Mitral Valve Implants for the Treatment of Valvular Regurgitation

Abstract

New techniques are provided for the treatment of mitral regurgitation and other heart valve diseases and / or for altering one or more properties of other valves in the body. The present invention, in some aspects, relates to devices for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assist devices, fixation systems for attaching the ventricular protrusions of the implantable coaptation devices, kits, and methods of using the implantable coaptation assist devices, among other methods.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 014060, entitled "Mitral Valve Implants for the Treatment of Valvular Regurgitation," filed June 18, 2014. The entire disclosure of the aforementioned priority application is hereby incorporated by reference herein for all purposes.

[0002] The present invention generally provides improved medical devices, systems, and methods, typically for the treatment of heart valve disease and / or for altering the properties of one or more valves in the human body. Embodiments of the invention include an implant for the treatment of mitral valve regurgitation. [Background technology]

[0003] The human heart receives blood from organs and tissues via the veins and pumps the blood through the lungs where it is oxygenated and pumps oxygen-rich blood out of the heart into the arteries so the body's organ systems can extract oxygen for proper function. Deoxygenated blood returns to the heart and is pumped back to the lungs.

[0004] The heart has four chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA), and the left ventricle (LV). The pumping action of the right and left sides of the heart is generally synchronized throughout the cardiac cycle.

[0005] The heart has four valves that are generally configured to selectively direct blood flow in the correct direction during the cardiac cycle. The valves that separate the atria from the ventricles are called atrioventricular (or AV) valves. The AV valve between the left atrium and left ventricle is the mitral valve. The AV valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow into the pulmonary artery and from there to the lungs, where blood returns to the left atrium via the pulmonary veins. The aortic valve directs flow into the aorta and from there to the periphery. There are usually no direct connections between the ventricles or between the atria.

[0006] Mechanical heartbeats are triggered by electrical impulses that spread throughout the cardiac tissue. The opening and closing of the heart valves is primarily the result of pressure differences between the ventricles, which are the result of passive filling or ventricular contraction. For example, the opening and closing of the mitral valve can result from pressure differences between the left atrium and the left ventricle.

[0007] At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the AV valves open, allowing unimpeded flow from the atria into the corresponding ventricles. Shortly after ventricular systole (i.e., the ventricles empty), the tricuspid and mitral valves normally close to form a seal that prevents backflow from the ventricles into the corresponding atria.

[0008] Unfortunately, AV valves can become damaged or otherwise fail to function properly, resulting in improper closure. AV valves are complex structures that generally include annulus, leaflets, chordae tendineae, and supporting structures. Each atrium coapts with the valve via an atrial vestibule. The mitral valve has two leaflets, whereas the similar structure of the tricuspid valve has three leaflets, and the opposition or engagement of the corresponding surfaces of the leaflets helps close or seal the valve to prevent blood from flowing in the wrong direction. The inability of the leaflets to seal during ventricular contraction is known as malcoaptation and can allow blood to flow backwards through the valve (regurgitation). Heart valve regurgitation can have serious consequences for the patient, often resulting in heart failure, reduced blood flow, low blood pressure, and / or reduced oxygen flow to body tissues. Mitral valve regurgitation can also cause blood to flow backwards from the left atrium into the pulmonary veins, resulting in congestion. Severe valvular regurgitation, if untreated, can result in permanent disability or death.

[0009] Various therapies have been applied to treat mitral regurgitation, and still others may have been proposed but not yet actually used to treat patients. Although some of the known therapies have been found to benefit at least some patients, it would be desirable to have more options. For example, pharmacological agents (such as diuretics and vasodilators) can be used in patients with mild mitral regurgitation to help reduce the amount of blood that flows back into the left atrium. However, drugs can have the drawback of lack of patient compliance. A significant number of patients may not take medications at times (or even regularly), despite the possibility of chronic and / or progressively worsening significant mitral regurgitation. Pharmacological therapy of mitral regurgitation can be inconvenient, often ineffective (especially when symptoms worsen), and can be associated with significant side effects (such as low blood pressure).

[0010] Various surgical options have also been proposed and / or employed for the treatment of mitral regurgitation. For example, open-heart surgery can replace or repair the incompetent mitral valve. In annuloplasty ring repair, the posterior mitral annulus is reduced in size along its circumference, optionally with coaptation using sutures threaded through a mechanical surgical annuloplasty sewing ring. Open surgery may also attempt to reshape the leaflets and / or otherwise modify the supporting structures. Regardless, mitral valvotomy surgery is a highly invasive procedure that is typically performed with the patient under general anesthesia on a heart-lung machine and with the chest cut open. Complications are common, and timing is challenging given the morbidity (and potential mortality) of open-heart surgery -- sicker patients are more likely to need surgery, but less likely to tolerate it. Successful mitral valvotomy surgery outcomes may also be highly dependent on the skill and experience of the surgeon.

[0011] Given the morbidity and mortality of open-heart surgery, inventors have sought less invasive surgical therapies. Robotic or endoscopic procedures are often still highly invasive, time-consuming, expensive, and, at least in some cases, highly dependent on the skill of the surgeon. It is desirable to inflict even less trauma on these sometimes frail patients, and to achieve a therapy that can be successfully performed by a greater number of physicians with varying degrees of skill. Towards that end, a number of purportedly less invasive techniques and approaches have been proposed. These include devices that attempt to reshape the mitral annulus from within the coronary sinus, devices that attempt to reshape the annulus by fitting either above or below the native annulus, devices that coapt the leaflets (mimicking the Alfieri suture), devices that reshape the left ventricle, and the like.

[0012] Perhaps most widely known, a variety of mitral valve replacement techniques have been developed that replace (or substitute) the native valve leaflets and generally rely on a surgically implanted structure to control the blood flow pathway between the ventricles. Although these various approaches and tools have achieved varying levels of acceptance, none has yet been universally recognized as the ideal therapy for most or all patients suffering from mitral regurgitation.

[0013] Because of the problems and disadvantages of known minimally invasive mitral regurgitation therapies and implants, still more alternative treatments have been proposed. Some of the alternative proposals have required that the implanted structure remain within the valve annulus throughout the entire cardiac cycle. One group of these proposals includes a cylindrical balloon or the like that remains implanted on a tether or rigid rod that extends between the atrium and ventricle through the valve opening. Another group relies on an arched ring structure or the like, often combined with a buttress or structural cross member that extends over the valve to secure the implant. Unfortunately, while a seal between the native leaflets and the entire circumference of the balloon or other coaxial body portion can prove difficult, significant contraction around the native annulus during each heartbeat can result in problems with significant fatigue failure over long-term implantation if the anchors interconnecting the buttresses or cross members are allowed to flex. Additionally, significant movement of the valve tissue can make accurate positioning of the implant difficult, regardless of whether the implant is rigid or flexible. Summary of the Invention [Problem to be solved by the invention]

[0014] In light of the above, it is desirable to provide improved medical devices, systems, and methods. It is particularly desirable to provide new techniques for the treatment of mitral regurgitation and other heart valve diseases, and / or for altering one or more characteristics of other valves in the body. There remains a need for devices that can directly enhance leaflet coaptation (rather than indirectly via annulus or ventricular remodeling), that do not disrupt the leaflet anatomy via fusion or otherwise, but that can be deployed simply and reliably, without excessive cost or surgical time. It would be particularly beneficial if these new techniques could be implemented using a minimally invasive approach, without stopping the heart or relying on a heart-lung machine for deployment, and without relying on the extraordinary skill of the surgeon to achieve improved valve and / or heart function. [Means for solving the problem]

[0015] In some embodiments, disclosed herein is an implant for treating mal-coaptation of a heart valve. The implant can include one or more of a shape memory structure, a biocompatible membrane coupled to the structure, a hub located on the proximal side of the implant and coupled to the membrane, one, two or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular protuberance coupled to a fixation device. The implant can be collapsible for delivery through a percutaneous catheter. The shape memory structure can include shape memory barbs, such as Nitinol or PEEK. A portion of the ventricular protuberance, such as the distal tip, can be radiopaque. The fixation device can be active or passive. The barbs can include features such as micro-holes and micro-hooks for coupling to the membrane and tissue.

[0016] Also disclosed herein is a steerable catheter comprising one or more of a steerable shaft, a rotatable handle coupled to a pull wire disposed within the shaft to adjust the bend radius of the distal tip of the shaft depending on the amount of torque applied to the handle. In some embodiments, the diameter of the catheter handle is equal to or less than the diameter of the steerable shaft. Also disclosed herein is a delivery catheter comprising one or more of a rotatable handle coupled to a pull wire disposed within the shaft that can be torqued to adjust the bend radius of the distal tip of the catheter shaft, a sheath designed to contain the implant when it is collapsed, and a distal tip further comprising a locking feature that allows the delivery catheter to be coupled to either the hub or anchor of the implant. In some embodiments, the catheter can also comprise a tearable, disposable funnel that aids in collapsing the implant. In some embodiments, the distal tip further comprises a locking tab that is naturally set to an unlocked position. The delivery catheter can be coupled to the annular hub of the implant with a feature that accepts the locking tab of the delivery catheter. In some embodiments, a guidewire or another catheter can be inserted into the shaft, which presses the locking tab against a corresponding feature on the hub of the implant, locking the catheter to the hub. The catheter can also include a loop, such as a wire, that is pulled from the proximal handle to the distal tip so that the tension of the loop can be controlled via a control on the handle. The delivery catheter can be coupled to the annular hub of the implant with a cross pin. A guidewire or another catheter can be inserted into the shaft, and the loop of the wire is tensioned against the cross pin and guidewire such that the delivery catheter is locked to the hub of the implant until tension in the loop is maintained.

[0017] The implant may be operably coupled to tissue, such as cardiac tissue, via a first coupling of the anchor to a delivery catheter and a second coupling of the anchor to an implant hub, where the delivery catheter is torqued to insert the anchor into the hub and tissue. The first coupling may be disengaged to retract the catheter.

[0018] In some embodiments, the commissure anchors can be delivered by one or more of the following steps: coupling the anchor to the shaft of the catheter, advancing the anchor and catheter to the anchor site, delivering the anchor to engage the implant and tissue, and uncoupling the anchor from the shaft. The shaft can be torqued and an engagement mechanism can torque the shaft to engage the anchor with the implant and tissue. The anchor can be made of a shape memory material and can be pressed into the shaft of the catheter for delivery to the anchor site, with the distal tip of the catheter shaped to pierce the tissue. The anchor can be advanced after the delivery catheter first pierces the tissue, and then the catheter is retracted to leave the anchor in place.

[0019] In some embodiments, disclosed is an implant for treating mal-coaptation of a heart valve. The implant can include one or more of a removable shape memory structure, a biocompatible membrane coupled to the structure, a hub disposed on the proximal side of the implant and coupled to the membrane, one, two, or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular protuberance coupled to a fixation device. The implant can also include at least one passageway, such as a passageway disposed around the annular edge and / or along the ventricular protuberance. In some embodiments, multiple anchors, such as two, three, four, five, or more, are delivered to couple the implant to the heart tissue. The delivery device can have a distal section with one, two, or more anchors rotatably coupled to a central rotating shaft. A spring-loaded mechanism can apply a pushing force to cause the anchors to exit the distal end. In some embodiments, the anchors can be housed in a housing having a groove on the inner diameter such that the anchors exit the distal end as the central rotating shaft rotates. The device may include, for example, one or more of a hollow shaft, a pointed end at the end of the hollow shaft, one, two or more hollow barrels disposed within the hollow shaft through which a wire is threaded, and a pusher at the proximal end such that the barrels emerge one at a time from the hollow shaft when a force is applied to the pusher.

[0020] In some embodiments, disclosed herein is a steerable guidewire comprising an elongated flexible body having a longitudinal axis, a proximal end, and a distal deflection zone, a control section on the proximal end for controllable deflection of the deflection zone, and a movable deflection element extending from the control section to the deflection zone. In some embodiments, no portion of the guidewire has an outer diameter greater than about 10 French, 8 French, 6 French, or 4 French. The control section can have an outer diameter that is equal to or less than the outer diameter of the body section. Rotation of the control section about the axis can cause lateral movement of the deflection zone. Rotation of the control section in a first direction about the axis can cause proximal retraction of the deflection element.

[0021] Also disclosed herein is an implantable coaptation assistance device comprising a flexible body, a first concave surface on the body configured to restrict the posterior leaflet, a second convex surface on the body configured to contact the anterior leaflet, an arcuate, peripheral upper edge on the body defining an opening facing away from the first surface, and a ventricular protuberance extending away from the body and configured to be anchored within the ventricle. The device may also comprise an anchor on the ventricular protuberance. The anchor may be active or passive. The device may also comprise a flexible barb for supporting the arcuate peripheral edge. The barb may be removable in some cases.

[0022] Also disclosed herein is a fixation system for mounting a ventricular protrusion of an implantable junction device. The system can include an implant having a shoulder with an opening therethrough, a helical tissue anchor extending distally from a hub, a first engagement structure on the anchor for releasable engagement of a torque shaft, a second engagement structure on the torque shaft for engaging the anchor, and a hub sized to receive the helical anchor therein, the torque shaft configured to rotate to drive the helical anchor into tissue and secure the implant to the tissue. The first engagement structure can be an opening and the second engagement structure can be a protrusion. The protrusion can be laterally movable in and out of the opening, such as in response to axial movement of an elongated element in the torque shaft.

[0023] In some embodiments, a steerable guidewire is provided. The steerable guidewire can include an elongated flexible body portion having a longitudinal axis, a proximal end, and a distal deflection zone. The steerable guidewire can include a control portion on the proximal end for controllable deflection of the deflection zone. The steerable guidewire can include a movable deflection element extending from the control portion to the deflection zone. In some embodiments, no portion of the guidewire has an outer diameter greater than about 10 French. In some embodiments, no portion of the guidewire has an outer diameter greater than about 6 French. In some embodiments, no portion of the guidewire has an outer diameter greater than about 4 French. In some embodiments, the control portion has an outer diameter that is equal to or less than the outer diameter of the body portion. In some embodiments, rotation of the control portion about the axis causes lateral movement of the deflection zone. In some embodiments, rotation of the control portion in a first direction about the axis causes proximal retraction of the deflection element.

[0024] In some embodiments, an implantable coaptation assist device is provided. The implantable coaptation assist device may include a flexible body portion. The implantable coaptation assist device may include a first concave surface on the body portion configured to confine the posterior leaflet. The implantable coaptation assist device may include a second convex surface on the body portion configured to contact the anterior leaflet. The implantable coaptation assist device may include an arcuate, peripheral upper edge on the body portion defining an opening facing away from the first surface. The implantable coaptation assist device may include a ventricular protuberance extending away from the body portion and configured to be anchored within the ventricle.

[0025] In some embodiments, the implantable coaptation assist device may include an anchor on the ventricular protuberance. In some embodiments, the implantable coaptation assist device may include an active anchor. In some embodiments, the implantable coaptation assist device may include a passive anchor. In some embodiments, the implantable coaptation assist device may include a flexible spine for supporting the arcuate peripheral edge. In some embodiments, the spine is removable.

[0026] In some embodiments, a fixation system for mounting a ventricular protrusion of an implantable junction device is provided. The fixation system may include a shoulder having an aperture therethrough. The fixation system may include a helical tissue anchor extending distally from a hub. The fixation system may include a first engagement structure on the anchor for releasable engagement of a torque shaft. The fixation system may include a second engagement structure on the torque shaft for engaging the anchor. The fixation system may include an implant having a hub dimensioned to receive the helical anchor therein. In some embodiments, the torque shaft is configured to rotate to drive the helical anchor into tissue and secure the implant to the tissue. In some embodiments, the first engagement structure is an aperture and the second engagement structure is a protrusion. In some embodiments, the protrusion is laterally movable into and out of the aperture. In some embodiments, the protrusion is laterally movable into and out of the aperture in response to axial movement of an elongate element within the torque shaft.

[0027] In some embodiments, an implantable coaptation assist device is provided. The implantable coaptation assist device can include a coaptation assist body portion including a first coaptation surface and an opposing second coaptation surface, each coaptation surface being bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The implantable coaptation assist device can include a ventricular protuberance extending from the lower edge. The implantable coaptation assist device can include a first support that penetrates at least a portion of the coaptation assist body portion between the upper edge and the ventricular protuberance. The implantable coaptation assist device can include a second support that penetrates at least a portion of the coaptation assist body portion between the first lateral edge and the second lateral edge. The implantable coaptation assist device can include a passageway that penetrates at least a portion of the coaptation assist device that is sized to receive a steerable catheter therein. In some embodiments, the first support has a first configuration in which the first support is generally straight and a second configuration in which the first support is curved. In some embodiments, the first and second supports are configured to allow for percutaneous insertion of the implantable coaptation assistance device.

[0028] In some embodiments, the passageway passes through at least a portion of the coaptation assist device between the top edge and the ventricular protuberance. In some embodiments, the steerable catheter comprises a distal tip configured to bend. In some embodiments, the distal tip is curved upon rotating a handle of the steerable catheter. In some embodiments, the first support comprises a shape memory material. In some embodiments, the first support is bonded to the coaptation assist body. In some embodiments, the coaptation assist body comprises a lumen sized to receive at least a portion of the first support. In some embodiments, the first support is removable. In some embodiments, the first support extends from the top edge to the ventricular protuberance. In some embodiments, the passageway passes through at least a portion of the coaptation assist body between the first side edge and the second side edge. In some embodiments, the second support comprises a shape memory material. In some embodiments, the second support is bonded to the coaptation assist body. In some embodiments, the coaptation assist body comprises a lumen sized to receive at least a portion of the second support. In some embodiments, the second support is removable. In some embodiments, the second support extends from the first side edge to the second side edge. In some embodiments, the first support is coupled to the second support. In some embodiments, the first support and the second support are coupled to a removable hub, the removable hub protruding from a surface of the joint aid body portion.

[0029] In some embodiments, a kit for containing is provided. The kit may include an implantable coaptation assist device. The implantable coaptation assist device may include a coaptation assist body portion having a first coaptation surface and an opposing second coaptation surface, each coaptation surface being bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. The implantable coaptation assist device may include a ventricular protuberance extending from the lower edge. The implantable coaptation assist device may include a passageway through at least a portion of the coaptation assist device sized to receive a steerable catheter therein. The kit may include a steerable catheter. In some embodiments, the steerable catheter is configured to pass through the mitral valve and curve toward the ventricular tissue, and the implantable coaptation assist device is configured to pass over the steerable catheter and bend toward the ventricular tissue.

[0030] In some embodiments, the passageway passes through at least a portion of the coaptation assist device between the superior edge and the ventricular protuberance. In some embodiments, the steerable catheter comprises a distal tip configured to bend. In some embodiments, upon rotation of the handle of the steerable catheter, the distal tip bends. In some embodiments, the passageway passes through at least a portion of the coaptation assist body between the first side edge and the second side edge.

[0031] In some embodiments, a method of using an implantable coaptation assist device is provided. The method may include inserting a coaptation assist body toward a heart valve. In some embodiments, the coaptation assist body includes a first coaptation surface and an opposing second coaptation surface, each coaptation surface being bounded by a first lateral edge, a second lateral edge, a lower edge, and an upper edge, with a ventricular protuberance extending from the lower edge. The method may include manipulating a first support to cause the coaptation assist body to assume a curved configuration. In some embodiments, the first support penetrates at least a portion of the coaptation assist device between the upper edge and the ventricular protuberance. The method may include manipulating a second support to cause the coaptation assist body to assume a curved configuration. In some embodiments, the second support penetrates at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge.

[0032] In some embodiments, the step of manipulating the first support includes releasing the coaptation assist body from the delivery catheter. In some embodiments, the step of manipulating the second support includes releasing the coaptation assist body from the delivery catheter. The method may include guiding the coaptation assist body onto the steerable catheter. The method may include passing the steerable catheter over the ventricular protuberance toward the superior rim before inserting the coaptation assist body toward the heart valve. The method may include moving a distal portion of the steerable catheter to curve along the posterior leaflet. The method may include passing the coaptation assist device over the curve of the steerable catheter. In some embodiments, the steerable catheter is removed after the ventricular protuberance engages the ventricular tissue. In some embodiments, the steerable catheter remains in place as the ventricular protuberance is advanced toward the ventricular tissue. The method may include removing the first support from the coaptation assist body. The method may include removing the second support from the coaptation assist body. The method may include engaging the ventricular protuberance with the ventricular tissue. In some embodiments, the method is performed percutaneously. [Brief description of the drawings]

[0033] [Figure 1A] FIG. 1 is a schematic diagram illustrating some of the anatomy of the heart and mitral valve that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1B] FIG. 1 is a schematic diagram illustrating some of the anatomy of the heart and mitral valve that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1C] FIG. 1 is a schematic diagram illustrating some of the anatomy of the heart and mitral valve that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1D] FIG. 1 is a schematic diagram illustrating some of the anatomy of the heart and mitral valve that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1E] FIG. 1 is a schematic diagram illustrating some of the anatomy of the heart and mitral valve that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 1F] FIG. 1 is a schematic diagram illustrating some of the anatomy of the heart and mitral valve that may interact with the implants and systems described herein, as described in the Background section and below. [Figure 2A] FIG. 1 illustrates a simplified cross-section of the heart showing an outline of mitral valve function during diastole. [Figure 2B] FIG. 1 illustrates a simplified cross-section of the heart showing an outline of mitral valve function during systole. [Figure 3A] FIG. 1 illustrates a simplified cross-section of the heart showing schematic mitral regurgitation during systole in the setting of malcoaptation of the mitral valve leaflets. [Figure 3B] FIG. 1 illustrates a simplified cross-section of the heart showing schematic mitral regurgitation during systole in the setting of malcoaptation of the mitral valve leaflets. [Figure 4A] FIG. 1 illustrates a stylized cross-section of the heart showing mitral valve mal-coaptation in the setting of functional mitral regurgitation. [Figure 4B] FIG. 1 illustrates a stylized cross-section of the heart showing mitral valve mal-coaptation in the setting of degenerative mitral regurgitation. [Figure 5A] 1 illustrates one embodiment of a coaptation assist device. [Figure 5B] 5B is a diagram illustrating various cross sections that the support structure may have along cross section AA of FIG. 5A. [Figure 5C] 13A-13C are diagrams illustrating various shapes of the anchor at the distal end of the ventricular protrusion. [Figure 5D] 1A-1C show non-limiting examples of a range of dimensions for coaptation assist devices. [Figure 5E] FIG. 1 illustrates a table of non-limiting examples of support structure variations (materials, size ranges). [Figure 5F] FIG. 13 illustrates one embodiment of the distal end of the ventricular protrusion. [Figure 5G] FIG. 13 illustrates that the position of the coaptation assist device can be maintained by utilizing the shape of the coaptation assist device to pinch the natural posterior leaflet. [Figure 5H] FIG. 13 illustrates one embodiment of how the coaptation assist device can be secured through the posterior leaflet from the ventricular side. [Figure 6A] FIG. 1 illustrates a steerable catheter. [Figure 6B] FIG. 6B illustrates the position of the steerable catheter of FIG. 6A within the heart. [Figure 7A] FIG. 1 illustrates a delivery catheter. [Figure 7B] 13A-13C illustrate one embodiment of a locking mechanism for locking the delivery catheter to the annular hub. [Figure 7C] 13A-13C illustrate another embodiment of a locking mechanism for locking the delivery catheter to the annular hub. [Figure 7D] FIG. 13 illustrates the coupling of an attachment assist device, a delivery catheter, and a guidewire or steerable catheter. [Figure 8A] 13A-13C illustrate how the coaptation assist device is folded, retracted into an implant sheath, and delivered into the heart through femoral access. [Figure 8B] 13A-13C illustrate how the coaptation assist device is folded, retracted into an implant sheath, and delivered into the heart through femoral access. [Figure 8C] 13A-13C illustrate how the coaptation assist device is folded, retracted into an implant sheath, and delivered into the heart through femoral access. [Figure 8D] 13A-13C illustrate how the coaptation assist device is folded, retracted into an implant sheath, and delivered into the heart through femoral access. [Figure 8E] FIG. 13 illustrates how the delivery catheter and implant sheath are positioned so that the ventricular protrusion of the coaptation assist device can be anchored. [Figure 8F] FIG. 13 illustrates how the delivery catheter and implant sheath are positioned so that the ventricular protrusion of the coaptation assist device can be anchored. [Figure 8G] FIG. 13 illustrates how the delivery catheter and implant sheath are positioned so that the ventricular protrusion of the coaptation assist device can be anchored. [Figure 8H] FIG. 13 illustrates the coaptation assist device fully open and the delivery catheter positioned over the annular hub to secure the annular hub to the valve annulus. [Figure 8I] 14A-14C illustrate one embodiment of an anchor that may be used to secure to the annular hub. [Figure 9A] 13A-13C illustrate a method for securing the coaptation assist device adjacent to the commissure via holes in the frame of the coaptation assist device. [Figure 9B] FIG. 9B is a top view of the anchor and crossbar of FIG. 9A. [Figure 10A]13 illustrates another embodiment of a delivery catheter having multiple lumens and connections to an implant. [Figure 10B] FIG. 10B is a cross-sectional view of the delivery catheter shown in FIG. 10A. [Figure 11A] 13A-13C illustrate various alternative embodiments of the anchor. [Figure 11B] 13A-13C illustrate various alternative embodiments of the anchor. [Figure 11C] FIG. 1 illustrates an example delivery tube through which anchors 11A and 11B may be delivered. [Figure 11D] FIG. 11C illustrates how the anchor of FIG. 11B looks after the fixation process is completed. [Figure 12] FIG. 12 illustrates an implant design without spines (illustration shown with structure 1220 that is later extracted from the implant). [Figure 13A] 13A-13C illustrate an early stage of the delivery procedure for an implant without spines. [Figure 13B] 13A-13C illustrate an early stage of the delivery procedure for an implant without spines. [Figure 14A] 13A-13C illustrate various types of fixation methods for non-spinous implants. [Figure 14B] 13A-13C illustrate various types of fixation methods for non-spinous implants. [Figure 15A] 1 illustrates an embodiment of an anchor catheter that is enabled to deliver multiple anchors, which also illustrates a multiple anchor design. [Figure 15B] 14A-14C illustrate another embodiment of an anchor catheter enabled to deliver multiple anchors. [Figure 15C] FIG. 15C illustrates how the anchor of FIG. 15B can be coupled to tissue. [Figure 15D] FIG. 15C illustrates how the anchor of FIG. 15B can be coupled to tissue. [Figure 16A] 14A-14C illustrate another embodiment of an anchor catheter enabled to deliver multiple anchors. [Figure 16B] FIG. 16B illustrates how the tool of FIG. 16A can be used to deliver multiple anchors. [Figure 16C] FIG. 16B illustrates how the tool of FIG. 16A can be used to deliver multiple anchors. [Figure 17A] 13A-13C illustrate another embodiment of an implant without spines. [Figure 17B] FIG. 17B illustrates how the embodiment of FIG. 17A can be secured. [Figure 17C] FIG. 17B illustrates how the embodiment of FIG. 17A can be secured. [Figure 17D] FIG. 17B illustrates how the embodiment of FIG. 17A can be secured. [Figure 17E] FIG. 17B illustrates how the embodiment of FIG. 17A can be secured. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] The devices, systems, and methods described within the present disclosure are generally for the treatment of mitral regurgitation (MR). Mitral regurgitation occurs when the mitral valve does not prevent blood from flowing backward from the left ventricle to the left atrium during systole. The mitral valve consists of two leaflets, anterior and posterior, which coapt or come together during systole to prevent regurgitation. In general, there are two types of mitral regurgitation, functional and degenerative regurgitation. Functional MR is caused by multiple mechanisms, including abnormal, or not functioning properly, left ventricular (LV) wall motion, LV enlargement, and papillary muscle disease. Degenerative MR is caused by structural abnormalities of the leaflets and subvalvular tissue, including stretching or rupture of the chordae tendineae. Damaged chordae tendineae can cause the leaflets to prolapse, i.e., the leaflets protrude (typically into the atrium) or flail if the chordae tendineae are ruptured, causing blood to flow backward. As described below, the devices, systems, and methods of the present disclosure create a new coaptation surface over the native posterior valve such that backflow of blood is minimized or eliminated.

[0035] 1A-1D, the four chambers of the heart are shown: left atrium 10, right atrium 20, left ventricle 30, and right ventricle 40. A mitral valve 60 is disposed between the left atrium 10 and the left ventricle 30. Also shown are the tricuspid valve 50, the aortic valve 80, and the pulmonary valve 70, which separate the right atrium 20 and the right ventricle 40. The mitral valve 60 consists of two leaflets, an anterior leaflet 12 and a posterior leaflet 14. In a healthy heart, the edges of the two leaflets oppose each other during systole at a coaptation zone 16.

[0036] The fibrous annulus 120 is part of the cardiac skeleton and provides the attachment for the two leaflets of the mitral valve, referred to as the anterior leaflet 12 and the posterior leaflet 14. The leaflets are supported axially by their attachment to the chordae tendineae 32. The chordae tendineae then attach to one or both of the papillary muscles 34, 36 of the left ventricle. In a healthy heart, the chordae tendineae support structures tether the mitral valve leaflets, allowing them to open easily during diastole but resist the high pressures generated during ventricular systole. In addition to the tethering effect of the support structures, the shape and tissue consistency of the leaflets act to promote effective sealing or coaptation. The anterior edges of the anterior and posterior leaflets come together along the coaptation zone 16, a cross-section 160 of the three-dimensional coaptation zone (CZ) is shown diagrammatically in FIG. 1E.

[0037] The anterior and posterior mitral leaflets have different shapes. The anterior leaflet is attached more firmly by the annulus, resting on the central fibrous body (cardiac skeleton), and is somewhat stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80% of the area closed is the anterior leaflet. Adjacent to the commissures 110, 114, on the annulus 120, or in front of the annulus 120 are the left (lateral) 124 and right (septal) 126 fibrous trigones, which form where the mitral annulus fuses with the base of the aortic non-coronary leaflet (FIG. 1F). The fibrous trigones 124, 126 form the septal and lateral extensions of the central fibrous body 128. The fibrous trigones 124, 126 may be advantageous in some embodiments in that they constitute a firm zone for stable engagement with one or more annular or atrial anchors. The coaptation zone CL between the leaflets 12, 14 is not a simple line, but rather a curved funnel-shaped surface interface. The first commissure 110 (lateral or left) and the second commissure 114 (septal or right) are where the anterior leaflet 12 meets the posterior leaflet 14 at the annulus 120. As is most evident in the axial view from the atrium in Figures 1C, 1D, and 1F, the axial cross-section of the coaptation zone shows a curved line CL that is generally separated from the centroid of the annulus CA and also from the opening through the valve at diastolic CO. In addition, the leaflet edges are wavy like the edges of a scallop, more so for the posterior and anterior leaflets. Malcoaptation can occur between one or more of these AP (anterior-posterior) segment pairs A1 / P1, A2 / P2, and A3 / P3, so that the malcoaptation characteristics can vary along the curvature of the coaptation zone CL.

[0038] 2A, a properly functioning mitral valve 60 of the heart opens during diastole, allowing blood to flow from the left atrium along a flow path FP toward the left ventricle 30, thereby filling the left ventricle. As shown in FIG. 2B, a functioning mitral valve 60 closes during systole, effectively sealing off the left ventricle 30 from the left atrium 10, first passively and then actively due to increased ventricular pressure, thereby allowing contraction of the cardiac tissue around the left ventricle to pump blood throughout the vascular system.

[0039] 3A-3B and 4A-4B, there are several conditions or pathologies in which the leaflet edges of the mitral valve cannot adequately oppose, thereby allowing blood to flow back from the ventricle into the atrium during systole. Regardless of the specific etiology in a particular patient, the inability of the leaflets to seal during ventricular systole is known as malcoaptation and can result in mitral regurgitation.

[0040] Generally, malcoaptation can occur as a result of excessive tethering by the support structures of one or both leaflets, or as a result of excessive stretching or tearing of the support structures. Other less common causes include infection, congenital abnormalities, and trauma to the heart valve. Valve insufficiency can occur as a result of the chordae tendineae being stretched, known as mitral valve prolapse, and in some cases, tearing of the chordae tendineae 215 or papillary muscles, known as flail leaflets 220, as shown in FIG. 3A. Or, if the leaflet tissue itself is redundant, the valve may prolapse so that the level of coaptation is higher into the atrium, opening the valve higher in the atrium during ventricular systole 230. Any one of the leaflets may undergo prolapse or flail. This condition is sometimes known as degenerative mitral regurgitation.

[0041] With excessive tethering, the normally structured valve leaflets may not function properly due to annular enlargement or shape change, so-called annular dilation 240, as shown in FIG. 3B. Such functional mitral regurgitation typically occurs as a result of myocardial failure and associated ventricular dilation. Moreover, the excessive volume load resulting from functional mitral regurgitation may itself exacerbate heart failure, ventricular and annular dilation, and thus exacerbate mitral regurgitation.

[0042] 4A-4B illustrate regurgitation of blood during systole BF in functional mitral regurgitation (FIG. 4A) and degenerative mitral regurgitation (FIG. 4B). Increased size of the annulus in FIG. 4A, combined with increased tethering due to hypertrophy of the ventricle 320 and papillary muscles 330, prevents the anterior leaflet 312 and posterior leaflet 314 from opposing, thereby preventing coaptation. In FIG. 4B, rupture of the chordae tendineae 215 causes superior prolapse of the posterior leaflet 344 into the left atrium, which prevents opposition against the anterior leaflet 342. In either situation, the result is a backflow of blood into the atrium, reducing the effectiveness of left ventricular compression.

[0043] 5A illustrates one embodiment of a coaptation assist device 500. The coaptation assist device 500 may include a coaptation assist body portion 515. The coaptation assist body portion 515 may include a first coaptation surface 535. The first coaptation surface 535 may be disposed toward the mal-coapted native leaflets, or in the case of a mitral valve, toward the posterior leaflet when implanted. The coaptation assist body portion 515 may include a second coaptation surface 540. The second coaptation surface 540 may be opposite the first coaptation surface 535 as shown in FIG. 5A. The second coaptation surface 540 may be disposed toward the mal-coapted native leaflets, or in the case of a mitral valve, toward the anterior leaflet when implanted. The first coaptation surface 535 and the second coaptation surface 540 may be bounded by first and second lateral edges. The first mating surface 535 and the second mating surface 540 may be bounded by a lower edge and an upper edge 545 .

[0044] The first and second mating surfaces 535, 540 are two surfaces of the same implant structure that form the mating assist body portion 515. The shape of the mating assist body portion 515, in some embodiments, may be generally characterized by the shape of the upper edge 545, the shape of the first mating surface 535, and the second mating surface 540.

[0045] The coaptation assist device 500 may include a ventricular projection 525 as shown in FIG. 5A. The ventricular projection 525 may extend from a lower edge of the coaptation assist body portion 515. The ventricular projection 525 may reside within the left ventricle when implanted. The ventricular projection 525 may include a fixation mechanism. A distal end 530 of the ventricular projection 525 generally includes the fixation mechanism.

[0046] The distal end 530 of the ventricular projection 525 may have different shapes as shown in FIG. 5C. FIG. 5C shows five embodiments of the distal end 530. It should be noted that many more variations are possible and are not limited to the five embodiments shown in FIG. 5C. Generally, in other embodiments, there are two types of anchors. Examples of passive anchors are shown in the embodiments 555.1 to 555.4 in FIG. 5C. Passive anchors rely on entrapment behind the chordae and / or interference with the chordae. With regard to passive anchors, in some embodiments, the maximum dimension or the dimension involved in entanglement with the chordae (usually the width) may be in the range of 10 mm to 40 mm, for example 25 mm.

[0047] The distal end 555.1 includes one or more protrusions. The protrusions may be elongated rods extending from a central hub as shown. In the illustrated embodiment, four protrusions extend from the central hub. In other embodiments, one or more protrusions extend from the central hub. The protrusions may extend at an angle from the central hub, thereby increasing the surface area of ​​the distal end 530. The distal end 555.2 may be generally rectangular, rectangular, generally square, square, generally diamond, or diamond shaped. The distal end 555.2 may include one or more notches. The notches may enhance the ability to grip tissue. In the illustrated embodiment, four notches are formed in the distal end. In other embodiments, one or more notches are included.

[0048] The distal end 555.3 includes one or more protrusions. The protrusions may be elongated rods extending from a central hub as shown. In the illustrated embodiment, two protrusions extend from the central hub. In other embodiments, one or more protrusions extend from the central hub. The protrusions may extend at a right angle from the central hub, thereby increasing the surface area of ​​the distal end 530.

[0049] The distal end 555.4 includes one or more barbs. The barbs may extend from a central hub as shown. The barbs may extend back toward the central hub. In the illustrated embodiment, three or more barbs extend from the central hub. In other embodiments, one or more barbs in one or more directions are included.

[0050] Distal end 555.5 includes one or more prongs and is similar to the configuration shown as distal end 555.1. Distal end 555.5 is an example of an active anchor. An active anchor can have features such as sharp points, barbs, or threads that can bond to ventricular tissue. An active anchor can require a driving force, such as a torque, to embed into tissue. Either passive or active anchors can be made from implant grade biocompatible materials such as silicone, PEEK, pebax, polyurethane, etc.

[0051] The size of the coaptation assist device 500 is detailed in Figure 5D, which shows the top and front views of the coaptation assist body portion 515 of the coaptation assist device 500. Three parameters "x", "y", and "z" shown in the figure characterize the coaptation assist device 500. Non-limiting examples of ranges and sizes of these variables x, y, and z are shown in the "Dimension Table" within the figure.

[0052] The coaptation assist device 500 may include a support structure 505. The support structure 505 may be referred to as a spine. The support structure 505 may define, at least in part, the shape of the coaptation assist device 500.

[0053] Referring again to FIG. 5A, the support structure 505 is shown in dotted lines. In some embodiments, the support structure 505 is made of a shape memory material, such as, but not limited to, Nitinol (NiTi), polyetheretherketone (PEEK), or other hard polymers or fatigue-resistant metals. The use of shape memory materials allows for the advantages described herein. For example, one advantage of shape memory materials is that their superelastic properties help the coaptation assist device 500 maintain its shape and function as a coaptation assist device as the heart contracts, expands, and exerts pressure on the coaptation assist device 500. Another example advantage is that shape memory materials are suitable for the percutaneous delivery methods described herein.

[0054] The support structure 505 can comprise one or more sections. In some embodiments, the support structure 505 comprises one section. In some embodiments, the support structure 505 comprises two sections. In some embodiments, the support structure 505 comprises three or more sections. In some embodiments, one or more sections of the support structure 505 can comprise one or more subsections. In some embodiments shown in FIG. 5A, the support structure 505 comprises two sections, namely, a first section 505.2 and a second section 505.1.

[0055] The first section 505.2 can extend through at least a portion of the coaptation assist device 500 between the upper edge 545 and the ventricular projection 525. In some embodiments, the first section 505.2 can extend the entire length of the coaptation assist device 500 between the upper edge 545 and the ventricular projection 525. In some embodiments, the first section 505.2 extends from a location between the upper edge 545 and the lower edge of the coaptation assist body 515. In some embodiments, the first section 505.2 extends from a location between the lower edge of the coaptation assist body 515 and the ventricular projection 525. In some embodiments, the first section 505.2 extends along the coaptation assist body 515 and continues to support the ventricular projection 525.

[0056] The second section 505.1 can penetrate at least a portion of the joint assist body 515 between the first side edge and the second side edge. In some embodiments, the second section 505.1 can penetrate the entire length between the first side edge and the second side edge. In some embodiments, the second section 505.1 extends from a position between the upper edge 545 and the lower edge of the joint assist body 515. In some embodiments, the second section 505.1 extends from a position closer to the upper edge 545 than to the lower edge of the joint assist body 515. In some embodiments, the second section 505.1 extends from the first side edge toward the second side edge. In some embodiments, the second section 505.1 extends from the second side edge toward the first side edge. In some embodiments, the second section 505.1 extends along the section between the first side edge and the second side edge. In some embodiments, the second section 505.1 extends along an edge of the coaptation assist device 500.

[0057] In some embodiments, the first section 505.2 and the second section 505.1 of the support structure 505 may be one integral piece or unitary construction. In some embodiments, the first section 505.2 and the second section 505.1 of the support structure 505 are separate components. In some embodiments, the first section 505.2 and the second section 505.1 may be two separate sections that are joined together by methods such as, but not limited to, crimping and laser welding.

[0058] In some embodiments, the first section 505.2 is integrated within the coaptation assist body portion 515 as described herein. In some embodiments, the first section 505.2 is integrated within the ventricular projection 525 as described herein. In some embodiments, the first section 505.2 is removable from the coaptation assist body portion 515 as described herein. In some embodiments, the first section 505.2 is removable from the ventricular projection 525 as described herein. In some embodiments, the second section 505.1 is integrated within the coaptation assist body portion 515 as described herein. In some embodiments, the second section 505.1 is removable from the coaptation assist body portion 515 as described herein. In some embodiments, the first section 505.2 can have a first zone that is generally oriented substantially parallel to the longitudinal axis of the body portion 515 and a second zone that is generally oriented substantially perpendicular to the longitudinal axis of the body portion 515 as illustrated.

[0059] The support structure 505, which supports the shape of the ventricular projection 525, may have various cross sections, as shown by cross section AA in FIG. 5A and illustrated in detail in FIG. 5B. It should be noted that while five cross section embodiments are shown in FIG. 5B, the cross section embodiments of the support structure 505 are not limited to these five. Cross section 550.1 is circular or approximately circular. Cross section 505.2 is circular or approximately circular. Cross section 550.1 may have a larger cross sectional area than cross section 550.2. Cross section 550.3 includes multiple circular or approximately circular cross sections. In the illustrated embodiment, seven circular or approximately circular cross sections are gathered to form cross section 550.3. In other embodiments, two or more circular or approximately circular cross sections are gathered to form cross section 550.3. Cross section 550.3 may take the form of a cable. Cross section 550.4 is rectangular or approximately rectangular. Cross section 550.5 is rectangular or approximately rectangular. Section 550.4 may have a larger cross-sectional area than section 550.5.

[0060] Also note that the first section 505.2 and the second section 505.1 may have different cross sections. Each cross section or embodiment shown in FIG. 5B may have some advantages, such as some cross sections being more flexible in one direction and not in another. Some other cross sections may have relatively higher reliability characteristics than others. The properties of each type of cross section are described in conjunction with the range of cross sections and non-limiting possible dimensions in Table 2 of FIG. 5E for two different materials, Nitinol and PEEK. While various configurations are presented in Table 2, in some embodiments, cross sections 550.4 and 550.5 may be utilized for both materials.

[0061] When the coaptation assist device 500 is placed in the heart, in some embodiments, the coaptation assist device 500 is such that the ventricular protuberance 525 is placed in the left ventricle as generally shown in Figure 5G. The ventricular protuberance 525 includes a mechanism for anchoring the coaptation assist device 500 using the structure of the ventricle. An example of positioning the coaptation assist device 500 over the posterior leaflet is illustrated in Figure 5G.

[0062] While keeping in mind that other examples of positioning are possible and described elsewhere in this disclosure, in this particular example, the coaptation assist device 500 is illustrated with a ventricular projection 525 having a curved shape. The ventricular projection 525 and / or the first support 505.2 may be made of a shape memory material, in which case the curved shape is retained after implantation. The curved shape may allow the coaptation assist device 500 to remain in place to engage the natural posterior leaflet 14.

[0063] 5F shows one embodiment of a passive anchor for the ventricular protuberance 525. In this embodiment, the tube 560 disposed along the length of the ventricular protuberance 525 terminates in two tubes 565.1 and 565.2 at the distal end of the coaptation assist device 500. The coaptation assist device 500 can be delivered to the left side of the heart with the straightening wire such that the two tubes 565.1 and 565.2 are approximately straight as shown by the dotted lines 565.1 and 565.2 (position A) indicating that the straightening wire is in an advanced state. In some embodiments, the two tubes 565.1 and 565.2 can be made of shape memory materials including, but not limited to, polyurethane, silicone, polyethylene, pebax, and nylon. Without the straightening wire, the two tubes 565.1 and 565.2 may have a predefined shape that may be curled or coiled as shown by the solid lines 565.1 and 565.2 (position B) in FIG. 5F.

[0064] After the implant is properly delivered and placed in the heart, the straightening wire is withdrawn, allowing the two tubes 565.1 and 565.2 to assume their predefined shape (position B). The two tubes 565.1 and 565.2 may constitute a fixed support due to the entanglement of the chordae tendineae. The advantage of this type of fixation is that if the coaptation assist device 500 needs to be repositioned due to an unsatisfactory placement, the straightening wire can be advanced back into the two tubes 565.1 and 565.2, straightening the two tubes 565.1 and 565.2 and disentangling them from the chordae tendineae. Although the above example describes two tubes 565.1 and 565.2, it will be understood that there can be one, two or more tubes.

[0065] Yet another embodiment for anchoring the coaptation assist device 500 is illustrated in FIG. 5H. An active anchor may be coupled to the distal end of the ventricular protuberance 525. After delivery of the implant, the active anchor may be threaded through the posterior leaflet and coupled to the coaptation assist device 500 at the annulus (atrium) as shown. Methods for positioning and actuating the anchor are described herein.

[0066] In another embodiment, the tip of the ventricular protuberance 525 may be radiopaque or echogenic to aid in the placement and fixation of the coaptation assist device 500 while it is being placed percutaneously. In such procedures, fluoroscopy or ultrasound imaging modalities may be used to visualize the heart and coaptation assist device 500.

[0067] Referring again to FIG. 5A, in another embodiment, the coaptation assist device 500 may include a hub 510. The hub 510 may have one or more purposes. One purpose may be to be used as a fixation device as described herein. Another purpose may be to provide a mechanism for percutaneously delivering the coaptation assist device 500 as described herein. In some embodiments, a hub (not shown) may be present at the distal end of the coaptation assist device 500. The hub may be located at the end of the ventricular protuberance 525. The ventricular hub may be located at the most distal tip of the distal end 530 of the ventricular protuberance 525. To distinguish between the two hubs, the proximal hub 510 may simply be referred to as the "hub," the "annular hub," or the "proximal hub." The hub at the distal tip of the ventricular protuberance is specifically referred to as the "ventricular hub."

[0068] 5A , the coaptation assist body portion 515 of the coaptation assist device 500 can be made from a variety of biocompatible materials, such as expanded polytetrafluoroethylene (ePTFE). This material constitutes the coaptation surface against which the anterior leaflet abuts. The coaptation assist body portion 515 of the coaptation assist device 500 can be coupled to the support structure 505 such that the shape of the support structure 505 imparts the general shape of the coaptation assist device 500.

[0069] The shape of the coaptation assist device 500 may be further supported by one or more ribs 546 (not shown). There may be one, two, or more ribs 546. The ribs 546 may be made from a variety of materials, such as, but not limited to, suture, polypropylene, nylon, NiTi cable, NiTi wire, and PEEK. The process of coupling the coaptation assist body portion 515 of the coaptation assist device 500 to the support structure 505 and / or the ribs 546 (if ribs 546 are present) is described herein.

[0070] In some methods of manufacture, the process may begin by sliding a polyethylene (PE) tube over the support structure 505 and / or ribs 546 (if ribs 546 are present). This combination is placed between two ePTFE sheets, after which heat and pressure are applied. The ePTFE bonds to the PE tube through pores in the ePTFE material into which the polyethylene material of the tube melts, forming a mechanical bond. Similarly, the PE tube material may melt and flow into micropores in the support structure 505 and / or ribs 546 when heat and compression are applied. Micropores in the support structure 505 and / or ribs 546 may be intentionally placed to improve bonding.

[0071] In a variation of the process described above, PE sheets can be placed where PE tubes may not be present. In this variation, a similar process of heat and compression can be applied just as described above to create a more uniform composite structure. In a further embodiment, the support structure 505 and / or ribs 546 can have features such as micropores that bond the ePTFE membrane. The aperture size of the micropores can be, for example, in the range of 0.005" to 0.030".

[0072] In variations on the types of materials that may be used to form the coaptation assist body portion 515 of the coaptation assist device 500, other materials may be utilized, such as, but not limited to, sponge materials, polyurethane, silicone, bovine or porcine pericardium, etc. Bonding processes may include, but are not limited to, heat bonding, suturing, and adhesive bonding.

[0073] 5A, in some embodiments, the coaptation assist device 500 has perforations or slots 520. There can be one or more perforations or slots 520. These perforations 520 can be used to provide sites where anchors can be placed as described herein.

[0074] One of the advantages of the coaptation assist device 500 is that it can be folded into a smaller structure. The coaptation assist device 500 can be delivered percutaneously through a delivery catheter. In some embodiments, the support structure 505 is made from a shape memory material. When the folded coaptation assist device 500 is deployed within the heart, the desired shape of the coaptation assist device 500 is restored. Various methods, devices, and systems that, in many embodiments, are used to deliver the coaptation assist device 500 into the heart are now described.

[0075] In some methods of use, the first support has a first configuration in which the first support 505.2 is generally straight and a second configuration in which the first support 505.2 is curved. In some methods of use, the first support 505.2 and the second support 505.1 are configured to allow for percutaneous insertion of the coaptation assist device 500.

[0076] The first few steps in the delivery procedure may be similar to those known in the art. The patient's body is punctured, for example, in the lower torso / upper thigh area (groin) to allow access to the femoral vein. Typically, a transseptal sheath and needle are inserted into the inferior vena cava and advanced to the atrial septum, where a transseptal puncture is performed and the transseptal sheath is advanced into the left atrium. The needle is removed and the transseptal sheath now provides access to the left atrium. Details of the above steps are described in the published medical literature.

[0077] The method may include various steps, including those currently described. The ventricular protrusion 525 of the coaptation assist device 500 may generally be placed in the left ventricle. It may be advantageous to use various navigation techniques to guide the coaptation assist device 500 to this location. For example, a simple guidewire may be placed inside a transseptal sheath and navigated into the left ventricle by first entering the left atrium and passing through the mitral valve. However, a simple guidewire may not provide sufficient precision in the placement of the ventricular protrusion 525.

[0078] In some embodiments, a method of placing a guidewire inside a steerable sheath may be used. The steerable sheath with the guidewire can be advanced through the transseptal sheath and then through the mitral valve and into the left ventricle, where the steerability of the steerable sheath allows additional support to properly position the guidewire. After the guidewire is placed, the steerable sheath needs to be removed prior to delivery of the coaptation assist device. This method results in more accurate positioning of the guidewire, but involves the extra step of removing the steerable sheath. Various embodiments of steerable sheaths are disclosed herein to improve this process in terms of reducing the number of steps required to perform the implantation.

[0079] Small Diameter Steerable Catheter Referring to FIG. 6A, a small caliber steerable catheter 600 is illustrated. In some embodiments, the caliber 615 of the handle 610 of the steerable catheter 600 may be equal or substantially equal to the caliber 620 of the body 605 of the steerable catheter 600. The steerable catheter 600 may have a pull wire 625 therein. When the handle 610 is rotated, for example, in the direction of the arrow 632, the distal portion of the steerable catheter 600 moves along the arrow 635 from a straight position 630 to a curved position 640. The curved position 640 may be useful for positioning the ventricular protuberance 625 as described herein. When the handle 610 is rotated, for example, in the opposite direction of the arrow 632, the distal portion of the steerable catheter 600 moves from the curved position 640 to the straight position 630. The straight position 630 of the steerable catheter 600 is shown in dotted lines and is not to be confused with the pull wire 625, which is also shown in dotted lines. The straight position 630 may aid in the insertion or retraction of the steerable catheter 600 from the anatomy.

[0080] In some embodiments, the caliber of the handle 610 may be equal to the caliber of the body 605. This may be advantageous because the docking assist device 500 may slide over the handle 610 and / or the body 605 after the steerable catheter 600 is placed in the ventricle. In some embodiments, the steerable catheter 600 may include an extension 612 at the proximal end extending from the handle 610. The extension 612 may be a wire or other elongated structure. The purpose of the extension 612 is to aid in the loading of other catheters or devices while allowing the physician or other operator to retain control of the steerable catheter 600. After loading the other catheter or device onto the extension 612, the steerable catheter 600 is utilized to guide the other catheter or device. The length of the extension 612 may match or be longer than the length of the catheter or device being loaded such that control of the steerable catheter 600 is retained during the process of loading and delivering the other catheter or device.

[0081] In some embodiments, the extension 612 may be coupled to the handle 610 only when needed. For example, during surgery, if the medical team determines that a longer catheter is needed, the extension 612 may be coupled to the handle 610. The coupling mechanism may include, but is not limited to, a threaded joint, a compression fit, or other mechanisms.

[0082] Non-limiting examples of dimensions of the various subcomponents (body 605, handle 615, extension 612) in some embodiments may be as follows: The diameter 620 of the body 605 may be in the range of 2 to 10 Fr, e.g., 4 Fr, about 2 Fr to about 6 Fr, about 3 Fr to about 5 Fr, or less than 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, or 2 Fr. The length of the handle 610 may be in the range of about ½" to about 2", e.g., about 1", in some cases, and the linear stroke of the handle (when actuating a pull wire) may be in the range of about ⅛" to about 3", e.g., about ¼", in some cases.

[0083] In the implantation process, some methods involve a guidewire or a guidewire and a steerable sheath. In some methods, the steerable catheter 600 can be advanced through the femoral access. As the handle 610 is outside the patient's body, it can be rotated so that the distal portion of the steerable catheter 600 is placed in the proper position under the posterior leaflet. An extension 612 can be attached to the proximal end of the handle 610, which then allows for loading of the coaptation assist device 500 and the delivery catheter 700 prior to insertion into the transseptal sheath 650 described herein. The delivery catheter 700 can be used as a guide to introduce the coaptation assist device 500 as described herein.

[0084] FIG. 6B illustrates the placement of the steerable catheter 600 in the heart. One embodiment of a transseptal sheath 650 is shown. Also shown are the left atrium 655, the left ventricle 660, the posterior leaflet 665 of the mitral valve, and the anterior leaflet 670 of the mitral valve. The steerable catheter 600 is shown passing through the mitral valve and positioned under the posterior leaflet 665. It can now be seen how being able to deflect the distal portion of the steerable catheter 600 can be advantageous in obtaining a proper position for the coaptation assist device 500. The distal portion of the steerable catheter 600 can be curved under the posterior leaflet 665 as shown. In some methods, the next common step after placing the steerable catheter 600 is to deliver the coaptation assist device 500 to the heart. Further embodiments of methods and devices for performing the delivery will now be described.

[0085] Delivery Catheter 7A, a delivery catheter 700 is described. The function of the delivery catheter 700 is to deliver the coaptation assist device 500 to the heart. The shaft body 710 of the delivery catheter 700 may be torquable and deflectable. The shaft body 710 is shown in cross-hatched lines. The delivery catheter 700 may include a handle 730. The handle 730 may have a rotation mechanism, such as a pull wire, that may deflect and steer the shaft body 710. Distal to the handle 730 is an implant sheath 725 that may deliver the coaptation assist device 500 to the heart as described herein. In some embodiments, even further distal to the implant sheath 725 is a peelable funnel 720. The peelable funnel 720 may facilitate collapsing of the coaptation assist device 500. In some embodiments, the farthest distal end of the shaft body 720 has features that allow the shaft body 710 to be locked to the coaptation assist device 500 so that the coaptation assist device 500 can be delivered to the heart and properly placed. The locking process and features will now be described with respect to Figures 7B, 7C, and 7D.

[0086] 7D , the delivery catheter 700 and the coaptation assist device 500 can have matching features that allow them to be temporarily locked. In some embodiments, the delivery catheter 700 includes one or more distal locking tabs 705. The coaptation assist device 500 can include an annular hub 510 as described herein. The distal locking tabs 705 of the delivery catheter 700 can mate with a feature in the annular hub 510 of the coaptation assist device 500 as described herein.

[0087] In some methods, the steerable catheter 600 or other guide wire or catheter can be advanced and threaded through the ventricular projection 525 and / or the fixation mechanism 530. In some embodiments, the fixation mechanism 530 can have a hole or passage in the center through which the steerable catheter 600 can be threaded, as shown in FIG. 7D. The steerable catheter 600 can be threaded from the fixation mechanism 530 to the annular hub 510. Other routes through the coaptation assist device 500 are also contemplated. The steerable catheter 600 can be threaded from the fixation mechanism 530 to the annular hub 510 and then to the delivery catheter 700.

[0088] Referring to FIG. 7B, the tip of the delivery catheter 700 is shown in an enlarged view. The annular hub 510 of the coaptation assist device 500 is also shown. The distal locking tabs 705 may be made of some shape memory material, such as Nitinol. The natural position of the locking tabs 705 is set to bend inward and toward each other as illustrated in FIG. 7A. In some methods, a guidewire or catheter such as the steerable catheter 600 may be inserted into the annular hub 510 and between the distal locking tabs 705, which may be pushed out and against the annular hub 510. The annular hub 510 is designed with matching pockets 740, and the distal locking tabs 705 fit within these pockets 740. As long as the steerable catheter 600 is present to push the distal locking tabs 705 outward and into the pockets 740, the tip of the delivery catheter 700 remains locked to the annular hub 510. Other locking mechanisms are possible, and one such alternative is next described in FIG. 7C.

[0089] 7C, the annular hub 510 can include a cross pin 745. The cross pin 745 can be a solid piece that traverses the annular hub 510 and is held in place by methods known in the art. The delivery catheter 700 can include a loop of wire or suture 750. The suture 750 can be looped around an object such as a guidewire or the steerable catheter 600 within the annular hub 510. The suture 750 can extend into a handle 730 of the delivery catheter 700. The handle 730 can have a mechanism to control the tension of the suture 750. By controlling the tension, the coaptation assist device 500 can be drawn and held securely against the distal end of the delivery catheter 700. When the steerable catheter 600 is retracted beyond the level of the cross pin 745 , the loop 755 of the suture 750 can slide over the cross pin 745 , thereby releasing the cross pin 745 and the coaptation assist device 500 .

[0090] Delivery Procedure 8A-8D show a method of delivery. In some methods, the implant sheath 725 and funnel 720 are advanced and fed over the coaptation assist device 500. After the delivery catheter 700 is locked with the coaptation assist device 500, the implant sheath 725 and funnel 720 can be advanced and fed over the coaptation assist device 500. The shape of the funnel 720 helps the coaptation assist device 500 close or fold back on itself. The advancement of the implant sheath 725 and funnel 720 is shown in FIGS. 8A and 8B. The arrow 760 in FIG. 8A shows how the coaptation assist device 500 is retracted into the funnel 720. After the coaptation assist device 500 is in the implant sheath 725, the funnel 720 is removed. In some embodiments, the funnel 720 is removed by pulling on the tab 715, thereby splitting the funnel 720, shown in FIG. 8C. The funnel 720 and tab 715 may then be discarded. In some methods, the implant sheath 725 containing the coaptation assist device 500 may be advanced and routed over the guidewire or steerable catheter 600. Again, the advantage of the steerable catheter 600 design is apparent as the coaptation assist device 500 can smoothly glide over the steerable catheter without the inconvenience of the different size calibers of the handle 610 and body portion 605. The implant sheath 725 may be inserted into the transseptal sheath 650 as shown in FIG. 8D.

[0091] The coaptation assist device 500 and implant sheath 725 system is advanced until it exits the transseptal sheath 650 as shown in FIG. 8E. The delivery catheter 700 is deflected so that the implant sheath 725 is positioned between the leaflets of the mitral valve, as shown in FIG. 8E. The implant sheath 725 is placed between the chordae tendineae 765 ("P2" position). After the implant sheath 725 reaches this position, the delivery catheter 700 is held in place and the implant sheath 725 is slowly retracted, causing the coaptation assist device 500 to begin to exit the implant sheath 725 as shown in FIG. 8F. Note that the steerable catheter 600 or equivalent guidewire can remain in place under the posterior leaflet and still be actively adjusted or deflected using the control handle 610. In some methods, as the delivery catheter 700 is advanced, the coaptation assist device 500 is pushed out, following the path of the steerable catheter 600 until the distal end 530 of the ventricular protuberance 525 is coupled to the ventricular tissue. This is illustrated in FIG. 8G. The implant sheath 725 may be retracted while the coaptation assist device 500 is being pushed out. In some methods, rotational adjustments may be made to the delivery catheter 700 to ensure proper placement.

[0092] fixed After the coaptation assist device 500 is opened, the method may include anchoring the coaptation assist device 500 on the atrial surface of the mitral valve, i.e., on the mitral valve annulus. In some embodiments, methods and systems for accomplishing anchoring are now described.

[0093] Support structures 505 made from shape memory material may be advantageous. When the coaptation assist device 500 opens, it takes on an intended shape due to the action of the shape memory material. The shape of the coaptation assist device 500 may be intended to form a new coaptation surface such that reflux is reduced or eliminated, as described herein. Referring back to the description of the delivery and fixation process, the delivery catheter 700, which may still be coupled to the annular hub 510 of the coaptation assist device 500, may then be manipulated (rotationally and axially) to properly position the coaptation assist device 500 over the posterior leaflet of the native valve. In one embodiment, the support structures 505 of the coaptation assist device 500 may have features that can attach to tissue. In some embodiments, these features are passive hooks. In some methods, these features engage the valve annulus such that the coaptation assist device 500 can be held in place while fixation is initiated. FIG. 8H shows the delivery catheter 700 with the implant sheath 725 retracted, with the shaft body 710 still coupled to the annular hub 510.

[0094] One embodiment of the anchor 800 is illustrated in detail in FIG. 8I. The anchor 800 may be coupled to the delivery catheter 700 and / or the articulation assist device 500 in a variety of ways. The annular hub 510 may have a cross pin 512. The cross pin 512 may form a portion around which the helical structure 815 of the anchor 800 may wrap as shown. The anchor 800 may have a shoulder 805. The shoulder 805 may fit around the shaft body 710 of the delivery catheter 700. The shoulder 805 may have a feature such as a window 810 that may lock the distal locking tab 705 of the delivery catheter 700. The distal locking tab 705 of the delivery catheter 700 may lock when a catheter such as a pin, guidewire, steerable catheter 600, or the like, is present within the shaft body 710 of the delivery catheter 700. In some methods, the anchor 800 may be preloaded onto the coaptation assist device 500 and locked into place with the delivery catheter 700 in the process of mounting the coaptation assist device 500 to the delivery catheter 700. This may be done before the coaptation assist device 500 is retracted into the implant sheath 725 and ready to be inserted into the femoral vein. Referring back to FIG. 8H, torque may be applied to the shaft body 710 as the anchor 800 is driven into the tissue. There may be fluoroscopic markers on the anchor 800 to provide feedback on whether the anchor 800 is properly secured. The markers may be located at the proximal end. These markers may inform the medical team how far the anchor 800 may have moved toward the annular hub 510 and may provide information regarding when the anchor 800 is definitely in place. In some embodiments, to ensure that the proper torque is applied, the torque level on the handle 730 may spike when the anchor 800 bottoms out on the annular hub 510. This increased torque level can be felt at the handle 730 and can provide feedback that proper torque is being applied. The central guidewire or steerable catheter 600 can be retracted.This causes the distal locking tab 705 to retract from the window 810 in the anchor 800, thereby unlocking the delivery catheter 700 and the anchor 800. This may cause the coaptation assist device 500 to be released. The delivery catheter 700 and the steerable catheter 600 may then be fully retracted.

[0095] Commissure fixation Some embodiments illustrate commissure fixation. One such embodiment is shown in FIG. 9A. The delivery catheter 700 (not shown) is retracted and the anchor catheter 900 is advanced through the femoral access. The anchor catheter 900 can be torqued. One or more anchor catheters 900 can be provided. The distal tip of the anchor catheter 900 can have one or more features to lock the anchor in place during delivery of the anchor. In FIG. 9A, the distal tip has a notch 905 that can receive a portion of the helical anchor 915. The anchor catheter 900 can also have a central pin 920. The central pin 920 can have a pointed end at the distal tip. In some embodiments, the central pin 920 can be retractable.

[0096] FIG. 9A shows a loop 910. An end (not shown) of the loop 910 may be moved a length to or between the handle of the anchor catheter 910 so that the tension of the loop 910 may be controlled. The loop 910 passes over a crossbar 917 or other portion that forms the proximal portion of the helical anchor 915. A top view of the helical anchor 915 with the crossbar 917 is shown in FIG. 9B. While outside the body, the helical anchor 915 may be placed adjacent to a central pin 920 prior to entering a transseptal sheath (not shown). The loop 910 may be configured such that when tension is applied to the loop 910, the loop 910 keeps the helical anchor 915, and the central pin 920, locked in place. In FIG. 9A, this configuration is shown with the notch 905 retracted to receive the proximal portion of the helical anchor 915. While maintaining tension on loop 910, the entire arrangement is advanced into a transseptal sheath.

[0097] Once in the desired location within the body, the anchor catheter 900 is adjusted so that the distal end of the anchor catheter 900 is positioned over the commissure foramen 520. The central pin 920 and the helical anchor 915 are advanced so that the central pin 920 pierces the tissue first after passing through the commissure foramen 520. Torque is applied to the anchor catheter 900, causing the helical anchor 915 to pierce the tissue. The helical anchor 915 secures the support structure 505 or frame of the coaptation assist device 500 to the tissue. After the helical anchor 915 is in place, the central pin 920 is retracted. Retraction of the central pin 920 allows the loop 910 to slide over the crossbar 917 of the helical anchor 915, thereby releasing the anchor 915. This process can be repeated until other commissure sites have secured both extreme protrusions of the coaptation assist device 500.

[0098] Alternative fixation techniques FIG. 10A shows an alternative fixation technique in another embodiment. In this embodiment, the delivery catheter 1000 may have multiple lumens 1040. The delivery catheter 1000 may have a cross section as shown in FIG. 10B. The lumens 1040 may carry individual torqueable drive shafts. Each drive shaft may be anchored on an anchor as in the case of shafts 1020 and 1030, or on an annular hub 510 as shown for shaft 1010. Each torqueable shaft 1010, 1020, 1030 may have the design of the anchor catheter 900 illustrated in FIG. 9A. The delivery catheter 1000 may have a central lumen 1050 through which a guidewire or steerable catheter 600 may pass. The multiple torqueable drive shafts 1010, 1020, 1030, guidewire or steerable catheter 600 along with the coaptation assist device 500 can all be loaded and retracted into the implant sheath of the delivery catheter 1000 prior to entering the transseptal sheath. This entire arrangement can be advanced and the coaptation assist device 500 deployed following the same procedures described herein. An advantageous aspect of this arrangement is that the fixation process can be performed without the need to retract the anchor catheter multiple times to reload and re-enter the body with the anchor.

[0099] Alternative Anchor Designs Although several anchors are described herein, other alternative embodiments are contemplated. Figure 11A shows an anchor with a grappling hook. Figure 11B shows an anchor resembling an umbrella. In both embodiments, the anchor may be made from a shape memory material. In both embodiments, the anchor may be loaded into a delivery catheter, such as the delivery catheter illustrated in Figure 11C.

[0100] A locking mechanism as described herein can be used to lock the anchors to a delivery catheter. The delivery catheter can have a pointed end, which can guide the delivery catheter to the proper location to initially pierce the tissue. After the delivery catheter is in place and the initial puncture is performed, one or more of these anchors can be advanced and set in place. After this step, the delivery catheter is unlocked and retracted.

[0101] Figure 11D shows how the umbrella anchor of Figure 11B looks after it has been set into tissue to secure the coaptation assist device 500. Due to the anchor's natural unstressed shape, when deployed into tissue over the coaptation assist device 500, the deformed shape exerts an effective spring force on the face of the coaptation assist device 500 ensuring good footing.

[0102] Non-spinous implants The coaptation assist device 500 illustrated in Figures 5A-5F may include a support structure 505. The support structure 505 may be made of a shape memory material as described herein. In some embodiments of the coaptation assist device, another configuration is contemplated. This configuration may be referred to as a spineless coaptation assist device to indicate that the support structure is removed after placement of the coaptation assist device in the heart. Both types of coaptation assist devices may have some advantages. A spineless coaptation assist device may be advantageous since it has fewer components and materials and no possible metal fatigue.

[0103] 12 illustrates one embodiment of a spinous coaptation assist device 1200. The spinous coaptation assist device 1200 may include a tube or passageway 1210. The passageway 1210 may be placed around the annular rim. This passageway 1210 may be referred to as an annular tube. The spinous coaptation assist device 1200 may include a tube or passageway 1212 along the ventricular protuberance. This passageway 1212 may be referred to as a ventricular tube.

[0104] The profile of the passageway 1210 may be seen towards the end of the annular tube. Although a circular profile is illustrated, the tubes or passageways 1210, 1212 may have other profiles, including, but not limited to, oval and flat.

[0105] The support structures 1210.1, 1210.2, 1210.3 are shown in dotted lines, except for the annular edges from which the support structures 1210.1 and 1210.3 protrude. The support structures 1210.1, 1210.2, 1210.3 may have three distinct sections, with 1210.1 and 1210.3 disposed within an annular tube and 1210.2 disposed within a ventricular tube. The support structures 1210.1, 1210.2, 1210.3 may be joined within a barbed hub 1220. In some embodiments, the support structures 1210.1, 1210.2, 1210.3 may be distinct and separate sections. In some embodiments, the support structures 1210.1, 1210.2, 1210.3 may be joined by one of a variety of methods, such as, but not limited to, crimping and laser welding. This arrangement of the support structures 1210.1, 1210.2, 1210.3 and the coaptation assist device 1200 allows the support structures 1210.1, 1210.2, 1210.3 to be extracted from the coaptation assist device 1200. In some methods, the support structures 1210.1, 1210.2, 1210.3 are extracted by applying a pulling force to the barbed hub 1220. Further details regarding the coaptation assist device 1200 and procedures for delivering and securing the coaptation assist device 1200 will now be described.

[0106] SPINOUS IMPLANT DELIVERY PROCEDURE Figures 13A and 13B illustrate a delivery procedure for the coaptation assist device 1200. Figure 13A shows the coaptation assist device 1200 of Figure 12. Figure 13A shows an additional feature, an anchor site 1300, which is described in more detail below.

[0107] A steerable catheter 600 may be inserted into the coaptation assist device 1200. The steerable catheter 600 may be inserted from the distal tip of the ventricular projection 1212. The steerable catheter 600 may exit from an exit opening 1335. A delivery catheter 1320 may be provided. The delivery catheter 1320 may include a torqueable shaft 1310. The delivery catheter 1320 may include a hub locking feature 1330 that couples with the hub anchor 1300. In FIG. 13A, the hub locking feature 1330 is shown as a screw. Other locking mechanisms described herein may also be utilized.

[0108] 13B illustrates in more detail the delivery catheter 1320. The distal tip of the delivery catheter 1320 can include a funnel 1360. Proximal to the funnel 1360 can be an implant introducer 1340. At the very proximal end, the delivery catheter 1320 can have a handle 1370.

[0109] The steerable catheter 600 may be threaded into the coaptation assist device 1200 as described herein. A funnel 1360 may be inserted onto the distal tip of the delivery catheter 1320. The coaptation assist device 1200 may be locked in place using a locking feature 1330, whereby the hub anchor 1300 is connected to a torqueable shaft 1310.

[0110] The steerable catheter 600 may be threaded into an angled side port 1350 on the implant introducer 1340. The coaptation assist device 1200 and steerable catheter 600 may be pulled through the funnel 1360 by retracting the delivery catheter 1320. Continued retraction causes the coaptation assist device 1200 to collapse into the implant introducer 1340. After the implant is within the introducer 1340, the funnel 1360 is removed and discarded. The funnel 1360 may be designed for easy removal. Funnel designs include, but are not limited to, a peel-away design (already shown in FIGS. 8A-8C) or a clamshell design (FIG. 13B).

[0111] The delivery catheter 1320 may be advanced with the implant introducer 1340 and routed over the steerable catheter 600 until the implant introducer 1340 couples with the hub of the transseptal sheath 650. At this point, the implant introducer 1340 cannot be advanced any further, but the coaptation assist device 1200 itself may be advanced into the transseptal sheath. The next few steps are similar to those shown in FIGS. 8E-8G, except that in this example, no implant sheath is used. The coaptation assist device 1200 is placed over the posterior leaflet and the ventricular protuberance 1212 is placed in the left ventricle. The steerable catheter 600 is retracted, allowing the ventricular protuberance 1212 to curl or coil under P2. After the ventricular protuberance 1212 is secured, the hub anchor 1300 may be rotated or otherwise actuated. The hub anchor 1300 can secure the proximal side of the coaptation assist device 1200 to the valve annulus. The torqueable shaft 1310 can be retracted. After additional fixation as described herein, the hub locking feature 1330 is retracted pulling the support structures 1210.1, 1210.2, 1210.3 with it. The coaptation assist device 1200 can now operate within the left heart without the support structures 1210.1, 1210.2, 1210.3.

[0112] Fixation procedure for non-spinous implants FIG. 14A illustrates one embodiment for anchoring the coaptation assist device 1200. Since rigid structures such as support structures 1210.1, 1210.2, 1210.3 may not be present after implantation, the coaptation assist device 1200 may require additional anchors. In some embodiments, the coaptation assist device may utilize dense anchors. In some embodiments, the coaptation assist device 1200 may utilize additional dense anchors than a similar coaptation assist device with support structure 505 described herein. FIG. 14A illustrates one embodiment of an anchor 1400 that may be used to attach the coaptation assist device 1200 to tissue. FIG. 14B illustrates another embodiment. In FIG. 14B, a suture or tape 1410 is used to "sew" the coaptation assist device 1200 to the tissue. The suture or tape 1410 may be made from one of several materials, including, but not limited to, polypropylene or nylon. Next, several embodiments are described herein that illustrate how multiple anchors are placed.

[0113] FIG. 15A illustrates an embodiment of an anchor catheter 1500 that delivers multiple anchors. Several anchors 1510, including anchor 1510.1 and anchor 1510.2, are stacked within the anchor catheter 1500. Although FIG. 15A illustrates two anchors 1510.1 and 1510.2 as stacked within the anchor catheter 1500, more or fewer anchors can be stacked. Each anchor 1510 can include a coil section 1550. The coil section 1550 can include a pointed end 1570. The anchor 1510 can include an anchor head 1560. The anchor head 1560 can have one of several cross sections, shown in FIG. 15A at 1545.1, 1545.2, 1545.3, and 1545.4. Other cross sections are possible.

[0114] To initially load the anchor catheter 1500, the anchor 1510 is loaded onto the central shaft 1520 of the anchor catheter 1500. The central shaft 1520 and the anchor 1510 may have matching cross sections such that the anchor 1510 may be rotatably coupled to the central shaft 1520. The proximal end of the anchor catheter 1500 may include a spring 1540 that provides a pushing force such that the anchor 1510 exits the distal end of the anchor catheter 1500 in the direction of arrow 1550 when the central shaft 1520 is rotated. Once the anchor 1510 exits, it may engage the coaptation assist device 1200 and tissue to couple the coaptation assist device 1200 to the tissue. The rotation of the central shaft 1520 may be controlled by an operator, such as a physician. In some embodiments, the central shaft 1520 is coupled to a torqueable wire (not shown) that may be coupled to a handle (not shown) at its proximal end. In some embodiments, the torqueable wires may be manually controlled. In some embodiments, the torqueable wires may be controlled via an electric motor. Other methods for imparting rotational motion to the central shaft 1520 are also contemplated. Features not shown in FIG. 15A are those that may steer and position the distal end of the anchor catheter 1500. Once one anchor 1510 is delivered, the distal tip may need to be repositioned to deliver the next anchor 1510. A steering mechanism such as a pull wire may be provided to steer the distal tip of the anchor catheter 1500.

[0115] FIG. 15B illustrates another embodiment of an anchor catheter 1600 that delivers multiple anchors. FIG. 15B illustrates only the distal tip of the anchor catheter 1600. The anchor catheter 1600 can include multiple anchors 1610, such as 1610.1 and 1610.2. Although the anchor catheter 1600 shows five anchors, more or fewer anchors 1610 can be loaded at one time. The anchor catheter 1600 can also have a central shaft 1630. The anchor catheter 1600 can include threads, such as 1620, on the inside of the housing 1605. These threads 1620 can house the coils of the anchor 1610 as shown. To initially load the anchor catheter 1600, the anchor 1610 is inserted into the housing 1605. The anchor 1610 is inserted onto the central shaft 1630. As previously described, the cross-section of the central shaft 1630 may match the cross-section of the anchor 1610 so that the anchor 1610 can be mounted onto the central shaft 1630. Rotation of the central shaft 1630 may be controlled by a torqueable cable (not shown) that may connect the central shaft 1630 to a handle (not shown) of the anchor catheter 1600. An operator, such as a physician, may control the rotation. In some embodiments, a torqueable wire may be manually controlled.

[0116] In some embodiments, the torqueable wires may be controlled via an electric motor. As the central shaft 1630 rotates, the threads act to move the anchors 1610 out of the anchor catheter 1600 and into engagement with the coaptation assist device 1200 and tissue, joining the coaptation assist device 1200 and tissue together. The anchor catheter 1600 may also have pull wires that steer the distal tip of the anchor catheter 1600 so that once one anchor 1610 has been delivered, the anchor catheter 1600 is positioned to deliver the next anchor 1610.

[0117] FIG. 15B illustrates a central suture 1635. The central suture 1635 may include a ball 1640 coupled to an end of the central suture 1635. FIGS. 15C and 15D illustrate how the central suture 1635 and ball 1640 may be used. The ball 1640 may fit within a pocket inside the first anchor 1610.1. The central suture 1635 may connect the first anchor 1610.1 to the second anchor 1610.2 and other anchors 1610 (not shown). In this arrangement, the central suture 1635 may be used as a guide wire to return to the anchor 1610 after it has been screwed into the tissue 1645. The operator may want to return to the anchor 1610 to reposition or adjust the anchor 1610. Additionally, if one or more of the anchors 1610 become loose, the central suture 1635 can provide a tether to the loosened anchors 1610, thus preventing an embolic event.

[0118] 16A-16C show another embodiment of an anchor catheter 1700 that delivers multiple anchors. The anchor catheter 1700 can have a hollow shaft. The hollow shaft can be directed to a distal end and can be used to pierce the coaptation assist device 1200 and tissue. Multiple anchors 1710, such as 1710.1, 1710.2, can be disposed within the hollow shaft of the anchor catheter 1700. The anchors 1710 can be hollow barrels.

[0119] The suture 1720 may be threaded through the anchor 1710 as shown. The suture 1720 may be secured to the first anchor 1710.1 by arranging the suture 1720 to exit the second anchor 1710.2 and enter the first anchor 1710.1 through the side opening 1740. The suture 1720 may then be secured using a knot as shown in dotted lines in the first anchor 1710.1. The suture 1720 in the other anchors 1710, except for the first anchor 1710.1, may appear as illustrated for anchor 1710.2. The anchors 1710, except for the first anchor 1710.1, have portions of the walls cut out. The cut outs may help better capture the anchor in the tissue and resemble a toggle bolt. At the proximal end of anchor catheter 1700, a feature such as a pusher tube 1750 may be present to force anchors 1710, such as 1710.1 and 1710.2, out of anchor catheter 1700 at the distal end. Pusher 1750 is attached to a handle (not shown) to allow an operator, such as a physician, to deposit one or more anchors 1710 at the appropriate time. Arrow 1760 indicates the direction of pushing.

[0120] 16B-16C illustrate how the anchor catheter 1700 of FIG. 16A can operate. In FIG. 16B, the anchor catheter 1700 is advanced through the coaptation assist device 1200 and through the slot as described at 520 in FIG. 5A. The anchor catheter 1700 then pierces the tissue 1645. The operator pushes the first 1710.1 out of the anchor catheter 1700 to deposit the anchor 1710.1 in the tissue. After the first anchor 1710.1 is deposited, the remainder of the anchors 1710 are deposited as illustrated in FIG. 16C. In FIG. 16C, the anchor catheter 1700 is withdrawn from the tissue after depositing the first anchor 1710.1 to enter a second position. At the second position, the anchor catheter 1700 can deposit the second anchor 1710.2. This process continues until it is desired to secure the coaptation assist device 1200 to the tissue. After the last anchor 1710 is delivered, a cutter (not shown) can be advanced inside the anchor catheter 1700 to cut the sutures 1720, leaving the anchors 1710 behind.

[0121] In some embodiments, the anchors 1710 may be radiopaque or covered with radiographic markers. During the process of delivery of the anchors 1710, the radiopaque markers may be visualized when a fluoroscope is used. This may aid in spacing and lining up the anchors 1710 around the annulus of the coaptation assist device 1200.

[0122] In some embodiments, MR is assessed while fixing the coaptation assist device 1200, and the pitch and / or placement of the stitching action is determined according to whether MR is present or absent.

[0123] SPINOIL IMPLANT WITH ANNULAR TUBE - Patent application 17A illustrates another embodiment of a coaptation assist device 1800 without spines. In this embodiment, the support structure 1810 may only traverse down the ventricular protuberance 1820. A tube or passageway 1830 may be present around the annular edge of the coaptation assist device 1800. Instead of utilizing the support structure 1810 to maintain the shape of the coaptation assist device 1800, an anchor catheter 1850 may be inserted into the tube 1830 as shown in FIG. 17B. In FIG. 17B, the anchor catheter 1850 may be a deflectable anchor catheter.

[0124] FIG. 17B also shows a first site 1860.1 where an anchor as described at 1560 in FIG. 15A can be delivered. At this site 1860.1 and all anchor sites 1860, the tip of the anchor catheter 1850 is deflected by a control located on the outside of the body. An anchor (not shown) can be delivered to secure the coaptation assist device 1800 to tissue. The tip of the anchor catheter 1850 can be radiopaque and then visualized during the anchor delivery process. Visualization of the tip can be utilized to place the anchor around the annulus of the coaptation assist device 1800. FIG. 17B illustrates the first anchor placement 1860.1 and FIG. 17C illustrates the second anchor placement 1860.2. After the appropriate number of anchors have been delivered, the anchor catheter 1850 is fully retracted as shown in FIG. 17D. Finally, the support structure 1810 can be removed as shown in FIG. 17E.

[0125] In a variation of the embodiment shown in Figures 17A-17E, the support structure 1810 may not be limited to the ventricular protuberance, but may be inserted through the annular tube 1830 so that the desired shape may be maintained. The support structure may be a shape memory material. As a result of utilizing a support structure around the annular tube 1830, the anchor catheter may have a relatively simple control mechanism compared to the anchor catheter 1850 used in the coaptation assist device 1800 described in Figure 17A.

[0126] It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and fall within the scope of one or more of the inventions. Moreover, the disclosure herein of a particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in conjunction with an embodiment may be used in all other embodiments described herein. Thus, it should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for one another to form various forms of the disclosed invention. Thus, it is intended that the scope of the invention disclosed herein should not be limited by the specific disclosed embodiments described above. Moreover, the invention is susceptible to various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. However, it should be understood that the invention should not be limited to the specific forms or methods disclosed, but rather, the invention should cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. The methods disclosed herein do not have to be performed in the order described. The methods disclosed herein include actions taken by a practitioner, but may also include third-party instructions for those actions, either explicitly or implicitly. For example, an action such as "insert the coaptation assist body proximate the mitral valve" includes "command the coaptation assist body to be inserted proximate the mitral valve." Ranges disclosed herein include all overlaps, subranges, and combinations thereof. Words such as "up to," "at least," "more than," "less than," "between (or from)," and the like, are inclusive of the recited number. Numbers accompanied by words such as "approximately," "about," and "substantially" as used herein are inclusive of the recited number and represent an amount close to the recited amount that performs the desired function or produces the desired result.For example, the terms "approximately," "about," and "substantially" may refer to amounts within 10%, within 5%, within 1%, within 0.1%, and within 0.01% of the stated amount. [Explanation of symbols]

[0127] 10 Left atrium 12 Anterior leaflet 14 Posterior apex 16 Junction Zone 20 Right atrium 30 left ventricle 32 Chordae tendineae 34, 36 papillary muscles 40 Right ventricle 50 Tricuspid Valve 60 Mitral Valve 70 Pulmonary valve 80 Aortic Valve 110, 114 commissure 120 Fibrous Annulus 124 Left (lateral) fibrous triangle 126 Right (septal) fibrous triangle 128 Central fibrous body 160 Cross Section 215 Chordae tendineae 220 Fluctuation of valve cusp 230 Ventricular systole 240 Annular Dilatation 312 Anterior leaflet 314 Posterior apex 320 Ventricle 330 Papillary muscle 342 Anterior leaflet 344 Posterior apex 500 Joint Support Device 505 Support Structure 505.1 Second Section 505.2 First Section 510 Hub 512 Cross Pin 515 Joint auxiliary body part 520 Perforations, slots, and commissures 525 Ventricular eminence 530 Distal end 535 First Joint Surface 540 Second Joint Surface 545 Upper edge 546 Rib 550.1 Section 550.2 Section 550.3 Section 550.4 Section 550.5 Section 555.1 Distal end 555.2 Distal end 555.3 Distal end 555.4 Distal end 555.5 Distal end 560 tubes 565.1 Tube 565.2 Tube 600 Small Diameter Steerable Catheter 605 Main body 610 Handle 612 Extension 615 caliber 620 caliber 625 Pull Wire 630 Straight position 632 Arrow 635 Arrow 640 curved position 650 Transseptal Sheath 655 Left atrium 660 left ventricle 665 Posterior leaflet of mitral valve 670 Anterior leaflet of mitral valve 700 Delivery Catheter 705 Distal Locking Tab 710 Shaft body 715 tabs 720 Peelable Funnel 725 Implant sheath 730 Handle 740 Pocket 745 Crosspin 750 Wire or Suture 755 Loop 760 Arrow 765 Chordae tendineae 800 Anchor 805 Shoulder 810 Windows 815 Spiral structure 900 Anchor Catheter 905 Notch 910 Loop 915 Spiral Anchor 917 Crossbar 920 Center pin 1000 Delivery Catheter 1010 Shaft 1020 Shaft 1030 Shaft 1040 Lumen 1050 Central lumen 1200 Non-spinous coaptation device 1210 Tube or passageway 1210.1, 1210.2, 1210.3 Support Structure 1212 Tube or passageway 1212 Ventricular eminence 1220 Structure 1220 Spiny Hub 1300 Anchor part 1310 Shaft 1320 Delivery Catheter 1330 Hub Locking Feature 1335 Exit opening 1340 Implant introducer 1350 Angled Side Port 1360 Funnel 1370 Handle 1400 Anchor 1410 Sutures or Tapes 1500 Anchor Catheter 1510 Anchor 1510.1 Anchor 1510.2 Anchors 1520 central shaft 1540 Spring 1550 Coil Section 1560 Anchorhead 1570 pointed end 1600 Anchor Catheter 1605 Housing 1610 Anchor 1620 thread 1630 central shaft 1635 Central suture 1640 Ball 1645 Organization 1700 Anchor Catheter 1710 Anchor 1710.1 First anchor 1710.2 Second anchor 1720 Sutures 1740 Side opening 1750 Pusher Tube 1760 Arrow 1800 Non-spinous coaptation device 1810 Support Structure 1820 Ventricular eminence 1830 Tube or passageway 1850 Anchor Catheter 1860 Anchor part 1860.1 First section, first anchor placement 1860.2 Second Anchor Arrangement

Claims

1. 1. A coaptation assist device, comprising: A flexible joint assist body portion; a first concave surface on the coaptation assist body portion, the first concave surface configured to confine a posterior leaflet; a second convex surface on the coaptation assist body portion, the second convex surface configured to contact the anterior leaflet; a support structure comprising a first section and a second section; an annular hub proximal to the joint assist body portion, the annular hub protruding from a surface of the joint assist body portion, the support structure extending from the annular hub; Equipped with a coaptation assist device, the coaptation assist body portion comprising a sheet of biocompatible material bonded to the support structure, the coaptation assist device maintaining its shape and function as a coaptation assist device when the heart contracts, expands and exerts pressure on the coaptation assist device; a delivery catheter configured to deliver the coaptation assist device to the heart, the delivery catheter being positioned over the annular hub to secure the annular hub to an atrial aspect of the mitral valve annulus; A bonding assist device system comprising:

2. The coaptation assist device system of claim 1 , further comprising a helical anchor, the annular hub configured to receive the helical anchor.

3. 2. The coaptation assist device system of claim 1, wherein the coaptation assist body portion includes one or more perforations, the perforations providing locations configured for additional anchors to be positioned.

4. The coaptation assist device system of claim 1 , wherein the coaptation assist body portion comprises a hole and a helical anchor, the helical anchor configured to secure the support structure to tissue.

5. The coaptation assist device system of claim 1 further comprising a helical anchor.

6. The coaptation assist device system of claim 1 , wherein the second convex surface is configured to coapt with the anterior leaflet during systole to prevent reflux.

7. The coaptation assist device system of claim 1 , wherein the first concave surface is defined by a first side edge, a second side edge, a bottom edge, and a top edge.

8. The coaptation assist device system of claim 1 , wherein the second convex surface is defined by a first lateral edge, a second lateral edge, a lower edge, and an upper edge.

9. The joint assist device system of claim 1 , wherein the second convex surface faces the first concave surface.

10. The coaptation assist device system of claim 1 , wherein the first concave surface and the second convex surface are bounded by a first side edge and a second side edge.

11. The coaptation assist device system of claim 1 , wherein the first concave surface extends along a portion of the coaptation assist device.

12. The coaptation assist device system of claim 1 , wherein the second convex surface extends along a portion of the coaptation assist device.

13. 2. The coaptation assist device system of claim 1, wherein the first section of the support structure extends through at least a portion of the coaptation assist device between an upper end and a lower end of the coaptation assist device.

14. The coaptation assist device system of claim 1 , wherein the support structure is configured to support an arcuate periphery.

15. 2. The coaptation assist device system of claim 1, wherein the second section of the support structure extends at least partially between a first side edge and a second side edge of the coaptation assist device.

16. The coaptation assist device system of claim 1 , wherein the first section of the support structure comprises a shape memory material.

17. The coaptation assist device system of claim 1 , wherein the second section of the support structure comprises a shape memory material.

18. The coaptation assist device system of claim 1 , wherein the support structure comprises Nitinol.

19. The joint assist device system of claim 1 , wherein the support structure comprises polyetheretherketone.

20. The coaptation assist device system of claim 1 , wherein the biocompatible material is made of expanded polytetrafluoroethylene (ePTFE).

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