Echo suture for cardiac surgery

Abstract

Disclosed herein are sutures (or cords) and methods for using sutures, wherein the sutures comprise a material or combination of materials configured to increase echoing of the suture. In some examples, the suture includes an echogenic material (e.g., ePTFE) incorporated into a suture material. In some examples, the suture includes a combination of materials having a sudden and relatively large density change to increase the reflection of ultrasound waves. The disclosed sutures enhance echoes to increase the visibility of the sutures using ultrasound imaging techniques. Further, disclosed herein are methods of utilizing the disclosed sutures in valve repair, including implantation of artificial cords, subvalvular techniques, organ remodeling, annuloplasty, and the like. Advanced results can be produced with the disclosed echo sutures, at least in part, as the physician can better visualize the placement and / or tensioning of the echo sutures.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 371,912, filed on August 19, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0003] Some examples described herein relate to the use of echogenic sutures in cardiac surgery. Background Art

[0004] Various disease processes may impair the normal function of one or more of the heart's valves. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic defects), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Additionally, damage to the ventricles from a previous heart attack (e.g., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) may distort the geometry of the heart, leading to valvular dysfunction in the heart. The vast majority of patients who undergo valve surgery, such as mitral valve surgery, suffer from degenerative disease that leads to dysfunction of the leaflets of the valve, which leads to prolapse and regurgitation.

[0005] Valvular regurgitation occurs when the leaflets of the valve do not fully close, thereby allowing blood to leak back into the previous chamber when the heart contracts. This may be due to annular dilatation (Carpentier type I dysfunction), prolapse of segments of one or both leaflets above the plane of coaptation (Carpentier type II dysfunction), or restriction of motion of one or more leaflets such that the leaflets are abnormally restricted below the plane of the annulus (Carpentier type II dysfunction). Mitral regurgitation (MR) leads to volume overload on the left ventricle, which progresses to ventricular dilatation, decreased ejection capacity, pulmonary hypertension, symptomatic congestive heart failure, atrial fibrillation, right ventricular dysfunction, and death.

[0006] A dysfunctional valve can be repaired or replaced. Replacement usually involves replacing the patient's dysfunctional valve with a biological or mechanical substitute. Repair usually involves preservation and correction of the patient's own valve. Successful surgical mitral valve repair restores mitral valve capacity, eliminates volume overload on the left ventricle, improves symptomatic status, and prevents adverse left ventricular remodeling.

[0007] In many cases of mitral valve regurgitation, repair is preferred to valve replacement. Many surgeons have moved to a "non-ablative" repair technique in which an artificial chord ("cord") made of expanded polytetrafluoroethylene ("ePTFE") suture or another suitable material is placed in the prolapsed leaflet and secured to the heart in the left ventricle, usually to the papillary muscles. Another technique developed by Dr. Alfieri involves securing the midpoints of the two leaflets together to create a double-orifice valve, known as an "edge-to-edge" repair or the Alfieri procedure. Another technique in addition to or in lieu of forming an edge-to-edge relationship includes securing together sutures extending from the leaflets to pull or otherwise move the posterior annulus toward the anterior leaflet and / or to move the anterior annulus toward the posterior leaflet to reduce the distance (or septal-lateral distance) between the anterior and posterior annuli.

[0008] Although mitral valve repair may utilize sutures, other heart surgeries also utilize sutures to repair other heart valves, reshape portions of the heart, and / or affect the function of targeted portions of the heart. Sutures may also be used in other surgeries aimed at resolving problems in other organs or helping to secure tissues such as tendons, ligaments, etc. Summary of the invention

[0009] Echoic sutures or ropes for surgical procedures such as cardiac surgery are described herein. For example, sutures comprising materials and combinations of materials described herein can be implanted as artificial ropes (e.g., to replace or supplement natural tendons) for repairing heart valves. The disclosed sutures are configured to amplify the echogenicity (signature) of the sutures to increase visibility when using ultrasound technology. The echogenic sutures include materials or combinations of materials that enhance echogenicity such as by including echogenic materials (e.g., microbubbles, nanoparticles, glass beads, glass microspheres, etc.) and / or by including a combination of materials that form a sharp density change. In some cases, the echogenic material may be included in a polymer, including in a strand of material that is wound with other suture materials to form a suture. In certain embodiments, the suture includes a braided or twisted rope material and / or may include a core material within a braided or twisted material. In various embodiments, the suture includes a plurality of ePTFE strands braided together, and the plurality of ePTFE strands may include one or more strands modified to include an echogenic material. In some cases, the rope material includes a core made of synthetic aramid, a high strength polymer such as polyethylene terephthalate (PET), ceramic, and / or metal with a coating of ePTFE, or other suitable material.

[0010] In some embodiments, the disclosed sutures include an echogenic material embedded throughout a polymer. In some embodiments, the disclosed sutures include an echogenic material embedded on a polymer surface. In various embodiments, the disclosed sutures include a polymer core surrounded by an echogenic material, and in some cases, the echogenic material may be surrounded by an outer polymer layer. In some embodiments, the disclosed sutures include an echogenic material core surrounded by a polymer. In some embodiments, the disclosed sutures include an echogenic material braided with other materials. In some embodiments, the disclosed sutures include an echogenic material embedded between braids forming the suture. In some embodiments, the disclosed sutures include a first material of a first density as a core and a second material of a second density as an outer layer, the first density being less than the second density. In these embodiments, the disclosed sutures are configured to enhance echogenicity and / or increase ultrasonic reflections off the suture to enhance visualization when using ultrasound imaging techniques.

[0011] In one aspect, the present disclosure provides an echogenic suture or cord for medical surgery, wherein the echogenic signal is enhanced by a sharp material density change of the echogenic cord. In some embodiments, the echogenic cord comprises two or more materials, wherein the density change between adjacent materials is relatively large or sharp to increase the echogenic signal. In some embodiments, the echogenic cord comprises an echogenic material embedded in the echogenic cord.

[0012] In some embodiments, the echogenic cord can be attached to target tissue of the heart. In some embodiments, the echogenic cord includes a distal anchor and a suture extending proximally from the distal anchor implant. In some embodiments, the echogenic cord has an echogenic material that increases visibility to an ultrasound imaging device. In some embodiments, the proximal end of the echogenic cord can be anchored to the heart.

[0013] In some embodiments, the echogenic cord comprises a polymer having an echogenic material embedded therein. In some embodiments, the echogenic cord comprises a polymer having an echogenic material embedded on an outer surface of the polymer. In some embodiments, the echogenic cord comprises an inner polymer core surrounded by an echogenic material layer, the echogenic material layer being surrounded by an outer polymer layer. In some embodiments, the echogenic cord comprises an inner polymer core surrounded by an echogenic material layer. In some embodiments, the echogenic cord comprises an echogenic material core surrounded by a polymer layer. In some embodiments, the echogenic cord comprises a strand having an echogenic material, the strand being woven together with strands of a polymer to form a braided echogenic cord. In some embodiments, the echogenic cord comprises a plurality of strands of a polymer, the plurality of strands being woven together to form a braid, wherein the echogenic material is captured in the braid of the braid. In some embodiments, the echogenic cord comprises an inner core having a first density and an outer jacket having a second density, wherein the density change between the first density and the second density provides a sharp density change to increase ultrasonic reflections leaving the echogenic cord. In some embodiments, the echogenic cord comprises one or more strands of a polymer and one or more strands of an echogenic material, the one or more strands of the polymer and the one or more strands of the echogenic material being twisted together to form the echogenic cord. In some embodiments, the echogenic cord comprises an ePTFE core surrounded by a jacket, the jacket comprising the echogenic material, the jacket being formed of a strip of a polymer having the echogenic material, the echogenic material being wrapped around the ePTFE core.

[0014] In some embodiments, anchoring the proximal end comprises securing the proximal end to an outer wall of the heart. In some embodiments, anchoring the proximal end comprises securing the proximal end to a papillary muscle of the heart. In some embodiments, the target tissue comprises a leaflet of a mitral valve. In some embodiments, the distal anchor is a large knot formed using the echogenic cord. In some embodiments, the distal anchor is a barb secured to a distal end of the echogenic cord.

[0015] In some embodiments, an echogenic suture for use in a medical procedure is presented that includes a material with a dramatic density change to enhance the echogenic signal.

[0016] In some embodiments, the echogenic suture comprises a polymer having an echogenic material embedded therein. In some embodiments, the echogenic suture comprises a polymer having an echogenic material embedded on an outer surface of the polymer. In some embodiments, the echogenic suture comprises an inner polymer core surrounded by an echogenic material layer, the echogenic material layer being surrounded by an outer polymer layer. In some embodiments, the echogenic suture comprises an inner polymer core surrounded by an echogenic material layer. In some embodiments, the echogenic suture comprises an echogenic material core surrounded by a polymer layer. In some embodiments, the echogenic suture comprises a strand having an echogenic material, the strand being braided together with strands of a polymer to form a braided echogenic suture. In some embodiments, the echogenic suture comprises a plurality of strands of a polymer, the plurality of strands being braided together to form a braid, wherein the echogenic material is captured in the braid of the braid. In some embodiments, the echogenic suture comprises an inner core having a first density and an outer jacket having a second density, wherein the density change between the first density and the second density provides a sharp density change to increase ultrasonic reflections off the echogenic suture. In some embodiments, the echogenic suture comprises one or more strands of a polymer and one or more strands of an echogenic material, the one or more strands of the polymer and the one or more strands of the echogenic material being twisted together to form the echogenic suture. In some embodiments, the echogenic suture comprises an ePTFE core surrounded by a jacket, the jacket comprising an echogenic material, the jacket being formed of a strip of a polymer having the echogenic material, the echogenic material being wrapped around the ePTFE core.

[0017] To summarize the present disclosure, certain aspects, advantages and novel features have been described herein. It should be understood that not all such advantages may be achieved according to any particular example. Therefore, the disclosed examples may be performed in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 A cutaway anterior view of the heart is shown, showing the internal chambers, valves, and adjacent structures.

[0019] Figure 2A Top perspective view of a healthy mitral valve showing closed mitral valve leaflets.

[0020] Figure 2B Shown is a top perspective view of a dysfunctional mitral valve with visible gaps between the mitral valve leaflets.

[0021] Figure 2C A cross-sectional view of the heart is shown, demonstrating the mitral valve prolapsed into the left atrium.

[0022] Figure 2D Shown Figure 2C Magnified view of a prolapsed mitral valve.

[0023] Figure 3 A cross-sectional view of the heart showing the left atrium, right atrium, left ventricle, right ventricle, and apex region is presented.

[0024] Figure 4 Valve repair using echogenic sutures or cords is demonstrated.

[0025] Figure 5 is a schematic diagram of the use of an echogenic cord with a large knot as an anchor to repair a mitral valve having leaflets separated by a gap.

[0026] Figure 6 Examples of an annuloplasty ring having a core surrounded by a jacket, the core comprising any of the echogenic sutures disclosed herein are shown.

[0027] Figure 7 An example subvalvular procedure using any of the echogenic sutures disclosed herein is demonstrated.

[0028] Figure 8 Demonstrating the use of echogenic sutures during surgery to reshape a portion of the heart.

[0029] Fig. 9 Demonstrated use of echogenic sutures in an annuloplasty procedure where a cord is implanted in the coronary sinus to reshape the annulus.

[0030] Fig.10 Demonstrated use of echogenic sutures in an annuloplasty procedure in which multiple anchors are implanted in the annulus and the echogenic sutures are used to draw the anchors together to reshape the annulus.

[0031] Fig.11 demonstrated the use of echogenic sutures to secure an implantable cardiac device.

[0032] Fig.12 demonstrated the use of echogenic sutures as ultrasound detectable landmarks of the graft site.

[0033] Fig.13 An example echogenic suture comprising an echogenic material embedded throughout a polymer is shown.

[0034] Fig.14 An example echogenic suture comprising an echogenic material embedded on a polymer surface is shown.

[0035] Fig.15 An example echogenic suture comprising an inner layer coated with an embedded echogenic material surrounded by a polymer is shown.

[0036] Fig.16 An example echogenic suture comprising a polymer completely coated with an echogenic material is shown.

[0037] Fig.17 An example echogenic suture comprising an echogenic material surrounded by a polymer layer is shown.

[0038] Fig.18 An example echogenic suture comprising strands of echogenic material woven between braids of the suture is shown.

[0039] Fig.19 An example echogenic suture comprising an echogenic material embedded between braids of the suture is shown.

[0040] Fig. 20 An example echogenic suture comprising a sharp density change between a higher density inner layer and a lower density outer layer is shown.

[0041] Fig.21 An example echogenic suture is shown that twists strands of ePTFE together with echogenic strands or yarns.

[0042] Fig. 22 An example echogenic suture comprising an ePTFE core covered by echogenic strands or yarns is shown.

[0043] Fig.23 A flow chart is presented of an example method for repairing a heart valve using any of the echogenic sutures disclosed herein. DETAILED DESCRIPTION

[0044] The headings provided herein, if any, are for convenience only and do not necessarily affect the scope or meaning of the disclosed methods, systems, or apparatus.

[0045] Overview

[0046] Doctors can perform a wide range of surgical procedures on defective heart valves. In degenerative mitral valve repair surgery, techniques include, for example, but not limited to, various forms of resection repair, tendon implantation, ventricular remodeling, and edge-to-edge repair. Cracks or perforations in the leaflets can be closed and occasionally the commissures of the valve sutures can be closed to minimize or eliminate MR. In these and similar surgeries, ePTFE ropes are often used for repair, such as as artificial ropes and / or sutures. For example, the mitral valve can be repaired by inserting an ePTFE rope into the mitral valve and anchoring the rope to the ventricle or papillary muscle. It would be beneficial to be able to visualize the suture or rope during such surgery. For example, increasing suture visibility during beating heart mitral valve repair surgery can improve medical outcomes. It is very advantageous to enable doctors to more accurately determine the position of the artificial rope and the tension applied. In addition, ultrasound follow-up after mitral valve repair will provide more accurate information. For example, it may be particularly difficult for ultrasound cardiologists to determine whether mitral valve regurgitation (MR) is increased due to rope pullout, rope breakage, or natural rope breakage. Therefore, there is a need for a suture or cord having amplified echogenic properties to increase the visibility of the suture using ultrasound techniques.

[0047] To address these and other problems, disclosed herein are sutures (or ropes) and methods for using sutures, wherein the sutures include a material or combination of materials configured to increase the echogenicity of the sutures. In some instances, the sutures include an echogenic material (e.g., ePTFE) incorporated into the suture material. In some instances, the sutures include a combination of materials having a sudden and relatively large density change to increase the reflection of ultrasound waves. The disclosed sutures enhance echogenicity to increase the visibility of the sutures using ultrasound imaging techniques. In addition, disclosed herein are methods for utilizing the disclosed sutures in valve repair, including implanting an artificial rope, subvalvular techniques, reshaping organs, annuloplasty, and the like. Utilizing the disclosed echogenic sutures can produce superior results, at least in part due to the physician's ability to better visualize the placement and / or tensioning of the echogenic sutures.

[0048] Use of the disclosed echogenic sutures in the vasculature may provide numerous advantages. The disclosed echogenic sutures and associated methods may be advantageous due, at least in part, to their increased visibility when ultrasound imaging is used to provide real-time feedback during surgery. Additionally, the disclosed echogenic sutures may also improve follow-up due, at least in part, to the clinician being able to better see the condition of the implanted suture. Several cardiac procedures may benefit from improved visualization due to the use of echogenic sutures, including, for example, but not limited to, tethers for annuloplasty, mitral valve remodeling and annulus reduction, ventricular volume reduction and remodeling of dilated myocardium, fixation of implantable cardiac devices, ultrasound-detectable markers of graft sites, and the like. The disclosed echogenic sutures may be configured for use within the vasculature or bloodstream and may be coated with materials to improve biostability and / or biocompatibility.

[0049] In some instances, in addition to valve repair, the disclosed sutures may be advantageous in annuloplasty procedures, subvalvular procedures, and procedures for reshaping or modifying chambers of the heart and / or other internal organs. For example, the disclosed sutures may be used to pull the ventricles inward to reduce the volume of the ventricles. The disclosed echogenic tethers may be used in open heart surgery, less invasive procedures, minimally invasive procedures, non-invasive procedures, transcatheter approaches, and the like. Although primarily described in the context of mitral valve repair, it should be understood that the disclosed tethers may be used in tricuspid valve repair and other valve repairs.

[0050] In some cases, the disclosed methods for repairing tissue include inserting a delivery device, such as the delivery device described in the '761 PCT application and / or International Patent Application No. PCT / US2016 / 055170 (published as WO 2017 / 059426A1 and referred to herein as the "'170 application"), into the body and extending the distal end of the delivery device proximal to the tissue, the entire disclosure of each of which is incorporated herein by reference. Advancement of the delivery device can be performed in conjunction with ultrasound examination or direct visualization (e.g., direct trans-blood visualization) and / or any other suitable remote visualization technology. In addition, one or more steps of the disclosed method can also be performed in conjunction with any suitable remote visualization technology. With respect to the disclosed method, one or more portions of the procedure can be monitored in conjunction with transesophageal (TEE) guidance or intracardiac echocardiography (ICE) guidance. For example, this can facilitate and guide movement and proper positioning of the delivery device for contacting an appropriate target cardiac region and / or target cardiac tissue (e.g., a valve leaflet, a valve annulus, or any other suitable cardiac tissue). A typical procedure using echo guidance is shown in Suematsu, Y., J. Thorac. Cardiovasc. Surg. 2005; 130: 1348-56 ("Suematsu"), the entire disclosure of which is incorporated herein by reference.

[0051] like Figure 1 As shown in FIG. 1 , a human heart 10 has four chambers including two upper chambers represented as atria 12, 16 and two lower chambers represented as ventricles 14, 18. The septum 20 (see, e.g., Figure 3 ) divide the heart 10 and separate the left atrium 12 and left ventricle 14 from the right atrium 16 and right ventricle 18. The heart further contains four valves 22, 23, 26 and 27. The function of the valves is to maintain pressure and unidirectional flow of blood through the body and to prevent blood from leaking back into the chamber from which it has been pumped.

[0052] Two valves, designated as atrioventricular valves, separate the atria 12, 16 from the ventricles 14, 18. The mitral valve 22, also known as the left atrioventricular valve, controls the passage of oxygenated blood from the left atrium 12 to the left ventricle 14. The second valve, the aortic valve 23, separates the left ventricle 14 from the aorta (large artery) 29, which delivers oxygenated blood to the body through the circulation. The aortic valve 23 and the mitral valve 22 are part of the "left" heart, which controls the flow of oxygen-rich blood from the lungs to the body. The right atrioventricular valve, the tricuspid valve 24, controls the passage of deoxygenated blood into the right ventricle 18. The fourth valve, the pulmonary valve 27, separates the right ventricle 18 from the pulmonary artery 25. The right ventricle 18 pumps deoxygenated blood to the lungs through the pulmonary artery 25, where the blood is oxygenated and then delivered to the left atrium 12 through the pulmonary veins. Thus, the tricuspid valve 24 and the pulmonary valve 27 are part of the right heart which controls the flow of oxygen-depleted blood from the body to the lungs.

[0053] Both the left ventricle 14 and the right ventricle 18 constitute the pumping chamber. The aortic valve 23 and the pulmonary valve 27 are located between the pumping chamber (ventricle) and the aorta and control the flow of blood out of the ventricle and into the circulation. The aortic valve 23 and the pulmonary valve 27 have three cusps or leaflets that open and close and thereby serve to prevent blood from leaking back into the ventricle after being ejected into the lungs or aorta 29 for circulation.

[0054] Both the left atrium 12 and the right atrium 16 are receiving chambers. Therefore, the mitral valve 22 and the tricuspid valve 24 are located between the receiving chambers (atria) and the ventricles to control the flow of blood from the atria to the ventricles and prevent blood from leaking back into the atria during ejection from the ventricles. Both the mitral valve 22 and the tricuspid valve 24 include two or more cusps or leaflets ( Figure 1 ), which is called the annulus ( Figure 1 The valve is surrounded by a variable density fibrous ring of tissue (not shown). The valve is anchored to the wall of the ventricle by chordae tendineae (tendons) 17. The chordae tendineae 17 are leaflets ( Figure 1 The papillary muscles 19 are located at the base of the chordae tendineae 17 and within the walls of the ventricles. The papillary muscles 19 do not open or close the valves of the heart, which close passively in response to pressure gradients; rather, the papillary muscles 19 support the valves against the high pressures required for blood to circulate throughout the body. The papillary muscles 19 and the chordae tendineae 17 are together referred to as the subvalvular apparatus. The function of the subvalvular apparatus is to prevent the valve from prolapsing into the atrium when closed.

[0055] Mitral valve 22 Figure 2A The mitral valve 22 includes two leaflets, anterior leaflet 52 and posterior leaflet 54, and a double-ringed incomplete ring called annulus 53 surrounding the valve. The mitral valve 22 has two papillary muscles 19, anterior medial papillary muscle and posterolateral papillary muscle (see, e.g. Figure 1 ), which papillary muscles attach the leaflets 52, 54 to the wall of the left ventricle 14 via chordae tendineae 17 (see e.g. Figure 1 ).

[0056] Figure 2B A prolapsed mitral valve 22 is shown. Figure 2B-2D As can be seen, prolapse occurs when the prolapsed sections of the leaflets 52, 54 of the mitral valve 22 are displaced above the plane of the mitral annulus into the left atrium 12 (see Figure 2C and 2D ) prevents the leaflets from properly sealing together to form a natural plane or line of coaptation between the valve leaflets during systole. Due to malfunction of one or more of the leaflets 52, 54, the mitral valve 22 does not close properly and, therefore, the leaflets 52, 54 fail to coapt. This failure to coapt results in a gap 55 between the leaflets 52, 54 allowing blood to flow back into the left atrium during systole as blood is ejected by the left ventricle. As described above, there are several different ways that the leaflets can malfunction, resulting in regurgitation.

[0057] Mitral regurgitation increases the load on the heart and, if left untreated, can lead to very serious conditions such as reduced ventricular function, pulmonary hypertension, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart is primarily responsible for moving blood throughout the body, dysfunction of the mitral valve 22 is particularly problematic and often life threatening.

[0058] Disclosed herein is an echogenic suture suitable for use in surgery to repair heart valves such as the mitral valve. Such surgery includes surgery to repair the regurgitation that occurs when the leaflets of the mitral valve do not engage at peak systolic pressure, resulting in an undesirable backflow of blood from the ventricle into the atrium. As described in the '761 PCT application and the '170 PCT application, corrective surgery can be performed after the dysfunctional heart valve has been evaluated and the source of the dysfunction has been verified. Various surgeries can be performed to achieve heart valve repair, which will depend on the specific abnormality and the tissue involved. The surgery can include open heart surgery, less invasive surgery, minimally invasive surgery, non-invasive surgery, surgery using a transcatheter approach, and the like. The surgery can include, for example, but not limited to, implantation of an artificial tether, annuloplasty, subvalvular technology (e.g., a manipulator of a subvalvular device), remodeling of the heart, and the like.

[0059] Figure 3It is shown that one or more chambers in the heart 10, such as the left atrium 12, the left ventricle 14, the right atrium 16, or the right ventricle 18, can be accessed according to any suitable method, including open heart surgery, less invasive surgery, minimally invasive surgery, non-invasive surgery, transcatheter methods, etc. Access to the chambers 12, 14, 16, 18 in the heart 10 can be performed at any suitable entry site. In some examples, less invasive and non-invasive procedures can preferably enter the desired chamber of the heart through the apex region of the heart, such as slightly above the apex 26, at the level of the papillary muscles 19 (see also Figure 2C Typically, access to the left ventricle 14 (e.g., to perform a mitral valve repair) is obtained through the apical region proximal to (or slightly tilted to the left of) the central axis 28 of the heart 10. Typically, access to the right ventricle 18 (e.g., to perform a tricuspid valve repair) is obtained through the apical region proximal to (or slightly tilted to the right of) the central axis 28 of the heart 10. Typically, the apical region of the heart is the base region of the heart that is within the left or right ventricular region and below the mitral valve 22 and tricuspid valve 24 and toward the tip or apex 26 of the heart 10. More specifically, the apical region AR of the heart (see, e.g., Figure 3 ) within a few centimeters to the right or left of the septum 20 of the heart 10 at or near the level of the papillary muscles 19. Thus, the ventricle can be entered directly through the apex 26, or through a non-apex location in the top or apex region AR, but slightly away from the apex 26, such as through the outer ventricular wall, the area between the apex 26 and the base of the papillary muscle 19, or even directly at or above the base of the papillary muscle 19.

[0060] The mitral valve 22 and the tricuspid valve 24 can be divided into three parts: the valve ring (see Figure 2A and 2B 53 in), leaflets (see Figure 2A and 2B 52, 54) and a subvalvular device. The subvalvular device includes a papillary muscle 19 that can be stretched and / or ruptured (see Figure 1 ) and chordae tendineae 17 (see Figure 1). If the valve is functioning properly, when closed, the free edges or margins of the leaflets come together and form a tight connection, the arc of which is called the coaptation line, plane or area in the mitral valve. When the ventricles relax, normal mitral and tricuspid valves open, allowing blood from the atria to fill the decompressed ventricles. When the ventricles contract, the chordae tendineae properly position the valve leaflets so that an increase in pressure within the ventricles causes the valves to close, thereby preventing blood from leaking into the atria and ensuring that all blood leaving the ventricles is ejected into the arteries of the body through the aortic valve (not shown) and the pulmonary valve (not shown). Therefore, proper function of the valve depends on a complex interaction between the annulus, leaflets, and subvalvular apparatus. Lesions in any of these components may lead to valve dysfunction and thereby valve regurgitation. As described herein, regurgitation occurs when the leaflets are not properly coapted at peak systolic pressures. As a result, undesirable backflow of blood from the ventricles to the atria occurs.

[0061] Although the procedures described herein refer to repairing the mitral or tricuspid valve of the heart using an artificial tether, the presented tether and method are readily applicable to various types of tissue, leaflet and annulus repair procedures. Generally, the methods herein are described with reference to the mitral valve 22, but should not be construed as limited to procedures involving the mitral valve.

[0062] Examples of cardiac repair using echogenic sutures

[0063] Figure 4 The use of one or more echogenic cords 410 to repair the mitral valve 22 is shown. Although described with respect to repairing the mitral valve, the disclosed cords may be used to repair the tricuspid valve or other heart valves. The one or more echogenic cords 410 are echogenic sutures or cords, examples of which are referred to herein. Figure 13-22 Disclosed in more detail. The mitral valve 22 can be repaired by inserting an echogenic cord 410 into the mitral valve 22 and anchoring the echogenic cord 410 to the ventricle 12 and / or the papillary muscle 19. In some instances, the echogenic cord 410 can be anchored to the septum 20. The echogenic cord 410 can be attached to the anterior leaflet 52 using a distal anchor 411. In some instances, the echogenic cord 410 can be attached to the posterior leaflet 54 and / or the annulus 53. The distal anchor 411 can be any suitable anchor, including, for example, a hook, a barb, a knot, a graft, a fabric, the like, or any combination thereof. The distal anchor 411 can be formed of any suitable material. In some cases, for example, the material of the distal anchor 411 can be the same as the echogenic cord 410 or can be an ePTFE suture, a polybutylate-coated polyester suture, or a polyester suture (e.g., ETHIBOND Polyester suture) any one or more.

[0064] In some examples, the distal anchor 411 can be made from the distal portion of the echogenic cord 410, such as a large knot, examples of which are referenced herein. Figure 5Description. In some examples, a distal portion of the echogenic cord 410 can be secured to the annulus 53 and / or the posterior leaflet 54 in addition to or as an alternative to the anterior leaflet 52 .

[0065] The echogenic cord 410 may be any of the echogenic cords described herein. For example, the echogenic cord 410 may include an echogenic suture having a customized topology, including a reinforcing material, and / or having a sharp density change within the suture. Figure 13-22 An example of an echogenic suture is described. Advantageously, the use of an echogenic cord 410 improves visualization of the synthetic cord during and after surgery. This enhanced visualization can be used to adjust the positioning or tensioning of the echogenic cord 410 during surgery, detect tangles or knots in the suture during or after surgery, and detect breaks or other failures of the suture after surgery.

[0066] Figure 5 363. is a schematic diagram of a mitral valve 322 having leaflets 352, 354 separated by a gap 363. Two anchors 331, 331' (e.g., large knot implants) are respectively placed on the atrial, distal, or apical sides of the leaflets 352, 354. Sutures 332, 333, 334 extend proximally from the anchors 331, 331' (e.g., large knot implants). Sutures 332, 333, 334 are echogenic sutures as described herein.

[0067] Anchors 331, 331' may be formed from the same suture material as sutures 332, 333, 334. The suture material used for anchors 331, 331' forms one or more loops on the atrial side of leaflets 352, 354 and extends through leaflets 352, 354, wherein sutures 332, 333, 334 may include two loose suture end portions extending on the ventricular, proximal, or basal side of leaflets 352, 354. Anchor 331 has sutures 332 and 333, and anchor 331' has suture 334 (and Figure 5 The suture material forming the anchors 331, 331' may be braided, twisted, or knotted (eg, with an overhand knot) to form the anchors 331, 331'.

[0068] After the anchors 331, 331' are in the desired or target position (which can be confirmed by, for example, imaging), the device can be used to secure the anchors 331, 331' in the desired position and secure the leaflets 352, 354 of the valve in an edge-to-edge relationship. In addition, in addition to or in lieu of forming an edge-to-edge relationship, to promote a larger engagement surface, the anchors 331, 331' can be secured together to pull or otherwise move the posterior annulus toward the anterior leaflet and / or pull or otherwise move the anterior annulus toward the posterior leaflet, thereby reducing the distance between the anterior annulus and the posterior annulus, for example, by reducing the septal-lateral distance by about 10%-40%. Approaching the anterior and posterior annuli in this manner can reduce the valve orifice and thereby reduce, limit, or otherwise prevent undesirable regurgitation.

[0069] Examples of forming distal anchors, preformed knots, and / or locking sutures are presented in U.S. Pat. No. 8,852,213, International Patent Publication No. 2017 / 059426, and U.S. Patent Publication No. 2019 / 0117401, each of which is incorporated by reference in its entirety for all purposes. For each of these anchors and / or knots, the material used can be the same as that used for sutures 332, 333, 334 (e.g., echogenic sutures).

[0070] Figure 6 An example of an annuloplasty ring 600 having a core 610 containing any of the echogenic sutures disclosed herein surrounded by a jacket 620 is shown. The annuloplasty ring 600 can be used to reshape, strengthen, or tighten the annulus around a heart valve. The annuloplasty ring 600 can be used by itself in a procedure or it can be used in conjunction with other procedures, such as those described herein, to repair a heart valve.

[0071] The jacket 620 can be made of any suitable combination of durable plastics, metals, and fabrics. Suitable materials include, for example, but are not limited to, silicone rubber, polyester knitted fabric, plastic strips, titanium alloys, silicone polymer rubbers, non-magnetic cobalt-chromium-nickel-molybdenum alloys, and the like. The jacket 620 can be configured so that the annuloplasty ring 600 has variable flexibility. For example, the variable flexibility of the annuloplasty ring 600 allows for physiological contractility of the valve in which it is implanted during contraction. The core 610 can include any echogenic suture disclosed herein. The core 610 can be a suture having an echogenic material and / or having a material that provides a sharp change in density. The echogenic suture can enhance visualization of the annuloplasty ring 600. In some instances, the core 610 can be used to adjust the size, shape, tension, etc. of the annuloplasty ring 600 to improve the performance of the valve after implantation of the annuloplasty ring 600.

[0072] Figure 7An example subvalvular procedure using one or more echogenic sutures 710 is shown. The echogenic sutures 710 may be referenced herein. Fig.13 – Any echogenic suture described in 22. Subvalvular procedures include procedures to reposition one or more papillary muscles 19 or manipulate or alter one or more chordae tendineae 17 to improve valve function (eg, to reduce regurgitation).

[0073] The illustrated subvalvular procedure anchors the one or more echogenic sutures 710 to the papillary muscles 19 and the wall of the heart to reposition the papillary muscles 19 to improve the performance of the chordae tendineae 17. The one or more echogenic sutures 710 can be anchored to additional papillary muscles 19 of the anterior leaflet 52 and / or to the papillary muscles of the posterior leaflet 54. In some instances, the echogenic sutures 710 can be used to form a loop around multiple papillary muscles to approximate the papillary muscles. In certain instances, the echogenic sutures 710 can be anchored to another portion of the anatomical structure, such as the atrium 14, the annulus 53, or the outside of the heart.

[0074] The procedure shown may generally be referred to as papillary muscle repositioning. Other similar subvalvular procedures may also utilize the one or more echogenic sutures 710. Example subvalvular procedures in which the disclosed echogenic sutures 710 may be used include, for example, but not limited to, papillary muscle repositioning, papillary muscle slings, papillary muscle approximations, papillary muscle sandwich annuloplasty, a "ring and string" procedure, or a ring sling string. In some instances, these procedures are performed in conjunction with implantation of an annuloplasty ring as disclosed herein.

[0075] Figure 8 The use of an echogenic suture 810 during surgery to reshape a portion of the heart is shown. The echogenic suture 810 may be a reference to Fig.13 –22. To reshape the heart, the front pad 813 can be implanted or anchored to the epicardial surface of the heart on one side of a target chamber of the heart (e.g., ventricle 12). The rear pad 815 can be implanted or anchored to the heart on the other side of the target chamber. The echogenic suture 810 extends between the front pad 813 and the rear pad 815. The length of the echogenic suture 810 can be adjusted to approximate the front pad 813 and the rear pad 815 to reshape the target chamber. In some instances, the front pad 813 is adjustable and is secured to the echogenic suture 810 after the device is sized. In some instances, the rear pad 815 has an upper head 816 and a lower head 817 that are configured to change shape at the level of the annulus and the papillary muscle, respectively.

[0076] In some instances, the transventricular tendon length can be reduced by approximately 25%.The procedure can beneficially affect and stabilize both the mitral annulus and papillary muscles, can be implanted in an off-pump procedure, can be easily reversed, and has little or no effect on annular dynamics.

[0077] Fig. 9The use of an echogenic suture 910 is shown in an annuloplasty procedure that implants the echogenic suture 910 into the coronary sinus 902 to reshape the annulus 904 of the mitral valve. The procedure involves implanting a pair of anchors 915a, 915b into the coronary sinus 902, connected by the echogenic suture 910, and then tying or tightening the echogenic suture 910 to reduce the distance between the anchors 915a, 915b, thereby reducing the size and / or altering the shape of the annulus 904 of the mitral valve. Thus, the procedure uses an intravascular support that is designed to alter the shape of the annulus adjacent to the coronary sinus in which the support is placed. The support is designed to help close the mitral valve. The support is placed in the coronary sinus and in a blood vessel located near the mitral valve and pushes the vessel wall toward the valve to help it close.

[0078] Fig.10 The use of an echogenic suture 1010 is shown in an annuloplasty procedure that implants a plurality of anchors 1015a, 1015b, 1015c in the annulus 1002 of the mitral valve and uses the echogenic suture 1010 to draw the anchors 1015a-1015c together to reshape the annulus 1002. In some examples, pledgeted anchors 1015a-1015c are deployed on the posterior mitral annulus at the P1P2 and P2P3 locations. The echogenic suture 1010 is used to tie these anchors 1015a-1015c to reduce the annulus 1002. The procedure includes anchoring tissue with an anchor assembly 1015a-1015c that includes a proximal portion, a distal portion, and a compressible intermediate portion located between the proximal portion and the distal portion and movable between an extended configuration and a shortened configuration. The procedure includes inserting at least one of the anchor elements 1015a–1015c into the tissue of the annulus 1002 and pulling the echogenic suture 1010 relative to the other anchor elements. This pulls the proximal and distal portions of the anchor assembly toward each other and compresses the intermediate portion into a shortened configuration in which the assembly engages the tissue. The tissue may include a mitral valve annulus and the anchor assembly may be engaged on opposite sides of the tissue, such as on opposite sides of the mitral valve annulus. The procedure includes pulling the anchor assemblies toward each other to wrinkle the tissue of the annulus 1002, whereby the anchor assemblies are locked relative to each other to lock the wrinkled state of the tissue of the annulus 1002. The procedure may be repeated any number of times, for example, to wrinkle the posterior portion of the mitral valve annulus for the purpose of annuloplasty. Mechanism 1020 may be used to tighten the echogenic suture to pull the anchor assemblies toward each other.

[0079] Fig.11The use of an echogenic suture 1110 to secure a cardiac device 1112 in a heart is shown. The echogenic suture 1110 can be used to implant the cardiac device 1112. The cardiac device 1112 can be any suitable device, including a stent, a sensor, a flow controller, a pacemaker, etc. The echogenic suture 1110 can help visualize the process of implanting the cardiac device 1112 and check the implantation status of the cardiac device 1112 during follow-up.

[0080] Fig.12 The use of echogenic suture 1210 as an ultrasound detectable marker of a graft site is shown. The echogenic suture 1210 can mark the graft site and / or can be used to secure the graft 1212 to tissue. The echogenic suture 1210 can mark the location of the graft, aid in visualization of the process of implanting the graft 1212, and aid in checking the implantation status of the graft 1212 during follow-up.

[0081] In some instances, echogenic sutures may be used to close punctures in the ventricular or atrial septum.

[0082] Examples of echogenic sutures

[0083] Increasing the echogenicity of sutures can include changing the composition of sutures. This can be achieved by changing the suture topology and / or density of one or more materials. There are various suitable echogenic materials that can be used to increase the echogenicity of sutures to produce highly reflective objects that can be easily imaged using ultrasound. These materials include, for example, but are not limited to microbubbles (e.g., gases surrounded by lipid shells, such as C3F8), silica nanoparticles, hollow glass microspheres, glass beads, and echogenic biomaterials.

[0084] There are a variety of methods for incorporating echogenic materials into sutures. For example, the echogenic material can be incorporated directly into the suture by using a pre-coated polymer adhesive layer to promote adhesion of the echogenic material. As another example, the echogenic material can be mixed with a solvent and applied using standard coating methods (such as by spraying, dipping, roller coating, rod coating, spin coating, or wipe processes). As another example, the echogenic material can be compounded into a resin and then extruded. As another example, the echogenic material can be mechanically captured between layers. As another example, strands of the echogenic material can be twisted, twisted, covered, interwoven, intertwined, or braided between layers using a textile manufacturing process.

[0085] The general structure of the echogenic sutures described herein can be a single polymer with echogenic materials dispersed throughout, or the suture can be made of two or more materials. In the case of using more than one material, the echogenic material can be applied to one or more materials to customize the echogenic properties. This can also be beneficial because it limits the impact of the echogenic material on the mechanical properties of the suture.

[0086] Fig.13 An example echogenic suture 1310 is shown that includes an echogenic material 1311 embedded throughout a polymer 1312. In some instances, the echogenic material 1311 can be added to the polymer by extruding an echogenic material such as glass beads into a polymer rod. Typically used in cardiac repair, ePTFE materials are used for sutures or cords. The benefit of using ePTFE materials is that they promote the formation of endothelial tissue due, at least in part, to their relatively high porosity. This is beneficial because endothelialization strengthens the ePTFE cord. Thus, the polymer 1312 can be ePTFE or other suitable polymers, such as ultra-high molecular weight polyethylene (UHMWPE), polyethylene terephthalate (PET), polyetheretherketone (PEEK), polypropylene (PP), ePTFE, PTFE, or polystyrene (PS). Additionally, the echogenic material 1311 can be any suitable echogenic material described herein.

[0087] Fig.14 An example echogenic suture 1410 is shown that includes an echogenic material 1411 embedded on a surface of a polymer 1412. The echogenic material 1411 can be applied to the surface of the polymer 1412 using any of the techniques described herein, such as spraying, dipping, rolling, rod coating, spin coating, or wiping processes. The polymer 1412 can be any suitable polymer described herein. Additionally, the echogenic material 1411 can be any suitable echogenic material described herein.

[0088] Fig.15 An example echogenic suture 1510 is shown that includes an inner polymer layer 1512 coated with an echogenic material layer 1511 surrounded by an outer polymer layer 1513. In some examples, the echogenic material 1511 can be embedded in the coating and the coating can be applied to the inner polymer layer 1512. The inner polymer layer 1512 and the outer polymer layer 1513 can be any suitable polymer described herein, and the two layers can be the same polymer or different polymers. Additionally, the echogenic material 1511 can be any suitable echogenic material described herein.

[0089] The echogenic material 1511 can be applied to the inner polymer layer 1512 and / or the outer polymer layer 1513 can be applied to the echogenic material 1511 using various coating processes, such as braiding, wrapping, extruding, laminating, dipping, spraying, or spin coating the material around the layer it surrounds. By surrounding the echogenic material 1511 with the outer polymer layer 1513, the benefits of using a polymer (e.g., an ePTFE material) can be achieved while also increasing the echogenicity of the echogenic suture 1510. For example, the outer polymer layer 1513 can promote tissue growth or endothelialization, as described herein. This can improve or enhance the strength of the echogenic suture 1510. In addition, the outer polymer layer 1513 can have a relatively low coefficient of friction, thereby reducing wear.

[0090] Fig.16 An example echogenic suture 1610 is shown that includes a polymer layer 1612 completely coated with an echogenic material 1611. This can be achieved using any of the procedures described herein. The polymer layer 1612 can be any suitable polymer described herein. Additionally, the echogenic material 1611 can be any suitable echogenic material described herein.

[0091] Fig.17 An example echogenic suture 1710 is shown that includes an echogenic material 1711 surrounded by a polymer layer 1712. Thus, the polymer layer 1712 can be configured to improve biostability and / or biocompatibility. Examples of such polymers include, for example, but are not limited to, a hydrophilic coating, a hydrophobic coating, or a polymer sleeve or coating (e.g., UHMWPE, PET, PEEK, PP, or PS). Additionally, the echogenic material 1711 can be any suitable echogenic material described herein.

[0092] Fig.18 An example echogenic suture 1810 is shown that includes strands of echogenic material 1811 woven between braids 1812 of the echogenic suture 1810. The braids 1812 can be bundles or assemblies of individual filaments, sometimes referred to as yarns. Each braid 1812 in the echogenic suture 1810 can be a polymer filament. As described herein, the echogenic material 1811 can include filaments modified to include echogenic material. The braids 1812 can be any suitable polymer described herein. Additionally, the echogenic material 1811 can be any suitable echogenic material described herein.

[0093] Fig.19An example echogenic suture 1910 is shown that includes an echogenic material 1911 embedded between braids 1912 of the echogenic suture 1910. In some examples, the echogenic material 1911 can be embedded between the braids 1912 of the echogenic suture 1910 by depositing the echogenic material onto the material of the braids 1912, and then braiding the material with the deposited echogenic material to form the braids 1912, thereby trapping the echogenic material between the braids. The braids 1912 can be any suitable polymer described herein. Additionally, the echogenic material 1911 can be any suitable echogenic material described herein.

[0094] Fig.18 and 19 The braid can be configured to simulate the porosity of the ePTFE rope. This may be beneficial to promote endothelialization in desired situations. Braided or twisted strands can promote tissue growth between strands. Braided strands can form a tubular braid structure. This can be formed by diagonally crossing multiple strands of the desired material (e.g., polymer and echogenic material) in a manner that each set of strands is alternately passed above and below a set of strands laid in opposite directions. The strands can have various cross-sectional shapes, including but not limited to circular, square, rectangular, etc. The strands can be braided using parallel strands of three or more materials. The strands can be interwoven in various different patterns. These patterns affect the order of the interlaced points in the braid structure and may affect the mechanical properties of the structure of the braid. The area between the braids can be used as a space for endothelial cell deposition and adhesion. This new endothelialization layer is expected to improve durability. The use of braided sutures can increase the mechanical strength, structural integrity and durability of cardiac repair by providing sufficient support to withstand the increased tendon tension associated with high intracardiac pressure.

[0095] Fig. 20 An example echogenic suture 2010 is shown that includes a sharp density change between a higher density inner layer 2012 and a lower density outer layer 2013. The higher density inner layer 2012 and the lower density outer layer 2013 can be any suitable polymer that causes a sharp density change between the two layers. A sharp density change can also be described as a sudden and relatively large density change between the two layers. The echogenic suture 2010 does not include an echogenic material, but rather relies on a sharp density change to increase or promote reflection of ultrasound waves leaving the echogenic suture 2010 to enhance echogenicity.

[0096] Fig.21 An example echogenic suture 2110 is shown that twists together ePTFE strands 2112 with echogenic strands 2111 or yarns. As described herein, the echogenic strands 2111 can be manufactured by embedding the echogenic material onto or into another material (e.g., a polymer) using any suitable procedure (e.g., extrusion, coating, adhesion, etc.).

[0097] Fig. 22 An example echogenic suture 2210 is shown that includes an ePTFE core 2212 covered by an echogenic sheath 2211. In some embodiments, the echogenic sheath 2211 can be made of echogenic strands or yarns. The echogenic sheath 2211 can be formed to surround the ePTFE core 2212. The echogenic sheath 2211 can be formed of a strip of flat echogenic material wrapped around the ePTFE core 2212. In some examples, the echogenic material (e.g., a polymer having the echogenic material incorporated therein) can be flattened into a strip, wrapped around the ePTFE core 2212 and heat fused to fuse the pleats together.

[0098] Exemplary methods for repairing heart valves with echogenic sutures

[0099] Fig.23 A flow chart of an example method 2300 for repairing a heart valve (e.g., mitral valve, tricuspid valve, pulmonary valve, aortic valve) using any of the echogenic sutures disclosed herein is shown. In block 2305, the echogenic suture is inserted into a target chamber (e.g., through the wall of the heart or using a transcatheter approach). For example, to repair the mitral valve, the echogenic suture may be inserted through the ventricle. The echogenic suture is any suture or cord disclosed herein, including any of the sutures or cords disclosed herein. Figure 13-22 Suture as described.

[0100] In some instances, the delivery device can be used to deliver the echogenic suture to a target chamber of the heart using minimally invasive surgery. The penetrating portion of the delivery device can be used to form an opening in the tissue through which the distal end of the delivery device can be inserted. However, it should be understood that any suitable surgery can be used, including open heart surgery, less invasive surgery, non-invasive surgery, and / or transcatheter approaches.

[0101] In block 2310, the distal end of the echogenic suture is anchored to the tissue of the target valve. When repairing a mitral valve, for example, the tissue of the target valve may include the posterior leaflet, the anterior leaflet, and / or the annulus of the valve. The distal end of the echogenic suture may include a large knot as an anchor, examples of which are described herein with reference to Figure 5 Description. The distal end of the echogenic suture may include any suitable anchor for securing the echogenic suture to tissue of the target valve, as described in greater detail herein.

[0102] The delivery device can be used to form or deliver a distal anchor to tissue distal to the target valve. The delivery device can be used in this manner to deliver two or more anchors to tissue distal to the target valve. The anchors can be delivered to a single tissue (e.g., the posterior mitral leaflet), or one or more anchors can be delivered to a first tissue (e.g., the posterior mitral leaflet) and one or more other implants can be delivered to a second tissue separate from the first tissue (e.g., the anterior mitral leaflet, the mitral annulus, or any other suitable tissue).

[0103] The proximal end of the echogenic suture is anchored to the wall of the heart and / or the papillary muscles of the heart in block 2315. To anchor the proximal end of the echogenic cord, cotton wool may be used.

[0104] In block 2320, the echogenic suture is visualized using ultrasound imaging. Visualization or imaging may be provided for feedback to monitor, adjust, fine-tune, or improve the implantation of the echogenic suture. The visualization step in block 2320 may be performed simultaneously with the steps in blocks 2305, 2310, and 2315.

[0105] The delivery device can then be removed, and the suture portion extending from the anchor can be extended to a location away from the tissue (e.g., the outer surface of the heart or other suitable organ). The suture portion is an echogenic suture that includes features and / or materials to enhance echogenicity, as described herein. Where the term anchor is used herein, it should be understood that anchor refers to any suitable component or element for anchoring the suture to tissue, such as, but not limited to, a hook, a barb, a knot (e.g., a large knot), etc. In some cases, the secured echogenic suture can be appropriately tensioned and / or pulled toward the entry site (e.g., into the ventricle of the heart), thereby creating a larger effective engagement surface area and improved engagement between the leaflets.

[0106] The anchoring step is performed to prevent or reduce the possibility of the suture becoming loose. The echogenic suture can be anchored to a tissue wall, such as the outer wall of the heart. Cotton wool can be used as an anchor. For example, PTFE ( Dupont, Wilmington, Delaware) felt can be used as an anchor, where the felt is attached to the tissue wall. In some examples, the anchor includes a hole through which the echogenic suture extends. Knots and / or locking sutures can be used to anchor the suture.

[0107] In the methods disclosed herein, additional anchors and tethers may be implanted. For example, to facilitate a larger engagement surface, anchors may be deployed in the body of the leaflets and / or at or near the annulus of the anterior and posterior leaflets, and tethers extending therefrom may be secured together and pulled out to move the posterior annulus toward the anterior leaflet and / or the anterior annulus toward the posterior leaflet, thereby reducing the distance between the anterior and posterior annuli, e.g., the septal-lateral distance. In other words, approaching the anterior and posterior annuli in this manner may reduce the valve orifice and thereby reduce, limit, or otherwise prevent undesirable backflow. One or more of the additional tethers may be echogenic sutures and / or one or more of the additional tethers may be of a different type (e.g., ePTFE sutures).

[0108] Method 2300 may be modified to reshape internal organs rather than repair heart valves, examples of which are described herein with reference to Figure 8 For example, the echogenic sutures may be anchored to enable force to be applied to move, shape, and / or reshape any portion of an internal organ such as the heart. The method 2300 may also be modified to include implanting an annuloplasty ring, examples of which are referenced herein. Figure 6 For example, an annuloplasty ring having an echogenic suture as the core material can be used to reduce the size of the annulus to improve the performance of the valve (e.g., to improve coaptation and / or reduce regurgitation). In addition, method 2300 can also be modified to manipulate the papillary muscles to improve the performance of the valve (commonly referred to as a subvalvular technique), examples of which are described herein with reference to Figure 7 For example, the echogenic suture may be secured to one or more papillary muscles and then used to reposition or otherwise manipulate the one or more papillary muscles to improve valve performance. In addition, the method 2300 may also be modified to perform an annuloplasty procedure to reshape the valve annulus, examples of which are described herein with reference to Figure 9-10 Additionally, method 2300 may be modified to implant a device or graft in the heart, examples of which are described herein with reference to Figure 11-12 describe.

[0109] The above-described procedures may be performed manually, such as by a physician, or may alternatively be performed in whole or in part with robotic or machine assistance. In addition, although not specifically described herein, in various circumstances, the heart may receive rapid pacing to reduce relative motion of the edges of the valve leaflets during the procedures described herein (e.g., during delivery and deployment of anchors, sutures, and / or locking sutures).

[0110] Additional Examples and Terminology

[0111] Although various examples have been described above, it should be understood that the examples are presented by way of illustration only and not limitation. Where the methods described above indicate that certain events occur in a certain order, the order of certain events may be modified. Additionally, as described above, certain of the events may be performed simultaneously in parallel processes, as well as sequentially, where possible.

[0112] In the case where the schematic diagram and / or examples described above indicate certain components arranged in certain orientations or positioning, the arrangement of the components can be modified. Although examples have been specifically shown and described, it should be understood that various changes in form and details can be made. Except for mutually exclusive combinations, any part of the equipment and / or methods described herein can be combined in any combination. The examples described herein may include various combinations and / or sub-combinations of the functions, components and / or features of the different implementations described.

[0113] The present disclosure describes various features, none of which is solely responsible for the benefits described herein. It should be understood that the various features described herein can be combined, modified or omitted, as will be apparent to those of ordinary skill. Other combinations and subcombinations other than those specifically described herein will be apparent to those of ordinary skill and are intended to form a part of the present disclosure. Various methods are described herein in conjunction with various flow chart steps and / or stages. It should be understood that in many cases, certain steps and / or stages can be combined together so that the multiple steps and / or stages shown in the flow chart can be performed as a single step and / or stage. In addition, certain steps and / or stages can be decomposed into additional subcomponents to perform separately. In some cases, the order of steps and / or stages can be rearranged and certain steps and / or stages can be completely omitted. In addition, the method described herein should be understood to be open, so that other steps and / or stages related to those steps and / or stages shown and described herein can also be performed.

[0114] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprise", "comprising", etc. should be interpreted in an inclusive sense, rather than in an exclusive or exhaustive sense; that is, in the sense of "including but not limited to". As generally used herein, the word "coupled" refers to two or more elements that can be directly connected or connected by means of one or more intermediate elements. Additionally, when used in this application, the words "herein", "above", "below" and similar inversions shall refer to the application as a whole, rather than to any particular part of the application. Where the context permits, words used in the singular or plural in the above specific embodiments may also include the plural or singular, respectively. The word "or", when referring to a list of two or more items, covers all of the following interpretations of the word: any item in the list, all items in the list, and any combination of items in the list.

[0115] The present disclosure is not intended to be limited to the embodiments shown herein. It is obvious to those skilled in the art that various modifications to the embodiments described in the present disclosure will be apparent, and the general principles defined herein may be applied to other embodiments without departing from the spirit or scope of the present disclosure. The teachings provided herein may be applied to other methods and systems, and are not limited to the methods and systems described above, and the elements and actions of the various examples described above may be combined to provide additional examples. Therefore, the novel methods and systems described herein may be embodied in various other forms; in addition, various omissions, substitutions and changes may be made to the forms of the methods and systems described herein without departing from the spirit of the present disclosure. The attached claims and their equivalents are intended to cover such forms or modifications that fall within the scope and spirit of the present disclosure.

Claims

1. An echogenic suture for use in medical surgery, wherein the echogenic signal is enhanced by a sharp material density change of the material in the echogenic suture.

2. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises a polymer having an echogenic material embedded therein.

3. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises a polymer, wherein the echogenic material is embedded on an outer surface of the polymer.

4. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises an inner polymer core surrounded by a layer of echogenic material, the layer of echogenic material surrounded by an outer polymer layer.

5. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises an inner polymer core surrounded by a layer of echogenic material.

6. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises a core of echogenic material surrounded by a polymer layer.

7. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises strands of echogenic material braided together with strands of a polymer to form a braided echogenic cord.

8. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises a plurality of strands of a polymer woven together to form a braid, wherein the echogenic material is captured in the weave of the braid.

9. The echogenic suture of claim 1 , wherein the material of the echogenic suture comprises an inner core having a first density and an outer jacket having a second density, wherein a density change between the first density and the second density provides the abrupt material density change of the material, the abrupt material density change enhancing the echogenic signal of the echogenic suture.

10. The echogenic suture of claim 1, wherein the material of the echogenic suture comprises one or more strands of a polymer and one or more strands of an echogenic material, the one or more strands of the polymer and the one or more strands of the echogenic material being twisted together to form the echogenic suture.

11. The echogenic suture of claim 1 , wherein the material of the echogenic suture comprises an ePTFE core surrounded by a jacket, the jacket comprising an echogenic material, the jacket being formed from a strip of a polymer having the echogenic material, the echogenic material being wrapped around the ePTFE core.

12. A method for performing a medical procedure, the method comprising: attaching an echogenic tether to target tissue of the heart, the tether comprising a distal anchor implant and a suture extending proximally from the distal anchor implant, the tether having an echogenic material that increases visibility to an ultrasound imaging device; and The proximal end of the echogenic cord is anchored to the heart.

13. The method of claim 12, wherein the echogenic cord comprises a polymer having an echogenic material embedded therein.

14. The method of claim 12, wherein the echogenic cord comprises a polymer, wherein the polymer has an echogenic material embedded on an outer surface thereof.

15. The method of claim 12, wherein the echogenic cord comprises an inner polymer core surrounded by a layer of echogenic material, the layer of echogenic material surrounded by an outer polymer layer.

16. The method of claim 12, wherein the echogenic cord comprises an inner polymer core surrounded by a layer of echogenic material.

17. The method of claim 12, wherein the echogenic cord comprises a core of echogenic material surrounded by a polymer layer.

18. The method of claim 12, wherein the echogenic cord comprises strands of echogenic material braided together with strands of a polymer to form a braided echogenic cord.

19. The method of claim 12, wherein the echogenic cord comprises a plurality of strands of a polymer woven together to form a braid, wherein the echogenic material is captured in the weave of the braid.

20. The method of claim 12, wherein the echogenic cord comprises an inner core having a first density and an outer jacket having a second density, wherein a density change between the first density and the second density provides an abrupt density change to increase ultrasonic reflection off the echogenic cord.

21. The method of claim 12, wherein the echogenic cord comprises one or more strands of a polymer and one or more strands of an echogenic material, the one or more strands of the polymer and the one or more strands of the echogenic material being twisted together to form the echogenic cord.

22. The method of claim 12, wherein the echogenic cord comprises an ePTFE core surrounded by a jacket, the jacket comprising an echogenic material, the jacket being formed from a strip of a polymer having the echogenic material wrapped around the ePTFE core.

23. The method of any one of claims 12 to 22, wherein anchoring the proximal end comprises securing the proximal end to an outer wall of the heart.

24. The method of any one of claims 12 to 22, wherein anchoring the proximal end comprises securing the proximal end to a papillary muscle of the heart.

25. The method of any one of claims 12 to 24, wherein the target tissue comprises a leaflet of a mitral valve.

26. The method of any one of claims 12 to 25, wherein the distal anchor implant is a large knot formed using the echogenic cord.

27. The method of any one of claims 12 to 25, wherein the distal anchor implant is a barb secured to the distal end of the echogenic cord.

28. An echogenic suture for use as an artificial tether in heart valve repair, the echogenic suture comprising an echogenic material that increases visibility to ultrasound imaging devices.

29. The echogenic suture of claim 28, wherein the echogenic suture comprises a polymer having an echogenic material embedded therein.

30. The echogenic suture of claim 28, wherein the echogenic suture comprises a polymer with an echogenic material embedded on an outer surface of the polymer.

31. The echogenic suture of claim 28, wherein the echogenic suture comprises an inner polymer core surrounded by a layer of echogenic material, the layer of echogenic material surrounded by an outer polymer layer.

32. The echogenic suture of claim 28, wherein the echogenic suture comprises an inner polymer core surrounded by a layer of echogenic material.

33. The echogenic suture of claim 28, wherein the echogenic suture comprises a core of echogenic material surrounded by a polymer layer.

34. The echogenic suture of claim 28, wherein the echogenic suture comprises strands of echogenic material braided together with strands of a polymer to form a braided echogenic suture.

35. The echogenic suture of claim 28, wherein the echogenic suture comprises a plurality of strands of a polymer braided together to form a braid, wherein the echogenic material is entrapped in the braid of the braid.

36. The echogenic suture of claim 28, wherein the echogenic suture comprises an inner core having a first density and an outer jacket having a second density, wherein a density change between the first density and the second density provides an abrupt density change to increase ultrasonic reflection off the echogenic suture.

37. The echogenic suture of claim 28, wherein the echogenic suture comprises one or more strands of a polymer and one or more strands of an echogenic material, the one or more strands of the polymer and the one or more strands of the echogenic material being twisted together to form the echogenic suture.

38. The echogenic suture of claim 28, wherein the echogenic suture comprises an ePTFE core surrounded by a jacket, the jacket comprising an echogenic material, the jacket formed from a strip of a polymer having the echogenic material, the echogenic material wrapped around the ePTFE core.

Images