Devices, systems, and methods for artificial chordae tendinae

Abstract

The present invention relates generally to the field of medical devices for treating heart disease. In particular, the present invention relates to medical devices, systems, and methods for delivering artificial chordae tendinae in a patient. A system for delivering a chordae tendinae into a heart can include a delivery catheter. A clip catheter can be configured to translate through the delivery catheter. An expander can be disposed on the clip catheter. A first clip can be at least partially contained in the expander in a closed configuration and can be attached to the chordae tendinae. An anchor catheter can be configured to translate through the delivery catheter and can have an anchor attached to the chordae tendinae. A sheath can extend over the anchor catheter and the anchor and can be configured to constrain arms of the anchor.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62 / 873,357, filed July 12, 2019; U.S. Provisional Patent Application No. 62 / 873,352, filed July 12, 2019; U.S. Provisional Patent Application No. 62 / 873,354, filed July 12, 2019; and U.S. Provisional Patent Application No. 62 / 870,343, filed July 3, 2019, the entire contents of which are incorporated herein by reference for all purposes. TECHNICAL FIELD

[0003] The present invention relates generally to the field of medical devices for treating heart disease. In particular, the present invention relates to medical devices, systems, and methods for delivering artificial chordae tendinae in a patient. BACKGROUND

[0004] In a healthy heart, chordae tendinae connect papillary muscles to heart valve leaflets to control opening and closing of the heart valve during heart contraction and relaxation. As heart disease progresses, chordae tendinae can stretch inelastically and can rupture. Stretched and / or ruptured chordae tendinae can result in flail leaflets that can no longer have the ability to form a valve seal for normal heart function. Abnormal blood flow regurgitation can occur, preventing adequate blood supply through the cardiovascular system.

[0005] Mitral valve disease is often repaired via invasive surgical intervention or by pinching the leaflets together, thereby creating a double, smaller opening or performing a mitral valve replacement of the native valve. These and other methods can be accompanied by risky bypass surgery, which can include openings into the patient’s chest and heart chamber to expose the mitral valve for direct observation and repair. Thus, there is a need for a transluminal solution for mitral valve disease.

[0006] A variety of advantageous medical outcomes can be achieved by the present invention including medical devices, systems, and methods for delivering artificial chordae tendinae in a patient. SUMMARY

[0007] Embodiments of the present invention can generally facilitate delivering artificial chordae tendinae in a patient. In one aspect, a system for delivering a chordae tendinae into a heart of a patient can include a delivery catheter. A clip catheter can be configured to translate through the delivery catheter. An expander can be disposed on the clip catheter. A first clip can be at least partially contained in the expander in a closed configuration. The first clip can be attached to a first end of the chordae tendinae. An anchor catheter can be configured to translate through the delivery catheter. The anchor catheter can have an anchor attached to a second end of the chordae tendinae. A sheath can extend over the anchor catheter and the anchor. The sheath can be configured to constrain arms of the anchor.

[0008] In various embodiments described herein or otherwise, a second end of a tendon can extend through a ratchet of an anchor. The second end of the tendon can be coupled to a tether that extends through an anchor conduit. The tether can be configured to increase tension in the tendon via translation of the tether. A release filament can extend through a release roller of the ratchet. The release filament can be configured to unlock the tendon from the ratchet via translation of the release filament. A first clip can be reversibly locked to an expander. A second clip can be attached to the first clip by a clip filament. The clip filament can be slidably coupled to a first end of the tendon. The anchor conduit and a sheath can extend through a clip conduit. The clip can include a plurality of clip arms at the first end. The plurality of clip arms can have a closed configuration in which the clip arms are oriented toward one another, and an open configuration in which the clip arms are oriented away from one another. A spring portion can be coupled to the plurality of clip arms at the second end. The spring portion can be configured to bias the clip arms to the closed configuration. The clip arms of the clip can be configured to fixedly engage leaflets of a heart valve. The first expander can include a base disposed on the clip conduit. A pin can extend from the base. A lever can be rotatably disposed about the pin. A first channel can extend through the base substantially parallel to a first aperture of one of the plurality of clip arms and can be configured to accept the one of the plurality of clip arms. A second channel can extend through the lever substantially parallel to a second aperture of the one of the plurality of arms and can be configured to accept the one of the plurality of arms. A first filament can extend from the lever. The filament can be configured to move the lever and move the clip between the closed configuration and the open configuration. A first pin can be disposed within the first aperture and the first channel. A second pin can be disposed within the second aperture and the second channel. Shape memory of the arms of the anchor of the anchor conduit can be configured to bias the arms to pierce muscle and can extend proximally upon transitioning of the arms from a constrained configuration toward a neutral configuration. The anchor conduit can be disposed within the sheath. The sheath can be disposed within the clip conduit. The clip conduit can be disposed within a delivery conduit. A handle can be coupled to the delivery conduit, the clip conduit, the anchor conduit, and the sheath and configured to allow a medical professional to selectively and independently translate the delivery conduit, the clip conduit, the anchor conduit, and the sheath. A second expander can be disposed on the clip conduit substantially opposite the first expander. The anchor can be attached to the anchor conduit by interlocking threads. The sheath can be configured to constrain the arms such that the arms extend distally.

[0009] In various embodiments, a method of delivering a chordae tendinea into a patient's heart can include transluminally inserting a delivery catheter into the heart. A clip catheter can extend through the delivery catheter. The clip catheter can have an expander containing a clip in a closed configuration. The clip can be attached to a first end of the chordae tendinea. The expander can be steered to transition the clip from the closed configuration to an open configuration. The clip can be positioned adjacent to a leaflet of a heart valve. The expander can be steered to transition the clip from the open configuration to the closed configuration onto the leaflet. A sheath can extend through the delivery catheter toward heart tissue. An anchor catheter having an anchor can extend, the anchor being attached to a second end of the chordae tendinea at a distal end of the anchor catheter through the sheath. The anchor can be driven into the tissue.

[0010] In various embodiments described herein or otherwise, regurgitation of a valve can be observed via transesophageal echocardiogram or fluoroscopy and adjusting tension in a chordae tendinea. The tension in the chordae tendinea can be adjusted by selectively translating the chordae tendinea through a ratchet of an anchor and selectively releasing the chordae tendinea from the ratchet. The clip can be deployed from the expander by removing a plurality of pins from the clip and the expander. Steering of the expander can be performed by proximally translating an expander filament through the clip catheter. The clip can be repositioned by transitioning the clip from the closed configuration to the open configuration, moving the clip from a first portion of the leaflet to a second portion of the leaflet, and transitioning the clip from the open configuration to the closed configuration onto the leaflet. The sheath extending through the delivery catheter can extend through the clip catheter. Driving the anchor can include deploying an arm from the anchor by extending the anchor catheter such that the arm extends at least partially out of a distal end of the sheath. The anchor can be repositioned by extending the anchor catheter proximally through the sheath from a first portion of the tissue and extending the anchor catheter to a second portion of the tissue. The clip catheter, the sheath, the anchor catheter, and the delivery catheter can be removed from the patient.

[0011] In one aspect, a method of delivering a chordae tendinea into a patient's heart can include delivering a clip onto a leaflet of a heart valve. The clip can be attached to a first end of the chordae tendinea. An anchor can be delivered into muscle of the heart. The anchor can be attached to a second end of the chordae tendinea. Tension in the chordae tendinea can be adjusted. Delivering the clip can further include steering an expander containing the clip in a closed configuration to transition the clip from the closed configuration to an open configuration, positioning the clip adjacent to the leaflet, and steering the expander to transition the clip from the open configuration to the closed configuration onto the leaflet.

[0012] In various embodiments, delivering the anchor can include deploying a plurality of arms from the anchor into the muscle by extending the anchor such that the arms extend at least partially out of a distal end of a sheath. Regurgitation of the heart valve can be observed via transesophageal echocardiogram or fluoroscopy. BRIEF DESCRIPTION OF DRAWINGS

[0013] Non-limiting embodiments of the application are described by way of example with reference to the accompanying drawings. In the drawings: Like reference numbers in different drawings indicate like components. For clarity, not every component that can be on the device is labeled in every drawing where it can be present. In the drawings:

[0014] Figure 1 A cross-sectional view of the mitral valve showing the flail leaflets during blood flow regurgitation.

[0015] Figure 2A A cross-sectional view of a heart and a clip catheter extending into the heart according to an embodiment of the application.

[0016] Figure 2B A cross-sectional view of a heart in Figure 2A and a clip of a clip catheter transitioning to an open configuration.

[0017] Figure 2C A cross-sectional view of a heart in Figure 2A and a clip transitioning to a closed configuration. 2B

[0018] A cross-sectional view of a heart in Figure 2D and an arm of an anchor partially deployed into heart tissue. Figures 2A-2C

[0019] A cross-sectional view of a heart in Figure 2E with an arm of an anchor deployed. Figures 2A-2D

[0020] A cross-sectional view of a heart in Figure 2F with a sheath retracted from the anchor. Figures 2A-2E

[0021] A cross-sectional view of a heart in Figure 2G with a clip released onto a leaflet of a heart valve. Figures 2A-2F

[0022] A cross-sectional view of a heart in Figure 2H and adjusting tension in an artificial chordae. Figures 2A-2G

[0023] A cross-sectional view of a heart in Figure 2I with an anchor released from an anchor catheter. Figures 2A-2H

[0024] A cross-sectional view of a heart in Figure 2J with a release filament withdrawn from the anchor. Figures 2A-2I

[0025] ​Figure 2K shows a cross-sectional view of the heart in Figures 2A-2J with the strap of the artificial chordae tendinae extracted.

[0026] Figure 2L shows a cross-sectional view of the heart in Figures 2A-2K with the artificial chordae tendinae delivered.

[0027] Figure 2M shows a cross-sectional view of the heart in Figures 2A-2L with an additional artificial chordae tendinae delivered.

[0028] Figure 2N shows a cross-sectional view of the heart in Figures 2A-2M with an additional artificial chordae tendinae delivered.

[0029] Figure 3 shows a cross-sectional view of the heart with the clip catheter engaging both leaflets of the valve.

[0030] Figure 4A shows a cross-sectional view of the heart and the artificial chordae tendinae with two clips delivered.

[0031] Figure 4B shows a cross-sectional view of the heart in Figure 4A with the artificial chordae tendinae delivered.

[0032] Figure 4C shows a cross-sectional view of the heart in Figure 4A and 4B with an additional artificial chordae tendinae with two clips delivered.

[0033] Figure 5A shows a cross-sectional view of the heart and the artificial chordae tendinae with two cords delivered.

[0034] Figure 5B shows a cross-sectional view of the heart in Figure 5A with the artificial chordae tendinae with two cords delivered.

[0035] Figure 6 shows a perspective view of an expander according to an embodiment of the present application arranged in an open configuration on a catheter. DETAILED DESCRIPTION

[0036] The present application is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present application beyond the appended claims. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this application belongs.

[0037] While embodiments of the present application can be described with particular reference to medical devices and systems for selective access to heart valves (e.g., transcatheter devices that are inserted through the femoral vein, etc.), it should be understood that such medical devices and systems can be used for a variety of medical procedures that involve clamping valve leaflets or clamping tissue walls. The disclosed medical devices and systems can also be inserted via different access points and modalities, e.g., percutaneously, endoscopically, laparoscopically, or combinations thereof.

[0038] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises" and "comprising," as used herein, specify the presence of stated features, regions, steps, elements, and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0039] As used herein, "proximal" refers to the end of a device that is closest to a medical professional when the device is introduced into a patient's body, and "distal" refers to the end of a device or object that is farthest from the medical professional during implantation, positioning, or delivery.

[0040] As used herein, the conjunction "and" includes each of the structures, components, features, etc. so conjoined, unless the context clearly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so conjoined, individually as well as in any combination and quantity, unless the context clearly indicates otherwise.

[0041] All numerical values are assumed to be modified by the term "about," whether or not specifically expressed. In the context of a numerical value, the term "about" generally refers to a range of numbers that a person of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" can include numbers that are rounded to the nearest significant figure. Unless otherwise specified, the term "about" (i.e., in contexts other than numerical values) can be assumed to have its ordinary and accustomed meaning as understood by and consistent with the context of the present specification. The recitation of numerical ranges by endpoints includes all numbers subsumed within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0042] It should be noted that references to "an embodiment", "some embodiments", "other embodiments", etc., in the specification do not necessarily refer to the same embodiment, although they can. In this specification, these singular forms are also meant to include the plural forms whenever appropriate. It also should be understood that the words "can" and "could" are used throughout this disclosure to mean "should" or "might" or possibly an anticipated result if the conditions were met. Also, the terms "preferably", "preferred", "favorably", "favorably", "desirably", "desirable", and words of similar meaning are not used to limit or optimize the specific features of the embodiments discussed. Rather, such terms are used to

[0043] Heart disease, including atrioventricular heart valve failure, impedes the patient's cardiac output, which reduces the patient's quality of life and life span. Referring to Figure 1 The heart 154, shown, as heart disease progresses, the chordae tendinae 155 that connect the papillary muscles 152 to the valve leaflets 151 can stretch inelastically and can rupture. The stretched and / or ruptured chordae tendinae 156 can cause flail leaflets 150, which can no longer have the ability to form a valve seal for normal heart function. For example, abnormal blood flow regurgitation in the direction of vector 158 can occur. The regurgitation prevents adequate blood supply to be delivered through the cardiovascular system.

[0044] Repositioning, repairing, and / or replacing one or more leaflets of a valve and / or chordae tendinae can be desirable for treating heart disease. The devices, systems, and methods of the present invention can be used alone or with other devices, systems, and methods to treat heart disease. Examples of devices, systems, and methods that can be used to practice embodiments of the present invention include, but are not limited to, U.S. Patent Application entitled "Devices, Systems, and Methods for Adjustable Tensioning Artificial Chordae Tendinae Between a Leaflet and a Papillary Muscle or Heart Wall" [Attorney Docket No. 8150.0591]; U.S. Patent Application entitled "Devices, Systems" [Attorney Docket No. 8150.0592]; U.S. Patent Application entitled "Devices, Systems, and Methods for Anchoring Artificial Chordae Tendinae to a Papillary Muscle or Heart Wall" [Attorney Docket No. 8150.0593], each of which is filed on the same date and each of which is incorporated by reference in its entirety for all purposes. Examples of devices described herein can be modified to incorporate embodiments of the present invention or one or more features.

[0045] Referring to Figure 2AAccording to an embodiment of the present invention, a method for delivering a chordae tendineae 206 includes a delivery catheter 240 extending through the inferior vena cava and through a diaphragm into the left atrium of a heart 254. A clamp catheter 200 extends distally through the delivery catheter 240 through a leaflet 250. The clamp catheter 200 has an expander 204 disposed at its distal end. The expander 204 includes a clamp 202 in a closed configuration. The artificial chordae tendineae 206 has a first end attached to the clamp 202, and the other end of the artificial chordae tendineae 206 extends proximally into the clamp catheter 200. The clamp catheter 200 extends proximally through the leaflet 250 into the delivery catheter 240. The expander 204 and the clamp 202 are in a closed configuration such that the expander 204 and the clamp 202 maintain a lower profile than in an open configuration to prevent undesirable friction with the delivery catheter 240 and surrounding anatomical structures as the clamp catheter 200 translates through the delivery catheter 240 and through the body.

[0046] refer to Figure 2B Through, for example, such as this article about Figure 6 As shown and described, translating a filament attached to the rod of expander 204 proximally through clamp conduit 200 manipulates expander 204 to change clamp 202 from a closed to an open state, thereby opening expander 204. Releasing the filament allows the spring portion of clamp 202 to close the rod of expander 204. Clamp conduit 200 can be oriented such that the open clamp 202 is positioned adjacent to leaflet 250 to receive leaflet 250 between the two arms 203, 205 of clamp 202. Clamp conduit 200 can be rotated and / or translated proximally or distally to position clamp 202 around leaflet 250. For example, the middle portion of the posterior leaflet can be flail-shaped, and clamps can be delivered on the flail portion of the leaflet, adjacent to the flail portion of the leaflet, and / or on either side of the flail portion.

[0047] refer to Figure 2C The expander 204 can be manipulated (e.g., via a handle, as discussed herein) to change the clamp from an open state to a closed state on the leaflet 250. Since the clamp 202 is fixed to the expander 204, the expander 204 can be further manipulated to change the clamp 202 from a closed state on the leaflet 250 to an open state to reposition the clamp 202 on the leaflet 250.

[0048] refer to Figures 2D-2Fsheath 216 toward the muscle 252 of the heart 254. In one embodiment, the sheath 216 constrains the one or more arms 214 (e.g., tines) of the anchor 212 in a constrained configuration for delivery. In some embodiments, the arms 214 of the anchor 212 are disposed to extend distally and are configured to engage the myocardium 252. The arms 214 can be deployed into the muscle 252 by extending the anchor catheter 210 such that the arms 214 extend at least partially out of the distal end of the sheath 216. When the arms 214 extend out of the sheath 216, the shape memory of the arms 214 biases them to pierce the muscle and extend proximally as the arms 214 transition from the constrained configuration toward the neutral configuration, as shown in Figure 2D The anchor 212 and the sheath 216 can further move away from each other (e.g., the sheath 216 is proximally withdrawn to expose the anchor catheter 210 and / or the anchor catheter 210 and the anchor 212 are distally advanced within the sheath 216) such that the arms 214 transition from the deployed configuration to the neutral configuration, as shown in Figure 2E The anchor 212 and the sheath 216 can move toward each other (e.g., the sheath 216 can be translated distally and / or the anchor catheter 210 and the anchor 212 can be translated proximally) to transition the arms 214 again to the constrained configuration within the sheath 216 for repositioning and redeployment into another location. When the arms 214 are deployed into the muscle 252, the sheath 216 can further be translated proximally away from the anchor 212. The deployed anchor 212, which is secured to the muscle 252, also secures the second end of the artificial chordae 206, which extends into the anchor 212 and proximally into the anchor catheter 210, relative to the muscle 252. The artificial chordae 206 is secured to the clip 202 at a first proximal end and to the anchor 212 at a second distal end.

[0049] Referring to Figure 2G The clip 202 in the closed configuration on the leaflet 250 can be released from the expander 204 by unlocking the clip 202 from the expander 204. The clip 202 can be released from the expander 204 by removing and / or deactivating the locking mechanism (e.g., a filament extending down through a lumen of the catheter, through a hole corresponding to an arm of the clip, and through the expander adjacent the hole and similarly through a hole corresponding to the opposite arm of the clip and the expander in a loop, and extending proximally through the lumen of the catheter to the handle of the catheter such that the end of the filament can be pulled to remove the filament from the system, or as described herein with respect to Figure 6The locking pin (shown and described as a locking pin) can unlock the clip 202 from the expander. The clip catheter 200 can be translated distally so that the expander 204 moves away from the clip 202 and off the leaflet 250. Without the clip 202, the expander 204 can be translated proximally out of the heart in the open configuration, where the expander can have a strong enough spring force to transition substantially toward the closed configuration without the spring portion of the clip 202. The clip 202 is secured to the leaflet 250, thereby securing the artificial chordae 206 relative to the leaflet 250, while the anchor 212 secures the artificial chordae relative to the muscle 252.

[0050] Generally, the tension of the chordae between the muscle 252 and the leaflet 204 of the heart affects valve function. Muscle displacement (e.g., papillary muscle) can increase the tension on some chords, inducing valve function. Some chords can be substantially insensitive to muscle movement to translate movement from the muscle to the leaflet, and can alternatively or additionally provide structural support for leaflet positioning. Too loose a chord can not properly support the attached leaflet, or can not properly transfer muscle displacement to the attached leaflet. Too tight a chord can improperly support the attached leaflet, strain, rupture, or transfer an inappropriate and / or insufficient amount of muscle displacement to the attached leaflet. An over-tightened chord can cause another leaflet to prolapse or can undesirably keep a leaflet substantially open. Over-tightening a leaflet in an alternative valve treatment can require emergency open-heart surgery to repair. However, because the tension in the chord in the devices described herein is reversible, a medical professional can repair an over-tightened leaflet by adjusting the tension in the chord.

[0051] According to one aspect, the disclosed systems allow for replacement and / or adjustment of the tension of the chord to overcome these problems. The tension and / or length of the chord between the leaflet and the muscle (e.g., between the clip on the leaflet and the anchor in the muscle) can be adjusted to bring the leaflet closer to or further from the muscle. A medical professional can adjust the tension and / or position of the devices described herein to mimic natural chordae to achieve heart function.

[0052] In various embodiments, the medical professional can make adjustments in response to visualization of the position of the devices in the heart and / or visualization of heart function (e.g., blood flow). The medical professional can visualize the devices in the heart and / or heart function via one or more of transesophageal echocardiography, ultrasound, fluoroscopy, combinations thereof, and the like. Visualization techniques during surgery can be used at certain points to confirm the desired position of one or more devices and / or anatomical structures before proceeding to the next step of the procedure. It can be appreciated that the particular adjustments used by the medical professional will vary depending on the characteristics of the patient, the state of the diseased heart, and the like.

[0053] Reference Figure 2H and2I The tension of the artificial chordae tendinae 206 can be adjusted to provide operable valve leaflets 250. The artificial chordae tendinae 206 can be selectively tightened by translating the artificial chordae tendinae 206 through the locking mechanism 218 (e.g., a one-way ratchet) of the anchor 212. The artificial chordae tendinae 206 can be translated through the locking mechanism 218 of the anchor 212 by the tether 220, which is coupled to the loops 206d at the ends of the artificial chordae tendinae 206 within the anchor conduit 210. Proximal translation of the tether 220 pulls the loops 206d, which in turn tightens the artificial chordae tendinae 206 by the locking mechanism 218 within the anchor 212. The tension of the artificial chordae tendinae 206 can be selectively loosened by releasing at least a portion of the artificial chordae tendinae 206 from the locking mechanism 218 in the anchor 212. The artificial chordae tendinae 206 can be released from the locking mechanism 218 by unlocking the locking mechanism 218, which is done by, for example, releasing the roller 219 of the one-way ratchet so that the artificial chordae tendinae 206 is free from the compression of the one-way ratchet. The locking mechanism 218 can be unlocked via proximal translation of the release filament 222, which extends from the delivery conduit 240 (and through the Figures 2A-2G the anchor conduit 210 and the sheath 216 in FIG. 1), and loops through the release portion (e.g., the roller 219 of the one-way ratchet) of the locking mechanism 218 in the anchor 212. Figure 2H The artificial chordae tendinae 206, which extends between the clamp 202 and the anchor 212, is shown tightened with a first length, which is loosened by proximal translation of the release filament 222. Figure 2I The artificial chordae tendinae 206, which extends between the clamp 202 and the anchor 212, is shown loosened with a second length, which is longer (i.e., looser) than the first length.

[0054] Referring to FIG. 1, Figures 2I-2K The anchor conduit 210 can be decoupled from the anchor 212 by unscrewing the engagement portion 210d of the anchor conduit 210 from the anchor 212. Because the anchor 212 is fixed to the muscle 252, the engagement portion 210d can be rotated relative to the anchor 212 so that the threads of the engagement portion 210d can be decoupled from the corresponding threads within the anchor 212. After the anchor 212 is delivered, the anchor conduit 210 can be proximally translated into the delivery conduit 240, leaving the tether 220 coupled to the loops 206d of the artificial chordae tendinae 206. Once the desired tension of the length of the artificial chordae tendinae 206 between the clamp 202 and the anchor has been achieved, the end of the release filament 222 can be proximally withdrawn so that the release filament 222 is withdrawn from the release portion of the locking mechanism of the anchor 212, but without damaging the release portion (e.g., without further loosening the artificial chordae tendinae 206). Once the desired tension of the length of the artificial chordae tendinae 206 has been achieved, the end of the tether 220 can be proximally withdrawn so that the tether 220 is withdrawn from the loops 206d, without damaging the artificial chordae tendinae 206 (e.g., without further tightening the artificial chordae tendinae 206).

[0055] Referring Figure 2L , the catheter and other delivery devices have been removed from the heart 254. In Figure 2L embodiments, the configuration of the artificial chordae 206, including but not limited to placement and / or tension, has been adjusted to bring the valve leaflets 250, 251 into an operable configuration such that they properly engage during heart function. The artificial chordae 206 are shown secured by the clip 202 to the valve leaflet 250 and the artificial chordae 206 are shown secured by the anchor 212 to the muscle 252. The artificial chordae 206 have a desired amount of tension such that they can operate in connection with the leaflet 250 and muscle 252 in normal heart function.

[0056] Generally, depending on the diseased state of the heart, it can be desirable to place one or more than one chordae. The systems disclosed herein enable the placement of multiple chordae without the need to remove the delivery catheter from the heart.

[0057] Referring Figure 2M and 2N , a second artificial chordae 236 can be delivered into the heart 252. The second artificial chordae 236 can be attached at one end to a second clip 230 and at a second end to a second anchor 232. Using the same methods described with reference to Figures 2A-2L , the second clip 230 and the second anchor 232 can be delivered to the heart 254 by the clip catheter 210 individually or the reloaded extender 204 and the anchor catheter 210, respectively. The second artificial chordae 236 can be secured by the second clip 230 to the same leaflet 250 of the valve, another leaflet 251 of the valve, or another leaflet of another valve. The second artificial chordae 236 can be secured by the second anchor 232 to the same muscle 252 of the heart 254 or a different muscle.

[0058] Referring Figure 3 , the clip catheter 310 can have a first extender 304 and a second extender 334 disposed on the distal end of the clip catheter containing the first clip 302 and the second clip 330, respectively. The first clip 302 can be coupled to the first artificial chordae 306 and the second clip 330 can be coupled to the second artificial chordae 336. Alternatively, one or both of the clips 302, 330 can not include artificial chordae 306, 336 and can be used to temporarily secure the clip catheter 310 and / or orient one or both of the leaflets 350, 351 during the procedure. For example, the clip catheter 310 can be temporarily secured to one or more of the leaflets 350, 351 to orient the clip catheter 310 and / or the leaflets 350, 351 for delivery of the artificial chordae 306, 336.

[0059] Referring Figures 4A-4CThe first artificial chordae 406 can be delivered into the heart 454, which is comprised of a first filament 408 and a second filament 409 coupled to one another. The second filament is coupled at each end to the first clamp 402 and the second clamp 430. The first filament 408 is coupled at one end to the anchor 412, and the first filament is coupled at a second end to the second filament 409, such that the second end can freely slide along the length of the second filament 409. The artificial chordae 406 can be pre-loaded within the delivery catheter 440, with the first filament 408 and the second filament 409 coupled to one another. The spreader 404 can deliver the clamps 402, 430 and the anchor catheter 410 can deliver the anchor 412. Because the first filament 408 can freely slide along the second filament 409 to the middle portion of the second filament 409, the first filament 408 can pull on each of the clamps 402, 430 with substantially equal force, thereby transferring force from the first filament 408 substantially equally to the clamps 402, 430. The medical professional can selectively adjust the length and tension of the first filament 408 and the second filament 409 to achieve proper heart function. The medical professional can additionally adjust the distance between the clamps 402, 430 along the leaflet 450 to achieve proper heart function. The second artificial chordae 407 can also be similarly delivered to the same leaflet 450, a different leaflet, the same muscle 452, or a different muscle.

[0060] With reference to Figure 5A and 5B The clamps 502 and associated anchors 512 can be coupled to the first artificial chordae 506 and the second artificial chordae 507. Such a system can be delivered with the artificial chordae 506, 507 pre-coupled to the clamps 502 and anchors 512. The tension of each artificial chordae 506, 507 can be independently and selectively adjusted by the professional operating the locking mechanism of the anchors 512. The second artificial chordae 507 can supplement and augment the transfer of force from the muscle 552 to the leaflet 550 and / or add additional support in the event of a delivery device failure.

[0061] With reference to Figure 6, the clip 600 with the expander 620 disposed on the catheter 634 can be used with the system embodiments described herein. The clip 600 with the arms 602 and spring portions 604 is shown in the open configuration. The spring portions 604 bias the arms 602 into the closed configuration. The expander 620 can be releasably coupled to the clip 600. The expander 620 can transition the clip 600 between the closed and open configurations. The expander 620 includes a base 622 with a first pin 624 extending from the base 622. A rod 626 can be rotatably disposed about the first pin 624. The base 622 includes a first channel 641 and the rod 626 includes a second channel 642, each configured to accept an arm 602 of the clip 600. The end of each arm 602 includes a hole 608. Each hole 608 has a central axis that extends substantially along each of the arms 602 and is configured to accept one of two locking pins 610. One locking pin 610 extends through the first channel 641 and into the hole 608 of one arm 602, while the other locking pin 610 extends through the second channel 642 and into the hole 608 of the opposite arm 602. The locking pins 610 secure the arms 602 to the base 622 and the rod 626 so that the expander 620 can manipulate the arms 602 between the open and closed configurations, so the clip 600 cannot be released from the expander 620. Because the arms 602 are locked within the channels 641, 642, the arms 602 can be transitioned between the closed and open configurations with movement of the rod 626. The rod 626 can be moved about the first pin 624 via translation of a first filament 630, which can be coupled to a slot 632 of the rod 626. When the rod 626 is rotated about the first pin 624, it also moves the arm 602 within the second channel 642, while the opposite arm 602 is fixed within the first channel 641 of the base 622. In some embodiments, the pins 610 can extend through third and fourth holes in each of the base 622 and the rod 626, instead of the first and second channels 641, 642, while still extending into the holes 608. A second filament 612 can be coupled to the locking pins 610 at each end, so that the second filament 612 can be grasped and pulled so that the locking pins 610 are removed from the holes 608 and channels 641, 642, releasing the arms 602 from the base 622 and the rod 626. Figure 6 The base 622 of the expander 620 is shown adhered to the distal end of the catheter 634. The first filament 630 extends proximally into the catheter 634 for manipulation by a medical professional. Because the base 620 is coupled to the catheter 634, the catheter 634 can be inserted into a patient to reach a target location for delivery of the clip 600. Also, because the base 622 is fixed to the catheter 634, when the first filament 630 manipulates the rod 626 containing the arms 602, the rod 626 works against the bias of the spring portions 604 and moves the clip 600 from the closed configuration to the open configuration by moving the arms 602 in the rod 626 away from the arms 602 fixed in the base 622.

[0062] Still referring to Figure 6 , embodiments according to the method of the present application can include inserting catheter 634 toward the valve (e.g., through the valve). In some embodiments, catheter 634 can include an expander 620 disposed on a distal end of catheter 634 that reversibly couples to clamp 600 in the closed configuration for navigation through the patient and / or working channel. Once catheter 634 approaches the target site of the valve, clamp 600 can be transitioned to the open configuration by pulling first filament 630 coupled to rod 626 proximally and maintaining tension on first filament 630. Rod 626 rotates about first pin 624 and moves arms 602 within rod 626 away from opposing arms 602 in base 622. With clamp 600 in the open configuration, catheter 634 can move the clamp into position proximate to a leaflet of the valve (e.g., around a flail leaflet) such that arms 602 are on either side of the leaflet (e.g., see Figure 2C and as discussed above). With clamp 600 in the proper position around the leaflet, tension on first filament 630 can be released, allowing biased spring portion 604 of clamp 600 to transition clamp 600 to the closed configuration around the leaflet. If desired, a medical professional can optionally reopen expander 620 and clamp 600 by repositioning clamp 600 by again pulling first filament 630 proximally. Repositioning clamp 600 can be desirable, for example, in the event of an accidental release, when a better position is achieved after deployment of clamp 600, or to configure tension in an artificial chord attached to clamp 600. Once clamp 600 is in the proper position, second filament 612 attached to locking pin 610 can be pulled (e.g., by a grasper, a third filament, etc.) such that pin 610 is removed from aperture 608 of arms 602. With pin 610 removed, clamp is no longer fixed to expander 620, and expander 620 releases clamp 600. Clamp 600 can remain for delivery over the leaflet, and catheter 634 and expander 620 can be removed from the patient. Additionally or alternatively, the clamp can be delivered with a fourth filament (e.g., an artificial chord) that can extend from clamp 600 (e.g., from spring portion 604) to another device (e.g., an anchor) to be used for medical treatment (e.g., anchoring the artificial chord to the leaflet and a ventricle or papillary muscle). Subsequent valve repair treatment can include transcatheter valve replacement, while alternative valve repair treatment can be further repaired only via, for example, open heart valve replacement.

[0063] In various embodiments, one or more of the catheters, sheaths, and / or filaments can be translated through the patient's body and / or through each other. One or more of the components of the system can be connected to the handle. The medical professional can translate one or more of the components proximally and / or distally relative to the handle. The handle can be connected to one or more of the components through one or more pulleys to translate the components. The medical professional can hold and / or lock one or more of the components so that it is fixed relative to the other components while one or more of the other components is translated proximally or distally. The devices herein can be navigated and delivered through the femoral vein and septal wall using an external delivery sheath, which can be, for example, about 24 to about 30 French and can be held in place during multiple treatments, such as reducing the mitral valve annulus, and subsequently delivering chordae tendinae.

[0064] In various embodiments of the present application, one or more arms of the clip can have locking features for use with a device that can convert the clip between the closed configuration and the open configuration. The locking features can include holes, edges for channels, lugs, etc. These locking features can be engaged by additional devices, such as locking pins, channels, clips, etc. The additional devices can engage the locking features to convert the clip between the closed and open configurations, and the additional devices can disengage the locking features to deliver the clip from one or more devices into a patient.

[0065] In accordance with the present application, all of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of this application have been described in terms of preferred embodiments, it will be apparent to those with ordinary skill in the art that variations in components, procedures, and methodologies can be made in the devices and / or methods described herein and in the steps or order of steps of the methods without departing from the concept, spirit, and scope of the application. All such similar alternatives and modifications are therefore considered to be within the scope of the present application as defined by the appended claims.

Claims

1. A system for delivering a chordae tendinae into a patient's heart, the system comprising: a delivery catheter; a clip catheter configured to translate through the delivery catheter; a first expander disposed on the clip catheter; a first clip at least partially contained in the first expander in a closed configuration, the first clip attached to a first end of the chordae tendinae; an anchor catheter configured to translate through the delivery catheter, the anchor catheter having an anchor attached to a second end of the chordae tendinae; wherein the second end of the chordae tendinae extends through a ratchet of the anchor, and the second end of the chordae tendinae is coupled to a tether extending through the anchor catheter, the tether configured to increase tension in the chordae tendinae via translation of the tether; and further comprising a release filament extending through a release roller of the ratchet, the release filament configured to unlock the chordae tendinae from the ratchet via translation of the release filament; and a sheath extending over the anchor catheter and anchor, the sheath configured to constrain arms of the anchor.

2. The system of claim 1, wherein the first clip is reversibly locked to the first expander.

3. The system of claim 1, further comprising a second clip attached to the first clip by a clip filament, the clip filament slidably coupled to the first end of the chordae tendinae.

4. The system of any of the preceding claims, wherein the anchor catheter and sheath extend through the clip catheter.

5. The system of any of claims 1-3, wherein the first clip further comprises: a plurality of clip arms at a first end, the plurality of clip arms having a closed configuration in which the clip arms are oriented toward one another, and an open configuration in which the clip arms are oriented away from one another; and a spring portion coupled to the plurality of clip arms at a second end, the spring portion configured to bias the clip arms to the closed configuration; wherein the clip arms of the clip are configured to fixedly engage with leaflets of a heart valve.

6. The system of claim 5, wherein the first expander further comprises: a base disposed on the clip catheter; a pin extending from the base; a rod rotatably disposed about the pin; a first channel extending through the base substantially parallel to a first one of the plurality of clip arms, the first channel configured to accept the first one of the plurality of clip arms; a second channel extending through the rod substantially parallel to a second one of the plurality of clip arms, the second channel configured to accept the second one of the plurality of clip arms; and a first filament extending from the rod, the filament configured to move the rod and move the clip between the closed configuration and the open configuration.

7. The system of claim 6, further comprising a first pin disposed within the first hole and the first channel, and a second pin disposed within the second hole and the second channel.

8. The system of any of claims 1-3, wherein a shape memory of the arms is configured to bias the arms to pierce muscle and extend proximally upon the arms transitioning from a constrained configuration toward a neutral configuration.

9. The system of any of claims 1-3, wherein the anchor catheter is disposed within the sheath, the sheath is disposed within the clamp catheter, and the clamp catheter is disposed within the delivery catheter.

10. The system of any of claims 1-3, further comprising a handle coupled to the delivery catheter, the clamp catheter, the anchor catheter, and the sheath, the handle configured to allow a medical professional to selectively and independently translate the delivery catheter, the clamp catheter, the anchor catheter, and the sheath.

11. The system of any of claims 1-3, further comprising a second expander disposed on the clamp catheter substantially opposite the first expander.

12. The system of any of claims 1-3, wherein the anchor is attached to the anchor catheter by way of an interlocking thread.

13. The system of any of claims 1-3, wherein the sheath is configured to constrain the arm such that the arm extends distally.

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