Implantable transcatheter intracardiac devices, devices for deploying intracardiac devices in a patient, and associated methods

Abstract

A valve device comprises a valve body with a framework and a valve portion coupled to the framework that is movable between open and closed positions. The framework comprises a plurality of wire portions. The valve portion may be formed of a material that promotes in-growth of native tissue so that the valve portion cooperates with native valve leaflets. The valve device also comprises one or more anchors and anchor tethers that secure the valve device in a heart. In some examples, the method includes folding and loading the valve body into a valve cartridge, delivering the valve body through a guide tube to a position the valve body at a target positioned within the heart, pushing the valve body out of the guide tube, and secure the anchors and anchor tethers in the heart, and cutting the anchor tethers to remove excess portions.

Description

Implantable Transcatheter Intracardiac Devices, Devices for Deploying Intracardiac Devices in a Patient, and Associated Methods CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 63 / 645,034, filed May 9, 2024, the disclosure of which is incorporated by reference in its entirety. TECHNICAL FIELD

[0002] These teachings relate generally to heart valve implants and methods of deploying heart valve implants in a patient. BACKGROUND

[0003] Atrioventricular valves regulate blood flow in the heart between the atria, the upper chambers, and the ventricles, the lower chambers. Atrioventricular valves include valve leaflets that open and close to control blood flow. Valve leaflets are thin, flexible flaps that anchor to a fibrous ring between the atrium and the ventricle called the valve annulus. When an atrioventricular valve is incompetent, the valve does not close tightly and leaks. The leakage of an atrioventricular valve results in blood flowing backwards from the ventricle into the atrium. This backward flow is called regurgitation.

[0004] Incompetent atrioventricular valves can be treated by removing the native valve leaflets of a patient and replacing the leaflets with an artificial valve. Some artificial valves, particularly those that are designed to be stationary or fixed relative to the valve annulus, can create a risk of left ventricular outflow track obstructions, paravalvular leaks, and stenosis, i.e., narrowing, or obstruction to the desired flow of blood into the ventricle.

[0005] Herein is contemplated a valve device that can be used to treat incompetent atrioventricular valves. Generally, the valve device can include a hub device securing a wire framework. A flexible valve portion is coupled to the wire framework and surrounds at least a portion of the framework. The flexible valve portion or portions thereof can be made from a material that promotes the in-growth of native valve tissue. Further, when the valve device is deployed in a patient, the valve portion cooperates with native valve leaflets. 1 Attorney Docket No.21885-161818

[0006] Also contemplated is a method for deploying the valve device in a patient. Generally, the method can include securing an anchor in a patient via an anchor tether using a steerable guiding sheath. A proximal end of the anchor tether extends out of a proximal end of the steerable guiding sheath. The proximal end of the anchor tether is threaded through a valve body that is folded and loaded in a valve cartridge. The valve body is then pushed distally along the anchor tether out of the valve cartridge, into the steerable guiding sheath, and into an atrioventricular valve of the patient such that a valve portion of the valve body engages native valve leaflets of the atrioventricular valve. The valve can be locked in place by a locking mechanism positioned proximal of the valve body. The anchor tethers are then cut proximal of the locking mechanism to remove a proximal end portion of the anchor tethers.

[0007] Also contemplated is a surgical kit that can be used to deploy the valve device. The surgical kit can include the valve device and at least one anchor coupled to an anchor tether. The surgical kit can further include one or more of: a table mount assembly for holding a steerable guiding sheath that is used to guide the valve and other deployment devices into a patient; a valve folding assembly for collapsing the valve body; an anchor handle assembly for deploying the anchors and anchor tethers in a patient; and a locking and cutting assembly for locking the valve device and cutting excess portions of the anchor tethers.

[0008] Also contemplated is a table mount assembly that can be used to deploy the valve device. The table mount assembly generally includes a guide sheath that removably secures the guide sheath used to insert the valve device and other deployment devices into a patient. The table mount assembly also includes suture clamps for holding the proximal end of the anchor tethers used to secure the valve body to the patient during the deployment process.

[0009] Also contemplated is a valve folding assembly that can be used to fold the valve device in preparation for the deployment process. The valve folding assembly generally includes a valve folding base with a cart that is slidably mounted thereto. A valve loading base is removably coupled to the valve folding base. The valve loading base includes a funnel, with a valve cartridge disposed at the narrow end of the funnel and a chuck assembly disposed at a wide end of the funnel. The valve body is loaded in the funnel and secured to the chuck assembly. A suture is coupled to the cart and extends through the cartridge and the narrow end of the funnel, coupling at another end to the valve body. Pulling the cart away from the funnel collapses the valve body by guiding the valve body towards the narrow end of the funnel. 2 Attorney Docket No.21885-161818Pushing the valve folding base towards the chuck assembly loads the collapsed valve into the cartridge.

[0010] Also contemplated is an anchor handle assembly with an outer tube coupled to an anchor handle. An anchor subassembly is also included which includes an inner tube disposed in the outer tube of the anchor handle assembly. A proximal end of the anchor handle assembly includes a plunger that is received by the anchor handle. A distal end of the anchor handle assembly includes the anchor and the anchor tether extends from the anchor to the anchor handle.

[0011] Also contemplated is a locking and cutting assembly that includes an outer casing with a pulling handle at a proximal end of the outer casing and a locking and cutting device at a distal end of the outer casing. The locking and cutting device includes inner and outer cutting tubes with complementary cutting lips for cutting the anchor tethers. The locking and cutting device also includes a locking pin and locking bead that secure the tethers therebetween to lock the valve device in place. A pulling wire extends through the outer casing and is coupled to the pulling handle at one end and the locking pin at the other end. Actuation of the pulling handle moves the pulling wire to draw the inner cutting tube into the outer cutting tube to cut the anchor tethers. Actuation of the pulling handle also pulls the locking pin into engagement with the locking bead to secure the anchor tethers. BRIEF DESCRIPTION OF DRAWINGS

[0012] The above needs are at least partially met through provision of the collapsible rolling walker described in the following detailed description, particularly when studied in conjunction with the drawings, wherein:

[0013] FIG.1 is a top perspective view of a valve body according to one embodiment with the valve portion in an open configuration;

[0014] FIG.2 is a top perspective view of the valve body of FIG.1 with the valve portion in a closed configuration;

[0015] FIG.3 is a bottom perspective view of the valve body of FIG.1 with the valve portion the open configuration;

[0016] FIG.4 is a bottom perspective view of the valve body of FIG.1 with the valve portion in the closed configuration; 3 Attorney Docket No.21885-161818

[0017] FIG.5 is an enlarged view of a distal end portion of the valve body of FIG.1 with the valve portion in the open configuration;

[0018] FIG.6 is an exploded view of the valve body of FIG.1 with the valve portion hidden;

[0019] FIG.7A is a top perspective view of the valve body of FIG.1 with the valve portion hidden;

[0020] FIG.7B is a side elevation view of the valve body of FIG.7A;

[0021] FIG.8 is a side elevation view of the valve body of FIG.7A with a portion of the wire framework hidden;

[0022] FIG.9 is a partial, cross-sectional view of a distal end portion of the valve body shown in FIG.7A;

[0023] FIGS.10A–10G show various views of the valve body of FIG.1 with the valve portion in the open configuration;

[0024] FIGS.11A–11G show various views of the valve body of FIG.1 with the valve portion in the closed configuration;

[0025] FIG.12 is a top perspective view of a valve device that includes the valve body of FIG.1 coupled to anchors and anchor tethers with the valve portion in the open configuration;

[0026] FIG.13 is a bottom perspective view of the valve device of FIG.12 with the valve portion in the open configuration;

[0027] FIG.14A is a cross-sectional view of the valve device of FIG.12 taken along line 14A-14A;

[0028] FIG.14B is a cross-sectional view of the valve device of FIG.12 taken along line 14B-14B;

[0029] FIG.15A–15G show various views of the valve device of FIG.12 with the valve portion the open configuration;

[0030] FIG.16 shows the valve device of FIG.12 installed in a heart;

[0031] FIG.17 is a side elevation view of the valve device of FIG.12 with the valve portion in the closed configuration;

[0032] FIG.18 is a top perspective view of a table mount assembly according to one embodiment;

[0033] FIG.19 is a top perspective view of the table mount assembly and a steerable guiding sheath in a first operational configuration in an embodiment;

[0034] FIG.20 is a top perspective view of the table mount assembly and steerable guiding sheath in a second operational configuration in an example embodiment; 4 Attorney Docket No.21885-161818

[0035] FIG.21 is a top perspective view of the table mount assembly and steerable guiding sheath in a third operational configuration in an embodiment;

[0036] FIG.22 is a top perspective view of the table mount assembly and steerable guiding sheath with an anchor handle assembly in a first operational configuration in an embodiment;

[0037] FIG.23 is an enlarged view of a proximal end portion of the anchor handle assembly in an embodiment;

[0038] FIG.24 is an exploded view of the proximal end portion of the anchor handle assembly in an embodiment;

[0039] FIG.25 is an enlarged view of a distal end portion of the anchor handle assembly in an embodiment;

[0040] FIG.26 is a top perspective view of the table mount assembly, steerable guiding sheath, and anchor handle assembly in a second operational configuration in an embodiment;

[0041] FIG.27 is an enlarged view a proximal end portion of the anchor handle assembly in an embodiment;

[0042] FIG.28 is an enlarged view a proximal end portion of the anchor handle assembly in an embodiment;

[0043] FIGS.29A–29C show cross-sectional views of the distal end portion of the anchor handle assembly in various operational configurations in an embodiment;

[0044] FIGS.30A–30E show cross-sectional views of the distal end portion of the anchor handle assembly in various operational configurations in an embodiment;

[0045] FIG.31 is a top perspective view of the table mount assembly and steerable guiding sheath in a fourth operational configuration in an embodiment;

[0046] FIG.32 is a top perspective view of the table mount assembly and steerable guiding sheath in a fifth operational configuration in an embodiment;

[0047] FIG.33 is a partial, enlarged view of the table mount assembly in the fifth operational configuration;

[0048] FIG.34 is a top perspective view of the table mount assembly and steerable guiding sheath in a sixth operational configuration in an embodiment;

[0049] FIG.35 is a top perspective view of the table mount assembly and steerable guiding sheath in a seventh operational configuration in an embodiment;

[0050] FIGS.36A and 36B show perspective views of an alternative anchor for the valve device in an embodiment; 5 Attorney Docket No.21885-161818

[0051] FIGS.37 is a perspective view of another alternative anchor for the valve device in an embodiment;

[0052] FIG.38 is a top perspective view of a valve loading jig according to one embodiment;

[0053] FIG.39 is an exploded partial view of the valve loading jig in an embodiment;

[0054] FIGS.40A–40D show top perspective views of the cart of the valve loading jig in various operational configurations in an embodiment;

[0055] FIG.41 is an exploded view of the valve folding assembly in an embodiment;

[0056] FIG.42 is a top perspective view of the valve folding assembly in a first operational configuration in an embodiment;

[0057] FIG.43 is a top perspective view of the valve folding assembly in a second operational configuration in an embodiment;

[0058] FIGS.44A and 44B show partial front perspective views of the valve folding assembly in different operational configurations in an embodiment;

[0059] FIG.45 is a top perspective view of the valve folding assembly in a third operational configuration in an embodiment;

[0060] FIG.46 is a top perspective view of the valve folding assembly in a fourth operational configuration in an embodiment;

[0061] FIG.47 is a top perspective view of the valve folding assembly in a fifth operational configuration in an embodiment;

[0062] FIGS.48A and 48B show enlarged cross-sectional views of the valve folding assembly in an embodiment;

[0063] FIG.49 is a top perspective view of the valve folding assembly in a sixth operational configuration in an embodiment;

[0064] FIG.50 is a top perspective view of the valve folding assembly in a seventh operational configuration in an embodiment;

[0065] FIG.51 is a top perspective view of the valve folding assembly in an eighth operational configuration in an embodiment;

[0066] FIG.52 is a top perspective view of the valve folding assembly in a ninth operational configuration in an embodiment;

[0067] FIG.53 is a top perspective view of the valve folding assembly in a tenth operational configuration in an embodiment;

[0068] FIG.54 is a top perspective view of a valve threader in an embodiment; 6 Attorney Docket No.21885-161818

[0069] FIG.55 is a top perspective view of the table mount assembly, steerable guiding sheath, and valve threader in a first operational configuration in an embodiment;

[0070] FIG.56 is a top perspective view of the table mount assembly, steerable guiding sheath, and valve threader in a second operational configuration in an embodiment;

[0071] FIG.57 is a top perspective view of the table mount assembly, steerable guiding sheath, and valve threader in a third configuration in an embodiment;

[0072] FIG.58 is a top perspective view of the table mount assembly with a loaded valve cartridge in an embodiment;

[0073] FIG.59 is a top perspective view of the table mount assembly and steerable guiding sheath with a valve pusher assembly in a first operational configuration;

[0074] FIG.60 is an enlarged view of a proximal end portion of the valve pusher assembly in an embodiment;

[0075] FIG.61 is an enlarged view of a distal end portion of the valve pusher assembly an embodiment;

[0076] FIG.62 a top perspective view of the table mount assembly, steerable guiding sheath, and valve pusher assembly in a second operational configuration;

[0077] FIG.63 is an enlarged view of a distal end portion of the valve pusher assembly in an embodiment;

[0078] FIG.64 a top perspective view of the table mount assembly, steerable guiding sheath, and valve pusher assembly in a third operational configuration;

[0079] FIG.65 is a top perspective view of the table mount assembly and steerable guiding sheath showing the valve body deployed in an embodiment;

[0080] FIG.66 is a top perspective view of the table mount assembly and steerable guiding sheath with a the locking and cutting assembly in a first operational configuration;

[0081] FIG.67 is an exploded view of the proximal end portion of the locking and cutting assembly in an embodiment;

[0082] FIG.68 is an enlarged, exploded view of the proximal end portion of the locking and cutting assembly in an embodiment;

[0083] FIG.69 is an enlarged, exploded view of a distal end portion of the locking and cutting assembly in an embodiment;

[0084] FIG.70 is an enlarged view of the distal end portion of the locking and cutting assembly in an embodiment; 7 Attorney Docket No.21885-161818

[0085] FIG.71 is an enlarged view of the distal end portion of the locking and cutting assembly in an embodiment;

[0086] FIG.72 is an enlarged view of the distal end portion of the locking and cutting assembly in an embodiment;

[0087] FIG.73 is an enlarged view of the distal end portion of the locking and cutting assembly in an embodiment;

[0088] FIG.74 is a top perspective view of the table mount assembly, steerable guiding sheath, and locking and cutting assembly in a second operational configuration;

[0089] FIG.75A is a top perspective view of the table mount assembly, steerable guiding sheath, and locking and cutting assembly in a third operational configuration;

[0090] FIG.75B is an enlarged view of a distal end of the table mount assembly, steerable guiding sheath, and locking and cutting assembly in the third operational configuration;

[0091] FIG.76 is an enlarged view of the proximal end portion of the locking and cutting assembly in an embodiment;

[0092] FIG.77 is a top perspective view of the table mount assembly, steerable guiding sheath, and locking and cutting assembly in a fourth operational configuration;

[0093] FIG.78 is an enlarged view of the proximal end portion of the locking and cutting assembly in an embodiment;

[0094] FIGS.79A–79E are cross-sectional views of the distal end portion of the locking and cutting assembly in various operational configurations;

[0095] FIG.80A is a top perspective view of the table mount assembly showing the valve device fully deployed in an embodiment;

[0096] FIG.80B is an enlarged view of a distal end portion of the table mount assembly with the valve device fully deployed;

[0097] FIG.81 is a top perspective view of an alternative embodiment of a valve body;

[0098] FIG.82 is a top perspective view of an alternative embodiment of a table mount assembly;

[0099] FIG.83 is a bottom perspective view of the alternative embodiment of the table mount assembly;

[0100] FIGS.84A and 84B are front elevation view of a steerable guiding sheath clamp on the alternative embodiment of the table mount assembly; 8 Attorney Docket No.21885-161818

[0101] FIG.85 is a top perspective view of an alternative embodiment of a steerable guiding sheath;

[0102] FIG.86 is a top perspective view of an alternative embodiment of an anchor handle assembly;

[0103] FIG.87 is an enlarged top perspective view of a distal end portion of the steerable guiding sheath with the valve body with constraining sutures;

[0104] FIG.88 is an enlarged top perspective view of a distal end portion of the steerable guiding sheath with the valve body and constraining sutures in a first operational configuration;

[0105] FIG.89 is an enlarged top perspective view of a distal end portion of the steerable guiding sheath with the valve body and constraining sutures in a second operational configuration;

[0106] FIG.90 is an enlarged top perspective view of a distal end portion of the steerable guiding sheath with the valve body and constraining sutures in a third operational configuration;

[0107] FIG.91 is a top perspective view of a suture cutting assembly, in an embodiment;

[0108] FIG.92 is an exploded, enlarged top perspective view of a proximal end portion of the suture cutting assembly;

[0109] FIG.93A is an enlarged side, cross-sectional view of a distal end portion of the suture cutting assembly, in a first operational configuration;

[0110] FIG.93B is an enlarged side, cross-sectional view of a distal end portion of the suture cutting assembly, in a second operational configuration;

[0111] FIG.94 is a top perspective view of a valve pusher, in an embodiment;

[0112] FIG.95 is an enlarged view of a distal end portion of the valve pusher, in an embodiment;

[0113] FIG.96 is an enlarged view of a distal end portion of the valve pusher, with the funnel and valve cartridge hidden; and

[0114] FIG.97 is a schematic diagram of a surgical kit, in an embodiment.

[0115] Elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present teachings. Also, common but well- understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments of 9 Attorney Docket No.21885-161818the present teachings. Certain actions and / or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. The terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein. DETAILED DESCRIPTION

[0116] Generally speaking, heart valve devices and the systems and methods for deploying heart valve devices are disclosed. The disclosed valve devices include transcatheter intracardiac devices designed for placement within an incompetent native atrioventricular valve (e.g., mitral valve, tricuspid valve). The valve devices are designed to reduce or eliminate regurgitant jet associated with an incompetent atrioventricular valve. The valve devices described herein cooperate with, rather than replace or interfere with, native valve structure. Thus, the valve devices reduce or eliminate regurgitant jet without requiring removal of native valve structure or disruption of the atrioventricular apparatus.

[0117] In some examples, the valve device comprises a valve body with a collapsible frame and a valve portion that is movable between open and closed positions. The valve device includes one or more anchors and anchor tethers that secure the valve device in a heart. When secured in the heart of a patient, the valve device extends from a distal portion of the ventricle to a more proximal portion which is proximal to native valve leaflets of an atrioventricular valve. The valve portion cooperates or works in cooperative apposition with native valve leaflets to improve coaptation. Native leaflets engage the valve portion and apply a sealing force to the valve device to ensure unidirectional blood flow from the atria into the ventricle. Cooperating with the native valve leaflets also synchronizes the valve device with natural opening and closing of the native valve caused by contraction of heart.

[0118] The valve devices can be deployed in a patient via a transcatheter venous approach or a trans-left auricular appendage approach. Various deployment devices are provided for deploying the heart valve devices described herein in a patient. Custom kits are disclosed which are equipped with the heart valve device and associated deployment devices.The disclosed valve devices, deployment devices, and deployment methods are intended for use in humans and other mammals. 10 Attorney Docket No.21885-161818

[0119] The valve devices and the deployment devices described herein have a low profile. The low profile reduces procedural risk associated with deploying the valve device in a patient. Unlike many transcatheter mitral valve replacement (TMVR) designs, which use large delivery systems and require transapical or large transseptal access, the valve devices described herein can be delivered using a sheath having an inner diameter in the range of about 6 French to about 13 French.

[0120] Further, the valve devices described herein are stentless. Traditional TMVR devices may include an outer stent to support artificial leaflets. The stent may secure native valve leaflets, preventing the natural functioning of native leaflets, and occlude the left ventricular outflow tract creating a risk of left ventricular outflow tract obstruction. In contrast, the valve devices described herein include a valve portion that is tubular and flexible and framework that is central to the valve portion, the valve portion engages and moves in cooperation with native valve leaflets. Because the valve devices are stentless and include a framework that is secured within the valve annulus, the valve devices also reduce the risk of left ventricular outflow tract obstruction.As used herein, the terms “proximal” and “proximally” are used to indicate positions closer to the surgeon along the path of a delivery device. The term “distal” and “distally” are used to indicate positions farther from the surgeon along the path of a delivery device.

[0121] As used herein, “radially” is used to include laterally and anteriorly / posteriorly in the patient while “longitudinally” is used to indicate the long axis of the heart.

[0122] Referring now to the drawings, FIGS.1–17 depict various views of a valve device 10. The valve device 10 generally includes a valve body 11 that comprises a hub assembly 12, a framework 14, and a valve portion 16. When deployed in a patient, the valve device 10 further comprises one or more anchors 36 and anchor tethers 38 to secure the valve body 11 to the native cardiac tissue of a patient. The framework 14 supports the valve portion 16 while hub assembly 12 supports the framework 14 and provides a structure for the anchors 36 to secure the framework 14 within the heart.

[0123] FIGS.1–11 show the valve body 11 of the valve device 10. The valve body 11 controls the flow of blood through the heart during systole and diastole. The framework 14, the hub assembly 12, and the valve portion 16 are collectively referred to as the “valve body”.

[0124] The framework 14 includes a plurality of wire sections 18 which are held in place by the hub assembly 12. In some examples, each of the wire sections 18 is formed of a single wire. As illustrated, the wire sections 18 are generally petal shaped. That is, the wire sections 18 are 11 Attorney Docket No.21885-161818shaped as curved, generally triangular sections. The curved portion of the petal promotes contact with the native valve annulus, while linear portions of the petal serve to inhibit prolapse or flail of the native leaflets and the valve portion 16. However, the wire sections 18 may have other suitable shapes that are suitable to support the valve portion 16. The shape of the framework 14 helps to prevent prolapse of the valve portion 16 during systole and to allow blood to flow through the valve device 10 during diastole. In the illustrated embodiment, the framework 14 includes three wires sections, though, the framework 14 can include any suitable number of wires sections 18. Other embodiments may comprise fewer or more wires or wire sections 18 (e.g., 2, 4, 5, 6, 7, 8 etc.).

[0125] The framework 14 is centrally located within the valve portion 16. Positioning the framework 14 centrally within the valve portion 16 may mitigate or eliminate the risk of left ventricular outflow tract obstruction since the framework 14 is not pinning natural valve leaflets against the ventricular wall or interfering with the left ventricular outflow tract.

[0126] Each wire section 18 of the framework 14 comprises a pair of stem portions 19, a pair of legs 20, and an outer rim portion 22. The legs 20 extend outward radially from the stem portion 19. The legs 20 of the wire sections 18 can be angled to diverge outwardly at substantially equal angles from the axis of the stem portion 19 (e.g., which aligns with the axis of the locking shaft 26) to improve the effectiveness of the framework 14 in preventing prolapse of the valve portion 16. The outer rim portion 22 extends circumferentially about the stem portion 19. The outer rim portion 22 of one or more of the wire sections 18 includes a protuberance 24. As discussed further below, the protuberances 24 are nipple-shaped and facilitate the loading of the valve body 11 into a valve cartridge 122 (see e.g., FIG.38) for delivery to the patient. The protuberances 24 also can facilitate re-constraining of the valve body 11 during the deployment process, e.g., for retracting the valve body 11 back into the steerable guiding sheath 52. Further, the protuberances 24 facilitate atrial anchoring of the valve body 11 to native valve tissue by providing space or notch in the framework 14 through which an anchor can be inserted. The stem portion 19 includes the two end portions of the wire that forms the wire section 18. The end portions of the wire include bends 21, which are shown in FIG.9.

[0127] As shown in Fig.7B, the framework 14 has a proximal side 14A and a distal side 14B. When deployed in a heart, the proximal side 14A of the framework 14 faces the atrium and the distal side 14B faces the ventricle. The valve portion 16 is disposed on the distal side 14B of the 12 Attorney Docket No.21885-161818framework 14. As described in further detail below, the anchor tethers 38 are inserted through the hub assembly 12 from the proximal side 14A of the framework 14.

[0128] In some embodiments, the framework 14 is formed from a Nitinol material (e.g., one or more Nitinol wires). Though, it is contemplated that other suitable shape memory alloys, metallic alloys, or polymeric compounds could be used. The framework 14 is formed from a flexible material such that the framework 14 can be folded or collapsed as is described further below when the valve body 11 is deployed in a patient. The flexibility of the framework 14 also allows petal shaped wire portions 18 of the framework 14 to conform the valve annulus of a native valve and to permit normal contraction of the valve annulus when the valve body 11 is deployed in a patient.

[0129] The valve portion 16 is coupled to the framework 14. The valve portion 16 surrounds the distal side 14B (e.g., an outward facing portion) of the framework 14. The valve portion 16 is a collapsable tube that is movable between an open configuration (see FIGS.10A–10G) and a closed configuration (see FIGS.11A–11G). The figures illustrating valve portion 16 in the closed configuration are not intended to limit the shape of the valve portion 16 when it is collapsed against the framework 14 and hub assembly 12 into the closed configuration during the systole. For example, while certain figures, such as FIGS.2, 4 and 10–10G, depict the valve portion 16 as smooth, during operation the valve portion 16 may be pressed up against the framework 14 and the hub assembly 12 in an uneven manner, resulting in wrinkling of the valve portion 16 as depicted in FIG.17.

[0130] The valve portion 16 includes an inward facing portion 16A (see FIGS.1 and 2) and an outward facing portion 16B (see FIGS.3 and 4). The inward facing portion 16A includes an inward facing surface that surrounds the hub assembly 12 and the framework 14. The outward facing portion 16B comprises an outward facing surface. The valve portion 16 is positioned distally of the framework 14 such that the inward facing portion 16A is adjacent to the distal side 14B (see FIG.7B) of the framework 14. Thus, in operation, the inward facing portion 16A of the valve portion 16 or portions thereof move into and out of engagement with the distal side 14B of the framework 14.

[0131] The valve portion 16 also includes a proximal end 13 and a distal end 9. When deployed in a heart, the proximal end 13 of the valve portion 16 is disposed in the atria and the distal end 9 is disposed in the ventricle. The proximal end 13 of the valve portion 16 is secured to the outer rim portions 22 of the framework 10. The distal end 9 of the valve portion 16 is disposed 13 Attorney Docket No.21885-161818adjacent to and surrounding the hub assembly 12 (or a portion of the hub assembly 12). The distal end 9 of the valve portion 16 is not secured to the framework 14. Because the distal end 9 is unsecured, the distal end 9 is free to move away from the hub assembly 12 and framework 14 when opening and collapse against the hub assembly 12 and the framework 14 when closing during the cardiac cycle.

[0132] In an alternative embodiment, the valve portion 16 is secured to portions of the legs 20. For example, the valve portion 16 can be secured to proximal portions of the legs 20 while leaving distal portions of the valve portion 16 (e.g., portions adjacent to the hub assembly 12) unsecured to the framework 14. This configuration keeps the valve portion 16 located generally distally of the framework 14 while allowing the valve portion 16 to move away from the framework 14 and the hub assembly 12 during the diastolic portion of the cardiac cycle and to be pushed against the framework 14 and the hub assembly 12 during the systolic portion of the cardiac cycle.

[0133] The valve portion 16 can be longer or shorter so that the valve portion 16 extends further or not as far down the hub assembly 12 as the valve portion 16 illustrated in the figures. The distal end 9 of the valve portion 16 can have a length that is shorter than, equal to, or longer than the hub assembly 12, In one example, the valve portion 16 is shorter than the hub assembly 12 such that the valve portion 16 does not cover the length of the hub assembly 12. In another example, the valve portion 16 is longer than the hub assembly 12 such that the valve portion 16 extends beyond the length of the hub assembly 12. In another example, the length of the valve portion 16 is such that the valve portion 16 is flush with the hub assembly 12.

[0134] The valve portion 16 includes an apron 34. The apron 34 is a generally annular region that curves outward radially. The apron 34 forms the radially outer, peripheral portion of the valve body 11. The apron 34 is curved outwardly or radially to conform to the outer portions of the valve annulus and / or the floor of the atrium. This shape also conforms to the preferred shape of the framework 14 and serves as a platform to facilitate the ingrowth of native valve tissue from the native valve annulus into the apron 34 of the valve portion 16 over time to better secure the valve device 10 to the valve annulus and within the atrium. The outer rim portions 22 of the framework 14 and the apron 34 of the valve portion 16 are sized to have a greater diameter than the native valve annulus of the patient. So sized, the framework 14 and the valve portion 16 cannot fall or be pushed into the ventricle by blood flow. The apron 34 is secured to the outer rim portion 22 of the framework 14. In the illustrated embodiment, the 14 Attorney Docket No.21885-161818valve portion 16 comprises tabs which are folded over the outer rim portions 22 of the framework 14. The tabs are secured to the apron 34, for example, via adhesive, welding, stitching, or other mechanical fasteners.

[0135] The valve portion 16 can be formed from any suitable material. Suitable materials include expanded polytetrafluoroethylene (ePTFE) made by W.L. Gore & Associates, Inc., porcine pericardium or processed small intestine submucosa, thermoplastic polyurethane (TPU), siliconized TPU, or a variety of other synthetic polymers such as polyglycolide, polycaprolactone, polylactide, polyurethane, Teflon®, polystyrene, polyester, polymethyl methacrylate (PMMA), or polyvinyl alcohol, or natural polymers such as gelatin, collagen, cellulose, chitin, silk or wool, or a combination of synthetic polymer(s) and / or natural polymer(s).

[0136] In some examples, the valve portion 16 is formed of a material which facilitates the in- growth of native tissue over time. In particular, the apron 34 can be formed of a material that facilitates in-growth of native tissue so that the apron 34 is secured to or mates with the native valve annulus over time. The apron 34 may be formed from the same material as the rest of the valve portion 16 or of a different material, for example, to promote the in-growth of native valve tissue in this portion of the valve portion 16. Use of siliconized TPU or collagen fibers may help to promote the endothelialization the valve portion 16. Siliconized TPU functions to enhance biocompatibility, thromboresistance, and durability of the valve portion 16. The electrospun material structure of siliconized TPU may promote ingrowth of native tissue. Ingrowth of native tissue may help to maintain the integrity of the native atrioventricular apparatus (e.g., including the native valve annulus, valve leaflets, chordae tendineae, and the ventricular papillary muscle) when the valve device 10 is deployed in a patient. In some aspects, the pattern in which the material is deposited can be adjusted, for example, to increase a gap between adjacent fibers to allow for improved tissue ingrowth with the valve portion 16. While tissue ingrowth promotes healing and device stabilization, excessive or inappropriate ingrowth may lead to complications. Thus, portions or sections of the valve portion 16 may be selectively made from materials that promote tissue ingrowth, such as siliconized TPU. The pattern in which the material is deposited may also be adjusted to allow for desirable tissue ingrowth.

[0137] In some embodiments, the valve portion 16 is formed from an electrospun polymer such as TPU or siliconized TPU (Si-TPU), or another electrospun synthetic polymer. The valve portion 16 can also be formed from biological fibers such as collagen. Electrospun polymers can be formed very thin and durable. For example, an individual electrospun TPU fiber can have a 15 Attorney Docket No.21885-161818diameter of about 500 nanometers to about 5 microns. An electrospun valve portion 16 can be formed with a single layer of electrospun material having a thickness of about 30 microns to about 100 microns. In some aspects, the thickness of the valve portion 16 is in the range of about 30 microns to about 80 microns, about 40 microns to about 60 microns, or, in some aspects, about 50 microns. The thinness of the valve portion 16 facilitates the collapsing of the valve portion 16 against the framework during systole to more closely mimic the motion of a healthy heart valve. Additionally, the thinness of the valve portion 16 results in a valve body 11 which can be compressed or folded into a smaller overall diameter than previously known valve devices and can be deployed using a guiding catheter (e.g., the steerable guiding sheath 52) having an inner diameter of about 7.5 French (Fr), or about 6 Fr to about 13 Fr. By permitting delivery to the heart through smaller diameter devices, the disclosed embodiments provide vascular access to the heart through smaller diameter blood vessels. Use of smaller diameter devices to deploy the valve body 11 also reduces the risk of complications with large bore delivery systems that are used with many other transcatheter valve devices.

[0138] In some forms, the valve portion 16 or portions thereof include one or more markers to permit a surgeon to observe the position of the valve device 10 via imaging techniques (e.g., fluoroscopy, ultrasound) during and / or after a surgery. The markers can be fibers, implants, or any other suitable objects that are incorporated into the valve device 10 or a portion thereof. In some implementations, the markers can be added to a polymer material that is incorporated into the valve device 10. For example, barium sulfate can be added to a polymer solution in an amount up to about 20%. In some examples, markers are made of a radiodense material that inhibits the passage of electromagnetic radiation making the markers visible on X-ray images. In some examples, the markers are made of an echogenic material that reflects ultrasound waves making the markers visible on ultrasound images.The hub assembly 12 comprises a locking shaft 26, at least one inner hub fastener 32, and at least one outer hub fastener 30. The hub assembly 12 may also be referred to herein as the “valve connector” and / or the “shaft assembly.” The locking shaft 26 is a tube formed from a smooth, curved wall that defines a longitudinal bore 28. The longitudinal bore 28 extends from a proximal end to a distal end of the hub assembly 12. The longitudinal bore 28 permits the anchors 36 and the anchor tethers 38 to extend through this central section of the valve body 11. The locking shaft 26 includes one or more slots 27. As illustrated in FIG.6 and 9, the slots 27 extend longitudinally along the locking shaft 26. The bends 21 on the wire portions 18 engage the slots 27 in the locking shaft 26 (see FIG.9). For 16 Attorney Docket No.21885-161818example, the bend 21 on the end portion of each wire protrudes inwardly towards the locking shaft 26 such that at least a portion of the bend 21 is received by the slot 27 in the locking shaft 26.

[0139] In the illustrated embodiment, the hub assembly 12 includes two inner hub fasteners 32 and two outer hub fasteners 30, though any suitable number of hub fasteners 30, 32 or a different configuration can be used. The outer hub fasteners 30 are annular shaped disks that include a plurality of recesses 31. FIG.14A shows a cross-sectional view of an outer hub fastener 30. The inner hub fasteners 32 are annular shaped disks that include a plurality of recesses 33. FIG.14B shows a cross-sectional view of an inner hub fastener 32.

[0140] Other shapes for the longitudinal bore 28 and / or different numbers of recesses 31, 33 in each hub fastener 30, 32 can be used to accommodate frameworks 14 formed of different shapes or numbers of wires.

[0141] The stem portions 19 of the wire sections 18 are coupled to the hub assembly 12. The stem portions 19 are secured in place between the hub fasteners 30, 32 and the locking shaft 26. The stem portions 19 of the wire sections 18 are received by the recesses 31, 33 in the hubs 30, 32. The stem portions 19 are also received by the slots 27 in the locking shaft 26. Together, the bends 21 on the wire sections 18, the slots 27 in the locking shaft 26, and the recesses 31, 33 in the hubs 30, 32 cooperate to maintain the wire sections 18 securely in the hub assembly 12. In this embodiment, the stem portions 19 of each wire section 18 are relatively straight and are held in parallel spaced relation by the hub assembly 12. FIGS.6, 7A–7B, and 8 show various views of the hub assembly 12 and the framework 14.

[0142] In some embodiments, the valve body 11 has a length in the range of about 15 millimeters (mm) to about 50 mm, in the range of about 15 to about 35 mm, or, in some aspects, in the range of about 15 mm to about 25 mm. The valve body 1may also have a diameter in the range of about 15 mm to about 45mm, in the range of about 15 mm to about 35 mm, or, in some aspects, in the range of about 25 mm to about 35 mm.

[0143] FIGS.12–17 show the valve device 10, namely the valve body 11 shown in FIGS.1–11, with one or more anchors 36. Each anchor 36 is coupled to a corresponding anchor tether 38. The anchors 36 hold the valve body 11 against the native valve annulus when the valve body 11 is installed in a patient. In the illustrated embodiment, the valve device 10 includes three anchors 36 and three corresponding anchor tethers 38. Any suitable number of anchors 36 can be used. 17 Attorney Docket No.21885-161818

[0144] The anchor 36 can be any suitable fixation device or fastener. Suitable fixation devices include hooks such as treble hooks or j-shaped hooks, corkscrews, pins, etc. FIGS.36A–36B and 37 show alternative types of fixation devices that can be used as the anchor 36. In some embodiments, a combination of different types of anchors 36 are used. For example, some of the anchors 36 can be treble hooks and others can be corkscrews. In some implementations, the anchors 36 are formed of a shape-memory alloy, such as Nitinol, which allows the anchor barbs 36A to be delivered to a site in a straight configuration and to assume a final curved configuration when deployed (see FIGS.29A–29C, FIGS.30A–30E). The anchor tethers 38 are sutures and can be formed of any biocompatible monofilament. Suitable biocompatible monofilaments include but are not limited to nylon, polypropylene, and Teflon®. In some embodiments, the anchor tethers 38 are Gore-Tex tethers or elecrospun tethers of a specific design.

[0145] With particular reference to FIG.16, the valve device 10 is shown installed in a heart, namely, in a tricuspid valve. The heart is shown during the diastolic portion of the cardiac cycle with the valve portion 16 and the native leaflets N fully open. The native valve leaflets N are secured by the chordae tendineae C. As illustrated in FIG.16, the valve portion 16 extends over a proximal portion of the native leaflets N and extends radially outwardly toward the native valve annulus. In this embodiment, the anchors 36 are in the form of treble hooks, shaped similarly to treble fishhooks. The anchoring system holds the valve body 11 against the native valve annulus. The outer rim sections 14 of framework 10 (not visible in FIG.16) and apron 34 of valve portion 16 are sized to have a greater diameter than the native valve annulus C so the framework 14 and valve portion 16 cannot fall or be pushed into the ventricle by blood flow.

[0146] When positioned in the heart, as shown in FIG.16, the framework 14 prevents or limits the prolapse of native leaflets and / or the valve portion 16. The framework 14 extends from the hub assembly 12 to the native valve annulus. The framework 14 is extensive in its coverage of the region in which any possible prolapse of either a native leaflet or the valve portion 16 could occur.

[0147] When positioned in the heart of a patient, the valve portion 16 is preferably in contact with the native leaflets and moves with the native leaflets during the cardiac cycle. During the cardiac cycle, the valve device 10 controls the one-way flow of blood from the atria into the ventricle. The valve portion 16 opens and collapses against the framework 14 with each cycle of the heart. The valve portion 16 moves with the native leaflets during systole and diastole. 18 Attorney Docket No.21885-161818

[0148] During diastole, the valve portion 16 moves away from the framework 14 and the hub assembly 12 into an open configuration by diastolic blood flow. Apart from the areas of the valve portion 16 which are affixed to the outer rim portions 22, and optionally to the legs 20 of the framework 14, the valve portion 16 is pushed in the distal direction (e.g., toward the ventricle). The valve portion 16 moves away from the hub assembly 12 and the framework 14 to open the valve portion 16. This allows blood to flow through the valve portion 16 into the ventricle. In other words, during diastole, blood flow initially opens the valve portion 16 and blood then flows through the open valve portion 16 as well as through the legs 20 of the framework 14.

[0149] During the systole, the valve portion 16 is collapsed against the framework 14 into a closed configuration. The valve portion 16 is pushed proximally (e.g., toward the atria) into the legs 20 and inwardly into the hub assembly 12 to close the valve portion 16 and minimize the risk of regurgitation. During systole, areas of the valve portion 16 may be pushed slightly proximally of the legs 20 but the framework 14 prevents the valve portion 16 from prolapsing into the atria. The valve portion 16 closes by collapsing on itself, the hub assembly 12, and the framework 14 due to pressure differentials created during the systolic portion of the cardiac cycle and is assisted by the motion of the native leaflets. The relative positions of the framework 14 and the valve portion 16 prevent the native leaflets and the valve portion 16 from prolapsing into the atria.

[0150] In some embodiments, the valve body 11 is constructed by first forming the framework 14. The framework 14 can be formed by organizing wires (e.g., Nitinol wirea) into the petal shaped configuration. The number of wires used to form the framework 14 corresponds to the number of petals desired in the final valve configuration. In some approaches, a metal jig is used to set the wires into the desired shape. The metal jig, with the wires, is then heat treated to set the wires in the desired shape and form the framework 14. An example heat treatment treats is performed in an oven at a temperature of between about 500 and about 600 degrees for a duration of about 10 to 20 minutes. The stem portions 19 of the framework 14 are then secured within the hub assembly 12 and the valve portion 16 is secured to the framework 14. As discussed above, in some approaches, the valve portion 16 is secured to the framework 14 along the outer rim portions 22, though, the valve portion 16 can be secured to the framework 14 at other suitable locations. The framework 14 can be secured in the hub assembly 12 using a 19 Attorney Docket No.21885-161818friction-fit connection by securing the stem portions 19 between the locking shaft 26 and the hub fasteners 30, 32 (see e.g., FIG.5).

[0151] The valve device 10 can be deployed in the heart of a patient in any suitable manner. In some embodiments, the disclosed artificial valves are placed via a transcatheter venous approach.

[0152] One method of deploying the valve device 10 comprises securing the valve device 10 within the heart of a patient with one or more anchors 36. Each anchor 36 is secured to cardiac tissue via a corresponding anchor tether 38. The valve body 11 is compressed or folded and loaded into a valve cartridge 122 (see e.g., FIGS.38–52). With the valve body 11 loaded, the valve cartridge 122 is delivered through a steerable guiding sheath 52 (e.g., a catheter) to a position the valve body 11 at a target positioned within the heart. The valve body 11 is then pushed out of the steerable guiding sheath 52 and secured via the anchors 36 and anchor tethers 38 at an anchor site on the ventricular apex or ventricular wall.

[0153] During placement, the overall length of the valve device 10 can be adjusted by adjusting the tension of each anchor tether 38 between the anchor site and the valve body 11 to facilitate optimal placement of the valve body 11 in the heart. After placement, the valve portion 16 is positioned within the native valve. The phrase “within” when used with reference to a native heart valve or native leaflets indicates that the artificial valve portion 16 is positioned between native leaflets. The valve portion 16 closes and opens in parallel with the movement of the native leaflets during a cardiac cycle. It is also contemplated that the valve portion 16 is able to open an close without native valve leaflets due to blood flow. In diastole, as the heart relaxes and fills with blood, native leaflets along with the valve portion 16 open, allowing blood to flow from the atrium into the ventricle. In systole, as the heart contracts, the native leaflets and the valve portion 16 move in conjunction to close to prevent blood from flowing back into the atrium and to allow blood to be pumped out of the ventricle. The force of native leaflets on the valve portion helps form a tight seal on the valve portion 16, resulting in a reduction or elimination of the regurgitant jet.

[0154] FIGS.17–80 illustrate methods and devices for deploying the valve device 10 in a patient, in accordance with some embodiments. The patient can be a human patient or another mammalian patient. The devices used to deploy or place the valve device 10 in a patient can include one or more of the following: a table mount assembly 40 (FIGS.18–21); an anchor handle assembly 42 (FIGS.22–34); a valve folding assembly 44 (FIGS.38–53); a threader 150 20 Attorney Docket No.21885-161818(FIGS.53–56); a valve pusher assembly 48 (FIGS.59–64); and a locking and cutting assembly 50 (FIGS.66–79E).

[0155] One exemplary method of deploying the valve device 10 in the heart of a patient using such devices includes placing a steerable guiding sheath 52 in the table mount assembly 40 (see FIG.18–21). The steerable guiding sheath 52 is advanced in the left ventricular cavity to a level of the papillary muscles below the chordae. A desired number of anchors 36 are secured to the heart via anchor tethers 38 using the steerable guiding sheath 52 and one or more anchor handle assemblies 42 (see FIGS.22–31). The proximal ends of the anchor tethers 38 are left extending out the proximal end of the steerable guiding sheath 52. The proximal ends of the anchor tethers 38 are secured to a suture clamping assembly 58 on the table mount assembly 40 (see FIGS.32–35). The steerable guiding sheath 52 is repositioned proximally so that the distal end of the steerable guiding sheath 52 is slightly proximal of native leaflets and proximate the valve annulus (see FIG.35). The valve body 11 is folded and inserted into a valve cartridge 122 in preparation for delivery and deployment in the patient (see FIGS.42–60). The proximal ends of the anchor tethers 38 are threaded through the valve body 11 and the valve cartridge 122 (see FIGS.55–57). The valve cartridge 122 and the folded valve body 11 are placed at the proximal end of the steerable guiding sheath 52 (see FIG.58). The valve pusher assembly 48 is used to push the valve body 11 distally out of the valve cartridge 122 and through the steerable guiding sheath 52 to position the valve body 11 in the heart (FIGS.59–64). The valve device 10 is secured in the desired position in the native heart using the locking and cutting assembly 50 which deploys a locking mechanism at the proximal end of the hub assembly 12 and cuts the anchor tethers 38 at a location slightly proximal of the locking mechanism in order to allow removal of the excess anchor tethers 38 (FIGS.66, 71–80). In some embodiments, the valve body 11 is also secured to the atrium of the patient with at least one anchor.

[0156] Subsequent figures describe each portion of the exemplary method of deploying the valve device 10 in detail, along with the associated devices.

[0157] With reference to FIGS.18–21, the table mount assembly 40 is shown with the steerable guiding sheath 52. The steerable guiding sheath 52 defines an inner channel that is sized to receive the valve body 11. The table mount assembly 40 generally includes a fixed base 54 and a movable base 56. The fixed base 54 defines a proximal end portion 54A and a distal end portion 54B. The fixed base 54 includes a track 57 that extends from the distal end portion 54B of the fixed base 54 to the proximal end portion 54A. The movable base 56 is coupled to and movable 21 Attorney Docket No.21885-161818along the track 57. As illustrated, the track 57 includes a pair of spaced rails 59 that form a slot 61. The slot 61 is sized to receive the movable base 56.

[0158] The table mount assembly 40 further includes a locking assembly 72 for securing the movable base 56 relative to the fixed base 54. The locking assembly 72 can include any suitable locking devices, such as retractable screws or break pads that contact the fixed base 54. In some embodiments, the locking assembly 72 includes a screw that is disposed through an opening in the movable base 56 and is received by a corresponding opening in the fixed base 54 to lock the movable base 56 in position. The locking assembly 72 includes a locking handle 76 for switching the locking assembly 72 between a locked and an unlocked position. In the unlocked position, the movable base 56 is free to move along the track 57 in either the proximal or distal direction.

[0159] The proximal end portion 54A of the fixed base 54 includes a suture clamping assembly 58. The suture clamping assembly 58 is used to hold the proximal end portions of the anchor tethers 38 as desired during and between various portions of the valve deployment process. The suture clamping assembly 58 includes a platform 63 with one or more suture clamps 60 for securing the anchor tethers 38. The suture clamping assembly 58 can include any suitable number of suture clamps 60 and, in some aspects, includes a number of suture clamps 60 corresponding to the number of anchor tethers 38 used to secure the valve body 11 to cardiac tissue. Each suture clamp 60 includes jaws 62A, 62B and a tightening knob 64 for opening and closing the jaws 62A, 62B. As illustrated, the suture clamps 60 include a movable jaw 62A and a fixed jaw 62B. The movable jaw 62A is coupled to the tightening knob 64. Turning the tightening knob 64 moves the movable jaw 62A between an open and closed position. The jaws 62A, 62B may be soft to limit damage to the anchor tethers 38. For example, the movable jaw 62A and the fixed jaw 62B each include a soft pad to cover hard edges or surfaces that clamp down on the anchor tethers 38.

[0160] The movable base 56 includes a guiding sheath clamp 66 for holding the steerable guiding sheath 52 steady for a surgeon. The steerable guiding sheath clamp 66 includes a clamp platform 69 that positions the steerable guiding sheath clamp 66 above the fixed base 54. The clamp platform 69 is approximately the same height as the platform 63. The guiding sheath clamp 66 includes a fixed jaw 68 and a movable jaw 70. The fixed jaw 68 is coupled to or integral with the clamp platform 69. The movable jaw 70 is hingedly coupled to the fixed jaw 68. A locking handle 76 is coupled to the movable jaw 70 to provide a grip for moving the movable jaw 70 between an open and closed position. 22 Attorney Docket No.21885-161818

[0161] The steerable guiding sheath 52 includes a guide tube 80 and a guiding handle 78. The guide tube 80 defines an interior channel that is sized to receive the valve body 11 and the outer tube 79 of the anchor handle assembly 42 (not shown but see FIG.22) and the locking and cutting assembly 50 (not shown but see FIGS.66–80). For example, the interior channel of the steerable guiding sheath 52 may be about the same size or larger than the outer diameter of the valve device 10. The guiding handle 70 as illustrated is cylindrical with a lever arm that provides a grip for rotating the steerable guiding sheath 52 or moving the steerable guiding sheath 52 proximally or distally within the guiding sheath clamp 66. The guiding handle 78 is disposed at the proximal end of the steerable guiding sheath 52. During deployment of the valve device 10, the steerable guiding sheath 52 is used to guide the valve body 11, the anchors 36, and the anchor tethers 38, into a patient. The steerable guiding sheath 52 is also used to guide the locking and cutting assembly 50 to the valve device 10 once positioned in the heart to secure the anchor tethers 38 to the valve body 11.

[0162] FIGS.19–21 show the placement of steerable guiding sheath 52 in the table mount assembly 40. In FIG.19, the guiding sheath clamp 66 opened by moving the movable jaw 70 away from the fixed jaw 68. In FIG.20, the steerable guiding sheath 52 is placed in the open steerable guiding sheath clamp 66. In FIG.21, the steerable guiding sheath 52 is secured on the movable base 56 by clamping the steerable guiding sheath 52 within the steerable guiding sheath clamp 66. The steerable guiding sheath 52 can be repositioned, for example, advanced, retracted, or rotated using the guiding sheath clamp 66.

[0163] Turning to FIGS.22–35, the anchor handle assembly 42 is shown. The anchor handle assembly 42 is used to deploy the anchors 36 and the anchor tethers 38 in a patient. The anchor handle assembly 42 is used to introduce the anchors 36 and the anchor tethers 38 into a body and deliver the place the anchors 36 in cardiac tissue. The anchors 36 and the anchor tethers 38 are deployed using the anchor handle assembly 42 and a number of anchor subassemblies 86 corresponding to the number of anchors 36 being deployed. The anchor subassemblies 86 are inserted into the anchor handle assembly 42 to deliver the anchors 36 into cardiac tissue.

[0164] FIG.22 shows the insertion of the anchor handle assembly 42 into the proximal end of the steerable guiding sheath 52. FIGS.23–24 show the proximal end portion 42A of the anchor handle assembly 42 with an anchor subassembly 86 preloaded into the anchor handle assembly 42. FIG.25 shows the distal end portion 42B of the anchor handle assembly 42 with the anchor 23 Attorney Docket No.21885-161818subassembly 86 preloaded into the anchor handle assembly 42. In the illustrated embodiment, there are three anchor tethers 38 but any suitable number of anchor tethers 38 can be used.

[0165] Referring to FIGS.23–25, the anchor handle assembly 42 is shown in detail. The anchor handle assembly 42 includes an anchor handle 85 and an outer tube 83 for guiding the anchor 36, the anchor tether 38, and any other components to a desired anchoring site within the heart. The anchor handle assembly 42 defines a proximal end portion 42A and a distal end portion 42B. The proximal end portion 42A (FIGS.23–24) of the anchor handle assembly 42 includes the anchor handle 85. The anchor handle 85 can be used by a surgeon to manipulate the position of the outer tube 83 to adjust the position the anchor 36 within cardiac tissue. The anchor handle 85 has a cylindrical body that defines an interior cavity. The cylindrical body of the anchor handle 85 includes finger rests 81 that project outward from the cylindrical body to provide a grip for a surgeon. As illustrated, the finger rests 81 are a pair of levers that extend from an outer surface of the anchor handle 85 to form a bow-tie handle. The distal end portion 42B (FIG.25) of the anchor handle assembly 42 is an open end of the outer tube 83. The anchor 36 exits from the distal end portion 42B of the anchor handle assembly 42 to deliver the anchor 36 into the heart. Since the anchor 36 can include sharp edges that could cut into the outer tube 83, the distal end of the outer tube 83 includes a reinforcement tube 108 to act as an inner protective sleeve. The reinforcement tube 108 extends through only a portion of the length of the outer tube 83. In some embodiments, the reinforcement tube 108 is formed of a metal.

[0166] In FIGS.23–25, the anchor subassembly 86 is shown inserted in the anchor handle assembly 42. The anchor subassembly 86 comprises an inner tube 88 coupled to a plunger 90. A proximal end portion of the anchor subassembly 86 (FIG.24) includes the plunger 90. The plunger 90 includes a plunger rod 96 with a plunger flange 99. The anchor handle 85 includes a cavity that is sized to receive the plunger 90. The anchor handle 85 functions as a barrel for the plunger 90. For example, the plunger 90 can be pushed into or pulled out of the cavity of the anchor handle 85. The anchor subassembly 86 also includes a stopper 94 on the plunger rod 96. The stopper 94 can be an O-ring. A safety lock 100 can be removably coupled to the plunger rod 96 to prevent the plunger 90 from being actuated. As illustrated in FIG.25, the anchor 36 is disposed within the outer tube 83 at a distal end portion of the anchor subassembly 86 (FIG.25). The anchor tether 38 extends through the central bore of the inner tube 88. The anchor 36 is coupled to the distal end of the anchor tether 38 and held within the distal end of the inner tube 24 Attorney Docket No.21885-16181888. The anchor tether 38 is received through an opening in the anchor 36 and secured to the anchor 36 via a fastener 104. As illustrated, the fastener 104 is a suture knot.

[0167] In some implementations, the anchor handle assembly 42 is provided to a surgeon in a kit with the anchor subassembly 86 preloaded in the outer tube 83. When preloaded, the anchor subassembly 86 can be assembled with the safety lock 100 positioned on the plunger rod 96 to prevent the anchor 36 from being released from the outer tube 83 unintentionally or prematurely.

[0168] FIGS.26–35 show the anchors 36 being deployed in a patient using the anchor handle assembly 42 and the anchor subassembly 86. Turning first to FIG.26, the anchor subassembly 86 is inserted into the anchor handle assembly 42 such that the inner tube 88 (not visible) of the anchor subassembly 86 is nested within the outer tube 83 of the anchor handle assembly 42. The anchor handle assembly 42 is inserted into the steerable guiding sheath 52. The proximal end portion 42A of the anchor handle assembly 42 is moved toward the proximal end portion of the steerable guiding sheath 52 (FIG.26). With this operation, the distal end portion of the anchor handle assembly 42 is placed against or adjacent to the cardiac tissue of the patient at a first anchoring site. The first anchoring site may be the apex area of the ventricle, however, outer suitable locations within the heart can be selected by the surgeon.

[0169] FIGS.27–28 illustrate actuation of the plunger 90 and the anchor handle 85 the anchor handle assembly 42. When the distal end portion 42B of the anchor handle assembly 42 is at the desired anchoring position, for example, as imaged fluoroscopically during the deployment process, the safety lock 100 is removed to allow the surgeon to advance the plunger 90 distally towards the anchor handle 85 (FIG.27). The plunger rod 96 and the inner tube 88 (not shown in FIGS.27–28) of the anchor subassembly 86 advance distally with the distal movement of the plunger 90. The plunger 90 is advanced until the stopper 94 on the anchor subassembly 86 contacts the anchor handle 85 (FIG.28). The distance that the plunger 90 is advanced corresponds to the distance the anchor 36 needs to be advanced distally to fully deploy the anchor 36 from the distal end of the outer tube 83 and into the cardiac tissue. Advancing the plunger 90 distally forces the anchor 36 out of the distal end portion of the outer tube 83 (not shown in FIGS.27–28 but see FIGS.29A–29C).

[0170] FIGS.29A–29C illustrate the deployment of the anchor 36 from the distal end portion 42B of the anchor handle assembly 42. When the anchor 36 is loaded in the outer tube 83, the anchor barbs 36A are relatively straight (see FIG.25). When the anchor 36 leaves the outer tube 25 Attorney Docket No.21885-16181883, the anchor barbs 36A curl (FIGS.29A). The anchor subassembly 86, less the anchor 36, is then moved proximally to withdraw the anchor subassembly 86 from the patient (FIG.29B– 29C). The anchor 36 and anchor suture 38 remain after the outer tube 83 is removed from the patient (FIG.29C).

[0171] FIGS.30A–30E show a sequential deployment of the anchor 36 into cardiac tissue 110 of a patient. When the anchor 36 is loaded in the outer tube 83, the anchor barbs 36A are relatively straight (FIGS.30A and 30B). When the anchor is slightly deployed, the anchor barbs 36A begin to exit the outer tube 83 and curve (FIGS.30C and 30D). As the anchor 36 is deployed, the portions of the anchor barbs 36A outside of the outer tube 83, which are no longer subject to the restricting forces of the outer tube 83, return to their final curved configuration and embed in the cardiac tissue of the patient. Once the anchor 36 fully exits the outer tube 83, the anchor 36 is fully deployed and the anchor barbs 36A assume their final curved configuration (FIG.30E).

[0172] FIG.31 shows the steerable guiding sheath 52 after the anchor 36 has been deployed. After the anchor has been deployed, the anchor handle assembly 42 and the anchor subassembly 86 (not shown in FIG.31), less the anchor 36 and the anchor tether 38, are removed from the steerable guiding sheath 52. The anchor 36 and the anchor tether 38 remain in the patient and in the steerable guiding sheath 52. The proximal end portions of the anchor tether 38 remain outside the patient after the anchor 36 is deployed. The proximal end portion of the anchor tether 38 is secured to the suture clamp 60 on the table mount assembly 40 (see FIGS.32–33). Once the anchor 36 and anchor tether 38 are deployed, the remainder of the anchor subassembly 86 (e.g., the plunger 90 and the inner tube 88) is discarded.

[0173] The surgeon can repeat the anchor deployment process using any suitable number of anchors 36 and anchor tethers 38. In the illustrated embodiment, three anchor subassemblies 86 are deployed. The surgeon repeats the anchor deployment process using second and third anchor subassemblies 86 to position and secure second and third anchors in their respective, desired locations as determined by the surgeon. In some embodiments, anchor handle assemblies having different shaped distal end portions (see FIG.86) are used to facilitate placement of the anchors at desired locations. Each anchor tether 38 is secured to the suture clamp 60 on the table mount assembly 40 as shown in FIG.35. Each of the anchor tethers 38 remain outside the patient after deployment. The anchor tethers 38 are ultimately threaded through valve body 11, which is loaded into the valve cartridge 122. The valve cartridge 11, 26 Attorney Docket No.21885-161818which contains the valve body 11, is guided along the anchor tethers 38 through the steerable guiding sheath 52 as the valve body 11 is delivered into the patient.

[0174] FIG.35 shows an adjustment to the table mount assembly 40 after the anchors 36 are deployed and the proximal ends of the anchor tethers 38 are secured to the sutures clamp 60. The movable base 56 that supports the guiding sheath clamp 66 is moved proximally in the fixed base 54 of the table mount assembly 40 to position the distal end of the steerable guiding sheath 52 proximate the native valve of the patient. This proximal movement shifts the distal end of the steerable guiding sheath 52 slightly proximal of the native valve leaflets in preparation for deployment of the valve body 11. The movable base 56 can be moved by unlocking the locking assembly 72. Once unlocked, the movable base 56 can slide proximally in the fixed base 54 as shown in FIG.35, as compared with FIG.34. Once in position, the locking assembly 72 can be moved to the locked position to secure the movable base 56 relative to the fixed base 54.

[0175] In some embodiments, the anchors 36 may be installed via rotation of the anchor handle assembly 42 rather than merely via movement in the proximal / distal direction as was illustrated in FIGS.26–35. Turning to FIGS.36A–36B and 37, alternate shapes for the anchors 36 are shown which are implanted into cardiac tissue via rotational motion.

[0176] FIGS.36A–36B show a corkscrew shaped anchor 112. The corkscrew shaped anchor 112 has a spiral shaped body. The corkscrew shaped anchor 112 includes an anchor base 114 and an anchor tip 116. The anchor base 114 is coupled to an anchor tether 118. The anchor base 114 of engages the distal end of the inner tube 88 of the anchor subassembly 86. The anchor tip 116 is sharpened to penetrate the cardiac tissue of the patient. Rather than simply pushing on the plunger 90, implantation of the corkscrew shaped anchor 112 involves rotation of the inner tube 88 by the surgeon.

[0177] FIG.37 shows another corkscrew shaped anchor 120. The corkscrew shaped anchor 120 is generally the same as the corkscrew shaped anchor 112, with a difference being that the spiral shaped body of the corkscrew shaped anchor 120 is flattened. Deployment of the corkscrew shaped anchor 120 in cardiac tissue also involves rotation by the surgeon. The corkscrew shaped anchor 120 is installed, for example, via a twisting action by the surgeon that results in one-way functionality. The one-way functionality prevents or reduces the risk of easy removal of the anchor and provides a stable hold within cardiac tissue. 27 Attorney Docket No.21885-161818

[0178] Before deployment of the valve body 11, the valve body 11 is folded or compressed into a configuration and size which can be deployed through the steerable guiding sheath 52. In some embodiments, a surgical kit can have the valve body 11 preloaded into the valve cartridge 122. The valve cartridge 122 is sized to fit into the steerable guiding sheath 52. Thus, in some embodiments, the valve body 11 is provided in the surgical kit in an unfolded configuration. The valve body 11 can then be folded and loaded into the valve cartridge 122, aka “loading tube”, before delivery to the patient through the steerable guiding sheath 52.

[0179] FIGS.38–52 show the valve folding assembly 44 and use of the valve folding assembly 44 in a valve folding and loading operation. The valve folding assembly 44 comprises a valve folding base 124 with a cart 126. The valve folding base 124 may be a reusable assembly that can be used to fold a number of valve bodies. The valve loading base 128 may be a disposable assembly that can be used to fold a single valve body and then disposed of.

[0180] Turning to FIGS.38 and 39, the components of the valve folding base 124 are illustrated. The valve folding base 124 defines a first end portion 124A and a second end portion 124B. The first end portion 124A includes the cart 126. The valve folding base 124 has slots at the first end portion 124A for slidably receiving the cart 126, a central mounting plate 132 for slidably mounting the valve loading base 128. The second end portion 124B comprises a cradle 130 for removably a chuck assembly 144 of the valve loading base 128. A central mounting plate 132 is disposed between the first end portion 44A and the second end portion 124B of the valve folding base 124. The valve loading base 128 can be mounted on the central mounting plate 132. In one configuration, the central mounting plate 132 is received by an opening in the valve loading base 128 to secure the valve loading base 128 on the valve folding base 124.

[0181] FIGS.39 and 40A–40D illustrate components of the cart 126 of the valve folding assembly 44. The cart 126 is slidably mounted on the valve folding base 124. The cart 126 includes a cart lock 129 for locking the position of the cart 126 relative to the valve folding base 124. The cart 126 comprises a cart base 134 with a post 136. A cart cover 138 encloses at least a portion of the cart base 134. The cart base 134 is received by slots in the valve folding base 124 and guides the cart smoothly along the slots in the valve loading base 128. The cart cover 138 defines an opening 141 for the post 136. The post 136 extends upward through the opening 141 in the cart cover 138. The post 136 is coupled to a biasing element 140 that is disposed within the cart cover 138. As illustrated, the biasing element 140 is a spring, though, any suitable biasing element can be used. 28 Attorney Docket No.21885-161818

[0182] Referring to 40A–40D, the cart 126 has a first configuration (shown in FIGS.40A and FIG. C) in which the biasing element 140 is in a relaxed state and, as discussed further below, the valve body 11 is unfolded. The cart 126 also has a second configuration (shown in FIGS.40B and 40D) in which the biasing element 140 is in a compressed state and, as discussed further below, the valve body 11 is folded. The cart cover 138 and the post 136 include markers 142 to provide a visual indication of whether the cart 126 is in the first or the second configuration. When the markers 142 are aligned, the cart 126 is in the second configuration with the biasing element 140 in the compressed state and the valve body 11 folded. The biasing element 140 is selected so that a predetermined amount of force is applied to the biasing element 140 (e.g., and the post 136) before the post 136 will move the desired distance, e.g., the distance to compress and fold the valve body 11. In some embodiments, the biasing element 140 requires about 900 grams of force to move the desired distance.

[0183] FIGS.38 and 41 illustrate components of the valve loading base 128. The valve loading base 128 supports the valve cartridge 122 and the valve body 11 during a valve folding and loading operation in which the valve body 11 is folded and loaded into the valve cartridge 122. The valve loading base 128 can be removably coupled to the central mounting plate 132 of the valve folding base 124. The valve loading base 128 includes a cartridge support frame 152, the chuck assembly 144, a funnel 146, and the threader 150. In FIG.41, the valve loading base 128 also includes sutures 154 coupled to a pulling ring 156. The cartridge support frame 152 can be any suitable structure for securing the valve cartridge 122 during the folding and loading operation. As illustrated, the cartridge support frame 152 includes C-shaped clips that mate with the outer diameter of the valve cartridge 122, which is cylindrical in shape. The chuck assembly 144 is removably received within the cradle 130 of the valve folding base 124. The chuck assembly 144 includes an elongated body 158 with movable jaws 160 at a tip of the elongated body 158. The movable jaws 160 grip the hub assembly 12 of the valve body 11 during the valve folding and loading operation. The chuck assembly 144 also includes a tightening mechanism 145 for untightening and tightening the movable jaws 160. The tightening mechanism 145 is disposed at an end of the elongated body 158 that is opposite the movable jaws 160. During the valve folding and loading operation, the movable jaws 160 of the elongated body 158 secure the valve body 11. The elongated body 158 of the chuck assembly 144 is received by the wide end of the funnel 146 (see FIG.47) as the cart 124 is translated toward the second end portion 124B to load the folded valve body into the valve cartridge 122. 29 Attorney Docket No.21885-161818

[0184] Still referring to FIGS.38 and 41, the funnel 146 holds the valve body 11 before the folding operation. In some embodiments, the funnel 146 is provided in a surgical kit with the valve body 11 pre-loaded therein. At least a portion of the valve portion 16 of the valve body 11 rests within the funnel 146. The funnel 146 is coupled to a funnel beam 148. The funnel beam 148 extends from the cartridge support frame 152 to the chuck assembly 144. An end of the funnel beam 148 is engaged and locked into the chuck assembly 144 (see FIGS.44A and 44B). A narrow end of the funnel 146 is disposed adjacent to the valve cartridge 122. A wide end of the funnel 146 is disposed adjacent to the chuck assembly 144.

[0185] Turning to FIGS.41 and 42, the threader 150 on the valve loading base 128 includes a wire that extends through the central bore of valve cartridge 122 and the center of the valve body 11, e.g., through the central bore of the hub assembly 12. The threader 150 is ultimately used to thread the anchor tethers 38 through the valve body 11 to couple the valve body 11 to the anchors 36 before the valve body 11 is deployed in a patient. The sutures 154 also extend through the central bore of the valve cartridge 122 and are coupled to the protuberances 24 on the valve body 11 to collapse the valve body 11 and pull the valve body 11 into the valve cartridge 122.

[0186] FIGS.42–52 illustrate an exemplary valve folding and loading operation that uses the valve folding assembly 44. In the valve folding and loading operation, the valve body 11 is folded and loaded into the valve cartridge 122. The valve folding assembly 44 folds or compresses the framework 14 and the valve portion 16 of the valve body 11. During the valve loading operation, the framework 14 and the valve portion 16 are initially positioned within the funnel 146. The chuck assembly 144 holds the hub assembly 12 of the valve body 11 in place while the post 136 exerts a pulling force on the sutures 154 which have been attached at one end to the protuberances 24 of the framework 14 and at the opposite end to the pulling ring 156. The sutures 154 extend through the funnel 146 which directs the pulling force on the protuberances 24 toward a central longitudinal axis that extends through the valve body 11. After the framework 14 has been folded or compressed, the valve cartridge 122 is slid over the compressed valve body 11 by pushing the valve loading base 128 towards the second end portion 124B.

[0187] As shown in FIG.38, the valve body 11 is first loaded into the valve loading base 128 in preparation for the valve folding and loading operation. At least a portion of the valve framework 14 and the valve portion 16 of the valve body 11 are seated within the funnel 146. At 30 Attorney Docket No.21885-161818least a portion of the hub assembly 12 is secured within the movable jaws 160 of the chuck assembly 144. In some implementations, the valve body 11 is provided to the surgical team already loaded in the valve folding assembly 44 as shown in FIG.38 to facilitate efficiency.

[0188] FIGS.42 and 43 show the valve loading base 128, which includes the valve body 11, before and after attachment to the valve folding base 124 and the cart 126, respectively. In FIG. 43, the pulling ring 156 has been placed over the post 136, the valve loading base 128 is positioned over the central mounting plate 132, and the chuck assembly 144 has been positioned on the cradle 130 of the valve folding base 124.

[0189] The chuck assembly 144 includes a funnel beam lock 162 that secures the funnel beam 148 to prevent movement of the funnel 146 before the valve loading base 128 is mated with the valve folding base 124. As illustrated in FIGS.44A and 44B, the funnel beam lock 162 includes a frame 162A with an opening that receives the funnel beam 148. The frame 162A includes legs 162B with protrusions 162C. The protrusions 162C engage with slots 144A in the chuck assembly 144. Engagement of the chuck assembly 144 on the cradle 130 as indicated in FIGS.44A and 44B releases the funnel beam 148. Engagement of the chuck assembly 144 on the cradle 130 pushes on the frame 162A such that the protrusions 162C are released from the slots 144A and the funnel beam 148 is no longer secured by the frame 162A. Thus, engagement of the chuck assembly 144 with the cradle 130 permits the funnel 146 to move relative to the chuck assembly 144.

[0190] FIGS.43–46 illustrate a sequence of the valve folding and loading operation in which the framework 14 (not visible) and the valve portion 16 of the valve body 11 are folded (or compressed). Sliding the cart 126 along the slots in the valve folding base 124 pulls on the sutures 154 to fold the valve body 11. The cart lock 129 is placed in an unlocked configuration to permit movement the cart 126 relative to the valve folding base 124. Moving the cart 126 away from the funnel 146 and towards the first end portion 124A moves the post 136 and the pulling ring 156 from the funnel 146 which compresses the biasing element 140 in the cart 126. Movement of the post 136 and the pulling ring 156 away from the funnel 146 and towards the first end portion 124A pulls on the sutures 154 which are coupled to the framework 14 of the valve body 11. As the cart 126 is moved away from the funnel 146, the sutures 154 are drawn through the hole in small end of the funnel 146. Pulling on the sutures 154 collapses the framework 14 and valve portion 16 of the valve body 11 to flatten the valve body 11. FIG.45 shows the valve body 11 in a partially flattened state. FIG.46 shows the valve body 11 in a fully 31 Attorney Docket No.21885-161818flattened state. The markers 142 on the cart 126 are aligned when a sufficient amount of force has been applied via the cart 126, indicating that the valve body 11 is fully flattened or compressed and is ready to be loaded to the valve cartridge 122. Once the markers 142 are aligned and the valve body 11 is fully compressed, the cart lock 129 can be placed in a locked configuration to secure the cart 126 relative to the valve folding base 124.

[0191] FIGS.47 and FIGS.48A and 48B illustrate a sequence of the valve folding and loading operation in which the valve body 11 is loaded into the valve cartridge 122. After the valve body 11 is folded, the valve loading base 128 is slid over the central mounting plate 132 on the valve folding base 124 toward the chuck assembly 144 until the funnel 146 contacts the chuck assembly 144 to load the folded framework 14, valve portion 16, and part of the hub assembly 12 into the valve cartridge 122. The funnel 146 is advanced into contact with the movable jaws 160 of the chuck assembly 144 (which are gripping the hub assembly 12). Pushing the valve loading base 128 towards the funnel 146 loads the folded valve body 11 into the valve cartridge 122. The valve loading base 128 is pushed until the funnel 146 abuts the movable jaws 160 of the chuck assembly 144 and the funnel beam 148 is locked onto the chuck assembly 144. Ridges 149 on the funnel beam 148 engage the chuck assembly 144 to lock the funnel beam 148 onto the chuck assembly 144 when the valve loading base 128 is fully advanced (see FIG.47).

[0192] Figures 49–53 illustrate the valve loading base 128, the valve cartridge 122, and the threader 150 being removed from the valve folding base 124 in preparation for the threading of the valve cartridge 122 with the anchor tethers 28. With the folded framework 14 and valve portion 16 and part of the hub assembly 12 loaded inside the valve cartridge 122, the valve body 11 is detached from the chuck assembly 144 by rotating the tightening mechanism 145 to loosen the movable jaws 160 as indicated in Figure 49. The valve cartridge 122 and valve body 11 (not visible) are then removed from the valve folding assembly 44 by cutting and removing the sutures 154 and pulling ring 156 (FIG.50 and 51), sliding the valve loading base 128 toward the cart 126 (FIG.52), and removing the valve loading base 128 from the valve folding base 124 (FIG.53).

[0193] FIGS.54–57 illustrate the threader 150 that is used to feed the anchor tethers 38 through the center of the folded valve body 11 within the valve cartridge 122. In preparation for deployment of the valve body 11 into the patient, the anchor tethers 38 are threaded through the valve body 11 (not visible). The threader 150 is used to thread the proximal portions of the anchor tethers 38 through the valve body 11 within the valve cartridge 122. In FIG.55, 32 Attorney Docket No.21885-161818the valve body 11 remains folded inside the valve cartridge 122 while the proximal ends of the anchor tethers 38 are passed through a wire loop 178 of the threader 150. In FIG.56, the threader 150 is then withdrawn proximally through the folded valve body 11, thereby threading the anchor tethers 38 through the valve body 11. After the anchor tethers 38 have been threaded through the valve body 11 as illustrated in FIG.56, the valve cartridge 122 is removed from the valve loading base 128 as shown in FIG.57. The valve cartridge 122 is used to load the valve body 11 into the steerable guiding sheath 52. In FIG.58, the valve cartridge 122 is slid along the anchor tethers 38 to insert the valve cartridge 122 into the steerable guiding sheath 52.

[0194] FIGS.59–64 show the valve pusher assembly 48 and use of the valve pusher assembly 48 to deploy the valve cartridge 122 into the patient.

[0195] With reference to FIGS.59–61, the valve pusher assembly 48 comprises a pusher tube 164 which extends substantially the full length of the valve pusher assembly 48. FIG.59 shows the valve cartridge 122 inserted into a proximal end of the steerable guiding sheath 52, with valve pusher assembly 48 having the anchor tethers 38 fed through the sutures threader 176. The valve pusher assembly 48 defines a proximal end portion 48A (FIG.60) and a distal end portion 48B (FIG.61). As shown in FIG.60, the proximal end portion 48A comprises a valve pusher handle 166. The valve pusher handle 166 includes a stopcock 167. The stopcock 167 can be used for flushing the valve pusher assembly 48 (e.g., with saline solution) to prevent or limit the introduction of air. As shown in FIG.61, the distal end portion 48B comprises a pushing tip 168. The pushing tip 168 includes a sidewall 170 with a sidewall opening 174 (not visible) formed therein. The sidewall opening 174 is proximate a distal tip (e.g., a distal opening) of the pushing tip 168. The sidewall opening 174 is sized to permit the anchor tethers 38 to be threaded therethrough. The sidewall 70 is a distal portion of the pusher tube 164. The sidewall 170 defines a longitudinal bore 172 that receives the anchor tethers 38 of the valve device 10. In some implementations, the pushing tip 168 is formed of a metal such as stainless steel. The suture threader 176 is coupled to the pushing tip 168. The suture threader 176 comprises a wire 182 and a threader base 180 having clips 181 that mate with an outer diameter of the pusher tube 164. A first end of the wire 182 is coupled to the threader base 180. A second end of the wire 182 includes the wire loop 178.

[0196] FIGS.59–64 illustrate the valve pusher assembly 48 deploying the valve body 11 through the steerable guiding sheath 52 into the heart of the patient. Before deployment of the valve 33 Attorney Docket No.21885-161818body 11 in the patient, the proximal ends of the anchor tethers 38 are threaded through the distal end portion 48B of the valve pusher assembly 48 (see FIGS.59–61). When the anchor sutures 38 are threaded into the valve pusher assembly 48, the anchor sutures 38 extend through the longitudinal bore 172 of the pushing tip 168 and out the sidewall opening 174 so that the anchor tethers 38 extend along the length of the pusher tube 164 (see FIG.62 and 63). When threaded into the valve pusher assembly 48, a portion of the anchor tethers 38 are external to the pusher tube 164.

[0197] Figures 61–63 illustrate the threading of the anchor tethers 38 through the valve pusher assembly 48. Threading the valve pusher assembly 48 comprises inserting the wire loop 178 of the suture threader 176 through the sidewall opening 174 of the pusher tube 164 and distally through the distal opening in the pushing tip 168. The proximal ends of the anchor tethers 38 are then passed through the wire loop 178. The wire loop 178 is withdrawn from the pusher tube 164 thereby leaving the anchor tethers 38 threaded through the longitudinal bore 172 of the pushing tip 168. Before deploying the valve body 11 in the patient with the valve pusher assembly 48, the proximal ends of the anchor tethers 38 are secured in the suture clamps 60 of the table mount assembly 40 (FIG.62).

[0198] FIGS.62, 64, and 65 show the valve pusher assembly 48 deploying the valve cartridge 122, which includes the valve body 11, into the patient via the steerable guiding sheath 52. The valve pusher assembly 48 is used to deploy the valve body 11 through the steerable guiding sheath 52 into the atrioventricular annulus of the patient. The valve body 11 is moved distally through the steerable guiding sheath 52 by moving the valve pusher handle 166 distally. Moving the valve pusher handle 166 also moves the pushing tip 168, which abuts the valve cartridge 122, which includes the folded valve body 11. The folded valve body 11 is advanced distally out of the distal end portion of the steerable guiding sheath 52 allowing the valve body 11 to expand (FIG.64). The valve body 11 is positioned against the floor of the atrioventricular annulus. Once the valve body 11 is deployed, the valve pusher assembly 48 is withdrawn from the steerable guiding sheath 52 and the patient (FIG.65).

[0199] Turning to FIGS.66–80, the locking and cutting assembly 50 is shown. FIGS.66–80 show the locking and cutting assembly 50 and how it is used adjust the position of the valve body 11, secure the valve body 11 in the patient, and cut the anchor tethers 38.

[0200] With reference to FIGS.66–70, the components of the locking and cutting assembly 50 are illustrated. The locking and cutting assembly 50 comprises an outer casing 184 that defines 34 Attorney Docket No.21885-161818an inner bore 186. The outer casing 184 has a proximal end portion 50A (FIGS.67–68) and a distal end portion 50B (FIGS.69–70). The proximal end portion 50A is coupled to a pulling handle 190. The distal end portion 50B is coupled to a locking and cutting device. The locking and cutting device includes an outer cutting tube 194, an inner cutting tube 196, a locking pin 192, and a locking bead 198. The outer cutting tube 194 and the inner cutting tube 196 include cutting lips that cooperate to cut the anchor tethers 38. The locking pin 192 and the locking bead 198 cooperate to secure the anchor tethers therebetween.

[0201] A pulling wire 188 extends through the inner bore 186 of the outer casing 184 along the full length of the locking and cutting assembly 50. The pulling wire 188 extends from the proximal end portion 50A to the distal end portion 50B. A proximal end of the pulling wire 188 is coupled to a pulling handle 190 at the proximal end portion 50A of the outer casing 184. A distal end of the pulling wire 188 is coupled to a locking pin 192 at the distal end portion 50B of the outer casing 184.

[0202] Turning to FIGS.67 and 68, the proximal end portion 50A comprises a pulling handle 190 and finger loop 202 coupled to a handle guide shaft 210. The pulling wire 188 is coupled to the pulling handle 190. The handle guide shaft 210 includes a track that receives a portion of the pulling handle 190 to guide the pulling handle 190 either proximally or distally along the handle guide shaft 210. A handle safety lock 208 is coupled to the handle guide shaft 210 between the pulling handle 190 and the finger loop 202 to prevent movement of the pulling handle 190 along the track of the handle guide shaft 210. In the illustrated embodiment, the pulling handle 190 is a bow tie shaped handle with two finger loops such that a surgeon can insert two fingers into the pulling handle 190 and a thumb into the finger loop 202 to actuate the locking and pulling assembly.

[0203] Turning to FIGS.69 and 70, the distal end portion 50B comprises the locking and cutting device which includes the outer cutting tube 194 and the inner cutting tube 196. The inner cutting tube 196 is slidably positioned within the outer cutting tube 194. The outer cutting tube 194 includes a first window 204 having a first cutting lip 214. The inner cutting tube 196 includes a second window 206 having a second cutting lip 216. The first window 204 and the second cutting window are aligned at the same circumferential position on the locking and cutting assembly 50 such that the first cutting lip 214 and the second cutting lip 216 align to cut the anchor tethers 38 when the inner cutting tube 196 moves proximally within the outer cutting tube 194 (FIG 70). The distal end of the outer cutting tube 194 includes a locking bead 198 and a 35 Attorney Docket No.21885-161818locking pin 192. The locking bead 198 is removably positioned in a distal opening of the outer cutting tube 194. The locking bead 198 at least partially hollow and includes a distal opening 190A formed therein. The locking bead 198 has a proximal end that is removably positioned in the distal end of the outer cutting tube 194. The locking pin 192 is lockingly engageable with the distal opening 190A of the locking bead 198. The suture threader 176 is coupled to the distal end portion 40B of the outer casing 184. The pulling wire 188 extends through the outer cutting tube 194, the inner cutting tube 196, and the locking bead 198 and terminates at the locking pin 192.

[0204] With reference to FIG.69, the pulling wire 188 comprises two engagement portions which are designed to sequentially move the locking pin 192 and the inner cutting tube 196 proximally when the pulling handle 190 is moved proximally. A distal tip 188A of the pulling wire 188 forms the first engagement portion. A shoulder 188B on the pulling wire 188 forms the second engagement potion.

[0205] As shown in FIGS.79A–79E, the distal tip 188A of the pulling wire 188 is initially curved. The material used to form the distal tip 188A of the pulling wire 188 allows sufficient plastic deformation so that proximal movement of the pulling wire 188 will move the locking pin 192 proximally into a locked engagement with the distal opening 190A of the locking bead 198 to lock the anchor tethers 38 (not shown) between the locking pin 192 and locking bead 198. The distal tip 188A of the pulling wire 188 is also designed to yield upon the application of further proximal forces (applied by the surgeon on the pulling handle 190) so that the distal tip 188A of the pulling wire 188 can be straightened sufficiently to allow the pulling wire 188 to be withdrawn proximally through the central bore in the locking pin 192.

[0206] Still referring to FIGS.79A–79E, after or while the distal tip 188A of the pulling wire 188 is withdrawn through the locking pin 192, the shoulder 188B on the pulling wire 188 engages the inner cutting tube 196. Engagement of the shoulder 188B with the inner cutting tube 196 moves the inner cutting tube 196 proximally inside the outer cutting tube 194 to cut the anchor tethers 38 (not visible) at a location proximally of where the anchor tethers 38 are pinched between the locking pin 192 and locking bead 198.

[0207] FIGS.71–73 illustrate a process for threading the locking and cutting assembly 50. During the threading process, the wire loop 178 of the suture threader 176 is fed distally through the first window 204 in the outer cutting tube 194, the second window 206 in the inner cutting tube 196, and out of an opening between the locking pin 192 and the locking bead 198 36 Attorney Docket No.21885-161818(see FIG.71). In preparation for threading the anchor tethers 38 through the distal end of the locking and cutting assembly 50, the anchor tethers 38 are fed through the wire loop 178 of the suture threader 176 (FIG.71). The anchor tethers 38 are then pulled proximally through the opening between the locking pin 192 and the locking bead 198 and then out of the first window 204 and the second window 206 (not visible). FIGS.72 and 73 show the state of the locking and cutting assembly 50 with the anchor tethers 38 threaded but before the valve body 11 is locked in place by the surgeon. Before the valve body 11 is locked in place, the locking pin 192 is not secured to the locking bead 198 and the anchor tethers 38 are free to move relative to the locking and cutting assembly 50.

[0208] As shown in FIG.74, after the anchor tethers 38 have been threaded through the locking and cutting assembly 50, the proximal portions of the anchor tethers 38 are secured to the suture clamps 60. In FIGS.75A and 75B, the locking and cutting assembly 50 is then inserted into the steerable guiding sheath 52. Once the locking and cutting assembly 50 is in the steerable guiding sheath 52, the surgeon can position the valve body 11 in an optimum position relative to the native valve leaflets by pulling on the anchor tethers 38. Pulling on any one anchor tether 38 will increase the tension in that anchor tether 38 between the anchor site and the hub assembly 12, moving the valve body 11 toward that anchor site. By relaxing tension in one anchor tether 38 the surgeon can also allow the valve body 11 to be pulled away from a particular anchor site and closer to the other anchor sites. By adjusting the tension in all of the anchor tethers 38, the surgeon can position and align the valve body 11 as desired.

[0209] A surgeon can adjust the position of the valve body 11 both radially, longitudinally (distally and proximally) and rotationally relative to the native leaflets by shortening and / or lengthening the length of each anchor tether 38 that extends from the hub assembly 12 to the respective anchor site of the anchor tether 38. The anchors 36 can be positioned in a generally triangular orientation around the apex of the ventricle. Such placement optimizes the ability to adjust the position of the valve body 11 relative to the valve annulus. Fluoroscopy, ultrasound image, or other suitable equipment and techniques can be used to view the valve body 11 within the cardiac tissue to provide the surgeon with feedback on valve positioning.

[0210] FIGS.75A–80 illustrate a process for locking the valve body 11 in place and cutting excess portions of the anchor tethers 38 using the locking and cutting assembly 50 once the valve body 11 is in position. When the surgeon is ready to lock the valve body 11 in place and cut excess portions of the anchor tethers 38, the distal end portion 50A of the outer casing 184 37 Attorney Docket No.21885-161818of the locking and cutting assembly 50 is positioned to bring the locking bead 198 in contact with the valve body 11 (FIGS.75A and 75B). The handle safety lock 208 is removed from the handle guide shaft 210 (FIGS.76 and 77). Once the handle safety lock 208 is removed, the pulling handle 190 is drawn in a proximal direction X toward the finger loop 202 (FIG.78). In the illustrated embodiment, the surgeon can place one or more fingers (e.g., the thumb) through the finger loop 202 and one or more fingers (e.g., the index and middle fingers) through the loops of the pulling handle 190 and squeeze to actuate the pulling handle 190 (FIG.78). Actuating the pulling handle 190 moves the pulling wire 188 proximally relative to the outer casing 184 and the outer cutting tube 194 (FIGS.79A–79E). A single squeezing motion can draw the locking pin 192 into the locking bead 198 to lock the anchor tethers 38 in place and align the first cutting lip 214 of the inner cutting tube 196 and the second cutting lip 216 of the outer cutting tube 194 to cut the proximal, excess portions of the anchor tethers 38.

[0211] Turning to FIGS.79A–79E, the distal end portion 50B of the locking and cutting assembly 50 is shown in detail to illustrate the locking and cutting operation. In FIGS.79A–79E, the pulling handle 190 (not shown) of the locking and cutting assembly 50 is being moved proximally. In FIG.79A, the curved distal tip 188A of the pulling wire 188 catches on the locking pin 192 to start moving the locking pin 192 proximally toward the locking bead 198. In FIG.79B, the locking pin 192 is locked in the central bore of the locking bead 198 thereby fixing the positions of the anchor tethers 38. In FIG.79C, the distal tip 188A is drawn into the central bore of the locking pin 192, which at least partially straightens the distal tip 188A. In addition, the shoulder 188B of the pulling wire 188 contacts the inner cutting tube 196 and acts as a catch to draw the inner cutting tube 196 proximally within the outer cutting tube 196. In FIG.79D, the inner cutting tube 196 has advanced further proximally within the outer cutting tube 194 cutting the anchor tethers 38 at a location proximal of the locking bead 198. Also, in FIG.79D, the inner cutting tube 196 is secured within the outer cutting tube 194 by a one-way tab 212 of the outer cutting tube 194. The one-way tab 212 on the outer cutting tube 194 prevents the inner cutting tube 196 from advancing out the distal end of the outer cutting tube 194 and inadvertently remaining in the patient after installation of the valve device 10. In FIG.79E, the locking pin 192 and the locking bead 198 remain in the patient while the rest of the locking and cutting assembly 50 is removed from the patient. The anchor tethers 38 are locked in place by the locking pin 192 and the locking bead 198 and excess portions of the anchor tethers 38 are cut. 38 Attorney Docket No.21885-161818

[0212] FIGS.80A and 80B show the valve device 10 and the steerable guiding sheath 52 after the locking and cutting assembly 50 has been withdrawn from the steerable guiding sheath 52. In FIGS.80A and 80B, the valve device 10 is fully deployed in the patient. The valve device 10 is locked in place and excess portions of the anchor tethers 38 have been cut to free the valve device 10 from the deployment equipment. The distal end of the valve device 10 is secured to cardiac tissue of the patient (not shown) via the anchors 36 and the anchor tethers 38. Excess anchor tethers 38 have be removed from the proximal end of the valve device 10 such that the valve device 10 is untethered at the proximal end.

[0213] While FIGS.18–80B generally depict a transcatheter venous approach for deploying the valve device 10 in a patient, it is contemplated that other deployment processes can be used. For example, the valve device 10 can also be deployed using a trans-left auricular appendage approach. In the trans-left auricular appendage approach, a incision (e.g., a keyhole incision) is made in the chest wall of a patient. The left auricular appendage of the heart is then accessed via the keyhole incision and a purse string suture is placed around the left auricular appendage. The steerable guiding sheath 52 is then inserted in the left atrium via the left auricular appendage. Once the guiding sheath 52 is inserted in the left atrium the deployment process proceeds using the method and devices that are shown and described with reference to FIGS. 18–80B.

[0214] Turning now to FIGS.81–86 alternative embodiments for the valve device 10 and the various devices that are used to deploy the valve device 10 in a patient are illustrated .

[0215] FIG.81 shows an alternative valve body 218. The valve body 218 that same as the valve body 11 that is shown and described with reference to FIGS.1–17, with a difference being that the valve body 218 includes a framework 220 with four wire sections 222. The structure of each wire section 222 in FIG.81 is generally the same as the wire section 16 shown and described with reference to FIGS.1–17. A design with four wire sections 222 may improve contact with the native valve annulus. For example, over time there will be tissue growth around the wire sections 222 to embed the framework 220 in portions of the native valve annulus. In this manner, the framework 220 becomes endothelialized to become a part of the native valve annulus. Such tissue growth around the framework 220 helps the valve body 218 to cooperate with the native valve annulus so that the valve body 218 moves in conjunction with the native valve annulus. Including four wire sections 222 may help promote such cooperation by providing a larger surface area for in-growth of native valve tissue. 39 Attorney Docket No.21885-161818

[0216] FIGS.82–84B show an alternative table mount assembly 224. The table mount assembly 224 that same as the table mount assembly 40 that is shown and described with reference to FIGS.18–21, with a difference being that the table mount assembly 224 has a different steerable guiding sheath clamp 226 and a longer fixed base 228. The table mount assembly 224 can be used in the same manner that is described with reference to the table mount assembly 40. The steerable guiding sheath clamp 226 includes an adjustable break 230 that permits the steerable guiding sheath clamp 226 to be loosened to facilitate movement of a steerable guiding sheath when the steerable guiding sheath clamp 226 is in a closed position. In addition, the table mount assembly 224 includes suture clamps 232 with at least one jaw 234 having a scalloped edge 236. The scalloped edge 236 of the jaw 234 helps to grip the anchor tethers 38 and prevent slippage when the anchor tethers 38 are secured within the suture clamps 232.

[0217] FIGS.84A and 84B show the steerable guiding sheath clamp 226 in further detail. In FIGS.84A and 84B, the steerable guiding sheath clamp 226 is shown in the locked position. The adjustable break 230 includes a breaking arm 239 coupled to a break pad 238. The break pad 238 is a cylindrical piece that selectively engages the steerable guiding sheath 52 to lock the steerable guiding sheath in place within the steerable guiding sheath clamp 226 when the steerable guiding sheath clamp is closed. The breaking arm 239 is a lever that is coupled to the break pad 238. Moving the breaking arm 239 rotates the break pad 238 to move the break pad 238 into and out of contact with the steerable guiding sheath 52 (not shown). In FIG.84A, the adjustable break 230 is in a locked configuration. In the locked configuration, the break pad 238 is lowed by the breaking arm 239 such at least a portion of the break pad 238 is positioned within an opening 241 in the steerable guiding sheath clamp 226 to secure the steerable guiding sheath 52. In FIG.84B, the adjustable break 230 is in an unlocked configuration. In the unlocked configuration, the break pad 238 is raised by rotating the breaking arm 239 such that the break pad 238 is removed from the opening 241 in the steerable guiding sheath clamp 226 to allow the steerable guiding sheath 52 to move freely. In the unlocked configuration, the steerable guiding sheath 52 is free to be rotated or maneuvered proximally or distally while still being held within the steerable guiding sheath clamp 226.

[0218] FIG.85 shows an alternative steerable guiding sheath 240. The steerable guiding sheath 240 is the same as the steerable guiding sheath 52 that is shown and described, for example, with reference to FIGS.18 and 19, with a difference being that a distal end 242 of the steerable guiding sheath 240 is curved to position the distal end 242 towards a target location within a 40 Attorney Docket No.21885-161818patient. In addition, the steerable guiding sheath 52 has an alternative steerable guiding sheath handle 244. The steerable guiding sheath 240 can be used in the same manner as described with reference to the steerable guiding sheath 52. The steerable guiding sheath handle 244 includes a tube 246 coupled to a stopcock 245. The tube 246 and stopcock 245 can be used to introduce fluids such as saline solution to the steerable guiding sheath 52. The steerable guiding sheath handle 244 also includes a grip portion 248. The grip portion 248 is a tapered cylinder that may include one or more raised ridges to provide a surface for the surgeon to grip when adjusting the steerable guiding sheath 240.

[0219] FIG.86 shows an alternative anchor handle assembly 250. The anchor handle assembly 250 is the same as the anchor handle assembly 42 that is shown and described with reference to FIGS.22–35, with a difference being that the anchor handle assembly 250 includes an outer tube 254 with a distal end 252 that has a curved portion 253 to position the distal end 252 at an angle relative to the outer tube 254. The curved portion 253 of the distal end 252 directs the distal tip of the outer tube 254 to a desired location within a placement. The can be used in the same manner as described with reference to the anchor handle assembly 42. The curved portion 253 of the distal end 252 may help with placement of the anchors 36 by disposing the anchors 36 outward towards the ventricle wall, reducing manual manipulations needed to place the anchors 36 at a target anchor site. The distal end 252 can be disposed at any suitable angle relative to the outer tube 254. The distal end 252 can be disposed at any angle between about 5 degrees and about 80 degrees for example, at an angle of between about 10 degrees and about 70 degrees, between about 10 degrees and about 60 degrees, between about 10 degrees and about 50 degrees, between about 10 degrees and about 40 degrees, or between about 10 degrees and about 30 degrees. In some implementations, the surgical kits described herein can include a plurality of anchor handle assemblies 250 with a distal ends 252 disposed at differing angles. For example, a surgical kit can include one anchor handle assembly 250 with a distal end 252 disposed at an angle of about 0 degrees, one with a distal end 252 disposed at an angle of about 20 degrees, and / or one with a distal end 252 disposed at an angle of about 30 degrees such that a surgeon can select an optimal angle for the deployment procedure.

[0220] Any combination of the devices described herein, including portions of the valve device 10 and equipment used to deploy the valve device 10 can be included in a surgical kit for deploying the valve device 10. The surgical kit can include one or more of the table mount assembly 40, the anchor handle assembly 42, the valve folding assembly 44, the threader 150, 41 Attorney Docket No.21885-161818the valve pusher assembly 48, and the locking and cutting assembly 50. The surgical kit can also include the valve body 11 and any suitable number of anchor subassemblies 86 which are provided to the surgical team ready for use and correspond to the number of anchors being deployed. In some configurations, the surgical kit includes the valve body 11 in an unfolded configuration with the valve folding assembly 44 so that the surgeon can fold and load the valve body 11 into the valve cartridge 122. In other configurations, the surgical kit includes a valve cartridge 122 with the valve body 11 pre-loaded within the valve cartridge 122. One or more components of the surgical kit can be included in a container that is provided to a surgeon or a surgical team.

[0221] FIGS.87–90 shown additional devices and methods for anchoring the valve body 11 to the heart of a patient. In FIGS.87–90, one or more anchors 262 are used to anchor the valve body to the valve annulus in the atrium. The anchor2262 are received within the protuberance 24 of the framework 14. Though the figures only illustrate one anchor 262, it is contemplated that any suitable number of anchors 262 may be coupled to the framework (e.g., 2, 3, 4).

[0222] In FIGS.87–90, the valve device 10 is coupled to a plurality of constraining sutures 264 secured to the framework 14 of the valve body 11. The constraining sutures 264 are coupled to the protuberances 24 of the framework 14. The constraining sutures 264 are used to guide the anchors 262 into place. The constraining sutures 264 can also be used to constrain or remove the valve body 11 during the deployment process if desirable. For example, if there is a problem with positioning or unfolding of the valve body 11 during the deployment process, a surgeon can pull on the constraining suture 264 to remove the valve body 11 from the patient. In some approaches, the constraining sutures 264 are coupled to the framework 14 when the valve body 11 is deployed or inserted in the patient.

[0223] Turning to FIGS.88–89, to install the anchor 262 an anchor catheter assembly 270 is slid over one of the constraining sutures 264. The anchor catheter assembly 270 is advanced distally toward the valve body 11. Once the anchor catheter assembly 270 reaches the framework 14 and, in particular, the protuberance 24 of the framework 14, the anchor 262 is deployed in tissue of the native valve annulus. As shown, the anchor 262 is a pig tail shaped anchor so the anchor 262 is deployed by twisting or screwing the anchor catheter assembly 270 through an opening in the framework 14 and into the valve annulus. Other types of anchors, such as treble hook anchors, can be used as the anchor 262. Once the anchor 262 is fully installed, the anchor 42 Attorney Docket No.21885-161818262 is released from the anchor catheter assembly 270 and the anchor catheter assembly 270 is removed from the steerable guiding sheath 52.

[0224] Turning to FIG.90, once the anchor 262 is installed, the constraining suture 264 is cut. A suture cutting tool assembly 280 is used to cut the constraining suture 264. The suture cutting tool assembly 280 is slid through the steerable guiding sheath 52 over the constraining suture 264. The distal end of the suture cutting tool assembly 280 is positioned adjacent to the anchor 262 so that a majority of proximal end portion of the constraining suture 264 is removed from the framework 14. After the suture cutting tool assembly 280 is in a desired position (e.g., a position where the constraining suture 264 is to be cut), the suture cutting tool 280 cuts the constraining suture 264. Once the constraining suture 264 is cut, the suture cutting tool assembly 280 is removed from the steerable guiding sheath 52. FIGS.91–93B illustrate the structure and operation of the suture cutting tool assembly 280 in further detail. This process can be repeated for any number of constraining sutures 264 and anchors 262.

[0225] FIGS.91–93B show the suture cutting tool assembly 280. The suture cutting tool assembly has a proximal end portion 280A, which is shown in FIG.92, and a distal end portion 280B, which is shown in FIGS.93A and 93B. An outer tube 282 extends from the proximal end portion 280A to the distal end portion 280B of the suture cutting tool assembly 280.

[0226] Turning to FIG.92, the proximal end portion 280A of the suture cutting tool assembly 280 includes a pulling handle 284 that can be actuated to operate a cutting device at the distal end portion 280A of the suture cutting tool assembly 280. The proximal end of the outer tube 282 is coupled to a handle base 288 that has a slot 290 formed therein. The slot 290 forms a track for the pulling handle 284. The pulling handle 284 is movable along the slot 290 in the proximal and distal directions. The pulling handle 284 is coupled to a pulling wire 294, which is coupled at a distal end to the cutting device at the distal end portion 280B of the suture cutting tool assembly 280 (not shown in FIG.92 but see FIGS.93A and 93B). A finger loop 286 is coupled to the proximal end of the handle base 288. A biasing element 292, such as a spring, is disposed in the handle base 290 between a distal end of the handle base 288 and the finger loop 286. The biasing element 293 is compressed during actuation of the pulling handle 284, namely, by pulling the pulling handle 284 along the slot 290 towards the finger loop 286. A surgeon can position a thumb in the finger loop 286 and fingers in the pulling handle 284 to actuate the pulling hand 284 and operate the cutting device at the distal end 280B. 43 Attorney Docket No.21885-161818

[0227] Turning to FIG.93A and 93B, the distal end portion 280B of the suture cutting tool assembly 280 includes a cutting device. The cutting device generally comprises an outer cutting tube 298 and an inner cutting tube 296 that is slidably received within the outer cutting tube 298. The outer cutting tube 298 is positioned distally of the inner cutting tube 296. The outer cutting tube 298 includes tapered portion at a distal tip of the outer cutting tube 298. The outer cutting tube 298 includes a first opening 300 and second opening 302 for receiving the constraining suture 264. The first opening 300 is formed in the tapered portion of the outer cutting tube 298 such that the first opening 300 is disposed at an angle relative to the second opening 302. The second opening 302 includes a first cutting lip 304. The second opening 302 is formed in a sidewall of the outer cutting tube 298. The inner cutting tube 296 includes tapered portion at a distal tip of the inner cutting tube 296. The inner cutting tube 296 includes a first opening 308 and second opening 310 for receiving the constraining suture 264. The first opening 308 is formed in the tapered portion of the inner cutting tube 296 such that the first opening 308 is disposed at an angle relative to the second opening 310. The second opening 310 includes a second cutting lip 312. The second cutting lip 312 engages the first cutting lip 304 when the inner cutting tube 296 is slid relative to the outer cutting tube 298 to cut the constraining suture 264. The second opening 302 is formed in a sidewall of the inner cutting tube 296. The inner cutting tube 296 is coupled to the pulling wire 294.

[0228] In operation, the pulling handle 284 is actuated by pulling the pulling handle 284 proximally. Pulling the pulling handle 284 pulls on the pulling wire 294 and compresses the biasing element 292. Pulling on the pulling wire 294 slides the inner cutting tube 296 within the outer cutting tube 298 causing the first cutting lip 304 on the outer cutting tube 298 to engage with the second cutting lip 312 on the inner cutting tube 296 to cut the constraining suture 264. Releasing the pulling handle 284 releases the biasing element 292 and causes the biasing element 292 to return to its natural state in which it pushes the pulling handle 294 towards the distal end of the handle base 288.

[0229] FIGS.94–96 show a valve pusher assembly 320 that can be used to fold and load the valve body 11 into the valve cartridge 122, according to some embodiments. The valve pusher assembly 320 has a proximal end portion 320A and a distal end portion 320B. A pusher tube 322 extends between the proximal end portion 320A and the distal end portion 320B.

[0230] Referring to FIG.94, the proximal end portion 320A of the valve pusher assembly 320 includes a pusher handle 324. The pusher handle 324 is coupled to a proximal end of the pusher 44 Attorney Docket No.21885-161818tube 322. The pusher handle 324 can be used to grasp and manipulate the valve pusher assembly 320, for example, to push the loaded valve cartridge 122 into and through the steerable guiding sheath 52. The pusher handle 324 is coupled to a tube and stopcock that can be used to flush the valve pusher assembly 320 (e.g., with a saline solution).

[0231] Referring to FIGS.95 and 96, the distal end portion 320B of the valve pusher assembly 320 is shown. The distal end portion 320B of the valve pusher assembly 320 includes a funnel 325 that is coupled to the valve loading cartridge 122. In FIG.96, the valve cartridge 122 and the funnel 325 are hidden. The valve loading cartridge 122 is coupled to a distal end of the pusher tube 322. As illustrated, a portion of the valve body 11 is inserted into the funnel 325 in an unfolded configuration. A threader 326 is inserted through the funnel 325, the valve cartridge 122 and through a central portion of the valve body 11. The threader 326 includes a tab portion 326A and a loop 326B. The tab portion 326A is a flange that provides a surface for gripping the threader 326 to pull sutures through the valve body 11. The tab portion 326 includes clips so that the treader can be coupled to the pusher tube 322. The loop 326B provides an opening that receives sutures to be threaded through the valve body 11. The constraining sutures 264 are coupled to the protuberances 24 of the valve body 24. The constraining sutures 264 extend through the pushing tube 322 to the proximal end portion 320A of the valve pusher assembly 320.

[0232] In a folding and loading operation, pulling proximally on the constraining sutures 364 while securing a distal end of the valve body 11 causes the framework 14 of the valve body 11 to collapse. Pushing the funnel 325 over the collapsed framework 14 and / or further pulling on the constraining sutures 364 loads the collapsed valve body 11 the valve cartridge 122. Once the valve body 11 is collapsed and loaded into the valve cartridge 122, proximal end portions of the anchor tethers 38 (not shown) can be inserted into the loop 326B of the threader 326 to thread the anchor tethers 38 through the valve body 11 and the valve cartridge 122. Once the valve body 11 and the valve cartridge 122 have been threaded, the valve pusher assembly 320 can positioned in the steerable guiding sheath 52 to push the valve body 11 out of the valve cartridge 122, through the steerable guiding sheath 52, and into the heart of a patient. Pushing on the pushing handle 324 can deploy the valve body 11 into the steerable guiding sheath 52 and into the heart.

[0233] FIG.97 illustrates an exemplary surgical kit comprising a container 260 with one or more of the table mount assembly 40, the anchor handle assembly 42, the valve folding assembly 44, 45 Attorney Docket No.21885-161818the threader 150, the valve pusher assembly 48, and the locking and cutting assembly 50, the valve body 11 and anchor subassemblies 86. Though the container 260 is illustrated as including each component, it is to be understood that the container can include any suitable combination of components. The surgical kit and / or individual components of the surgical kit can be sterilized using such a sterilization process such as ethylene oxide or gamma radiation sterilization.

[0234] In some embodiments, a method of treating an incompetent atrioventricular valve includes the steps of placing the valve body 11 in a patient, adjusting a position of the valve body 11, and anchoring the valve body 11 in the patient with one or more anchors 36 and anchor tethers 38.

[0235] The devices and methods described above offer several advantages. With the present methods of treating incompetent atrioventricular valves, the proximal portion of the valve device 10 helps to prevent paravalvular leaks, i.e. leaks around the valve device 10. There is also no need to remove the native valves or leaflets or disrupt the native atrioventricular valve apparatus. The presence of the native leaflets contributes to the integrity of the seal formed by the disclosed valve devices during the systolic portion of the cardiac cycle. The illustrated design of the valve device 10 also avoids the complication of ventricular outflow tract obstruction which can occur with other transcatheter valve devices.

[0236] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above-described embodiments without departing from the scope of the invention. As one example, referring to FIGS.18–80, the devices and processes used to deploy the valve device 10 in a patient can also be used to deploy a valve device with the valve body 218 as shown in FIG.81. Accordingly, it will be understood that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept. 46 Attorney Docket No.21885-161818

Claims

CLAIMS 1. A heart valve implant comprising: a hub assembly including a tube having a central opening and a hub fastener coupled to the tube; a framework having a plurality of wire sections, each of the plurality of wire sections having a distal end portion and a proximal end portion, the distal end portion coupled to the hub assembly and the proximal end portion having an outer rim portion that extends in a circumferential direction about the hub assembly, wherein at least a portion of the framework is secured between the tube and the hub fastener; and a flexible valve portion surrounding at least part of an outward-facing portion of the framework, the flexible valve portion coupled to at least some of the plurality of wire sections, wherein a distal portion of the flexible valve portion is unsecured to the framework such that the valve portion works in cooperation with native valve tissue.

2. The heart valve implant of claim 1, wherein the framework is located central to the flexible valve portion.

3. The heart valve implant of claim 1, wherein at least a portion of the flexible valve portion formed from a material that promotes in-growth of native valve tissue.

4. The heart valve implant of claim 3, wherein the flexible valve portion includes an apron comprising a generally annular region that curves outward from the hub assembly and couples to the outer rim portion, and wherein the apron is formed from the material.

5. The heart valve implant of claim 3, wherein material includes at least one of polytetrafluoroethylene (ePTFE), porcine pericardium, porcine processed small intestine submucosa, thermoplastic polyurethane (TPU), siliconized TPU, a synthetic polymer, or collagen fibers.

6. The heart valve implant of claim 1, wherein the outer rim portion includes an outwardly extending protuberance. 47 Attorney Docket No.21885-1618187. The heart valve implant of claim 1, wherein the distal end portion of each wire section includes a pair of legs that are secured between the tube and the hub fastener.

8. The heart valve implant of claim 7, wherein at least a portion of the legs extend radially outwardly away from the hub assembly toward the outer rim portion.

9. The heart valve implant of claim 1, wherein the proximal end portion of each wire section is petal shaped.

10. A surgical kit comprising: a container; a heart valve implant comprising a hub assembly, a framework, and a flexible valve portion, the framework including a plurality of wire sections coupled to the hub assembly and having outer rim portions that extend in a circumferential direction about the hub assembly, the flexible valve portion coupled to the outer rim portions and surrounding an outward-facing portion of the framework; and at least one anchor with an anchor tether coupled thereto.

11. The surgical kit of claim 10, further comprising: an anchor handle assembly comprising an outer tube, a proximal end portion of the outer tube including an anchor handle; and an anchor subassembly including an inner tube disposed within the outer tube, the inner tube having the anchor tether extending therethrough, a proximal end portion of the inner tube coupled to a plunger and a distal end portion of the inner tube coupled to the anchor, the anchor handle comprising an interior cavity that is sized to receive the plunger.

12. The surgical kit of claim 10, further comprising: a table mount assembly comprising a fixed base and a movable base, the fixed base having a proximal portion with a suture clamping assembly and a distal portion, the fixed base including track that extends from the distal portion towards the proximal portion, the movable base coupled to and movable along the track, the movable base having a steerable guiding sheath clamp mounted thereon. 48 Attorney Docket No.21885-16181813. The surgical kit of claim 10, further comprising: a steerable guiding sheath defining a channel sized to receive the heart valve implant.

14. The surgical kit of claim 10, further comprising: a valve pusher assembly comprising a pusher tube, a proximal end portion of the pusher tube including a valve pusher handle, a distal end portion of the pusher tube including a pushing tip that comprises a sidewall surrounding a longitudinal bore, the sidewall including a sidewall opening sized to permit the anchor tether to be threaded therethrough.

15. The surgical kit of claim 10, further comprising: a locking and cutting assembly comprising an outer tube with a proximal end coupled to a handle guide shaft and a distal end coupled to an outer cutting tube, the outer tube having an inner bore with a pulling wire extending therethrough, a proximal end of the pulling wire affixed to a pulling handle that is slidably coupled to the handle guide shaft, a distal end portion of the pulling wire coupled to a locking pin, wherein an inner cutting tube is slidably positioned within the outer cutting tube and a locking bead is positioned between the inner cutting tube and the locking pin, wherein the locking bead removably positioned in the outer cutting tube and the locking pin is lockingly engageable with the locking bead.

16. The surgical kit of claim 15, wherein a proximal end of the handle guide shaft is coupled to a finger loop, the finger loop disposed proximally relative to the pulling handle.

17. The surgical kit of claim 15, wherein the inner cutting tube and the outer cutting tube have windows with complementary cutting lips that align when the inner cutting tube slides within the outer cutting tube.

18. The surgical kit of claim 10, further comprising a valve folding assembly comprising: a valve folding base defining a first end portion and a second end portion, the first end portion comprising a cart slidably mounted to the valve folding base, the second end portion comprising a cradle, and a central mounting plate disposed between the first end portion and the second end portion; and 49 Attorney Docket No.21885-161818a valve loading base that holds a valve cartridge, the valve loading base removably coupled to the central mounting plate, the valve loading base including a chuck assembly that is removably received within the cradle and a funnel, a narrow end of the funnel disposed adjacent to the valve cartridge and a wide end of the funnel facing the chuck assembly, where in the heart valve implant is disposed in the funnel in an unfolded configuration, the chuck assembly having an elongated body with an end that selectively secures the heart valve implant and is slidably received by the wide end of the funnel.

19. The surgical kit of claim 18, wherein valve folding assembly further comprises a suture having a first end coupled to the heart valve implant and a second end that is removably coupled to the cart.

20. The surgical kit of claim 18, wherein the valve folding assembly further comprises a threader comprising a wire having a wire ring, the wire extending through the valve cartridge.

21. The surgical kit of claim 10, wherein the heart valve implant is folded and preloaded into a cartridge.

22. A mounting assembly for deploying a heart valve implant in a patient, the mounting assembly comprising: a fixed base defining a proximal portion and a distal portion, the fixed base including a track that extends from the distal portion towards the proximal portion, the proximal portion including a suture clamping assembly, the suture clamping assembly comprising at least one suture clamp with a pair of adjustable jaws coupled to a tightening knob; and a movable base coupled to and movable along the track, the movable base including a steerable guiding sheath clamp.

23. The mounting assembly of claim 22, wherein the steerable guiding sheath clamp comprises a fixed jaw coupled to the movable base and a movable jaw hingedly coupled to the fixed jaw.

24. The mounting assembly of claim 22, further comprising a locking mechanism for securing the movable base in the fixed base. 50 Attorney Docket No.21885-16181825. A valve pusher assembly comprising: a pusher tube, a proximal end portion of the pusher tube including a valve pusher handle, a distal end portion of the pusher tube including a pushing tip that comprises a sidewall surrounding a longitudinal bore, the sidewall including a sidewall opening sized to permit an anchor tether to be threaded therethrough.

26. The valve pusher assembly of claim 25, wherein the sidewall opening is positioned proximate a distal opening of the pusher tube.

27. The valve pusher assembly of claim 26, wherein a suture threader is coupled to the pushing tip for threading one or more sutures through the distal opening of the pushing tip and the sidewall opening.

28. The valve pusher assembly of claim 25, wherein the pushing tip is formed of a metal.

29. A locking and cutting assembly comprising: an outer casing having an inner bore with a pulling wire extending therethrough; a pulling handle coupled to the pulling wire at a proximal end of the outer casing, the pulling handle slidably coupled to handle guide shaft; and a locking and cutting device coupled to the pulling wire at a distal end of the outer casing, the locking and cutting device comprising: an outer cutting tube with a first cutting lip; an inner cutting tube that is slidably received within the outer cutting tube, the inner cutting tube including a second cutting lip; a locking bead positioned distally of the outer cutting tube and the inner cutting tube, wherein the locking bead removably positioned in the outer cutting tube; and a locking pin disposed distally of the locking bead, the locking pin coupled to the pulling wire, the locking pin lockingly engageable with the locking bead.

30. The locking and cutting assembly of claim 29, wherein a proximal end of the handle guide shaft is coupled to a finger loop, the finger loop disposed proximally relative to the pulling handle. 51 Attorney Docket No.21885-16181831. The locking and cutting assembly of claim 29, wherein the outer cutting tube includes a first window bounded by the first cutting lip and the inner cutting tube includes a second window bounded by the second cutting lip.

32. The locking and cutting assembly of claim 31, wherein the first cutting lip is engageable with the second cutting lip upon proximal movement of the inner cutting tube within the outer cutting tube.

33. The locking and cutting assembly of claim 29, wherein the pulling wire extends through an inner bore of the inner cutting tube and the outer cutting tube.

34. The locking and cutting assembly of claim 29, wherein the locking pin includes a distal opening and the locking pin is lockingly engageable with the distal opening of the locking bead.

35. A valve folding assembly comprising: a valve folding base defining a first end portion and a second end portion, the first end portion comprising a cart slidably mounted to the valve folding base, the second end portion comprising a cradle, and a central mounting plate disposed between the first end portion and the second end portion; and a valve loading base that holds a valve cartridge, the valve loading base removably coupled to the central mounting plate, the valve loading base including a chuck assembly that is removably received within the cradle and a funnel, the funnel having a narrow end of the funnel disposed adjacent to the valve cartridge and a wide end of the funnel is disposed adjacent to the chuck assembly, the chuck assembly having an elongated body with movable jaws.

36. The valve folding assembly of claim 35, wherein valve folding assembly further comprises a heart valve implant disposed in the funnel, a suture having a first end coupled to the heart valve implant, and a second end that is removably coupled to the cart.

37. The valve folding assembly of claim 35, wherein the valve folding assembly further comprises a threader comprising a wire having a wire ring, the wire extending through the valve cartridge. 52 Attorney Docket No.21885-16181838. The valve folding assembly of claim 35, wherein the elongated body of the chuck assembly is slidably received by the wide end of the funnel.

39. The valve folding assembly of claim 35, wherein a valve body of a heart valve implant is disposed in the funnel in an unfolded configuration.

40. The valve folding assembly of claim 35, wherein the movable jaws are disposed at an end of the elongated body that is adjacent to the funnel.

41. The valve folding assembly of claim 35, wherein the cart includes a cart base surrounded at least in part by a cart cover, the cart base having a post that extends through an opening in the cart cover, wherein a biasing member disposed between the post and the cart cover.

42. An anchor handle assembly comprising: an outer tube, a proximal end portion of the outer tube including an anchor handle; and an anchor subassembly including an inner tube disposed within the outer tube, the inner tube having an anchor tether extending therethrough, a proximal end portion of the inner tube coupled to a plunger and a distal end portion of the inner tube coupled to an anchor, the anchor handle comprising an interior cavity that is sized to receive the plunger.

43. The anchor handle assembly of claim 42, wherein the anchor is a treble hook anchor, and wherein the anchor tether is a suture.

44. The anchor handle assembly of claim 42, wherein a distal end portion of the outer tube includes a curved portion to position a distal tip of the outer tube at an angle relative to the outer tube.

45. A method of deploying a heart valve implant, the method comprising: securing an anchor in a patient via an anchor tether using a steerable guiding sheath, with a proximal end of the anchor tether extending out of a proximal end of the steerable guiding sheath; threading the proximal end of the anchor tether through a valve body that is folded and loaded in a valve cartridge; 53 Attorney Docket No.21885-161818pushing the valve body distally along the anchor tether out of the valve cartridge, into the steerable guiding sheath, and into an atrioventricular valve of the patient such that a valve portion of the valve body engages native valve leaflets of the atrioventricular valve; deploying a locking mechanism proximal of the valve body to secure the valve body in the atrioventricular valve; and cutting the anchor tether proximal of the locking mechanism to remove a proximal end portion of the anchor tether.

46. The method of claim 45, further comprising: placing the steerable guiding sheath in a table mount assembly; and securing the steerable guiding sheath via a steerable guiding sheath clamp of the table mount assembly.

47. The method of claim 45, wherein the patient is a mammalian patient.

48. The method of claim 47, wherein the patient is a human.

49. The method of claim 45, wherein the anchor is secured in a ventricle of the patient.

50. The method of claim 45, further comprising: folding the valve body via a valve folding assembly to place the valve body in a folded configuration; and loading the valve body into the valve cartridge in the folded configuration.

51. The method of claim 45, further comprising: securing the proximal end of the anchor tether via a suture clamp on a table mount assembly.

52. The method of claim 45, wherein deploying the locking mechanism includes securing the anchor tether between a locking bead and a locking pin, the locking pin engaging a distal opening in the locking bead.

53. The method of claim 45, further comprising: 54 Attorney Docket No.21885-161818positioning the steerable guiding sheath proximally in a table mount assembly to place a distal end of the steerable guiding sheath proximal of native valve leaflets in an atrioventricular valve of the patient before pushing the folded valve body.

54. The method of claim 45, wherein the anchor is secured within a ventricle of the patient.

55. The method of claim 45, further comprising: securing the valve body to an atrium of the patient with at least one anchor.

56. A method of deploying a heart valve implant, the method comprising: making an incision in a chest of a patient; accessing a left auricular appendage of the patient via the incision; placing a suture around the left auricular appendage; inserting a steerable guiding sheath into a left atrium of the patient via the left auricular appendage; deploying an anchor coupled to an anchor tether in the patient via the steerable guiding sheath; deploying a valve body in an atrioventricular valve of the patient via the steerable guiding sheath by passing the valve body over the anchor tether; and securing the valve body to the anchor tether.

57. The method of claim 56, wherein deploying the anchor coupled to the anchor tether includes: securing the anchor in the patient, with a proximal end of the anchor tether extending out of a proximal end of the steerable guiding sheath and threading the proximal end of the anchor tether through the valve body, wherein the valve body is folded and loaded in a valve cartridge; 58. The method of claim 57, wherein deploying the valve body includes: pushing the valve body distally along the anchor tether out of the valve cartridge, into the steerable guiding sheath, and into the atrioventricular valve such that a valve portion of the valve body engages native valve leaflets of the atrioventricular valve, 55 Attorney Docket No.21885-16181859. The method of claim 58, wherein securing the valve body to the anchor tether includes: deploying a locking mechanism proximal of the valve body to secure the valve body in the atrioventricular valve; and cutting the anchor tether proximal of the locking mechanism to remove a proximal end portion of the anchor tether 60. A method comprising: positioning a valve body comprising a tube-shaped flexible valve portion coupled to an outward facing portion of a wire framework within a valve annulus of an atrioventricular valve such that the tube-shaped flexible valve portion engages and cooperates with native valve leaflets, at least a portion of the wire framework secured by a hub assembly comprising a tube and hub fastener; and securing the valve body to a ventricle via an anchor and an anchor tether, wherein the anchor tether is threaded through the tube-shaped flexible valve portion, the framework, and the tube of the hub assembly.

61. The method of claim 60, wherein the native valve leaflets are not removed from the patient.

62. The method of claim 60, wherein movement of the native valve leaflets is not prevented due the positioning of the valve body.

63. The method of claim 60, further comprising: securing the valve body to the valve annulus via at least one anchor. 56 Attorney Docket No.21885-161818

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