Systems and methods for applying pressure to a body organ

Abstract

The present invention particularly discloses embodiments of a band or strap that can be used to treat tricuspid regurgitation. In some embodiments, such a band can be heat-set into a specific configuration to effectively reduce the tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tension sutures for applying tightening or tension to the band during deployment, and structures for effectively distributing forces during such tightening. Embodiments of tension members, protective members, and devices and methods for open surgical placement (e.g., around the heart for annuloplasty) are also disclosed.

Description

Technical Field

[0001] The present disclosure generally relates to devices for insertion into a patient's body to apply pressure to an organ as a way to treat a patient's condition. In particular, embodiments of a band for at least partially surrounding an organ are disclosed. Background Art

[0002] In the treatment of tricuspid regurgitation (TR), it has been proposed to deliver a band or strap around the heart, particularly into the atrioventricular (AV) groove of the heart. When properly positioned, the band tightens or otherwise tensions around the heart, thereby narrowing the tricuspid annulus and alleviating the TR condition. To narrow the tricuspid annulus, the band must overcome the pressure from the heart, which can vary from patient to patient and can be considered an unfortunate side effect that needs to be addressed.

[0003] It has been proposed to use sutures to provide tension to the band when necessary. Several problems have been noted with this method. For example, when tightening the band, excessive pressure may be exerted on the AV groove and / or coronary vessels or other tissues, which can limit coronary blood flow and have a negative impact on heart function. Additionally, when tightening is performed using sutures attached to the band, it can be located anywhere within the band and can move freely axially and transversely. Thus, there is a lack of control over the sutures relative to the band and relative to the biological structures of the heart.

[0004] In summary, there is a need for structures and methods for tightening a band and ensuring that any risk of the band compressing the coronary arteries (such as vascular compression that restricts or blocks flow) is minimized. Summary of the Invention

[0005] The present invention discloses, in particular, devices and methods for treating conditions including tricuspid regurgitation. Such devices include a band or strap for placement along the AV groove of the heart, which may include a heat-set mesh tube having a first open end and a second open end and a lumen passing through the tube along the longitudinal axis of the tube from the first open end to the second open end. The tube may be longitudinally configured into a ring so as to surround the heart and be placed along the AV groove. A first suture portion is within the tube and is fixed to the tube adjacent to the first open end and extends through the lumen toward the second open end. The first suture portion may be connected to the tube within the lumen by a plurality of retaining elements so that the first suture portion may be moved longitudinally relative to the tube by the retaining elements. In some embodiments, a second suture portion is within the tube and is parallel to the first suture portion and spaced apart from the first suture portion. The second suture portion may be fixed to the tube adjacent to the first open end and extend through the lumen toward the second open end. The second suture portion may be connected to the tube within the lumen by a plurality of retaining elements so that the second suture portion may be moved longitudinally relative to the tube by the retaining elements. Pulling the first and / or second suture portions tightens the tube to reduce the area of ​​the loop, causing the tube to compress longitudinally at at least selected locations along the tube.

[0006] In some embodiments, the first suture portion and the second suture portion each extend through the second open end of the tube to provide a corresponding portion of the first and second suture portions that is located outside the tube and can be pulled to tighten the tube. Alternatively, the first suture portion and the second suture portion can be parts of a single tensioning suture, with an intermediate portion between the first suture portion and the second suture portion. The locking suture can be attached to the intermediate portion of the tensioning suture. A loop portion can be provided in the tube and adjacent to the second open end, and in this case, the tensioning suture can be folded on the loop portion and passed through the loop portion so that the first and second suture portions are on one side of the loop portion and the intermediate portion is on the other side of the loop portion. An embodiment of the loop portion may include a circular joint portion around which the tensioning suture is folded, and / or adjacent to the second open end parallel to the first and second linear sides of the tube. The first and second linear sides can be connected to the tube by one or more corresponding retaining elements. The locking suture may include a plurality of protrusions for maintaining the tension applied to the locking suture and transmitted to the first and second suture portions. In one example, the locking suture has a length within the tube and has a portion that exits the tube through the first open end, and the protrusion is within the tube for the full length of the locking suture and adjacent to the first open end and not within the length of the locking suture within the tube.

[0007] An example of a tube mesh is a thermosetting material, such as Nitinol. An embodiment includes a heat-set mesh so that when the tube reaches body temperature, its cross-section presents a barbell, oval, or flat ribbon shape. A further example includes a heat-set mesh so that when the tube reaches body temperature, it presents a shape including a first region having a first hoop diameter and a first cross-sectional size and a second region having a second hoop diameter and a second cross-sectional size. The first hoop diameter can be greater than the second hoop diameter, and the first cross-sectional size can be greater than the second cross-sectional size. The intermediate portion between the first and second regions can include a profile adapted to conform to at least a portion of the atrioventricular groove. Another example can include a heat-set mesh so that when the tube reaches body temperature, it presents a saddle shape having one or more lower circular contour regions. At least one of the lower circular contour regions can be adapted to fit tightly within the AV groove.

[0008] The disclosed structure minimizes the risk of coronary artery compression when the compression band is tensioned, and methods are disclosed for distributing the applied force of the band over a sufficiently wide arc of the AV groove so as not to over-compress the coronary arteries while still achieving the therapeutic benefit of reducing tricuspid and / or mitral regurgitation. During ventricular diastole, when coronary artery flow is expected to be highest, embodiments of the band disclosed herein should not apply an inward pressure (i.e., toward the heart) greater than the coronary artery pressure. Such embodiments should be shaped and / or constructed to minimize any trauma to adjacent structures (e.g., no sharp edges on the band) and to minimize the risk of slipping on or around the heart once the band is placed and tightened (if necessary). Some band embodiments as disclosed can control the position of sutures or other tensioning elements so as to optimally distribute the forces or pressures applied by or otherwise associated with the tensioning elements. In particular embodiments, if retraction or correction is required, the ends of the band are configured to be easily pulled into a delivery catheter or other (e.g., tapered) device. Some band embodiments are stretchable or compressible to fit compactly over a delivery frame and into a delivery catheter or other device and will then assume a desired shape or configuration when deployed that will effectively distribute tension, pressure, or force. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a top view of a belt according to embodiments disclosed herein.

[0010] Figure 1A yes Figure 1 A perspective view of the web tube used for the belt.

[0011] Figure 2 yes Figure 1 A cross-sectional view taken along line II-II and observed in the direction of the arrow.

[0012] Figure 3A yes Figure 1Perspective sectional view of an embodiment of the belt in a specific set shape.

[0013] Figure 3B is Figure 1 Perspective sectional view of an embodiment of the belt in a specific set shape.

[0014] Figure 4 is Figure 1 Perspective sectional view of an embodiment of the belt in a specific set shape.

[0015] Figure 5 is Figure 1 Perspective sectional view of an embodiment of the belt in a specific set shape.

[0016] Figure 6 is Figure 1 Perspective sectional view of an embodiment of the belt in a specific set shape.

[0017] Figure 7 Plan view of an embodiment of a belt with a single tensioning suture.

[0018] Figures 8 - 10 Plan view of an embodiment of a belt with two tensioning suture portions.

[0019] Figure 11 Plan view of an embodiment of a belt with two tensioning suture portions having an intermediate loop.

[0020] Figure 12 Plan view of an embodiment of a belt with two tensioning suture portions having an intermediate loop and additional structure.

[0021] Figure 13 Schematic view of an embodiment of a tensioning member.

[0022] Figure 14 Partial perspective view of an embodiment of a protective member.

[0023] Figure 15 Top view of an embodiment of a protective member.

[0024] Figure 16 Top view of an embodiment of a protective member.

[0025] Figure 17 Partial side view of an embodiment of a protective member with a tensioning member.

[0026] Figure 18 Top view of an embodiment of a protective member with a tensioning member.

[0027] Figure 19 Partial side view of an embodiment of a protective member.

[0028] Figure 20A is a schematic diagram of a method and apparatus for an embodiment for manufacturing a protective member (shown in end view in Figure 20B and 20C ).

[0029] Figure 21 is a schematic diagram of an embodiment of a protective member.

[0030] Figure 22 is a perspective view of an end of an embodiment of a protective member having a locking disk.

[0031] Figure 23 is a partial perspective view of an embodiment of a locking mechanism.

[0032] Figure 24 is a perspective view of an embodiment of a stabilizing plate for holding and / or adjusting a tension member and / or a protective member in a tensioned state.

[0033] Figure 25 is Figure 24 a perspective view of an embodiment of a stabilizing plate having additional structures and embodiments of a tension member and a protective member.

[0034] Figure 26 is Figure 25 a perspective view of the embodiment shown together with an embodiment of a guiding tool.

[0035] Figure 27 is a schematic diagram of an embodiment of a mechanism for tensioning and / or adjusting the tension on a tension member and / or a protective member.

[0036] Figure 28 is a schematic diagram of an embodiment of a mechanism for tensioning and / or adjusting the tension on a tension member and / or a protective member. DETAILED DESCRIPTION

[0037] While the present disclosure may be embodied in many different forms, for purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments shown in the drawings and specific language will be used to describe the same. However, it should be understood that no limitation of the scope of the disclosure is thereby intended. Any changes and further modifications of the described embodiments and any further applications of the principles of the disclosure as described herein are contemplated as would normally occur to one of ordinary skill in the art to which the disclosure pertains.

[0038] Referring now generally to the drawings, an embodiment of a band 20 for applying pressure to a body organ is shown. As will be discussed below, the band 20 may be particularly prepared for application to the atrioventricular (AV) groove of the heart when treating a tricuspid regurgitation (TR) condition. While the disclosure herein may sometimes focus on such use and placement, it should be understood that the disclosed structures and methods may be used for a variety of conditions, treatments, implants, or purposes.

[0039] The band 20 in the illustrated embodiment is a flexible mesh tube 22 of biocompatible material having opposite open ends 24, 26 and a natural diameter (i.e., the diameter of the tube when there is no stress or after heat setting) extending between the tapered or otherwise narrowed ends 24 and 26 around an internal volume or lumen 28. One or more sutures or other tensioning members are connected to the band 20 to provide tension to the band 20, as will be discussed further below. This tension can tighten the band 20 in the AV groove for treatment of TR. The mesh of the tube 20 can be formed by strands, wires, or fibers 36 separated by gaps 38, or by cutting, etching, stamping, or otherwise processing a sheet to remove portions to form gaps 38. The mesh allows the band 20 to be stretched longitudinally along its length or central axis A under tension, thereby reducing its diameter in the stretched region, and to be compressed longitudinally along its length or central axis A under compression or relaxation of tension, thereby increasing its diameter in the compressed region.

[0040] It should be understood that the mesh of tube 22 can be made of many available natural or synthetic strong biocompatible materials. In a particular embodiment, the mesh of band 20 is nitinol, for example one or more individual nitinol wires (as strands 36) are fixed and / or twisted to each other to form interstices 38. Figure 1 The band 20 in the illustrated embodiment has an original cylindrical shape having a length L and a diameter D measured transverse to the longitudinal axis A. During manufacture, or at least prior to use, embodiments of the band 20 made of a heat-settable material (e.g., Nitinol) can be heat-set into a configuration to be adopted when deployed in vivo. In this example, the band 20 has its original (e.g., cylindrical) form at room temperature, is packaged for delivery, and assumes the heat-set configuration when inserted into the body and its temperature is at or near body temperature.

[0041] As a specific example of an ideal thermally set configuration, the strap 20 is shown in FIG. 3 and is in the shape of a thermally set flat strap. The flat strap shape can be thermally set into the nitinol mesh such that the strap 20 has a desired width w (from side 40 to side 42) in its deployed state to conform to the initial length L. It has been determined that the width w should be set as follows in order to maintain the pressure from the strap 20 during ventricular diastole not to exceed the coronary artery pressure, e.g., about 30 mmHg. For a specific tension F, the stress on the cross-section of the strap 20 is σ0 = F / (tw), where t is the thickness of the mesh of the strap 20 and w is the width of the strap 20 as defined above. The circumferential stress equation relates the stress to the desired pressure P as σ0 = Pr / t, where t is defined as above and r is the radius of the AV groove. Setting these representations of the cross-sectional stress equal to each other gives F / tw = Pr / t. Canceling terms and rearranging gives w = F / Pr. For an experimentally determined tension of 0.4 pounds (1.8 N), a vascular pressure of 0.58 psi (30 mmHg), and a radius of the AV groove of 2 inches (51 mm), the width w of the strap 20 is determined to be 0.35 inches (8.9 mm). It should be understood that different values of the width w of the strap 20 will be determined by the above method for variations in a particular patient, such as differences in the AV groove radius or vascular pressure. Thus, the strap 20 can be customized to have a width w suitable for a particular patient. This width w is configured by the thermally set strap 20, such as one of the braided nitinol wires, such that when the body applies heat (i.e., body temperature), the strap 20 assumes a configuration with a width of w.

[0042] Preferably, the strap 20 is thermally set to present a flat state, as in the previous example, in order to distribute the force from the tensioning member to the strap. The flattening of the original cylindrical cross-section ranges from simply ellipticizing the cross-section ( Figure 3A , a higher width w) to forming a strap cross-section where the opposing sides 40, 42 of the strap 20 are parallel to each other and are closely adjacent to each other ( Figure 3B , a lower width w). In Figure 3A , the strap 20 is shown as having an oblong or elliptical cross-section that has edges 44, 46 that intersect and are separated by the major axis and an intermediate portion between the edges 44, 46, and the width w is along the minor axis or at least substantially parallel to the minor axis. As Figure 3B shown, again, the edges 44, 46 intersect and are separated by the major axis, and the width w is along the minor axis or parallel to the minor axis. The edges 44, 46 provide a location for tensioning by one or more sutures, as will be discussed further below.

[0043] In a particular embodiment, the webbing 20 can be heat-set and have enlarged circular edges 50, 52 on either side of the longitudinal axis A. In cross-section, this example of the webbing 20 looks like a dog bone or a barbell. As an example, the intermediate portion 54 of the webbing 20 between the edges 50, 52 is flat and has at least approximately planar meshes in each side 40, 42 between the edges 50, 52, and these sides 40, 42 are close to or in contact with each other. The edges 50, 52 are circular or curved, for example having a circular or oval cylindrical cross-section. In some illustrated embodiments (e.g., Figure 4 ), the edges 50, 52 have the same configuration as each other. The enlarged edges 50, 52 provide additional surface area to engage and clamp the underlying tissue in the AV groove. The edges 50, 52, because they are circular, reduce the possibility of sharp corners or other surfaces that could cause any damage to adjacent heart tissue. Since appendages or flaps of the heart chamber may overhang the webbing 20 in the AV groove, such surfaces are preferably absent.

[0044] In another embodiment, the webbing 20 is heat-set such that its cross-section produces a region 60 with a larger hoop diameter on one side and a region 62 with a tighter / smaller hoop diameter on the other side. The region 60 is designed to be placed on the ventricular wall that is thicker than the atrial tissue and has a higher chamber pressure. The thicker cross-section of the region 60 has the advantage of holding the ventricular tissue more firmly, and the higher chamber pressure will withstand the thicker material. The region 62 is designed to be placed on the thinner AV groove and atrial wall, which has a lower chamber pressure. The thinner region 62 can allow the intermediate portion 64 of the webbing 20 to fit more closely in the AV groove. The intermediate portion 64, as Figure 5 seen in the example of, may include a profile 66 in one side 42 that conforms to at least a portion of the AV groove.

[0045] In another embodiment, the webbing 20 is heat-set into an annulus having or approximating the natural curve of the exterior of the heart such that the webbing 20 can assume a natural position or fit around the heart. For example, an image of the heart can be taken to model the organ, and this image is used to create a curve in the webbing 20, which is then heat-set into the webbing 20. Such an embodiment simplifies deployment because the webbing 20 will assume the shape of the heart when deployed. The webbing 20 in this shape will fit better on the heart, similar to fitting an oval peg into a hole with a corresponding size and shape, and will conform better to the contour of the heart before the webbing 20 is finally tensioned.

[0046] In another embodiment, the webbing 20 is heat-set into a three-lobed or saddle shape. Figure 6 is an exemplary cross-sectional shape that allows three sutures to pass through, for example, one suture along each lobe, in order to distribute the load transversely along the AV groove. This shape addresses the fact that the AV groove itself does not lie in a single plane. The shape of the webbing 20 is asFigure 6 As shown, it is allowed to sit more naturally in the AV groove during deployment. In addition, when used with three tension sutures, the leaflet retention sutures keep the sutures separated and distribute the compressive force applied by the sutures. In this example, the band 20 has an upper flat region 70 and one or more lower contoured regions, such as two side leaflets 72 and an intermediate leaflet 74. The intermediate leaflet 74 is circular, such as a partially cylindrical or circular ridge, which is adapted to fit within the AV groove, preferably tightly within the AV groove. The side leaflets 72 are circular, such as having at least partially substantially the same curvature as the intermediate leaflet 74, and the edges 76 are also circular. Such edge regions, as pointed out above with respect to the (dog bone version), provide a more secure engagement without sharp corners. More generally, the path of the band 20 can be heat-set into a non-planar three-dimensional shape that better tracks the path of the AV groove in the heart.

[0047] In any of these embodiments, the band 20 can be heat-set to provide a greater width w of the band 20 in the region of the band that will be placed over the heart region where the artery (more likely) passes through from below. The greater width allows for a relatively lower pressure in that region of the band 20 when tensioned, and that region should be above the heart region where the artery passes through. In the portion that will be located above or near the tricuspid annulus of the heart, the width of the band 20 can be narrower. When tensioned, this narrower width can provide a relatively greater pressure in that region of the band 20 and thus direct a greater pressure to the location where tricuspid regurgitation needs to be treated.

[0048] In any of the embodiments of the band disclosed herein, the tension is applied by one or more sutures passing through the band. "Suture" refers not only to the general definition but also to any biocompatible thread or filament having sufficient flexibility and tensile strength to pass through the band for a procedure such as TR treatment and to tension it upon deployment, as discussed herein. In addition, "suture" refers not only to a completely independent item but also to a part of one or more such items. Pulling or otherwise placing the suture in a tensioned state applies compression to the band and thus to the AV groove of the heart.

[0049] In an embodiment where only one tension suture is attached or otherwise connected to the band 20 (e.g., Figure 7) The suture 78 can float within the tape 20 through the lumen 28. In a particular embodiment, one end of the tensioned suture 78 is fixed to the tape 20 (and the locking mechanism M attached or otherwise connected to the tape 20) at or near one end 24 of the tape 20. The suture 78 passes through the lumen 28 and exits the end 26 of the tape 20 and passes through the locking mechanism M. The tensioned suture 78 within the tape 20 can move axially and laterally relative to the tape 20. In the case where the other end is fixed to the tape 20, pulling the end of the tensioned suture 78 passing through the locking mechanism causes a portion of the suture 78 to move through the tape 20. The end 24 is pulled along the axis A together with the suture 78 to reduce the length of the tape 20 and bring it into a tensioned state. Activation of the locking mechanism M holds the suture 78 and the tape 20 around the heart by means of the tension.

[0050] In Figure 8 the illustrated embodiment, the tape 20 includes two parallel sutures or suture portions 80, 82 therein to provide tension. It has been found that using two sutures 80, 82 is more effective than using a single suture floating within the tape 20 in providing stable tension to the tape 20 and distributing pressure or force when tightening or tensioning the tape 20 around the heart. For example, the risk of the tape 20 rotating or pivoting during tensioning or tightening is reduced or eliminated by applying force through two separate sutures, such as by rotating the tape around an edge (such as 44, 46, 50 or 52), causing the flat tape 20 to lift or stand up at one edge. It has also been found that using the two sutures 80, 82 together with the tape 20 is more effective when the sutures 80, 82 are laterally restricted, i.e., kept separate from each other. It has been found that due to minimization of potential energy, or being pulled together during deployment or tightening of the tape 20, the two floating sutures tend to stay together. When the sutures stay together, they tend to behave like a single thicker suture, which loses the force application and distribution of the two sutures and other benefits.

[0051] The sutures 80, 82 are attached to the tape 20 at positions that are opposite to each other across the longitudinal axis of the tape 20, and in the illustrated embodiment, the sutures 80, 82 are attached to the inner side of the tape 20. In embodiments where the tape 20 is heat-set to a particular shape, the sutures 80, 82 are placed after heat-setting. A series of retaining elements 84 surround the sutures 80, 82 at different positions along the tape 20. In a particular embodiment, the elements 84 are threads or filaments of a net that surrounds the respective sutures 80, 82 and passes through the tape 20. For example, a retaining element 84 in the form of a filament 86 passes through the net, around the suture 80, and back through the net one or more times, and is then knotted, heat-sealed, or otherwise secured. In the illustrated embodiment, the filament 86 is threaded or looped around the suture 80 at least twice and secured at or near the tape 20, such as on the outer surface of the tape 20. It will be understood that securing the filament 86 relative to itself and the tape 20 (e.g., by knotting) leaves some slack or flexibility in the filament 86 to form an opening or passage 88 through each retaining element 84 that permits the suture 80 to longitudinally move through the passage 88 of the respective retaining elements 84 with minimal resistance. As a particular case, the respective tubes for each respective tensioning suture 80, 82 can be placed through the lumen of the tape 20, similar to Figure 10 the tube 100 shown therein. The respective tensioning sutures are initially extended or by passing through their respective tubes after the tubes are placed within the tape 20. The filament 86 can pass through the net of the tape 20 and around the tube, for example, two or more times, and is tightened to fit tightly around the tube and knotted or otherwise secured to form the retaining element 84. The tube can then be slid out of the element 84 and over the respective tensioning suture. The tight fit of the element 84 around the tube makes it easier to tie or secure the element and ensures that the element is slack relative to the tensioning suture when the tube is removed. Similar or identical retaining or securing elements 84 exist for the suture 82.

[0052] In other embodiments, the retaining element can be or include a loop portion, tube, or sheath attached to the tape 20. The filaments as described above act as loop portions. In an example of the tape 20 made of a net-like nitinol wire, an internal guide loop portion ( Figure 9 92 in Figure 10) whose channel dimensions allow the suture 80 or 82 to pass longitudinally through the loop portion with minimal resistance. Several individual tubes can be placed within the band 20 and separated from each other by a gap, especially if the longitudinal compressibility of these tubes is lower than that of the band 20, or if a single tube 100 is used as a retaining element, then such a tube should be compressible so as not to limit the tightening of the band 20 when tensioned.

[0053] In the illustrated embodiment, the fixing or retaining elements 84 are spaced evenly along the band 20. Since the sutures 80, 82 are intended to be kept taut or substantially linear in the retaining elements 84 along the band 20, the retaining elements 84 can be spaced relatively far apart from each other, for example, in a particular embodiment, up to 5 mm, up to 10 mm, up to 15 mm, up to 20 mm apart from each other, or close enough to each other such that any slack that may exist in one or both of the sutures 80, 82 will not allow one of the sutures 80, 82 to contact the other when the band is being deployed. Additionally, in one embodiment, the positions of the retaining elements 84 are shown to be staggered along the sutures 80, 82, i.e., a plane perpendicular to the longitudinal axis of the band 20 passing through one retaining element 84 that holds one suture 80 will pass between the retaining elements 84 that hold the other suture 82, and in a particular embodiment, will pass through the middle (e.g. Figure 8 ). This staggered state allows the band 20 to be folded, compressed, or otherwise packaged into a delivery device, where the retaining elements 84 are offset from each other, thereby providing a lower profile for the delivery device. In other embodiments, the retaining elements 84 can be symmetric in the band 20 or only very slightly offset (e.g., offset by 1 - 3 mm such that the above-mentioned plane passing through the retaining element with the suture 80 can pass closely adjacent to the retaining element with the suture 82). In this case, the tension of the sutures 80, 82 is applied to the band 20 at or near the same position on the sides 40, 42 of the band 20 by the retaining elements 84.

[0054] In other embodiments, one or both of the sutures 80, 82 may be woven through the mesh of the band 20 along two lines that are each transverse to the longitudinal axis of the band 20. In one example, the suture 80 may be fixed at one end 24 inside the band 20, pass through the mesh of the band 20 and extend along the outside of the band 20 for a length, and then pass through the mesh back to the inside of the band 20 for a length (which may be the same or different than the length extending along the outside of the band 20). This weaving continues over the length of the band 20. The suture 82 may be woven similarly or identically through the other side of the band 20. It has been found that this weaving creates higher friction between the sutures 80, 82 and the band 20, and when the sutures 80, 82 are tightened, the tension provided to the band 20 may be uneven, causing a portion of the band 20 to contract around the heart while other portions may remain relatively loose. Therefore, weaving the sutures 80, 82 through the band 20 may be effective in some cases, but other embodiments disclosed herein operate in a more effective manner.

[0055] In another embodiment, Figure 11 , a belt 20 similar or identical to the above-described belt 20 embodiments is shown, including a mesh tube 22 having narrow 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 edge of the belt 20 and a second suture portion 82 extending along the opposite side or edge of the belt 20. As with the other belt embodiments described herein, the suture S is secured to the tube 22 at the end 24, such that one end of the suture portion 80 and one end of the suture portion 82 are secured to the tube 22, respectively, as shown in FIG. Figure 11 24, or fixed to a locking mechanism M adjacent to or connected to the tube 22. From those fixed ends, each suture portion 80, 84 extends toward the end 26 and is retained to the tube 22 by one or more retaining elements 84, as described above. In this embodiment, when the suture portions 80, 82 approach or reach the end 26, the suture S is looped back through the lumen 28 of the band 20 to form a loop 85. The loop 85 in this embodiment extends through the lumen 28 and through the end 24 (and through the locking mechanism M, if present) to the outside of the tube 22 of the band 20. The loop 85 can be connected to a tensioning line T, such as by a hook, clamp or other structure, which can be part of a system for delivering the band 20. After the band 20 is deployed as generally described below, the tensioning line T can preferably be disengaged from the loop 85 and retracted. This embodiment provides redundancy so that if one of the suture portions 80, 82 fails, the other suture portion continues to provide tension to the band 20.

[0056] In another embodiment, the belt 20 ( Figure 12) is configured to be the same as the above-described embodiment and has a retaining element 184 that is similar or identical to the above-described retaining element 84. It should be understood that the strap 20 can be manufactured, shaped, and / or configured as described above for embodiments regarding specific shapes or arrangements. The first suture or suture portion 180 passes through the retaining element 184 along one side 140 of the strap 20, and the second suture or suture portion 182 passes through the retaining element 184 along the other side 142 of the strap 20, for example, across the longitudinal axis A of the strap 20 on the side opposite the suture or suture portion 180. The locking suture 210 is connected to the suture portions 180, 182 at or near one end 226 of the strap 20, and the suture portions 180, 182 pass through the loop portion 212 at or near the end 226 of the strap 180.

[0057] In the illustrated embodiment, the suture portions 180, 182 are part of a single tensioning suture S. Each of the suture portions 180, 182 is fixed to the end 224 of the strap 20 (e.g., by a hem stitch), as described above regarding the sutures 80, 82. The suture portion 180 passes through the retaining element 184 on one side of the strap 20 (e.g., the top as Figure 12 shown), then the center loop 214 of the suture S passes through the loop portion 212 at or near the other end 226 of the strap 20, and the remainder of the suture S passes through the retaining element 184 on the other side of the strap 80 (e.g., the bottom as Figure 12 shown) and is fixed at the end 224 of the strap 20. The loop 214 passing through the loop portion 212 is fixed to one end 222 of the locking suture 210 such that the tensioning suture S is folded over a portion of the loop portion 212 (i.e., bent 180 degrees around and through the loop portion 212), with the portions 80, 82 on one side of the loop portion 212 and the loop 214 on the other side. It should be understood that in other embodiments, the suture portions 80, 82 can be separate tensioning sutures, each of which passes through the loop portion 212 as described above and is attached to the locking suture 210.

[0058] 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 within the band 220 and engage the locking mechanism M (described above). In other embodiments, the protrusions 230 may be present only in a portion of the suture 210, such as in a portion of the locking suture 210 that is within the band 220 and engages the locking mechanism M, and is at least one-third to one-half the distance from the loop portion 212 that is farthest away. It has been found that a tensioned or tightened band (such as band 20) may need to have a length between 60% and 80% of the initial length L of the band, and thus the length of the suture 210 (such as between 80% and 40% of the initial length of the suture 210 within the band) will have to exit the band and reach or pass through the locking mechanism M. Thus, it is advantageous to place the protrusions in at least 40% to 80% of the suture 210 that is adjacent to the mechanism M and enters the band 20, and thus is likely to be pulled through the end of the band and the locking mechanism.

[0059] The loop portion 212 in the illustrated embodiment has a circular (e.g., annular) portion 250 and two linear sides 252, 254 that are connected to each other and to the circular portion 250, over which the tensioning suture or suture portions 180, 182 are folded. The loop portion 212 may be made of a biocompatible wire or other sturdy material and is less flexible so as to be able to effectively transfer tension from the locking suture 210 to the tensioning suture portions 180, 182. The outer surface 256 of the loop portion 212 is circular (e.g., made of a wire having a circular cross-section) and in some embodiments is smooth so as to reduce friction between the loop portion 212 and the tensioning suture portions 180, 182 during use. It has been found in experimental tests that the cross-sectional diameter of the wire used in the embodiment of the loop portion 212 has a significant effect on the friction between the loop portion 212 and the suture portions 180, 182, and for a 0.35 mm diameter suture made of ultra-high molecular weight polyethylene (UHMWPE), the diameter of the wire used to make the loop portion 212 should be 0.021 inches or greater.

[0060] The side portions 252 and 254 are integral or monolithic with the circular portion 250 and are linear in this embodiment, connecting to each other at the vertex 258. The linear nature of the side portions 252, 254 is intended to closely mate with the tapered side portions 240, 242 of the band 20 at the end 226 of the band 20, and in a particular embodiment, the angle between the side portions 252, 254 at the vertex 258 is between 5 degrees and 30 degrees. The side portions 252, 254 can initially be separate and connected at the vertex 258, such as by welding, adhesives, or other techniques, or they can be formed to be connected to each other and to the circular portion 250. The loop portion 212 is held to the tapered side portions 240, 242 of the band 20 by a retaining element 260, which can be similar or identical to the embodiments of the retaining element 84 described above.

[0061] The embodiment of the band 20 with the loop portion 212 provides several advantages, including low friction between the tensioning sutures 180, 182 and the band 20, and a lower risk of the locking suture 210 with the protrusion 230 jamming on the band 20. This design will allow the band 20 to be tightened by up to approximately 50% of the original length of the band 20, which will provide sufficient tricuspid annulus reduction in TR treatment. Additionally, as described above with respect to Figure 11 If one of the sutures 180 or 182 fails, the other suture remains to provide tension to the band 20.

[0062] The use of the band 20 will now be discussed in the context of being placed in or along the AV groove of a patient and tensioned to treat TR or other conditions. It will be understood that the disclosed structure can be used in other positions or contexts. The embodiments in Figure 12 are specifically referenced in the following discussion. However, it should be understood that the methods described below generally apply to other embodiments of the band 20 described herein, with the main difference being the absence of the loop portion 212 and / or the locking suture 210.

[0063] The band 20 is delivered to the AV groove, such as by a delivery system (not shown), which can include an introducer as disclosed in PCT / US2017 / 058245 filed on October 25, 2017, which is incorporated herein by reference in its entirety. The band 20 exits the delivery system and encircles the heart and is located in the AV groove. The band 20 and the suture portions 180, 182 thus encircle the heart.

[0064] When it is determined that the placement of the band 20 is satisfactory, the user continues to tighten the band 20 to reduce the tricuspid annulus around the AV groove on the heart. The user pulls on the locking suture 210 using a suitable tool (not shown) such that the locking suture begins to exit the end 224 of the band 20 and move 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 is transmitted around the loop portion 212 to tension the suture portions 180, 182. The suture portions 180, 182 are thus pulled through their respective retaining elements 184. Pulling on the suture portions 180, 182 reduces the radius of the suture portions 180, 182 around the heart, forcing the band 20 inward against the heart, and the respective ends of the suture portions 180, 182 that are fixed to the end 224 of the band 20 compress the length of the band 20. As the length of the band 20 is compressed, the mesh of the band 20 converts this compression into an expansion in width, providing flexibility to limit or reduce the pressure applied to the coronary arteries or other structures.

[0065] The locking suture 210 is pulled until the desired tricuspid annulus reduction is achieved. In a particular embodiment, as described above, this amount is achieved by reducing the length of the band 20 to up to 60% of its original length. Once the tightening or tensioning is complete, the locking mechanism M is actuated to hold the locking suture 210 in a tensioned state. The delivery and other tools can then be removed and the procedure is complete.

[0066] The structures or other features specified in the above clauses may be included in the device of the present invention alone or in any combination with other structures or features described above with respect to any embodiment.

[0067] According to the above device, similar or identical devices can be used to treat body organs or tissues in an open surgical environment, particularly (but not limited to) treating the heart. That is, an annuloplasty device delivered surgically is disclosed for placement on the epicardial surface of the heart, such as around the AV groove, and the device is delivered by a surgical thoracotomy method. For example, after exposing the epicardial space by a sternotomy or thoracotomy, the device is placed and secured around the heart. The device can be tightened to restrict the annular size of one or both of the tricuspid and mitral valves. By restricting these sizes, the leaflets are pulled closer together, enabling them to seal better and reduce regurgitation through either valve.

[0068] In the following discussion, devices are described that have features similar or identical to those of the sutures or other tensioning elements 78, 80, 82, 180, 182 and / or the band 20 around the above-described elements. It can be seen that the devices as described above can be used with open surgical methods. The following embodiments have been developed with particular attention to such methods, although it can be seen that they (or their features) can be used with other methods or other embodiments described herein.

[0069] At its bottom, the device described below (starting with the embodiment of device 300 shown in Figure 13 includes a tension member 302 that wraps around the heart, preferably at the level of the AV groove. The tension member 302 is preferably a high-strength surgical suture material, such as a braided suture made of high molecular weight polyethylene, but it can also be made of other materials, such as wire, other surgical suture materials, braided tapes of such materials, fabric tapes of biocompatible or bioabsorbable fabrics, or bioabsorbable materials, such as absorbable sutures or tapes made of biological products such as small intestinal submucosa (SIS) tissue. The tension member 302 can be tensioned or shortened to provide additional tension or pressure on the heart, or loosened or lengthened to relieve such tension or pressure. In this way, the amount of restriction on the cardiac annular dimension and the valve to be treated can be controlled.

[0070] In a particular embodiment, the tension member 302 is used without a cover, tape (such as the tape embodiments described above), or other protective member. For open surgery, the surgeon can simply manipulate the tension member 302 to wrap it around the heart (schematically represented by H in Figure 13 ), for example, place it above or within the AV groove. For example, using existing tools (such as clamping tools like hemostats or threading tools like needles) and / or hands, the surgeon can manually wrap or thread the tension member 302 around the heart. The tension member 302 can be held in a tensioned state around the heart by tying knots and / or using holders or tools described below. When the tension member 302 is tensioned around the heart, excessive slack accumulates at the junctions of the two ends 304, 306 of the tension member 302. This excessive slack can be passed through a lock or buckle (discussed further below) and allowed to accumulate in the pericardial space around the heart. Once the desired amount of force or restraint has been established around the heart, it can also be trimmed with a cutting tool.

[0071] In Figure 13In an embodiment, each end 304, 306 of the tension member 302 is fixedly attached to a respective buckle 310, 312. Each buckle 310, 312 then slides along opposite ends of the tension member 302, e.g., buckle 310 slides along end 304 while buckle 312 slides along end 306. When the buckles 310, 312 are pushed apart relative to each other (as indicated by arrow A), the tension member 302 is pulled tighter, thereby reducing the area surrounded by the tension member and increasing the force or constraint on the heart. Conversely, when the buckles 310, 312 are pulled together (arrow B), the tension member 302 loosens, expanding the area within the tension member and reducing or eliminating the force acting on the heart. One or more tools may be provided to hold, guide, or provide force to one or both of the buckles 310, 312 when pulling the buckles 310, 312 apart or pushing them together to adjust the tension while minimizing any lateral force applied to the heart.

[0072] The tension member 302 is preferably designed to apply a load extensively to the outer surface of the heart. Thus, it may have a shape or structure that is significantly wider than its height, such as a widened structure like a band or ribbon (as described in the examples above with respect to FIGS. 3 - 6). Such a band or ribbon may have a lateral stiffness sufficient to prevent or inhibit twisting during use to ensure that it contacts the heart with its widened dimension rather than a narrow edge. As an example, the tension member 302 may be woven with transverse strengthening members 318 (shown as ribs in Figure 14 ) or molded therein or onto it to provide such lateral stiffness. The ribs 318 may extend along part or all of the top and / or bottom of the tension member 302. The stiffness of each rib 318 may be greater than or similar to the stiffness of the tension member 302. The ribs 318 prevent or minimize the ability or chance of one side of the tension member 302 from flipping over or the whole turning to a narrow edge by increasing the required torque.

[0073] In a particular embodiment ( Figure 15 ), the tension member 302' is an elastic fiber structure that has a natural stress - free diameter or internal dimension but can be stretched or expanded to a larger size for placement around the heart. In this embodiment, the tension member 302' may be a complete loop, as initially formed or having pre - connected ends. The tension member 302' will be pre - selected based on the patient's heart size so as to elastically constrain the heart after placement. The tension member 302' will expand during placement around the heart according to the surgeon's desire, remain around the heart, equal to or slightly larger than its initial stress - free size, thereby engaging the heart tissue and applying a force on the heart tissue. The elastic material for this embodiment may include a structure woven from nitinol that is heat - set to a shortened state but can be stretched to a larger state when placed around the heart.

[0074] As previously described, the tensioning member itself can be used in open surgery. In some embodiments, the tensioning member (e.g., the suture or tensioning member 302, 302' as described above) can pass through the band 20 (as described above) or other protective member 320 (e.g., Figure 16 ). The protective member 320 in the following discussion can be or include the features of the band 20 described and shown above. For example, outside of the tensioning members 302, 302' passing through the protective member 320, the protective member 320 can be shortened or lengthened to provide complete coverage of the entire length of the tensioning member 302, even when the length of the tensioning member 302 is shortened or lengthened (accompanied by the associated contraction or expansion of the area defined by the tensioning member 302) to adjust to the cardiac size and / or degree of constraint desired by the surgeon. As previously described, the mesh band expands or contracts in length (e.g., widens as it shortens) to better distribute the contact force applied to the heart or organ and can be used as the protective member 320.

[0075] In a particular embodiment, similar to the embodiment of the tensioning member 302 described above, the protective member 320 is made of a twist-resistant memory material and tends to maintain the widened dimension (rather than the narrower edge) of the protective member to maintain contact with the heart. The protective member 320 is preferably readily visible in any of a variety of imaging modalities, such as fluoroscopy, CT scan, ultrasound imaging, and / or magnetic resonance imaging. Particularly with respect to MRI, embodiments of the protective member 320 can be materials that do not cause local heating or generate stimulating electric fields during scanning. To this end, the protective member 320 can be made of a non-conductive material and coated to prevent such effects.

[0076] Similar to the band 20 described above, the protective member 320 can have one or more tensioning members extending through it as described above. In a particular embodiment, the protective member 320 has a guiding member to guide a single tensioning member or multiple tensioning members within the protective member 320. The guiding member can hold the tensioning members at opposite ends of the cross-section of the protective member 320 (see Figure 8 、 9 、11、12), which, as described above, allows for better distribution of the applied force of the tensioning member 302. When the protective member 320 widens, the multiple tensioning members 302 are further apart.

[0077] Such guiding members can be the same as or similar to the structures discussed above and shown in Figure 8 、 9 、11、12. For example, they can be suture loops ( Figure 8 、 11 、12) or loop portions attached to points on the protective member ( Figure 9)。In other embodiments, the protective member 320 may have a guide loop that is heat welded or heat set into the structure (e.g., in a braided structure, to one or more braided filaments) to allow the tension member to pass therethrough easily. Such a heat set guide loop may be positioned as the suture loop seen in the figures above. As a further alternative, the protective member 320 may have a guide coil 330 wound therethrough to allow the tension member 302 to pass through. The coil 330 defines a lumen 332 as it is wound through the filaments or material of the protective member 320, and the tension member 302 may pass through the lumen 332.

[0078] Several possible treatments (mechanical, chemical, or by application of a composition) are contemplated for the tension member and / or the protective member. For example, the entirety (or at least the heart contact surface) of the tension member (e.g., tension member 302) and / or the protective member (e.g., strap 20 or other protective member 320) may be treated to promote tissue ingrowth. The surface may be textured or have a Velcro-like loop structure that promotes tissue growth on or within the surface. As another example, the surface (e.g., the pericardial surface) may be treated to prevent pericardial adhesions, such as by making it smooth and / or made of or having a coating that resists tissue ingrowth. As another example, one or both of the tension member and the protective member may be treated or coated with an antimicrobial agent to produce anti-infectivity, or treated or coated with an anti-inflammatory agent to resist inflammation and produce pericardial adhesions.

[0079] The above-described embodiments of the protective member (including the strap 20) are single units, the ends of which are either separated to tighten or joined to form a continuous loop portion. In Figure 18 the illustrated embodiment, the protective member 420 is divided into two half-loop portions 422, 424, but is otherwise consistent with the embodiments discussed herein. That is, each half-loop is constructed in the manner disclosed herein, such as a wire mesh having a lumen, and each half-loop has its own suture or tension member 426, 428. The two half-loop portions 422, 424 allow independent control by the surgeon of the protection and restraint around the left and right sides of the heart, respectively. As Figure 18 shown, the tension members 426, 428 form respective loops within the half-loop portions 422, 424 and engage the respective half-loop portions in a manner that allows them to be tensioned and restrained around a portion of the heart independently of each other.

[0080] The two half-loop portions 422, 424 may be at the heart location where the right heart RH abuts the left heart LH (at Figure 18At the connection points (schematically indicated by H). The anchor 430 to the heart can be placed at these connection points or locations, and preferably, each of the half-ring portions 422, 424 is independently anchored to the heart to fix the half-ring portions 422, 424 to the heart. The anchor 430 can be a suture or a known small helical anchor for anchoring soft tissue, which can be inserted into the heart wall. A set of one or more tension members 426 can be arranged around the right side of the heart within the half-ring portion 422, while a separate set of tension members 428 is arranged around the left side of the heart within the half-ring 424. These two sets of tension members 426, 428 can be tightened independently to allow selective control of the force or constraint on the mitral annulus (left heart) or tricuspid annulus (right heart).

[0081] In some embodiments, the protection member can be or include an inflatable balloon or sac that creates a constraint when inflated against heart tissue. As Figure 19 shown, the protection member 520 includes a series of independent balloons or sacs 522 connected together (such as by sutures or other flexible connections), which form segments or portions of the annuloplasty device, enabling local application of force or constraint to the heart. As an example, the tension members and / or protection members as described above can extend through a known radially expandable balloon such that the balloon can be inflated at least on the side facing the heart tissue. There can be a left-sided balloon or sac and a right-sided balloon or sac to allow independent control of either side of the heart tissue, as discussed above with respect to the protection member 420.

[0082] As discussed above with respect to the band 20, the protection members in various embodiments can be formed or configured (e.g., wider) in different ways in certain portions of the AV groove where there is a greater risk of coronary artery occlusion. Similarly, the protection members in various embodiments can be heat-set into various shapes, such as a saddle shape to conform to the saddle-shaped AV groove.

[0083] A specific example of the protection member 620( Figures 20A - 20C ) can be or include a flat ribbon-like braid 622 heat-set in place. A plurality of channels 624 are formed in the braid 622 to allow a plurality of (e.g., 2 or 3) tension members to pass through the protection member 620 and be generally parallel to each other. The protection member 620 can be made of nitinol filaments or strips and heat-set on parallel mandrels 626, thereby forming a plurality of different channels. In the illustrated embodiment, the cross-section of the protection member 620 has three lumens 624 for three independent tension members to pass through. Figure 20B A basic braid with three passages or channels 624 is shown, while Figure 20C a two-sided channel 624 with additional loops is shown. The central channel can be used between the outer loop channels on the sides.

[0084] Embodiments of the tensioning member and / or the protecting member as described herein may also include an auxiliary arm for providing additional tension or restraint to the heart at a location other than the location affected by the main portion of the tensioning member and / or the protecting member. In Figure 21 the embodiment schematically shown in, the tensioning member and / or the protecting member 720 includes such an auxiliary arm 722 connected to the main member 724. The arm 722 may pivot or otherwise be adjustable relative to the main member 724. While the main member 724 encircles the AV groove or other desired location on the heart, the arm 722 encircles another location, such as a lower point on the ventricle. When the protecting member 720 is implanted, the arm 722 in this embodiment engages the main member 724 near the junction of the left and right hearts. In such an embodiment, the arm 722 may pass downwardly over the free wall of the ventricle, thereby imposing a restraint on the heart at the anchor points of the papillary muscles and further enhancing the ability of one or both of the mitral and tricuspid valve leaflets to close properly.

[0085] The tensioning member and / or the protecting member as disclosed herein is intended to provide convenience for initial placement and adjustment when they are implanted. The free ends of the tensioning member and / or the protecting member as disclosed herein can be pulled to tension around the heart, temporarily held to allow the surgeon to evaluate placement, the amount of tension or other factors, and then can be easily adjusted before permanent locking or easily removed if withdrawal is indicated.

[0086] Embodiments of the tensioning member preferably include two parallel members or portions (such as Figure 13 304, 306 in or Figure 8 , 9 , 80, 82 in 11), which are connected together or adjacent at one end. This end can be pulled out through a sliding hole or loop at the end of the protecting member and / or the tensioning member. The hole or loop can be or include any of a variety of structures. For example, the tensioning member itself may include a loop through which the adjacent or connected ends pass (similar to a lasso knot). The sliding loop in the tensioning member can be fixedly held when the surgeon pulls the end through it, thereby causing the tensioning of the tensioning member.

[0087] In a similar arrangement, the parallel tensioning member portions (such as 304, 306) independently pass through corresponding holes 800 in a button-shaped disk 802 fixed to one end of the tensioning member or the protecting member ( Figure 22)。The surgeon can pull the legs 304, 306 through their respective holes 800 to tighten the tensioning member (and any protective member) around the heart. When a sufficient amount of tension is applied by pulling, the two legs can be held or connected together (i.e., knotted or connected at position 804). When the two legs 304, 306 are tied or connected together, the joint at 804 cannot pass through the hole 800, thereby locking the length of the tensioning member as needed. As an alternative to the separate disc 802, a pair of parallel loops can be heat-set to the ends of the protective member (such as a nitinol braided protective member) to provide the holes 800 and to prevent the tied or connected legs 304, 306 from passing through and to maintain the tension.

[0088] In this example, the two legs 304, 306 can be temporarily held or connected together by a temporary clamp (such as a hemostat) or other locking device to prevent them from returning through the hole 800. This allows the surgeon to temporarily set the restraint level by pulling the legs 304, 306 through the hole 800 and then evaluate the physiological response before permanently locking the length of the tensioning member.

[0089] Other types of locking structures can be fixedly attached to one or both ends of one or more tensioning members (such as 302) and / or protective members (such as 320). An example of such a locking structure 900 is shown schematically in Figure 23 FIG. The lock 900 includes a body 902 shown in cross-section as a cylinder to minimize the edge surfaces on the implantable lock. The body 902 defines a channel or chamber 904 having openings 906, 908, shown in one embodiment as being opposite each other. Within the channel 904 is a rod or jaw 910 pivotally anchored to the body 902 by an axis or pivot point 912. The engaging end of the jaw 910 can include a rough or toothed portion 914 for engaging a suture or other tensioning member passing through the channel 904. A spring 916 is fixed to the inner surface 918 of the body 902 and enters the channel 904 and contacts the surface of the jaw 910 opposite the rough portion 914 so as to bias the jaw 910 away from the surface 918 and towards or against the opposite surface 920 within the channel 904. A button 922 is connected to the body 902 so as to contact (or be able to be placed in contact with) the lever end of the jaw 910, which is opposite the engaging end of the jaw, on the opposite side of the axis or pivot point 912.

[0090] One or more adjustable ends (such as 304, 306) of one or more tension members (such as 302) can pass through channel 904 via openings 906, 908. As described above, the locking structure 900 in the illustrated embodiment is normally closed by the biasing of spring 916. By pressing button 922 to pivot jaws 910 and move the engaging end away from the surface of channel 904, such a suture or tension member portion can slide along locking structure 900 or slide into and out of locking structure 900. When button 922 is released, jaws 910 pivot under the biasing of spring 916 such that the rough portion 914 presses the suture or tension member portion against the surface of channel 904. The locking structure 900 is thus locked, and the adjustable end of the tension member is fixed within the locking structure 900, holding the tension member at a specific length and amount of restraint on the heart. Movement of the tension member is restricted until button 922 is pressed to pivot jaws 910 and unlock the lock, thus allowing the tension member to slide through lock 900 and its overall length to be adjusted. Thus, lock 900 can have a temporary locking position, allowing unlocking and further adjustment as needed, but can be held in a permanent locked state as desired. Lock 900 can include a shape or specific outer surface that allows engagement with a holding or grasping tool, thus making operation of lock 900 and the tension member passing through it easier.

[0091] In other embodiments, the locking structure can be normally open, such that jaws 910 are biased by a spring (such as 916) to an open position, allowing the tension member to slide through until it is actuated by a tool or handle designed to press jaws 910 against the tension member, or otherwise allowing it to engage the tension member. Such a tool can have jaws (such as a hemostat). In some embodiments, multiple jaws 910 can pivot or operate together within lock 900 like a hemostat. Other types of locking structures can be used, such as those described in application serial number 16 / 394,192 (filed on April 25, 2019) and PCT / US2019 / 032216 (filed on May 14, 2019), the entire contents of which are incorporated herein by reference.

[0092] Embodiments of the open surgical system described herein include not only the ability to adjust the annuloplasty implant during placement, but also the ability to control, evaluate, and provide information regarding the tightening of the system and its effects. As described above, the tension member (with or without a protective member) can be initially placed around the heart and be in a tensioned state to provide correction for valve problems or other heart problems. Tension can be applied in a variety of ways, such as by pulling on the adjustable end of the tension member while supporting or providing counter-traction to another portion of the tension member and / or the locking structure, sliding ring, or disk attached to it (as described above). The adjustable end of the tension member can be pulled with a tool, such as a ratchet pulling tool designed for single-handed operation.

[0093] Examples of structures that can be used to assist in tensioning the tension member and / or protecting the member are shown in Figures 24 to 26 . An example of a suture or tension member 302 is shown extending from a protective member or band (such as 20, 320). Each free end 304, 306 of the tension member 302 is tied or otherwise secured to a spool 950. A stabilizing plate 952 is also provided, which has holes 954, stabilizing arms 956, and valleys 958 between the arms 956 and the holes 954. The holes 954 are sized to be approximately the same as the maximum external dimension of the base of the spool 950, so that the spool 950 can be inserted into the holes 954. In a particular embodiment, the spool 950 fits tightly against the inner wall of the holes 954, so that the spool 950 does not rotate relative to the plate 952 after insertion. The arms 956 are separated from the body of the plate 952 by slots 960, and in the illustrated embodiment, both the slots 960 and the arms 956 are generally parallel to the valleys 958. Although in this embodiment the holes 954 and the arms 956 are in a portion of the plate 952 that is in the same plane, the valleys 958 are connected to those portions that curve (such as cylindrically) out of the plane. The valleys 958 have a concave surface 962 that is lower (as Figures 24 - 26 shown) than the plane of the rest of the plate 952.

[0094] A guiding tool 970 is also shown, which includes a central shaft or rod 972 and opposite ends 974, 976. The ends 974, 976 are enlarged compared to the shaft 972 and can be generally circular with a diameter approximately twice the width of the shaft 972. The end 974 includes a gap or slot 978 that is rectangular in the illustrated embodiment, which has side surfaces 980 that are generally parallel to the longitudinal axis of the shaft 972. The end 976 includes a gap or slot 982 that is also rectangular in the illustrated embodiment, but whose side surfaces 984 are inclined (such as approximately 30 to 45 degrees) relative to the longitudinal axis of the shaft 972.

[0095] In one usage example, the protection members 20, 320 are mechanically positioned around the heart (e.g., in an open surgery), and the slack of the tension member 302 accommodates dimensional variability and ease of positioning. The spool 950 (the connecting end with the tension member 302) is placed in the hole 954 of the stabilizing plate 952, and the tension member enters the slot 960 to extend between the arm 956 and the rest of the plate 952 and over the valley 958. Then the surgeon can pre-tension the protection member and the tension member by aggregating the slack in the tension member into one or more loops placed around the spool 950. Alternatively, if there is excessive slack in the tension member, a portion of the tension member can be removed, and the tension member can be re-tied or otherwise re-connected to the spool 950. The valley 958 makes the operation of the tension member easier (either by hand or with tools) by maintaining the space between the plate 952 and the tension member. The valley 958 thus allows a finger or tool to easily manipulate under the tension member so that it can be grasped.

[0096] The guiding tool 970 is placed such that the end 974 faces generally towards the spool 950, the shaft 972 passes through the valley 958, and the end 976 is adjacent to the arm 956. The gap 982 faces away from the arm 956. The guiding tool 970 is also placed such that when the tension member 302 goes from the slot 960 to the spool 950, it passes through or around the gaps 978, 982. The surgeon can fine-tune the tension in the tension member by winding (to tension) or unwinding (to loosen) the tension member around the spool 950. When the tension member is wound or unwound from the spool, the guiding tool 970 ensures that the tension member stays in place and does not twist. When the desired tension has been reached, the guiding tool 970 can be removed. The spool 950, the plate 952, and / or the tool 970 can be made of biocompatible materials, and at least the spool 950 and the plate 952 can be retained in the body after the surgery is completed.

[0097] Other devices for tightening and pulling the adjustable end of the tension member to tension the tension member (and / or the protection member) around the heart are contemplated. For example, the spool 1000 can be rotatably mounted to the end of the protection or tension member, and the adjustable end of one or more tension members is fixed to or looped around the spool. When the spool rotates (e.g., directly rotated using a gripping or rotating tool, or remotely rotated using a long flexible torque coil), the adjustable end of the tension member is pulled around the spool to slacken and / or tighten it. Such a spool allows the heart tissue to be better mechanically isolated from the application of force.

[0098] An implantable micro motor and / or transmission 1002 can be used with the spool 1000 or with other structures to tension the tension member. As Figure 27As schematically seen, the motor and / or transmission 1002 can be rotatably connected to the drive shaft 1004 of the reel 1000 (e.g., forming a worm gear drive), rotating the reel 1000 (as shown by the arrow) to pull the slack in the tension member. In a particular embodiment, the motor and / or transmission 1002 is remotely controllable. Thus, even after implantation is complete and the surgical site is closed, the adjustability of the tension in the tension member (and thus the force acting on the heart) can be maintained. Alternatively, instead of a reel, an implanted linear slider 1010 ( Figure 28 ) can be connected to the adjustable end of the tension member and also to the motor and / or transmission 1002. Whether the motor and / or transmission 1002 rotates or linearly moves the shaft 1004, the slider 1010 moves towards the motor and / or transmission 1002 to pull the slack in the tension member and increase the tension.

[0099] Devices and methods for measuring the amount (length) of the tensioned tension member and / or protective member are also contemplated. For example, in the above embodiment with the motor 1002, the motor mechanism can include an encoder that measures the displacement of the tension member. This displacement amount can be monitored or used to calculate the amount of constriction applied to the heart. The motor mechanism can also or alternatively allow the user to indirectly measure the tension load based on the current consumption on the motor. Since the current consumption increases as the tension increases, these two factors can be correlated to provide an estimate of the tension on the tension member.

[0100] As other examples, embodiments as described herein can include one or more torque sensors attached to the motor shaft or the reel for winding the tension member to measure the applied tension. A load sensor can be placed in series with the tension member to measure the tension applied thereto, or the tension member can extend over a pulley or reel connected to the load sensor to measure the applied tension. The tension member and / or protective member can be marked in increments (e.g., in millimeters or tenths of a millimeter) to allow the surgeon to directly observe the amount of displacement during tensioning. Similarly, a pull or other tensioning tool with a scale or gauge for measuring displacement or tension can be used to tension the tension member.

[0101] When tensioning occurs, information or commands related to the tension in the tensioning member and / or the displacement of the tensioning member can be sent to or received from a remote monitor or controller. For example, signals from a tension sensor or displacement sensor as described above can be transmitted wirelessly, optically, acoustically, or wired to a computer, video, or other external monitor or controller. An implantable monitor or controller can also collect, store control signals, and apply the control signals to a motor (as described above) as needed, and in certain embodiments can include a transmitter to periodically send the collected data (e.g., regarding tension, cardiac function, or other variables) to a remote monitor for clinician access. Such a controller and / or monitoring system allows for the periodic monitoring of the annuloplasty system without an invasive procedure. The system can include a control loop that allows the tensioning member to be tightened or loosened based on the observed tension (e.g., via an implanted motor). If the tension changes, or if a change in the observed tension is noted, the system can notify or alert the patient and / or clinician.

[0102] Other examples of sensors that can be included in an annuloplasty device as described herein are accelerometers mounted to one or more tensioning members and / or one or more protective members, or microphones attached to or associated with them. The accelerometer can detect cardiac motion and be used as a surrogate for directly measuring stroke volume or ejection fraction. This information can allow for the direct adjustment of device tension and can also be used as diagnostic information for the management of heart failure in the patient pharmacologically or otherwise. The microphone can be focused on the valve (mitral and / or tricuspid) and used to assess regurgitation. The signal can be used to guide further adjustment of the annuloplasty device as needed to minimize regurgitation.

[0103] In some embodiments, the annuloplasty device (tensioning member and / or protective member) as described herein can include electrodes that contact the right atrium, right ventricle, left atrium, and / or left ventricle. Such electrodes sense and provide electrogram timing information from each cardiac chamber and can be used to pace the cardiac chamber. Larger electrodes (or a single large electrode) can be incorporated into a defibrillation device. The electrodes can also be used to sense impedance changes related to volume changes during the cardiac cycle or impedance changes related to fluid overload due to heart failure. Independent regulation on the right and left sides of the heart can allow for the control of fluid distribution through the heart and body and can be guided based on information sensed by the electrodes. If pacing and sensing locations separate from the AV groove region are needed, satellite electrodes can be placed and connected to the annuloplasty device by a wire. Additionally, a pulse generator can be incorporated into the annuloplasty device, allowing for pacing without a transvenous lead placed within the heart or through a heart valve.

[0104] In the above discussion, particular attention is paid to the use of the devices described herein in open annuloplasty, i.e., by placing one or more contraction tensioning members and / or one or more protective members around the heart in a direct manner. It should be understood that the above-described structures, steps, and features may be used in conjunction with other body structures, therapies, or surgical procedures.

[0105] Although the present disclosure has been described and illustrated in detail in the drawings and the foregoing description, it should be considered illustrative rather than restrictive, and it should be understood that only selected embodiments are shown and described, and all equivalents, variations, modifications and variations falling within the spirit of the disclosure as defined herein or defined by the appended claims are intended to be protected. It should be understood that features described particularly with respect to one or more specific structures or embodiments may be combined with other structures or embodiments disclosed herein or otherwise used with other structures or embodiments.

[0106] The following numbered clauses list specific embodiments that may be helpful in understanding the present invention:

[0107] 1. A band for placement along the atrioventricular groove of the heart, comprising:

[0108] 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 longitudinally configured into a ring so as to surround the heart and be placed along the atrioventricular groove;

[0109] a first suture portion within the tube, secured to the tube adjacent the first open end and extending through the lumen of the tube toward the second open end, the first suture portion being connected to the tube within the lumen of the tube by a plurality of retaining elements such that the first suture portion is longitudinally movable relative to the tube by the retaining elements;

[0110] a second suture portion within the tube parallel to and spaced apart from the first suture portion, the second suture portion being secured to the tube adjacent the first open end and extending through the lumen of the tube toward the second open end, the second suture portion being connected to the tube within the lumen of the tube by a plurality of retaining elements such that the second suture portion is longitudinally movable relative to the tube by the retaining elements;

[0111] Wherein pulling the first and second suture portions tightens the tube to reduce the area of ​​the loop, causing the tube to compress longitudinally at at least selected locations along the tube.

[0112] 2. A belt according to claim 1, wherein the first stitch portion and the second stitch portion each extend through the second open end of the tube to provide the first and second stitch portions outside the tube and capable of being pulled to tighten the corresponding portions of the tube.

[0113] 3. A belt according to any of clauses 1-2, wherein the first stitch portion and the second stitch portion are portions of a single tensioning stitch having a middle portion between the first stitch portion and the second stitch portion, and further comprising a locking stitch attached to the middle portion of the tensioning stitch.

[0114] 4. A belt according to any one of clauses 1-3, further comprising a loop portion within the tube and adjacent to the second open end, wherein the tensioning suture is folded over and passes through the loop portion, wherein the first and second suture portions are on one side of the loop portion and the middle portion is on the other side of the loop portion.

[0115] 5. The belt according to clause 4, wherein the loop portion includes a circular joint portion, and the tensioning stitching is folded around the circular joint portion.

[0116] 6. A belt according to claim 4, wherein the loop portion includes a first and a second linear side, the first and second linear sides are parallel to the tube near the second open end, the first linear side is connected to the tube by at least one retaining element, and the second linear side is connected to the tube by at least one retaining element.

[0117] 7. The belt according to any of clauses 3 to 6, wherein the locking suture includes a plurality of protrusions for maintaining tension applied to the locking suture and transmitted to the first suture portion and the second suture portion.

[0118] 8. A belt as described in claim 7, wherein the locking suture has a length within the tube and a portion that exits the tube through the first open end, and wherein the protrusion is over the entire length of the locking suture within the tube and adjacent to the first open end, and is not otherwise over the length of the locking suture within the tube.

[0119] 9. The belt of any of clauses 1-8, wherein the mesh is nitinol.

[0120] 10. A belt according to any of clauses 1 to 9, wherein the mesh is heat set so that when the tube reaches body temperature its cross section assumes a barbell shape.

[0121] 11. A belt according to any of clauses 1 to 9, wherein the mesh is heat set so that when the tube reaches body temperature its cross-section assumes an elliptical or oval shape.

[0122] 12. A belt according to any one of clauses 1 to 9, wherein the mesh is heat set so that when the tube reaches body temperature it assumes a flat belt shape.

[0123] 13. The band according to any one of clauses 1-9, wherein the mesh is heat-set such that when the tube reaches body temperature, it assumes a shape having a first region and a second region, the first region having a first annulus diameter and a first cross-sectional dimension, and the second region having a second annulus diameter and a first cross-sectional dimension, wherein the first annulus diameter is greater than the second annulus diameter, and the first cross-sectional dimension is greater than the second cross-sectional dimension.

[0124] 14. The band according to clause 13, wherein an intermediate portion between the first region and the second region includes a contour adapted to conform to at least a portion of the atrioventricular groove.

[0125] 15. The band according to any one of clauses 1-9, wherein the mesh is heat-set such that when the tube reaches body temperature, it assumes a saddle shape having one or more lower circular contour regions, and wherein at least one of the lower circular contour regions is adapted to fit snugly within the atrioventricular groove.

[0126] 16. The band according to any one of clauses 1-15, wherein each of the two suture portions is part of a respective separate suture.

[0127] 17. The band according to any one of clauses 1-16, wherein the two suture portions are joined to form a loop.

[0128] 18. The band according to clause 17, wherein the loop is connected to an elongate element at least partially external to the band, the elongate element being one of a locking suture and a delivery filament.

[0129] 19. An annuloplasty system for open surgery, comprising:

[0130] A tensioning member adapted to be implanted by wrapping around the heart external to a catheter system;

[0131] Locking means for maintaining the tensioning member in a tensioned state around the heart and for allowing adjustment of the tension in the tensioning member.

[0132] 20. The annuloplasty system according to clause 19, further comprising a protective member through which the tensioning member passes, the protective member having a guide for the tensioning member and being made of a torsion-resistant shape memory material.

[0133] 21. The annuloplasty system according to clause 20, wherein the protective member has a first half-ring portion adapted to be attached to a first part of the heart and a second half-ring portion adapted to be attached to a second part of the heart.

[0134] 22. The annuloplasty system according to clause 20, wherein the tension member includes a first leg and a second leg, and the locking device is attached to the protection member and includes a first hole and a second hole, wherein the first leg extends through the first hole and the second leg extends through the second hole, and the legs can be held in a holding position, wherein the first hole and the second hole are located between the holding position and the protection member.

[0135] 23. The annuloplasty system according to clause 20, wherein the locking device includes a stabilizing plate having holes and valleys, and a spool located in the holes, wherein the tension member can be wound around the spool to increase the tension on the tension member and unwound from the spool to decrease the tension on the tension member.

[0136] 24. The annuloplasty system according to clause 20, further comprising at least one of a micro motor and a transmission operably connected to the tension member, wherein the operation of the at least one of the micro motor and the transmission is adapted to perform at least one of tensioning and relaxing the tension member when the tension member is placed around the heart.

[0137] 25. The annuloplasty system according to clause 19, further comprising a device operably connected to the tension member for directly or indirectly measuring the tension or length of the tension member that has been displaced when tensioning the tension member, the device being selected from the group consisting of: an encoder that measures the displacement of the tension member; a sensor that measures the current consumed on a motor operably connected to the tension member; a torque sensor that is operably connected to the tension member; a load cell placed in series with the tension member; a tensioning tool that includes a scale or gauge for measuring the displacement of the tension member.

Claims

1. An annuloplasty system for open surgery, comprising: A tension member adapted to be implanted by wrapping around the heart outside a catheter system during open surgery; A locking device for maintaining the tension member in a tensioned state around the heart and allowing adjustment of the tension in the tension member during open surgery; And A protection member through which the tension member passes, the protection member having a guide for the tension member and being made of a torsion-resistant shape memory material, the protection member comprising a material that can be seen by means of any one of fluoroscopy, CT scan, ultrasound imaging, and / or magnetic resonance imaging.

2. The annuloplasty system according to claim 1, wherein, The protection member has a first half-ring portion adapted to be attached to a first portion of the heart and a second half-ring portion adapted to be attached to a second portion of the heart.

3. The annuloplasty system according to claim 1, wherein the tension member comprises a first leg and a second leg, and the locking device is attached to the protection member and comprises a first hole and a second hole, wherein the first leg extends through the first hole and the second leg extends through the second hole, and the legs can be held in a holding position, wherein the first hole and the second hole are located between the holding position and the protection member.

4. The annuloplasty system according to claim 1, wherein The locking device comprises a stabilizing plate having holes and valleys, and a spool located in the holes, wherein the tension member can be wound around the spool to increase the tension in the tension member and unwound from the spool to decrease the tension in the tension member.

5. The annuloplasty system according to claim 1, further comprising at least one of a micro motor and a transmission operably connected to the tension member, wherein the operation of the at least one of the micro motor and the transmission is adapted to perform at least one of tensioning and relaxing the tension member when the tension member is placed around the heart.

6. The annuloplasty system according to claim 1, further comprising means operably connected to the tension member for directly or indirectly measuring the tension or length of the tension member that has been displaced when the tension member is tensioned, the means being selected from the group consisting of: an encoder for measuring the displacement of the tension member; a sensor for measuring the current consumed by a motor operably connected to the tension member; A torque sensor operably connected to the tension member; A load sensor placed in series with the tension member; A tensioning tool comprising a scale or gauge for measuring the displacement of the tension member.

7. The annuloplasty system according to claim 1, wherein the locking device comprises a first buckle configured to engage the tension member at a first position.

8. The annuloplasty system according to claim 7, wherein the locking device comprises a second buckle configured to engage the tension member at a second position.

9. The annuloplasty system according to claim 8, wherein the tension member comprises an elongate member forming a loop having a first end attached to the first buckle and a second end attached to the second buckle; A first portion of the tension member is slidably received in the second buckle, the first portion being towards the first end of the tension member; And A second portion of the tension member is slidably received in the first buckle, the second portion being towards the second end of the tension member, such that the tension member is tightened when the first buckle and the second buckle are pushed apart.

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