1-15 above, wherein the first and second suture portions are each part of a separate suture. 17. A belt according to any one of claims 1-16, wherein the first and second suture portions are connected to form a loop. 18. The belt of claim 17, wherein the loop is connected to an elongated element that is at least partially external to the belt, the elongated element being one of a locking suture and a delivery filament. 19. An annuloplasty system for use in open surgery, comprising: a tensioning member adapted to be implanted by wrapping it around the heart outside the catheter system; a locking means for holding the tensioning member in tension around the heart and for allowing adjustment of the tension of the tensioning member; 1. An annuloplasty system comprising: 20. The annuloplasty system of claim 19, further comprising a protective member through which the tensioning member passes, the protective member having a guide for the tensioning member and made of a shape memory material that resists twisting. 21. The annuloplasty system of claim 20, wherein the protective element has a first ring half adapted to be attached to a first portion of the heart and a second half adapted to be attached to a second portion of the heart. 22. The annuloplasty system of claim 20, wherein the tensioning member includes first and second ends, and the locking means is attached to the protective member and includes first and second holes, the first end extending through the first hole and the second end extending through the second hole, the ends retainable in a retaining position, and the first and second holes located between the retaining position and the protective member. 23. The annuloplasty system of claim 20, wherein the locking means includes a stabilizing plate having a well and a recess, and a spool seated in the well, the tensioning member being adapted to be wound onto the spool to increase tension in the tensioning member and unwound from the spool to decrease tension in the tensioning member. 24. The annuloplasty system of claim 20, further comprising at least one of a miniature motor and a transmission operatively connected to the tensioning member, such that when the tensioning member is positioned around the heart, operation of the at least one of the miniature motor and the transmission at least one of tightens and loosens the tensioning member around the heart. 25. The annuloplasty system of claim 19, further comprising a device operatively connected to the tensioning member for directly or indirectly measuring the tension or length of displacement of the tensioning member upon tightening of the tensioning member, the device being selected from the group consisting of an encoder for measuring displacement of the tensioning member; a sensor for measuring current draw on a motor operatively connected to the tensioning member; a torque sensor operatively connected to the tensioning member; a load cell disposed in series with the tensioning member; and a tensioning tool including a scale or gauge for measuring displacement of the tensioning member.

Claims

1. An annuloplasty system for use in open surgery, comprising: a tensioning member configured to be implanted by wrapping around the heart, the tensioning member including an elongated member forming a continuous loop configured to be positioned around the heart; and a protective member through which the tensioning member passes, the protective member being made of a shape memory material configured to resist kinking and to contact the heart in an expanded dimension of the protective member, the protective member including a material visible by one or more of fluoroscopy, CT scan, ultrasound imaging, and / or magnetic resonance imaging, and further having a continuous ring structure; a locking means for holding the tensioning member in tension around the heart and for allowing adjustment of the tension of the tensioning member; 1. An annuloplasty system comprising:

2. An annuloplasty system as described in claim 1, wherein the protective member has a guide for the tensioning member.

3. An annuloplasty system as described in claim 2, wherein the locking means includes a stabilizing plate having a well and a recessed section, and a spool disposed within the well, and the tensioning member is adapted to be wound around the spool to increase the tension of the tensioning member and to be unwound from the spool to decrease the tension of the tensioning member.

4. An annuloplasty system as described in claim 2, further comprising at least one of a small motor and a transmission, the at least one of the small motor and the transmission being operatively connected to the tensioning member, and wherein operation of the at least one of the small motor and the transmission causes at least one of tightening and loosening of the tensioning member when the tensioning member is positioned around the heart.

5. The annuloplasty system of claim 1, further comprising a device operatively connected to the tensioning member for directly or indirectly measuring the tension of the tensioning member or the length of displacement caused by tightening the tensioning member, the device being selected from the group consisting of an encoder for measuring the displacement of the tensioning member, a sensor for measuring the current draw of a motor operatively connected to the tensioning member, a torque sensor operatively connected to the tensioning member, a load cell arranged in series with the tensioning member, and a tensioning tool having a scale or gauge for measuring the displacement of the tensioning member.

6. The annuloplasty system of claim 1, wherein the locking means includes a first buckle configured to engage with the tensioning member at a first position of the tensioning member.

7. The annuloplasty system of claim 6, wherein the locking means includes a second buckle configured to engage with the tensioning member at a second position of the tensioning member.

8. A first tensioning member passing through a first protective member configured to apply tension to a first portion of the heart; a second tensioning member passing through the second protective member configured to apply tension to a second portion of the heart; 1. An annuloplasty system comprising:

9. The annuloplasty system of claim 8, wherein the first protective member and the second protective member comprise a shape memory material.

10. The annuloplasty system of claim 9, wherein the shape memory material is nitinol.

11. The annuloplasty system of claim 8, wherein the first protective member and the second protective member form a single loop configured to be positioned around the heart.

12. The annuloplasty system of claim 11, wherein the first protective member and the second protective member are connected to each other at a central portion, and the central portion is configured to be fixed to patient tissue.

13. The annuloplasty system of claim 11, wherein the first protective member and the second protective member are configured to be independently tensioned so as to restrain the first and second portions of the heart independently of each other.

14. The first protective member includes a first mesh tube having an open end and a closed end, and the first tensioning member extends from the closed end to at least the open end; 12. The annuloplasty system of claim 11, wherein the second protective member comprises a second mesh tube having an open end and a closed end, the second tensioning member extending from the closed end to at least the open end.

15. The annuloplasty system of claim 14, wherein the first tensioning member is fixed to the closed end of the first mesh tube and the second tensioning member is fixed to the closed end of the second mesh tube.

16. The annuloplasty system of claim 8, wherein the first protective member includes a first loop configured to be positioned around the heart at a first position, and the second protective member includes a second loop configured to be positioned around the heart at a second position.

17. An annuloplasty system as described in claim 16, wherein the first protective member and the second protective member are configured to be independently tensioned so as to restrain the heart in a first position and / or a second position that are independent of each other.

18. The first protective member comprises a first mesh tube having a lumen, the lumen passing through the first mesh tube from a first open end to a second open end, and the first tensioning member extending from the first open end to the second open end; 17. The annuloplasty system of claim 16, wherein the second protective member comprises a second mesh tube having a lumen passing through the second mesh tube from a first open end to a second open end, and the second tensioning member extending from the first open end to the second open end.

19. The annuloplasty system of claim 16, wherein the first protective member and the second protective member are connected to each other by a connector such that the first loop extends at an angle from the second loop.

20. An annuloplasty system as described in claim 19, wherein the connecting portion is positioned at a central position of each of the first protective member and the second protective member.

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