JP6506813B2 - Modular percutaneous valve structure and delivery method - Google Patents

Description

This application claims the benefit of priority of US Provisional Patent Application No. 61 / 144,007, filed January 12, 2009.

The present invention relates to an artificial valve device for implantation into a body and a method of deploying the same. In particular, the present invention is a multi-component or modular, percutaneous transcutaneous prosthetic valve device, ie, delivered in a disassembled state, capable of being assembled in the body, and thus fully assembled. The present invention relates to an artificial valve which can be smaller than the delivery diameter. Also, the present invention utilizes a system comprising such a modular valve device and a delivery device having a smaller diameter compared to the delivery device for a fully assembled transdermal valve device, as well as utilizing this small diameter delivery device system The present invention relates to methods of delivering and deploying such modular valve devices. Furthermore, the invention relates to a method of assembling a modular valve device, comprising locking device modules together using a locking mechanism.

The human body includes a variety of natural valves, such as heart valves, esophageal valves, gastric valves, intestinal valves, and valves in the lymphatic system. Natural valves can be altered for various reasons such as disease and age. The malfunctioning valve can not maintain fluid flow in a single direction with minimal pressure drop. An example of a malfunctioning valve is a heart valve that may have stenosis (i.e. the valve leaflets do not open completely) or incompetence (i.e. the valve leaflets do not close properly). In order to restore the proper function of the organ to which the valve is involved, it is desirable to restore the valve function. For example, with proper valve function in the heart, blood flow can be maintained in a single direction through the valve with minimal pressure loss, thereby enabling blood circulation and blood pressure to be maintained. Similarly, with proper esophageal valve function, acid gastric fluid secretion does not cause inflammation or permanent damage to the lining of the esophagus.

Several percutaneous prosthetic valve systems have been described. One example described in Andersen et al. (US Pat. No. 5,411,552) comprises an expandable stent and a folding valve which is placed on the stent prior to deployment. The folding valve may be a living valve or may be made of synthetic material. 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. Further, U.S. Patent No. 6,168,614 (Andersen et al.) Entitled "Valve Prosthesis for Implantation in the Body" and U.S. Patent No. 5, "System and Method for Implanting Cardiac Valves". See 840,081 (Andersen et al.).

Spenser et al. (US Pat. No. 6,893,460) describes another prosthetic valve device comprising a valve structure made of biomaterial or synthetic material and a support structure such as a stent . The Spenser prosthetic valve is a crimpable leafed-valve assembly made of a flexible material configured to provide a collapsible wall at the outlet, comprising a conduit having an inlet and an outlet. is there. The valve assembly is attached to the support stent prior to deployment. The finished valve device is deployed at the target location within the body conduit using a deployment means such as a balloon catheter or similar device.

Transdermal implantation of prosthetic valves is safer and cheaper 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 problem with this bulkiness is the need for a delivery catheter with an even larger diameter. Large catheters are generally not suitable for percutaneous procedures and require phlebotomy and surgeon and / or complicated and difficult piercing and suturing techniques. In addition, the bulkiness of current valve devices and delivery systems, and the large diameter combined with the anatomical structures that need to deliver these devices throughout, results in a successful rate of delivery into body cavities , Deployment accuracy, and risk of complications may be problematic. In particular, the complexity of delivery may be caused by the shape of the body cavity, such as, for example, the large natural curve of the aortic arch into which the catheter is introduced and / or the serpentine iliac artery / femoral artery. Furthermore, such diameter catheters tend to be less flexible than smaller diameter catheters, especially when bulky non-flexible devices are loaded, so loaded catheters can be used to remove small blood vessels and in particular Manipulating through a curved blood vessel greatly increases the potential for damage to the blood vessel wall.

Accurate placement of current percutaneous valve devices relative to existing innate anatomical structures is often a problem, particularly in the case of aortic valve replacement. Prosthetic valves placed too distally (ie, in the direction of the aorta) may block or impede flow into the foramen of the coronary arteries. For example, depending on the location of the coronary artery port, a prosthetic valve or large natural leaflets skirt pressed against the aortic wall may physically or functionally block the hole and prevent coronary flow. . For example, Piazza, N., et al., "Anatomy of the Aortic Valvar Complex and Its Implications for Transcatheter Implantation of the Aortic Valve," CIRCULATION CARDIOVACSCULAR INTERVENTIONS, 1: 74-81 (2008); Webb, JG, et al. "Percutaneous aortic valve implantation retrograde from the memorial art," CIRCULATION, 113: 842-850 (2006). This occlusion may be physical or functional. That is, even though the hole in the coronary artery is physically open, the flow pattern changes caused by the prosthetic valve will partially impair the flow into the coronary artery. A prosthetic valve placed too proximally (ie, in the direction of the outflow of the left ventricle) may interfere with the posterior leaflet of the mitral valve, the atrioventricular node, or the His bundle (conductive tissue) . About 30% of patients who have a prosthetic valve percutaneously placed in their body require a pacemaker. The reason is that this valve is placed at the end of the ventricle and exerts pressure on the electrical conduction device, in close proximity to or on the left leg. For example, Piazza, N., et al., "Early and persistent intraventricular conduction abnormalities and requirements for pacing following following percutaneous replacement," JACC CARDIOVSCUAL INTERVENTIONS, 1: 310-316 (2008); Piazza, N., et al. al., "Anatomy of the Aortic Valvar Complex and Its Implications for Transcatheter Implantation of the Aortic Valve," see CIRCULATION CARDIOVACSCULAR INTERVENTIONS, 1: 74-81 (2008).

U.S. Patent No. 5,411,552 U.S. Patent No. 6,168,614 U.S. Pat. No. 5,840,081 U.S. Patent No. 6,893,460

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) Piazza, N., et al., "Early and persistent intraventricular conduction abnormalities and requirements for pacing following following replacement of the aortic valve," JACC Cardiovascular Interventions, 1: 310-316 (2008)

Therefore, 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 a pre-assembled percutaneous valve device and can be delivered through a blood vessel without causing further damage to the wall of the body cavity is highly desirable.

The present invention relates to a multi-component or modular, percutaneous valve device and system, and a method of delivering a prosthetic valve device in a disassembled state and assembling the modular valve device in the body.

The present invention provides a minimally invasive modular percutaneous prosthetic valve device, a system including such a device, and a method of transdermal valve delivery.

The modular prosthetic valve device comprises a plurality of device modules for delivery. In one embodiment, the plurality of device modules includes a valve module and a support structure, which are designed to be combined into an assembled valve device in the body. The valve module is part of a valve device having a valve leaflet and, when assembled, forms a conduit having an inlet end and an outlet end. The valve module itself may include multiple device modules. Further, in one embodiment, the valve module may further include a plurality of valve sections, which can be assembled in vivo to form a valve assembly. The valve assembly can then be combined with the support structure into an assembled valve device. In another embodiment, a plurality of device modules may be deployed, assembled into a valve assembly, and include a plurality of valve sections that may be implanted without a support structure. Alternatively, individual valve sections may be implanted, for example when the native valve leaflets are suffering from a disease.

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 cavity. Additionally, the system may include an arrangement for adjustably connecting the valve module to the support structure and / or for adjustably connecting the support structure to a fixed point. The system of the present invention may further include a temporary valve.

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

The valve module may be attached to the support structure and / or the valve section may be combined by a locking mechanism. The locking mechanism of the present invention may be part of the device module, ie the locking mechanism is integral with the structure of the device module as a whole, or one or more prior to delivery into the body cavity and deployment. Attached to two or more device modules. Alternatively, the locking mechanism of the present invention may not be integral with the device module, ie at least part of the locking mechanism is a separate structure from the modular valve device, ie the device module (or plurality of Device module) is applied to one or more device modules after delivery and deployment into the body, or removed from the valve device in a locking process or after locking.

For example, in one embodiment, the valve module includes a set of lockable tabs that apply a radial force to the support structure sufficient to couple the support structure to the valve module when engaged. May be. In another embodiment, the support structure engages a portion of a valve module designed to exert an outward radial force on the support structure, for example a geometrical engagement such as a ring in a groove It may include a set of composite structures. In yet another embodiment, the valve module and the support structure may each have a female component, and the locking tab with the male component is inserted into the assembled valve device and the assembled valve It may be arranged to hold the two components together against both the valve module and the support structure of the device. 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 valve module that are not assembled may include interlocking geometries that allow for integral locking of the edges together with the zip lock type fasteners. Several other embodiments of locking mechanisms 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. The integral locking mechanism may allow portions of the device module that are to be locked together to automatically engage once properly positioned.

In addition, the device module may be fixed in place by frictional forces or other positive positioning forces such as magnetic, interference or static fit. The valve sections may be positioned relative to each other during assembly of the valve sections using pull wires or push rods to form the valve assembly, and further combining the device modules to form an assembled valve device If so, it may aid in the positioning of the valve module (eg, valve assembly) within the support structure. In addition, the pull wire may serve to connect the device modules during delivery so that the modules can be delivered and deployed in tandem.

In addition, a system for valve delivery that allows for maintaining the valve function while the modular valve device is assembled and deployed at the implantation site, and a transcutaneous modular valve by providing a temporary valve A method is provided for maintaining valve function during accurate assembly and implantation of the device. In one embodiment, the temporary valve may be part of the delivery system (eg attached to the delivery device) and may be removed as the delivery device is withdrawn from the blood vessel. In another embodiment, the temporary valve may be located on the support structure of the permanent valve device, and of the valve module of the permanent valve (e.g. a valve substructure, a valve assembly or an individual valve section etc) The temporary leaflet may be crushed or flattened by implantation. The method of delivering a modular prosthetic valve may include an intermediate step of deploying a temporary valve. The use of the temporary valve according to the invention is not necessary for the method of delivering a modular valve device, but is intended to improve the safety and outcome of the percutaneous valve replacement procedure.

The advantages that can be realized by the present invention include reducing the bulk of the valve for delivery and increasing the freedom of the delivery device by means of the percutaneous prosthetic valve system according to the present invention. In addition, the prosthetic valve device is minimally invasive and this method of transdermal delivery reduces traumatic injury and minimizes the complexity of the procedure, thereby increasing the safety of the procedure and the system To increase the number of medical facilities that perform percutaneous valve replacement procedures. One advantage of placing a temporary valve prior to implantation of a permanent prosthetic valve is that the time constraints for assembly and placement of the percutaneous valve device are alleviated by preventing unlimited regurgitation during the replacement procedure It is. The use of a temporary valve allows the operator to assemble a modular percutaneous valve device, position the prosthetic valve device carefully and accurately, and adjust the position of the valve without adversely affecting the outcome of the valve replacement procedure. A grace period of minutes is given.
That is, the present invention is as follows.
(1) A modular prosthetic valve device comprising a plurality of device modules, wherein the device modules are designed to be assembled into the valve device after deployment from a delivery device.
(2) The valve device according to (1), wherein the plurality of device modules include a support structure and a valve module.
(3) The valve device according to (2) above, wherein the valve module further comprises a plurality of valve sections.
(4) The valve device according to (1), wherein the plurality of device modules includes a plurality of valve sections.
(5) The valve device according to (2) above, wherein the valve module is a leaflet lower structure.
(6) The valve device according to (2) above, wherein the valve module is a valve leaflet-ring.
(7) The valve device according to any one of (1) to (5), further including a pull wire. (8) The valve device according to any one of (1) to (7), further including a locking mechanism.
(9) The valve device according to (8), wherein the locking mechanism is integral with the plurality of device modules.
(10) The valve device according to (8), wherein the locking mechanism is not integral with the plurality of device modules.
(11) The valve device according to (2), wherein the support structure is a stent.
(12) A system for assembling the artificial valve device in the body in need of the artificial valve device, comprising a delivery device and the valve device according to any one of (1) to (6) above.
(13) The system according to (12) above, further including a temporary valve.
(14) The system according to (12) above, further comprising a first tube.
(15) The system according to (12) above, wherein the delivery device is a catheter.
(16) providing a delivery device for accommodating a plurality of device modules;
Deploying the device module from the delivery device;
Assembling the device module to form a valve device.
(17) The above (16), wherein the device module comprises a support structure and a plurality of valve sections, and the step of deploying includes the steps of deploying the support structure and then deploying the valve section. Method described.
(18) The device module comprises a support structure and a plurality of valve sections and the steps of assembling are:
Assembling the valve section to form a valve assembly;
Assembling the valve assembly and the support structure to form a valve device.
(19) The device module has a locking mechanism, and the method
The method according to (16), further including the step of uniting the modules by the locking mechanism.
(20) The delivery device further accommodates a plurality of pull wires, and the pull wires respectively connect and assemble two or more device modules, further comprising assembling the device modules using the pull wires. The method as described in said (16).
(21) The device module comprises a support structure and a plurality of valve sections, and the steps of assembling are:
Assembling the valve section to form a valve assembly;
Assembling the valve assembly and the support structure to form a valve device.
(22) The device module comprises a first locking mechanism and a second locking mechanism, the method comprising
The method according to (21), further including the step of combining the valve sections by the first locking mechanism and attaching the valve assembly to the support structure by the second locking mechanism.
(23) 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 assembles the valve section using the first pull wire The method according to (21), further comprising: forming a valve assembly; and assembling the valve assembly and the support structure using the second pull wire to form a valve device.
(24) A method of delivering the prosthetic valve device to a body cavity in need of the prosthetic valve device, the method comprising the steps of:
Introducing a modular valve system comprising a delivery device and a valve device into a body cavity, the valve device comprising a plurality of device modules;
Deploying the device module from the delivery device;
Assembling the device module.
(25) In (24) above, wherein the device module comprises a support structure and a plurality of valve sections, and the step of deploying includes the steps of deploying the support structure and then deploying the valve section. Method described.
(26) The device module comprises a support structure and a plurality of valve sections and the steps of assembling are:
Combining the valve sections to form a valve assembly;
Combining the valve assembly and the support structure to form a valve device.
(27) The method according to (24) above, wherein the assembling step is performed at the implantation position.
(28) The method according to (24) above, wherein the body cavity is an aorta, and the assembling step is performed in the aorta.
(29) The system further includes a plurality of pull wires, and the steps of assembling are:
24. A method according to (24) above, comprising forming an assembled valve device using the pull wire.
(30) The device module comprises a locking mechanism, and the method comprises
The method according to (24), further including the step of combining the device modules by the locking mechanism.
(31) The system further includes a temporary valve, and the method is
The method according to (24) above, further comprising the step of deploying the temporary valve.

FIG. 7 illustrates one embodiment of assembling a modular prosthetic valve device (bottom) by combining a valve module (shown at the top) and a support structure (center) by using a pull wire in the present embodiment. . FIG. 7 illustrates one embodiment of a valve module that includes multiple valve sections. In this example, three valve sections are assembled to form a valve assembly. 1 shows a valve device comprising four device modules, namely three valve sections (constituting a valve module) and one support structure, which can be loaded consecutively on a delivery device which in this embodiment is a catheter FIG. Here, the catheter forms a vehicle for delivering and deploying the device module to the desired site in the body. FIG. 7 illustrates one embodiment of a method that may use pull wires to assemble one embodiment of a valve device that includes four device modules. FIG. 4A illustrates a pull wire passed through an unassembled module of a valve device such as the embodiment illustrated in FIG. FIG. 4B illustrates the use of pull wires and push rods to assemble the valve section into the valve assembly. FIG. 4C illustrates the use of pull wires and push rods to assemble the valve assembly and support structure into a valve device. FIG. 5D illustrates the valve module including the valve leaflet substructure in an unassembled configuration (FIG. 5A), a delivery configuration (FIG. 5B), and an assembled into a valve component (FIG. 5C). FIG. 6C shows the valve module including the leaflet-ring in an unassembled configuration (FIG. 6A), a delivery configuration (FIG. 6B), and assembled into a valve component (FIG. 6C). FIG. 3 illustrates one embodiment of a locking mechanism for combining the valve leaflets of FIG. 2 to form a valve assembly. FIG. 7 illustrates one embodiment of a locking mechanism for mounting a valve module on a support structure. FIG. 7 illustrates one embodiment of a locking tab as an integral locking mechanism for attaching a valve module to a support structure. FIG. 7 illustrates one embodiment of a stud-harbor lock as an integral locking mechanism for attaching a valve module to a support structure. FIG. 10A shows the studs located on the ring of the valve module and the harbor located on the posts of the support structure. FIG. 10B shows the stud docked in the harbor located on the post of the support structure. 10C and 10C 'show the vertical channels on the studs as part of the ridge / channel base lock between the studs and the harbor in front and top views, respectively. 10D and 10D 'show vertical ridges on the harbor as part of the ridge / channel base lock between the stud and the harbor in side and front views, respectively. FIG. 10 illustrates one embodiment of a quick release locking mechanism for attaching a valve module to a support structure. FIG. 7 illustrates one embodiment of a snap fit lock as an integral locking mechanism and a non-integral locking mechanism. FIG. 12A shows a non-integral snap fit lock for attaching the valve module to the support structure. FIG. 12A 'shows a snap fit prong. FIG. 12B shows another embodiment of the non-integral snap fit lock with the valve module attached to the support structure by a snap fit receptacle. FIG. 7 illustrates the interlocking geometry as a non-integral locking mechanism for attaching the valve module to the support structure. FIG. 13A shows a pin. FIG. 13B shows the pins in use. FIG. 13C shows a peg. FIG. 13D shows a rivet. FIG. 13E shows a stud-tube connector. FIG. 7 illustrates aspects of an embodiment of an interlocking curvilinear groove mechanism. FIG. 14A shows in side view how a side of an unassembled valve module can be attached to an interlocking curvilinear groove mechanism using a string. FIG. 14B shows a cross-sectional view of one embodiment of an interlocking curvilinear groove mechanism. 14C and 14C 'show cross-sectional views of another embodiment of the interlocking curvilinear groove mechanism in the unlocked (FIG. 14C) and locked (FIG. 14C') state. FIG. 7 shows a post attached to a support structure. FIG. 7 illustrates one embodiment of a temporary valve as part of a delivery system according to the present invention. FIG. 7 illustrates one embodiment of a temporary valve attached to a support structure and co-delivered.

The present invention transcutaneously delivers implantable modular percutaneous prosthetic valve devices, systems, and implantable transdermal modular heart valve devices and other implantable percutaneous modular valve devices into a body cavity Provide a method for deployment. The present invention provides a modular prosthetic valve system that allows for the safe delivery of a prosthetic valve device into a body cavity without the need for invasive surgery.

The prosthetic valve device of the present invention comprises a plurality of device modules for delivery and in vivo assembly. These device modules can be delivered to a desired location in the body, for example near the valve implantation site, at the valve implantation site or at a distance slightly away from the implantation site, and assembled by assembling at these locations Can form a valve device. From a functional point of view, these multiple device modules can include a support structure and a valve module. The support structure forms the framework or skeleton of the device, accommodates the valve module, and holds the valve module in place within the body cavity. The valve module includes the valve leaflets of the valve device and, when assembled into the operative configuration, forms a conduit having an inlet end and an outlet end. The valve module may include multiple device modules or may be one device module.

As used herein, the term "device module" is delivered in an unassembled state, such as, for example, a support structure, a valve substructure, or a valve section (e.g., part of a valve assembly), and then the valve Refers to a component of a modular valve device that can be assembled in vivo into the device. As used herein, the term "valve module" is delivered in an unassembled folded configuration and assembled to form part of a permanent valve device comprising one or more valve leaflets such as a valve assembly Refers to one or more device modules that can be Thus, the valve module itself may include one or more device modules. The term "temporary valve" refers to a valve that is installed to perform ad hoc functions, as distinguished from modular valve devices that are "permanently" installed valves. The terms multicomponent and modular are used herein as interchangeable. The terms "implant site", "implant location", and "target site" are used interchangeably herein.

In one embodiment, the modular valve device comprises a plurality of device modules, ie a support structure, and a plurality of valve sections (each including a valve leaflet) that can be assembled into a valve assembly. The plurality of valve sections are shaped so that they can be attached together to form a valve assembly that opens and closes to allow one-way fluid flow. The valve section or leaflets function to closely match the physiology of a normally functioning native valve. The support structure and the valve section may be delivered sequentially into the body cavity. The valve section may be combined into the valve assembly within the support structure or combined within the support structure after being combined into the valve assembly. Alternatively, the valve sections may form an assembled valve device by attaching one by one to the support structure.

In another embodiment, the modular valve device may include multiple valve sections to be delivered, assembled and implanted without a support structure.

The valve assembly, which may have (but is not limited to) a three-leaflet configuration, may be placed on a support structure that is configured to be positioned at a target location within a body cavity. 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 re-calibrates the position of the support structure relative to the blood vessel wall or repositions the valve module relative to the support structure after deployment. It may be adjustably connected to the support structure, as possible.

In yet another embodiment, the modular valve device includes two device modules, one support structure, and one valve module which is a single valve component. The two device modules can be sequentially delivered to the body cavity and assembled in the body. The unitary valve component may be configured to be effective to fold the valve component into a low profile delivery configuration as an unassembled configuration, or may be an assembled operative configuration having a conduit.

In one embodiment, the one-piece valve component, in the unassembled configuration, has a leaflet lower structure, ie, a first end, a second end, and a base-to-tip axis. It may be a substantially flat single layer structure. The unassembled leaflet sub-structure is rolled into the delivery configuration, for example by winding along a single axis, and delivered away from the support structure (or fixedly connected to the support structure) The first end and the second end may be locked together, which may be unfolded and attached to the valve component (operating configuration). The leaflet substructure comprises a plastically deformable member which can be formed into a ring for winding with the leaflet substructure and assisting in deforming the leaflet substructure into its assembled operating configuration . In another embodiment, the one-piece valve component, in the unassembled configuration, has a leaflet-ring, ie, a first end, a second end, and a base-to-tip axis. It may be a substantially flat bilayer structure. This unassembled leaflet-ring can be rolled into a delivery configuration, such as by rolling along a single axis. The folded, unassembled leaflet ring can be delivered and then opened and attached (actuated configuration) to the valve component. The leaflet-ring comprises a plastically deformable ring member, which is expanded with an unassembled configuration which can maintain the leaflet-ring in an unassembled configuration, the leaflet-ring being And an assembled configuration that can be maintained in an assembled operating configuration.

In any of the embodiments, after transforming the unassembled form into an assembled operative configuration, the one-piece valve component is combined with the support structure and locked onto the support structure, An assembled valve device can be formed. An example of a similar one-piece valve component including a self-organizing member, and a method of using the self-organizing member to fold and assemble this one-piece valve component, filed on January 12, 2010 FIGS. 2a-4b and paragraphs 43, 48 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". Are described in detail. The application is incorporated herein by reference.

In yet another embodiment of the modular valve device, the support structure may be provided as two or more device modules. For example, the support structure may be split along the circumferential axis to include, for example, two expandable tubular structures etc. that may be assembled in longitudinal alignment and linked together. In such an embodiment, each portion of the multi-part support structure is delivered as two or more compressed tubes while having greater radial stiffness than a single piece support structure. It is possible to maintain longitudinal flexibility at the time of delivery. Alternatively, the support structure may be delivered as a bifurcated tube which may be divided along the longitudinal axis and each half may be compressed to a smaller diameter than the overall support structure.

As used herein, “assembled” means that the valve assembly, valve component, or valve device is in an operative configuration (eg, not a flat, rolled or separated device module, but substantially But it means that the modules are not necessarily locked together. Further, the assembled configuration can also be referred to as an actuating configuration, wherein the valve module is a configuration that is substantially tubular and forms a conduit with a valve leaflet in place. The "unassembled" valve module may be folded for delivery (delivery configuration) or may be open and ready for assembly. The "unassembled" one-piece valve component may comprise a leaflet substructure having a first end and a second end, the leaflet substructure having their ends Can be configured into the ring as described above such that the valve components are connected to form an assembled valve component (operating configuration). Similarly, as mentioned above, the "unassembled" valve assembly includes a plurality of valve sections, which are configured, for example, in a ring to optimize the folding of the module for delivery. Can be merged in tandem, such as being arranged in a single row instead of Alternatively, the valve sections may be delivered separately without attachment.

The unassembled configuration of one or more device modules that make up the valve module provides a particular advantage for delivery. The reason is that the valve module can be folded into a delivery configuration, which minimizes the diameter of the valve module for delivery. This feature can not be realized in current percutaneous valve devices.

The present invention provides a locking mechanism for combining the modules of an implantable modular transcutaneous valve device or the ends of a single piece unassembled valve component. The locking mechanism of the present invention can be an integral locking mechanism or a non-integral locking mechanism. "Integral" means 1 or 2 in that the component (or components) of the locking mechanism is attached to the device module upon delivery or is structurally part of the device module It means that it is continuous with the above device module. Integrated locking mechanisms generally provide for locking of the device module during or after assembly. "Non-integral" means that the locking mechanism is delivered in one or more structures separate and spaced apart from the device module, preferably in the same delivery device as the device module, and after the valve device has been assembled Applies to device modules and is meant to include those locking the device modules together or being removed from the valve device during or after the locking process. For example, the 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 mechanism may be a locking prevention member, such as a blocking tab, which can be removed to allow the modules to be locked together. The non-integral locking mechanism may partially utilize integral features of the device module, such as holes, grooves or other structural parts that interact with the non-integral part. Also, the integrated locking mechanism of the present invention may be applicable to lock together parts of a pre-assembled transdermal valve device.

For example, the valve section (or the side of the leaflet substructure) may be an integral locking mechanism, such as a telescoping joint type component, a slotted hook mechanism, an interlocking curvilinear groove (zip lock) mechanism, an interference fit, friction locking Integrated snap-fit mechanism comprising snap-fit prongs and snap-fit receptacles, as well as hooking components, hooks, interlocking geometry or interlocking geometry (eg dovetails or pins, pegs, rivets or stud-tube connectors etc) May be attached by Alternatively, non-integral snap-fit mechanisms where the valve section or the side of the valve leaflet sub-structure comprises snap-fit prongs and snap-fit receptacles, pressure-locking connectors and pins, pegs, rivets, stud-tube connectors etc May be coalesced using a separate (non-integral) locking component, such as a non-integral interlocking geometry.

Similarly, the present invention provides a locking mechanism for combining the valve module and the support structure. For example, the valve module and the support structure may be a hook-and-groove component, a slotted hook mechanism, a locking tab, a stud-harbor lock, a snap-in coupling component, an integral snap-in mechanism, a hooking component, a hook and a pin, It may be attached by an integral locking mechanism, such as an integral interlocking geometry such as pegs, rivets, and stud-tube connectors. Alternatively, the valve module and the support structure may be separate (such as pressure-locking connectors, non-integral snap-fit mechanisms, and non-integral interlocking geometries such as pins, pegs, rivets, and stud-tube connectors) Non-integral) locking components may be used and coalesced.

These locking mechanisms may be made of the same material as the support structure, eg, stainless steel, a shape memory alloy such as nitinol, or an amorphous metal of a suitable atomic composition such as cobalt chromium, or It may be made of valve module material, or other suitable biocompatible material as recognized in the art.

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 within 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 the delivery device may be in a body cavity After being inserted, it may be loaded into the delivery device. The support structure and the valve module (or valve section) may be loaded into the catheter in tandem. Alternatively, the support structure may be initially loaded into the catheter and delivered, and then the valve module or section is loaded into the catheter in tandem and delivered into the support structure where the complete device is assembled It may be done.

Further, the present invention provides a method for delivering a modular valve device to a target location within a body cavity and assembling the modular valve device. The device modules may be sequentially delivered within a suitable delivery device, such as a catheter, eg, an intravascular catheter or an intraluminal catheter. The device module may be provided pre-loaded into the delivery device or may be loaded into the delivery device after the delivery device is inserted into the body cavity. Device modules can be delivered in any order. In one particular embodiment where the device module includes a support structure and a plurality of valve sections, the support structure may be delivered first, followed by each valve section.

After being delivered and deployed from the delivery device, the device module is assembled within the body, eg, a body cavity or a body cavity such as an implant site, to form a fully assembled valve device and use the locking mechanism of the present invention It can be made to unite. The device modules may be assembled, for example using pull wires to position the modules or parts of the modules relative to each other. For example, multiple valve sections may be connected via pull wires for sequential delivery, and after delivery in tandem and positioning at the target site, the device can be used during assembly of the valve sections using pull wires. The positions of the modules may be mutually positioned. Also, the pull wire can facilitate the connection of the valve section to the support structure via the locking mechanism and can help position the valve assembly within the support structure to form an assembled valve device. In other embodiments, a push rod may be used to assemble the device module, alone or together with other components, such as, for example, in combination with pull wires. The push rod may be, for example, a stiff wire or a tubular structure. Remote control of the device module facilitates assembly of parts within the body. Alternatively, the device module may be configured as described in paragraphs 38-38, 45-46, 51-69 of co-pending U.S. patent application no.
As described in detail in 10, it may be assembled by at least partially utilizing a self-organizing member such as, for example, a shape memory wire or a shape memory band. The application is incorporated herein by reference. For example, the leaflet substructure is used to assemble the leaflet substructure into a valve component with the edges of the leaflet substructure joined together, with or without the use of a push rod Once attached to the self-organizing member, it may be delivered, and a locking mechanism according to the present invention may lock the edges of the valve leaflet substructure together. A second self-organizing 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 present invention. The valve module may be adjustably coupled to the support structure for final adjustment of the position of the valve module after implantation of the valve device. Non-integral locking mechanisms may be similarly delivered and deployed via the delivery device.

By delivering the valve device as an unassembled section and assembling the valve section in the body according to the method described herein, a diameter smaller than the diameter currently required for the art percutaneous man-made valve is provided. The artificial artificial valve can be delivered percutaneously through the body cavity. For example, the holes required for the insertion of the prosthetic valve into the body of the valve device by assembling modules of the valve device one at a time in the final implantation position, for example the ascending aorta, or in the body cavity before repositioning the position in the final target site The size of the device is reduced and the ease and freedom to deliver the device to the desired location in the blood The reduced profile of the unassembled valve device of the present invention allows the delivery device of the present invention to have a substantially smaller diameter compared to the typical diameter of the delivery device 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.

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, the valve action is maintained using a temporary valve that functions during assembly and implantation of the modular valve device so that it can proceed with the assembly of the percutaneous modular valve, which takes about 30 seconds or more. You may Since this temporary valve is only used temporarily, the temporary valve needs to function optimally, repeatedly, and as expected over a long period of time as required for a permanent valve. Absent. Also, the temporary valve does not have to be completely open or completely closed. Temporary valves are more efficient because temporary valves do not have to have the same functional accuracy and duration, they do not have to be made of the same material, or have the same long-term viability in the body. It is possible to have a different design. The temporary valve can be made of a thin material, and the leaflets need only be partially attached to perform a sufficient temporary function during the replacement procedure, thus the temporary valve Can be configured to occupy less space, eg, during delivery.

In one embodiment, the temporary valve is placed on the delivery device and rapidly deployed without requiring precise placement, while the modular valve device is assembled and correctly placed in the implantation position The valve function may be maintained. The temporary valve may be placed at the permanent valve implantation site or at a position moved from the permanent valve implantation site. In another embodiment, the temporary valve may be attached to the support structure such that certain valve functions are established as soon as the support structure is expanded and implanted. This is the time for the operator to assemble the valve module (or multiple valve modules) and move it correctly into place in the support structure without much concern that the proper blood flow will be impeded Bring The valve module (or valve modules) may be arranged to cover the temporary valve and may be combined with the support structure. Preferably, the temporary valve is a one-piece construction, such as a membrane having a simple design that is easy to fold, for example, for transdermal delivery, easy to install, and easy to pop open for actuation. It is a structure. Alternatively, the temporary valve may comprise two or more pieces, but preferably still easy to fold for delivery, easy to install and easy to pop open for actuation It is.

When the temporary valve is delivered folded inside the compressed support structure, a delivery profile smaller than that achievable with permanent type pre-assembled percutaneous valve devices is realized can do. The reason is that the temporary valve has a relatively simple geometry and can be manufactured from a thinner and less durable material than the permanent valve module. In some aspects of this embodiment, the temporary valve may be comprised of biodegradable material.

The devices, systems, and methods of the invention are specifically configured for use in transcutaneous aortic valve replacement, but other heart valves such as, for example, pulmonary valves, mitral valves, and tricuspid valves, and peripherals. It can also be used as a substitute for valves in the vasculature or in other body cavities such as the gastrointestinal tract, lymphatics, collecting bile ducts, and any other body cavity having a valve requiring replacement or requiring valve implantation. it can. If a modular valve device is designed to replace the aortic valve, the device may be in the ascending aorta, in the descending aorta, in the ventricle, at the implantation site, or at a portion of the implantation site and partially at the aorta. , May be assembled. These devices, systems, and methods are specifically configured for use in the body cavity of the human body, although applications in animals are also possible.

The valve component and valve assembly of the modular valve device can be made of a suitable material such as a polymer, metal or biological material. Selection of materials, constructions and manufacturing methods is preferably made to optimize valve function, durability and biocompatibility.

The support structure is preferably expandable such 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 manufactured from a biocompatible material that is sufficiently durable to allow the structure to support the valve component while maintaining the position of the device in a body cavity. Also, the material of the support structure is compatible with delivery of the support structure in a compressed state, and expansion of the compressed support structure upon deployment in a body cavity. In one embodiment of the invention, the support structure is manufactured from stainless steel or a shape memory alloy such as, for example, 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 manufactured from similar biocompatible materials 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 cavity where the valve is to 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 according to the present invention.

During deployment, the support structure is secured within the body wall such that the valve assembly does not move within the body cavity and not displace from the desired position, for example due to the pressure of fluid flow in the valve or its impact on the closed valve. As such, it should engage the body cavity wall. The support structure may be provided with a locking mechanism such as those described herein to secure the valve assembly (or valve component) 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.

The devices and methods of the present invention are specifically configured for use in transcutaneous aortic valve replacement, but other heart valves such as, for example, pulmonary valves, mitral valves, and tricuspid valves, and peripheral vasculature It can also be used as a substitute for valves in other body cavities, such as in the digestive tract, lymphatics, collecting bile ducts, and any other body cavity with valves that require replacement or require valve implantation. If a modular valve device is designed to replace the aortic valve, the device may be in the ascending aorta, in the descending aorta, in the left ventricle, at the implantation site, or partially at the implantation site and partially in the aorta. May be assembled. These devices, systems, and methods are specifically configured for use in the body cavity of the human body, although applications in animals are also possible.

The foregoing embodiments, as well as other embodiments, delivery methods, alternative designs, and other 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 one exemplary understanding of the present invention and to schematically illustrate particular embodiments of the present invention. Similarly, other similar examples within the scope of the present invention will be readily recognized by those skilled in the art. The drawings are not intended to limit the scope of the invention as defined in the appended claims.

FIG. 1 shows an embodiment of how the valve module 10 and the support structure 20 of a modular man-made valve device can be assembled. In order to show how the valve module and the support structure are combined to form an assembled valve device, in FIG. 1 the valve module is shown assembled and corresponds to a valve assembly or valve component It may be In this embodiment, the valve module 10 and the support structure 20 can be assembled by a pull wire 40 or the like to provide an assembled valve device 30. The support structure 20 and the valve module 10 may be delivered sequentially in tandem, as illustrated in FIG. 1, in which case the modules may be connected by a pull wire 40. The valve module 10 may be drawn into the support structure 20 using a pull wire 40 that may be coupled 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, in a body cavity of the aortic outflow channel or in the ascending aorta. The attachment of the valve module 10 to the support structure 20 may be by any of a plurality of locking mechanisms, as described herein. Alternatively, the support structure 20 and the valve module 10 may be delivered separately, i.e. not in tandem (not shown). For example, the support structure 20 is delivered and deployed in its final position, and then the valve module 10 is delivered and deployed within the support structure 20, thereby assembling the module into the assembled valve device 30. It is also good.

FIG. 2 shows an embodiment of a modular valve device having four device modules, one support structure (not shown) and three valve sections 50a-50c. The valve sections 50 a-50 c are designed to unite to form the valve assembly 15. In use, the valve section operates in the same manner as a fistula of tissue in a natural valve. The valve sections 50a-50c may be pre-mounted to the pullwires 40 or strings and be tethered by the pullwires 40 or strings.

The pull wire 40 or string may have two purposes. First, the pull wire 40 can connect the valve sections 50a-50c together for delivery so that the valve sections 50a-50c can be delivered through the body cavity in tandem. Second, the pull wire 40 extending outwardly from the end of the catheter can be pulled to assemble the valve sections 50a-50c to create the valve assembly 15. As an example of how pull wires can be used to assemble the modular valve device of FIG. 2, the pull wires are tightened one by one so that the valve sections are pulled together, thereby forming the valve assembly in the support structure Alternatively or alternatively, the valve sections may be pulled together outside the support structure, thereby forming a completed valve assembly and further directing the valve assembly into the support structure. Other means for positioning and mounting the valve section may be used and will be readily recognized by those skilled in the art in view of the disclosure herein.

In one aspect (not shown) of this embodiment, the pull wire is assembled by assembling the valve assembly 15 and the support structure 20 in the same manner as the aspect illustrated in FIG. 1 by pulling the pull wire 40. The valve sections 50a-50c may be coupled to the support structure 20 (see FIG. 3) such that a valve device (not shown) may be made. The exact number of valve sections may vary from embodiment to embodiment, but in particular the valve assembly may comprise, for example, 2 to 6 or more valve sections. In one embodiment, an assembled valve device designed to replace a tricuspid valve may have four device modules, ie, three valve sections forming an assembled valve assembly, The valve assembly is secured within the body cavity by the support structure. The assembled valve device designed to replace the mitral valve has, for example, three device modules, ie two valve sections forming an assembled valve assembly fixed in the body cavity by the support structure May be

FIG. 3 schematically illustrates how the four modules of the embodiment illustrated in FIG. 2 can be packaged for delivery into a body cavity. The four device modules may be connected by pull wires and delivered in tandem with the support structure as a lead device module as shown. 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 a pull wire 40 to allow continuous delivery and assembly. As illustrated on the right of the figure, the module is 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 crimped on the balloon for delivery and deployment, or by other means known in the art. It may be extended from a compressed configuration. A series of (four in FIG. 3) modules are then introduced into the catheter 60 so that the loaded catheter can be used to deliver the modules to the deployment site in a body cavity. The valve device module may be placed in the delivery device before being inserted into the body cavity or after being inserted into the body cavity, depending on the needs of the particular treatment. In one embodiment where the catheter 60 is an intravascular catheter, the valve device module may be located on a guidewire.

The method of delivering and assembling one embodiment of the modular prosthetic valve device of the present invention comprising the valve assembly 15 of FIG. 2 may proceed, for example, as follows. As illustrated in FIG. 3, a delivery device, such as a catheter 60 carrying a support structure 20 and a plurality of valve sections 50a-50c, is in the final position where the valve device is to be implanted, via appropriate blood vessels. It may be sent. The support structure may be initially deployed so as to be able to receive the valve section. Once the support structure is in place, the valve sections 50a-50c may be sequentially deployed, and in the embodiment illustrated in FIG. 3, the valve sections are chained together and deployed in tandem. . The valve sections 50a-50c can be assembled as described above, for example by using a pull wire 40, to make the valve assembly 15. The modules of the valve assembly 15 may be assembled within the support structure 20 or may be assembled outside the support structure 20, and then the valve assembly 15 is supported as shown in FIG. It may be positioned within the body 20. When the valve sections 50a-50c are assembled to form the valve assembly 15 in the support structure 20, each valve section 50a-50c may be sequentially attached to the support structure 20 and then coalesced. The valve sections 50a-50c may be coalesced and the valve assembly may then be secured to the support structure by any of a number of locking mechanisms as described herein. The valve device of FIGS. 2 and 3 may be assembled in the body and then positioned for implantation in the final position or may be assembled in the final position. Additional fixation mechanisms may be configured and used to guide and / or secure the valve device fully assembled to the remaining tissue of the body cavity wall or natural blood vessel wall.

The pull wire allows the valve assembly and support structure to be loosely coupled for delivery, but also the valve assembly to allow the modules of the device to be combined or assembled as the pull wire is pulled by the operator. And through the support structure. The pull wire may be tethered to the module of the modular prosthetic valve device by any suitable means known in the art, this interlocking to remove the pull wire after the device is implanted and secured in the body cavity It can be released by pulling one end of the wire. Thus, for example, the module of the valve device may comprise a loop or eyelet through which the pull wire passes. Alternatively, the pull wire may be part of a delivery system that includes a mechanism for manipulating the pull wire to assemble the valve section and combine the valve assembly and the support structure. For example, an activator, mechanical mechanism, or current in the delivery system may be used to pull the pull wire to assemble the device module.

4A-4C present an example of how a device module may be assembled using pull wires and push rods. Furthermore, other methods for positioning and assembling the device module of the present invention, such as, for example, only pull wires only, push rods only, or in combination with self-organizing members, and only self-organizing members such as shape memory wires, It may be used with the present invention. Self-organizing members are described in co-pending US patent application Ser. No. 12 / 686,338 filed on Jan. 12, 2010 (self-assembly), paragraphs 36-38, 45-46, 51-69, and 2A-10 are described in detail. The application is incorporated herein by reference.

In particular, FIGS. 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 FIG. Is illustrated. FIG. 4A shows the first pull wire 41 through the valve sections 50a-50c disposed within a body cavity such as the aorta 81, including the first loop 41a, through the valve sections 50a-50c and the support structure 20. And a second pull wire 42 including a second loop 42a. For clarity of illustration, the delivery device is not depicted in FIGS. 4A-4C. The first loop 41a may be passed through the first valve section 50a, and the 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 routed through another valve section (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 pull wire 42 may extend outside the proximal end of the delivery device.

FIG. 4B illustrates the later stages of assembly in which the valve section is assembled into the valve assembly 15 by using the first pull wire 41 in the aorta 81. In this embodiment, two push rods having a tubular structure are used with the pull wire 41 for assembly of the device module, referred to as the first tube 63 and the 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, a first tube 63 is placed over the end of the pull wire 41 and inserted into and through the delivery device and within the aorta 81. It may be advanced to the most recent valve section (e.g., 50c in FIG. 4A). The ends 41 b of the first pull wire 41 are then pulled against the first tube 63 to assemble the valve sections together to form the valve assembly 15 as illustrated in FIG. 4B, It can help to 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 in a threaded condition around the valve assembly 15, but the first pull wire 41 and the first loop 41a to the valve assembly of the valve section. Indicate that the valve section may be threaded in any manner that facilitates assembly of the valve. The first pull wire 41 may be removed by pulling one end. Alternatively, the first pull wire 41 may be tied and cut to keep the valve assembly connected. The second loop 42 a is still through the independent support structure 20 and the second pull wire 42 is through the valve assembly 15.

The support structure 20 may then be positioned at the implant target location 70 of the valve device and expanded. As illustrated in FIG. 4C, to assemble the support structure and valve device, the second tube 64 is then placed over the end of the second pull wire 42 and a delivery device (not shown) It may be inserted into and through the delivery device and advanced to the valve assembly 15. The two ends 42 b of the second pull wire 42 can then be pulled against the second tube 64 to assemble the valve assembly 15 and the support structure 20 into the assembled valve device. Specifically, the second pull wire 42 can 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 stepwise pulling on 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 in a threaded manner around the support structure 20, but the second loop 42a does within the valve device assembly and support structure 20. The support structure 20 may be threaded in any manner that facilitates the positioning of the valve assembly 15 of FIG. Further, FIG. 4C shows the support structure 20 deployed and expanded to press the native valve leaflet 76 against the aortic wall 82, but if this procedure requires a native valve The tines may be removed prior to placement and expansion of the support structure. 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.

The first pull wire and the second pull wire may comprise biodegradable material and be left in place and capable of being degraded. In the embodiment illustrated in FIGS. 4A-4C, the support structure 20 is placed after assembly of the valve sections 50a-50c and expanded to minimize the period of valve inactivity in the patient. . However, in another embodiment, the support structure 20 may be positioned before the valve section is assembled into the valve assembly. For example, the support structure may be positioned using the second pull wire 42 and the second tube 64 and then expanded, and then the second tube 64 is preferably removed and the second pull wire 42 are left in place, then the valve section 5
0a-50c may be assembled into the valve assembly 15 using the first pull wire 41 and the first tube 63. The valve assembly 15 may then be moved into place and assembled to the support structure 20 using the first pull wire 41 and the second pull wire 42. These methods of valve assembly apply to modular valve devices including more or less than four modules illustrated in FIGS. 4A-4C, including modular valve devices including only valve sections as device modules Such methods are possible and are properly included within the scope of the present invention. For example, a modular valve device comprising two modules, a valve component and a support structure, may be assembled in the same way using pull wires and tubes, which according to the art in view of the above Included appropriately within the technology. Where appropriate, a set of three or more pull wires may be used to assemble the device module. One skilled in the art can readily use other assembly means similar to those described above and as described in co-pending US patent application Ser. No. 12 / 686,338 (self-assembling), as desired. It is possible.

5A-5C illustrate one embodiment of a one-piece valve module that may include the leaflet sub-structure 150 in an unassembled state. This one-piece valve module can be folded in an aspect that minimizes the delivery diameter, ie, in its delivery configuration. Prior to loading the leaflet sub-structure 150 into the delivery system, the leaflet sub-structure 150 extends (ie is assembled) between the base and the tip as illustrated in FIG. 5A. Unfolded, unfolded, unassembled, substantially flat and generally rectangular or trapezoidal in form, having a height axis along the longitudinal axis of the valve device and a circumferential axis 101 It may be done. In the embodiment illustrated in FIGS. 5A-5C, the leaflet substructure 150 comprises three leaflets 150a-150c, while in other embodiments the leaflet substructures comprise two or more leaflets. It may have a valve leaflet. The circumferential axis 101 of the leaflet substructure is equal to the outer periphery of the leaflet substructure in its assembled valve component configuration 110 (see FIG. 5C). A plastically deformable member 100 may be mounted along the circumferential axis 101 of the leaflet lower structure, whereby for example in the unassembled state the plastically deformable member 100 is illustrated in FIG. 5A. May be attached along the base line 102, or along the bond line 103 (not shown), or along other peripheral lines along the base-tip axis. Before loading the delivery device into the delivery device, the leaflet substructure 150 is formed by the first end 151 and the second end 152 of the leaflet substructure 150 being a cylinder of the folded leaflet substructure 155. It may be wound along its circumferential axis from the base to the tip or from the tip to the base as illustrated in FIG. 5B to form the end of the shaped delivery configuration.

After deploying the folded leaflet substructure from the delivery device, the leaflets can be opened and assembled to form a three dimensional structure of the valve component as illustrated in FIG. 5C. The act of opening the leaflet sub-structure 155 from the delivery configuration may be assisted (not shown), for example by a balloon catheter, by a pull wire and / or by a push rod, or a combination thereof. In one embodiment, a pull wire and / or push rod is used to release the structure, and the first end 151 and the second end 152 of the leaflet substructure 150 and the end of the plastically deformable member 100 Can be in the form of a ring, for example circular, oval, D-shaped or any other shape suitable for the valve module. In one such embodiment, the plastically deformable member 100 may be attached to the base line 102 and the leaflet substructure 150 may be wound along the circumferential axis 101 from the base to the tip. The plastically deformable member 100 may be enclosed within the folded leaflet sub-structure 155, as illustrated in FIG. 5B. In this embodiment, one or more pull wires (not shown) may be passed through the base of the leaflet substructure 150 and wrapped by the folded leaflet substructure 155. The pull wire is pulled similar to that illustrated in FIGS. 4B-C, such as, for example, in combination with a tubular push rod, to move the leaflet sub-structure 155 from the delivery configuration to the non-assembled configuration 150. It can help to spread. As will be appreciated by one skilled in the art, alternatively, for example, in embodiments where the leaflet substructure is folded from the tip to the base (not shown), one or more pull wires may be disposed below the leaflet. It may be attached to one or more tips of the leaflets 150 a-150 c of the structure 150 and be encased within the folded leaflet sub-structure 155.

For example, in one embodiment, the first end 151 and the second end 152 of the valve leaflet sub-structure 150 may be formed of, for example, a pull wire and / or a push rod to form the three-dimensional valve component 110. They may be joined together using a not shown) or the like. For example, one end of the plastically deformable member 100 may have an attached pull wire (not shown), and the other end of the plastically deformable member 100 is a loop through which the pull wire passes (Figure Not shown). The first end 151 and the second end 152 of the leaflet substructure may likewise have a pull wire attached therethrough. For example, a push rod, such as a tubular push rod similar to that described above in FIGS. 4B-C may be used in combination with one or more pull wires to allow the plastically deformable member 100 and the valve leaflet substructure 150 The ends of the may be pulled together to form a tubular structure (not shown). A balloon catheter is then inserted through the tubular structure and expanded to expand the plastically deformable member 100 and the leaflet substructure 150 into a ring-like shape, as illustrated in FIG. 5C, It is possible to form an operating arrangement with the valve component 110 assembled, ie a conduit. The "ring-like shape" may be a circular shape, an oval shape, a multi-lobule shape, a D-shape, or a shape suitable for any other valve device. Before locking into the assembled configuration, or after expanding into the assembled configuration, to lock the first end 151 together with the second end 152 as will be further described below A locking mechanism may be provided.

In another aspect of the one-piece valve module embodiment illustrated in FIGS. 6A-C, the valve module may be a valve leaflet ring (leaflet-ring) 250. In this embodiment, the leaflet-ring 250 may have an unassembled configuration, ie, a substantially flat bilayer, as illustrated in FIG. 6A. The leaflet-ring 250 may have a plastically deformable ring member 200 attached or integrated to, for example, the base of the valve module (see FIG. 6C) or the like. The leaflet-ring 250 has an unassembled configuration having a two-layer substantially flat shape, as illustrated in FIG. 6A. When squeezed 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 elongated portions 200a and two bent ends 200b, as illustrated in FIG. 6A. The leaflet-ring 250 may be held in a substantially flat, unassembled configuration. From this unassembled configuration, the leaflet-ring 250 is, for example, as shown by the arrow in FIG. 6A and as shown in FIG. 6B, from tip to base, or from base to tip, etc. It may be folded into a delivery configuration 255 by winding along the circumferential axis in the height direction.

Pull wires and / or push rods (not shown) may be used to unfold the unassembled valve leaflet-ring 255 folded from the delivery configuration. For example, in one embodiment (not shown), the tip portion of the leaflet-ring 250 may be coupled to one or more pullwires, which may be a valve for delivery. It may be wound with a pointed ring 250. The rolled leaflets-ring 255 may be opened by pulling one or more pull wires. As will be appreciated by those skilled in the art, alternatively, one or more pull wires are attached to the base of the leaflet-ring, for example when the leaflet-ring is wound from the base to the tip. Thus, it may help to open the valve leaflet-ring 255 wound from the delivery configuration.

Unassembled plastically deformable ring members 200a, 200b are expanded, for example by balloon expansion or the like, by using push rods and / or pull wires, or combinations thereof, to form a three-dimensional valve component 210. Thus, as illustrated in FIG. 6C, the leaflet-ring 250 deforms into an assembled valve component 210, ie, an operative configuration having a conduit. In one embodiment, for example, a balloon catheter (not shown) is inserted through the unfolded and unassembled leaflet-ring 250 and expanded to allow the plastically deformable ring member 200 to be shaped like a ring. Can be extended to The "ring-like shape" may be circular, oval, D-shaped or any other shape suitable for a valve device. In one aspect (not shown) of this embodiment, the leaflet or leaflets may be leaflets such that a string or pull wire is connected to the balloon catheter at one end to assist in pulling the balloon catheter into the leaflet-ring 250. The ring 250 may be pre-threaded. When the leaflet-ring 250 is assembled into the three-dimensional valve component 210, the valve component 210 is combined with a support structure (not shown) using a locking mechanism to form a support structure (not shown) ), Thereby forming 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.

7-15 illustrate examples of locking mechanisms that may be used to secure or attach device modules together after the device modules are combined or assembled.

7 and 7A illustrate one embodiment of a locking mechanism that may be suitable for making the valve assembly 15 illustrated in FIG. 2 by combining valve sections, such as 50a, 50b, for example. The pull wire 40 can be used to pull the valve sections 50a, 50b together so that the first side 51a of the first valve section 50a is on the second side 52b of the second valve section 50b. Lock it. FIG. 7A illustrates one embodiment of a locking mechanism. Each valve section may have multiple attachment points with locking mechanisms or the like, including, for example, male component 16 and female component 17. Male component 16 and female component 17 are positioned such that male component 16 from one valve section matches female component 17 of another valve section.

As specifically shown in FIG. 7A, for example, the first side in which the first valve section 50a mates with the plurality of female components 17 on the second side 52b of the second valve section 50b. A plurality of male components 16 on the part 51a may be provided. The male component 16 of the first valve section 50a locks into the female component 17 of another valve section 50b.

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

8A-C illustrate one embodiment of a locking mechanism for attaching the valve module and the support structure. In particular, as illustrated in FIGS. 8A and 8B, the support structure 20 comprises a plurality of attachment points including hooks 21. The valve module 10 comprises a groove 22 along its proximal edge 12 as defined by the fluid flow in the body cavity, i.e. the "upstream" edge. The hooks 21 of the support structure 20 are mounted in the grooves 22 of the valve module 10, as illustrated in FIG. 8B, to secure the two modules together as illustrated in FIG. 8C. The groove 22 may extend across the entire proximal edge 12 of the valve module 10 so that the hooks 21 can capture the groove 22 independently of the axial rotation of the valve module 10. Alternatively, the valve module 10 may have a plurality of short grooves spaced around the proximal edge 12 to be aligned with the hooks 21 of the support structure 20.

The support structure may be designed such that the valve section can be coupled to the support structure at various axial positions. For example, the support structure 20 may have a set of spaced apart hooks 21 spaced along the longitudinal axis to provide more than one attachment position in the proximal-distal direction. You may Such a design provides the clinician with freedom as to where the valve assembly can be placed within the support structure.

FIG. 9 illustrates one embodiment of a locking tab 392 for attaching the valve module 310 to a support structure (not shown for clarity). The locking tabs 392 lock the device modules together by an interference fit. The valve module 310 comprises or is attached to the ring 300 and the locking tab 392 is attached to the ring 300. As illustrated in FIG. 9, the locking tab 392 is connected to the valve module 310 at its base. After the valve module 310 and the support structure are combined, one or more 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 illustrated in FIG. 9 uses a component that is integral with the valve module rotationally operable between the unlocked position 392a and the locked position 392b about pivot 395. It is a mechanism. Preferably, valve module 310 has two or more locking tabs 392.

As FIG. 9 shows, the locking tab 392 has a pivoting end 397 and a pivoting end 399, and an unlocking position 392a in which the pivoting end 399 is oriented towards the middle of the valve module; The oscillating end 399 operates by rotating between an axially oriented, i.e., locking position 392b oriented parallel to the longitudinal axis of the valve device. The pivoting end 397 has a substantially circular shape and a pivot axis 395 about which the pivoting end 397 of the locking tab 392 rotates. As illustrated in FIG. 9, the pivot axis 395 is not centrally located within the substantially circular shape of the pivot end 397 and is in the unlocked position 392 a, the pivot end 397. Side edge 394a of the valve module 310 is substantially flush with the outer periphery of the valve module 310, and in the locking position 392b, the side edge 394b of the pivoting end 397 is beyond the outer periphery of the valve module 310. Extending and exerting a radial force on the support structure sufficient to lock the modules together by means of an interference fit.

10A-D illustrate another embodiment of a stud-harbor lock that is an integral locking mechanism. A stud-harbor lock may be used to attach the valve module to the 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 comprises a plurality of studs 404 positioned on its outer surface at predetermined intervals around the periphery of the ring 400. The studs 404 project outwardly from the outer surface of the ring 400 in a fixed manner. A support structure (not shown) comprises a plurality of axially oriented posts 426 mounted thereon relative to its inner surface. A plurality of posts 426 are attached to the support structure at predetermined intervals around the inner periphery that mates with the studs 404 on the ring 400. Each post 426 comprises a plurality of "harvest" 425 (e.g. notch grooves etc) on the inner surface. Harbor 425 is operable to receive studs 404 in alignment relationship. Thus, the stud-harbor lock comprises a stud 404 positioned on the ring 400 to which the valve module 410 is attached and docked within the harbor 425 positioned on the post 426 attached to the support structure, Lock the valve module and the support structure together.

The studs 404 on the ring 400 are post by rotating the valve module 410 relative to the support structure (not shown) so that the studs 404 are aligned with the harbor 425 as illustrated in FIG. 10B. It is possible to dock to the harbor 425 on 426, whereby two modules are attached. The studs 404 and the harbor 425 can be locked together by, for example, an interference fit, magnetic traction, ratchets, vertical ridge-channel, or other mechanisms known in the art. Depending on the particular choice of attachment mechanism, the device module may be as illustrated by the vertical channel-ridge mechanism in FIGS. 10C, 10C ′, 10D and 10D ′, or the studs 404 and the harbor 425 may for example be As illustrated in one embodiment locked together by the ratchet mechanism by rotating the valve module 410 in one direction, such as clockwise, as shown in one embodiment, for example, clockwise or counterclockwise. It can be locked and unlocked by rotating 410.

As illustrated in FIGS. 10C and 10C ′, the studs 404 may have vertical channels 408, and as illustrated in FIGS. 10D and 10D ′, the harbor 425 may have vertical ridges 4328. You may have. FIG. 10C illustrates channel 408 in stud 404 on ring 400 in a front view, and FIG. 10C 'illustrates channel 408 in stud 404 in a top view. FIG. 10D illustrates the ridge 428 in the harbor 425 in a side view of the post 326 and FIG. 10D ′ illustrates the ridge 428 in the harbor 425 in a front view. The valve module 410 may be rotated until the vertical channel 408 in the stud 404 engages the vertical ridge 428 in the harbor 425 to limit further rotation of the valve module 410.

In a ratcheting mechanism (not shown), the studs 404 and the harbor 425 are angled at an complementary angle to each other (e.g. in a sawtooth pattern) so that the valve modules rotate in one direction, e.g. clockwise. It may be done. The reason is that the front side of the stud 404 is smaller than the rear side. In this embodiment of the ratchet type mechanism for the stud 404 and the harbor 425, the valve module 410 holds the stud 404 in position with the harbor 425 configured to be in alignment with the stud 404 The valve module 410 may be locked by rotating the valve module 410 in one direction, for example clockwise, with respect to the post 426. At this point, due to the geometry of the stud and the harbor, the stud and the harbor can be unlocked as needed by rotating the valve module 410 in the same direction, for example clockwise, with respect to the post. Reverse rotation, for example, counterclockwise, is prevented by the diameter discontinuities between the ring 400 and the back of the stud 404.

11A and 11B illustrate a quick release button locking mechanism with a plurality of "buttons" 505 that lock into complementary "harbors" 525. As illustrated in FIG. 11A, the valve module 510 may be attached to the ring 500 or may comprise the ring 500. The ring 500 comprises a plurality of buttons 505 positioned on its outer surface at predetermined intervals around the periphery of the ring 500. The support structure (not shown for clarity) comprises a plurality of axially oriented posts 526 mounted on its inner surface, as illustrated in FIG. 11B. A plurality of posts 526 are attached to the support structure at predetermined intervals around the inner periphery coinciding with the button 505 on the ring 500. Each post 526 comprises a harbor 525 (e.g. a notch) on the inner surface. As illustrated in FIG. 11B, the ring 500 and thus the valve module 510 may be locked to the support structure (not shown) by means of a button-harbor pair, the button 505 comprising the quick release mechanism being Locked in the harbor 525 on the plurality of posts 526 attached to the support structure. 11A and 11B illustrate an embodiment where the valve device comprises four mating positions where the valve module button and the support structure harbor engage. However, in other embodiments, the valve device may have three, or as many as six or eight such mating positions. In another embodiment, to facilitate rotational positioning of the valve module relative to the support structure, for example, twice or three times as many buttons as the number of posts on the support structure (or vice versa) It may be present on the module ring. In an alternative embodiment, the harbor member may comprise a grooved ring on the inner surface of the support structure.

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 skilled in the art. In one aspect of the embodiment illustrated in FIGS. 11A and 11B, the quick release mechanism can be activated or deactivated by pulling or pushing the safety device. For example, when the safety device is actuated, the button 505 can be actuated to lock within the harbor 525 of the post 526 by projecting outwardly from the outer surface of the ring 500. Similarly, when the safety device is deactivated, the button 505 unlocks the valve member from the device frame by retracting from the harbor 525 to appear substantially flush with the outer surface of the ring 500 To be shut down. In an alternative aspect of this embodiment, the button 505 can be spring loaded and activated and deactivated depending on whether the spring is engaged or disengaged. The activated button and the deactivated button are illustrated in FIG. 11B. Thus, referring to the spring based system, the button 505 a facing the post 526 is axially displaced along the post 526 until the ring 500 a faces the harbor 525 by the protrusion being limited by the post 526 It becomes possible. A button 505 facing the harbor 525 can freely project outwardly from the ring 500 and engage the harbor 525. When sufficient force is applied, the button 505 a can be disengaged from the harbor 525 and limited by the post 526 so that the ring 500 can be moved axially again along the post 525. The option of a post 526 having multiple harbors 525 is further illustrated in FIG. 11B, this configuration being simultaneously filed entitled “Method and Apparatus for Fine Adjustment of a Perforated Valve Structure” filed on the same day as the present application. FIG. 1a of the pending US patent application no.
As described in detail in 1b and paragraphs 28-29, it is useful for fine tuning the valve module 510 relative to the support structure. The application is incorporated herein by reference.

Additionally, the valve device module may be attached using components that are independent of (i.e., not integral with) the device module. Non-integral locking mechanisms are applicable for combining valve sections or for attaching a valve module to a support structure. Thus, independent components are used as a locking mechanism to join device modules together, as illustrated by way of example for joining a valve module to a support structure as illustrated in FIGS. It may be done. The locking mechanism of the present invention which is not integral with the device module is preferably of the type which is easily engaged from a remote location, but additionally provides a fixed attachment which does not disengage when in use. Alternatively, the non-integral locking mechanism comprises a member attached to the valve module and / or the support structure that prevents engagement until removed, such as a tab that prevents the two components from engaging. It is also good.

After the valve module (or plurality of valve modules) and the support structure are assembled and positioned, one or more components may be percutaneously inserted into the valve device as illustrated in FIGS. 12A-12B. It may be inserted and arranged to lock the two modules together, for example using a snap fit mechanism or the like. FIG. 12A illustrates one embodiment of a separate (non-integral) snap fit locking mechanism using a one-piece snap fit prong 692 comprising a leading edge 692a and a base end 692b. Details of snap fit prongs 692 are illustrated in FIG. 12A ′. In the embodiment of FIG. 12A, the valve module 610 is attached to, for example, the ring 600 at or near its base, at a predetermined distance around its outer periphery, which extends axially from the valve module 610. Also, there may be a plurality of axial tabs 613. Each axial tab 613 comprises a hole (not shown), each hole being 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 the sake of clarity) comprises a plurality of axially oriented posts 626 attached thereto on its inner surface. A plurality of posts 626 are attached to the support structure at predetermined intervals around the inner periphery that matches (i.e. is in alignment with) the valve module axial tabs 613. Each post 5626 is provided with a post hole (not shown) which is further configured to receive the snap fit prongs 592 at the same axial level, whereby the valve module 510 and the support structure are assembled And each post hole of post 626 may be aligned with the hole in axial tab 613 of valve module 610.

In another embodiment, as illustrated in FIG. 12B, the snap-fit mechanism is a two-piece mechanism. Snap fit prongs 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 prongs may be disposed. In particular, FIG. 12B shows how the base end 692b of the snap fit prong 692 can secure one device module, here the valve module 610, and the leading end 692a of the snap fit prong 692 as the valve. How can extend through the integral holes 611 in the module 610 and the integral holes 627 in the support structure 620 to engage the snap fit receptacle 693 thereby securing the valve module and the support structure , Schematically shown. In another aspect (not shown) of the two-piece snap fit mechanism, snap fit prongs 692 and snap fit receptacles 693 may be further used with axial tabs 613 and posts 626.

The snap fit prongs 692 may be disposed from within the assembled valve device to the outside of the valve device as illustrated in FIG. 12B, ie, the leading edge 692a is initially in the valve module 610. Through the hole 611 and then through the hole 627 in the support structure 620 post. Alternatively, snap fit prongs 692 are disposed in the center to the outside of the valve device, as illustrated in FIG. 12A, first through the holes in post 626 and then through valve module holes 611. You may pass through. In the latter case, the snap fit prongs 692 may be disposed through the valve module and the support structure before the support structure is fully expanded and implanted in the implantation position of the valve device.

The snap-fit locking mechanism operates in a manner similar to one of the embodiments illustrated in FIG. 12A or 12B, for example the first valve section relative to the second side of the second valve section. The sides of the valve section (not shown) may be attached together, such as attaching the first side of the valve or combining the sides of the 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 end is continuous with the support structure. In this embodiment, the valve module may be spaced around its periphery to include holes, or receiving spaces that are the structural equivalent of a snap-fit receptacle, aligned with each post. The lumen end of the integral snap fit prong may be disposed through a hole or integral receiving space that is an integral part of the valve module so as to be effective for attaching the two device modules. Alternatively, a snap fit prong may be engaged with a hole attached to the base of the valve module or the ring attached to the valve module and attached to a hole or support structure integral with the support structure, or The post may be provided with a receiving space which is, for example, the structural equivalent of a snap fit receptacle on the post.

13A-13E illustrate the interlocking geometry associated with the non-integral snap-fit mechanism illustrated in FIGS. 12A-12B, but may also be referred to as pins, pegs, rivets, and stud-tube connectors. For example, FIG. 13A illustrates a pin 792 feature that secures the first device module 718 and the second device module 719 as a sandwich. The pin 792 mechanism of the present invention comprises 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 edge 792a is straight when the leading edge 792a of the pin 792 is disposed through the first device module 718 and the second device module 719, and the head of the base edge 792b There are two prongs 795a, 795b adapted to be folded flat against the outer surface of the device module sandwich opposite to the side where the is located. As illustrated in FIG. 13B, the pins 792 are holes integral with the pin tabs 713 extending away from the base of the valve module 710, and the posts 726 of the support structure (not shown for clarity). It may be disposed through the integral post hole 727. 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-organizing member, a plastically deformable ring, or the like structure . In the embodiment illustrated in FIG. 13B, the pins 792 are oriented to secure the device module in the direction from the blood vessel side to the lumen side of the valve device, whereby the pins 792 initially receive the post holes 727. It may be disposed through and then through a valve module hole (not shown). A device for securing the pin may then be inserted into the valve device to cause pin prongs 795a, 795b to bend so as to abut the lumen surface of pin tab 713. Alternatively, the pin prongs 795a, 795b may be manufactured from a shape memory material having a preset bending configuration. Suitable devices can include inflatable balloon catheters. 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 wall of the body cavity can serve to fix the pin by bending the pin prongs 795a, 795b.

13C-13E illustrate other possible geometries for embodiments using pins, pegs, rivets, and stud-tube connectors. In particular, FIG. 13C shows a peg 892 according to the invention that can be used with post holes or valve module holes, FIG. 13D shows a rivet 992 according to the invention that can be used with post holes or valve module holes, and FIG. 7 shows a stud-tube connector 1092 according to the invention that may be used with a post hole or valve module hole. The device module is a structure equivalent to any of the peg locking mechanism, the rivet locking mechanism, and the stud-tube connector locking mechanism illustrated in FIGS. 13C-13E, or a structure similar to the pins illustrated in FIGS. 13A and 13B. May be integral with the device component such that it is not necessary to apply the interlocking geometry to the device component, thereby allowing the locking procedure to be simplified. Other variations of interlocking geometries that can be an integral locking mechanism within the scope of the present invention include dovetails, rivets, and tacks. For example, the stud-harbor mechanism may be designed with a dovetail geometry.

In each of the embodiments described above, the ring is, for example, a foldable but rigid part of the valve module that can be positioned at the base of the valve module, or a plastically deformable member as described herein or the like. May be As an alternative, the ring may for example be described in co-pending U.S. patent application Ser. No. 12 / 686,338 filed on Jan. 12, 2010 (self-assembly), paragraphs 36-38, 45-46, 51-69. And may be self-organizing members as described in FIGS. The application is incorporated herein by reference.

Another example of an integral interlocking geometry feature is an interlocking curvilinear groove mechanism, also referred to in the art as a zip lock mechanism, as illustrated in FIGS. 14A-14C. This is particularly useful for combining the edge of the valve section or the edge of the leaflet substructure. In one aspect of this embodiment, the interlocking curvilinear groove mechanism may be a sliding interlocking curvilinear groove mechanism.

As illustrated in FIGS. 14A-C, the first side 1151 and the second side 1152 of the valve module may be locked together by an interlocking curvilinear groove mechanism. The reason is that the first side 1151 has a geometrical shape that can be interlocked in alignment with the second side 1152. As illustrated in FIG. 14A, the first side 1151 and the second side 1152 of the valve module use a string 1145 or wire that is threaded through the first side 1151 and the second side 1152 Can be guided in the direction of each other. The string 1145 may be a pull wire, as described in FIGS. 4A-4C. The first side 1151 may have an edge with a bulbous cross-section 1153 which has a round shape, for example substantially circular, as shown in FIG. 14B. Although it may be, for example, as shown in FIG. 14C and FIG. 14C ′, it may be a rectangle (including a square), a triangle, or any other suitable geometric shape. The second side 1152 of the valve module has 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. You may have. Thus, for example, if the bulbous edge 1153 of the first side 1151 is substantially round or round as illustrated in FIG. 14B, the receiving path edge of the second side 1152 1154 has a complementary circular cross-section in which the bulbous edge 1153 of the first side 1151 engages or mates by means of an interlock fit and an interference fit. This locking mechanism is preferably as shown in FIG. 14A, with the bulbous edge 1153 and the receiving passage edge 1154 along the entire contact portion of the first side 1151 and the second side 1152 of the valve module, respectively. Because it includes a strip that extends out, it is referred to as an interlocking curvilinear groove mechanism. Thus, the bulbous edge 1153 may be substantially cylindrical, for example in embodiments where the cross section is substantially circular, and the receiving channel edge 1154 is a substantially cylindrical groove. It may be.

In another aspect of the interlocking curvilinear groove mechanism, as illustrated in FIG. 14C, the first side 1151 may have a first hook shaped edge 1157 and the second side 1151. May have a second hook-shaped edge 1058, the first hook edge 1157 and the second hook edge 1158 being in a static fit or tightened as illustrated in FIG. 14C '. It is possible to interlock and hold by fitting.

Valve leaflets in an unassembled configuration, for example as described in connection with FIGS. 5A-C, are single valve sub-structures, as well as co-pending U.S. patent application Ser. In one aspect of this interlocking curvilinear groove mechanism or ziplock, which is a leaflet substructure comprising a self-assembling member as described in paragraphs 52-53 of FIG. 2 and FIGS. 2a-2c. The first side 1151 and the second side 1152 shown above having interlocking edge geometry may be the first side and the second side of the leaflet substructure. In this aspect of the zip-lock embodiment, a push rod and / or pull wire or a guide string is used to provide complementary reception for the bulbous first edge and the second edge of the valve leaflet substructure. The process may be initiated to place the

The valve module may be, for example, a plurality of valve sections as described above in connection with FIGS. 2 to 4C, as well as paragraphs 48 to 51 of the co-pending U.S. patent application Ser. In another aspect of an interlocking curvilinear groove mechanism or zip lock embodiment including a valve section including a self-assembling member as described in 1a-1d, the above-described first embodiment having interlocking edge geometry The one side 1151 and the second side 1152 may be the first side of the first valve section and the second side of the adjacent second valve section. Thus, as an example of a valve module including three valve sections, a linear interference fit mechanism may operate as follows. The receiving passage of the second side of the second valve section by mounting the first side of the first valve section in the receiving passage of the second side of the second valve section in alignment relation It may have a bulbous edge to mate with. The edges of each valve section may be drawn together, such as by a wire 1145, such as a pull wire or string, which is threaded through the edge as illustrated in FIG. 14A, or by actuation of a self-organizing member. Push rods may be used in combination with pull wires or strings. A linear interference fit may begin at the proximal or distal end of the valve assembly. In a similar manner, the first side of the second valve section may have a bulbous edge that mates with the receiving passage of the second side of the third valve section, the third The first side of the valve section may have a bulbous edge that mates with the receiving passage of the second side of the second edge of the first valve section. In view 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.

In the embodiment illustrated in FIGS. 14A and 14B, the linear interference locking mechanism comprises mating edges of the first side and the second side of the valve module. However, in another zip-lock type embodiment applicable to either the leaflet substructure or the plurality of valve sections, the interlocking curvilinear groove mechanism comprises, for example, the inner surface of the first side 1151 and the first The facing surfaces of the first side 1151 and the second side 1152 may be located between the facing surfaces of the first side 1151 and the second side 1152, such as between the second side 1152 of the second side It is positioned near the edge of the side 1151 and the second side 1152. Interlocking geometries are illustrated in FIG. 6, FIG. 7, and third row, lines 31-37 of U.S. Pat. No. 5,540,366 and in U.S. Pat. No. 2,039,887. It can be attached by an interference fit in the same manner as that shown in FIG. 2, FIG. 3, and the first row, lines 31-36, etc. The application is incorporated herein by reference. In one aspect, the locking mechanism may be a sliding zip lock mechanism, and in this embodiment, the bulbous edge 1153 of the first side 1151 or the first hook edge 1157 and the second The receiving path edge 1154 or the second hook edge 1158 of the side portion 1152 or the interlocking facing surfaces are slidingly complementary along their edges, like a slider zip lock arrangement The geometric structures may be engaged or paired by a device that brings them into alignment.

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-organizing member having a preset ring configuration, is filed on January 12, 2010 Co-pending US patent application Ser. No. 12 / 686,338 (Self-Assembly), FIG. The application is incorporated herein by reference. In short, the valve module may be attached to a self-organizing member, such as a ring or band, capable of returning from the delivery configuration to the preset ring configuration, or such self-organizing member inside May be passed through. The support structure may have a groove or similar structure capable of receiving a ring or band when pushed outward into its pre-set configuration, thereby providing a support structure with an interference fit. Lock the valve module.

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 sufficiently flexible so as not to excessively inhibit the axial flexibility of the support structure, but sufficiently radiused to function as required in the particular embodiment used. It is rigid in direction. 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 "posts" may be replaced with grooves, such as, for example, a notch in the ring on the support structure. The harbor and post holes as described with respect to the embodiment of FIGS. 10-13 may be depressions or holes in the grooves.

The locking mechanism may be any fixture of the type that preferably further realizes a fixed fixture that is easily engaged from a remote position but not disengaged in use. Those skilled in the art will readily recognize that different locking mechanisms and their different uses may be substituted herein.

In any of these embodiments, it may be possible or desirable to adjustably couple the valve module to the support structure to allow accurate final positioning of the valve module. Thus, for example, the valve assembly may be adjustably coupled to the support structure to allow final adjustment of the position of the valve assembly relative to the support structure after implantation of the valve device. Co-pending U.S. Patent Application No .: "Method and Apparatus for Fine Adjustment of a Perforated Valve Structure", filed January 12, 2010, for a mechanism for adjusting the position of a valve module relative to a support structure. It is described in detail in paragraphs 21-24, 28-39 of the specification of 12 / 686,340, and FIGS. The application is incorporated herein by reference. Also, the support structure may be adjustably coupled to the vessel wall.

In embodiments where a temporary valve is used, the temporary valve may be located at the permanent valve implant site or at a location remote from the permanent valve implant site. In aortic valve replacement, as illustrated by way of example in FIG. 16, the temporary valve may be placed in the ascending aorta proximal (downstream) of the implantation position of the modular valve device. This configuration may be effective in procedures where the modular valve is delivered by the tip approach (ie, introducing the device from the ventricular side of the coronary vein valve). See, for example, Singh, IM et al., "Percutaneous treatment of aortic valve stenosis," CLEVE. CLIN. J. MED. 75 (11): 805-812 (2008). But,
In some situations, it may also be preferable to place a temporary valve proximal to the implant location, when a retrograde approach (i.e. introducing the device from the arterial side of the coronary vein valve) is utilized.

One embodiment of the temporary valve of the present invention is illustrated in FIG. In this embodiment, the temporary valve 1395 is a one-piece construction, having the same dimensions as the delivery system, which in this case is a catheter 1360, although the temporary valve may be comprised of more than one piece Good. One advantage of having the temporary valve flush with or attached to the delivery device is that it can be easily removed when removing the delivery system. The catheter 1360 to which the temporary valve 1395 is attached is also advanced to a position at which the modular valve device is to be implanted, which in this embodiment is the distal position of the coronary artery ports 1386, 1387 in the aorta 1381. Often, the temporary valve 1395 may be actuated to automatically expand like a flipped umbrella, for example using a shape memory wire or the like. In an alternative embodiment (not shown), the temporary valve may be designed to include two pieces and allow the device module to be passed through the temporary valve to the implantation site. In an alternative embodiment, the temporary valve may be connected by a pull wire that can be removed from the delivery device but used to pull the temporary valve from the aorta when it is no longer needed.

If the temporary valve is installed at the target site and the device module is to be assembled away from the implantation site, the delivery device is pulled back after installing the temporary valve for deployment of the permanent valve device module. It may be If the temporary valve is placed at the target site, the support structure may (1) deploy the temporary valve by means of an independent catheter using a reverse percutaneous approach from the delivery device carrying the temporary valve or (2) deployment of the temporary valve It may be implanted in front of the temporary valve by deploying the support structure from the delivery device before.

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

It is important that the prosthetic valve device be precisely located within the blood vessel (or body cavity) to ensure proper valve function and patient safety. Accordingly, the devices and systems of the present invention, and methods of delivering the devices, are filed on paragraphs 67-82 and 7a-8 of US Priority Application No. 61 / 144,007, and January 12, 2010. "A System
The modular device described in paragraphs 1a-2 and in FIGS. 24-42 of co-pending US patent application Ser. No. 12 / 686,337 (Arrangement) entitled It can be used in combination with a deployment system and deployment method. The application is incorporated herein by reference. Placing a prosthetic valve device in a body cavity with improved accuracy, as described in US Patent Application No. 61 / 144,007 and co-pending US Patent Application No. 12 / 686,337 (Arrangement) The method includes, for example, attaching an anchor in a body cavity at the implantation position of a permanent valve, and guiding the prosthetic valve device to the implantation position using the anchor. The deployment system includes a valve device, a delivery device, and an anchor. The anchors may include button or rivet type devices, hooks, percutaneously inserted lead sutures, interconnecting geometry, or any other type of docking device device. Additionally, the system may include a deployment wire coupled to the anchor. In the embodiment where an anchor is coupled to the deployment wire, the method comprises the steps of: passing the deployment wire through the valve device; and the free end of the deployment wire exiting the proximal end of the delivery device. The method may further include loading the valve device into a delivery device and directing the device along the deployment wire towards the anchor. In embodiments where the anchor includes a lead suture, the method may further include passing the lead suture through the valve device and loading the valve device into a delivery device. Methods of placing a valve device in a body cavity encompass the use of other types of anchors.

It will be understood by those skilled in the art that numerous variations, additions, modifications and other applications can be made to what has been particularly shown and described herein as an embodiment without departing from the spirit or scope of the present invention. I will understand. Accordingly, the scope of the present invention is intended to encompass all predictable variations, additions, modifications or applications as defined by the following claims.

Claims (32)

A modular percutaneous prosthetic valve device comprising a plurality of device modules, said device module comprising a valve module, said valve module comprising a flat non-assembled configuration and a folded non-assembled delivery configuration. Having the substantially flat unassembled valve module either crushed or rolled along an axis to form the folded unassembled delivery configuration. After the device module is deployed from the transdermal delivery device, it is assembled into a valve device in a deployed configuration, at least one of the device modules comprising a locking mechanism, locking the deployed configuration via the locking mechanism, Said valve device. The valve device according to claim 1, wherein the valve module includes a leaflet substructure having first and second locking members interlocking in the deployed configuration. The first locking member is formed on a first edge of the leaflet lower structure, and the second locking member is formed on a second edge of the leaflet lower structure. Description valve device. A first locking member is formed on the inner surface of the first end of the leaflet substructure and a second locking member is formed on the outer surface of the second end of the leaflet lower structure. The valve device according to claim 2, wherein the leaflet substructures partially overlap in the deployed configuration. Valve module comprises a plurality of valves sections, each valve section having a first and a second locking member, the first locking member of the first valve section, in the configuration deployed, the adjacent valve section The valve device according to claim 1, interlocking with the second locking member. 6. A method according to claim 5, wherein a first locking member is formed on the first edge of each of the valve sections and a second locking member is formed on the second edge of each of the valve sections. Valve device. 6. A method according to claim 5, wherein a first locking member is formed on the inner surface of the first end of each of the valve sections and a second locking member is formed on the outer surface of each of the valve sections. Valve device. The valve device according to claim 2 or 5, wherein the locking mechanism is one of a curvilinear groove mechanism or an interlocking curvilinear groove mechanism. 6. The valve device of claim 2 or 5, further comprising a pull wire. The valve device according to claim 2 or 5, further comprising a push rod. The valve device of claim 1, further comprising a self-organizing member. A system for assembling a prosthetic valve device into the body in need, said system comprising a transdermal delivery device and the valve device according to any of the preceding claims contained within said delivery device. The system according to claim 12, further comprising a temporary valve, wherein the temporary valve has any one of a single piece structure and a multi-piece structure. 14. The system of claim 13, wherein the temporary valve is as wide as the delivery device. The valve device of claim 1, wherein the locking mechanism is integral with at least one of the device modules. The valve device of claim 1, wherein the locking mechanism is not integral with at least one of the device modules. The valve device according to claim 1, wherein the locking mechanism is integral with the valve module. The valve device according to claim 1, wherein the locking mechanism is not integral with the valve module. Modular percutaneous prosthetic valve device comprising a plurality of device modules, wherein the device module comprises a valve module, the valve module being assembled and unassembled for attachment to a delivery device Not have a delivery configuration,
The unassembled valve module is one of (a) rolled along one axis or (b) crushed to form a flat configuration,
The valve module is assembled in an operative configuration, and the device module is assembled to the valve device after deployment from a transdermal delivery device.
Said valve device. 20. The valve device of claim 19 , wherein the valve module includes a deformable member having a straight delivery configuration, the deformable member adapted to assist in deforming the valve module into an assembled operating configuration. . 21. The valve device of claim 20 , wherein the deformable member is a linear element. 21. A valve device according to claim 20 , wherein the deformable member is a ring-like element, said ring-like element having a bent end holding the valve module in a flat configuration. 20. The valve device of claim 19 , further comprising one or more pull wires, a push rod, and a balloon catheter to aid in transforming the valve module into the assembled actuation configuration. The valve module has a tip-to-base aspect, a circumferential axis, and a height axis, and from tip to base and from base to tip to form a folded, unassembled delivery configuration 20. The valve device of claim 19 , wherein the valve device is wound in a method selected from the group consisting of Modular percutaneous prosthetic valve device comprising a plurality of device modules, wherein the device module comprises a valve module, the valve module being unassembled and unassembled for attachment to a delivery device Have a delivery configuration,
The valve module may be rolled along one axis or (b) crushed to form the unassembled delivery configuration from the unassembled configuration. Yes,
The valve module is assembled in an operative configuration, and the device module is assembled to the valve device after deployment from a transdermal delivery device.
Said valve device. 26. The valve according to claim 25 , wherein the valve module comprises a deformable member having a straight delivery configuration, the deformable member adapted to assist in transforming the valve module into an assembled operating configuration. device. 26. The valve device of claim 25 , wherein the deformable member is a linear element. 26. The valve device according to claim 25 , wherein the deformable member is a ring-like element, the ring-like element having a bent end holding the valve module in an unassembled delivery configuration. 26. The valve device of claim 25 , further comprising one or more pull wires, a push rod, and a balloon catheter to aid in transforming the valve module into the assembled actuation configuration. The valve module has a tip-to-base aspect, a circumferential axis, and a height axis, and from the tip-to-base and base-to-tip groups to form an unassembled delivery configuration. 26. The valve device of claim 25 , wherein the valve device is wound in a more selected manner. 26. The valve device of claim 25 , wherein the valve module comprises a leaflet structure. 26. The valve device of claim 25 , wherein the transdermal delivery device is a catheter.

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