Tissue grasping devices and related methods

Abstract

To provide tissue grasping devices and related methods.SOLUTION: A clip for immobilizing leaflets of a cardiac or a venous valve includes a hub having a pair of tangle resistant spring-biased outer arms coupled to an inferior end of the hub and a pair of tangle resistant spring-biased inner arms adjacent to the outer arms and coupled to a superior end of the hub. A delivery catheter may be used to position the valve clip adjacent to a target valve while the outer and inner arms are biased in an opened position relative to each other. After the valve leaflets are located between the opened outer and inner arms, biasing force may be released to allow the clip to self-close the clip over the valve leaflets.SELECTED DRAWING: Figure 70

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of Provisional Application No. 62 / 617,946 (Attorney Docket No. 52206 - 709.101), filed on Jan. 16, 2018, which is incorporated herein by reference in its entirety.

[0002] The disclosure of this application is related to that of PCT International Application No. PCT / US2017 / 042003, filed on Jul. 13, 2017, entitled "TISSUE GRASPING DEVICES AND RELATED METHODS", the entire disclosure of which is incorporated herein by reference.

[0003] (1. Technical Field) The present invention generally relates to medical methods, devices, and systems. In particular, the present invention relates to methods, devices, and systems for intravascular, percutaneous, or minimally invasive surgical procedures on body tissues such as tissue access or valve repair. More specifically, the present invention relates to methods and devices for the repair of mitral and tricuspid heart valves, venous valves, and other tissue structures through minimally invasive and other techniques.

Background Art

[0004] Surgical repair of body tissues often involves tissue access and fastening of such tissues in an access arrangement. When repairing a valve, tissue access often involves joining the valve leaflets in a treatment arrangement, which can then be maintained by fastening or fixing the leaflets. Such fixation of the leaflets can be used to treat the most common regurgitation in the mitral valve.

[0005] Mitral regurgitation is characterized by the backflow of blood from the left ventricle of the heart into the left atrium through a malfunctioning mitral valve. During the normal cycle of the heart's contraction (systole), the mitral valve acts as a check valve to prevent the flow of oxygenated blood from returning into the left atrium. Thus, the oxygenated blood is pumped into the aorta through the aortic valve. Valve regurgitation can significantly reduce the heart's pumping efficiency and expose the patient to the risk of severe progressive heart failure.

[0006] Mitral regurgitation can result from several different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the chordae tendineae that connect the leaflets to the papillary muscles, the papillary muscles themselves, or the left ventricular wall can be damaged or otherwise malfunction. Generally, the valve annulus can be damaged, dilated, or weakened, limiting the ability of the mitral valve to close properly against the high pressure in the left ventricle during systole.

[0007] The most common treatments for mitral regurgitation rely on valve replacement or valve repair, including leaflet and annulus reconstruction, the latter of which is generally referred to as valvuloplasty. One technique for mitral valve repair that relies on suturing together adjacent sections of opposing valve leaflets is called the "bow tie" or "cut edge" technique. All of these techniques can be effective, but they typically rely on open-heart surgery in which the patient's chest is typically opened via a sternotomy and the patient undergoes cardiopulmonary bypass. The need for both opening the chest and subjecting the patient to bypass is traumatic and associated with high mortality and morbidity.

[0008] In some patients, a fixation device can be deployed into the heart using minimally invasive techniques. The fixation device can hold together adjacent sections of opposing valve leaflets and reduce mitral regurgitation. One such device that is used to clip together the anterior and posterior leaflets of the mitral valve is the MitraClip® fixation device sold by Abbott Vascular (Santa Clara, California, USA).

[0009] Fixing devices such as the MitraClip® leaflet fixation device often include a clip designed to grip and hold valve tissue as clip arms are moved, positioned against tissue at the treatment site, and then closed against the tissue. Such clips are designed to be closed in a final position and then mechanically locked in that position to continuously grip the tissue.

[0010] In addition, the act of gripping and closing in a final position tightens the leaflets and potentially the valve annulus. Considering that the MitraClip® is a relatively rigid device with mechanically locked steel (Elgiloy®) arms, the natural expansion and contraction of the valve annulus is modified.

[0011] Furthermore, to achieve detachment and remove or reposition the device, it is required to flex the device at extreme angles (up to the inflection point) to release the grip. Such extreme movement and deformation of the components of the fixing device during pre-deployment, positioning, closing, and detachment of the device can lead to weakening and premature degradation of the fixing device. In addition, this greatly complicates the device with multiple components and contributes to the relatively large overall size of the device, and thus correspondingly large (about 24Fr for the MitraClip® fixing device) delivery systems. This large catheter size can impose additional trauma on the patient. In comparison, typical transseptal introducer sheaths are 8.5Fr - 12Fr (inner diameter) and 9Fr - 16Fr (outer diameter).

[0012] Some tissue fixation procedures require that the fixation device maintain some flexibility and mobility and allow a range of physiological movement even after the device is properly deployed and the target tissue is properly fixed in place. This can increase the risk of early failure of the complex locking mechanisms of the device as continued deformation of the flexing components (such as from continuous opening and closing of the leaflets) can lead to undesirable degradation of the device.

[0013] Depending on the anatomical structure of the valve and the disease state, generally, there can be variations in the junction length and dissimilarity (e.g., dissimilarity between the anterior mitral valve leaflet and the posterior mitral valve leaflet) in the pointed shape. However, the current devices and the market-leading MitraClip® fixation device are provided in only one size, and only recently, another size has been added to the mix. However, the shape of the device is the same, which is mainly optimized to regress mitral regurgitation. This can pose a problem for surgeons when presenting various valve sizes, junction lengths, vulnerabilities, and various functional and degenerative valve defects to be treated.

[0014] The ability to detach and reposition is an important safety consideration for most medical devices. The current market-leading MitraClip® fixation device has some of these attributes to enable detachment and repositioning. However, the return is on the side of the grasping arm, which creates a safety risk that the tissue or delivery mechanism can become snagged on the return of the tissue grasping feature.

[0015] Finally, visualization during and after this procedure plays an important role in the proper delivery of the device and the outcome of the result. Current state-of-the-art devices rely on fluoroscopy and transesophageal echocardiogram (TEE). TEE mainly requires general anesthesia and adds significant risks to the elderly and frail patient population in which this type of repair procedure is typically performed.

[0016] For at least these aforementioned reasons, the following needs still exist. a) A simpler device with fewer components: alternative and / or additional methods, devices, and systems for tissue fixation that can provide the beneficial elasticity and durability of flexible components without increasing the safety and manufacturing risks associated with numerous and complex components. b) Lockless device: The need for a simpler device to eliminate the procedural risks associated with locking the device and the risks associated with failure of the locking mechanism after deployment. c) Elastic and stretchable device: The need for a device that gently tightens the valve ring (or cusp) while preserving some natural expansion and contraction of the valve ring (or cusp). d) Smaller catheter size / profile: Considering that most patients undergoing these procedures may be elderly and debilitated by multiple co-existing diseases, there is also a need to create a delivery device much smaller than 24Fr to reduce the risks associated with vascular access. e) Multiple device sizes: Provide such methods, devices, and systems in a manner that does not limit the tissue grasping ability of the fixation device. For example, there may be a need for the ability to grasp beyond the cusp junction region while conforming to the cusp shape and length to address short junction lengths and / or weak cusps. f) Entanglement-free design: The current market-leading MitraClip® fixation device has returns that are exposed on both sides of the tissue grasping feature. Tendons, tissue, and the device delivery mechanism can become entrapped by such exposed returns. Therefore, there is a need to improve the safety of device detachment and repositioning to further reduce the risk of tissue or the delivery mechanism sticking within the device during the procedure. g) Visualization: There is a need for improved visualization and feedback to perform the procedure safely and normally with little trauma to the patient. h) Local anesthesia: The ideal procedure would be under local anesthesia without the use of general anesthesia. This reduces the higher risks associated with general anesthesia.

[0017] At least some of these objectives will be met by the inventions and embodiments described below.

[0018] (2. Background description) Minimally invasive and percutaneous techniques for joining and repairing the mitral valve leaflets and treating mitral regurgitation are described in PCT Publications WO 98 / 35638, WO 99 / 00059, WO 99 / 01377, and WO 00 / 03759, WO 2000 / 060995, WO 2004 / 103162. Maisano et al. (1998) Eur. J. Cardiothorac. Surg. 13:240-246, Fucci et al. (1995) Eur. J. Cardiothorac. Surg. 9:621-627, and Umana et al. (1998) Ann. Thorac. Surg. 66:1640-1646 describe open surgical techniques for performing "cut edge" or "bow tie" mitral valve repairs in which the edges of opposing valve leaflets are sutured together to reduce regurgitation. Dec and Fuster (1994) N. Engl. J. Med. 331:1564-1575, as well as Alvarez et al. (1996) J. Thorac. Cardiovasc. Surg. 112:238-247 are review articles discussing the nature and treatment of dilated cardiomyopathy.

[0019] Mitral valvuloplasty is described in the following publications, namely, Bach and Bolling (1996) Am. J. Cardiol. 78:966-969, Kameda et al. (1996) Ann. Thorac. Surg. 61:1829-1832, Bach and Bolling (1995) Am. Heart J. 129:1165-1170, and Bolling et al. (1995) 109:676-683. Linear segment valvuloplasty for mitral valve repair is described in Ricchi et al. (1997) Ann. Thorac. Surg. 63:1805-1806. Tricuspid valvuloplasty is described in McCarthy and Cosgrove (1997) Ann. Thorac. Surg. 64:267-268, Tager et al. (1998) Am. J. Cardiol. 81:1013-1016, and Abe et al. (1989) Ann. Thorac. Surg. 48:670-676.

[0020] Percutaneous transcatheter heart repair techniques are described in Park et al. (1978) Circulation 58:600-608, Uchida et al. (1991) Am. Heart J. 121: 1221-1224, and Ali Khan et al. (1991) Cathet. Cardiovasc. Diagn. 23:257-262. Endovascular heart valve replacement is described in U.S. Pat. Nos. 5,840,081, 5,411,552, 5,554,185, 5,332,402, 4,994,077, and 4,056,854. U.S. Pat. No. 3,671,979 describes a catheter for the temporary retention of an artificial heart valve.

[0021] Other percutaneous and endovascular heart repair techniques are described in U.S. Pat. Nos. 4,917,089, 4,484,579, and 3,874,338, and PCT Publication No. WO 91 / 01689.

[0022] Laparoscopic and other minimally invasive cardiac valve repair and replacement techniques are described in U.S. Patent Nos. 5,855,614, 5,829,447, 5,823,956, 5,797,960, 5,769,812, and 5,718,725.

[0023] MitraClip® devices, systems, and methods for engaging tissue are described in U.S. Patent Nos. 8,057,493, 7,226,467, and 10,159,570.

[0024] U.S. Patent Publication No. 2015 / 0257883, and PCT Publication Nos. WO 2019 / 010370, WO 2018 / 013856, and WO 2017 / 015288 are particularly relevant to the present application, where the primary inventors are the inventors herein.

Prior Art Documents

Patent Documents

[0025]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0026] (Summary of the Invention) The present invention provides devices, systems, and methods for tissue access and repair at a treatment site. The devices, systems, and methods of the present invention find use in a variety of therapeutic procedures, including endovascular, minimally invasive, and open surgical techniques, and can be used in a variety of anatomical regions, including the abdomen, chest, cardiovascular system, heart, intestine, stomach, urinary tract, bladder, lung, and other organs, blood vessels, and tissues. The present invention is particularly useful in those procedures that require minimally invasive or endovascular access to remote tissue locations, particularly those in which the instrument utilized must pass through a long, narrow, tortuous path to the treatment site. Additionally, many of the devices and systems of the present invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to the internal tissue. **Means for Solving the Problems**

[0027] In preferred embodiments, the devices, systems, and methods of the present invention are adapted for fixation of tissue at a treatment site. Exemplary tissue fixation applications include heart valve repair, septal defect repair, vessel ligation and grasping, laceration repair, and wound closure, although the present invention may find use in a wide variety of tissue access and repair techniques. In particularly preferred embodiments, the devices, systems, and methods of the present invention are adapted for repair of heart valves, particularly the mitral valve, as a treatment for regurgitation. The present invention enables two or more valve leaflets to be joined using a "cut edge" or "bow tie" technique to reduce regurgitation, without requiring open surgery through the chest and heart wall as in conventional approaches. Additionally, the position of the leaflets can vary in the diseased mitral valve depending on the type and extent of the disease, such as calcification, detachment, or fluttering. These types of diseases can result in one leaflet being more mobile (e.g., more difficult to capture) than the other, and thus more difficult to symmetrically grasp in the same grip as the other leaflet. A feature of the present invention is that the fixation device is adapted to meet the challenges of unpredictable target tissue geometries and is capable of providing a more robust grip on the tissue once it is captured. Additionally, the present invention optionally incorporates visualization techniques and enables the device placement procedure to be performed without the use of general anesthesia.

[0028] The devices, systems, and methods of the present invention center around various devices that can be used individually or in various combinations to form an intervention system. In preferred embodiments, the intervention system includes a multi-catheter guidance system, a delivery catheter, and an intervention device. Each of these components will be discussed herein.

[0029] In an exemplary embodiment, the present invention provides a fixation device having a pair of arms (or fixation elements), each arm having a free end and an engagement surface for engaging tissue, the arms being movable between a first position for capturing tissue and a second position for fixing tissue. Preferably, the engagement surfaces are spaced apart in the first position and closer together in the second position and generally face each other. Preferably, the arms are biased to be telescopically extensible towards each other. The arms may have friction elements such as returns or teeth, and in a preferred embodiment, the returns or teeth may be serrated. The fixation device preferably consists of 1 or 2 or 3 or more pairs of arms and is delivered to a target location within a patient's body by a delivery catheter having an elongate shaft, a proximal end, and a distal end, the delivery catheter being configured to be positioned at the target location from a remote access point such as a vascular puncture or incision or surgical penetration. In a preferred embodiment, the target location is a valve within the heart. In a preferred embodiment, the pair of arms as described above consists of an inner arm that captures the cusp from the atrial side and an opposing outer arm that captures the cusp from the ventricular side. The arms may have friction elements such as returns or teeth, and in a preferred embodiment, only the inner arm has a friction element.

[0030] A particular advantage of the present invention is its ability to use two pairs of arms to join the mitral valve cusp (or any other tissue for which it is used) in a parallel or perpendicular relationship. In other words, the cusps can be captured, pulled together, and fixed such that their proximal upstream surfaces are arranged parallel to each other and generally aligned with the direction of flow through the valve at the junction point. In some embodiments of the fixation device, the use of a sufficiently rigid outer arm, a high friction and compressible inner arm, and a passive closure mechanism allows the cusps to be held perpendicular (aligned with the blood flow) while being gripped in a spaced relationship and then pulled together in a joined relationship to achieve an optimal joining configuration.

[0031] A particular advantage of the present invention is its ability to join the mitral valve leaflets (or any other tissue to which it is applied) in a parallel or perpendicular relationship while gripping along the anatomical contour of the leaflets. In other words, the leaflets can be captured, drawn together, and secured while additionally gripping along the anatomical contour away from the join, such that their proximal upstream surfaces are arranged parallel to each other and generally aligned with the direction of flow through the valve at the point of join. In some embodiments of the fixation device, the use of a sufficiently flexible outer arm, a high friction, compressible, and / or flexible inner arm, and a passive closure mechanism allows the leaflets to be held perpendicular (aligned with the blood flow) while being gripped in a spaced relationship and then drawn together in a joined relationship to achieve an optimal joining configuration.

[0032] A particular advantage of the present invention is its ability to join the mitral valve leaflets (or any other tissue to which it is applied) in the adjacent anatomical relationship of the leaflet shape while gripping along the anatomical contour of the leaflets. In other words, the leaflets can be captured, drawn together, and secured such that their natural anatomical shape is maintained. In some embodiments of the fixation device, the use of a sufficiently flexible outer arm, a high friction and flexible inner arm, and a passive closure mechanism allows the leaflets to be held perpendicular (aligned with the blood flow) while gripping the leaflets along the natural contour beyond the joining length, enabling the leaflets to be gripped in a spaced relationship and then drawn together in a joined relationship to achieve an optimal joining configuration.

[0033] The fixation device is preferably delivered with the outer arm at the delivery position configured to minimize the outer profile of the device. When approaching the mitral valve from the atrial side, some embodiments of the fixation device allow the device to be delivered with the free end of the outer arm oriented in a generally proximal direction forming an angle of less than about 90°, preferably less than about 20°, with respect to the longitudinal axis of the delivery device shaft. In this position, the engagement surfaces generally face each other and are disposed at an angle of less than about 180°, preferably less than about 40°, with respect to each other. With respect to the ventricular approach, at the delivery position, the free end of the outer arm is oriented in a generally distal direction and forms an angle of less than about 90°, preferably less than about 20°, with respect to the longitudinal axis of the delivery device shaft. In this position, the engagement surfaces generally face each other and are typically disposed at an angle of less than about 180°, preferably less than about 90°, with respect to each other. Alternatively, in some ventricular approaches, it may be preferable to have a free end of the fixation element oriented in a generally proximal direction at the delivery position and engagement surfaces that face away from each other.

[0034] To provide reversibility and removability of the devices and systems of the present invention, the tines are lifted from the sufficiently flexible outer arms using sutures or actuating wires, effectively mimicking the inversion of the outer arms, which minimizes entanglement and interference with surrounding tissue if the device is desired to be removed. In mitral valve repair applications, this is particularly important due to the presence of chordae tendineae, valve leaflets, and other tissues that the device may become entangled with. With respect to the approach to the mitral valve from the atrial side (in the mimicked inverted position), the sutures or wires are disposed at an angle greater than about 180°, preferably greater than 270°, with respect to each other. With respect to the ventricular approach to the valve in the mimicked inverted position, the sutures or wires are oriented distally with respect to the catheter shaft and the engagement surfaces generally face each other and will typically be disposed at an angle less than about 180°, preferably less than 90°, with respect to each other.

[0035] A particular advantage of the present invention is to enable the inversion of the arm using an inversion device by effectively utilizing the direction of the pulling force applied by the suture or the actuating wire. An example of the inversion device used in the present invention is a lever arm that swings and closes, enables a thin profile during passage through the catheter system, swings away, and provides an increased lever arm necessary to invert the arm.

[0036] In the open position, the engaging surfaces of the outer arms preferably form an angle of up to 180° with respect to each other so as to maximize the area for capturing the valve tip or other target tissue therein. The outer arms are preferably flexible up to the closed position where the engaging surfaces engage each other or form an angle as small as or less than about 0° with respect to each other. The outer arms are flexible while applying a compressive force equal to or exceeding the force of the opposing inner arms to enable fixation of tissues of various thicknesses, geometries, and spacings, and are configured to remain permanently in any of various positions.

[0037] A particular advantage of the present invention is that both the outer and inner arms are sufficiently superelastic and flexible to apply a permanent and gentle (non-traumatic) reaction force to the tissue while allowing slight movement to conform to a) the anatomical shape of the tip and b) the physiological forces on the tip.

[0038] A particular advantage of the present invention is that both the outer and inner arms are sufficiently superelastic, stretchable, and flexible, which preserves a degree of natural dilation during expansion and assists the natural contraction of the valve annulus during contraction while imparting a gentle therapeutic constriction (either directly or via the leaflets) to the valve annulus in response to capturing the leaflets in the closed final configuration in the open state. This gentle constriction of the valve annulus potentially promotes positive remodeling of the valve annulus, particularly in the dilated valve annulus of an enlarged heart. Additionally, this preserves the natural valve annulus dilation during expansion, which in turn increases the orifice area of the valve for enhanced blood flow from the atrium to the ventricle during expansion. The valve clip of the present invention will be less traumatic and more flexible than the MitraClip® device, but the clip will still be robust enough to firmly grip and immobilize the valve leaflets so that it can function as desired to improve flow control through the valve being treated.

[0039] A particular advantage of the present invention is that it is possible to have various sizes and shapes of arms or pairs of arms that can be attached to the same catheter delivery system. A particular advantage of the present invention is that the reaction forces of the inner and outer arms can be configured to desired specifications by varying the respective material, thickness, width, length, shape, and cut pattern of the inner arm or its corresponding outer arm. For example, the reaction force of the outer arm can be the same as, less than, or greater than that of the inner arm. In a preferred embodiment, the reaction force of the outer arm is either 1, 1.2, 1.5, 2, 3, 5, 10, 20, 30 times that of the inner arm or greater than that.

[0040] Another specific advantage of the present invention is that the friction element (return) is installed inward along the long axis of the arm body and is confined by a continuous and solid side surface. Unlike the MitraClip® device, the return is not exposed along the side surface. This is advantageous as it significantly reduces the risk of entanglement of the chordae tendineae, valve leaflets, and other tissues that the device may become entangled with. Further, this feature reduces the risk of entanglement of suture threads or wires or other such delivery catheter elements that may potentially come into contact with the fixation device.

[0041] A specific advantage of the present invention is the configuration in which the return (like the MitraClip® device) is on the side surface and side guardrail-like features or plugs along the side surface of the return are used to prevent unintentional entanglement.

[0042] In a preferred embodiment, the fixation device of the present invention will further include at least one inner arm (or gripping element) and one outer arm (or joining element). Each inner arm and outer arm will be movable relative to each other and will be configured to capture tissue between the inner arm and the engagement surface of the outer arm. Preferably, the outer arm and inner arm are independently movable, although in some embodiments they may be movable using the same mechanism. The inner arm is preferably biased towards the engagement surface of the fixation element and vice versa and may provide a compressive force to the tissue captured therebetween.

[0043] In a preferred configuration with two pairs of arms, the outer arms are positioned on each side, the two inner arms are clamped therebetween, and the outer arms are configured to have more juxtaposing force than the inner arms. This not only provides an additional compressive force on the captured tissue but also strongly joins the tissue captured between each pair of arms. One particular advantage of the present invention is that the joining force can be preconfigured to a desired force by configuring the thickness, size, width, shape, outer profile, material, Af, cold working, and / or other characteristics of the arms. One particular advantage of the present invention is that this joining force can be used for the tightening of the valve ring when used on a valve.

[0044] In another aspect, the present invention provides a fixation device comprising a coupling member configured for coupling to a catheter and a pair of outer arms connected to the coupling member, each outer arm holding an engagement surface for gripping tissue.

[0045] In some applications such as the repair of mitral valves, the fixation device is removed from the delivery catheter and adapted to remain permanently within the patient. In such applications, it is often desirable to promote tissue growth around the fixation device. For this purpose, some or all of the components of the fixation device are preferably coated with a cover or coating for promoting tissue growth and improving biocompatibility. In one embodiment, a biocompatible fabric cover is positioned over the outer arm and / or the inner arm. The cover may optionally be impregnated or coated with various therapeutic agents including agents that promote tissue growth, antibiotics, anticoagulants, blood thinners, and other agents. Alternatively, or in addition, some or all of the fixation elements and / or the cover may be made of a bioerodible, biodegradable, or bioabsorbable material so that they can decompose or be absorbed by the body after the repaired tissue has grown together. In a preferred embodiment, the coating and / or cover can be used to limit or eliminate leachable substances (e.g., nickel ions that leach from nitinol) and further improve biocompatibility (and / or reduce allergic reactions).

[0046] In some applications such as the repair of mitral valves, the fixation device is adapted to be removed from the delivery catheter and left temporarily within the patient. In such applications, it is often desirable to provide a blood-compatible and biocompatible surface while not promoting tissue growth around the fixation device. For this purpose, some or all of the components of the fixation device are preferably coated with a cover or coating for promoting blood compatibility without tissue growth. In one embodiment, a biocompatible fabric cover is positioned over the outer arm and / or inner arm. The cover may optionally be impregnated or coated with various therapeutic agents including agents that inhibit tissue growth, antibiotics, anticoagulants, blood thinners, and other agents. Alternatively, or in addition, some or all of the fixation element and / or cover may be made of a bioerodible, biodegradable, or bioabsorbable material such that they degrade or are absorbed by the body after the repaired tissue has grown together.

[0047] The outer and inner arms will be configured to provide sufficient retention force such that the fixation device remains securely fastened to the target tissue throughout the cardiac cycle. At the same time, the outer and inner arms will be configured to minimize any acute trauma to the tissue they engage. This allows the fixation device to be removed from the tissue after initial application without creating clinically significant damage to the tissue. To enhance retention without creating significant trauma, the inner arm and / or outer arm may have friction-enhancing features on its surface that engages the target tissue. Such friction-enhancing features may include, among other things, returns, protrusions, grooves, apertures, channels, roughening, covers, and coatings. Preferably, the friction-enhancing features will be configured to increase the retention force of the distal and inner arms against the tissue without leaving significant damage or scarring if the device is removed. For example, instead of a long, pointed return, the tip of the return may have one or more very small teeth that limit complete penetration of the return into the tissue, thereby reducing the risk of tissue penetration.

[0048] The outer and inner arms may further have a shape and flexibility to maximize the holding power and minimize trauma to the target tissue. In a preferred embodiment, the engagement surface of the outer arm has a concave shape configured to allow the inner arm to nest or retract within the outer arm with the target tissue. This increases the surface area of the tissue engaged by the outer arm and creates a tissue engagement geometry with a higher holding power than a planar engagement surface. To minimize trauma, the longitudinal edges as well as the free ends of the outer arm preferably curve outwardly away from the engagement surface such that these edges present a rounded surface to the target tissue. The outer arm and / or the inner arm may also be flexible such that they deflect to some extent in response to the forces exerted on the tissue they engage, reducing the likelihood that the tissue will tear or be damaged in response to such forces.

[0049] The fixation device will include an actuation mechanism for moving the outer arm between open, closed, and reverse positions. Various actuation mechanisms and reversing devices may be used. In an exemplary embodiment, a suture or string or wire or lever controllable by the user via a delivery system handle may be used to raise and lower the outer or inner arm and to capture the tip.

[0050] A particular advantage of the present invention is the ability to move all of the arms independently and capture tissue, one at a time or simultaneously, between each pair of arms.

[0051] The fixation device of the present invention preferably includes a coupling member that is removably connectable to a delivery catheter. The coupling member may have various structures, but in an exemplary embodiment, it comprises a flexible rod, wire, or stylet of sufficient tensile strength that extends coaxially and slidably from a handle to the fixation device. When desired by the user, the user operates a handle release mechanism that allows the coupling member or release rod to be retracted. This, in turn, slides the coupling member out of an engagement element between the delivery system and the fixation device. The delivery catheter will be configured to removably connect to both the coupling member and the fixation device. In one embodiment, the delivery catheter has a round hole through an extension member and a rod / wire / stylet slidably disposed within the hole of the extension member. The junctions of the coupling member, extension member, and fixation device comprise meshing surfaces that can have various shapes, including S-shaped curves or angled or flat surfaces. The release rod / wire / stylet extends through an axial channel within an outer member from the delivery catheter and maintains its connection to the fixation device. The rod / wire / stylet may be connected by various connection structures, including threaded connections. Removal and retraction of the release rod / wire / stylet back into the delivery catheter disconnects the delivery catheter (including the actuating suture / wire) and allows deployment of the fixation device. Further, by strategically configuring the device and suture attachment points to the delivery system, the degree and rate of device disconnection can be controlled by the amount of retraction of the release rod by the user.

[0052] The delivery device of the present invention delivers an intervention device to a target location within the body. Such intervention devices include, in particular, any device that accesses tissue, such as a fixation device or valve tip. The delivery device and system direct the intervention device to the target location through a minimally invasive approach through the patient's vasculature and the like, and provide for manipulation of the intervention device at the target location, such as to access tissue. Optionally, the delivery device and system may provide for disconnection of the intervention device and allow the intervention device to remain as an implant.

[0053] In one aspect of the present invention, preferably, a delivery device is provided that comprises an elongatable flexible shaft suitable for introduction through a tortuous path within the body. The elongating shaft has a proximal end, a distal end, and a main lumen therebetween. Contained within the delivery device is at least one elongating body, in particular at least one flexible tubular guide, that extends through the main lumen. In some embodiments, the tubular guide is fixed to the shaft near the proximal end and near the distal end and is unconstrained relative to the shaft therebetween such that it is laterally movable within the main lumen. Alternatively, the tubular guide may be unconstrained only at the distal portion of the shaft to provide greater flexibility of that portion.

[0054] In some embodiments, two flexible tubular guides are present. However, three, four, five, six, or more flexible guides may alternatively be present. The tubular guide may be made of any suitable material that provides lateral flexibility while providing strength under compression, such as a metal or polymer coil. In addition, other elongating bodies such as rods, tubes, wires, sutures, stylets, etc. may be present and may provide additional tensile strength or elasticity. In some embodiments, the main lumen is occupied by a fluid and thus the elongating body is surrounded by such fluid. In one element, a nitinol rod may be used to keep the catheter shaft straight (when unconstrained) despite passing through a tortuous anatomical curve.

[0055] In one aspect of the present invention, the delivery device is movably disposed within at least one of the flexible tubular guides and includes an actuating element that extends between a proximal end and a distal end. The actuating element is adapted for coupling with a movable component of the intervening element such that movement of the actuating element moves the movable element. Such an intervening element is typically removably coupled to the distal end of the shaft. The movable component may have any of a variety of functions including grasping, approaching, cutting, ablation, stapling, or otherwise engaging tissue. In one embodiment, the movable component provides access to tissue such as apposition of valve leaflets. In a preferred embodiment, the intervening element has first and second tissue engaging elements that are adapted to engage tissue therebetween. Thus, in these embodiments, the actuating element is used to move the tissue engaging elements to engage tissue. Further, in some embodiments, the shaft and the intervening element are adapted for positioning through a blood vessel.

[0056] In one aspect of the present invention, a system is provided for accessing tissue at a treatment site. In some embodiments, the system comprises an elongate flexible shaft having a proximal end, a distal end, a main lumen therebetween, and at least one flexible tubular guide extending through the main lumen. Again, in a preferred embodiment, the tubular guide is fixed to the shaft near the proximal end and near the distal end and is unrestrained within at least a portion of the main lumen such that it is laterally movable within the main lumen. Nitinol wires, rods, springs, and / or tubes, or other elastic, superelastic, and / or shape memory materials may be used in this unrestrained section to keep them linearly extensible. In some embodiments, the system also includes an actuating element movably disposed within the tubular guide and an access device coupled to the distal end of the shaft, the access device having first and second engaging elements for engaging tissue therebetween, at least one of the engaging elements being movable and coupled to the actuating element.

[0057] The delivery device of the present invention is adapted to allow a user to deliver a fixation device from a remote access point to a target site (whether through an endovascular approach or a surgical approach), align the device with the target tissue, and selectively close, open, reverse, lock, or unlock the outer arm. The delivery device will preferably have a highly flexible, kink- and twist-resistant shaft with minimal elongation and high tensile and compressive strength. The delivery device will also have movable components and associated actuators used to move the arm between a lowered and raised position, move the arm to engage the target tissue, and remove the outer arm from the delivery catheter. Preferably, a plurality of tubular guides, preferably in the form of coils, tubes, or multi-lumen tubes, with a low coefficient of friction, extend through the inner lumen of the shaft and are fixed to the shaft near its proximal and distal ends but are unconstrained therebetween, providing a highly flexible and kink-resistant structure. In a preferred embodiment, a multi-lumen braided shaft with various durometers may be used. Additionally, superelastic, elastic, and / or shape memory materials are used in the unconstrained region immediately proximal to the device attachment for increased flexibility with stretchability such that they remain straight when unconstrained. Lines / rods for actuating the arm and deployment mechanism of the fixation device extend through these tubular guides and are removably coupled to the arm and device. In an exemplary embodiment, the line / wire / suture only allows the ability to pull. In an exemplary embodiment, the line is fully or partially combined with a rod (e.g., a suture loop crimped to the end of the rod) or is reinforced with a tube / braid to allow the ability to pull and push. The ability to push is desired to overcome the friction of the sliding of the line / wire within the catheter lumen or to further actuate the device.

[0058] The delivery catheter may further include a suture or wire or tether consisting of a flexible rod removably coupled to a portion of the fixation device for the purpose of retrieving the present device following removal from the delivery catheter. The tether may be a separate flexible filament extending from the delivery catheter to the fixation device, but alternatively may be the same line used to actuate an arm or device. In either case, the tether will be removable from the fixation device such that it can be removed once the present device has been properly deployed.

[0059] In some embodiments, the delivery device further includes an actuating element movably disposed within at least one flexible tubular guide, and a fixation device coupled to the distal end of the shaft and adapted to be positioned within a cardiac chamber. Typically, the fixation device is releasably coupled to the shaft. In some embodiments, the fixation device has at least one inner arm and at least one outer arm adapted to engage the valve leaflets therebetween, and at least one of the inner and outer arms is movable and coupled to the actuating element. Alternatively or in addition, the actuating element comprises a flexible line such as a suture loop and optionally a reversing device.

[0060] The system may further comprise first and second flexible tubular guides extending from the proximal end to the distal end through the main lumen. The first and second tubular guides are preferably fixed to the shaft near the proximal end and near the distal end and are constrained within at least a portion of the main lumen such that they are laterally movable within the main lumen. Further, a first movable element extends through the first tubular guide and a second movable element is movably disposed within the second tubular guide.

[0061] The system may further include an actuator handle connected to the proximal end of the shaft, the actuator handle having a body, and first, second, and third actuating elements movably coupled thereto, the first, second, and third actuating elements being coupled to the first, second, and third movable elements.

[0062] The system of the present invention may additionally include a guide that facilitates the introduction and navigation of a delivery catheter and a fixation device to a target location. The guide is preferably tubular with a channel extending between its proximal and distal ends through which the delivery catheter and the fixation device can be slidably positioned. The distal end of the guide is steerable and is typically deflectable about at least one axis, preferably about two or four axes. The guide may have more than one such deflectable distal section, either in conjunction or at intervals. The guide will have a size, material, flexibility, and other characteristics suitable for the application for which it is being used. For mitral valve repair, the guide is preferably configured to be introduced into the femoral vein, advanced through the inferior vena cava into the heart, across a penetration in the atrial septum, and aligned with the mitral valve in the left atrium.

[0063] Alternatively, the guide may be configured to be introduced into the brachiocephalic vein or axillary vein or jugular vein (neck / shoulder access), advanced through the superior vena cava into the heart, across a penetration in the atrial septum, and aligned with the mitral valve in the left atrium.

[0064] Alternatively, the guide may be configured for introduction into the femoral artery, axillary artery, or brachiocephalic artery and advancement through the aorta and aortic valve into the ventricle such that it is steered to align with the mitral valve. In a further alternative, the guide may be configured for introduction through a puncture or incision in the chest wall and through an incision in the heart wall for approaching the mitral valve.

[0065] In an exemplary embodiment, the guide comprises a multi-catheter guidance system having two components, an inner tubular member or inner guide catheter and an outer tubular member or outer guide catheter. The outer tubular member has a distal end that is deflectable about an axis. The inner tubular member has a distal end that is deflectable about an additional axis. Further, the distal end of the inner tubular member may be angularly deflectable. Mobility in an additional direction and about an additional axis may optionally be provided.

[0066] The present invention further provides a method of performing a therapeutic intervention at a tissue site. In one embodiment, the method includes advancing an intervention tool having a proximal end, a distal end, and a fixation device in the vicinity of the distal end, to a location within a patient's body, the fixation device including a pair of outer arms each having a free end and an engagement surface, the step of moving the outer arms to an open position, the free ends being separated, the step of positioning the outer arms such that the engagement surface engages tissue at the tissue site, and the step of removing the fixation device from the intervention tool. Preferably, the method further includes the step of decoupling the tip from the outer arms to enable detachment or to retry the procedure.

[0067] At least one embodiment of the present disclosure relates to a tissue grasping device that includes a base section, a first outer arm having a free end and a fixed end coupled to the base, a first inner arm having a free end and a fixed end coupled to the base, and subsequently, a second outer arm and a second inner arm similarly coupled to the base in a modular fashion, wherein tissue is grasped between the outer and inner arms, and the outer and inner arms are formed from an elastoplastic material or a viscous material or a shape memory material configured to exhibit superelasticity in a physiological environment, and the base is formed from an elastic / plastic material or a shape memory material configured to exhibit superelasticity in a physiological environment. In an alternative embodiment, each pair of inner and outer arms is coupled to different bases using the ability to tighten, attach, or join the two bases together before, during, and / or after a procedure.

[0068] At least one embodiment of the present disclosure relates to a tissue fixation system configured for intravascular delivery and configured for use in suturing mitral valve (or tricuspid valve) tissue during treatment of the mitral valve (or tricuspid valve), the system including a tissue grasping device that includes a base section, a first outer arm having a free end and a fixed end coupled to the base, a first proximal arm having a free end and a fixed end coupled to the base, and subsequently, a second outer arm and a second proximal arm similarly coupled to the base in a modular fashion, wherein tissue is grasped between the outer and inner arms, and the inner and outer arms are formed from a shape memory material configured to exhibit superelasticity in a physiological environment, the inner and outer arms are independently movable, and the base is formed from titanium, stainless steel, metal, plastic, ceramic, an elastic / plastic material, and / or a shape memory material configured to exhibit superelasticity in a physiological environment.

[0069] At least one embodiment of the inner or outer arm has a return included within a smooth outer edge or barrier or plug on both sides of the return, limiting the risk of tissue or delivery mechanism sticking in the return, and the return is formed from an elastoplastic material or a viscous material or a shape memory material configured to exhibit superelasticity in a physiological environment. At least one embodiment of the inner or outer arm has a return that limits full-length penetration (e.g., using a V-shaped return tip that prevents penetration of tissue beyond the depth of the return) and reduces tissue trauma or perforation.

[0070] In at least one embodiment of the fixation device delivery system, there is provided a stand-alone or dedicated probe incorporated within the delivery system that incorporates an active ultrasonic probe, the probe being retractable, translatable, rotatable, steerable, and having at least one or more features useful for assisting, identifying, and navigating before, during, and after the procedure, such as, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, synchronization or desynchronization to limit physiological artifacts (e.g., caused by heartbeats and respiration), whether or not an ultrasonic marker or contrast agent is used.

[0071] In at least one embodiment of the fixation device delivery system, there is provided a stand-alone or dedicated probe incorporated within the delivery system that incorporates a passive ultrasonic probe, the probe being retractable, translatable, rotatable, steerable, and having at least one or more multimodality imaging enabling features useful for assisting, identifying, and navigating before and / or during and / or after the procedure, such as, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, synchronization or desynchronization to limit physiological artifacts (e.g., caused by heartbeats and respiration), whether or not an ultrasonic marker or contrast agent is used.

[0072] In at least one embodiment of a fixed device delivery system, there is provided a stand-alone or dedicated probe incorporated into the delivery system that incorporates an active optical coherence tomography (OCT) probe, the probe being retractable, translatable, rotatable, steerable, and having at least one or more enabling features such as, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, synchronization or desynchronization to limit physiological artifacts (e.g., but not limited to, caused by heartbeat and respiration), assistance, identification, and navigation before, during, and / or after a procedure, whether or not an OCT marker or contrast agent is used.

[0073] In at least one embodiment of a fixed device delivery system, there is provided a stand-alone or dedicated probe incorporated into the delivery system that incorporates a passive optical coherence tomography (OCT) probe, the probe being retractable, translatable, rotatable, steerable, and having at least one or more features such as, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, synchronization or desynchronization to limit physiological artifacts (e.g., but not limited to, caused by heartbeat and respiration), assistance, identification, and navigation before, during, and / or after a procedure, whether or not an OCT marker or contrast agent is used.

[0074] In at least one embodiment of the fixed device delivery system, there is provided a stand-alone or dedicated probe incorporated within the delivery system that incorporates an active optical camera-based imaging system housed inside a balloon, the balloon being fillable with a fluid (gas or liquid) that enables visualization when the balloon is either in contact with or in the vicinity of the target tissue, the probe being retractable, translatable, rotatable, steerable, and having at least one or more enabling features such as, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, synchronization or desynchronization to limit physiological artifacts (such as, but not limited to, those caused by heartbeat and respiration), pre-procedure, and / or during and / or after the procedure to assist, identify, and navigate, whether or not optical markers or contrast agents are used.

[0075] In at least one embodiment of the fixed device delivery system, there is provided a stand-alone or dedicated probe incorporated within the delivery system that incorporates a passive optical camera-based imaging system (such as, but not limited to, a fiber optic imaging system) housed inside a balloon, the balloon being fillable with a fluid (gas or liquid) that enables visualization when the balloon is either in contact with or in the vicinity of the target tissue, the probe being retractable, translatable, rotatable, steerable, and having at least one or more features such as, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, synchronization or desynchronization to limit physiological artifacts (such as, but not limited to, those caused by heartbeat and respiration), pre-procedure, and / or during and / or after the procedure to assist, identify, and navigate, whether or not optical markers or contrast agents are used.

[0076] In at least one embodiment of the fixed device delivery system, there is provided a stand-alone or dedicated probe incorporated within the delivery system that incorporates an active sensor / transducer / actuator system, the probe being retractable, translatable, rotatable, steerable, and having at least one or more enabling features such as, but not limited to, pressure, strain, stress, ECG, EMG, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, synchronization or desynchronization to limit physiological artifacts (e.g., but not limited to, those caused by heartbeat and respiration), pre-procedure, and / or intra-procedure, and / or post-procedure to assist, identify, and navigate, whether or not a marker or contrast agent is used.

[0077] In at least one embodiment of the fixed device delivery system, there is provided a stand-alone or dedicated probe incorporated within the delivery system that incorporates a passive sensor / transducer / actuator system (e.g., but not limited to, an RFID-based system), the probe being retractable, translatable, rotatable, steerable, and having at least one or more enabling features such as, but not limited to, pressure, strain, stress, ECG, EMG, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality sensing / transducing features, synchronization or desynchronization to limit physiological artifacts (e.g., but not limited to, those caused by heartbeat and respiration), pre-procedure and / or intra-procedure, and / or post-procedure to assist, identify, and navigate.

[0078] In at least one embodiment of the fixation device delivery system, there is provided a device that is coated to enhance biocompatibility and tissue interface, and the coating is a metal (e.g., but not limited to, titanium, tantalum, gold, platinum, iridium, tungsten, or combinations thereof), and / or a ceramic, and / or a polymer, e.g., but not limited to, fluoropolymers (PTFE, PFA, FEP, ECTFE, ETFE), parylene, polyester, PER, polypropylene, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, hydroxyapatite, CaP, THV, biodegradable materials (polylactic acid, polyglycolic acid), polydioxanone, poly(ε-caprolactone), polyanhydrides, poly(orthoesters), copoly(ether-ester), polyamide, polylactone, poly(propylene fumarate) and other bioerodible materials, and / or combinations thereof, and these coatings can be hydrophilic or hydrophobic.

[0079] In at least one embodiment of the fixation device delivery system, there is provided a device that is coated to enhance biocompatibility and tissue interface, and the coating is a metal (e.g., but not limited to, titanium, tantalum, gold, platinum, iridium, tungsten, or combinations thereof), and / or a ceramic, and / or a polymer, e.g., but not limited to, fluoropolymers (PTFE, PFA, FEP, ECTFE, ETFE), parylene, polyester, PER, polypropylene, polyurethane, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, hydroxyapatite, CaP, THV, and biodegradable materials (polylactic acid, polyglycolic acid), polydioxanone, poly(ε-caprolactone), polyanhydrides, poly(orthoesters), copoly(ether-ester), polyamide, polylactone, poly(propylene fumarate) and other bioerodible materials, and / or combinations thereof, and these coatings can be hydrophilic or hydrophobic.

[0080] At least one embodiment of the present disclosure relates to a method of gripping tissue, the method comprising positioning a tissue gripping device in the vicinity of a target tissue, the tissue gripping device being formed from a shape memory material and including a base section, a first arm, and a second arm, each arm having a first end coupled to the base section and a free end extending from the base section, the first and second arms being disposed opposite each other, and moving the tissue gripping device from a pre-deployment configuration toward a deployment configuration, wherein the first and second arms are configured to elastically flex toward a relaxed configuration in a distal direction as the tissue gripping device is moved from the pre-deployment configuration toward the deployment configuration.

[0081] At least one embodiment of the present disclosure relates to a method of manufacturing a tissue gripping device, the method comprising cutting one or more structural features into a strip or sheet stock of shape memory alloy, the one or more structural features including a plurality of slotted indentations disposed at one or more locations spaced from a side edge of the stock, and thermally setting one or more bending features into the stock.

[0082] In a first specific aspect, a valve clip according to the present invention comprises a hub, a first pair of pointed capture arms comprising a first inner arm and a first outer arm coupled to the hub, and a second pair of pointed capture arms comprising a second inner arm and a second outer arm coupled to the hub. The outer and inner arms are biased to move apart to create a pointed capture space therebetween and are configured to self-close over the valve tip when the bias is released after the tip has been captured.

[0083] The hub is typically configured to be removably attached to the deployment shaft, and at least some of the cusp capture arms are typically formed as leaf springs. The outer surface of each inner arm is positioned adjacent to the inner surface of each outer arm, the lower end of each arm is coupled to the hub, and the lower end of each inner arm is typically above the lower end of each outer arm. The terms "lower" and "upper" are defined in relation to the patient anatomical structure into which the valve clip will be implanted. For example, when implanted within the mitral valve, upper refers to the side of the clip facing the atrium and lower refers to the side of the clip facing the ventricle. When implanted within a vein, upper will refer to the upstream direction while lower will refer to the downstream direction.

[0084] The spring-biased outer and inner arms are configured to "open," first capture a pair of valve cusps, and then self-close over the cusps after the cusps are captured. "Opening" means that the individual arms can be flexed or biased such that they are moved from their normal unbiased configuration, i.e., when there is no deformation due to the application of an external force to them.

[0085] In certain embodiments, at least some of the outer and inner arms of the valve clip are formed as "leaf springs" with a stretchable base and a less stretchable (more rigid) valve gripping element. The stretchable base typically provides most or all of the stretchability or flexing ability associated with the leaf spring structure and is configured to be directly or indirectly attached to the hub. The valve gripping element (e.g., but not limited to, a barb), in contrast, will typically experience little or no flexing when deployed over the cusp of the target valve. Typically, all of the outer and inner arms will have the configuration as described.

[0086] In other specific embodiments, the adjacent outer and inner arms of the valve clip will have substantially the same shape. Substantially the same means that the outer and inner arms have the same or complementary shapes and are attachable to the hub and would be able to "nest" when in their de-energized configuration. Typically, when the outer and inner arms are in their de-energized configuration and the valve tip is captured by the valve clip and the valve tip is accommodated therebetween, there will typically be a short distance or gap, typically between 0 mm and 6 mm, preferably between 0.5 mm and 2.5 mm, between the lower surface of the inner arm and the upper surface of the outer arm. These gap values accommodate a single tip of typical thickness between the inner and outer arms. In other specific embodiments where two or more tips are captured between a pair of arms, these gap values can be increased two or three times. There may be a minimum gap, but the spring biasing of the arms may be sufficient by itself to accommodate the full range of tip wall thicknesses.

[0087] In the first illustrated embodiment, the valve gripping element of the valve clip will branch from a common axis through the hub and form a V shape when the outer and inner arms are de-energized. Typically, the resilient base is curved and the valve gripping element is straight in both the outer and inner arms. Even more typically, the resilient base on the outer arm has an S-shaped curve that is selected to provide a gap or separation and offset or separate the upper surface of the outer arm from the lower surface of the inner arm to accommodate the valve tip as described above. Alternatively, a spacer may be used between the arms to create a space for accommodating the tip.

[0088] In other illustrated embodiments, the valve gripping element is parallel to the common axis when the outer and inner arms are de-energized. In such cases, the inner arm is substantially straight, but the base of the outer arm has a curve that is selected to separate the upper surface of the outer arm from the lower surface of the inner arm to accommodate the valve tip therebetween.

[0089] In a second aspect of the present invention, a system for delivering a valve clip to a heart or venous valve will comprise any of the valve clip designs described above or elsewhere or herein. The system will further comprise a deployment shaft configured to be removably attached to the hub of the valve clip.

[0090] In certain embodiments of the system of the present invention, the deployment shaft may extend upwardly from the hub along the axis of symmetry through the hub and between the right outer and inner arms and the left outer and inner arms.

[0091] In an exemplary embodiment, the system further comprises a steerable deployment catheter removably or fixedly coupled to the deployment shaft. In some cases, the lower end of the deployment shaft is configured to be coupled to the steerable deployment catheter. In other cases, the upper end of the deployment shaft is configured to be coupled to the steerable deployment catheter.

[0092] In yet further embodiments, the steerable catheter may include an imaging component to enable real-time visualization of the implant procedure. The imaging component may include one or more than one of an optical imaging component, an ultrasonic imaging component, an OCT imaging component, or the like. The imaging component will be positioned on the deployment catheter such that it can visualize both the target anatomical valve and the valve clip when the valve clip is being manipulated for implantation across the valve leaflets. In yet further embodiments, the delivery system and / or the fixation device contains a radiopaque and / or acoustic generator indicator that changes position when the tip is fully inserted, thereby enabling the user to confirm tip insertion by visualization via conventional fluoroscopy or ultrasonic imaging.

[0093] In yet other embodiments of the system of the present invention, the steerable catheter may include a mechanism for selectively applying a biasing force to the outer and / or inner arms of the valve clip to open the arm and create a gap or space for receiving and capturing the valve tip. In the illustrated embodiment, a first set of tethers may be positioned on or through the delivery catheter such that the tether can be tensioned to selectively bias the outer arm to the valve tip capture position and coupled to the outer arm. Both sets of tethers are typically further configured to selectively release the biasing force on the outer and inner arms, either individually or simultaneously, such that the outer and inner arms are allowed to self-close toward and across the valve tip to fix the tip for treatment of any of the conditions described herein and above.

[0094] In a third specific aspect, the present invention provides a method for clipping an anatomical valve and fixing the tip of the valve for treating various conditions. For example, the mitral valve tip can be clipped to treat mitral valve regurgitation. In another example, the venous valve tip can be clipped to treat venous insufficiency.

[0095] The method of the present invention includes advancing a valve clip having a pair of outer arms and a pair of inner arms to a location adjacent to a target anatomical valve. At least one of (1) the pair of outer arms and (2) the pair of inner arms is biased to open a valve tip capture space or gap between the adjacent outer and inner arms. The valve clip is then positioned such that one valve tip is located or captured within the gap or space between the left outer and inner arms and another valve tip is positioned within the gap or space between the right outer and inner arms. The valve tips can then be fixed by releasing the biasing force or tension on at least one pair of outer or inner arms such that the left outer and inner arms and the right outer and inner arms self-close across the valve tips and thus fix the tips together.

[0096] In certain embodiments of the method of the present invention, both the pair of outer arms and the pair of inner arms will first be biased to provide an opening of a valve tip capture gap or space therebetween. The biasing is typically accomplished by pulling on a tether attached to at least one of the pair of outer and inner arms, and typically a separate tether structure is attached to each pair of outer and inner arms. The tether can be tensioned to bias the outer and inner arms to move away from each other and create a valve tip capture gap or space therebetween. After the outer and inner arms are biased to open and the valve tip is captured, the tension on the tether can be released such that the outer and inner arms self-close over the valve tip.

[0097] As an alternative to the use of a tether, the biasing step may include advancing a pair of struts or other engagement members against at least the pair of outer and inner arms. The struts may engage at least two lower arms or at least two upper arms and selectively open the lower and upper arms to a valve tip capture position. In some cases, the strut may engage the upper surface of each outer arm such that advancing the strut downward opens the outer arm relative to the inner arm. The inner arm may optionally be configured to remain stationary as the strut is advanced. In other cases, the strut may engage the lower surface of each inner arm such that advancing the strut upward opens the inner arm relative to the outer arm. The outer arm may optionally be configured to remain stationary as the strut is advanced.

[0098] In other embodiments of the method of the present specification, the step of positioning the valve clip includes the step of operating the delivery catheter, and the valve clip is releasably attached to the distal end of the delivery catheter. The positioning step may further include observing the anatomical valve as well as the valve clip by observing a mechanical valve position indicator (as described above) and / or by using an imaging component on the delivery catheter when the valve clip is positioned.

[0099] Certain advantages of the present invention are the multiple sizes and shapes of the fixation device. The fixation device can be configured to be attached to a smaller section with a small tip (where the tip junction forms a parallel seal together), or in a preferred embodiment, a larger section including a parallel junction section with a tip and a curved contour section. Longer contour arms allow for easier capture of the tip.

[0100] Another specific advantage of the present invention is that the fixation device is lockless by using superelastic and sufficiently flexible inner and outer arms.

[0101] Another specific advantage of the present invention is that the fixation device is made from sufficiently flexible inner and outer arms that securely but non-invasively grip tissue while allowing sufficient dynamic movement of the tip under physiological forces.

[0102] Another specific advantage of the present invention is that the friction elements of the inner and outer arms are recessed and barricaded on the sides, which reduces the risk of entanglement with tendons, tissue, or the delivery system.

[0103] Another specific advantage of the present invention involves modular manufacturing and / or assembly of both the outer and inner arms. Combinations of inner and outer arms of various shapes and sizes can be manufactured and / or assembled in an interchangeable, modular fashion to fit the patient / user clinical treatment needs. For example, one side of the inner and outer arms can be longer to grasp a larger anterior mitral valve leaflet, while a combination of shorter inner and outer arms can be used to grasp a shorter posterior mitral valve leaflet.

[0104] Another specific advantage of the present invention is the elimination of large increased movement of the fixation device during detachment, such as inversion of the cusp grasping arm. This is achieved by use of a suture, string, or wire to lift the cusp away from the grasping arm. In an alternative embodiment that allows inversion of the arm, this is done by simply further flexing the arm.

[0105] Another specific advantage of the present invention is the relatively simple and compact size of the fixation device. This allows for the use of a smaller diameter catheter and thus makes deployment less traumatic to the patient. For example, the MitraClip® device uses a 24Fr outer diameter guide catheter. In a preferred embodiment, the present invention uses a 12Fr outer diameter guide catheter.

[0106] Another particular advantage of the present invention is its compatibility with commercially available transseptal inserter sheaths. This is achieved by making the delivery device compatible with standard commercially available fixed or steerable transseptal inserter sheaths. Some examples of commercially available inserter sheath sizes include, but are not limited to, 7Fr, 7.5Fr, 8Fr, 8.5Fr, 9Fr, 9.5Fr, 10Fr, 10.5Fr, 11Fr, 11.5Fr, and 12Fr inner diameters. Some examples (but not limited to these examples) of commercially available inserters are the HeartSpan Fixed Curve Braided Transseptal Sheath and HeartSpan Steerable Sheath Introducer by Merit Medical Systems, Inc. (UT), DIREX by Boston Scientific Corporation (MA) TM and the ZurpazTM Steerable Sheath, as well as the Agilis NxT by St. Jude Medical (MN) TM , and the Composer® Deflectable Catheter Handle Platform by Freudenberg Medical Minimally Invasive Solutions, Inc. (IN).

[0107] Another advantage of the present invention is the potential to perform this procedure under local anesthesia, thus eliminating the risks of general anesthesia. This is achieved by incorporating visualization techniques within or in conjunction with the delivery catheter system, replacing the need for transesophageal echocardiography (TEE).

[0108] Other objects and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings.

[0109] Another specific advantage of the present invention is that the non-traumatic friction element (return) is installed inside along the long axis of the arm body and enclosed by a continuous and solid side surface. Unlike the MitraClip® device, the return is not exposed along the side surface. This is advantageous because it significantly reduces the risk of entanglement of the chordae tendineae, valve leaflets, and other tissues that the device may become entangled with. Further, this feature reduces the risk of entanglement of the suture or wire or other such delivery catheter elements that may potentially come into contact with the fixation device.

[0110] In the above exemplary variations, the friction element (return) is installed inside and / or towards the outside along the long axis of the arm body. However, the return may be protected or enclosed by alternating or continuous wires or spring-like members that provide a barrier and prevent tissue or tendon or suture from becoming disengaged from the return.

[0111] In the above exemplary variations, the friction element (return) is installed inside along the long axis of the arm body and / or outside. However, below or above the return, there may be a wire, flat tube, balloon, or other mechanism that can release the entangled tissue, tendon, suture, etc., as required. For example (not limited to this embodiment), a flat tube balloon may be installed along the return. When contracted, the return protrudes and can grip the tissue or tip as designed. However, in response to inflation, the flat tube balloon extends beyond the return and thus releases the captured tissue or tendon or suture.

[0112] The atraumatic advantage is derived from a design that resists complete penetration of the suture within the tissue and thus reduces the risk of tissue perforation. In one preferred embodiment, the length of the suture is about 1 mm and the tip of the suture has V-shaped teeth with a depth of 0.25 mm. In another preferred embodiment, the length of the suture is about 1.5 mm and the depth of the V-shaped teeth is about 0.25 mm. Thus, in both exemplary embodiments, the depth of tissue penetration is generally about 0.25 mm, well below the typical thickness of the mitral valve leaflet. Additionally, the V-shaped teeth are sufficiently blunt while providing the required gripping friction. While V-shaped teeth are used as an example, any such tissue penetration design apparent to those skilled in the art may be used.

[0113] Another advantage of the present invention is the ability to deploy a pair of inner and outer arms with a base comprising an adjustable tether that can either remain in a temporarily or permanently implanted state or be removed during or after deployment. Further, multiple such pairs can be deployed. In one exemplary embodiment, two such pairs are deployed and their bases are pulled or tightened together using an adjustable tether during or after deployment. The adjustable tether can remain in a temporarily or permanently implanted state. Alternatively, two or more adjustable tethers are fixed distally (closer to the device) and the proximal segment can be removed. Any or all of the following exemplary methods, i.e., engagement within a serpentine polymer, adhesion, joining, welding, tying, ligating, crimping, clamping, squeezing, etc. may be used to secure the distal implanted section of the adjustable tether.

[0114] The advantages of the above invention are to reduce mitral regurgitation by adjusting the tether using one, two, three, or more pairs of devices. In one exemplary embodiment, the tip of the ruptured tendon is grasped and the tether is used to stabilize the tip and / or reduce regurgitation. In an alternative exemplary embodiment, two such pairs are used to grasp each tip and together the tethers are used to bring the tips into full or partial engagement and / or approximation to create a cut edge repair, the degree of engagement or approximation being variable during or after deployment or being gradually increased. In an alternative exemplary embodiment, two such pairs are used on the same tip to close and / or tighten a cleft, laceration, to reduce regurgitation. In an alternative exemplary embodiment, three such pairs, namely a first and a second pair on the anterior leaflet, are tightened to close a cleft and a third pair on the posterior leaflet is joined to the first pair to create a cut edge Alfieri repair.

[0115] An alternative advantage of the invention as described above is two or more pairs of tethered arms for grasping the tips adjacent to the annulus and / or grasping the annulus, the adjustable tethers can then be used to tighten the annulus laterally, circumferentially, and / or radially to reduce regurgitation.

[0116] Exemplary embodiments of the invention described above for a tissue grasping device with an adjustable tether comprise a leaf spring or clamp (e.g., a c-clamp) or gripping device (e.g., a rat-tooth gripping device) consisting of metal plate components, a single or multiple loops of wire, a tube with a stent-like pattern, machined components, molded metal or polymer or ceramic, active or passive sensors and transducers, coatings and / or fabric covers, a base, and a set of tissue grasping elements such as an adjustable tether. One exemplary method of deploying such a device within a valve includes the steps of deploying a first set of pointed grasping elements, deploying a second set of pointed grasping elements adjustably connected to the first set of pointed grasping elements, and adjusting the distance between the two elements to reduce valve backflow.

[0117] In an alternative method, the invention further includes the steps of adjusting the distance between two sets of pointed grasping elements of the tissue grasping device prior to insertion within the heart and continuously deploying the first and second elements.

[0118] In an alternative method for the invention described above using a tissue grasping device, the steps include deploying a first pointed grasping element connected to a tether, sliding a second pointed grasping pair along / across the tether, deploying a second pointed grasping element on the tip and the tether, tightening the wire to adjust the space between the two pointed grasping pairs during or after the procedure and fixing the space between the two pointed grasping elements, and removing and eliminating excess tether during or after the procedure.

[0119] The following numbered appendices describe other examples, aspects, and embodiments of the invention described herein.

[0120] (Appendix 1) A tissue grasping device comprising: a hub configured to be removably attached to a deployment shaft; a first pair of tissue grasping arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of tissue grasping arms comprising a second inner arm and a second outer arm coupled to the hub, wherein each pair of outer and inner arms is biased to move apart to create a tissue capture space therebetween and is configured to expand and contract and self-close around the tissue after the bias is released when the tissue is captured / grasped.

[0121] (Appendix 2) A valve repair cusp grasping device comprising: a hub configured to be removably attached to a deployment shaft; a first pair of cusp capture arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of cusp capture arms comprising a second inner arm and a second outer arm coupled to the hub, wherein each pair of outer and inner arms is biased to move apart to create a cusp capture space therebetween and is configured to expand and contract and self-close around the cusp after the bias is released when the cusp is captured.

[0122] (Appendix 3) A valve repair cusp grasping device comprising: a hub configured to be removably attached to a deployment shaft; a first pair of cusp capture arms comprising a first inner arm and a first outer arm coupled to the hub; a second pair of cusp capture arms comprising a second inner arm and a second outer arm coupled to the hub; and a third pair of cusp capture arms comprising a third inner arm and a third outer arm coupled to the hub, wherein each pair of outer and inner arms is biased to move apart to create a cusp capture space therebetween and is configured to expand and contract and self-close around the cusp after the bias is released when the cusp is captured.

[0123] (Appendix 4) A tissue grasping device, comprising a hub configured to be removably attached to a deployment shaft, the deployment shaft consisting of a pair of inversion devices, a release rod, an actuating suture, and a plurality of slots; a first pair of tissue grasping arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of tissue grasping arms comprising a second inner arm and a second outer arm coupled to the hub, wherein each pair of outer and inner arms are biased apart, an actuating suture is used to create a tissue capture space therebetween, and are configured to expand and contract continuously or simultaneously and self-close around the tissue after the tissue is captured / grasped / stabilized within the tissue capture space and the biasing is released. The inner arm actuating suture is removably looped through one or more slots, the release rod is configured to pass through the slots and lift / raise the inner arm from the tissue, and the outer arm actuating suture is removably looped through the inversion devices and through one or more slots to create the tissue grasping space and / or invert the arms to enable detachment, and is configured to deploy the device after tissue capture and in response to removal of the release rod from the deployment shaft.

[0124] (Supplementary Note 5) A valve repair tip grasping device, comprising a hub configured to be removably attached to a deployment shaft, the deployment shaft comprising a pair of inversion devices, a release rod, an actuating suture, and a plurality of slots; a first pair of tip grasping arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of tip grasping arms comprising a second inner arm and a second outer arm coupled to the hub, each pair of outer and inner arms being biased apart to create a tip capture space therebetween using the actuating suture, and configured to telescopically self-close over the tip upon release of the bias, either continuously or simultaneously, using the actuating suture after the tip has been captured in the tip capture space, the inner arm actuating suture being removably looped through one or more slots, the release rod being configured to pass through the slots and lift the inner arm from the tissue, the outer arm actuating suture being removably looped through the inversion device and through one or more slots to create a tissue grasping space and / or invert the arms to enable detachment and to deploy the device after tip capture in response to removal of the release rod from the deployment shaft.

[0125] (Appendix 6) A valve repair tip grasping device, comprising a hub configured to be removably attached to a deployment shaft, wherein the deployment shaft consists of a pair of reversing devices, a release rod, an actuating suture, and a plurality of slots; the hub; a first pair of tip grasping arms comprising a first inner arm and a first outer arm coupled to the hub; a second pair of tip grasping arms comprising a second inner arm and a second outer arm coupled to the hub; and a third pair of tip grasping arms comprising a third inner arm and a third outer arm coupled to the hub, wherein each pair of outer and inner arms is biased to move apart, generates a tip capture space therebetween using the actuating suture, and is configured to self-close in a telescoping manner continuously or simultaneously across the tip after the bias is released when the tip is captured / grasped / stabilized within the tip capture space; the inner arm actuating suture is removably looped through one or more slots; the release rod is configured to pass through the slots and lift / raise the inner arm from the tissue; the outer arm actuating suture is removably looped through the reversing device and through one or more slots to generate a tissue grasping space and / or to reverse the arms to enable detachment, and is configured to deploy the device after tip capture in response to removal of the release rod from the deployment shaft.

[0126] (Appendix 7) The device according to Appendices 1-6, configured to enable repair of the cut edge of the mitral valve.

[0127] (Appendix 8) The device according to Appendices 1-6, configured to enable repair of the cut edge of the tricuspid valve.

[0128] (Appendix 9) The device according to Appendices 1-6, configured to enable repair of the cut edge of the leaflet cleft within the mitral valve.

[0129] (Appendix 10) The device according to Appendices 1-6, configured to enable repair of the cut edge of the leaflet cleft within the tricuspid valve.

[0130] (Appendix 11) A tissue grasping device, comprising at least a pair of arms configured to flex telescopically towards each other, a hub, and an adjustable tether. At least one arm has a tissue grasping element. The arms are each connected at one end of the hub, and the hub is configured to be removably connected to a delivery device. The adjustable tether is configured to be implantable temporarily or permanently. The free ends of the arms are biased using a delivery system to create a tissue capture space therebetween, and are configured to self-close telescopically across the tissue when the bias is released after the tissue is captured. The adjustable tether is used to join, approximate, or tighten the tissue, a tissue grasping device.

[0131] (Appendix 12) A method of repairing a mitral valve, comprising the step of deploying at least two pairs of tissue grasping devices according to Appendix 11, wherein the first pair of devices is used to grasp the anterior leaflet edge and the second pair of devices is used to grasp the posterior leaflet edge; the step of using an adjustable tether to tighten and / or juxtapose the two devices to join the leaflets; and the step of creating an Alfieri edge repair.

[0132] (Appendix 13) A method of repairing a tricuspid valve, comprising the step of deploying at least three pairs of tissue grasping devices according to Appendix 11, wherein the first pair of devices is used to grasp the edge of the first leaflet, the second pair of devices is used to grasp the edge of the second leaflet, and the third pair of devices is used to grasp the edge of the third leaflet; the step of using an adjustable tether to tighten and / or juxtapose the two devices to join the leaflets; and the step of creating an Alfieri edge repair.

[0133] (Appendix 14) A method of repairing a valve, comprising the steps of deploying at least two pairs of tissue grasping devices as described in Appendix 11, wherein the first pair of devices is used to grasp the first cusp edge, and the second pair of devices is used to grasp the papillary muscle or tendon or ventricular tissue; using an adjustable tether to tighten and / or juxtapose the two devices and join the cusps; and generating chordae tendineae repair.

[0134] (Appendix 15) A method of repairing a valve, comprising the steps of deploying at least two pairs of tissue grasping devices as described in Appendix 11, wherein the first pair of devices is used to grasp the body of the first cusp, and the second pair of devices is used to grasp the body of the second cusp; using an adjustable tether to tighten and / or juxtapose the two devices and join the cusps; and generating annulus repair.

[0135] (Appendix 16) A method of repairing a valve, comprising the steps of deploying at least two pairs of tissue grasping devices as described in Appendix 11, wherein the first pair of devices is used to grasp the valve annulus at one site, and the second pair of devices is used to grasp the valve annulus at a second site; using an adjustable tether to tighten and / or juxtapose the two devices and join the cusps; and generating annulus repair.

[0136] (Appendix 17) A method of repairing a valve, comprising the steps of deploying at least two pairs of tissue grasping devices as described in Appendix 11, wherein the first pair of devices is used to grasp the cusp body or edge, and the second pair of devices is used to grasp the cusp body or edge across the commissure; using an adjustable tether to tighten and / or juxtapose the two devices and join or juxtapose the cusps; and generating commissure repair.

[0137] (Appendix 18) A method of repairing a valve, comprising the step of deploying at least two pairs of tissue grasping devices as described in Appendix 11, wherein the first pair of devices is used to grasp atrial or ventricular tissue at one site, and the second pair of devices is used to grasp atrial or ventricular tissue at a second site; and the step of using an adjustable tether to tighten and / or juxtapose the two devices.

[0138] (Appendix 19) The tether is temporarily implanted into the body to adjust the junction during the device implantation procedure, and the method of repairing the mitral valve as described in Appendices 11-18, including the steps of removing excess tether and finishing the adjustment.

[0139] (Appendix 20) The tether is temporarily implanted into the body after initial adjustment during the device implantation procedure, and the method of repairing the mitral valve as described in Appendices 11-18, including the steps of performing at least a second procedure at a later time or date to make additional fine adjustments, removing excess tether, and finishing the adjustment.

[0140] (Appendix 21) The method as described in Appendices 11-19 for removing excess tether after finishing the adjustment, using a delivery catheter or a second catheter specifically designed to fasten, cut, trim, and remove the excess length.

[0141] (Appendix 22) A valve clip or method as described in Appendices 1-21, wherein the clip joins a captured pair of cusps or tissue.

[0142] (Appendix 23) A valve clip or method as described in Appendices 1-22, wherein the clip joins a captured pair of cusps and also tightens the cusps together.

[0143] (Appendix 24) A valve clip or method as described in Appendices 1-23, wherein the clip tightens and / or joins 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, and / or 0% of the captured section of the cusp.

[0144] (Appendix 25) The final outer shape of the tip within the grasped area is substantially linear and / or curved, the valve clip or method according to Appendices 1-24.

[0145] (Appendix 26) The arm captures the tip along its anatomical curve from the edge to the valve ring or from the valve ring to the edge, the valve clip or method according to Appendices 1-25.

[0146] (Appendix 27) The embedded clip is 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, and / or 0% below and / or above the joining line, the valve clip or method according to Appendices 1-26.

[0147] (Appendix 28) The embedded clip is 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, and / or 0% within, or below and / or above the juxtaposed zone, the valve clip or method according to Appendix 27.

[0148] (Appendix 29) The final position of the inner arm is substantially parallel and / or joined, the valve clip or method according to Appendices 1-28.

[0149] (Appendix 30) The final position of the inner arm is partially parallel or joined, the valve clip or method according to Appendices 1-29.

[0150] (Appendix 31) The final position of the inner arm is partially curved and diverges from each other, the valve clip or method according to Appendices 1-30.

[0151] (Appendix 32) The final position of the outer arm is substantially parallel and / or joined, the valve clip or method according to Appendices 1-28.

[0152] (Appendix 33) The final position of the outer arm is partially parallel or joined, the valve clip or method according to Appendices 1-29.

[0153] (Appendix 34) The final position of the outer arm is partially curved and diverges from each other, the valve clip or method described in Appendix 1-29.

[0154] (Appendix 35) Both arms capture the same tip, the valve clip or method described in Appendix 1-34.

[0155] (Appendix 36) At least some of the tip-capturing arms are formed as leaf springs or cantilevers, the valve clip or method described in Appendix 1-35.

[0156] (Appendix 37) At least some of the outer and inner arms are formed as leaf springs or cantilevers with a stretchable base attached to a hub and a valve gripping element that extends from the base and is less stretchable, the valve clip or method described in Appendix 1-36.

[0157] (Appendix 38) The outer and inner arms are each formed as leaf springs or cantilevers with a stretchable base attached to a hub and a valve gripping element that extends from the base and is less stretchable, of the same stretchability, or more stretchable, the valve clip or method described in Appendix 1-37.

[0158] (Appendix 39) The outer and inner arms are each formed as leaf springs or cantilevers, and the outer arm is much more stretchable than the inner arm, the valve clip or method described in Appendix 1-38.

[0159] (Appendix 40) The outer and inner arms are each formed as leaf springs or cantilevers, and the outer arm has the same or less stretchability than the inner arm, the valve clip or method described in Appendix 1-39.

[0160] (Appendix 41) The arms branch from a common axis and form a V or W shape or tooth shape and / or a claw shape, having a valve gripping return or feature, the valve clip or method described in Appendix 1-40.

[0161] (Appendix 42) The inner and / or outer arms have a C or S-shaped curve, separating the upper surface of the inner arm from the lower surface of the outer arm, and such separation is a valve clip or method as described in Appendix 1-41 that adapts to the valve tip.

[0162] (Appendix 43) The valve gripping element is parallel or curved to the common axis when the outer and inner arms are de-energized, which is a valve clip or method as described in Appendix 1-41.

[0163] (Appendix 44) The valve gripping element branches from the common axis and forms a curved shape that closely contours to the natural tip shape when the outer and inner arms are de-energized, which is a valve clip or method as described in Appendix 1-43.

[0164] (Appendix 45) The inner and outer arms are configured to capture the tip within the tip joining section, which is a valve clip or method as described in Appendix 1-44.

[0165] (Appendix 46) The inner and outer arms capture the tip within the tip joining section and the non-joining section, which is a valve clip or method as described in Appendix 1-45.

[0166] (Appendix 47) The inner arm and the outer arm are configured to capture the tip within the joining section and the non-joining section along the contour of the natural tip and the valve ring, which is a valve clip or method as described in Appendix 1-46.

[0167] (Appendix 48) The inner and outer arms are configured to capture the tip simultaneously, which is a valve clip or method as described in Appendix 1-47.

[0168] (Appendix 49) The inner and outer arms are configured to capture the tip continuously, which is a valve clip or method as described in Appendix 1-48.

[0169] (Appendix 50) The inner and outer arms are configured to capture the tip independently, which is a valve clip or method as described in Appendix 1-49.

[0170] (Supplementary Note 51) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein the thickness of the outer arm is the same as or greater than that of the inner arm.

[0171] (Supplementary Note 52) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein the thickness of the outer arm is the same as or less than that of the inner arm.

[0172] (Supplementary Note 53) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein the thickness of the outer arm is > 0.0055 inches, preferably 0.008 inches to 0.020 inches, and preferably 0.010 inches, 0.012 inches, or 0.014 inches.

[0173] (Supplementary Note 54) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein the thickness of the inner arm is > 0.0055 inches, preferably 0.007 inches to 0.090 inches, and preferably 0.008 inches, 0.009 inches, or 0.010 inches.

[0174] (Supplementary Note 55) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein the thickness of the inner arm is > 0.0055 inches, preferably 0.007 inches to 0.090 inches, and preferably 0.008 inches, 0.009 inches, or 0.010 inches.

[0175] (Supplementary Note 56) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein each arm can be actuated or moved independently.

[0176] (Supplementary Note 57) A valve clip, tissue grasping device, or method according to any of the supplementary notes, comprising more than one pair of arms.

[0177] (Supplementary Note 58) A valve clip, tissue grasping device, or method according to any of the supplementary notes, comprising two pairs of arms configured to grip the anterior and / or posterior tips of the mitral valve.

[0178] (Supplementary Note 59) A valve clip, tissue grasping device, or method according to any of the supplementary notes, comprising more than one pair of arms configured to grasp the same valve tip or tissue.

[0179] (Supplementary Note 60) A valve clip, tissue grasping device, or method according to any of the supplementary notes, comprising three pairs of arms configured to grasp the three tips of the tricuspid valve.

[0180] (Supplementary Note 61) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein each pair is configured relative to the other pair to reduce backflow between the captured tissues.

[0181] (Supplementary Note 62) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein each pair is configured to exhibit elastic biasing toward the other pair to reduce backflow between the captured tissues.

[0182] (Supplementary Note 63) A valve clip, tissue grasping device, or method according to any of the supplementary notes, formed from arms having the same or various thicknesses, sizes, lengths, shapes, elasticities, and / or biasing forces (abrupt or constant).

[0183] (Supplementary Note 64) A valve clip, tissue grasping device, or method according to any of the supplementary notes, having the same or various thicknesses, sizes, lengths, shapes, elasticities, and / or biasing forces (abrupt or constant).

[0184] (Supplementary Note 65) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein the arms are made of a shape memory material.

[0185] (Supplementary Note 66) A valve clip, tissue grasping device, or method according to any of the supplementary notes, wherein the shape memory material consists of one or more than one of a shape memory alloy or a shape memory polymer.

[0186] (Appendix 67) The shape memory material is a shape memory alloy selected from the group consisting of copper-zinc-aluminum, copper-aluminum-nickel, nickel-titanium, nickel-titanium-platinum, and nickel-titanium-palladium alloys, for the valve clip, tissue grasping device, or method described in any of the appendices.

[0187] (Appendix 68) The shape memory material is a nickel-titanium alloy, for the valve clip, tissue grasping device, or method described in any of the appendices.

[0188] (Appendix 69) The shape memory material is a shape memory polymer selected from the group consisting of oligo(e-caprolactone) diol, oligo(p-dioxanone) diol, polynorbornene, polyisoprene, styrene-butadiene, polyurethane-based materials, and vinyl acetate polyester-based compounds, for the valve clip, tissue grasping device, or method described in any of the appendices.

[0189] (Appendix 70) Each pair of arms is configured to capture the tip or tissue, for the valve clip, tissue grasping device, or method described in any of the appendices.

[0190] (Appendix 71) Each pair captures the tip from both the atrial and ventricular sides, for the valve clip, tissue grasping device, or method described in any of the appendices.

[0191] (Appendix 72) The device is configured such that, in response to being positioned in a deployed state relative to the mitral valve tip, the arms of the tissue grasping device apply a force of about 0.06 to about 0.10 pounds (sudden and / or constant) to the tip, for the valve clip, tissue grasping device, or method described in any of the appendices.

[0192] (Appendix 73) The device is a valve clip, tissue grasping device, or method according to any of the appendices, configured such that, in response to being positioned in an expanded state relative to the mitral valve tip, the arm of the tissue grasping device applies a force (sudden and / or constant) of about 0.001 to about 0.06 pounds to the tip.

[0193] (Appendix 74) The device is a valve clip, tissue grasping device, or method according to any of the appendices, configured such that, in response to being positioned in an expanded state relative to the mitral valve tip, the arm of the tissue grasping device applies a force (sudden and / or constant) of about 0.1 to about 1.0 pounds to the tip.

[0194] (Appendix 75) The device is a valve clip, tissue grasping device, or method according to any of the appendices, configured such that, in response to being positioned in an expanded state relative to the mitral valve tip, the arm of the tissue grasping device applies a force (sudden and / or constant) of about 0.10 to about 5 pounds to the tip.

[0195] (Appendix 76) The device is a valve clip, tissue grasping device, or method according to any of the appendices, configured such that, in response to being positioned in an expanded state relative to the mitral valve tip, the arm of the tissue grasping device applies a force (sudden and / or constant) of about 0.10 to about 50 pounds to the tip.

[0196] (Appendix 77) The device is a valve clip, tissue grasping device, or method according to any of the appendices, configured such that, in response to being positioned in an expanded state relative to the mitral valve tip, the arm of the tissue grasping device applies a net force (sudden and / or constant) of about 0.15 to about 100 pounds to the tip.

[0197] (Appendix 78) The device is positioned in a deployed state relative to the mitral valve tip, and accordingly, a pair of outer arms (e.g., as shown in FIGS. 110-112), or two pairs of arms (e.g., as shown in FIGS. 4-9), the outer arms are configured to apply a joining force (sudden and / or constant) of 0.01 to 100 pounds, or preferably about 0.03 to 10.0 pounds, or preferably about 0.1 to 5.0 pounds, or preferably about 0.2 to 2.0 pounds to the tip, the valve clip, tissue grasping device, or method described in any of the appendices.

[0198] (Appendix 79) The arms of a given pair of tissue grasping devices deploy and engage the valve tissue against the tissue engagement surface of the other arm of the pair of elements while the other arm is either stationary or moving as the arms transition from a pre-deployed configuration to a deployed configuration, the valve clip, tissue grasping device, or method described in any of the appendices.

[0199] (Appendix 80) A pair of arms grasps tissue at 100% of their length, the valve clip, tissue grasping device, or method described in any of the appendices.

[0200] (Appendix 81) A pair of arms grasps tissue at about 100% to 80% of their length, the valve clip, tissue grasping device, or method described in any of the appendices.

[0201] (Appendix 82) A pair of arms grasps tissue at about 100% to 50% of their length, the valve clip, tissue grasping device, or method described in any of the appendices.

[0202] (Appendix 83) A pair of arms grasps tissue at about 75% to 20% of their length, the valve clip, tissue grasping device, or method described in any of the appendices.

[0203] (Appendix 84) A pair of arms grasps tissue at about 100% to 0.01% of their length, the valve clip, tissue grasping device, or method described in any of the appendices.

[0204] (Appendix 85) A pair of arms grip tissue at about 20% to 1% of their length, a valve clip, tissue gripping device, or method described in any of the appendices.

[0205] (Appendix 86) The shape memory alloy or shape memory polymer has a transformation temperature of about -15 to about 37 degrees Celsius, preferably -5 to about 27 degrees Celsius, a valve clip, tissue gripping device, or method described in any of the appendices.

[0206] (Appendix 87) The shape memory alloy or shape memory polymer has a transformation temperature of -5 to about 10 degrees Celsius, a valve clip, tissue gripping device, or method described in any of the appendices.

[0207] (Appendix 88) The shape memory alloy or shape memory polymer has a transformation temperature of 10 to about 27 degrees Celsius, a valve clip, tissue gripping device, or method described in any of the appendices.

[0208] (Appendix 89) A method of manufacturing a tissue gripping device described in any of the appendices, comprising the step of cutting one or more structural features into a strip or sheet stock of shape memory alloy, wherein the one or more structural features include a plurality of slotted recesses disposed on one or more side edges of the stock, and the step of barrier and thermally setting one or more bending features into the stock.

[0209] (Appendix 90) A method of manufacturing a tissue gripping device described in any of the appendices, comprising the step of cutting one or more structural features into a strip or sheet stock of shape memory alloy, wherein the one or more structural features include a plurality of slotted recesses disposed inside, centrally, or within the stock, and the step of thermally setting one or more bending features into the stock.

[0210] (Supplementary Note 91) A method for manufacturing a tissue grasping device according to any one of the supplementary notes, the method comprising the steps of forming and / or joining individual strands or loops of a wire material of a shape memory alloy, and thermally setting one or more bending features in the raw material.

[0211] (Supplementary Note 92) A method for manufacturing a tissue grasping device according to any one of the supplementary notes, the method comprising the steps of forming and / or joining individual strands or loops of a wire material of a shape memory alloy, thermally setting one or more bending features in the raw material, and forming smaller loops at the tip for the passage of suture thread.

[0212] (Supplementary Note 93) A method for manufacturing a tissue grasping device according to any one of the supplementary notes, the method comprising the steps of forming and / or joining individual strands or loops of a wire material of a shape memory alloy, thermally setting one or more bending features in the raw material, and adding bands, crimps, loops, and / or friction elements of the same or different materials.

[0213] (Supplementary Note 94) The method according to any one of Supplementary Notes 89-93, wherein one or more features include friction elements formed by thermally setting one or more portions of a raw material slot recess as a protruding loop.

[0214] (Supplementary Note 95) The method according to any one of Supplementary Notes 89-94, wherein one or more features include friction elements or loops formed by crimping or adding a band or additional material to the arm as a protruding loop.

[0215] (Supplementary Note 96) The method according to any one of Supplementary Notes 89-95 for making a tissue grasping device, wherein the friction element comprises internal or external side barrier features that prevent entanglement of tendons or other device elements.

[0216] (Supplementary Note 97) The friction elements are produced by the method according to any one of Supplementary Notes 89-96 for producing a tissue grasping device having them, by forming the inner side barrier features inwardly or away from the edges.

[0217] (Supplementary Note 98) The friction elements are produced by the method according to any one of Supplementary Notes 89-97 for producing a tissue grasping device having outer side barrier features, by extending a wire or continuous structure along the side surface so as to block or cover the slotted recesses, or to prevent or reduce the entanglement of the tissue or device features with the friction elements.

[0218] (Supplementary Note 99) The method according to any one of Supplementary Notes 89-98, further comprising the step of subtracting the amount of the raw material using a subtractive process after obtaining the raw material.

[0219] (Supplementary Note 100) The method according to any one of Supplementary Notes 89-99, further comprising the step of subtracting the amount of the raw material using a subtractive process, for example, but not limited to, these examples, namely, wire EDM, laser cutting and machining, Swiss machining, water jet cutting, conventional machining, after obtaining the raw material.

[0220] (Supplementary Note 101) A method for manufacturing a tissue grasping device according to any one of the supplementary notes, preferably including an additive process of components using metal 3D printing.

[0221] (Supplementary Note 102) A method for manufacturing a tissue grasping device according to any one of the supplementary notes, including a molding process of components, preferably metal powder compression molding.

[0222] (Supplementary Note 103) The method for manufacturing a tissue grasping device according to any one of the supplementary notes, further comprising the steps of thermally setting the valve repair device and finishing it by one or more mechanical deburring, grinding, machining, particulate blasting, electropolishing, cleaning, and / or passivation.

[0223] (Supplementary Note 104) A method of manufacturing a tissue grasping device according to any of the supplementary notes, comprising the step of coating and / or covering and improving biocompatibility and / or the device tissue.

[0224] (Supplementary Note 105) The length of the arm in interfacial contact with the tissue / tip is greater than 0.1 mm, preferably 9 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 50 mm and / or 100 mm, for a valve clip, tissue grasping device, or method according to any of the supplementary notes.

[0225] (Supplementary Note 106) The length of the tissue / tip captured by a pair of arms is greater than 0.1 mm, preferably 9 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 50 mm and / or 100 mm, for a valve clip, tissue grasping device, or method according to any of the supplementary notes.

[0226] (Supplementary Note 107) A single arm is divided to form outer and inner arms, for a valve clip, tissue grasping device, or method according to any of the supplementary notes.

[0227] (Supplementary Note 108) A pair of inner arms or a pair of outer arms, or a pair of inner and outer arms, is formed from a single continuous sheet or wire loop, for a valve clip, tissue grasping device, or method according to any of the supplementary notes.

[0228] (Supplementary Note 109) Each pair of inner and outer arms is configured to have different tissue / tip engagement lengths. In one preferred configuration, one pair has a length of 9 mm and the other has a length of 12 mm. In another preferred configuration, one pair has a length of 10 mm and the other has a length of 15 mm. In another preferred configuration, one pair has a length of 20 mm and the other has a length of 30 mm, for a valve clip, tissue grasping device, or method according to any of the supplementary notes.

[0229] (Supplementary Note 110) The inner and outer arms of each pair are configured to have different tissue / engagement shapes. In one preferred configuration, one pair is substantially straight (mainly for gripping tissue at or below the joining zone), while the other pair is curved (mainly for gripping tissue above the joining zone). In one preferred configuration, in the first pair, the straight section is 3 mm and the curved section is 6 mm. In the second pair, the straight section is 3 mm and the curved section is 12 mm. A valve clip, tissue gripping device, or method as described in any of the supplementary notes.

[0230] (Supplementary Note 111) The arm has a valve gripping return or feature that is enclosed by a side barrier, projects from a common axis with a depth < 10 mm, width < 100 mm, and length < 100 mm, preferably with a depth of about 0.7 mm, width of about 0.7 mm, and length of about 1.5 mm. A valve clip, tissue gripping device, or method as described in any of the supplementary notes.

[0231] (Supplementary Note 112) The arm has a valve gripping return or feature that is formed by a plurality of slots within the body and is spaced away from the side, projects from a common axis with a depth < 10 mm, width < 100 mm, and length < 100 mm, preferably with a depth of about 0.7 mm, width of about 0.7 mm, and length of about 1.5 mm. A valve clip, tissue gripping device, or method as described in any of the supplementary notes.

[0232] (Supplementary Note 113) The arm has a valve gripping hook-like feature at the free end of the arm. A valve clip, tissue gripping device, or method as described in any of the supplementary notes.

[0233] (Supplementary Note 114) The arm may have a tissue penetration limiting feature, has a valve gripping hook-like feature at the free end of the arm, and the penetration limiting depth is < 0.01%, < 1%, < 10%, < 20%, < 30%, < 40%, < 50%, < 60%, < 70%, < 80%, < 90%, and / or < 100% of the length of the arm. A valve clip, tissue gripping device, or method as described in any of the supplementary notes.

[0234] (Appendix 115) The arm has a valve gripping return or feature formed by a plurality of slots within the body away from the side surface and is bent at 10 to 160 degrees, preferably about 60 degrees, the valve clip, tissue grasping device, or method according to any of the appendices.

[0235] (Appendix 116) The arm has a valve gripping return or feature formed by a plurality of slots within the body away from the side surface and has a tissue penetration limiting feature (e.g., t, v, or w-shaped teeth or barbs) at the tip of the return, and the penetration limiting depth is <0.01%, <1%, <10%, <20%, <30%, <40%, <50%, <60%, <70%, <80%, <90%, and / or <100% of the length of the return, the valve clip, tissue grasping device, or method according to any of the appendices.

[0236] (Appendix 117) The device is removably coupled to a delivery system, and the device is loaded from the front with a delivery system along the back surface of the device offset from the central longitudinal axis of the catheter shaft, the valve clip, tissue grasping device, or method according to any of the appendices.

[0237] (Appendix 118) Configured to have a tissue grasping structure with an extended structure along the device that increases the asymmetric tip engagement length and / or the symmetric tip engagement width and / or the tip contact surface area of the device, and / or sidewalls to prevent unintentional entanglement, the valve clip, tissue grasping device, or method according to any of the appendices.

[0238] (Supplementary Note 119) An intracardiac valve repair device, comprising an elongatable flexible guide shaft having a proximal end, a distal end, and a main lumen therebetween, the elongatable flexible shaft being adaptable to be positioned into the cardiac chamber through a blood vessel, a delivery catheter adaptable to be passed through a guide catheter lumen having a flexible distal section, a proximal section, and a main section therebetween, the distal section being configured to be telescopically straight when extended outside the cardiac chamber unsupported, the distal end of the delivery catheter having a release bar for mounting the device, a valve repair tip grasping device comprising a hub configured to be removably attached to the release bar, a first pair of tip capture arms comprising a first inner arm and a first outer arm coupled to the hub, and a second pair of tip capture arms comprising a second inner arm and a second outer arm coupled to the hub, each pair of outer and inner arms being biased apart to create a tip capture space therebetween and configured to telescopically self-close over the tip upon release of the bias after the tip is captured.

[0239] (Supplementary Note 120) An intracardiac valve repair device, comprising an elongatable flexible guide shaft having a proximal end, a distal end, and a main lumen therebetween, wherein the distal end consists of at least primary and secondary multi-directionally steerable sections and is adaptable to be positioned into the cardiac chamber through the blood vessel; a delivery catheter having a flexible distal section, a proximal section, and a main section therebetween, and being adaptable to be passed through the guide catheter lumen, wherein the distal section is configured to be telescopically straight when extending outside the cardiac chamber without support; the distal end of the delivery catheter has a release bar for mounting the device, the release bar consisting of a pair of inversion devices, a release rod, an actuating suture, and a plurality of slots; a valve repair tip grasping device comprising a hub configured to be removably attached to the release bar; a first pair of tip grasping arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of tip grasping arms comprising a second inner arm and a second outer arm coupled to the hub, wherein each pair of outer and inner arms is biased to move apart, generating a tip capture space therebetween using the actuating suture, and configured to telescopically self-close over the tip when the actuating suture is used to continuously or simultaneously release the bias after the tip has been captured, gripped, and / or stabilized within the tip capture space; the inner arm actuating suture is removably looped through one or more slots; the release rod is configured to pass through the slots of the release bar and lift / raise the inner arm from the tissue; the outer arm actuating suture is removably looped through the inversion device and through one or more slots, configured to generate a tissue gripping space and / or invert the arms to allow detachment and deploy the device after tip capture in response to removal of the release rod from the release bar. An intracardiac valve repair device.

[0240] (Supplementary Note 121) An intracardiac valve repair device, comprising a first elongatable flexible guide shaft having a proximal end, a distal end, and a main lumen therebetween, wherein the distal end comprises at least a (primary) multi-directionally steerable section; a second elongatable flexible guide shaft having a proximal end, a distal end, and a main lumen therebetween, and being adapted to be passed through a first guide lumen, wherein the distal end comprises at least a (secondary) multi-directionally steerable section; the first and second guide shafts being adapted to be positioned into the cardiac chamber through the blood vessel; a delivery catheter having a flexible distal section, a proximal section, and a main section therebetween, and being adapted to be passed through a guide catheter lumen, wherein the distal section is configured to be telescopically straight when extended outside the cardiac chamber without support, and the distal end of the delivery catheter has a release bar for mounting the device, the release bar comprising a pair of inversion devices, a release rod, an actuating suture, and a plurality of slots; a valve repair tip grasping device comprising a hub configured to be removably attached to the release bar; a first pair of tip grasping arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of tip grasping arms comprising a second inner arm and a second outer arm coupled to the hub, wherein each pair of outer and inner arms are biased apart to create a tip capture space therebetween using the actuating suture, and are configured to telescopically self-close over the tip when the actuating suture is used to continuously or simultaneously release the bias after the tip has been captured, held, and / or stabilized within the tip capture space, the inner arm actuating suture being removably looped through one or more slots, the release rod being configured to pass through a slot in the release bar and lift / raise the inner arm from the tissue, and the outer arm actuating suture being removably looped through the inversion device and through one or more slots to create a tissue grasping space and / or invert the arm to allow detachment and to deploy the device after tip capture in response to removal of the release rod from the release bar.

[0241] (Appendix 122) The delivery catheter is further adapted to comprise a replaceable cartridge and cartridge receiving features, the plurality of cartridges being removably connectable to the delivery catheter and comprising a valve repair device of selectable size and / or shape configured to deliver at least one device, a valve clip, tissue grasping device, or method according to any of the appendices.

[0242] (Appendix 123) Comprising a distal section, a proximal section, and a main section therebetween, the distal section of the delivery catheter is adapted to comprise a replaceable cartridge and cartridge receiving features, the plurality of cartridges comprising a valve repair device of selectable size and / or shape, and a part of the distal section of the catheter being removably connectable to the cartridge receiving features of the remaining distal section of the delivery catheter, a valve clip, tissue grasping device, or method according to any of the appendices.

[0243] (Appendix 124) Comprising a distal section, a proximal section, and a main section therebetween, the main section of the delivery catheter is adapted to comprise a replaceable cartridge and cartridge receiving features, the plurality of cartridges comprising a valve repair device of selectable size and / or shape, and the entire distal section and a part of the main section of the catheter being removably connectable to the cartridge receiving features of the remaining main section of the delivery catheter, a valve clip, tissue grasping device, or method according to any of the appendices.

[0244] (Appendix 125) Comprising a distal section, a proximal section, and a main section therebetween, the proximal section of the delivery catheter is adapted to comprise a replaceable cartridge and cartridge receiving features, the plurality of cartridges comprising a valve repair device of selectable size and / or shape, and the entire distal section, main section, and a part of the proximal section of the catheter being removably connectable to the cartridge receiving features of the remaining proximal end of the delivery catheter, a valve clip, tissue grasping device, or method according to any of the appendices.

[0245] (Appendix 126) A cartridge distal section that can be removably connected, a proximal section, a main section therebetween, and a handle with distal cartridge receiving features, wherein the end of the proximal section of the delivery catheter is adapted to include an exchangeable cartridge, the plurality of cartridges include valve repair devices of selectable sizes and / or shapes, and the distal section, main section, and proximal section of the catheter are removably connectable to the cartridge receiving features of the delivery catheter handle, a valve clip, tissue grasping device, or method according to any of the appendices.

[0246] (Appendix 127) The actuating suture includes a polymer-based suture, a metal wire, a monofilament, or a multi-strand rope, a valve clip or tissue grasping device according to any of the appendices.

[0247] (Appendix 128) The actuating suture has the ability to apply tension or pulling force, a valve clip, tissue grasping device, or method according to any of the appendices.

[0248] (Appendix 129) The actuating suture has sufficient structural strength to apply both tension (or pulling force) and compression (or pushing force), a valve clip, tissue grasping device, or method according to any of the appendices.

[0249] (Appendix 130) The actuating suture includes a pulling / pushing wire section and a pulling-only wire / suture section, a valve clip, tissue grasping device, or method according to any of the appendices.

[0250] (Appendix 131) Including an electric handle, the handle includes at least sensors, transducers, circuits, power sources, switches, motors, actuators, and / or audio / video display interfaces for enabling direct or remote deployment of the device, a delivery catheter according to any of the appendices.

[0251] (Appendix 132) A guiding catheter according to any of the appendices, comprising an electric handle, the handle comprising at least sensors, transducers, circuits, power sources, switches, motors, actuators, and / or audio / video display interfaces for enabling direct or remote deployment of the device.

[0252] (Appendix 133) A valve clip or tissue grasping device delivery system according to any of the appendices, adaptable to deliver a valve repair device to any of the heart cavities, heart structures, and / or valves.

[0253] (Appendix 134) A valve clip or tissue grasping device delivery system according to any of the appendices, adaptable to deliver a valve repair device to any of the heart cavities, heart structures, and / or valves via an antegrade or retrograde approach, and a percutaneous or transcutaneous approach, an intervention or endoscopic or minimally invasive approach.

[0254] (Appendix 135) A valve clip, tissue grasping device, or method according to any of the appendices, configured to have a balloon or expandable member for resisting accidental retraction of the catheter.

[0255] (Appendix 136) A valve clip, tissue grasping device, or method according to any of the appendices, configured to have a balloon or expandable and / or deployable storage feature for assisting non-traumatic advancement or retrieval of the device.

[0256] (Appendix 137) A valve clip, tissue grasping device, or method according to any of the appendices, configured to have a balloon or expandable and / or deployable storage feature for assisting non-traumatic advancement or retrieval of the device.

[0257] (Appendix 138) A valve clip, tissue grasping device, or method according to any of the appendices, configured to enable echocardiography imaging, physiological measurements, and / or robotic device delivery.

[0258] (Supplementary Note 139) Any, some, or all of the above supplementary notes and the exemplary embodiments and examples described in this application can be made recoverable using a known device recovery method that includes some of the techniques described in this application. A valve clip or tissue grasping device delivery system described in any of the supplementary notes.

[0259] (Supplementary Note 140) For example, as shown in FIG. 120F, a valve clip, tissue grasping device, or method described in any of the supplementary notes that consists of a recovery suture that traverses the arm.

[0260] (Supplementary Note 141) For example, as shown in FIG. 104A, a valve clip, tissue grasping device, or method described in any of the supplementary notes that consists of a recovery / removal shaft.

[0261] (Supplementary Note 142) Certain variations and modifications that will be apparent to those skilled in the art may not provide all of the features and advantages described herein. Embodiments or examples or supplementary notes are included, including such apparent modifications and equivalents, and include embodiments consisting of various combinations or sub-combinations of the specific features and aspects of the examples of the embodiments claimed in the above supplementary notes. The steps of any method need not be performed continuously. A valve clip, tissue grasping device, or method described in any of the supplementary notes.

[0262] (Supplementary Note 143) Certain variations and modifications that will be apparent to those skilled in the art may not provide all of the features and advantages described in this specification or in any of the co-owned and referenced patent applications. Embodiments or examples or supplementary notes are included, including such apparent modifications and equivalents, and include embodiments consisting of various combinations or sub-combinations of the specific features and aspects of the examples of the embodiments claimed in the above supplementary notes or claimed in any of the co-owned and referenced patent applications. The steps of any method need not be performed continuously. A valve clip, tissue grasping device, or method described in any of the supplementary notes. This specification also provides, for example, the following items. (Item 1) An endovascular heart valve repair system, A delivery catheter having a distal end configured to be introduced into a heart chamber adjacent to a pair of joined heart valve leaflets, the delivery catheter including a release bar having a pair of inversion devices, the delivery catheter, A valve repair leaflet grasping device including a hub configured to be removably attached to the release bar of the delivery catheter, a first pair of leaflet capture arms including a first inner arm and a first outer arm coupled to the hub, and a second pair of leaflet capture arms including a second inner arm and a second outer arm coupled to the hub, the valve repair leaflet grasping device, A first set of control tethers positioned on or through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms to a leaflet capture position, the first set of control tethers, A second set of tethers positioned on or through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms to a leaflet capture position, the second set of tethers Comprising, The first set of control tethers is screwed through laterally spaced locations on the inversion device such that pulling the proximal portion of the first set of control tethers proximally causes the outer section of the outer arm to be pulled distally to the leaflet capture position, the endovascular heart valve repair device. (Item 2) The endovascular heart valve repair device according to Item 1, wherein pulling the proximal portion of the second set of control tethers proximally causes the outer section of the outer arm to be pulled proximally to the leaflet capture position. (Item 3) The pair of inversion devices includes a first inversion device extending laterally in a first direction from the distal tip of the delivery catheter, and a second inversion device extending laterally in a second direction from the distal tip of the delivery catheter. The endovascular heart valve repair device according to item 1. (Item 4) The first direction and the second direction face each other. The endovascular heart valve repair device according to item 3. (Item 5) The first inversion device and the second inversion device are each pivotally attached to the distal tip of the delivery catheter. The endovascular heart valve repair device according to item 4. (Item 6) The pivotal attachment is configured such that when the first tether is pulled proximally to apply an opening force to the inversion device, the inversion device expands laterally, but can be axially crushed in alignment with the delivery catheter when there is no opening force. The endovascular heart valve repair device according to item 5. (Item 7) The first set of tethers passes through the distal end of the release bar and is slidably coupled to each of the inversion device and the outer arm, and is fixedly attached to the release bar. The endovascular heart valve repair device according to item 6. (Item 8) The second set of tethers passes through the distal end of the delivery catheter and is slidably coupled to each of the inner arms, and is fixedly attached to the release bar. The endovascular heart valve repair device according to item 7. (Item 9) The inner arm and the outer arm include an inner leaf spring and an outer leaf spring. The endovascular heart valve repair device according to item 1. (Item 10) The inner leaf spring is biased to open laterally outward away from the release bar, and the outer leaf spring is biased to close laterally inward toward the release bar such that the tip can be captured therebetween when the leaf spring is released. The endovascular heart valve repair device according to item 1. (Item 11) The intravascular heart valve repair device according to item 10, wherein the outward opening bias of the inner plate spring is less than the inward closing bias of the outer plate spring. (Item 12) The intravascular heart valve repair device according to item 10, wherein the outer plate spring is substantially straight and, when all the plate springs are free of bias, approaches and is positioned across the release bar so as to laterally close the inner plate spring when the bias is released.

[0263] (Incorporation by reference) All publications, patents, and patent applications described herein are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

[0264] The novel features of the invention are set forth in detail in the appended claims. A further understanding of the features and advantages of the invention will be obtained by reference to the following detailed description of the invention, which describes exemplary embodiments in which the principles of the invention are utilized, and the accompanying drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0344] I. Heart Physiological Function The left ventricle LV of the normal heart H during systole is illustrated in FIG. 1. The left ventricle LV is contracting, and blood flow is flowing outward through the tricuspid (aortic) valve AV in the direction of the arrow. Backflow or "regurgitation" of blood through the mitral valve MV is prevented because the mitral valve is configured as a "check valve" that prevents backflow when the pressure within the left ventricle is higher than that within the left atrium LA. The mitral valve MV has a pair of cusps with a free edge FE that uniformly contacts to close as illustrated in FIG. 1. The opposite ends of the cusps LF attach to the peripheral heart structure along an annular region called the annulus AN. The free edge FE of the cusps LF is attached to the lower portion of the left ventricle LV through chordae tendineae CT (hereinafter referred to as tendons), which include a plurality of branched tendons fixed across the respective lower surfaces of the valve cusps LF. The tendons CT, in turn, attach to the papillary muscles PM, which extend upward from the lower portion of the left ventricle and the intraventricular septum IVS.

[0345] Several structural defects within the heart can cause mitral valve regurgitation. Regurgitation occurs when the valve leaflets do not close properly, allowing leakage from the ventricle into the atrium. As shown in Figure 2, the free edges of the anterior and posterior leaflets normally contact along the junction line C. An example of a defect that causes regurgitation is shown in Figure 3. Here, cardiac dilation causes the mitral valve annulus to be enlarged, making it impossible for the free edge FE to contact during systole. This results in a gap G that allows blood to leak through the valve during ventricular systole. Ruptured or elongated chordae can also cause the valve leaflets to disengage because improper tension is transmitted through the chordae to the leaflets. The other leaflets maintain a normal contour, but the two leaflets do not contact properly, and leakage from the left ventricle into the left atrium will occur. Such regurgitation can also occur in patients with ischemic heart disease where the left ventricle does not contact sufficiently to effect proper closure.

[0346] II. General Overview The present invention provides methods and devices for gripping, approaching, and fixing tissue such as valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. The present invention also provides features that allow repositioning and removal of the device, particularly in areas where removal may be obstructed by anatomical features such as chordae tendineae CT, if so desired. Such removal would allow the surgeon to re-approach the valve in a new manner, if so desired.

[0347] Grasping will preferably be non-invasive and provide several benefits. Non-invasive means that the devices and methods of the present invention can be applied to and then removed from the valve leaflets without causing any significant clinical impairment of the leaflet structure or function. The leaflets and valves continue to function substantially the same as before the present invention is applied. Thus, some slight penetration or indentation of the leaflets can occur using the present invention, but still meet the definition of "non-invasive". This allows the devices of the present invention to be applied to diseased valves and, if desired, removed or repositioned without adversely affecting valve function. Additionally, it should be understood that in some cases it may be necessary or desirable to puncture or otherwise permanently affect the leaflets during grasping, fixation, or both. In some of these cases, grasping and fixation can be accomplished by a single device. Several embodiments are provided to achieve these results, but a general overview of the basic features will be presented herein. Such features are not intended to limit the scope of the present invention and are presented for the purpose of providing a basis for the description of the individual embodiments presented later in this application.

[0348] The devices and methods of the present invention are positioned in the vicinity of a desired treatment site and rely on the use of an intervention tool for grasping the target tissue. In intravascular applications, the intervention tool is typically an interventional catheter. In surgical applications, the intervention tool is typically an interventional instrument. In a preferred embodiment, fixation of the grasped tissue is accomplished by maintaining the grasp using a portion of the intervention tool that remains as an implant. The present invention can have various applications for tissue access and fixation throughout the body, but is particularly well-suited for the repair of valves, especially cardiac valves such as the mitral and tricuspid valves.

[0349] As described in the co-owned reference application (PCT / US2017 / 042003), the fixation device is adaptable to both retrograde and antegrade configurations for deployment. The fixation device is attached to a release bar that is part of a distal delivery catheter, as referenced in the previous PCT. In both methods, the placement and position of the device remain unchanged. This may enable the fixation device to be deployed using various access points that best suit the user's needs. For purposes of illustration, the antegrade approach will primarily be described below.

[0350] Figures 4-9 show images of some exemplary combinations and configurations of preferred implant devices.

[0351] Figures 4 and 5 show images of exemplary standard-sized straight and curved configurations of an implant device.

[0352] Figures 6 and 7 show images of exemplary larger-sized straight and curved configurations of an implant device.

[0353] Figures 8 and 9 show images of exemplary asymmetric configurations of straight and curved implant devices using standard and larger sizes.

[0354] Figure 10 shows an image of an exemplary configuration of a device that is a combination of straight and curved devices. Note that each arm can also be of different thicknesses, widths, lengths, and outer shapes to constitute / vary the gripping or joining length, gripping force, and valve ring tightening force.

[0355] Figure 11 shows an image of an exemplary configuration of a curved device with only one side. This enables a configuration that is optimized for single-point gripping. This concept can also be used in other competing devices. For example, an exemplary embodiment of the present invention can be seen in Figure 12, where the arm of MitraClip® is cut and removed from one side while keeping all other aspects of the design intact.

[0356] In one preferred method, two such single-tip devices (Figs. 10-12) may be deployed on the same tip or different tips at different sites, both actuated, and configured to be restrained in a fixed position. This can be done by techniques and designs common to those skilled in the art. For example, the device can be configured with attached sutures or tethers, regardless of the presence or absence of key-like or meshing features. Once these devices are each deployed on the tip, the sutures or tethers may also be used to actuate both devices together. Once close enough (as determined via ultrasonic or fluoroscopic imaging feedback) to eliminate or reduce regurgitation, the sutures are crimped / fixed / crimped together and excess strands may be cut and removed. Thus, the device is restrained in a configuration that prevents regurgitation. Alternatively, the action of actuating both devices together can be used to mechanically lock them in a fixed position.

[0357] FIG. 13 shows an image of a MitraClip® device with an asymmetric arm length, similar to the exemplary device shown in FIG. 8.

[0358] FIG. 14 shows a flat pattern of a preferred exemplary embodiment of the inner arm 12 of a linear fixation device. The inner arm consists of a non-traumatic double fold or v-shaped protrusion 18 that allows the inner arm 12 to grip the LF of the MV. Features 24-25 allow for the passage of sutures and / or attachment of suture loops and manipulate the inner arm. Features 20-21 couple the base bracket 5 to the inner arm. The opening 26 allows the polyester fabrics to adhere to each other and prevents movement of the polyester fabrics during advancement and / or retraction of the fixation device through the catheter system.

[0359] FIG. 15 shows a 3D image of an exemplary embodiment of the inner arm 14 of the fixation device shown in FIG. 14.

[0360] Figure 16 shows a 3D image of an exemplary embodiment of the outer arm 15 of the linear fixation device.

[0361] Figure 17 shows the flat pattern of the outer arm 13 shown in Figure 16. Features 32 and 34 couple the base bracket 5 to the outer arm. Features 37 - 40 enable the passage of suture threads and / or the attachment of suture loops and manipulate the outer arm 13. The opening 37 enables the polyester fabrics to adhere to each other and prevents the movement of the polyester fabrics during the forward and / or backward movement of the fixation device through the catheter system.

[0362] Figure 18 shows the component 50 of the base bracket 5. This consists of a hinge joint 56 and threaded openings 60 and 62 and enables a small screw to fasten the arm between components 50 and 52.

[0363] Figure 19 shows the right component 52 of the base bracket 5. This consists of openings 61 and 63 that enable a small screw to fasten the arm between components 50 and 52.

[0364] Figure 20 shows an alternative view of the base bracket 5 depicting the hinge joint 56. The opening 65 enables the passage of the release rod 160 for the removable attachment of the base bracket 5 to the release bars 70, 72.

[0365] Figure 21 shows an image of a front view of short and long linear design prototypes next to a 10 - cent coin for a comparative dimension view.

[0366] Figure 22 shows an image of a side view of the long linear design prototype next to a 10 - cent coin as a scale.

[0367] Figure 23 shows an alternative exemplary embodiment of the release bar 70 where a) instead of the mounting feature 80, there are here a plurality of such features 81 - 84, and b) instead of the struts (see Figure 13G - 2, PCT / US2017 / 042003), the inversion devices 101, 102 are used. These inversion devices provide an increased lever arm and flex the outer arm as compared to the struts.

[0368] The inversion devices 101, 102 are hingedly connected at 95 and thus can provide a combination of configurations that can pivot to allow easy passage through the catheter and be used to manipulate the arms (e.g., outer arms 13, 15, 195, 197).

[0369] The inversion devices 101, 102 may be simple single components or may have complex shapes with multiple sub - components. Further, they may be hingedly connected, flexible, rigid, stationary, or moveable and may be integrally joined together. They can be arranged in any configuration to allow optimal operation of the arms. Further, their surfaces may be suitably configured to improve functionality and / or reduce friction.

[0370] Figure 24 shows an exemplary schematic where the inner arm 12 elastically drops in response to the removal of the biasing force (as indicated by arrow direction 120 and shown from the initial dotted line position to the final solid line position).

[0371] Figure 25 shows a relatively equal increase in the lengths of the suture sections 126 and 128 and their angles. This configuration can cause a) an increase in frictional resistance that impedes the elastic rebound of the arm and b) a decrease in the force required to raise (straighten or bias) the inner arm.

[0372] Figure 26 shows a schematic view of the inner arm 12 in the raised position. This is achieved by pulling 136 the suture 130, as described above in the PCT. That is, the pulling 136 of the suture section 130 causes a progressive shortening of the suture sections 128 and 126, leading to the raising of the inner arm 12.

[0373] Similarly, releasing (or pushing) the suture enables the inner arm to elastically rebound and return to its relaxed configuration. However, one skilled in the art can appreciate that this elastic rebound force is relatively low. Therefore, reducing the friction within the suture section is of utmost importance. Some of the characteristics that affect friction are: a) the coefficient of friction, b) the angle between sections 126 and 128, c) the incremental length of suture advancement, d) the number of bends and curves where the suture is exposed, e) the flexibility of the suture, f) the pushability of the suture within the catheter lumen, etc.

[0374] Figures 27 - 28 show an exemplary alternative embodiment as shown in Figure 25, where the suture section 126 is along the length of the inner arm 12 and terminates around the release bar 76 at feature 84 (instead of 88). Note the increase in the angle between the suture sections 126 and 128.

[0375] As can be inferred from Figures 27 - 28, the length of section 126 remains essentially the same over the movement of the inner arm, and thus there is minimal advancement of the suture at the tip of the inner arm 12. Further, the inner arm only needs to overcome and pull section 128. Therefore, under a given condition where all other variable characteristics are the same, the alternative configuration of terminating the suture loop at feature 84 (compared to feature 88) provides lower resistance to the elastic lowering of the inner arm 12.

[0376] Similarly, FIGS. 29-33 show alternative exemplary embodiments and / or configurations for lowering (and / or inverting) the outer arms. In this configuration, the operation of the outer arms 13, 15, 195, 197 is accomplished by screwing the suture 180 through feature 84, screwing the suture section 178 through suture loop 281, screwing the suture section 176 through suture loop 282, and coupling the suture section 174 to feature 83 of the release bar 70. The inversion of the outer arms 13, 15, 195, 197 can be further assisted during detachment.

[0377] FIG. 34 shows an exemplary embodiment of the release bar 76 with the inversion devices 101, 102, and an image of an exemplary implant device embodiment such as that depicted in FIG. 13D of the referenced PCT application.

[0378] FIG. 35 shows a rear view image of the prototype of FIG. 34 where all the arms are in the raised configuration.

[0379] FIG. 36 shows an image of the exemplary ability to operate each arm independently, for example, only the outer arm 13 is lowered.

[0380] FIG. 37 shows an image of both outer arms 13, 15 in the lowered / inverted position.

[0381] FIG. 38 shows an image of both outer arms 13, 15 lowered to the gripping angle and both inner arms 12, 14 lowered across the outer arms.

[0382] As previously described in the PCT, the present invention provides means and methods for independent arm manipulation. This improves ease of use in procedures and is employed according to diseases and anatomical conditions. Additionally, this enables the user to correct grip alignment if required. For example, in response to gripping, if the user determines that one side of the grip is sub-optimal, only that side can be released and re-gripped. Thus, compared to restarting the entire gripping procedure by releasing both tips, a significant amount of time is saved.

[0383] Figures 39 - 41 show some possible combinations of configurations of the inversion devices 101, 102. The inversion devices 101, 102 may be simple single components or may have complex shapes with multiple sub-components. Further, they may be hinged, flexible, rigid, immovable, or movable and may be integrated together in any configuration so as to enable optimal operation of the arm. Further, their surfaces may be suitably configured so as to improve functionality and / or reduce friction.

[0384] Figure 42 shows a suture 126 bonded or crimped to a metal wire 138 that reduces friction inside the catheter lumen as it is pulled or pushed. Pulling is not a problem for any suture or rope (high tensile strength, low column / compression strength), but having a metal wire or rod over most of the proximal length of the catheter (with sufficient column / compression strength when inside the catheter lumen) provides the required pushing force to overcome and a frictional resistance that impedes the elastic recoil of the arm. In some embodiments, pushability may be used to enhance the recoil of the arm.

[0385] Further, FIG. 43 illustrates an exemplary embodiment of suture 126 coupled to rigid tube 139, which can be a stainless steel wire, a plastic tube, and / or a metal tube. The rigid tube 139 can be pulled or pushed, thereby reducing the internal friction of the catheter and / or enhancing the strain recovery of the arm.

[0386] FIG. 44 illustrates a schematic view of a suture looped around release rod 160 that utilizes key features of exemplary release bar 72. As can be seen, release rod 160 is fully inserted through release bar 72, securing suture 125 to feature 84 and sutures 174 and 175 to feature 82. Further, the suture is inserted from the front of release bar 72 through features 82 and 84; however, due to the versatility of release bar 72, the suture can be inserted from the rear, or any combination of front and / or rear insertions.

[0387] FIG. 45 shows an enlarged view of sutures 125, 174, and 175 around release rod 160 of FIG. 43. As can be seen, features 82 and 84 have sufficient clearance for sutures 125, 174, and 175 to move freely without additional tension on the sutures.

[0388] FIG. 46 illustrates a schematic view of sutures 125, 174, and 175 after release rod 160 has been partially retracted beyond feature 82, decoupling sutures 174 and 175 from release bar 72.

[0389] FIG. 47 shows an enlarged view of FIG. 45 where sutures 174 and 175 are released from release bar 72 after release rod 160 has been partially retracted. As can be seen, sutures 174 and 175 are decoupled without entanglement. This is the case regardless of the entry point of the suture (i.e., from behind and / or in front of release bar 72).

[0390] FIG. 48 shows an exemplary embodiment of the inversion devices 116 and 117 consisting of a stop feature 142 that is utilized to prevent the inversion devices from overlapping or moving in the opposite direction when loading a fixation device into the catheter and / or during deployment of the fixation device.

[0391] FIG. 49 shows an exemplary embodiment of the release bar 72 with the inversion device 117 in the deployed state. The release bar 72 is shown with a plurality of features 80 - 88 for enabling the passage of loop-forming suture and for manipulating the arms of the fixation device. Additionally, any of these features may be used to couple the device with a base directed towards the distal end (towards 80) or proximal end (towards 88) of the release bar. Thus, it enables flexibility in the device configuration, for example, enabling a antegrade or retrograde approach to the mitral valve.

[0392] FIG. 50 shows an exemplary embodiment of the release bar 72 with the inversion device 117 in the catheter loading configuration. The stop feature 142 of the inversion device 117 is shown to limit the rotation of the inversion device 117, for example, to limit it from exceeding 10 or 20 or 120 degrees beyond the central axis of the release bar 72 in the catheter loading configuration.

[0393] FIGS. 51 - 52 show schematic views of the inner arm 14 in various positions. In contrast to the previous configuration, the suture section 128 is here looped through the suture loop 283 of the inner arm 14 instead of the inner arm 12 such that the suture section 128 operates the opposite arm. This cross configuration enables a more aggressive elevation of the inner arm. As can further be seen in this configuration, the suture section 126 is looped through the feature 84 of the release bar 72. This configuration reduces the friction on the suture when operating the inner arm. Further, the suture section is away from the tissue interface contact / gripping side of the inner arm so as to further reduce the risk of suture entanglement.

[0394] Figures 53-54 show schematic views of the outer arm 15 at various positions. As can be seen, the suture is positioned such that the operation of the outer arm 15 utilizes the feature 82 of the release bar 72, thereby reducing the tension applied to the suture when operating the outer arm. In this configuration, the outer arm 15 is operated by screwing the suture 181 through the suture loop 280 at the feature 80, screwing the suture section 175 through the suture loop 281, and screwing the suture section 177 through the suture loop 282.

[0395] Figure 55 shows an exemplary prototype image (front view) depicting an exemplary embodiment of a short delivery system for a trans-thoracic approach. As can be seen in this image, the actuating rods 330, 331, 332, and 333 are inserted into the handle 350 to enable the operation of the outer arm 13, inner arm 14, inner arm 12, and outer arm 15, respectively. The stainless steel tube 360 can be bent by the user as required to obtain better access to the valve since it is easily deformable.

[0396] Figure 56 shows an image (rear view) of the prototype described in Figure 55.

[0397] Figure 57 shows an image of a prototype depicting an alternative embodiment of a delivery system where the handle 350 is mostly cylindrical and / or conical.

[0398] Figure 58 shows an image of a preferred linear prototype where the fixation device (rear view) is covered with a fabric. As can be seen in this image, the suture controlling the outer arm is inserted through the rear portion of the release bar. This reduces the contact between the sutures controlling the inner arms, thereby reducing the friction between the sutures.

[0399] Figure 59 shows an image of the prototype shown in Figure 58 where the fixation device (side view) is covered with a polyester fabric.

[0400] Figure 60 shows an image of the prototype shown in Figure 58, where the fixing device (front view) is covered with a polyester fabric.

[0401] Figure 61 shows an image of the prototype shown in Figure 60 with the inversion device deployed.

[0402] Figure 62 shows an image of the prototype with the outer arm at a preferred sharp gripping angle / position while the inner arm remains raised.

[0403] Figure 63 shows an image of a linear prototype with the outer arm at a preferred gripping angle while the left inner arm is descending. If the tip was between the inner and outer arms, the tip would be captured by the inner arm in this configuration.

[0404] Figure 64 shows an image of the prototype with both the outer and inner arms in the gripping position so that any tissue or tip between the arms is gripped.

[0405] Figures 65A - 65C show images of a preferred method of deployment of the linear device prototype as it is advanced through a transparent shaft representing a 12Fr guide catheter. Figure 65A shows the device inside the 12Fr shaft. Figure 65B shows the device being advanced out of the 12Fr shaft. Figure 65C shows the exposed device. In Figure 65D, the outer arms of the device are lowered to the gripping angle. In Figure 65E, the tip is stabilized by the outer arm. In Figure 65F, one tip is gripped by lowering one of the gripper arms. In Figure 65G, the second tip is gripped by lowering the other gripper. In Figure 65H, both outer arms are raised. In Figure 65I, the device is fully deployed. Figure 65J is a view of the device from the ventricular side. Figures 65K and 65L are the release positions showing the raised grippers and the inverted outer arms.

[0406] Figures 66A - 66J show images of preferred curve prototypes during bench testing. Figure 66A shows the device inside a 12Fr shaft. Figure 66B shows the device advanced out of the 12Fr shaft. Figure 66C shows the exposed device. In Figure 66D, the outer arm of the device is lowered to the gripping angle. In Figure 66E, the tip is stabilized by the outer arm. In Figure 66F, one tip is gripped by lowering one of the gripper arms. In Figure 66G, the second tip is gripped by lowering the other gripper. In Figure 66H, the device is fully deployed. Figure 66I is a view of the device from the ventricular side. Figure 66J is the release position showing the raised grippers and the inverted outer arms.

[0407] Figure 67 shows an exemplary embodiment of a curve fixation device. The inner arms 12 and 14 consist of a plurality of return - like protrusions 18. As can be seen in the 3D image of Figure 68, while the inner arms 12, 14 are made from a metal plate, the outer arms 191, 193 are made from wire loops.

[0408] Figure 69A shows an exemplary embodiment of a fixation device where the inner arms 192, 194 and the outer arms 195, 197 consist of a single primary loop of a metal wire such as nitinol. The inner arm 192 further consists of a band 250 used to attach the metal wires together and a small wire loop 252 for passing the actuation suture. These small suture loops 252 provide local attachment points on the arm.

[0409] Figure 69B illustrates a method of assembling nested wire loops and optionally forming either an inner or outer arm held together by the band 250. The nested loops may be of a single wire or multiple wires.

[0410] FIG. 70 shows an exemplary schematic view of a suture fixation device such as that of FIG. 68. Further, this demonstrates a configuration in which the fixation device is attached onto the release bar 72. As can be seen, the suture 130 controls the inner arm 14 instead of the inner arm 12 in the previous configuration. Similarly, the suture 131 controls the inner arm 12. This configuration allows for an improved elevation angle of the inner arm. The suture sections 125, 126 are sufficiently spaced apart and are looped around the release rod 160 through feature 85 which is away from the tissue interface contact gap of the arm. Additionally, the sutures 180, 181 control the outer arms 191, 193 respectively. The suture sections 175, 175 of the sutures 180, 181 are well below and away from the tissue interface contact gap between the two arms and are looped around the release rod 160 through feature 82. An advantage of the present invention is the reduction of contact between the sutures 125, 126 and the sutures 174, 175, thereby reducing friction and entanglement between the sutures. Also, this separation improves manufacturability.

[0411] FIGS. 71A and 71B show an alternative embodiment of the catheter handle 350. The release knob 372 controls the release rod 160. Feature 400 allows for the attachment of the actuating rods 330, 331, 332, 333 to the catheter handle 350 and for screws to be installed to reduce the possibility of unintentional movement during a surgical procedure. This is additional to the friction provided by the O-ring of the handle.

[0412] FIG. 72 shows an alternative view of the catheter handle 350. Feature 422 allows for the positioning screw to fasten the stainless steel tube 360 to the nozzle 382.

[0413] FIG. 73 illustrates a front view of the catheter handle 350 depicting the nozzle 382 and feature 422.

[0414] FIG. 74 shows a rear view of the catheter handle 350. Features 462, 463, 464, 465, 466 each allow the insertion of the actuating rods 333, 332, 331, 330. Alternatively, the actuating rods can be inserted through features 467 and 468, or any combination of features 462, 463, 464, 465, 466, 467, 468 into the actuating rods 330, 331, 332, 333. Also, features 467 and 466 may be used as cleaning ports for flowing saline, inserting sensors and actuators, and / or inserting an actuating rod for the release suture 602.

[0415] FIG. 75 shows a cross-sectional view of an exemplary catheter handle 350. Features 462, 463, 464, 465 each allow the smooth insertion of the actuating rods 333, 332, 331, 330. Further, the acute angles at which channels 462, 463, 464, and 465 can be tapered allow the prevention of kinking and / or entanglement of guide wires, suture plastic tubes, and / or metal tubes.

[0416] FIG. 76 illustrates an exemplary method of operating the release rod 160 to decouple the securing device from the release bar. The release rod 160 is controlled by the release knob 372 via the threaded features 500 and 502. The threaded features 500 and 502 prevent the unintentional removal of the release rod 160 because the release knob 372 needs to be unscrewed prior to retraction. There is a gap / slot designed between the threads 502 and 500 to improve the rate of unscrewing and to limit the amount of retraction. In an exemplary preferred embodiment, the release knob 372 is unscrewed from the threaded feature 502 and the knob is retracted until the threaded feature 500 decouples the linear securing device from the release bars 70 and 72. In an alternative preferred embodiment for a curved device, unscrewing the release knob 372 from the threaded feature 502 and retracting it to the feature 500 only partially decouples the device from the release bars 70 and 72 and the release suture will still remain attached to the feature 88. This allows the device to be retracted back into the guide catheter. However, if full deployment is desired (such as in the case of successful grasping of tissue), the release knob 372 must be completely removed from both the distal 502 and proximal 500 threads.

[0417] As seen in FIG. 76A, the release rod 372 represents the device fully inserted and loaded. To deploy this device, the user first unscrews the release knob 372, as shown in FIG. 76B, and partially retracts it through the threadless slot between the two threads 502 and 500, as shown in FIG. 76C. Based on the suture attachment points (e.g., between 80 - 85), preferably, the linear device can be configured to be released and deployed. To further retract the release rod 160 (e.g., through 86 - 88), the user may optionally unscrew the release knob from the proximal thread 500. For example, the curved device may be configured to have a release suture within feature 88. Thus, to deploy the curved device within the tip, the user will need to completely remove the release knob 372 from the handle body, as shown in FIG. 76D.

[0418] FIG. 77 shows the release rod 160 fully inserted within the release bar 72. As can be seen, the release rod 160 is inserted through features 80 - 88. Further, it is exposed at the distal end of the release bar 72.

[0419] FIG. 78 shows a schematic view of the curved device 650 attached to the release bar 72 in a loaded configuration where the release rod 160 is fully inserted through the release bar. As can be seen, the curved device 650 has a suture loop 622 that allows the suture 600 to attach the device to the release bar 72 through feature 88. Note that for simplicity, the other sutures for actuating the arm are not shown.

[0420] FIG. 79 illustrates a schematic view of a release rod 160 (corresponding to FIG. 76C) that is partially retracted from a release bar 72 such that features 80 - 85 are free, as indicated by arrow 675. Subsequently, FIG. 80 shows a schematic view of a curved device 650 that is partially removed from the release bar 72 as the release rod 160 is partially retracted. As a result, the curved device 650 is in an inverted position where the release suture at feature 88 remains coupled to the suture loop 622 of the curved device 650. Thus, as shown in FIG. 81, the backward movement and removal of the device 650 through a guide catheter 700 are enabled.

[0421] FIG. 82 illustrates a schematic view of a release rod 160 that is completely removed from the release bar 72, releasing features 80 - 88 of the suture and the fixation device.

[0422] FIG. 83 shows a full deployment of the curved device 650 with the release rod 160 completely retracted from the release bar 72 (corresponding to FIG. 76D). Thus, the suture 602 is released from the suture loop 622 and feature 88, thereby decoupling the curved device 650 from the release bar 72.

[0423] FIGS. 84A - 84D show images of an exemplary curved device prototype demonstrating a detachment method as described in FIGS. 76 - 83, where the fixation device is partially deployed but still attached to the deployment sutures 600 - 609 (FIG. 84A). FIGS. 84B - 84D show sequential steps of the backward movement of the device inside an exemplary 12F shaft.

[0424] FIG. 85 shows an image of the distal end of an exemplary delivery system sub - assembly of a short catheter (as shown in FIGS. 55 - 57).

[0425] FIG. 86 shows a single - lumen braided shaft 700 in which the release rod 160 is floating freely within the shaft. Optionally, the shaft 734 is enclosed inside another freely - floating single - lumen shaft 732.

[0426] Figures 87 - 93 illustrate alternative configurations of a multi - lumen braided shaft that can be used in a catheter. Metal wires, metal tubes, plastic tubes, pull wires, and / or sutures can be inserted through lumens 730, 734, 736, 737, 738, 739. Additionally, nitinol wires may be inserted to strengthen or maintain the stiffness of the catheter. In Figure 87, in a preferred embodiment, an actuating suture is passed through the inner ring of lumen 737 and a nitinol mandrel is inserted, optionally, into the larger lumens 730, 736, particularly into the distal unsupported section of the delivery catheter shaft, so as to maintain the linearity of the shaft as it extends out from the guide curve. The release rod is passed through one of the larger loops 730, 736.

[0427] Figure 88 shows an alternative embodiment of the shaft of Figure 87 where torque cables or peak tubes are joined to lumen 736 so as to improve the torque, tension, flexibility, and compression characteristics of the catheter shaft.

[0428] Figure 89 shows an alternative embodiment of the shaft with torque cables and / or peak tubes.

[0429] Figure 90 shows the embodiment of Figure 88 with sutures. As can be seen, each pair of suture strands can be passed through diametrically opposed lumens, as shown, for example, with suture 180. Such a configuration is preferred to maintain balance of suture pulling forces across the center of the catheter and to reduce pull - force - induced curvature of the catheter.

[0430] Figure 91 shows the embodiment of Figure 89 with sutures. As can be seen, each pair of suture strands can be passed through the same lumen.

[0431] Figures 92 and 93 show alternative embodiments of the delivery shaft.

[0432] Figures 94A - 94C each show a schematic view of an exemplary preferred nested catheter system, as per the present invention.

[0433] Figure 95 shows an image of the distal section of a preferred nested catheter system prototype. As can be seen, an exemplary 9Fr outer diameter delivery catheter shaft 1020 passes through the lumen of an exemplary 12Fr steerable guide catheter shaft 1000.

[0434] Figure 96 shows an image of a preferred steerable guide and delivery catheter handle prototype in a side view. An exemplary stainless steel tube 950 provides means for supporting and attaching a steerable guide catheter handle on a suitable stand (not shown). And an exemplary stainless steel tube 940 provides means for supporting and translating a delivery catheter when nested inside the steerable guide handle.

[0435] Figure 97 shows an image of a guide catheter prototype with a transseptal curve 980 in section 901. The transseptal curve 520 can range from -5 degrees to 180 degrees. This curvature allows for easy access across the septum for delivering a fixation device. In an alternative embodiment, the catheter of the present invention is designed to be fully bidirectionally steerable from -180 to 180 or -270 to 270 or -359 to 359 degrees for additional functionality.

[0436] Figure 98 shows an image of a catheter prototype where the guide catheter has a bidirectional transseptal curve 980 in section 901 and four - direction mitral valve curves 985, 986, 987, 988 in section 1010. The mitral valve curves range from -90 to 90, or -180 to 180, or -270 to 270, or -359 to 359 degrees 983. Further, it has a high strength to resist torsion and can be rotated along its longitudinal axis 983 981. The four - direction mitral valve curve with rotation allows for easy access to the MV. The guide catheter and the delivery catheter may optionally have pre - set curves.

[0437] Figure 99 shows an image of an exemplary guide catheter prototype in an anatomical heart model.

[0438] Figure 100 shows an image of an exemplary delivery system prototype with an inflatable balloon-like feature 1050 on a guide catheter. The balloon feature 1050 can function as a buffer to prevent trauma to surrounding tissue as the delivery system advances or retracts within a blood vessel. Further, the balloon feature 1050 can be inflated to stabilize the guide catheter and prevent unintentional movement (i.e., retraction, advancement) of the delivery system. The balloon feature 1050 can be positioned at any location along the guide and / or delivery catheter. In a preferred embodiment, the balloon is distally mounted at the tip and, when inflated after septum crossing, serves to prevent unintentional retraction of the guide into the right atrium.

[0439] Figure 101 illustrates the curvature of a preferred nested catheter system as the delivery catheter 1020 is advanced across the MV. The mitral valve curve of the distal guide shaft 1010 and the septal curve of the proximal guide shaft 901 allow for easier access to the LF and, advantageously, position a fixation device 1040 below the MV. This also shows the unsupported straight section of the delivery catheter 1020.

[0440] Figure 102 illustrates the curvature of a preferred nested catheter system with the addition of a balloon-like feature 1050 on the distal end of the guide catheter 1010 as the delivery catheter 1020 is advanced across the MV. Potential advantages of the nested catheter system over a tripartite catheter system are lower cost and a thinner profile.

[0441] FIG. 103 shows the curvature of the triple - nested guide catheter 1020 with the addition of the balloon - like feature 1050 on the distal end of the guide catheter 1052 as the delivery catheter 1020 is advanced beyond the MV. In this configuration, the balloon 1050 stabilizes the distal end of the guide catheter 1052 and prevents accidental retraction across the septum S.

[0442] FIG. 104A shows the detachment catheter guide 1055 with the long pull / push feature 1057. The feature 1057 controls the detachment guide catheter 1055 and encapsulates / coats / shields the fixation device during retraction / detachment. In preferred embodiments and methods, the detachment catheter is positioned outside the patient and is not advanced inside the patient unless detachment is desired. This is an advantage of the present invention that reduces the need and risk of inserting a large - diameter detachment catheter in most cases. This advantage can typically be easily applied to large - French - size triple - nested catheter systems such as the MitraClip® delivery system by using a detachment catheter design as per the present invention, adding steerability in the trans - septal curve to a steerable sleeve, and using a distal balloon as a buffer or shield.

[0443] FIG. 104B shows an exemplary double - nested catheter system such as FIG. 101, optionally with the addition of the detachment guide catheter 1055 inserted close to the septum S. The detachment catheter guide 1055 can be used to encapsulate / coat / shield the fixation device 1040 during retrieval to prevent trauma to the surrounding tissue as the delivery system is retracted from the patient after detachment. The detachment catheter 1055 may optionally consist of the balloon 1050.

[0444] Figures 105-106 show the umbrella-like feature 1110 at the tip of the guide catheter 1010, 1052, or the delivery catheter 1020, or the detachment catheter 1055. The umbrella feature 1110 functions as an enclosure device for surrounding the fixation device 1040 as the delivery system advances and / or retracts during the procedure. The umbrella feature 1110 is expanded / inflated to stabilize the delivery system during mitral valve repair surgery, thereby increasing efficiency.

[0445] Figure 107 shows the inflatable bumper-like balloon feature 1115, which can optionally be part of the stand-alone attachment feature 1060 that can be mounted on the catheters 1010, 1020, 1052, 1055. The bumper feature 1115 prevents the fixation device 1040 or the delivery system from causing trauma to the lumen wall and / or blood vessels.

[0446] Figures 108-109 illustrate cross-sections of the self-expanding bell / funnel-shaped nested flat feature 1120 (like a petal) that can be attached to the guide catheter and / or the delivery catheter to enclose / deliver the fixation device 1040 during the advancement and / or retraction of the delivery system. The feature 1120 can be actuated using the pull wires and / or sutures 1130, 1131 to collapse or expand, as indicated by the arrows.

[0447] Figures 110 and 111 show alternative embodiments of the tissue fixation devices 1140, 1141 with barbs 210 on the proximal end of each of the two outer arms 204. The barbs 210 are used to increase the surface area of the outer arm 204 to grip more target tissue. The base 5 is not shown for simplicity.

[0448] Furthermore, Figure 112 shows an alternative embodiment of the same tissue fixation devices 1140, 1141 with the addition of loops 212. The base 5 is not shown for simplicity.

[0449] Figures 113A - 113F show alternative views including an illustration of the flat pattern of the outer arm 204 detailing the preferred angles and positions of the return 212 and the claw 210.

[0450] Figure 114 illustrates the functional length 225 of the outer arm 204 and the functional width 227 of tissue fixation device embodiments 1140, 1141. The thickness of the fixation device is modeled by the length of the device base 222 and the width of the device base 224. In a preferred embodiment, the functional length of the arm 225 is manufactured to be > 1.5 times longer than the functional width 227. Thus, varying the functional length 225 and the functional width 227 of the fixation device will vary the amount of tissue to be grasped and / or the force applied and / or the area of tissue engagement. Additionally, varying the base length 222 and the thickness of the arm 204 will improve and / or increase the amount of tissue gripping force.

[0451] Alternative embodiments / prototypes of the two - arm - based tissue fixation devices 1140, 1141 can be seen in FIGS. 10 - 12.

[0452] In another exemplary preferred embodiment, the two - arm fixation devices 1140, 1141 may optionally consist of an adjustable tether as described in the "Summary of the Invention" section.

[0453] FIG. 115 illustrates an embodiment of an anchored tissue fixation device used to more closely approximate and / or cinch a target tissue. For example, tissue grasping device 1140 is coupled to tether 1146 while tissue grasping device 1141 is coupled to tether 1147. The tethers are tightened and attached using connector 1144. Tethers 1146 and 1147 can be of metal wire and / or polymeric suture. The tissue grasping devices can be positioned at location 2000 or 2002. Location 2000 refers to the atrial wall of the heart and location 2002 refers to the mitral annulus. Reinforcing the structural and functional integrity of the heart by cinching and / or approximating the annulus and / or strategic locations within the heart such as the leaflet edges are some of the obvious advantages of the present invention.

[0454] FIG. 116 illustrates an embodiment of an anchored tissue fixation device at an exemplary preferred location 2004 at the leaflet edge. Positioning and approximating the fixation device at location 2004 creates a Mitral Valve Alfieri Edge-to-Edge repair and reduces regurgitation. FIG. 116 also shows other exemplary locations such as 2006 at the tip of the leaflet.

[0455] FIG. 117 illustrates an embodiment of anchored tissue fixation devices 1150, 1151 where connector 1144 is not used. In this embodiment, fixation device 1150 is coupled to fixation device 1151 via adjustable tether 1155. Similar to tethers 1146 and 1147, tether 1155 can be a metal wire or suture. As can be seen in this figure, fixation device embodiment 1150 is grasped on the papillary muscle PM and embodiment 1151 is grasped on the leaflet edge, thereby mimicking the function of the chordae.

[0456] Figures 118A - 118D show the modular design of the distal and proximal ends of the actuating rod 138 at various unlocking (Figures 118A - 118B) and locking (Figures 118C - 118D) positions. This configuration allows for easy removal and / or addition of the actuating rod 138 within the catheter 737 with respect to surgical requirements. Further, this modular design enables assembly and disassembly of the catheter system for easy and compact storage as a cartridge.

[0457] Figure 119A shows an alternative embodiment of a catheter with a modular configuration where the distal shaft of the delivery catheter 1020 consists of a male connector 1072 at the proximal end. The male connector 1072 may be inserted into a female connector 1070 configured at the distal end of the distal shaft of the delivery catheter 1020 or the proximal shaft of the delivery catheter 1021 to assemble or disassemble the catheter system for easy use and storage as a cartridge. Further, the connector may be positioned at any location along the catheter system such that alternative configurations of the catheter shaft or catheter system may be produced as shown in Figures 119B - 119C.

[0458] Figures 120A - 120E show images of a prototype during bench testing of a retrieval system where a fixation device consists of retrieval sutures 1170, 1172 for the retrieval system to grip and raise and / or lower the inner and outer arms.

[0459] Figure 120F shows a schematic of an alternative embodiment of a fixation system consisting of inner arms 12 and 14 and outer arms 191 and 193. The retrieval sutures 1170, 1172 are connected to the inner and outer arms for the retrieval system of Figures 120A - 120E to grip to raise and / or lower the arms.

[0460] Mooring of the release rod: The referenced application PCT / US2017 / 042003 describes a release rod. One or more distal portions of the release rod may include one or more tethering portions that reduce the risk of accidental release of the release rod from the delivery system. Examples of tethering portions include, but are not limited to, bends, curves, expanded regions, wider regions, deployable elements, and the like.

[0461] Guide and delivery catheter: The referenced PCT describes a two - catheter system for performing trans - catheter percutaneous deployment. In a preferred embodiment, all curves achieved using a three - catheter system (as described, for example, in US 7226467B2) are configured to be achieved using a two - catheter system. That is, the individual curves of the guide and sleeve as described in US 7226467B2 would be incorporated into a single steerable guide using common catheter manufacturing techniques.

[0462] Catheters are typically steered using a pull - wire or pull - and - push lumen while advancing or retracting. Thus, a robotic interface can be created to replicate human manipulation using common and typical electromechanical interfaces such as linear rollers, linear actuators, electro - pneumatic pistons, motors, and the like. Similarly, the delivery catheter can be controlled. Current technologies, such as those used in robotic surgery, are far more advanced and complex than the movement and manipulation used in percutaneous trans - catheter - based structural heart devices. Thus, remote or robotic control of the catheter can be implemented.

[0463] In addition, in a preferred embodiment, the catheter can be configured to incorporate pressure sensing and dye injection features. This can be done through a) the main lumen of the catheter shaft, b) ports or grooves and / or tubular lumens within the wall of the steerable guide (and / or delivery) catheter along the inner and outer diameters, and c) the use of thin film or spot pressure sensors at various strategic locations on the catheter shaft.

[0464] One or more guide catheters and delivery catheters disclosed herein may have one or more additional lumens that can function to accommodate one or more additional elements including, but not limited to, sensors (e.g., pressure sensors, flow sensors, optical sensors, ultrasonic sensors, vibration sensors, Doppler sensors, force sensors, etc.), one or more elements of a Swan Ganz type catheter, OCT elements, gyroscopes, accelerometers, etc. In another embodiment, one or more sensors or elements disclosed herein may be incorporated or integrated within one or more portions of the devices disclosed herein.

[0465] Sensors and actuators that may be used in connection with the present invention are for improving the safety, ease of use, and effectiveness of delivery systems and fixation devices. The sensors and actuators may be used to assist and evaluate device delivery (short-term) and effectiveness (short-term or long-term). The sensors and actuators may be active or passive, removable, or implantable and may provide short-term or long-term physiological or non-physiological data for assessing or evaluating patient health. The sensors and actuators may be active or passive, removable, or implantable and may provide short-term or long-term physiological or non-physiological data for assessing or evaluating implant integrity and / or function. The sensors may be used for visualization, and the heat, optical, ultrasonic (including ICE), OCT, fluorescence sensors and actuators may be electrical, mechanical, magnetic, RF, chemical, or a combination. The sensors and actuators may be wired or wireless and may communicate with a mobile or fixed external interface. The catheter of the present invention may be used as a conduit for an external sensor, for example, a pressure sensor that replaces a Swan-Ganz catheter. The terms "sensor", "electrode", "transducer", "IC", "circuit", "chip", and "actuator" may be used synonymously. The sensors and actuators listed are merely examples. Any suitable metal or polymer or ceramic, organic or inorganic, flexible or rigid, matrix or material, and combinations thereof may be used to produce the desired sensors and actuators. Further, a motor may be used to steer the catheter and deploy the device. For example, the motor may be used in place of a manual knob or lever to pull or push an actuating suture or a steerable catheter towing wire or other common mechanism.

[0466] All implant embodiments described in the present invention may optionally be coated, adhered, coated, or the like, to improve biocompatibility and tissue interface. Suitable covers can be woven, linked mesh, fibrous, braided, woven, or non-woven. The coating can be metal, ceramic, polymer, or a combination thereof. Suitable metal coatings include titanium, TiN, tantalum, gold, platinum, and their alloys. Suitable ceramic and inorganic coatings include titanium dioxide, hydroxyapatite, CaP, and the like. Suitable polymer coatings include fluoropolymers such as PTFE, PFA, FEP, ECTFE, ETFE, parylene, polyester, PET, polypropylene, polyurethane, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, THV, and the like. Suitable biodegradable materials include poly(lactic acid), poly(glycolic acid), polydioxanone, poly(ε-caprolactone), polyanhydrides, poly(orthoesters), copoly(ether-ester), polyamides, polylactones, poly(propylene fumarate), and combinations thereof. Such metal, ceramic, and / or polymer coatings are listed by way of example only. Any suitable metal, ceramic, polymer, and combinations thereof may be used to produce the desired coating.

[0467] In one particular exemplary embodiment of the medical method, the user assesses leaflet regurgitation through one or more medical imaging methods including, but not limited to, fluoroscopy and ultrasound. Based on the assessment of the leaflet junction depth, contour, disease, and / or size, a linear or curved or composite shaped device of one or more sizes is implanted. The advantage of deploying an implant of the selected shape and size is to improve effectiveness, safety, and minimize the number of device implants.

[0468] Any of the implant arms disclosed herein may comprise one or more telescoping elements.

[0469] For purposes of this description, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, and the disclosed embodiments do not require that any one or more specific advantages exist or that any problems be solved.

[0470] Although some of the operations of the disclosed methods are described in a particular order for convenience of presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular order is required by specific terms. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Also, for simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. As used herein, the terms "a", "an", and "at least one" encompass one or more than one of the specified elements. That is, if two of the specified elements exist, then one of these elements also exists, and thus, "one" element exists. The terms "a plurality of" and "plural" mean two or more than two of the specified elements.

[0471] As used herein, the term "and / or" used between the last two of a list of terms means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A", "B", "C", "A and B", "A and C", "B and C", or "A, B, and C".

[0472] As used herein, the term "coupled" generally means physically joined or connected and, in the absence of specific contrary terms, does not exclude the presence of intermediate elements between the coupled items.

[0473] The following is a list of reference numbers used in this application. 1 Exemplary embodiments of a fixation device 5 Base bracket 12 Flat pattern of the inner arm, exemplary embodiment of a linear fixation device used to capture the tip 13 Flat pattern of the outer arm, exemplary embodiment of a linear fixation device used to capture the tip 14 Inner arm, exemplary embodiment of a fixation device used to capture the tip 15 Outer arm, exemplary embodiment of a fixation device used to capture the tip 18 Non-traumatic return-like friction element of the inner arm 20 Features of the inner arm 12 that enable attachment to the base 5 21 Features of the inner arm 12 that enable attachment to the base 5 24 Features of the inner arm 12 that enable the suture to form a loop and manipulate the arm of the fixation device 25 Features of the inner arm 12 that enable the suture to form a loop and manipulate the arm of the fixation device 26 Slot features of the inner arm 12 under the return 18 32 Features of the outer arm 14 that enable attachment to the base 5 34 Features of the outer arm 14 that enable attachment to the base 5 37 Slot features of the outer arm 14 38 Features of the outer arm 14 that enable the suture to form a loop and manipulate the arm of the fixation device 39 Features of the outer arm 14 that enable the suture to form a loop and manipulate the arm of the fixation device 40 Features of the outer arm 14 that enable the suture to form a loop and manipulate the arm of the fixation device Features of the outer arm 14 that enable the suture to form a loop and operate the arm of the fixation device 50 Left bracket of the base bracket 5 52 Right bracket of the base bracket 5 56 Coupling features of the base bracket 5 60 Features of the bracket 50 that allow the passage of a screw 61 Features of the bracket 52 that allow the passage of a screw 62 Features of the bracket 50 that allow the passage of a screw 63 Features of the bracket 52 that allow the passage of a screw 65 Hole for passing the release rod 70 Release bar, the most distal component of the delivery catheter that makes interface contact with the fixation device 72 Release bar, the most distal component of the delivery catheter that makes interface contact with the fixation device 80 Features of the release bars 70, 72 that enable the suture to form a loop and operate the arm of the fixation device 81 Features of the release bars 70, 72 that allow the passage of the suture 82 Features of the release bars 70, 72 that allow the passage of the suture 83 Features of the release bars 70, 72 that allow the passage of the suture 84 Features of the release bars 70, 72 that allow the passage of the suture 85 Features of the release bars 70, 72 that allow the passage of the suture 86 Features of the release bars 70, 72 that allow the passage of the suture 87 Features of the release bars 70, 72 that allow the passage of the suture 88 Features of the release bars 70, 72 that allow the passage of the suture 95 Hinge components coupled to the inversion devices 101 and 102 101 Right inversion device 102 Left inversion device 110 Features of the inversion device 117 that moors the inversion device to the release bars 70, 72 111 Features of the inversion device 101 that enable the suture to form a loop and allow the operation of the arm Features of the reversing device 102 that enable the suture to form a loop and enable the operation of the arm Embodiment of the left reversing device with the stopper 142 Embodiment of the right reversing device with the stopper 142 Operation of the inner arm Operation of the inner arm Compartment of the suture 131 Compartment of the suture 130 Compartment of the suture 131 Compartment of the suture 130 Suture that enables the control of the inner arm 12 or 14 Suture that enables the control of the inner arm 12 or 14 Operation of the suture 130, straightening the inner arm 12 Actuating rod with a distal suture loop Structural actuating tube with a distal suture loop and a proximal suture end Stopping features of the reversing devices 116 and 117 to prevent the reversing device from reversing to the wrong side Features of the release bars 70, 72 that allow the passage of sutures, wires, plastic tubes, and / or metal tubes Features of the release bars 70, 72 that allow the passage of the release rod 160 Release rod that attaches the fixing device to the release bars 70, 72 Compartment of the suture 180 Compartment of the suture 181 Compartment of the suture 180 Compartment of the suture 181 Compartment of the suture 180 Compartment of the suture 181 Suture that enables the control of the outer arm 13 or 15 Suture that enables the control of the outer arm 13 or 15 Exemplary embodiment of a fixing device used to capture the tip of the outer arm 193 Outer arm, exemplary embodiment of a fixation device used to capture a tip 192 Inner arm, exemplary embodiment of a fixation device used to capture a tip 194 Inner arm, exemplary embodiment of a fixation device used to capture a tip 195 Outer arm, exemplary embodiment of a fixation device used to capture a tip 197 Outer arm, exemplary embodiment of a fixation device used to capture a tip 204 Tissue grasping arm 210 Hook feature of tissue grasping arm 204 212 Return feature of tissue grasping arm 204 222 Base length of fixation device embodiment 224 Base width of fixation device embodiment 225 Functional length of tissue grasping arm 204 227 Functional width of tissue grasping device 250 Band-like feature of inner arm 192 that attaches wire loops together 252 Small wire loop within the arm made from wire for passing the actuating suture 280 Suture loop that allows passage of the suture and controls the outer arm 281 Suture loop that allows passage of the suture and controls the outer arm 282 Suture loop that allows passage of the suture and controls the outer arm 283 Suture loop that allows passage of the suture and controls the inner arm 330 Actuating rod of the handle that enables operation of the outer arm 331 Actuating rod of the handle that enables operation of the inner arm 332 Actuating rod of the handle that enables operation of the inner arm 333 Actuating rod of the handle that enables operation of the outer arm 350 Exemplary embodiment of a custom handle for outer and inner arm operation 360 Short delivery shaft Release knob of the handle 350 enabling the control of the release rod 160 Opening of the handle 350 for the delivery shaft Features of the handle for tightening the screw to control 350 Positioning screw features of the handle 350 for fastening the delivery shaft Features of the handle 350 for operating the arm Features of the handle 350 for operating the arm Features of the handle 350 for operating the arm Features of the handle 350 for operating the arm Features of the handle 350 for flushing a line or sensor line or for operating the arm Features of the handle 350 for flushing a line or sensor line or for operating the arm Features of the handle 350 enabling the coupling of the release knob 372 Proximal thread features of the handle 350 enabling the control and operation of the release knob 372 Distal thread features of the handle 350 enabling the control and operation of the release knob 372 Detachment suture section of the curved fixation device Detachment suture section of the curved fixation device Detachment suture section of the curved fixation device Suture loop enabling the passage of the suture 600 Embodiment of the curved fixation device Operation of the release rod 160 Operation of the suture 602 Operation of the release bar 72 Single lumen braided shaft Multi-lumen braided shaft Braiding Inner lumen of the braided shaft Peripheral lumen for the guide wire, release rod, and / or suture 732 Single-lumen shaft 734 Floating lumen for passing a guide wire, suture, plastic tube, and / or metal tube 736 Lumen of a multi-lumen catheter that enables passage of a wire, suture, plastic tube, and / or metal tube 737 Lumen of a multi-lumen catheter that enables passage of a wire, suture, plastic tube, and / or metal tube 739 Lumen of a multi-lumen catheter that enables passage of a wire, suture, plastic tube, and / or metal tube 740 PEEK tubes / Torque cables 800 Features of a catheter handle 850 Distal tip of a guiding catheter 900 Radiopaque marker of a steerable guiding catheter 901 Intermediate steerable guide shaft section that enables a stiffness transition for bi-directional and / or 4-directional steering 905 Proximal shaft of a steerable guiding catheter 940 Stainless steel sheath for supporting a delivery catheter 950 Stainless steel sheath for supporting a steerable guide handle 975 Exemplary embodiments of a custom steerable guiding catheter handle 977 Exemplary embodiments of a custom delivery catheter handle 980 Operation of a guiding catheter 981 Operation of a guiding catheter 982 Operation of a guiding catheter 985 Operation of a delivery catheter 986 Operation of a delivery catheter 987 Operation of a delivery catheter 988 Operation of a delivery catheter 1000 Shaft of a guiding catheter 1010 Distal steerable guide shaft section that enables a stiffness transition for bi-directional and / or 4-directional steering The distal shaft of the delivery catheter that is potentially unsupported when extending outside the 1020 guide catheter The proximal shaft of the delivery catheter 1021 Exemplary embodiments of the fixation device 1040 The balloon-like feature 1052 of the feature 1060 that stabilizes the delivery catheter 1020 during the procedure The third steerable guide catheter The detachable guide catheter 1055 The pushing / pulling feature of the detachable guide catheter 1057 1055 Features that can be attached to the guide catheter 1000 or the delivery catheter 1060 1020 The suture loop 1082 The umbrella-like feature of the feature 1060 1100 The umbrella-like feature of the feature 1060 1110 The bumper-like feature of the feature 1060 1115 The nested planar shape of the bell shape 1120 The suture that enables the operation of the feature 1120 1130 The suture that enables the operation of the feature 1120 1131 The tissue grasping device 1140 The tissue grasping device 1141 The connector base 1144 The tether that connects the tissue grasping arm 1040 to the base 1044 1146 The tether that connects the tissue grasping arm 1041 to the base 1044 1147 The tissue grasping device with a tether 1150 The tissue grasping device with a tether 1151 The tether that connects the tissue grasping arm 1150 to the tissue grasping arm 1151 1155 The location of the tissue grasping device on the atrial wall 2000 The location of the tissue grasping device on the mitral annulus 2002 The location of the tissue grasping device at the tip edge of the mitral valve 2004 The location of the tissue grasping device at the tip of the mitral valve tip 2006 LF Mitral valve tip PM Papillary muscle of the left ventricle

[0474] Although many embodiments of the present disclosure have been described in detail, certain variations and modifications will be apparent to those skilled in the art, including embodiments that do not provide all of the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and / or uses and their obvious modifications and equivalents. Additionally, although some variations have been shown and described in detail, other modifications within the scope of the present disclosure will be readily apparent to those skilled in the art based on the present disclosure. Also, various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and are still considered to be within the scope of the present disclosure. Therefore, it should be understood that the various features and aspects of the disclosed embodiments may be combined with each other or substituted for each other to form various modes of the present disclosure. Accordingly, it is intended that the scope of the present disclosure herein disclosed should not be limited by the specific disclosed embodiments described above. For all of the embodiments described above, the steps of any method need not be performed continuously.

Claims

【Claim 1】 The invention described in the drawings of the present application.

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