Modular percutaneous valve structures and delivery methods

Abstract

To provide a modular percutaneous prosthetic valve device for implantation in a patient.SOLUTION: The valve device is designed as two or more modules to be delivered unassembled and combined into an assembled valve device in the body, e.g., in the body at or near the site where implantation occurs. The two or more modules may be a support structure and a valve assembly. The valve assembly may be formed from two or more valve sections. Because the valve device of the invention is deliverable as modules, it may have a smaller delivery diameter than pre-assembled percutaneous valves and permits use of a delivery device of reduced diameter. Delivering the valve device as modules increases the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 61 / 144,007, filed January 12, 2009.

[0002] The present invention relates to prosthetic valve devices for implantation in the body and methods for their deployment. In particular, the present invention relates to multi-component, or modular, percutaneous prosthetic valve devices, i.e., prosthetic valves that can be delivered in a disassembled state and assembled in the body, thus allowing for a smaller delivery diameter than a fully assembled percutaneous valve device. The present invention also relates to systems including such modular valve devices and delivery devices having a smaller diameter compared to the delivery devices for the fully assembled percutaneous valve devices, as well as methods for delivering and deploying such modular valve devices using the small diameter delivery device systems. Furthermore, the present invention relates to methods for assembling modular valve devices, including locking device modules together using a locking mechanism. [Background technology]

[0003] There are a variety of natural valves in the human body, such as heart valves, esophageal valves, stomach valves, intestinal valves, and valves in the lymphatic system. Natural valves can deteriorate for a variety of reasons, including disease and aging. A malfunctioning valve cannot maintain unidirectional fluid flow with minimal pressure loss. One example of a malfunctioning valve is a heart valve, which can be stenotic (i.e., the leaflets of the valve do not open completely) or incompetent (i.e., the leaflets of the valve do not close properly). It is desirable to restore valve function in order to restore proper function of the organ with which the valve is associated. For example, proper valve function in the heart allows blood flow to be maintained unidirectional through the valve with minimal pressure loss, thereby maintaining blood circulation and blood pressure. Similarly, proper esophageal valve function prevents acidic gastric secretions from irritating and permanently damaging the lining of the esophagus.

[0004] Several percutaneous prosthetic valve systems have been described. One example, described by Andersen et al. (U.S. Pat. No. 5,411,552), comprises an expandable stent and a collapsible valve that is placed over the stent prior to deployment. The collapsible valve may be a biological valve or may be made of synthetic materials. The Anderson prosthetic valve is delivered and deployed using a balloon catheter with a balloon used to expand the valve-stent prosthesis to its final size. Additionally, a paper entitled "Valve Prosthesis for Implantation in the Body" by Andersen et al. No. 6,168,614 (Andersen et al.), and U.S. Pat. No. 5,840,081 (Andersen et al.), entitled "System and Method for Implanting Cardiac Valves."

[0005] Spenser et al. (U.S. Pat. No. 6,893,460) have developed a method for producing a cellular membrane made from biomaterials or synthetic materials. The authors describe another prosthetic valve device that includes a valve structure fabricated from a stent and a support structure such as a stent. The Spenser prosthetic valve consists of a conduit with an inlet and an outlet, and a collapsible support structure at the outlet. A crimpable rib made from a flexible material configured to provide a wall. The valve assembly is a leafed-valve assembly that is attached to a supporting stent prior to deployment. The completed valve device is deployed at a target location within a body passageway using a deployment means such as a balloon catheter or similar device.

[0006] Percutaneous implantation of prosthetic valves is safer and less expensive than standard surgical procedures and can reduce patient recovery time. However, current man-made percutaneous prosthetic valves have the disadvantage of being extremely bulky, even when compressed for delivery. The problems associated with this bulk are compounded by the fact that The problem is that a delivery catheter with a large diameter is required. Large catheters are generally not suitable for percutaneous procedures and require cut-down procedures and surgeons and / or complex and difficult punch-and-suturing techniques. Furthermore, the bulkiness and large diameter of current valve devices and delivery systems, coupled with the anatomical structures through which these devices must be delivered, can make delivery into body lumens problematic in terms of success rate, deployment accuracy, and risk of complications. In particular, delivery complications can be caused by the shape of the body lumen, such as the large natural curves of the aortic arch and / or tortuous iliac / femoral arteries through which the catheter is introduced. Furthermore, catheters of such diameters tend to be less flexible than catheters of smaller diameters, especially when loaded with bulky, non-flexible devices, and maneuvering such loaded catheters through small and especially curved blood vessels greatly increases the possibility of causing damage to the vessel walls.

[0007] Accurate placement of current percutaneous valve devices relative to the existing native anatomy is often problematic, especially in the case of aortic valve replacement. A prosthetic valve placed too distally (i.e., toward the aorta) can block or impede flow into the coronary ostium. For example, depending on the location of the coronary ostium, the skirt of the prosthetic valve or large native valve leaflets pressing against the aortic wall may physically or functionally occlude the ostium and impede coronary flow. See, e.g., Piazza, N., et al., "Anatomy of the Aortic Valvar Complex and Its Implications for Transcatheter Implantation of the Aortic Valve," CIRCULATION CARDIOVASCULAR INTERVENTIONS, 1:74-81 (2008); Webb, JG, et al., "Percutaneous aortic valve implantation retrograde from the femoral artery," CIRCULATION, 113:842-850 (2006). This obstruction can be physical or functional; that is, the coronary artery ostium is physically open, but flow into the coronary artery is partially compromised due to a change in the flow pattern caused by the prosthetic valve. A prosthetic valve positioned too proximally (i.e., toward the left ventricular outflow tract) can obstruct the posterior leaflet of the mitral valve, the atrioventricular node, or the bundle of His (conductive tissue). Approximately 30% of patients who have a prosthetic valve placed percutaneously in their body require a pacemaker because the valve is positioned at the end of the ventricle too close to or on the left bundle branch, putting pressure on the electrical conduction system.For example, Piazza, N., et al., "Early and persistent intraventricularconduction abnormalities and requirements for pacemakingfollowing percutaneous replacement of the aortic valve," JACCCARDIOVASCULAR INTERVENTIONS, 1:310-316 (2008); Piazza, N., et al.,"Anatomy of the Aortic Valvar Complex and Its Implications forTranscatheter Implantation of the Aortic Valve," CIRCULATIONCARDIOVASCULAR INTERVENTIONS, 1:74-81 (2008). [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Pat. No. 5,411,552 [Patent Document 2] U.S. Patent No. 6,168,614 [Patent Document 3] U.S. Patent No. 5,840,081 [Patent Document 4] U.S. Patent No. 6,893,460 [Non-patent literature]

[0009] [Non-Patent Document 1] Piazza, N., et al., "Anatomy of theAortic Valvar Complex and Its Implications for Transcatheter Implantation of the Aortic Valve," Circulation Cardiovascular Interventions, 1:74-81(2008) [Non-Patent Document 2] Webb, JG, et al., "Percutaneous aortic valve implantation retrograde from the femoral artery," Circulation,113:842-850 (2006) [Non-Patent Document 3] Piazza, N., et al., "Early and persistent intraventricular conduction abnormalities and requirements for pacemaking following percutaneous replacement of the aortic valve," JACCCardiovascular Interventions, 1:310-316 (2008) Summary of the Invention [Problem to be solved by the invention]

[0010] Thus, there is a need to facilitate the delivery of artificial valves and to increase the safety of the procedure. A valve device that has a smaller delivery diameter than pre-assembled percutaneous valve devices and that can be delivered through a blood vessel without causing further damage to the wall of the body cavity is highly desirable. [Means for solving the problem]

[0011] The present invention relates to multi-component, or modular, percutaneous valve devices and systems, as well as methods for delivering prosthetic valve devices in a disassembled state and for assembling the modular valve devices in vivo.

[0012] The present invention provides minimally invasive, modular percutaneous prosthetic valve devices, systems including such devices, and methods of percutaneous valve delivery.

[0013] The modular prosthetic valve device comprises multiple device modules for delivery. In one embodiment, the multiple device modules include valve modules and support structures that are designed to be combined into an assembled valve device in vivo. The valve modules are portions of a valve device with valve leaflets that, when assembled, form a conduit with an inlet end and an outlet end. The valve module itself may include multiple device modules. Additionally, in one embodiment, the valve module may further include multiple valve sections that can be assembled in vivo to form a valve assembly. The valve assembly can then be combined with a support structure to become an assembled valve device. In another embodiment, the multiple device modules may include multiple valve sections that can be deployed and assembled into a valve assembly and implanted without a support structure. Alternatively, individual valve sections may be implanted, for example when the native valve leaflets are diseased.

[0014] The system of the present invention includes a modular prosthetic valve device and a delivery device for delivering the valve device to a desired location within a body lumen. Additionally, the system may include a configuration for adjustably coupling the valve module to a support structure and / or for adjustably coupling the support structure to a fixed point. The system of the present invention may further include a temporary valve.

[0015] The invention further relates to methods of delivering the modular valve device to a body cavity requiring a valve and methods of assembling the modular valve device within the body cavity. Various methods can be used to deliver the device modules to a desired location for assembly within the body. The methods include percutaneously introducing the valve in a disassembled (modular) state, rather than as a whole, by a delivery device such as a catheter. These parts may include a support structure and a valve module. The valve module may be a one-piece valve component or may be a valve assembly including multiple parts. The device modules may be assembled sequentially at the implantation site, or may be assembled (and then implanted) sequentially at a site different from the implantation site. The device modules may be assembled and implanted in any order suitable for the particular valve replacement procedure. Thus, for example, sections of the valve assembly may be assembled at a remote site, e.g., in the ascending or descending aorta, and then delivered to the target site, where the valve assembly is then coupled to the support structure. Alternatively, the valve assembly may be combined with the support structure at the remote site and then implanted. The valve device may then be delivered to the target site. As another alternative, the valve device may be fully assembled at the target site.

[0016] The valve modules may be attached to a support structure and / or the valve sections may be held together by a locking mechanism. The locking mechanisms of the present invention may be part of the device modules, i.e., the locking mechanisms in their entirety are integral to the structure of the device modules or are attached to one or more device modules prior to delivery and deployment within a body lumen. Alternatively, the locking mechanisms of the present invention may not be integral to the device modules, i.e., at least a portion of the locking mechanism is a separate structure from the modular valve device, i.e., applied to one or more device modules after delivery and deployment of the device module(s) within the body, or removed from the valve device during or after the locking process.

[0017] For example, in one embodiment, the valve module may include a set of lockable tabs that, when engaged, exert a radial force against the support structure sufficient to couple the valve module to the support structure. In another embodiment, the support structure may include a set of geometric engagement structures, such as rings in grooves, that engage a portion of the valve module designed to exert an outward radial force against the support structure. In yet another embodiment, the valve module and the support structure may each have a female component, and a locking tab with a male component may be inserted into the assembled valve device and positioned to mate with both the valve module and the support structure of the assembled valve device to hold the two components together. In yet another embodiment, a set of pins or rivets may join the valve module to the support structure. In another embodiment, the edges of the unassembled valve module may include an interlocking geometry that allows the edges to lock together with a zip-lock type fastener. Several other embodiments of the locking mechanism are included within the scope of the present invention, as described herein or as would be readily recognized by one of ordinary skill in the art. An integral locking mechanism may allow the portions of the device module that are to be locked together to automatically engage when properly positioned.

[0018] Additionally, device modules may be secured in place by frictional or other positive positioning forces such as magnetic forces, interference fits, or static fits. Pull wires or push rods may be used to position the valve sections relative to one another during assembly of the valve sections to form a valve assembly, and may also assist in positioning the valve module (e.g., valve assembly) within a support structure when device modules are combined to form an assembled valve device. Additionally, pull wires may serve to tether the device modules during delivery, allowing the modules to be delivered and deployed in tandem.

[0019] Additionally provided are systems for valve delivery that allow for maintaining valve function while the modular valve device is assembled and positioned at the implantation site, and methods for maintaining valve function during accurate assembly and implantation of a percutaneous modular valve device by providing a temporary valve. In one embodiment, the temporary valve may be part of the delivery system (e.g., attached to the delivery device) and may be removed when the delivery device is withdrawn from the vessel. In another embodiment, the temporary valve may be placed on a support structure of a permanent valve device, and the temporary leaflets may be crushed or flattened by implantation of a valve module (e.g., leaflet substructure, valve assembly, or individual valve section, etc.) of the permanent valve. The method of delivering a modular prosthetic valve may include the intermediate step of deploying a temporary valve. The use of a temporary valve according to the present invention is not required for the method of delivering a modular valve device, but may be used in conjunction with the percutaneous valve. It is intended to improve the safety and outcome of replacement procedures.

[0020] The advantages that can be realized by the present invention include the percutaneous prosthetic valve system according to the present invention reduces the bulkiness of the valve for delivery and increases the flexibility of the delivery device. Furthermore, the prosthetic valve device is minimally invasive, and the percutaneous delivery method reduces traumatic injury and minimizes the complexity of the procedure, thereby increasing the safety of the procedure and increasing the number of medical facilities that install the system and perform percutaneous valve replacement procedures. One advantage of installing a temporary valve before implantation of a permanent prosthetic valve is that it reduces the time constraints for assembling and positioning the percutaneous valve device by preventing unrestricted backflow during the replacement procedure. The use of a temporary valve gives the operator some time to assemble the modular percutaneous valve device, carefully and accurately position the prosthetic valve device, and adjust the position of the valve without adversely affecting the outcome of the valve replacement procedure. That is, the present invention is as follows. (1) A modular prosthetic valve device comprising a plurality of device modules, the device modules being designed to be assembled into the valve device after deployment from a delivery device. (2) A valve device as described in (1) above, wherein the plurality of device modules includes a support structure and a valve module. (3) A valve device as described in (2) above, wherein the valve module further includes a plurality of valve sections. (4) A valve device as described in (1) above, wherein the multiple device modules include multiple valve sections. (5) The valve device described in (2) above, wherein the valve module is a valve leaflet substructure. (6) The valve device described in (2) above, wherein the valve module is a leaflet-ring. (7) The valve device according to any one of (1) to (5) above, further comprising a pull wire. (8) The valve device according to any one of (1) to (7) above, further comprising a locking mechanism. (9) A valve device as described in (8) above, wherein the locking mechanism is integral with a plurality of device modules. (10) A valve device as described in (8) above, wherein the locking mechanism is not integral with the multiple device modules. (11) The valve device described in (2) above, wherein the support structure is a stent. (12) A system for assembling an artificial valve device in a body requiring the artificial valve device, the system comprising a delivery device and a valve device described in any one of (1) to (6) above. (13) The system described in (12) above, further comprising a temporary valve. (14) The system described in (12) above, further comprising a first tube. (15) The system described in (12) above, wherein the delivery device is a catheter. (16) providing a delivery device housing a plurality of device modules; deploying the device module from the delivery device; assembling the device modules to form a valve device; A method for assembling a modular valve device, comprising: (17) The method of (16) above, wherein the device module comprises a support structure and a plurality of valve sections, and the deploying step includes the steps of deploying the support structure and then deploying the valve sections. (18) A device module comprising a support structure and a plurality of valve sections, the step of assembling comprising: assembling the valve sections to form a valve assembly; assembling the valve assembly and the support structure to form a valve device; The method according to (16) above, (19) The device module includes a locking mechanism, and the method includes: coupling the modules together using the locking mechanism; The method according to (16) above, further comprising: (20) The method of (16) above, wherein the delivery device further contains a plurality of pull wires, each of which connects two or more device modules, and the assembling step further includes assembling the device modules using the pull wires. (21) A device module comprising a support structure and a plurality of valve sections, the assembling step comprising: assembling the valve sections to form a valve assembly; assembling the valve assembly and the support structure to form a valve device; The method according to (16) above, (22) A device module includes a first locking mechanism and a second locking mechanism, and the method includes: locking the valve sections together with the first locking mechanism and attaching the valve assembly to a support structure with the second locking mechanism. The method according to (21) above, further comprising: (23) The method of (21) above, wherein the delivery device further contains a plurality of pull wires, the plurality of pull wires including a first pull wire and a second pull wire, and the assembling step further includes assembling the valve sections using the first pull wire to form a valve assembly, and assembling the valve assembly and a support structure using the second pull wire to form a valve device. (24) A method for delivering a prosthetic valve device to a body cavity in need thereof, comprising: introducing into a body cavity a modular valve system including a delivery device and a valve device, the valve device including a plurality of device modules; deploying the device module from the delivery device; assembling the device module; A method comprising: (25) The method of (24) above, wherein the device module comprises a support structure and a plurality of valve sections, and the deploying step includes the steps of deploying the support structure and then deploying the valve sections. (26) A device module comprising a support structure and a plurality of valve sections, the assembling step comprising: combining the valve sections to form a valve assembly; combining the valve assembly with the support structure to form a valve device; The method according to (24) above, (27) The method according to (24) above, wherein the assembling step is carried out at the implantation site. (28) The method according to (24) above, wherein the body cavity is the aorta and the assembling step is carried out in the aorta. (29) The system further includes a plurality of pull wires, and the assembling step comprises: forming an assembled valve device using said pull wires The method according to (24) above, (30) The device module includes a locking mechanism, and the method includes: coupling the device modules together using the locking mechanism; The method according to (24) above, further comprising: (31) The system further includes a temporary valve, and the method further comprises: Deploying the temporary valve. The method according to (24) above, further comprising: [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 illustrates one embodiment of assembling a modular prosthetic valve device (bottom) by combining a valve module (shown at top) and a support structure (middle), in this embodiment using pull wires. [Diagram 2] 1 illustrates an embodiment of a valve module including multiple valve sections, in this example three valve sections assembled to form a valve assembly. [Diagram 3] FIG. 1 illustrates a valve device including four device modules, i.e. three valve sections (comprising the valve modules) and one support structure that can be sequentially loaded onto a delivery device, in this embodiment a catheter, where the catheter forms a vehicle for delivering and deploying the device modules to a desired site within the body. [Figure 4A-C]

[0023] Figures 4A and 4B show an embodiment of how pull wires may be used to assemble an embodiment of a valve device including four device modules. Figure 4A illustrates pull wires threaded through unassembled modules of a valve device such as the embodiment shown in Figure 3. Figure 4B illustrates the use of pull wires and push rods to assemble valve sections into a valve assembly. Figure 4C illustrates the use of pull wires and push rods to assemble a valve assembly and a support structure into a valve device. [Figure 5A-C]5A-5C show a valve module including leaflet substructures in an unassembled configuration (FIG. 5A), a delivery configuration (FIG. 5B), and assembled into a valve component (FIG. 5C). [Figure 6A-C] 6A-6C show a valve module including a leaflet-ring in an unassembled configuration (FIG. 6A), a delivery configuration (FIG. 6B), and assembled into a valve component (FIG. 6C). [Figure 7-7A] 3A-3C show an embodiment of a locking mechanism for combining the leaflets of FIG. 2 to form a valve assembly. [Figure 8A-C] FIG. 13 illustrates one embodiment of a locking mechanism for mounting the valve module on a support structure. [Figure 9] 13A-13C show an embodiment of locking tabs as an integral locking mechanism for attaching the valve module to a support structure. [Figure 10A-D] 10A shows an embodiment of a stud-harbor lock as an integrated locking mechanism for mounting a valve module to a support structure. FIG. 10A shows a stud located on a ring of the valve module and a harbor located on a post of the support structure. FIG. 10B shows a stud docked into a harbor located on a post of the support structure. FIGs. 10C and 10C' show a vertical channel on the stud as part of a ridge / channel base lock between the stud and the harbor in front and top views, respectively. FIGs. 10D and 10D' show a vertical ridge on the harbor as part of a ridge / channel base lock between the stud and the harbor in side and front views, respectively. [Figure 11A-B] 13A-13C illustrate one embodiment of a quick release locking mechanism for mounting the valve module to a support structure. [Figure 12A-B]

[0033] Figures 12A and 12B show an embodiment of a snap-fit ​​lock as an integral and non-integral locking mechanism. Figure 12A shows a non-integral snap-fit ​​lock for attaching a valve module to a support structure. Figure 12A' shows snap-fit ​​prongs. Figure 12B shows another embodiment of a non-integral snap-fit ​​lock with the valve module attached to a support structure by a snap-fit ​​receptacle. [Figure 13A-E] 13A-13E show interlocking geometries as non-integral locking mechanisms for mounting a valve module to a support structure: Fig. 13A shows a pin; Fig. 13B shows a pin in use; Fig. 13C shows a peg; Fig. 13D shows a rivet; Fig. 13E shows a stud-tube connector; [Figure 14A-C] 14A-14C illustrate several aspects of one embodiment of an interlocking curvilinear groove feature. FIG. 14A illustrates in side view how a string can be used to attach the sides of an unassembled valve module to the interlocking curvilinear groove feature. FIG. 14B illustrates a cross-sectional view of one embodiment of an interlocking curvilinear groove feature. FIG. 14C and FIG. 14C' illustrate cross-sectional views of another embodiment of an interlocking curvilinear groove feature in an unlocked (FIG. 14C) and locked (FIG. 14C') state. [Figure 15] FIG. 1 shows a post attached to a support structure. [Figure 16] FIG. 1 illustrates one embodiment of a temporary valve as part of a delivery system according to the present invention. [Figure 17] FIG. 13 illustrates one embodiment of a temporary valve that is attached to and delivered with a support structure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The present invention provides implantable modular percutaneous prosthetic valve devices, systems, and methods for percutaneously delivering and deploying implantable percutaneous modular heart valve devices and other implantable percutaneous modular valve devices within a body lumen. The present invention provides a modular prosthetic valve system that allows for the safe delivery of prosthetic valve devices within a body lumen without the need for invasive surgery.

[0023] The artificial valve device of the present invention includes multiple device modules for delivery and in vivo assembly. These device modules can be delivered to desired locations in the body, such as near the valve implantation site, at the valve implantation site, or at a location some distance from the implantation site, and assembled at those locations to form an assembled valve device. From a functional standpoint, these multiple device modules can include a support structure and a valve module. The support structure provides a framework or skeleton for the device, houses the valve module, and holds the valve module in place within the body cavity. The valve module includes the leaflets of the valve device, and when assembled into an operating configuration, forms a conduit with an inlet end and an outlet end. The valve module may include multiple device modules or may be one device module.

[0024] As used herein, the term "device module" refers to a component of a modular valve device, such as a support structure, a leaflet substructure, or a valve section (e.g., part of a valve assembly), that can be delivered in an unassembled state and then assembled in vivo into a valve device. As used herein, the term "valve module" refers to one or more device modules that can be delivered in an unassembled, folded configuration and assembled to form a part of a permanent valve device with one or more leaflets, such as a valve assembly. Thus, a valve module itself may include one or more device modules. The term "temporary valve" refers to a valve that is installed to perform a temporary function, as distinguished from a modular valve device, which is a "permanently" installed valve. The terms multi-component and modular are used interchangeably herein. The terms "implantation site," "implantation location," and "target site" are used interchangeably herein.

[0025] In one embodiment, the modular valve device comprises multiple device modules, i.e., a support structure and multiple valve sections (each including a valve leaflet) that can be assembled into a valve assembly. The multiple valve sections are shaped such that they can be attached together to form a valve assembly that opens and closes to allow unidirectional fluid flow. The valve sections or leaflets function in a manner that closely matches the physiology of a normally functioning natural valve. The support structure and valve sections can be delivered sequentially into the body cavity. The valve sections can be assembled into the valve assembly within the support structure, or assembled into the valve assembly and then assembled within the support structure. Alternatively, the valve sections can be , one at a time, may be attached to a support structure to form an assembled valve device.

[0026] In another embodiment, a modular valve device may include multiple valve sections that are delivered, assembled, and implanted without a support structure.

[0027] The valve assembly, which may have (but is not limited to) a tri-leaflet configuration, may be mounted on a support structure configured to be positioned at a target location within a body lumen. The valve assembly may include two, three, four or more valve sections. The support structure may be adjustably coupled to the vessel wall, and the valve module may be adjustably coupled to the support structure to allow fine adjustment of the position of the support structure relative to the vessel wall or fine adjustment of the position of the valve module relative to the support structure after deployment.

[0028] In yet another embodiment, a modular valve device includes two device modules, a support structure, and a valve module that is a unitary valve component that may be delivered sequentially to a body cavity and assembled in vivo, the unitary valve component may be in an unassembled configuration, a shape effective to collapse the valve component into a low profile delivery configuration, and an assembled working configuration with a conduit.

[0029] In one embodiment, the unitary valve component may be a leaflet substructure, i.e., a substantially flat, single-layer structure in an unassembled configuration, having a first end, a second end, and a base-tip axis. The unassembled leaflet substructure may be rolled, e.g., by rolling along a single axis, into a delivery configuration, delivered away from a support structure (or fixedly coupled to the support structure), unfolded, and attached to the valve component (actuated configuration), and the first and second ends may be locked together. The leaflet substructure comprises a plastically deformable member that may be rolled with the leaflet substructure and formed into a ring to assist in transforming the leaflet substructure into its assembled, actuated configuration. In another embodiment, the unitary valve component may be a leaflet-ring, i.e., a substantially flat, bi-layer structure in an unassembled configuration, having a first end, a second end, and a base-tip axis. The unassembled leaflet-ring may be rolled, e.g., by rolling along a single axis, into a delivery configuration. The folded, unassembled leaflet-ring can be delivered and then opened and attached to a valve component (actuated configuration). The leaflet-ring comprises a plastically deformable ring member having an unassembled configuration in which it can maintain the leaflet-ring in the unassembled configuration and an assembled configuration in which it can be expanded to maintain the leaflet-ring in the assembled, actuated configuration.

[0030] In either embodiment, after transformation from the unassembled shape to the assembled, working configuration, the one-piece valve component can be combined with and locked onto a support structure to form an assembled valve device. An example of a similar one-piece valve component including self-assembling members, and the method by which the one-piece valve component may be folded and assembled using self-assembling members, is described in detail in Figures 2a-4b and paragraphs 43, 48-57 of co-pending U.S. patent application Ser. No. 12 / 686,338 (Self-Assembly), entitled "Self-Assembling Modular Percutaneous Valve and Methods of Folding, Assembly and Delivery," filed Jan. 12, 2010, which is incorporated herein by reference.

[0031] In yet another embodiment of the modular valve device, the support structure may be provided for two or more device modules. For example, the support structure may be arranged, for example, longitudinally aligned. The support structure may be split along a circumferential axis to include two expandable tubular structures that can be aligned and assembled by linking them together. In one such embodiment, each portion of the multi-part support structure may have a higher radial stiffness than a one-piece support structure, but may be delivered as two or more compressed tubes to maintain longitudinal flexibility during delivery. Alternatively, the support structure may be split along a longitudinal axis and delivered as a bi-halved tube, with each half being compressible to a smaller diameter than the entire support structure.

[0032] As used herein, "assembled" means that the valve assembly, valve components, or valve devices are in an operational configuration (e.g., substantially tubular, rather than flat, rolled, or separate device modules), but the modules are not necessarily locked together. Additionally, the assembled configuration may also be referred to as an operational configuration, in which the valve modules are substantially tubular and form a conduit with the valve leaflets in place. An "unassembled" valve module may be folded for delivery (delivery configuration) or open and ready for assembly. An "unassembled" one-piece valve component may include a leaflet substructure having a first end and a second end, which may be configured into a ring as described above, such that the ends are joined to form an assembled valve component (operating configuration). Similarly, as described above, an "unassembled" valve assembly may include multiple valve sections, which may be joined together in a tandem, e.g., arranged in a row rather than configured into a ring, to optimize folding of the modules for delivery. Alternatively, the valve sections may be delivered separately, unattached.

[0033] The unassembled configuration of one or more device modules that make up the valve module provides a particular advantage with respect to delivery because the valve module can be collapsed into a delivery configuration that minimizes the diameter of the valve module for delivery, a feature that cannot be achieved in current percutaneous valve devices.

[0034] The present invention provides a locking mechanism for mating modules of an implantable modular percutaneous valve device or end-to-end unassembled valve components of a single piece. The locking mechanism of the present invention can be an integral locking mechanism or a non-integral locking mechanism. By "integral" we mean that the component (or components) of the locking mechanism are continuous with one or more device modules in that they are attached to the device modules during delivery or are structurally part of the device modules. An integral locking mechanism generally serves to lock the device modules during or after assembly. By "non-integral" we mean that the locking mechanism includes one or more structures that are separate and apart from the device modules, preferably delivered in the same delivery device as the device modules, and applied to the device modules after the valve device is assembled to lock the device modules together, or removed from the valve device during or after the locking process. For example, a non-integral locking mechanism may be delivered separately and applied to the device modules after the valve device is assembled to lock the device modules together. Alternatively, the non-integral feature may be an anti-locking member, such as a blocking tab, that can be removed to allow the modules to be locked together. The non-integral locking feature may utilize, in part, an integral feature of the device module, such as a hole, groove, or other structural part that interoperates with the non-integral part. The integral locking feature of the present invention may also be applicable to lock parts of a pre-assembled percutaneous valve device together.

[0035] For example, the valve sections (or the sides of the leaflet substructures) may be fitted with male-female type components. The valve sections may be attached by integral locking features such as, slotted hook features, interlocking curvilinear groove (zip lock) features, interference fit, friction locking, integral snap-fit ​​features with snap-fit ​​prongs and snap-fit ​​receptacles, as well as hook-and-loop components, fish hooks, interconnecting or interlocking geometries such as dovetails or pins, pegs, rivets, or stud-tube connectors. Alternatively, the sides of the valve sections or leaflet substructures may be held together using separate (non-integral) locking components, such as non-integral snap-fit ​​features with snap-fit ​​prongs and snap-fit ​​receptacles, pressure fixation connectors, and non-integral interlocking geometries such as pins, pegs, rivets, and stud-tube connectors.

[0036] Similarly, the present invention provides locking mechanisms for mating the valve module and the support structure. For example, the valve module and the support structure may be attached by integral locking mechanisms, such as hook-and-groove components, slotted hook mechanisms, locking tabs, stud-and-harbor locks, male and female joint components, integral snap-fit ​​mechanisms, barb components, fish hooks, and integral interlocking geometries such as pins, pegs, rivets, and stud-to-tube connectors. Alternatively, the valve module and the support structure may be mated using separate (non-integral) locking components, such as pressure-fixed connectors, non-integral snap-fit ​​mechanisms, and non-integral interlocking geometries such as pins, pegs, rivets, and stud-to-tube connectors.

[0037] These locking mechanisms may be manufactured from the same material as the support structures, such as, for example, stainless steel, a shape memory alloy such as, for example, Nitinol, or an amorphous metal of appropriate atomic composition such as, for example, Cobalt Chromium, or may be made from the valve module material or other suitable biocompatible material as recognized in the art.

[0038] The system of the present invention includes a module of a valve device and a delivery device. The modular valve device is delivered in a disassembled state in the delivery device. Two or more modules of the valve device may be provided preloaded in a delivery device such as a catheter or other similar device known in the art, or may be loaded into the delivery device after the delivery device is inserted into the body cavity. The support structure and the valve module (or valve section) may be loaded into the catheter in tandem. Alternatively, the support structure may be loaded into the catheter first and delivered, and then the valve module or valve section may be loaded into the catheter in tandem and delivered into the support structure where the complete device is assembled.

[0039] The present invention further provides methods for delivering a modular valve device to a target location within a body cavity and for assembling the modular valve device. The device modules may be delivered sequentially within a suitable delivery device, such as a catheter, e.g., an intravascular or intraluminal catheter. The device modules may be provided preloaded within the delivery device or may be loaded into the delivery device after the delivery device has been inserted into the body cavity. The device modules may be delivered in any order. In one particular embodiment in which a device module includes a support structure and multiple valve sections, the support structure may be delivered first, followed by each valve section.

[0040] After delivery and deployment from the delivery device, the device modules may be assembled within the body, e.g., within a body cavity or a body lumen, such as an implantation site, to form a fully assembled valve device and may be held together using the locking mechanism of the present invention. The device modules may be assembled, e.g., using pull wires to position the modules or portions of the modules relative to each other. For example, multiple valve sections may be linked via pull wires for sequential delivery and may be delivered in tandem and aligned to the target position. Once positioned at the target site, pull wires may be used to position the device modules relative to one another during assembly of the valve sections. The pull wires may also facilitate coupling of the valve sections to a support structure via a locking mechanism and aid in positioning the valve assembly within the support structure to form an assembled valve device. In other embodiments, push rods may be used to assemble the device modules, either alone or with other members, e.g., in combination with pull wires. The push rods may be, for example, stiff wires or tubular structures. Remote manipulation of the device modules facilitates assembly of the parts in the body. Alternatively, the device modules may be configured as described in paragraphs 38-38, 45-46, 51-69, and Figures 2a-2f of co-pending U.S. Patent Application Serial No. (Self-Assembly), filed on even date herewith. The valve modules may be assembled at least in part by utilizing self-assembling members, such as shape memory wires or bands, as described in detail in US Pat. No. 6,399,363, filed on Dec. 10, which is incorporated herein by reference. For example, the leaflet substructures may be delivered attached to a self-assembling member that is used to assemble the leaflet substructures into a valve component with or without the use of a push rod, and a locking mechanism according to the invention may lock the edges of the leaflet substructures together. A second self-assembling member may assist in the assembly of the valve component and the support structure, which may then be attached using the locking mechanism of the invention. The valve module may be adjustably coupled to the support structure, allowing final adjustment of the position of the valve module after implantation of the valve device. Non-integral locking mechanisms may be delivered and deployed via a delivery device as well.

[0041] The method described herein allows the delivery of a prosthetic valve percutaneously through a body cavity with a smaller diameter than currently required for percutaneous prosthetic valves in the art by delivering the valve device in unassembled sections and assembling the valve sections in the body. For example, by assembling the valve device modules one by one at the final implantation location, such as the ascending aorta, or in the body cavity before repositioning the location at the final target site, the size of the hole required to insert the prosthetic valve into the body is reduced, allowing for greater ease and freedom to deliver the device to the desired location in the blood vessel. The reduced profile of the unassembled valve device of the present invention allows the delivery device of the present invention to have a significantly smaller diameter than the typical diameter of delivery devices required in the art. Thus, for example, the delivery device in the present invention can have a diameter of less than 15 French or 5 mm.

[0042] The system of the present invention may further include a device for maintaining valve action during assembly and implantation of the modular valve device. For example, a temporary valve may be used to maintain valve action during assembly and implantation of the modular valve device, so that assembly of the percutaneous modular valve can proceed, which may take about 30 seconds or more. Because the temporary valve is only used temporarily, it does not need to function optimally, repeatedly, and predictably over an extended period of time, as required for a permanent valve. Nor does it need to open or close completely. The temporary valve can have a more efficient design, since it does not need to have the same functional accuracy and duration, be made from the same material, or have the same long-term persistence in the body. The temporary valve can be made from a thin material, and the leaflets only need to be partially attached to perform a sufficient temporary function during the replacement procedure, and therefore the temporary valve can be configured to occupy less space, for example, during delivery.

[0043] In one embodiment, the temporary valve may be placed on a delivery device and rapidly deployed without the need for precise placement, thereby maintaining valve function while the modular valve device is assembled and precisely placed at the implantation location. The temporary valve may be placed at or near the site of permanent valve implantation. In another embodiment, the temporary valve may be placed in a position where it has been moved from the support structure to a new position. In another embodiment, the temporary valve may be attached to the support structure such that a certain valve function is established as soon as the support structure is expanded and implanted. This allows time for the operator to assemble the valve module (or valve modules) and move it into position within the support structure accurately and without too much concern that proper blood flow will be obstructed. The valve module (or valve modules) may be placed over the temporary valve and combined with the support structure. Preferably, the temporary valve is a one-piece structure, such as a membrane with a simple design that is easy to fold for percutaneous delivery, easy to install, and easy to pop open for actuation. Alternatively, the temporary valve may include two or more pieces, but is preferably still easy to fold for delivery, easy to install, and easy to pop open for actuation.

[0044] When the temporary valve is delivered in a collapsed state within a compressed support structure, a smaller delivery profile can be achieved than that achievable with a permanent pre-assembled percutaneous valve device because the temporary valve has a relatively simple geometry and can be manufactured from thinner, less durable materials than the permanent valve module. In some aspects of this embodiment, the temporary valve may be constructed from a biodegradable material.

[0045] The devices, systems, and methods of the present invention are particularly adapted for use in percutaneous aortic valve replacement, but may also be used as replacements for other heart valves, such as the pulmonary, mitral, and tricuspid valves, as well as valves in other body cavities, such as the peripheral vasculature or in the digestive tract, lymphatics, bile collecting ducts, and any other body cavity having a valve that requires replacement or valve implantation. When a modular valve device is designed to replace an aortic valve, the device may be assembled in the ascending aorta, the descending aorta, in a ventricle, at the implantation site, or partially at the implantation site and partially in the aorta. Although these devices, systems, and methods are particularly adapted for use in a body cavity of the human body, applications in animals are also possible.

[0046] The valve components and valve assemblies of the modular valve device may be manufactured from suitable materials, such as polymers, metals, or biological materials. The selection of materials, structures, and manufacturing methods is preferably made to optimize valve function, durability, and biocompatibility.

[0047] The support structure is preferably expandable so that it can be delivered in a compressed (unexpanded) state and then expanded for implantation and assembly of the valve device. The support structure may be made of a biocompatible material that is durable enough to allow the structure to support the valve components while maintaining the position of the device in the body lumen. The material of the support structure is also compatible with delivery of the support structure in a compressed state and expansion of the compressed support structure upon deployment in the body lumen. In one embodiment of the present invention, the support structure is made of stainless steel or a shape memory alloy, such as Nitinol. In another embodiment, the support structure may be made of an amorphous metal alloy of appropriate atomic composition as known in the art. Other embodiments may be made of similar biocompatible materials as known in the art. In one embodiment, the support structure is annular, but may be formed in other shapes depending on the cross-sectional shape of the body lumen where the valve will be implanted. One non-limiting example of a suitable support structure is a stent. The stent, or any other support structure, can be self-expanding or balloon-expandable. Other similar support structures are known in the art and can be substituted for the stent of the present invention.

[0048] During deployment, the support structure is secured within the body cavity wall to, for example, regulate fluid flow through the valve. It should engage the body cavity wall such that the valve assembly does not move within the body cavity and is displaced from the desired position due to pressure or its impact against a closed valve, etc. The support structure may include a locking mechanism, such as those described herein, to secure the valve assembly (or valve components) therein. Additionally, the support structure may include hooks, ribs, loops, or other fixation devices to facilitate fixation of the assembled valve device to the body cavity wall. The connection of the support structure to the vessel wall and the connection of the valve assembly to the support structure may be adjustable in position.

[0049] The devices and methods of the present invention are particularly adapted for use in percutaneous aortic valve replacement, but may also be used as replacements for other heart valves, such as the pulmonary, mitral, and tricuspid valves, as well as valves in other body cavities, such as the peripheral vasculature or in the digestive tract, lymphatics, bile duct collection, and any other body cavity having a valve that requires replacement or valve implantation. When a modular valve device is designed to replace an aortic valve, the device may be assembled in the ascending aorta, the descending aorta, the left ventricle, the implantation site, or partially at the implantation site and partially in the aorta. Although these devices, systems, and methods are particularly adapted for use in human body cavities, applications in animals are also possible.

[0050] The above-mentioned embodiments, as well as other embodiments, delivery methods, alternative designs, and alternative types of valve devices and locking mechanisms, will now be discussed and described below with reference to the accompanying drawings. It should be noted that the drawings are presented as an exemplary understanding of the present invention and to illustrate a specific embodiment of the present invention in a schematic manner. Similarly, other similar examples within the scope of the present invention will be easily recognized by those skilled in the art. The drawings are not intended to limit the scope of the present invention as defined in the appended claims.

[0051] FIG. 1 illustrates one embodiment of how the valve module 10 and support structure 20 of a modular artificial valve device may be assembled. To illustrate how the valve module and support structure are combined to form an assembled valve device, the valve module is shown assembled in FIG. 1 and may represent a valve assembly or valve component. In this embodiment, the valve module 10 and support structure 20 may be assembled by pull wires 40 or the like to provide an assembled valve device 30. The support structure 20 and the valve module 10 may be delivered in tandem, one after the other, as illustrated in FIG. 1, in which case the modules may be tethered by the pull wires 40. The valve module 10 may be pulled into the support structure 20 using the pull wires 40, which may be connected to both modules, and the valve module 10 may then be attached to the support structure 20. This assembly step may be performed, for example, within the body lumen of the aortic outflow tract or within the ascending aorta. Attachment of the valve module 10 to the support structure 20 may be by any of a number of locking mechanisms, as described herein. Alternatively, the support structure 20 and valve module 10 may be delivered separately, i.e., non-tandem (not shown). For example, the support structure 20 may be delivered and deployed in a final location, and then the valve module 10 may be delivered and deployed within the support structure 20, thereby assembling the modules into the assembled valve device 30.

[0052] 2 shows one embodiment of a modular valve device having four device modules, i.e., one support structure (not shown) and three valve sections 50a-50c. The valve sections 50a-50c are designed to combine to form a valve assembly 15. In use, the valve sections act similarly to the folds of tissue in a native valve. The valve sections 50a-50c may be pre-attached to and tethered by the pull wires 40 or strings.

[0053] The pull wire 40 or string may have two purposes. First, the pull wire 40 may string the valve sections 50a-50c together for delivery so that they may be delivered through a body lumen in tandem. Second, the pull wire 40 extending outward from the end of the catheter may be pulled to assemble the valve sections 50a-50c to create the valve assembly 15. As an example of how the pull wire may be used to assemble the modular valve device of FIG. 2, the pull wire may be tightened one at a time to pull the valve sections together, thereby forming the valve assembly within the support structure, or alternatively, the valve sections may be pulled together outside the support structure, thereby forming the completed valve assembly, and further guiding the valve assembly within the support structure. Other means for positioning and attaching the valve sections may be used and will be readily recognized by those of skill in the art in view of the disclosure herein.

[0054] In one aspect of this embodiment (not shown), the pull wires may couple the valve sections 50a-50c to the support structure 20 (see FIG. 3) such that the pull wires 40 are pulled to assemble the valve assembly 15 and the support structure 20 in a manner similar to that shown in FIG. 1 to create an assembled valve device (not shown). The exact number of valve sections may vary from embodiment to embodiment, but in particular the valve assembly may include, for example, two to six or more valve sections. In one embodiment, an assembled valve device designed to replace a tricuspid valve may have four device modules, i.e., three valve sections forming an assembled valve assembly, which is secured within a body cavity by a support structure. An assembled valve device designed to replace a mitral valve may have, for example, three device modules, i.e., two valve sections forming an assembled valve assembly, which is secured within a body cavity by a support structure.

[0055] FIG. 3 illustrates generally how the four modules of the embodiment illustrated in FIG. 2 may be packaged for delivery into a body lumen. The four device modules may be tethered by pull wires and delivered in tandem with the support structure as the lead device module as illustrated. Alternatively, the valve sections may be delivered in tandem, but the support structure may not be tethered to the valve sections. As illustrated in FIG. 3, the support structure 20 and the three valve sections 50a-50c are loosely coupled by pull wires 40 to allow for sequential delivery and assembly. As illustrated on the right side of the drawing, the modules are folded into a delivery configuration for loading into a delivery device, in this case a catheter 60. The support structure 20 may be self-expanding and / or may be crimped onto a balloon for delivery and deployment, or may be folded into a delivery configuration as described in the art. The modules may be expanded from the compressed configuration by other means known in the art. A series (four in FIG. 3) of modules are then introduced into catheter 60, such that the loaded catheter is ready to be used to deliver the modules to a deployment site within the body cavity. The valve device modules may be placed into a delivery device before or after insertion into the body cavity, depending on the requirements of the particular procedure. In one embodiment where catheter 60 is an intravascular catheter, the valve device modules may be capable of being placed over a guidewire.

[0056] A method for delivering and assembling one embodiment of a modular prosthetic valve device of the present invention comprising the valve assembly 15 of Figure 2 may, for example, proceed as follows: As illustrated in Figure 3, a delivery device such as a catheter 60 carrying the support structure 20 and a number of valve sections 50a-50c may be passed via a suitable blood vessel to the final location where the valve device is to be implanted. The support structure is first pre-assembled so as to be capable of receiving the valve sections. Once the support structure is in place, the valve sections 50a-50c may be deployed sequentially, and in the embodiment illustrated in FIG. 3, the valve sections are tethered together and deployed in tandem. The valve sections 50a-50c may be assembled, for example using pull wires 40, as described above, to create the valve assembly 15. The modules of the valve assembly 15 may be assembled within the support structure 20 or may be assembled external to the support structure 20, and the valve assembly 15 may then be positioned within the support structure 20 as illustrated in FIG. 1. Once the valve sections 50a-50c are assembled to form the valve assembly 15 within the support structure 20, each valve section 50a-50c may be attached sequentially to the support structure 20 and then mated. The valve sections 50a-50c may be mated, and the valve assembly may then be secured to the support structure by any of several locking mechanisms, as described herein. 2 and 3 may be assembled in vivo and then positioned for implantation in a final location, or may be assembled in the final location, and additional fixation mechanisms may be configured and used to guide and / or fix the fully assembled valve device to the remaining tissue of the body cavity wall or native vessel wall.

[0057] The pull wires may be threaded through the valve assembly and support structure to loosely connect the valve assembly and support structure for delivery, but also to allow the modules of the device to be combined or assembled when the pull wires are pulled by an operator. The pull wires may be tethered to the modules of the modular prosthetic valve device by any suitable means known in the art, and the connection is releasable by pulling one end of the wire to remove the pull wire after the device is implanted and secured to the body cavity. Thus, for example, the modules of the valve device may include a loop or eyelet through which the pull wires are threaded. Alternatively, the pull wires may be part of a delivery system that includes a mechanism for manipulating the pull wires to assemble the valve sections and combine the valve assembly and support structure. For example, an activator, mechanical mechanism, or electrical current within the delivery system may be used to pull the pull wires to assemble the device modules.

[0058] Figures 4A-4C provide one example of how device modules may be assembled using pull wires and push rods. Additionally, other methods for positioning and assembling device modules of the present invention may be used with the present invention, such as pull wires alone, push rods alone, or in combination with self-assembling members and self-assembling members alone, such as shape memory wires. Self-assembling members are described in detail in paragraphs 36-38, 45-46, 51-69, and Figures 2A-10 of co-pending U.S. patent application Ser. No. 12 / 686,338 (Self-Assembly), filed Jan. 12, 2010, which is incorporated herein by reference.

[0059] In particular, Figures 4A-4C illustrate a push rod having a unidirectional pull wire and a tubular structure that may be used to assemble one embodiment of a modular valve device including four modules, such as the embodiment illustrated in Figure 3. Figure 4A illustrates a first pull wire 41 threaded through valve sections 50a-50c and including a first loop 41a, and a second pull wire 42 threaded through valve sections 50a-50c and support structure 20 and including a second loop 42a, disposed within a body lumen, such as an aorta 81. For clarity of illustration, a delivery device is not depicted in Figures 4A-4C. The first loop 41a may be threaded through the first valve section 50a, and an end 41b of the first pull wire 41 may extend outside the proximal end of the delivery device. Additionally, the first pull wire may be threaded through other valve sections (not shown for clarity of illustration). The second loop 42a may be threaded through the support structure 20, and the end 42b of the second pullwire 42 may extend outside the proximal end of the delivery device.

[0060] FIG. 4B illustrates a later stage of assembly where the valve sections are assembled into a valve assembly 15 by using a first pull wire 41 within the aorta 81. In this embodiment, two push rods having tubular structures are used with the pull wire 41 for assembly of the device modules and are referred to as a first tube 63 and a second tube 64 in FIGS. 4B and 4C. However, one or more structures may be used as the first tube 63 and the second tube 64. To assemble the valve sections 50a-50c as shown in FIG. 4A, the first tube 63 may be placed over the ends of the pull wires 41 and inserted into and through the delivery device and advanced into the aorta 81 to the proximal-most valve section (such as 50c in FIG. 4A). Both ends 41b of the first pull wire 41 can then be pulled against the first tube 63 to assemble the valve sections together to form the valve assembly 15 as shown in FIG. 4B and help lock the valve sections together. The first tube 63 may then be removed. FIG. 4B shows that in this embodiment, the first loop 41a terminates threaded around the valve assembly 15, but the first pull wire 41 and first loop 41a may be threaded through the valve sections in any manner that facilitates assembly of the valve sections into the valve assembly. The first pull wire 41 may be removed by pulling on one end. Alternatively, the first pull wire 41 may be tied and cut to leave the valve assemblies connected. The second loop 42a remains threaded through the still independent support structure 20 and the second pull wire 42 remains threaded through the valve assembly 15.

[0061] The support structure 20 may then be positioned and expanded at the implantation target location 70 of the valve device. As illustrated in FIG. 4C, to assemble the support structure and valve device, the second tube 64 may then be placed over the end of the second pull wire 42 and inserted into and through a delivery device (not shown) and advanced to the valve assembly 15. Both ends 42b of the second pull wire 42 may then be pulled against the second tube 64 to assemble the valve assembly 15 and support structure 20 into an assembled valve device. Specifically, the second pull wire 42 may be used to properly position the valve assembly 15 relative to the support structure 20. The position of the valve assembly 15 may be adjusted by incrementally pulling the second pull wire 42 and then locked relative to the support structure 20. The second tube 64 may then be removed. FIG. 4C shows that in this embodiment, the second loop 42a terminates threaded around the support structure 20, but the second loop 42a may be threaded through the support structure 20 in any manner that facilitates assembly of the valve device and positioning of the valve assembly 15 within the support structure 20. Additionally, FIG. 4C shows the support structure 20 deployed and expanded to press the native valve leaflets 76 against the aortic wall 82, although the native leaflets may be removed prior to deployment and expansion of the support structure if required by the procedure. Once the assembled valve device is in place at the implantation site 70, the second pull wire 42 may be removed by pulling on one end. Alternatively, the second pull wire 42 may be tied and cut off.

[0062] The first and second pull wires may comprise biodegradable materials and may be left in place and degraded. In the embodiment illustrated in FIGS. 4A-4C, the support structure 20 is positioned and expanded after assembly of the valve sections 50a-50c to minimize the period of valve inactivity in the patient. However, in another embodiment, the support structure 20 may be positioned before the valve sections are assembled into a valve assembly. For example, the support structure may be positioned and expanded using the second pull wire 42 and the second tube 64, and then the second tube 64 is preferably removed, the second pull wire 42 is left in place, and then the valve sections 50a-50c are assembled. 0a-50c may be assembled into a valve assembly 15 using a first pull wire 41 and a first tube 63. The valve assembly 15 may then be moved into position and assembled to the support structure 20 using a first pull wire 41 and a second pull wire 42. These methods of valve assembly are applicable to modular valve devices including more than or less than the four modules illustrated in FIGS. 4A-4C, including modular valve devices including only valve sections as device modules, and such methods are properly included within the scope of the present invention. For example, a modular valve device including two modules, i.e., a valve component and a support structure, may be assembled using pull wires and tubes in a similar manner, which is properly included within the skill of the art in view of the above. If appropriate, a device module may be assembled using more than two sets of pull wires. Those skilled in the art may readily use other assembly means similar to those described above and as described in co-pending U.S. patent application Ser. No. 12 / 686,338 (Self-Assembly) as desired.

[0063] 5A-5C show an embodiment of a unitary valve module that may include a leaflet substructure 150 in an unassembled state. The unitary valve module may be folded in a manner that minimizes the delivery diameter, i.e., in its delivery configuration. Prior to loading the leaflet substructure 150 into a delivery system, the leaflet substructure 150 may be unfolded in an unfolded, unassembled, substantially flat, and generally rectangular or trapezoidal configuration having a height axis (i.e., along the longitudinal axis of the assembled valve device) extending between the base and tip, and a circumferential axis 101, as shown in FIG. 5A. In the embodiment shown in FIGS. 5A-5C, the leaflet substructure 150 has three leaflets 150a-150c, although in other embodiments the leaflet substructure may have two or more leaflets. The circumferential axis 101 of the leaflet substructure is equal to the circumference of the leaflet substructure in its assembled valve component configuration 110 (see FIG. 5C). The plastically deformable member 100 may be attached along the circumferential axis 101 of the leaflet substructure, such that, for example, in an unassembled state, the plastically deformable member 100 may be attached along a base line 102 as shown in FIG. 5A, or along a coaptation line 103 (not shown), or along other circumferential lines along a base-tip axis. Prior to loading into the delivery device, the leaflet substructure 150 may be rolled along its circumferential axis from base to tip or tip to base as shown in FIG. 5B, such that the first end 151 and the second end 152 of the leaflet substructure 150 form the ends of a cylindrical delivery configuration of the folded leaflet substructure 155.

[0064] After deployment of the folded leaflet substructures from the delivery device, the leaflets can be opened and assembled to form the three-dimensional structure of the valve component as illustrated in FIG. 5C. Opening the leaflet substructures 155 from the delivery configuration can be assisted, for example, by a balloon catheter, by pull wires and / or by push rods, or a combination thereof (not shown). In one embodiment, pull wires and / or push rods can be used to unravel the structure and allow the first and second ends 151 and 152 of the leaflet substructures 150 and the ends of the plastically deformable member 100 to assume a ring shape, such as a circular shape, an elliptical shape, a D-shape, or any other shape suitable for the valve module. In one such embodiment, the plastically deformable member 100 can be attached to a base 102, the leaflet substructures 150 can be wrapped around a circumferential axis 101 from base to tip, and the plastically deformable member 100 can be wrapped within the folded leaflet substructures 155 as illustrated in FIG. 5B. In this embodiment, one or more pull wires (not shown) may be threaded through the base of the leaflet substructures 150 and encased by the folded leaflet substructures 155. The pull wires may be pulled, such as in combination with a tubular push rod, to assist in spreading the leaflet substructures 155 from a delivery configuration to an unassembled configuration 150, similar to that illustrated in FIGS. As will be appreciated by one of ordinary skill in the art, alternatively, for example in an embodiment in which the leaflet substructure is folded tip to base (not shown), one or more pull wires may be attached to one or more tips of leaflets 150a-150c of leaflet substructure 150 and encased within the folded leaflet substructure 155.

[0065] To form the three-dimensional valve component 110, for example, in one embodiment, the first end 151 and the second end 152 of the leaflet substructure 150 may be joined together, such as with the aid of a pull wire and / or a push rod (not shown). For example, one end of the plastically deformable member 100 may have a pull wire attached (not shown) and the other end of the plastically deformable member 100 may have a loop (not shown) through which the pull wire is threaded. The first end 151 and the second end 152 of the leaflet substructure may also have a pull wire attached and threaded therethrough. A push rod, such as a tubular push rod similar to that described above in Figures 4B-C, may be used in combination with one or more pull wires to pull the ends of the plastically deformable member 100 and the leaflet substructure 150 together to form a tubular structure (not shown). A balloon catheter can then be inserted through the tubular structure and inflated to expand the plastically deformable member 100 and leaflet substructure 150 into a ring-like shape to form the assembled valve component 110, i.e., working configuration with the conduit, as illustrated in FIG. 5C. The "ring-like shape" may be a circular shape, an elliptical shape, a multi-leaflet shape, a D-shape, or any other shape suitable for a valve device. A locking mechanism may be provided to lock the first end 151 together against the second end 152, as described further below, either prior to expansion into the assembled configuration or after expansion into the assembled configuration.

[0066] In another aspect of the embodiment of the one-piece valve module illustrated in Figures 6A-C, the valve module may be a ring of leaflets (leaflet-ring) 250. In this embodiment, the leaflet-ring 250 may have an unassembled configuration, i.e., a substantially flat bi-layer structure, as illustrated in Figure 6A. The leaflet-ring 250 may have a plastically deformable ring member 200 attached or embedded, for example, in the base of the valve module (see Figure 6C). The leaflet-ring 250 has an unassembled configuration, as illustrated in Figure 6A, having a bi-layered, substantially flat shape. When collapsed into this substantially flat unassembled configuration, the leaflet-ring 250 has a length (or circumferential axis) and a width (or height). The plastically deformable ring member 200 in an unassembled configuration may have two substantially parallel elongate portions 200a and two folded ends 200b, as shown in Figure 6A, which may hold the leaflet-ring 250 in a substantially flat unassembled configuration. From this unassembled configuration, the leaflet-ring 250 may be folded into a delivery configuration 255 by rolling along its circumferential axis in the direction of its height, such as from tip to base or from base to tip, as shown by the arrows in Figure 6A and as shown in Figure 6B.

[0067] Pull wires and / or push rods (not shown) may be used to unfold the folded, unassembled leaflet-ring 255 from the delivery configuration. For example, in one embodiment (not shown), a tip portion of the leaflet-ring 250 may be coupled to one or more pull wires, which may be rolled with the leaflet-ring 250 for delivery. The rolled leaflet-ring 255 may be opened by pulling on the one or more pull wires. As will be appreciated by one of ordinary skill in the art, alternatively, one or more pull wires may be attached to the base of the leaflet-ring to assist in opening the rolled leaflet-ring 255 from the delivery configuration, such as when the leaflet-ring is rolled from base to tip.

[0068] To form the three-dimensional valve component 210, the unassembled plastically deformable ring members 200a, 200b are expanded, such as by balloon expansion, using push rods and / or pull wires, or a combination thereof, which transforms the leaflet-ring 250 into the assembled valve component 210, i.e., working configuration with a conduit, as illustrated in FIG. 6C. In one embodiment, for example, a balloon catheter (not shown) can be inserted through the unfolded unassembled leaflet-ring 250 and inflated to expand the plastically deformable ring member 200 into a ring-like shape. The "ring-like shape" can be circular, elliptical, D-shaped, or any other shape suitable for a valve device. In one aspect of this embodiment (not shown), a string or pull wire can be pre-threaded through the leaflet-ring 250 with one end connected to the balloon catheter to assist in pulling the balloon catheter into the leaflet-ring 250. Once the leaflet-ring 250 has been assembled into the three-dimensional valve component 210, the valve component 210 can be combined with a support structure (not shown) using a locking mechanism and locked to the support structure (not shown) to form an assembled valve device. In an alternative embodiment, the leaflet-ring 250 may be assembled into the three-dimensional valve component 210 within the support structure.

[0069] 7-15 illustrate examples of locking mechanisms that may be used to secure or attach the device modules together after they have been mated or assembled.

[0070] 7 and 7A show an embodiment of a locking mechanism that may be suitable for making the valve assembly 15 shown in FIG. 2 by mating valve sections, such as 50a, 50b. A pull wire 40 can be used to pull the valve sections 50a, 50b together, causing a first side 51a of the first valve section 50a to lock to a second side 52b of the second valve section 50b. FIG. 7A shows an embodiment of a locking mechanism. Each valve section may have multiple attachment points, such as with a locking mechanism including a male component 16 and a female component 17. The male component 16 and female component 17 are positioned such that the male component 16 from one valve section mates with the female component 17 of another valve section.

[0071] As specifically shown in Figure 7A, for example, a first valve section 50a may include a plurality of male components 16 on a first side 51a that mate with a plurality of female components 17 on a second side 52b of a second valve section 50b. The male components 16 of the first valve section 50a lock into the female components 17 of another valve section 50b.

[0072] If there are three valve sections, the second side 52a of the first valve section 50a can have a plurality of female components 17 that mate with a plurality of male components 16 on a first side (not shown) of a third valve section (not shown), and the first side 51b of the second valve section 50b can have a plurality of male components 16 that mate with a plurality of female components 17 on a second side (not shown) of the third valve section (not shown). Similar configurations are possible for valve assemblies including two, four, five, or more valve sections. The attachment points on the valve sections may be positioned along the side edges of the sections as illustrated in FIG. 7.

[0073] 8A-C show one embodiment of a locking mechanism for attaching the valve module to a support structure. In particular, as shown in FIGS. 8A and 8B, a support structure 20 includes a number of attachment points including hooks 21. The valve module 10 includes a groove 22 along its proximal edge 12, i.e., the "upstream" edge, as defined by fluid flow in the body cavity. 8B, the hooks 21 of the support structure 20 mount within grooves 22 of the valve module 10 to secure the two modules together as shown in FIG. 8C. The grooves 22 may extend the entire length of the proximal edge 12 of the valve module 10, allowing the hooks 21 to capture the grooves 22 independent of axial rotation of the valve module 10. Alternatively, the valve module 10 may have multiple short grooves spaced around the periphery of the proximal edge 12 to align with the hooks 21 of the support structure 20.

[0074] The support structure may be designed so that the valve sections can be coupled to the support structure at various axial locations. For example, the support structure 20 may have a set of multiple hooks 21 spaced apart along the longitudinal axis to provide two or more attachment locations in the proximal-distal direction. Such a design allows the clinician flexibility as to where the valve assembly may be placed within the support structure.

[0075] FIG. 9 shows one embodiment of a locking tab 392 for mounting the valve module 310 to a support structure (not shown for clarity). The locking tab 392 locks the device modules together by an interference fit. The valve module 310 includes or is attached to a ring 300, and the locking tab 392 is attached to the ring 300. As shown in FIG. 9, the locking tab 392 is coupled to the valve module 310 at its base. After the valve module 310 and the support structure are assembled, one or more of the locking tabs 392 may be actuated to engage the support structure to lock the valve module and the support structure together. The embodiment of the locking tab 392 shown in FIG. 9 is an interference fit locking mechanism that uses a component integral with the valve module that is rotatably actuable about a pivot 395 between an unlocked position 392a and a locked position 392b. Preferably, the valve module 310 has two or more locking tabs 392.

[0076] 9 shows, the locking tab 392 has a pivot end 397 and a swing end 399 and operates by rotating between an unlocked position 392a in which the swing end 399 is oriented toward the middle of the valve module, and a locked position 392b in which the swing end 399 is oriented axially, i.e., parallel to the longitudinal axis of the valve device. The pivot end 397 has a substantially circular shape and a pivot axis 395 about which the pivot end 397 of the locking tab 392 rotates. As shown in FIG. 9 , the pivot axis 395 is not centered within the substantially circular shape of the pivot end 397, and when in the unlocked position 392a, the side edge 394a of the pivot end 397 is substantially flush with the outer periphery of the valve module 310, and in the locked position 392b, the side edge 394b of the pivot end 397 extends beyond the outer periphery of the valve module 310 and exerts sufficient radial force on the support structure to lock the modules together by an interference fit.

[0077] 10A-D show another embodiment of the integrated locking mechanism, the stud-harbor lock. The stud-harbor lock may be used to attach the valve module to a support structure. In this embodiment, the valve module 410 has a ring 400 along its outer periphery. As illustrated in FIG. 10A, the ring 400 includes a plurality of studs 404 positioned on its outer surface at predetermined intervals around the periphery of the ring 400. The studs 404 project fixedly outwardly from the outer surface of the ring 400. A support structure (not shown) includes a plurality of posts 426 mounted thereto on its inner surface and axially oriented. The plurality of posts 426 are mounted to the support structure at predetermined intervals around the inner periphery that mate with the studs 404 on the ring 400. Each post 426 includes a plurality of "harbors" 425 (e.g., notched grooves, etc.) on its inner surface. The harbors 425 are operable to receive the studs 404 in a registered relationship. Thus, the stud-harbor lock is the link to which the valve module 410 is attached. The valve module includes a stud 404 positioned on the mounting 400 and docked into a harbor 425 positioned on a post 426 attached to the support structure, thereby locking the valve module and the support structure together.

[0078] The studs 404 on the ring 400 can be docked against the harbors 425 on the posts 426 by rotating the valve module 410 relative to a support structure (not shown) such that the studs 404 are aligned with the harbors 425 as shown in FIG. 10B, thereby attaching the two modules. The studs 404 and harbors 425 can be locked together, such as by an interference fit, magnetic traction, ratchet, vertical ridge-channel, or other mechanisms known in the art. Depending on the particular choice of attachment mechanism, the device module can be locked and unlocked by rotating the valve module 410 in either direction, such as clockwise or counterclockwise, as shown in FIG. 10C, FIG. 10C', FIG. 10D, and FIG. 10D' with a vertical channel-ridge mechanism, or in one embodiment where the studs 404 and harbors 425 are locked together by a ratchet mechanism by rotating the valve module 410 in one direction, such as clockwise.

[0079] As shown in Figures 10C and 10C', the studs 404 may have vertical channels 408, and as shown in Figures 10D and 10D', the harbors 425 may have vertical ridges 4328. Figure 10C illustrates the channels 408 in the studs 404 on the ring 400 in a front view, and Figure 10C' illustrates the channels 408 in the studs 404 in a top view. Figure 10D illustrates the ridges 428 in the harbors 425 in a side view of the post 326, and Figure 10D' illustrates the ridges 428 in the harbors 425 in a front view. The valve module 410 may be rotated until the vertical channels 408 in the studs 404 engage the vertical ridges 428 in the harbors 425 to limit further rotation of the valve module 410.

[0080] In a ratchet mechanism (not shown), the studs 404 and harbors 425 may be angled at complementary angles relative to one another (e.g., in a sawtooth pattern) so that the valve module rotates in one direction, such as a clockwise direction, because the front side of the stud 404 is smaller than the rear side. In this embodiment of a ratchet type mechanism for the studs 404 and harbors 425, the valve module 410 may be locked by rotating the valve module 410 in one direction, such as a clockwise direction, relative to the post 426 until the harbors 425, which are configured to be in register with the studs 404, hold the studs 404 in place. At this point, due to the geometry of the studs and harbors, the studs and harbors may be unlocked, if desired, by rotating the valve module 410 in the same direction, such as a clockwise direction, relative to the post. Rotation in the opposite direction, such as a counterclockwise direction, is prevented by a radial discontinuity between the ring 400 and the rear side of the studs 404.

[0081] 11A and 11B illustrate a quick release button locking mechanism comprising a plurality of "buttons" 505 that lock into complementary "harbors" 525. As illustrated in FIG. 11A, the valve module 510 may be attached to or comprise a ring 500. The ring 500 comprises a plurality of buttons 505 positioned on its outer surface at predetermined intervals around the circumference of the ring 500. A support structure (not shown for clarity) comprises a plurality of posts 526 mounted thereto on its inner surface and axially oriented thereto, as illustrated in FIG. 11B. The plurality of posts 526 are attached to the support structure at predetermined intervals around the inner circumference that mate with the buttons 505 on the ring 500. Each post 526 comprises a harbor 525 (e.g., a notched groove) on its inner surface. As illustrated in FIG. 11B, the ring 500, and thus the valve module 510, , may be locked to a support structure (not shown) by a button-harbor pair, where a button 505 including a quick release mechanism locks into a harbor 525 on a number of posts 526 attached to the support structure. FIGS. 11A and 11B illustrate an embodiment in which the valve device includes four mating positions where the valve module buttons and support structure harbors engage. However, in other embodiments, the valve device may have three, or even six or eight such mating positions. In another embodiment, there may be, for example, two or three times as many buttons on the valve module ring as there are posts on the support structure (or vice versa) to facilitate rotational positioning of the valve module relative to the support structure. In an alternative embodiment, the harbor members may include a groove ring on the inner surface of the support structure.

[0082] The quick release mechanism of the button 505 may comprise a spring, or a push or pull release mechanism, or any other suitable configuration apparent to one of ordinary skill in the art. In one aspect of the embodiment illustrated in FIGS. 11A and 11B, the quick release mechanism may be activated or deactivated by pulling or pushing the safety. For example, when the safety is activated, the button 505 may be activated to lock into the harbor 525 of the post 526 by protruding outwardly from the outer surface of the ring 500. Similarly, when the safety is deactivated, the button 505 is deactivated to unlock the valve member from the device frame by pulling back from the harbor 525 so that it appears substantially flush with the outer surface of the ring 500. In an alternative aspect of this embodiment, the button 505 is spring loaded and may be activated and deactivated depending on whether the spring is engaged or disengaged. An activated button and a deactivated button are illustrated in FIG. 11B. Thus, referring to the spring-based system, the button 505a facing the post 526 is restrained from protruding by the post 526, allowing the ring 500a to move axially along the post 526 until it faces the harbor 525. The button 505 facing the harbor 525 is free to protrude outwardly from the ring 500 and engage the harbor 525. If sufficient force is applied, the button 505a will disengage from the harbor 525 and be restrained by the post 526, allowing the ring 500 to again move axially along the post 525. The option of a post 526 having multiple harbors 525 is further illustrated in FIG. 11B, and this configuration is shown in FIGS. 1a-1c of co-pending U.S. patent application Ser. No. 2005 / 023999, entitled "Method and Apparatus for Fine Adjustment of a Percutaneous Valve Structure," filed on even date herewith. 1b and paragraphs 28-29, which is incorporated herein by reference.

[0083] Additionally, the valve device module may be attached using a component that is separate from (i.e., not integral with) the device module. A non-integral locking mechanism is applicable to hold valve sections together or to attach the valve module to a support structure. Thus, an independent component may be used as a locking mechanism to join device modules together, as shown by way of example to join the valve module to a support structure as illustrated in Figures 12-14. Locking mechanisms of the present invention that are not integral with the device module are preferably of a type that are easily engaged from a remote location, yet still provide a fixed attachment that does not disengage in use. Alternatively, a non-integral locking mechanism may comprise a member attached to the valve module and / or support structure that prevents engagement until removed, such as, for example, a tab that prevents the two components from engaging.

[0084] After the valve module (or valve modules) and support structure are assembled and positioned, one or more components are percutaneously inserted into the valve device as shown in FIGS. 12A-12B, and the two modules are secured together, for example, using a snap-fit ​​mechanism. 12A illustrates an embodiment of an independent (non-integral) snap-fit ​​locking mechanism using a one-piece snap-fit ​​prong 692 having a leading end 692a and a base end 692b. Details of the snap-fit ​​prong 692 are illustrated in FIG. 12A'. In the embodiment of FIG. 12A, the valve module 610 may have a plurality of axial tabs 613 at or near its base, spaced apart around its circumference extending axially from the valve module 610, attached to, for example, the ring 600. Each axial tab 613 includes a hole (not shown), each hole configured to receive a snap-fit ​​prong 692. Alternatively, the plurality of holes 611 may be positioned directly on the ring or base of the valve module 610 (as illustrated in FIG. 12B). A support structure (not shown for clarity) includes a plurality of posts 626 attached on its inner surface and axially oriented thereto. A plurality of posts 626 are attached to the support structure at predetermined intervals around an inner periphery that mates (i.e., aligns) with the valve module axial tabs 613. Each post 5626 includes a post hole (not shown) that is further configured to receive a snap-fit ​​prong 592 at the same axial level such that each post hole of the post 626 can align with a hole in the axial tab 613 of the valve module 610 when the valve module 510 and the support structure are assembled.

[0085] In another embodiment, as illustrated in Fig. 12B, the snap-fit ​​mechanism is a two-piece mechanism. The snap-fit ​​prong 692 may be received by a snap-fit ​​receptacle 693 opposite the second hole to interlock an interventional device component having an integral hole in which the snap-fit ​​prong may be disposed. In particular, Fig. 12B shows generally how a base end 692b of the snap-fit ​​prong 692 may secure one device module, here the valve module 610, and how a leading end 692a of the snap-fit ​​prong 692 may extend through integral hole 611 in the valve module 610 and integral hole 627 in the support structure 620 to engage the snap-fit ​​receptacle 693, thereby securing the valve module and the support structure. In another embodiment of a two-piece snap-fit ​​mechanism (not shown), the snap-fit ​​prongs 692 and snap-fit ​​receptacles 693 may also be used in conjunction with the axial tabs 613 and posts 626 .

[0086] The snap-fit ​​prongs 692 may be disposed from within the assembled valve device to the exterior of the valve device, as shown in Figure 12B, i.e., with the leading end 692a first passing through the hole 611 in the valve module 610 and then through the hole 627 in the support structure 620 post. Alternatively, the snap-fit ​​prongs 692 may be disposed in a central direction from the exterior of the valve device, first passing through the hole in the post 626 and then through the valve module hole 611, as shown in Figure 12A. In the latter case, the snap-fit ​​prongs 692 may be disposed through the valve module and support structure before the support structure is fully expanded and implanted in the implantation location of the valve device.

[0087] The snap-fit ​​locking mechanism may operate in a manner similar to one of the embodiments illustrated in FIG. 12A or FIG. 12B to attach sides of valve sections together (not shown), such as attaching a first side of a first valve section against a second side of a second valve section, or mating sides of a leaflet substructure. Additionally, the snap-fit ​​locking mechanism may be an integral locking mechanism (not shown). For example, the snap-fit ​​prongs may be integral with the posts of the support structure, in which case the base ends are continuous with the support structure. In this embodiment, the valve module may include holes or receiving spaces that are the structural equivalent of snap-fit ​​receptacles spaced around its periphery in alignment with each post, and the lumen ends of the integral snap-fit ​​prongs may be disposed through holes or integral receiving spaces that are an integral part of the valve module, effective to attach the two device modules. Alternatively ... snap-fit ​​prongs may be integral with the posts of the support structure. The long may be integral with the base of the valve module or a ring attached to the valve module and may engage with a hole integral with the support structure or a post attached to the support structure, or the post may include a receiving space that is, for example, the structural equivalent of a snap-fit ​​receptacle on the post.

[0088] Figures 13A-13E show interlocking geometries associated with the non-integral snap-fit ​​mechanism depicted in Figures 12A-12B, but which may also be referred to as pins, pegs, rivets, and stud-tube connectors. For example, Figure 13A illustrates a pin 792 mechanism that secures a first device module 718 and a second device module 719 as a sandwich. The pin 792 mechanism of the present invention includes a leading end 792a and a base end 792b. The base end 792b preferably has a head that secures the base end 792b of the pin 792 on one side of the device module sandwich. The leading end 792a includes two prongs 795a, 795b that are straight when the leading end 792a of the pin 792 is disposed through the first device module 718 and the second device module 719, and are adapted to bend flat against the outer surface of the device module sandwich opposite the side where the head of the base end 792b is located. As shown in FIG. 13B, the pin 792 may be disposed through a hole that is integral with a pin tab 713 that extends away from the base of the valve module 710, and a post hole 727 that is integral with a post 726 of a support structure (not shown for clarity). The pin tab 713 may be attached to, for example, a ring 700 on the valve module 710, which may be, for example, a self-assembling member, a plastically deformable ring, or a similar structure. In the embodiment illustrated in FIG. 13B, the pins 792 are oriented to secure the device module in a direction from the vascular side to the luminal side of the valve device, such that the pins 792 may be disposed first through the post holes 727 and then through the valve module holes (not shown). A device for securing the pins may then be inserted into the valve device to bend the pin prongs 795a, 795b to abut the luminal surface of the pin tabs 713. Alternatively, the pin prongs 795a, 795b may be fabricated from a shape memory material having a pre-set bent configuration. A suitable device may include an inflatable balloon catheter. Alternatively, the pins may be disposed in the opposite direction through the first device module 718 and the second device module 719.In this case, the walls of the body cavity may act to anchor the pin by bending the pin prongs 795a, 795b.

[0089] 13C-13E illustrate other possible geometries for embodiments using pins, pegs, rivets, and stud-tube connectors. In particular, FIG. 13C illustrates a peg 892 according to the present invention that may be used with a post hole or a valve module hole, FIG. 13D illustrates a rivet 992 according to the present invention that may be used with a post hole or a valve module hole, and FIG. 13E illustrates a stud-tube connector 1092 according to the present invention that may be used with a post hole or a valve module hole. Device modules may be manufactured such that structures equivalent to any of the peg locking mechanisms, rivet locking mechanisms, and stud-tube connector locking mechanisms illustrated in FIGS. 13C-13E, or structures similar to the pins illustrated in FIGS. 13A and 13B, are integral with the device components, thereby eliminating the need to apply interlocking geometries to the device components, thereby simplifying the locking procedure. Other variations in interlocking geometries that may result in integral locking mechanisms that fall within the scope of the present invention include dovetail, riveted, and barbed. For example, the stud-harbor mechanism may be designed with a dovetail geometry.

[0090] In each of the above-described embodiments, the ring may be, for example, a foldable but rigid portion of the valve module that may be positioned at the base of the valve module or may be a flexible, foldable portion of the valve module as described herein. Alternatively, the ring may be a self-assembling member, for example as described in paragraphs 36-38, 45-46, 51-69, and Figures 2a-10 of co-pending U.S. patent application Ser. No. 12 / 686,338 (Self-Assembly), filed Jan. 12, 2010, which is incorporated herein by reference.

[0091] Another example of an integral interlocking geometric feature is an interlocking curvilinear groove feature, also referred to in the art as a zip-lock feature, as illustrated in Figures 14A-14C. This is particularly useful for bringing together edges of valve sections or edges of leaflet substructures. In one aspect of this embodiment, the interlocking curvilinear groove feature may be a sliding interlocking curvilinear groove feature.

[0092] As illustrated in Figures 14A-C, the first side 1151 and the second side 1152 of the valve module can be locked together by an interlocking curved groove mechanism because the first side 1151 has a geometry that allows it to interlock in an aligned relationship with the second side 1152. As illustrated in Figure 14A, the first side 1151 and the second side 1152 of the valve module can be guided toward each other using a string 1145 or wire that is threaded through the first side 1151 and the second side 1152. The string 1145 can be a pull wire, as described in Figures 4A-4C. The first side 1151 may have an edge with a bulbous cross-section 1153, which may have a rounded shape, e.g., substantially circular, as shown in Figure 14B, but may also be rectangular (including square), triangular, or any other suitable geometric shape, e.g., as shown in Figures 14C and 14C'. The second side 1152 of the valve module may have a complementary receiving channel edge 1154 having a cross-section configured to be in alignment with the cross-sectional shape of the bulbous edge 1153 of the first side 1151. Thus, for example, if the bulbous edge 1153 of the first side 1151 is substantially round or circular as shown in Figure 14B, the receiving channel edge 1154 of the second side 1152 has a complementary circular cross-section into which the bulbous edge 1153 of the first side 1151 engages or mates with an interlocking and interference fit. This locking mechanism is referred to as an interlocking curvilinear groove mechanism because the bulbous edge 1153 and the receiving channel edge 1154 preferably comprise strips that extend along the entire contacting portions of the first side 1151 and second side 1152 of the valve module, respectively, as shown in Figure 14A. Thus, the bulbous edge 1153 may be substantially cylindrical, such as in an embodiment having a substantially circular cross-section, and the receiving channel edge 1154 may be a substantially cylindrical groove.

[0093] As shown in FIG. 14C, in another aspect of the interlocking curved groove feature, a first side 1151 can have a first hook-shaped edge 1157 and a second side 1151 can have a second hook-shaped edge 1158, which first hook edge 1157 and second hook edge 1158 can interlock and be held by a static or interference fit, as shown in FIG. 14C'.

[0094] In one aspect of this embodiment of the interlocking curvilinear groove feature or zip-lock, where the valve module in the unassembled configuration is a one-piece leaflet substructure, as described in connection with Figures 5A-C, for example, and a leaflet substructure comprising self-assembling members, as described in paragraphs 52-53 and Figures 2a-2c of co-pending U.S. patent application Ser. No. 12 / 686,338 (Self-Assembly), the first side 1151 and second side 1152 shown above having interlocking edge geometries may be the first and second sides of the leaflet substructure. In this aspect of the zip-lock embodiment, push rods and / or pull wires or guide strings may be used to secure the bulbous first edge and the leaflet substructure together. A process may then be initiated to bring the structure into alignment with the complementary receiving channel on the second edge of the structure.

[0095] In another aspect of the embodiment of the interlocking curvilinear groove mechanism or zip lock, where the valve module includes a plurality of valve sections, for example as described above in connection with Figures 2-4C, and valve sections including self-assembling members, as described in paragraphs 48-51 and Figures 1a-1d of co-pending U.S. Patent Application Serial No. 12 / 686,338 (Self-Assembly), the first side 1151 and second side 1152 shown above having interlocking edge geometries may be a first side of a first valve section and a second side of an adjacent second valve section. Thus, for an example valve module including three valve sections, the linear interference fit mechanism may operate as follows: A first side of the first valve section may have a bulbous edge that mates with a receiving channel of the second side of the second valve section by fitting within the receiving channel of the second side of the second valve section in a registered relationship. The edges of each valve section may be pulled together, such as by a wire 1145, e.g., a pull wire or string, threaded through the edges as shown in FIG. 14A, or by actuation of a self-assembling member. A push rod may be used in combination with the pull wire or string. A linear interference fit may begin at the proximal or distal end of the valve assembly. In a similar manner, a first side of the second valve section may have a bulbous edge that mates with a receiving channel of a second side of the third valve section, and a first side of the third valve section may have a bulbous edge that mates with a receiving channel of a second side of the second edge of the first valve section. In light of the description herein, similar configurations for valve modules having two valve sections or four or more valve sections are within the scope of the art.

[0096] 14A and 14B, the linear interference fit locking feature comprises mating edges of the first and second sides of the valve module. However, in another zip-lock type embodiment applicable to either the leaflet substructures or multiple valve sections, the interlocking curvilinear groove feature may be located between facing surfaces of the first and second sides 1151, 1152, such as between an inner surface of the first side 1151 and an outer surface of the second side 1152, where these facing surfaces are positioned near the edges of the first and second sides 1151, 1152. The interlocking geometries may be attached by an interference fit in a manner similar to that shown in U.S. Pat. No. 5,540,366, Figures 6, 7, and col. 3, lines 31-37, and U.S. Pat. No. 2,039,887, Figures 2, 3, and col. 1, lines 31-36, which applications are incorporated herein by reference. In one aspect, the locking mechanism may be a sliding zip-lock mechanism, in which the bulbous edge 1153 or first hook edge 1157 of the first side 1151 and the receiving channel edge 1154 or second hook edge 1158 of the second side 1152, or the interlocking mating surfaces, may be engaged or mated by a device that slides along the edges to bring the complementary geometric structures into alignment, such as in a slider zip-lock configuration.

[0097] One embodiment of an interference fit locking mechanism useful for attaching a valve module to a support structure, particularly where the valve module comprises a self-assembling member having a preset ring configuration, is described in detail in Figure 7 and paragraph 60 of co-pending U.S. patent application Ser. No. 12 / 686,338 (Self-Assembly), filed Jan. 12, 2010, which is incorporated herein by reference. In short, the valve module may be attached to or threaded through a self-assembling member, such as a ring or band, that is capable of returning from a delivery configuration to a preset ring configuration. The support structure may have a groove or similar structure capable of receiving the ring or band when pressed outwardly into its preset configuration, thereby allowing the valve module to be attached to the support structure by an interference fit. Lock the module.

[0098] FIG. 15 shows a post 1226 attached to a support structure 1120. Specifically, FIG. 15 shows how a post according to any of the embodiments of FIGS. 9-13 can be attached to a frame or support structure without interfering with the extensibility of the structure. Preferably, the post is flexible enough not to overly inhibit the axial flexibility of the support structure, but is sufficiently radially stiff to function as needed in the particular embodiment used. The post may be made of the same material as the valve frame or an equivalent material that does not chemically interact with the material of the valve frame. In any of the embodiments of FIGS. 9-13, the "post" may be replaced with a groove, such as a notch in a ring on the support structure. The harbor and post hole as described with respect to the embodiment of FIGS. 10-13 may be a recess or hole in the groove.

[0099] The locking mechanism may be any type of attachment that is preferably easily engaged from a remote location, yet still provides a secure attachment that does not disengage during use. Those skilled in the art will readily recognize that different locking mechanisms and their different applications are interchangeable herein.

[0100] In any of these embodiments, it may be possible and desirable to adjustably couple the valve module to the support structure to allow for precise final positioning of the valve module. Thus, for example, the valve assembly may be adjustably coupled to the support structure to allow for final adjustment of the position of the valve assembly relative to the support structure after implantation of the valve device. Mechanisms for adjusting the position of the valve module relative to the support structure are described in detail in paragraphs 21-24, 28-39, and Figures 1a-7 of co-pending U.S. patent application Ser. No. 12 / 686,340, entitled "Method and Apparatus for Fine Adjustment of a Percutaneous Valve Structure," filed Jan. 12, 2010, which is incorporated herein by reference. The support structure may also be adjustably coupled to the vessel wall.

[0101] In embodiments in which a temporary valve is used, the temporary valve may be placed at the permanent valve implantation site or at a location remote from the permanent valve implantation site. As an example, as illustrated in FIG. 16, in an aortic valve replacement, the temporary valve may be placed in the ascending aorta proximal (downstream) to the implantation location of the modular valve device. This configuration may be useful in procedures in which the modular valve is delivered via a distal approach (i.e., introducing the device from the ventricular side of the coronary venous valve). See, e.g., Singh, IM et al., "Percutaneous treatment of aortic valvestenosis," CLEVE. CLIN. J. MED. 75(11):805-812 (2008). However, In some circumstances, when a retrograde approach (ie, introducing the device from the arterial side of the coronary venous valve) is utilized, it may be preferable to place a temporary valve proximal to the implantation site as well.

[0102] One embodiment of the temporary valve of the present invention is illustrated in FIG. 16. In this embodiment, the temporary valve 1395 is a one-piece structure, coextensive with the delivery system, in this case the catheter 1360, although the temporary valve may be comprised of two or more pieces. One advantage of having the temporary valve coextensive with or attached to the delivery device is that it may be easily removed when the delivery system is removed. The catheter 1360 to which the temporary valve 1395 is attached may be advanced to approximately the location where the modular valve device is to be implanted, which in this embodiment is distal to the coronary ostia 1386, 1387 in the aorta 1381, and the temporary valve 1395 may be actuated to automatically expand, such as an everted umbrella, using, for example, a shape memory wire. In an alternative embodiment (not shown), the temporary valve includes two pieces, with the device module passing through the temporary valve. In an alternative embodiment, the temporary valve may be connected by a pull wire that can be detached from the delivery device but used to pull the temporary valve out of the aorta when it is no longer needed.

[0103] If a temporary valve is placed at the target site and the device modules are to be assembled away from the implantation site, the delivery device may be retracted after placing the temporary valve for deployment of the device modules of the permanent valve. If a temporary valve is placed at the target site, a support structure may be implanted before the temporary valve by (1) a separate catheter using a reverse percutaneous approach from a delivery device carrying the temporary valve, or (2) by deploying the support structure from the delivery device prior to deployment of the temporary valve.

[0104] In another embodiment illustrated in FIG. 17, the temporary valve may be attached to the support structure and delivered, deployed, and expanded by the support structure. The temporary valve 1495 may be attached to the support structure 1420 by sewing, gluing, or similar means known in the art for prefabricated percutaneous valves, or by removable means. Thus, for example, the temporary valve 1495, in this embodiment shown as a two-piece structure, is attached to the support structure 1420 before compressing the support structure 1420 and placing it in a delivery device (not shown). As illustrated in FIG. 17, when the support structure 1420 is expanded, the temporary valve 1495 is deployed and controls blood flow until the valve portion of a modular valve device (not shown) is mated to the support structure 1420. The temporary valve 1495 in this embodiment may be used with a self-expanding support structure or a balloon-expanding support structure. In the latter case, the temporary valve may be attached to the support structure and then placed on a balloon catheter for delivery. 17, the temporary valves 1495 are not removed, but may be crushed or disassembled when the valve module (or multiple valve modules) is assembled with the support structure 1420. In an alternative embodiment, such temporary valves 1495 may be removed just before the assembled valve module is deployed or after the assembled valve module is attached to the support structure.

[0105] It is important that the prosthetic valve device be precisely positioned within the vessel (or body cavity) to ensure proper valve function and safety for the patient. Accordingly, the devices and systems of the present invention, and methods of delivering the devices, are described in U.S. priority application Ser. No. 61 / 144,007, at paragraphs 67-82 and Figs. 7a-8, and in U.S. application Ser. No. 2005 / 0123634, filed Jan. 12, 2010, entitled "A System and Method for Placing a Percutaneous Valve Device” It can be used in combination with a deployment system and method for deploying modular devices, as described in paragraphs 1a-2 and Figures 24-42 of application Ser. No. 12 / 686,337 (Deployment), which is incorporated herein by reference. As described in U.S. priority application Ser. No. 61 / 144,007 and co-pending U.S. patent application Ser. No. 12 / 686,337 (Deployment), a method for deploying a prosthetic valve device in a body cavity with improved accuracy includes, for example, attaching an anchor in a body cavity at a permanent valve implantation location and guiding the prosthetic valve device to the implantation location using the anchor. The deployment system includes a valve device, a delivery device, and an anchor. The anchor may include a button or rivet type device, a hook, a lead suture inserted percutaneously, an interconnecting geometry, or any other type of docking device. Additionally, the system may include a deployment wire coupled to the anchor. In embodiments in which an anchor is coupled to a deployment wire, the method may further include threading the deployment wire through the valve device, loading the valve device into the delivery device such that a free end of the deployment wire exits a proximal end of the delivery device, and guiding the device along the deployment wire toward the anchor. In embodiments in which an anchor comprises a lead suture, the method may further include threading the lead suture through the valve device, and loading the valve device into the delivery device such that a free end of the deployment wire exits a proximal end of the delivery device. and loading the valve device into a body cavity. Methods of deploying a valve device within a body cavity include the use of other types of anchors.

[0106] It will be appreciated by those skilled in the art that numerous modifications, additions, alterations, and other applications may be made to what has been particularly shown and described herein as an embodiment without departing from the spirit or scope of the invention.The scope of the invention, as defined by the following claims, is therefore intended to encompass any foreseeable modifications, additions, alterations, or applications.

Claims

1. 1. A modular percutaneous prosthetic valve device comprising a plurality of device modules, the device modules including an expandable support structure, in particular a stent, and a valve module comprising a leaflet substructure (150), the support structure having a compressed, unexpanded delivery configuration, the leaflet substructure (150) having a first end (151) and a second end (152), in the delivery configuration, the first end and the second end are not joined together, and in the deployed configuration, the first end and the second end are joined together forming a valve module having a ring shape, the support structure and the valve module being delivered sequentially and separately from a percutaneous delivery device (60) and locked together to form a valve device in the deployed configuration.

2. The valve device of claim 1 , wherein the leaflet substructure (150) is a substantially flat, single-layer structure (150) that is folded into a delivery configuration.

3. 10. The valve device of claim 1, further comprising a locking mechanism that locks the support structure and the valve module together into a valve device in a deployed configuration after deployment from the transdermal delivery device.

4. The valve device of claim 3 , wherein the locking mechanism is integral with the plurality of device modules.

5. The valve device of claim 3 , wherein the locking mechanism is not integral with the plurality of device modules.

6. 5. The valve device of claim 4, wherein the leaflet substructure includes first and second locking members that interlock to bring the first and second ends of the leaflet substructure together in the deployed configuration.

7. 7. The valve device of claim 6, wherein the first locking member is formed on the first end (151) of the leaflet substructure (150) and the second locking member is formed on the second end (152) of the leaflet substructure (150).

8. 8. The valve device of claim 7, wherein the first locking member is formed on an inner surface of the first end of the leaflet substructure and the second locking member is formed on an outer surface of the second end of the leaflet substructure, the leaflet substructures overlapping in the deployed configuration.

9. The valve device of claim 3 , wherein the locking mechanism is a curved groove mechanism.

10. 10. A system for assembling a prosthetic valve device in a body in need thereof, the system comprising a percutaneous delivery device and a valve device according to any one of claims 1 to 9 in the form of a separate device module contained within the delivery device.

11. The system of claim 10 , further comprising a temporary valve, the temporary valve having one of a one-piece construction and a multi-piece construction.

12. The system of claim 11 , wherein the temporary valve is attached to the delivery device.

13. The system of claim 10 , further comprising one of a pull wire, a push rod, or a self-assembling member to assist in transforming the valve module into an assembled, actuated configuration.

14. The system of claim 10 , wherein the device modules are contained within a single delivery device.

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