Transcutaneous sling for accessing papillary muscles

Abstract

An implant system and delivery method includes a catheter system including a sling catheter having a plurality of distal openings and a delivery catheter disposed within the sling catheter and having a distal port. Suture-linked anchors can be sequentially delivered by the delivery catheter to a cardiac treatment site to embed the anchors in cardiac tissue, such as papillary muscle tissue, by aligning the port of the delivery catheter with a different opening of the sling catheter and pushing an anchor through the port and the sling catheter. Each anchor can have a linear configuration for translation within the delivery catheter and a biased configuration that resists re-entry into the sling catheter once deployed. Once all anchors are deployed, the sutures can be tightened, the anchoring portion of the sling catheter can be detached, and the catheter system can be withdrawn.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application 62 / 942,779, filed December 3, 2019, the entire contents of which are incorporated herein by reference for all purposes. TECHNICAL FIELD

[0003] The present disclosure relates generally to the field of implantable medical devices, and more specifically, to implantable devices, systems, and methods for modulating cardiac features. BACKGROUND

[0004] Mitral insufficiency (MI) is a form of heart disease in which the mitral annulus is over dilated and the leaflets no longer effectively coapt during systole of the heart. Regurgitation occurs during ventricular systole, thus reducing cardiac output.

[0005] Annuloplasty can be performed to restore the physiological shape and function of the mitral annulus. Annuloplasty can involve surgically implanting a ring around the mitral annulus to restore the diameter of the patient’s mitral annulus to a healthy state in which the leaflets properly coapt and mitral regurgitation is minimized. In addition, a subvalvular repair procedure, such as repositioning the papillary muscles or repairing the chordae tendinae within the left ventricle, can be performed.

[0006] Due to the invasiveness of surgical methods of mitral valve repair, several transcatheter techniques have been developed to mimic the surgical methods. As the delivery catheter carrying the mitral valve or subvalvular assembly can be as long as 52 inches, accurately navigating and delivering the assembly to the treatment site can be challenging. SUMMARY

[0007] One general aspect includes an implant, the implant comprising: a sling catheter having a first opening and a second opening, the first opening and the second opening extending through a wall of the sling catheter; a first anchor configured to be disposed adjacent to and outside of the first opening of the sling catheter; a second anchor configured to be disposed adjacent to and outside of the second opening of the sling catheter; and a suture extending through a lumen of the sling catheter, the suture having a first end coupled to the first anchor and a second end coupled to the second anchor.

[0008] In various embodiments, the first opening and the second opening are two of a plurality of spaced apart openings of the sling conduit, where the spaced apart openings can be uniformly spaced or variably spaced. The sling conduit can be composed of a polytetrafluoroethylene tube. At least one of the first opening or the second opening can be oriented toward the papillary muscle. The first opening and the second opening can be aligned along a common longitudinal axis of the sling conduit or disposed along different longitudinal axes of the sling conduit. The first anchor and the second anchor can be two of a plurality of anchors of the implant, and each anchor can be biased toward a configuration that resists the anchor from returning into the sling conduit.

[0009] According to another aspect, a delivery system includes a first conduit having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, where a portion of the first conduit distal end includes a sling having a plurality of spaced apart openings extending through a wall of the first conduit. The system can include a second conduit having a proximal end, a distal end, and a delivery lumen extending from the proximal end to the distal end, where the second conduit distal end includes a delivery port extending through a wall of the second conduit. The second conduit can be translatably disposed within the lumen of the first conduit to enable the port to align with one or more of the plurality of spaced apart openings of the sling. The delivery system can further include a plurality of anchors and a push tube translatably disposed within the delivery lumen and configured to advance at least one of the plurality of anchors through the delivery lumen and through the delivery port.

[0010] In various embodiments, the sling of the first conduit can be formed from a polytetrafluoroethylene tube. The sling can have a higher flexibility than the second conduit. The sling can have an outer diameter between 1 millimeter (mm) and 12 mm, a length between 1 centimeter (cm) and 35 cm, and the plurality of spaced apart openings can be spaced at least 2 mm apart. In some embodiments, the plurality of anchors can be joined via one or more sutures. In some embodiments, a cinching mechanism can be configured to reduce a spacing between the plurality of anchors, where in some embodiments, the cinching mechanism can be configured to decouple the sling from the first conduit. The cinching mechanism can be configured to couple at least a portion of the suture to at least one of the anchors.

[0011] In some embodiments, each of the plurality of anchors can include a first configuration that is translatable through the second conduit and the delivery port, and a second configuration in which the anchor is translated through the delivery port, and the second conduit can hold the plurality of anchors in the second configuration. In some embodiments, the plurality of spaced apart openings of the sling can be aligned along a common longitudinal axis of the first conduit or can be disposed along different longitudinal axes of the first conduit. The plurality of spaced apart openings can be uniformly spaced apart, or the spacing of the plurality of spaced apart openings can vary. For example, the spacing of the openings in a region expected to contact the papillary muscle can be closer, enabling sufficient flexibility in the number and location of anchors placed. The delivery system can include a cinching mechanism for cinching the suture.

[0012] According to another aspect, a method of subvalvular repair includes advancing a catheter system to a left ventricle, the catheter system including a sling catheter having a plurality of openings extending through a distal wall of the sling catheter and a delivery catheter translatably disposed within the sling catheter, the delivery catheter having a distal port extending through a wall of the delivery catheter. The method includes orienting the plurality of openings toward papillary muscles and advancing a first anchor toward the distal port of the delivery catheter, the first anchor having a linear configuration that enables the first anchor to translate through the delivery catheter. The method includes aligning the distal port with a first opening of the sling catheter and urging the first anchor through the distal port and the first opening into a first papillary tissue, the first anchor assuming a biased configuration that inhibits the first anchor from returning into the first opening as the first anchor is advanced out of the delivery catheter, and advancing a second anchor toward the distal port of the delivery catheter, the second anchor having a linear configuration during translation through the delivery catheter, the second anchor being joinable to the first anchor by a suture. The method includes aligning the distal port with a second opening of the sling catheter. The method includes urging the second anchor through the distal port and the second opening into a second papillary tissue, the second anchor assuming a biased configuration that inhibits the second anchor from returning into the second opening as the second anchor is advanced out of the delivery catheter, and cinching the suture to draw the first anchor and the second anchor together to adjust a spacing between the first papillary tissue and the second papillary tissue.

[0013] In some embodiments, the method can further include coupling one or more portions of the suture to the at least one anchor, decoupling at least a portion of the sling catheter, and removing the catheter system from the left ventricle.

[0014] With this arrangement, an implant and delivery method are disclosed that enable non-invasive subvalvular repair. BRIEF DESCRIPTION OF DRAWINGS

[0015] Non-limiting embodiments of the present disclosure are described by way of example in the accompanying drawings which are schematic and not intended to be drawn to scale. In the figures, each identical, or nearly identical, component that is illustrated in various figures is represented with a like numeral. For purposes of clarity, not every component is called out in every figure, nor is every embodiment of the present disclosure shown. In the figures:

[0016] Figure 1 a portion of a heart in which a delivery catheter such as those disclosed in various embodiments herein can be deployed;

[0017] Figure 2A and 2B several embodiments of a sling catheter according to the present disclosure are shown;

[0018] Figure 3 One embodiment of an anchor delivery catheter is shown in accordance with various aspects of the present disclosure;

[0019] Figure 4 is a cross-sectional view of a distal end of a sling catheter, an anchor catheter, and a push tube as disclosed in one embodiment herein;

[0020] Figures 5A-5E shows an example of steps for deploying anchors to papillary tissue for subvalvular repair using one embodiment of the delivery system disclosed herein; and

[0021] Figure 6A and 6B shows one embodiment of an anchor that can be used in embodiments disclosed herein;

[0022] Figure 7A and 7B shows one embodiment of an anchor that can be used in embodiments disclosed herein;

[0023] Figure 8A and 8B shows one embodiment of an anchor that can be used in embodiments disclosed herein;

[0024] Figure 9A and 9B shows one embodiment of an anchor that can be used in embodiments disclosed herein;

[0025] Figure 10 is a view of a portion of a heart after subvalvular repair as disclosed in one embodiment herein. DETAILED DESCRIPTION

[0026] An implantation system and delivery method includes a catheter system including a sling catheter having a plurality of distal openings and an anchor delivery catheter disposed within the sling catheter and having a distal port. Suture-linked anchors can be sequentially delivered by the anchor delivery catheter to a heart treatment site to embed the anchors in heart tissue, such as papillary muscle tissue, by aligning the port of the anchor delivery catheter with different openings of the sling catheter and pushing the anchors through the port and the sling catheter. Each anchor can have a linear configuration for translation within the delivery catheter and a biased configuration that inhibits its re-entry into the sling catheter once deployed. Once all anchors are deployed, the sutures can be tightened, the anchoring portion of the sling catheter can be detached, and the catheter system can be withdrawn. Such a system can be used to more closely bind together tissue features of a heart, for example, for valvular and / or subvalvular repair procedures, such as annuloplasty and repair, replacement, and / or repositioning of valve leaflets, papillary muscles, or chordae tendinae to improve valve function.

[0027] These and other beneficial aspects of the system for subvalvular repair are described in more detail below. It should be noted that although embodiments of this disclosure may be described specifically with reference to papillary muscles, the principles disclosed herein can be readily applied to any other dilation, valvular insufficiency, valvular leakage, and other similar heart failure conditions.

[0028] As used in this article, the term "distal" refers to the end furthest from the medical professional when the medical device is introduced into the patient, while the term "proximal" refers to the end closest to the medical professional when the medical device is introduced into the patient.

[0029] Figure 1 This is a diagram of the left ventricle of the heart 100, including the left atrium 110 separated from the left ventricle 130 by the mitral valve 120. The mitral valve 120 includes anterior leaflets 122a and posterior leaflets 122b, which in a healthy heart are attached to papillary muscles 134a and 134b via chordae tendineae 132a and 132b, respectively. Contraction of papillary muscles 134a and 134b prevents inversion or prolapse of leaflets 122a and 122b during systole of the left ventricle 130. The mitral valve annulus 115 includes a fibrous ring, which in a healthy heart is saddle-shaped, with a diameter that allows the valve to close or engage during the systolic phase of cardiac contraction.

[0030] In a diseased heart, one or more of the chordae tendineae 132a and 132b may elongate or rupture, resulting in flail leaflets 122a and 122b that no longer close effectively, thus causing regurgitation. Alternatively or in combination, the mitral annulus 115 may become stretched or deformed, and the valve may also fail to close as a result.

[0031] To repair heart failure, the repair component can be deployed transcavitarily into the heart. Figure 1 In this case, the delivery system 150 disclosed herein is shown to advance through the femoral artery to the aorta 140 and into the left ventricle 130 for retrograde delivery of the repair component via the femoral artery. Depending on the characteristics of the heart to be repaired, it should be understood that this disclosure is not limited to the manner in which the delivery system is introduced into the heart 100. For example, for delivering the repair component to the left atrium, transapical or transseptal delivery pathways may be used with the embodiments of the delivery catheters and systems disclosed herein.

[0032] In one embodiment, the delivery system 150 may include a plurality of nested catheters having a steerable distal end 155 to facilitate navigation of the repair component into the left ventricle. According to one aspect, as described in more detail below, the delivery system 150 includes a sling catheter 160 including a removable distal portion comprising a tubular sling 175 having a plurality of openings 176 extending therethrough.

[0033] During delivery, a distal guidewire (not shown) disposed within the sling catheter 160 can facilitate transluminal navigation. For example, as shown in Figure 1 the distal guidewire can deliver the sling 175 into the left ventricle 130, pushing the sheath against the left ventricular wall around the base of the papillary muscles 134a, 134b. An anchor delivery catheter, which can be translatably disposed within the sling 175, can advance one or more suture-linked anchors through the opening 176 of the sling 175 into the papillary tissue. After deployment of the anchors, the sutures can be tightened to pull the papillary muscles together to approximate a healthy papillary structure, with the leaflets 122a, 122b pulled together to improve cardiac function. As will now be described in greater detail below, the sling 175 can then be detached and left within the left ventricle to maintain the papillary muscles in their reconfigured state.

[0034] Figure 2A , 2B FIGS. 1-3 illustrate examples of catheters that can form nested catheters of the delivery system 150 Figure 1 . For example, Figure 2A FIG. 4 illustrates a top perspective view of one embodiment of the sling catheter 160. In some embodiments, the sling catheter 160 can include a tubular body having a proximal end 215, a distal end 205, and an elongate body 210 extending therebetween. An inner lumen 212 can extend along an axis "A" from the proximal end through the distal end of the sling catheter 160. A connector 225 can be disposed at the proximal end 215 such that the sling catheter 160 can be releasably linked to a connector of a steerable catheter that can be used to guide the sling catheter 160 into an intracardiac position. The connector 225 can take any of a variety of forms, including but not limited to a threaded connector, a snap connector, a luer connector, and the like. Accordingly, the present disclosure is not limited to the mechanism used to link the sling catheter 160 to a steerable catheter. Figure 2A

[0035] ​In one embodiment, the sling conduit 160 is formed of a pliable material, such as a polytetrafluoroethylene (PTFE) tube or other various materials suitable for implantable devices. The sling conduit 160 can include different properties and / or materials along the length of the sling 175 or around the cross-sectional diameter of the sling 175 to achieve desired properties (e.g., wear resistance, strength, etc.). The sling conduit 160 can include a composite material, such as fibers of one material embedded in a matrix of a second material. Some examples of materials (in addition to those already mentioned) can include polyether-polyurethane (PE-PUR copolymer), poly(styrene-isobutylene-styrene) (SIBS) triblock polymer, polyisobutylene polyurethane copolymer (PIB-PUR), polyisobutylene (PIB), polyethylene, or other similar materials. In some embodiments, the length of the sling conduit 160 can be between 24" - 52", more particularly between 42" - 46". In one embodiment, the inner diameter of the sling conduit 160 can be between 0.75 mm - 11.5 mm, and the outer diameter can be between 1 mm - 12 mm or more. In an example of an embodiment, the inner diameter can be, for example, 28 Fr and the outer diameter can be 32 Fr.

[0036] As mentioned above, in some embodiments, the distal end 205 of the sling conduit 160 includes a plurality of openings 176. According to one aspect, the distal end 205 of the sling conduit 160 including a plurality of openings 176 is referred to as a "sling." The length of the sling can be between 1 to 35 cm. For example, longer slings can be envisioned that can loop around the papillary muscle multiple times (2-3 times or more) within the left ventricle. In some embodiments, the plurality of openings includes spaced apart openings that are selected to have a cross-sectional diameter that enables the anchor to pass through the opening into the heart tissue. For example, the cross-sectional diameter of the openings can be between 0.50 mm and 10 mm. In some embodiments, the openings 176 are uniformly spaced apart. In alternative embodiments, the spacing between the openings can vary, for example, providing tighter openings in areas where the sling is likely to be located near the papillary muscle, and having increased spacing in areas where the sling is likely to be generally located between the papillary muscles. In some embodiments, the plurality of spaced apart openings can be aligned on a common axis parallel to the central axis A, as shown in Figure 2A In alternative embodiments, the plurality of spaced apart openings can not be aligned on a common axis, but can be distributed along different linear axes of the wall of the sling conduit 160. For example, Figure 2B Figures illustrate embodiments of a sling conduit 275 having openings 276 that are variably spaced and distributed along different linear axes of the sling conduit body. In other embodiments, it is envisioned that the sling conduit 160 can not actually have pre-formed openings; rather, the anchor (which is delivered through an anchor delivery conduit) pierces the sling conduit 160 and into the tissue at a location determined by the physician during the procedure. In this case, the openings in the sling conduit 160 for the sutures will be defined by the size of the sutures.

[0037] Figure 3 is a side perspective view of one embodiment of a steerable catheter that is translatably disposed within a sling catheter 160 Figure 2A ) or a sling catheter 275 Figure 2B ). For example, the steerable catheter can include an anchor delivery catheter 300 that includes a steerable shaft 310 extending from a distal end 305 to a proximal end 315. The proximal end 315 of the anchor delivery catheter 300 can include a handle 325 having a dial 330, or other control mechanism configured to manipulate the distal end 305 of the delivery catheter 300. For example, the steerable shaft 310 can include an embedded pull wire that can be linked to a mechanism in the handle 325 configured to deflect the distal end 305 of the delivery catheter 300 as it is navigated through a lumen of an artery or vein into the left ventricle. It should be appreciated that while a dial 330 is shown, alternative steering control mechanisms can include, for example, thumbwheels, dials, knobs, switches, etc., and the present disclosure is not limited by the manner in which the anchor delivery catheter 300 is manipulated.

[0038] According to one aspect, the shaft 310 of the anchor delivery catheter 300 includes a generally tubular structure having a lumen extending therethrough. The lumen is configured to enable translation of an anchor from the proximal end 315 to the distal end 305 of the delivery catheter 300. In one embodiment, the distal end 305 of the anchor delivery catheter 300 includes one or more anchor ports, such as port 340. The port 340 is sized to allow ejection of an anchor from the lumen of the anchor delivery catheter 300. In some embodiments, the diameter of the port 340 of the anchor is related to the diameter of an opening in an associated sling catheter (e.g., opening 176 of the mid-sling catheter 160). In some embodiments, the diameter of the port 340 of the anchor is at least equal to the diameter of the opening in the associated sling catheter to facilitate passage of the anchor, but this is not required. Figure 2A In some embodiments, the anchor delivery catheter 300 includes a pull wire 350 that is embedded within the shaft 310 of the anchor delivery catheter 300. The pull wire 350 is configured to be manipulated by the handle 325 to cause the distal end 305 of the anchor delivery catheter 300 to deflect. For example, the handle 325 can include a knob or other control mechanism that is configured to be manipulated by a user to cause the distal end 305 of the anchor delivery catheter 300 to deflect. In some embodiments, the pull wire 350 is configured to be manipulated by the handle 325 to cause the distal end 305 of the anchor delivery catheter 300 to deflect in a first direction. In some embodiments, the pull wire 350 is configured to be manipulated by the handle 325 to cause the distal end 305 of the anchor delivery catheter 300 to deflect in a second direction that is opposite the first direction.

[0039] In one embodiment, the anchor delivery conduit 300 can comprise a composite material of thermoplastic elastomer (TPE) layers, such as PEBAX offered by ARKEMA of Colombes, France. Alternatively, nylon, polyurethane, polyester, silicone, or other similar materials can be used to provide thin walls that can be extruded and layered over a braided wire or coil to obtain tensile and hoop strength, although the disclosed system is not limited to any particular material composition for the anchor delivery conduit 300. In some embodiments, the length of the anchor delivery conduit 300 can be between 24" - 52", more particularly between 42" - 46". In one embodiment, the inner diameter can be between 0.25 mm to 11 mm. The outer diameter is related to the inner diameter of the sling conduit 160, and is sized such that the anchor delivery conduit 300 is able to freely translate within the sling conduit 160. For example, the outer diameter can be in the range of 0.75 mm to 11.5 mm.

[0040] In some embodiments, the handle 325 can comprise a coupler 350 configured to accept a push tube (e.g., push tube 355) or a guide wire, enabling the push tube 355 or guide wire to be advanced between the proximal end 315 and the distal end 305 of the anchor delivery conduit 300.

[0041] Although the anchor delivery conduit 300 has been described as a steerable conduit, in alternative embodiments, the anchor delivery conduit 300 can be a flexible conduit, and a steerable guide wire can be used to steer the sling conduit 160 into position.

[0042] Figure 4 is a cross-section of a distal end 405 of a delivery system 400, comprising a sling conduit 410 and an anchor delivery conduit 420 translatably disposed within the sling conduit 410. In various embodiments, the delivery system 400 can be formed similarly to the delivery systems described above. The sling conduit 410 is shown as comprising a plurality of spaced apart openings 476. The anchor delivery conduit 420 is shown as comprising an anchor port 440. In one embodiment, the delivery system delivers an anchor by aligning the port 440 of the anchor delivery conduit 420 and one of the openings 476 of the sling conduit 410. An anchor 450 can be advanced through an inner lumen of the anchor delivery conduit 420 toward the port 440, for example by a push tube 430 translatably disposed within the inner lumen of the anchor delivery conduit 420.

[0043] The anchors 450 can take a variety of forms. In some embodiments, the anchors 450 can be composed of a shape memory material, such as copper-aluminum-nickel, nickel-titanium (NiTi) alloy, or other alloys of zinc, copper, gold, and / or iron. In some embodiments, the anchors 450 include a generally linear configuration and a biased that facilitates translation through the lumen of the anchor delivery catheter 420 and an expanded configuration that resists translation of the anchor through the opening 476 / port 440. For example, the anchors 450 are shown to include a prong 423a disposed at a distal end, and a suture connector having an eyelet 423b disposed at a proximal end.

[0044] The suture 460 can be connected to the anchor eyelet 423b. In some embodiments, the suture 460 can be tied to the eyelet 423b of the anchor 450, in some embodiments, the suture 460 can be threaded through the eyelet 423b, enabling the anchor 450 to be cinched as described in Figures 5A-5E

[0045] The suture can be formed of any of a variety of biocompatible materials, including nylon, polyester, polymeric or metallic wire, and the like. In some embodiments, the suture can be braided and / or manufactured from two or more materials. Some other examples of materials (in addition to those mentioned) can include polypropylene, ultra-high-molecular-weight polyethylene, polyether ether ketone, polytetrafluoroethylene (PTFE), silk, or combinations thereof. In some embodiments, the suture can be composed of a metal such as stainless steel and nitinol. For example, the suture can include a pre-shaped, heat-set nitinol spring / braid / structure (i.e., a nitinol tensile spring, helical extender, etc.) that collapses on itself when deployed from the catheter around the papillary muscle, causing the papillary muscle to be drawn more tightly together.

[0046] Figures 5A-5E A top view of a delivery system 500 including anchors that have been delivered into the left ventricle. In Figures 5A-5E the sling catheter 510 and the anchor delivery catheter 520 are shown in cross-section. In some embodiments, the sling catheter 510 encircles the papillary muscles PM1, PM2. In some embodiments, the sling catheter encircles the base of the papillary muscles PM1, PM2. In alternative embodiments, the sling catheter 510 is positioned at any location between the base of the papillary muscles PM1, PM2 and the mid-portion of the papillary muscles PM1, PM2. It will be appreciated that positioning the sling catheter 510 between the midpoint and the base of the papillary muscle can reduce the likelihood of the anchors interfering with the chordae tendineae.

[0047] Once positioned, the sling catheter 510 can be contracted to engage the outer surface (e.g., the inner circumferential outer surface) of the sling catheter with the papillary muscles PM1, PM2. The sling catheter 510 can be advantageously positioned such that at least a portion of the openings 576a-576k are oriented toward the papillary muscles PM1, PM2, ensuring that the anchors expelled from the delivery system 500 can attach to the papillary tissue. Figure 5A ​An anchor 550 is shown being advanced through push tube 530 into opening 576a. Anchor 550 is connected to thread 560, which can thread over push tube 530 back to the proximal end of the delivery system (e.g., ...). Figure 4 (as shown), or optionally thread-through push tube 530, such as Figure 5A As shown. In Figure 5A In one embodiment, the anchor 550 for the first anchoring of the sling conduit 510 is shown attached to the anchor 550. The push tube 530 continues to advance, pushing the anchor 550 through the port 540 of the anchor delivery conduit and deploying the anchor 550 into the tissue of the papillary muscle PM1 through the opening 576a.

[0048] Figure 5B The deployment of the delivery system 500 to the second anchor 552 is illustrated. As shown, the first anchor 550 has been deployed and restored to its biased expansion configuration, which prevents it from retracting into the opening 576a of the sling catheter 510. The surgeon can select any opening 576a-576k of the sling catheter 510 for deployment of the anchor 552. Figure 5B After the anchor delivery conduit 520 is translated proximally to align port 540 with opening 576e, the anchor 552 is discharged through port 540 of the anchor delivery conduit 520 and opening 576e of the sling conduit. The anchor 552 is then advanced into the papillary tissue PM2 by the action of the push tube 530.

[0049] Figure 5C The diagram illustrates a conveying system 500 after the deployment of anchors 550 and 552, wherein each anchor has been returned to an offset configuration that inhibits the anchor from returning to the corresponding openings 576a, 576e. Figure 5C In this configuration, the port 540 of the anchor delivery conduit 520 has been retracted proximally to align the port 540 with the opening 576h of the sling conduit 510, and the push tube 530 is shown advancing the anchor 554 to the port 540 / opening 576h to deploy the anchor 554 into the papillary muscle PM2 tissue. Figure 5D As can be seen, the delivery system 500 has deployed anchor 554 into the tissue, and the anchor delivery conduit 520 has been retracted proximally to align port 540 with opening 576k. The pusher tube 530 then advances anchor 556 through port 540 and opening 576k toward the papillary tissue PM1. Suture 560 connects all four anchors 550, 552, 554, and 556, and the biased configuration of anchors 550, 552, 554, and 556 prevents them from returning to the sling conduit 510.

[0050] Accordingly, the anchor delivery catheter can be withdrawn at this point, and the proximal end of the suture 560 is pulled proximally or otherwise tightened to draw the anchors and papillary muscles PM1, PM2 more closely together. For example, Figure 5E The sling catheter 510 is shown with the suture 560 tightened, where it can be seen that the papillary muscles PM1 and PM2 have been drawn together by the tightening action. The anchors 550, 552, 554, and 556, while being drawn toward the respective openings 576a, 576e, 576h, and 576k, are inhibited from being drawn back into the sling catheter by their biased expanded configuration. Once the suture 560 is tightened, the suture can be secured to the distal end of the sling catheter 510 to maintain the tightened configuration of the sling catheter 510, for example using resistance welding 565 or the like, the distal end of the sling catheter 510 can be separated at point 566, for example using a burn or other means, whereupon the remainder of the delivery system can be removed from the heart treatment site. Although Figures 5A-5E The openings 576a, 576e, 576h, and 576k are shown for delivery of respective anchors, but it will be appreciated that more or fewer openings 576a-576k can be used to achieve the desired alteration to the papillary muscles PM1, PM2.

[0051] Various methods of separating the sling catheter can be employed. For example, an electrical current can be delivered to resistively heat a local region of the catheter, causing it to separate under a point of tension or torsion. For this purpose, such a sheath can include an electrical conductor within the wall of the removable portion of the sheath. In other embodiments, the sling portion can be mechanically separated, for example, using a push rod that engages and causes it to "break away" from the removable portion, or a threaded joint can be provided between the sling catheter and the sling portion of the sling catheter, the two portions being separable by rotating the sling catheter to release the threaded portion. In yet other embodiments, an energy source, such as a laser, can be advanced through the lumen of the delivery catheter to "cut" the two portions, leaving the sling behind.

[0052] It should be noted that while delivery of four anchors has been shown and described, subvalvular improvement can be achieved with as few as two anchors or as many anchors as there are openings in the sling catheter, and / or as many anchors as can be pushed through the openings or walls of the sling catheter. Accordingly, the present disclosure is not limited to use of any particular number of anchors.

[0053] Furthermore, while the figures illustrate anchors having extending tines, the present invention is not limited to use of a particular anchor, but rather any form of anchor that can travel freely within the lumen but is inhibited from returning to the lumen upon deployment can be used. For example, Figures 6A-9B Various embodiments of anchors that can be suitable for this purpose are shown. For example, Figure 6A An anchor 600 is shown in a linear configuration for translation within the lumen. Figure 6BAnchors 600 are shown in an expanded configuration, with the tines of the anchors extending radially outward. Figure 7A An annular anchor 700 is shown in a linear configuration, Figure 7B An annular anchor is shown in an expanded configuration. Figure 8A A helical anchor 800 is shown in a linear configuration, Figure 8B A helical anchor is shown deployed, with the turns of the helical anchor capturing the edges of the port / opening to prevent the anchor 800 from returning into the sling catheter. The helical anchor can be incompressible (such that its diameter does not change when pushed through the catheter), for example, composed of MP35N or stainless steel, or can be formed of a shape memory material, such as Nitinol, which self-expands when released from the catheter.

[0054] Figure 9A A twisted anchor 900 is illustrated in a linear configuration, Figure 9B A twisted anchor 900 is shown in a deployed profile. The tine anchors 600, annular anchors 700, and twisted anchors 900 can each be formed of a memory-based material that is biased toward an expanded configuration, and / or can return to their biased configuration in response to body heat. In any of various embodiments, the anchors can be composed of stainless steel, Nitinol, or the like, and can include a sharp distal end and / or barbs disposed on some portions of the anchor body to secure the anchor to the treatment site. The overall axial length of the anchors can range from about 2 mm to about 15 mm and the diameter can range from about 0.2 mm or less to 3 mm or more. However, other embodiments can be used according to the anchoring purpose, and thus the present disclosure is not limited to a particular form of anchor.

[0055] Figure 10 is Figure 1 The heart 100 in Figures 5A-5E is shown in a schematic view after subvalvular repair as disclosed in the Figure 10 The sling catheter 510 is shown retaining a position around the papillary muscles 134a, 134b. The sling catheter 510 has been cinched using anchors and sutures and constrained in the cinched configuration by welding 565, thereby holding the papillary muscles together and pulling the leaflets 122a, 122b of the mitral valve 120 together to restore heart function.

[0056] Accordingly, systems and methods for sub-valvular repair have been shown and described. Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word "example" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "example" is not necessarily to be construed as preferred or advantageous over other implementations.

[0057] Certain features described in the specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features can be described above as acting in particular combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination and the claimed combination can be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring or implying that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Further, other implementations can be within the scope of the following claims. In certain cases, the actions recited in the claims can be performed in a different order, and still achieve desirable results.

[0058] Those skilled in the art will appreciate that, in general, the term "comprises" is always meant to be interpreted as "comprises, but does not necessarily comprise" and the term "comprising" is always meant to be interpreted as "including, but not necessarily limited to". The term "having" should, unless specifically stated to the contrary, be interpreted as "having at least". The term "including" should, unless specifically stated to the contrary, be interpreted as "including without limitation". The term "consisting of" should, unless specifically stated to the contrary, be interpreted as "consisting of, but not necessarily limited to".

[0059] Those skilled in the art will further appreciate that, when relative terms are used (e.g., beneath, below, lower, under, upper, over, higher, greater than... etc.), these are intended to be interpreted as relative to a particular structure, object, or other reference object as would be understood by one of ordinary skill in the art having the benefit of the present disclosure. Those skilled in the art will further appreciate that, if a particular number of introduced claims is intended to be referenced, such intent will be explicitly recited in the claims, and in the absence of such recitation, no such intent exists. For example, to aid understanding, the appended claims can contain the use of introductory phrases such as "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases is not to be construed as implying any specific claim limitation to only those embodiments containing such recited claim limitation followed by the introductory phrase (e.g., that an embodiment recited only once by the indefinite article "a" or "an" is limited to only that embodiment with one such recitation) even when the same claim includes the introductory phrase "one or more" or "at least one" and the indefinite article, e.g., "a" (e.g., "a" is generally to be interpreted to mean "at least one" or "one or more"); the same applies to the use of the definite article to introduce claim recitations. Moreover, even if a particular number of introduced claim recitations is explicitly recited, those skilled in the art will recognize that such a recitation is typically to be interpreted to mean at least the recited number (e.g., a simple recitation of "two recitations" is to be interpreted to mean at least two recitations, or two or more recitations, without further modifiers) unless other modifiers are specified. Additionally, in the event a convention similar to "at least one of A, B, and C, etc." is recited, then, if such a structure is used in a claim, it is to be interpreted in the manner that one of ordinary skill in the art would understand the convention (e.g., "a system having at least one of A, B, or C" would include, but not be limited to, a system wherein: A is present alone, B is present alone, C is present alone, A and B are present together, A and C are present together, B and C are present together, and / or A, B, and C are present together, etc.). In those instances where a convention similar to "at least one of A, B or C, etc." is recited, in

[0060] In accordance with the present disclosure, the devices and / or methods disclosed and claimed herein can be manufactured and used without undue experimentation in accordance with the description and figures set forth. While various embodiments of the devices and methods of the present disclosure have been described above, it should be understood that they have been presented by way of example only, and not limitation. None of the steps or the steps sequence described herein are essential, nor are they performed in any specific order, except when the steps depend on each other, and none of the steps or the steps sequence are exclusive of any other steps or steps sequence. Numerous modifications, changes, variations, substitutions, deletions, additions, and other can be made to the steps sequence described herein without departing from the spirit and scope of the present disclosure, which is set forth in the following claims.

Claims

1. An implant, comprising: a cinchable sling conduit having a first opening and a second opening, the first and second openings extending through a wall of the sling conduit; a first anchor configured to be disposed outside the sling conduit adjacent the first opening; a second anchor configured to be disposed outside the sling conduit adjacent the second opening; and a cinchable suture carrying at least the first and second anchors, the cinchable suture configured to extend through a lumen of the cinchable sling conduit, and the cinchable suture cinchable to cinch the cinchable sling conduit and draw the first and second anchors together when the first and second anchors have been deployed relative to tissue.

2. The implant of claim 1, wherein the first and second openings are two of a plurality of spaced apart openings of the sling conduit, wherein the spaced apart openings are uniformly spaced apart or variably spaced apart.

3. The implant of claim 1, wherein the sling conduit comprises a polytetrafluoroethylene tube.

4. The implant of claim 1, wherein the sling conduit is configured to be circumferentially disposed about one or more papillary muscles, and when circumferentially disposed, at least one of the first or second openings is oriented toward the one or more papillary muscles.

5. The implant of any one of claims 1-4, wherein the first and second openings are aligned along a common longitudinal axis of the sling conduit or are disposed along different longitudinal axes of the sling conduit.

6. The implant of any one of claims 1-4, wherein the first and second anchors are two of a plurality of anchors of the implant, and wherein each anchor is biased toward a configuration that resists return of the anchor into the sling conduit.

7. The implant of any one of claims 1-4, as part of a delivery system, comprising: a delivery conduit translatably disposed within the sling conduit, the delivery conduit having a port at a distal end, the delivery conduit configured to orient the port toward a plurality of spaced apart openings of the sling conduit; wherein the first and second anchors comprise a linear configuration that enables the first and second anchors to translate through the delivery conduit, the port, and respective first and second openings of the sling conduit, and wherein the delivery conduit is configured to maintain the first and second anchors in the linear configuration. ​

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